Photo by Larry Young

LA JOLLA, CA—Results of a phase 1 trial suggest MRG-106 can provide clinical improvement in patients with mycosis fungoides (MF), whether the drug is given alone or in conjunction with other therapies.

MRG-106 is an inhibitor of microRNA-155, which is upregulated in MF.

In this ongoing trial, 90% of patients who received MRG-106 have experienced an improvement in mSWAT score, and 59% of patients who received the drug for at least 1 month had a partial response.

The most common adverse events (AEs) attributed to MRG-106 were neutropenia, injection site pain, and fatigue.

Christiane Querfeld, MD, PhD, of the City of Hope in Duarte, California, presented these results at the 10th Annual T-cell Lymphoma Forum. The research is sponsored by miRagen Therapeutics, Inc., the company developing MRG-106.

The trial has enrolled 36 MF patients, 69% of whom are male. Their median age at enrollment was 63 (range, 21-85).

Patients had received a median of 4 prior systemic therapies (range, 1-13) and a median of 3 prior skin-directed therapies (range, 1-8).

At baseline, patients had a median mSWAT score of 43 (range, 2-180). The modified Severity Weighted Assessment Tool (mSWAT) measures the severity of skin disease over a patient’s body.

Part A

In part A of the study, 6 patients received MRG-106 via intralesional injection. A 75 mg dose of the drug was found to be well-tolerated, producing generally minor injection site reactions.

In addition, intralesional injection of MRG-106 produced improvements in CAILS score. The Composite Assessment of Index Lesion Severity (CAILS) score is obtained by adding the severity score of erythema, scaling, plaque elevation, and surface area for up to 5 index lesions.

Part B

In part B, 30 patients received MRG-106 via subcutaneous (SQ) injection, intravenous (IV) infusion, or IV bolus injection.

Patients who received SQ injection or IV infusion received doses of 300 mg, 600 mg, or 900 mg. Those who received an IV bolus only received the 300 mg dose.

Twenty-nine of the 30 patients in part B were evaluable for efficacy. Twenty-six of these patients—90%—had an improvement in mSWAT score from baseline.

“Twenty-six patients had at least stable disease to partial response,” Dr Querfeld noted. “No complete responses yet, but we’re close.”

Twelve patients were still receiving MRG-106 at last follow-up.

Ten of the 17 patients (59%) who had received MRG-106 for more than 1 month had at least a 50% improvement in mSWAT score, or a partial response. Once this was achieved, responses were durable.

One patient was still in response at roughly 470 days of follow-up.

Concomitant therapies

Dr Querfeld and her colleagues looked at patient outcomes in the context of concomitant therapies as well. They analyzed data from 26 patients who had received at least 6 doses of MRG-106.

Half of these patients were receiving MRG-106 alone, and the other half were receiving concomitant therapies, including bexarotene (n=7), interferon-alfa (n=2), methotrexate (n=1), vorinostat (n=1), and “other” treatments (n=2). Patients had been receiving these therapies for anywhere from 4 months to 45 months.

Outcomes were similar in the monotherapy and combination treatment groups. Seven patients in each group had at least a 50% improvement in mSWAT score.

Dosing and administration

“It appears the infusion is superior to the subcutaneous administration,” Dr Querfeld said.

She noted that durable partial responses have been achieved at all dose levels, but the 300 mg and 600 mg IV infusions had the best efficacy and tolerability profiles.

With the 300 mg IV bolus, fewer patients remained on treatment for more than 1 cycle, as compared to the other dosing cohorts. Dr Querfeld said this may be a result of lower total exposure or tolerability due to higher plasma C_max.

She also noted that patients who received MRG-106 SQ at 600 mg or higher had a higher incidence of injection site reactions.

Safety

AEs of any grade that were attributed to MRG-106 include neutropenia (16%), injection site pain (16%), fatigue (14%), nausea (5%), pruritus (5%), and headache (5%).

Grade 3/4 AEs attributed to MRG-106 were neutropenia (5%) and pruritus (5%).

There were no serious AEs attributed to MRG-106, but there were 2 dose-limiting toxicities. One was a grade 3 tumor flare in a patient receiving the 300 mg IV bolus.

The other dose-limiting toxicity was grade 3 worsening pruritus and possible tumor flare, which occurred twice in 1 patient—with the 900 mg SQ dose and with the 300 mg IV infusion.

The 300 mg IV infusion is the anticipated phase 2 dose.

Photo by Larry Young

LA JOLLA, CA—Results of a phase 1 trial suggest MRG-106 can provide clinical improvement in patients with mycosis fungoides (MF), whether the drug is given alone or in conjunction with other therapies.

MRG-106 is an inhibitor of microRNA-155, which is upregulated in MF.

In this ongoing trial, 90% of patients who received MRG-106 have experienced an improvement in mSWAT score, and 59% of patients who received the drug for at least 1 month had a partial response.

The most common adverse events (AEs) attributed to MRG-106 were neutropenia, injection site pain, and fatigue.

Christiane Querfeld, MD, PhD, of the City of Hope in Duarte, California, presented these results at the 10th Annual T-cell Lymphoma Forum. The research is sponsored by miRagen Therapeutics, Inc., the company developing MRG-106.

The trial has enrolled 36 MF patients, 69% of whom are male. Their median age at enrollment was 63 (range, 21-85).

Patients had received a median of 4 prior systemic therapies (range, 1-13) and a median of 3 prior skin-directed therapies (range, 1-8).

At baseline, patients had a median mSWAT score of 43 (range, 2-180). The modified Severity Weighted Assessment Tool (mSWAT) measures the severity of skin disease over a patient’s body.

Part A

In part A of the study, 6 patients received MRG-106 via intralesional injection. A 75 mg dose of the drug was found to be well-tolerated, producing generally minor injection site reactions.

In addition, intralesional injection of MRG-106 produced improvements in CAILS score. The Composite Assessment of Index Lesion Severity (CAILS) score is obtained by adding the severity score of erythema, scaling, plaque elevation, and surface area for up to 5 index lesions.

Part B

In part B, 30 patients received MRG-106 via subcutaneous (SQ) injection, intravenous (IV) infusion, or IV bolus injection.

Patients who received SQ injection or IV infusion received doses of 300 mg, 600 mg, or 900 mg. Those who received an IV bolus only received the 300 mg dose.

Twenty-nine of the 30 patients in part B were evaluable for efficacy. Twenty-six of these patients—90%—had an improvement in mSWAT score from baseline.

“Twenty-six patients had at least stable disease to partial response,” Dr Querfeld noted. “No complete responses yet, but we’re close.”

Twelve patients were still receiving MRG-106 at last follow-up.

Ten of the 17 patients (59%) who had received MRG-106 for more than 1 month had at least a 50% improvement in mSWAT score, or a partial response. Once this was achieved, responses were durable.

One patient was still in response at roughly 470 days of follow-up.

Concomitant therapies

Dr Querfeld and her colleagues looked at patient outcomes in the context of concomitant therapies as well. They analyzed data from 26 patients who had received at least 6 doses of MRG-106.

Half of these patients were receiving MRG-106 alone, and the other half were receiving concomitant therapies, including bexarotene (n=7), interferon-alfa (n=2), methotrexate (n=1), vorinostat (n=1), and “other” treatments (n=2). Patients had been receiving these therapies for anywhere from 4 months to 45 months.

Outcomes were similar in the monotherapy and combination treatment groups. Seven patients in each group had at least a 50% improvement in mSWAT score.

Dosing and administration

“It appears the infusion is superior to the subcutaneous administration,” Dr Querfeld said.

She noted that durable partial responses have been achieved at all dose levels, but the 300 mg and 600 mg IV infusions had the best efficacy and tolerability profiles.

With the 300 mg IV bolus, fewer patients remained on treatment for more than 1 cycle, as compared to the other dosing cohorts. Dr Querfeld said this may be a result of lower total exposure or tolerability due to higher plasma C_max.

She also noted that patients who received MRG-106 SQ at 600 mg or higher had a higher incidence of injection site reactions.

Safety

AEs of any grade that were attributed to MRG-106 include neutropenia (16%), injection site pain (16%), fatigue (14%), nausea (5%), pruritus (5%), and headache (5%).

Grade 3/4 AEs attributed to MRG-106 were neutropenia (5%) and pruritus (5%).

There were no serious AEs attributed to MRG-106, but there were 2 dose-limiting toxicities. One was a grade 3 tumor flare in a patient receiving the 300 mg IV bolus.

The other dose-limiting toxicity was grade 3 worsening pruritus and possible tumor flare, which occurred twice in 1 patient—with the 900 mg SQ dose and with the 300 mg IV infusion.

The 300 mg IV infusion is the anticipated phase 2 dose.

Photo by Larry Young

LA JOLLA, CA—Results of a phase 1 trial suggest MRG-106 can provide clinical improvement in patients with mycosis fungoides (MF), whether the drug is given alone or in conjunction with other therapies.

MRG-106 is an inhibitor of microRNA-155, which is upregulated in MF.

In this ongoing trial, 90% of patients who received MRG-106 have experienced an improvement in mSWAT score, and 59% of patients who received the drug for at least 1 month had a partial response.

The most common adverse events (AEs) attributed to MRG-106 were neutropenia, injection site pain, and fatigue.

Christiane Querfeld, MD, PhD, of the City of Hope in Duarte, California, presented these results at the 10th Annual T-cell Lymphoma Forum. The research is sponsored by miRagen Therapeutics, Inc., the company developing MRG-106.

The trial has enrolled 36 MF patients, 69% of whom are male. Their median age at enrollment was 63 (range, 21-85).

Patients had received a median of 4 prior systemic therapies (range, 1-13) and a median of 3 prior skin-directed therapies (range, 1-8).

At baseline, patients had a median mSWAT score of 43 (range, 2-180). The modified Severity Weighted Assessment Tool (mSWAT) measures the severity of skin disease over a patient’s body.

Part A

In part A of the study, 6 patients received MRG-106 via intralesional injection. A 75 mg dose of the drug was found to be well-tolerated, producing generally minor injection site reactions.

In addition, intralesional injection of MRG-106 produced improvements in CAILS score. The Composite Assessment of Index Lesion Severity (CAILS) score is obtained by adding the severity score of erythema, scaling, plaque elevation, and surface area for up to 5 index lesions.

Part B

In part B, 30 patients received MRG-106 via subcutaneous (SQ) injection, intravenous (IV) infusion, or IV bolus injection.

Patients who received SQ injection or IV infusion received doses of 300 mg, 600 mg, or 900 mg. Those who received an IV bolus only received the 300 mg dose.

Twenty-nine of the 30 patients in part B were evaluable for efficacy. Twenty-six of these patients—90%—had an improvement in mSWAT score from baseline.

“Twenty-six patients had at least stable disease to partial response,” Dr Querfeld noted. “No complete responses yet, but we’re close.”

Twelve patients were still receiving MRG-106 at last follow-up.

Ten of the 17 patients (59%) who had received MRG-106 for more than 1 month had at least a 50% improvement in mSWAT score, or a partial response. Once this was achieved, responses were durable.

One patient was still in response at roughly 470 days of follow-up.

Concomitant therapies

Dr Querfeld and her colleagues looked at patient outcomes in the context of concomitant therapies as well. They analyzed data from 26 patients who had received at least 6 doses of MRG-106.

Half of these patients were receiving MRG-106 alone, and the other half were receiving concomitant therapies, including bexarotene (n=7), interferon-alfa (n=2), methotrexate (n=1), vorinostat (n=1), and “other” treatments (n=2). Patients had been receiving these therapies for anywhere from 4 months to 45 months.

Outcomes were similar in the monotherapy and combination treatment groups. Seven patients in each group had at least a 50% improvement in mSWAT score.

Dosing and administration

“It appears the infusion is superior to the subcutaneous administration,” Dr Querfeld said.

She noted that durable partial responses have been achieved at all dose levels, but the 300 mg and 600 mg IV infusions had the best efficacy and tolerability profiles.

With the 300 mg IV bolus, fewer patients remained on treatment for more than 1 cycle, as compared to the other dosing cohorts. Dr Querfeld said this may be a result of lower total exposure or tolerability due to higher plasma C_max.

She also noted that patients who received MRG-106 SQ at 600 mg or higher had a higher incidence of injection site reactions.

Safety

AEs of any grade that were attributed to MRG-106 include neutropenia (16%), injection site pain (16%), fatigue (14%), nausea (5%), pruritus (5%), and headache (5%).

Grade 3/4 AEs attributed to MRG-106 were neutropenia (5%) and pruritus (5%).

There were no serious AEs attributed to MRG-106, but there were 2 dose-limiting toxicities. One was a grade 3 tumor flare in a patient receiving the 300 mg IV bolus.

The other dose-limiting toxicity was grade 3 worsening pruritus and possible tumor flare, which occurred twice in 1 patient—with the 900 mg SQ dose and with the 300 mg IV infusion.

The 300 mg IV infusion is the anticipated phase 2 dose.

osteoclast in cell culture

In a phase 3 trial, denosumab proved non-inferior to zoledronic acid for delaying skeletal-related events (SREs) in patients with multiple myeloma (MM).

The median time to first on-study SRE was 23 months in the denosumab arm and 24 months in the zoledronic acid arm.

There were fewer renal adverse events (AEs) but more hypocalcemia AEs in the denosumab arm.

“Until recently, treatment options for the prevention of skeletal-related events in multiple myeloma were limited to bisphosphonates, which are cleared through the kidneys and can be associated with increased renal impairment,” said Noopur Raje, MD, of Massachusetts General Hospital Cancer Center in Boston.

“Denosumab, which is not cleared through the kidneys, provides a new treatment option for the prevention of skeletal-related events in patients with multiple myeloma.”

Dr Raje and her colleagues conducted this phase 3 trial of denosumab and reported the results in The Lancet Oncology. The trial was sponsored by Amgen, the company developing denosumab.

Denosumab is the first fully human monoclonal antibody that binds to and neutralizes RANK ligand—a protein essential for the formation, function, and survival of osteoclasts—thereby inhibiting osteoclast-mediated bone destruction.

In this trial, researchers compared denosumab to zoledronic acid for the prevention of SREs in adults with newly diagnosed MM and bone disease.

The team randomized 1718 patients to receive subcutaneous denosumab at 120 mg and intravenous placebo every 4 weeks (n=859) or intravenous zoledronic acid at 4 mg (adjusted for renal function at baseline) and subcutaneous placebo every 4 weeks (n=859). All patients also received investigators’ choice of first-line MM therapy.

Skeletal surveys using conventional radiography were obtained every 12 to 24 weeks per protocol. The primary endpoint of the study was non-inferiority of denosumab to zoledronic acid for time to first on-study SRE (pathologic fracture, radiation to bone, surgery to bone, or spinal cord compression).

The primary endpoint was met. The median time to first on-study SRE was 22.8 months for patients in the denosumab arm and 24 months for those in the zoledronic acid arm (hazard ratio [HR]=0.98; 95% confidence interval [CI]: 0.85-1.14; P non-inferiority=0.010).

Approximately 60% of all first SREs occurred within the first 3 months, and 81% occurred within the first 6 months.

Overall survival, a secondary endpoint, was similar between the denosumab and zoledronic acid arms (HR=0.90; 95% CI: 0.70-1.16; P=0.41).

There were fewer renal treatment-emergent AEs in the denosumab arm than the zoledronic acid arm—10% and 17%, respectively. There were more hypocalcemia AEs in the denosumab arm than the zoledronic acid arm—17% and 12%, respectively.

The incidence of osteonecrosis of the jaw was 4% in the denosumab arm and 3% in the zoledronic acid arm.

The most common grade 3 or higher treatment-emergent AEs (in the denosumab and zoledronic acid arms, respectively) were neutropenia (15% in both arms), thrombocytopenia (14% and 12%), anemia (12% and 10%), febrile neutropenia (11% and 10%), and pneumonia (8% in both arms).

The most common serious AE was pneumonia (8% in both arms).

Treatment-emergent AEs led to study drug discontinuation in 13% of patients in the denosumab arm and 12% in the zoledronic acid arm.

One patient in the zoledronic acid arm died of cardiac arrest that was deemed treatment-related. No other deaths were considered treatment-related.

osteoclast in cell culture

In a phase 3 trial, denosumab proved non-inferior to zoledronic acid for delaying skeletal-related events (SREs) in patients with multiple myeloma (MM).

The median time to first on-study SRE was 23 months in the denosumab arm and 24 months in the zoledronic acid arm.

There were fewer renal adverse events (AEs) but more hypocalcemia AEs in the denosumab arm.

“Until recently, treatment options for the prevention of skeletal-related events in multiple myeloma were limited to bisphosphonates, which are cleared through the kidneys and can be associated with increased renal impairment,” said Noopur Raje, MD, of Massachusetts General Hospital Cancer Center in Boston.

“Denosumab, which is not cleared through the kidneys, provides a new treatment option for the prevention of skeletal-related events in patients with multiple myeloma.”

Dr Raje and her colleagues conducted this phase 3 trial of denosumab and reported the results in The Lancet Oncology. The trial was sponsored by Amgen, the company developing denosumab.

Denosumab is the first fully human monoclonal antibody that binds to and neutralizes RANK ligand—a protein essential for the formation, function, and survival of osteoclasts—thereby inhibiting osteoclast-mediated bone destruction.

In this trial, researchers compared denosumab to zoledronic acid for the prevention of SREs in adults with newly diagnosed MM and bone disease.

The team randomized 1718 patients to receive subcutaneous denosumab at 120 mg and intravenous placebo every 4 weeks (n=859) or intravenous zoledronic acid at 4 mg (adjusted for renal function at baseline) and subcutaneous placebo every 4 weeks (n=859). All patients also received investigators’ choice of first-line MM therapy.

Skeletal surveys using conventional radiography were obtained every 12 to 24 weeks per protocol. The primary endpoint of the study was non-inferiority of denosumab to zoledronic acid for time to first on-study SRE (pathologic fracture, radiation to bone, surgery to bone, or spinal cord compression).

The primary endpoint was met. The median time to first on-study SRE was 22.8 months for patients in the denosumab arm and 24 months for those in the zoledronic acid arm (hazard ratio [HR]=0.98; 95% confidence interval [CI]: 0.85-1.14; P non-inferiority=0.010).

Approximately 60% of all first SREs occurred within the first 3 months, and 81% occurred within the first 6 months.

Overall survival, a secondary endpoint, was similar between the denosumab and zoledronic acid arms (HR=0.90; 95% CI: 0.70-1.16; P=0.41).

There were fewer renal treatment-emergent AEs in the denosumab arm than the zoledronic acid arm—10% and 17%, respectively. There were more hypocalcemia AEs in the denosumab arm than the zoledronic acid arm—17% and 12%, respectively.

The incidence of osteonecrosis of the jaw was 4% in the denosumab arm and 3% in the zoledronic acid arm.

The most common grade 3 or higher treatment-emergent AEs (in the denosumab and zoledronic acid arms, respectively) were neutropenia (15% in both arms), thrombocytopenia (14% and 12%), anemia (12% and 10%), febrile neutropenia (11% and 10%), and pneumonia (8% in both arms).

The most common serious AE was pneumonia (8% in both arms).

Treatment-emergent AEs led to study drug discontinuation in 13% of patients in the denosumab arm and 12% in the zoledronic acid arm.

One patient in the zoledronic acid arm died of cardiac arrest that was deemed treatment-related. No other deaths were considered treatment-related.

osteoclast in cell culture

In a phase 3 trial, denosumab proved non-inferior to zoledronic acid for delaying skeletal-related events (SREs) in patients with multiple myeloma (MM).

The median time to first on-study SRE was 23 months in the denosumab arm and 24 months in the zoledronic acid arm.

There were fewer renal adverse events (AEs) but more hypocalcemia AEs in the denosumab arm.

“Until recently, treatment options for the prevention of skeletal-related events in multiple myeloma were limited to bisphosphonates, which are cleared through the kidneys and can be associated with increased renal impairment,” said Noopur Raje, MD, of Massachusetts General Hospital Cancer Center in Boston.

“Denosumab, which is not cleared through the kidneys, provides a new treatment option for the prevention of skeletal-related events in patients with multiple myeloma.”

Dr Raje and her colleagues conducted this phase 3 trial of denosumab and reported the results in The Lancet Oncology. The trial was sponsored by Amgen, the company developing denosumab.

Denosumab is the first fully human monoclonal antibody that binds to and neutralizes RANK ligand—a protein essential for the formation, function, and survival of osteoclasts—thereby inhibiting osteoclast-mediated bone destruction.

In this trial, researchers compared denosumab to zoledronic acid for the prevention of SREs in adults with newly diagnosed MM and bone disease.

The team randomized 1718 patients to receive subcutaneous denosumab at 120 mg and intravenous placebo every 4 weeks (n=859) or intravenous zoledronic acid at 4 mg (adjusted for renal function at baseline) and subcutaneous placebo every 4 weeks (n=859). All patients also received investigators’ choice of first-line MM therapy.

Skeletal surveys using conventional radiography were obtained every 12 to 24 weeks per protocol. The primary endpoint of the study was non-inferiority of denosumab to zoledronic acid for time to first on-study SRE (pathologic fracture, radiation to bone, surgery to bone, or spinal cord compression).

The primary endpoint was met. The median time to first on-study SRE was 22.8 months for patients in the denosumab arm and 24 months for those in the zoledronic acid arm (hazard ratio [HR]=0.98; 95% confidence interval [CI]: 0.85-1.14; P non-inferiority=0.010).

Approximately 60% of all first SREs occurred within the first 3 months, and 81% occurred within the first 6 months.

Overall survival, a secondary endpoint, was similar between the denosumab and zoledronic acid arms (HR=0.90; 95% CI: 0.70-1.16; P=0.41).

There were fewer renal treatment-emergent AEs in the denosumab arm than the zoledronic acid arm—10% and 17%, respectively. There were more hypocalcemia AEs in the denosumab arm than the zoledronic acid arm—17% and 12%, respectively.

The incidence of osteonecrosis of the jaw was 4% in the denosumab arm and 3% in the zoledronic acid arm.

The most common grade 3 or higher treatment-emergent AEs (in the denosumab and zoledronic acid arms, respectively) were neutropenia (15% in both arms), thrombocytopenia (14% and 12%), anemia (12% and 10%), febrile neutropenia (11% and 10%), and pneumonia (8% in both arms).

The most common serious AE was pneumonia (8% in both arms).

Treatment-emergent AEs led to study drug discontinuation in 13% of patients in the denosumab arm and 12% in the zoledronic acid arm.

One patient in the zoledronic acid arm died of cardiac arrest that was deemed treatment-related. No other deaths were considered treatment-related.

A 54-year-old man presents to the emergency department (ED) with acute-onset left flank pain that radiates to the groin. CT of the abdomen/pelvis without contrast reveals a 7-mm distal ureteral stone. He is deemed an appropriate candidate for outpatient management. In addition to pain medications, should you prescribe tamsulosin?

According to the most recent National Health and Nutrition Examination Survey, the population prevalence of kidney stones is 8.8%, with a self-reported prevalence of 10.6% in men and 7.1% in women.² Most ureteral stones can be treated in the outpatient setting with oral hydration, antiemetics, and pain control with NSAIDs as firstline treatment and opioids as a second-line option.³

In addition, α-blockers are used for medical expulsive therapy (MET). In fact, the European Association of Urology guideline on urolithiasis states that MET may accelerate passage of ureteral stones.³

Recently, however, uncertainty has surrounded the effectiveness of the α-blocker tamsulosin. Two systematic reviews (limited by heterogeneity because some of the studies lacked a placebo control and blinding) concluded that α-blockers increased stone passage within one to six weeks when compared with placebo or no additional therapy.^4,5 However, a recent large, multicenter RCT revealed no difference between tamsulosin and nifedipine, or either one compared with placebo, at decreasing the need for further treatment to achieve stone passage within four weeks.⁶

STUDY SUMMARY

Results broken down by stone size

This meta-analysis, comprising eight double-blind RCTs, examined the effect of oral tamsulosin (0.4 mg/d; average course, 28 d) on distal ureteral stone passage in adult patients (N = 1,384).¹ A subgroup analysis comparing stone size (< 5 mm and 5-10 mm) was also conducted to determine whether size modified the effect of tamsulosin.

The eight selected studies were published between 2009 and 2015; the trials were conducted in multiple countries, in ED and outpatient urology settings. The main outcome measure was the risk difference (RD) in stone passage between the tamsulosin group and placebo group after follow-up imaging at three weeks with CT or plain film radiographs.

Tamsulosin helps some, but not all. The pooled risk for stone passage was higher in the tamsulosin group than in the placebo group (85% vs 66%; RD, 17%), but significant heterogeneity existed across the trials (I², 80.2%). Subgroup analysis by stone size (< 5 mm vs 5-10 mm) revealed that, compared to placebo, tamsulosin was beneficial for larger stones (6 trials, N = 514; RD, 22%; number needed to treat, 5) but not for smaller stones (4 trials, N = 533; RD, –0.3%). The 5-to-10–mm subgroup had a less heterogeneous population of studies than did the < 5-mm subgroup (I², 33% and 0% respectively).

In terms of adverse events, tamsulosin did not increase the risk for dizziness (RD, 0.2%) or postural hypotension (RD, 0.1%), compared with placebo.

WHAT’S NEW

Increased passage of larger stones

This meta-analysis included only double-blind RCTs; prior meta-analyses did not. Also, this review included the SUSPEND (Spontaneous Urinary Stone Passage Enabled by Drugs) trial, an RCT discussed in a previous PURL (Clinician Reviews. 2016;26[4]:20,44), which recommended against the use of α-blockers tamsulosin and nifedipine for ureteral stones measuring < 10 mm.^6,7

But the subgroup analysis in this review went one step further by examining passage rates by stone size (< 5 mm vs 5-10 mm) and revealing that passage of larger stones increased with tamsulosin use. The different results based on stone size may explain the recent uncertainty as to whether tamsulosin improves the rate of stone passage.

 

 

CAVEATS

What about proximal or XL stones?

Only distal stones were included in seven of the eight trials in this analysis. Thus, this meta-analysis was unable to determine the effect on more proximal stones. Also, it’s unclear if the drug provides any benefit with stones > 10 mm in size.

CHALLENGES TO IMPLEMENTATION

None worth mentioning

We see no challenges to implementation of this recommendation.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018; 67[1]:37-38).

A 54-year-old man presents to the emergency department (ED) with acute-onset left flank pain that radiates to the groin. CT of the abdomen/pelvis without contrast reveals a 7-mm distal ureteral stone. He is deemed an appropriate candidate for outpatient management. In addition to pain medications, should you prescribe tamsulosin?

According to the most recent National Health and Nutrition Examination Survey, the population prevalence of kidney stones is 8.8%, with a self-reported prevalence of 10.6% in men and 7.1% in women.² Most ureteral stones can be treated in the outpatient setting with oral hydration, antiemetics, and pain control with NSAIDs as firstline treatment and opioids as a second-line option.³

In addition, α-blockers are used for medical expulsive therapy (MET). In fact, the European Association of Urology guideline on urolithiasis states that MET may accelerate passage of ureteral stones.³

Recently, however, uncertainty has surrounded the effectiveness of the α-blocker tamsulosin. Two systematic reviews (limited by heterogeneity because some of the studies lacked a placebo control and blinding) concluded that α-blockers increased stone passage within one to six weeks when compared with placebo or no additional therapy.^4,5 However, a recent large, multicenter RCT revealed no difference between tamsulosin and nifedipine, or either one compared with placebo, at decreasing the need for further treatment to achieve stone passage within four weeks.⁶

STUDY SUMMARY

Results broken down by stone size

This meta-analysis, comprising eight double-blind RCTs, examined the effect of oral tamsulosin (0.4 mg/d; average course, 28 d) on distal ureteral stone passage in adult patients (N = 1,384).¹ A subgroup analysis comparing stone size (< 5 mm and 5-10 mm) was also conducted to determine whether size modified the effect of tamsulosin.

The eight selected studies were published between 2009 and 2015; the trials were conducted in multiple countries, in ED and outpatient urology settings. The main outcome measure was the risk difference (RD) in stone passage between the tamsulosin group and placebo group after follow-up imaging at three weeks with CT or plain film radiographs.

Tamsulosin helps some, but not all. The pooled risk for stone passage was higher in the tamsulosin group than in the placebo group (85% vs 66%; RD, 17%), but significant heterogeneity existed across the trials (I², 80.2%). Subgroup analysis by stone size (< 5 mm vs 5-10 mm) revealed that, compared to placebo, tamsulosin was beneficial for larger stones (6 trials, N = 514; RD, 22%; number needed to treat, 5) but not for smaller stones (4 trials, N = 533; RD, –0.3%). The 5-to-10–mm subgroup had a less heterogeneous population of studies than did the < 5-mm subgroup (I², 33% and 0% respectively).

In terms of adverse events, tamsulosin did not increase the risk for dizziness (RD, 0.2%) or postural hypotension (RD, 0.1%), compared with placebo.

WHAT’S NEW

Increased passage of larger stones

This meta-analysis included only double-blind RCTs; prior meta-analyses did not. Also, this review included the SUSPEND (Spontaneous Urinary Stone Passage Enabled by Drugs) trial, an RCT discussed in a previous PURL (Clinician Reviews. 2016;26[4]:20,44), which recommended against the use of α-blockers tamsulosin and nifedipine for ureteral stones measuring < 10 mm.^6,7

But the subgroup analysis in this review went one step further by examining passage rates by stone size (< 5 mm vs 5-10 mm) and revealing that passage of larger stones increased with tamsulosin use. The different results based on stone size may explain the recent uncertainty as to whether tamsulosin improves the rate of stone passage.

 

 

CAVEATS

What about proximal or XL stones?

Only distal stones were included in seven of the eight trials in this analysis. Thus, this meta-analysis was unable to determine the effect on more proximal stones. Also, it’s unclear if the drug provides any benefit with stones > 10 mm in size.

CHALLENGES TO IMPLEMENTATION

None worth mentioning

We see no challenges to implementation of this recommendation.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018; 67[1]:37-38).

A 54-year-old man presents to the emergency department (ED) with acute-onset left flank pain that radiates to the groin. CT of the abdomen/pelvis without contrast reveals a 7-mm distal ureteral stone. He is deemed an appropriate candidate for outpatient management. In addition to pain medications, should you prescribe tamsulosin?

According to the most recent National Health and Nutrition Examination Survey, the population prevalence of kidney stones is 8.8%, with a self-reported prevalence of 10.6% in men and 7.1% in women.² Most ureteral stones can be treated in the outpatient setting with oral hydration, antiemetics, and pain control with NSAIDs as firstline treatment and opioids as a second-line option.³

In addition, α-blockers are used for medical expulsive therapy (MET). In fact, the European Association of Urology guideline on urolithiasis states that MET may accelerate passage of ureteral stones.³

Recently, however, uncertainty has surrounded the effectiveness of the α-blocker tamsulosin. Two systematic reviews (limited by heterogeneity because some of the studies lacked a placebo control and blinding) concluded that α-blockers increased stone passage within one to six weeks when compared with placebo or no additional therapy.^4,5 However, a recent large, multicenter RCT revealed no difference between tamsulosin and nifedipine, or either one compared with placebo, at decreasing the need for further treatment to achieve stone passage within four weeks.⁶

STUDY SUMMARY

Results broken down by stone size

This meta-analysis, comprising eight double-blind RCTs, examined the effect of oral tamsulosin (0.4 mg/d; average course, 28 d) on distal ureteral stone passage in adult patients (N = 1,384).¹ A subgroup analysis comparing stone size (< 5 mm and 5-10 mm) was also conducted to determine whether size modified the effect of tamsulosin.

The eight selected studies were published between 2009 and 2015; the trials were conducted in multiple countries, in ED and outpatient urology settings. The main outcome measure was the risk difference (RD) in stone passage between the tamsulosin group and placebo group after follow-up imaging at three weeks with CT or plain film radiographs.

Tamsulosin helps some, but not all. The pooled risk for stone passage was higher in the tamsulosin group than in the placebo group (85% vs 66%; RD, 17%), but significant heterogeneity existed across the trials (I², 80.2%). Subgroup analysis by stone size (< 5 mm vs 5-10 mm) revealed that, compared to placebo, tamsulosin was beneficial for larger stones (6 trials, N = 514; RD, 22%; number needed to treat, 5) but not for smaller stones (4 trials, N = 533; RD, –0.3%). The 5-to-10–mm subgroup had a less heterogeneous population of studies than did the < 5-mm subgroup (I², 33% and 0% respectively).

In terms of adverse events, tamsulosin did not increase the risk for dizziness (RD, 0.2%) or postural hypotension (RD, 0.1%), compared with placebo.

WHAT’S NEW

Increased passage of larger stones

This meta-analysis included only double-blind RCTs; prior meta-analyses did not. Also, this review included the SUSPEND (Spontaneous Urinary Stone Passage Enabled by Drugs) trial, an RCT discussed in a previous PURL (Clinician Reviews. 2016;26[4]:20,44), which recommended against the use of α-blockers tamsulosin and nifedipine for ureteral stones measuring < 10 mm.^6,7

But the subgroup analysis in this review went one step further by examining passage rates by stone size (< 5 mm vs 5-10 mm) and revealing that passage of larger stones increased with tamsulosin use. The different results based on stone size may explain the recent uncertainty as to whether tamsulosin improves the rate of stone passage.

 

 

CAVEATS

What about proximal or XL stones?

Only distal stones were included in seven of the eight trials in this analysis. Thus, this meta-analysis was unable to determine the effect on more proximal stones. Also, it’s unclear if the drug provides any benefit with stones > 10 mm in size.

CHALLENGES TO IMPLEMENTATION

None worth mentioning

We see no challenges to implementation of this recommendation.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018; 67[1]:37-38).

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

This video was filmed at Metabolic & Endocrine Disease Summit (MEDS). Click here to learn more.

SAN DIEGO – Compared with controls, patients who developed MS were more frequently admitted to the hospital or visited a physician for problems related to the nervous system, sensory organs, musculoskeletal system, and genitourinary system in the 5 years prior to MS onset, a multicenter matched cohort study found.

“People are seeking help for different conditions that are most likely related to their MS,” one of the study authors, Elaine Kingwell, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “It suggests there could be opportunity to recognize and possibly diagnose and treat MS earlier.”

Doug Brunk/Frontline Medical News

The researchers used rate ratios and 95% confidence intervals to compare the rates of physician and hospital encounters between MS cases and controls and the proportion test to compare the percentage of people with one or more filled prescriptions between MS cases and controls. They used random-effects meta-analyses to pool results across Canadian provinces.

The population consisted of 13,951 MS patients and 66,940 controls derived from a health administration cohort and 3,202 MS patients and 16,006 controls derived from MS clinics. Compared with controls, in the 5 years before the first demyelinating claim or symptom onset, cases had more physician and hospital encounters for the nervous system (rate ratio = 1.70-4.75), sensory organs (RR = 1.40-2.28), musculoskeletal system (RR = 1.19-1.70), and genitourinary system (RR = 1.17-1.59), Dr. Kingwell and her associates reported.

SOURCE: Kingwell E et al. ACTRIMS Forum 2018, late-breaking poster 254.

SAN DIEGO – Compared with controls, patients who developed MS were more frequently admitted to the hospital or visited a physician for problems related to the nervous system, sensory organs, musculoskeletal system, and genitourinary system in the 5 years prior to MS onset, a multicenter matched cohort study found.

“People are seeking help for different conditions that are most likely related to their MS,” one of the study authors, Elaine Kingwell, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “It suggests there could be opportunity to recognize and possibly diagnose and treat MS earlier.”

Doug Brunk/Frontline Medical News

The researchers used rate ratios and 95% confidence intervals to compare the rates of physician and hospital encounters between MS cases and controls and the proportion test to compare the percentage of people with one or more filled prescriptions between MS cases and controls. They used random-effects meta-analyses to pool results across Canadian provinces.

The population consisted of 13,951 MS patients and 66,940 controls derived from a health administration cohort and 3,202 MS patients and 16,006 controls derived from MS clinics. Compared with controls, in the 5 years before the first demyelinating claim or symptom onset, cases had more physician and hospital encounters for the nervous system (rate ratio = 1.70-4.75), sensory organs (RR = 1.40-2.28), musculoskeletal system (RR = 1.19-1.70), and genitourinary system (RR = 1.17-1.59), Dr. Kingwell and her associates reported.

SOURCE: Kingwell E et al. ACTRIMS Forum 2018, late-breaking poster 254.

SAN DIEGO – Compared with controls, patients who developed MS were more frequently admitted to the hospital or visited a physician for problems related to the nervous system, sensory organs, musculoskeletal system, and genitourinary system in the 5 years prior to MS onset, a multicenter matched cohort study found.

“People are seeking help for different conditions that are most likely related to their MS,” one of the study authors, Elaine Kingwell, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “It suggests there could be opportunity to recognize and possibly diagnose and treat MS earlier.”

Doug Brunk/Frontline Medical News

The researchers used rate ratios and 95% confidence intervals to compare the rates of physician and hospital encounters between MS cases and controls and the proportion test to compare the percentage of people with one or more filled prescriptions between MS cases and controls. They used random-effects meta-analyses to pool results across Canadian provinces.

The population consisted of 13,951 MS patients and 66,940 controls derived from a health administration cohort and 3,202 MS patients and 16,006 controls derived from MS clinics. Compared with controls, in the 5 years before the first demyelinating claim or symptom onset, cases had more physician and hospital encounters for the nervous system (rate ratio = 1.70-4.75), sensory organs (RR = 1.40-2.28), musculoskeletal system (RR = 1.19-1.70), and genitourinary system (RR = 1.17-1.59), Dr. Kingwell and her associates reported.

SOURCE: Kingwell E et al. ACTRIMS Forum 2018, late-breaking poster 254.

SAN DIEGO – A new study finds that physicians at two multiple sclerosis centers in the Southeast often failed to annually screen patients for depression and cognitive decline. Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.

In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.

SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.

SAN DIEGO – A new study finds that physicians at two multiple sclerosis centers in the Southeast often failed to annually screen patients for depression and cognitive decline. Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.

In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.

SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.

SAN DIEGO – A new study finds that physicians at two multiple sclerosis centers in the Southeast often failed to annually screen patients for depression and cognitive decline. Physicians who did perform screening hardly ever used validated tools and often didn’t refer appropriate patients for higher-level care.

In addition, researchers interviewed 13 leading MS specialists from coast to coast and “found that about half reported not using formal screening tools to assess cognitive impairment and depression,” said study coauthor Tamar Sapir, PhD, chief scientific officer with Prime Education, a firm based in Fort Lauderdale, Fla., that provides a variety of health-related services such as training and research.

SOURCE: Buckle GJ et al. ACTRIMS Forum 2018, abstract No. P161.

A majority of women want to know about restrictions on care imposed by some religious hospitals, based on data from a survey of 1,430 women.

The survey results, published in the American Journal of Obstetrics and Gynecology, showed that 35% of women thought knowing a hospital’s religion was important when choosing care, but many more – 81% – said that knowing a hospital’s religious restrictions on care was important.

The discrepancy between respondents’ desire to know a hospital’s religious orientation and to know any religious restrictions suggests that many women may have been unaware of restrictions before taking the survey, wrote Lori R. Freedman, PhD, of the University of California, San Francisco, and her colleagues.

Religious hospitals in the United States, 70% of which are Catholic, are a growing part of the health care system, but “no prior studies have asked women from across the United States what information they have and want to have before deciding where to seek care for a miscarriage or other reproductive condition that may be affected by the hospital’s religion,” the researchers said.

The researchers conducted an online survey of women aged 18-45 years who were part of the AmeriSpeak panel, a national database that includes civilian, noninstitutionalized adults. Approximately one-quarter (24%) of the women reported attending a weekly religious service.

Overall, Catholic women were no more likely than non-Catholic women to state that knowing a hospital’s religion or religious-based care restrictions was important. For example, 71% of the participants overall said an acceptable option was to admit a patient, inform her of all treatment options for miscarriage, and refer her elsewhere if she chose an option not available on religious grounds.

“ACOG recommends that institutions make information about all reproductive options available to patients and safeguard patients’ rights to access care consistent with the patient’s own values; however, Catholic hospitals may lack financial, legal, and ideological incentives to voluntarily comply with ACOG’s recommendations,” the researchers noted.

The study findings were limited by several factors, including the use of a panel-based sample and a response rate of approximately 50%. The results, however, suggest that patients need more complete information before choosing a hospital, the researchers said.

The researchers had no financial conflicts to disclose. Dr. Freedman was supported by the Greenwall Foundation. The study was supported by the Society for Family Planning.

SOURCE: Freedman LR et al. Am J Obstet Gynecol. 2018;218:251.e1-9.

A majority of women want to know about restrictions on care imposed by some religious hospitals, based on data from a survey of 1,430 women.

The survey results, published in the American Journal of Obstetrics and Gynecology, showed that 35% of women thought knowing a hospital’s religion was important when choosing care, but many more – 81% – said that knowing a hospital’s religious restrictions on care was important.

The discrepancy between respondents’ desire to know a hospital’s religious orientation and to know any religious restrictions suggests that many women may have been unaware of restrictions before taking the survey, wrote Lori R. Freedman, PhD, of the University of California, San Francisco, and her colleagues.

Religious hospitals in the United States, 70% of which are Catholic, are a growing part of the health care system, but “no prior studies have asked women from across the United States what information they have and want to have before deciding where to seek care for a miscarriage or other reproductive condition that may be affected by the hospital’s religion,” the researchers said.

The researchers conducted an online survey of women aged 18-45 years who were part of the AmeriSpeak panel, a national database that includes civilian, noninstitutionalized adults. Approximately one-quarter (24%) of the women reported attending a weekly religious service.

Overall, Catholic women were no more likely than non-Catholic women to state that knowing a hospital’s religion or religious-based care restrictions was important. For example, 71% of the participants overall said an acceptable option was to admit a patient, inform her of all treatment options for miscarriage, and refer her elsewhere if she chose an option not available on religious grounds.

“ACOG recommends that institutions make information about all reproductive options available to patients and safeguard patients’ rights to access care consistent with the patient’s own values; however, Catholic hospitals may lack financial, legal, and ideological incentives to voluntarily comply with ACOG’s recommendations,” the researchers noted.

The study findings were limited by several factors, including the use of a panel-based sample and a response rate of approximately 50%. The results, however, suggest that patients need more complete information before choosing a hospital, the researchers said.

The researchers had no financial conflicts to disclose. Dr. Freedman was supported by the Greenwall Foundation. The study was supported by the Society for Family Planning.

SOURCE: Freedman LR et al. Am J Obstet Gynecol. 2018;218:251.e1-9.

A majority of women want to know about restrictions on care imposed by some religious hospitals, based on data from a survey of 1,430 women.

The survey results, published in the American Journal of Obstetrics and Gynecology, showed that 35% of women thought knowing a hospital’s religion was important when choosing care, but many more – 81% – said that knowing a hospital’s religious restrictions on care was important.

The discrepancy between respondents’ desire to know a hospital’s religious orientation and to know any religious restrictions suggests that many women may have been unaware of restrictions before taking the survey, wrote Lori R. Freedman, PhD, of the University of California, San Francisco, and her colleagues.

Religious hospitals in the United States, 70% of which are Catholic, are a growing part of the health care system, but “no prior studies have asked women from across the United States what information they have and want to have before deciding where to seek care for a miscarriage or other reproductive condition that may be affected by the hospital’s religion,” the researchers said.

The researchers conducted an online survey of women aged 18-45 years who were part of the AmeriSpeak panel, a national database that includes civilian, noninstitutionalized adults. Approximately one-quarter (24%) of the women reported attending a weekly religious service.

Overall, Catholic women were no more likely than non-Catholic women to state that knowing a hospital’s religion or religious-based care restrictions was important. For example, 71% of the participants overall said an acceptable option was to admit a patient, inform her of all treatment options for miscarriage, and refer her elsewhere if she chose an option not available on religious grounds.

“ACOG recommends that institutions make information about all reproductive options available to patients and safeguard patients’ rights to access care consistent with the patient’s own values; however, Catholic hospitals may lack financial, legal, and ideological incentives to voluntarily comply with ACOG’s recommendations,” the researchers noted.

The study findings were limited by several factors, including the use of a panel-based sample and a response rate of approximately 50%. The results, however, suggest that patients need more complete information before choosing a hospital, the researchers said.

The researchers had no financial conflicts to disclose. Dr. Freedman was supported by the Greenwall Foundation. The study was supported by the Society for Family Planning.

SOURCE: Freedman LR et al. Am J Obstet Gynecol. 2018;218:251.e1-9.

KAUAI, HAWAII – Up to 130,000 patients hospitalized for treatment of lower extremity cellulitis annually in the United States turn out to have been misdiagnosed – and therein lies an opportunity for dermatologists to make a difference, according to Erik J. Stratman, MD, chairman of the department of dermatology at the Marshfield (Wisc.) Clinic.

As a section editor for UptoDate, he monitors the medical literature to identify practice gaps in dermatology, which he defines as things he and, he suspects, many other dermatologists are “either doing or not doing in practice that we shouldn’t or should be doing,” he explained at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

At the Hawaii meeting, he zeroed in on two such practice gaps pertaining to missed diagnoses.
 

Lower extremity cellulitis

A 2017 American Academy of Dermatology report on the national burden of skin disease contained eye-popping figures on the heavy toll of cellulitis. Cellulitis is the most common form of skin and soft tissue infection (SSTI). To put that into perspective, the annual incidence of SSTIs is 10-fold greater than that of pneumonia. Indeed, SSTIs account for 10% of all infectious disease–related hospitalizations across the country. There are 2.3 million emergency department visits per year for cellulitis, 14%-17% of which result in hospitalization (J Am Acad Dermatol. 2017 May;76[5]:958-972.e2).

Dr. Stratman, who is on the board of directors of the American Board of Dermatology, was favorably impressed with the work of a multicenter group of investigators who scrutinized 259 consecutive patients admitted with a diagnosis of lower extremity cellulitis through the emergency department at Massachusetts General Hospital in Boston. Seventy-nine of them (30.5%), were found to be misdiagnosed. Fifty-two of the 79 misdiagnosed patients had been admitted primarily for treatment of their supposed cellulitis: 44 of these 52, or 85%, didn’t require hospitalization, and 48 of the 52, or 92%, received unnecessary antibiotics.

Extrapolating from this experience, with application of cost data provided by the U.S. Agency for Healthcare Research and Quality, the investigators estimated that misdiagnosis of cellulitis results in 50,000 to 130,000 unnecessary hospitalizations annually. These hospitalizations for what the investigators termed “pseudocellulitis,” the majority of which is stasis dermatitis, resulted in inpatient costs estimated at up to $515 million per year. The unnecessary hospitalizations also led to an estimated 9,000 nosocomial infections, up to 5,000 Clostridium difficile infections, and a projected two to six cases of anaphylaxis resulting from exposure to the unnecessary antibiotics (JAMA Dermatol. 2017;153[2]:141-6).

Dr. Stratman said that the large Massachusetts General Hospital study mirrors his own experience when called upon to do a hospital consultation, as well as that of other dermatologists he has spoken with: “The number-one reason we get consulted is for stuff that is wrongfully admitted, mainly cellulitis.”

The investigators then went on to develop a simple prediction model for lower extremity cellulitis based upon their data. It’s called the ALT-70 score, an acronym for Asymmetric, Leukocytosis, Tachycardia, and Age greater than 70. A patient gets 3 points if one leg is affected, zero if both are. Age 70 or more is worth 2 points. A heart rate of 90 beats per minute or higher gets 1 point, as does a WBC of at least 10,000 per uL. A score of 0-2 spells at least an 83% likelihood that the patient has pseudocellulitis, while a score of 5 or points indicates at least an 82% likelihood of true cellulitis (J Am Acad Dermatol. 2017 Apr;76[4]:618-625.e2).

“If you don’t reach a score of 3, you’d better think a little bit harder before you hang that bag of vancomycin,” Dr. Stratman observed.

He ascribed the huge problem of misdiagnosed lower extremity cellulitis to several causes: emergency medicine physicians, hospitalists, and primary care physicians receive minimal dermatology training. In addition, there are no reliable diagnostic studies for the infection, and dermatologists are seldom consulted on patients with red legs, either because there are no dermatologists in a particular community or they don’t want to be consulted.

“It’s not all the dermatologists’ fault. Have you tried to get credentialed at a hospital lately? It’s a 1½-inch stack of papers and 8½ hours of electronic medical record training, if you’re lucky. So there are definitely barriers to overcoming this gap,” Dr. Stratman pointed out.

The best solution, he continued, is for dermatologists to take the initiative in educating hospitalists, emergency medicine specialists, and primary care physicians on the common mimickers of cellulitis, especially stasis dermatitis and contact dermatitis. This can happen through grand rounds presentations and feedback to consulting physicians.

“I think dermatologists have to take the lead on this,” Dr. Stratman said.

Underscreening for autoimmune thyroid disease in vitiligo patients

The international Vitiligo Working Group, citing evidence that 19% of patients with vitiligo have concomitant autoimmune thyroid disease and that the risk of developing this endocrine disease doubles every 5 years that a patient has vitiligo, has issued a call to action for dermatologists to ensure that their patients with vitiligo undergo periodic screening (J Am Acad Dermatol. 2017 Jul;77[1]:1-13).

This recommendation was based upon insights provided by a French prospective, observational study of 626 patients with vitiligo. The French investigators found that the risk of autoimmune thyroid disease doubled every 5 years and was associated with female sex, younger age at vitiligo onset, vitiligo on the trunk, and a personal history of autoimmune disease. They recommended screening every 2 years for thyroid-stimulating hormone and free thyroxine levels, as well as checking for serum antithyroperoxidase antibodies (Br J Dermatol. 2013 Apr;168[4]:756-61).

Dr. Stratman noted that some dermatologists may feel that ordering thyroid screening tests is outside their scope of practice. In that case, it’s important to engage with their vitiligo patient’s primary care physician to make sure the screening gets done.

He reported having no financial conflicts of interest regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

KAUAI, HAWAII – Up to 130,000 patients hospitalized for treatment of lower extremity cellulitis annually in the United States turn out to have been misdiagnosed – and therein lies an opportunity for dermatologists to make a difference, according to Erik J. Stratman, MD, chairman of the department of dermatology at the Marshfield (Wisc.) Clinic.

As a section editor for UptoDate, he monitors the medical literature to identify practice gaps in dermatology, which he defines as things he and, he suspects, many other dermatologists are “either doing or not doing in practice that we shouldn’t or should be doing,” he explained at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

At the Hawaii meeting, he zeroed in on two such practice gaps pertaining to missed diagnoses.
 

Lower extremity cellulitis

A 2017 American Academy of Dermatology report on the national burden of skin disease contained eye-popping figures on the heavy toll of cellulitis. Cellulitis is the most common form of skin and soft tissue infection (SSTI). To put that into perspective, the annual incidence of SSTIs is 10-fold greater than that of pneumonia. Indeed, SSTIs account for 10% of all infectious disease–related hospitalizations across the country. There are 2.3 million emergency department visits per year for cellulitis, 14%-17% of which result in hospitalization (J Am Acad Dermatol. 2017 May;76[5]:958-972.e2).

Dr. Stratman, who is on the board of directors of the American Board of Dermatology, was favorably impressed with the work of a multicenter group of investigators who scrutinized 259 consecutive patients admitted with a diagnosis of lower extremity cellulitis through the emergency department at Massachusetts General Hospital in Boston. Seventy-nine of them (30.5%), were found to be misdiagnosed. Fifty-two of the 79 misdiagnosed patients had been admitted primarily for treatment of their supposed cellulitis: 44 of these 52, or 85%, didn’t require hospitalization, and 48 of the 52, or 92%, received unnecessary antibiotics.

Extrapolating from this experience, with application of cost data provided by the U.S. Agency for Healthcare Research and Quality, the investigators estimated that misdiagnosis of cellulitis results in 50,000 to 130,000 unnecessary hospitalizations annually. These hospitalizations for what the investigators termed “pseudocellulitis,” the majority of which is stasis dermatitis, resulted in inpatient costs estimated at up to $515 million per year. The unnecessary hospitalizations also led to an estimated 9,000 nosocomial infections, up to 5,000 Clostridium difficile infections, and a projected two to six cases of anaphylaxis resulting from exposure to the unnecessary antibiotics (JAMA Dermatol. 2017;153[2]:141-6).

Dr. Stratman said that the large Massachusetts General Hospital study mirrors his own experience when called upon to do a hospital consultation, as well as that of other dermatologists he has spoken with: “The number-one reason we get consulted is for stuff that is wrongfully admitted, mainly cellulitis.”

The investigators then went on to develop a simple prediction model for lower extremity cellulitis based upon their data. It’s called the ALT-70 score, an acronym for Asymmetric, Leukocytosis, Tachycardia, and Age greater than 70. A patient gets 3 points if one leg is affected, zero if both are. Age 70 or more is worth 2 points. A heart rate of 90 beats per minute or higher gets 1 point, as does a WBC of at least 10,000 per uL. A score of 0-2 spells at least an 83% likelihood that the patient has pseudocellulitis, while a score of 5 or points indicates at least an 82% likelihood of true cellulitis (J Am Acad Dermatol. 2017 Apr;76[4]:618-625.e2).

“If you don’t reach a score of 3, you’d better think a little bit harder before you hang that bag of vancomycin,” Dr. Stratman observed.

He ascribed the huge problem of misdiagnosed lower extremity cellulitis to several causes: emergency medicine physicians, hospitalists, and primary care physicians receive minimal dermatology training. In addition, there are no reliable diagnostic studies for the infection, and dermatologists are seldom consulted on patients with red legs, either because there are no dermatologists in a particular community or they don’t want to be consulted.

“It’s not all the dermatologists’ fault. Have you tried to get credentialed at a hospital lately? It’s a 1½-inch stack of papers and 8½ hours of electronic medical record training, if you’re lucky. So there are definitely barriers to overcoming this gap,” Dr. Stratman pointed out.

The best solution, he continued, is for dermatologists to take the initiative in educating hospitalists, emergency medicine specialists, and primary care physicians on the common mimickers of cellulitis, especially stasis dermatitis and contact dermatitis. This can happen through grand rounds presentations and feedback to consulting physicians.

“I think dermatologists have to take the lead on this,” Dr. Stratman said.

Underscreening for autoimmune thyroid disease in vitiligo patients

The international Vitiligo Working Group, citing evidence that 19% of patients with vitiligo have concomitant autoimmune thyroid disease and that the risk of developing this endocrine disease doubles every 5 years that a patient has vitiligo, has issued a call to action for dermatologists to ensure that their patients with vitiligo undergo periodic screening (J Am Acad Dermatol. 2017 Jul;77[1]:1-13).

This recommendation was based upon insights provided by a French prospective, observational study of 626 patients with vitiligo. The French investigators found that the risk of autoimmune thyroid disease doubled every 5 years and was associated with female sex, younger age at vitiligo onset, vitiligo on the trunk, and a personal history of autoimmune disease. They recommended screening every 2 years for thyroid-stimulating hormone and free thyroxine levels, as well as checking for serum antithyroperoxidase antibodies (Br J Dermatol. 2013 Apr;168[4]:756-61).

Dr. Stratman noted that some dermatologists may feel that ordering thyroid screening tests is outside their scope of practice. In that case, it’s important to engage with their vitiligo patient’s primary care physician to make sure the screening gets done.

He reported having no financial conflicts of interest regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

KAUAI, HAWAII – Up to 130,000 patients hospitalized for treatment of lower extremity cellulitis annually in the United States turn out to have been misdiagnosed – and therein lies an opportunity for dermatologists to make a difference, according to Erik J. Stratman, MD, chairman of the department of dermatology at the Marshfield (Wisc.) Clinic.

As a section editor for UptoDate, he monitors the medical literature to identify practice gaps in dermatology, which he defines as things he and, he suspects, many other dermatologists are “either doing or not doing in practice that we shouldn’t or should be doing,” he explained at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

At the Hawaii meeting, he zeroed in on two such practice gaps pertaining to missed diagnoses.
 

Lower extremity cellulitis

A 2017 American Academy of Dermatology report on the national burden of skin disease contained eye-popping figures on the heavy toll of cellulitis. Cellulitis is the most common form of skin and soft tissue infection (SSTI). To put that into perspective, the annual incidence of SSTIs is 10-fold greater than that of pneumonia. Indeed, SSTIs account for 10% of all infectious disease–related hospitalizations across the country. There are 2.3 million emergency department visits per year for cellulitis, 14%-17% of which result in hospitalization (J Am Acad Dermatol. 2017 May;76[5]:958-972.e2).

Dr. Stratman, who is on the board of directors of the American Board of Dermatology, was favorably impressed with the work of a multicenter group of investigators who scrutinized 259 consecutive patients admitted with a diagnosis of lower extremity cellulitis through the emergency department at Massachusetts General Hospital in Boston. Seventy-nine of them (30.5%), were found to be misdiagnosed. Fifty-two of the 79 misdiagnosed patients had been admitted primarily for treatment of their supposed cellulitis: 44 of these 52, or 85%, didn’t require hospitalization, and 48 of the 52, or 92%, received unnecessary antibiotics.

Extrapolating from this experience, with application of cost data provided by the U.S. Agency for Healthcare Research and Quality, the investigators estimated that misdiagnosis of cellulitis results in 50,000 to 130,000 unnecessary hospitalizations annually. These hospitalizations for what the investigators termed “pseudocellulitis,” the majority of which is stasis dermatitis, resulted in inpatient costs estimated at up to $515 million per year. The unnecessary hospitalizations also led to an estimated 9,000 nosocomial infections, up to 5,000 Clostridium difficile infections, and a projected two to six cases of anaphylaxis resulting from exposure to the unnecessary antibiotics (JAMA Dermatol. 2017;153[2]:141-6).

Dr. Stratman said that the large Massachusetts General Hospital study mirrors his own experience when called upon to do a hospital consultation, as well as that of other dermatologists he has spoken with: “The number-one reason we get consulted is for stuff that is wrongfully admitted, mainly cellulitis.”

The investigators then went on to develop a simple prediction model for lower extremity cellulitis based upon their data. It’s called the ALT-70 score, an acronym for Asymmetric, Leukocytosis, Tachycardia, and Age greater than 70. A patient gets 3 points if one leg is affected, zero if both are. Age 70 or more is worth 2 points. A heart rate of 90 beats per minute or higher gets 1 point, as does a WBC of at least 10,000 per uL. A score of 0-2 spells at least an 83% likelihood that the patient has pseudocellulitis, while a score of 5 or points indicates at least an 82% likelihood of true cellulitis (J Am Acad Dermatol. 2017 Apr;76[4]:618-625.e2).

“If you don’t reach a score of 3, you’d better think a little bit harder before you hang that bag of vancomycin,” Dr. Stratman observed.

He ascribed the huge problem of misdiagnosed lower extremity cellulitis to several causes: emergency medicine physicians, hospitalists, and primary care physicians receive minimal dermatology training. In addition, there are no reliable diagnostic studies for the infection, and dermatologists are seldom consulted on patients with red legs, either because there are no dermatologists in a particular community or they don’t want to be consulted.

“It’s not all the dermatologists’ fault. Have you tried to get credentialed at a hospital lately? It’s a 1½-inch stack of papers and 8½ hours of electronic medical record training, if you’re lucky. So there are definitely barriers to overcoming this gap,” Dr. Stratman pointed out.

The best solution, he continued, is for dermatologists to take the initiative in educating hospitalists, emergency medicine specialists, and primary care physicians on the common mimickers of cellulitis, especially stasis dermatitis and contact dermatitis. This can happen through grand rounds presentations and feedback to consulting physicians.

“I think dermatologists have to take the lead on this,” Dr. Stratman said.

Underscreening for autoimmune thyroid disease in vitiligo patients

The international Vitiligo Working Group, citing evidence that 19% of patients with vitiligo have concomitant autoimmune thyroid disease and that the risk of developing this endocrine disease doubles every 5 years that a patient has vitiligo, has issued a call to action for dermatologists to ensure that their patients with vitiligo undergo periodic screening (J Am Acad Dermatol. 2017 Jul;77[1]:1-13).

This recommendation was based upon insights provided by a French prospective, observational study of 626 patients with vitiligo. The French investigators found that the risk of autoimmune thyroid disease doubled every 5 years and was associated with female sex, younger age at vitiligo onset, vitiligo on the trunk, and a personal history of autoimmune disease. They recommended screening every 2 years for thyroid-stimulating hormone and free thyroxine levels, as well as checking for serum antithyroperoxidase antibodies (Br J Dermatol. 2013 Apr;168[4]:756-61).

Dr. Stratman noted that some dermatologists may feel that ordering thyroid screening tests is outside their scope of practice. In that case, it’s important to engage with their vitiligo patient’s primary care physician to make sure the screening gets done.

He reported having no financial conflicts of interest regarding his presentation.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

JACKSONVILLE, FLA. – Surgeons who choose to wear a skullcap in the OR can point to yet another study with evidence to bolster their preference.

Two major hospital and nursing credentialing organizations have recommended that hospitals ban skullcaps from the operating room as a practice to control surgical site infections, but a study of almost 2,000 operations at an academic medical center has found that strictly enforcing the ban had no impact on infection rates, according to results of a study presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.

SOURCE: Rios-Diaz AJ et al. Annual Academic Surgical Congress. Abstract 09.11.

JACKSONVILLE, FLA. – Surgeons who choose to wear a skullcap in the OR can point to yet another study with evidence to bolster their preference.

Two major hospital and nursing credentialing organizations have recommended that hospitals ban skullcaps from the operating room as a practice to control surgical site infections, but a study of almost 2,000 operations at an academic medical center has found that strictly enforcing the ban had no impact on infection rates, according to results of a study presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.

SOURCE: Rios-Diaz AJ et al. Annual Academic Surgical Congress. Abstract 09.11.

JACKSONVILLE, FLA. – Surgeons who choose to wear a skullcap in the OR can point to yet another study with evidence to bolster their preference.

Two major hospital and nursing credentialing organizations have recommended that hospitals ban skullcaps from the operating room as a practice to control surgical site infections, but a study of almost 2,000 operations at an academic medical center has found that strictly enforcing the ban had no impact on infection rates, according to results of a study presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.

SOURCE: Rios-Diaz AJ et al. Annual Academic Surgical Congress. Abstract 09.11.

Adding dermoscopy to the classic and modified melanoma ABCD criteria will help speed detection of melanoma in children, said Cristina Carrera, MD, of the University of Barcelona, and her associates.

Pediatric melanomas make up less than 3% of pediatric cancers and 1%-4% of all melanomas, occurring more commonly in adolescents than in children aged 5-9 years. These cancers often are thicker when first seen because of delay in diagnosis and/or differences in growth dynamics. Delay in diagnosis may occur because of the low incidence of pediatric melanoma and because classic melanoma criteria – ABCD: asymmetry, border irregularity, multiple colors, diameter (6 mm) – don’t always apply, they said.

©Zerbor/Thinkstock

SOURCE: Carrera C et al. J Am Acad Dermatol. 2018;78(2):278-88. doi: 10.1016/j.jaad.2017.09.065.

Adding dermoscopy to the classic and modified melanoma ABCD criteria will help speed detection of melanoma in children, said Cristina Carrera, MD, of the University of Barcelona, and her associates.

Pediatric melanomas make up less than 3% of pediatric cancers and 1%-4% of all melanomas, occurring more commonly in adolescents than in children aged 5-9 years. These cancers often are thicker when first seen because of delay in diagnosis and/or differences in growth dynamics. Delay in diagnosis may occur because of the low incidence of pediatric melanoma and because classic melanoma criteria – ABCD: asymmetry, border irregularity, multiple colors, diameter (6 mm) – don’t always apply, they said.

©Zerbor/Thinkstock

SOURCE: Carrera C et al. J Am Acad Dermatol. 2018;78(2):278-88. doi: 10.1016/j.jaad.2017.09.065.

Adding dermoscopy to the classic and modified melanoma ABCD criteria will help speed detection of melanoma in children, said Cristina Carrera, MD, of the University of Barcelona, and her associates.

Pediatric melanomas make up less than 3% of pediatric cancers and 1%-4% of all melanomas, occurring more commonly in adolescents than in children aged 5-9 years. These cancers often are thicker when first seen because of delay in diagnosis and/or differences in growth dynamics. Delay in diagnosis may occur because of the low incidence of pediatric melanoma and because classic melanoma criteria – ABCD: asymmetry, border irregularity, multiple colors, diameter (6 mm) – don’t always apply, they said.

©Zerbor/Thinkstock

SOURCE: Carrera C et al. J Am Acad Dermatol. 2018;78(2):278-88. doi: 10.1016/j.jaad.2017.09.065.