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Registry helps track pelvic organ prolapse outcomes in the U.S.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
AT PFD WEEK 2016
Pembrolizumab boosts response but not survival in small study of advanced NSCLC
COPENHAGEN – Adding the PD-1 checkpoint inhibitor pembrolizumab (Keytruda) to a standard platinum-doublet chemotherapy regimen nearly doubled response rates among patients with previously untreated advanced nonsquamous non–small cell lung cancer, but did not result in an overall survival advantage, results of a phase II trial show.
After a median follow-up of 10.6 months, the objective response rate among patients randomized to receive carboplatin and pemetrexed plus pembrolizumab was 55%, compared with 29% for patients treated with the platinum doublet alone, reported Corey J. Langer, MD, from the Abramson Cancer Center of the University of Pennsylvania, Philadelphia.
Dr. Langer presented results on one cohort in the KEYNOTE 021 trial, a phase II, randomized, open-label multicohort study looking at pembrolizumab in combination with chemotherapy or immunotherapy.
In this cohort, 123 patients with untreated stage IIIB or IV nonsquamous non–small cell lung cancer with no activating EGFR mutations or ALK translocations were randomly assigned to receive either pembrolizumab 200 mg every 3 weeks for 2 years plus carboplatin dosed to the area under the curve and infused at 5 mg/mL per min plus pemetrexed 500 mg/m2 every 3 weeks for four cycles, or to chemotherapy alone.
Following completion of the trial, patients randomized to chemotherapy could be switched over to pembrolizumab at the same dose and scheduled for up to 2 years.
As noted, for the primary endpoint of confirmed objective response rates, the rate in the pembrolizumab/chemo group was nearly double that of the chemo-alone group (55% vs. 29%, P = .0016).
Among 33 patients on the pembrolizumab/chemo combination and 18 on chemo alone who had clinical responses according to independent central review, the median time to response was 1.5 months vs. 2.7 months, respectively. The median duration of response had not been reached in either trial arm at the time of data cutoff, and 88% and 78% of patients, respectively, had ongoing treatment responses.
Progression-free survival, a secondary endpoint, was also significantly better with the combo, with a hazard ratio of 0.53 (P = .0102).
There was no difference in overall survival, however: 75% of patients on the combination were alive at 1 year, compared with 72% of the patients on chemo alone.
Grade 3 or greater treatment-related adverse events were seen in 39% of patients on pembrolizumab, compared with 26% of patients on chemotherapy.
The most common grade 3 or greater adverse events in the combination arm were anemia, decreased neutrophil count, acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, sepsis, and thrombocytopenia. In the chemotherapy-alone group, the most common grade 3 or greater events were anemia, decreased neutrophil count, pancytopenia, and thrombocytopenia.
There were three deaths, one from sepsis each in the pembrolizumab-treated group and chemotherapy alone group, and one from pancytopenia in the chemo alone group.
One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis, compared with two (3%) of 62 patients in the chemotherapy group.
Invited discussant Jean-Charles Soria, MD, chair of drug development at Gustave Roussy Cancer Center in Paris, said that although the findings of the trial are “intriguing,” there were not enough patients to allow for drawing significant conclusions about the potential use of the combination in clinical practice.
COPENHAGEN – Adding the PD-1 checkpoint inhibitor pembrolizumab (Keytruda) to a standard platinum-doublet chemotherapy regimen nearly doubled response rates among patients with previously untreated advanced nonsquamous non–small cell lung cancer, but did not result in an overall survival advantage, results of a phase II trial show.
After a median follow-up of 10.6 months, the objective response rate among patients randomized to receive carboplatin and pemetrexed plus pembrolizumab was 55%, compared with 29% for patients treated with the platinum doublet alone, reported Corey J. Langer, MD, from the Abramson Cancer Center of the University of Pennsylvania, Philadelphia.
Dr. Langer presented results on one cohort in the KEYNOTE 021 trial, a phase II, randomized, open-label multicohort study looking at pembrolizumab in combination with chemotherapy or immunotherapy.
In this cohort, 123 patients with untreated stage IIIB or IV nonsquamous non–small cell lung cancer with no activating EGFR mutations or ALK translocations were randomly assigned to receive either pembrolizumab 200 mg every 3 weeks for 2 years plus carboplatin dosed to the area under the curve and infused at 5 mg/mL per min plus pemetrexed 500 mg/m2 every 3 weeks for four cycles, or to chemotherapy alone.
Following completion of the trial, patients randomized to chemotherapy could be switched over to pembrolizumab at the same dose and scheduled for up to 2 years.
As noted, for the primary endpoint of confirmed objective response rates, the rate in the pembrolizumab/chemo group was nearly double that of the chemo-alone group (55% vs. 29%, P = .0016).
Among 33 patients on the pembrolizumab/chemo combination and 18 on chemo alone who had clinical responses according to independent central review, the median time to response was 1.5 months vs. 2.7 months, respectively. The median duration of response had not been reached in either trial arm at the time of data cutoff, and 88% and 78% of patients, respectively, had ongoing treatment responses.
Progression-free survival, a secondary endpoint, was also significantly better with the combo, with a hazard ratio of 0.53 (P = .0102).
There was no difference in overall survival, however: 75% of patients on the combination were alive at 1 year, compared with 72% of the patients on chemo alone.
Grade 3 or greater treatment-related adverse events were seen in 39% of patients on pembrolizumab, compared with 26% of patients on chemotherapy.
The most common grade 3 or greater adverse events in the combination arm were anemia, decreased neutrophil count, acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, sepsis, and thrombocytopenia. In the chemotherapy-alone group, the most common grade 3 or greater events were anemia, decreased neutrophil count, pancytopenia, and thrombocytopenia.
There were three deaths, one from sepsis each in the pembrolizumab-treated group and chemotherapy alone group, and one from pancytopenia in the chemo alone group.
One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis, compared with two (3%) of 62 patients in the chemotherapy group.
Invited discussant Jean-Charles Soria, MD, chair of drug development at Gustave Roussy Cancer Center in Paris, said that although the findings of the trial are “intriguing,” there were not enough patients to allow for drawing significant conclusions about the potential use of the combination in clinical practice.
COPENHAGEN – Adding the PD-1 checkpoint inhibitor pembrolizumab (Keytruda) to a standard platinum-doublet chemotherapy regimen nearly doubled response rates among patients with previously untreated advanced nonsquamous non–small cell lung cancer, but did not result in an overall survival advantage, results of a phase II trial show.
After a median follow-up of 10.6 months, the objective response rate among patients randomized to receive carboplatin and pemetrexed plus pembrolizumab was 55%, compared with 29% for patients treated with the platinum doublet alone, reported Corey J. Langer, MD, from the Abramson Cancer Center of the University of Pennsylvania, Philadelphia.
Dr. Langer presented results on one cohort in the KEYNOTE 021 trial, a phase II, randomized, open-label multicohort study looking at pembrolizumab in combination with chemotherapy or immunotherapy.
In this cohort, 123 patients with untreated stage IIIB or IV nonsquamous non–small cell lung cancer with no activating EGFR mutations or ALK translocations were randomly assigned to receive either pembrolizumab 200 mg every 3 weeks for 2 years plus carboplatin dosed to the area under the curve and infused at 5 mg/mL per min plus pemetrexed 500 mg/m2 every 3 weeks for four cycles, or to chemotherapy alone.
Following completion of the trial, patients randomized to chemotherapy could be switched over to pembrolizumab at the same dose and scheduled for up to 2 years.
As noted, for the primary endpoint of confirmed objective response rates, the rate in the pembrolizumab/chemo group was nearly double that of the chemo-alone group (55% vs. 29%, P = .0016).
Among 33 patients on the pembrolizumab/chemo combination and 18 on chemo alone who had clinical responses according to independent central review, the median time to response was 1.5 months vs. 2.7 months, respectively. The median duration of response had not been reached in either trial arm at the time of data cutoff, and 88% and 78% of patients, respectively, had ongoing treatment responses.
Progression-free survival, a secondary endpoint, was also significantly better with the combo, with a hazard ratio of 0.53 (P = .0102).
There was no difference in overall survival, however: 75% of patients on the combination were alive at 1 year, compared with 72% of the patients on chemo alone.
Grade 3 or greater treatment-related adverse events were seen in 39% of patients on pembrolizumab, compared with 26% of patients on chemotherapy.
The most common grade 3 or greater adverse events in the combination arm were anemia, decreased neutrophil count, acute kidney injury, decreased lymphocyte count, fatigue, neutropenia, sepsis, and thrombocytopenia. In the chemotherapy-alone group, the most common grade 3 or greater events were anemia, decreased neutrophil count, pancytopenia, and thrombocytopenia.
There were three deaths, one from sepsis each in the pembrolizumab-treated group and chemotherapy alone group, and one from pancytopenia in the chemo alone group.
One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatment-related death because of sepsis, compared with two (3%) of 62 patients in the chemotherapy group.
Invited discussant Jean-Charles Soria, MD, chair of drug development at Gustave Roussy Cancer Center in Paris, said that although the findings of the trial are “intriguing,” there were not enough patients to allow for drawing significant conclusions about the potential use of the combination in clinical practice.
Key clinical point: Adding pembrolizumab to platinum-based chemotherapy for upfront therapy of advanced NSCLC nearly doubled response rates.
Major finding: The overall response rate in the pembrolizumab/chemo group was 55% vs. 29% for chemotherapy alone (P = .0016)
Data source: Phase II randomized, open-label trial in 123 patients with untreated stage IIIB or IV nonsquamous NSCLC.
Disclosures: The study was funded by Merck, Sharp, and Dohme. Dr. Langer disclosed research funding from the company. Dr. Soria disclosed financial relationships (consulting/honoraria, research funding) with several companies, but not Merck.
Surgical Risks From Systemic Psoriasis Therapies
I am a coauthor on a recent literature review (J Am Acad Dermatol. 2016;75:798.e7-805.e7) that addressed a common question regarding the use of systemic agents: What should a clinician do if a patient on one of these therapies has an upcoming elective surgery?
Treatment with systemic immunomodulatory agents commonly is employed in patients with moderate to severe plaque psoriasis and psoriatic arthritis. In these individuals, the concern is that surgery may carry an increased risk for infectious or surgical complications. Based on the available literature, my coauthors and I sought to create recommendations for the perioperative management of systemic immunosuppressive therapies in patients with psoriasis and psoriatic arthritis. We conducted a literature review to examine studies that addressed the use of methotrexate, cyclosporine, and biologic agents in patients undergoing surgery. A total of 46 studies were examined, nearly all retrospective studies in patients with inflammatory bowel disease and rheumatoid arthritis.
Based on level III evidence, we concluded that infliximab, adalimumab, etanercept, methotrexate, and cyclosporine can be safely continued through low-risk operations in patients with psoriasis and psoriatic arthritis. For moderate- and high-risk surgeries, a case-by-case approach should be taken based on the patient’s individual risk factors and comorbidities.
What’s the issue?
This study does not provide specific guidelines because of limited and conflicting literature. However, it does provide general guidelines that hopefully will be augmented in the future. How will you handle this situation when it arises in your practice?
I am a coauthor on a recent literature review (J Am Acad Dermatol. 2016;75:798.e7-805.e7) that addressed a common question regarding the use of systemic agents: What should a clinician do if a patient on one of these therapies has an upcoming elective surgery?
Treatment with systemic immunomodulatory agents commonly is employed in patients with moderate to severe plaque psoriasis and psoriatic arthritis. In these individuals, the concern is that surgery may carry an increased risk for infectious or surgical complications. Based on the available literature, my coauthors and I sought to create recommendations for the perioperative management of systemic immunosuppressive therapies in patients with psoriasis and psoriatic arthritis. We conducted a literature review to examine studies that addressed the use of methotrexate, cyclosporine, and biologic agents in patients undergoing surgery. A total of 46 studies were examined, nearly all retrospective studies in patients with inflammatory bowel disease and rheumatoid arthritis.
Based on level III evidence, we concluded that infliximab, adalimumab, etanercept, methotrexate, and cyclosporine can be safely continued through low-risk operations in patients with psoriasis and psoriatic arthritis. For moderate- and high-risk surgeries, a case-by-case approach should be taken based on the patient’s individual risk factors and comorbidities.
What’s the issue?
This study does not provide specific guidelines because of limited and conflicting literature. However, it does provide general guidelines that hopefully will be augmented in the future. How will you handle this situation when it arises in your practice?
I am a coauthor on a recent literature review (J Am Acad Dermatol. 2016;75:798.e7-805.e7) that addressed a common question regarding the use of systemic agents: What should a clinician do if a patient on one of these therapies has an upcoming elective surgery?
Treatment with systemic immunomodulatory agents commonly is employed in patients with moderate to severe plaque psoriasis and psoriatic arthritis. In these individuals, the concern is that surgery may carry an increased risk for infectious or surgical complications. Based on the available literature, my coauthors and I sought to create recommendations for the perioperative management of systemic immunosuppressive therapies in patients with psoriasis and psoriatic arthritis. We conducted a literature review to examine studies that addressed the use of methotrexate, cyclosporine, and biologic agents in patients undergoing surgery. A total of 46 studies were examined, nearly all retrospective studies in patients with inflammatory bowel disease and rheumatoid arthritis.
Based on level III evidence, we concluded that infliximab, adalimumab, etanercept, methotrexate, and cyclosporine can be safely continued through low-risk operations in patients with psoriasis and psoriatic arthritis. For moderate- and high-risk surgeries, a case-by-case approach should be taken based on the patient’s individual risk factors and comorbidities.
What’s the issue?
This study does not provide specific guidelines because of limited and conflicting literature. However, it does provide general guidelines that hopefully will be augmented in the future. How will you handle this situation when it arises in your practice?
Scalp Psoriasis: Weighing Treatment Options
Scalp psoriasis often is the initial presentation of psoriasis, and it can be one of the most challenging aspects of the disease. It can be difficult to treat for several reasons. First, hair can interfere with topical therapy reaching its site of action on the scalp. Second, facial skin also can be exposed to these treatments with the associated risk for adverse events. Finally, compliance often is difficult.
An evidence-based review published online on September 21 in the American Journal of Clinical Dermatology examined treatments for scalp psoriasis, including newer systemic therapies. Of 475 studies initially identified from PubMed and 845 from Embase (up to May 2016), the review included 27 clinical trials, 4 papers reporting pooled analyses of other clinical trials, 10 open-label trials, 1 case series, and 2 case reports after excluding non-English literature.
Wang and Tsai noted that few randomized controlled trials have been performed specifically in scalp psoriasis. The authors found that topical corticosteroids provide good effects and are usually recommended as first-line treatment. Calcipotriol–betamethasone dipropionate is more highly effective than either of its individual components.
The analysis also suggested that localized phototherapy is better than generalized phototherapy on hair-bearing areas. Methotrexate, cyclosporine, fumaric acid esters, and acitretin are well-recognized agents in the treatment of psoriasis, but they located no published randomized controlled trials specifically evaluating these agents in scalp psoriasis. Wang and Tsai also commented that biologics and new small-molecule agents show excellent effects on scalp psoriasis, but the high cost of these treatments mean they may be limited to use in extensive scalp psoriasis. They suggested that more controlled studies are needed for an evidence-based approach to scalp psoriasis.
What’s the issue?
Scalp psoriasis can be an isolated condition or may occur in association with more extensive disease. There has been increased attention to its treatment over the last several years, with several new options. What is your preferred approach to scalp psoriasis?
Scalp psoriasis often is the initial presentation of psoriasis, and it can be one of the most challenging aspects of the disease. It can be difficult to treat for several reasons. First, hair can interfere with topical therapy reaching its site of action on the scalp. Second, facial skin also can be exposed to these treatments with the associated risk for adverse events. Finally, compliance often is difficult.
An evidence-based review published online on September 21 in the American Journal of Clinical Dermatology examined treatments for scalp psoriasis, including newer systemic therapies. Of 475 studies initially identified from PubMed and 845 from Embase (up to May 2016), the review included 27 clinical trials, 4 papers reporting pooled analyses of other clinical trials, 10 open-label trials, 1 case series, and 2 case reports after excluding non-English literature.
Wang and Tsai noted that few randomized controlled trials have been performed specifically in scalp psoriasis. The authors found that topical corticosteroids provide good effects and are usually recommended as first-line treatment. Calcipotriol–betamethasone dipropionate is more highly effective than either of its individual components.
The analysis also suggested that localized phototherapy is better than generalized phototherapy on hair-bearing areas. Methotrexate, cyclosporine, fumaric acid esters, and acitretin are well-recognized agents in the treatment of psoriasis, but they located no published randomized controlled trials specifically evaluating these agents in scalp psoriasis. Wang and Tsai also commented that biologics and new small-molecule agents show excellent effects on scalp psoriasis, but the high cost of these treatments mean they may be limited to use in extensive scalp psoriasis. They suggested that more controlled studies are needed for an evidence-based approach to scalp psoriasis.
What’s the issue?
Scalp psoriasis can be an isolated condition or may occur in association with more extensive disease. There has been increased attention to its treatment over the last several years, with several new options. What is your preferred approach to scalp psoriasis?
Scalp psoriasis often is the initial presentation of psoriasis, and it can be one of the most challenging aspects of the disease. It can be difficult to treat for several reasons. First, hair can interfere with topical therapy reaching its site of action on the scalp. Second, facial skin also can be exposed to these treatments with the associated risk for adverse events. Finally, compliance often is difficult.
An evidence-based review published online on September 21 in the American Journal of Clinical Dermatology examined treatments for scalp psoriasis, including newer systemic therapies. Of 475 studies initially identified from PubMed and 845 from Embase (up to May 2016), the review included 27 clinical trials, 4 papers reporting pooled analyses of other clinical trials, 10 open-label trials, 1 case series, and 2 case reports after excluding non-English literature.
Wang and Tsai noted that few randomized controlled trials have been performed specifically in scalp psoriasis. The authors found that topical corticosteroids provide good effects and are usually recommended as first-line treatment. Calcipotriol–betamethasone dipropionate is more highly effective than either of its individual components.
The analysis also suggested that localized phototherapy is better than generalized phototherapy on hair-bearing areas. Methotrexate, cyclosporine, fumaric acid esters, and acitretin are well-recognized agents in the treatment of psoriasis, but they located no published randomized controlled trials specifically evaluating these agents in scalp psoriasis. Wang and Tsai also commented that biologics and new small-molecule agents show excellent effects on scalp psoriasis, but the high cost of these treatments mean they may be limited to use in extensive scalp psoriasis. They suggested that more controlled studies are needed for an evidence-based approach to scalp psoriasis.
What’s the issue?
Scalp psoriasis can be an isolated condition or may occur in association with more extensive disease. There has been increased attention to its treatment over the last several years, with several new options. What is your preferred approach to scalp psoriasis?
Pharmacists urge more focus on kidney disease indicator
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
SAN DIEGO – Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.
“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”
Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.
At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.
“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”
It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.
But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”
For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.
According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.
The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.
The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.
The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.
Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
AT THE ANNUAL MEETING OF AADE
STIM1 long-term follow-up confirms imatinib discontinuation safety
Imatinib discontinuation is safe in patients with chronic myeloid leukemia (CML) who have sustained deep molecular response with no late molecular recurrence, according to long-term follow-up of the French Stop Imatinib Study (STIM1).
Over a median follow-up of 77 months after treatment discontinuation in 100 patients with CML who had undetectable minimal residual disease (UMRD) for at least 2 years, 61 lost UMRD after a median of 2.5 months, and 1 died with UMRD at 10 months, Gabriel Etienne, MD, of Institut Bergonie, Bordeaux, France, and colleagues reported online in the Journal of Clinical Oncology.
Of the 61 patients who lost UMRD, 57 restarted treatment and 55 achieved a second UMRD at a median of 4.3 months. The median time to second UMRD in patients with molecular recurrence with or without loss of major molecular response at the time of relapse was 4.2 months and 5 months, respectively. At a median of 73 months, none of the patients with molecular recurrence experienced CML progression. The rate of molecular recurrence-free survival overall was 43% at 6 months, 40% at 18 months, and 38% at 60 months, the investigators reported (2016 Oct. 3. doi: 10.1200/JCO.2016.68.2914).
These final long-term results of the STIM1 trial confirm the safety of imatinib discontinuation in CML patients with deep molecular response, and “make treatment-free remission legitimate as a criterion of treatment evaluation in the future,” the investigators concluded, noting that the possibility of improved results in patients treated with second-generation tyrosine kinase inhibitors as first- or second-line therapy is currently being evaluated in ongoing discontinuation trials.
Imatinib discontinuation is safe in patients with chronic myeloid leukemia (CML) who have sustained deep molecular response with no late molecular recurrence, according to long-term follow-up of the French Stop Imatinib Study (STIM1).
Over a median follow-up of 77 months after treatment discontinuation in 100 patients with CML who had undetectable minimal residual disease (UMRD) for at least 2 years, 61 lost UMRD after a median of 2.5 months, and 1 died with UMRD at 10 months, Gabriel Etienne, MD, of Institut Bergonie, Bordeaux, France, and colleagues reported online in the Journal of Clinical Oncology.
Of the 61 patients who lost UMRD, 57 restarted treatment and 55 achieved a second UMRD at a median of 4.3 months. The median time to second UMRD in patients with molecular recurrence with or without loss of major molecular response at the time of relapse was 4.2 months and 5 months, respectively. At a median of 73 months, none of the patients with molecular recurrence experienced CML progression. The rate of molecular recurrence-free survival overall was 43% at 6 months, 40% at 18 months, and 38% at 60 months, the investigators reported (2016 Oct. 3. doi: 10.1200/JCO.2016.68.2914).
These final long-term results of the STIM1 trial confirm the safety of imatinib discontinuation in CML patients with deep molecular response, and “make treatment-free remission legitimate as a criterion of treatment evaluation in the future,” the investigators concluded, noting that the possibility of improved results in patients treated with second-generation tyrosine kinase inhibitors as first- or second-line therapy is currently being evaluated in ongoing discontinuation trials.
Imatinib discontinuation is safe in patients with chronic myeloid leukemia (CML) who have sustained deep molecular response with no late molecular recurrence, according to long-term follow-up of the French Stop Imatinib Study (STIM1).
Over a median follow-up of 77 months after treatment discontinuation in 100 patients with CML who had undetectable minimal residual disease (UMRD) for at least 2 years, 61 lost UMRD after a median of 2.5 months, and 1 died with UMRD at 10 months, Gabriel Etienne, MD, of Institut Bergonie, Bordeaux, France, and colleagues reported online in the Journal of Clinical Oncology.
Of the 61 patients who lost UMRD, 57 restarted treatment and 55 achieved a second UMRD at a median of 4.3 months. The median time to second UMRD in patients with molecular recurrence with or without loss of major molecular response at the time of relapse was 4.2 months and 5 months, respectively. At a median of 73 months, none of the patients with molecular recurrence experienced CML progression. The rate of molecular recurrence-free survival overall was 43% at 6 months, 40% at 18 months, and 38% at 60 months, the investigators reported (2016 Oct. 3. doi: 10.1200/JCO.2016.68.2914).
These final long-term results of the STIM1 trial confirm the safety of imatinib discontinuation in CML patients with deep molecular response, and “make treatment-free remission legitimate as a criterion of treatment evaluation in the future,” the investigators concluded, noting that the possibility of improved results in patients treated with second-generation tyrosine kinase inhibitors as first- or second-line therapy is currently being evaluated in ongoing discontinuation trials.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: The rate of molecular recurrence-free survival overall was 43% at 24 months, 40% at 18 months, and 38% at 60 months.
Data source: Long-term follow-up of 100 patients from the STIM1 trial.
Disclosures: STIM1 was supported by grants from the French Ministry of Health Programme Hospitalier de Recherche and by the Institut National du Cancer. Dr. Etienne reported financial relationships with Novartis, Bristol-Myers Squibb, and ARIAD Pharmaceuticals. Coauthors reported relationships with several pharmaceutical companies.
2016 Pediatric Hospital Medicine Award Winners Announced
Congratulations to the recipients of the 2016 Pediatric Hospital Medicine Awards, who were recently recognized at the 2016 Pediatric Hospital Medicine meeting in Chicago. The awards are presented to pediatric hospitalists who make exemplary contributions to hospital medicine, quality improvement, and patient care.
The awards are presented in four categories:
Safety and Quality Improvement
Recipient: Kavita Parikh, MD, Children’s National Medical Center, Washington, D.C.
Dr. Parikh is a member of the Value in Inpatient Pediatrics Network and has worked with the group to improve the care of community-acquired pneumonia. The group has enrolled more than 50 hospitals around the country and one international site to standardize care so that all children hospitalized with pneumonia can receive the same high-quality care, including the use of narrow-spectrum antibiotics.
Educational Achievement and Innovation
Recipient: H. Barrett Fromme, MD, University of Chicago
Dr. Fromme is well known as a leader in pediatric medical education and was instrumental in establishing the Pediatric National Nighttime Curriculum, which includes approximately 75 percent of all residency programs across the U.S. She also led the Advancing Pediatric Educator Excellence Teaching Program for hospitalists, which helps develop their teaching skills. Dr. Fromme has also been named a Master Educator at the University of Chicago Academy of Distinguished Medical Educators.
Research Excellence
Recipient: Derek Williams, MD, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville
Dr. Williams is a pediatric hospitalist whose research activities have focused on respiratory infections in hospitalized children. He has received multiple grants and awards from the Centers for Disease Control and Prevention, National Institutes of Health, and Patient-Centered Outcomes Research Institute and has served as the lead investigator at his institution for the CDC-sponsored study entitled Etiology of Pneumonia in the Community (EPIC), which has generated several publications, including in The New England Journal of Medicine.
Lifetime Achievement
Recipient: Ken Roberts, MD, chairman emeritus, University of North Carolina, Chapel Hill
While he is now retired, Dr. Roberts has served as a mentor to many pediatric hospitalists throughout his storied career and has more than 200 publications, including one in Pediatrics called “A Hospitalist Movement? Where to?”
Congratulations to the recipients of the 2016 Pediatric Hospital Medicine Awards, who were recently recognized at the 2016 Pediatric Hospital Medicine meeting in Chicago. The awards are presented to pediatric hospitalists who make exemplary contributions to hospital medicine, quality improvement, and patient care.
The awards are presented in four categories:
Safety and Quality Improvement
Recipient: Kavita Parikh, MD, Children’s National Medical Center, Washington, D.C.
Dr. Parikh is a member of the Value in Inpatient Pediatrics Network and has worked with the group to improve the care of community-acquired pneumonia. The group has enrolled more than 50 hospitals around the country and one international site to standardize care so that all children hospitalized with pneumonia can receive the same high-quality care, including the use of narrow-spectrum antibiotics.
Educational Achievement and Innovation
Recipient: H. Barrett Fromme, MD, University of Chicago
Dr. Fromme is well known as a leader in pediatric medical education and was instrumental in establishing the Pediatric National Nighttime Curriculum, which includes approximately 75 percent of all residency programs across the U.S. She also led the Advancing Pediatric Educator Excellence Teaching Program for hospitalists, which helps develop their teaching skills. Dr. Fromme has also been named a Master Educator at the University of Chicago Academy of Distinguished Medical Educators.
Research Excellence
Recipient: Derek Williams, MD, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville
Dr. Williams is a pediatric hospitalist whose research activities have focused on respiratory infections in hospitalized children. He has received multiple grants and awards from the Centers for Disease Control and Prevention, National Institutes of Health, and Patient-Centered Outcomes Research Institute and has served as the lead investigator at his institution for the CDC-sponsored study entitled Etiology of Pneumonia in the Community (EPIC), which has generated several publications, including in The New England Journal of Medicine.
Lifetime Achievement
Recipient: Ken Roberts, MD, chairman emeritus, University of North Carolina, Chapel Hill
While he is now retired, Dr. Roberts has served as a mentor to many pediatric hospitalists throughout his storied career and has more than 200 publications, including one in Pediatrics called “A Hospitalist Movement? Where to?”
Congratulations to the recipients of the 2016 Pediatric Hospital Medicine Awards, who were recently recognized at the 2016 Pediatric Hospital Medicine meeting in Chicago. The awards are presented to pediatric hospitalists who make exemplary contributions to hospital medicine, quality improvement, and patient care.
The awards are presented in four categories:
Safety and Quality Improvement
Recipient: Kavita Parikh, MD, Children’s National Medical Center, Washington, D.C.
Dr. Parikh is a member of the Value in Inpatient Pediatrics Network and has worked with the group to improve the care of community-acquired pneumonia. The group has enrolled more than 50 hospitals around the country and one international site to standardize care so that all children hospitalized with pneumonia can receive the same high-quality care, including the use of narrow-spectrum antibiotics.
Educational Achievement and Innovation
Recipient: H. Barrett Fromme, MD, University of Chicago
Dr. Fromme is well known as a leader in pediatric medical education and was instrumental in establishing the Pediatric National Nighttime Curriculum, which includes approximately 75 percent of all residency programs across the U.S. She also led the Advancing Pediatric Educator Excellence Teaching Program for hospitalists, which helps develop their teaching skills. Dr. Fromme has also been named a Master Educator at the University of Chicago Academy of Distinguished Medical Educators.
Research Excellence
Recipient: Derek Williams, MD, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville
Dr. Williams is a pediatric hospitalist whose research activities have focused on respiratory infections in hospitalized children. He has received multiple grants and awards from the Centers for Disease Control and Prevention, National Institutes of Health, and Patient-Centered Outcomes Research Institute and has served as the lead investigator at his institution for the CDC-sponsored study entitled Etiology of Pneumonia in the Community (EPIC), which has generated several publications, including in The New England Journal of Medicine.
Lifetime Achievement
Recipient: Ken Roberts, MD, chairman emeritus, University of North Carolina, Chapel Hill
While he is now retired, Dr. Roberts has served as a mentor to many pediatric hospitalists throughout his storied career and has more than 200 publications, including one in Pediatrics called “A Hospitalist Movement? Where to?”
Prenatal SSRI exposure linked to speech, language disorders
Selective serotonin reuptake inhibitors taken during pregnancy are linked to a 37% increased risk of speech and language disorders in the children prenatally exposed to them, according to a prospective birth cohort study.
That risk occurs when children exposed prenatally are compared with children whose mothers did not take SSRIs but who had a diagnosis for which the antidepressants are indicated.
“The finding was observed only in offspring of mothers who purchased at least two SSRI prescriptions during pregnancy,” reported Alan S. Brown, MD, of New York State Psychiatric Institute in New York City, and his associates (JAMA Psychiatry. 2016 Oct 12. doi: 10.1001/jamapsychiatry.2016.2594). “This finding is particularly noteworthy because these women were more likely to have taken these medications and were exposed for a longer period and to larger amounts of SSRIs during pregnancy, compared with women who filled only one prescription.”
From among an initial cohort of 845,345 pregnant women in Finland, the researchers followed a final cohort of 56,340 offspring. Most of the children (86.6%) were 9 years old or younger at the end of study follow-up, running from 1996 to 2010, and the oldest children were aged 14 years. The researchers used Finland’s national registries to determine the children’s and mothers’ diagnoses and the mothers’ history of prescriptions from 30 days before pregnancy through delivery.
Among all children, 15,596 children were born to women who took SSRIs for depression or another SSRI-indicated psychiatric condition, and 31,207 children were born to mothers who had neither a psychiatric diagnosis nor a history of taking SSRIs during pregnancy. The remaining 9,537 children had mothers with a psychiatric diagnosis but who did not take SSRIs during pregnancy.
The average ages of the children at diagnosis were 4.4 years for speech or language disorders, 3.6 years for scholastic problems, and 7.7 years for motor disorders. When the researchers compared the children prenatally exposed to SSRIs to the children of mothers with a depression-related diagnosis but not taking SSRIs during pregnancy, the rates of scholastic or motor disorders did not differ.
For language and speech disorders, however, children whose mothers purchased two SSRI prescriptions had a 37% increased risk of a disorder, compared with children whose mothers had a diagnosis but did not purchase SSRIs. Without the requirement of at least two prescriptions, the statistical difference did not exist.
That increased risk occurred after adjustment for sex, mother’s parity, marital status, socioeconomic status, place of residence, both parents’ ages, the children’s gestational age at birth, prenatal exposure to antiepileptic drugs, exposure to anxiolytics/sedatives, history of chronic diseases, death of the child’s parent, mother’s country of birth, maternal smoking or substance abuse, and the psychiatric history of both parents. Data on maternal alcohol consumption were unavailable. Both the children exposed to SSRIs and the children of unmedicated mothers with a psychiatric condition had a higher risk of speech and language disorders.
The research was funded by the National Institutes of Health; the Sackler Foundation of Columbia University, New York; and the University of Turku (Finland). One of the researchers, David Gyllenberg, MD, reported receiving research funding from the Sigrid Juselius Foundation, the Foundation for Pediatric Research in Finland, and the Finnish Medical Foundation. No other conflicts of interest were disclosed.
Alan S. Brown, MD, and his associates examined a great deal of data, but the clinical implications of their findings are fuzzy, wrote Lee S. Cohen, MD, and Ruta Nonacs, MD, in an accompanying editorial (JAMA Psychiatry. 2016 Oct 12. doi: 10.1001/jamapsychiatry.2016.2705).
“The frequency of speech/language problems following referral to specialized health care services are relatively small; disorders occurred in 1.6% of patients from the SSRI-exposed group, 1.9% from the unmedicated group, and 1.0% from the nonexposed group,” Dr. Cohen and Dr. Nonacs wrote. “Are the data presented a signal of concern requiring further study or just background noise?”
Dr. Cohen has received support from several companies, including Cephalon, Takeda/Lundbeck Pharmaceuticals, GlaxoSmithKline, and JayMac Pharmaceuticals. Dr. Nonacs reported no disclosures. Dr. Cohen and Dr. Nonacs are affiliated with the department of psychiatry at Massachusetts General Hospital and Harvard Medical School, both in Boston.
Alan S. Brown, MD, and his associates examined a great deal of data, but the clinical implications of their findings are fuzzy, wrote Lee S. Cohen, MD, and Ruta Nonacs, MD, in an accompanying editorial (JAMA Psychiatry. 2016 Oct 12. doi: 10.1001/jamapsychiatry.2016.2705).
“The frequency of speech/language problems following referral to specialized health care services are relatively small; disorders occurred in 1.6% of patients from the SSRI-exposed group, 1.9% from the unmedicated group, and 1.0% from the nonexposed group,” Dr. Cohen and Dr. Nonacs wrote. “Are the data presented a signal of concern requiring further study or just background noise?”
Dr. Cohen has received support from several companies, including Cephalon, Takeda/Lundbeck Pharmaceuticals, GlaxoSmithKline, and JayMac Pharmaceuticals. Dr. Nonacs reported no disclosures. Dr. Cohen and Dr. Nonacs are affiliated with the department of psychiatry at Massachusetts General Hospital and Harvard Medical School, both in Boston.
Alan S. Brown, MD, and his associates examined a great deal of data, but the clinical implications of their findings are fuzzy, wrote Lee S. Cohen, MD, and Ruta Nonacs, MD, in an accompanying editorial (JAMA Psychiatry. 2016 Oct 12. doi: 10.1001/jamapsychiatry.2016.2705).
“The frequency of speech/language problems following referral to specialized health care services are relatively small; disorders occurred in 1.6% of patients from the SSRI-exposed group, 1.9% from the unmedicated group, and 1.0% from the nonexposed group,” Dr. Cohen and Dr. Nonacs wrote. “Are the data presented a signal of concern requiring further study or just background noise?”
Dr. Cohen has received support from several companies, including Cephalon, Takeda/Lundbeck Pharmaceuticals, GlaxoSmithKline, and JayMac Pharmaceuticals. Dr. Nonacs reported no disclosures. Dr. Cohen and Dr. Nonacs are affiliated with the department of psychiatry at Massachusetts General Hospital and Harvard Medical School, both in Boston.
Selective serotonin reuptake inhibitors taken during pregnancy are linked to a 37% increased risk of speech and language disorders in the children prenatally exposed to them, according to a prospective birth cohort study.
That risk occurs when children exposed prenatally are compared with children whose mothers did not take SSRIs but who had a diagnosis for which the antidepressants are indicated.
“The finding was observed only in offspring of mothers who purchased at least two SSRI prescriptions during pregnancy,” reported Alan S. Brown, MD, of New York State Psychiatric Institute in New York City, and his associates (JAMA Psychiatry. 2016 Oct 12. doi: 10.1001/jamapsychiatry.2016.2594). “This finding is particularly noteworthy because these women were more likely to have taken these medications and were exposed for a longer period and to larger amounts of SSRIs during pregnancy, compared with women who filled only one prescription.”
From among an initial cohort of 845,345 pregnant women in Finland, the researchers followed a final cohort of 56,340 offspring. Most of the children (86.6%) were 9 years old or younger at the end of study follow-up, running from 1996 to 2010, and the oldest children were aged 14 years. The researchers used Finland’s national registries to determine the children’s and mothers’ diagnoses and the mothers’ history of prescriptions from 30 days before pregnancy through delivery.
Among all children, 15,596 children were born to women who took SSRIs for depression or another SSRI-indicated psychiatric condition, and 31,207 children were born to mothers who had neither a psychiatric diagnosis nor a history of taking SSRIs during pregnancy. The remaining 9,537 children had mothers with a psychiatric diagnosis but who did not take SSRIs during pregnancy.
The average ages of the children at diagnosis were 4.4 years for speech or language disorders, 3.6 years for scholastic problems, and 7.7 years for motor disorders. When the researchers compared the children prenatally exposed to SSRIs to the children of mothers with a depression-related diagnosis but not taking SSRIs during pregnancy, the rates of scholastic or motor disorders did not differ.
For language and speech disorders, however, children whose mothers purchased two SSRI prescriptions had a 37% increased risk of a disorder, compared with children whose mothers had a diagnosis but did not purchase SSRIs. Without the requirement of at least two prescriptions, the statistical difference did not exist.
That increased risk occurred after adjustment for sex, mother’s parity, marital status, socioeconomic status, place of residence, both parents’ ages, the children’s gestational age at birth, prenatal exposure to antiepileptic drugs, exposure to anxiolytics/sedatives, history of chronic diseases, death of the child’s parent, mother’s country of birth, maternal smoking or substance abuse, and the psychiatric history of both parents. Data on maternal alcohol consumption were unavailable. Both the children exposed to SSRIs and the children of unmedicated mothers with a psychiatric condition had a higher risk of speech and language disorders.
The research was funded by the National Institutes of Health; the Sackler Foundation of Columbia University, New York; and the University of Turku (Finland). One of the researchers, David Gyllenberg, MD, reported receiving research funding from the Sigrid Juselius Foundation, the Foundation for Pediatric Research in Finland, and the Finnish Medical Foundation. No other conflicts of interest were disclosed.
Selective serotonin reuptake inhibitors taken during pregnancy are linked to a 37% increased risk of speech and language disorders in the children prenatally exposed to them, according to a prospective birth cohort study.
That risk occurs when children exposed prenatally are compared with children whose mothers did not take SSRIs but who had a diagnosis for which the antidepressants are indicated.
“The finding was observed only in offspring of mothers who purchased at least two SSRI prescriptions during pregnancy,” reported Alan S. Brown, MD, of New York State Psychiatric Institute in New York City, and his associates (JAMA Psychiatry. 2016 Oct 12. doi: 10.1001/jamapsychiatry.2016.2594). “This finding is particularly noteworthy because these women were more likely to have taken these medications and were exposed for a longer period and to larger amounts of SSRIs during pregnancy, compared with women who filled only one prescription.”
From among an initial cohort of 845,345 pregnant women in Finland, the researchers followed a final cohort of 56,340 offspring. Most of the children (86.6%) were 9 years old or younger at the end of study follow-up, running from 1996 to 2010, and the oldest children were aged 14 years. The researchers used Finland’s national registries to determine the children’s and mothers’ diagnoses and the mothers’ history of prescriptions from 30 days before pregnancy through delivery.
Among all children, 15,596 children were born to women who took SSRIs for depression or another SSRI-indicated psychiatric condition, and 31,207 children were born to mothers who had neither a psychiatric diagnosis nor a history of taking SSRIs during pregnancy. The remaining 9,537 children had mothers with a psychiatric diagnosis but who did not take SSRIs during pregnancy.
The average ages of the children at diagnosis were 4.4 years for speech or language disorders, 3.6 years for scholastic problems, and 7.7 years for motor disorders. When the researchers compared the children prenatally exposed to SSRIs to the children of mothers with a depression-related diagnosis but not taking SSRIs during pregnancy, the rates of scholastic or motor disorders did not differ.
For language and speech disorders, however, children whose mothers purchased two SSRI prescriptions had a 37% increased risk of a disorder, compared with children whose mothers had a diagnosis but did not purchase SSRIs. Without the requirement of at least two prescriptions, the statistical difference did not exist.
That increased risk occurred after adjustment for sex, mother’s parity, marital status, socioeconomic status, place of residence, both parents’ ages, the children’s gestational age at birth, prenatal exposure to antiepileptic drugs, exposure to anxiolytics/sedatives, history of chronic diseases, death of the child’s parent, mother’s country of birth, maternal smoking or substance abuse, and the psychiatric history of both parents. Data on maternal alcohol consumption were unavailable. Both the children exposed to SSRIs and the children of unmedicated mothers with a psychiatric condition had a higher risk of speech and language disorders.
The research was funded by the National Institutes of Health; the Sackler Foundation of Columbia University, New York; and the University of Turku (Finland). One of the researchers, David Gyllenberg, MD, reported receiving research funding from the Sigrid Juselius Foundation, the Foundation for Pediatric Research in Finland, and the Finnish Medical Foundation. No other conflicts of interest were disclosed.
FROM JAMA PSYCHIATRY
Key clinical point: Selective serotonin reuptake inhibitors taken during pregnancy may increase the risk of speech/language disorders in the offspring.
Major finding: Children of mothers taking SSRIs during pregnancy had a 37% increased risk of speech/language disorders, compared with children of unmedicated mothers with a diagnosis of depression.
Data source: The findings are based on a prospective birth cohort involving 56,340 children tracked in Finland from 1996 to 2010.
Disclosures: The research was funded by the National Institutes of Health; the Sackler Foundation of Columbia University, New York; and the University of Turku (Finland). One of the researchers, David Gyllenberg, MD, reported receiving research funding from the Sigrid Juselius Foundation, the Foundation for Pediatric Research in Finland, and the Finnish Medical Foundation. No other conflicts of interest were disclosed.
Diluted Apple Juice Versus Electrolyte Solution in Gastroenteritis
Clinical Question: Is diluted apple juice inferior to apple-flavored electrolyte oral rehydration solution in children with mild dehydration due to acute gastroenteritis?
Background: In the setting of acute gastroenteritis, teaching has classically been that the simple sugars in juice and sports drinks can worsen diarrhea and that they could cause hyponatremia since they are not isotonic. Due to this, the American Academy of Pediatrics recommends an electrolyte oral rehydration solution for children with dehydration and acute gastroenteritis. These solutions are more expensive and less palatable than juices. The authors sought to determine if diluted apple juice versus electrolyte oral rehydration fluid decreased the need for IV fluids, hospitalization, return visits, prolonged symptoms, or ongoing dehydration in mildly dehydrated children with acute gastroenteritis.
Study Design: Randomized single-blind non-inferiority prospective trial.
Setting: Single large tertiary-care pediatric emergency room.
Synopsis: Over five years, 3,668 patients were identified. Inclusion criteria were age >6 months or 8 kg of weight; Clinical Dehydration Scale score
Patients were challenged with small aliquots of these solutions and given ondansetron if they vomited. Upon discharge, they were sent home with 2 L of their solution. In the control arm, families were instructed to use this solution to make up for any ongoing losses. In the experimental arm, families were instructed to provide whatever fluids they would prefer. Follow-up was via phone, mail, and in-person reassessments. Patients were considered to have failed treatment if they required hospitalization, IV fluids, or a repeat unscheduled visit to a physician or experienced diarrhea lasting more than seven days or worsening dehydration on follow-up.
In the experimental arm, 16.7% of patients failed treatment (95% CI, 12.8%–21.2%) compared to 25% in the control arm (95% CI, 20.4%–30.1%; P < 0.001 for non-inferiority, P = .006 for superiority). The experimental arm also required IV fluids (2.5% versus 9%) significantly less often, though without a significantly decreased rate of hospitalization. These differences were present primarily in children >24 months old. No difference in the frequency of diarrheal stools was found, and no episodes of significant hyponatremia occurred.
Bottom Line: Giving children with mild dehydration due to acute gastroenteritis diluted apple juice and preferred fluids rather than the currently recommended electrolyte oral rehydration solution leads to decreased treatment failures and decreased need for IV fluids. There was no evidence of worsened diarrhea or significant hyponatremia.
Citation: Freedman SB, Willan AR, Boutis K, Schuh S. Effect of dilute apple juice and preferred fluids vs electrolyte maintenance solution on treatment failure among children with mild gastroenteritis: a randomized clinical trial. JAMA. 2016;315(18):1966-1974. doi:10.1001/jama.2016.5352.
Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. Dupont Hospital for Children in Wilmington, Del., and assistant professor of pediatrics at Thomas Jefferson Medical College in Philadelphia.
Clinical Question: Is diluted apple juice inferior to apple-flavored electrolyte oral rehydration solution in children with mild dehydration due to acute gastroenteritis?
Background: In the setting of acute gastroenteritis, teaching has classically been that the simple sugars in juice and sports drinks can worsen diarrhea and that they could cause hyponatremia since they are not isotonic. Due to this, the American Academy of Pediatrics recommends an electrolyte oral rehydration solution for children with dehydration and acute gastroenteritis. These solutions are more expensive and less palatable than juices. The authors sought to determine if diluted apple juice versus electrolyte oral rehydration fluid decreased the need for IV fluids, hospitalization, return visits, prolonged symptoms, or ongoing dehydration in mildly dehydrated children with acute gastroenteritis.
Study Design: Randomized single-blind non-inferiority prospective trial.
Setting: Single large tertiary-care pediatric emergency room.
Synopsis: Over five years, 3,668 patients were identified. Inclusion criteria were age >6 months or 8 kg of weight; Clinical Dehydration Scale score
Patients were challenged with small aliquots of these solutions and given ondansetron if they vomited. Upon discharge, they were sent home with 2 L of their solution. In the control arm, families were instructed to use this solution to make up for any ongoing losses. In the experimental arm, families were instructed to provide whatever fluids they would prefer. Follow-up was via phone, mail, and in-person reassessments. Patients were considered to have failed treatment if they required hospitalization, IV fluids, or a repeat unscheduled visit to a physician or experienced diarrhea lasting more than seven days or worsening dehydration on follow-up.
In the experimental arm, 16.7% of patients failed treatment (95% CI, 12.8%–21.2%) compared to 25% in the control arm (95% CI, 20.4%–30.1%; P < 0.001 for non-inferiority, P = .006 for superiority). The experimental arm also required IV fluids (2.5% versus 9%) significantly less often, though without a significantly decreased rate of hospitalization. These differences were present primarily in children >24 months old. No difference in the frequency of diarrheal stools was found, and no episodes of significant hyponatremia occurred.
Bottom Line: Giving children with mild dehydration due to acute gastroenteritis diluted apple juice and preferred fluids rather than the currently recommended electrolyte oral rehydration solution leads to decreased treatment failures and decreased need for IV fluids. There was no evidence of worsened diarrhea or significant hyponatremia.
Citation: Freedman SB, Willan AR, Boutis K, Schuh S. Effect of dilute apple juice and preferred fluids vs electrolyte maintenance solution on treatment failure among children with mild gastroenteritis: a randomized clinical trial. JAMA. 2016;315(18):1966-1974. doi:10.1001/jama.2016.5352.
Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. Dupont Hospital for Children in Wilmington, Del., and assistant professor of pediatrics at Thomas Jefferson Medical College in Philadelphia.
Clinical Question: Is diluted apple juice inferior to apple-flavored electrolyte oral rehydration solution in children with mild dehydration due to acute gastroenteritis?
Background: In the setting of acute gastroenteritis, teaching has classically been that the simple sugars in juice and sports drinks can worsen diarrhea and that they could cause hyponatremia since they are not isotonic. Due to this, the American Academy of Pediatrics recommends an electrolyte oral rehydration solution for children with dehydration and acute gastroenteritis. These solutions are more expensive and less palatable than juices. The authors sought to determine if diluted apple juice versus electrolyte oral rehydration fluid decreased the need for IV fluids, hospitalization, return visits, prolonged symptoms, or ongoing dehydration in mildly dehydrated children with acute gastroenteritis.
Study Design: Randomized single-blind non-inferiority prospective trial.
Setting: Single large tertiary-care pediatric emergency room.
Synopsis: Over five years, 3,668 patients were identified. Inclusion criteria were age >6 months or 8 kg of weight; Clinical Dehydration Scale score
Patients were challenged with small aliquots of these solutions and given ondansetron if they vomited. Upon discharge, they were sent home with 2 L of their solution. In the control arm, families were instructed to use this solution to make up for any ongoing losses. In the experimental arm, families were instructed to provide whatever fluids they would prefer. Follow-up was via phone, mail, and in-person reassessments. Patients were considered to have failed treatment if they required hospitalization, IV fluids, or a repeat unscheduled visit to a physician or experienced diarrhea lasting more than seven days or worsening dehydration on follow-up.
In the experimental arm, 16.7% of patients failed treatment (95% CI, 12.8%–21.2%) compared to 25% in the control arm (95% CI, 20.4%–30.1%; P < 0.001 for non-inferiority, P = .006 for superiority). The experimental arm also required IV fluids (2.5% versus 9%) significantly less often, though without a significantly decreased rate of hospitalization. These differences were present primarily in children >24 months old. No difference in the frequency of diarrheal stools was found, and no episodes of significant hyponatremia occurred.
Bottom Line: Giving children with mild dehydration due to acute gastroenteritis diluted apple juice and preferred fluids rather than the currently recommended electrolyte oral rehydration solution leads to decreased treatment failures and decreased need for IV fluids. There was no evidence of worsened diarrhea or significant hyponatremia.
Citation: Freedman SB, Willan AR, Boutis K, Schuh S. Effect of dilute apple juice and preferred fluids vs electrolyte maintenance solution on treatment failure among children with mild gastroenteritis: a randomized clinical trial. JAMA. 2016;315(18):1966-1974. doi:10.1001/jama.2016.5352.
Dr. Stubblefield is a pediatric hospitalist at Nemours/Alfred I. Dupont Hospital for Children in Wilmington, Del., and assistant professor of pediatrics at Thomas Jefferson Medical College in Philadelphia.
Underlay mesh for hernia repair yields better postop pain outcomes
Chronic pain that typically follows primary inguinal hernia repair can be significantly reduced by adopting procedures that use underlay mesh rather than overlay mesh, according to a new study published in the Journal of Surgical Research.
“Although chronic pain and discomfort is still one of the greatest problems after inguinal hernia repair due to the fact that it interferes with patients’ quality of life, there are very little data available from previous studies concerning presentation, diagnosis, and modes of treatment of this issue. In particular, the data in the literature concerning the cause of chronic pain are very limited,” wrote the authors, led by Hideyuki Takata, MD, of Nippon Medical School, Tokyo.
Dr. Takata and his coinvestigators looked at patients who underwent a mesh repair operation for primary inguinal hernia at a single institution – Nippon Medical School – between May 2011 and May 2014. All patients were aged 40 years or older, and the overwhelming majority were male. A total of 334 patients were identified, with 378 lesions among them; all patients’ operations were performed via the Lichtenstein (onlay mesh only), Ultrapro Plug (onlay and plug mesh), modified Kugel Patch (onlay and underlay mesh), or laparoscopic transabdominal preperitoneal (underlay mesh only, TAPP) surgical routes.
Forty-four patients had bilateral lesions, 152 had lesions on the right, and 138 on the left; 76 patients received Lichtenstein operations, 85 received Ultrapro Plug, 156 received modified Kugel Patch, and 61 received TAPP. (J Surg Res 2016 Aug 11. doi: 10.1016/j.jss.2016.08.027).
Patients received questionnaires at 2-3 weeks, 3 months, and 6 months after the operation to determine their pain and discomfort levels. Responses for all 378 lesions (100%) were received at the first follow-up, with questionnaires received for 229 lesions (60.5%) at the 3-month follow-up and 249 lesions (65.9%) at the 6-month follow-up. Of those who responded at the 6-month follow-up, 46 received Lichtenstein, 59 received Ultrapro Plug, 101 received modified Kugel Patch, and 61 received TAPP.
No patients reported moderate or severe pain while at rest. Mild pain was reported by 11 (4.4%) of all respondents; 0 of those who received Lichtenstein, 4 (6.8%) of those who received Ultrapro Plug, 7 (6.9%) of those who received modified Kugel Patch, and 0 of those who received TAPP (P less than .01).
Pain with movement was reported in 35 (14.1%) of respondents: 6 (13.0%) of those who received Lichtenstein, 7 (11.9%) of those who received Ultrapro Plug, 20 (19.8%) of those who received modified Kugel Patch, and 2 (4.7%) of those who received TAPP (P less than .05). One respondent reported experiencing moderate pain with movement, and that individual received Ultrapro Plug (1.7%). No patients reported experiencing severe pain with movement.
“We conclude that the sensory nerves in the inguinal region should be kept away from the mesh to prevent the development of chronic pain and discomfort,” the investigators concluded. “Further study is required to determine the mechanism involved in the generation of chronic pain and discomfort to improve the patient’s quality of life after primary inguinal hernia repair.”
No funding source was disclosed for this study. Dr. Takata and his coauthors did not report any relevant financial disclosures.
Chronic pain that typically follows primary inguinal hernia repair can be significantly reduced by adopting procedures that use underlay mesh rather than overlay mesh, according to a new study published in the Journal of Surgical Research.
“Although chronic pain and discomfort is still one of the greatest problems after inguinal hernia repair due to the fact that it interferes with patients’ quality of life, there are very little data available from previous studies concerning presentation, diagnosis, and modes of treatment of this issue. In particular, the data in the literature concerning the cause of chronic pain are very limited,” wrote the authors, led by Hideyuki Takata, MD, of Nippon Medical School, Tokyo.
Dr. Takata and his coinvestigators looked at patients who underwent a mesh repair operation for primary inguinal hernia at a single institution – Nippon Medical School – between May 2011 and May 2014. All patients were aged 40 years or older, and the overwhelming majority were male. A total of 334 patients were identified, with 378 lesions among them; all patients’ operations were performed via the Lichtenstein (onlay mesh only), Ultrapro Plug (onlay and plug mesh), modified Kugel Patch (onlay and underlay mesh), or laparoscopic transabdominal preperitoneal (underlay mesh only, TAPP) surgical routes.
Forty-four patients had bilateral lesions, 152 had lesions on the right, and 138 on the left; 76 patients received Lichtenstein operations, 85 received Ultrapro Plug, 156 received modified Kugel Patch, and 61 received TAPP. (J Surg Res 2016 Aug 11. doi: 10.1016/j.jss.2016.08.027).
Patients received questionnaires at 2-3 weeks, 3 months, and 6 months after the operation to determine their pain and discomfort levels. Responses for all 378 lesions (100%) were received at the first follow-up, with questionnaires received for 229 lesions (60.5%) at the 3-month follow-up and 249 lesions (65.9%) at the 6-month follow-up. Of those who responded at the 6-month follow-up, 46 received Lichtenstein, 59 received Ultrapro Plug, 101 received modified Kugel Patch, and 61 received TAPP.
No patients reported moderate or severe pain while at rest. Mild pain was reported by 11 (4.4%) of all respondents; 0 of those who received Lichtenstein, 4 (6.8%) of those who received Ultrapro Plug, 7 (6.9%) of those who received modified Kugel Patch, and 0 of those who received TAPP (P less than .01).
Pain with movement was reported in 35 (14.1%) of respondents: 6 (13.0%) of those who received Lichtenstein, 7 (11.9%) of those who received Ultrapro Plug, 20 (19.8%) of those who received modified Kugel Patch, and 2 (4.7%) of those who received TAPP (P less than .05). One respondent reported experiencing moderate pain with movement, and that individual received Ultrapro Plug (1.7%). No patients reported experiencing severe pain with movement.
“We conclude that the sensory nerves in the inguinal region should be kept away from the mesh to prevent the development of chronic pain and discomfort,” the investigators concluded. “Further study is required to determine the mechanism involved in the generation of chronic pain and discomfort to improve the patient’s quality of life after primary inguinal hernia repair.”
No funding source was disclosed for this study. Dr. Takata and his coauthors did not report any relevant financial disclosures.
Chronic pain that typically follows primary inguinal hernia repair can be significantly reduced by adopting procedures that use underlay mesh rather than overlay mesh, according to a new study published in the Journal of Surgical Research.
“Although chronic pain and discomfort is still one of the greatest problems after inguinal hernia repair due to the fact that it interferes with patients’ quality of life, there are very little data available from previous studies concerning presentation, diagnosis, and modes of treatment of this issue. In particular, the data in the literature concerning the cause of chronic pain are very limited,” wrote the authors, led by Hideyuki Takata, MD, of Nippon Medical School, Tokyo.
Dr. Takata and his coinvestigators looked at patients who underwent a mesh repair operation for primary inguinal hernia at a single institution – Nippon Medical School – between May 2011 and May 2014. All patients were aged 40 years or older, and the overwhelming majority were male. A total of 334 patients were identified, with 378 lesions among them; all patients’ operations were performed via the Lichtenstein (onlay mesh only), Ultrapro Plug (onlay and plug mesh), modified Kugel Patch (onlay and underlay mesh), or laparoscopic transabdominal preperitoneal (underlay mesh only, TAPP) surgical routes.
Forty-four patients had bilateral lesions, 152 had lesions on the right, and 138 on the left; 76 patients received Lichtenstein operations, 85 received Ultrapro Plug, 156 received modified Kugel Patch, and 61 received TAPP. (J Surg Res 2016 Aug 11. doi: 10.1016/j.jss.2016.08.027).
Patients received questionnaires at 2-3 weeks, 3 months, and 6 months after the operation to determine their pain and discomfort levels. Responses for all 378 lesions (100%) were received at the first follow-up, with questionnaires received for 229 lesions (60.5%) at the 3-month follow-up and 249 lesions (65.9%) at the 6-month follow-up. Of those who responded at the 6-month follow-up, 46 received Lichtenstein, 59 received Ultrapro Plug, 101 received modified Kugel Patch, and 61 received TAPP.
No patients reported moderate or severe pain while at rest. Mild pain was reported by 11 (4.4%) of all respondents; 0 of those who received Lichtenstein, 4 (6.8%) of those who received Ultrapro Plug, 7 (6.9%) of those who received modified Kugel Patch, and 0 of those who received TAPP (P less than .01).
Pain with movement was reported in 35 (14.1%) of respondents: 6 (13.0%) of those who received Lichtenstein, 7 (11.9%) of those who received Ultrapro Plug, 20 (19.8%) of those who received modified Kugel Patch, and 2 (4.7%) of those who received TAPP (P less than .05). One respondent reported experiencing moderate pain with movement, and that individual received Ultrapro Plug (1.7%). No patients reported experiencing severe pain with movement.
“We conclude that the sensory nerves in the inguinal region should be kept away from the mesh to prevent the development of chronic pain and discomfort,” the investigators concluded. “Further study is required to determine the mechanism involved in the generation of chronic pain and discomfort to improve the patient’s quality of life after primary inguinal hernia repair.”
No funding source was disclosed for this study. Dr. Takata and his coauthors did not report any relevant financial disclosures.
Key clinical point:
Major finding: Mild pain at rest and with movement were both significantly lower in patients who received TAPP than in those who received one of three other surgical procedures.
Data source: Retrospective analysis of 334 primary inguinal hernia patients with 378 lesions undergoing TAPP or Lichtenstein procedures.
Disclosures: The authors did not report any relevant financial disclosures.