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How often does risk-reducing salpingo-oophorectomy identify cancer?
Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.
The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.
said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”
Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.
BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.
When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.
During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.
To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.
They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.
The researchers evaluated adherence to recommendations by reviewing operative reports.
In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.
Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.
Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.
Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).
Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.
It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”
For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”
One of the study authors is a surgeon educator for Covidien and Medtronic.
SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.
Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.
The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.
said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”
Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.
BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.
When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.
During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.
To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.
They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.
The researchers evaluated adherence to recommendations by reviewing operative reports.
In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.
Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.
Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.
Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).
Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.
It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”
For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”
One of the study authors is a surgeon educator for Covidien and Medtronic.
SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.
Among women with BRCA mutations who underwent risk-reducing bilateral salpingo-oophorectomy, the procedure led to a cancer diagnosis in 3%, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Of 269 patients, 8 (3%) received a cancer diagnosis. In five cases, the cancer was diagnosed on final pathology, and three had immediate conversion to staging.
The data suggest that gynecologists as well as gynecologic oncologists may perform the procedure, but gynecologists may be less likely to obtain pelvic washings in accordance with guidelines for this indication.
said study author Coralee Toal, MD, of UPMC Magee-Womans Hospital in Pittsburgh. “It is often a diagnosis that is found at the time of pathology, so the initial procedure would not have been changed either way.”
Still, doctors who perform the procedure should follow recommended practices such as obtaining pelvic washings and identifying patients for the procedure within target age ranges, Dr. Toal said.
BRCA1 and BRCA2 mutations confer an increased risk of ovarian and breast cancer, but there is no effective form of ovarian cancer screening. Women with a known mutation may have a bilateral salpingo-oophorectomy to reduce the risk of cancer. The recommended age range for the procedure is 35-40 years for women with BRCA1 mutations and 40-45 years for women with BRCA2 mutations.
When the procedure is performed for this indication, various recommendations apply that may differ from those when the procedure is performed under different circumstances.
During risk-reducing bilateral salpingo-oophorectomy, the surgeon should thoroughly evaluate the abdominal cavity, obtain pelvic washings for cytology, remove at least 2 cm of the infundibulopelvic ligament, and divide the fallopian tube at the uterine cornua.
To assess the incidence of occult ovarian cancer at the time of risk-reducing bilateral salpingo-oophorectomy and surgeon adherence to recommended practices, Dr. Toal and colleagues performed a retrospective chart review.
They included patients who had a known BRCA mutation and underwent a risk-reducing bilateral salpingo-oophorectomy between July 2007 and September 2018. They excluded patients who had a suspicious adnexal mass before the procedure but not a known diagnosis, as well as patients with another malignancy or genetic syndrome.
The researchers evaluated adherence to recommendations by reviewing operative reports.
In all, they reviewed data from 269 patients. In 220 cases, a gynecologic oncologist performed the procedure, and in 49 cases a gynecologist performed the procedure.
Patients tended to be older than would be expected, said Dr. Toal. Patients with BRCA1 mutations had an average age of 46 years, and patients with BRCA2 mutations had an average age of 49 years.
Patients who received a cancer diagnosis were significantly older on average, compared with the other patients: 58 years versus 48 years.
Pelvic washings were performed during 95% of the procedures performed by a gynecologic oncologist, compared with 63% of the procedures performed by a gynecologist. In addition, patients who had the procedure performed by a gynecologist were significantly older than those who had the procedure performed by a gynecologic oncologist (49 vs. 47 years).
Miles Murphy, MD, president of the Society of Gynecologic Surgeons, asked how doctors should weigh the possibility of risk-reducing oophorectomy at the time of benign hysterectomy in patients without a family history of female cancer.
It could be that genetic testing would be appropriate for some of those patients, Dr. Toal said. It is “important to take a thorough family history to make sure that you are identifying anybody who may benefit from genetic counseling and genetic testing, where you might identify an otherwise not known mutation prior to an otherwise benign or routine surgery,” Dr. Toal said. “Then you would have the opportunity to perform this.”
For patients without known mutations, however, “we do know the benefit of ovaries remaining in situ ... including cardiac health,” she said. “You have to remember that people can die of a broken hip as well. The risk of osteoporosis and those things is not zero and in fact may be much higher than their ovarian cancer risk.”
One of the study authors is a surgeon educator for Covidien and Medtronic.
SOURCE: Newcomb LK et al. SGS 2020, Abstract 18.
FROM SGS 2020
Range of interventions reduces likelihood of infection after hysterectomy
Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
“Implementation of said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.
To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.
Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.
The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.
Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.
Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).
“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”
After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.
In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.
The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.
“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.
In addition, the study “pertains to one of CMS’s major programs to reduce and prevent health care-associated infections,” Dr. Park said at the virtual meeting. Several CMS quality indicators in 2020 relate to gynecologic surgery, including postoperative wound dehiscence rate, catheter-related UTI rate, and surgical site infection related to hysterectomy. The CMS will reduce hospital payments to institutions in the worst performing quartile for hospital-acquired infection scores by 1%.
Dr. Uppal advised that hospitals need four things to achieve similar results: a commitment from the team and leadership to reduce infections; patience; making it easy for doctors to implement the new interventions; and periodic feedback.
The process may be tedious but worth it in the end, he said.
Dr. Uppal disclosed salary support from Blue Cross Blue Shield of Michigan. A coauthor disclosed salary support from the company plus royalties from UpToDate. Dr. Park disclosed speaking for Allergan and royalties from UpToDate.
SOURCE: Uppal S et al. SGS 2020, Abstract 16.
Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
“Implementation of said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.
To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.
Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.
The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.
Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.
Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).
“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”
After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.
In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.
The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.
“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.
In addition, the study “pertains to one of CMS’s major programs to reduce and prevent health care-associated infections,” Dr. Park said at the virtual meeting. Several CMS quality indicators in 2020 relate to gynecologic surgery, including postoperative wound dehiscence rate, catheter-related UTI rate, and surgical site infection related to hysterectomy. The CMS will reduce hospital payments to institutions in the worst performing quartile for hospital-acquired infection scores by 1%.
Dr. Uppal advised that hospitals need four things to achieve similar results: a commitment from the team and leadership to reduce infections; patience; making it easy for doctors to implement the new interventions; and periodic feedback.
The process may be tedious but worth it in the end, he said.
Dr. Uppal disclosed salary support from Blue Cross Blue Shield of Michigan. A coauthor disclosed salary support from the company plus royalties from UpToDate. Dr. Park disclosed speaking for Allergan and royalties from UpToDate.
SOURCE: Uppal S et al. SGS 2020, Abstract 16.
Improving hand hygiene, optimizing antibiotic order sets, and removing catheters sooner were among the interventions associated with a decreased risk of infections after hysterectomy, according to research presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
“Implementation of said study author Shitanshu Uppal, MBBS, an ob.gyn. specializing in gynecologic oncology at the University of Michigan in Ann Arbor.
To assess the impact of quality improvement efforts on infectious morbidity after hysterectomy, Dr. Uppal and colleagues analyzed data from 1,867 hysterectomies performed between Oct. 8, 2015, and Oct. 7, 2018. Patients were at least 18 years old, younger than 90 years old, and underwent hysterectomy via any route at the University of Michigan Medical Center Hospital.
Interventions to reduce infections included the use of cefazolin as a preferred antibiotic, the addition of metronidazole to first-generation cephalosporins for antibiotic prophylaxis, subcuticular closure of open incisions, and earlier removal of Foley catheters. In addition, the institution evaluated and shared information about doctors’ hand hygiene, implemented enhanced recovery after surgery (ERAS) protocols, and held periodic meetings with doctors to discuss efforts to reduce infections. Most interventions were implemented by November 2017.
The primary outcome was overall infection rate in the 30 days after surgery for each of the 3 years included the study. Infections included superficial surgical site infections, deep infections, Clostridium difficile infections, and urinary tract infections, among others.
Patients’ baseline clinical characteristics did not differ during the 3 years studied. Length of stay decreased, which may be attributed to increased use of ERAS protocols and institution of same-day discharge in laparoscopic cases, Dr. Uppal said. The rate of malignancy on final pathology decreased from 29% in year 1 to 23% in year 3. The rate of laparoscopic surgery increased from 55% to 64%.
Infectious morbidity rates decreased from 7% in year 1 (47 infections per 644 cases) to 4% in year 3 (22 infections per 616 cases).
“We saw a reduction in infection rate in all categories,” said Dr. Uppal. “However, the reduction in urinary tract infection as well as superficial surgical site infection was most pronounced.”
After adjustment for the route of surgery, body mass index, age, malignancy on final pathology, modality of surgery, and comorbidities, performance of hysterectomy in year 3 was independently predictive of lower rates of infectious morbidity by 56%.
In addition, the standardized incidence ratio for surgical site infection as reported by the Centers for Medicare & Medicaid Services decreased. In December 2016, Michigan Medicine’s ratio was 1.057. At the end of 2018, the projected ratio was 0.243.
The interventions started on different dates, and “we are unable to conclude, from all the implemented interventions, which one worked,” Dr. Uppal noted.
“I hope the elements from this quality improvement initiative will become the standard of care in order to benefit our patients,” said Amy Park, MD, section head of female pelvic medicine and reconstructive surgery at Cleveland Clinic.
In addition, the study “pertains to one of CMS’s major programs to reduce and prevent health care-associated infections,” Dr. Park said at the virtual meeting. Several CMS quality indicators in 2020 relate to gynecologic surgery, including postoperative wound dehiscence rate, catheter-related UTI rate, and surgical site infection related to hysterectomy. The CMS will reduce hospital payments to institutions in the worst performing quartile for hospital-acquired infection scores by 1%.
Dr. Uppal advised that hospitals need four things to achieve similar results: a commitment from the team and leadership to reduce infections; patience; making it easy for doctors to implement the new interventions; and periodic feedback.
The process may be tedious but worth it in the end, he said.
Dr. Uppal disclosed salary support from Blue Cross Blue Shield of Michigan. A coauthor disclosed salary support from the company plus royalties from UpToDate. Dr. Park disclosed speaking for Allergan and royalties from UpToDate.
SOURCE: Uppal S et al. SGS 2020, Abstract 16.
FROM SGS 2020
Local analgesia before prolapse surgery may not be needed to reduce postop pain
Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.
In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.
Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.
To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.
Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
A range of procedures
Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.
The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.
Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m2. Most patients were white, and demographic variables did not significantly differ among the groups.
“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.
Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.
The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.
Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.
“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.
In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.
Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
The role of ERAS protocols
The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.
“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”
The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.
“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”
Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.
The researchers and Dr. Balgobin had no relevant financial disclosures.
SOURCE: Giugale L et al. SGS 2020, Abstract 10.
Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.
In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.
Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.
To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.
Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
A range of procedures
Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.
The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.
Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m2. Most patients were white, and demographic variables did not significantly differ among the groups.
“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.
Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.
The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.
Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.
“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.
In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.
Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
The role of ERAS protocols
The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.
“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”
The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.
“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”
Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.
The researchers and Dr. Balgobin had no relevant financial disclosures.
SOURCE: Giugale L et al. SGS 2020, Abstract 10.
Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.
In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.
Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.
To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.
Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
A range of procedures
Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.
The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.
Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m2. Most patients were white, and demographic variables did not significantly differ among the groups.
“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.
Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.
The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.
Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.
“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.
In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.
Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
The role of ERAS protocols
The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.
“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”
The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.
“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”
Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.
The researchers and Dr. Balgobin had no relevant financial disclosures.
SOURCE: Giugale L et al. SGS 2020, Abstract 10.
FROM SGS 2020
Are laser treatments better than steroids for lichen sclerosus?
Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.
Topical steroids are the standard treatment. To assess whether fractional CO2 laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.
The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.
Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.
Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.
Patients in the laser arm received three laser treatments 4-6 weeks apart.
At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.
Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.
Differences between the groups were statistically significant for all but the functional subscore.
Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.
For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.
Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.
Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.
There were no major adverse events.
The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.
“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.
“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.
The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.
Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.
The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.
SOURCE: Burkett L et al. SGS 2020, Abstract 09.
Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.
Topical steroids are the standard treatment. To assess whether fractional CO2 laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.
The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.
Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.
Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.
Patients in the laser arm received three laser treatments 4-6 weeks apart.
At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.
Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.
Differences between the groups were statistically significant for all but the functional subscore.
Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.
For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.
Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.
Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.
There were no major adverse events.
The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.
“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.
“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.
The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.
Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.
The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.
SOURCE: Burkett L et al. SGS 2020, Abstract 09.
Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.
Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.
Topical steroids are the standard treatment. To assess whether fractional CO2 laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.
The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.
Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.
Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.
Patients in the laser arm received three laser treatments 4-6 weeks apart.
At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.
Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.
Differences between the groups were statistically significant for all but the functional subscore.
Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.
For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.
Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.
Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.
There were no major adverse events.
The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.
“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.
“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.
The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.
Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.
The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.
SOURCE: Burkett L et al. SGS 2020, Abstract 09.
FROM SGS 2020
Cerclage in twin pregnancies reduces perinatal mortality in randomized trial
according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention.
The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage.
“We’ve already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success,” senior author Vincenzo Berghella, MD, said in a news release.
“These results have the potential to change practice and help many more women have healthy twin babies,” said Dr. Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia.
A shift in perspective
More research is needed to establish a standardized approach, but the trial should “open physicians’ perspectives to think about how, in selected cases and with the proper approach, cerclage can work well,” said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore.
Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. “If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea,” Dr. Turan said in an interview.
In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, “Do the stitch,” he said. “But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome.”
The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it “unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study,” the researchers said.
Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.
“The small number of participants reflects how rare this condition is among all pregnancies,” first author Amanda Roman, MD, of the division of maternal fetal medicine at Thomas Jefferson University, Philadelphia, said in the news release. “But because women were randomized to treatment and nontreatment groups, the results are strong, as confirmed by the independent data and safety monitoring board.”
The researchers enrolled women with twin pregnancies and asymptomatic cervical dilation from 1 to 4 cm before 24 weeks. Exclusion criteria included monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis.
In all, 17 women were randomized to cerclage and 13 to the no-cerclage group. Both groups had similar patient characteristics. About 93% of the twin gestations were diamniotic-dichorionic. Assisted reproductive technology was used by about 36% of the participants, and 20% had a history of singleton preterm birth. Four women assigned to cerclage did not undergo the procedure but were included in the intention-to-treat analysis. Two of the four patients had contraindications that occurred soon after randomization (rupture of amniotic membranes and vaginal bleeding), one had a friable cervix, and one declined cerclage after being randomized.
Spontaneous preterm birth before 34 weeks of gestation, the primary outcome, occurred in 12 of 17 women in the cerclage group and in all 13 women in the no-cerclage group (70% vs. 100%).
Trial to assess ultrasound indicated cerclage
“Expectant management with no cerclage is the current standard of care for these women,” Dr. Roman and coauthors wrote. “Despite small sample size, we were able to show a significant benefit to physical exam–indicated cerclage.”
Inability to place the cerclage in one patient due to friable cervix was the only intraoperative complication. “Larger cohorts in singleton pregnancies have informed a 10%-20% risk of intraoperative rupture of the membranes, cervical laceration, and bleeding during the procedure,” the researchers noted.
All women who received cerclage also received indomethacin and antibiotics, although these elements of management were not prespecified. Given the relatively small sample size, it is unclear what role factors such as indomethacin, which was administered to 82% of the cerclage group versus 31% of the no-cerclage group, and antibiotics may have played, said Dr. Turan.
Prospective studies may help clarify how the degree of cervical dilation, gestational age, use of progesterone, or surgical techniques may influence outcomes. In addition, the researchers are enrolling patients in another trial. That study aims to assess whether cerclage reduces the incidence of spontaneous preterm birth in asymptomatic women with twin gestations and cervical length of 15 mm or less diagnosed by transvaginal ultrasound between 16 and 24 weeks of gestation.
The study had no external financial support. The authors had no conflicts of interest. Dr. Turan said he had no relevant financial disclosures.
SOURCE: Roman A et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.047.
according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention.
The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage.
“We’ve already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success,” senior author Vincenzo Berghella, MD, said in a news release.
“These results have the potential to change practice and help many more women have healthy twin babies,” said Dr. Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia.
A shift in perspective
More research is needed to establish a standardized approach, but the trial should “open physicians’ perspectives to think about how, in selected cases and with the proper approach, cerclage can work well,” said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore.
Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. “If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea,” Dr. Turan said in an interview.
In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, “Do the stitch,” he said. “But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome.”
The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it “unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study,” the researchers said.
Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.
“The small number of participants reflects how rare this condition is among all pregnancies,” first author Amanda Roman, MD, of the division of maternal fetal medicine at Thomas Jefferson University, Philadelphia, said in the news release. “But because women were randomized to treatment and nontreatment groups, the results are strong, as confirmed by the independent data and safety monitoring board.”
The researchers enrolled women with twin pregnancies and asymptomatic cervical dilation from 1 to 4 cm before 24 weeks. Exclusion criteria included monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis.
In all, 17 women were randomized to cerclage and 13 to the no-cerclage group. Both groups had similar patient characteristics. About 93% of the twin gestations were diamniotic-dichorionic. Assisted reproductive technology was used by about 36% of the participants, and 20% had a history of singleton preterm birth. Four women assigned to cerclage did not undergo the procedure but were included in the intention-to-treat analysis. Two of the four patients had contraindications that occurred soon after randomization (rupture of amniotic membranes and vaginal bleeding), one had a friable cervix, and one declined cerclage after being randomized.
Spontaneous preterm birth before 34 weeks of gestation, the primary outcome, occurred in 12 of 17 women in the cerclage group and in all 13 women in the no-cerclage group (70% vs. 100%).
Trial to assess ultrasound indicated cerclage
“Expectant management with no cerclage is the current standard of care for these women,” Dr. Roman and coauthors wrote. “Despite small sample size, we were able to show a significant benefit to physical exam–indicated cerclage.”
Inability to place the cerclage in one patient due to friable cervix was the only intraoperative complication. “Larger cohorts in singleton pregnancies have informed a 10%-20% risk of intraoperative rupture of the membranes, cervical laceration, and bleeding during the procedure,” the researchers noted.
All women who received cerclage also received indomethacin and antibiotics, although these elements of management were not prespecified. Given the relatively small sample size, it is unclear what role factors such as indomethacin, which was administered to 82% of the cerclage group versus 31% of the no-cerclage group, and antibiotics may have played, said Dr. Turan.
Prospective studies may help clarify how the degree of cervical dilation, gestational age, use of progesterone, or surgical techniques may influence outcomes. In addition, the researchers are enrolling patients in another trial. That study aims to assess whether cerclage reduces the incidence of spontaneous preterm birth in asymptomatic women with twin gestations and cervical length of 15 mm or less diagnosed by transvaginal ultrasound between 16 and 24 weeks of gestation.
The study had no external financial support. The authors had no conflicts of interest. Dr. Turan said he had no relevant financial disclosures.
SOURCE: Roman A et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.047.
according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention.
The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage.
“We’ve already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success,” senior author Vincenzo Berghella, MD, said in a news release.
“These results have the potential to change practice and help many more women have healthy twin babies,” said Dr. Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia.
A shift in perspective
More research is needed to establish a standardized approach, but the trial should “open physicians’ perspectives to think about how, in selected cases and with the proper approach, cerclage can work well,” said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore.
Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. “If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea,” Dr. Turan said in an interview.
In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, “Do the stitch,” he said. “But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome.”
The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it “unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study,” the researchers said.
Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.
“The small number of participants reflects how rare this condition is among all pregnancies,” first author Amanda Roman, MD, of the division of maternal fetal medicine at Thomas Jefferson University, Philadelphia, said in the news release. “But because women were randomized to treatment and nontreatment groups, the results are strong, as confirmed by the independent data and safety monitoring board.”
The researchers enrolled women with twin pregnancies and asymptomatic cervical dilation from 1 to 4 cm before 24 weeks. Exclusion criteria included monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis.
In all, 17 women were randomized to cerclage and 13 to the no-cerclage group. Both groups had similar patient characteristics. About 93% of the twin gestations were diamniotic-dichorionic. Assisted reproductive technology was used by about 36% of the participants, and 20% had a history of singleton preterm birth. Four women assigned to cerclage did not undergo the procedure but were included in the intention-to-treat analysis. Two of the four patients had contraindications that occurred soon after randomization (rupture of amniotic membranes and vaginal bleeding), one had a friable cervix, and one declined cerclage after being randomized.
Spontaneous preterm birth before 34 weeks of gestation, the primary outcome, occurred in 12 of 17 women in the cerclage group and in all 13 women in the no-cerclage group (70% vs. 100%).
Trial to assess ultrasound indicated cerclage
“Expectant management with no cerclage is the current standard of care for these women,” Dr. Roman and coauthors wrote. “Despite small sample size, we were able to show a significant benefit to physical exam–indicated cerclage.”
Inability to place the cerclage in one patient due to friable cervix was the only intraoperative complication. “Larger cohorts in singleton pregnancies have informed a 10%-20% risk of intraoperative rupture of the membranes, cervical laceration, and bleeding during the procedure,” the researchers noted.
All women who received cerclage also received indomethacin and antibiotics, although these elements of management were not prespecified. Given the relatively small sample size, it is unclear what role factors such as indomethacin, which was administered to 82% of the cerclage group versus 31% of the no-cerclage group, and antibiotics may have played, said Dr. Turan.
Prospective studies may help clarify how the degree of cervical dilation, gestational age, use of progesterone, or surgical techniques may influence outcomes. In addition, the researchers are enrolling patients in another trial. That study aims to assess whether cerclage reduces the incidence of spontaneous preterm birth in asymptomatic women with twin gestations and cervical length of 15 mm or less diagnosed by transvaginal ultrasound between 16 and 24 weeks of gestation.
The study had no external financial support. The authors had no conflicts of interest. Dr. Turan said he had no relevant financial disclosures.
SOURCE: Roman A et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.047.
FROM THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Despite guidelines, children receive opioids and steroids for pneumonia and sinusitis
A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.
Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.
“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”
To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.
The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.
Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).
Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).
In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.
“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.
The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”
Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.
The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.
A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.
A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.
Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.
“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”
To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.
The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.
Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).
Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).
In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.
“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.
The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”
Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.
The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.
A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.
A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina.
Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics.
“Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription,” wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. “These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines.”
To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included.
The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis.
Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001).
Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001).
In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis.
“I was disappointed to read of these results, although not necessarily surprised,” Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said in an interview.
The data suggest that improved prescribing practices may be needed, “especially in the ED,” wrote Dr. Phang and colleagues. “Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients.”
Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. “Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control,” they wrote.
The use of Medicaid data from 1 year in one state limits the generalizability of the findings. Nevertheless, the visits occurred “well after publication of relevant guidelines and after concerns of opioid prescribing had become widespread,” according to Dr. Phang and colleagues.
A post hoc evaluation identified one patient with a secondary diagnosis of fracture and 24 patients with a secondary diagnosis of pain, but none of these patients had received an opioid. “Thus, the small subset of patients who may have had secondary diagnoses that would warrant an opioid prescription would not have changed the overall results,” they wrote.
The study was funded by the National Institutes of Health. The authors had no relevant financial disclosures.
SOURCE: Phang KG et al. Pediatrics. 2020 Jul 2. doi: 10.1542/peds.2019-3690.
FROM PEDIATRICS
Subclinical hypothyroidism appears common in women with miscarriage
according to a prospective observational study published in the Journal of Clinical Endocrinology & Metabolism.
Whether asymptomatic patients should be screened for mild subclinical hypothyroidism (SCH) or thyroid peroxidase antibodies (TPOAb) remains an open question, however. “In the absence of evidence of benefit with LT4 [levothyroxine] treatment and possible suggestion of harm ... we pose the question of whether screening should be performed at all in asymptomatic individuals,” wrote Rima K. Dhillon-Smith, MBChB, PhD, of the University of Birmingham (England), and colleagues. “Large randomized trials are needed to establish if preconception LT4 treatment of mild SCH with or without TPOAb positivity is beneficial. If treatment is found to be beneficial, this study presents the prevalence of thyroid disorders that can be expected.”
Subclinical hypothyroidism may represent an early stage of thyroid dysfunction. The condition has been associated with subfertility, miscarriage, preterm birth, preeclampsia, and perinatal mortality. Thyroid peroxidase antibodies also have been associated with adverse pregnancy outcomes, and their presence increases the risk of subclinical and overt thyroid disease in pregnancy. “There is international agreement on the treatment of overt thyroid disease,” the researchers wrote. “However, the treatment strategies for SCH or TPOAb preconception and antenatally are debated.”
The Thyroid Antibodies and Levothyroxine (TABLET) trial, to which the present study was linked, “found no improvement in live birth or any secondary pregnancy or neonatal outcomes in euthyroid women with TPOAb taking 50 mcg of LT4, compared with placebo.”
To examine various thyroid-stimulating hormone (TSH) cutoff levels for diagnosing subclinical thyroid disease in preconception asymptomatic women with a history of miscarriage or subfertility, Dr. Dhillon-Smith and colleagues conducted a prospective, observational cohort study at 49 hospitals in the United Kingdom. The study included more than 19,200 patients between November 2011 and January 2016. Participants were aged 16-41 years, had a history of miscarriage or subfertility, and were actively trying to get pregnant.
Using accepted reference ranges, the investigators identified undiagnosed overt hypothyroidism in 0.2%, overt hyperthyroidism in 0.3%, severe SCH (TSH greater than 10 mIU/L) in 0.2%, and SCH (TSH greater than 4.5 mIU/L) in 2.4%. “Lowering the upper limit of TSH to 2.5 mIU/L, as is the recommendation by international societies for ‘high-risk’ women,” such as those with recurrent pregnancy loss or those undergoing assisted reproductive technology, “would class 16%-20% of women as subclinically hypothyroid,” the authors reported.
The prevalence of TPOAb was 9.5%, and the presence of these antibodies “was the factor associated most significantly with any degree of thyroid dysfunction, after adjustment for confounders,” Dr. Dhillon-Smith and colleagues wrote. Multiple regression analyses found that the likelihood of subclinical hypothyroidism (TSH greater than 4.5 mIU/L) was increased for participants with a body mass index of 35 kg/m2 or greater (adjusted odds ratio, 1.71) and Asian ethnicity (aOR, 1.76).
The U.K. rates of thyroid dysfunction appear to be lower than rates in the United States, and it is unclear why higher body mass index and Asian ethnicity were independently associated with higher TSH concentrations, commented Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
Women with a history of three or more miscarriages or subfertility were not more likely to be TPOAb positive, compared with women with one or two previous miscarriages, which “underscores the evidence that a recurrent pregnancy loss evaluation yields similar diagnostic findings at two versus three or more losses,” Dr. Trolice said.
According to the American Society for Reproductive Medicine, it is reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH within the normal range. Women who have TSH greater than 2.5 mIU/L and/or are TPOAb positive can be considered for treatment with levothyroxine.
The Endocrine Society recommends levothyroxine treatment in women with SCH, especially if they are TPOAb positive.
An American Thyroid Association guideline recommends that subclinically hypothyroid women undergoing in vitro fertilization or intracytoplasmic sperm injection be treated with levothyroxine. A 2019 Cochrane Database review, however, found that low-quality evidence precludes clear conclusions.
“While thyroid autoimmunity has been associated with increased miscarriage, preterm births, and lower live birth rates, the confusion lies in which preconception women to test, when to obtain testing, and how to manage nonovert thyroid disease,” said Dr. Trolice, who is a member of the Ob.Gyn. News editorial advisory board.
The observational study was linked to the TABLET trial, which was funded by the National Institute for Health Research. The researchers had no relevant conflicts of interest.
SOURCE: Dhillon-Smith RK et al. J Clin Endocrinol Metab. 2020 Jun 17. doi: 10.1210/clinem/dgaa302.
according to a prospective observational study published in the Journal of Clinical Endocrinology & Metabolism.
Whether asymptomatic patients should be screened for mild subclinical hypothyroidism (SCH) or thyroid peroxidase antibodies (TPOAb) remains an open question, however. “In the absence of evidence of benefit with LT4 [levothyroxine] treatment and possible suggestion of harm ... we pose the question of whether screening should be performed at all in asymptomatic individuals,” wrote Rima K. Dhillon-Smith, MBChB, PhD, of the University of Birmingham (England), and colleagues. “Large randomized trials are needed to establish if preconception LT4 treatment of mild SCH with or without TPOAb positivity is beneficial. If treatment is found to be beneficial, this study presents the prevalence of thyroid disorders that can be expected.”
Subclinical hypothyroidism may represent an early stage of thyroid dysfunction. The condition has been associated with subfertility, miscarriage, preterm birth, preeclampsia, and perinatal mortality. Thyroid peroxidase antibodies also have been associated with adverse pregnancy outcomes, and their presence increases the risk of subclinical and overt thyroid disease in pregnancy. “There is international agreement on the treatment of overt thyroid disease,” the researchers wrote. “However, the treatment strategies for SCH or TPOAb preconception and antenatally are debated.”
The Thyroid Antibodies and Levothyroxine (TABLET) trial, to which the present study was linked, “found no improvement in live birth or any secondary pregnancy or neonatal outcomes in euthyroid women with TPOAb taking 50 mcg of LT4, compared with placebo.”
To examine various thyroid-stimulating hormone (TSH) cutoff levels for diagnosing subclinical thyroid disease in preconception asymptomatic women with a history of miscarriage or subfertility, Dr. Dhillon-Smith and colleagues conducted a prospective, observational cohort study at 49 hospitals in the United Kingdom. The study included more than 19,200 patients between November 2011 and January 2016. Participants were aged 16-41 years, had a history of miscarriage or subfertility, and were actively trying to get pregnant.
Using accepted reference ranges, the investigators identified undiagnosed overt hypothyroidism in 0.2%, overt hyperthyroidism in 0.3%, severe SCH (TSH greater than 10 mIU/L) in 0.2%, and SCH (TSH greater than 4.5 mIU/L) in 2.4%. “Lowering the upper limit of TSH to 2.5 mIU/L, as is the recommendation by international societies for ‘high-risk’ women,” such as those with recurrent pregnancy loss or those undergoing assisted reproductive technology, “would class 16%-20% of women as subclinically hypothyroid,” the authors reported.
The prevalence of TPOAb was 9.5%, and the presence of these antibodies “was the factor associated most significantly with any degree of thyroid dysfunction, after adjustment for confounders,” Dr. Dhillon-Smith and colleagues wrote. Multiple regression analyses found that the likelihood of subclinical hypothyroidism (TSH greater than 4.5 mIU/L) was increased for participants with a body mass index of 35 kg/m2 or greater (adjusted odds ratio, 1.71) and Asian ethnicity (aOR, 1.76).
The U.K. rates of thyroid dysfunction appear to be lower than rates in the United States, and it is unclear why higher body mass index and Asian ethnicity were independently associated with higher TSH concentrations, commented Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
Women with a history of three or more miscarriages or subfertility were not more likely to be TPOAb positive, compared with women with one or two previous miscarriages, which “underscores the evidence that a recurrent pregnancy loss evaluation yields similar diagnostic findings at two versus three or more losses,” Dr. Trolice said.
According to the American Society for Reproductive Medicine, it is reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH within the normal range. Women who have TSH greater than 2.5 mIU/L and/or are TPOAb positive can be considered for treatment with levothyroxine.
The Endocrine Society recommends levothyroxine treatment in women with SCH, especially if they are TPOAb positive.
An American Thyroid Association guideline recommends that subclinically hypothyroid women undergoing in vitro fertilization or intracytoplasmic sperm injection be treated with levothyroxine. A 2019 Cochrane Database review, however, found that low-quality evidence precludes clear conclusions.
“While thyroid autoimmunity has been associated with increased miscarriage, preterm births, and lower live birth rates, the confusion lies in which preconception women to test, when to obtain testing, and how to manage nonovert thyroid disease,” said Dr. Trolice, who is a member of the Ob.Gyn. News editorial advisory board.
The observational study was linked to the TABLET trial, which was funded by the National Institute for Health Research. The researchers had no relevant conflicts of interest.
SOURCE: Dhillon-Smith RK et al. J Clin Endocrinol Metab. 2020 Jun 17. doi: 10.1210/clinem/dgaa302.
according to a prospective observational study published in the Journal of Clinical Endocrinology & Metabolism.
Whether asymptomatic patients should be screened for mild subclinical hypothyroidism (SCH) or thyroid peroxidase antibodies (TPOAb) remains an open question, however. “In the absence of evidence of benefit with LT4 [levothyroxine] treatment and possible suggestion of harm ... we pose the question of whether screening should be performed at all in asymptomatic individuals,” wrote Rima K. Dhillon-Smith, MBChB, PhD, of the University of Birmingham (England), and colleagues. “Large randomized trials are needed to establish if preconception LT4 treatment of mild SCH with or without TPOAb positivity is beneficial. If treatment is found to be beneficial, this study presents the prevalence of thyroid disorders that can be expected.”
Subclinical hypothyroidism may represent an early stage of thyroid dysfunction. The condition has been associated with subfertility, miscarriage, preterm birth, preeclampsia, and perinatal mortality. Thyroid peroxidase antibodies also have been associated with adverse pregnancy outcomes, and their presence increases the risk of subclinical and overt thyroid disease in pregnancy. “There is international agreement on the treatment of overt thyroid disease,” the researchers wrote. “However, the treatment strategies for SCH or TPOAb preconception and antenatally are debated.”
The Thyroid Antibodies and Levothyroxine (TABLET) trial, to which the present study was linked, “found no improvement in live birth or any secondary pregnancy or neonatal outcomes in euthyroid women with TPOAb taking 50 mcg of LT4, compared with placebo.”
To examine various thyroid-stimulating hormone (TSH) cutoff levels for diagnosing subclinical thyroid disease in preconception asymptomatic women with a history of miscarriage or subfertility, Dr. Dhillon-Smith and colleagues conducted a prospective, observational cohort study at 49 hospitals in the United Kingdom. The study included more than 19,200 patients between November 2011 and January 2016. Participants were aged 16-41 years, had a history of miscarriage or subfertility, and were actively trying to get pregnant.
Using accepted reference ranges, the investigators identified undiagnosed overt hypothyroidism in 0.2%, overt hyperthyroidism in 0.3%, severe SCH (TSH greater than 10 mIU/L) in 0.2%, and SCH (TSH greater than 4.5 mIU/L) in 2.4%. “Lowering the upper limit of TSH to 2.5 mIU/L, as is the recommendation by international societies for ‘high-risk’ women,” such as those with recurrent pregnancy loss or those undergoing assisted reproductive technology, “would class 16%-20% of women as subclinically hypothyroid,” the authors reported.
The prevalence of TPOAb was 9.5%, and the presence of these antibodies “was the factor associated most significantly with any degree of thyroid dysfunction, after adjustment for confounders,” Dr. Dhillon-Smith and colleagues wrote. Multiple regression analyses found that the likelihood of subclinical hypothyroidism (TSH greater than 4.5 mIU/L) was increased for participants with a body mass index of 35 kg/m2 or greater (adjusted odds ratio, 1.71) and Asian ethnicity (aOR, 1.76).
The U.K. rates of thyroid dysfunction appear to be lower than rates in the United States, and it is unclear why higher body mass index and Asian ethnicity were independently associated with higher TSH concentrations, commented Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
Women with a history of three or more miscarriages or subfertility were not more likely to be TPOAb positive, compared with women with one or two previous miscarriages, which “underscores the evidence that a recurrent pregnancy loss evaluation yields similar diagnostic findings at two versus three or more losses,” Dr. Trolice said.
According to the American Society for Reproductive Medicine, it is reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH within the normal range. Women who have TSH greater than 2.5 mIU/L and/or are TPOAb positive can be considered for treatment with levothyroxine.
The Endocrine Society recommends levothyroxine treatment in women with SCH, especially if they are TPOAb positive.
An American Thyroid Association guideline recommends that subclinically hypothyroid women undergoing in vitro fertilization or intracytoplasmic sperm injection be treated with levothyroxine. A 2019 Cochrane Database review, however, found that low-quality evidence precludes clear conclusions.
“While thyroid autoimmunity has been associated with increased miscarriage, preterm births, and lower live birth rates, the confusion lies in which preconception women to test, when to obtain testing, and how to manage nonovert thyroid disease,” said Dr. Trolice, who is a member of the Ob.Gyn. News editorial advisory board.
The observational study was linked to the TABLET trial, which was funded by the National Institute for Health Research. The researchers had no relevant conflicts of interest.
SOURCE: Dhillon-Smith RK et al. J Clin Endocrinol Metab. 2020 Jun 17. doi: 10.1210/clinem/dgaa302.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Report describes intoxication with new psychoactive substance
When evaluated at local emergency departments, lethargy and slurred speech were the most common clinical findings.
One student had mild respiratory depression with a respiratory rate of 10 breaths per minute.
“All patients had sufficient clinical improvement within 6 hours such that they could be discharged from the hospital,” according to a description of the cases that was published online in Pediatrics.
The report is the first to detail clinical toxicity from flualprazolam, and “it is likely that physicians will again encounter patients” with intoxication from this new psychoactive drug, said Adam Blumenberg, MD, of Oregon Health & Science University in Portland and colleagues.
Internet purchasing has increased rates of exposure to new psychoactive substances since the early 2000s, and law enforcement agents have seized tons of these drugs. “In the United States, the incidence of exposures to designer benzodiazepines in particular has been rising since 2014,” the authors said.
According to an addiction researcher, the COVID-19 pandemic may exacerbate abuse of designer benzodiazepines.
“This is an important paper describing what medical examiners, pathologists, and emergency rooms have been seeing recently – an increase in designer benzodiazepines,” commented Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis. “Recent increases in these drugs have started to be seen in many locations as the traditional drugs of abuse, grown and distributed in bulk, have been disrupted” by the pandemic, he said in an interview. Although it may be too early for such cases to appear in Centers for Disease Control and Prevention reports, they can be described in studies like this one and, “I suspect, sadly, in medical examiner case reports.”
Flualprazolam, known colloquially as Hulk, is structurally related to the Food and Drug Administration–approved drugs alprazolam and triazolam. During 1 week in June 2019, the patients in Oregon received the drug as a free sample from another student from their Oregon high school. They believed it was commercial Xanax (alprazolam). “The flualprazolam tablets were identical in appearance and labeling to 2-mg tablets of alprazolam,” according to the report. “This indicates an intentionally counterfeit product entering the drug supply chain.”
Five of the six patients were boys, and they ranged in age from 14 to 16 years. The patient with mild respiratory depression received 0.4-mg naloxone, which physicians gave empirically because of the unknown identity of the drug, but did not respond. Two of the six patients initially felt drowsy but were asymptomatic during the clinical evaluation.
A urine immunoassay was performed in five of the patients, and all tested positive for benzodiazepines. One patient also tested positive for cannabinoids. Analysis of a tablet fragment revealed that it contained flualprazolam.
“Although flualprazolam intoxication cannot be clinically differentiated from that of other benzodiazepines without advanced testing, patient management should be the same,” Dr. Blumenberg and coauthors said. “For mild to moderate intoxication, patients should be treated with close monitoring and supportive care until symptom resolution. The benzodiazepine antidote flumazenil may be considered a safe and effective antidote in pediatric patients with significant CNS or respiratory depression. In patients for whom there is a concern of benzodiazepine dependence and flumazenil-induced seizures, airway protection and mechanical ventilation may be considered.”
Although patients rarely die from isolated benzodiazepine toxicity, death from respiratory depression or aspiration is more common when benzodiazepine toxicity occurs “in combination with alcohol, opioids, or other sedatives,” the authors noted. In addition, counterfeit alprazolam tablets have contained adulterants such as fentanyl and the opioid U-47700, which can be deadly.
The authors had no relevant financial disclosures, and there was no external funding for the study.
SOURCE: Blumenberg A et al. Pediatrics. 2020 Jun 24. doi: 10.1542/peds.2019-2953.
When evaluated at local emergency departments, lethargy and slurred speech were the most common clinical findings.
One student had mild respiratory depression with a respiratory rate of 10 breaths per minute.
“All patients had sufficient clinical improvement within 6 hours such that they could be discharged from the hospital,” according to a description of the cases that was published online in Pediatrics.
The report is the first to detail clinical toxicity from flualprazolam, and “it is likely that physicians will again encounter patients” with intoxication from this new psychoactive drug, said Adam Blumenberg, MD, of Oregon Health & Science University in Portland and colleagues.
Internet purchasing has increased rates of exposure to new psychoactive substances since the early 2000s, and law enforcement agents have seized tons of these drugs. “In the United States, the incidence of exposures to designer benzodiazepines in particular has been rising since 2014,” the authors said.
According to an addiction researcher, the COVID-19 pandemic may exacerbate abuse of designer benzodiazepines.
“This is an important paper describing what medical examiners, pathologists, and emergency rooms have been seeing recently – an increase in designer benzodiazepines,” commented Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis. “Recent increases in these drugs have started to be seen in many locations as the traditional drugs of abuse, grown and distributed in bulk, have been disrupted” by the pandemic, he said in an interview. Although it may be too early for such cases to appear in Centers for Disease Control and Prevention reports, they can be described in studies like this one and, “I suspect, sadly, in medical examiner case reports.”
Flualprazolam, known colloquially as Hulk, is structurally related to the Food and Drug Administration–approved drugs alprazolam and triazolam. During 1 week in June 2019, the patients in Oregon received the drug as a free sample from another student from their Oregon high school. They believed it was commercial Xanax (alprazolam). “The flualprazolam tablets were identical in appearance and labeling to 2-mg tablets of alprazolam,” according to the report. “This indicates an intentionally counterfeit product entering the drug supply chain.”
Five of the six patients were boys, and they ranged in age from 14 to 16 years. The patient with mild respiratory depression received 0.4-mg naloxone, which physicians gave empirically because of the unknown identity of the drug, but did not respond. Two of the six patients initially felt drowsy but were asymptomatic during the clinical evaluation.
A urine immunoassay was performed in five of the patients, and all tested positive for benzodiazepines. One patient also tested positive for cannabinoids. Analysis of a tablet fragment revealed that it contained flualprazolam.
“Although flualprazolam intoxication cannot be clinically differentiated from that of other benzodiazepines without advanced testing, patient management should be the same,” Dr. Blumenberg and coauthors said. “For mild to moderate intoxication, patients should be treated with close monitoring and supportive care until symptom resolution. The benzodiazepine antidote flumazenil may be considered a safe and effective antidote in pediatric patients with significant CNS or respiratory depression. In patients for whom there is a concern of benzodiazepine dependence and flumazenil-induced seizures, airway protection and mechanical ventilation may be considered.”
Although patients rarely die from isolated benzodiazepine toxicity, death from respiratory depression or aspiration is more common when benzodiazepine toxicity occurs “in combination with alcohol, opioids, or other sedatives,” the authors noted. In addition, counterfeit alprazolam tablets have contained adulterants such as fentanyl and the opioid U-47700, which can be deadly.
The authors had no relevant financial disclosures, and there was no external funding for the study.
SOURCE: Blumenberg A et al. Pediatrics. 2020 Jun 24. doi: 10.1542/peds.2019-2953.
When evaluated at local emergency departments, lethargy and slurred speech were the most common clinical findings.
One student had mild respiratory depression with a respiratory rate of 10 breaths per minute.
“All patients had sufficient clinical improvement within 6 hours such that they could be discharged from the hospital,” according to a description of the cases that was published online in Pediatrics.
The report is the first to detail clinical toxicity from flualprazolam, and “it is likely that physicians will again encounter patients” with intoxication from this new psychoactive drug, said Adam Blumenberg, MD, of Oregon Health & Science University in Portland and colleagues.
Internet purchasing has increased rates of exposure to new psychoactive substances since the early 2000s, and law enforcement agents have seized tons of these drugs. “In the United States, the incidence of exposures to designer benzodiazepines in particular has been rising since 2014,” the authors said.
According to an addiction researcher, the COVID-19 pandemic may exacerbate abuse of designer benzodiazepines.
“This is an important paper describing what medical examiners, pathologists, and emergency rooms have been seeing recently – an increase in designer benzodiazepines,” commented Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis. “Recent increases in these drugs have started to be seen in many locations as the traditional drugs of abuse, grown and distributed in bulk, have been disrupted” by the pandemic, he said in an interview. Although it may be too early for such cases to appear in Centers for Disease Control and Prevention reports, they can be described in studies like this one and, “I suspect, sadly, in medical examiner case reports.”
Flualprazolam, known colloquially as Hulk, is structurally related to the Food and Drug Administration–approved drugs alprazolam and triazolam. During 1 week in June 2019, the patients in Oregon received the drug as a free sample from another student from their Oregon high school. They believed it was commercial Xanax (alprazolam). “The flualprazolam tablets were identical in appearance and labeling to 2-mg tablets of alprazolam,” according to the report. “This indicates an intentionally counterfeit product entering the drug supply chain.”
Five of the six patients were boys, and they ranged in age from 14 to 16 years. The patient with mild respiratory depression received 0.4-mg naloxone, which physicians gave empirically because of the unknown identity of the drug, but did not respond. Two of the six patients initially felt drowsy but were asymptomatic during the clinical evaluation.
A urine immunoassay was performed in five of the patients, and all tested positive for benzodiazepines. One patient also tested positive for cannabinoids. Analysis of a tablet fragment revealed that it contained flualprazolam.
“Although flualprazolam intoxication cannot be clinically differentiated from that of other benzodiazepines without advanced testing, patient management should be the same,” Dr. Blumenberg and coauthors said. “For mild to moderate intoxication, patients should be treated with close monitoring and supportive care until symptom resolution. The benzodiazepine antidote flumazenil may be considered a safe and effective antidote in pediatric patients with significant CNS or respiratory depression. In patients for whom there is a concern of benzodiazepine dependence and flumazenil-induced seizures, airway protection and mechanical ventilation may be considered.”
Although patients rarely die from isolated benzodiazepine toxicity, death from respiratory depression or aspiration is more common when benzodiazepine toxicity occurs “in combination with alcohol, opioids, or other sedatives,” the authors noted. In addition, counterfeit alprazolam tablets have contained adulterants such as fentanyl and the opioid U-47700, which can be deadly.
The authors had no relevant financial disclosures, and there was no external funding for the study.
SOURCE: Blumenberg A et al. Pediatrics. 2020 Jun 24. doi: 10.1542/peds.2019-2953.
FROM PEDIATRICS
Suicide thoughts, attempts in adolescence correlate with mental health symptoms
About one in five adolescents has thought about suicide, about 10% have experienced serious suicidal ideation, and 7% have attempted suicide by age 20 years, according to a longitudinal study of Canadian adolescents published online in Pediatrics.
In multivariable analyses, depression and anxiety were independently associated with passive and serious suicidal ideation at some ages, but none of the externalizing problems were significantly associated with passive or serious suicidal ideation. However, “both depressive and conduct symptoms [were] independently associated with suicidal risk,” the researchers found. Most adolescents with suicidal ideation or suicide attempt met criteria for at least one mental health problem.
“These findings suggest that suicide risk should be systematically assessed in adolescents who present with mental health symptoms and not solely in adolescents with clinically diagnosed mental disorders,” said Massimiliano Orri, PhD, and colleagues. Dr. Orri is affiliated with the McGill Group for Suicide Studies, Douglas Mental Health University Institute, Montreal, and the University of Bordeaux (France).
To document the prevalence of passive or serious suicidal ideation and suicide attempt from ages 13-20 years and examine correlations with mental health symptoms, Dr. Orri and colleagues analyzed data from 1,618 participants in the Quebec Longitudinal Study of Child Development. The population-based study follows individuals born in 1997 and 1998 in Quebec. Participants answered questions about suicidal ideation or suicide attempt in the past year at ages 13, 15, 17, or 20 years (“Did you ever think about suicide?” “Did you ever seriously think of attempting suicide?” and “How many times did you attempt suicide?”). The researchers assessed symptoms of mental health problems using self-report questionnaires.
Lifetime prevalence of suicide-related outcomes was higher for female participants than for male participants. The prevalence of passive suicidal ideation was 28% in females versus 15% in males. The prevalence of serious suicidal ideation was 12% in females versus 8% in males. The prevalence of suicide attempt was 9% in females versus 4% in males. “Sex differences in suicidal ideation and suicide attempt might be attributed to various factors, such as mental health (e.g., higher prevalence of depression in female participants) or social stigma (e.g., greater stigma around suicide in male than in female participants),” the authors wrote.
In the entire cohort, the prevalence of passive suicidal ideation increased from 12% at 13 years to 18% at 17 years. The prevalence of serious suicidal ideation increased from 3% at 13 years to 10% at 20 years. The prevalence of suicide attempt was approximately 4% at each age.
“Although having a major depressive episode is a well-known risk factor of suicidal ideation and suicide attempt, our study adds to the general body of knowledge by showing associations with suicide-related outcomes across the full spectrum of depressive symptoms,” Dr. Orri and colleagues wrote. “This suggests that youth who present with depressive symptoms (and not solely those who are clinically depressed) may be more likely to experience suicidal ideation or attempt suicide.”
The estimated rates of serious suicidal ideation and attempted suicide by age 20 years are consistent with previous U.S. and Canadian surveys. Sample attrition, the use of different questionnaires in early and late adolescence, and the lack of information about substance use and psychotic symptoms are among the study’s limitations.
Six of the authors were supported by grants from a variety of Canadian and European agencies and the American Foundation for Suicide Prevention. All of the authors said they had no relevant financial disclosures.
SOURCE: Orri M et al. Pediatrics. 2020 Jun 8. doi: 10.1542/peds.2019-3823.
Interestingly, this study by Orri et al. found that there was not a peak in suicide attempts in mid-adolescence; instead, rates of attempts were stable throughout adolescence and serious suicidal ideation actually increased with age. This was an unexpected finding for me, and something I will be more mindful about in my clinical practice when seeing older teens and young adults. Additionally, all mental health problems – not just depression – evaluated in univariate analyses in the study were associated with suicidal thoughts and attempts. On multivariable analysis that accounted for the impact of the effect of comorbid mental health symptoms, depressive symptoms had the highest and most consistent correlation to suicidal thoughts, and conduct symptoms were associated with an increase in suicide attempts. The authors conclude that youth with mental health symptoms – not just those who meet diagnostic criteria – should be assessed for suicide risk.
In my subspecialty practice, we screen every new patient for suicide regardless of the reason for their visit and more often for those with mental health symptoms. I know this may seem onerous, but screening and counseling typically take under 5 minutes – and in many instances around 1-2 minutes. Having ready-to-go resources including mental health professionals to refer to, screening algorithms (such as protocols published in MedEdPORTAL or Family Practice Management), and suicide prevention resources for patients and family for those who screen positive can help expedite this process. I think these recommendations can be adapted with relative ease into any visit for a teen or young adult who is presenting with a mental health complaint.
Kelly A. Curran, MD, is an assistant professor of pediatrics at the University of Oklahoma in Oklahoma City. She is a member of the Pediatric News editorial advisory board. Dr. Curran said she had no relevant financial disclosures.
Interestingly, this study by Orri et al. found that there was not a peak in suicide attempts in mid-adolescence; instead, rates of attempts were stable throughout adolescence and serious suicidal ideation actually increased with age. This was an unexpected finding for me, and something I will be more mindful about in my clinical practice when seeing older teens and young adults. Additionally, all mental health problems – not just depression – evaluated in univariate analyses in the study were associated with suicidal thoughts and attempts. On multivariable analysis that accounted for the impact of the effect of comorbid mental health symptoms, depressive symptoms had the highest and most consistent correlation to suicidal thoughts, and conduct symptoms were associated with an increase in suicide attempts. The authors conclude that youth with mental health symptoms – not just those who meet diagnostic criteria – should be assessed for suicide risk.
In my subspecialty practice, we screen every new patient for suicide regardless of the reason for their visit and more often for those with mental health symptoms. I know this may seem onerous, but screening and counseling typically take under 5 minutes – and in many instances around 1-2 minutes. Having ready-to-go resources including mental health professionals to refer to, screening algorithms (such as protocols published in MedEdPORTAL or Family Practice Management), and suicide prevention resources for patients and family for those who screen positive can help expedite this process. I think these recommendations can be adapted with relative ease into any visit for a teen or young adult who is presenting with a mental health complaint.
Kelly A. Curran, MD, is an assistant professor of pediatrics at the University of Oklahoma in Oklahoma City. She is a member of the Pediatric News editorial advisory board. Dr. Curran said she had no relevant financial disclosures.
Interestingly, this study by Orri et al. found that there was not a peak in suicide attempts in mid-adolescence; instead, rates of attempts were stable throughout adolescence and serious suicidal ideation actually increased with age. This was an unexpected finding for me, and something I will be more mindful about in my clinical practice when seeing older teens and young adults. Additionally, all mental health problems – not just depression – evaluated in univariate analyses in the study were associated with suicidal thoughts and attempts. On multivariable analysis that accounted for the impact of the effect of comorbid mental health symptoms, depressive symptoms had the highest and most consistent correlation to suicidal thoughts, and conduct symptoms were associated with an increase in suicide attempts. The authors conclude that youth with mental health symptoms – not just those who meet diagnostic criteria – should be assessed for suicide risk.
In my subspecialty practice, we screen every new patient for suicide regardless of the reason for their visit and more often for those with mental health symptoms. I know this may seem onerous, but screening and counseling typically take under 5 minutes – and in many instances around 1-2 minutes. Having ready-to-go resources including mental health professionals to refer to, screening algorithms (such as protocols published in MedEdPORTAL or Family Practice Management), and suicide prevention resources for patients and family for those who screen positive can help expedite this process. I think these recommendations can be adapted with relative ease into any visit for a teen or young adult who is presenting with a mental health complaint.
Kelly A. Curran, MD, is an assistant professor of pediatrics at the University of Oklahoma in Oklahoma City. She is a member of the Pediatric News editorial advisory board. Dr. Curran said she had no relevant financial disclosures.
About one in five adolescents has thought about suicide, about 10% have experienced serious suicidal ideation, and 7% have attempted suicide by age 20 years, according to a longitudinal study of Canadian adolescents published online in Pediatrics.
In multivariable analyses, depression and anxiety were independently associated with passive and serious suicidal ideation at some ages, but none of the externalizing problems were significantly associated with passive or serious suicidal ideation. However, “both depressive and conduct symptoms [were] independently associated with suicidal risk,” the researchers found. Most adolescents with suicidal ideation or suicide attempt met criteria for at least one mental health problem.
“These findings suggest that suicide risk should be systematically assessed in adolescents who present with mental health symptoms and not solely in adolescents with clinically diagnosed mental disorders,” said Massimiliano Orri, PhD, and colleagues. Dr. Orri is affiliated with the McGill Group for Suicide Studies, Douglas Mental Health University Institute, Montreal, and the University of Bordeaux (France).
To document the prevalence of passive or serious suicidal ideation and suicide attempt from ages 13-20 years and examine correlations with mental health symptoms, Dr. Orri and colleagues analyzed data from 1,618 participants in the Quebec Longitudinal Study of Child Development. The population-based study follows individuals born in 1997 and 1998 in Quebec. Participants answered questions about suicidal ideation or suicide attempt in the past year at ages 13, 15, 17, or 20 years (“Did you ever think about suicide?” “Did you ever seriously think of attempting suicide?” and “How many times did you attempt suicide?”). The researchers assessed symptoms of mental health problems using self-report questionnaires.
Lifetime prevalence of suicide-related outcomes was higher for female participants than for male participants. The prevalence of passive suicidal ideation was 28% in females versus 15% in males. The prevalence of serious suicidal ideation was 12% in females versus 8% in males. The prevalence of suicide attempt was 9% in females versus 4% in males. “Sex differences in suicidal ideation and suicide attempt might be attributed to various factors, such as mental health (e.g., higher prevalence of depression in female participants) or social stigma (e.g., greater stigma around suicide in male than in female participants),” the authors wrote.
In the entire cohort, the prevalence of passive suicidal ideation increased from 12% at 13 years to 18% at 17 years. The prevalence of serious suicidal ideation increased from 3% at 13 years to 10% at 20 years. The prevalence of suicide attempt was approximately 4% at each age.
“Although having a major depressive episode is a well-known risk factor of suicidal ideation and suicide attempt, our study adds to the general body of knowledge by showing associations with suicide-related outcomes across the full spectrum of depressive symptoms,” Dr. Orri and colleagues wrote. “This suggests that youth who present with depressive symptoms (and not solely those who are clinically depressed) may be more likely to experience suicidal ideation or attempt suicide.”
The estimated rates of serious suicidal ideation and attempted suicide by age 20 years are consistent with previous U.S. and Canadian surveys. Sample attrition, the use of different questionnaires in early and late adolescence, and the lack of information about substance use and psychotic symptoms are among the study’s limitations.
Six of the authors were supported by grants from a variety of Canadian and European agencies and the American Foundation for Suicide Prevention. All of the authors said they had no relevant financial disclosures.
SOURCE: Orri M et al. Pediatrics. 2020 Jun 8. doi: 10.1542/peds.2019-3823.
About one in five adolescents has thought about suicide, about 10% have experienced serious suicidal ideation, and 7% have attempted suicide by age 20 years, according to a longitudinal study of Canadian adolescents published online in Pediatrics.
In multivariable analyses, depression and anxiety were independently associated with passive and serious suicidal ideation at some ages, but none of the externalizing problems were significantly associated with passive or serious suicidal ideation. However, “both depressive and conduct symptoms [were] independently associated with suicidal risk,” the researchers found. Most adolescents with suicidal ideation or suicide attempt met criteria for at least one mental health problem.
“These findings suggest that suicide risk should be systematically assessed in adolescents who present with mental health symptoms and not solely in adolescents with clinically diagnosed mental disorders,” said Massimiliano Orri, PhD, and colleagues. Dr. Orri is affiliated with the McGill Group for Suicide Studies, Douglas Mental Health University Institute, Montreal, and the University of Bordeaux (France).
To document the prevalence of passive or serious suicidal ideation and suicide attempt from ages 13-20 years and examine correlations with mental health symptoms, Dr. Orri and colleagues analyzed data from 1,618 participants in the Quebec Longitudinal Study of Child Development. The population-based study follows individuals born in 1997 and 1998 in Quebec. Participants answered questions about suicidal ideation or suicide attempt in the past year at ages 13, 15, 17, or 20 years (“Did you ever think about suicide?” “Did you ever seriously think of attempting suicide?” and “How many times did you attempt suicide?”). The researchers assessed symptoms of mental health problems using self-report questionnaires.
Lifetime prevalence of suicide-related outcomes was higher for female participants than for male participants. The prevalence of passive suicidal ideation was 28% in females versus 15% in males. The prevalence of serious suicidal ideation was 12% in females versus 8% in males. The prevalence of suicide attempt was 9% in females versus 4% in males. “Sex differences in suicidal ideation and suicide attempt might be attributed to various factors, such as mental health (e.g., higher prevalence of depression in female participants) or social stigma (e.g., greater stigma around suicide in male than in female participants),” the authors wrote.
In the entire cohort, the prevalence of passive suicidal ideation increased from 12% at 13 years to 18% at 17 years. The prevalence of serious suicidal ideation increased from 3% at 13 years to 10% at 20 years. The prevalence of suicide attempt was approximately 4% at each age.
“Although having a major depressive episode is a well-known risk factor of suicidal ideation and suicide attempt, our study adds to the general body of knowledge by showing associations with suicide-related outcomes across the full spectrum of depressive symptoms,” Dr. Orri and colleagues wrote. “This suggests that youth who present with depressive symptoms (and not solely those who are clinically depressed) may be more likely to experience suicidal ideation or attempt suicide.”
The estimated rates of serious suicidal ideation and attempted suicide by age 20 years are consistent with previous U.S. and Canadian surveys. Sample attrition, the use of different questionnaires in early and late adolescence, and the lack of information about substance use and psychotic symptoms are among the study’s limitations.
Six of the authors were supported by grants from a variety of Canadian and European agencies and the American Foundation for Suicide Prevention. All of the authors said they had no relevant financial disclosures.
SOURCE: Orri M et al. Pediatrics. 2020 Jun 8. doi: 10.1542/peds.2019-3823.
FROM PEDIATRICS
Survey: 26% of parents hesitant about influenza vaccine
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
according to a nationally representative survey.
Influenza vaccination hesitancy may be driven by concerns about vaccine effectiveness, researchers wrote in Pediatrics. These findings “underscore the importance of better communicating to providers and parents the effectiveness of influenza vaccines in reducing severity and morbidity from influenza, even in years when the vaccine has relatively low effectiveness,” noted Allison Kempe, MD, MPH, professor of pediatrics and director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science at the University of Colorado at Denver, Aurora, and colleagues.
The World Health Organization considers vaccine hesitancy a leading threat to global health, but national data about vaccine hesitancy in the United States are limited. To assess hesitancy about routine childhood and influenza vaccinations and related factors, Dr. Kempe and colleagues surveyed more than 2,000 parents in February 2019.
The investigators used an online panel to survey a nationally representative sample of families with children aged between 6 months and 18 years. Parents completed a modified version of the Vaccine Hesitancy Scale, which measures confidence in and concerns about vaccines. Parents with an average score greater than 3 on the scale were considered hesitant.
Factors associated with vaccine hesitancy
Of 4,445 parents sampled, 2,176 completed the survey and 2,052 were eligible respondents. For routine childhood vaccines, the average score on the modified Vaccine Hesitancy Scale was 2 and the percentage of hesitant parents was 6%. For influenza vaccine, the average score was 2 and the percentage of hesitant parents was 26%.
Among hesitant parents, 68% had deferred or refused routine childhood vaccination, compared with 9% of nonhesitant parents (risk ratio, 8.0). For the influenza vaccine, 70% of hesitant parents had deferred or refused influenza vaccination for their child versus 10% of nonhesitant parents (RR, 7.0). Parents were more likely to strongly agree that routine childhood vaccines are effective, compared with the influenza vaccine (70% vs. 26%). “Hesitancy about influenza vaccination is largely driven by concerns about low vaccine effectiveness,” Dr. Kempe and associates wrote.
Although concern about serious side effects was the factor most associated with hesitancy, the percentage of parents who were strongly (12%) or somewhat (27%) concerned about serious side effects was the same for routine childhood vaccines and influenza vaccines. Other factors associated with hesitancy for both routine childhood vaccines and influenza vaccines included lower educational level and household income less than 400% of the federal poverty level.
The survey data may be subject to reporting bias based on social desirability, the authors noted. In addition, the exclusion of infants younger than 6 months may have resulted in an underestimate of hesitancy.
“Although influenza vaccine could be included as a ‘routine’ vaccine, in that it is recommended yearly, we hypothesized that parents view it differently from other childhood vaccines because each year it needs to be given again, its content and effectiveness vary, and it addresses a disease that is often perceived as minor, compared with other childhood diseases,” Dr. Kempe and colleagues wrote. Interventions to counter hesitancy have “a surprising lack of evidence,” and “more work needs to be done to develop methods that are practical and effective for convincing vaccine-hesitant parents to vaccinate.”
Logical next step
“From the pragmatic standpoint of improving immunization rates and disease control, determining the correct evidence-based messaging to counter these perceptions is the next logical step,” Annabelle de St. Maurice, MD, MPH, an assistant professor of pediatrics in the division of infectious diseases at University of California, Los Angeles, and Kathryn Edwards, MD, a professor of pediatrics and director of the vaccine research program at Vanderbilt University, Nashville, wrote in an accompanying editorial.
“Communications should be focused on the burden of influenza in children, rebranding influenza vaccine as a ‘routine’ childhood immunization, reassurance on influenza vaccine safety, and discussion of the efficacy of influenza vaccine in preventing severe disease,” they wrote. “Even in the years when there is a poor match, the vaccine is impactful.”
The research was supported by the National Institutes of Health. Two study authors disclosed financial ties to Sanofi Pasteur, with one also disclosing financial ties to Merck, for work related to vaccinations. The remaining investigators had no relevant financial disclosures. Dr. de St. Maurice indicated that she had no relevant financial disclosures. Dr. Edwards disclosed grants from the Centers for Disease Control and Prevention and the NIH; consulting for Merck, Bionet, and IBM; and serving on data safety and monitoring boards for Sanofi, X4 Pharmaceuticals, Seqirus, Moderna, and Pfizer.
SOURCE: Kempe A et al. Pediatrics. 2020 Jun 15. doi: 10.1542/peds.2019-3852.
FROM PEDIATRICS