LAS VEGAS – Inappropriate patient positioning can cause nerve injuries in gynecologic laparoscopic surgery, and it’s not just nerves below the waist that are vulnerable.

But the risk can be lowered through careful positioning that avoids pressure and over-stretching, the two main causes of nerve injuries in these surgeries, Cleveland Clinic obstetrician-gynecologist and surgeon Tommaso Falcone, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Falcone offered tips about avoiding injuries to these nerves:

Brachial plexus. To avoid injury to this nerve, arms should be tucked and pronated or kept at less than a 90-degree angle from the body. Hyperextension injuries can occur when the arm is outstretched too much, said Dr. Falcone, who recommends putting a cushion under the elbow and wrist.

How can you know if an injury has occurred? The patient will typically wake up with a dropped wrist and numbness in the arm, he said, signs suggesting a stretch injury to the brachial plexus.

Ulnar nerve: Improper tucking of the arms can injure the ulnar nerve and cause numbness and weakness in the fourth and fifth fingers. Dr. Falcone recommends keeping the arms pronated if they’re tucked and supinated if they’re on arm boards. Again, he emphasized placing a cushion under the elbow and wrist.

Femoral nerve: Hyperflexion or hyperextension can compress the femoral nerve under the inguinal ligament and cause it to become ischemic, Dr. Falcone said.

Femoral nerve injury can lead to numbness (in the anterior and medial thigh), decreased patellar reflex, weakness of the quadriceps, and loss of knee extension flexibility. Patients may need to use a wheelchair for a time and undergo physical therapy, he said.

Obdurator nerve: Excessive lateral thigh abduction – outward movement – can stretch this nerve, Dr. Falcone said. Avoid excessive abduction by keeping the thigh-to-thigh angle under 90 degrees, he recommended. (This rule also helps to prevent femoral nerve injury.)

Signs of injury can include numbness on the medial aspect of the thigh and weakness in the adductor muscles. Physical therapy can be helpful, he said.

Sciatic nerve: Beware of hyperflexion of the hips followed by sudden straightening of the knees, he said. According to him, this can occur when candy-cane stirrups are used. Signs of injury can include foot drop and numbness (calf, dorsum, sole, and lateral side of the foot).

Peroneal nerve: Prolonged pressure against the knee can injure this nerve and cause foot drop and numbness (over the lower anterior leg and dorsum of the foot).

Dr. Falcone reports honoraria (Journal of Minimally Invasive Gynecology and Up-To-Date) and federal research funds. This meeting was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

LAS VEGAS – Inappropriate patient positioning can cause nerve injuries in gynecologic laparoscopic surgery, and it’s not just nerves below the waist that are vulnerable.

But the risk can be lowered through careful positioning that avoids pressure and over-stretching, the two main causes of nerve injuries in these surgeries, Cleveland Clinic obstetrician-gynecologist and surgeon Tommaso Falcone, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Falcone offered tips about avoiding injuries to these nerves:

Brachial plexus. To avoid injury to this nerve, arms should be tucked and pronated or kept at less than a 90-degree angle from the body. Hyperextension injuries can occur when the arm is outstretched too much, said Dr. Falcone, who recommends putting a cushion under the elbow and wrist.

How can you know if an injury has occurred? The patient will typically wake up with a dropped wrist and numbness in the arm, he said, signs suggesting a stretch injury to the brachial plexus.

Ulnar nerve: Improper tucking of the arms can injure the ulnar nerve and cause numbness and weakness in the fourth and fifth fingers. Dr. Falcone recommends keeping the arms pronated if they’re tucked and supinated if they’re on arm boards. Again, he emphasized placing a cushion under the elbow and wrist.

Femoral nerve: Hyperflexion or hyperextension can compress the femoral nerve under the inguinal ligament and cause it to become ischemic, Dr. Falcone said.

Femoral nerve injury can lead to numbness (in the anterior and medial thigh), decreased patellar reflex, weakness of the quadriceps, and loss of knee extension flexibility. Patients may need to use a wheelchair for a time and undergo physical therapy, he said.

Obdurator nerve: Excessive lateral thigh abduction – outward movement – can stretch this nerve, Dr. Falcone said. Avoid excessive abduction by keeping the thigh-to-thigh angle under 90 degrees, he recommended. (This rule also helps to prevent femoral nerve injury.)

Signs of injury can include numbness on the medial aspect of the thigh and weakness in the adductor muscles. Physical therapy can be helpful, he said.

Sciatic nerve: Beware of hyperflexion of the hips followed by sudden straightening of the knees, he said. According to him, this can occur when candy-cane stirrups are used. Signs of injury can include foot drop and numbness (calf, dorsum, sole, and lateral side of the foot).

Peroneal nerve: Prolonged pressure against the knee can injure this nerve and cause foot drop and numbness (over the lower anterior leg and dorsum of the foot).

Dr. Falcone reports honoraria (Journal of Minimally Invasive Gynecology and Up-To-Date) and federal research funds. This meeting was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

LAS VEGAS – Inappropriate patient positioning can cause nerve injuries in gynecologic laparoscopic surgery, and it’s not just nerves below the waist that are vulnerable.

But the risk can be lowered through careful positioning that avoids pressure and over-stretching, the two main causes of nerve injuries in these surgeries, Cleveland Clinic obstetrician-gynecologist and surgeon Tommaso Falcone, MD, said at the Pelvic Anatomy and Gynecologic Surgery Symposium.

Dr. Falcone offered tips about avoiding injuries to these nerves:

Brachial plexus. To avoid injury to this nerve, arms should be tucked and pronated or kept at less than a 90-degree angle from the body. Hyperextension injuries can occur when the arm is outstretched too much, said Dr. Falcone, who recommends putting a cushion under the elbow and wrist.

How can you know if an injury has occurred? The patient will typically wake up with a dropped wrist and numbness in the arm, he said, signs suggesting a stretch injury to the brachial plexus.

Ulnar nerve: Improper tucking of the arms can injure the ulnar nerve and cause numbness and weakness in the fourth and fifth fingers. Dr. Falcone recommends keeping the arms pronated if they’re tucked and supinated if they’re on arm boards. Again, he emphasized placing a cushion under the elbow and wrist.

Femoral nerve: Hyperflexion or hyperextension can compress the femoral nerve under the inguinal ligament and cause it to become ischemic, Dr. Falcone said.

Femoral nerve injury can lead to numbness (in the anterior and medial thigh), decreased patellar reflex, weakness of the quadriceps, and loss of knee extension flexibility. Patients may need to use a wheelchair for a time and undergo physical therapy, he said.

Obdurator nerve: Excessive lateral thigh abduction – outward movement – can stretch this nerve, Dr. Falcone said. Avoid excessive abduction by keeping the thigh-to-thigh angle under 90 degrees, he recommended. (This rule also helps to prevent femoral nerve injury.)

Signs of injury can include numbness on the medial aspect of the thigh and weakness in the adductor muscles. Physical therapy can be helpful, he said.

Sciatic nerve: Beware of hyperflexion of the hips followed by sudden straightening of the knees, he said. According to him, this can occur when candy-cane stirrups are used. Signs of injury can include foot drop and numbness (calf, dorsum, sole, and lateral side of the foot).

Peroneal nerve: Prolonged pressure against the knee can injure this nerve and cause foot drop and numbness (over the lower anterior leg and dorsum of the foot).

Dr. Falcone reports honoraria (Journal of Minimally Invasive Gynecology and Up-To-Date) and federal research funds. This meeting was jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

MADRID – Soft tissue ultrasound is helpful in determining whether fistulae in patients with hidradenitis suppurativa will respond to medical therapy or require surgical excision, Antonio Martorell, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

This distinction is critical in recognizing a window of opportunity in the management of hidradenitis suppurativa (HS): The period early in the disease course when medical therapy alone can be life-changing.

“The window of opportunity is an old concept in gastroenterology, but it’s a new idea in dermatology: It’s the moment in which the patient can have the best results with medical control of inflammation, before progression to tissue scarring has occurred,” explained Dr. Martorell, a dermatologist at the Hospital of Manises in Valencia, Spain, and coauthor of recent HS treatment recommendations by an international expert panel (J Eur Acad Dermatol Venereol. 2019 Jan;33[1]:19-31).

Symptoms in patients with HS can be caused by either dynamic or static lesions. Dynamic lesions arise directly from acute inflammation that can be treated with antibiotics and immunomodulatory therapy. Static lesions are associated with tissue scarring secondary to inflammatory activity and generally benefit only from surgery.

Dynamic lesions consist of nodules, abscesses, and some but not all fistulae. Although the traditional view among dermatologists has been that fistulae simply don’t respond to medical therapy and must be treated surgically, Dr. Martorell and coinvestigators have recently demonstrated in a retrospective study of 117 fistulae in 40 patients that ultrasound was useful in distinguishing four fistular subtypes, two of which responded reasonably well to medical management.

What the investigators call Type A or dermal fistulae are by definition not connected to tunnels. In Dr. Martorell’s study, they had a 95% complete resolution rate after 6 months of various medications. Dermoepidermal fistulae tunnel through the dermis to the epidermis; they had a 65% complete resolution rate. In contrast, Type C or complex fistulae, identified by the ultrasound finding of multiple tunnels extending through the dermis into underlying fat tissue, had no significant response to medical management. Neither did Type D fistulae, which are essentially Type C lesions with scarring (Dermatol Surg. 2019 Oct;45[10]:1237-44).

Thus, ultrasound can have an important impact on patient management and the decision to opt for a combined medical/surgical approach.

“It’s important to apply the HS severity scores and complete the clinical exam, but it’s also important to use ultrasound or another imaging technique,” Dr. Martorell concluded.
 

bjancin@mdedge.com

MADRID – Soft tissue ultrasound is helpful in determining whether fistulae in patients with hidradenitis suppurativa will respond to medical therapy or require surgical excision, Antonio Martorell, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

This distinction is critical in recognizing a window of opportunity in the management of hidradenitis suppurativa (HS): The period early in the disease course when medical therapy alone can be life-changing.

“The window of opportunity is an old concept in gastroenterology, but it’s a new idea in dermatology: It’s the moment in which the patient can have the best results with medical control of inflammation, before progression to tissue scarring has occurred,” explained Dr. Martorell, a dermatologist at the Hospital of Manises in Valencia, Spain, and coauthor of recent HS treatment recommendations by an international expert panel (J Eur Acad Dermatol Venereol. 2019 Jan;33[1]:19-31).

Symptoms in patients with HS can be caused by either dynamic or static lesions. Dynamic lesions arise directly from acute inflammation that can be treated with antibiotics and immunomodulatory therapy. Static lesions are associated with tissue scarring secondary to inflammatory activity and generally benefit only from surgery.

Dynamic lesions consist of nodules, abscesses, and some but not all fistulae. Although the traditional view among dermatologists has been that fistulae simply don’t respond to medical therapy and must be treated surgically, Dr. Martorell and coinvestigators have recently demonstrated in a retrospective study of 117 fistulae in 40 patients that ultrasound was useful in distinguishing four fistular subtypes, two of which responded reasonably well to medical management.

What the investigators call Type A or dermal fistulae are by definition not connected to tunnels. In Dr. Martorell’s study, they had a 95% complete resolution rate after 6 months of various medications. Dermoepidermal fistulae tunnel through the dermis to the epidermis; they had a 65% complete resolution rate. In contrast, Type C or complex fistulae, identified by the ultrasound finding of multiple tunnels extending through the dermis into underlying fat tissue, had no significant response to medical management. Neither did Type D fistulae, which are essentially Type C lesions with scarring (Dermatol Surg. 2019 Oct;45[10]:1237-44).

Thus, ultrasound can have an important impact on patient management and the decision to opt for a combined medical/surgical approach.

“It’s important to apply the HS severity scores and complete the clinical exam, but it’s also important to use ultrasound or another imaging technique,” Dr. Martorell concluded.
 

bjancin@mdedge.com

MADRID – Soft tissue ultrasound is helpful in determining whether fistulae in patients with hidradenitis suppurativa will respond to medical therapy or require surgical excision, Antonio Martorell, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

This distinction is critical in recognizing a window of opportunity in the management of hidradenitis suppurativa (HS): The period early in the disease course when medical therapy alone can be life-changing.

“The window of opportunity is an old concept in gastroenterology, but it’s a new idea in dermatology: It’s the moment in which the patient can have the best results with medical control of inflammation, before progression to tissue scarring has occurred,” explained Dr. Martorell, a dermatologist at the Hospital of Manises in Valencia, Spain, and coauthor of recent HS treatment recommendations by an international expert panel (J Eur Acad Dermatol Venereol. 2019 Jan;33[1]:19-31).

Symptoms in patients with HS can be caused by either dynamic or static lesions. Dynamic lesions arise directly from acute inflammation that can be treated with antibiotics and immunomodulatory therapy. Static lesions are associated with tissue scarring secondary to inflammatory activity and generally benefit only from surgery.

Dynamic lesions consist of nodules, abscesses, and some but not all fistulae. Although the traditional view among dermatologists has been that fistulae simply don’t respond to medical therapy and must be treated surgically, Dr. Martorell and coinvestigators have recently demonstrated in a retrospective study of 117 fistulae in 40 patients that ultrasound was useful in distinguishing four fistular subtypes, two of which responded reasonably well to medical management.

What the investigators call Type A or dermal fistulae are by definition not connected to tunnels. In Dr. Martorell’s study, they had a 95% complete resolution rate after 6 months of various medications. Dermoepidermal fistulae tunnel through the dermis to the epidermis; they had a 65% complete resolution rate. In contrast, Type C or complex fistulae, identified by the ultrasound finding of multiple tunnels extending through the dermis into underlying fat tissue, had no significant response to medical management. Neither did Type D fistulae, which are essentially Type C lesions with scarring (Dermatol Surg. 2019 Oct;45[10]:1237-44).

Thus, ultrasound can have an important impact on patient management and the decision to opt for a combined medical/surgical approach.

“It’s important to apply the HS severity scores and complete the clinical exam, but it’s also important to use ultrasound or another imaging technique,” Dr. Martorell concluded.
 

bjancin@mdedge.com

A new study summarizing and reanalyzing the international evidence base for uterine balloon tamponade for postpartum hemorrhage found it an overall safe and efficacious procedure.

Of 90 studies that reported efficacy data for uterine balloon tamponade (UBT), the procedure had overall success of 85.9% in treating postpartum hemorrhage (PPH). The pooled success rate was highest for women who were treated with a condom UBT, at 90.4%, compared with those treated with a Bakri balloon, at 83.2%, though the one randomized trial that compared the two devices head-to-head found no difference in success rates, wrote Sebastian Suarez, MD, and coauthors.

In all, the investigators looked at 91 studies involving 4,729 women who sustained PPH. The systematic review and meta-analysis included randomized controlled trials (RCTs), nonrandomized studies, and case series in which UBT was used to treat PPH.

Dr. Suarez, of Boston University Medical Center, and colleagues explained that postpartum hemorrhage (PPH) accounts for more maternal mortality and morbidity worldwide than any other complication of pregnancy, with the vast majority of PPH deaths occurring in low- and middle-income countries.

“While treatment of PPH varies depending on the cause, generally less invasive methods should be tried initially,” commented Angela Martin, MD, a maternal-fetal medicine specialist at the University of Kansas, Lawrence,in interview. Dr. Martin, who was not involved in the study, explained that “these options typically include administration of uterotonics or pharmacologic agents, and tamponade of the uterus with intrauterine balloons.” The hope in using less invasive options is that pelvic artery embolization, other surgical techniques, or even hysterectomy can be avoided in the face of the emergency of severe PPH.

One retrospective, nonrandomized study compared UBT plus standard of care with standard of care alone for uterine atony after vaginal delivery. The study found significantly less blood loss (759 mL vs. 1,582 mL) and a 0.22 relative risk of surgical interventions and 0.18 relative risk of blood transfusion for women receiving UBT. However, the authors assessed the evidence for UBT in this study to be of very low quality. Two other RCTs compared UBT and no UBT, and the authors’ meta-analysis of these two studies showed no significant differences between the two groups in risk of maternal death or surgical interventions. The evidence was considered very low quality in these studies as well.

UBT was also examined in uterine atony after Cesarean delivery; a subgroup analysis found overall less efficacy than that in cases of vaginal delivery. Other subgroup analyses found that UBT was more likely to be successful when uterine atony or placenta previa was the cause of PPH, compared with PPH from placenta accreta spectrum or retained products of conception. Also, the overall success of UBT was higher for PPH in vaginal delivery, compared with Cesarean delivery, at 87% versus 81%, regardless of the etiology of hemorrhage.

Looking at safety of UBT, Dr. Suarez and coinvestigators found 39 studies reporting various complications of UBT use for PPH, not all of which reported on all complications. The overall rate for fever or infection was 6.5% in studies reporting on this complication, and endometritis was recorded in 2.3% of participants in studies tracking that complication. Cervical tears, laceration of the lower segment of the vagina, uterine incision rupture or uterine perforation, and acute colonic pseudo-obstruction were all reported in 2% or less of the patients participating in studies that recorded these complications.

The authors excluded studies that included simultaneous use of surgical techniques and UBT and those that involved UBT for hemorrhage after pregnancy loss with a gestation less than 20 weeks’ duration. However, studies were included if UBT was used after surgical procedure failure.

To assess the primary outcome of UBT success rate, the authors used the raw ratio of cases of success divided by the total number of women treated with UBT. For the analysis, successful UBT use was considered to be arrest of PPH bleeding without maternal death or other surgical or radiological interventions after UBT placement, regardless of the definition of “UBT success” used in each study. Similarly, the authors considered “UBT failure” to have occurred in cases of maternal death or when additional surgical or radiological interventions happened after UBT placement.

The authors considered a composite primary outcome measure for the RCT and nonrandomized studies that was made up of maternal death and/or surgical or radiologic interventions.

Secondary outcome measures included UBT’s success rate for individual PPH causes, frequency of surgical and invasive procedures, and maternal outcomes such as death, blood loss, transfusion, ICU admission, and complication rates.

Overall, about half of the studies (n = 48; 53%) were conducted in low- and middle-income countries. Asian countries were the site of 46 studies, or 52% of the total. A quarter were conducted in Europe, and just five studies were conducted in the United States; the remainder were conducted in Africa or Latin America or were multinational studies.

Dr. Martin said that “[the review] findings provide reassurance that UBT can be implemented as a treatment option with a high success rate and low complication rate.” However, she noted, “There was a discrepancy between nonrandomized studies and RCTs on the efficacy and effectiveness of UBT.”

“Two randomized studies concluded there is no benefit to introduction of UBT in management of refractory PPH,” she continued. “The authors point out risk of bias and multiple methodological concerns that likely favored the control group in one effectiveness trial. Lack of benefit may have been due to suboptimal implementation strategies and lack of consistent UBT use.”

Dr. Martin concluded, “Overall, UBT success rates were consistently high across all study types. These findings are reassuring to the practicing clinician. There are many benefits to UBT including ease of use by a variety of health care providers, affordability, and its minimally invasive nature. Now there is evidence that UBT appears safe and has a high rate of success for management of PPH.”

The study’s senior author is a board member of the nonprofit organization Ujenzi Charitable Trust, which received Food and Drug Administration approval for the “Every Second Matters–Uterine Balloon Tamponade” device. Dr. Suarez reported that he had no financial conflicts of interest. The authors reported that there were no external sources of funding for the research. Dr. Martin serves on the editorial board of Ob.Gyn. News.

SOURCE: Suarez S et al. Am J Obstet Gynecol. 2020 Jan 6. doi: 10.1016/j.ajog.2019.11.1287.

A new study summarizing and reanalyzing the international evidence base for uterine balloon tamponade for postpartum hemorrhage found it an overall safe and efficacious procedure.

Of 90 studies that reported efficacy data for uterine balloon tamponade (UBT), the procedure had overall success of 85.9% in treating postpartum hemorrhage (PPH). The pooled success rate was highest for women who were treated with a condom UBT, at 90.4%, compared with those treated with a Bakri balloon, at 83.2%, though the one randomized trial that compared the two devices head-to-head found no difference in success rates, wrote Sebastian Suarez, MD, and coauthors.

In all, the investigators looked at 91 studies involving 4,729 women who sustained PPH. The systematic review and meta-analysis included randomized controlled trials (RCTs), nonrandomized studies, and case series in which UBT was used to treat PPH.

Dr. Suarez, of Boston University Medical Center, and colleagues explained that postpartum hemorrhage (PPH) accounts for more maternal mortality and morbidity worldwide than any other complication of pregnancy, with the vast majority of PPH deaths occurring in low- and middle-income countries.

“While treatment of PPH varies depending on the cause, generally less invasive methods should be tried initially,” commented Angela Martin, MD, a maternal-fetal medicine specialist at the University of Kansas, Lawrence,in interview. Dr. Martin, who was not involved in the study, explained that “these options typically include administration of uterotonics or pharmacologic agents, and tamponade of the uterus with intrauterine balloons.” The hope in using less invasive options is that pelvic artery embolization, other surgical techniques, or even hysterectomy can be avoided in the face of the emergency of severe PPH.

One retrospective, nonrandomized study compared UBT plus standard of care with standard of care alone for uterine atony after vaginal delivery. The study found significantly less blood loss (759 mL vs. 1,582 mL) and a 0.22 relative risk of surgical interventions and 0.18 relative risk of blood transfusion for women receiving UBT. However, the authors assessed the evidence for UBT in this study to be of very low quality. Two other RCTs compared UBT and no UBT, and the authors’ meta-analysis of these two studies showed no significant differences between the two groups in risk of maternal death or surgical interventions. The evidence was considered very low quality in these studies as well.

UBT was also examined in uterine atony after Cesarean delivery; a subgroup analysis found overall less efficacy than that in cases of vaginal delivery. Other subgroup analyses found that UBT was more likely to be successful when uterine atony or placenta previa was the cause of PPH, compared with PPH from placenta accreta spectrum or retained products of conception. Also, the overall success of UBT was higher for PPH in vaginal delivery, compared with Cesarean delivery, at 87% versus 81%, regardless of the etiology of hemorrhage.

Looking at safety of UBT, Dr. Suarez and coinvestigators found 39 studies reporting various complications of UBT use for PPH, not all of which reported on all complications. The overall rate for fever or infection was 6.5% in studies reporting on this complication, and endometritis was recorded in 2.3% of participants in studies tracking that complication. Cervical tears, laceration of the lower segment of the vagina, uterine incision rupture or uterine perforation, and acute colonic pseudo-obstruction were all reported in 2% or less of the patients participating in studies that recorded these complications.

The authors excluded studies that included simultaneous use of surgical techniques and UBT and those that involved UBT for hemorrhage after pregnancy loss with a gestation less than 20 weeks’ duration. However, studies were included if UBT was used after surgical procedure failure.

To assess the primary outcome of UBT success rate, the authors used the raw ratio of cases of success divided by the total number of women treated with UBT. For the analysis, successful UBT use was considered to be arrest of PPH bleeding without maternal death or other surgical or radiological interventions after UBT placement, regardless of the definition of “UBT success” used in each study. Similarly, the authors considered “UBT failure” to have occurred in cases of maternal death or when additional surgical or radiological interventions happened after UBT placement.

The authors considered a composite primary outcome measure for the RCT and nonrandomized studies that was made up of maternal death and/or surgical or radiologic interventions.

Secondary outcome measures included UBT’s success rate for individual PPH causes, frequency of surgical and invasive procedures, and maternal outcomes such as death, blood loss, transfusion, ICU admission, and complication rates.

Overall, about half of the studies (n = 48; 53%) were conducted in low- and middle-income countries. Asian countries were the site of 46 studies, or 52% of the total. A quarter were conducted in Europe, and just five studies were conducted in the United States; the remainder were conducted in Africa or Latin America or were multinational studies.

Dr. Martin said that “[the review] findings provide reassurance that UBT can be implemented as a treatment option with a high success rate and low complication rate.” However, she noted, “There was a discrepancy between nonrandomized studies and RCTs on the efficacy and effectiveness of UBT.”

“Two randomized studies concluded there is no benefit to introduction of UBT in management of refractory PPH,” she continued. “The authors point out risk of bias and multiple methodological concerns that likely favored the control group in one effectiveness trial. Lack of benefit may have been due to suboptimal implementation strategies and lack of consistent UBT use.”

Dr. Martin concluded, “Overall, UBT success rates were consistently high across all study types. These findings are reassuring to the practicing clinician. There are many benefits to UBT including ease of use by a variety of health care providers, affordability, and its minimally invasive nature. Now there is evidence that UBT appears safe and has a high rate of success for management of PPH.”

The study’s senior author is a board member of the nonprofit organization Ujenzi Charitable Trust, which received Food and Drug Administration approval for the “Every Second Matters–Uterine Balloon Tamponade” device. Dr. Suarez reported that he had no financial conflicts of interest. The authors reported that there were no external sources of funding for the research. Dr. Martin serves on the editorial board of Ob.Gyn. News.

SOURCE: Suarez S et al. Am J Obstet Gynecol. 2020 Jan 6. doi: 10.1016/j.ajog.2019.11.1287.

A new study summarizing and reanalyzing the international evidence base for uterine balloon tamponade for postpartum hemorrhage found it an overall safe and efficacious procedure.

Of 90 studies that reported efficacy data for uterine balloon tamponade (UBT), the procedure had overall success of 85.9% in treating postpartum hemorrhage (PPH). The pooled success rate was highest for women who were treated with a condom UBT, at 90.4%, compared with those treated with a Bakri balloon, at 83.2%, though the one randomized trial that compared the two devices head-to-head found no difference in success rates, wrote Sebastian Suarez, MD, and coauthors.

In all, the investigators looked at 91 studies involving 4,729 women who sustained PPH. The systematic review and meta-analysis included randomized controlled trials (RCTs), nonrandomized studies, and case series in which UBT was used to treat PPH.

Dr. Suarez, of Boston University Medical Center, and colleagues explained that postpartum hemorrhage (PPH) accounts for more maternal mortality and morbidity worldwide than any other complication of pregnancy, with the vast majority of PPH deaths occurring in low- and middle-income countries.

“While treatment of PPH varies depending on the cause, generally less invasive methods should be tried initially,” commented Angela Martin, MD, a maternal-fetal medicine specialist at the University of Kansas, Lawrence,in interview. Dr. Martin, who was not involved in the study, explained that “these options typically include administration of uterotonics or pharmacologic agents, and tamponade of the uterus with intrauterine balloons.” The hope in using less invasive options is that pelvic artery embolization, other surgical techniques, or even hysterectomy can be avoided in the face of the emergency of severe PPH.

One retrospective, nonrandomized study compared UBT plus standard of care with standard of care alone for uterine atony after vaginal delivery. The study found significantly less blood loss (759 mL vs. 1,582 mL) and a 0.22 relative risk of surgical interventions and 0.18 relative risk of blood transfusion for women receiving UBT. However, the authors assessed the evidence for UBT in this study to be of very low quality. Two other RCTs compared UBT and no UBT, and the authors’ meta-analysis of these two studies showed no significant differences between the two groups in risk of maternal death or surgical interventions. The evidence was considered very low quality in these studies as well.

UBT was also examined in uterine atony after Cesarean delivery; a subgroup analysis found overall less efficacy than that in cases of vaginal delivery. Other subgroup analyses found that UBT was more likely to be successful when uterine atony or placenta previa was the cause of PPH, compared with PPH from placenta accreta spectrum or retained products of conception. Also, the overall success of UBT was higher for PPH in vaginal delivery, compared with Cesarean delivery, at 87% versus 81%, regardless of the etiology of hemorrhage.

Looking at safety of UBT, Dr. Suarez and coinvestigators found 39 studies reporting various complications of UBT use for PPH, not all of which reported on all complications. The overall rate for fever or infection was 6.5% in studies reporting on this complication, and endometritis was recorded in 2.3% of participants in studies tracking that complication. Cervical tears, laceration of the lower segment of the vagina, uterine incision rupture or uterine perforation, and acute colonic pseudo-obstruction were all reported in 2% or less of the patients participating in studies that recorded these complications.

The authors excluded studies that included simultaneous use of surgical techniques and UBT and those that involved UBT for hemorrhage after pregnancy loss with a gestation less than 20 weeks’ duration. However, studies were included if UBT was used after surgical procedure failure.

To assess the primary outcome of UBT success rate, the authors used the raw ratio of cases of success divided by the total number of women treated with UBT. For the analysis, successful UBT use was considered to be arrest of PPH bleeding without maternal death or other surgical or radiological interventions after UBT placement, regardless of the definition of “UBT success” used in each study. Similarly, the authors considered “UBT failure” to have occurred in cases of maternal death or when additional surgical or radiological interventions happened after UBT placement.

The authors considered a composite primary outcome measure for the RCT and nonrandomized studies that was made up of maternal death and/or surgical or radiologic interventions.

Secondary outcome measures included UBT’s success rate for individual PPH causes, frequency of surgical and invasive procedures, and maternal outcomes such as death, blood loss, transfusion, ICU admission, and complication rates.

Overall, about half of the studies (n = 48; 53%) were conducted in low- and middle-income countries. Asian countries were the site of 46 studies, or 52% of the total. A quarter were conducted in Europe, and just five studies were conducted in the United States; the remainder were conducted in Africa or Latin America or were multinational studies.

Dr. Martin said that “[the review] findings provide reassurance that UBT can be implemented as a treatment option with a high success rate and low complication rate.” However, she noted, “There was a discrepancy between nonrandomized studies and RCTs on the efficacy and effectiveness of UBT.”

“Two randomized studies concluded there is no benefit to introduction of UBT in management of refractory PPH,” she continued. “The authors point out risk of bias and multiple methodological concerns that likely favored the control group in one effectiveness trial. Lack of benefit may have been due to suboptimal implementation strategies and lack of consistent UBT use.”

Dr. Martin concluded, “Overall, UBT success rates were consistently high across all study types. These findings are reassuring to the practicing clinician. There are many benefits to UBT including ease of use by a variety of health care providers, affordability, and its minimally invasive nature. Now there is evidence that UBT appears safe and has a high rate of success for management of PPH.”

The study’s senior author is a board member of the nonprofit organization Ujenzi Charitable Trust, which received Food and Drug Administration approval for the “Every Second Matters–Uterine Balloon Tamponade” device. Dr. Suarez reported that he had no financial conflicts of interest. The authors reported that there were no external sources of funding for the research. Dr. Martin serves on the editorial board of Ob.Gyn. News.

SOURCE: Suarez S et al. Am J Obstet Gynecol. 2020 Jan 6. doi: 10.1016/j.ajog.2019.11.1287.

Clinicians managing patients who have Candida bloodstream infection should consider an infectious disease (ID) consultation, findings from a large retrospective study suggest.

GrahamColm/Wikimedia Commons

Mortality attributable to Candida bloodstream infection ranges between 15% and 47%, and delay in initiation of appropriate treatment has been associated with increased mortality. Previous small studies showed that ID consultation has conferred benefits to patients with Candida bloodstream infections. Carlos Mejia-Chew, MD, and colleagues from Washington University, St. Louis, sought to explore this further by performing a retrospective, single-center cohort study of 1,691 patients aged 18 years or older with Candida bloodstream infection from 2002 to 2015. They analyzed demographics, comorbidities, predisposing factors, all-cause mortality, antifungal use, central-line removal, and ophthalmological and echocardiographic evaluation in order to compare 90-day all-cause mortality between individuals with and without an ID consultation.

They found that those patients who received an ID consult for a Candida bloodstream infection had a significantly lower 90-day mortality rate than did those who did not (29% vs. 51%).

With a model using inverse weighting by the propensity score, they found that ID consultation was associated with a hazard ratio of 0.81 for mortality (95% confidence interval, 0.73-0.91; P less than .0001). In the ID consultation group, the median duration of antifungal therapy was significantly longer (18 vs. 14 days; P less than .0001); central-line removal was significantly more common (76% vs. 59%; P less than .0001); echocardiography use was more frequent (57% vs. 33%; P less than .0001); and ophthalmological examinations were performed more often (53% vs. 17%; P less than .0001). Importantly, fewer patients in the ID consultation group were untreated (2% vs. 14%; P less than .0001).

In an accompanying commentary, Katrien Lagrou, MD, and Eric Van Wijngaerden, MD, of the department of microbiology, immunology and transplantation, University Hospitals Leuven (Belgium) stated: “We think that the high proportion of patients (14%) with a Candida bloodstream infection who did not receive any antifungal treatment and did not have an infectious disease consultation is a particularly alarming finding. ... Ninety-day mortality in these untreated patients was high (67%).”

“We believe every hospital should have an expert management strategy addressing all individual cases of candidaemia. The need for such expert management should be incorporated in all future candidaemia management guidelines,” they concluded.

The study was funded by the Astellas Global Development Pharma, the Washington University Institute of Clinical and Translational Sciences, and the Agency for Healthcare Research and Quality. Several of the authors had financial connections to Astellas Global Development or other pharmaceutical companies. Dr. Lagrou and Dr. Van Wijngaerden both reported receiving personal fees and nonfinancial support from a number of pharmaceutical companies, but all outside the scope of the study.

mlesney@mdedge.com

SOURCE: Mejia-Chew C et al. Lancet Infect Dis. 2019;19:1336-44.

Clinicians managing patients who have Candida bloodstream infection should consider an infectious disease (ID) consultation, findings from a large retrospective study suggest.

GrahamColm/Wikimedia Commons

Mortality attributable to Candida bloodstream infection ranges between 15% and 47%, and delay in initiation of appropriate treatment has been associated with increased mortality. Previous small studies showed that ID consultation has conferred benefits to patients with Candida bloodstream infections. Carlos Mejia-Chew, MD, and colleagues from Washington University, St. Louis, sought to explore this further by performing a retrospective, single-center cohort study of 1,691 patients aged 18 years or older with Candida bloodstream infection from 2002 to 2015. They analyzed demographics, comorbidities, predisposing factors, all-cause mortality, antifungal use, central-line removal, and ophthalmological and echocardiographic evaluation in order to compare 90-day all-cause mortality between individuals with and without an ID consultation.

They found that those patients who received an ID consult for a Candida bloodstream infection had a significantly lower 90-day mortality rate than did those who did not (29% vs. 51%).

With a model using inverse weighting by the propensity score, they found that ID consultation was associated with a hazard ratio of 0.81 for mortality (95% confidence interval, 0.73-0.91; P less than .0001). In the ID consultation group, the median duration of antifungal therapy was significantly longer (18 vs. 14 days; P less than .0001); central-line removal was significantly more common (76% vs. 59%; P less than .0001); echocardiography use was more frequent (57% vs. 33%; P less than .0001); and ophthalmological examinations were performed more often (53% vs. 17%; P less than .0001). Importantly, fewer patients in the ID consultation group were untreated (2% vs. 14%; P less than .0001).

In an accompanying commentary, Katrien Lagrou, MD, and Eric Van Wijngaerden, MD, of the department of microbiology, immunology and transplantation, University Hospitals Leuven (Belgium) stated: “We think that the high proportion of patients (14%) with a Candida bloodstream infection who did not receive any antifungal treatment and did not have an infectious disease consultation is a particularly alarming finding. ... Ninety-day mortality in these untreated patients was high (67%).”

“We believe every hospital should have an expert management strategy addressing all individual cases of candidaemia. The need for such expert management should be incorporated in all future candidaemia management guidelines,” they concluded.

The study was funded by the Astellas Global Development Pharma, the Washington University Institute of Clinical and Translational Sciences, and the Agency for Healthcare Research and Quality. Several of the authors had financial connections to Astellas Global Development or other pharmaceutical companies. Dr. Lagrou and Dr. Van Wijngaerden both reported receiving personal fees and nonfinancial support from a number of pharmaceutical companies, but all outside the scope of the study.

mlesney@mdedge.com

SOURCE: Mejia-Chew C et al. Lancet Infect Dis. 2019;19:1336-44.

Clinicians managing patients who have Candida bloodstream infection should consider an infectious disease (ID) consultation, findings from a large retrospective study suggest.

GrahamColm/Wikimedia Commons

Mortality attributable to Candida bloodstream infection ranges between 15% and 47%, and delay in initiation of appropriate treatment has been associated with increased mortality. Previous small studies showed that ID consultation has conferred benefits to patients with Candida bloodstream infections. Carlos Mejia-Chew, MD, and colleagues from Washington University, St. Louis, sought to explore this further by performing a retrospective, single-center cohort study of 1,691 patients aged 18 years or older with Candida bloodstream infection from 2002 to 2015. They analyzed demographics, comorbidities, predisposing factors, all-cause mortality, antifungal use, central-line removal, and ophthalmological and echocardiographic evaluation in order to compare 90-day all-cause mortality between individuals with and without an ID consultation.

They found that those patients who received an ID consult for a Candida bloodstream infection had a significantly lower 90-day mortality rate than did those who did not (29% vs. 51%).

With a model using inverse weighting by the propensity score, they found that ID consultation was associated with a hazard ratio of 0.81 for mortality (95% confidence interval, 0.73-0.91; P less than .0001). In the ID consultation group, the median duration of antifungal therapy was significantly longer (18 vs. 14 days; P less than .0001); central-line removal was significantly more common (76% vs. 59%; P less than .0001); echocardiography use was more frequent (57% vs. 33%; P less than .0001); and ophthalmological examinations were performed more often (53% vs. 17%; P less than .0001). Importantly, fewer patients in the ID consultation group were untreated (2% vs. 14%; P less than .0001).

In an accompanying commentary, Katrien Lagrou, MD, and Eric Van Wijngaerden, MD, of the department of microbiology, immunology and transplantation, University Hospitals Leuven (Belgium) stated: “We think that the high proportion of patients (14%) with a Candida bloodstream infection who did not receive any antifungal treatment and did not have an infectious disease consultation is a particularly alarming finding. ... Ninety-day mortality in these untreated patients was high (67%).”

“We believe every hospital should have an expert management strategy addressing all individual cases of candidaemia. The need for such expert management should be incorporated in all future candidaemia management guidelines,” they concluded.

The study was funded by the Astellas Global Development Pharma, the Washington University Institute of Clinical and Translational Sciences, and the Agency for Healthcare Research and Quality. Several of the authors had financial connections to Astellas Global Development or other pharmaceutical companies. Dr. Lagrou and Dr. Van Wijngaerden both reported receiving personal fees and nonfinancial support from a number of pharmaceutical companies, but all outside the scope of the study.

mlesney@mdedge.com

SOURCE: Mejia-Chew C et al. Lancet Infect Dis. 2019;19:1336-44.

A new tool specifically designed to evaluate immune checkpoint inhibitor–related toxicity, developed based on direct patient involvement, picks up on cutaneous and other side effects that would be missed using traditional quality of life questionnaires, investigators say.

The 25-item list represents the first-ever health-related quality of life (HRQOL) toxicity subscale developed for patients receiving checkpoint inhibitors, according to the investigators, led by Aaron R. Hansen, MBBS, of the division of medical oncology and hematology in the department of medicine at the University of Toronto.

The toxicity subscale is combined with the Functional Assessment of Cancer Therapy–General (FACT-G), which measures physical, emotional, family and social, and functional domains, to form the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT-ICM), Dr. Hansen stated in a recent report that describes initial development and early validation efforts.

The FACT-ICM could become an important tool for measuring HRQOL in patients receiving checkpoint inhibitors, depending on results of further investigations including more patients, the authors wrote in that report.

“Currently, we would recommend that our toxicity subscale be validated first before use in clinical care, or in trials with QOL as a primary or secondary endpoint,” wrote Dr. Hansen and colleagues in the report, which appears in Cancer.

The toxicity subscale asks patients to rate items such as “I am bothered by dry skin,” “I feel pain, soreness or aches in some of my muscles,” and “My fatigue keeps me from doing the things I want do” on a scale of 0 (not at all) to 4 (very much).

Development of the toxicity subscale was based on focus groups and interviews with 37 patients with a variety of cancer types who were being treated with a PD-1, PD-L1, and CTLA-4 immune checkpoint inhibitors. Sixteen physicians were surveyed to evaluate the patient input, while 11 of them also participated in follow-up interviews.

“At every step in this process, the patients were central,” the investigators wrote in their report.

According to the investigators, that approach is in line with guidance from the Food and Drug Administration, which has said that meaningful patient input should be used in the upfront development of patient-reported outcome (PRO) measures, rather than obtaining patient endorsement after the fact.

By contrast, an electronic PRO immune-oncology module recently developed, based on 19 immune-related adverse events from drug labels and clinical trial reports, had “no evaluation” of effects on HRQOL, according to Dr. Hansen and coauthors, who added that the tool “did not adhere” to the FDA call for meaningful patient input.

Some previous studies of quality of life in immune checkpoint inhibitor–treated patients have used tumor-specific PROs and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 Items (EORTC-QLQ-C30).

The new, immune checkpoint inhibitor–specific toxicity subscale has “broader coverage” of side effects that reportedly affect HRQOL in patients treated with these agents, including taste disturbance, cough, and fever or chills, according to the investigators.

Moreover, the EORTC-QLQ-C30 and the EORTC head and neck cancer–specific-35 module (EORTC QLQ-H&N35), do not include items related to cutaneous adverse events such as itch, rash, and dry skin that have been seen in some checkpoint inhibitor clinical trials, they noted.

“This represents a clear limitation of such preexisting PRO instruments, which should be addressed with our immune checkpoint moduator–specific tool,” they wrote.

The study was supported by a grant from the University of Toronto. Authors of the study provided disclosures related to Merck, Bristol-Myers Squibb, Karyopharm, Boston Biomedical, Novartis, Genentech, Hoffmann La Roche, GlaxoSmithKline, and others.

SOURCE: Hansen AR et al. Cancer. 2020 Jan 8. doi: 10.1002/cncr.32692.

A new tool specifically designed to evaluate immune checkpoint inhibitor–related toxicity, developed based on direct patient involvement, picks up on cutaneous and other side effects that would be missed using traditional quality of life questionnaires, investigators say.

The 25-item list represents the first-ever health-related quality of life (HRQOL) toxicity subscale developed for patients receiving checkpoint inhibitors, according to the investigators, led by Aaron R. Hansen, MBBS, of the division of medical oncology and hematology in the department of medicine at the University of Toronto.

The toxicity subscale is combined with the Functional Assessment of Cancer Therapy–General (FACT-G), which measures physical, emotional, family and social, and functional domains, to form the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT-ICM), Dr. Hansen stated in a recent report that describes initial development and early validation efforts.

The FACT-ICM could become an important tool for measuring HRQOL in patients receiving checkpoint inhibitors, depending on results of further investigations including more patients, the authors wrote in that report.

“Currently, we would recommend that our toxicity subscale be validated first before use in clinical care, or in trials with QOL as a primary or secondary endpoint,” wrote Dr. Hansen and colleagues in the report, which appears in Cancer.

The toxicity subscale asks patients to rate items such as “I am bothered by dry skin,” “I feel pain, soreness or aches in some of my muscles,” and “My fatigue keeps me from doing the things I want do” on a scale of 0 (not at all) to 4 (very much).

Development of the toxicity subscale was based on focus groups and interviews with 37 patients with a variety of cancer types who were being treated with a PD-1, PD-L1, and CTLA-4 immune checkpoint inhibitors. Sixteen physicians were surveyed to evaluate the patient input, while 11 of them also participated in follow-up interviews.

“At every step in this process, the patients were central,” the investigators wrote in their report.

According to the investigators, that approach is in line with guidance from the Food and Drug Administration, which has said that meaningful patient input should be used in the upfront development of patient-reported outcome (PRO) measures, rather than obtaining patient endorsement after the fact.

By contrast, an electronic PRO immune-oncology module recently developed, based on 19 immune-related adverse events from drug labels and clinical trial reports, had “no evaluation” of effects on HRQOL, according to Dr. Hansen and coauthors, who added that the tool “did not adhere” to the FDA call for meaningful patient input.

Some previous studies of quality of life in immune checkpoint inhibitor–treated patients have used tumor-specific PROs and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 Items (EORTC-QLQ-C30).

The new, immune checkpoint inhibitor–specific toxicity subscale has “broader coverage” of side effects that reportedly affect HRQOL in patients treated with these agents, including taste disturbance, cough, and fever or chills, according to the investigators.

Moreover, the EORTC-QLQ-C30 and the EORTC head and neck cancer–specific-35 module (EORTC QLQ-H&N35), do not include items related to cutaneous adverse events such as itch, rash, and dry skin that have been seen in some checkpoint inhibitor clinical trials, they noted.

“This represents a clear limitation of such preexisting PRO instruments, which should be addressed with our immune checkpoint moduator–specific tool,” they wrote.

The study was supported by a grant from the University of Toronto. Authors of the study provided disclosures related to Merck, Bristol-Myers Squibb, Karyopharm, Boston Biomedical, Novartis, Genentech, Hoffmann La Roche, GlaxoSmithKline, and others.

SOURCE: Hansen AR et al. Cancer. 2020 Jan 8. doi: 10.1002/cncr.32692.

A new tool specifically designed to evaluate immune checkpoint inhibitor–related toxicity, developed based on direct patient involvement, picks up on cutaneous and other side effects that would be missed using traditional quality of life questionnaires, investigators say.

The 25-item list represents the first-ever health-related quality of life (HRQOL) toxicity subscale developed for patients receiving checkpoint inhibitors, according to the investigators, led by Aaron R. Hansen, MBBS, of the division of medical oncology and hematology in the department of medicine at the University of Toronto.

The toxicity subscale is combined with the Functional Assessment of Cancer Therapy–General (FACT-G), which measures physical, emotional, family and social, and functional domains, to form the Functional Assessment of Cancer Therapy–Immune Checkpoint Modulator (FACT-ICM), Dr. Hansen stated in a recent report that describes initial development and early validation efforts.

The FACT-ICM could become an important tool for measuring HRQOL in patients receiving checkpoint inhibitors, depending on results of further investigations including more patients, the authors wrote in that report.

“Currently, we would recommend that our toxicity subscale be validated first before use in clinical care, or in trials with QOL as a primary or secondary endpoint,” wrote Dr. Hansen and colleagues in the report, which appears in Cancer.

The toxicity subscale asks patients to rate items such as “I am bothered by dry skin,” “I feel pain, soreness or aches in some of my muscles,” and “My fatigue keeps me from doing the things I want do” on a scale of 0 (not at all) to 4 (very much).

Development of the toxicity subscale was based on focus groups and interviews with 37 patients with a variety of cancer types who were being treated with a PD-1, PD-L1, and CTLA-4 immune checkpoint inhibitors. Sixteen physicians were surveyed to evaluate the patient input, while 11 of them also participated in follow-up interviews.

“At every step in this process, the patients were central,” the investigators wrote in their report.

According to the investigators, that approach is in line with guidance from the Food and Drug Administration, which has said that meaningful patient input should be used in the upfront development of patient-reported outcome (PRO) measures, rather than obtaining patient endorsement after the fact.

By contrast, an electronic PRO immune-oncology module recently developed, based on 19 immune-related adverse events from drug labels and clinical trial reports, had “no evaluation” of effects on HRQOL, according to Dr. Hansen and coauthors, who added that the tool “did not adhere” to the FDA call for meaningful patient input.

Some previous studies of quality of life in immune checkpoint inhibitor–treated patients have used tumor-specific PROs and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 Items (EORTC-QLQ-C30).

The new, immune checkpoint inhibitor–specific toxicity subscale has “broader coverage” of side effects that reportedly affect HRQOL in patients treated with these agents, including taste disturbance, cough, and fever or chills, according to the investigators.

Moreover, the EORTC-QLQ-C30 and the EORTC head and neck cancer–specific-35 module (EORTC QLQ-H&N35), do not include items related to cutaneous adverse events such as itch, rash, and dry skin that have been seen in some checkpoint inhibitor clinical trials, they noted.

“This represents a clear limitation of such preexisting PRO instruments, which should be addressed with our immune checkpoint moduator–specific tool,” they wrote.

The study was supported by a grant from the University of Toronto. Authors of the study provided disclosures related to Merck, Bristol-Myers Squibb, Karyopharm, Boston Biomedical, Novartis, Genentech, Hoffmann La Roche, GlaxoSmithKline, and others.

SOURCE: Hansen AR et al. Cancer. 2020 Jan 8. doi: 10.1002/cncr.32692.

Dementia patients undergoing hip fracture surgery had higher functional status with more intensive postsurgery rehabilitation, according to a recent Japanese study in the Archives of Physical Medicine and Rehabilitation.

Ingram Pub.l

Looking at 43,506 patients cared for at 1,053 hospitals, Kazuaki Uda, MPH, and colleagues of the University of Tokyo found that scores on the Barthel Index, a measure of functional status, climbed significantly as the frequency and duration of postoperative rehabilitation increased. There was also a statistically significant, but small, association with improved functional status and early initiation of rehabilitation.

“Our results suggest that additional days of rehabilitation or an additional 20 minutes for each daily rehabilitation session in acute-care hospitals may provide better functional outcomes for patients with dementia,” concluded Mr. Uda and coinvestigators.

The Barthel Index (BI) measures independence in performing 10 activities of daily living (ADLs), including feeding, bathing, grooming, and dressing; bowel, bladder, and toileting; and transfers, mobility, and stair use. Each ADL is rate 0, 5, 10, or, for some, 15 points, and higher scores indicate more independence.

Compared with patients who received 3 days or fewer of rehabilitation weekly, patients receiving 3-4 days of rehabilitation saw an improvement of 2.62 on the BI. For those receiving 4-5 days, 5-6 days, and 6 or more days of rehabilitation, BI scores were higher by 5.83, 7.56, and 9.16, respectively. The results were statistically significant for all but the 3-4 day rehabilitation group.

Similarly, patients who received longer periods of rehabilitation saw more improvement in functional status. Compared with those who received 20-39 minutes per day of rehabilitation, those who received 40-59 minutes of therapy saw an increase of 4.37 on the BI, and those receiving an hour or more of therapy saw BI scores rise by 6.60 – both significant increases.

These results included a multivariable analysis that accounted for a number of patient characteristics such as comorbidities and body mass index, as well as fracture, fixation, and anesthesia type, and the interval from injury to surgery.

Representing the data in another way, the investigators found that “each increase in the average units of rehabilitation (units per day) was associated with a 5.46 increase in the BI.”

This retrospective cohort study, when placed in the context of previous work, suggests that “patients with cognitive impairment may benefit from rehabilitation for functional gains after hip fracture surgery in both acute and postacute settings,” the investigators wrote. They noted, however, that patients with dementia have often been excluded from larger outcome studies of hip fracture rehabilitation.

Patients in this study had a median 21-day inpatient stay after admission for their hip fracture, so much of the rehabilitation included as inpatient care in the Japanese schema would be delivered in the outpatient setting in the United States, where the mean inpatient length of stay after hip fracture is about 5 days.

Patients aged 65 years and older were included in the study if they had a prefracture diagnosis of dementia and sustained a hip fracture that was surgically repaired. Patients with multiple fracture sites, those with incomplete data, and those who didn’t undergo surgery or died in the hospital were excluded from the study. Almost two-thirds of patients (65.7%) were aged 85 years or older, and about a third (36.6%) were living in nursing facilities at the time of fracture. About 60% of patients were assessed as having mild dementia – a classification requiring little assistance with ADLs – before admission.

The authors noted that their study broke out timing, duration, and frequency of rehabilitation separately, unlike some previous work. They posited that longer or more frequent rounds of rehabilitation may be particularly effective in patients with dementia, who may face some communication barriers and require reteaching.

The study was unrandomized by design, and unmeasured confounders may have affected the results, they noted. Also, the study wasn’t designed to detect whether patient factors such as premorbid functional status, level of dementia, or living situation affected the timing, duration, and intensity of rehabilitation they were provided. The investigators recommended randomized studies to validate the effect of early, intensive rehabilitation for hip fracture surgery in patients with dementia.

The study was funded by the Japanese Ministry of Health, Labor, and Welfare. The authors reported that they have no relevant conflicts of interest.

koakes@mdedge.com

SOURCE: Uda K et al. Arch Phys Med Rehabil. 2019;100:2301-7.

Dementia patients undergoing hip fracture surgery had higher functional status with more intensive postsurgery rehabilitation, according to a recent Japanese study in the Archives of Physical Medicine and Rehabilitation.

Ingram Pub.l

Looking at 43,506 patients cared for at 1,053 hospitals, Kazuaki Uda, MPH, and colleagues of the University of Tokyo found that scores on the Barthel Index, a measure of functional status, climbed significantly as the frequency and duration of postoperative rehabilitation increased. There was also a statistically significant, but small, association with improved functional status and early initiation of rehabilitation.

“Our results suggest that additional days of rehabilitation or an additional 20 minutes for each daily rehabilitation session in acute-care hospitals may provide better functional outcomes for patients with dementia,” concluded Mr. Uda and coinvestigators.

The Barthel Index (BI) measures independence in performing 10 activities of daily living (ADLs), including feeding, bathing, grooming, and dressing; bowel, bladder, and toileting; and transfers, mobility, and stair use. Each ADL is rate 0, 5, 10, or, for some, 15 points, and higher scores indicate more independence.

Compared with patients who received 3 days or fewer of rehabilitation weekly, patients receiving 3-4 days of rehabilitation saw an improvement of 2.62 on the BI. For those receiving 4-5 days, 5-6 days, and 6 or more days of rehabilitation, BI scores were higher by 5.83, 7.56, and 9.16, respectively. The results were statistically significant for all but the 3-4 day rehabilitation group.

Similarly, patients who received longer periods of rehabilitation saw more improvement in functional status. Compared with those who received 20-39 minutes per day of rehabilitation, those who received 40-59 minutes of therapy saw an increase of 4.37 on the BI, and those receiving an hour or more of therapy saw BI scores rise by 6.60 – both significant increases.

These results included a multivariable analysis that accounted for a number of patient characteristics such as comorbidities and body mass index, as well as fracture, fixation, and anesthesia type, and the interval from injury to surgery.

Representing the data in another way, the investigators found that “each increase in the average units of rehabilitation (units per day) was associated with a 5.46 increase in the BI.”

This retrospective cohort study, when placed in the context of previous work, suggests that “patients with cognitive impairment may benefit from rehabilitation for functional gains after hip fracture surgery in both acute and postacute settings,” the investigators wrote. They noted, however, that patients with dementia have often been excluded from larger outcome studies of hip fracture rehabilitation.

Patients in this study had a median 21-day inpatient stay after admission for their hip fracture, so much of the rehabilitation included as inpatient care in the Japanese schema would be delivered in the outpatient setting in the United States, where the mean inpatient length of stay after hip fracture is about 5 days.

Patients aged 65 years and older were included in the study if they had a prefracture diagnosis of dementia and sustained a hip fracture that was surgically repaired. Patients with multiple fracture sites, those with incomplete data, and those who didn’t undergo surgery or died in the hospital were excluded from the study. Almost two-thirds of patients (65.7%) were aged 85 years or older, and about a third (36.6%) were living in nursing facilities at the time of fracture. About 60% of patients were assessed as having mild dementia – a classification requiring little assistance with ADLs – before admission.

The authors noted that their study broke out timing, duration, and frequency of rehabilitation separately, unlike some previous work. They posited that longer or more frequent rounds of rehabilitation may be particularly effective in patients with dementia, who may face some communication barriers and require reteaching.

The study was unrandomized by design, and unmeasured confounders may have affected the results, they noted. Also, the study wasn’t designed to detect whether patient factors such as premorbid functional status, level of dementia, or living situation affected the timing, duration, and intensity of rehabilitation they were provided. The investigators recommended randomized studies to validate the effect of early, intensive rehabilitation for hip fracture surgery in patients with dementia.

The study was funded by the Japanese Ministry of Health, Labor, and Welfare. The authors reported that they have no relevant conflicts of interest.

koakes@mdedge.com

SOURCE: Uda K et al. Arch Phys Med Rehabil. 2019;100:2301-7.

Dementia patients undergoing hip fracture surgery had higher functional status with more intensive postsurgery rehabilitation, according to a recent Japanese study in the Archives of Physical Medicine and Rehabilitation.

Ingram Pub.l

Looking at 43,506 patients cared for at 1,053 hospitals, Kazuaki Uda, MPH, and colleagues of the University of Tokyo found that scores on the Barthel Index, a measure of functional status, climbed significantly as the frequency and duration of postoperative rehabilitation increased. There was also a statistically significant, but small, association with improved functional status and early initiation of rehabilitation.

“Our results suggest that additional days of rehabilitation or an additional 20 minutes for each daily rehabilitation session in acute-care hospitals may provide better functional outcomes for patients with dementia,” concluded Mr. Uda and coinvestigators.

The Barthel Index (BI) measures independence in performing 10 activities of daily living (ADLs), including feeding, bathing, grooming, and dressing; bowel, bladder, and toileting; and transfers, mobility, and stair use. Each ADL is rate 0, 5, 10, or, for some, 15 points, and higher scores indicate more independence.

Compared with patients who received 3 days or fewer of rehabilitation weekly, patients receiving 3-4 days of rehabilitation saw an improvement of 2.62 on the BI. For those receiving 4-5 days, 5-6 days, and 6 or more days of rehabilitation, BI scores were higher by 5.83, 7.56, and 9.16, respectively. The results were statistically significant for all but the 3-4 day rehabilitation group.

Similarly, patients who received longer periods of rehabilitation saw more improvement in functional status. Compared with those who received 20-39 minutes per day of rehabilitation, those who received 40-59 minutes of therapy saw an increase of 4.37 on the BI, and those receiving an hour or more of therapy saw BI scores rise by 6.60 – both significant increases.

These results included a multivariable analysis that accounted for a number of patient characteristics such as comorbidities and body mass index, as well as fracture, fixation, and anesthesia type, and the interval from injury to surgery.

Representing the data in another way, the investigators found that “each increase in the average units of rehabilitation (units per day) was associated with a 5.46 increase in the BI.”

This retrospective cohort study, when placed in the context of previous work, suggests that “patients with cognitive impairment may benefit from rehabilitation for functional gains after hip fracture surgery in both acute and postacute settings,” the investigators wrote. They noted, however, that patients with dementia have often been excluded from larger outcome studies of hip fracture rehabilitation.

Patients in this study had a median 21-day inpatient stay after admission for their hip fracture, so much of the rehabilitation included as inpatient care in the Japanese schema would be delivered in the outpatient setting in the United States, where the mean inpatient length of stay after hip fracture is about 5 days.

Patients aged 65 years and older were included in the study if they had a prefracture diagnosis of dementia and sustained a hip fracture that was surgically repaired. Patients with multiple fracture sites, those with incomplete data, and those who didn’t undergo surgery or died in the hospital were excluded from the study. Almost two-thirds of patients (65.7%) were aged 85 years or older, and about a third (36.6%) were living in nursing facilities at the time of fracture. About 60% of patients were assessed as having mild dementia – a classification requiring little assistance with ADLs – before admission.

The authors noted that their study broke out timing, duration, and frequency of rehabilitation separately, unlike some previous work. They posited that longer or more frequent rounds of rehabilitation may be particularly effective in patients with dementia, who may face some communication barriers and require reteaching.

The study was unrandomized by design, and unmeasured confounders may have affected the results, they noted. Also, the study wasn’t designed to detect whether patient factors such as premorbid functional status, level of dementia, or living situation affected the timing, duration, and intensity of rehabilitation they were provided. The investigators recommended randomized studies to validate the effect of early, intensive rehabilitation for hip fracture surgery in patients with dementia.

The study was funded by the Japanese Ministry of Health, Labor, and Welfare. The authors reported that they have no relevant conflicts of interest.

koakes@mdedge.com

SOURCE: Uda K et al. Arch Phys Med Rehabil. 2019;100:2301-7.

Better insurance coverage within minority populations can help close racial disparities in the detection of early-stage breast cancer, according to new study.

Insurance coverage “mediates nearly half of the increased risk for later-stage breast cancer diagnosis seen among racial/ethnic minorities,” Naomi Ko, MD, of Boston University and colleagues wrote in a research report published in JAMA Oncology.

With Surveillance, Epidemiology, and End Results Program data, the researchers looked at patient records on 177,075 women (148,124 insured and 28,951 uninsured or on Medicaid) aged 40-64 years who received a breast cancer diagnosis between Jan. 1, 2010, and Dec. 31, 2016. They found that a higher proportion of women (20%) uninsured or on Medicaid received a diagnosis of a higher-stage breast cancer (stage III), compared with women who had health insurance (11%).

More non-Hispanic black women (17%), American Indian or Alaskan native (15%), and Hispanic women (16%) received a stage III breast cancer diagnosis, compared with non-Hispanic white women (12%). Non-Hispanic white women were more likely to have insurance coverage at the time of diagnosis (89%), compared with non-Hispanic black women (75%), American Indian or Alaskan native (58%), and Hispanic women (67%).

“Without insurance coverage, the lack of prevention, screening, and access to care, as well as delays in diagnosis, lead to later stage of disease at diagnosis and thus worse survival,” Dr. Ko and colleagues wrote, adding that patients with a diagnosis of later-stage cancer require more intensive treatment and are at higher risk for treatment-associated morbidity and poorer overall quality of life.

Another consequence of the later-stage diagnosis is increased financial costs related to treatment for these patients, according to the investigator. They cite research that shows stage III cancer was 58% more costly to treat than was stage I or II breast cancer.

“Overall, earlier stage at diagnosis of breast cancer is not only beneficial for individual patients and families but also on society as a whole to decrease costs and equity among all populations,” Dr. Ko and colleagues added.

The researchers noted some of the limitations of the study, which include the source of data (the Surveillance, Epidemiology, and End Results Program, which covers 18 regions and might not be generalizable to all populations), as well as the age range of the studied population.

That being said, the authors also acknowledged that the findings “do not suggest that insurance alone will eliminate racial/ethnic disparities in breast cancer,” but “the ability to quantify the association that insurance has with breast cancer stage is relevant to potential policy changes regarding insurance and a prioritization of solutions for the increased burden of cancer mortality and morbidity disproportionately placed on racial/ethnic minority populations.”

Funding sources include the National Institutes of Health, National Center for Advancing Translational Sciences, National Cancer Institute, and National Institute on Minority Health and Health Disparities. The authors reported no conflicts of interest related to this study.

gtwachtman@mdedge.com

SOURCE: Ko N et al. JAMA Onc. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5672.

Better insurance coverage within minority populations can help close racial disparities in the detection of early-stage breast cancer, according to new study.

Insurance coverage “mediates nearly half of the increased risk for later-stage breast cancer diagnosis seen among racial/ethnic minorities,” Naomi Ko, MD, of Boston University and colleagues wrote in a research report published in JAMA Oncology.

With Surveillance, Epidemiology, and End Results Program data, the researchers looked at patient records on 177,075 women (148,124 insured and 28,951 uninsured or on Medicaid) aged 40-64 years who received a breast cancer diagnosis between Jan. 1, 2010, and Dec. 31, 2016. They found that a higher proportion of women (20%) uninsured or on Medicaid received a diagnosis of a higher-stage breast cancer (stage III), compared with women who had health insurance (11%).

More non-Hispanic black women (17%), American Indian or Alaskan native (15%), and Hispanic women (16%) received a stage III breast cancer diagnosis, compared with non-Hispanic white women (12%). Non-Hispanic white women were more likely to have insurance coverage at the time of diagnosis (89%), compared with non-Hispanic black women (75%), American Indian or Alaskan native (58%), and Hispanic women (67%).

“Without insurance coverage, the lack of prevention, screening, and access to care, as well as delays in diagnosis, lead to later stage of disease at diagnosis and thus worse survival,” Dr. Ko and colleagues wrote, adding that patients with a diagnosis of later-stage cancer require more intensive treatment and are at higher risk for treatment-associated morbidity and poorer overall quality of life.

Another consequence of the later-stage diagnosis is increased financial costs related to treatment for these patients, according to the investigator. They cite research that shows stage III cancer was 58% more costly to treat than was stage I or II breast cancer.

“Overall, earlier stage at diagnosis of breast cancer is not only beneficial for individual patients and families but also on society as a whole to decrease costs and equity among all populations,” Dr. Ko and colleagues added.

The researchers noted some of the limitations of the study, which include the source of data (the Surveillance, Epidemiology, and End Results Program, which covers 18 regions and might not be generalizable to all populations), as well as the age range of the studied population.

That being said, the authors also acknowledged that the findings “do not suggest that insurance alone will eliminate racial/ethnic disparities in breast cancer,” but “the ability to quantify the association that insurance has with breast cancer stage is relevant to potential policy changes regarding insurance and a prioritization of solutions for the increased burden of cancer mortality and morbidity disproportionately placed on racial/ethnic minority populations.”

Funding sources include the National Institutes of Health, National Center for Advancing Translational Sciences, National Cancer Institute, and National Institute on Minority Health and Health Disparities. The authors reported no conflicts of interest related to this study.

gtwachtman@mdedge.com

SOURCE: Ko N et al. JAMA Onc. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5672.

Better insurance coverage within minority populations can help close racial disparities in the detection of early-stage breast cancer, according to new study.

Insurance coverage “mediates nearly half of the increased risk for later-stage breast cancer diagnosis seen among racial/ethnic minorities,” Naomi Ko, MD, of Boston University and colleagues wrote in a research report published in JAMA Oncology.

With Surveillance, Epidemiology, and End Results Program data, the researchers looked at patient records on 177,075 women (148,124 insured and 28,951 uninsured or on Medicaid) aged 40-64 years who received a breast cancer diagnosis between Jan. 1, 2010, and Dec. 31, 2016. They found that a higher proportion of women (20%) uninsured or on Medicaid received a diagnosis of a higher-stage breast cancer (stage III), compared with women who had health insurance (11%).

More non-Hispanic black women (17%), American Indian or Alaskan native (15%), and Hispanic women (16%) received a stage III breast cancer diagnosis, compared with non-Hispanic white women (12%). Non-Hispanic white women were more likely to have insurance coverage at the time of diagnosis (89%), compared with non-Hispanic black women (75%), American Indian or Alaskan native (58%), and Hispanic women (67%).

“Without insurance coverage, the lack of prevention, screening, and access to care, as well as delays in diagnosis, lead to later stage of disease at diagnosis and thus worse survival,” Dr. Ko and colleagues wrote, adding that patients with a diagnosis of later-stage cancer require more intensive treatment and are at higher risk for treatment-associated morbidity and poorer overall quality of life.

Another consequence of the later-stage diagnosis is increased financial costs related to treatment for these patients, according to the investigator. They cite research that shows stage III cancer was 58% more costly to treat than was stage I or II breast cancer.

“Overall, earlier stage at diagnosis of breast cancer is not only beneficial for individual patients and families but also on society as a whole to decrease costs and equity among all populations,” Dr. Ko and colleagues added.

The researchers noted some of the limitations of the study, which include the source of data (the Surveillance, Epidemiology, and End Results Program, which covers 18 regions and might not be generalizable to all populations), as well as the age range of the studied population.

That being said, the authors also acknowledged that the findings “do not suggest that insurance alone will eliminate racial/ethnic disparities in breast cancer,” but “the ability to quantify the association that insurance has with breast cancer stage is relevant to potential policy changes regarding insurance and a prioritization of solutions for the increased burden of cancer mortality and morbidity disproportionately placed on racial/ethnic minority populations.”

Funding sources include the National Institutes of Health, National Center for Advancing Translational Sciences, National Cancer Institute, and National Institute on Minority Health and Health Disparities. The authors reported no conflicts of interest related to this study.

gtwachtman@mdedge.com

SOURCE: Ko N et al. JAMA Onc. 2020 Jan 9. doi: 10.1001/jamaoncol.2019.5672.

For children with milk-induced eosinophilic esophagitis (EoE), 9 months of epicutaneous immunotherapy (EPIT) with Viaskin Milk did not significantly improve eosinophil counts or symptoms, compared with placebo, according to the results of an intention-to-treat analysis of a randomized, double-blinded pilot study.

Average maximum eosinophil counts were 50.1 per high-power field in the Viaskin Milk group versus 48.2 in the placebo group, said Jonathan M. Spergel, MD, of the Children’s Hospital of Philadelphia and associates. However, in the per-protocol analysis, the seven patients who received Viaskin Milk had mean eosinophil counts of 25.6 per high-power field, compared with 95.0 for the two children who received placebo (P = .038). Moreover, 47% of patients had fewer than 15 eosinophils per high-power field after an additional 11 months of open-label treatment with Viaskin Milk. Taken together, the findings justify larger, multicenter studies to evaluate EPIT for treating EoE and other non-IgE mediated food diseases, Dr. Spergel and associates wrote in Clinical Gastroenterology and Hepatology.

EoE results from an immune response to specific food allergens, including milk. Classic symptoms include difficulty feeding and failure to thrive in infants, abdominal pain in young children, and dysphagia in older children and adults. Definitive diagnosis requires an esophageal biopsy with an eosinophil count of 15 or more cells per high-power field. “There are no approved therapies [for eosinophilic esophagitis] beyond avoidance of the allergen(s) or treatment of inflammation,” the investigators wrote.

In prior studies, exposure to EPIT was found to mitigate eosinophilic gastrointestinal disease in mice and pigs. In humans, milk is the most common dietary cause of eosinophilic esophagitis. Accordingly, Viaskin Milk is an EPIT containing an allergen extract of milk that is administered epicutaneously using a specialized delivery system. To evaluate its use for the treatment of pediatric milk-induced EoE (at least 15 eosinophils per high-power frame despite at least 2 months of high-dose proton pump–inhibitor therapy at 1-2 mg/kg twice daily), the researchers randomly assigned 20 children on a 3:1 basis to receive either Viaskin Milk or placebo for 9 months. Patients and investigators were double-blinded for this phase of the study, during most of which patients abstained from milk. Toward the end of the 9 months, patients resumed consuming milk and continued doing so if their upper endoscopy biopsy showed resolution of EoE (eosinophil count less than 15 per high-power field).

In the intention-to-treat analysis, Viaskin Milk did not meet the primary endpoint of the difference in least squares mean compared with placebo (8.6; 95% confidence interval, –35.36 to 52.56). Symptom scores also were similar between groups. In contrast, at the end of the 11-month, open-label period, 9 of 19 evaluable patients had eosinophil biopsy counts of fewer than 15 per high-power field, for a response rate of 47%. “The number of adverse events did not differ significantly between the Viaskin Milk and placebo groups,” the researchers added.

Protocol violations might explain why EPIT failed to meet the primary endpoint in the intention-to-treat analysis, they wrote. “For example, the patients on the active therapy wanted to ingest more milk, while the patients in the placebo group wanted less milk,” they reported. “Three patients in the active therapy went on binge milk diets drinking 4 to 8 times the amount of milk compared with baseline.” The use of proton pump inhibitors also was inconsistent between groups, they added. “The major limitation in the [per-protocol] population was the small sample size of this pilot study, raising the possibility of false-positive results.”

The study was funded by DBV Technologies and by the Children’s Hospital of Philadelphia Eosinophilic Esophagitis Family Fund. Dr. Spergel disclosed consulting agreements, grants funding, and stock equity with DBV Technologies. Three coinvestigators also disclosed ties to DBV. The remaining five coinvestigators reported having no conflicts of interest.

SOURCE: Spergel JM et al. Clin Gastroenterol Hepatol. 2019 May 14. doi: 10.1016/j.cgh.2019.05.014.

For children with milk-induced eosinophilic esophagitis (EoE), 9 months of epicutaneous immunotherapy (EPIT) with Viaskin Milk did not significantly improve eosinophil counts or symptoms, compared with placebo, according to the results of an intention-to-treat analysis of a randomized, double-blinded pilot study.

Average maximum eosinophil counts were 50.1 per high-power field in the Viaskin Milk group versus 48.2 in the placebo group, said Jonathan M. Spergel, MD, of the Children’s Hospital of Philadelphia and associates. However, in the per-protocol analysis, the seven patients who received Viaskin Milk had mean eosinophil counts of 25.6 per high-power field, compared with 95.0 for the two children who received placebo (P = .038). Moreover, 47% of patients had fewer than 15 eosinophils per high-power field after an additional 11 months of open-label treatment with Viaskin Milk. Taken together, the findings justify larger, multicenter studies to evaluate EPIT for treating EoE and other non-IgE mediated food diseases, Dr. Spergel and associates wrote in Clinical Gastroenterology and Hepatology.

EoE results from an immune response to specific food allergens, including milk. Classic symptoms include difficulty feeding and failure to thrive in infants, abdominal pain in young children, and dysphagia in older children and adults. Definitive diagnosis requires an esophageal biopsy with an eosinophil count of 15 or more cells per high-power field. “There are no approved therapies [for eosinophilic esophagitis] beyond avoidance of the allergen(s) or treatment of inflammation,” the investigators wrote.

In prior studies, exposure to EPIT was found to mitigate eosinophilic gastrointestinal disease in mice and pigs. In humans, milk is the most common dietary cause of eosinophilic esophagitis. Accordingly, Viaskin Milk is an EPIT containing an allergen extract of milk that is administered epicutaneously using a specialized delivery system. To evaluate its use for the treatment of pediatric milk-induced EoE (at least 15 eosinophils per high-power frame despite at least 2 months of high-dose proton pump–inhibitor therapy at 1-2 mg/kg twice daily), the researchers randomly assigned 20 children on a 3:1 basis to receive either Viaskin Milk or placebo for 9 months. Patients and investigators were double-blinded for this phase of the study, during most of which patients abstained from milk. Toward the end of the 9 months, patients resumed consuming milk and continued doing so if their upper endoscopy biopsy showed resolution of EoE (eosinophil count less than 15 per high-power field).

In the intention-to-treat analysis, Viaskin Milk did not meet the primary endpoint of the difference in least squares mean compared with placebo (8.6; 95% confidence interval, –35.36 to 52.56). Symptom scores also were similar between groups. In contrast, at the end of the 11-month, open-label period, 9 of 19 evaluable patients had eosinophil biopsy counts of fewer than 15 per high-power field, for a response rate of 47%. “The number of adverse events did not differ significantly between the Viaskin Milk and placebo groups,” the researchers added.

Protocol violations might explain why EPIT failed to meet the primary endpoint in the intention-to-treat analysis, they wrote. “For example, the patients on the active therapy wanted to ingest more milk, while the patients in the placebo group wanted less milk,” they reported. “Three patients in the active therapy went on binge milk diets drinking 4 to 8 times the amount of milk compared with baseline.” The use of proton pump inhibitors also was inconsistent between groups, they added. “The major limitation in the [per-protocol] population was the small sample size of this pilot study, raising the possibility of false-positive results.”

The study was funded by DBV Technologies and by the Children’s Hospital of Philadelphia Eosinophilic Esophagitis Family Fund. Dr. Spergel disclosed consulting agreements, grants funding, and stock equity with DBV Technologies. Three coinvestigators also disclosed ties to DBV. The remaining five coinvestigators reported having no conflicts of interest.

SOURCE: Spergel JM et al. Clin Gastroenterol Hepatol. 2019 May 14. doi: 10.1016/j.cgh.2019.05.014.

For children with milk-induced eosinophilic esophagitis (EoE), 9 months of epicutaneous immunotherapy (EPIT) with Viaskin Milk did not significantly improve eosinophil counts or symptoms, compared with placebo, according to the results of an intention-to-treat analysis of a randomized, double-blinded pilot study.

Average maximum eosinophil counts were 50.1 per high-power field in the Viaskin Milk group versus 48.2 in the placebo group, said Jonathan M. Spergel, MD, of the Children’s Hospital of Philadelphia and associates. However, in the per-protocol analysis, the seven patients who received Viaskin Milk had mean eosinophil counts of 25.6 per high-power field, compared with 95.0 for the two children who received placebo (P = .038). Moreover, 47% of patients had fewer than 15 eosinophils per high-power field after an additional 11 months of open-label treatment with Viaskin Milk. Taken together, the findings justify larger, multicenter studies to evaluate EPIT for treating EoE and other non-IgE mediated food diseases, Dr. Spergel and associates wrote in Clinical Gastroenterology and Hepatology.

EoE results from an immune response to specific food allergens, including milk. Classic symptoms include difficulty feeding and failure to thrive in infants, abdominal pain in young children, and dysphagia in older children and adults. Definitive diagnosis requires an esophageal biopsy with an eosinophil count of 15 or more cells per high-power field. “There are no approved therapies [for eosinophilic esophagitis] beyond avoidance of the allergen(s) or treatment of inflammation,” the investigators wrote.

In prior studies, exposure to EPIT was found to mitigate eosinophilic gastrointestinal disease in mice and pigs. In humans, milk is the most common dietary cause of eosinophilic esophagitis. Accordingly, Viaskin Milk is an EPIT containing an allergen extract of milk that is administered epicutaneously using a specialized delivery system. To evaluate its use for the treatment of pediatric milk-induced EoE (at least 15 eosinophils per high-power frame despite at least 2 months of high-dose proton pump–inhibitor therapy at 1-2 mg/kg twice daily), the researchers randomly assigned 20 children on a 3:1 basis to receive either Viaskin Milk or placebo for 9 months. Patients and investigators were double-blinded for this phase of the study, during most of which patients abstained from milk. Toward the end of the 9 months, patients resumed consuming milk and continued doing so if their upper endoscopy biopsy showed resolution of EoE (eosinophil count less than 15 per high-power field).

In the intention-to-treat analysis, Viaskin Milk did not meet the primary endpoint of the difference in least squares mean compared with placebo (8.6; 95% confidence interval, –35.36 to 52.56). Symptom scores also were similar between groups. In contrast, at the end of the 11-month, open-label period, 9 of 19 evaluable patients had eosinophil biopsy counts of fewer than 15 per high-power field, for a response rate of 47%. “The number of adverse events did not differ significantly between the Viaskin Milk and placebo groups,” the researchers added.

Protocol violations might explain why EPIT failed to meet the primary endpoint in the intention-to-treat analysis, they wrote. “For example, the patients on the active therapy wanted to ingest more milk, while the patients in the placebo group wanted less milk,” they reported. “Three patients in the active therapy went on binge milk diets drinking 4 to 8 times the amount of milk compared with baseline.” The use of proton pump inhibitors also was inconsistent between groups, they added. “The major limitation in the [per-protocol] population was the small sample size of this pilot study, raising the possibility of false-positive results.”

The study was funded by DBV Technologies and by the Children’s Hospital of Philadelphia Eosinophilic Esophagitis Family Fund. Dr. Spergel disclosed consulting agreements, grants funding, and stock equity with DBV Technologies. Three coinvestigators also disclosed ties to DBV. The remaining five coinvestigators reported having no conflicts of interest.

SOURCE: Spergel JM et al. Clin Gastroenterol Hepatol. 2019 May 14. doi: 10.1016/j.cgh.2019.05.014.

Eradication of Helicobacter pylori infection was associated with a more than 75% decrease in hazard of subsequent stomach cancer in a large retrospective cohort study.

Simply being treated for H. pylori infection did not mitigate the risk of gastric adenocarcinoma, and patients whose H. pylori was not eradicated were at increased risk, said Shria Kumar, MD, of the Perelman Center for Advanced Medicine in Philadelphia, and with her associates. “This speaks to the ability of H. pylori eradication to modify future risks of gastric adenocarcinoma, and the need to not only treat those diagnosed with H. pylori, but to confirm eradication, and re-treat those who fail eradication,” they wrote in Gastroenterology.

Gastric adenocarcinoma remains a grave diagnosis, with a 5-year survival rate of less than 30%. Although H. pylori infection is an established risk factor for gastric cancer (particularly nonproximal disease), most studies have used national cancer databases that do not track H. pylori infection. Accordingly, Dr. Kumar and her associates analyzed data for 371,813 patients diagnosed with H. pylori infection at U.S. Veterans Health Administration facilities between 1994 and 2018. A total of 92% of patients were men, 58% were white, 24% were black, and approximately 1% each were Native American, Asian, or Native Hawaiian/Pacific Islander. Median age was 62 years.

Patients with H. pylori infection who subsequently were diagnosed with nonproximal gastric cancer were significantly (P less than .001) more likely to be older (median age, 65.1 vs. 62.0 years), current or historical smokers, or racial or ethnic minorities (black or African American, Asian, or Hispanic/Latino), compared with patients with H. pylori who did not develop cancer. In the multivariable analysis, standardized hazard ratios for these variables remained statistically significant, with point estimates ranging from 1.13 (for each 5-year increase in age at diagnosis of infection) to 2.00 (for black or African American race). Cumulative incidence rates of distal gastric adenocarcinoma following H. pylori infection were 0.37% at 5 years, 0.5% at 10 years, and 0.65% at 20 year.

Patients whose infections were confirmed to have been eradicated were at markedly lower risk for subsequent gastric cancer than were patients whose infections were not eradicated (SHR, 0.24; 95% confidence interval, 0.15-0.41; P less than .001). Importantly, simply being treated for H. pylori did not significantly affect cancer risk (SHR, 1.16; 95% CI, 0.74-1.83).

Rates in Japan are approximately five times higher, while in sub-Saharan Africa, H. pylori infection is prevalent but gastric cancer is uncommon, the researchers noted. These discrepancies support the idea that carcinogenesis depends on additional genetic or environmental variables in addition to H. pylori infection alone, they said. They called for future studies of protective factors.

Dr. Kumar is supported by a training grant from the National Institutes of Health. She disclosed travel support from Boston Scientific and Olympus. Her coinvestigators disclosed ties to Takeda, Novartis, Janssen, Gilead, Bayer, and several other companies.

SOURCE: Kumar S et al. Gastroenterology. 2019 Jul 31. doi: 10.1053/j.gastro.2019.10.019.

Eradication of Helicobacter pylori infection was associated with a more than 75% decrease in hazard of subsequent stomach cancer in a large retrospective cohort study.

Simply being treated for H. pylori infection did not mitigate the risk of gastric adenocarcinoma, and patients whose H. pylori was not eradicated were at increased risk, said Shria Kumar, MD, of the Perelman Center for Advanced Medicine in Philadelphia, and with her associates. “This speaks to the ability of H. pylori eradication to modify future risks of gastric adenocarcinoma, and the need to not only treat those diagnosed with H. pylori, but to confirm eradication, and re-treat those who fail eradication,” they wrote in Gastroenterology.

Gastric adenocarcinoma remains a grave diagnosis, with a 5-year survival rate of less than 30%. Although H. pylori infection is an established risk factor for gastric cancer (particularly nonproximal disease), most studies have used national cancer databases that do not track H. pylori infection. Accordingly, Dr. Kumar and her associates analyzed data for 371,813 patients diagnosed with H. pylori infection at U.S. Veterans Health Administration facilities between 1994 and 2018. A total of 92% of patients were men, 58% were white, 24% were black, and approximately 1% each were Native American, Asian, or Native Hawaiian/Pacific Islander. Median age was 62 years.

Patients with H. pylori infection who subsequently were diagnosed with nonproximal gastric cancer were significantly (P less than .001) more likely to be older (median age, 65.1 vs. 62.0 years), current or historical smokers, or racial or ethnic minorities (black or African American, Asian, or Hispanic/Latino), compared with patients with H. pylori who did not develop cancer. In the multivariable analysis, standardized hazard ratios for these variables remained statistically significant, with point estimates ranging from 1.13 (for each 5-year increase in age at diagnosis of infection) to 2.00 (for black or African American race). Cumulative incidence rates of distal gastric adenocarcinoma following H. pylori infection were 0.37% at 5 years, 0.5% at 10 years, and 0.65% at 20 year.

Patients whose infections were confirmed to have been eradicated were at markedly lower risk for subsequent gastric cancer than were patients whose infections were not eradicated (SHR, 0.24; 95% confidence interval, 0.15-0.41; P less than .001). Importantly, simply being treated for H. pylori did not significantly affect cancer risk (SHR, 1.16; 95% CI, 0.74-1.83).

Rates in Japan are approximately five times higher, while in sub-Saharan Africa, H. pylori infection is prevalent but gastric cancer is uncommon, the researchers noted. These discrepancies support the idea that carcinogenesis depends on additional genetic or environmental variables in addition to H. pylori infection alone, they said. They called for future studies of protective factors.

Dr. Kumar is supported by a training grant from the National Institutes of Health. She disclosed travel support from Boston Scientific and Olympus. Her coinvestigators disclosed ties to Takeda, Novartis, Janssen, Gilead, Bayer, and several other companies.

SOURCE: Kumar S et al. Gastroenterology. 2019 Jul 31. doi: 10.1053/j.gastro.2019.10.019.

Eradication of Helicobacter pylori infection was associated with a more than 75% decrease in hazard of subsequent stomach cancer in a large retrospective cohort study.

Simply being treated for H. pylori infection did not mitigate the risk of gastric adenocarcinoma, and patients whose H. pylori was not eradicated were at increased risk, said Shria Kumar, MD, of the Perelman Center for Advanced Medicine in Philadelphia, and with her associates. “This speaks to the ability of H. pylori eradication to modify future risks of gastric adenocarcinoma, and the need to not only treat those diagnosed with H. pylori, but to confirm eradication, and re-treat those who fail eradication,” they wrote in Gastroenterology.

Gastric adenocarcinoma remains a grave diagnosis, with a 5-year survival rate of less than 30%. Although H. pylori infection is an established risk factor for gastric cancer (particularly nonproximal disease), most studies have used national cancer databases that do not track H. pylori infection. Accordingly, Dr. Kumar and her associates analyzed data for 371,813 patients diagnosed with H. pylori infection at U.S. Veterans Health Administration facilities between 1994 and 2018. A total of 92% of patients were men, 58% were white, 24% were black, and approximately 1% each were Native American, Asian, or Native Hawaiian/Pacific Islander. Median age was 62 years.

Patients with H. pylori infection who subsequently were diagnosed with nonproximal gastric cancer were significantly (P less than .001) more likely to be older (median age, 65.1 vs. 62.0 years), current or historical smokers, or racial or ethnic minorities (black or African American, Asian, or Hispanic/Latino), compared with patients with H. pylori who did not develop cancer. In the multivariable analysis, standardized hazard ratios for these variables remained statistically significant, with point estimates ranging from 1.13 (for each 5-year increase in age at diagnosis of infection) to 2.00 (for black or African American race). Cumulative incidence rates of distal gastric adenocarcinoma following H. pylori infection were 0.37% at 5 years, 0.5% at 10 years, and 0.65% at 20 year.

Patients whose infections were confirmed to have been eradicated were at markedly lower risk for subsequent gastric cancer than were patients whose infections were not eradicated (SHR, 0.24; 95% confidence interval, 0.15-0.41; P less than .001). Importantly, simply being treated for H. pylori did not significantly affect cancer risk (SHR, 1.16; 95% CI, 0.74-1.83).

Rates in Japan are approximately five times higher, while in sub-Saharan Africa, H. pylori infection is prevalent but gastric cancer is uncommon, the researchers noted. These discrepancies support the idea that carcinogenesis depends on additional genetic or environmental variables in addition to H. pylori infection alone, they said. They called for future studies of protective factors.

Dr. Kumar is supported by a training grant from the National Institutes of Health. She disclosed travel support from Boston Scientific and Olympus. Her coinvestigators disclosed ties to Takeda, Novartis, Janssen, Gilead, Bayer, and several other companies.

SOURCE: Kumar S et al. Gastroenterology. 2019 Jul 31. doi: 10.1053/j.gastro.2019.10.019.

In patients with Barrett’s esophagus and low-grade dysplasia confirmed by repeat endoscopy, endoscopic eradication therapy is the optimal cost-effective management strategy, according to an analysis of population-based models. For patients with nondysplastic Barrett’s esophagus, the optimal surveillance interval is every 3 years for men and every 5 years for women, according to the study, which was published in Clinical Gastroenterology and Hepatology.

Clinical guidelines recommend surveillance or treatment of patients with Barrett’s esophagus, a precursor lesion for esophageal adenocarcinoma, depending on the presence and grade of dysplasia. For high-grade dysplasia, guidelines recommend endoscopic eradication therapy. For low-grade dysplasia, the optimal strategy is unclear, said first study author Amir-Houshang Omidvari, MD, MPH, a researcher at Erasmus MC University Medical Center Rotterdam (the Netherlands) and colleagues. In addition, the ideal surveillance interval for patients with nondysplastic Barrett’s esophagus is unknown.

Simulated cohorts

To identify optimal management strategies, the investigators simulated cohorts of 60-year-old patients with Barrett’s esophagus in the United States using three independent population-based models. They followed each cohort until death or age 100 years. The study compared disease progression without surveillance or treatment with 78 management strategies. The cost-effectiveness analyses used a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).

For low-grade dysplasia, the researchers assessed various surveillance intervals, endoscopic eradication therapy with confirmation of low-grade dysplasia by a repeat endoscopy after 2 months of high-dose acid suppression, and endoscopic eradication therapy without confirmatory testing. For nondysplastic Barrett’s esophagus, the researchers evaluated no surveillance and surveillance intervals of 1, 2, 3, 4, 5, or 10 years. The researchers made assumptions based on published data about rates of misdiagnosis, treatment efficacy, recurrence, complications, and other outcomes. They used Centers for Medicare & Medicaid Services reimbursement rates to evaluate costs. For all management strategies, the researchers assumed surveillance would stop at age 80 years.

In a simulated cohort of men with Barrett’s esophagus who did not receive surveillance or endoscopic eradication therapy, the models predicted an average esophageal adenocarcinoma cumulative incidence of 111 cases per 1,000 patients and mortality of 77 deaths per 1,000 patients, with a total cost of $5.7 million for their care. Management strategies “prevented 23%-75% of [esophageal adenocarcinoma] cases and decreased mortality by 31%-88% while increasing costs to $6.2-$17.3 million depending on the management strategy,” the authors said. The optimal cost-effective strategy – endoscopic eradication therapy for patients with low-grade dysplasia after endoscopic confirmation, and surveillance every 3 years for patients with nondysplastic Barrett’s esophagus – decreased esophageal adenocarcinoma incidence to 38 cases (–66%) and mortality to 15 deaths (–81%) per 1,000 patients, compared with natural history. This approach increased costs to $9.8 million and gained 358 QALYs.

The models predicted fewer esophageal adenocarcinoma cases in women without surveillance or treatment (75 cases per 1,000 patients). “Because of the higher incremental costs per QALY gained in women, the optimal strategy was surveillance every 5 years for [nondysplastic Barrett’s esophagus],” the researchers reported.

Avoiding misdiagnosis

“Despite the potential harms and cost of endoscopic therapy, [endoscopic eradication therapy of low-grade dysplasia] reduces the number of endoscopies required for surveillance ... because of prolonged surveillance intervals after successful treatment, and [it] generally prevents more [esophageal adenocarcinoma] cases than strategies using only surveillance,” wrote Dr. Omidvari and colleagues. Confirmation of low-grade dysplasia with repeat testing before treatment was more cost-effective than treatment without confirmatory testing. Although this approach requires one more endoscopy per patient, a decrease in inappropriate treatment of patients with false-positive low-grade dysplasia diagnoses compensates for the additional testing costs, they said.

The researchers noted that available data on long-term outcomes are limited. Nevertheless, the analysis may have important implications for patients with Barrett’s esophagus without dysplasia or with low-grade dysplasia, the authors said.

The National Institutes of Health/National Cancer Institute supported the study and provided funding for the authors.

jremaly@mdedge.com

SOURCE: Omidvari A-H et al. Clin Gastroenterol Hepatol. 2019 Dec 6. doi: 10.1016/j.cgh.2019.11.058.

In patients with Barrett’s esophagus and low-grade dysplasia confirmed by repeat endoscopy, endoscopic eradication therapy is the optimal cost-effective management strategy, according to an analysis of population-based models. For patients with nondysplastic Barrett’s esophagus, the optimal surveillance interval is every 3 years for men and every 5 years for women, according to the study, which was published in Clinical Gastroenterology and Hepatology.

Clinical guidelines recommend surveillance or treatment of patients with Barrett’s esophagus, a precursor lesion for esophageal adenocarcinoma, depending on the presence and grade of dysplasia. For high-grade dysplasia, guidelines recommend endoscopic eradication therapy. For low-grade dysplasia, the optimal strategy is unclear, said first study author Amir-Houshang Omidvari, MD, MPH, a researcher at Erasmus MC University Medical Center Rotterdam (the Netherlands) and colleagues. In addition, the ideal surveillance interval for patients with nondysplastic Barrett’s esophagus is unknown.

Simulated cohorts

To identify optimal management strategies, the investigators simulated cohorts of 60-year-old patients with Barrett’s esophagus in the United States using three independent population-based models. They followed each cohort until death or age 100 years. The study compared disease progression without surveillance or treatment with 78 management strategies. The cost-effectiveness analyses used a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).

For low-grade dysplasia, the researchers assessed various surveillance intervals, endoscopic eradication therapy with confirmation of low-grade dysplasia by a repeat endoscopy after 2 months of high-dose acid suppression, and endoscopic eradication therapy without confirmatory testing. For nondysplastic Barrett’s esophagus, the researchers evaluated no surveillance and surveillance intervals of 1, 2, 3, 4, 5, or 10 years. The researchers made assumptions based on published data about rates of misdiagnosis, treatment efficacy, recurrence, complications, and other outcomes. They used Centers for Medicare & Medicaid Services reimbursement rates to evaluate costs. For all management strategies, the researchers assumed surveillance would stop at age 80 years.

In a simulated cohort of men with Barrett’s esophagus who did not receive surveillance or endoscopic eradication therapy, the models predicted an average esophageal adenocarcinoma cumulative incidence of 111 cases per 1,000 patients and mortality of 77 deaths per 1,000 patients, with a total cost of $5.7 million for their care. Management strategies “prevented 23%-75% of [esophageal adenocarcinoma] cases and decreased mortality by 31%-88% while increasing costs to $6.2-$17.3 million depending on the management strategy,” the authors said. The optimal cost-effective strategy – endoscopic eradication therapy for patients with low-grade dysplasia after endoscopic confirmation, and surveillance every 3 years for patients with nondysplastic Barrett’s esophagus – decreased esophageal adenocarcinoma incidence to 38 cases (–66%) and mortality to 15 deaths (–81%) per 1,000 patients, compared with natural history. This approach increased costs to $9.8 million and gained 358 QALYs.

The models predicted fewer esophageal adenocarcinoma cases in women without surveillance or treatment (75 cases per 1,000 patients). “Because of the higher incremental costs per QALY gained in women, the optimal strategy was surveillance every 5 years for [nondysplastic Barrett’s esophagus],” the researchers reported.

Avoiding misdiagnosis

“Despite the potential harms and cost of endoscopic therapy, [endoscopic eradication therapy of low-grade dysplasia] reduces the number of endoscopies required for surveillance ... because of prolonged surveillance intervals after successful treatment, and [it] generally prevents more [esophageal adenocarcinoma] cases than strategies using only surveillance,” wrote Dr. Omidvari and colleagues. Confirmation of low-grade dysplasia with repeat testing before treatment was more cost-effective than treatment without confirmatory testing. Although this approach requires one more endoscopy per patient, a decrease in inappropriate treatment of patients with false-positive low-grade dysplasia diagnoses compensates for the additional testing costs, they said.

The researchers noted that available data on long-term outcomes are limited. Nevertheless, the analysis may have important implications for patients with Barrett’s esophagus without dysplasia or with low-grade dysplasia, the authors said.

The National Institutes of Health/National Cancer Institute supported the study and provided funding for the authors.

jremaly@mdedge.com

SOURCE: Omidvari A-H et al. Clin Gastroenterol Hepatol. 2019 Dec 6. doi: 10.1016/j.cgh.2019.11.058.

In patients with Barrett’s esophagus and low-grade dysplasia confirmed by repeat endoscopy, endoscopic eradication therapy is the optimal cost-effective management strategy, according to an analysis of population-based models. For patients with nondysplastic Barrett’s esophagus, the optimal surveillance interval is every 3 years for men and every 5 years for women, according to the study, which was published in Clinical Gastroenterology and Hepatology.

Clinical guidelines recommend surveillance or treatment of patients with Barrett’s esophagus, a precursor lesion for esophageal adenocarcinoma, depending on the presence and grade of dysplasia. For high-grade dysplasia, guidelines recommend endoscopic eradication therapy. For low-grade dysplasia, the optimal strategy is unclear, said first study author Amir-Houshang Omidvari, MD, MPH, a researcher at Erasmus MC University Medical Center Rotterdam (the Netherlands) and colleagues. In addition, the ideal surveillance interval for patients with nondysplastic Barrett’s esophagus is unknown.

Simulated cohorts

To identify optimal management strategies, the investigators simulated cohorts of 60-year-old patients with Barrett’s esophagus in the United States using three independent population-based models. They followed each cohort until death or age 100 years. The study compared disease progression without surveillance or treatment with 78 management strategies. The cost-effectiveness analyses used a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY).

For low-grade dysplasia, the researchers assessed various surveillance intervals, endoscopic eradication therapy with confirmation of low-grade dysplasia by a repeat endoscopy after 2 months of high-dose acid suppression, and endoscopic eradication therapy without confirmatory testing. For nondysplastic Barrett’s esophagus, the researchers evaluated no surveillance and surveillance intervals of 1, 2, 3, 4, 5, or 10 years. The researchers made assumptions based on published data about rates of misdiagnosis, treatment efficacy, recurrence, complications, and other outcomes. They used Centers for Medicare & Medicaid Services reimbursement rates to evaluate costs. For all management strategies, the researchers assumed surveillance would stop at age 80 years.

In a simulated cohort of men with Barrett’s esophagus who did not receive surveillance or endoscopic eradication therapy, the models predicted an average esophageal adenocarcinoma cumulative incidence of 111 cases per 1,000 patients and mortality of 77 deaths per 1,000 patients, with a total cost of $5.7 million for their care. Management strategies “prevented 23%-75% of [esophageal adenocarcinoma] cases and decreased mortality by 31%-88% while increasing costs to $6.2-$17.3 million depending on the management strategy,” the authors said. The optimal cost-effective strategy – endoscopic eradication therapy for patients with low-grade dysplasia after endoscopic confirmation, and surveillance every 3 years for patients with nondysplastic Barrett’s esophagus – decreased esophageal adenocarcinoma incidence to 38 cases (–66%) and mortality to 15 deaths (–81%) per 1,000 patients, compared with natural history. This approach increased costs to $9.8 million and gained 358 QALYs.

The models predicted fewer esophageal adenocarcinoma cases in women without surveillance or treatment (75 cases per 1,000 patients). “Because of the higher incremental costs per QALY gained in women, the optimal strategy was surveillance every 5 years for [nondysplastic Barrett’s esophagus],” the researchers reported.

Avoiding misdiagnosis

“Despite the potential harms and cost of endoscopic therapy, [endoscopic eradication therapy of low-grade dysplasia] reduces the number of endoscopies required for surveillance ... because of prolonged surveillance intervals after successful treatment, and [it] generally prevents more [esophageal adenocarcinoma] cases than strategies using only surveillance,” wrote Dr. Omidvari and colleagues. Confirmation of low-grade dysplasia with repeat testing before treatment was more cost-effective than treatment without confirmatory testing. Although this approach requires one more endoscopy per patient, a decrease in inappropriate treatment of patients with false-positive low-grade dysplasia diagnoses compensates for the additional testing costs, they said.

The researchers noted that available data on long-term outcomes are limited. Nevertheless, the analysis may have important implications for patients with Barrett’s esophagus without dysplasia or with low-grade dysplasia, the authors said.

The National Institutes of Health/National Cancer Institute supported the study and provided funding for the authors.

jremaly@mdedge.com

SOURCE: Omidvari A-H et al. Clin Gastroenterol Hepatol. 2019 Dec 6. doi: 10.1016/j.cgh.2019.11.058.