Low back pain in not uncommon in children and adolescents.^1-3 Although the prevalence of low back pain in children < 7 years is low, it increases with age, with studies reporting lifetime prevalence at age 12 years between 16% and 18% and rates as high as 66% by 16 years of age.^4,5 Although children and adolescents usually have pain that is transient and benign without a defined cause, structural causes of low back pain should be considered in school-aged children with pain that persists for > 3 to 6 weeks. ⁴ The most common structural causes of adolescent low back pain are reviewed here.

Etiology: A mixed bag

Back pain in school-aged children is most commonly due to muscular strain, overuse, or poor posture. The pain is often transient in nature and responds to rest and postural education.^4,6 A herniated disc is an uncommon finding in younger school-aged children, but incidence increases slightly among older adolescents, particularly those who are active in collision sports and/or weight-lifting.^7,8 Pain caused by a herniated disc often radiates along the distribution of the sciatic nerve and worsens during lumbar flexion.

Spondylolysis and spondylolisthesis are important causes of back pain in children. Spondylolysis is defined as a defect or abnormality of the pars interarticularis and surrounding lamina and pedicle. Spondylolisthesis, which is less common, is defined as the translation or “slippage” of one vertebral segment in relation to the next caudal segment. These conditions commonly occur as a result of repetitive stress.

In a prospective study of adolescents < 19 years with low back pain for > 2 weeks, the prevalence of spondylolysis was 39.7%.⁹ Adolescent athletes with symptomatic low back pain are more likely to have spondylolysis than nonathletes (32% vs 2%, respectively).^2,10 Pain is often made worse by extension of the spine. Spondylolysis and spondylolisthesis can be congenital or acquired, and both can be asymptomatic. Children and teens who are athletes are at higher risk for symptomatic spondylolysis and spondylolisthesis.^10-12 This is especially true for those involved in gymnastics, dance, football, and/or volleyball, where a repetitive load is placed onto an extended spine.

Idiopathic scoliosis is an abnormal lateral curvature of the spine that usually develops during adolescence and worsens with growth. Historically, painful scoliosis was considered rare, but more recently researchers determined that children with scoliosis have a higher rate of pain compared to their peers.^13,14 School-aged children with scoliosis were found to be at 2 times the risk of low back pain compared to those without scoliosis.¹³ It is important to identify scoliosis in adolescents so that progression can be monitored.

Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side.

Screening for scoliosis in primary care is somewhat controversial. The US Preventive Services Task Force (USPSTF) finds insufficient evidence for screening asymptomatic adolescents for scoliosis.¹⁵ This recommendation is based on the fact that there is little evidence on the effect of screening on long-term outcomes. Screening may also lead to unnecessary radiation. Conversely, a position statement released by the Scoliosis Research Society, the Pediatric Orthopedic Society of North America, the American Association of Orthopedic Surgeons, and the American Academy of Pediatrics recommends scoliosis screening during routine pediatric office visits.¹⁶ Screening for girls is recommended at ages 10 and 12 years, and for boys, once between ages 13 and 14 years. The statement highlights evidence showing that focused screening by appropriate personnel has value in detecting a clinically significant curve (> 20°).

Scheuermann disease is a rare cause of back pain in children that usually develops during adolescence and results in increasing thoracic kyphosis. An autosomal dominant mutation plays a role in this disease of the growth cartilage endplate; repetitive strain on the growth cartilage is also a contributing factor.^17,18 An atypical variant manifests with kyphosis in the thoracolumbar region.¹⁷

Continue to: Other causes of low back pain

Other causes of low back pain—including inflammatory arthritis, infection (eg, discitis), and tumor—are rare in children but must always be considered, especially in the setting of persistent symptoms.^4,19-21 More on the features of these conditions is listed in TABLE 1.^{1-7,13-15,17-30}

History: Focus on onset, timing, and duration of symptoms

As with adults, obtaining a history that includes the onset, timing, and duration of symptoms is key in the evaluation of low back pain in children, as is obtaining a history of the patient’s activities; sports that repetitively load the lumbar spine in an extended position increase the risk of injury.¹⁰

Specific risk factors for low back pain in children and adolescents are poorly understood.^4,9,31 Pain can be associated with trauma, or it can have a more progressive or insidious onset. Generally, pain that is present for up to 6 weeks and is intermittent or improving has a self-limited course. Pain that persists beyond 3 to 6 weeks or is worsening is more likely to have an anatomical cause that needs further evaluation.^2,3,10,21

Identifying exacerbating and alleviating factors can provide useful information. Pain that is worse with lumbar flexion is more likely to come from muscular strain or disc pathology. Pain with extension is more likely due to a structural cause such as spondylolysis/spondylolisthesis, scoliosis, or Scheuermann disease.^{2,4,10,17,18,21} See TABLE 2 for red flag symptoms that indicate the need for imaging and further work-up.

The physical exam: Visualize, assess range of motion, and reproduce pain

The physical examination of any patient with low back pain should include direct visualization and inspection of the back, spine, and pelvis; palpation of the spine and paraspinal regions; assessment of lumbar range of motion and of the lumbar nerve roots, including tests of sensation, strength, and deep tendon reflexes; and an evaluation of the patient’s posture, which can provide clues to underlying causes of pain.

Continue to: Increased thoracic kyphosis...

Increased thoracic kyphosis that is not reversible is concerning for Scheuermann disease.^9,17,18 A significant elevation in one shoulder or side of the pelvis can be indicative of scoliosis. Increased lumbar lordosis may predispose a patient to spondylolysis.

In patients with spondylolysis, lumbar extension will usually reproduce pain, which is often unilateral. Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side. The sensitivity of the Stork test for unilateral spondylolysis is approximately 50%.³² (For more information on the Stork test, see www.physio-pedia.com/Stork_test.)

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain. Lumbar flexion with concomitant radicular pain is associated with disc pathology.⁸ Pain with a straight-leg raise is also associated with disk pathology, especially if raising the contralateral leg increases pain.⁸

Using a scoliometer. Evaluate the flexed spine for the presence of asymmetry, which can indicate scoliosis.³³ If asymmetry is present, use a scoliometer to determine the degree of asymmetry. Zero to 5° is considered clinically insignificant; monitor and reevaluate these patients at subsequent visits.^34,35 Ten degrees or more of asymmetry with a scoliometer should prompt you to order radiographs.^35,36 A smartphone-based scoliometer for iPhones was evaluated in 1 study and was shown to have reasonable reliability and validity for clinical use.³⁷

Deformity of the lower extremities. Because low back pain may be caused by biomechanical or structural deformity of the lower extremities, examine the flexibility of the hip flexors, gluteal musculature, hamstrings, and the iliotibial band.³⁸ In addition, evaluate for leg-length discrepancy and lower-extremity malalignment, such as femoral anteversion, tibial torsion, or pes planus.

Continue to: Imaging

Imaging: Know when it’s needed

Although imaging of the lumbar spine is often unnecessary in the presence of acute low back pain in children, always consider imaging in the setting of bony tenderness, pain that wakes a patient from sleep, and in the setting of other red flag symptoms (see TABLE 2). Low back pain in children that is reproducible with lumbar extension is concerning for spondylolysis or spondylolisthesis. If the pain with extension persists beyond 3 to 6 weeks, order imaging starting with radiographs.^2,39

Traditionally, 4 views of the spine—­anteroposterior (AP), lateral, and oblique (one right and one left)—were obtained, but recent evidence indicates that 2 views (AP and lateral) have similar sensitivity and specificity to 4 views with significantly reduced radiation exposure.^2,39 Because the sensitivity of plain films is relatively low, consider more advanced imaging if spondylolysis or spondylolisthesis is strongly suspected. Recent studies indicate that magnetic resonance imaging (MRI) may be as effective as computed tomography (CT) or bone scan and has the advantage of lower radiation (FIGURE 1).^2,22

Similarly, order radiographs if there is > 10° of asymmetry noted on physical exam using a scoliometer.^15,23 Calculate the Cobb angle to determine the severity of scoliosis. Refer patients with angles ≥ 20° to a pediatric orthopedist for monitoring of progression and consideration of bracing (FIGURE 2).^23,34 For patients with curvatures between 10° and 19°, repeat imaging every 6 to 12 months. Because scoliosis is a risk factor for spondylolysis, evaluate radiographs in the setting of painful scoliosis for the presence of a spondylolysis.^34,35

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain.

If excessive kyphosis is noted on exam, order radiographs to evaluate for Scheuermann disease. Classic imaging findings include Schmorl nodes, vertebral endplate changes, and anterior wedging (FIGURE 3).^17,18

In the absence of the above concerns, defer imaging of the lumbar spine until after adequate rest and rehabilitation have been attempted.

Continue to: Treatment typically involves restor physical therapy

 

 

Treatment typically involves restor physical therapy

Most cases of low back pain in children and adolescents are benign and self-limited. Many children with low back pain can be treated with relative rest from the offending activity. For children with more persistent pain, physical therapy (PT) is often indicated. Similar to that for adults, there is little evidence for specific PT programs to help children with low back pain. Rehabilitation should be individualized based on the condition being treated.

Medications. There have been no high-quality studies on the benefit of medications to treat low back pain in children. Studies have shown nonsteroidal anti-inflammatory drugs (NSAIDs) have value in adults, and they are likely safe for use in children,⁴⁰ but the risk of opiate abuse is significantly increased in adolescents who have been prescribed opiate pain medication prior to 12th grade.⁴¹

Lumbar disc herniation. Although still relatively rare, lumbar disc herniation is more common in older children and adolescents than in younger children and is treated similarly to that in adults.⁸ Range-of-motion exercise to restore lumbar motion is often first-line treatment. Research has shown that exercises that strengthen the abdominal or “core” musculature help prevent the return of low back pain.^24,25

In the case of spondylolysis or spondylolisthesis, rest from activity is generally required for a minimum of 4 to 6 weeks. Rehabilitation in the form of range of motion, especially into the lumbar extension, and spinal stabilization exercises are effective for both reducing pain and restoring range-­of-motion and strength.⁴² Have patients avoid heavy backpacks, which can reproduce pain. Children often benefit from leaving a second set of schoolbooks at home. For most patients with spondylolysis, conservative treatment with rehabilitation is equal to or better than surgical intervention in returning the patient to his/her pre-injury activity level.^26,43,44 When returning athletes to their sport, aggressive PT, defined as rest for < 10 weeks prior to initiating PT, is superior to delaying PT beyond 10 weeks of rest.²⁷

Idiopathic scoliosis. Much of the literature on the treatment of scoliosis is focused on limiting progression of the scoliotic curvature. Researchers thought that more severe curves were associated with more severe pain, but a recent systematic review showed that back pain can occur in patients with even small curvatures.²⁸ Treatment for patients with smaller degrees of curvature is similar to that for mechanical low back pain. PT may have a role in the treatment of scoliosis, but there is little evidence in the literature of its effectiveness.

Continue to: A Cochrane review showed...

Always consider imaging in the setting of bony tenderness, pain that wakes the patient from sleep, and when there is > 10° of asymmetry on physical exam using a scoliometer.

A Cochrane review showed that PT and exercise-based treatments had no effect on back pain or disability in patients with scoliosis.²⁹ And outpatient PT alone, in the absence of bracing, does not arrest progression of the scoliotic curvature.³⁵ One trial did demonstrate that an intensive inpatient treatment program of 4 to 6 weeks for patients with curvature of at least 40° reduced progression of curvature compared to an untreated control group at 1 year.³⁴ The outcomes of functional mobility and pain were not measured. Follow-up data on curve progression beyond 1 year are not available. Unfortunately, intensive inpatient treatment is not readily available or cost-effective for most patients with scoliosis.

Scheuermann disease. The mainstay of treatment for mild Scheuermann disease is advising the patient to avoid repetitive loading of the spine. Patients should avoid sports such as competitive weight-lifting, gymnastics, and football. Lower impact athletics are encouraged. Refer patients with pain to PT to address posture and core stabilization. Patients with severe kyphosis may require surgery.^17,18

Bracing: Rarely helpful for low back pain

The use of lumbar braces or corsets is rarely helpful for low back pain in children. Bracing in the setting of spondylolysis is controversial.One study indicated that bracing in combination with activity restriction and lumbar extension exercise is superior to activity restriction and lumbar flexion exercises alone.⁴³ But a meta-analysis did not demonstrate a significant difference in recovery when bracing was added.⁴⁴ Bracing may help to reduce pain initially in patients with spondylolysis who have pain at rest. Bracing is not recommended for patients with pain that abates with activity modification.

Scoliosis and Scheuermann kyphosis. Treatment of adolescent idiopathic scoliosis usually consists of observation and periodic reevaluation. Bracing is a mainstay of the nonsurgical management of scoliosis and is appropriate for curves of 20° to 40°; studies have reported successful control of curve progression in > 70% of patients.³⁶ According to 1 study, the number of cases of scoliosis needed to treat with bracing to prevent 1 surgery is 3.³⁰ Surgery is often indicated for patients with curvatures > 40°, although this is also debated.³³

Bracing is used rarely for Scheuermann kyphosis but may be helpful in more severe or painful cases.¹⁷

CORRESPONDENCE
Shawn F. Phillips, MD, MSPT, 500 University Drive H154, Hershey, PA, 17033; sphillips6@pennstatehealth.psu.edu.

Low back pain in not uncommon in children and adolescents.^1-3 Although the prevalence of low back pain in children < 7 years is low, it increases with age, with studies reporting lifetime prevalence at age 12 years between 16% and 18% and rates as high as 66% by 16 years of age.^4,5 Although children and adolescents usually have pain that is transient and benign without a defined cause, structural causes of low back pain should be considered in school-aged children with pain that persists for > 3 to 6 weeks. ⁴ The most common structural causes of adolescent low back pain are reviewed here.

Etiology: A mixed bag

Back pain in school-aged children is most commonly due to muscular strain, overuse, or poor posture. The pain is often transient in nature and responds to rest and postural education.^4,6 A herniated disc is an uncommon finding in younger school-aged children, but incidence increases slightly among older adolescents, particularly those who are active in collision sports and/or weight-lifting.^7,8 Pain caused by a herniated disc often radiates along the distribution of the sciatic nerve and worsens during lumbar flexion.

Spondylolysis and spondylolisthesis are important causes of back pain in children. Spondylolysis is defined as a defect or abnormality of the pars interarticularis and surrounding lamina and pedicle. Spondylolisthesis, which is less common, is defined as the translation or “slippage” of one vertebral segment in relation to the next caudal segment. These conditions commonly occur as a result of repetitive stress.

In a prospective study of adolescents < 19 years with low back pain for > 2 weeks, the prevalence of spondylolysis was 39.7%.⁹ Adolescent athletes with symptomatic low back pain are more likely to have spondylolysis than nonathletes (32% vs 2%, respectively).^2,10 Pain is often made worse by extension of the spine. Spondylolysis and spondylolisthesis can be congenital or acquired, and both can be asymptomatic. Children and teens who are athletes are at higher risk for symptomatic spondylolysis and spondylolisthesis.^10-12 This is especially true for those involved in gymnastics, dance, football, and/or volleyball, where a repetitive load is placed onto an extended spine.

Idiopathic scoliosis is an abnormal lateral curvature of the spine that usually develops during adolescence and worsens with growth. Historically, painful scoliosis was considered rare, but more recently researchers determined that children with scoliosis have a higher rate of pain compared to their peers.^13,14 School-aged children with scoliosis were found to be at 2 times the risk of low back pain compared to those without scoliosis.¹³ It is important to identify scoliosis in adolescents so that progression can be monitored.

Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side.

Screening for scoliosis in primary care is somewhat controversial. The US Preventive Services Task Force (USPSTF) finds insufficient evidence for screening asymptomatic adolescents for scoliosis.¹⁵ This recommendation is based on the fact that there is little evidence on the effect of screening on long-term outcomes. Screening may also lead to unnecessary radiation. Conversely, a position statement released by the Scoliosis Research Society, the Pediatric Orthopedic Society of North America, the American Association of Orthopedic Surgeons, and the American Academy of Pediatrics recommends scoliosis screening during routine pediatric office visits.¹⁶ Screening for girls is recommended at ages 10 and 12 years, and for boys, once between ages 13 and 14 years. The statement highlights evidence showing that focused screening by appropriate personnel has value in detecting a clinically significant curve (> 20°).

Scheuermann disease is a rare cause of back pain in children that usually develops during adolescence and results in increasing thoracic kyphosis. An autosomal dominant mutation plays a role in this disease of the growth cartilage endplate; repetitive strain on the growth cartilage is also a contributing factor.^17,18 An atypical variant manifests with kyphosis in the thoracolumbar region.¹⁷

Continue to: Other causes of low back pain

Other causes of low back pain—including inflammatory arthritis, infection (eg, discitis), and tumor—are rare in children but must always be considered, especially in the setting of persistent symptoms.^4,19-21 More on the features of these conditions is listed in TABLE 1.^{1-7,13-15,17-30}

History: Focus on onset, timing, and duration of symptoms

As with adults, obtaining a history that includes the onset, timing, and duration of symptoms is key in the evaluation of low back pain in children, as is obtaining a history of the patient’s activities; sports that repetitively load the lumbar spine in an extended position increase the risk of injury.¹⁰

Specific risk factors for low back pain in children and adolescents are poorly understood.^4,9,31 Pain can be associated with trauma, or it can have a more progressive or insidious onset. Generally, pain that is present for up to 6 weeks and is intermittent or improving has a self-limited course. Pain that persists beyond 3 to 6 weeks or is worsening is more likely to have an anatomical cause that needs further evaluation.^2,3,10,21

Identifying exacerbating and alleviating factors can provide useful information. Pain that is worse with lumbar flexion is more likely to come from muscular strain or disc pathology. Pain with extension is more likely due to a structural cause such as spondylolysis/spondylolisthesis, scoliosis, or Scheuermann disease.^{2,4,10,17,18,21} See TABLE 2 for red flag symptoms that indicate the need for imaging and further work-up.

The physical exam: Visualize, assess range of motion, and reproduce pain

The physical examination of any patient with low back pain should include direct visualization and inspection of the back, spine, and pelvis; palpation of the spine and paraspinal regions; assessment of lumbar range of motion and of the lumbar nerve roots, including tests of sensation, strength, and deep tendon reflexes; and an evaluation of the patient’s posture, which can provide clues to underlying causes of pain.

Continue to: Increased thoracic kyphosis...

Increased thoracic kyphosis that is not reversible is concerning for Scheuermann disease.^9,17,18 A significant elevation in one shoulder or side of the pelvis can be indicative of scoliosis. Increased lumbar lordosis may predispose a patient to spondylolysis.

In patients with spondylolysis, lumbar extension will usually reproduce pain, which is often unilateral. Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side. The sensitivity of the Stork test for unilateral spondylolysis is approximately 50%.³² (For more information on the Stork test, see www.physio-pedia.com/Stork_test.)

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain. Lumbar flexion with concomitant radicular pain is associated with disc pathology.⁸ Pain with a straight-leg raise is also associated with disk pathology, especially if raising the contralateral leg increases pain.⁸

Using a scoliometer. Evaluate the flexed spine for the presence of asymmetry, which can indicate scoliosis.³³ If asymmetry is present, use a scoliometer to determine the degree of asymmetry. Zero to 5° is considered clinically insignificant; monitor and reevaluate these patients at subsequent visits.^34,35 Ten degrees or more of asymmetry with a scoliometer should prompt you to order radiographs.^35,36 A smartphone-based scoliometer for iPhones was evaluated in 1 study and was shown to have reasonable reliability and validity for clinical use.³⁷

Deformity of the lower extremities. Because low back pain may be caused by biomechanical or structural deformity of the lower extremities, examine the flexibility of the hip flexors, gluteal musculature, hamstrings, and the iliotibial band.³⁸ In addition, evaluate for leg-length discrepancy and lower-extremity malalignment, such as femoral anteversion, tibial torsion, or pes planus.

Continue to: Imaging

Imaging: Know when it’s needed

Although imaging of the lumbar spine is often unnecessary in the presence of acute low back pain in children, always consider imaging in the setting of bony tenderness, pain that wakes a patient from sleep, and in the setting of other red flag symptoms (see TABLE 2). Low back pain in children that is reproducible with lumbar extension is concerning for spondylolysis or spondylolisthesis. If the pain with extension persists beyond 3 to 6 weeks, order imaging starting with radiographs.^2,39

Traditionally, 4 views of the spine—­anteroposterior (AP), lateral, and oblique (one right and one left)—were obtained, but recent evidence indicates that 2 views (AP and lateral) have similar sensitivity and specificity to 4 views with significantly reduced radiation exposure.^2,39 Because the sensitivity of plain films is relatively low, consider more advanced imaging if spondylolysis or spondylolisthesis is strongly suspected. Recent studies indicate that magnetic resonance imaging (MRI) may be as effective as computed tomography (CT) or bone scan and has the advantage of lower radiation (FIGURE 1).^2,22

Similarly, order radiographs if there is > 10° of asymmetry noted on physical exam using a scoliometer.^15,23 Calculate the Cobb angle to determine the severity of scoliosis. Refer patients with angles ≥ 20° to a pediatric orthopedist for monitoring of progression and consideration of bracing (FIGURE 2).^23,34 For patients with curvatures between 10° and 19°, repeat imaging every 6 to 12 months. Because scoliosis is a risk factor for spondylolysis, evaluate radiographs in the setting of painful scoliosis for the presence of a spondylolysis.^34,35

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain.

If excessive kyphosis is noted on exam, order radiographs to evaluate for Scheuermann disease. Classic imaging findings include Schmorl nodes, vertebral endplate changes, and anterior wedging (FIGURE 3).^17,18

In the absence of the above concerns, defer imaging of the lumbar spine until after adequate rest and rehabilitation have been attempted.

Continue to: Treatment typically involves restor physical therapy

 

 

Treatment typically involves restor physical therapy

Most cases of low back pain in children and adolescents are benign and self-limited. Many children with low back pain can be treated with relative rest from the offending activity. For children with more persistent pain, physical therapy (PT) is often indicated. Similar to that for adults, there is little evidence for specific PT programs to help children with low back pain. Rehabilitation should be individualized based on the condition being treated.

Medications. There have been no high-quality studies on the benefit of medications to treat low back pain in children. Studies have shown nonsteroidal anti-inflammatory drugs (NSAIDs) have value in adults, and they are likely safe for use in children,⁴⁰ but the risk of opiate abuse is significantly increased in adolescents who have been prescribed opiate pain medication prior to 12th grade.⁴¹

Lumbar disc herniation. Although still relatively rare, lumbar disc herniation is more common in older children and adolescents than in younger children and is treated similarly to that in adults.⁸ Range-of-motion exercise to restore lumbar motion is often first-line treatment. Research has shown that exercises that strengthen the abdominal or “core” musculature help prevent the return of low back pain.^24,25

In the case of spondylolysis or spondylolisthesis, rest from activity is generally required for a minimum of 4 to 6 weeks. Rehabilitation in the form of range of motion, especially into the lumbar extension, and spinal stabilization exercises are effective for both reducing pain and restoring range-­of-motion and strength.⁴² Have patients avoid heavy backpacks, which can reproduce pain. Children often benefit from leaving a second set of schoolbooks at home. For most patients with spondylolysis, conservative treatment with rehabilitation is equal to or better than surgical intervention in returning the patient to his/her pre-injury activity level.^26,43,44 When returning athletes to their sport, aggressive PT, defined as rest for < 10 weeks prior to initiating PT, is superior to delaying PT beyond 10 weeks of rest.²⁷

Idiopathic scoliosis. Much of the literature on the treatment of scoliosis is focused on limiting progression of the scoliotic curvature. Researchers thought that more severe curves were associated with more severe pain, but a recent systematic review showed that back pain can occur in patients with even small curvatures.²⁸ Treatment for patients with smaller degrees of curvature is similar to that for mechanical low back pain. PT may have a role in the treatment of scoliosis, but there is little evidence in the literature of its effectiveness.

Continue to: A Cochrane review showed...

Always consider imaging in the setting of bony tenderness, pain that wakes the patient from sleep, and when there is > 10° of asymmetry on physical exam using a scoliometer.

A Cochrane review showed that PT and exercise-based treatments had no effect on back pain or disability in patients with scoliosis.²⁹ And outpatient PT alone, in the absence of bracing, does not arrest progression of the scoliotic curvature.³⁵ One trial did demonstrate that an intensive inpatient treatment program of 4 to 6 weeks for patients with curvature of at least 40° reduced progression of curvature compared to an untreated control group at 1 year.³⁴ The outcomes of functional mobility and pain were not measured. Follow-up data on curve progression beyond 1 year are not available. Unfortunately, intensive inpatient treatment is not readily available or cost-effective for most patients with scoliosis.

Scheuermann disease. The mainstay of treatment for mild Scheuermann disease is advising the patient to avoid repetitive loading of the spine. Patients should avoid sports such as competitive weight-lifting, gymnastics, and football. Lower impact athletics are encouraged. Refer patients with pain to PT to address posture and core stabilization. Patients with severe kyphosis may require surgery.^17,18

Bracing: Rarely helpful for low back pain

The use of lumbar braces or corsets is rarely helpful for low back pain in children. Bracing in the setting of spondylolysis is controversial.One study indicated that bracing in combination with activity restriction and lumbar extension exercise is superior to activity restriction and lumbar flexion exercises alone.⁴³ But a meta-analysis did not demonstrate a significant difference in recovery when bracing was added.⁴⁴ Bracing may help to reduce pain initially in patients with spondylolysis who have pain at rest. Bracing is not recommended for patients with pain that abates with activity modification.

Scoliosis and Scheuermann kyphosis. Treatment of adolescent idiopathic scoliosis usually consists of observation and periodic reevaluation. Bracing is a mainstay of the nonsurgical management of scoliosis and is appropriate for curves of 20° to 40°; studies have reported successful control of curve progression in > 70% of patients.³⁶ According to 1 study, the number of cases of scoliosis needed to treat with bracing to prevent 1 surgery is 3.³⁰ Surgery is often indicated for patients with curvatures > 40°, although this is also debated.³³

Bracing is used rarely for Scheuermann kyphosis but may be helpful in more severe or painful cases.¹⁷

CORRESPONDENCE
Shawn F. Phillips, MD, MSPT, 500 University Drive H154, Hershey, PA, 17033; sphillips6@pennstatehealth.psu.edu.

Low back pain in not uncommon in children and adolescents.^1-3 Although the prevalence of low back pain in children < 7 years is low, it increases with age, with studies reporting lifetime prevalence at age 12 years between 16% and 18% and rates as high as 66% by 16 years of age.^4,5 Although children and adolescents usually have pain that is transient and benign without a defined cause, structural causes of low back pain should be considered in school-aged children with pain that persists for > 3 to 6 weeks. ⁴ The most common structural causes of adolescent low back pain are reviewed here.

Etiology: A mixed bag

Back pain in school-aged children is most commonly due to muscular strain, overuse, or poor posture. The pain is often transient in nature and responds to rest and postural education.^4,6 A herniated disc is an uncommon finding in younger school-aged children, but incidence increases slightly among older adolescents, particularly those who are active in collision sports and/or weight-lifting.^7,8 Pain caused by a herniated disc often radiates along the distribution of the sciatic nerve and worsens during lumbar flexion.

Spondylolysis and spondylolisthesis are important causes of back pain in children. Spondylolysis is defined as a defect or abnormality of the pars interarticularis and surrounding lamina and pedicle. Spondylolisthesis, which is less common, is defined as the translation or “slippage” of one vertebral segment in relation to the next caudal segment. These conditions commonly occur as a result of repetitive stress.

In a prospective study of adolescents < 19 years with low back pain for > 2 weeks, the prevalence of spondylolysis was 39.7%.⁹ Adolescent athletes with symptomatic low back pain are more likely to have spondylolysis than nonathletes (32% vs 2%, respectively).^2,10 Pain is often made worse by extension of the spine. Spondylolysis and spondylolisthesis can be congenital or acquired, and both can be asymptomatic. Children and teens who are athletes are at higher risk for symptomatic spondylolysis and spondylolisthesis.^10-12 This is especially true for those involved in gymnastics, dance, football, and/or volleyball, where a repetitive load is placed onto an extended spine.

Idiopathic scoliosis is an abnormal lateral curvature of the spine that usually develops during adolescence and worsens with growth. Historically, painful scoliosis was considered rare, but more recently researchers determined that children with scoliosis have a higher rate of pain compared to their peers.^13,14 School-aged children with scoliosis were found to be at 2 times the risk of low back pain compared to those without scoliosis.¹³ It is important to identify scoliosis in adolescents so that progression can be monitored.

Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side.

Screening for scoliosis in primary care is somewhat controversial. The US Preventive Services Task Force (USPSTF) finds insufficient evidence for screening asymptomatic adolescents for scoliosis.¹⁵ This recommendation is based on the fact that there is little evidence on the effect of screening on long-term outcomes. Screening may also lead to unnecessary radiation. Conversely, a position statement released by the Scoliosis Research Society, the Pediatric Orthopedic Society of North America, the American Association of Orthopedic Surgeons, and the American Academy of Pediatrics recommends scoliosis screening during routine pediatric office visits.¹⁶ Screening for girls is recommended at ages 10 and 12 years, and for boys, once between ages 13 and 14 years. The statement highlights evidence showing that focused screening by appropriate personnel has value in detecting a clinically significant curve (> 20°).

Scheuermann disease is a rare cause of back pain in children that usually develops during adolescence and results in increasing thoracic kyphosis. An autosomal dominant mutation plays a role in this disease of the growth cartilage endplate; repetitive strain on the growth cartilage is also a contributing factor.^17,18 An atypical variant manifests with kyphosis in the thoracolumbar region.¹⁷

Continue to: Other causes of low back pain

Other causes of low back pain—including inflammatory arthritis, infection (eg, discitis), and tumor—are rare in children but must always be considered, especially in the setting of persistent symptoms.^4,19-21 More on the features of these conditions is listed in TABLE 1.^{1-7,13-15,17-30}

History: Focus on onset, timing, and duration of symptoms

As with adults, obtaining a history that includes the onset, timing, and duration of symptoms is key in the evaluation of low back pain in children, as is obtaining a history of the patient’s activities; sports that repetitively load the lumbar spine in an extended position increase the risk of injury.¹⁰

Specific risk factors for low back pain in children and adolescents are poorly understood.^4,9,31 Pain can be associated with trauma, or it can have a more progressive or insidious onset. Generally, pain that is present for up to 6 weeks and is intermittent or improving has a self-limited course. Pain that persists beyond 3 to 6 weeks or is worsening is more likely to have an anatomical cause that needs further evaluation.^2,3,10,21

Identifying exacerbating and alleviating factors can provide useful information. Pain that is worse with lumbar flexion is more likely to come from muscular strain or disc pathology. Pain with extension is more likely due to a structural cause such as spondylolysis/spondylolisthesis, scoliosis, or Scheuermann disease.^{2,4,10,17,18,21} See TABLE 2 for red flag symptoms that indicate the need for imaging and further work-up.

The physical exam: Visualize, assess range of motion, and reproduce pain

The physical examination of any patient with low back pain should include direct visualization and inspection of the back, spine, and pelvis; palpation of the spine and paraspinal regions; assessment of lumbar range of motion and of the lumbar nerve roots, including tests of sensation, strength, and deep tendon reflexes; and an evaluation of the patient’s posture, which can provide clues to underlying causes of pain.

Continue to: Increased thoracic kyphosis...

Increased thoracic kyphosis that is not reversible is concerning for Scheuermann disease.^9,17,18 A significant elevation in one shoulder or side of the pelvis can be indicative of scoliosis. Increased lumbar lordosis may predispose a patient to spondylolysis.

In patients with spondylolysis, lumbar extension will usually reproduce pain, which is often unilateral. Hyperextension in a single-leg stance, commonly known as the Stork test, is positive for unilateral spondylolysis when it reproduces pain on the ipsilateral side. The sensitivity of the Stork test for unilateral spondylolysis is approximately 50%.³² (For more information on the Stork test, see www.physio-pedia.com/Stork_test.)

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain. Lumbar flexion with concomitant radicular pain is associated with disc pathology.⁸ Pain with a straight-leg raise is also associated with disk pathology, especially if raising the contralateral leg increases pain.⁸

Using a scoliometer. Evaluate the flexed spine for the presence of asymmetry, which can indicate scoliosis.³³ If asymmetry is present, use a scoliometer to determine the degree of asymmetry. Zero to 5° is considered clinically insignificant; monitor and reevaluate these patients at subsequent visits.^34,35 Ten degrees or more of asymmetry with a scoliometer should prompt you to order radiographs.^35,36 A smartphone-based scoliometer for iPhones was evaluated in 1 study and was shown to have reasonable reliability and validity for clinical use.³⁷

Deformity of the lower extremities. Because low back pain may be caused by biomechanical or structural deformity of the lower extremities, examine the flexibility of the hip flexors, gluteal musculature, hamstrings, and the iliotibial band.³⁸ In addition, evaluate for leg-length discrepancy and lower-extremity malalignment, such as femoral anteversion, tibial torsion, or pes planus.

Continue to: Imaging

Imaging: Know when it’s needed

Although imaging of the lumbar spine is often unnecessary in the presence of acute low back pain in children, always consider imaging in the setting of bony tenderness, pain that wakes a patient from sleep, and in the setting of other red flag symptoms (see TABLE 2). Low back pain in children that is reproducible with lumbar extension is concerning for spondylolysis or spondylolisthesis. If the pain with extension persists beyond 3 to 6 weeks, order imaging starting with radiographs.^2,39

Traditionally, 4 views of the spine—­anteroposterior (AP), lateral, and oblique (one right and one left)—were obtained, but recent evidence indicates that 2 views (AP and lateral) have similar sensitivity and specificity to 4 views with significantly reduced radiation exposure.^2,39 Because the sensitivity of plain films is relatively low, consider more advanced imaging if spondylolysis or spondylolisthesis is strongly suspected. Recent studies indicate that magnetic resonance imaging (MRI) may be as effective as computed tomography (CT) or bone scan and has the advantage of lower radiation (FIGURE 1).^2,22

Similarly, order radiographs if there is > 10° of asymmetry noted on physical exam using a scoliometer.^15,23 Calculate the Cobb angle to determine the severity of scoliosis. Refer patients with angles ≥ 20° to a pediatric orthopedist for monitoring of progression and consideration of bracing (FIGURE 2).^23,34 For patients with curvatures between 10° and 19°, repeat imaging every 6 to 12 months. Because scoliosis is a risk factor for spondylolysis, evaluate radiographs in the setting of painful scoliosis for the presence of a spondylolysis.^34,35

Pain reproduced with lumbar flexion is less concerning for bony pathology and is most often related to soft-tissue strain.

If excessive kyphosis is noted on exam, order radiographs to evaluate for Scheuermann disease. Classic imaging findings include Schmorl nodes, vertebral endplate changes, and anterior wedging (FIGURE 3).^17,18

In the absence of the above concerns, defer imaging of the lumbar spine until after adequate rest and rehabilitation have been attempted.

Continue to: Treatment typically involves restor physical therapy

 

 

Treatment typically involves restor physical therapy

Most cases of low back pain in children and adolescents are benign and self-limited. Many children with low back pain can be treated with relative rest from the offending activity. For children with more persistent pain, physical therapy (PT) is often indicated. Similar to that for adults, there is little evidence for specific PT programs to help children with low back pain. Rehabilitation should be individualized based on the condition being treated.

Medications. There have been no high-quality studies on the benefit of medications to treat low back pain in children. Studies have shown nonsteroidal anti-inflammatory drugs (NSAIDs) have value in adults, and they are likely safe for use in children,⁴⁰ but the risk of opiate abuse is significantly increased in adolescents who have been prescribed opiate pain medication prior to 12th grade.⁴¹

Lumbar disc herniation. Although still relatively rare, lumbar disc herniation is more common in older children and adolescents than in younger children and is treated similarly to that in adults.⁸ Range-of-motion exercise to restore lumbar motion is often first-line treatment. Research has shown that exercises that strengthen the abdominal or “core” musculature help prevent the return of low back pain.^24,25

In the case of spondylolysis or spondylolisthesis, rest from activity is generally required for a minimum of 4 to 6 weeks. Rehabilitation in the form of range of motion, especially into the lumbar extension, and spinal stabilization exercises are effective for both reducing pain and restoring range-­of-motion and strength.⁴² Have patients avoid heavy backpacks, which can reproduce pain. Children often benefit from leaving a second set of schoolbooks at home. For most patients with spondylolysis, conservative treatment with rehabilitation is equal to or better than surgical intervention in returning the patient to his/her pre-injury activity level.^26,43,44 When returning athletes to their sport, aggressive PT, defined as rest for < 10 weeks prior to initiating PT, is superior to delaying PT beyond 10 weeks of rest.²⁷

Idiopathic scoliosis. Much of the literature on the treatment of scoliosis is focused on limiting progression of the scoliotic curvature. Researchers thought that more severe curves were associated with more severe pain, but a recent systematic review showed that back pain can occur in patients with even small curvatures.²⁸ Treatment for patients with smaller degrees of curvature is similar to that for mechanical low back pain. PT may have a role in the treatment of scoliosis, but there is little evidence in the literature of its effectiveness.

Continue to: A Cochrane review showed...

Always consider imaging in the setting of bony tenderness, pain that wakes the patient from sleep, and when there is > 10° of asymmetry on physical exam using a scoliometer.

A Cochrane review showed that PT and exercise-based treatments had no effect on back pain or disability in patients with scoliosis.²⁹ And outpatient PT alone, in the absence of bracing, does not arrest progression of the scoliotic curvature.³⁵ One trial did demonstrate that an intensive inpatient treatment program of 4 to 6 weeks for patients with curvature of at least 40° reduced progression of curvature compared to an untreated control group at 1 year.³⁴ The outcomes of functional mobility and pain were not measured. Follow-up data on curve progression beyond 1 year are not available. Unfortunately, intensive inpatient treatment is not readily available or cost-effective for most patients with scoliosis.

Scheuermann disease. The mainstay of treatment for mild Scheuermann disease is advising the patient to avoid repetitive loading of the spine. Patients should avoid sports such as competitive weight-lifting, gymnastics, and football. Lower impact athletics are encouraged. Refer patients with pain to PT to address posture and core stabilization. Patients with severe kyphosis may require surgery.^17,18

Bracing: Rarely helpful for low back pain

The use of lumbar braces or corsets is rarely helpful for low back pain in children. Bracing in the setting of spondylolysis is controversial.One study indicated that bracing in combination with activity restriction and lumbar extension exercise is superior to activity restriction and lumbar flexion exercises alone.⁴³ But a meta-analysis did not demonstrate a significant difference in recovery when bracing was added.⁴⁴ Bracing may help to reduce pain initially in patients with spondylolysis who have pain at rest. Bracing is not recommended for patients with pain that abates with activity modification.

Scoliosis and Scheuermann kyphosis. Treatment of adolescent idiopathic scoliosis usually consists of observation and periodic reevaluation. Bracing is a mainstay of the nonsurgical management of scoliosis and is appropriate for curves of 20° to 40°; studies have reported successful control of curve progression in > 70% of patients.³⁶ According to 1 study, the number of cases of scoliosis needed to treat with bracing to prevent 1 surgery is 3.³⁰ Surgery is often indicated for patients with curvatures > 40°, although this is also debated.³³

Bracing is used rarely for Scheuermann kyphosis but may be helpful in more severe or painful cases.¹⁷

CORRESPONDENCE
Shawn F. Phillips, MD, MSPT, 500 University Drive H154, Hershey, PA, 17033; sphillips6@pennstatehealth.psu.edu.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

A recently approved agent, burosumab (Crysvita), was better than placebo across a range of efficacy outcomes for 14 predefined subgroups of adults with X-linked hypophosphatemia (XLH), new research shows.

The authors analyzed data from the initial 24-week randomized blinded phase of the pivotal phase 3 trial that led to regulatory approval of this drug in the United States in 2018 for XLH, a rare form of rickets characterized by low serum phosphorus levels, skeletal defects, pain, and stiffness.

As in the main analysis, in the subgroups, among patients who received burosumab, serum phosphorus levels were improved, and outcomes were better on the following measures: Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness scale, the WOMAC physical function measure, and the Brief Pain Inventory (BPI), which were the main efficacy outcomes. Improvements were seen for many other outcomes as well.

Maria-Luisa Brandi, MD, Careggi University Hospital, Florence, Italy, presented the new subanalysis during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.

The subgroup results were consistent with the overall trial findings, “showing a favorable direction of effect of burosumab relative to placebo” except for results in patients recruited in Asia and non-White patients; those results were considered inconclusive because there were too few participants in those categories, she told Medscape Medical News,.

Lorenz Hofbauer, MD, scientific chair of the ASBMR meeting, said that the take-away message is that the drug “works to reduce pain and disability” in adults with XLH with more severe/less severe symptoms, and “it provides new hope for many patients suffering from this disease,” he told Medscape Medical News.

Burosemab also appears superior to what has previously been considered standard therapy for XLH, phosphate/calcitriol, the experts say.
 

‘Rare is relative,’ burosumab is a ‘transformative therapy’

“The disease prevalence is 1 to 9 in a million,” Brandi said. “Undiagnosed adults are treated by the doctor that makes the diagnosis, usually a nephrologist or a rheumatologist or a bone doctor; this depends on the prevalent complications in a given patient. The endocrinologist who treats this patient is the one expert in bone disorders.”

Hofbauer noted, however, that “[r]are is relative. If you run a bone clinic, you will see four to five patients with XLH; if you are a regional center, 20 to 30 patients. People with rare disease travel more than 1000 miles to see experts.”

The US Food and Drug Administration approved burosumab for use in children and adults with XLH 2 years ago. The European Medicines Agency (EMA) approved it for use in children.

The drug is expected to be approved by the EMA for adults with XLH some time this year, said Hofbauer, who is from Dresden Technical University, Dresden, Germany.

Burosumab is a “game changer” with respect to previous treatments, he stressed.

This study is one of the top five clinical abstracts of the ASBMR meeting, which are selected on the basis of “scientific content/novelty, making a difference in clinical practice,” Hofbauer explained. He noted that “new drugs that work are always in the top ranks.”

Craig Munns, PhD, who was senior author of a recent review about burosumab, agrees.

“Burosumab is transformative, as it is a paradigm shift in the way we manage XLH,” he told Medscape Medical News.

“Standard therapy for children is with oral phosphate and calcitriol, and many adults do not receive any therapy,” said Munns, from the University of Sydney, Sydney, Australia.

“Phosphate and calcitriol need to be taken multiple times per day, is an incomplete therapy, and has many complications. Burosumab offers a 2-weekly (children) or 4-weekly (adult) dosing regime with superior outcomes compared to no treatment or phosphate/calcitriol,” he emphasized.
 

Efficacy in 14 predefined subgroups

“Burosumab is an anti-FGF-23 [anti–fibroblast growth factor-23] antibody for a rare genetic disease, XLH, in which the gene for PHEX is defective,” Hofbauer explained.

“PHEX is an enzyme that clears FGF-23; if it does not work, then FGF-23 accumulates in the body and causes phosphate wasting with wide consequences for bone, muscle, and joints. Burosumab is a smart approach, since it blocks these excessive FGF-23 effects.”

Children with XLH have rickets, deformities in the lower skeleton, and short stature, Brandi noted, whereas adults have fractures, pseudofractures, enthesopathy (calcification of joint capsule, tendon insertions, and ligaments), pain, stiffness, and impaired physical function.

However, “treatment with oral phosphate and vitamin D is associated with nephrocalcinosis and hyperparathyroidism,” she said.

In the phase 3 trial, 134 adults (aged 18 to 65 years) with XLH were randomly assigned in a double-blind manner to receive either burosumab or placebo for 24 weeks, followed by 24 weeks of open-label burosumab. The patients’ serum phosphorus levels were <2.5 mg/dL, and they were experiencing measurable bone/joint pain.

Baseline characteristics were similar for the patients who received placebo (66) and those who received burosumab (68). The mean age of the patients was 40 years; 65% were women; and 81% were White.

The current exploratory analysis examined efficacy outcomes in patients grouped according to the following factors and characteristics: sex; age (≤41 years or >41 years); race (non-White, White); region (Asia, North America/Europe); baseline WOMAC pain score; WOMAC total pain; WOMAC stiffness; WOMAC physical function; BPI worst pain; BPI average pain; opioid use; pain medication use; active fractures and pseudofractures; and 6-minute walking test distance.

The efficacy outcomes were as follows: serum phosphorus level (primary outcome), BPI worst pain, WOMAC stiffness, and WOMAC physical function (key secondary outcomes); and WOMAC pain, WOMAC total score, BPI average pain, BPI pain interference, BPI worst fatigue, BPI global score, patient global impression (PGI), and 6-minute walking distance.

In the overall cohort, at 24 weeks, in comparison with patients who received placebo, patients who received burosumab had favorable responses with respect to serum phosphorus level, WOMAC stiffness (P =. 012),WOMAC physical function (P = .048), and BPI worst pain (P = .092, not significant), as well as significant improvements in WOMAC total score and the 6-minute walk test. There were nonsignificant improvements in WOMAC pain and BPI average pain.

In the subgroup analysis, burosumab was superior to placebo for the primary outcome (serum phosphorus) in all subgroups. It was also superior to placebo for the key secondary outcomes (worst pain, stiffness, and physical function) across all subgroups except for patients from Asia (18 patients) and non-White patients (26).

The study was funded by Kyowa Kirin in partnership with Ultragenyx. Brandi receives consultancy and speaker fees as well as research grants from Kyowa Kirin and other pharmaceutical companies. Munns has received research funding from Kyowa Kirin.
 

This article first appeared on Medscape.com.

The combination of islatravir (ISL) and doravirine (DOR) maintains HIV-1 viral suppression for at least 96 weeks, according to new data.

ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), Jean-Michel Molina, MD, PhD, of Saint‐Louis and Lariboisière Hospitals in Paris, explained at the annual HIV drug therapy meeting in Glasgow, Scotland. The randomized, double-blind, dose‐ranging trial compared ISL+DOR to a fixed‐dose combination of DOR, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF) daily in 121 patients.

Patients in the ISL+DOR group initially received 0.25, 0.75, or 2.25 mg of ISL along with 100 mg of DOR and 200 mg of 3TC. Beginning at week 20, participants achieving HIV viral loads of 50 copies/mL or less discontinued 3TC but continued on their assigned dose of ISL+DOR for at least 24 weeks. At that point the investigators noted a greater number of discontinuations in the 2.25-mg group and settled on the 0.75-mg ISL dose. All patients in the ISL group were transitioned to that dose between weeks 60 and 72.

At week 96, 81.1% of the patients in the combined ISL group maintained viral loads <50 copies/mL, comparable to the 80.6% of those in the DOR/3TC/TDF group.

ISL+DOR appeared to be “well tolerated,” the investigators noted. They found drug-related adverse events in 7.8% of the patients in the ISL+DOR group compared with 22.6% of patients in the DOR/3TC/TDF group. In addition, among the 90 patients in the ISL+DOR group, no more than 5% of participants experienced any specific drug-related adverse event.

Source: HIV Glasgow 2020 Virtual Conference: Abstract O415. Oct. 5-8, 2020.

A version of this article originally appeared on Medscape.com.

The combination of islatravir (ISL) and doravirine (DOR) maintains HIV-1 viral suppression for at least 96 weeks, according to new data.

ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), Jean-Michel Molina, MD, PhD, of Saint‐Louis and Lariboisière Hospitals in Paris, explained at the annual HIV drug therapy meeting in Glasgow, Scotland. The randomized, double-blind, dose‐ranging trial compared ISL+DOR to a fixed‐dose combination of DOR, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF) daily in 121 patients.

Patients in the ISL+DOR group initially received 0.25, 0.75, or 2.25 mg of ISL along with 100 mg of DOR and 200 mg of 3TC. Beginning at week 20, participants achieving HIV viral loads of 50 copies/mL or less discontinued 3TC but continued on their assigned dose of ISL+DOR for at least 24 weeks. At that point the investigators noted a greater number of discontinuations in the 2.25-mg group and settled on the 0.75-mg ISL dose. All patients in the ISL group were transitioned to that dose between weeks 60 and 72.

At week 96, 81.1% of the patients in the combined ISL group maintained viral loads <50 copies/mL, comparable to the 80.6% of those in the DOR/3TC/TDF group.

ISL+DOR appeared to be “well tolerated,” the investigators noted. They found drug-related adverse events in 7.8% of the patients in the ISL+DOR group compared with 22.6% of patients in the DOR/3TC/TDF group. In addition, among the 90 patients in the ISL+DOR group, no more than 5% of participants experienced any specific drug-related adverse event.

Source: HIV Glasgow 2020 Virtual Conference: Abstract O415. Oct. 5-8, 2020.

A version of this article originally appeared on Medscape.com.

The combination of islatravir (ISL) and doravirine (DOR) maintains HIV-1 viral suppression for at least 96 weeks, according to new data.

ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), Jean-Michel Molina, MD, PhD, of Saint‐Louis and Lariboisière Hospitals in Paris, explained at the annual HIV drug therapy meeting in Glasgow, Scotland. The randomized, double-blind, dose‐ranging trial compared ISL+DOR to a fixed‐dose combination of DOR, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF) daily in 121 patients.

Patients in the ISL+DOR group initially received 0.25, 0.75, or 2.25 mg of ISL along with 100 mg of DOR and 200 mg of 3TC. Beginning at week 20, participants achieving HIV viral loads of 50 copies/mL or less discontinued 3TC but continued on their assigned dose of ISL+DOR for at least 24 weeks. At that point the investigators noted a greater number of discontinuations in the 2.25-mg group and settled on the 0.75-mg ISL dose. All patients in the ISL group were transitioned to that dose between weeks 60 and 72.

At week 96, 81.1% of the patients in the combined ISL group maintained viral loads <50 copies/mL, comparable to the 80.6% of those in the DOR/3TC/TDF group.

ISL+DOR appeared to be “well tolerated,” the investigators noted. They found drug-related adverse events in 7.8% of the patients in the ISL+DOR group compared with 22.6% of patients in the DOR/3TC/TDF group. In addition, among the 90 patients in the ISL+DOR group, no more than 5% of participants experienced any specific drug-related adverse event.

Source: HIV Glasgow 2020 Virtual Conference: Abstract O415. Oct. 5-8, 2020.

A version of this article originally appeared on Medscape.com.

A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.

The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.

Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.

The median surprise bill was $418 (range $152-$981).

The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”

Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.

“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”

“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”

But is it really that simple for physicians to make sure that all members of the team are in-network?

It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.

“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”

In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.

Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”

“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
 

Details of the surprise bills

Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.

To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.

The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.

A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).

If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.

The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.

“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.

The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.

This article first appeared on Medscape.com.

A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.

The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.

Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.

The median surprise bill was $418 (range $152-$981).

The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”

Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.

“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”

“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”

But is it really that simple for physicians to make sure that all members of the team are in-network?

It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.

“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”

In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.

Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”

“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
 

Details of the surprise bills

Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.

To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.

The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.

A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).

If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.

The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.

“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.

The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.

This article first appeared on Medscape.com.

A colonoscopy screening for colorectal cancer should be covered by commercial health insurance, but a new study reports that some patients receive a “surprise” bill.

The study was published online Oct. 13 as a research letter in the Annals of Internal Medicine.

Nearly 1 in 8 commercially insured patients who had an elective colonoscopy between 2012 and 2017 received an out-of-network bill, resulting in hundreds of dollars more than the typical insurance payment.

The median surprise bill was $418 (range $152-$981).

The findings are “disconcerting” say the authors, “because Section 2713 of the Patient Protection and Affordable Care Act eliminates consumer cost sharing for screening colonoscopy, and because a recent Federal Reserve study reported that 40% of Americans do not have $400 to cover unnecessary expenses.”

Most of these surprise costs were incurred from the use of out-of network anesthesiologists and pathologists, the authors note.

“Doctors need to be aware of these out-of-network bills so that patients know what to expect when they undergo these screening procedures,” said study author Karan R. Chhabra, MD, MSc, a resident in general surgery at Brigham and Women’s Hospital, Boston, Massachusetts. “Ideally, they should do their colonoscopies at facilities where all providers participate in the same major insurance plans.”

“If gastroenterologists own their endoscopy facility, this is an obvious situation in which they should not be working with anesthesiologists or pathologists who are not in the same networks as them,” he told Medscape Medical News. “And as we point out in our paper, anesthesiology and pathology review are not necessary in every single case — endoscopists can perform their own sedation, and in certain settings, lesions can be discarded without pathological examination.”

But is it really that simple for physicians to make sure that all members of the team are in-network?

It’s not simple at all, and in fact it’s a rather difficult task, said Glenn Melnick, PhD, professor and chair in health care finance at USC and director of USC’s Center for Health Financing, Policy, and Management in Los Angeles.

“It would be really difficult for Dr Smith to know that Dr Jones is out of network, so it’s really hard to hold the doctors responsible,” Melnick told Medscape Medical News. “There are so many insurers and it may be difficult to know who is in-network and who isn’t.”

In this study, anesthesiologists and pathologists were a source of surprise bills, and they are behind the scenes, he pointed out. “The patient doesn’t select them directly and there is no opportunity to even find out who they are,” said Melnick.

Most patients have no idea that there may be other doctors involved with a colonoscopy, and Melnick highlighted his own recent experience. “I just had a colonoscopy and it never would have occurred to me. It never crossed my mind to even ask who is in network and who isn’t,” he said. “And I’m an expert on this.”

“The health plan could bear some responsibility here,” Melnick commented, although he added that patients need to be informed. Patients who are undergoing an elective procedure should be told that other doctors may be involved, and then to ask if these doctors are in the network. “If enough patients do this, maybe then the gastroenterologist will use people in network,” he commented.
 

Details of the surprise bills

Federal regulations eliminate consumer cost-sharing when screening colonoscopies are performed in-network, but there are no stipulations regarding expenses when out-of-network providers are used, the authors note.

To investigate this issue, the authors used a claims database from a large national insurer and identified patients aged 18 to 64 years who had undergone colonoscopy between 2012 and 2017.

The analysis was limited to cases where both the facility and the endoscopist were in-network, and the colonoscopies were stratified into those with visual inspection only and those during which an intervention was done, such as a biopsy. The primary outcome measure was the prevalence of out-of-network claims when the endoscopist and facility were in-network, and the secondary outcome was the amount of the potential surprise bills, which were calculated as the total out-of network charges less the typical in-network price.

A total of 1,118,769 elective colonoscopies with in-network endoscopists and facilities were identified and of these, 12.1% (n = 135,626) were involved with out-of-network claims. Out-of network anesthesiologists accounted for 64% of cases (median potential surprise bill, $488), while out-of-network pathologists were involved in 40% of cases (median potential surprise bill, $248). The likelihood of receiving an out-of-network claim was significantly higher if an intervention was performed during colonoscopy, as compared with those without intervention (13.9% vs. 8.2%; difference, 5.7%).

If an intervention was performed, 56% of potential surprise bills involved anesthesiologists and 51% pathologists. In cases with visual inspection only, 95% of out-of-network claims involved anesthesiologists.

The authors suggest that measures that can be taken to avoid surprise bills include having endoscopists and hospitals partner with anesthesia and pathology providers who are in-network. Another cost-saving strategy is the use of endoscopist-provided sedation rather than use of deeper anesthesia, and the authors also suggest that not all low-risk polyps need to be sent for pathological evaluation.

“Providers must realize many of our patients are at risk for considerable balance bills, and therefore they should provide resources that can provide reliable estimates for out-of-pocket costs relevant to site of service,” said lead author James Scheiman, MD, a professor of medicine at the University of Virginia School of Medicine in Charlottesville.

The study was funded by the University of Michigan. Chhabra reports personal fees from Blue Cross Blue Shield of Massachusetts, Inc. Scheiman and Melnick have no disclosures.

This article first appeared on Medscape.com.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

In pediatric Crohn’s disease, a Clostridioides difficile infection detected within the first year after diagnosis is associated with a shorter time to first bowel resection surgery, according to a study that included both a retrospective and prospective analysis. The researchers also found evidence that changes in methionine biosynthesis and depletion of beneficial bacteria may contribute to risk of surgery.

C. difficile infection (CDI) disproportionately affects individuals with inflammatory bowel disease (IBD). Pediatric IBD patients have a 34% risk of recurrent CDI infection, compared with 7.5% in the general population. Previous research found that adults with ulcerative colitis and CDI are at more risk of colectomy, but the finding has not been replicated in children.

In a study published in Inflammatory Bowel Diseases, researchers led by Jennifer Hellmann and Lee Denson of the University of Cincinnati conducted a single-center retrospective analysis of 75 pediatric Crohn’s disease patients. They also conducted a prospective study of 70 pediatric Crohn’s disease patients, using shotgun metagenome sequencing to examine the relationship between microbiota composition and C. difficile carriage or surgery history.

Nineteen percent of patients tested positive for C. difficile. Use of antibiotics was associated with C. difficile (odds ratio, 7.9; P = .02). Of patients who underwent C. difficile testing in the first year, 23 went on to have surgery: 21% who were C. difficile negative required surgery, compared with 67% of those who were positive (hazard ratio, 4.4; P = .0003). The mean time to surgery was 527 days for C. difficile–positive patients and 1,268 days for those who were negative.

A multivariate regression analysis on 54 patients with complete data sets showed that the presence of C. difficile was associated with increased risk of surgery (OR, 16.2; P = .0006). When the analysis was run on all 73 patients, using null value for missing data, the results were similar (OR, 9.17; P = .008).

Shotgun sequencing found that 47 of 114 bacterial species that were associated with the presence of C. difficile were also associated with prior surgery for Crohn’s disease. Species included some that may play a role in mucosal homeostasis, such as Bifidobacterium breve and several Alistipes and Ruminococcus species. That suggests that a reduction in the numbers of these taxa may be associated with C. difficile presence and surgical risk.

The researchers also found that methionine synthesis pathways were depressed in C. difficile–positive and surgery patients. Methionine may bolster antioxidant capacity and improve villus morphology. IBD patients with dysbiosis and those experiencing Crohn’s disease exacerbations have been shown to have decreased methionine pathway activity, suggesting methionine biosynthesis changes have clinical relevance.

The study was funded by the National Institutes of Health.

SOURCE: Hellmann J et al. Inflamm Bowel Dis. 2020. doi: 10.1093/ibd/izz263.

Vancomycin followed by fecal microbiota transplant (FMT) was associated with reduced Clostridioides difficile (C. diff)-related mortality in patients hospitalized with refractory severe or fulminant C. diff infection (CDI) at a single center. The improvements came after Indiana University implemented an FMT option in 2013.

About 8% of C. diff patients develop severe or fulminant CDI (SFCDI), which can lead to toxic colon and multiorgan failure. Surgery is the current recommended treatment for these patients if they are refractory to vancomycin, but 30-day mortality is above 40%. FMT is recommended for recurrent CDI, and it achieves cure rates greater than 80%, along with fewer relapses compared with anti-CDI antibiotic therapy.

FMT has been shown to be effective for SFCDI, with a 91% cure rate for serious CDI and 66% for fulminant CDI.

In the study published in the September issue of Clinical Gastroenterology and Hepatology, researchers led by Yao-Wen Cheng, MD, and Monika Fischer, MD, of Indiana University, assessed the effect of FMT on SFCDI after their institution adopted it as a treatment protocol for SFCDI. Patients could receive FMT if there was evidence that their SFCDI was refractory, or if they had two or more CDI recurrences. The treatment includes oral vancomycin and pseudomembrane-driven sequential FMT.

Two hundred five patients were admitted before FMT implementation, 225 after. Fifty patients received FMT because of refractory SFCDI. A median of two FMTs was conducted per patient. 21 other patients received FMT for nonrefractory SFCDI or other conditions, including 18 patients with multiple recurrent CDI.

Thirty-day CDI-related mortality dropped after FMT implementation (4.4% versus 10.2%; P =.02). This was true in both the fulminant subset (9.1% versus 21.3%; P =.015) and the refractory group (12.1% versus 43.2%; P < .001).

The researchers used segmented logistic regression to determine if the improved outcomes could be due to nontreatment factors that varied over time, and found that the difference in CDI-related mortality was eliminated except for refractory SFCDI patients (odds of mortality after FMT implementation, 0.09; P =.023). There was no significant difference between those receiving non-CDI antibiotics (4.8%) and those who did not (6.9%; P =.75).

FMT was associated with lower frequency of CDI-related colectomy overall (2.7% versus 6.8%; P =.041), as well as in the fulminant (5.5% versus 15.7%; P =.017) and refractory subgroups (7.6% versus 31.8%; P =.001).

The findings follow another study that showed improved 3-month mortality for FMT among patients hospitalized with severe CDI (12.1% versus 42.2%; P < .003).

The results underscore the utility of FMT for SFCDI, and suggest it might have the most benefit in refractory SFCDI. The authors believe that FMT should be an alternative to colectomy when first-line anti-CDI antibiotics are partially or completely ineffective. In the absence of FMT, patients who go on to fail vancomycin or fidaxomicin will likely continue to be managed medically, with up to 80% mortality, or through salvage colectomy, with postsurgical morality rates of 30-40%.

Although a randomized trial could answer the question of FMT efficacy more definitively, it is unlikely to be conducted for ethical reasons.

“Further investigation is required to clearly define FMT’s role and timing in the clinical course of severe and fulminant CDI. However, our study suggests that FMT should be offered to patients with severe and fulminant CDI who do not respond to a 5-day course of anti-CDI antibiotics and may be considered in lieu of or before colectomy,” the researchers wrote.

No source of funding was disclosed.

SOURCE: Cheng YW et al. Clin Gastroenterol Hepatol. 2020;18:2234-43. doi: 10.1016/j.cgh.2019.12.029.

Vancomycin followed by fecal microbiota transplant (FMT) was associated with reduced Clostridioides difficile (C. diff)-related mortality in patients hospitalized with refractory severe or fulminant C. diff infection (CDI) at a single center. The improvements came after Indiana University implemented an FMT option in 2013.

About 8% of C. diff patients develop severe or fulminant CDI (SFCDI), which can lead to toxic colon and multiorgan failure. Surgery is the current recommended treatment for these patients if they are refractory to vancomycin, but 30-day mortality is above 40%. FMT is recommended for recurrent CDI, and it achieves cure rates greater than 80%, along with fewer relapses compared with anti-CDI antibiotic therapy.

FMT has been shown to be effective for SFCDI, with a 91% cure rate for serious CDI and 66% for fulminant CDI.

In the study published in the September issue of Clinical Gastroenterology and Hepatology, researchers led by Yao-Wen Cheng, MD, and Monika Fischer, MD, of Indiana University, assessed the effect of FMT on SFCDI after their institution adopted it as a treatment protocol for SFCDI. Patients could receive FMT if there was evidence that their SFCDI was refractory, or if they had two or more CDI recurrences. The treatment includes oral vancomycin and pseudomembrane-driven sequential FMT.

Two hundred five patients were admitted before FMT implementation, 225 after. Fifty patients received FMT because of refractory SFCDI. A median of two FMTs was conducted per patient. 21 other patients received FMT for nonrefractory SFCDI or other conditions, including 18 patients with multiple recurrent CDI.

Thirty-day CDI-related mortality dropped after FMT implementation (4.4% versus 10.2%; P =.02). This was true in both the fulminant subset (9.1% versus 21.3%; P =.015) and the refractory group (12.1% versus 43.2%; P < .001).

The researchers used segmented logistic regression to determine if the improved outcomes could be due to nontreatment factors that varied over time, and found that the difference in CDI-related mortality was eliminated except for refractory SFCDI patients (odds of mortality after FMT implementation, 0.09; P =.023). There was no significant difference between those receiving non-CDI antibiotics (4.8%) and those who did not (6.9%; P =.75).

FMT was associated with lower frequency of CDI-related colectomy overall (2.7% versus 6.8%; P =.041), as well as in the fulminant (5.5% versus 15.7%; P =.017) and refractory subgroups (7.6% versus 31.8%; P =.001).

The findings follow another study that showed improved 3-month mortality for FMT among patients hospitalized with severe CDI (12.1% versus 42.2%; P < .003).

The results underscore the utility of FMT for SFCDI, and suggest it might have the most benefit in refractory SFCDI. The authors believe that FMT should be an alternative to colectomy when first-line anti-CDI antibiotics are partially or completely ineffective. In the absence of FMT, patients who go on to fail vancomycin or fidaxomicin will likely continue to be managed medically, with up to 80% mortality, or through salvage colectomy, with postsurgical morality rates of 30-40%.

Although a randomized trial could answer the question of FMT efficacy more definitively, it is unlikely to be conducted for ethical reasons.

“Further investigation is required to clearly define FMT’s role and timing in the clinical course of severe and fulminant CDI. However, our study suggests that FMT should be offered to patients with severe and fulminant CDI who do not respond to a 5-day course of anti-CDI antibiotics and may be considered in lieu of or before colectomy,” the researchers wrote.

No source of funding was disclosed.

SOURCE: Cheng YW et al. Clin Gastroenterol Hepatol. 2020;18:2234-43. doi: 10.1016/j.cgh.2019.12.029.

Vancomycin followed by fecal microbiota transplant (FMT) was associated with reduced Clostridioides difficile (C. diff)-related mortality in patients hospitalized with refractory severe or fulminant C. diff infection (CDI) at a single center. The improvements came after Indiana University implemented an FMT option in 2013.

About 8% of C. diff patients develop severe or fulminant CDI (SFCDI), which can lead to toxic colon and multiorgan failure. Surgery is the current recommended treatment for these patients if they are refractory to vancomycin, but 30-day mortality is above 40%. FMT is recommended for recurrent CDI, and it achieves cure rates greater than 80%, along with fewer relapses compared with anti-CDI antibiotic therapy.

FMT has been shown to be effective for SFCDI, with a 91% cure rate for serious CDI and 66% for fulminant CDI.

In the study published in the September issue of Clinical Gastroenterology and Hepatology, researchers led by Yao-Wen Cheng, MD, and Monika Fischer, MD, of Indiana University, assessed the effect of FMT on SFCDI after their institution adopted it as a treatment protocol for SFCDI. Patients could receive FMT if there was evidence that their SFCDI was refractory, or if they had two or more CDI recurrences. The treatment includes oral vancomycin and pseudomembrane-driven sequential FMT.

Two hundred five patients were admitted before FMT implementation, 225 after. Fifty patients received FMT because of refractory SFCDI. A median of two FMTs was conducted per patient. 21 other patients received FMT for nonrefractory SFCDI or other conditions, including 18 patients with multiple recurrent CDI.

Thirty-day CDI-related mortality dropped after FMT implementation (4.4% versus 10.2%; P =.02). This was true in both the fulminant subset (9.1% versus 21.3%; P =.015) and the refractory group (12.1% versus 43.2%; P < .001).

The researchers used segmented logistic regression to determine if the improved outcomes could be due to nontreatment factors that varied over time, and found that the difference in CDI-related mortality was eliminated except for refractory SFCDI patients (odds of mortality after FMT implementation, 0.09; P =.023). There was no significant difference between those receiving non-CDI antibiotics (4.8%) and those who did not (6.9%; P =.75).

FMT was associated with lower frequency of CDI-related colectomy overall (2.7% versus 6.8%; P =.041), as well as in the fulminant (5.5% versus 15.7%; P =.017) and refractory subgroups (7.6% versus 31.8%; P =.001).

The findings follow another study that showed improved 3-month mortality for FMT among patients hospitalized with severe CDI (12.1% versus 42.2%; P < .003).

The results underscore the utility of FMT for SFCDI, and suggest it might have the most benefit in refractory SFCDI. The authors believe that FMT should be an alternative to colectomy when first-line anti-CDI antibiotics are partially or completely ineffective. In the absence of FMT, patients who go on to fail vancomycin or fidaxomicin will likely continue to be managed medically, with up to 80% mortality, or through salvage colectomy, with postsurgical morality rates of 30-40%.

Although a randomized trial could answer the question of FMT efficacy more definitively, it is unlikely to be conducted for ethical reasons.

“Further investigation is required to clearly define FMT’s role and timing in the clinical course of severe and fulminant CDI. However, our study suggests that FMT should be offered to patients with severe and fulminant CDI who do not respond to a 5-day course of anti-CDI antibiotics and may be considered in lieu of or before colectomy,” the researchers wrote.

No source of funding was disclosed.

SOURCE: Cheng YW et al. Clin Gastroenterol Hepatol. 2020;18:2234-43. doi: 10.1016/j.cgh.2019.12.029.

There are many challenges facing modern medicine today. Recent events have highlighted important issues affecting our society as a whole – systemic racism, sexism, and implicit bias. In medicine, we have seen a renewed focus on health equity, health disparities and the implicit systemic bias that affect those who work in the field. It is truly troubling that it has taken the continued loss of black lives to police brutality and a pandemic for this conversation to happen at every level in society.

Systemic bias is present throughout corporate America, and it is no different within the physician workforce. Overall, there has been gradual interest in promoting and teaching diversity. Institutions have been slowly creating policies and administrative positions focused on inclusion and diversity over the last decade. So has diversity training objectively increased representation and advancement of women and minority groups? Do traditionally marginalized groups have better access to health? And are women and people of color (POC) represented equally in leadership positions in medicine?

Clearly, the answers are not straightforward.
 

Diving into the data

A guilty pleasure of mine is to assess how diverse and inclusive an institution is by looking at the wall of pictures recognizing top leadership in hospitals. Despite women accounting for 47.9% of graduates from medical school in 2018-2019, I still see very few women or POC elevated to this level. Of the total women graduates, 22.6% were Asian, 8% were Black and 5.4% were Hispanic.

Being of Indian descent, I am a woman of color (albeit one who may not be as profoundly affected by racism in medicine as my less represented colleagues). It is especially rare for me to see someone I can identify with in the ranks of top leadership. I find encouragement in seeing any woman on any leadership board because to me, it means that there is hope. The literature seems to support this degree of disparity as well. For example, a recent analysis shows that presidential leadership in medical societies are predominantly held by men (82.6% male vs. 17.4% female). Other datasets demonstrate that only 15% of deans and interim deans are women and AAMC’s report shows that women account for only 18% of all department chairs.

Growing up, my parents fueled my interest to pursue medicine. They described it as a noble profession that rewarded true merit and dedication to the cause. However, those that have been traditionally elevated in medicine are men. If merit knows no gender, why does a gender gap exist? If merit is blind to race, why are minorities so poorly represented in the workforce (much less in leadership)? My view of the wall leaves me wondering about the role of both sexism and racism in medicine.

These visual representations of the medical culture reinforce the acceptable norms and values – white and masculine – in medicine. The feminist movement over the last several decades has increased awareness about the need for equality of the sexes. However, it was not until the concept of intersectionality was introduced by Black feminist Professor Kimberle Crenshaw, that feminism become a more inclusive term. Professor Crenshaw’s paper details how every individual has intersecting factors – race, gender, sexual identity, socioeconomic status – that create the sum of their experience be it privilege, oppression, or discrimination.

For example, a White woman has privileges that a woman of color does not. Among non-white women, race and sexual identity are confounding factors – a Black woman, a Black LGBTQ woman, and an Asian woman, for example, will not experience discrimination in the same way. The farther you deviate from the accepted norms and values, the harder it is for you to obtain support and achieve recognition.
 

Addressing the patriarchal structure and systemic bias in medicine

Why do patriarchal structures still exist in medicine? How do we resolve systemic bias? Addressing them in isolation – race or gender or sexual identity – is unlikely to create long-lasting change. For change to occur, organizations and individuals need to be intrinsically motivated. Creating awareness and challenging the status quo is the first step.

Over the last decade, implicit bias training and diversity training have become mandatory in various industries and states. Diversity training has grown to be a multi-billion-dollar industry that corporate America has embraced over the last several years. And yet, research shows that mandating such training may not be the most effective. To get results, organizations need to implement programs that “spark engagement, increase contact between different groups and draw on people’s desire to look good to others.”

Historically, the medical curriculum has not included a discourse on feminist theories and the advancement of women in medicine. Cultural competency training is typically offered on an annual basis once we are in the workforce, but in my experience, it focuses more on our interactions with patients and other health care colleagues, and less with regards to our physician peers and leadership. Is this enough to change deep rooted beliefs and traditions?

We can take our cue from non-medical organizations and consider changing this culture of no culture in medicine – introducing diversity task forces that hold departments accountable for recruiting and promoting women and minorities; employing diversity managers; voluntary training; cross-training to increase contact among different groups and mentoring programs that match senior leadership to women and POC. While some medical institutions have implemented some of these principles, changing century-old traditions will require embracing concepts of organizational change and every available effective tool.
 

Committing to change

Change is especially hard when the target outcome is not accurately quantifiable – even if you can measure attitudes, values, and beliefs, these are subject to reporting bias and tokenism. At the organizational level, change management involves employing a systematic approach to change organizational values, goals, policies, and processes.

Individual change, self-reflection, and personal growth are key components in changing culture. Reflexivity is being aware of your own values, norms, position, and power – an important concept to understand and apply in our everyday interactions. Believing that one’s class, gender, race and sexual orientation are irrelevant to their practice of medicine would not foster the change that we direly need in medicine. Rather, identifying how your own values and professional identity are shaped by your medical training, your organization and the broader cultural context are critically important to developing a greater empathic sense to motivate systemic change.

There has been valuable discussion on bottom-up changes to ensure women and POC have support, encouragement and a pathway to advance in an organization. Some of these include policy and process changes including providing flexible working conditions for women and sponsorship of women and minorities to help them navigate the barriers and microaggressions they encounter at work. While technical (policy) changes form the foundation for any organizational change, it is important to remember that the people side of change – the resistance that you encounter for any change effort in an organization – is equally important to address at the organizational level. A top-down approach is also vital to ensure that change is permanent in an organization and does not end when the individuals responsible for the change leave the organization.

Lewin’s three-stage change management model provides a framework for structural and organizational change in hospital systems. The three-stages of this model are: unfreezing, changing, and refreezing. Unfreezing is the process of determining what needs to change and obtaining leadership support. The actual change process involves getting people on board, empowering them to change and communicating with them frequently. Refreezing cements this change into the organization’s culture by providing support and training to sustain changes. Research has shown that Lewin’s change management model has applicability in the hospital setting.

Industry research in change management methodologies in the business sector has identified sponsorship by CEOs/senior management of an organization and having a structured implementation model for change management as two important factors for ensuring that change efforts are successful and sustainable.

This can be extrapolated to health care organizations – top leadership committed to changing the status quo should solidify organizational commitment by incorporating new attainable and measurable goals into their vision for the organization. Designing a phased implementation of change management methodologies should follow an open discussion to identify an organization’s weaknesses, strengths, capacity, and readiness for change. Lastly, helping busy professionals adapt to change requires innovative and continuous improvement strategies using formal, systematic tools for organization-wide strategic deployment.

Without a concrete commitment at the organizational level, programs such as diversity training may end up being band-aids on wounds that run deep.

I believe that the combination of both individual and organizational commitment to change systemic bias in medicine can be quite powerful. One without the other will fail to permanently change the system. The work to true equality – regardless of the intersecting factors of discrimination – starts with a commitment to change. We may all have different opportunities because of the inequality that is apparent in our systems today, but if we unite around the goal of a bias-free, merit-based equality, it gives us the strength we need to overcome challenges that we once thought insurmountable.

Each one of us is a leader in our own right. Speaking up for those with less power or opportunity than us and supporting talent and hard work solidifies medicine as a meritocracy. Even if the magnitude of change that we fight for may not be realized during our time in medical practice, our commitment to eradicate sexism, racism and discrimination will shape the future of medicine.

Just as our children are a legacy that we leave behind, our work in correcting bias in medicine will pave the path for a better future for the doctors of tomorrow. After all, when I think that my young daughter will be affected by what I do or do not do to address the discrimination, there is no better motivation for me to break down every barrier for her success.

Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany Medical College in Albany, NY. This article first appeared on The Hospital Leader, the official blog of SHM.

There are many challenges facing modern medicine today. Recent events have highlighted important issues affecting our society as a whole – systemic racism, sexism, and implicit bias. In medicine, we have seen a renewed focus on health equity, health disparities and the implicit systemic bias that affect those who work in the field. It is truly troubling that it has taken the continued loss of black lives to police brutality and a pandemic for this conversation to happen at every level in society.

Systemic bias is present throughout corporate America, and it is no different within the physician workforce. Overall, there has been gradual interest in promoting and teaching diversity. Institutions have been slowly creating policies and administrative positions focused on inclusion and diversity over the last decade. So has diversity training objectively increased representation and advancement of women and minority groups? Do traditionally marginalized groups have better access to health? And are women and people of color (POC) represented equally in leadership positions in medicine?

Clearly, the answers are not straightforward.
 

Diving into the data

A guilty pleasure of mine is to assess how diverse and inclusive an institution is by looking at the wall of pictures recognizing top leadership in hospitals. Despite women accounting for 47.9% of graduates from medical school in 2018-2019, I still see very few women or POC elevated to this level. Of the total women graduates, 22.6% were Asian, 8% were Black and 5.4% were Hispanic.

Being of Indian descent, I am a woman of color (albeit one who may not be as profoundly affected by racism in medicine as my less represented colleagues). It is especially rare for me to see someone I can identify with in the ranks of top leadership. I find encouragement in seeing any woman on any leadership board because to me, it means that there is hope. The literature seems to support this degree of disparity as well. For example, a recent analysis shows that presidential leadership in medical societies are predominantly held by men (82.6% male vs. 17.4% female). Other datasets demonstrate that only 15% of deans and interim deans are women and AAMC’s report shows that women account for only 18% of all department chairs.

Growing up, my parents fueled my interest to pursue medicine. They described it as a noble profession that rewarded true merit and dedication to the cause. However, those that have been traditionally elevated in medicine are men. If merit knows no gender, why does a gender gap exist? If merit is blind to race, why are minorities so poorly represented in the workforce (much less in leadership)? My view of the wall leaves me wondering about the role of both sexism and racism in medicine.

These visual representations of the medical culture reinforce the acceptable norms and values – white and masculine – in medicine. The feminist movement over the last several decades has increased awareness about the need for equality of the sexes. However, it was not until the concept of intersectionality was introduced by Black feminist Professor Kimberle Crenshaw, that feminism become a more inclusive term. Professor Crenshaw’s paper details how every individual has intersecting factors – race, gender, sexual identity, socioeconomic status – that create the sum of their experience be it privilege, oppression, or discrimination.

For example, a White woman has privileges that a woman of color does not. Among non-white women, race and sexual identity are confounding factors – a Black woman, a Black LGBTQ woman, and an Asian woman, for example, will not experience discrimination in the same way. The farther you deviate from the accepted norms and values, the harder it is for you to obtain support and achieve recognition.
 

Addressing the patriarchal structure and systemic bias in medicine

Why do patriarchal structures still exist in medicine? How do we resolve systemic bias? Addressing them in isolation – race or gender or sexual identity – is unlikely to create long-lasting change. For change to occur, organizations and individuals need to be intrinsically motivated. Creating awareness and challenging the status quo is the first step.

Over the last decade, implicit bias training and diversity training have become mandatory in various industries and states. Diversity training has grown to be a multi-billion-dollar industry that corporate America has embraced over the last several years. And yet, research shows that mandating such training may not be the most effective. To get results, organizations need to implement programs that “spark engagement, increase contact between different groups and draw on people’s desire to look good to others.”

Historically, the medical curriculum has not included a discourse on feminist theories and the advancement of women in medicine. Cultural competency training is typically offered on an annual basis once we are in the workforce, but in my experience, it focuses more on our interactions with patients and other health care colleagues, and less with regards to our physician peers and leadership. Is this enough to change deep rooted beliefs and traditions?

We can take our cue from non-medical organizations and consider changing this culture of no culture in medicine – introducing diversity task forces that hold departments accountable for recruiting and promoting women and minorities; employing diversity managers; voluntary training; cross-training to increase contact among different groups and mentoring programs that match senior leadership to women and POC. While some medical institutions have implemented some of these principles, changing century-old traditions will require embracing concepts of organizational change and every available effective tool.
 

Committing to change

Change is especially hard when the target outcome is not accurately quantifiable – even if you can measure attitudes, values, and beliefs, these are subject to reporting bias and tokenism. At the organizational level, change management involves employing a systematic approach to change organizational values, goals, policies, and processes.

Individual change, self-reflection, and personal growth are key components in changing culture. Reflexivity is being aware of your own values, norms, position, and power – an important concept to understand and apply in our everyday interactions. Believing that one’s class, gender, race and sexual orientation are irrelevant to their practice of medicine would not foster the change that we direly need in medicine. Rather, identifying how your own values and professional identity are shaped by your medical training, your organization and the broader cultural context are critically important to developing a greater empathic sense to motivate systemic change.

There has been valuable discussion on bottom-up changes to ensure women and POC have support, encouragement and a pathway to advance in an organization. Some of these include policy and process changes including providing flexible working conditions for women and sponsorship of women and minorities to help them navigate the barriers and microaggressions they encounter at work. While technical (policy) changes form the foundation for any organizational change, it is important to remember that the people side of change – the resistance that you encounter for any change effort in an organization – is equally important to address at the organizational level. A top-down approach is also vital to ensure that change is permanent in an organization and does not end when the individuals responsible for the change leave the organization.

Lewin’s three-stage change management model provides a framework for structural and organizational change in hospital systems. The three-stages of this model are: unfreezing, changing, and refreezing. Unfreezing is the process of determining what needs to change and obtaining leadership support. The actual change process involves getting people on board, empowering them to change and communicating with them frequently. Refreezing cements this change into the organization’s culture by providing support and training to sustain changes. Research has shown that Lewin’s change management model has applicability in the hospital setting.

Industry research in change management methodologies in the business sector has identified sponsorship by CEOs/senior management of an organization and having a structured implementation model for change management as two important factors for ensuring that change efforts are successful and sustainable.

This can be extrapolated to health care organizations – top leadership committed to changing the status quo should solidify organizational commitment by incorporating new attainable and measurable goals into their vision for the organization. Designing a phased implementation of change management methodologies should follow an open discussion to identify an organization’s weaknesses, strengths, capacity, and readiness for change. Lastly, helping busy professionals adapt to change requires innovative and continuous improvement strategies using formal, systematic tools for organization-wide strategic deployment.

Without a concrete commitment at the organizational level, programs such as diversity training may end up being band-aids on wounds that run deep.

I believe that the combination of both individual and organizational commitment to change systemic bias in medicine can be quite powerful. One without the other will fail to permanently change the system. The work to true equality – regardless of the intersecting factors of discrimination – starts with a commitment to change. We may all have different opportunities because of the inequality that is apparent in our systems today, but if we unite around the goal of a bias-free, merit-based equality, it gives us the strength we need to overcome challenges that we once thought insurmountable.

Each one of us is a leader in our own right. Speaking up for those with less power or opportunity than us and supporting talent and hard work solidifies medicine as a meritocracy. Even if the magnitude of change that we fight for may not be realized during our time in medical practice, our commitment to eradicate sexism, racism and discrimination will shape the future of medicine.

Just as our children are a legacy that we leave behind, our work in correcting bias in medicine will pave the path for a better future for the doctors of tomorrow. After all, when I think that my young daughter will be affected by what I do or do not do to address the discrimination, there is no better motivation for me to break down every barrier for her success.

Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany Medical College in Albany, NY. This article first appeared on The Hospital Leader, the official blog of SHM.

There are many challenges facing modern medicine today. Recent events have highlighted important issues affecting our society as a whole – systemic racism, sexism, and implicit bias. In medicine, we have seen a renewed focus on health equity, health disparities and the implicit systemic bias that affect those who work in the field. It is truly troubling that it has taken the continued loss of black lives to police brutality and a pandemic for this conversation to happen at every level in society.

Systemic bias is present throughout corporate America, and it is no different within the physician workforce. Overall, there has been gradual interest in promoting and teaching diversity. Institutions have been slowly creating policies and administrative positions focused on inclusion and diversity over the last decade. So has diversity training objectively increased representation and advancement of women and minority groups? Do traditionally marginalized groups have better access to health? And are women and people of color (POC) represented equally in leadership positions in medicine?

Clearly, the answers are not straightforward.
 

Diving into the data

A guilty pleasure of mine is to assess how diverse and inclusive an institution is by looking at the wall of pictures recognizing top leadership in hospitals. Despite women accounting for 47.9% of graduates from medical school in 2018-2019, I still see very few women or POC elevated to this level. Of the total women graduates, 22.6% were Asian, 8% were Black and 5.4% were Hispanic.

Being of Indian descent, I am a woman of color (albeit one who may not be as profoundly affected by racism in medicine as my less represented colleagues). It is especially rare for me to see someone I can identify with in the ranks of top leadership. I find encouragement in seeing any woman on any leadership board because to me, it means that there is hope. The literature seems to support this degree of disparity as well. For example, a recent analysis shows that presidential leadership in medical societies are predominantly held by men (82.6% male vs. 17.4% female). Other datasets demonstrate that only 15% of deans and interim deans are women and AAMC’s report shows that women account for only 18% of all department chairs.

Growing up, my parents fueled my interest to pursue medicine. They described it as a noble profession that rewarded true merit and dedication to the cause. However, those that have been traditionally elevated in medicine are men. If merit knows no gender, why does a gender gap exist? If merit is blind to race, why are minorities so poorly represented in the workforce (much less in leadership)? My view of the wall leaves me wondering about the role of both sexism and racism in medicine.

These visual representations of the medical culture reinforce the acceptable norms and values – white and masculine – in medicine. The feminist movement over the last several decades has increased awareness about the need for equality of the sexes. However, it was not until the concept of intersectionality was introduced by Black feminist Professor Kimberle Crenshaw, that feminism become a more inclusive term. Professor Crenshaw’s paper details how every individual has intersecting factors – race, gender, sexual identity, socioeconomic status – that create the sum of their experience be it privilege, oppression, or discrimination.

For example, a White woman has privileges that a woman of color does not. Among non-white women, race and sexual identity are confounding factors – a Black woman, a Black LGBTQ woman, and an Asian woman, for example, will not experience discrimination in the same way. The farther you deviate from the accepted norms and values, the harder it is for you to obtain support and achieve recognition.
 

Addressing the patriarchal structure and systemic bias in medicine

Why do patriarchal structures still exist in medicine? How do we resolve systemic bias? Addressing them in isolation – race or gender or sexual identity – is unlikely to create long-lasting change. For change to occur, organizations and individuals need to be intrinsically motivated. Creating awareness and challenging the status quo is the first step.

Over the last decade, implicit bias training and diversity training have become mandatory in various industries and states. Diversity training has grown to be a multi-billion-dollar industry that corporate America has embraced over the last several years. And yet, research shows that mandating such training may not be the most effective. To get results, organizations need to implement programs that “spark engagement, increase contact between different groups and draw on people’s desire to look good to others.”

Historically, the medical curriculum has not included a discourse on feminist theories and the advancement of women in medicine. Cultural competency training is typically offered on an annual basis once we are in the workforce, but in my experience, it focuses more on our interactions with patients and other health care colleagues, and less with regards to our physician peers and leadership. Is this enough to change deep rooted beliefs and traditions?

We can take our cue from non-medical organizations and consider changing this culture of no culture in medicine – introducing diversity task forces that hold departments accountable for recruiting and promoting women and minorities; employing diversity managers; voluntary training; cross-training to increase contact among different groups and mentoring programs that match senior leadership to women and POC. While some medical institutions have implemented some of these principles, changing century-old traditions will require embracing concepts of organizational change and every available effective tool.
 

Committing to change

Change is especially hard when the target outcome is not accurately quantifiable – even if you can measure attitudes, values, and beliefs, these are subject to reporting bias and tokenism. At the organizational level, change management involves employing a systematic approach to change organizational values, goals, policies, and processes.

Individual change, self-reflection, and personal growth are key components in changing culture. Reflexivity is being aware of your own values, norms, position, and power – an important concept to understand and apply in our everyday interactions. Believing that one’s class, gender, race and sexual orientation are irrelevant to their practice of medicine would not foster the change that we direly need in medicine. Rather, identifying how your own values and professional identity are shaped by your medical training, your organization and the broader cultural context are critically important to developing a greater empathic sense to motivate systemic change.

There has been valuable discussion on bottom-up changes to ensure women and POC have support, encouragement and a pathway to advance in an organization. Some of these include policy and process changes including providing flexible working conditions for women and sponsorship of women and minorities to help them navigate the barriers and microaggressions they encounter at work. While technical (policy) changes form the foundation for any organizational change, it is important to remember that the people side of change – the resistance that you encounter for any change effort in an organization – is equally important to address at the organizational level. A top-down approach is also vital to ensure that change is permanent in an organization and does not end when the individuals responsible for the change leave the organization.

Lewin’s three-stage change management model provides a framework for structural and organizational change in hospital systems. The three-stages of this model are: unfreezing, changing, and refreezing. Unfreezing is the process of determining what needs to change and obtaining leadership support. The actual change process involves getting people on board, empowering them to change and communicating with them frequently. Refreezing cements this change into the organization’s culture by providing support and training to sustain changes. Research has shown that Lewin’s change management model has applicability in the hospital setting.

Industry research in change management methodologies in the business sector has identified sponsorship by CEOs/senior management of an organization and having a structured implementation model for change management as two important factors for ensuring that change efforts are successful and sustainable.

This can be extrapolated to health care organizations – top leadership committed to changing the status quo should solidify organizational commitment by incorporating new attainable and measurable goals into their vision for the organization. Designing a phased implementation of change management methodologies should follow an open discussion to identify an organization’s weaknesses, strengths, capacity, and readiness for change. Lastly, helping busy professionals adapt to change requires innovative and continuous improvement strategies using formal, systematic tools for organization-wide strategic deployment.

Without a concrete commitment at the organizational level, programs such as diversity training may end up being band-aids on wounds that run deep.

I believe that the combination of both individual and organizational commitment to change systemic bias in medicine can be quite powerful. One without the other will fail to permanently change the system. The work to true equality – regardless of the intersecting factors of discrimination – starts with a commitment to change. We may all have different opportunities because of the inequality that is apparent in our systems today, but if we unite around the goal of a bias-free, merit-based equality, it gives us the strength we need to overcome challenges that we once thought insurmountable.

Each one of us is a leader in our own right. Speaking up for those with less power or opportunity than us and supporting talent and hard work solidifies medicine as a meritocracy. Even if the magnitude of change that we fight for may not be realized during our time in medical practice, our commitment to eradicate sexism, racism and discrimination will shape the future of medicine.

Just as our children are a legacy that we leave behind, our work in correcting bias in medicine will pave the path for a better future for the doctors of tomorrow. After all, when I think that my young daughter will be affected by what I do or do not do to address the discrimination, there is no better motivation for me to break down every barrier for her success.

Dr. Kanikkannan is a practicing hospitalist and assistant professor of medicine at Albany Medical College in Albany, NY. This article first appeared on The Hospital Leader, the official blog of SHM.

It has been almost 15 years since the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy established the Task Force on Quality Endoscopy and published the first set of quality indicators for GI endoscopic procedures.

This work was motivated by two seminal reports on patient safety that fostered a demand by the public, policy makers, and payers to accurately define and measure the quality of health care services.

While the Centers for Medicare & Medicaid Services initially designated and required reporting on several basic outcome measures, leaders within the field of gastroenterology recognized the importance of developing evidence-based quality measures for our field, and specifically for endoscopic procedures.

Integrating safety measures into our daily operations has always been important, and over the years, policies have been implemented to incentivize health care providers to meet standards in everything from patient safety to patient satisfaction. With our health care system moving from fee-for-service to value-based care, increased emphasis will continue to be placed on meeting these quality measures.
 

Defining quality and how to measure it

The goals of implementing quality measures within private practices include effective patient care and safety, but they also include issues like access and affordability, as well as the professionalism of your physicians and advanced practice providers.

As a larger practice, we have the resources to support a quality coordinator who spends half their time focused on quality measures. Every provider is required to complete annual education on quality parameters.

We have two committees that propose and track quality initiatives in our practice. We have one on the practice side and one for our ambulatory surgery centers (ASCs). The committees are made of physicians who have a particular interest in quality measures. On the ASC side, our ASC center director from our management partner AmSurg is also a member of the committee.

The road to improving quality within a private practice starts by defining the aspects of care that affect the quality of the patient experience.
 

Tracking quality in the office and in the surgery center

In our practices we have about 60 physicians. Start times and coding accuracy are good examples of what we have tracked in the past as areas of quality improvement. For instance, if only one or two providers get started late, it can cause a domino effect. Schedules get cramped, which can increase stress and possibly cause our team members to rush. Even things that seem like patient satisfaction issues can affect patient care, so it is important to make sure they are being measured.

On the ASC side, we track adenoma detection rates, colonoscopy intervals, complication rates, and many other additional criteria. As an example, when a pathology report is issued, we require our physicians to provide results to our patients within 72 hours.

Data on all providers are tabulated quarterly and then distributed to the providers in the form of a scorecard. The scorecard is then used for constructive feedback on improvements that can be made. A cumulative annual report is given to the providers, which is also incorporated into reviews. Not paying attention to quality measures can potentially have financial ramifications for providers in our group.
 

Find the right fit from a quality standpoint

In terms of what we are tracking, we are probably not that different from most groups of our size. Standardization will continue to increase, and it is important as an early career physician to familiarize yourself with quality measures in gastroenterology.

I often interview early career physicians who would like to join Regional GI, and the most impressive are the young men and women who ask about our processes for tracking quality measures and implementing programs geared toward improvement. If you are thinking of joining a practice, bring it up. You will be glad you did.

The interest in quality shows that you are invested in providing the best evidence-based patient care. As an independent group, this is critical because so much of what we do depends on having a track record of measurement. For instance, an ASC might not be credentialed if the quality metrics do not meet a certain threshold.

We are looking for potential partners who are seriously interested in joining us on our mission to provide the highest-quality care to our patients. After all, that is why became gastroenterologists in the first place.

Dr. Lalani serves as treasurer on the executive committee of the Digestive Health Physicians Association and is a practicing gastroenterologist at U.S. Digestive Health.

It has been almost 15 years since the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy established the Task Force on Quality Endoscopy and published the first set of quality indicators for GI endoscopic procedures.

This work was motivated by two seminal reports on patient safety that fostered a demand by the public, policy makers, and payers to accurately define and measure the quality of health care services.

While the Centers for Medicare & Medicaid Services initially designated and required reporting on several basic outcome measures, leaders within the field of gastroenterology recognized the importance of developing evidence-based quality measures for our field, and specifically for endoscopic procedures.

Integrating safety measures into our daily operations has always been important, and over the years, policies have been implemented to incentivize health care providers to meet standards in everything from patient safety to patient satisfaction. With our health care system moving from fee-for-service to value-based care, increased emphasis will continue to be placed on meeting these quality measures.
 

Defining quality and how to measure it

The goals of implementing quality measures within private practices include effective patient care and safety, but they also include issues like access and affordability, as well as the professionalism of your physicians and advanced practice providers.

As a larger practice, we have the resources to support a quality coordinator who spends half their time focused on quality measures. Every provider is required to complete annual education on quality parameters.

We have two committees that propose and track quality initiatives in our practice. We have one on the practice side and one for our ambulatory surgery centers (ASCs). The committees are made of physicians who have a particular interest in quality measures. On the ASC side, our ASC center director from our management partner AmSurg is also a member of the committee.

The road to improving quality within a private practice starts by defining the aspects of care that affect the quality of the patient experience.
 

Tracking quality in the office and in the surgery center

In our practices we have about 60 physicians. Start times and coding accuracy are good examples of what we have tracked in the past as areas of quality improvement. For instance, if only one or two providers get started late, it can cause a domino effect. Schedules get cramped, which can increase stress and possibly cause our team members to rush. Even things that seem like patient satisfaction issues can affect patient care, so it is important to make sure they are being measured.

On the ASC side, we track adenoma detection rates, colonoscopy intervals, complication rates, and many other additional criteria. As an example, when a pathology report is issued, we require our physicians to provide results to our patients within 72 hours.

Data on all providers are tabulated quarterly and then distributed to the providers in the form of a scorecard. The scorecard is then used for constructive feedback on improvements that can be made. A cumulative annual report is given to the providers, which is also incorporated into reviews. Not paying attention to quality measures can potentially have financial ramifications for providers in our group.
 

Find the right fit from a quality standpoint

In terms of what we are tracking, we are probably not that different from most groups of our size. Standardization will continue to increase, and it is important as an early career physician to familiarize yourself with quality measures in gastroenterology.

I often interview early career physicians who would like to join Regional GI, and the most impressive are the young men and women who ask about our processes for tracking quality measures and implementing programs geared toward improvement. If you are thinking of joining a practice, bring it up. You will be glad you did.

The interest in quality shows that you are invested in providing the best evidence-based patient care. As an independent group, this is critical because so much of what we do depends on having a track record of measurement. For instance, an ASC might not be credentialed if the quality metrics do not meet a certain threshold.

We are looking for potential partners who are seriously interested in joining us on our mission to provide the highest-quality care to our patients. After all, that is why became gastroenterologists in the first place.

Dr. Lalani serves as treasurer on the executive committee of the Digestive Health Physicians Association and is a practicing gastroenterologist at U.S. Digestive Health.

It has been almost 15 years since the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy established the Task Force on Quality Endoscopy and published the first set of quality indicators for GI endoscopic procedures.

This work was motivated by two seminal reports on patient safety that fostered a demand by the public, policy makers, and payers to accurately define and measure the quality of health care services.

While the Centers for Medicare & Medicaid Services initially designated and required reporting on several basic outcome measures, leaders within the field of gastroenterology recognized the importance of developing evidence-based quality measures for our field, and specifically for endoscopic procedures.

Integrating safety measures into our daily operations has always been important, and over the years, policies have been implemented to incentivize health care providers to meet standards in everything from patient safety to patient satisfaction. With our health care system moving from fee-for-service to value-based care, increased emphasis will continue to be placed on meeting these quality measures.
 

Defining quality and how to measure it

The goals of implementing quality measures within private practices include effective patient care and safety, but they also include issues like access and affordability, as well as the professionalism of your physicians and advanced practice providers.

As a larger practice, we have the resources to support a quality coordinator who spends half their time focused on quality measures. Every provider is required to complete annual education on quality parameters.

We have two committees that propose and track quality initiatives in our practice. We have one on the practice side and one for our ambulatory surgery centers (ASCs). The committees are made of physicians who have a particular interest in quality measures. On the ASC side, our ASC center director from our management partner AmSurg is also a member of the committee.

The road to improving quality within a private practice starts by defining the aspects of care that affect the quality of the patient experience.
 

Tracking quality in the office and in the surgery center

In our practices we have about 60 physicians. Start times and coding accuracy are good examples of what we have tracked in the past as areas of quality improvement. For instance, if only one or two providers get started late, it can cause a domino effect. Schedules get cramped, which can increase stress and possibly cause our team members to rush. Even things that seem like patient satisfaction issues can affect patient care, so it is important to make sure they are being measured.

On the ASC side, we track adenoma detection rates, colonoscopy intervals, complication rates, and many other additional criteria. As an example, when a pathology report is issued, we require our physicians to provide results to our patients within 72 hours.

Data on all providers are tabulated quarterly and then distributed to the providers in the form of a scorecard. The scorecard is then used for constructive feedback on improvements that can be made. A cumulative annual report is given to the providers, which is also incorporated into reviews. Not paying attention to quality measures can potentially have financial ramifications for providers in our group.
 

Find the right fit from a quality standpoint

In terms of what we are tracking, we are probably not that different from most groups of our size. Standardization will continue to increase, and it is important as an early career physician to familiarize yourself with quality measures in gastroenterology.

I often interview early career physicians who would like to join Regional GI, and the most impressive are the young men and women who ask about our processes for tracking quality measures and implementing programs geared toward improvement. If you are thinking of joining a practice, bring it up. You will be glad you did.

The interest in quality shows that you are invested in providing the best evidence-based patient care. As an independent group, this is critical because so much of what we do depends on having a track record of measurement. For instance, an ASC might not be credentialed if the quality metrics do not meet a certain threshold.

We are looking for potential partners who are seriously interested in joining us on our mission to provide the highest-quality care to our patients. After all, that is why became gastroenterologists in the first place.

Dr. Lalani serves as treasurer on the executive committee of the Digestive Health Physicians Association and is a practicing gastroenterologist at U.S. Digestive Health.

Each year on Oct. 10, the world takes a moment to commemorate the significance of mental health and its impact on an individual’s life. This year, as we continue to reflect beyond World Mental Health Day, we see the world in a different light. Creating awareness for mental health issues and expanding access to psychiatric services has now become more essential than ever before.

The year 2020 will forever be known as the beginning of the “COVID era” as, unfortunately, the whole world as we know it adapts and reconstructs amid the rise of this global pandemic. This era has brought with it a wave of unemployment, social isolation, economic disaster, death, and disability. It is inevitable that such changes have brought forth perpetual fear and uncertainty, which have taken their toll not only on individuals’ physical health but largely on their mental health as well.

Factors that perpetuate deteriorating mental health include unemployment, poverty, isolation, fear and loss of loved ones – all of which have been further exacerbated globally, thanks to the current pandemic. According to the World Health Organization (WHO), 450 million people in the world suffer from mental illness, and one in four individuals are affected by mental illness in some stage of their lives. This means that mental illness accounts for 13% of the total global burden of disease.

The past few months have been particularly challenging for health care workers around the globe. These challenges include providing care in difficult circumstances, going to work afraid of bringing COVID-19 home, and vulnerability toward becoming mentally and physically ill. An immense sense of responsibility toward patients with mental illness, coupled with continuous fear of becoming infected with this novel virus, has made managing the mental health of our patients all the more challenging.

As a psychiatrist (A.A.M.), I have noticed a massive increase in both the incidence and prevalence of mental illness. Emergency departments are full of patients presenting with suicidal attempts/ideation. Substance abuse has increased in greater magnitude, and outpatients are presenting with escalating numbers of depression and anxiety. Relapse of symptoms among stable patients has been another major problem. Incidents of domestic violence, road rage, and impaired driving secondary to alcoholism leading to psychiatric consultations have also risen drastically.

Mental health units in hospitals are tremendously busy with scarce availability of beds. The increase in waiting times for allocation of beds has also become a major concern globally.

Governments have allocated more funds and are actively attempting to mobilize resources in the developed world. However, adapting to the circumstances has proven to be far more challenging in many regions of the developing world. To avoid personal contacts in health settings, governments have allowed virtual consultations, which has proven to be a highly commendable decision. The use of telephone and video consultations has allowed physicians, particularly psychiatrists, to continue to provide health care to their patients while maintaining social distance. Crisis services have also become far more active, which can help in alleviating mental health emergencies to a great extent.

International crisis is possible

According to the director of the World Federation for Mental Health, citing the report of World Economic Forum, mental health problems could cost the global economy up to $16 trillion between 2010 and 2030, and if this matter is not addressed, it could potentially lead to an international mental health crisis. If the pandemic continues to create such a large impact for a prolonged period of time, the state of mental health globally will continue to be a major concern.

Universal effort is imperative to strengthen the mental health service and increase our ability to provide care for vulnerable individuals. This can be achieved through collaboration with other stakeholders, the allied health sector, the WHO, and the World Bank. The efforts should be directed toward the availability of funds, mobilizing and enhancing resources and training health care and crisis workers. This focus should not only be for developed countries but also for developing countries alike because we are all suffering from the impacts of this global crisis together.

It is important to raise awareness and support one another now more than ever before as we strive to improve and strengthen our mental health on this World Mental Health Day.
 

Dr. Muhammad is clinical professor of psychiatry at McMaster University, Hamilton, Ont. Ms. Amin is a 5th-year MBBS student at St. George’s University Hospital in London.

Each year on Oct. 10, the world takes a moment to commemorate the significance of mental health and its impact on an individual’s life. This year, as we continue to reflect beyond World Mental Health Day, we see the world in a different light. Creating awareness for mental health issues and expanding access to psychiatric services has now become more essential than ever before.

The year 2020 will forever be known as the beginning of the “COVID era” as, unfortunately, the whole world as we know it adapts and reconstructs amid the rise of this global pandemic. This era has brought with it a wave of unemployment, social isolation, economic disaster, death, and disability. It is inevitable that such changes have brought forth perpetual fear and uncertainty, which have taken their toll not only on individuals’ physical health but largely on their mental health as well.

Factors that perpetuate deteriorating mental health include unemployment, poverty, isolation, fear and loss of loved ones – all of which have been further exacerbated globally, thanks to the current pandemic. According to the World Health Organization (WHO), 450 million people in the world suffer from mental illness, and one in four individuals are affected by mental illness in some stage of their lives. This means that mental illness accounts for 13% of the total global burden of disease.

The past few months have been particularly challenging for health care workers around the globe. These challenges include providing care in difficult circumstances, going to work afraid of bringing COVID-19 home, and vulnerability toward becoming mentally and physically ill. An immense sense of responsibility toward patients with mental illness, coupled with continuous fear of becoming infected with this novel virus, has made managing the mental health of our patients all the more challenging.

As a psychiatrist (A.A.M.), I have noticed a massive increase in both the incidence and prevalence of mental illness. Emergency departments are full of patients presenting with suicidal attempts/ideation. Substance abuse has increased in greater magnitude, and outpatients are presenting with escalating numbers of depression and anxiety. Relapse of symptoms among stable patients has been another major problem. Incidents of domestic violence, road rage, and impaired driving secondary to alcoholism leading to psychiatric consultations have also risen drastically.

Mental health units in hospitals are tremendously busy with scarce availability of beds. The increase in waiting times for allocation of beds has also become a major concern globally.

Governments have allocated more funds and are actively attempting to mobilize resources in the developed world. However, adapting to the circumstances has proven to be far more challenging in many regions of the developing world. To avoid personal contacts in health settings, governments have allowed virtual consultations, which has proven to be a highly commendable decision. The use of telephone and video consultations has allowed physicians, particularly psychiatrists, to continue to provide health care to their patients while maintaining social distance. Crisis services have also become far more active, which can help in alleviating mental health emergencies to a great extent.

International crisis is possible

According to the director of the World Federation for Mental Health, citing the report of World Economic Forum, mental health problems could cost the global economy up to $16 trillion between 2010 and 2030, and if this matter is not addressed, it could potentially lead to an international mental health crisis. If the pandemic continues to create such a large impact for a prolonged period of time, the state of mental health globally will continue to be a major concern.

Universal effort is imperative to strengthen the mental health service and increase our ability to provide care for vulnerable individuals. This can be achieved through collaboration with other stakeholders, the allied health sector, the WHO, and the World Bank. The efforts should be directed toward the availability of funds, mobilizing and enhancing resources and training health care and crisis workers. This focus should not only be for developed countries but also for developing countries alike because we are all suffering from the impacts of this global crisis together.

It is important to raise awareness and support one another now more than ever before as we strive to improve and strengthen our mental health on this World Mental Health Day.
 

Dr. Muhammad is clinical professor of psychiatry at McMaster University, Hamilton, Ont. Ms. Amin is a 5th-year MBBS student at St. George’s University Hospital in London.

Each year on Oct. 10, the world takes a moment to commemorate the significance of mental health and its impact on an individual’s life. This year, as we continue to reflect beyond World Mental Health Day, we see the world in a different light. Creating awareness for mental health issues and expanding access to psychiatric services has now become more essential than ever before.

The year 2020 will forever be known as the beginning of the “COVID era” as, unfortunately, the whole world as we know it adapts and reconstructs amid the rise of this global pandemic. This era has brought with it a wave of unemployment, social isolation, economic disaster, death, and disability. It is inevitable that such changes have brought forth perpetual fear and uncertainty, which have taken their toll not only on individuals’ physical health but largely on their mental health as well.

Factors that perpetuate deteriorating mental health include unemployment, poverty, isolation, fear and loss of loved ones – all of which have been further exacerbated globally, thanks to the current pandemic. According to the World Health Organization (WHO), 450 million people in the world suffer from mental illness, and one in four individuals are affected by mental illness in some stage of their lives. This means that mental illness accounts for 13% of the total global burden of disease.

The past few months have been particularly challenging for health care workers around the globe. These challenges include providing care in difficult circumstances, going to work afraid of bringing COVID-19 home, and vulnerability toward becoming mentally and physically ill. An immense sense of responsibility toward patients with mental illness, coupled with continuous fear of becoming infected with this novel virus, has made managing the mental health of our patients all the more challenging.

As a psychiatrist (A.A.M.), I have noticed a massive increase in both the incidence and prevalence of mental illness. Emergency departments are full of patients presenting with suicidal attempts/ideation. Substance abuse has increased in greater magnitude, and outpatients are presenting with escalating numbers of depression and anxiety. Relapse of symptoms among stable patients has been another major problem. Incidents of domestic violence, road rage, and impaired driving secondary to alcoholism leading to psychiatric consultations have also risen drastically.

Mental health units in hospitals are tremendously busy with scarce availability of beds. The increase in waiting times for allocation of beds has also become a major concern globally.

Governments have allocated more funds and are actively attempting to mobilize resources in the developed world. However, adapting to the circumstances has proven to be far more challenging in many regions of the developing world. To avoid personal contacts in health settings, governments have allowed virtual consultations, which has proven to be a highly commendable decision. The use of telephone and video consultations has allowed physicians, particularly psychiatrists, to continue to provide health care to their patients while maintaining social distance. Crisis services have also become far more active, which can help in alleviating mental health emergencies to a great extent.

International crisis is possible

According to the director of the World Federation for Mental Health, citing the report of World Economic Forum, mental health problems could cost the global economy up to $16 trillion between 2010 and 2030, and if this matter is not addressed, it could potentially lead to an international mental health crisis. If the pandemic continues to create such a large impact for a prolonged period of time, the state of mental health globally will continue to be a major concern.

Universal effort is imperative to strengthen the mental health service and increase our ability to provide care for vulnerable individuals. This can be achieved through collaboration with other stakeholders, the allied health sector, the WHO, and the World Bank. The efforts should be directed toward the availability of funds, mobilizing and enhancing resources and training health care and crisis workers. This focus should not only be for developed countries but also for developing countries alike because we are all suffering from the impacts of this global crisis together.

It is important to raise awareness and support one another now more than ever before as we strive to improve and strengthen our mental health on this World Mental Health Day.
 

Dr. Muhammad is clinical professor of psychiatry at McMaster University, Hamilton, Ont. Ms. Amin is a 5th-year MBBS student at St. George’s University Hospital in London.

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.
 

In older men, circulating levels of dihydrotestosterone (DHT) and sex hormone–binding globulin (SHBG) independently predict risk of hip fracture, but testosterone does not, according to a study involving more than 1,000 men.

iStock/Thinkstock

These findings could influence clinical measurement of male hormone levels and possibly intervention for low DHT, reported lead author Emily A. Rosenberg, MD, of Brigham and Women’s Hospital in Boston and colleagues.

“Male aging is associated with a decrease in serum sex hormones, and this decline has been shown to influence bone health, although the links between androgen levels in men and bone mineral density and fracture risk remain an ongoing source of debate,” the investigators wrote in Metabolism.

According to Dr. Rosenberg and colleagues, most previous studies in this area have focused on total or bioavailable testosterone; however, DHT demonstrates greater affinity with and slower dissociation from the androgen receptor, which could translate to a more significant role in bone metabolism. With the advent of mass spectrometry–based DHT assays, it is now possible to accurately measure small concentrations of DHT in blood, they added.

Their prospective, multicenter, cohort study involved 1,128 men who were 65 years or older and without history of cardiovascular disease. Beginning in 1989-1990, participants underwent a baseline examination that included standardized medical history questionnaires, physical exam, and laboratory testing. Additional participants joined the study in 1992-1993, and in 1994-1995, a subset of participants (n = 439) underwent dual-energy x-ray absorptiometry (DXA) scanning.

Hormone assays were conducted in 2010 using frozen serum samples from 1994-1995. Testosterone and DHT were measured by liquid chromatography–tandem mass spectrometry assay, while SHBG was measured by fluoroimmunoassay.

The primary outcome, incident hip fracture, was identified from medical records through 2013. Secondary outcomes included lean body mass and bone mineral density of the hip. A variety of covariates were also recorded, including age, sex, weight, alcohol consumption, smoking status, and others.

After a median follow-up of 10.2 years (interquartile range, 5.9-15.5 years), 106 cases of hip fracture occurred, which translated to an incidence rate of 0.89 per 100 person-years. Cox regression models mutually adjusted for covariates, and the other analyses showed that each standard deviation increase in DHT correlated with a 26% decreased risk of hip fracture (adjusted hazard ratio, 0.74; 95% confidence interval, 0.55-1.00; P = .049). Conversely, each standard deviation increase in SBHG was associated with a 26% increased risk of hip fracture (aHR, 1.26; 95% CI, 1.01-1.58; P = .045). In contrast with both DHT and SBHG, testosterone was not significantly associated with the primary outcome (aHR, 1.16; 95% CI, 0.86-1.56; P = .324).

Further analysis showed that testosterone, DHT, and SBHG were not significantly associated with bone mineral density of the hip. In adjusted models, testosterone and DHT were independently associated with higher lean body mass; however, in mutually adjusted models, these associations were not statistically significant, although they remained similar and positive.

“More research is needed to determine the mechanism(s) by which DHT may affect bone health and whether interventions that regulate DHT might be used to reduce risk of hip fracture,” the investigators concluded. “While our results require confirmation, there may be a role for measurement of DHT along with testosterone when the clinical scenario requires measurement of male hormone levels.”

The study was funded by the National Heart, Lung and Blood Institute and the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Rosenberg EA et al. Metabolism. 2020 Oct 12. doi: 10.1016/j.metabol.2020.154399.