The broad picture of interstitial cystitis

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Tue, 08/28/2018 - 10:16

 

Interstitial cystitis (IC) is a controversial diagnosis that has become muddied and oversimplified. It was originally described as a distinct ulcer (Hunner’s lesion) seen in the bladder on cystoscopy, the treatment of which often led to symptomatic relief. Hunner’s lesion IC is the “classic” form of IC and should be considered a separate disease; it is not a progression of nonulcerative interstitial cystitis/painful bladder syndrome (IC/BPS).

Only a fraction of patients with the key symptoms of IC/BPS – urinary frequency, urgency, and pelvic pain – have ulcers within the bladder. And many of the patients who are diagnosed with IC/BPS are found not to have bladder pathology as the name implies, but rather pelvic floor dysfunction. That the bladder is often an innocent bystander to a larger process means that, as clinicians, we must be thoughtful and astute about our diagnostic process.

Hunner’s lesions

Patients with Hunner’s lesions have a rapid onset of symptoms, typically are older, and have a visible lesion in their bladder that almost always is on the dome or lateral walls. The lesion is often erythematous with central vascularity and mucosal sloughing.

Courtesy Beaumont Urology
The image shows a Hunner's lesion with erythema and central vascularity.

The bladder is a storage organ and urine is toxic. The exposed ulcer results in severe pain with bladder filling and also pain at the end of voiding as the bladder collapses, causing ulcerated tissue to come into contact with other sections of the bladder wall and sending a “jolt” of pain through the pelvis.

If the initial cystoscopy demonstrates inflammatory-appearing lesions or ulcerations suggestive of Hunner’s lesions, I will still do a hydrodistension. By stretching the bladder, the lesions typically expand, crack, and bleed. This helps define the entire diseased area and shows what areas of the bladder need to be cauterized to seal the ulcers and destroy the exposed nerve endings. If this is a new diagnosis, the lesion should be biopsied after the hydrodistension to rule out carcinoma.

Hunner’s lesions can lead to rapid disease progression due to chronic inflammation and subsequent collagen deposition and scarring. Even on initial diagnosis of Hunner’s lesions, a capacity of 350 cc or less (compared with 1,100 cc in a normal bladder) on hydrodistension under anesthesia is not uncommon. This markedly reduced bladder capacity may lead to end-stage bladder impacting the kidneys and requiring a urinary diversion.

Eradicating the ulcers with resection or cautery often results in marked and immediate improvement in bladder pain, albeit not long-lasting. I will typically place a resectoscope and use a roller ball at 25 watts of current. The entire ulcerated areas are cauterized by rapidly rolling the ball over the area of inflammation and avoiding a deep thermal burn. The goal is to seal the ulcer and destroy the exposed nerve endings so that urine can no longer act as an irritant. Recurrence in 6 months to 1 year is common and retreatment is almost always necessary. We have demonstrated, however, that recurrent cautery of ulcers does not lead to smaller anesthetic bladder capacities (Urology. 2015 Jan;85[1]:74-8).

Low-dose cyclosporine can be very effective at reducing Hunner’s lesion recurrence and improving storage symptoms (Exp Ther Med. 2016 Jul;12[1]:445-50). I use 100 mg twice a day for a month and then 1 pill a day thereafter. This is a relatively low dose, but hypertension can be a side effect and blood pressure should be monitored along with routine labs.

The broader picture

Hunner’s lesion IC is pretty straightforward and clearly a bladder disease. However, in recent years the term IC/BPS has been broadly used to describe women who have symptoms of pelvic pain, urinary urgency, and frequency, but no true bladder pathology to explain their symptoms. One problem: There is no definitive diagnostic test or evidence-based diagnostic process for IC/BPS. In fact, the diagnosis section of the American Urological Association guideline on diagnosis and treatment of IC/BPS, last updated in 2015, is almost entirely consensus-based (J Urol. 2015 May;193[5]:1545-53). It largely remains a diagnosis of exclusion.

As the AUA guidelines state, a careful history, physical examination, and laboratory assessment are all important for documenting symptoms and signs and ruling out significant causes of the symptoms. I frequently see patients who have been diagnosed with IC who have frequency and urgency but no pain (in which case overactive bladder should be considered) or who have pelvic pain but no bladder symptoms, again likely not IC. Pain that worsens with bladder filling and improves after bladder emptying is typical of IC/BPS. This finding in the absence of other confusing symptoms supports the diagnosis of IC/BPS.

It has become too easy for the average clinician to apply a label of IC/BPS to a patient complaining of pelvic pain; this often results in the patient undergoing invasive and nonhelpful therapies such as cystoscopy, hydrodistension, urodynamics, bladder instillations, and other bladder-directed therapies.

More than 20 years of research supported by the National Institutes of Health and industry have failed to show that bladder-directed therapy is superior to placebo. This fact suggests that the bladder may be an innocent bystander in a larger pelvic process. As clinicians, we must be willing to look beyond the bladder and examine for pelvic floor issues and other causes of patient’s symptoms and not be too quick to begin bladder-focused treatments.

A number of disease processes – such as recurrent urinary tract infection, urethral diverticulum, endometriosis, and pudendal neuropathy – can mimic the symptoms of IC/BPS. The most common missed diagnosis in the IC patient is pelvic floor dysfunction that results in a hypertonic contracted state of the levator muscles – a chronic spasm, in essence – that in turn leads to decreased muscle function, increased myofascial pain, and myofascial trigger points (Curr Urol Rep. 2006 Nov;7[6]:450-5).

We and others have reported that up to 85% of patients labeled with IC/BPS have been found on examination to have pelvic floor dysfunction or a diffuse pelvic floor hypersensitivity. The pelvic floor is important in maintaining healthy bladder, bowel, and sexual function. If the pelvic floor is in spasm, this can result in urinary frequency, hesitancy, and pelvic pain.

Many of these patients with contracted pelvic floor muscles report pain with sexual intercourse – often so severe as to cause abstention. In fact, when patients answer no to the question of whether they have pain with intercourse, I know it is unlikely that they have significant pelvic floor dysfunction. This is a key question for history taking.

Other key questions concern the impact of stress on symptoms and a history of any type of abuse. In a study we conducted about 10 years ago, we found that among 76 women who were diagnosed with IC and subsequently evaluated in our clinic, almost half (49%) reported abuse (emotional, physical, and/or sexual). The vast majority (85%) had levator pain (J Urol. 2007 Sep;178[3 Pt 1]:891-5).

Other types of stress – from past surgeries to traumatic life events – may similarly serve as triggers or precursors to pelvic floor dysfunction in some women. I often tell patients that people put stress in different areas of their bodies. While some get tension headaches or low-back aches, others get pelvic pain from contracting and guarding the levator muscles.

 

 

Pelvic floor dysfunction

The most important component of the physical exam in patients with the symptoms of frequency, urgency, and pelvic pain – and the most overlooked – is assessment of the levator muscles for tightness and tenderness. Levator pain and trigger points may be identified during the pelvic exam by pressing laterally on the levator complex in each quadrant of the vagina and at the ischial spines. The tension of the muscles and severity of pain should be assessed, and it is helpful to ask the patient if the pain reproduces her normal pelvic pain symptoms.

Courtesy Beaumont Urology
Transvaginal trigger point injections can serve as a helpful adjunct to pelvic floor physical therapy.

We’ve found that identifying and treating pelvic floor dysfunction with modalities such as pelvic floor physical therapy with intravaginal myofascial release, intravaginal valium, trigger point injections into the levator complex, pudendal nerve blocks, and neuromodulation can frequently resolve or significantly lessen the patient’s pain and bladder symptoms, suggesting that the diagnosis of IC/BPS was wrong.

Courtesy Beaumont Urology
Transvaginal trigger point injections can serve as a helpful adjunct to pelvic floor physical therapy.


Pelvic floor physical therapy works to stretch the contracted anterior pelvic muscles by releasing trigger points and connective tissue restrictions, and by decreasing periurethral tension; it also may decrease neurogenic triggers and central nervous system sensitivity. Kegel exercises will worsen pain in these patients and should be avoided.

When pelvic floor dysfunction is identified, such treatment by a therapist knowledgeable in intravaginal myofascial release is a next reasonable step before any medications or invasive testing, such as bladder hydrodistension, are used.

One of the only National Institutes of Health–funded studies to show benefit of a treatment in an IC population, in fact, was a multicenter randomized controlled trial comparing 10 sessions of myofascial pelvic floor physical therapy with “global therapeutic massage.” Myofascial physical therapy led to significant improvement, compared with the generalized spa-like massage (J Urol. 2012 Jun;187[6]:2113-8).

Dr. Kenneth M. Peters
In our practice, we often use intravaginal valium, transvaginal trigger point injections, and pudendal nerve blocks as an adjunct to physical therapy. It is not uncommon for a therapist to report to us that progress in therapy is being stymied by pain in a particular area; in such cases a trigger point injection in the office with local anesthetic and sometimes corticosteroids will help the muscle relax enough and provide enough pain relief so that physical therapy can move forward successfully.

Our patients with IC/BPS symptoms and pelvic floor dysfunction require 1-2 visits weekly for an average of 12 weeks for tightness and tenderness to be significantly minimized or eliminated. Patients are also prescribed home stretching exercises and advised to use internal vaginal dilators. Most patients will report resolution of their pelvic pain, sexual pain, and bladder symptoms – especially with the combination of physical therapy and trigger point injections. In more severe cases, we may use sacral or pudendal neuromodulation to improve the frequency, urgency and pelvic pain.

Turning to the bladder

When urinary symptoms persist after the completion of pelvic floor therapy, or when pelvic floor dysfunction is not identified in the first place, we proceed with bladder-specific therapies. I will often suggest trials of amitriptyline or hydroxyzine, for instance, and/or changes in hydration and caffeine consumption. I am not a fan of pentosan polysulfate sodium (Elmiron) as it is a very expensive medication that has minimal benefit for the majority of patients.

When conservative therapies do not work, I move to cystoscopy with hydrodistension. The procedure can serve several purposes. It can be diagnostic, enabling us to rule out other potential symptom-causing pathologies, and it can be prognostic, helping us to understand when bladder capacity is severely reduced and to plan treatment. In some patients, it can even be therapeutic. Some of my patients have significant relief of symptoms from a hydrodistension of the bladder once or twice a year.

There is no standard method for performing a hydrodistension. I perform a complete cystoscopy to look for tumors, stones, diverticulum or Hunner’s lesions and, if the bladder is normal in appearance, I proceed with a 2-minute hydrodistension at 80-100 cm of water pressure under anesthesia. The bag is raised above the bladder, allowing the bladder to fill with the force of gravity and the pressures to equalize. The urethra must be compressed so that water doesn’t leak around the cystoscope. After 2 minutes of hydrodistension, the bladder is drained, volume is measured, and the procedure is repeated.

After the hydrodistension, the bladder is reinspected to be certain there is no bladder perforation and to evaluate for diffuse glomerulations (petechial hemorrhages) that are suggestive, but not diagnostic, of IC/BPS.

 

 

A holistic approach

Managing patients with voiding dysfunction and chronic pelvic pain can be a challenge, and a multidisciplinary approach is most effective. At Beaumont, we have a Women’s Urology Center that includes urologists, gynecologists, nurse practitioners, pelvic floor physical therapists, pain psychologists, colorectal specialists, sex therapists, and naturopathic and integrative medicine specialists who perform acupuncture, Reiki therapy, medical massage, and guided imagery.

The goal is to break out of our box of specialties and look at the whole patient – mind, body, and soul – while identifying pain triggers and directing therapy toward these triggers using a multidisciplinary, collaborative approach. For us, this approach has been very effective for managing complex pelvic pain issues (Transl Androl Urol. 2015 Dec;4[6]:611-9).

Ongoing studies

A number of research studies are ongoing to help treat the symptoms of IC/BPS. We currently have a Department of Defense grant to prospectively assess bladder-directed therapy (instillations) compared to pelvic floor physical therapy. Patients diagnosed with IC/BPS are being randomized into these two treatment arms and we hope to get a better understanding of the role of these modalities in managing IC/BPS.

Allergan is completing a phase II placebo-controlled trial using a lidocaine delivery device that is placed in the bladder and continuously releases lidocaine over 14 days. The LiNKA trial is designed to assess the impact of lidocaine on not only improving bladder symptoms, but also eradicating Hunner’s lesions through the anti-inflammatory effect of lidocaine. Early open-label data were very promising. In addition, a new medication for IC/BPS that modulates the SHIP1 pathway is being studied by Aquinox Pharmaceuticals. The agent, AQX-1125, is an activator of SHIP1, which controls the phosphoinositide 3-kinase (PI3K) cellular signaling pathway. If the PI3K pathway is overactive, immune cells can produce an abundance of proinflammatory signaling molecules and migrate to and concentrate in tissues, resulting in excessive or chronic inflammation. Early data in IC/BPS patients were supportive of the compound’s potential for reducing the pain associated with this condition.
 

A note from Charles E. Miller, MD, Master Class Medical Editor:

In a double-blind, placebo-controlled study by J.C. Nickel, et al., pentosan polysulfate sodium was shown to improve pain, urgency, and frequency over the control group (Urology. 2005 Apr;65[4]:654-8). Also, longer duration of treatment with pentosan polysulfate sodium was associated with greater response rates – 50% improved by 26 weeks (J Urol. 2005 Dec;174[6]:2235-8).
 

Dr. Peters is professor and chairman of urology at Oakland University William Beaumont School of Medicine, Royal Oak, Mich. He reported serving as a consultant for Taris, Medtronic, StimGuard, and Amphora Medical.

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Interstitial cystitis (IC) is a controversial diagnosis that has become muddied and oversimplified. It was originally described as a distinct ulcer (Hunner’s lesion) seen in the bladder on cystoscopy, the treatment of which often led to symptomatic relief. Hunner’s lesion IC is the “classic” form of IC and should be considered a separate disease; it is not a progression of nonulcerative interstitial cystitis/painful bladder syndrome (IC/BPS).

Only a fraction of patients with the key symptoms of IC/BPS – urinary frequency, urgency, and pelvic pain – have ulcers within the bladder. And many of the patients who are diagnosed with IC/BPS are found not to have bladder pathology as the name implies, but rather pelvic floor dysfunction. That the bladder is often an innocent bystander to a larger process means that, as clinicians, we must be thoughtful and astute about our diagnostic process.

Hunner’s lesions

Patients with Hunner’s lesions have a rapid onset of symptoms, typically are older, and have a visible lesion in their bladder that almost always is on the dome or lateral walls. The lesion is often erythematous with central vascularity and mucosal sloughing.

Courtesy Beaumont Urology
The image shows a Hunner's lesion with erythema and central vascularity.

The bladder is a storage organ and urine is toxic. The exposed ulcer results in severe pain with bladder filling and also pain at the end of voiding as the bladder collapses, causing ulcerated tissue to come into contact with other sections of the bladder wall and sending a “jolt” of pain through the pelvis.

If the initial cystoscopy demonstrates inflammatory-appearing lesions or ulcerations suggestive of Hunner’s lesions, I will still do a hydrodistension. By stretching the bladder, the lesions typically expand, crack, and bleed. This helps define the entire diseased area and shows what areas of the bladder need to be cauterized to seal the ulcers and destroy the exposed nerve endings. If this is a new diagnosis, the lesion should be biopsied after the hydrodistension to rule out carcinoma.

Hunner’s lesions can lead to rapid disease progression due to chronic inflammation and subsequent collagen deposition and scarring. Even on initial diagnosis of Hunner’s lesions, a capacity of 350 cc or less (compared with 1,100 cc in a normal bladder) on hydrodistension under anesthesia is not uncommon. This markedly reduced bladder capacity may lead to end-stage bladder impacting the kidneys and requiring a urinary diversion.

Eradicating the ulcers with resection or cautery often results in marked and immediate improvement in bladder pain, albeit not long-lasting. I will typically place a resectoscope and use a roller ball at 25 watts of current. The entire ulcerated areas are cauterized by rapidly rolling the ball over the area of inflammation and avoiding a deep thermal burn. The goal is to seal the ulcer and destroy the exposed nerve endings so that urine can no longer act as an irritant. Recurrence in 6 months to 1 year is common and retreatment is almost always necessary. We have demonstrated, however, that recurrent cautery of ulcers does not lead to smaller anesthetic bladder capacities (Urology. 2015 Jan;85[1]:74-8).

Low-dose cyclosporine can be very effective at reducing Hunner’s lesion recurrence and improving storage symptoms (Exp Ther Med. 2016 Jul;12[1]:445-50). I use 100 mg twice a day for a month and then 1 pill a day thereafter. This is a relatively low dose, but hypertension can be a side effect and blood pressure should be monitored along with routine labs.

The broader picture

Hunner’s lesion IC is pretty straightforward and clearly a bladder disease. However, in recent years the term IC/BPS has been broadly used to describe women who have symptoms of pelvic pain, urinary urgency, and frequency, but no true bladder pathology to explain their symptoms. One problem: There is no definitive diagnostic test or evidence-based diagnostic process for IC/BPS. In fact, the diagnosis section of the American Urological Association guideline on diagnosis and treatment of IC/BPS, last updated in 2015, is almost entirely consensus-based (J Urol. 2015 May;193[5]:1545-53). It largely remains a diagnosis of exclusion.

As the AUA guidelines state, a careful history, physical examination, and laboratory assessment are all important for documenting symptoms and signs and ruling out significant causes of the symptoms. I frequently see patients who have been diagnosed with IC who have frequency and urgency but no pain (in which case overactive bladder should be considered) or who have pelvic pain but no bladder symptoms, again likely not IC. Pain that worsens with bladder filling and improves after bladder emptying is typical of IC/BPS. This finding in the absence of other confusing symptoms supports the diagnosis of IC/BPS.

It has become too easy for the average clinician to apply a label of IC/BPS to a patient complaining of pelvic pain; this often results in the patient undergoing invasive and nonhelpful therapies such as cystoscopy, hydrodistension, urodynamics, bladder instillations, and other bladder-directed therapies.

More than 20 years of research supported by the National Institutes of Health and industry have failed to show that bladder-directed therapy is superior to placebo. This fact suggests that the bladder may be an innocent bystander in a larger pelvic process. As clinicians, we must be willing to look beyond the bladder and examine for pelvic floor issues and other causes of patient’s symptoms and not be too quick to begin bladder-focused treatments.

A number of disease processes – such as recurrent urinary tract infection, urethral diverticulum, endometriosis, and pudendal neuropathy – can mimic the symptoms of IC/BPS. The most common missed diagnosis in the IC patient is pelvic floor dysfunction that results in a hypertonic contracted state of the levator muscles – a chronic spasm, in essence – that in turn leads to decreased muscle function, increased myofascial pain, and myofascial trigger points (Curr Urol Rep. 2006 Nov;7[6]:450-5).

We and others have reported that up to 85% of patients labeled with IC/BPS have been found on examination to have pelvic floor dysfunction or a diffuse pelvic floor hypersensitivity. The pelvic floor is important in maintaining healthy bladder, bowel, and sexual function. If the pelvic floor is in spasm, this can result in urinary frequency, hesitancy, and pelvic pain.

Many of these patients with contracted pelvic floor muscles report pain with sexual intercourse – often so severe as to cause abstention. In fact, when patients answer no to the question of whether they have pain with intercourse, I know it is unlikely that they have significant pelvic floor dysfunction. This is a key question for history taking.

Other key questions concern the impact of stress on symptoms and a history of any type of abuse. In a study we conducted about 10 years ago, we found that among 76 women who were diagnosed with IC and subsequently evaluated in our clinic, almost half (49%) reported abuse (emotional, physical, and/or sexual). The vast majority (85%) had levator pain (J Urol. 2007 Sep;178[3 Pt 1]:891-5).

Other types of stress – from past surgeries to traumatic life events – may similarly serve as triggers or precursors to pelvic floor dysfunction in some women. I often tell patients that people put stress in different areas of their bodies. While some get tension headaches or low-back aches, others get pelvic pain from contracting and guarding the levator muscles.

 

 

Pelvic floor dysfunction

The most important component of the physical exam in patients with the symptoms of frequency, urgency, and pelvic pain – and the most overlooked – is assessment of the levator muscles for tightness and tenderness. Levator pain and trigger points may be identified during the pelvic exam by pressing laterally on the levator complex in each quadrant of the vagina and at the ischial spines. The tension of the muscles and severity of pain should be assessed, and it is helpful to ask the patient if the pain reproduces her normal pelvic pain symptoms.

Courtesy Beaumont Urology
Transvaginal trigger point injections can serve as a helpful adjunct to pelvic floor physical therapy.

We’ve found that identifying and treating pelvic floor dysfunction with modalities such as pelvic floor physical therapy with intravaginal myofascial release, intravaginal valium, trigger point injections into the levator complex, pudendal nerve blocks, and neuromodulation can frequently resolve or significantly lessen the patient’s pain and bladder symptoms, suggesting that the diagnosis of IC/BPS was wrong.

Courtesy Beaumont Urology
Transvaginal trigger point injections can serve as a helpful adjunct to pelvic floor physical therapy.


Pelvic floor physical therapy works to stretch the contracted anterior pelvic muscles by releasing trigger points and connective tissue restrictions, and by decreasing periurethral tension; it also may decrease neurogenic triggers and central nervous system sensitivity. Kegel exercises will worsen pain in these patients and should be avoided.

When pelvic floor dysfunction is identified, such treatment by a therapist knowledgeable in intravaginal myofascial release is a next reasonable step before any medications or invasive testing, such as bladder hydrodistension, are used.

One of the only National Institutes of Health–funded studies to show benefit of a treatment in an IC population, in fact, was a multicenter randomized controlled trial comparing 10 sessions of myofascial pelvic floor physical therapy with “global therapeutic massage.” Myofascial physical therapy led to significant improvement, compared with the generalized spa-like massage (J Urol. 2012 Jun;187[6]:2113-8).

Dr. Kenneth M. Peters
In our practice, we often use intravaginal valium, transvaginal trigger point injections, and pudendal nerve blocks as an adjunct to physical therapy. It is not uncommon for a therapist to report to us that progress in therapy is being stymied by pain in a particular area; in such cases a trigger point injection in the office with local anesthetic and sometimes corticosteroids will help the muscle relax enough and provide enough pain relief so that physical therapy can move forward successfully.

Our patients with IC/BPS symptoms and pelvic floor dysfunction require 1-2 visits weekly for an average of 12 weeks for tightness and tenderness to be significantly minimized or eliminated. Patients are also prescribed home stretching exercises and advised to use internal vaginal dilators. Most patients will report resolution of their pelvic pain, sexual pain, and bladder symptoms – especially with the combination of physical therapy and trigger point injections. In more severe cases, we may use sacral or pudendal neuromodulation to improve the frequency, urgency and pelvic pain.

Turning to the bladder

When urinary symptoms persist after the completion of pelvic floor therapy, or when pelvic floor dysfunction is not identified in the first place, we proceed with bladder-specific therapies. I will often suggest trials of amitriptyline or hydroxyzine, for instance, and/or changes in hydration and caffeine consumption. I am not a fan of pentosan polysulfate sodium (Elmiron) as it is a very expensive medication that has minimal benefit for the majority of patients.

When conservative therapies do not work, I move to cystoscopy with hydrodistension. The procedure can serve several purposes. It can be diagnostic, enabling us to rule out other potential symptom-causing pathologies, and it can be prognostic, helping us to understand when bladder capacity is severely reduced and to plan treatment. In some patients, it can even be therapeutic. Some of my patients have significant relief of symptoms from a hydrodistension of the bladder once or twice a year.

There is no standard method for performing a hydrodistension. I perform a complete cystoscopy to look for tumors, stones, diverticulum or Hunner’s lesions and, if the bladder is normal in appearance, I proceed with a 2-minute hydrodistension at 80-100 cm of water pressure under anesthesia. The bag is raised above the bladder, allowing the bladder to fill with the force of gravity and the pressures to equalize. The urethra must be compressed so that water doesn’t leak around the cystoscope. After 2 minutes of hydrodistension, the bladder is drained, volume is measured, and the procedure is repeated.

After the hydrodistension, the bladder is reinspected to be certain there is no bladder perforation and to evaluate for diffuse glomerulations (petechial hemorrhages) that are suggestive, but not diagnostic, of IC/BPS.

 

 

A holistic approach

Managing patients with voiding dysfunction and chronic pelvic pain can be a challenge, and a multidisciplinary approach is most effective. At Beaumont, we have a Women’s Urology Center that includes urologists, gynecologists, nurse practitioners, pelvic floor physical therapists, pain psychologists, colorectal specialists, sex therapists, and naturopathic and integrative medicine specialists who perform acupuncture, Reiki therapy, medical massage, and guided imagery.

The goal is to break out of our box of specialties and look at the whole patient – mind, body, and soul – while identifying pain triggers and directing therapy toward these triggers using a multidisciplinary, collaborative approach. For us, this approach has been very effective for managing complex pelvic pain issues (Transl Androl Urol. 2015 Dec;4[6]:611-9).

Ongoing studies

A number of research studies are ongoing to help treat the symptoms of IC/BPS. We currently have a Department of Defense grant to prospectively assess bladder-directed therapy (instillations) compared to pelvic floor physical therapy. Patients diagnosed with IC/BPS are being randomized into these two treatment arms and we hope to get a better understanding of the role of these modalities in managing IC/BPS.

Allergan is completing a phase II placebo-controlled trial using a lidocaine delivery device that is placed in the bladder and continuously releases lidocaine over 14 days. The LiNKA trial is designed to assess the impact of lidocaine on not only improving bladder symptoms, but also eradicating Hunner’s lesions through the anti-inflammatory effect of lidocaine. Early open-label data were very promising. In addition, a new medication for IC/BPS that modulates the SHIP1 pathway is being studied by Aquinox Pharmaceuticals. The agent, AQX-1125, is an activator of SHIP1, which controls the phosphoinositide 3-kinase (PI3K) cellular signaling pathway. If the PI3K pathway is overactive, immune cells can produce an abundance of proinflammatory signaling molecules and migrate to and concentrate in tissues, resulting in excessive or chronic inflammation. Early data in IC/BPS patients were supportive of the compound’s potential for reducing the pain associated with this condition.
 

A note from Charles E. Miller, MD, Master Class Medical Editor:

In a double-blind, placebo-controlled study by J.C. Nickel, et al., pentosan polysulfate sodium was shown to improve pain, urgency, and frequency over the control group (Urology. 2005 Apr;65[4]:654-8). Also, longer duration of treatment with pentosan polysulfate sodium was associated with greater response rates – 50% improved by 26 weeks (J Urol. 2005 Dec;174[6]:2235-8).
 

Dr. Peters is professor and chairman of urology at Oakland University William Beaumont School of Medicine, Royal Oak, Mich. He reported serving as a consultant for Taris, Medtronic, StimGuard, and Amphora Medical.

 

Interstitial cystitis (IC) is a controversial diagnosis that has become muddied and oversimplified. It was originally described as a distinct ulcer (Hunner’s lesion) seen in the bladder on cystoscopy, the treatment of which often led to symptomatic relief. Hunner’s lesion IC is the “classic” form of IC and should be considered a separate disease; it is not a progression of nonulcerative interstitial cystitis/painful bladder syndrome (IC/BPS).

Only a fraction of patients with the key symptoms of IC/BPS – urinary frequency, urgency, and pelvic pain – have ulcers within the bladder. And many of the patients who are diagnosed with IC/BPS are found not to have bladder pathology as the name implies, but rather pelvic floor dysfunction. That the bladder is often an innocent bystander to a larger process means that, as clinicians, we must be thoughtful and astute about our diagnostic process.

Hunner’s lesions

Patients with Hunner’s lesions have a rapid onset of symptoms, typically are older, and have a visible lesion in their bladder that almost always is on the dome or lateral walls. The lesion is often erythematous with central vascularity and mucosal sloughing.

Courtesy Beaumont Urology
The image shows a Hunner's lesion with erythema and central vascularity.

The bladder is a storage organ and urine is toxic. The exposed ulcer results in severe pain with bladder filling and also pain at the end of voiding as the bladder collapses, causing ulcerated tissue to come into contact with other sections of the bladder wall and sending a “jolt” of pain through the pelvis.

If the initial cystoscopy demonstrates inflammatory-appearing lesions or ulcerations suggestive of Hunner’s lesions, I will still do a hydrodistension. By stretching the bladder, the lesions typically expand, crack, and bleed. This helps define the entire diseased area and shows what areas of the bladder need to be cauterized to seal the ulcers and destroy the exposed nerve endings. If this is a new diagnosis, the lesion should be biopsied after the hydrodistension to rule out carcinoma.

Hunner’s lesions can lead to rapid disease progression due to chronic inflammation and subsequent collagen deposition and scarring. Even on initial diagnosis of Hunner’s lesions, a capacity of 350 cc or less (compared with 1,100 cc in a normal bladder) on hydrodistension under anesthesia is not uncommon. This markedly reduced bladder capacity may lead to end-stage bladder impacting the kidneys and requiring a urinary diversion.

Eradicating the ulcers with resection or cautery often results in marked and immediate improvement in bladder pain, albeit not long-lasting. I will typically place a resectoscope and use a roller ball at 25 watts of current. The entire ulcerated areas are cauterized by rapidly rolling the ball over the area of inflammation and avoiding a deep thermal burn. The goal is to seal the ulcer and destroy the exposed nerve endings so that urine can no longer act as an irritant. Recurrence in 6 months to 1 year is common and retreatment is almost always necessary. We have demonstrated, however, that recurrent cautery of ulcers does not lead to smaller anesthetic bladder capacities (Urology. 2015 Jan;85[1]:74-8).

Low-dose cyclosporine can be very effective at reducing Hunner’s lesion recurrence and improving storage symptoms (Exp Ther Med. 2016 Jul;12[1]:445-50). I use 100 mg twice a day for a month and then 1 pill a day thereafter. This is a relatively low dose, but hypertension can be a side effect and blood pressure should be monitored along with routine labs.

The broader picture

Hunner’s lesion IC is pretty straightforward and clearly a bladder disease. However, in recent years the term IC/BPS has been broadly used to describe women who have symptoms of pelvic pain, urinary urgency, and frequency, but no true bladder pathology to explain their symptoms. One problem: There is no definitive diagnostic test or evidence-based diagnostic process for IC/BPS. In fact, the diagnosis section of the American Urological Association guideline on diagnosis and treatment of IC/BPS, last updated in 2015, is almost entirely consensus-based (J Urol. 2015 May;193[5]:1545-53). It largely remains a diagnosis of exclusion.

As the AUA guidelines state, a careful history, physical examination, and laboratory assessment are all important for documenting symptoms and signs and ruling out significant causes of the symptoms. I frequently see patients who have been diagnosed with IC who have frequency and urgency but no pain (in which case overactive bladder should be considered) or who have pelvic pain but no bladder symptoms, again likely not IC. Pain that worsens with bladder filling and improves after bladder emptying is typical of IC/BPS. This finding in the absence of other confusing symptoms supports the diagnosis of IC/BPS.

It has become too easy for the average clinician to apply a label of IC/BPS to a patient complaining of pelvic pain; this often results in the patient undergoing invasive and nonhelpful therapies such as cystoscopy, hydrodistension, urodynamics, bladder instillations, and other bladder-directed therapies.

More than 20 years of research supported by the National Institutes of Health and industry have failed to show that bladder-directed therapy is superior to placebo. This fact suggests that the bladder may be an innocent bystander in a larger pelvic process. As clinicians, we must be willing to look beyond the bladder and examine for pelvic floor issues and other causes of patient’s symptoms and not be too quick to begin bladder-focused treatments.

A number of disease processes – such as recurrent urinary tract infection, urethral diverticulum, endometriosis, and pudendal neuropathy – can mimic the symptoms of IC/BPS. The most common missed diagnosis in the IC patient is pelvic floor dysfunction that results in a hypertonic contracted state of the levator muscles – a chronic spasm, in essence – that in turn leads to decreased muscle function, increased myofascial pain, and myofascial trigger points (Curr Urol Rep. 2006 Nov;7[6]:450-5).

We and others have reported that up to 85% of patients labeled with IC/BPS have been found on examination to have pelvic floor dysfunction or a diffuse pelvic floor hypersensitivity. The pelvic floor is important in maintaining healthy bladder, bowel, and sexual function. If the pelvic floor is in spasm, this can result in urinary frequency, hesitancy, and pelvic pain.

Many of these patients with contracted pelvic floor muscles report pain with sexual intercourse – often so severe as to cause abstention. In fact, when patients answer no to the question of whether they have pain with intercourse, I know it is unlikely that they have significant pelvic floor dysfunction. This is a key question for history taking.

Other key questions concern the impact of stress on symptoms and a history of any type of abuse. In a study we conducted about 10 years ago, we found that among 76 women who were diagnosed with IC and subsequently evaluated in our clinic, almost half (49%) reported abuse (emotional, physical, and/or sexual). The vast majority (85%) had levator pain (J Urol. 2007 Sep;178[3 Pt 1]:891-5).

Other types of stress – from past surgeries to traumatic life events – may similarly serve as triggers or precursors to pelvic floor dysfunction in some women. I often tell patients that people put stress in different areas of their bodies. While some get tension headaches or low-back aches, others get pelvic pain from contracting and guarding the levator muscles.

 

 

Pelvic floor dysfunction

The most important component of the physical exam in patients with the symptoms of frequency, urgency, and pelvic pain – and the most overlooked – is assessment of the levator muscles for tightness and tenderness. Levator pain and trigger points may be identified during the pelvic exam by pressing laterally on the levator complex in each quadrant of the vagina and at the ischial spines. The tension of the muscles and severity of pain should be assessed, and it is helpful to ask the patient if the pain reproduces her normal pelvic pain symptoms.

Courtesy Beaumont Urology
Transvaginal trigger point injections can serve as a helpful adjunct to pelvic floor physical therapy.

We’ve found that identifying and treating pelvic floor dysfunction with modalities such as pelvic floor physical therapy with intravaginal myofascial release, intravaginal valium, trigger point injections into the levator complex, pudendal nerve blocks, and neuromodulation can frequently resolve or significantly lessen the patient’s pain and bladder symptoms, suggesting that the diagnosis of IC/BPS was wrong.

Courtesy Beaumont Urology
Transvaginal trigger point injections can serve as a helpful adjunct to pelvic floor physical therapy.


Pelvic floor physical therapy works to stretch the contracted anterior pelvic muscles by releasing trigger points and connective tissue restrictions, and by decreasing periurethral tension; it also may decrease neurogenic triggers and central nervous system sensitivity. Kegel exercises will worsen pain in these patients and should be avoided.

When pelvic floor dysfunction is identified, such treatment by a therapist knowledgeable in intravaginal myofascial release is a next reasonable step before any medications or invasive testing, such as bladder hydrodistension, are used.

One of the only National Institutes of Health–funded studies to show benefit of a treatment in an IC population, in fact, was a multicenter randomized controlled trial comparing 10 sessions of myofascial pelvic floor physical therapy with “global therapeutic massage.” Myofascial physical therapy led to significant improvement, compared with the generalized spa-like massage (J Urol. 2012 Jun;187[6]:2113-8).

Dr. Kenneth M. Peters
In our practice, we often use intravaginal valium, transvaginal trigger point injections, and pudendal nerve blocks as an adjunct to physical therapy. It is not uncommon for a therapist to report to us that progress in therapy is being stymied by pain in a particular area; in such cases a trigger point injection in the office with local anesthetic and sometimes corticosteroids will help the muscle relax enough and provide enough pain relief so that physical therapy can move forward successfully.

Our patients with IC/BPS symptoms and pelvic floor dysfunction require 1-2 visits weekly for an average of 12 weeks for tightness and tenderness to be significantly minimized or eliminated. Patients are also prescribed home stretching exercises and advised to use internal vaginal dilators. Most patients will report resolution of their pelvic pain, sexual pain, and bladder symptoms – especially with the combination of physical therapy and trigger point injections. In more severe cases, we may use sacral or pudendal neuromodulation to improve the frequency, urgency and pelvic pain.

Turning to the bladder

When urinary symptoms persist after the completion of pelvic floor therapy, or when pelvic floor dysfunction is not identified in the first place, we proceed with bladder-specific therapies. I will often suggest trials of amitriptyline or hydroxyzine, for instance, and/or changes in hydration and caffeine consumption. I am not a fan of pentosan polysulfate sodium (Elmiron) as it is a very expensive medication that has minimal benefit for the majority of patients.

When conservative therapies do not work, I move to cystoscopy with hydrodistension. The procedure can serve several purposes. It can be diagnostic, enabling us to rule out other potential symptom-causing pathologies, and it can be prognostic, helping us to understand when bladder capacity is severely reduced and to plan treatment. In some patients, it can even be therapeutic. Some of my patients have significant relief of symptoms from a hydrodistension of the bladder once or twice a year.

There is no standard method for performing a hydrodistension. I perform a complete cystoscopy to look for tumors, stones, diverticulum or Hunner’s lesions and, if the bladder is normal in appearance, I proceed with a 2-minute hydrodistension at 80-100 cm of water pressure under anesthesia. The bag is raised above the bladder, allowing the bladder to fill with the force of gravity and the pressures to equalize. The urethra must be compressed so that water doesn’t leak around the cystoscope. After 2 minutes of hydrodistension, the bladder is drained, volume is measured, and the procedure is repeated.

After the hydrodistension, the bladder is reinspected to be certain there is no bladder perforation and to evaluate for diffuse glomerulations (petechial hemorrhages) that are suggestive, but not diagnostic, of IC/BPS.

 

 

A holistic approach

Managing patients with voiding dysfunction and chronic pelvic pain can be a challenge, and a multidisciplinary approach is most effective. At Beaumont, we have a Women’s Urology Center that includes urologists, gynecologists, nurse practitioners, pelvic floor physical therapists, pain psychologists, colorectal specialists, sex therapists, and naturopathic and integrative medicine specialists who perform acupuncture, Reiki therapy, medical massage, and guided imagery.

The goal is to break out of our box of specialties and look at the whole patient – mind, body, and soul – while identifying pain triggers and directing therapy toward these triggers using a multidisciplinary, collaborative approach. For us, this approach has been very effective for managing complex pelvic pain issues (Transl Androl Urol. 2015 Dec;4[6]:611-9).

Ongoing studies

A number of research studies are ongoing to help treat the symptoms of IC/BPS. We currently have a Department of Defense grant to prospectively assess bladder-directed therapy (instillations) compared to pelvic floor physical therapy. Patients diagnosed with IC/BPS are being randomized into these two treatment arms and we hope to get a better understanding of the role of these modalities in managing IC/BPS.

Allergan is completing a phase II placebo-controlled trial using a lidocaine delivery device that is placed in the bladder and continuously releases lidocaine over 14 days. The LiNKA trial is designed to assess the impact of lidocaine on not only improving bladder symptoms, but also eradicating Hunner’s lesions through the anti-inflammatory effect of lidocaine. Early open-label data were very promising. In addition, a new medication for IC/BPS that modulates the SHIP1 pathway is being studied by Aquinox Pharmaceuticals. The agent, AQX-1125, is an activator of SHIP1, which controls the phosphoinositide 3-kinase (PI3K) cellular signaling pathway. If the PI3K pathway is overactive, immune cells can produce an abundance of proinflammatory signaling molecules and migrate to and concentrate in tissues, resulting in excessive or chronic inflammation. Early data in IC/BPS patients were supportive of the compound’s potential for reducing the pain associated with this condition.
 

A note from Charles E. Miller, MD, Master Class Medical Editor:

In a double-blind, placebo-controlled study by J.C. Nickel, et al., pentosan polysulfate sodium was shown to improve pain, urgency, and frequency over the control group (Urology. 2005 Apr;65[4]:654-8). Also, longer duration of treatment with pentosan polysulfate sodium was associated with greater response rates – 50% improved by 26 weeks (J Urol. 2005 Dec;174[6]:2235-8).
 

Dr. Peters is professor and chairman of urology at Oakland University William Beaumont School of Medicine, Royal Oak, Mich. He reported serving as a consultant for Taris, Medtronic, StimGuard, and Amphora Medical.

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Safety of corticosteroids in pregnancy: Is it the drug or the disease?

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Thu, 12/06/2018 - 11:36

 

Corticosteroids such as prednisone are relatively frequently administered in pregnancy for their immunosuppressive and anti-inflammatory effects. Treatment may be initiated on a short-term basis for acute conditions. Alternatively, treatment may be more or less ongoing for severe chronic diseases such as asthma or a variety of other autoimmune conditions when disease symptoms do not remit in pregnancy. However, the safety of corticosteroid use with respect to risk of specific birth defects, preterm delivery, and low birth weight has been the subject of debate over some time.

Concerns about the teratogenicity of corticosteroids were raised as early as the 1950s, based on animal studies suggesting an increased risk for oral clefts. The association between corticosteroids and oral clefts has also been observed in some human epidemiologic studies. However, results of these studies have been inconsistent.

Dr. Christina D. Chambers
Earlier studies that were incorporated into a meta-analysis published in 2000 suggested a 3.4-times increased odds of cleft lip with or without cleft palate following first trimester corticosteroid use (95% confidence interval, 2.0-5.7).1 However, a 2014 update from the multisite U.S. National Birth Defects Prevention case-control study (NBDPS) demonstrated that, while data from 1997 to 2002 indicated an elevated risk for oral clefts, more recent data from 2003 to 2009 did not.2 The authors speculated that typical doses of corticosteroids or duration of use in pregnancy could have declined over time as more disease modifying alternative treatments have become available for some conditions and that this could have resulted in attenuated risk estimates in recent years.

Similar to the NBDPS findings, in a large Danish cohort study covering 832,636 live births from 1996 to 2008, exposure to any corticosteroids during the first trimester was not associated with an increased risk for cleft lip or cleft palate. Only those exposed to topical corticosteroids had a higher risk of cleft lip with or without cleft palate (odds ratio, 1.45; 95% CI, 1.03-2.05).3 Another, smaller Danish study covered primiparous births from 1999 to 2009 (n = 83,043). The unadjusted odds of oral clefts following exposure to any corticosteroids (inhaled or oral) in the first trimester was null (OR, 0.4; 95% CI, 0.1-2.8).4

Inconsistencies across these studies, as speculated by authors of the NBDPS analysis, may result from a lack of information on the dose of drug used by the mother, the indication for its use, or any measure of the severity of the underlying maternal disease for which the corticosteroids were prescribed. It is possible that maternal disease or disease activity in and of itself is a direct cause of oral clefts or that corticosteroids are linked to increased risk for clefts through co-occurring other exposures such as smoking, alcohol, or obesity. However, these questions have yet to be answered.

With respect to other birth outcomes, a few disease-specific studies have examined birth weight or intrauterine growth restriction following corticosteroid use. In general, study findings have been reassuring. Among Danish women with Crohn’s disease, corticosteroids were not associated with reduced birth weight after adjusting for gestational age and disease activity (adjusted risk ratio, 1.1; 95% CI, 0.2-5.7).5 In another study of pregnant women with rheumatoid arthritis, birth weight was not associated with prednisone use after adjustment for gestational age at delivery and sex of the newborn.6 In a third cohort study of pregnant women with systemic lupus erythematosus, there was no a significant elevation in odds of intrauterine growth restriction following prednisone use.7

Several disease-specific studies have also examined corticosteroid use and risk of preterm birth. From the Danish cohort of pregnant women with Crohn’s disease, the researchers reported no association between prednisolone and preterm birth after adjustment for covariates. In contrast, in a separate Danish cohort of pregnant women with irritable bowel disease, there was an increased risk of preterm delivery following systemic corticosteroid use, compared with women without disease (adjusted hazard ratio, 6.3; 95% CI, 3.1-12.7).8 However, data were not available to address underlying disease severity as a possible contributing factor. Of note, among women with irritable bowel disease who did not use medication in pregnancy, there was a 50% increase in the risk of preterm birth, compared with women without disease (aHR, 1.5; 95% CI, 1.0-2.4). This suggests that the disease itself contributed to the increased risk of preterm birth.

Currently available data regarding corticosteroid use and adverse birth outcomes are generally reassuring. Recent estimates for oral clefts suggest a low elevation in risk, if any at all. This translates to a very low absolute risk for clefts, which occur in the general population in approximately 1 in 1,000 births. The clinical benefit of adequate treatment in the first trimester for inflammatory or immune-mediated diseases may far outweigh any small and tenuous risks for oral clefts.

With respect to reduced birth weight and preterm delivery, available evidence suggests either no association or that maternal disease and disease severity are driving any increased risks noted for these outcomes. Future studies of pregnancy safety for medications used to treat maternal diseases that themselves are potentially linked to adverse outcomes must incorporate appropriate measures of disease type and disease severity in the study designs.

 

 

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at [email protected].

References

1. Teratology. 2000 Dec;62(6):385-92.

2. Birth Defects Res A Clin Mol Teratol. 2014 Jun;100(6):499-506.

3. CMAJ. 2011 Apr 19;183(7):796-804.

4. Am J Ther. 2014 Mar-Apr;21(2):73-80.

5. Am J Gastroenterol. 2007 Jul;102(7):1406-13.

6. Arthritis Rheum. 2009 Nov;60(11):3196-206.

7. Lupus. 2010 Dec;19(14):1665-73.

8. PLoS One. 2015 Jun 17;10(6):e0129567.

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Corticosteroids such as prednisone are relatively frequently administered in pregnancy for their immunosuppressive and anti-inflammatory effects. Treatment may be initiated on a short-term basis for acute conditions. Alternatively, treatment may be more or less ongoing for severe chronic diseases such as asthma or a variety of other autoimmune conditions when disease symptoms do not remit in pregnancy. However, the safety of corticosteroid use with respect to risk of specific birth defects, preterm delivery, and low birth weight has been the subject of debate over some time.

Concerns about the teratogenicity of corticosteroids were raised as early as the 1950s, based on animal studies suggesting an increased risk for oral clefts. The association between corticosteroids and oral clefts has also been observed in some human epidemiologic studies. However, results of these studies have been inconsistent.

Dr. Christina D. Chambers
Earlier studies that were incorporated into a meta-analysis published in 2000 suggested a 3.4-times increased odds of cleft lip with or without cleft palate following first trimester corticosteroid use (95% confidence interval, 2.0-5.7).1 However, a 2014 update from the multisite U.S. National Birth Defects Prevention case-control study (NBDPS) demonstrated that, while data from 1997 to 2002 indicated an elevated risk for oral clefts, more recent data from 2003 to 2009 did not.2 The authors speculated that typical doses of corticosteroids or duration of use in pregnancy could have declined over time as more disease modifying alternative treatments have become available for some conditions and that this could have resulted in attenuated risk estimates in recent years.

Similar to the NBDPS findings, in a large Danish cohort study covering 832,636 live births from 1996 to 2008, exposure to any corticosteroids during the first trimester was not associated with an increased risk for cleft lip or cleft palate. Only those exposed to topical corticosteroids had a higher risk of cleft lip with or without cleft palate (odds ratio, 1.45; 95% CI, 1.03-2.05).3 Another, smaller Danish study covered primiparous births from 1999 to 2009 (n = 83,043). The unadjusted odds of oral clefts following exposure to any corticosteroids (inhaled or oral) in the first trimester was null (OR, 0.4; 95% CI, 0.1-2.8).4

Inconsistencies across these studies, as speculated by authors of the NBDPS analysis, may result from a lack of information on the dose of drug used by the mother, the indication for its use, or any measure of the severity of the underlying maternal disease for which the corticosteroids were prescribed. It is possible that maternal disease or disease activity in and of itself is a direct cause of oral clefts or that corticosteroids are linked to increased risk for clefts through co-occurring other exposures such as smoking, alcohol, or obesity. However, these questions have yet to be answered.

With respect to other birth outcomes, a few disease-specific studies have examined birth weight or intrauterine growth restriction following corticosteroid use. In general, study findings have been reassuring. Among Danish women with Crohn’s disease, corticosteroids were not associated with reduced birth weight after adjusting for gestational age and disease activity (adjusted risk ratio, 1.1; 95% CI, 0.2-5.7).5 In another study of pregnant women with rheumatoid arthritis, birth weight was not associated with prednisone use after adjustment for gestational age at delivery and sex of the newborn.6 In a third cohort study of pregnant women with systemic lupus erythematosus, there was no a significant elevation in odds of intrauterine growth restriction following prednisone use.7

Several disease-specific studies have also examined corticosteroid use and risk of preterm birth. From the Danish cohort of pregnant women with Crohn’s disease, the researchers reported no association between prednisolone and preterm birth after adjustment for covariates. In contrast, in a separate Danish cohort of pregnant women with irritable bowel disease, there was an increased risk of preterm delivery following systemic corticosteroid use, compared with women without disease (adjusted hazard ratio, 6.3; 95% CI, 3.1-12.7).8 However, data were not available to address underlying disease severity as a possible contributing factor. Of note, among women with irritable bowel disease who did not use medication in pregnancy, there was a 50% increase in the risk of preterm birth, compared with women without disease (aHR, 1.5; 95% CI, 1.0-2.4). This suggests that the disease itself contributed to the increased risk of preterm birth.

Currently available data regarding corticosteroid use and adverse birth outcomes are generally reassuring. Recent estimates for oral clefts suggest a low elevation in risk, if any at all. This translates to a very low absolute risk for clefts, which occur in the general population in approximately 1 in 1,000 births. The clinical benefit of adequate treatment in the first trimester for inflammatory or immune-mediated diseases may far outweigh any small and tenuous risks for oral clefts.

With respect to reduced birth weight and preterm delivery, available evidence suggests either no association or that maternal disease and disease severity are driving any increased risks noted for these outcomes. Future studies of pregnancy safety for medications used to treat maternal diseases that themselves are potentially linked to adverse outcomes must incorporate appropriate measures of disease type and disease severity in the study designs.

 

 

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at [email protected].

References

1. Teratology. 2000 Dec;62(6):385-92.

2. Birth Defects Res A Clin Mol Teratol. 2014 Jun;100(6):499-506.

3. CMAJ. 2011 Apr 19;183(7):796-804.

4. Am J Ther. 2014 Mar-Apr;21(2):73-80.

5. Am J Gastroenterol. 2007 Jul;102(7):1406-13.

6. Arthritis Rheum. 2009 Nov;60(11):3196-206.

7. Lupus. 2010 Dec;19(14):1665-73.

8. PLoS One. 2015 Jun 17;10(6):e0129567.

 

Corticosteroids such as prednisone are relatively frequently administered in pregnancy for their immunosuppressive and anti-inflammatory effects. Treatment may be initiated on a short-term basis for acute conditions. Alternatively, treatment may be more or less ongoing for severe chronic diseases such as asthma or a variety of other autoimmune conditions when disease symptoms do not remit in pregnancy. However, the safety of corticosteroid use with respect to risk of specific birth defects, preterm delivery, and low birth weight has been the subject of debate over some time.

Concerns about the teratogenicity of corticosteroids were raised as early as the 1950s, based on animal studies suggesting an increased risk for oral clefts. The association between corticosteroids and oral clefts has also been observed in some human epidemiologic studies. However, results of these studies have been inconsistent.

Dr. Christina D. Chambers
Earlier studies that were incorporated into a meta-analysis published in 2000 suggested a 3.4-times increased odds of cleft lip with or without cleft palate following first trimester corticosteroid use (95% confidence interval, 2.0-5.7).1 However, a 2014 update from the multisite U.S. National Birth Defects Prevention case-control study (NBDPS) demonstrated that, while data from 1997 to 2002 indicated an elevated risk for oral clefts, more recent data from 2003 to 2009 did not.2 The authors speculated that typical doses of corticosteroids or duration of use in pregnancy could have declined over time as more disease modifying alternative treatments have become available for some conditions and that this could have resulted in attenuated risk estimates in recent years.

Similar to the NBDPS findings, in a large Danish cohort study covering 832,636 live births from 1996 to 2008, exposure to any corticosteroids during the first trimester was not associated with an increased risk for cleft lip or cleft palate. Only those exposed to topical corticosteroids had a higher risk of cleft lip with or without cleft palate (odds ratio, 1.45; 95% CI, 1.03-2.05).3 Another, smaller Danish study covered primiparous births from 1999 to 2009 (n = 83,043). The unadjusted odds of oral clefts following exposure to any corticosteroids (inhaled or oral) in the first trimester was null (OR, 0.4; 95% CI, 0.1-2.8).4

Inconsistencies across these studies, as speculated by authors of the NBDPS analysis, may result from a lack of information on the dose of drug used by the mother, the indication for its use, or any measure of the severity of the underlying maternal disease for which the corticosteroids were prescribed. It is possible that maternal disease or disease activity in and of itself is a direct cause of oral clefts or that corticosteroids are linked to increased risk for clefts through co-occurring other exposures such as smoking, alcohol, or obesity. However, these questions have yet to be answered.

With respect to other birth outcomes, a few disease-specific studies have examined birth weight or intrauterine growth restriction following corticosteroid use. In general, study findings have been reassuring. Among Danish women with Crohn’s disease, corticosteroids were not associated with reduced birth weight after adjusting for gestational age and disease activity (adjusted risk ratio, 1.1; 95% CI, 0.2-5.7).5 In another study of pregnant women with rheumatoid arthritis, birth weight was not associated with prednisone use after adjustment for gestational age at delivery and sex of the newborn.6 In a third cohort study of pregnant women with systemic lupus erythematosus, there was no a significant elevation in odds of intrauterine growth restriction following prednisone use.7

Several disease-specific studies have also examined corticosteroid use and risk of preterm birth. From the Danish cohort of pregnant women with Crohn’s disease, the researchers reported no association between prednisolone and preterm birth after adjustment for covariates. In contrast, in a separate Danish cohort of pregnant women with irritable bowel disease, there was an increased risk of preterm delivery following systemic corticosteroid use, compared with women without disease (adjusted hazard ratio, 6.3; 95% CI, 3.1-12.7).8 However, data were not available to address underlying disease severity as a possible contributing factor. Of note, among women with irritable bowel disease who did not use medication in pregnancy, there was a 50% increase in the risk of preterm birth, compared with women without disease (aHR, 1.5; 95% CI, 1.0-2.4). This suggests that the disease itself contributed to the increased risk of preterm birth.

Currently available data regarding corticosteroid use and adverse birth outcomes are generally reassuring. Recent estimates for oral clefts suggest a low elevation in risk, if any at all. This translates to a very low absolute risk for clefts, which occur in the general population in approximately 1 in 1,000 births. The clinical benefit of adequate treatment in the first trimester for inflammatory or immune-mediated diseases may far outweigh any small and tenuous risks for oral clefts.

With respect to reduced birth weight and preterm delivery, available evidence suggests either no association or that maternal disease and disease severity are driving any increased risks noted for these outcomes. Future studies of pregnancy safety for medications used to treat maternal diseases that themselves are potentially linked to adverse outcomes must incorporate appropriate measures of disease type and disease severity in the study designs.

 

 

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at [email protected].

References

1. Teratology. 2000 Dec;62(6):385-92.

2. Birth Defects Res A Clin Mol Teratol. 2014 Jun;100(6):499-506.

3. CMAJ. 2011 Apr 19;183(7):796-804.

4. Am J Ther. 2014 Mar-Apr;21(2):73-80.

5. Am J Gastroenterol. 2007 Jul;102(7):1406-13.

6. Arthritis Rheum. 2009 Nov;60(11):3196-206.

7. Lupus. 2010 Dec;19(14):1665-73.

8. PLoS One. 2015 Jun 17;10(6):e0129567.

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Alternative CME

Optimizing surveillance for gynecologic cancers

Article Type
Changed
Tue, 08/28/2018 - 10:16

 

Gynecologic cancers contribute to approximately 15% of cancer survivorship care for women. Many patients share surveillance visits between their gynecologic oncologist and their ob.gyn. or primary care physician to capitalize on preexisting relationships and ensure the provision of comprehensive wellness care. Providing high quality surveillance care is challenging because it requires vigilance in the detection of recurrence but also avoidance of unnecessary, costly, and inaccurate testing.

The oncologic benefits for various surveillance guidelines are not well established by prospective studies. However, in updated surveillance recommendations, the Society of Gynecologic Oncology (SGO) takes available data, costs, and benefits into consideration.1 The guidelines, authored by Ritu Salani, MD, provide an excellent resource for understanding appropriate testing and evaluation during surveillance care.

Dr. Emma C. Rossi
As with screening, the goal of surveillance is to detect recurrence and, thereby, extend survival or palliate symptoms.

The cornerstone of a surveillance visit is a thorough symptom assessment. Positive reporting of symptoms remains the most sensitive method for detecting recurrences; therefore, patients should be educated and quizzed on common recurrence symptoms. For example, endometrial cancer most commonly recurs in the vagina with symptoms of vaginal bleeding or discharge. Lower extremity swelling can signify pelvic sidewall recurrences and abdominal bloating or pain can signify peritoneal recurrence of ovarian or endometrial cancer.

All women who are undergoing surveillance for gynecologic cancers should receive physical examinations that include a pelvic exam with a speculum and bimanual exam with rectovaginal exam. Many locoregional recurrences are salvageable for most gynecologic cancers, which is not true for most distant recurrences, emphasizing the importance of pelvic examinations.

In addition to surveillance of recurrence, these visits should focus on risk modification – tobacco, obesity, bone demineralization – as well as preventive health strategies, such as vaccinations, nongynecologic cancer screenings, and cardiovascular disease intervention. Clinicians should also ask about sequelae to cancer therapy, such as neuropathy, lymphedema, sexual dysfunction, depression, and fatigue.

Dr. Rossi

Endometrial cancer

Endometrial cancer recurs most commonly among women with a history of advanced stage cancer or early stage disease with high/intermediate risk factors, but all survivors should be evaluated regularly for recurrence. The vagina is the most common site for recurrence. Fortunately, many vaginal recurrences can be cured with salvage therapies.

Women with the lowest risk for recurrence (stage IA, grades 1 and 2 disease) who did not originally qualify for adjuvant therapy can be followed every 6 months for 2 years and then annually.

Vaginal cytology is no longer recommended for the routine surveillance of endometrial cancer because of its poor sensitivity in detecting recurrence and low positive predictive value (particularly after vaginal radiation).2 Any suspicious lesions identified on speculum examination should be biopsied, rather than sampled with cytologic smear. Routine imaging (with CT or PET/CT) and cancer antigen (CA) 125 tumor marker assessment is not supported unless the initial stage was advanced. These tests should be reserved for confirmation of concerning symptoms or examination findings.

This group of patients has particular survivorship needs with respect to obesity interventions. Obesity is associated with poor prognosis from endometrial cancer, and patients should be counseled about this and offered strategies for weight loss and lifestyle modification. Lynch syndrome testing and colon cancer screening are also an important consideration in this population.
 

Ovarian cancer

Ovarian cancer recurrence rates are high, and, while salvage therapies are rarely curative, enduring responses may be achieved in some patients, making surveillance visits critical. The SGO recommends surveillance visits every 3 months in the first 2 years, every 4 months in year 3, and then every 6 months for an additional 2 years. At these visits, patients should be queried about symptoms with particular emphasis on peritoneal signs (bloating, distension, gastrointestinal disturbance, and abdominal pain) as most recurrences will be within the peritoneal cavity.

CA 125 tumor marker elevation during the surveillance phase may signal recurrence prior to the development of symptoms but initiating chemotherapy early because of elevations in CA 125 does not improve survival.3 However, in the platinum-sensitive population with a longer disease-free interval, earlier detection of recurrence by CA 125 may identify patients in whom complete secondary cytoreduction is more attainable and is associated with improved survival.4 Therefore, the SGO suggests that CA 125 assessment is optional. The benefits and limitations of earlier detection of recurrence should be discussed with each patient. This recommendation differs for survivors of nonepithelial ovarian cancers (such as germ-cell or sex-cord stromal), in which case the measurement of the appropriate tumor markers (such as alpha-fetoprotein, human chorionic gonadotropin, and inhibin) should be performed routinely as part of surveillance evaluation.

Evidence does not support routine imaging (such as CT or PET). It should be reserved as a confirmatory measure for patients with concerning symptoms, examination findings, or elevations in tumor markers. When ovarian cancer has been treated with fertility-preserving surgery in women of younger reproductive ages, pelvic ultrasounds may be used as part of their surveillance care to monitor retained ovaries and pelvic structures.

BRCA-gene testing should be offered to all women with epithelial ovarian, fallopian tube, and primary peritoneal cancer as it impacts future cancer risk, as well as chemotherapy selection.5
 

 

 

Cervical cancer

In the first 2 years after completing primary treatment for cervical cancer, those at high risk for recurrence (including those who were recommended to adjuvant therapy) should be evaluated every 3 months for 2 years, followed by visits at 6-month intervals for an additional 3 years. Low-risk patients can be followed every 6 months for 2 years, followed by annual visits thereafter.

Pap testing should be performed annually, rather than at each surveillance visit. It should not to detect recurrence – for which it has poor sensitivity and specificity – but rather to detect new HPV-related dysplasia.6

Many patients with cervical cancer have a tobacco use history, placing them at risk for other cancers. Educate patients about the risk and provide cessation assistance.
 

Vulvar cancer

Prognosis for early stage vulvar cancer is very good; however, local recurrences are common (as much as 40%) in the 10 years following diagnosis.7 It is important to thoroughly inspect the vulva, vagina, and cervix at each surveillance visit. In high-risk patients, examinations should take place every 3 months for the first 2 years after completing primary treatment and every 6 months until 5 years post treatment. Low-risk patients can be followed every 6 months for 2 years and annually thereafter.

Identification and early treatment of dysplasia is important. Careful attention should also be made to palpation of the inguinal nodal regions. One in 10 women will have a late recurrence (greater than 5 years), so vulvar inspections should continue at least annually for the remainder of a woman’s life.
 

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.

References

1. Gynecol Oncol. 2017 Mar 31. doi: 10.1016/j.ygno.2017.03.022.

2. Obstet Gynecol. 2013 Jan;121(1):129-35.

3. Lancet. 2010 Oct 2;376(9747):1155-63.

4. Gynecol Oncol. 2009 Jan;112(1):265-74.

5. Gynecol Oncol. 2015 Jan;136(1):3-7.

6. Obstet Gynecol. 2011 Sep;118(3):548-53.

7. Gynecol Oncol. 2016 Jan;140(1):8-14.

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Gynecologic cancers contribute to approximately 15% of cancer survivorship care for women. Many patients share surveillance visits between their gynecologic oncologist and their ob.gyn. or primary care physician to capitalize on preexisting relationships and ensure the provision of comprehensive wellness care. Providing high quality surveillance care is challenging because it requires vigilance in the detection of recurrence but also avoidance of unnecessary, costly, and inaccurate testing.

The oncologic benefits for various surveillance guidelines are not well established by prospective studies. However, in updated surveillance recommendations, the Society of Gynecologic Oncology (SGO) takes available data, costs, and benefits into consideration.1 The guidelines, authored by Ritu Salani, MD, provide an excellent resource for understanding appropriate testing and evaluation during surveillance care.

Dr. Emma C. Rossi
As with screening, the goal of surveillance is to detect recurrence and, thereby, extend survival or palliate symptoms.

The cornerstone of a surveillance visit is a thorough symptom assessment. Positive reporting of symptoms remains the most sensitive method for detecting recurrences; therefore, patients should be educated and quizzed on common recurrence symptoms. For example, endometrial cancer most commonly recurs in the vagina with symptoms of vaginal bleeding or discharge. Lower extremity swelling can signify pelvic sidewall recurrences and abdominal bloating or pain can signify peritoneal recurrence of ovarian or endometrial cancer.

All women who are undergoing surveillance for gynecologic cancers should receive physical examinations that include a pelvic exam with a speculum and bimanual exam with rectovaginal exam. Many locoregional recurrences are salvageable for most gynecologic cancers, which is not true for most distant recurrences, emphasizing the importance of pelvic examinations.

In addition to surveillance of recurrence, these visits should focus on risk modification – tobacco, obesity, bone demineralization – as well as preventive health strategies, such as vaccinations, nongynecologic cancer screenings, and cardiovascular disease intervention. Clinicians should also ask about sequelae to cancer therapy, such as neuropathy, lymphedema, sexual dysfunction, depression, and fatigue.

Dr. Rossi

Endometrial cancer

Endometrial cancer recurs most commonly among women with a history of advanced stage cancer or early stage disease with high/intermediate risk factors, but all survivors should be evaluated regularly for recurrence. The vagina is the most common site for recurrence. Fortunately, many vaginal recurrences can be cured with salvage therapies.

Women with the lowest risk for recurrence (stage IA, grades 1 and 2 disease) who did not originally qualify for adjuvant therapy can be followed every 6 months for 2 years and then annually.

Vaginal cytology is no longer recommended for the routine surveillance of endometrial cancer because of its poor sensitivity in detecting recurrence and low positive predictive value (particularly after vaginal radiation).2 Any suspicious lesions identified on speculum examination should be biopsied, rather than sampled with cytologic smear. Routine imaging (with CT or PET/CT) and cancer antigen (CA) 125 tumor marker assessment is not supported unless the initial stage was advanced. These tests should be reserved for confirmation of concerning symptoms or examination findings.

This group of patients has particular survivorship needs with respect to obesity interventions. Obesity is associated with poor prognosis from endometrial cancer, and patients should be counseled about this and offered strategies for weight loss and lifestyle modification. Lynch syndrome testing and colon cancer screening are also an important consideration in this population.
 

Ovarian cancer

Ovarian cancer recurrence rates are high, and, while salvage therapies are rarely curative, enduring responses may be achieved in some patients, making surveillance visits critical. The SGO recommends surveillance visits every 3 months in the first 2 years, every 4 months in year 3, and then every 6 months for an additional 2 years. At these visits, patients should be queried about symptoms with particular emphasis on peritoneal signs (bloating, distension, gastrointestinal disturbance, and abdominal pain) as most recurrences will be within the peritoneal cavity.

CA 125 tumor marker elevation during the surveillance phase may signal recurrence prior to the development of symptoms but initiating chemotherapy early because of elevations in CA 125 does not improve survival.3 However, in the platinum-sensitive population with a longer disease-free interval, earlier detection of recurrence by CA 125 may identify patients in whom complete secondary cytoreduction is more attainable and is associated with improved survival.4 Therefore, the SGO suggests that CA 125 assessment is optional. The benefits and limitations of earlier detection of recurrence should be discussed with each patient. This recommendation differs for survivors of nonepithelial ovarian cancers (such as germ-cell or sex-cord stromal), in which case the measurement of the appropriate tumor markers (such as alpha-fetoprotein, human chorionic gonadotropin, and inhibin) should be performed routinely as part of surveillance evaluation.

Evidence does not support routine imaging (such as CT or PET). It should be reserved as a confirmatory measure for patients with concerning symptoms, examination findings, or elevations in tumor markers. When ovarian cancer has been treated with fertility-preserving surgery in women of younger reproductive ages, pelvic ultrasounds may be used as part of their surveillance care to monitor retained ovaries and pelvic structures.

BRCA-gene testing should be offered to all women with epithelial ovarian, fallopian tube, and primary peritoneal cancer as it impacts future cancer risk, as well as chemotherapy selection.5
 

 

 

Cervical cancer

In the first 2 years after completing primary treatment for cervical cancer, those at high risk for recurrence (including those who were recommended to adjuvant therapy) should be evaluated every 3 months for 2 years, followed by visits at 6-month intervals for an additional 3 years. Low-risk patients can be followed every 6 months for 2 years, followed by annual visits thereafter.

Pap testing should be performed annually, rather than at each surveillance visit. It should not to detect recurrence – for which it has poor sensitivity and specificity – but rather to detect new HPV-related dysplasia.6

Many patients with cervical cancer have a tobacco use history, placing them at risk for other cancers. Educate patients about the risk and provide cessation assistance.
 

Vulvar cancer

Prognosis for early stage vulvar cancer is very good; however, local recurrences are common (as much as 40%) in the 10 years following diagnosis.7 It is important to thoroughly inspect the vulva, vagina, and cervix at each surveillance visit. In high-risk patients, examinations should take place every 3 months for the first 2 years after completing primary treatment and every 6 months until 5 years post treatment. Low-risk patients can be followed every 6 months for 2 years and annually thereafter.

Identification and early treatment of dysplasia is important. Careful attention should also be made to palpation of the inguinal nodal regions. One in 10 women will have a late recurrence (greater than 5 years), so vulvar inspections should continue at least annually for the remainder of a woman’s life.
 

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.

References

1. Gynecol Oncol. 2017 Mar 31. doi: 10.1016/j.ygno.2017.03.022.

2. Obstet Gynecol. 2013 Jan;121(1):129-35.

3. Lancet. 2010 Oct 2;376(9747):1155-63.

4. Gynecol Oncol. 2009 Jan;112(1):265-74.

5. Gynecol Oncol. 2015 Jan;136(1):3-7.

6. Obstet Gynecol. 2011 Sep;118(3):548-53.

7. Gynecol Oncol. 2016 Jan;140(1):8-14.

 

Gynecologic cancers contribute to approximately 15% of cancer survivorship care for women. Many patients share surveillance visits between their gynecologic oncologist and their ob.gyn. or primary care physician to capitalize on preexisting relationships and ensure the provision of comprehensive wellness care. Providing high quality surveillance care is challenging because it requires vigilance in the detection of recurrence but also avoidance of unnecessary, costly, and inaccurate testing.

The oncologic benefits for various surveillance guidelines are not well established by prospective studies. However, in updated surveillance recommendations, the Society of Gynecologic Oncology (SGO) takes available data, costs, and benefits into consideration.1 The guidelines, authored by Ritu Salani, MD, provide an excellent resource for understanding appropriate testing and evaluation during surveillance care.

Dr. Emma C. Rossi
As with screening, the goal of surveillance is to detect recurrence and, thereby, extend survival or palliate symptoms.

The cornerstone of a surveillance visit is a thorough symptom assessment. Positive reporting of symptoms remains the most sensitive method for detecting recurrences; therefore, patients should be educated and quizzed on common recurrence symptoms. For example, endometrial cancer most commonly recurs in the vagina with symptoms of vaginal bleeding or discharge. Lower extremity swelling can signify pelvic sidewall recurrences and abdominal bloating or pain can signify peritoneal recurrence of ovarian or endometrial cancer.

All women who are undergoing surveillance for gynecologic cancers should receive physical examinations that include a pelvic exam with a speculum and bimanual exam with rectovaginal exam. Many locoregional recurrences are salvageable for most gynecologic cancers, which is not true for most distant recurrences, emphasizing the importance of pelvic examinations.

In addition to surveillance of recurrence, these visits should focus on risk modification – tobacco, obesity, bone demineralization – as well as preventive health strategies, such as vaccinations, nongynecologic cancer screenings, and cardiovascular disease intervention. Clinicians should also ask about sequelae to cancer therapy, such as neuropathy, lymphedema, sexual dysfunction, depression, and fatigue.

Dr. Rossi

Endometrial cancer

Endometrial cancer recurs most commonly among women with a history of advanced stage cancer or early stage disease with high/intermediate risk factors, but all survivors should be evaluated regularly for recurrence. The vagina is the most common site for recurrence. Fortunately, many vaginal recurrences can be cured with salvage therapies.

Women with the lowest risk for recurrence (stage IA, grades 1 and 2 disease) who did not originally qualify for adjuvant therapy can be followed every 6 months for 2 years and then annually.

Vaginal cytology is no longer recommended for the routine surveillance of endometrial cancer because of its poor sensitivity in detecting recurrence and low positive predictive value (particularly after vaginal radiation).2 Any suspicious lesions identified on speculum examination should be biopsied, rather than sampled with cytologic smear. Routine imaging (with CT or PET/CT) and cancer antigen (CA) 125 tumor marker assessment is not supported unless the initial stage was advanced. These tests should be reserved for confirmation of concerning symptoms or examination findings.

This group of patients has particular survivorship needs with respect to obesity interventions. Obesity is associated with poor prognosis from endometrial cancer, and patients should be counseled about this and offered strategies for weight loss and lifestyle modification. Lynch syndrome testing and colon cancer screening are also an important consideration in this population.
 

Ovarian cancer

Ovarian cancer recurrence rates are high, and, while salvage therapies are rarely curative, enduring responses may be achieved in some patients, making surveillance visits critical. The SGO recommends surveillance visits every 3 months in the first 2 years, every 4 months in year 3, and then every 6 months for an additional 2 years. At these visits, patients should be queried about symptoms with particular emphasis on peritoneal signs (bloating, distension, gastrointestinal disturbance, and abdominal pain) as most recurrences will be within the peritoneal cavity.

CA 125 tumor marker elevation during the surveillance phase may signal recurrence prior to the development of symptoms but initiating chemotherapy early because of elevations in CA 125 does not improve survival.3 However, in the platinum-sensitive population with a longer disease-free interval, earlier detection of recurrence by CA 125 may identify patients in whom complete secondary cytoreduction is more attainable and is associated with improved survival.4 Therefore, the SGO suggests that CA 125 assessment is optional. The benefits and limitations of earlier detection of recurrence should be discussed with each patient. This recommendation differs for survivors of nonepithelial ovarian cancers (such as germ-cell or sex-cord stromal), in which case the measurement of the appropriate tumor markers (such as alpha-fetoprotein, human chorionic gonadotropin, and inhibin) should be performed routinely as part of surveillance evaluation.

Evidence does not support routine imaging (such as CT or PET). It should be reserved as a confirmatory measure for patients with concerning symptoms, examination findings, or elevations in tumor markers. When ovarian cancer has been treated with fertility-preserving surgery in women of younger reproductive ages, pelvic ultrasounds may be used as part of their surveillance care to monitor retained ovaries and pelvic structures.

BRCA-gene testing should be offered to all women with epithelial ovarian, fallopian tube, and primary peritoneal cancer as it impacts future cancer risk, as well as chemotherapy selection.5
 

 

 

Cervical cancer

In the first 2 years after completing primary treatment for cervical cancer, those at high risk for recurrence (including those who were recommended to adjuvant therapy) should be evaluated every 3 months for 2 years, followed by visits at 6-month intervals for an additional 3 years. Low-risk patients can be followed every 6 months for 2 years, followed by annual visits thereafter.

Pap testing should be performed annually, rather than at each surveillance visit. It should not to detect recurrence – for which it has poor sensitivity and specificity – but rather to detect new HPV-related dysplasia.6

Many patients with cervical cancer have a tobacco use history, placing them at risk for other cancers. Educate patients about the risk and provide cessation assistance.
 

Vulvar cancer

Prognosis for early stage vulvar cancer is very good; however, local recurrences are common (as much as 40%) in the 10 years following diagnosis.7 It is important to thoroughly inspect the vulva, vagina, and cervix at each surveillance visit. In high-risk patients, examinations should take place every 3 months for the first 2 years after completing primary treatment and every 6 months until 5 years post treatment. Low-risk patients can be followed every 6 months for 2 years and annually thereafter.

Identification and early treatment of dysplasia is important. Careful attention should also be made to palpation of the inguinal nodal regions. One in 10 women will have a late recurrence (greater than 5 years), so vulvar inspections should continue at least annually for the remainder of a woman’s life.
 

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.

References

1. Gynecol Oncol. 2017 Mar 31. doi: 10.1016/j.ygno.2017.03.022.

2. Obstet Gynecol. 2013 Jan;121(1):129-35.

3. Lancet. 2010 Oct 2;376(9747):1155-63.

4. Gynecol Oncol. 2009 Jan;112(1):265-74.

5. Gynecol Oncol. 2015 Jan;136(1):3-7.

6. Obstet Gynecol. 2011 Sep;118(3):548-53.

7. Gynecol Oncol. 2016 Jan;140(1):8-14.

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When to consider external cephalic version

Article Type
Changed
Thu, 03/28/2019 - 14:52

 

Editor’s Note: This is the fourth installment of a six-part series that will review key concepts and articles that ob.gyns. can use to prepare for the American Board of Obstetrics and Gynecology Maintenance of Certification examination. The series is adapted from Ob/Gyn Board Master (obgynboardmaster.com), an online board review course created by Erudyte Inc. The series will cover issues in reproductive endocrinology and infertility, maternal-fetal medicine, gynecologic oncology, and female pelvic medicine, as well as general test-taking and study tips.

The American College of Obstetricians and Gynecologists’ “Practice Bulletins” are important practice management guidelines for ob.gyn. clinicians. The Practice Bulletins are rich sources of material often tested on board exams. In February 2016, ACOG issued a revised Practice Bulletin (#161) on external cephalic version outlining clinical considerations and recommendations and providing an algorithm for patient management.1 We recommend you read this bulletin and review this topic carefully.

Dr. Sam Siddighi

Let’s begin with a possible medical board question: According to the Practice Bulletin, which of the following is TRUE about external cephalic version (ECV)?

A. Success rate is lower in women with a previous cesarean delivery.

B. Placental location affects the success rate.

C. External cephalic version should be stopped after 15 minutes.

D. Women at 37 weeks’ gestation are preferred candidates.

E. Tocolysis decreases success rate.

The correct answer is D.

Women at 37 weeks’ gestation are the preferred candidates for an ECV because spontaneous version would likely have already occurred by this time and the risk of spontaneous reversion is lower. Answers A-C and E are incorrect statements.

Key points

Women at 37 weeks’ gestation are the preferred candidates for an ECV.

The overall pooled success rate for ECV is 58% with a 6% pooled complication rate.

The use of parenteral tocolysis has been associated with increased success rates of ECV, though there are not enough data to make a recommendation regarding use of regional anesthesia with the procedure.

Literature summary

ECV is a procedure designed to turn a fetus into vertex presentation by applying external pressure to a woman’s abdomen. Women at 37 weeks’ gestation are the preferred candidates. At this gestational age, spontaneous version is most likely to have occurred, and there is decreased risk of spontaneous reversion after the ECV. All patients who are near term and found to have a fetus in a nonvertex presentation should be offered an ECV as long as there are no contraindications to the procedure. ECV is not appropriate for women who have a contraindication to a vaginal delivery.

There are limited studies of ECV in women who undergo the procedure in early labor and in those who have had a previous uterine surgery. ECV success rates are not affected by a previous cesarean delivery, though the risks of uterine rupture are not clear. The procedure should be attempted only in settings where cesarean delivery services are immediately available.

The success rates of ECV have been reported to be anywhere from 16% to 100%, with an overall pooled success of 58% with a 6% pooled complication rate. Some studies have documented higher success rates with higher parity and a transverse or oblique fetal lie. However, placental location, maternal weight, and amniotic fluid volume have not been consistently found to be predictive of ECV success. The use of parenteral tocolysis has been associated with increased success rates of ECV, though there are not enough data to make a recommendation regarding use of regional anesthesia with the procedure.

ECV should be stopped in the face of a prolonged or significant fetal bradycardia or if the patient is experiencing intolerable levels of discomfort. However, there are no guidelines to recommend the total time limit of the procedure. After the ECV, there should be fetal heart rate monitoring for at least 30 minutes and anti-D immune globulin should be administered to those women who are Rh-negative if delivery is not anticipated in the next 72 hours.
 

Dr. Siddighi is editor-in-chief of the Ob/Gyn Board Master and director of female pelvic medicine and reconstructive surgery and director of grand rounds at Loma Linda University Health in California. Ob.Gyn. News and Ob/Gyn Board Master are owned by the same parent company, Frontline Medical Communications.

Reference

1. Obstet Gynecol. 2016 Feb;127(2):e54-61.

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Editor’s Note: This is the fourth installment of a six-part series that will review key concepts and articles that ob.gyns. can use to prepare for the American Board of Obstetrics and Gynecology Maintenance of Certification examination. The series is adapted from Ob/Gyn Board Master (obgynboardmaster.com), an online board review course created by Erudyte Inc. The series will cover issues in reproductive endocrinology and infertility, maternal-fetal medicine, gynecologic oncology, and female pelvic medicine, as well as general test-taking and study tips.

The American College of Obstetricians and Gynecologists’ “Practice Bulletins” are important practice management guidelines for ob.gyn. clinicians. The Practice Bulletins are rich sources of material often tested on board exams. In February 2016, ACOG issued a revised Practice Bulletin (#161) on external cephalic version outlining clinical considerations and recommendations and providing an algorithm for patient management.1 We recommend you read this bulletin and review this topic carefully.

Dr. Sam Siddighi

Let’s begin with a possible medical board question: According to the Practice Bulletin, which of the following is TRUE about external cephalic version (ECV)?

A. Success rate is lower in women with a previous cesarean delivery.

B. Placental location affects the success rate.

C. External cephalic version should be stopped after 15 minutes.

D. Women at 37 weeks’ gestation are preferred candidates.

E. Tocolysis decreases success rate.

The correct answer is D.

Women at 37 weeks’ gestation are the preferred candidates for an ECV because spontaneous version would likely have already occurred by this time and the risk of spontaneous reversion is lower. Answers A-C and E are incorrect statements.

Key points

Women at 37 weeks’ gestation are the preferred candidates for an ECV.

The overall pooled success rate for ECV is 58% with a 6% pooled complication rate.

The use of parenteral tocolysis has been associated with increased success rates of ECV, though there are not enough data to make a recommendation regarding use of regional anesthesia with the procedure.

Literature summary

ECV is a procedure designed to turn a fetus into vertex presentation by applying external pressure to a woman’s abdomen. Women at 37 weeks’ gestation are the preferred candidates. At this gestational age, spontaneous version is most likely to have occurred, and there is decreased risk of spontaneous reversion after the ECV. All patients who are near term and found to have a fetus in a nonvertex presentation should be offered an ECV as long as there are no contraindications to the procedure. ECV is not appropriate for women who have a contraindication to a vaginal delivery.

There are limited studies of ECV in women who undergo the procedure in early labor and in those who have had a previous uterine surgery. ECV success rates are not affected by a previous cesarean delivery, though the risks of uterine rupture are not clear. The procedure should be attempted only in settings where cesarean delivery services are immediately available.

The success rates of ECV have been reported to be anywhere from 16% to 100%, with an overall pooled success of 58% with a 6% pooled complication rate. Some studies have documented higher success rates with higher parity and a transverse or oblique fetal lie. However, placental location, maternal weight, and amniotic fluid volume have not been consistently found to be predictive of ECV success. The use of parenteral tocolysis has been associated with increased success rates of ECV, though there are not enough data to make a recommendation regarding use of regional anesthesia with the procedure.

ECV should be stopped in the face of a prolonged or significant fetal bradycardia or if the patient is experiencing intolerable levels of discomfort. However, there are no guidelines to recommend the total time limit of the procedure. After the ECV, there should be fetal heart rate monitoring for at least 30 minutes and anti-D immune globulin should be administered to those women who are Rh-negative if delivery is not anticipated in the next 72 hours.
 

Dr. Siddighi is editor-in-chief of the Ob/Gyn Board Master and director of female pelvic medicine and reconstructive surgery and director of grand rounds at Loma Linda University Health in California. Ob.Gyn. News and Ob/Gyn Board Master are owned by the same parent company, Frontline Medical Communications.

Reference

1. Obstet Gynecol. 2016 Feb;127(2):e54-61.

 

Editor’s Note: This is the fourth installment of a six-part series that will review key concepts and articles that ob.gyns. can use to prepare for the American Board of Obstetrics and Gynecology Maintenance of Certification examination. The series is adapted from Ob/Gyn Board Master (obgynboardmaster.com), an online board review course created by Erudyte Inc. The series will cover issues in reproductive endocrinology and infertility, maternal-fetal medicine, gynecologic oncology, and female pelvic medicine, as well as general test-taking and study tips.

The American College of Obstetricians and Gynecologists’ “Practice Bulletins” are important practice management guidelines for ob.gyn. clinicians. The Practice Bulletins are rich sources of material often tested on board exams. In February 2016, ACOG issued a revised Practice Bulletin (#161) on external cephalic version outlining clinical considerations and recommendations and providing an algorithm for patient management.1 We recommend you read this bulletin and review this topic carefully.

Dr. Sam Siddighi

Let’s begin with a possible medical board question: According to the Practice Bulletin, which of the following is TRUE about external cephalic version (ECV)?

A. Success rate is lower in women with a previous cesarean delivery.

B. Placental location affects the success rate.

C. External cephalic version should be stopped after 15 minutes.

D. Women at 37 weeks’ gestation are preferred candidates.

E. Tocolysis decreases success rate.

The correct answer is D.

Women at 37 weeks’ gestation are the preferred candidates for an ECV because spontaneous version would likely have already occurred by this time and the risk of spontaneous reversion is lower. Answers A-C and E are incorrect statements.

Key points

Women at 37 weeks’ gestation are the preferred candidates for an ECV.

The overall pooled success rate for ECV is 58% with a 6% pooled complication rate.

The use of parenteral tocolysis has been associated with increased success rates of ECV, though there are not enough data to make a recommendation regarding use of regional anesthesia with the procedure.

Literature summary

ECV is a procedure designed to turn a fetus into vertex presentation by applying external pressure to a woman’s abdomen. Women at 37 weeks’ gestation are the preferred candidates. At this gestational age, spontaneous version is most likely to have occurred, and there is decreased risk of spontaneous reversion after the ECV. All patients who are near term and found to have a fetus in a nonvertex presentation should be offered an ECV as long as there are no contraindications to the procedure. ECV is not appropriate for women who have a contraindication to a vaginal delivery.

There are limited studies of ECV in women who undergo the procedure in early labor and in those who have had a previous uterine surgery. ECV success rates are not affected by a previous cesarean delivery, though the risks of uterine rupture are not clear. The procedure should be attempted only in settings where cesarean delivery services are immediately available.

The success rates of ECV have been reported to be anywhere from 16% to 100%, with an overall pooled success of 58% with a 6% pooled complication rate. Some studies have documented higher success rates with higher parity and a transverse or oblique fetal lie. However, placental location, maternal weight, and amniotic fluid volume have not been consistently found to be predictive of ECV success. The use of parenteral tocolysis has been associated with increased success rates of ECV, though there are not enough data to make a recommendation regarding use of regional anesthesia with the procedure.

ECV should be stopped in the face of a prolonged or significant fetal bradycardia or if the patient is experiencing intolerable levels of discomfort. However, there are no guidelines to recommend the total time limit of the procedure. After the ECV, there should be fetal heart rate monitoring for at least 30 minutes and anti-D immune globulin should be administered to those women who are Rh-negative if delivery is not anticipated in the next 72 hours.
 

Dr. Siddighi is editor-in-chief of the Ob/Gyn Board Master and director of female pelvic medicine and reconstructive surgery and director of grand rounds at Loma Linda University Health in California. Ob.Gyn. News and Ob/Gyn Board Master are owned by the same parent company, Frontline Medical Communications.

Reference

1. Obstet Gynecol. 2016 Feb;127(2):e54-61.

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On Tap Wednesday

Article Type
Changed
Fri, 09/14/2018 - 11:59

 

HM17 kicks off today with the presentation of the annual SHM Awards of Excellence, which honor work done in service to HM. A nod to the past, as it were. As those physicians are honored, others will be given their prizes as the winners of the Best of Research and Innovations in 2017, a nod to the present state of HM’s investigative spirit.

Dr. Leonard Feldman
Then, the gathered thousands will hear from Patrick M. Conway, MD, MSc, MHM, deputy administrator for innovation and quality for the Centers for Medicare & Medicaid Services and director of its Center for Medicare and Medicaid Innovation. His keynote address on health care transformation will be a road map of the future.

“We’re in the midst ... of a lot of change in the health care system,” said HM17 course director Lenny Feldman, MD, FACP, FAAP, SFHM. “To be able to hear from Dr. Conway as to how the priorities of CMS might be changing and what this all means to us in the future is an amazing opportunity. There is no better time to hear from Pat Conway. I’m really looking forward to it.”

A new highlight this year is Wednesday’s track of Repeated Sessions, something organizers added to ensure that some of the most-popular sessions – “Updates and Pearls in Infectious Diseases,” and “Non-Evidence Based Medicine: Things We Do for No Reason” – are available to as many attendees as possible.

“We’ve added that in this year because we know there are sessions that are standing room only on a regular basis,” Dr. Feldman said. “People should not have to stand.

“I’m hoping that these repeated sessions will be well received and will allow folks to be able to go to some other sessions they might not have in fear they were going to miss some of these typically ‘standing room only’ sessions.”

Meeting/Event
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Meeting/Event
Meeting/Event

 

HM17 kicks off today with the presentation of the annual SHM Awards of Excellence, which honor work done in service to HM. A nod to the past, as it were. As those physicians are honored, others will be given their prizes as the winners of the Best of Research and Innovations in 2017, a nod to the present state of HM’s investigative spirit.

Dr. Leonard Feldman
Then, the gathered thousands will hear from Patrick M. Conway, MD, MSc, MHM, deputy administrator for innovation and quality for the Centers for Medicare & Medicaid Services and director of its Center for Medicare and Medicaid Innovation. His keynote address on health care transformation will be a road map of the future.

“We’re in the midst ... of a lot of change in the health care system,” said HM17 course director Lenny Feldman, MD, FACP, FAAP, SFHM. “To be able to hear from Dr. Conway as to how the priorities of CMS might be changing and what this all means to us in the future is an amazing opportunity. There is no better time to hear from Pat Conway. I’m really looking forward to it.”

A new highlight this year is Wednesday’s track of Repeated Sessions, something organizers added to ensure that some of the most-popular sessions – “Updates and Pearls in Infectious Diseases,” and “Non-Evidence Based Medicine: Things We Do for No Reason” – are available to as many attendees as possible.

“We’ve added that in this year because we know there are sessions that are standing room only on a regular basis,” Dr. Feldman said. “People should not have to stand.

“I’m hoping that these repeated sessions will be well received and will allow folks to be able to go to some other sessions they might not have in fear they were going to miss some of these typically ‘standing room only’ sessions.”

 

HM17 kicks off today with the presentation of the annual SHM Awards of Excellence, which honor work done in service to HM. A nod to the past, as it were. As those physicians are honored, others will be given their prizes as the winners of the Best of Research and Innovations in 2017, a nod to the present state of HM’s investigative spirit.

Dr. Leonard Feldman
Then, the gathered thousands will hear from Patrick M. Conway, MD, MSc, MHM, deputy administrator for innovation and quality for the Centers for Medicare & Medicaid Services and director of its Center for Medicare and Medicaid Innovation. His keynote address on health care transformation will be a road map of the future.

“We’re in the midst ... of a lot of change in the health care system,” said HM17 course director Lenny Feldman, MD, FACP, FAAP, SFHM. “To be able to hear from Dr. Conway as to how the priorities of CMS might be changing and what this all means to us in the future is an amazing opportunity. There is no better time to hear from Pat Conway. I’m really looking forward to it.”

A new highlight this year is Wednesday’s track of Repeated Sessions, something organizers added to ensure that some of the most-popular sessions – “Updates and Pearls in Infectious Diseases,” and “Non-Evidence Based Medicine: Things We Do for No Reason” – are available to as many attendees as possible.

“We’ve added that in this year because we know there are sessions that are standing room only on a regular basis,” Dr. Feldman said. “People should not have to stand.

“I’m hoping that these repeated sessions will be well received and will allow folks to be able to go to some other sessions they might not have in fear they were going to miss some of these typically ‘standing room only’ sessions.”

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NIOSH Tracks Needle Injuries

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Wed, 03/27/2019 - 11:48
The National Institute of Occupational Safety and Health released 2 new web-based portals to track workplace injuries and violence.

The National Institute of Occupational Safety and Health (NIOSH) released 2 new modules for tracking sharps incidents, blood, and body fluid exposures. The Occupational Health Safety Network (OHSN), a free, voluntary system “uniquely available” to U.S. health care facilities, collects injury, data such as date of injury or illness, location of incident, description of illness, and days away from work. The information is intended to help facilities identify high-risk jobs, develop interventions for safety and health of hospital staff, and objectively measure impact over time.

The modules join others that track incidence of slips, trips, and falls; patient handling injuries; and workplace violence.

The OHSN developers say that the secure electronic system hosts facilities across 20 states, all providing data to the web-based portal. The system allows participants to determine the root cause for each incident, analyzes the data, and presents the results in easy-to-read charts. Members can use OHSN to analyze and report workplace-specific data to illustrate the magnitude of injury and illness events among workers, monitor trends, and access a library of resources specific to health care.

As the pool of participants expands, “an increasingly more accurate picture can be drawn,” NIOSH says, and recommendations, interventions, and prevention strategies utilized.

To enroll, visit https://www.cdc.gov/niosh/topics/ohsn/enrollment.html?s_cid=3ni7d2niupdateOHSN-Enroll032017.

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The National Institute of Occupational Safety and Health released 2 new web-based portals to track workplace injuries and violence.
The National Institute of Occupational Safety and Health released 2 new web-based portals to track workplace injuries and violence.

The National Institute of Occupational Safety and Health (NIOSH) released 2 new modules for tracking sharps incidents, blood, and body fluid exposures. The Occupational Health Safety Network (OHSN), a free, voluntary system “uniquely available” to U.S. health care facilities, collects injury, data such as date of injury or illness, location of incident, description of illness, and days away from work. The information is intended to help facilities identify high-risk jobs, develop interventions for safety and health of hospital staff, and objectively measure impact over time.

The modules join others that track incidence of slips, trips, and falls; patient handling injuries; and workplace violence.

The OHSN developers say that the secure electronic system hosts facilities across 20 states, all providing data to the web-based portal. The system allows participants to determine the root cause for each incident, analyzes the data, and presents the results in easy-to-read charts. Members can use OHSN to analyze and report workplace-specific data to illustrate the magnitude of injury and illness events among workers, monitor trends, and access a library of resources specific to health care.

As the pool of participants expands, “an increasingly more accurate picture can be drawn,” NIOSH says, and recommendations, interventions, and prevention strategies utilized.

To enroll, visit https://www.cdc.gov/niosh/topics/ohsn/enrollment.html?s_cid=3ni7d2niupdateOHSN-Enroll032017.

The National Institute of Occupational Safety and Health (NIOSH) released 2 new modules for tracking sharps incidents, blood, and body fluid exposures. The Occupational Health Safety Network (OHSN), a free, voluntary system “uniquely available” to U.S. health care facilities, collects injury, data such as date of injury or illness, location of incident, description of illness, and days away from work. The information is intended to help facilities identify high-risk jobs, develop interventions for safety and health of hospital staff, and objectively measure impact over time.

The modules join others that track incidence of slips, trips, and falls; patient handling injuries; and workplace violence.

The OHSN developers say that the secure electronic system hosts facilities across 20 states, all providing data to the web-based portal. The system allows participants to determine the root cause for each incident, analyzes the data, and presents the results in easy-to-read charts. Members can use OHSN to analyze and report workplace-specific data to illustrate the magnitude of injury and illness events among workers, monitor trends, and access a library of resources specific to health care.

As the pool of participants expands, “an increasingly more accurate picture can be drawn,” NIOSH says, and recommendations, interventions, and prevention strategies utilized.

To enroll, visit https://www.cdc.gov/niosh/topics/ohsn/enrollment.html?s_cid=3ni7d2niupdateOHSN-Enroll032017.

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Experts to review ‘hot topics’ in pediatric hospital medicine research

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Pediatric hospital medicine (PHM) is a fast-moving field, so having the best information is part of being a good doctor. But try going through all the relevant journals every month and pulling out the relevant findings. It’s a tall task.

Never fear! Akshata Hopkins, MD, an academic hospitalist at Johns Hopkins All Children’s Hospital in St. Petersburg, Fla., and Amit Singh, MD, of Stanford (Calif.) Children’s Health, have done the work for you. They reviewed every issue from 18 relevant journals over the last year and chose studies that are “hot topics” and involve important, evolving clinical questions that any physician caring for hospitalized children should know about.
As pediatric hospitalists, “we’re looking at articles from a pediatric hospital medicine standpoint, but the way that we chose the articles was based on topics that are prevalent to not only academic centers but community centers – and so it’s more broad,” Dr. Hopkins said. “The topics themselves are not necessarily new, but there are nuances to management [for which] every year there is new data that’s coming out. So what we’ve done is digest it for them.”

[[{"fid":"195832","view_mode":"medstat_image_flush_right","attributes":{"alt":"Dr. Akshata Hopkins","height":"220","width":"146","class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Akshata Hopkins","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Akshata Hopkins","field_file_image_credit[und][0][value]":""}}}]]Their session at 5:30 p.m. today, “Pediatric Update: Top Articles in Pediatric Hospital Medicine 2016,” will touch on both clinical and systems issues, often with a case used as a way to introduce topics, followed by a review of findings from a recent article. Dr. Hopkins said that questions will be answered throughout the session. Topics will include the management of young febrile infants, nasogastric feeding in bronchiolitis, prediction of severe pneumonia outcomes in children, and a review of quality measures that include patient experience and antibiotic stewardship.

“With the rise of more PCR testing and discussions of Choosing Wisely and high-value care, there’s more testing available,” Dr. Hopkins said. “But what is that going to cost versus what are the benefits that it brings? Are these tests valuable and in what way? And that’s kind of a hot topic. It depends on the age of the child and actually the results of [testing] are a little surprising.”

Dr. Amit Singh

Dr. Singh said he hopes the session appeals to hospitalists in a wide array of care settings. “You want to make sure you are covering the breadth and scope of practice we might find ourselves in, whether it is in an adult hospital as the only hospital-based pediatrician covering ED consults, a NICU, a delivery room, and a small pediatric ward, or whether it is a pediatric hospitalist leading a team of medical students and residents in a large, free-standing, university-affiliated, children’s hospital,” he said.
 

Pediatric Update: Top Articles in Pediatric Hospital Medicine 2016
Wednesday, 5:30–6:20 p.m.

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Pediatric hospital medicine (PHM) is a fast-moving field, so having the best information is part of being a good doctor. But try going through all the relevant journals every month and pulling out the relevant findings. It’s a tall task.

Never fear! Akshata Hopkins, MD, an academic hospitalist at Johns Hopkins All Children’s Hospital in St. Petersburg, Fla., and Amit Singh, MD, of Stanford (Calif.) Children’s Health, have done the work for you. They reviewed every issue from 18 relevant journals over the last year and chose studies that are “hot topics” and involve important, evolving clinical questions that any physician caring for hospitalized children should know about.
As pediatric hospitalists, “we’re looking at articles from a pediatric hospital medicine standpoint, but the way that we chose the articles was based on topics that are prevalent to not only academic centers but community centers – and so it’s more broad,” Dr. Hopkins said. “The topics themselves are not necessarily new, but there are nuances to management [for which] every year there is new data that’s coming out. So what we’ve done is digest it for them.”

[[{"fid":"195832","view_mode":"medstat_image_flush_right","attributes":{"alt":"Dr. Akshata Hopkins","height":"220","width":"146","class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Akshata Hopkins","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Akshata Hopkins","field_file_image_credit[und][0][value]":""}}}]]Their session at 5:30 p.m. today, “Pediatric Update: Top Articles in Pediatric Hospital Medicine 2016,” will touch on both clinical and systems issues, often with a case used as a way to introduce topics, followed by a review of findings from a recent article. Dr. Hopkins said that questions will be answered throughout the session. Topics will include the management of young febrile infants, nasogastric feeding in bronchiolitis, prediction of severe pneumonia outcomes in children, and a review of quality measures that include patient experience and antibiotic stewardship.

“With the rise of more PCR testing and discussions of Choosing Wisely and high-value care, there’s more testing available,” Dr. Hopkins said. “But what is that going to cost versus what are the benefits that it brings? Are these tests valuable and in what way? And that’s kind of a hot topic. It depends on the age of the child and actually the results of [testing] are a little surprising.”

Dr. Amit Singh

Dr. Singh said he hopes the session appeals to hospitalists in a wide array of care settings. “You want to make sure you are covering the breadth and scope of practice we might find ourselves in, whether it is in an adult hospital as the only hospital-based pediatrician covering ED consults, a NICU, a delivery room, and a small pediatric ward, or whether it is a pediatric hospitalist leading a team of medical students and residents in a large, free-standing, university-affiliated, children’s hospital,” he said.
 

Pediatric Update: Top Articles in Pediatric Hospital Medicine 2016
Wednesday, 5:30–6:20 p.m.

Pediatric hospital medicine (PHM) is a fast-moving field, so having the best information is part of being a good doctor. But try going through all the relevant journals every month and pulling out the relevant findings. It’s a tall task.

Never fear! Akshata Hopkins, MD, an academic hospitalist at Johns Hopkins All Children’s Hospital in St. Petersburg, Fla., and Amit Singh, MD, of Stanford (Calif.) Children’s Health, have done the work for you. They reviewed every issue from 18 relevant journals over the last year and chose studies that are “hot topics” and involve important, evolving clinical questions that any physician caring for hospitalized children should know about.
As pediatric hospitalists, “we’re looking at articles from a pediatric hospital medicine standpoint, but the way that we chose the articles was based on topics that are prevalent to not only academic centers but community centers – and so it’s more broad,” Dr. Hopkins said. “The topics themselves are not necessarily new, but there are nuances to management [for which] every year there is new data that’s coming out. So what we’ve done is digest it for them.”

[[{"fid":"195832","view_mode":"medstat_image_flush_right","attributes":{"alt":"Dr. Akshata Hopkins","height":"220","width":"146","class":"media-element file-medstat-image-flush-right","data-delta":"1"},"fields":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Akshata Hopkins","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"Dr. Akshata Hopkins","field_file_image_credit[und][0][value]":""}}}]]Their session at 5:30 p.m. today, “Pediatric Update: Top Articles in Pediatric Hospital Medicine 2016,” will touch on both clinical and systems issues, often with a case used as a way to introduce topics, followed by a review of findings from a recent article. Dr. Hopkins said that questions will be answered throughout the session. Topics will include the management of young febrile infants, nasogastric feeding in bronchiolitis, prediction of severe pneumonia outcomes in children, and a review of quality measures that include patient experience and antibiotic stewardship.

“With the rise of more PCR testing and discussions of Choosing Wisely and high-value care, there’s more testing available,” Dr. Hopkins said. “But what is that going to cost versus what are the benefits that it brings? Are these tests valuable and in what way? And that’s kind of a hot topic. It depends on the age of the child and actually the results of [testing] are a little surprising.”

Dr. Amit Singh

Dr. Singh said he hopes the session appeals to hospitalists in a wide array of care settings. “You want to make sure you are covering the breadth and scope of practice we might find ourselves in, whether it is in an adult hospital as the only hospital-based pediatrician covering ED consults, a NICU, a delivery room, and a small pediatric ward, or whether it is a pediatric hospitalist leading a team of medical students and residents in a large, free-standing, university-affiliated, children’s hospital,” he said.
 

Pediatric Update: Top Articles in Pediatric Hospital Medicine 2016
Wednesday, 5:30–6:20 p.m.

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Telehospitalists can expand capability, capacity

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The cost of health care is on the lips of everyone, from the thousands of HM17 attendees to congressional leaders to President Donald Trump. Yet, one long-promoted answer – telemedicine practiced by telehospitalists – is not as widely adopted as its proponents say it should be. After Wednesday’s session, “Foundations of a Hospital Medicine Telemedicine Program,” which begins at 4:15 p.m., at least a few more physicians will see it as an option.

“The timing is there,” said copresenter Talbot “Mac” McCormick, MD, president and chief executive officer of Eagle Telemedicine of Atlanta. “Telemedicine has come of age.”

[[{"fid":"194482","view_mode":"medstat_image_flush_left","attributes":{"alt":"Dr. Talbot \\\u0022Mac\u0022 McCormick, Eagle telemedicine, Atlanta","height":"220","width":"157","class":"media-element file-medstat-image-flush-left","data-delta":"1"},"fields":{"format":"medstat_image_flush_left","field_file_image_caption[und][0][value]":"Dr. Talbot \u0022Mac\u0022 McCormick","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_left","field_file_image_caption[und][0][value]":"Dr. Talbot \u0022Mac\u0022 McCormick","field_file_image_credit[und][0][value]":""}}}]]Copresenter Shannon Carpenter, BS, MBA, vice president at Charlotte, N.C.–based Carolinas Healthcare System, said telemedicine is a “relevancy issue.”

“We are hearing so much about a need for an alternative care model, [and] the virtual-care model is incredibly relevant in today’s environment,” Ms. Carpenter said. Adding to telemedicine’s basic advantage is its ability to help alleviate staffing issues.

Ms. Shannon Carpenter
Institutions that can’t afford additional full-time equivalents can take advantage of hospitalists based elsewhere who consult via video screens or other technological connections.

“Telemedicine and telehospitalists can support and fill out gaps [and] can expand capability and capacity,” Dr. McCormick added. “Then, the other part is economy of scale. You can share a telehospitalist amongst a couple of small hospitals ... an advantage over each one trying to do it themselves.”

For example, individual institutions might not be able to keep a hospitalist busy 12 hours a night, but a nocturnist is still a requirement.

“When they need somebody, they sure need them,” Dr. McCormick said. “So, you get an economy of scale that several small hospitals effectively can share one physician because the space continuum – not necessarily the time continuum – but the space continuum and the geographic continuum is different engaging telemedicine versus people physically on the ground.”

Ms. Carpenter said that one of the obstacles to telemedicine is simply getting physicians to change habits.

“The biggest hurdles that we experienced were with buy-in for the care-delivery model,” she said. “Surprisingly, it’s not from the patients’ perspectives. It’s from either from the physicians who should be providing the service and/or from the staff in the hospital who aren’t used to the technology or the method of care delivery. To avoid this, it’s just like anything else: over-communication, education, and an ability to explain why and how care will be delivered.”

In addition to the difficulty of changing the culture, integration failures are another potential pitfall, according to Dr. McCormick.

“I think that communication gets to part of that,” he said. “I think [telemedicine should be viewed] ... not [as] a segmented silo of a hospitalist team – to be functional and to work well, it has to be integrated with the team so that it’s just a seamless part of the care team of the doctors, the nurses, the nurse practitioners.”

Both presenters agree that, as value-based payments and alternative payment models proliferate in the coming years, telemedicine will only grow as hospitals and hospitalist group leaders look for cost efficiencies. It will also be broader than just nocturnist services.

Ms. Carpenter said future uses could include expansion to ambulatory clinics for transitioning patients from acute care back to their medical home environment or to telehospitalists supporting paramedics on home visits.

“The use of tools and technology like this can allow care to bridge across these multiple geographic locations of care and do it in a way that provides continuity, economy of scale, consistent and high quality care,” Dr. McCormick said.
 

Foundations of a Hospital Medicine Telemedicine Program
Wednesday, 4:15–5:20 p.m.
Available via HM17 On Demand

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The cost of health care is on the lips of everyone, from the thousands of HM17 attendees to congressional leaders to President Donald Trump. Yet, one long-promoted answer – telemedicine practiced by telehospitalists – is not as widely adopted as its proponents say it should be. After Wednesday’s session, “Foundations of a Hospital Medicine Telemedicine Program,” which begins at 4:15 p.m., at least a few more physicians will see it as an option.

“The timing is there,” said copresenter Talbot “Mac” McCormick, MD, president and chief executive officer of Eagle Telemedicine of Atlanta. “Telemedicine has come of age.”

[[{"fid":"194482","view_mode":"medstat_image_flush_left","attributes":{"alt":"Dr. Talbot \\\u0022Mac\u0022 McCormick, Eagle telemedicine, Atlanta","height":"220","width":"157","class":"media-element file-medstat-image-flush-left","data-delta":"1"},"fields":{"format":"medstat_image_flush_left","field_file_image_caption[und][0][value]":"Dr. Talbot \u0022Mac\u0022 McCormick","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_left","field_file_image_caption[und][0][value]":"Dr. Talbot \u0022Mac\u0022 McCormick","field_file_image_credit[und][0][value]":""}}}]]Copresenter Shannon Carpenter, BS, MBA, vice president at Charlotte, N.C.–based Carolinas Healthcare System, said telemedicine is a “relevancy issue.”

“We are hearing so much about a need for an alternative care model, [and] the virtual-care model is incredibly relevant in today’s environment,” Ms. Carpenter said. Adding to telemedicine’s basic advantage is its ability to help alleviate staffing issues.

Ms. Shannon Carpenter
Institutions that can’t afford additional full-time equivalents can take advantage of hospitalists based elsewhere who consult via video screens or other technological connections.

“Telemedicine and telehospitalists can support and fill out gaps [and] can expand capability and capacity,” Dr. McCormick added. “Then, the other part is economy of scale. You can share a telehospitalist amongst a couple of small hospitals ... an advantage over each one trying to do it themselves.”

For example, individual institutions might not be able to keep a hospitalist busy 12 hours a night, but a nocturnist is still a requirement.

“When they need somebody, they sure need them,” Dr. McCormick said. “So, you get an economy of scale that several small hospitals effectively can share one physician because the space continuum – not necessarily the time continuum – but the space continuum and the geographic continuum is different engaging telemedicine versus people physically on the ground.”

Ms. Carpenter said that one of the obstacles to telemedicine is simply getting physicians to change habits.

“The biggest hurdles that we experienced were with buy-in for the care-delivery model,” she said. “Surprisingly, it’s not from the patients’ perspectives. It’s from either from the physicians who should be providing the service and/or from the staff in the hospital who aren’t used to the technology or the method of care delivery. To avoid this, it’s just like anything else: over-communication, education, and an ability to explain why and how care will be delivered.”

In addition to the difficulty of changing the culture, integration failures are another potential pitfall, according to Dr. McCormick.

“I think that communication gets to part of that,” he said. “I think [telemedicine should be viewed] ... not [as] a segmented silo of a hospitalist team – to be functional and to work well, it has to be integrated with the team so that it’s just a seamless part of the care team of the doctors, the nurses, the nurse practitioners.”

Both presenters agree that, as value-based payments and alternative payment models proliferate in the coming years, telemedicine will only grow as hospitals and hospitalist group leaders look for cost efficiencies. It will also be broader than just nocturnist services.

Ms. Carpenter said future uses could include expansion to ambulatory clinics for transitioning patients from acute care back to their medical home environment or to telehospitalists supporting paramedics on home visits.

“The use of tools and technology like this can allow care to bridge across these multiple geographic locations of care and do it in a way that provides continuity, economy of scale, consistent and high quality care,” Dr. McCormick said.
 

Foundations of a Hospital Medicine Telemedicine Program
Wednesday, 4:15–5:20 p.m.
Available via HM17 On Demand

The cost of health care is on the lips of everyone, from the thousands of HM17 attendees to congressional leaders to President Donald Trump. Yet, one long-promoted answer – telemedicine practiced by telehospitalists – is not as widely adopted as its proponents say it should be. After Wednesday’s session, “Foundations of a Hospital Medicine Telemedicine Program,” which begins at 4:15 p.m., at least a few more physicians will see it as an option.

“The timing is there,” said copresenter Talbot “Mac” McCormick, MD, president and chief executive officer of Eagle Telemedicine of Atlanta. “Telemedicine has come of age.”

[[{"fid":"194482","view_mode":"medstat_image_flush_left","attributes":{"alt":"Dr. Talbot \\\u0022Mac\u0022 McCormick, Eagle telemedicine, Atlanta","height":"220","width":"157","class":"media-element file-medstat-image-flush-left","data-delta":"1"},"fields":{"format":"medstat_image_flush_left","field_file_image_caption[und][0][value]":"Dr. Talbot \u0022Mac\u0022 McCormick","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][format]":"plain_text","field_file_image_credit[und][0][format]":"plain_text"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_left","field_file_image_caption[und][0][value]":"Dr. Talbot \u0022Mac\u0022 McCormick","field_file_image_credit[und][0][value]":""}}}]]Copresenter Shannon Carpenter, BS, MBA, vice president at Charlotte, N.C.–based Carolinas Healthcare System, said telemedicine is a “relevancy issue.”

“We are hearing so much about a need for an alternative care model, [and] the virtual-care model is incredibly relevant in today’s environment,” Ms. Carpenter said. Adding to telemedicine’s basic advantage is its ability to help alleviate staffing issues.

Ms. Shannon Carpenter
Institutions that can’t afford additional full-time equivalents can take advantage of hospitalists based elsewhere who consult via video screens or other technological connections.

“Telemedicine and telehospitalists can support and fill out gaps [and] can expand capability and capacity,” Dr. McCormick added. “Then, the other part is economy of scale. You can share a telehospitalist amongst a couple of small hospitals ... an advantage over each one trying to do it themselves.”

For example, individual institutions might not be able to keep a hospitalist busy 12 hours a night, but a nocturnist is still a requirement.

“When they need somebody, they sure need them,” Dr. McCormick said. “So, you get an economy of scale that several small hospitals effectively can share one physician because the space continuum – not necessarily the time continuum – but the space continuum and the geographic continuum is different engaging telemedicine versus people physically on the ground.”

Ms. Carpenter said that one of the obstacles to telemedicine is simply getting physicians to change habits.

“The biggest hurdles that we experienced were with buy-in for the care-delivery model,” she said. “Surprisingly, it’s not from the patients’ perspectives. It’s from either from the physicians who should be providing the service and/or from the staff in the hospital who aren’t used to the technology or the method of care delivery. To avoid this, it’s just like anything else: over-communication, education, and an ability to explain why and how care will be delivered.”

In addition to the difficulty of changing the culture, integration failures are another potential pitfall, according to Dr. McCormick.

“I think that communication gets to part of that,” he said. “I think [telemedicine should be viewed] ... not [as] a segmented silo of a hospitalist team – to be functional and to work well, it has to be integrated with the team so that it’s just a seamless part of the care team of the doctors, the nurses, the nurse practitioners.”

Both presenters agree that, as value-based payments and alternative payment models proliferate in the coming years, telemedicine will only grow as hospitals and hospitalist group leaders look for cost efficiencies. It will also be broader than just nocturnist services.

Ms. Carpenter said future uses could include expansion to ambulatory clinics for transitioning patients from acute care back to their medical home environment or to telehospitalists supporting paramedics on home visits.

“The use of tools and technology like this can allow care to bridge across these multiple geographic locations of care and do it in a way that provides continuity, economy of scale, consistent and high quality care,” Dr. McCormick said.
 

Foundations of a Hospital Medicine Telemedicine Program
Wednesday, 4:15–5:20 p.m.
Available via HM17 On Demand

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Welcome to Annual Meeting Day 2

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Day 1 has already raised the bar for the SHM Annual Meeting. Day 2, Wednesday, will set a whole new standard with courses, speakers, content, and perspective.

Leading off the day will be the presentation of the best of Research and Innovations. This year, we had hundreds of submissions, and the kickoff of Day 2 will showcase the very best of the best! Following immediately, we will recognize the winners of the SHM Awards of Excellence.

Dr. Brian Harte
After the awards, we will be treated to a highlight – Pat Conway, MD, MSc, MHM, returns to the SHM plenary stage, to give us an update and thoughts from his perch at the Centers for Medicare & Medicaid Services and the Center for Medicare and Medicaid Innovation on the direction of health care reform and transformation. The past 6 months have brought uncertainty and drama to the national health care policy landscape, so this will be a particularly timely and prescient topic.

Then, off to the main meeting!

This year, we anticipated that some sessions would be so hot that we would have to hold them twice to meet the demand. These sessions are labeled with their own track and include my own personal favorite – and ironically named – series at SHM, “Things We Do for No Reason.” So if you missed this or any of the other talks – heart failure, pulmonary embolism, infectious diseases, delirium, and syncope – here’s your second chance!

But wait – there’s more! This year, for the first time, we have Maintenance of Certification credit available for attendees of the MOC-Clinical Updates sessions and the Rapid Fire Sessions. So, go right ahead and get the MOC credits while you catch up on the latest evidence.

Every year, hospitalists, residents, and students from all over submit hundreds of insightful clinical vignettes posters. Lunch and learn in the Exhibit Hall and peruse the great cases while the judges debate over the absolute best. Afterward is the can’t- miss feature at every Annual Meeting: the Update in Hospital Medicine – this year being delivered by a pair of hospitalist leaders from the heartland, Rachel Thompson, MD, MPH, SFHM and Chad Miller, MD, FHM. Come for Rachel and Chad’s interpretation of the most important and relevant recent literature in adult hospital medicine.

Resident or medical student? You’re in good company at HM17. We have more trainees here than ever before. At 5:30 p.m., we’re holding a special session for you: A skills workshop on “Mastering the Job Interview.” We don’t learn these things in medical or residency – learn them at HM17!

A few other key sessions close out Day 2: Ron Greeno, MD, FCCP, MHM, and Nasim Afsar, MD, SFHM, present on the role hospitalists can (and must) play in the rollout and management of Alternative Payment Models. Then, there’s the mysteriously titled “Myths, Misunderstandings, Medicare & Money: PA/NP and Physician Teams in Hospital Medicine.”

Finally, wind down and see what’s new in the pediatrics world with the Pediatric Hospital Medicine Update with Akshata Hopkins, MD, and Amit Singh, MD.

If yesterday set the tone and tomorrow is the wrap up, Day 2 – today – is the middle act of HM17 and is sure to be educational, provocative, exciting, and an exceptional learning experience. Be sure to take time to walk through the exhibit hall. Please also stop by the SHM Booth to meet the hardworking SHM staff who have made this meeting a great success and introduce yourself to members of the Board who will be present in the booth during the course of the meeting!

Dr. Harte is outgoing president of SHM and president of Cleveland Clinic Akron General and Southern Region.

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Day 1 has already raised the bar for the SHM Annual Meeting. Day 2, Wednesday, will set a whole new standard with courses, speakers, content, and perspective.

Leading off the day will be the presentation of the best of Research and Innovations. This year, we had hundreds of submissions, and the kickoff of Day 2 will showcase the very best of the best! Following immediately, we will recognize the winners of the SHM Awards of Excellence.

Dr. Brian Harte
After the awards, we will be treated to a highlight – Pat Conway, MD, MSc, MHM, returns to the SHM plenary stage, to give us an update and thoughts from his perch at the Centers for Medicare & Medicaid Services and the Center for Medicare and Medicaid Innovation on the direction of health care reform and transformation. The past 6 months have brought uncertainty and drama to the national health care policy landscape, so this will be a particularly timely and prescient topic.

Then, off to the main meeting!

This year, we anticipated that some sessions would be so hot that we would have to hold them twice to meet the demand. These sessions are labeled with their own track and include my own personal favorite – and ironically named – series at SHM, “Things We Do for No Reason.” So if you missed this or any of the other talks – heart failure, pulmonary embolism, infectious diseases, delirium, and syncope – here’s your second chance!

But wait – there’s more! This year, for the first time, we have Maintenance of Certification credit available for attendees of the MOC-Clinical Updates sessions and the Rapid Fire Sessions. So, go right ahead and get the MOC credits while you catch up on the latest evidence.

Every year, hospitalists, residents, and students from all over submit hundreds of insightful clinical vignettes posters. Lunch and learn in the Exhibit Hall and peruse the great cases while the judges debate over the absolute best. Afterward is the can’t- miss feature at every Annual Meeting: the Update in Hospital Medicine – this year being delivered by a pair of hospitalist leaders from the heartland, Rachel Thompson, MD, MPH, SFHM and Chad Miller, MD, FHM. Come for Rachel and Chad’s interpretation of the most important and relevant recent literature in adult hospital medicine.

Resident or medical student? You’re in good company at HM17. We have more trainees here than ever before. At 5:30 p.m., we’re holding a special session for you: A skills workshop on “Mastering the Job Interview.” We don’t learn these things in medical or residency – learn them at HM17!

A few other key sessions close out Day 2: Ron Greeno, MD, FCCP, MHM, and Nasim Afsar, MD, SFHM, present on the role hospitalists can (and must) play in the rollout and management of Alternative Payment Models. Then, there’s the mysteriously titled “Myths, Misunderstandings, Medicare & Money: PA/NP and Physician Teams in Hospital Medicine.”

Finally, wind down and see what’s new in the pediatrics world with the Pediatric Hospital Medicine Update with Akshata Hopkins, MD, and Amit Singh, MD.

If yesterday set the tone and tomorrow is the wrap up, Day 2 – today – is the middle act of HM17 and is sure to be educational, provocative, exciting, and an exceptional learning experience. Be sure to take time to walk through the exhibit hall. Please also stop by the SHM Booth to meet the hardworking SHM staff who have made this meeting a great success and introduce yourself to members of the Board who will be present in the booth during the course of the meeting!

Dr. Harte is outgoing president of SHM and president of Cleveland Clinic Akron General and Southern Region.

Day 1 has already raised the bar for the SHM Annual Meeting. Day 2, Wednesday, will set a whole new standard with courses, speakers, content, and perspective.

Leading off the day will be the presentation of the best of Research and Innovations. This year, we had hundreds of submissions, and the kickoff of Day 2 will showcase the very best of the best! Following immediately, we will recognize the winners of the SHM Awards of Excellence.

Dr. Brian Harte
After the awards, we will be treated to a highlight – Pat Conway, MD, MSc, MHM, returns to the SHM plenary stage, to give us an update and thoughts from his perch at the Centers for Medicare & Medicaid Services and the Center for Medicare and Medicaid Innovation on the direction of health care reform and transformation. The past 6 months have brought uncertainty and drama to the national health care policy landscape, so this will be a particularly timely and prescient topic.

Then, off to the main meeting!

This year, we anticipated that some sessions would be so hot that we would have to hold them twice to meet the demand. These sessions are labeled with their own track and include my own personal favorite – and ironically named – series at SHM, “Things We Do for No Reason.” So if you missed this or any of the other talks – heart failure, pulmonary embolism, infectious diseases, delirium, and syncope – here’s your second chance!

But wait – there’s more! This year, for the first time, we have Maintenance of Certification credit available for attendees of the MOC-Clinical Updates sessions and the Rapid Fire Sessions. So, go right ahead and get the MOC credits while you catch up on the latest evidence.

Every year, hospitalists, residents, and students from all over submit hundreds of insightful clinical vignettes posters. Lunch and learn in the Exhibit Hall and peruse the great cases while the judges debate over the absolute best. Afterward is the can’t- miss feature at every Annual Meeting: the Update in Hospital Medicine – this year being delivered by a pair of hospitalist leaders from the heartland, Rachel Thompson, MD, MPH, SFHM and Chad Miller, MD, FHM. Come for Rachel and Chad’s interpretation of the most important and relevant recent literature in adult hospital medicine.

Resident or medical student? You’re in good company at HM17. We have more trainees here than ever before. At 5:30 p.m., we’re holding a special session for you: A skills workshop on “Mastering the Job Interview.” We don’t learn these things in medical or residency – learn them at HM17!

A few other key sessions close out Day 2: Ron Greeno, MD, FCCP, MHM, and Nasim Afsar, MD, SFHM, present on the role hospitalists can (and must) play in the rollout and management of Alternative Payment Models. Then, there’s the mysteriously titled “Myths, Misunderstandings, Medicare & Money: PA/NP and Physician Teams in Hospital Medicine.”

Finally, wind down and see what’s new in the pediatrics world with the Pediatric Hospital Medicine Update with Akshata Hopkins, MD, and Amit Singh, MD.

If yesterday set the tone and tomorrow is the wrap up, Day 2 – today – is the middle act of HM17 and is sure to be educational, provocative, exciting, and an exceptional learning experience. Be sure to take time to walk through the exhibit hall. Please also stop by the SHM Booth to meet the hardworking SHM staff who have made this meeting a great success and introduce yourself to members of the Board who will be present in the booth during the course of the meeting!

Dr. Harte is outgoing president of SHM and president of Cleveland Clinic Akron General and Southern Region.

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Accountability and Whistleblowers in VA Spotlight

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Wed, 03/27/2019 - 11:48
VA Secretary Shulkin vows to root out bad employees but some worry that whistleblowers will not be protected.

In an ongoing effort to improve oversight and to protect potential whistleblowers at the VA, President Trump has signed a new executive order creating the Office of Accountability and Whistleblower Protection. The executive order establishes an office that will report directly to VA Secretary David. J. Shulkin, MD. “Accountability is an important issue to us at VA and something that we’re focusing on to make sure that we have employees who work and are committed to the mission of serving our veterans,” Dr. Shulkin explained at an April 26 press conference. “When we find employees that have deviated from those values, we want to make sure that we can move them outside the VA and not have them working at VA.”

The new office is not the first effort at the VA to protect whistleblowers or to expedite the removal of employees. In 2014 the Office of Accountability and Review was established to increase central office scrutiny of senior-level executives at local and regional VA facilities. In contrast Dr. Shulkin noted, “This is a broader office that will be taking a look at all of our employees.” The current VA Whistleblower Office, created just last year will be incorporated into the new office, according to Dr. Shulkin.

Related: VA Secretary Shulkin Calls for New Powers to Fire VA Employees

Not everyone greeted the announcement with praise. “This rush to fire feds faster, first at VA, but with attempts to spread it across government, comes with a serious risk,” argued Washington Post columnist Joe Davidson. “Yes, due process rights can be slow and cumbersome. They protect, however, not just employees, but more importantly, also the public from a politicized system that favors citizens of one political party over another. Reforms must respect civil service protections. They should be acknowledged by government leaders and not be ignored as they were at the signing.”

Officials at the Project on Government Oversight expressed concern that whistleblowers should have an independent channel to report their concerns. Like the current whistleblower office, the new structure “may do far more damage than good,” the organization reported “It is incredibly important that whistleblowers have the ability to go to an independent office to report wrongdoing, since an internal office could be pressured to act in the VA’s interest by covering up problems and silencing whistleblowers.”

Related: VA Launches Investigation into Cincinnati Facility Mismanagement

Dr. Shulkin insisted that the office did not negate the need for the new legislation that he has called for that would speed the process of firing problem employees. Nor will the new office replace the hot line set up by the White House for veteran complaints about VA service. “These are all 3 efforts that are important for us to identify issues that are preventing us from doing the very best job that we can,” he explained. “We’re keeping our employees and our executives accountable to the values, to be able to work at the VA.  We are soliciting input from veterans who feel that they have issues that they want to share with us, and that’s what the hotline will be doing.” 

While the focus on the effort is on employees malfeasance, Dr. Shulkin cautioned that the VA was still concerned about employee morale and protecting whistleblowers from retaliation. “Our employees have to feel safe, when they see something, to tell us about it,” he explained. “The message is clear that we will not tolerate whistleblower retaliation in the [VA]. And we will take actions if we do determine that retaliation has been imposed upon an employee who has come forth with an issue.”

Related: Deputy Secretary of Veterans Affairs Gibson Defends VA Discipline Guidelines

Dr. Shulkin also announced a new task force that would tackle fraud, waste, and abuse, “to make sure that we are aggressively investigating any issues that might lead to the waste of taxpayer dollars.”

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VA Secretary Shulkin vows to root out bad employees but some worry that whistleblowers will not be protected.
VA Secretary Shulkin vows to root out bad employees but some worry that whistleblowers will not be protected.

In an ongoing effort to improve oversight and to protect potential whistleblowers at the VA, President Trump has signed a new executive order creating the Office of Accountability and Whistleblower Protection. The executive order establishes an office that will report directly to VA Secretary David. J. Shulkin, MD. “Accountability is an important issue to us at VA and something that we’re focusing on to make sure that we have employees who work and are committed to the mission of serving our veterans,” Dr. Shulkin explained at an April 26 press conference. “When we find employees that have deviated from those values, we want to make sure that we can move them outside the VA and not have them working at VA.”

The new office is not the first effort at the VA to protect whistleblowers or to expedite the removal of employees. In 2014 the Office of Accountability and Review was established to increase central office scrutiny of senior-level executives at local and regional VA facilities. In contrast Dr. Shulkin noted, “This is a broader office that will be taking a look at all of our employees.” The current VA Whistleblower Office, created just last year will be incorporated into the new office, according to Dr. Shulkin.

Related: VA Secretary Shulkin Calls for New Powers to Fire VA Employees

Not everyone greeted the announcement with praise. “This rush to fire feds faster, first at VA, but with attempts to spread it across government, comes with a serious risk,” argued Washington Post columnist Joe Davidson. “Yes, due process rights can be slow and cumbersome. They protect, however, not just employees, but more importantly, also the public from a politicized system that favors citizens of one political party over another. Reforms must respect civil service protections. They should be acknowledged by government leaders and not be ignored as they were at the signing.”

Officials at the Project on Government Oversight expressed concern that whistleblowers should have an independent channel to report their concerns. Like the current whistleblower office, the new structure “may do far more damage than good,” the organization reported “It is incredibly important that whistleblowers have the ability to go to an independent office to report wrongdoing, since an internal office could be pressured to act in the VA’s interest by covering up problems and silencing whistleblowers.”

Related: VA Launches Investigation into Cincinnati Facility Mismanagement

Dr. Shulkin insisted that the office did not negate the need for the new legislation that he has called for that would speed the process of firing problem employees. Nor will the new office replace the hot line set up by the White House for veteran complaints about VA service. “These are all 3 efforts that are important for us to identify issues that are preventing us from doing the very best job that we can,” he explained. “We’re keeping our employees and our executives accountable to the values, to be able to work at the VA.  We are soliciting input from veterans who feel that they have issues that they want to share with us, and that’s what the hotline will be doing.” 

While the focus on the effort is on employees malfeasance, Dr. Shulkin cautioned that the VA was still concerned about employee morale and protecting whistleblowers from retaliation. “Our employees have to feel safe, when they see something, to tell us about it,” he explained. “The message is clear that we will not tolerate whistleblower retaliation in the [VA]. And we will take actions if we do determine that retaliation has been imposed upon an employee who has come forth with an issue.”

Related: Deputy Secretary of Veterans Affairs Gibson Defends VA Discipline Guidelines

Dr. Shulkin also announced a new task force that would tackle fraud, waste, and abuse, “to make sure that we are aggressively investigating any issues that might lead to the waste of taxpayer dollars.”

In an ongoing effort to improve oversight and to protect potential whistleblowers at the VA, President Trump has signed a new executive order creating the Office of Accountability and Whistleblower Protection. The executive order establishes an office that will report directly to VA Secretary David. J. Shulkin, MD. “Accountability is an important issue to us at VA and something that we’re focusing on to make sure that we have employees who work and are committed to the mission of serving our veterans,” Dr. Shulkin explained at an April 26 press conference. “When we find employees that have deviated from those values, we want to make sure that we can move them outside the VA and not have them working at VA.”

The new office is not the first effort at the VA to protect whistleblowers or to expedite the removal of employees. In 2014 the Office of Accountability and Review was established to increase central office scrutiny of senior-level executives at local and regional VA facilities. In contrast Dr. Shulkin noted, “This is a broader office that will be taking a look at all of our employees.” The current VA Whistleblower Office, created just last year will be incorporated into the new office, according to Dr. Shulkin.

Related: VA Secretary Shulkin Calls for New Powers to Fire VA Employees

Not everyone greeted the announcement with praise. “This rush to fire feds faster, first at VA, but with attempts to spread it across government, comes with a serious risk,” argued Washington Post columnist Joe Davidson. “Yes, due process rights can be slow and cumbersome. They protect, however, not just employees, but more importantly, also the public from a politicized system that favors citizens of one political party over another. Reforms must respect civil service protections. They should be acknowledged by government leaders and not be ignored as they were at the signing.”

Officials at the Project on Government Oversight expressed concern that whistleblowers should have an independent channel to report their concerns. Like the current whistleblower office, the new structure “may do far more damage than good,” the organization reported “It is incredibly important that whistleblowers have the ability to go to an independent office to report wrongdoing, since an internal office could be pressured to act in the VA’s interest by covering up problems and silencing whistleblowers.”

Related: VA Launches Investigation into Cincinnati Facility Mismanagement

Dr. Shulkin insisted that the office did not negate the need for the new legislation that he has called for that would speed the process of firing problem employees. Nor will the new office replace the hot line set up by the White House for veteran complaints about VA service. “These are all 3 efforts that are important for us to identify issues that are preventing us from doing the very best job that we can,” he explained. “We’re keeping our employees and our executives accountable to the values, to be able to work at the VA.  We are soliciting input from veterans who feel that they have issues that they want to share with us, and that’s what the hotline will be doing.” 

While the focus on the effort is on employees malfeasance, Dr. Shulkin cautioned that the VA was still concerned about employee morale and protecting whistleblowers from retaliation. “Our employees have to feel safe, when they see something, to tell us about it,” he explained. “The message is clear that we will not tolerate whistleblower retaliation in the [VA]. And we will take actions if we do determine that retaliation has been imposed upon an employee who has come forth with an issue.”

Related: Deputy Secretary of Veterans Affairs Gibson Defends VA Discipline Guidelines

Dr. Shulkin also announced a new task force that would tackle fraud, waste, and abuse, “to make sure that we are aggressively investigating any issues that might lead to the waste of taxpayer dollars.”

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