While clinicians are accustomed to managing patients with rheumatoid arthritis and comorbidities, RA patients more frequently have “multimorbidities” – the simultaneous presence of two or more chronic conditions.

“For anyone who sees patients, this is the reality of our lives,” said Jeffrey R. Curtis, MD, at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. Some conditions are “bystanders” that don’t impact RA, some are risk factors for RA, and some can be caused by RA treatments, said Dr. Curtis, professor of medicine and William J. Koopman Professor in Rheumatology and Immunology at the University of Alabama at Birmingham. He discussed several comorbid conditions and their interactions with RA.
 

Obesity’s toll on disease activity

It’s long been recognized that obesity along with RA makes things worse for patients, he said: “If you have a patient who is obese, with a BMI [body mass index] over 30-35, they’re less likely clinically to achieve low disease activity or remission.”

RA and the somatization comorbidity phenotype

A second common co-occurrence is what Dr. Curtis calls a somatization comorbidity phenotype (SCP), defined as RA with several other ailments such as fibromyalgia, depression, anxiety, sleep apnea, or neuropathy. “The troubling thing about this is I could cure this patient’s RA tomorrow, but they actually wouldn’t feel better in their overall health because of other things dragging down their function,” he said, noting patients are more concerned about their fatigue and pain than their swollen joint count or DAS28 score.

Dr. Curtis and his colleagues completed a recent analysis that’s in press in Arthritis Research & Therapy of about 800 RA patients in the United States starting certolizumab pegol (Cimzia) to look for how well patients with this phenotype responded to a tumor necrosis factor (TNF) inhibitor. The percentage of patients with RA plus SCP who achieved American College of Rheumatology (ACR) 20/50/70 scores were all about 10% lower than for patients with RA alone, and about 15% fewer patients achieved remission using a score of less than 2.6 on the DAS28, based on erythrocyte sedimentation rate. There was about a 10% higher withdrawal rate among the RA plus SCP group, compared with those with RA alone, mainly for lack of efficacy, and the RA plus SCP patients had three times the rate of serious infections and twice the rate of nonserious infections of typical RA patients.
 

Impact on choice of therapy

Clinicians have questioned whether multimorbidities should affect the choice of RA therapy, Dr. Curtis said. One of the most vexing scenarios has been in patients with a history of cancer, he noted. There have been five studies worldwide looking at RA therapy in this population. One from Sweden (Ann Rheum Dis. 2015 Dec;74[12]:2137-43), of 240 breast cancer survivors, found no difference in the occurrence or hazard ratio of recurrent breast cancer between those treated with TNF inhibitors versus those who were not. Another study coauthored by Dr. Curtis found similar results (Arthritis Rheumatol. 2016 Dec;68[10]:2403–11).

According to the ACR’s 2015 treatment guidelines, “If your RA patient has a previously treated, solid organ malignancy, there’s no restrictions on what you and I should use,” he said. “Basically, treat them like they hadn’t had a history of cancer.” The exception is for patients with previously treated nonmelanoma skin cancer or melanoma, in whom conventional synthetic DMARDs are preferred over biologics or tofacitinib (Xeljanz). In addition, patients with previously treated lymphoproliferative disorders should be given rituximab (Rituxan) – or DMARDs, abatacept (Orencia), or tocilizumab (Actemra) – over TNF inhibitors. “This is good news,” Dr. Curtis said. “It really expands the range of options for patients, now supported by data, who have a history of cancer and bad RA.”

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Curtis receives research support or serves as a consultant for Amgen, Bristol-Myers Squibb, Corrona, Lilly, Janssen, Myriad, Pfizer, and Sanofi/Regeneron.

While clinicians are accustomed to managing patients with rheumatoid arthritis and comorbidities, RA patients more frequently have “multimorbidities” – the simultaneous presence of two or more chronic conditions.

“For anyone who sees patients, this is the reality of our lives,” said Jeffrey R. Curtis, MD, at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. Some conditions are “bystanders” that don’t impact RA, some are risk factors for RA, and some can be caused by RA treatments, said Dr. Curtis, professor of medicine and William J. Koopman Professor in Rheumatology and Immunology at the University of Alabama at Birmingham. He discussed several comorbid conditions and their interactions with RA.
 

Obesity’s toll on disease activity

It’s long been recognized that obesity along with RA makes things worse for patients, he said: “If you have a patient who is obese, with a BMI [body mass index] over 30-35, they’re less likely clinically to achieve low disease activity or remission.”

RA and the somatization comorbidity phenotype

A second common co-occurrence is what Dr. Curtis calls a somatization comorbidity phenotype (SCP), defined as RA with several other ailments such as fibromyalgia, depression, anxiety, sleep apnea, or neuropathy. “The troubling thing about this is I could cure this patient’s RA tomorrow, but they actually wouldn’t feel better in their overall health because of other things dragging down their function,” he said, noting patients are more concerned about their fatigue and pain than their swollen joint count or DAS28 score.

Dr. Curtis and his colleagues completed a recent analysis that’s in press in Arthritis Research & Therapy of about 800 RA patients in the United States starting certolizumab pegol (Cimzia) to look for how well patients with this phenotype responded to a tumor necrosis factor (TNF) inhibitor. The percentage of patients with RA plus SCP who achieved American College of Rheumatology (ACR) 20/50/70 scores were all about 10% lower than for patients with RA alone, and about 15% fewer patients achieved remission using a score of less than 2.6 on the DAS28, based on erythrocyte sedimentation rate. There was about a 10% higher withdrawal rate among the RA plus SCP group, compared with those with RA alone, mainly for lack of efficacy, and the RA plus SCP patients had three times the rate of serious infections and twice the rate of nonserious infections of typical RA patients.
 

Impact on choice of therapy

Clinicians have questioned whether multimorbidities should affect the choice of RA therapy, Dr. Curtis said. One of the most vexing scenarios has been in patients with a history of cancer, he noted. There have been five studies worldwide looking at RA therapy in this population. One from Sweden (Ann Rheum Dis. 2015 Dec;74[12]:2137-43), of 240 breast cancer survivors, found no difference in the occurrence or hazard ratio of recurrent breast cancer between those treated with TNF inhibitors versus those who were not. Another study coauthored by Dr. Curtis found similar results (Arthritis Rheumatol. 2016 Dec;68[10]:2403–11).

According to the ACR’s 2015 treatment guidelines, “If your RA patient has a previously treated, solid organ malignancy, there’s no restrictions on what you and I should use,” he said. “Basically, treat them like they hadn’t had a history of cancer.” The exception is for patients with previously treated nonmelanoma skin cancer or melanoma, in whom conventional synthetic DMARDs are preferred over biologics or tofacitinib (Xeljanz). In addition, patients with previously treated lymphoproliferative disorders should be given rituximab (Rituxan) – or DMARDs, abatacept (Orencia), or tocilizumab (Actemra) – over TNF inhibitors. “This is good news,” Dr. Curtis said. “It really expands the range of options for patients, now supported by data, who have a history of cancer and bad RA.”

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Curtis receives research support or serves as a consultant for Amgen, Bristol-Myers Squibb, Corrona, Lilly, Janssen, Myriad, Pfizer, and Sanofi/Regeneron.

While clinicians are accustomed to managing patients with rheumatoid arthritis and comorbidities, RA patients more frequently have “multimorbidities” – the simultaneous presence of two or more chronic conditions.

“For anyone who sees patients, this is the reality of our lives,” said Jeffrey R. Curtis, MD, at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. Some conditions are “bystanders” that don’t impact RA, some are risk factors for RA, and some can be caused by RA treatments, said Dr. Curtis, professor of medicine and William J. Koopman Professor in Rheumatology and Immunology at the University of Alabama at Birmingham. He discussed several comorbid conditions and their interactions with RA.
 

Obesity’s toll on disease activity

It’s long been recognized that obesity along with RA makes things worse for patients, he said: “If you have a patient who is obese, with a BMI [body mass index] over 30-35, they’re less likely clinically to achieve low disease activity or remission.”

RA and the somatization comorbidity phenotype

A second common co-occurrence is what Dr. Curtis calls a somatization comorbidity phenotype (SCP), defined as RA with several other ailments such as fibromyalgia, depression, anxiety, sleep apnea, or neuropathy. “The troubling thing about this is I could cure this patient’s RA tomorrow, but they actually wouldn’t feel better in their overall health because of other things dragging down their function,” he said, noting patients are more concerned about their fatigue and pain than their swollen joint count or DAS28 score.

Dr. Curtis and his colleagues completed a recent analysis that’s in press in Arthritis Research & Therapy of about 800 RA patients in the United States starting certolizumab pegol (Cimzia) to look for how well patients with this phenotype responded to a tumor necrosis factor (TNF) inhibitor. The percentage of patients with RA plus SCP who achieved American College of Rheumatology (ACR) 20/50/70 scores were all about 10% lower than for patients with RA alone, and about 15% fewer patients achieved remission using a score of less than 2.6 on the DAS28, based on erythrocyte sedimentation rate. There was about a 10% higher withdrawal rate among the RA plus SCP group, compared with those with RA alone, mainly for lack of efficacy, and the RA plus SCP patients had three times the rate of serious infections and twice the rate of nonserious infections of typical RA patients.
 

Impact on choice of therapy

Clinicians have questioned whether multimorbidities should affect the choice of RA therapy, Dr. Curtis said. One of the most vexing scenarios has been in patients with a history of cancer, he noted. There have been five studies worldwide looking at RA therapy in this population. One from Sweden (Ann Rheum Dis. 2015 Dec;74[12]:2137-43), of 240 breast cancer survivors, found no difference in the occurrence or hazard ratio of recurrent breast cancer between those treated with TNF inhibitors versus those who were not. Another study coauthored by Dr. Curtis found similar results (Arthritis Rheumatol. 2016 Dec;68[10]:2403–11).

According to the ACR’s 2015 treatment guidelines, “If your RA patient has a previously treated, solid organ malignancy, there’s no restrictions on what you and I should use,” he said. “Basically, treat them like they hadn’t had a history of cancer.” The exception is for patients with previously treated nonmelanoma skin cancer or melanoma, in whom conventional synthetic DMARDs are preferred over biologics or tofacitinib (Xeljanz). In addition, patients with previously treated lymphoproliferative disorders should be given rituximab (Rituxan) – or DMARDs, abatacept (Orencia), or tocilizumab (Actemra) – over TNF inhibitors. “This is good news,” Dr. Curtis said. “It really expands the range of options for patients, now supported by data, who have a history of cancer and bad RA.”

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Curtis receives research support or serves as a consultant for Amgen, Bristol-Myers Squibb, Corrona, Lilly, Janssen, Myriad, Pfizer, and Sanofi/Regeneron.

Sexual health screening and counseling is an important part of wellness care for all adolescents, and transgender and gender nonconforming (TGNC) youth are no exception. TGNC youth may avoid routine health visits and sexual health conversations because they fear discrimination in the health care setting and feel uncomfortable about physical exams.¹ Providers should be aware of the potential anxiety patients may feel during health care visits and work to establish an environment of respect and inclusiveness. Below are some tips to help provide care that is inclusive of the diverse gender and sexual identities of the patients we see.

JackF/Thinkstock

Obtaining a sexual history

1. Clearly explain the reasons for asking sexually explicit questions.

TGNC youth experiencing dysphoria may have heightened levels of anxiety when discussing sexuality. Before asking these questions, acknowledge the sensitivity of this topic and explain that this information is important for providers to know so that they can provide appropriate counseling and screening recommendations. This may alleviate some of their discomfort.

2. Ensure confidentiality.

When obtaining sexual health histories, it is crucial to ensure confidential patient encounters, as described by the American Academy of Pediatrics and Society for Adolescent Health and Medicine.^2,3 The Guttmacher Institute provides information about minors’ consent law in each state.⁴

3. Do not assume identity equals behavior.

Sexual and gender identity may not be predictive of sexual behaviors, and providers should not assume behaviors based on a patient’s identity.

Here are some sexual health questions you need to ask:

• Who are you attracted to? What is/are the gender(s) of your partner(s)?
• Have you ever had anal, genital, or oral sex? If yes:

Do you give, receive, or both?

When was the last time you had sex?

How many partners have you had in past 6 months?

Do you use barrier protection most of the time, some of the time, always, or never?

Do you have symptoms of an infection, such as burning when you pee, abnormal genital discharge, pain with sex, or irregular bleeding?

• Have you ever been forced/coerced into having sex?

Starting with open-ended questions about attraction can give patients an opportunity to describe their pattern of attraction. If needed, patients can be prompted with more specific questions about their partners’ genders. It is important to ask explicitly about genital, oral, and anal sex because patients sometimes do not realize that the term sex includes oral and anal sex. Patients also may not be aware that it is possible to spread infections through oral and anal sex.

4. Anatomy and behavior may change over time, and it is important to reassess sexually transmitted infection risk at each visit

Studies suggest that, as gender dysphoria decreases, sexual desires may increase; this is true for all adolescents but of particular interest with TGNC youth. This may affect behaviors.⁵ For youth on hormone therapy, testosterone can increase libido, whereas estrogen may decrease libido and affect sexual function.⁶
 

Physical exam

Dysphoria related to primary and secondary sex characteristics may make exams particularly distressing. Providers should clearly explain reasons for performing various parts of the physical exam. When performing the physical exam, providers should use a gender-affirming approach. This includes using the patient’s identified name and pronouns throughout the visit and asking patients preference for terminology when discussing body parts (some patients may prefer the use of the term “front hole” to vagina).^1,7,8 The exam and evaluation may need to be modified based on comfort. If a patient refuses a speculum exam after the need for the its use has been discussed, consider offering an external genital exam and bimanual exam instead. If a patient refuses to allow a provider to obtain a rectal or vaginal swab, consider allowing patients to self-swab. Providers also should consider whether genital exams can be deferred to subsequent visits. These techniques offer an opportunity to build trust and rapport with patients so that they remain engaged in care and may become comfortable with the necessary tests and procedures at future visits.

Sexual health counseling

Sexual health counseling should address reducing risk and optimizing physical and emotional satisfaction in relationships and encounters.⁹ In addition to assessing risky behaviors and screening for sexually transmitted infections, providers also should provide counseling on safer-sex practices. This includes the use of lubrication to reduce trauma to genital tissues, which can potentiate the spread of infections, and the use of barrier protection, such as external condoms (often referred to as male condoms), internal condoms (often referred to as female condoms), dental dams during oral sex, and gloves for digital penetration. Patients at risk for pregnancy should receive comprehensive contraceptive counseling. TGNC patients may be at increased risk of sexual victimization, and honest discussions about safety in relationships is important. The goal of sexual health counseling should be to promote safe, satisfying experiences for all patients.

Email her at [email protected].

References

1. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People, in Center of Excellence for Transgender Health, Department of Family and Community Medicine, 2nd ed. (San Francisco: University of California, 2016).

2. Pediatrics. 2008. doi: 10.1542/peds.2008-0694.

3. J Adol Health. 2004;35:160-7.

4. An Overview of Minors’ Consent Law: State Laws and Policies. 2017, by the Guttmacher Institute.

5. Eur J Endocrinol. 2011 Aug;165(2):331-7.

6. J Clin Endocrinol Metab. 2009 Sep;94(9):3132-54.

7. Sex Roles. 2013 Jun 1;68(11-12):675-89.

8. J Midwifery Womens Health. 2008 Jul-Aug;53(4):331-7.

9. “The Fenway Guide to Lesbian, Gay, Bisexual, and Transgender Health,” 2nd ed. (Philadelphia: American College of Physicians Press, 2008).

Sexual health screening and counseling is an important part of wellness care for all adolescents, and transgender and gender nonconforming (TGNC) youth are no exception. TGNC youth may avoid routine health visits and sexual health conversations because they fear discrimination in the health care setting and feel uncomfortable about physical exams.¹ Providers should be aware of the potential anxiety patients may feel during health care visits and work to establish an environment of respect and inclusiveness. Below are some tips to help provide care that is inclusive of the diverse gender and sexual identities of the patients we see.

JackF/Thinkstock

Obtaining a sexual history

1. Clearly explain the reasons for asking sexually explicit questions.

TGNC youth experiencing dysphoria may have heightened levels of anxiety when discussing sexuality. Before asking these questions, acknowledge the sensitivity of this topic and explain that this information is important for providers to know so that they can provide appropriate counseling and screening recommendations. This may alleviate some of their discomfort.

2. Ensure confidentiality.

When obtaining sexual health histories, it is crucial to ensure confidential patient encounters, as described by the American Academy of Pediatrics and Society for Adolescent Health and Medicine.^2,3 The Guttmacher Institute provides information about minors’ consent law in each state.⁴

3. Do not assume identity equals behavior.

Sexual and gender identity may not be predictive of sexual behaviors, and providers should not assume behaviors based on a patient’s identity.

Here are some sexual health questions you need to ask:

• Who are you attracted to? What is/are the gender(s) of your partner(s)?
• Have you ever had anal, genital, or oral sex? If yes:

Do you give, receive, or both?

When was the last time you had sex?

How many partners have you had in past 6 months?

Do you use barrier protection most of the time, some of the time, always, or never?

Do you have symptoms of an infection, such as burning when you pee, abnormal genital discharge, pain with sex, or irregular bleeding?

• Have you ever been forced/coerced into having sex?

Starting with open-ended questions about attraction can give patients an opportunity to describe their pattern of attraction. If needed, patients can be prompted with more specific questions about their partners’ genders. It is important to ask explicitly about genital, oral, and anal sex because patients sometimes do not realize that the term sex includes oral and anal sex. Patients also may not be aware that it is possible to spread infections through oral and anal sex.

4. Anatomy and behavior may change over time, and it is important to reassess sexually transmitted infection risk at each visit

Studies suggest that, as gender dysphoria decreases, sexual desires may increase; this is true for all adolescents but of particular interest with TGNC youth. This may affect behaviors.⁵ For youth on hormone therapy, testosterone can increase libido, whereas estrogen may decrease libido and affect sexual function.⁶
 

Physical exam

Dysphoria related to primary and secondary sex characteristics may make exams particularly distressing. Providers should clearly explain reasons for performing various parts of the physical exam. When performing the physical exam, providers should use a gender-affirming approach. This includes using the patient’s identified name and pronouns throughout the visit and asking patients preference for terminology when discussing body parts (some patients may prefer the use of the term “front hole” to vagina).^1,7,8 The exam and evaluation may need to be modified based on comfort. If a patient refuses a speculum exam after the need for the its use has been discussed, consider offering an external genital exam and bimanual exam instead. If a patient refuses to allow a provider to obtain a rectal or vaginal swab, consider allowing patients to self-swab. Providers also should consider whether genital exams can be deferred to subsequent visits. These techniques offer an opportunity to build trust and rapport with patients so that they remain engaged in care and may become comfortable with the necessary tests and procedures at future visits.

Sexual health counseling

Sexual health counseling should address reducing risk and optimizing physical and emotional satisfaction in relationships and encounters.⁹ In addition to assessing risky behaviors and screening for sexually transmitted infections, providers also should provide counseling on safer-sex practices. This includes the use of lubrication to reduce trauma to genital tissues, which can potentiate the spread of infections, and the use of barrier protection, such as external condoms (often referred to as male condoms), internal condoms (often referred to as female condoms), dental dams during oral sex, and gloves for digital penetration. Patients at risk for pregnancy should receive comprehensive contraceptive counseling. TGNC patients may be at increased risk of sexual victimization, and honest discussions about safety in relationships is important. The goal of sexual health counseling should be to promote safe, satisfying experiences for all patients.

Email her at [email protected].

References

1. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People, in Center of Excellence for Transgender Health, Department of Family and Community Medicine, 2nd ed. (San Francisco: University of California, 2016).

2. Pediatrics. 2008. doi: 10.1542/peds.2008-0694.

3. J Adol Health. 2004;35:160-7.

4. An Overview of Minors’ Consent Law: State Laws and Policies. 2017, by the Guttmacher Institute.

5. Eur J Endocrinol. 2011 Aug;165(2):331-7.

6. J Clin Endocrinol Metab. 2009 Sep;94(9):3132-54.

7. Sex Roles. 2013 Jun 1;68(11-12):675-89.

8. J Midwifery Womens Health. 2008 Jul-Aug;53(4):331-7.

9. “The Fenway Guide to Lesbian, Gay, Bisexual, and Transgender Health,” 2nd ed. (Philadelphia: American College of Physicians Press, 2008).

Sexual health screening and counseling is an important part of wellness care for all adolescents, and transgender and gender nonconforming (TGNC) youth are no exception. TGNC youth may avoid routine health visits and sexual health conversations because they fear discrimination in the health care setting and feel uncomfortable about physical exams.¹ Providers should be aware of the potential anxiety patients may feel during health care visits and work to establish an environment of respect and inclusiveness. Below are some tips to help provide care that is inclusive of the diverse gender and sexual identities of the patients we see.

JackF/Thinkstock

Obtaining a sexual history

1. Clearly explain the reasons for asking sexually explicit questions.

TGNC youth experiencing dysphoria may have heightened levels of anxiety when discussing sexuality. Before asking these questions, acknowledge the sensitivity of this topic and explain that this information is important for providers to know so that they can provide appropriate counseling and screening recommendations. This may alleviate some of their discomfort.

2. Ensure confidentiality.

When obtaining sexual health histories, it is crucial to ensure confidential patient encounters, as described by the American Academy of Pediatrics and Society for Adolescent Health and Medicine.^2,3 The Guttmacher Institute provides information about minors’ consent law in each state.⁴

3. Do not assume identity equals behavior.

Sexual and gender identity may not be predictive of sexual behaviors, and providers should not assume behaviors based on a patient’s identity.

Here are some sexual health questions you need to ask:

• Who are you attracted to? What is/are the gender(s) of your partner(s)?
• Have you ever had anal, genital, or oral sex? If yes:

Do you give, receive, or both?

When was the last time you had sex?

How many partners have you had in past 6 months?

Do you use barrier protection most of the time, some of the time, always, or never?

Do you have symptoms of an infection, such as burning when you pee, abnormal genital discharge, pain with sex, or irregular bleeding?

• Have you ever been forced/coerced into having sex?

Starting with open-ended questions about attraction can give patients an opportunity to describe their pattern of attraction. If needed, patients can be prompted with more specific questions about their partners’ genders. It is important to ask explicitly about genital, oral, and anal sex because patients sometimes do not realize that the term sex includes oral and anal sex. Patients also may not be aware that it is possible to spread infections through oral and anal sex.

4. Anatomy and behavior may change over time, and it is important to reassess sexually transmitted infection risk at each visit

Studies suggest that, as gender dysphoria decreases, sexual desires may increase; this is true for all adolescents but of particular interest with TGNC youth. This may affect behaviors.⁵ For youth on hormone therapy, testosterone can increase libido, whereas estrogen may decrease libido and affect sexual function.⁶
 

Physical exam

Dysphoria related to primary and secondary sex characteristics may make exams particularly distressing. Providers should clearly explain reasons for performing various parts of the physical exam. When performing the physical exam, providers should use a gender-affirming approach. This includes using the patient’s identified name and pronouns throughout the visit and asking patients preference for terminology when discussing body parts (some patients may prefer the use of the term “front hole” to vagina).^1,7,8 The exam and evaluation may need to be modified based on comfort. If a patient refuses a speculum exam after the need for the its use has been discussed, consider offering an external genital exam and bimanual exam instead. If a patient refuses to allow a provider to obtain a rectal or vaginal swab, consider allowing patients to self-swab. Providers also should consider whether genital exams can be deferred to subsequent visits. These techniques offer an opportunity to build trust and rapport with patients so that they remain engaged in care and may become comfortable with the necessary tests and procedures at future visits.

Sexual health counseling

Sexual health counseling should address reducing risk and optimizing physical and emotional satisfaction in relationships and encounters.⁹ In addition to assessing risky behaviors and screening for sexually transmitted infections, providers also should provide counseling on safer-sex practices. This includes the use of lubrication to reduce trauma to genital tissues, which can potentiate the spread of infections, and the use of barrier protection, such as external condoms (often referred to as male condoms), internal condoms (often referred to as female condoms), dental dams during oral sex, and gloves for digital penetration. Patients at risk for pregnancy should receive comprehensive contraceptive counseling. TGNC patients may be at increased risk of sexual victimization, and honest discussions about safety in relationships is important. The goal of sexual health counseling should be to promote safe, satisfying experiences for all patients.

Email her at [email protected].

References

1. Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People, in Center of Excellence for Transgender Health, Department of Family and Community Medicine, 2nd ed. (San Francisco: University of California, 2016).

2. Pediatrics. 2008. doi: 10.1542/peds.2008-0694.

3. J Adol Health. 2004;35:160-7.

4. An Overview of Minors’ Consent Law: State Laws and Policies. 2017, by the Guttmacher Institute.

5. Eur J Endocrinol. 2011 Aug;165(2):331-7.

6. J Clin Endocrinol Metab. 2009 Sep;94(9):3132-54.

7. Sex Roles. 2013 Jun 1;68(11-12):675-89.

8. J Midwifery Womens Health. 2008 Jul-Aug;53(4):331-7.

9. “The Fenway Guide to Lesbian, Gay, Bisexual, and Transgender Health,” 2nd ed. (Philadelphia: American College of Physicians Press, 2008).

CHICAGO – The American Academy of Pediatrics has released a new policy statement that in part suggests that physicians can administer influenza vaccine to children and teenagers with egg allergies without any special precautions beyond those that apply to other vaccines.

This is some “egg-citing news,” said Mary Ann Jackson, MD. “In 28 studies with 4,315 egg allergic subjects, 656 of whom had severe allergies, there were no serious allergic reactions.” In other words, there was no respiratory distress or hypotension observed after participants received the influenza vaccine in these studies, she added.

Yangna/Thinkstock

Other reasons to recommend flu vaccination

Dr. Jackson also gave an overview of influenza epidemiology and why ongoing education of patients and families remains essential. “It’s almost flu season now. It’s inevitable – like RSV [respiratory syncytial virus] is inevitable – but when the seasons starts is unknown,” she said. “How severe and long the season will be is also unpredictable.” Which viruses are spread and whether there is a good match between circulating virus and the vaccine are additional unknowns each year.

CHICAGO – The American Academy of Pediatrics has released a new policy statement that in part suggests that physicians can administer influenza vaccine to children and teenagers with egg allergies without any special precautions beyond those that apply to other vaccines.

This is some “egg-citing news,” said Mary Ann Jackson, MD. “In 28 studies with 4,315 egg allergic subjects, 656 of whom had severe allergies, there were no serious allergic reactions.” In other words, there was no respiratory distress or hypotension observed after participants received the influenza vaccine in these studies, she added.

Yangna/Thinkstock

Other reasons to recommend flu vaccination

Dr. Jackson also gave an overview of influenza epidemiology and why ongoing education of patients and families remains essential. “It’s almost flu season now. It’s inevitable – like RSV [respiratory syncytial virus] is inevitable – but when the seasons starts is unknown,” she said. “How severe and long the season will be is also unpredictable.” Which viruses are spread and whether there is a good match between circulating virus and the vaccine are additional unknowns each year.

CHICAGO – The American Academy of Pediatrics has released a new policy statement that in part suggests that physicians can administer influenza vaccine to children and teenagers with egg allergies without any special precautions beyond those that apply to other vaccines.

This is some “egg-citing news,” said Mary Ann Jackson, MD. “In 28 studies with 4,315 egg allergic subjects, 656 of whom had severe allergies, there were no serious allergic reactions.” In other words, there was no respiratory distress or hypotension observed after participants received the influenza vaccine in these studies, she added.

Yangna/Thinkstock

Other reasons to recommend flu vaccination

Dr. Jackson also gave an overview of influenza epidemiology and why ongoing education of patients and families remains essential. “It’s almost flu season now. It’s inevitable – like RSV [respiratory syncytial virus] is inevitable – but when the seasons starts is unknown,” she said. “How severe and long the season will be is also unpredictable.” Which viruses are spread and whether there is a good match between circulating virus and the vaccine are additional unknowns each year.

CHICAGO – Exposure to radiation therapy prior to PD-1/PD-L1 therapy was not associated with improved outcomes in a retrospective review of 66 lung cancer patients.

The patients had stage IIIB or IV non–small cell lung cancer, median age of 64 years, received at least 6 weeks of single-agent anti-PD-1/PD-L1 therapy in the second-line setting or beyond, and had survived at least 8 weeks from immunotherapy initiation. Compared with 13 patients who received no radiation therapy, the 53 who received any prior radiation therapy – including 44 with extracranial radiation and 22 with intracranial radiation – did not differ significantly with respect to progression-free survival (median 4-5 months; hazard ratio, 0.83), or overall survival (median of about 12 months in both groups; HR, 0.96), Christopher Strouse, MD, of the University of Iowa, Iowa City, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

There also were no significant differences in the outcomes between those who had extracranial radiation and those who had intracranial radiation (HRs for PFS and OS, respectively, 0.91 and 1.19), or (on univariate analysis), between those receiving any vs. no intracranial radiation therapy (HRs for PFS and OS, respectively, 0.92 and 0.98), Dr. Strouse said.

The patients who received extracranial radiation therapy had lower lymphocyte counts at the time of anti-PD-1/PD-L1 therapy initiation vs. those who received only radiation therapy (mean lymphocyte count, 809 vs. 1,519), and those who received intracranial radiation therapy were younger than those who did not (median age, 59 vs. 65 years), but the groups were similar with respect to other variables, including gender, histology, performance status, smoking history, KRAS mutation, and number of prior lines of systemic therapies. Anti-PD-1/PD-L1 therapies are promising treatment options for metastatic non–small cell lung cancer, and combining these agents with other immune-modulating therapies may enhance their efficacy and lead to a greater proportion of patients with responses to these treatments, Dr. Strouse noted.

“It’s known that immune response depends on a lot of steps, even beyond the PD-1/PD-L1 axis, and one possible explanation for some of these patients [not responding] may be that there is some failure along the way in some other step,” he said. “Our hypothesis was that radiation therapy would be helpful in overcoming some of these barriers.”

However, in this study, which is limited by small sample size and single-institution retrospective design, no such effect was identified.

The findings conflict with some larger studies, including the recently-reported PACIFIC study, which showed a significant PFS benefit in lung cancer patients who received chemoradiation therapy followed by treatment with the PD-L1 inhibitor durvalumab.

Dr. Strouse said he looks forward to seeing further reports looking into the effects of radiation therapy at different doses and timing.

Invited discussant Heather Wakelee, MD, of Stanford (Calif.) University, also stressed the limitations of the University of Iowa study, and noted that while there are many unanswered questions, findings such as those from the PACIFIC trial show that radiation and PD-L1 inhibition is here to stay.

“It appears safe; there will be more coming,” she said.

Dr. Strouse reported having no disclosures. Dr. Wakelee has been the institutional principal investigator for studies of nivolumab, tocilizumab, and other agents. She has consulted for Peregrine, ACEA, Pfizer, Helsinn, Genentech/Roche, Clovis, and Lilly, and received research/grant support from Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Gilead, Pharmacyclics, and Lilly.

[email protected]

CHICAGO – Exposure to radiation therapy prior to PD-1/PD-L1 therapy was not associated with improved outcomes in a retrospective review of 66 lung cancer patients.

The patients had stage IIIB or IV non–small cell lung cancer, median age of 64 years, received at least 6 weeks of single-agent anti-PD-1/PD-L1 therapy in the second-line setting or beyond, and had survived at least 8 weeks from immunotherapy initiation. Compared with 13 patients who received no radiation therapy, the 53 who received any prior radiation therapy – including 44 with extracranial radiation and 22 with intracranial radiation – did not differ significantly with respect to progression-free survival (median 4-5 months; hazard ratio, 0.83), or overall survival (median of about 12 months in both groups; HR, 0.96), Christopher Strouse, MD, of the University of Iowa, Iowa City, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

There also were no significant differences in the outcomes between those who had extracranial radiation and those who had intracranial radiation (HRs for PFS and OS, respectively, 0.91 and 1.19), or (on univariate analysis), between those receiving any vs. no intracranial radiation therapy (HRs for PFS and OS, respectively, 0.92 and 0.98), Dr. Strouse said.

The patients who received extracranial radiation therapy had lower lymphocyte counts at the time of anti-PD-1/PD-L1 therapy initiation vs. those who received only radiation therapy (mean lymphocyte count, 809 vs. 1,519), and those who received intracranial radiation therapy were younger than those who did not (median age, 59 vs. 65 years), but the groups were similar with respect to other variables, including gender, histology, performance status, smoking history, KRAS mutation, and number of prior lines of systemic therapies. Anti-PD-1/PD-L1 therapies are promising treatment options for metastatic non–small cell lung cancer, and combining these agents with other immune-modulating therapies may enhance their efficacy and lead to a greater proportion of patients with responses to these treatments, Dr. Strouse noted.

“It’s known that immune response depends on a lot of steps, even beyond the PD-1/PD-L1 axis, and one possible explanation for some of these patients [not responding] may be that there is some failure along the way in some other step,” he said. “Our hypothesis was that radiation therapy would be helpful in overcoming some of these barriers.”

However, in this study, which is limited by small sample size and single-institution retrospective design, no such effect was identified.

The findings conflict with some larger studies, including the recently-reported PACIFIC study, which showed a significant PFS benefit in lung cancer patients who received chemoradiation therapy followed by treatment with the PD-L1 inhibitor durvalumab.

Dr. Strouse said he looks forward to seeing further reports looking into the effects of radiation therapy at different doses and timing.

Invited discussant Heather Wakelee, MD, of Stanford (Calif.) University, also stressed the limitations of the University of Iowa study, and noted that while there are many unanswered questions, findings such as those from the PACIFIC trial show that radiation and PD-L1 inhibition is here to stay.

“It appears safe; there will be more coming,” she said.

Dr. Strouse reported having no disclosures. Dr. Wakelee has been the institutional principal investigator for studies of nivolumab, tocilizumab, and other agents. She has consulted for Peregrine, ACEA, Pfizer, Helsinn, Genentech/Roche, Clovis, and Lilly, and received research/grant support from Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Gilead, Pharmacyclics, and Lilly.

[email protected]

CHICAGO – Exposure to radiation therapy prior to PD-1/PD-L1 therapy was not associated with improved outcomes in a retrospective review of 66 lung cancer patients.

The patients had stage IIIB or IV non–small cell lung cancer, median age of 64 years, received at least 6 weeks of single-agent anti-PD-1/PD-L1 therapy in the second-line setting or beyond, and had survived at least 8 weeks from immunotherapy initiation. Compared with 13 patients who received no radiation therapy, the 53 who received any prior radiation therapy – including 44 with extracranial radiation and 22 with intracranial radiation – did not differ significantly with respect to progression-free survival (median 4-5 months; hazard ratio, 0.83), or overall survival (median of about 12 months in both groups; HR, 0.96), Christopher Strouse, MD, of the University of Iowa, Iowa City, reported at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

There also were no significant differences in the outcomes between those who had extracranial radiation and those who had intracranial radiation (HRs for PFS and OS, respectively, 0.91 and 1.19), or (on univariate analysis), between those receiving any vs. no intracranial radiation therapy (HRs for PFS and OS, respectively, 0.92 and 0.98), Dr. Strouse said.

The patients who received extracranial radiation therapy had lower lymphocyte counts at the time of anti-PD-1/PD-L1 therapy initiation vs. those who received only radiation therapy (mean lymphocyte count, 809 vs. 1,519), and those who received intracranial radiation therapy were younger than those who did not (median age, 59 vs. 65 years), but the groups were similar with respect to other variables, including gender, histology, performance status, smoking history, KRAS mutation, and number of prior lines of systemic therapies. Anti-PD-1/PD-L1 therapies are promising treatment options for metastatic non–small cell lung cancer, and combining these agents with other immune-modulating therapies may enhance their efficacy and lead to a greater proportion of patients with responses to these treatments, Dr. Strouse noted.

“It’s known that immune response depends on a lot of steps, even beyond the PD-1/PD-L1 axis, and one possible explanation for some of these patients [not responding] may be that there is some failure along the way in some other step,” he said. “Our hypothesis was that radiation therapy would be helpful in overcoming some of these barriers.”

However, in this study, which is limited by small sample size and single-institution retrospective design, no such effect was identified.

The findings conflict with some larger studies, including the recently-reported PACIFIC study, which showed a significant PFS benefit in lung cancer patients who received chemoradiation therapy followed by treatment with the PD-L1 inhibitor durvalumab.

Dr. Strouse said he looks forward to seeing further reports looking into the effects of radiation therapy at different doses and timing.

Invited discussant Heather Wakelee, MD, of Stanford (Calif.) University, also stressed the limitations of the University of Iowa study, and noted that while there are many unanswered questions, findings such as those from the PACIFIC trial show that radiation and PD-L1 inhibition is here to stay.

“It appears safe; there will be more coming,” she said.

Dr. Strouse reported having no disclosures. Dr. Wakelee has been the institutional principal investigator for studies of nivolumab, tocilizumab, and other agents. She has consulted for Peregrine, ACEA, Pfizer, Helsinn, Genentech/Roche, Clovis, and Lilly, and received research/grant support from Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Gilead, Pharmacyclics, and Lilly.

[email protected]

The International Continence Society (ICS) defines overactive bladder (OAB) as a syndrome of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection [UTI] or obvious pathology."¹ The Agency for Healthcare Research and Quality (AHRQ) reported OAB prevalence to be 15% in US women, with 11% reporting UUI.² OAB represents a significant health care burden that impacts nearly every aspect of life, including physical, emotional, and psychological domains.^3,4 The economic impact is notable; the projected cost is estimated to reach $82.6 billion annually by 2020.⁵

The American Urological Association (AUA) and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) have endorsed an algorithm for use in the evaluation of idiopathic OAB (FIGURE).⁶ If the patient's symptoms are certain, minimal evaluation is needed and it is reasonable to proceed with first-line therapy, which includes fluid management (decreasing caffeine intake and limiting evening fluid intake), bladder retraining drills such as timed voiding, and improving pelvic floor muscles with the use of biofeedback and functional electrical stimulation.^6,7 Pelvic floor muscle training can be facilitated with a referral to a physical therapist trained in pelvic floor muscle education.

If treatment goals are not met with first-line strategies, second-line therapy may be initiated with anticholinergic or β3-adrenergic receptor agonist medications. If symptoms persist after 4 to 8 weeks of pharmacologic therapy, clinicians are encouraged to reassess or refer the patient to a specialist. Further evaluation may include a bladder diary in which the patient documents voided volumes, voiding frequency, and number of incontinent episodes; symptom-specific questionnaires; and/or urodynamic testing.

Related article:
The latest treatments for urinary and fecal incontinence: Which hold water?

Based on that evaluation, the patient may be a candidate for third-line therapy with either intradetrusor onabotulinumtoxinA, posterior tibial nerve stimulation (PTNS), or sacral neuromodulation.

There is a paucity of information comparing third-line therapies. In this Update, we focus on 4 randomized clinical trials that compare third-line treatment options for idiopathic OAB.

Read about how anticholinergic medication and onabotulinumtoxinA compare for treating UUI.

Anticholinergic therapy and onabotulinumtoxinA produce equivalent reductions in the frequency of daily UUI episodes

Visco AG, Brubaker L, Richter HE, et al; for the Pelvic Floor Disorders Network. Anticholinergic therapy vs onabotulinumtoxinA for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.

In a double-blind, double-placebo-controlled randomized trial, Visco and colleagues compared anticholinergic medication with onabotulinumtoxinA 100 U for the treatment of women with UUI.

Details of the study

Two hundred forty-one women with moderate to severe UUI received either 6 months of oral anticholinergic therapy (solifenacin 5 mg daily with the option of dose escalation to 10 mg daily or change to trospium XR 60 mg daily based on the Patient Global Symptom Control score) plus a single intradetrusor injection of saline, or a single intradetrusor injection of onabotulinumtoxinA 100 U plus a 6-month oral placebo regimen.

Inclusion criteria were 5 or more UUI episodes on a 3-day diary, insufficient resolution of symptoms after 2 medications, or being drug naive. Exclusions included a postvoid residual (PVR) urine volume greater than 150 mL or previous therapy with onabotulinumtoxinA.

Participants were scheduled for follow up every 2 to 6 months post randomization, at which time all study medications were discontinued. The primary outcome was reduction from baseline in the mean number of UUI episodes per day over the 6-month period, as recorded in the monthly 3-day bladder diaries. Secondary outcomes included the proportion of participants with complete resolution of UUI, the proportion of participants with 75% or more reduction in UUI episodes, Overactive Bladder Questionnaire Short Form (OABq-SF) scores, other symptom-specific questionnaire scores, and adverse events.

Related article:
Which treatments for pelvic floor disorders are backed by evidence?

Both treatments significantly reduced UUI episodes

At baseline, participants reported a mean (SD) of 5.0 (2.7) UUI episodes per day, and 41% of participants were drug naive. Both treatment groups experienced significant reductions compared with baseline in mean UUI episodes, and the reductions were similar between the 2 groups (reduction of 3.4 episodes per day in the anticholinergic group, reduction of 3.3 episodes in the onabotulinumtoxinA group; P = .81). Complete resolution of UUI was more common in the onabotulinumtoxinA group (27%) as compared with the anticholinergic group (13%) (P = .003). There were no differences in improvement in OABq-SF scores (37.05 in the anticholinergic group vs 37.13 in the onabotulinumtoxinA group; P = .98) or other quality-of-life measures.

Adverse events. The anticholinergic group experienced a higher rate of dry mouth compared with the onabotulinumtoxinA group (46% vs 31%; P = .02) but had lower rates of intermittent catheterization use at 2 months (0% vs 5%, P = .01) and UTIs (13% vs 33%, P<.001).

Strengths and limitations. This was a well-designed, multicenter, randomized double-blind, double placebo-controlled trial. The study design allowed for dose escalation and change to another medication for inadequate symptom control and included drug-naive participants, which increases the generalizability of the results. However, current guidelines recommend reserving onabotulinumtoxinA therapy for third-line therapy, thus deterring this treatment's use in the drug-naive population. Additionally, the lack of a pure placebo arm makes it difficult to interpret the extent to which a placebo effect contributed to observed improvements in clinical symptoms.

Read: onabotulinumtoxinA vs PTNS for OAB.

OnabotulinumtoxinA has greater 9-month durability for OAB symptoms compared with12 weeks of PTNS

Sherif H, Khalil M, Omar R. Management of refractory idiopathic overactive bladder: intradetrusor injection of botulinum toxin type A versus posterior tibial nerve stimulation. Can J Urol. 2017;24(3):8838-8846.

In this randomized clinical trial, Sherif and colleagues compared the safety and efficacy of a single intradetrusor injection of onabotulinumtoxinA 100 U with that of PTNS for OAB.

Details of the study

Sixty adult men and women with OAB who did not respond to medical therapy were randomly assigned to treatment with either onabotulinumtoxinA 100 U or PTNS. Criteria for exclusion were current UTI, PVR urine volume of more than 150 mL, previous radiation therapy or chemotherapy, previous incontinence surgery or bladder malignancy, or presence of mixed urinary incontinence.

At baseline, participants completed a 3-day bladder diary, an OAB symptom score (OABSS) questionnaire, and urodynamic testing. The OABSS questionnaire included 7 questions (scoring range, 0-28), with higher scores indicating worse symptoms, and included subscales for urgency and quality-of-life measures. Total OABSS, urgency score, quality-of-life score, bladder diary records, and urodynamic testing parameters were assessed at 6, 12, 24, and 36 weeks, along with adverse events.

OnabotulinumtoxinA injections were performed under spinal anesthesia. If PVR urine volume was greater than 200 mL at any follow-up visit, participants were instructed to begin clean intermittent self-catheterization. PTNS was administered as weekly 30-minute sessions for 12 consecutive weeks.

Participants' baseline demographics and symptoms were similar. Average age was 45 years. Averages (SD) for duration of anticholinergic use was 13 (0.8) weeks, UUI episode score was 4.5 (1) on 3-day bladder diary, and OABSS was 22 (2.7). Nine-month data were available for 29 participants in the onabotulinumtoxinA group and for 8 in the PTNS group.

Related article:
Update on pelvic floor dysfunction: Focus on urinary incontinence

OnabotulinumtoxinA treatment benefits sustained for 9 months

Through 6 months, compared with baseline assessments, both treatment groups had significant improvements in clinical symptoms and OABSS total score, as well as urgency and quality-of-life subscales. At 3 months, urodynamic study parameters were similarly improved from baseline in both groups.

At 9 months, however, only the onabotulinumtoxinA group, compared with the PTNS group, maintained the significant improvement from baseline in 3-day bladder diary voiding episodes (average [SD], 10.7 [1.01] vs 11.6 [1.09]; P = .009), 3-day bladder diary nocturia episodes (average [SD], 3.8 [1.09] vs 4.4 [0.8]; P = .02), and average [SD] UUI episodes over 3 days (3.5 [1.2] vs 4.2 [1.04]; P = .02). Similarly, onabotulinumtoxinA-treated participants, compared with those treated with PTNS, maintained improvements at 9 months in average (SD): OABSS total score (19.2 [2.4] vs 20.4 [1.7]; P = .03), urgency scores (10.9 [1.3] vs 11.8 [1.4]; P = .009), urine volume at first desire (177.8 [9.2] vs 171.8 [7.7]), maximum cystometric capacity (304 [17.6] vs 290 [13.1]), and Qmax (mL/sec) (20.7 [1.6] vs 22.2 [1.2]).

Adverse events. Average PVR urine volumes were higher in the onabotulinumtoxinA group compared with the PTNS group (36.8 [2.7] vs 32.4 [3.03]; P = .0001) at all time points, and self-catheterization was required in 6.6% of onabotulinumtoxinA-treated participants. Urinary tract infection occurred in 6.6% of participants in the onabotulinumtoxinA group and in none of the PTNS group. In the PTNS group, few experienced pain and minor bleeding at the needle site.

Strengths and limitations. This randomized, open-label trial comparing treatment with onabotulinumtoxinA 100 U and PTNS included both men and women with idiopathic OAB symptoms. The participants were assessed at regular intervals with various measures, and follow-up adherence was good. The sample size was small, so the study may not have been powered to see differences prior to 9 months.

Although at 9 months only the onabotulinumtoxinA group maintained significant improvement over baseline levels, the improvement was diminished, and therefore the clinical meaningfulness is uncertain. Further, participants in the PTNS group did not undergo monthly maintenance therapy after 3 months, which is recommended for those with a 12-week therapeutic response; this may have affected 9-month outcomes in this group. Since the one-time onabotulinumtoxinA 100 U injection was performed under spinal anesthesia, cost comparisons should be considered, since future onabotulinumtoxinA injections would be necessary. 

Read about using different doses of onabotulinumtoxinA for OAB.

OnabotulinumtoxinA 200-U injection provides longer OAB symptom  improvement than 100-U injection

Abdelwahab O, Sherif H, Soliman T, Elbarky I, Eshazly A. Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder. Int Braz J Urol. 2015;41(6):1132-1140.

Abdelwahab and colleagues conducted a single-center, randomized clinical trial to investigate the safety and efficacy of a single injection of intradetrusor onabotulinumtoxinA in 2 different doses (100 U and 200 U) for treatment of OAB.

Details of the study

Eighty adults (63 women, 17 men) who did not benefit from anticholinergic medication during the previous 3 months were randomly assigned to receive either a 100-U (n = 40) or a 200-U (n = 40) injection of onabotulinumtoxinA. Exclusion criteria were PVR urine volume greater than 150 mL and previous radiation therapy or chemotherapy.

Initial assessments -- completed at baseline and at 1, 3, 6, and 9 months -- included the health-related quality-of-life (HR-QOL) questionnaire (maximum score, 100; higher score indicates better quality of life), an abbreviated OABSS questionnaire (4 questions; score range, 0-15; higher score indicates more severe symptoms), and urodynamic evaluation. Outcomes included OABSS, HR-QOL score, and urodynamic parameters at the various time points.

Related article:
Is there a link between impaired mobility and urinary incontinence in elderly, community-dwelling women?

Higher dose, greater symptom improvement and higher adverse event rate

At baseline, participants (average age, 31 years) had an average (SD) OABSS of 1.7 (1.6). OnabotulinumtoxinA treatment with both a 100-U and a 200-U dose resulted in significant improvements (compared with baseline levels) in frequency, nocturia, UUI episodes, OABSS, and urodynamic parameters throughout the 9 months. At 9 months, however, the group treated with the 200-U dose had greater improvements, compared with the group who received a 100-U dose, in urinary frequency symptom scores (mean [SD], 0.32 [0.47] vs 1.1 [0.51]; P<.05), nocturia symptom scores (mean [SD], 0.13 [0.34] vs 0.36 [0.49]; P<.05), UUI symptom scores (mean [SD], 0.68 [0.16] vs 1.26 [1.1]; P<.05), and mean (SD) total OABSS (2.6 [2.31] vs 5.3 [2.11]; P<.05). Similarly, at 9 months the 200-U dose resulted in greater improvements in volume at first desire (mean [SD], 291.8 [42.8] vs 246.8 [53.8] mL; P<.05), volume at strong desire (mean [SD], 392.1 [37.3] vs 313.1 [67.4] mL; P<.05), detrusor pressure (mean [SD], 10.4 [4.0] vs 19.2 [7.8] cm H₂O; P<.05), and maximum cystometric capacity (mean [SD], 430.5 [34.2] vs 350 [69.1] mL; P<.05) compared with the 100-U dose.

Adverse events. No participant had a PVR urine volume greater than 100 mL at any follow-up visit. Postoperative hematuria occurred in 23% of the group treated with onabotulinumtoxinA 200 U versus in 15% of those treated with a 100-U dose. Similarly, UTIs occurred in 17.5% of the 200-U dose group and in 7.5% of the 100-U dose group. Dysuria was reported in 37.5% and 15% of the 200-U and 100-U dose groups, respectively.

Strengths and limitations. This randomized, open-label trial comparing a single injection of 100 U versus 200 U of onabotulinumtoxinA included mostly women. OAB symptoms and urodynamic parameters improved after treatment with both dose levels, but a longer duration of improvement was seen with the 200-U dose. The cohort had a low baseline OAB severity, based on the OABSS questionnaire, and a young average age of participants, which limits the generalizability of the study results to a population with refractory OAB. The 0% rate of clean intermittent self-catheterization postinjection might be based on the study's criteria for requiring clean intermittent catheterization. In addition, the initial postinjection visit occurred at 1 month, possibly missing participants who had symptoms of retention soon after injection.

Read: onabotulinumtoxinA vs sacral neuromodulation therapy for UUI.

Treatment with onabotulinumtoxinA may control UUI symptoms better than sacral neuromodulation therapy

Amundsen CL, Richter HE, Menefee SA, et al; Pelvic Floor Disorders Network. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA. 2016;316(13):1366-1374.

In this multicenter open-label randomized trial, Amundsen and colleagues compared the efficacy and safety of onabotulinumtoxinA 200 U with that of sacral neuromodulation.

Details of the study

Three hundred sixty-four women with UUI had data available for primary analysis at  6 months. Women were considered eligible for the study if they had 6 or more UUI episodes on a 3-day bladder diary, persistent symptoms despite anticholinergic therapy, a PVR urine volume of less than 150 mL, and had never previously received either study treatment.

There were no differences in baseline characteristics of the participants. The average (SD) age of the study population was 63 (11.6) years, with an average (SD) daily number of UUI episodes of 5.3 (2.8). The average (SD) body mass index was 32 (8) kg/m².

Participants were randomly assigned to undergo either sacral neuromodulation (n = 174) or intradetrusor injection of onabotulinumtoxinA 200 U (n = 190). The primary outcome was change from baseline in mean number of daily UUI episodes averaged over 6 months as recorded on a monthly 3-day bladder diary. Secondary outcomes included complete resolution of urgency incontinence, 75% or more reduction in UUI episodes, the Overactive Bladder Questionnaire Short Form (SF) score (range, 0-100; higher score indicates higher symptom severity), the Overactive Bladder Satisfaction of Treatment questionnaire (range, 0-100; higher score indicates better satisfaction), other quality-of-life measures, and adverse events.

Related article:
2015 Update on pelvic floor dysfunction: Bladder pain syndrome

Greater symptom bother improvement, treatment satisfaction with onabotulinumtoxinA 200 U

Participants treated with onabotulinumtoxinA had a greater mean reduction of 3.9 UUI episodes per day than the sacral neuromodulation group's reduction of 3.3 UUI episodes per day (mean difference, 0.63; 95% confidence interval [CI], 0.13-1.14; P = .01). In addition, complete UUI resolution was higher in the onabotulinumtoxinA group as compared with the sacral neuromodulation group (20% vs 4%; P<.001). The onabotulinumtoxinA group also had higher rates of 75% or more reduction of UUI episodes compared with the sacral neuromodulation group (46% vs 26%; P<.001). Over 6 months, both groups had improvements in all quality-of-life measures, but the onabotulinumtoxinA group had greater improvement in symptom bother compared with the sacral neuromodulation group (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0-13.3; P = .002). Furthermore, the onabotulinumtoxinA group had greater treatment satisfaction compared with the sacral neuromodulation group (mean difference, 7.8; 95% CI, 1.6-14.1; P = .01).

Adverse events. Six women (3%) underwent sacral neuromodulation device revision or removal. Approximately 8% of onabotulinumtoxinA-treated participants required intermittent self-catheterization at 1 month, 4% at 3 months, and 2% at 6 months. The risk of UTI was higher in the onabotulinumtoxinA group compared with the sacral neuromodulation group (35% vs 11%; risk difference, 23%; 95% CI, -33% to -13%; P<.001).

Strengths and limitations. This is a well-designed randomized clinical trial comparing clinical outcomes and adverse events after treatment with onabotulinumtoxinA 200-U versus sacral neuromodulation. The interventions were standardized across investigators at multiple sites, and the study design required close follow-up to assess efficacy and adverse events. The study used a 200-U dose based on reported durability of effect at that time and findings of equivalency between onabotulinumtoxinA 100 U and anticholinergic therapy. The US Food and Drug Administration's recommendation to use a 100-U dose in all patients with idiopathic OAB might dissuade clinicians from considering the higher dose of onabotulinumtoxinA. The study was limited by the lack of a placebo group.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The International Continence Society (ICS) defines overactive bladder (OAB) as a syndrome of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection [UTI] or obvious pathology."¹ The Agency for Healthcare Research and Quality (AHRQ) reported OAB prevalence to be 15% in US women, with 11% reporting UUI.² OAB represents a significant health care burden that impacts nearly every aspect of life, including physical, emotional, and psychological domains.^3,4 The economic impact is notable; the projected cost is estimated to reach $82.6 billion annually by 2020.⁵

The American Urological Association (AUA) and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) have endorsed an algorithm for use in the evaluation of idiopathic OAB (FIGURE).⁶ If the patient's symptoms are certain, minimal evaluation is needed and it is reasonable to proceed with first-line therapy, which includes fluid management (decreasing caffeine intake and limiting evening fluid intake), bladder retraining drills such as timed voiding, and improving pelvic floor muscles with the use of biofeedback and functional electrical stimulation.^6,7 Pelvic floor muscle training can be facilitated with a referral to a physical therapist trained in pelvic floor muscle education.

If treatment goals are not met with first-line strategies, second-line therapy may be initiated with anticholinergic or β3-adrenergic receptor agonist medications. If symptoms persist after 4 to 8 weeks of pharmacologic therapy, clinicians are encouraged to reassess or refer the patient to a specialist. Further evaluation may include a bladder diary in which the patient documents voided volumes, voiding frequency, and number of incontinent episodes; symptom-specific questionnaires; and/or urodynamic testing.

Related article:
The latest treatments for urinary and fecal incontinence: Which hold water?

Based on that evaluation, the patient may be a candidate for third-line therapy with either intradetrusor onabotulinumtoxinA, posterior tibial nerve stimulation (PTNS), or sacral neuromodulation.

There is a paucity of information comparing third-line therapies. In this Update, we focus on 4 randomized clinical trials that compare third-line treatment options for idiopathic OAB.

Read about how anticholinergic medication and onabotulinumtoxinA compare for treating UUI.

Anticholinergic therapy and onabotulinumtoxinA produce equivalent reductions in the frequency of daily UUI episodes

Visco AG, Brubaker L, Richter HE, et al; for the Pelvic Floor Disorders Network. Anticholinergic therapy vs onabotulinumtoxinA for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.

In a double-blind, double-placebo-controlled randomized trial, Visco and colleagues compared anticholinergic medication with onabotulinumtoxinA 100 U for the treatment of women with UUI.

Details of the study

Two hundred forty-one women with moderate to severe UUI received either 6 months of oral anticholinergic therapy (solifenacin 5 mg daily with the option of dose escalation to 10 mg daily or change to trospium XR 60 mg daily based on the Patient Global Symptom Control score) plus a single intradetrusor injection of saline, or a single intradetrusor injection of onabotulinumtoxinA 100 U plus a 6-month oral placebo regimen.

Inclusion criteria were 5 or more UUI episodes on a 3-day diary, insufficient resolution of symptoms after 2 medications, or being drug naive. Exclusions included a postvoid residual (PVR) urine volume greater than 150 mL or previous therapy with onabotulinumtoxinA.

Participants were scheduled for follow up every 2 to 6 months post randomization, at which time all study medications were discontinued. The primary outcome was reduction from baseline in the mean number of UUI episodes per day over the 6-month period, as recorded in the monthly 3-day bladder diaries. Secondary outcomes included the proportion of participants with complete resolution of UUI, the proportion of participants with 75% or more reduction in UUI episodes, Overactive Bladder Questionnaire Short Form (OABq-SF) scores, other symptom-specific questionnaire scores, and adverse events.

Related article:
Which treatments for pelvic floor disorders are backed by evidence?

Both treatments significantly reduced UUI episodes

At baseline, participants reported a mean (SD) of 5.0 (2.7) UUI episodes per day, and 41% of participants were drug naive. Both treatment groups experienced significant reductions compared with baseline in mean UUI episodes, and the reductions were similar between the 2 groups (reduction of 3.4 episodes per day in the anticholinergic group, reduction of 3.3 episodes in the onabotulinumtoxinA group; P = .81). Complete resolution of UUI was more common in the onabotulinumtoxinA group (27%) as compared with the anticholinergic group (13%) (P = .003). There were no differences in improvement in OABq-SF scores (37.05 in the anticholinergic group vs 37.13 in the onabotulinumtoxinA group; P = .98) or other quality-of-life measures.

Adverse events. The anticholinergic group experienced a higher rate of dry mouth compared with the onabotulinumtoxinA group (46% vs 31%; P = .02) but had lower rates of intermittent catheterization use at 2 months (0% vs 5%, P = .01) and UTIs (13% vs 33%, P<.001).

Strengths and limitations. This was a well-designed, multicenter, randomized double-blind, double placebo-controlled trial. The study design allowed for dose escalation and change to another medication for inadequate symptom control and included drug-naive participants, which increases the generalizability of the results. However, current guidelines recommend reserving onabotulinumtoxinA therapy for third-line therapy, thus deterring this treatment's use in the drug-naive population. Additionally, the lack of a pure placebo arm makes it difficult to interpret the extent to which a placebo effect contributed to observed improvements in clinical symptoms.

Read: onabotulinumtoxinA vs PTNS for OAB.

OnabotulinumtoxinA has greater 9-month durability for OAB symptoms compared with12 weeks of PTNS

Sherif H, Khalil M, Omar R. Management of refractory idiopathic overactive bladder: intradetrusor injection of botulinum toxin type A versus posterior tibial nerve stimulation. Can J Urol. 2017;24(3):8838-8846.

In this randomized clinical trial, Sherif and colleagues compared the safety and efficacy of a single intradetrusor injection of onabotulinumtoxinA 100 U with that of PTNS for OAB.

Details of the study

Sixty adult men and women with OAB who did not respond to medical therapy were randomly assigned to treatment with either onabotulinumtoxinA 100 U or PTNS. Criteria for exclusion were current UTI, PVR urine volume of more than 150 mL, previous radiation therapy or chemotherapy, previous incontinence surgery or bladder malignancy, or presence of mixed urinary incontinence.

At baseline, participants completed a 3-day bladder diary, an OAB symptom score (OABSS) questionnaire, and urodynamic testing. The OABSS questionnaire included 7 questions (scoring range, 0-28), with higher scores indicating worse symptoms, and included subscales for urgency and quality-of-life measures. Total OABSS, urgency score, quality-of-life score, bladder diary records, and urodynamic testing parameters were assessed at 6, 12, 24, and 36 weeks, along with adverse events.

OnabotulinumtoxinA injections were performed under spinal anesthesia. If PVR urine volume was greater than 200 mL at any follow-up visit, participants were instructed to begin clean intermittent self-catheterization. PTNS was administered as weekly 30-minute sessions for 12 consecutive weeks.

Participants' baseline demographics and symptoms were similar. Average age was 45 years. Averages (SD) for duration of anticholinergic use was 13 (0.8) weeks, UUI episode score was 4.5 (1) on 3-day bladder diary, and OABSS was 22 (2.7). Nine-month data were available for 29 participants in the onabotulinumtoxinA group and for 8 in the PTNS group.

Related article:
Update on pelvic floor dysfunction: Focus on urinary incontinence

OnabotulinumtoxinA treatment benefits sustained for 9 months

Through 6 months, compared with baseline assessments, both treatment groups had significant improvements in clinical symptoms and OABSS total score, as well as urgency and quality-of-life subscales. At 3 months, urodynamic study parameters were similarly improved from baseline in both groups.

At 9 months, however, only the onabotulinumtoxinA group, compared with the PTNS group, maintained the significant improvement from baseline in 3-day bladder diary voiding episodes (average [SD], 10.7 [1.01] vs 11.6 [1.09]; P = .009), 3-day bladder diary nocturia episodes (average [SD], 3.8 [1.09] vs 4.4 [0.8]; P = .02), and average [SD] UUI episodes over 3 days (3.5 [1.2] vs 4.2 [1.04]; P = .02). Similarly, onabotulinumtoxinA-treated participants, compared with those treated with PTNS, maintained improvements at 9 months in average (SD): OABSS total score (19.2 [2.4] vs 20.4 [1.7]; P = .03), urgency scores (10.9 [1.3] vs 11.8 [1.4]; P = .009), urine volume at first desire (177.8 [9.2] vs 171.8 [7.7]), maximum cystometric capacity (304 [17.6] vs 290 [13.1]), and Qmax (mL/sec) (20.7 [1.6] vs 22.2 [1.2]).

Adverse events. Average PVR urine volumes were higher in the onabotulinumtoxinA group compared with the PTNS group (36.8 [2.7] vs 32.4 [3.03]; P = .0001) at all time points, and self-catheterization was required in 6.6% of onabotulinumtoxinA-treated participants. Urinary tract infection occurred in 6.6% of participants in the onabotulinumtoxinA group and in none of the PTNS group. In the PTNS group, few experienced pain and minor bleeding at the needle site.

Strengths and limitations. This randomized, open-label trial comparing treatment with onabotulinumtoxinA 100 U and PTNS included both men and women with idiopathic OAB symptoms. The participants were assessed at regular intervals with various measures, and follow-up adherence was good. The sample size was small, so the study may not have been powered to see differences prior to 9 months.

Although at 9 months only the onabotulinumtoxinA group maintained significant improvement over baseline levels, the improvement was diminished, and therefore the clinical meaningfulness is uncertain. Further, participants in the PTNS group did not undergo monthly maintenance therapy after 3 months, which is recommended for those with a 12-week therapeutic response; this may have affected 9-month outcomes in this group. Since the one-time onabotulinumtoxinA 100 U injection was performed under spinal anesthesia, cost comparisons should be considered, since future onabotulinumtoxinA injections would be necessary. 

Read about using different doses of onabotulinumtoxinA for OAB.

OnabotulinumtoxinA 200-U injection provides longer OAB symptom  improvement than 100-U injection

Abdelwahab O, Sherif H, Soliman T, Elbarky I, Eshazly A. Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder. Int Braz J Urol. 2015;41(6):1132-1140.

Abdelwahab and colleagues conducted a single-center, randomized clinical trial to investigate the safety and efficacy of a single injection of intradetrusor onabotulinumtoxinA in 2 different doses (100 U and 200 U) for treatment of OAB.

Details of the study

Eighty adults (63 women, 17 men) who did not benefit from anticholinergic medication during the previous 3 months were randomly assigned to receive either a 100-U (n = 40) or a 200-U (n = 40) injection of onabotulinumtoxinA. Exclusion criteria were PVR urine volume greater than 150 mL and previous radiation therapy or chemotherapy.

Initial assessments -- completed at baseline and at 1, 3, 6, and 9 months -- included the health-related quality-of-life (HR-QOL) questionnaire (maximum score, 100; higher score indicates better quality of life), an abbreviated OABSS questionnaire (4 questions; score range, 0-15; higher score indicates more severe symptoms), and urodynamic evaluation. Outcomes included OABSS, HR-QOL score, and urodynamic parameters at the various time points.

Related article:
Is there a link between impaired mobility and urinary incontinence in elderly, community-dwelling women?

Higher dose, greater symptom improvement and higher adverse event rate

At baseline, participants (average age, 31 years) had an average (SD) OABSS of 1.7 (1.6). OnabotulinumtoxinA treatment with both a 100-U and a 200-U dose resulted in significant improvements (compared with baseline levels) in frequency, nocturia, UUI episodes, OABSS, and urodynamic parameters throughout the 9 months. At 9 months, however, the group treated with the 200-U dose had greater improvements, compared with the group who received a 100-U dose, in urinary frequency symptom scores (mean [SD], 0.32 [0.47] vs 1.1 [0.51]; P<.05), nocturia symptom scores (mean [SD], 0.13 [0.34] vs 0.36 [0.49]; P<.05), UUI symptom scores (mean [SD], 0.68 [0.16] vs 1.26 [1.1]; P<.05), and mean (SD) total OABSS (2.6 [2.31] vs 5.3 [2.11]; P<.05). Similarly, at 9 months the 200-U dose resulted in greater improvements in volume at first desire (mean [SD], 291.8 [42.8] vs 246.8 [53.8] mL; P<.05), volume at strong desire (mean [SD], 392.1 [37.3] vs 313.1 [67.4] mL; P<.05), detrusor pressure (mean [SD], 10.4 [4.0] vs 19.2 [7.8] cm H₂O; P<.05), and maximum cystometric capacity (mean [SD], 430.5 [34.2] vs 350 [69.1] mL; P<.05) compared with the 100-U dose.

Adverse events. No participant had a PVR urine volume greater than 100 mL at any follow-up visit. Postoperative hematuria occurred in 23% of the group treated with onabotulinumtoxinA 200 U versus in 15% of those treated with a 100-U dose. Similarly, UTIs occurred in 17.5% of the 200-U dose group and in 7.5% of the 100-U dose group. Dysuria was reported in 37.5% and 15% of the 200-U and 100-U dose groups, respectively.

Strengths and limitations. This randomized, open-label trial comparing a single injection of 100 U versus 200 U of onabotulinumtoxinA included mostly women. OAB symptoms and urodynamic parameters improved after treatment with both dose levels, but a longer duration of improvement was seen with the 200-U dose. The cohort had a low baseline OAB severity, based on the OABSS questionnaire, and a young average age of participants, which limits the generalizability of the study results to a population with refractory OAB. The 0% rate of clean intermittent self-catheterization postinjection might be based on the study's criteria for requiring clean intermittent catheterization. In addition, the initial postinjection visit occurred at 1 month, possibly missing participants who had symptoms of retention soon after injection.

Read: onabotulinumtoxinA vs sacral neuromodulation therapy for UUI.

Treatment with onabotulinumtoxinA may control UUI symptoms better than sacral neuromodulation therapy

Amundsen CL, Richter HE, Menefee SA, et al; Pelvic Floor Disorders Network. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA. 2016;316(13):1366-1374.

In this multicenter open-label randomized trial, Amundsen and colleagues compared the efficacy and safety of onabotulinumtoxinA 200 U with that of sacral neuromodulation.

Details of the study

Three hundred sixty-four women with UUI had data available for primary analysis at  6 months. Women were considered eligible for the study if they had 6 or more UUI episodes on a 3-day bladder diary, persistent symptoms despite anticholinergic therapy, a PVR urine volume of less than 150 mL, and had never previously received either study treatment.

There were no differences in baseline characteristics of the participants. The average (SD) age of the study population was 63 (11.6) years, with an average (SD) daily number of UUI episodes of 5.3 (2.8). The average (SD) body mass index was 32 (8) kg/m².

Participants were randomly assigned to undergo either sacral neuromodulation (n = 174) or intradetrusor injection of onabotulinumtoxinA 200 U (n = 190). The primary outcome was change from baseline in mean number of daily UUI episodes averaged over 6 months as recorded on a monthly 3-day bladder diary. Secondary outcomes included complete resolution of urgency incontinence, 75% or more reduction in UUI episodes, the Overactive Bladder Questionnaire Short Form (SF) score (range, 0-100; higher score indicates higher symptom severity), the Overactive Bladder Satisfaction of Treatment questionnaire (range, 0-100; higher score indicates better satisfaction), other quality-of-life measures, and adverse events.

Related article:
2015 Update on pelvic floor dysfunction: Bladder pain syndrome

Greater symptom bother improvement, treatment satisfaction with onabotulinumtoxinA 200 U

Participants treated with onabotulinumtoxinA had a greater mean reduction of 3.9 UUI episodes per day than the sacral neuromodulation group's reduction of 3.3 UUI episodes per day (mean difference, 0.63; 95% confidence interval [CI], 0.13-1.14; P = .01). In addition, complete UUI resolution was higher in the onabotulinumtoxinA group as compared with the sacral neuromodulation group (20% vs 4%; P<.001). The onabotulinumtoxinA group also had higher rates of 75% or more reduction of UUI episodes compared with the sacral neuromodulation group (46% vs 26%; P<.001). Over 6 months, both groups had improvements in all quality-of-life measures, but the onabotulinumtoxinA group had greater improvement in symptom bother compared with the sacral neuromodulation group (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0-13.3; P = .002). Furthermore, the onabotulinumtoxinA group had greater treatment satisfaction compared with the sacral neuromodulation group (mean difference, 7.8; 95% CI, 1.6-14.1; P = .01).

Adverse events. Six women (3%) underwent sacral neuromodulation device revision or removal. Approximately 8% of onabotulinumtoxinA-treated participants required intermittent self-catheterization at 1 month, 4% at 3 months, and 2% at 6 months. The risk of UTI was higher in the onabotulinumtoxinA group compared with the sacral neuromodulation group (35% vs 11%; risk difference, 23%; 95% CI, -33% to -13%; P<.001).

Strengths and limitations. This is a well-designed randomized clinical trial comparing clinical outcomes and adverse events after treatment with onabotulinumtoxinA 200-U versus sacral neuromodulation. The interventions were standardized across investigators at multiple sites, and the study design required close follow-up to assess efficacy and adverse events. The study used a 200-U dose based on reported durability of effect at that time and findings of equivalency between onabotulinumtoxinA 100 U and anticholinergic therapy. The US Food and Drug Administration's recommendation to use a 100-U dose in all patients with idiopathic OAB might dissuade clinicians from considering the higher dose of onabotulinumtoxinA. The study was limited by the lack of a placebo group.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The International Continence Society (ICS) defines overactive bladder (OAB) as a syndrome of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence (UUI), in the absence of urinary tract infection [UTI] or obvious pathology."¹ The Agency for Healthcare Research and Quality (AHRQ) reported OAB prevalence to be 15% in US women, with 11% reporting UUI.² OAB represents a significant health care burden that impacts nearly every aspect of life, including physical, emotional, and psychological domains.^3,4 The economic impact is notable; the projected cost is estimated to reach $82.6 billion annually by 2020.⁵

The American Urological Association (AUA) and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) have endorsed an algorithm for use in the evaluation of idiopathic OAB (FIGURE).⁶ If the patient's symptoms are certain, minimal evaluation is needed and it is reasonable to proceed with first-line therapy, which includes fluid management (decreasing caffeine intake and limiting evening fluid intake), bladder retraining drills such as timed voiding, and improving pelvic floor muscles with the use of biofeedback and functional electrical stimulation.^6,7 Pelvic floor muscle training can be facilitated with a referral to a physical therapist trained in pelvic floor muscle education.

If treatment goals are not met with first-line strategies, second-line therapy may be initiated with anticholinergic or β3-adrenergic receptor agonist medications. If symptoms persist after 4 to 8 weeks of pharmacologic therapy, clinicians are encouraged to reassess or refer the patient to a specialist. Further evaluation may include a bladder diary in which the patient documents voided volumes, voiding frequency, and number of incontinent episodes; symptom-specific questionnaires; and/or urodynamic testing.

Related article:
The latest treatments for urinary and fecal incontinence: Which hold water?

Based on that evaluation, the patient may be a candidate for third-line therapy with either intradetrusor onabotulinumtoxinA, posterior tibial nerve stimulation (PTNS), or sacral neuromodulation.

There is a paucity of information comparing third-line therapies. In this Update, we focus on 4 randomized clinical trials that compare third-line treatment options for idiopathic OAB.

Read about how anticholinergic medication and onabotulinumtoxinA compare for treating UUI.

Anticholinergic therapy and onabotulinumtoxinA produce equivalent reductions in the frequency of daily UUI episodes

Visco AG, Brubaker L, Richter HE, et al; for the Pelvic Floor Disorders Network. Anticholinergic therapy vs onabotulinumtoxinA for urgency urinary incontinence. N Engl J Med. 2012;367(19):1803-1813.

In a double-blind, double-placebo-controlled randomized trial, Visco and colleagues compared anticholinergic medication with onabotulinumtoxinA 100 U for the treatment of women with UUI.

Details of the study

Two hundred forty-one women with moderate to severe UUI received either 6 months of oral anticholinergic therapy (solifenacin 5 mg daily with the option of dose escalation to 10 mg daily or change to trospium XR 60 mg daily based on the Patient Global Symptom Control score) plus a single intradetrusor injection of saline, or a single intradetrusor injection of onabotulinumtoxinA 100 U plus a 6-month oral placebo regimen.

Inclusion criteria were 5 or more UUI episodes on a 3-day diary, insufficient resolution of symptoms after 2 medications, or being drug naive. Exclusions included a postvoid residual (PVR) urine volume greater than 150 mL or previous therapy with onabotulinumtoxinA.

Participants were scheduled for follow up every 2 to 6 months post randomization, at which time all study medications were discontinued. The primary outcome was reduction from baseline in the mean number of UUI episodes per day over the 6-month period, as recorded in the monthly 3-day bladder diaries. Secondary outcomes included the proportion of participants with complete resolution of UUI, the proportion of participants with 75% or more reduction in UUI episodes, Overactive Bladder Questionnaire Short Form (OABq-SF) scores, other symptom-specific questionnaire scores, and adverse events.

Related article:
Which treatments for pelvic floor disorders are backed by evidence?

Both treatments significantly reduced UUI episodes

At baseline, participants reported a mean (SD) of 5.0 (2.7) UUI episodes per day, and 41% of participants were drug naive. Both treatment groups experienced significant reductions compared with baseline in mean UUI episodes, and the reductions were similar between the 2 groups (reduction of 3.4 episodes per day in the anticholinergic group, reduction of 3.3 episodes in the onabotulinumtoxinA group; P = .81). Complete resolution of UUI was more common in the onabotulinumtoxinA group (27%) as compared with the anticholinergic group (13%) (P = .003). There were no differences in improvement in OABq-SF scores (37.05 in the anticholinergic group vs 37.13 in the onabotulinumtoxinA group; P = .98) or other quality-of-life measures.

Adverse events. The anticholinergic group experienced a higher rate of dry mouth compared with the onabotulinumtoxinA group (46% vs 31%; P = .02) but had lower rates of intermittent catheterization use at 2 months (0% vs 5%, P = .01) and UTIs (13% vs 33%, P<.001).

Strengths and limitations. This was a well-designed, multicenter, randomized double-blind, double placebo-controlled trial. The study design allowed for dose escalation and change to another medication for inadequate symptom control and included drug-naive participants, which increases the generalizability of the results. However, current guidelines recommend reserving onabotulinumtoxinA therapy for third-line therapy, thus deterring this treatment's use in the drug-naive population. Additionally, the lack of a pure placebo arm makes it difficult to interpret the extent to which a placebo effect contributed to observed improvements in clinical symptoms.

Read: onabotulinumtoxinA vs PTNS for OAB.

OnabotulinumtoxinA has greater 9-month durability for OAB symptoms compared with12 weeks of PTNS

Sherif H, Khalil M, Omar R. Management of refractory idiopathic overactive bladder: intradetrusor injection of botulinum toxin type A versus posterior tibial nerve stimulation. Can J Urol. 2017;24(3):8838-8846.

In this randomized clinical trial, Sherif and colleagues compared the safety and efficacy of a single intradetrusor injection of onabotulinumtoxinA 100 U with that of PTNS for OAB.

Details of the study

Sixty adult men and women with OAB who did not respond to medical therapy were randomly assigned to treatment with either onabotulinumtoxinA 100 U or PTNS. Criteria for exclusion were current UTI, PVR urine volume of more than 150 mL, previous radiation therapy or chemotherapy, previous incontinence surgery or bladder malignancy, or presence of mixed urinary incontinence.

At baseline, participants completed a 3-day bladder diary, an OAB symptom score (OABSS) questionnaire, and urodynamic testing. The OABSS questionnaire included 7 questions (scoring range, 0-28), with higher scores indicating worse symptoms, and included subscales for urgency and quality-of-life measures. Total OABSS, urgency score, quality-of-life score, bladder diary records, and urodynamic testing parameters were assessed at 6, 12, 24, and 36 weeks, along with adverse events.

OnabotulinumtoxinA injections were performed under spinal anesthesia. If PVR urine volume was greater than 200 mL at any follow-up visit, participants were instructed to begin clean intermittent self-catheterization. PTNS was administered as weekly 30-minute sessions for 12 consecutive weeks.

Participants' baseline demographics and symptoms were similar. Average age was 45 years. Averages (SD) for duration of anticholinergic use was 13 (0.8) weeks, UUI episode score was 4.5 (1) on 3-day bladder diary, and OABSS was 22 (2.7). Nine-month data were available for 29 participants in the onabotulinumtoxinA group and for 8 in the PTNS group.

Related article:
Update on pelvic floor dysfunction: Focus on urinary incontinence

OnabotulinumtoxinA treatment benefits sustained for 9 months

Through 6 months, compared with baseline assessments, both treatment groups had significant improvements in clinical symptoms and OABSS total score, as well as urgency and quality-of-life subscales. At 3 months, urodynamic study parameters were similarly improved from baseline in both groups.

At 9 months, however, only the onabotulinumtoxinA group, compared with the PTNS group, maintained the significant improvement from baseline in 3-day bladder diary voiding episodes (average [SD], 10.7 [1.01] vs 11.6 [1.09]; P = .009), 3-day bladder diary nocturia episodes (average [SD], 3.8 [1.09] vs 4.4 [0.8]; P = .02), and average [SD] UUI episodes over 3 days (3.5 [1.2] vs 4.2 [1.04]; P = .02). Similarly, onabotulinumtoxinA-treated participants, compared with those treated with PTNS, maintained improvements at 9 months in average (SD): OABSS total score (19.2 [2.4] vs 20.4 [1.7]; P = .03), urgency scores (10.9 [1.3] vs 11.8 [1.4]; P = .009), urine volume at first desire (177.8 [9.2] vs 171.8 [7.7]), maximum cystometric capacity (304 [17.6] vs 290 [13.1]), and Qmax (mL/sec) (20.7 [1.6] vs 22.2 [1.2]).

Adverse events. Average PVR urine volumes were higher in the onabotulinumtoxinA group compared with the PTNS group (36.8 [2.7] vs 32.4 [3.03]; P = .0001) at all time points, and self-catheterization was required in 6.6% of onabotulinumtoxinA-treated participants. Urinary tract infection occurred in 6.6% of participants in the onabotulinumtoxinA group and in none of the PTNS group. In the PTNS group, few experienced pain and minor bleeding at the needle site.

Strengths and limitations. This randomized, open-label trial comparing treatment with onabotulinumtoxinA 100 U and PTNS included both men and women with idiopathic OAB symptoms. The participants were assessed at regular intervals with various measures, and follow-up adherence was good. The sample size was small, so the study may not have been powered to see differences prior to 9 months.

Although at 9 months only the onabotulinumtoxinA group maintained significant improvement over baseline levels, the improvement was diminished, and therefore the clinical meaningfulness is uncertain. Further, participants in the PTNS group did not undergo monthly maintenance therapy after 3 months, which is recommended for those with a 12-week therapeutic response; this may have affected 9-month outcomes in this group. Since the one-time onabotulinumtoxinA 100 U injection was performed under spinal anesthesia, cost comparisons should be considered, since future onabotulinumtoxinA injections would be necessary. 

Read about using different doses of onabotulinumtoxinA for OAB.

OnabotulinumtoxinA 200-U injection provides longer OAB symptom  improvement than 100-U injection

Abdelwahab O, Sherif H, Soliman T, Elbarky I, Eshazly A. Efficacy of botulinum toxin type A 100 units versus 200 units for treatment of refractory idiopathic overactive bladder. Int Braz J Urol. 2015;41(6):1132-1140.

Abdelwahab and colleagues conducted a single-center, randomized clinical trial to investigate the safety and efficacy of a single injection of intradetrusor onabotulinumtoxinA in 2 different doses (100 U and 200 U) for treatment of OAB.

Details of the study

Eighty adults (63 women, 17 men) who did not benefit from anticholinergic medication during the previous 3 months were randomly assigned to receive either a 100-U (n = 40) or a 200-U (n = 40) injection of onabotulinumtoxinA. Exclusion criteria were PVR urine volume greater than 150 mL and previous radiation therapy or chemotherapy.

Initial assessments -- completed at baseline and at 1, 3, 6, and 9 months -- included the health-related quality-of-life (HR-QOL) questionnaire (maximum score, 100; higher score indicates better quality of life), an abbreviated OABSS questionnaire (4 questions; score range, 0-15; higher score indicates more severe symptoms), and urodynamic evaluation. Outcomes included OABSS, HR-QOL score, and urodynamic parameters at the various time points.

Related article:
Is there a link between impaired mobility and urinary incontinence in elderly, community-dwelling women?

Higher dose, greater symptom improvement and higher adverse event rate

At baseline, participants (average age, 31 years) had an average (SD) OABSS of 1.7 (1.6). OnabotulinumtoxinA treatment with both a 100-U and a 200-U dose resulted in significant improvements (compared with baseline levels) in frequency, nocturia, UUI episodes, OABSS, and urodynamic parameters throughout the 9 months. At 9 months, however, the group treated with the 200-U dose had greater improvements, compared with the group who received a 100-U dose, in urinary frequency symptom scores (mean [SD], 0.32 [0.47] vs 1.1 [0.51]; P<.05), nocturia symptom scores (mean [SD], 0.13 [0.34] vs 0.36 [0.49]; P<.05), UUI symptom scores (mean [SD], 0.68 [0.16] vs 1.26 [1.1]; P<.05), and mean (SD) total OABSS (2.6 [2.31] vs 5.3 [2.11]; P<.05). Similarly, at 9 months the 200-U dose resulted in greater improvements in volume at first desire (mean [SD], 291.8 [42.8] vs 246.8 [53.8] mL; P<.05), volume at strong desire (mean [SD], 392.1 [37.3] vs 313.1 [67.4] mL; P<.05), detrusor pressure (mean [SD], 10.4 [4.0] vs 19.2 [7.8] cm H₂O; P<.05), and maximum cystometric capacity (mean [SD], 430.5 [34.2] vs 350 [69.1] mL; P<.05) compared with the 100-U dose.

Adverse events. No participant had a PVR urine volume greater than 100 mL at any follow-up visit. Postoperative hematuria occurred in 23% of the group treated with onabotulinumtoxinA 200 U versus in 15% of those treated with a 100-U dose. Similarly, UTIs occurred in 17.5% of the 200-U dose group and in 7.5% of the 100-U dose group. Dysuria was reported in 37.5% and 15% of the 200-U and 100-U dose groups, respectively.

Strengths and limitations. This randomized, open-label trial comparing a single injection of 100 U versus 200 U of onabotulinumtoxinA included mostly women. OAB symptoms and urodynamic parameters improved after treatment with both dose levels, but a longer duration of improvement was seen with the 200-U dose. The cohort had a low baseline OAB severity, based on the OABSS questionnaire, and a young average age of participants, which limits the generalizability of the study results to a population with refractory OAB. The 0% rate of clean intermittent self-catheterization postinjection might be based on the study's criteria for requiring clean intermittent catheterization. In addition, the initial postinjection visit occurred at 1 month, possibly missing participants who had symptoms of retention soon after injection.

Read: onabotulinumtoxinA vs sacral neuromodulation therapy for UUI.

Treatment with onabotulinumtoxinA may control UUI symptoms better than sacral neuromodulation therapy

Amundsen CL, Richter HE, Menefee SA, et al; Pelvic Floor Disorders Network. OnabotulinumtoxinA vs sacral neuromodulation on refractory urgency urinary incontinence in women: a randomized clinical trial. JAMA. 2016;316(13):1366-1374.

In this multicenter open-label randomized trial, Amundsen and colleagues compared the efficacy and safety of onabotulinumtoxinA 200 U with that of sacral neuromodulation.

Details of the study

Three hundred sixty-four women with UUI had data available for primary analysis at  6 months. Women were considered eligible for the study if they had 6 or more UUI episodes on a 3-day bladder diary, persistent symptoms despite anticholinergic therapy, a PVR urine volume of less than 150 mL, and had never previously received either study treatment.

There were no differences in baseline characteristics of the participants. The average (SD) age of the study population was 63 (11.6) years, with an average (SD) daily number of UUI episodes of 5.3 (2.8). The average (SD) body mass index was 32 (8) kg/m².

Participants were randomly assigned to undergo either sacral neuromodulation (n = 174) or intradetrusor injection of onabotulinumtoxinA 200 U (n = 190). The primary outcome was change from baseline in mean number of daily UUI episodes averaged over 6 months as recorded on a monthly 3-day bladder diary. Secondary outcomes included complete resolution of urgency incontinence, 75% or more reduction in UUI episodes, the Overactive Bladder Questionnaire Short Form (SF) score (range, 0-100; higher score indicates higher symptom severity), the Overactive Bladder Satisfaction of Treatment questionnaire (range, 0-100; higher score indicates better satisfaction), other quality-of-life measures, and adverse events.

Related article:
2015 Update on pelvic floor dysfunction: Bladder pain syndrome

Greater symptom bother improvement, treatment satisfaction with onabotulinumtoxinA 200 U

Participants treated with onabotulinumtoxinA had a greater mean reduction of 3.9 UUI episodes per day than the sacral neuromodulation group's reduction of 3.3 UUI episodes per day (mean difference, 0.63; 95% confidence interval [CI], 0.13-1.14; P = .01). In addition, complete UUI resolution was higher in the onabotulinumtoxinA group as compared with the sacral neuromodulation group (20% vs 4%; P<.001). The onabotulinumtoxinA group also had higher rates of 75% or more reduction of UUI episodes compared with the sacral neuromodulation group (46% vs 26%; P<.001). Over 6 months, both groups had improvements in all quality-of-life measures, but the onabotulinumtoxinA group had greater improvement in symptom bother compared with the sacral neuromodulation group (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0-13.3; P = .002). Furthermore, the onabotulinumtoxinA group had greater treatment satisfaction compared with the sacral neuromodulation group (mean difference, 7.8; 95% CI, 1.6-14.1; P = .01).

Adverse events. Six women (3%) underwent sacral neuromodulation device revision or removal. Approximately 8% of onabotulinumtoxinA-treated participants required intermittent self-catheterization at 1 month, 4% at 3 months, and 2% at 6 months. The risk of UTI was higher in the onabotulinumtoxinA group compared with the sacral neuromodulation group (35% vs 11%; risk difference, 23%; 95% CI, -33% to -13%; P<.001).

Strengths and limitations. This is a well-designed randomized clinical trial comparing clinical outcomes and adverse events after treatment with onabotulinumtoxinA 200-U versus sacral neuromodulation. The interventions were standardized across investigators at multiple sites, and the study design required close follow-up to assess efficacy and adverse events. The study used a 200-U dose based on reported durability of effect at that time and findings of equivalency between onabotulinumtoxinA 100 U and anticholinergic therapy. The US Food and Drug Administration's recommendation to use a 100-U dose in all patients with idiopathic OAB might dissuade clinicians from considering the higher dose of onabotulinumtoxinA. The study was limited by the lack of a placebo group.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The final session of the course opened with Uri Ladabaum, MD, entertaining the question “Colon cancer screening and surveillance: who, when, and how?” Dr. Ladabaum pointed out that there is consensus that colorectal cancer screening for average-risk individuals should begin at age 50 with a choice of modalities and that surveillance depends on the findings on each colonoscopy. He reviewed the evidence for screening modalities and for surveillance and offered perspectives on the role of the gastroenterologist/colonoscopist in the quality of colonsocopy. Douglas K. Rex, MD, AGAF followed by asking “Does every big polyp need EMR?” Dr. Rex discussed the available approaches to the large colonic polyp, including endoscopic mucosal resection, endoscopic submucosal dissection, and surgery. He provided evidence for the advantages and expanded use of EMR, with the conclusion that almost every large benign polyp needs EMR.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Cohen is the chief of the division of gastroenterology and hepatology in the Weill department of medicine, New York–Presbyterian Hospital Center, New York.

The final session of the course opened with Uri Ladabaum, MD, entertaining the question “Colon cancer screening and surveillance: who, when, and how?” Dr. Ladabaum pointed out that there is consensus that colorectal cancer screening for average-risk individuals should begin at age 50 with a choice of modalities and that surveillance depends on the findings on each colonoscopy. He reviewed the evidence for screening modalities and for surveillance and offered perspectives on the role of the gastroenterologist/colonoscopist in the quality of colonsocopy. Douglas K. Rex, MD, AGAF followed by asking “Does every big polyp need EMR?” Dr. Rex discussed the available approaches to the large colonic polyp, including endoscopic mucosal resection, endoscopic submucosal dissection, and surgery. He provided evidence for the advantages and expanded use of EMR, with the conclusion that almost every large benign polyp needs EMR.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Cohen is the chief of the division of gastroenterology and hepatology in the Weill department of medicine, New York–Presbyterian Hospital Center, New York.

The final session of the course opened with Uri Ladabaum, MD, entertaining the question “Colon cancer screening and surveillance: who, when, and how?” Dr. Ladabaum pointed out that there is consensus that colorectal cancer screening for average-risk individuals should begin at age 50 with a choice of modalities and that surveillance depends on the findings on each colonoscopy. He reviewed the evidence for screening modalities and for surveillance and offered perspectives on the role of the gastroenterologist/colonoscopist in the quality of colonsocopy. Douglas K. Rex, MD, AGAF followed by asking “Does every big polyp need EMR?” Dr. Rex discussed the available approaches to the large colonic polyp, including endoscopic mucosal resection, endoscopic submucosal dissection, and surgery. He provided evidence for the advantages and expanded use of EMR, with the conclusion that almost every large benign polyp needs EMR.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Cohen is the chief of the division of gastroenterology and hepatology in the Weill department of medicine, New York–Presbyterian Hospital Center, New York.

Clinical question: Is hospital acquired anemia associated with increased postdischarge adverse outcomes?

Background: Hospital acquired anemia (HAA) is defined as the development of anemia during the course of a hospitalization when starting with a normal hemoglobin on admission. The incidence of HAA is at least 25% when using the last hemoglobin prior to discharge as the index value. HAA is felt to be potentially preventable and usually iatrogenic due to phlebotomy.

Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.

Clinical question: Is hospital acquired anemia associated with increased postdischarge adverse outcomes?

Background: Hospital acquired anemia (HAA) is defined as the development of anemia during the course of a hospitalization when starting with a normal hemoglobin on admission. The incidence of HAA is at least 25% when using the last hemoglobin prior to discharge as the index value. HAA is felt to be potentially preventable and usually iatrogenic due to phlebotomy.

Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.

Clinical question: Is hospital acquired anemia associated with increased postdischarge adverse outcomes?

Background: Hospital acquired anemia (HAA) is defined as the development of anemia during the course of a hospitalization when starting with a normal hemoglobin on admission. The incidence of HAA is at least 25% when using the last hemoglobin prior to discharge as the index value. HAA is felt to be potentially preventable and usually iatrogenic due to phlebotomy.

Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.

Biotin supplementation showed signs of interference with biotinylated assays in a crossover trial.

The proposed benefits of biotin (vitamin B₇), including stimulating hair growth and assisting in the treatment of various forms of diabetes, have made it a popular supplement. Supplementation generally leads to artificially high levels of biotin, which was shown to cause inaccurate results in biotinylated assays, according to Danni Li, PhD, of the advanced research and diagnostic laboratory at the University of Minnesota, Minneapolis, and her colleagues.

They analyzed the results of both biotinylated and nonbiotinylated assays of six patients – two women and four men – who ingested 10 mg/day of biotin supplement for 7 days. Two blood samples were obtained in the course of the study: one prior to starting biotin supplementation as a baseline and one a week ofter biotin supplementation had ended. The assays tested the presence of nine hormones and two nonhormones using multiple diagnostic systems to run the assays. In total, 37 immunoassays were conducted on each sample (JAMA. 2017;318[12]:1150-60. doi: 10.1001/jama.2017.13705).

Two immunoassay testing techniques were used in the diagnostic assays. The sandwich technique was used in testing TSH, parathyroid hormone (PTH), prolactin, N-terminal pro-brain natriuretic peptide (NT-proBNP), PSA, and ferritin and competitive technique was used in testing total T₄, total T₃, free T₄, free T₃, and 25-OHD. In assays utilizing competitive techniques, false highs were reported in three Roche cobas e602 machines and one Siemens Vista Dimension 1500 machine.

Assays utilizing the sandwich technique experienced false decreases in TSH, PTH, and NT-proBNP when compared with baseline measurements in Roche cobas e602 and OCD Vitros 5600 machines. A predominance of the falsely low results were present in the assays conducted by the OCD Vitros machine, with significant changes from baseline measurements. TSH experienced a 94% decrease of 1.67 mIU/L, PTH experienced a 61% decrease of 25.8 pg/mL, and NT-proBNP falsely decreased by more than 13.9 pg/mL. In Roche cobas e602 assays, TSH levels were falsely low and measurements decreased by 0.72 mIU/L (37%) when compared with baseline measurements.

Biotin did not interfere in all biotinylated assays and was only observed in 9 of the 23 (39%) of the assays conducted. Specifically, 4 of 15 (27%) sandwich immunoassays were falsely decreased while five of eight (63%) competitive binding assays were falsely increased.

“Among the 23 biotinylated assays studied, biotin interference was of greatest clinical significance in the OCD Vitros TSH assay, where falsely decreased TSH concentrations (to less than 0.15 mU/L) could have resulted in misdiagnosis of thyrotoxicosis in otherwise euthyroid individuals,” according to Dr. Li and her associates, “Likewise, falsely decreased OCD Vitros NT-proBNP, to lower than assay detection limits, could possibly result in failure to identify congestive heart failure.”

One investigator received funding and nonfinanical support from Siemens Healthcare Diagnostics, one reported receiving financial support from Abbott Laboratories, and another reported receiving personal fees from Roche and Abbott Laboratories. Dr. Li and the other researchers had no relevant financial disclosures.

[email protected]

Biotin supplementation showed signs of interference with biotinylated assays in a crossover trial.

The proposed benefits of biotin (vitamin B₇), including stimulating hair growth and assisting in the treatment of various forms of diabetes, have made it a popular supplement. Supplementation generally leads to artificially high levels of biotin, which was shown to cause inaccurate results in biotinylated assays, according to Danni Li, PhD, of the advanced research and diagnostic laboratory at the University of Minnesota, Minneapolis, and her colleagues.

They analyzed the results of both biotinylated and nonbiotinylated assays of six patients – two women and four men – who ingested 10 mg/day of biotin supplement for 7 days. Two blood samples were obtained in the course of the study: one prior to starting biotin supplementation as a baseline and one a week ofter biotin supplementation had ended. The assays tested the presence of nine hormones and two nonhormones using multiple diagnostic systems to run the assays. In total, 37 immunoassays were conducted on each sample (JAMA. 2017;318[12]:1150-60. doi: 10.1001/jama.2017.13705).

Two immunoassay testing techniques were used in the diagnostic assays. The sandwich technique was used in testing TSH, parathyroid hormone (PTH), prolactin, N-terminal pro-brain natriuretic peptide (NT-proBNP), PSA, and ferritin and competitive technique was used in testing total T₄, total T₃, free T₄, free T₃, and 25-OHD. In assays utilizing competitive techniques, false highs were reported in three Roche cobas e602 machines and one Siemens Vista Dimension 1500 machine.

Assays utilizing the sandwich technique experienced false decreases in TSH, PTH, and NT-proBNP when compared with baseline measurements in Roche cobas e602 and OCD Vitros 5600 machines. A predominance of the falsely low results were present in the assays conducted by the OCD Vitros machine, with significant changes from baseline measurements. TSH experienced a 94% decrease of 1.67 mIU/L, PTH experienced a 61% decrease of 25.8 pg/mL, and NT-proBNP falsely decreased by more than 13.9 pg/mL. In Roche cobas e602 assays, TSH levels were falsely low and measurements decreased by 0.72 mIU/L (37%) when compared with baseline measurements.

Biotin did not interfere in all biotinylated assays and was only observed in 9 of the 23 (39%) of the assays conducted. Specifically, 4 of 15 (27%) sandwich immunoassays were falsely decreased while five of eight (63%) competitive binding assays were falsely increased.

“Among the 23 biotinylated assays studied, biotin interference was of greatest clinical significance in the OCD Vitros TSH assay, where falsely decreased TSH concentrations (to less than 0.15 mU/L) could have resulted in misdiagnosis of thyrotoxicosis in otherwise euthyroid individuals,” according to Dr. Li and her associates, “Likewise, falsely decreased OCD Vitros NT-proBNP, to lower than assay detection limits, could possibly result in failure to identify congestive heart failure.”

One investigator received funding and nonfinanical support from Siemens Healthcare Diagnostics, one reported receiving financial support from Abbott Laboratories, and another reported receiving personal fees from Roche and Abbott Laboratories. Dr. Li and the other researchers had no relevant financial disclosures.

[email protected]

Biotin supplementation showed signs of interference with biotinylated assays in a crossover trial.

The proposed benefits of biotin (vitamin B₇), including stimulating hair growth and assisting in the treatment of various forms of diabetes, have made it a popular supplement. Supplementation generally leads to artificially high levels of biotin, which was shown to cause inaccurate results in biotinylated assays, according to Danni Li, PhD, of the advanced research and diagnostic laboratory at the University of Minnesota, Minneapolis, and her colleagues.

They analyzed the results of both biotinylated and nonbiotinylated assays of six patients – two women and four men – who ingested 10 mg/day of biotin supplement for 7 days. Two blood samples were obtained in the course of the study: one prior to starting biotin supplementation as a baseline and one a week ofter biotin supplementation had ended. The assays tested the presence of nine hormones and two nonhormones using multiple diagnostic systems to run the assays. In total, 37 immunoassays were conducted on each sample (JAMA. 2017;318[12]:1150-60. doi: 10.1001/jama.2017.13705).

Two immunoassay testing techniques were used in the diagnostic assays. The sandwich technique was used in testing TSH, parathyroid hormone (PTH), prolactin, N-terminal pro-brain natriuretic peptide (NT-proBNP), PSA, and ferritin and competitive technique was used in testing total T₄, total T₃, free T₄, free T₃, and 25-OHD. In assays utilizing competitive techniques, false highs were reported in three Roche cobas e602 machines and one Siemens Vista Dimension 1500 machine.

Assays utilizing the sandwich technique experienced false decreases in TSH, PTH, and NT-proBNP when compared with baseline measurements in Roche cobas e602 and OCD Vitros 5600 machines. A predominance of the falsely low results were present in the assays conducted by the OCD Vitros machine, with significant changes from baseline measurements. TSH experienced a 94% decrease of 1.67 mIU/L, PTH experienced a 61% decrease of 25.8 pg/mL, and NT-proBNP falsely decreased by more than 13.9 pg/mL. In Roche cobas e602 assays, TSH levels were falsely low and measurements decreased by 0.72 mIU/L (37%) when compared with baseline measurements.

Biotin did not interfere in all biotinylated assays and was only observed in 9 of the 23 (39%) of the assays conducted. Specifically, 4 of 15 (27%) sandwich immunoassays were falsely decreased while five of eight (63%) competitive binding assays were falsely increased.

“Among the 23 biotinylated assays studied, biotin interference was of greatest clinical significance in the OCD Vitros TSH assay, where falsely decreased TSH concentrations (to less than 0.15 mU/L) could have resulted in misdiagnosis of thyrotoxicosis in otherwise euthyroid individuals,” according to Dr. Li and her associates, “Likewise, falsely decreased OCD Vitros NT-proBNP, to lower than assay detection limits, could possibly result in failure to identify congestive heart failure.”

One investigator received funding and nonfinanical support from Siemens Healthcare Diagnostics, one reported receiving financial support from Abbott Laboratories, and another reported receiving personal fees from Roche and Abbott Laboratories. Dr. Li and the other researchers had no relevant financial disclosures.

[email protected]

Uma Mahadevan, MD, AGAF, and I moderated this session on IBD, and we were fortunate enough to secure four of the best IBD educators in the AGA.

David Rubin, MD, AGAF, opened with “Selecting the correct therapy for your outpatients with IBD: From mesalamine to biologics.” Treatment goals have evolved from symptom control to remission based on measures of inflammation (e.g., serum C-reactive protein, fecal calprotectin, or endoscopy). For ulcerative colitis (UC), high-risk markers include extensive disease, deep ulcers, younger age at diagnosis, elevated biomarkers, and early need for steroids or hospitalization. For Crohn’s disease (CD), these include younger age, extensive involvement, and fistulizing disease. The 5-aminosalicylate drugs remain a backbone in mild to moderate UC. Judicious use of corticosteroids is reasonable, but we need an exit strategy. The thiopurines are decent drugs, but studies have called into question their efficacy as monotherapy, and safety issues persist. Methotrexate is underutilized. The anti–tumor necrosis factor (TNF) biologics are excellent therapies but controversies persist as to whether these drugs require combination therapy or if they can be managed as “optimized monotherapy” with therapeutic drug monitoring (TDM). There are now two infliximab biosimilars available in the U.S.. Vedolizumab is an efficacious gut-selective anti-integrin (for both CD and UC). Ustekinumab, an anti-IL-12/23 antibody, is now available for moderate to severe CD, and has a favorable safety profile.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Loftus is a professor of medicine, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Uma Mahadevan, MD, AGAF, and I moderated this session on IBD, and we were fortunate enough to secure four of the best IBD educators in the AGA.

David Rubin, MD, AGAF, opened with “Selecting the correct therapy for your outpatients with IBD: From mesalamine to biologics.” Treatment goals have evolved from symptom control to remission based on measures of inflammation (e.g., serum C-reactive protein, fecal calprotectin, or endoscopy). For ulcerative colitis (UC), high-risk markers include extensive disease, deep ulcers, younger age at diagnosis, elevated biomarkers, and early need for steroids or hospitalization. For Crohn’s disease (CD), these include younger age, extensive involvement, and fistulizing disease. The 5-aminosalicylate drugs remain a backbone in mild to moderate UC. Judicious use of corticosteroids is reasonable, but we need an exit strategy. The thiopurines are decent drugs, but studies have called into question their efficacy as monotherapy, and safety issues persist. Methotrexate is underutilized. The anti–tumor necrosis factor (TNF) biologics are excellent therapies but controversies persist as to whether these drugs require combination therapy or if they can be managed as “optimized monotherapy” with therapeutic drug monitoring (TDM). There are now two infliximab biosimilars available in the U.S.. Vedolizumab is an efficacious gut-selective anti-integrin (for both CD and UC). Ustekinumab, an anti-IL-12/23 antibody, is now available for moderate to severe CD, and has a favorable safety profile.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Loftus is a professor of medicine, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Uma Mahadevan, MD, AGAF, and I moderated this session on IBD, and we were fortunate enough to secure four of the best IBD educators in the AGA.

David Rubin, MD, AGAF, opened with “Selecting the correct therapy for your outpatients with IBD: From mesalamine to biologics.” Treatment goals have evolved from symptom control to remission based on measures of inflammation (e.g., serum C-reactive protein, fecal calprotectin, or endoscopy). For ulcerative colitis (UC), high-risk markers include extensive disease, deep ulcers, younger age at diagnosis, elevated biomarkers, and early need for steroids or hospitalization. For Crohn’s disease (CD), these include younger age, extensive involvement, and fistulizing disease. The 5-aminosalicylate drugs remain a backbone in mild to moderate UC. Judicious use of corticosteroids is reasonable, but we need an exit strategy. The thiopurines are decent drugs, but studies have called into question their efficacy as monotherapy, and safety issues persist. Methotrexate is underutilized. The anti–tumor necrosis factor (TNF) biologics are excellent therapies but controversies persist as to whether these drugs require combination therapy or if they can be managed as “optimized monotherapy” with therapeutic drug monitoring (TDM). There are now two infliximab biosimilars available in the U.S.. Vedolizumab is an efficacious gut-selective anti-integrin (for both CD and UC). Ustekinumab, an anti-IL-12/23 antibody, is now available for moderate to severe CD, and has a favorable safety profile.

This is a summary provided by the moderator of one of the AGA Postgraduate Courses held at DDW 2017. Dr. Loftus is a professor of medicine, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

It is my privilege this month to assume responsibility for the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology. I am honored to join an impressive board of editors led by Dr Fasiha Kanwal, and anchored by global leaders in the field of gastroenterology and hepatology. This board of editors promises to continue the high level of excellence that has propelled the journal to its preeminent position among clinical journals. I am confident that the practice management section will uphold that tradition and continue to meet the expectation of our readers. I would like to mark this transition by acknowledging the history of the practice management section of Clinical Gastroenterology and Hepatology and outlining a vision for the future.

The section was introduced in 2010 under the leadership of Dr. Joel V. Brill. The section, titled “Practice Management: Opportunities and Challenges,” aimed to help practices navigate the disparate issues facing the field. Some of these issues included use of capnography in endoscopy, the importance of registries for quality reporting, and the burdens of meaningful use on physician practices. Dr Brill introduced this section in a video in May 2010 (https://www.youtube.com/watch?v=8FMsc2Wl5E8). Dr. Brill’s reference to these “interesting and challenging times” in gastroenterology resonates even more loudly today.

• • Governance and culture: The structure of health delivery systems, as conceptualized by Donabedian,¹³ is a key determinant of quality. Structural attributes include regulatory requirements on gastrointestinal practices, such as the rules governing use of anesthesia providers in ambulatory surgical settings; role of allied health professionals in clinical settings; and the impact of financial incentives in driving provider behavior.
• • Financial readiness: Value-based reimbursement, accountable care, medical homes, reference pricing, and physician tiering are some of the new terms in this era of value-based medicine. It is important for practices to assess patient costs longitudinally and manage financial risks. The Road Ahead section will continue to include papers that describe the impact of these reforms on gastroenterology and hepatology practices while providing guidance on implementation of these new models of care. Some examples include papers on the effect of payment policy on specialty practices, the development of a medical home in inflammatory bowel disease, and the physician experience with episode-based payments for colonoscopy.
• • Health information technology: All of the organizational competencies required for reform rely on a robust information technology platform that collects meaningful data and harnesses that data for analytic purposes. These platforms can be enterprise systems deployed by large health delivery systems or smaller, more nimble platforms, created by innovative start-up companies. The Road Ahead will include papers that share best practices in the use of these platforms to provide high-quality and cost-efficient care. In addition, the Road Ahead will continue to explore the use of health information technology to expand the reach of clinicians beyond brick and mortar clinics.
• • Patient risk assessment: Tailoring interventions to high-risk patients is necessary to deploy limited resources in a cost-effective manner. Risk assessment is also needed to more accurately and effectively personalize care for patients with chronic conditions. The Road Ahead will include papers that evaluate risk assessment tools and/or describe real-life implementation of these tools in different contexts.
• • Care coordination: The ability to provide team-based longitudinal care across the continuum of care will be integral to providing high value health care. The Road Ahead will serve as a means to disseminate best practices and innovative methods to care for increasingly complex patients, especially those with chronic diseases, such as cirrhosis and inflammatory bowel disease. For example, papers will explore the implementation of specialty medical homes, patient navigators, community-based care services, and involvement of patients in their own care.
• • Quality improvement: Providing high-value care by definition will require clinicians to accurately measure the quality of care provided to patients and use data to guide process improvement. The Road Ahead will continue to serve as an educational resource for clinicians with papers that discuss challenges and opportunities in quality measurement and improvement. Similarly, this section will present data on novel or impactful quality-improvement initiatives.
• • Patient centeredness: Patient experience measures and patient-reported outcomes are becoming increasingly important as meaningful indicators of quality. These measures are designed to ensure that patient perspectives are incorporated into the governance, design, and delivery of health care. The Road Ahead will serve as a dissemination mechanism for sharing best practices in developing, validating, implementing, and tracking patient-reported outcomes.

References

1. Allen, J.I. The road ahead. Clin Gastroenterol Hepatol. 2012;10:692-6.

2. Dorn, S.D., Vesy, C.J. Medicare’s revaluation of gastrointestinal endoscopic procedures: implications for academic and community-based practices. Clin Gastroenterol Hepatol. 2017;14:924-8.

3. Dorn, S.D. The road ahead 3.0: changing payments, changing practice. Clin Gastroenterol Hepatol. 2016;14:785-9.

4. Meier, S.K., Shah, N.D., Talwalkar, J.A. Adapting the patient-centered specialty practice model for populations with cirrhosis. Clin Gastroenterol Hepatol. 2016;14:492-6.

5. Mehta, S.J. Bundled payment for gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2016;14:1681-4.

6. Weizman, A.V., Mosko, J., Bollegala, N., et al. Quality improvement primer series: launching a quality improvement initiative. Clin Gastroenterol Hepatol. 2017;14:1067-71.

7. Bernstein, M., Hou, J.K., Weizman, A.V., et al. Quality improvement primer series: how to sustain a quality improvement effort. Clin Gastroenterol Hepatol. 2017;14:1371-5.

8. Bollegala, N., Patel, K., Mosko, J.D., et al. Quality improvement primer series: the plan-do-study-act cycle and data display. Clin Gastroenterol Hepatol. 2016;14:1230-3.

9. Adams, M.A. Covert recording by patients of encounters with gastroenterology providers: path to empowerment or breach of trust?. Clin Gastroenterol Hepatol. 2017;15:13-6.

10. Oza, V.M., El-Dika, S., and Adams, M.A. Reaching safe harbor: legal implications of clinical practice guidelines. Clin Gastroenterol Hepatol. 2016;14:172-4.

11. Lin, M., Pappas, S.C., Sellin, J., et al. Curbside consultations: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2016;14:2-4.

12. McClellan, M.B., Leavitt, M.O. Competencies and tools to shift payments from volume to value. JAMA. 2016; 316: 1655–1656

13. Donabedian, A. Evaluating the quality of medical care. Milbank Q. 1966;44:166-203.

14. Rosenberg, F.B., Kim, L.S., Ketover, S.R. Challenges facing independent integrated gastroenterology. Clin Gastroenterol Hepatol. 2017;15:335-8.

15. Leiman, D.A., Metz, D.C., Ginsberg, G.G., et al. A novel electronic medical record-based workflow to measure and report colonoscopy quality measures. Clin Gastroenterol Hepatol. 2016;14:333-7.

16. Cross, R.K., Kane, S. Integration of telemedicine into clinical gastroenterology and hepatology Practice. Clin Gastroenterol Hepatol. 2017;15:175-81.

17. Llor, X. Building a cancer genetics and prevention program. Clin Gastroenterol Hepatol. 2016;14:1516-20.

18. Patel, K.K., Cummings, S., Sellin, J., et al. Applying Lean design principles to a gastrointestinal endoscopy program for uninsured patients improves health care utilization. Clin Gastroenterol Hepatol. 2015;13:1556-9.

19. Saini, S.D., Adams, M.A., Brill, J.V., et al. Colorectal cancer screening quality measures: beyond colonoscopy. Clin Gastroenterol Hepatol. 2016;14:644-7.
 

Dr. Gellad is an associate professor of medicine in the division of gastroenterology at Durham VA Medical Center, Durham, N.C.; and Duke Clinical Research Institute, Durham, N.C. He reports a consulting relationship with Merck & Co. and he is also a cofounder and equity holder in Higgs Boson, LLC. He is funded by Veterans Affairs Health Services Research and Development Career Development Award (CDA 14-158 ).

It is my privilege this month to assume responsibility for the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology. I am honored to join an impressive board of editors led by Dr Fasiha Kanwal, and anchored by global leaders in the field of gastroenterology and hepatology. This board of editors promises to continue the high level of excellence that has propelled the journal to its preeminent position among clinical journals. I am confident that the practice management section will uphold that tradition and continue to meet the expectation of our readers. I would like to mark this transition by acknowledging the history of the practice management section of Clinical Gastroenterology and Hepatology and outlining a vision for the future.

The section was introduced in 2010 under the leadership of Dr. Joel V. Brill. The section, titled “Practice Management: Opportunities and Challenges,” aimed to help practices navigate the disparate issues facing the field. Some of these issues included use of capnography in endoscopy, the importance of registries for quality reporting, and the burdens of meaningful use on physician practices. Dr Brill introduced this section in a video in May 2010 (https://www.youtube.com/watch?v=8FMsc2Wl5E8). Dr. Brill’s reference to these “interesting and challenging times” in gastroenterology resonates even more loudly today.

• • Governance and culture: The structure of health delivery systems, as conceptualized by Donabedian,¹³ is a key determinant of quality. Structural attributes include regulatory requirements on gastrointestinal practices, such as the rules governing use of anesthesia providers in ambulatory surgical settings; role of allied health professionals in clinical settings; and the impact of financial incentives in driving provider behavior.
• • Financial readiness: Value-based reimbursement, accountable care, medical homes, reference pricing, and physician tiering are some of the new terms in this era of value-based medicine. It is important for practices to assess patient costs longitudinally and manage financial risks. The Road Ahead section will continue to include papers that describe the impact of these reforms on gastroenterology and hepatology practices while providing guidance on implementation of these new models of care. Some examples include papers on the effect of payment policy on specialty practices, the development of a medical home in inflammatory bowel disease, and the physician experience with episode-based payments for colonoscopy.
• • Health information technology: All of the organizational competencies required for reform rely on a robust information technology platform that collects meaningful data and harnesses that data for analytic purposes. These platforms can be enterprise systems deployed by large health delivery systems or smaller, more nimble platforms, created by innovative start-up companies. The Road Ahead will include papers that share best practices in the use of these platforms to provide high-quality and cost-efficient care. In addition, the Road Ahead will continue to explore the use of health information technology to expand the reach of clinicians beyond brick and mortar clinics.
• • Patient risk assessment: Tailoring interventions to high-risk patients is necessary to deploy limited resources in a cost-effective manner. Risk assessment is also needed to more accurately and effectively personalize care for patients with chronic conditions. The Road Ahead will include papers that evaluate risk assessment tools and/or describe real-life implementation of these tools in different contexts.
• • Care coordination: The ability to provide team-based longitudinal care across the continuum of care will be integral to providing high value health care. The Road Ahead will serve as a means to disseminate best practices and innovative methods to care for increasingly complex patients, especially those with chronic diseases, such as cirrhosis and inflammatory bowel disease. For example, papers will explore the implementation of specialty medical homes, patient navigators, community-based care services, and involvement of patients in their own care.
• • Quality improvement: Providing high-value care by definition will require clinicians to accurately measure the quality of care provided to patients and use data to guide process improvement. The Road Ahead will continue to serve as an educational resource for clinicians with papers that discuss challenges and opportunities in quality measurement and improvement. Similarly, this section will present data on novel or impactful quality-improvement initiatives.
• • Patient centeredness: Patient experience measures and patient-reported outcomes are becoming increasingly important as meaningful indicators of quality. These measures are designed to ensure that patient perspectives are incorporated into the governance, design, and delivery of health care. The Road Ahead will serve as a dissemination mechanism for sharing best practices in developing, validating, implementing, and tracking patient-reported outcomes.

References

1. Allen, J.I. The road ahead. Clin Gastroenterol Hepatol. 2012;10:692-6.

2. Dorn, S.D., Vesy, C.J. Medicare’s revaluation of gastrointestinal endoscopic procedures: implications for academic and community-based practices. Clin Gastroenterol Hepatol. 2017;14:924-8.

3. Dorn, S.D. The road ahead 3.0: changing payments, changing practice. Clin Gastroenterol Hepatol. 2016;14:785-9.

4. Meier, S.K., Shah, N.D., Talwalkar, J.A. Adapting the patient-centered specialty practice model for populations with cirrhosis. Clin Gastroenterol Hepatol. 2016;14:492-6.

5. Mehta, S.J. Bundled payment for gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2016;14:1681-4.

6. Weizman, A.V., Mosko, J., Bollegala, N., et al. Quality improvement primer series: launching a quality improvement initiative. Clin Gastroenterol Hepatol. 2017;14:1067-71.

7. Bernstein, M., Hou, J.K., Weizman, A.V., et al. Quality improvement primer series: how to sustain a quality improvement effort. Clin Gastroenterol Hepatol. 2017;14:1371-5.

8. Bollegala, N., Patel, K., Mosko, J.D., et al. Quality improvement primer series: the plan-do-study-act cycle and data display. Clin Gastroenterol Hepatol. 2016;14:1230-3.

9. Adams, M.A. Covert recording by patients of encounters with gastroenterology providers: path to empowerment or breach of trust?. Clin Gastroenterol Hepatol. 2017;15:13-6.

10. Oza, V.M., El-Dika, S., and Adams, M.A. Reaching safe harbor: legal implications of clinical practice guidelines. Clin Gastroenterol Hepatol. 2016;14:172-4.

11. Lin, M., Pappas, S.C., Sellin, J., et al. Curbside consultations: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2016;14:2-4.

12. McClellan, M.B., Leavitt, M.O. Competencies and tools to shift payments from volume to value. JAMA. 2016; 316: 1655–1656

13. Donabedian, A. Evaluating the quality of medical care. Milbank Q. 1966;44:166-203.

14. Rosenberg, F.B., Kim, L.S., Ketover, S.R. Challenges facing independent integrated gastroenterology. Clin Gastroenterol Hepatol. 2017;15:335-8.

15. Leiman, D.A., Metz, D.C., Ginsberg, G.G., et al. A novel electronic medical record-based workflow to measure and report colonoscopy quality measures. Clin Gastroenterol Hepatol. 2016;14:333-7.

16. Cross, R.K., Kane, S. Integration of telemedicine into clinical gastroenterology and hepatology Practice. Clin Gastroenterol Hepatol. 2017;15:175-81.

17. Llor, X. Building a cancer genetics and prevention program. Clin Gastroenterol Hepatol. 2016;14:1516-20.

18. Patel, K.K., Cummings, S., Sellin, J., et al. Applying Lean design principles to a gastrointestinal endoscopy program for uninsured patients improves health care utilization. Clin Gastroenterol Hepatol. 2015;13:1556-9.

19. Saini, S.D., Adams, M.A., Brill, J.V., et al. Colorectal cancer screening quality measures: beyond colonoscopy. Clin Gastroenterol Hepatol. 2016;14:644-7.
 

Dr. Gellad is an associate professor of medicine in the division of gastroenterology at Durham VA Medical Center, Durham, N.C.; and Duke Clinical Research Institute, Durham, N.C. He reports a consulting relationship with Merck & Co. and he is also a cofounder and equity holder in Higgs Boson, LLC. He is funded by Veterans Affairs Health Services Research and Development Career Development Award (CDA 14-158 ).

It is my privilege this month to assume responsibility for the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology. I am honored to join an impressive board of editors led by Dr Fasiha Kanwal, and anchored by global leaders in the field of gastroenterology and hepatology. This board of editors promises to continue the high level of excellence that has propelled the journal to its preeminent position among clinical journals. I am confident that the practice management section will uphold that tradition and continue to meet the expectation of our readers. I would like to mark this transition by acknowledging the history of the practice management section of Clinical Gastroenterology and Hepatology and outlining a vision for the future.

The section was introduced in 2010 under the leadership of Dr. Joel V. Brill. The section, titled “Practice Management: Opportunities and Challenges,” aimed to help practices navigate the disparate issues facing the field. Some of these issues included use of capnography in endoscopy, the importance of registries for quality reporting, and the burdens of meaningful use on physician practices. Dr Brill introduced this section in a video in May 2010 (https://www.youtube.com/watch?v=8FMsc2Wl5E8). Dr. Brill’s reference to these “interesting and challenging times” in gastroenterology resonates even more loudly today.

• • Governance and culture: The structure of health delivery systems, as conceptualized by Donabedian,¹³ is a key determinant of quality. Structural attributes include regulatory requirements on gastrointestinal practices, such as the rules governing use of anesthesia providers in ambulatory surgical settings; role of allied health professionals in clinical settings; and the impact of financial incentives in driving provider behavior.
• • Financial readiness: Value-based reimbursement, accountable care, medical homes, reference pricing, and physician tiering are some of the new terms in this era of value-based medicine. It is important for practices to assess patient costs longitudinally and manage financial risks. The Road Ahead section will continue to include papers that describe the impact of these reforms on gastroenterology and hepatology practices while providing guidance on implementation of these new models of care. Some examples include papers on the effect of payment policy on specialty practices, the development of a medical home in inflammatory bowel disease, and the physician experience with episode-based payments for colonoscopy.
• • Health information technology: All of the organizational competencies required for reform rely on a robust information technology platform that collects meaningful data and harnesses that data for analytic purposes. These platforms can be enterprise systems deployed by large health delivery systems or smaller, more nimble platforms, created by innovative start-up companies. The Road Ahead will include papers that share best practices in the use of these platforms to provide high-quality and cost-efficient care. In addition, the Road Ahead will continue to explore the use of health information technology to expand the reach of clinicians beyond brick and mortar clinics.
• • Patient risk assessment: Tailoring interventions to high-risk patients is necessary to deploy limited resources in a cost-effective manner. Risk assessment is also needed to more accurately and effectively personalize care for patients with chronic conditions. The Road Ahead will include papers that evaluate risk assessment tools and/or describe real-life implementation of these tools in different contexts.
• • Care coordination: The ability to provide team-based longitudinal care across the continuum of care will be integral to providing high value health care. The Road Ahead will serve as a means to disseminate best practices and innovative methods to care for increasingly complex patients, especially those with chronic diseases, such as cirrhosis and inflammatory bowel disease. For example, papers will explore the implementation of specialty medical homes, patient navigators, community-based care services, and involvement of patients in their own care.
• • Quality improvement: Providing high-value care by definition will require clinicians to accurately measure the quality of care provided to patients and use data to guide process improvement. The Road Ahead will continue to serve as an educational resource for clinicians with papers that discuss challenges and opportunities in quality measurement and improvement. Similarly, this section will present data on novel or impactful quality-improvement initiatives.
• • Patient centeredness: Patient experience measures and patient-reported outcomes are becoming increasingly important as meaningful indicators of quality. These measures are designed to ensure that patient perspectives are incorporated into the governance, design, and delivery of health care. The Road Ahead will serve as a dissemination mechanism for sharing best practices in developing, validating, implementing, and tracking patient-reported outcomes.

References

1. Allen, J.I. The road ahead. Clin Gastroenterol Hepatol. 2012;10:692-6.

2. Dorn, S.D., Vesy, C.J. Medicare’s revaluation of gastrointestinal endoscopic procedures: implications for academic and community-based practices. Clin Gastroenterol Hepatol. 2017;14:924-8.

3. Dorn, S.D. The road ahead 3.0: changing payments, changing practice. Clin Gastroenterol Hepatol. 2016;14:785-9.

4. Meier, S.K., Shah, N.D., Talwalkar, J.A. Adapting the patient-centered specialty practice model for populations with cirrhosis. Clin Gastroenterol Hepatol. 2016;14:492-6.

5. Mehta, S.J. Bundled payment for gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2016;14:1681-4.

6. Weizman, A.V., Mosko, J., Bollegala, N., et al. Quality improvement primer series: launching a quality improvement initiative. Clin Gastroenterol Hepatol. 2017;14:1067-71.

7. Bernstein, M., Hou, J.K., Weizman, A.V., et al. Quality improvement primer series: how to sustain a quality improvement effort. Clin Gastroenterol Hepatol. 2017;14:1371-5.

8. Bollegala, N., Patel, K., Mosko, J.D., et al. Quality improvement primer series: the plan-do-study-act cycle and data display. Clin Gastroenterol Hepatol. 2016;14:1230-3.

9. Adams, M.A. Covert recording by patients of encounters with gastroenterology providers: path to empowerment or breach of trust?. Clin Gastroenterol Hepatol. 2017;15:13-6.

10. Oza, V.M., El-Dika, S., and Adams, M.A. Reaching safe harbor: legal implications of clinical practice guidelines. Clin Gastroenterol Hepatol. 2016;14:172-4.

11. Lin, M., Pappas, S.C., Sellin, J., et al. Curbside consultations: the good, the bad, and the ugly. Clin Gastroenterol Hepatol. 2016;14:2-4.

12. McClellan, M.B., Leavitt, M.O. Competencies and tools to shift payments from volume to value. JAMA. 2016; 316: 1655–1656

13. Donabedian, A. Evaluating the quality of medical care. Milbank Q. 1966;44:166-203.

14. Rosenberg, F.B., Kim, L.S., Ketover, S.R. Challenges facing independent integrated gastroenterology. Clin Gastroenterol Hepatol. 2017;15:335-8.

15. Leiman, D.A., Metz, D.C., Ginsberg, G.G., et al. A novel electronic medical record-based workflow to measure and report colonoscopy quality measures. Clin Gastroenterol Hepatol. 2016;14:333-7.

16. Cross, R.K., Kane, S. Integration of telemedicine into clinical gastroenterology and hepatology Practice. Clin Gastroenterol Hepatol. 2017;15:175-81.

17. Llor, X. Building a cancer genetics and prevention program. Clin Gastroenterol Hepatol. 2016;14:1516-20.

18. Patel, K.K., Cummings, S., Sellin, J., et al. Applying Lean design principles to a gastrointestinal endoscopy program for uninsured patients improves health care utilization. Clin Gastroenterol Hepatol. 2015;13:1556-9.

19. Saini, S.D., Adams, M.A., Brill, J.V., et al. Colorectal cancer screening quality measures: beyond colonoscopy. Clin Gastroenterol Hepatol. 2016;14:644-7.
 

Dr. Gellad is an associate professor of medicine in the division of gastroenterology at Durham VA Medical Center, Durham, N.C.; and Duke Clinical Research Institute, Durham, N.C. He reports a consulting relationship with Merck & Co. and he is also a cofounder and equity holder in Higgs Boson, LLC. He is funded by Veterans Affairs Health Services Research and Development Career Development Award (CDA 14-158 ).