I appreciate the opportunity to share medical myths each month, hopefully to highlight topics where new knowledge and data may help change ways we approach common problems in medicine. I have been researching medical myths since the early 1990s, and some have actually evolved in such a way that they are no longer myths – that is, accepted practice now is very different than it was decades ago, and has incorporated updated research.

Some myths are timeless. The vitamin B12 myth I shared in this column last year continues to this day, despite evidence that has been present since the 1960s.

I will share with you two of my all-time favorite myths that have now been retired, where current practice now does not perpetuate these myths.

When I was in medical school, I was taught that the best way to treat a corneal abrasion was to patch the affected eye.¹ Pretty much everyone who was seen in an emergency department for a corneal abrasion before the 1990s left the ED with an eye patch. This standard approach was not based on any evidence of benefit of healing or decreased pain.

Dr. Harold Jackson reported in a study of patients with corneal abrasions published in 1960 that there was no difference in healing between eyes that were patched and eyes that were left unpatched.² The largest published study on eye patches for corneal abrasions involved 201 patients who were evaluated for corneal abrasions.³ The patients who did not receive an eye patch had less pain and quicker healing of the corneal abrasions. Other studies all showed no benefit to eye patches.^4,5

A Cochrane Review published in 2006 concluded: “Treating simple corneal abrasions with a patch does not improve healing rates on the first day post-injury and does not reduce pain. In addition, use of patches results in a loss of binocular vision. Therefore, it is recommended that patches should not be used for simple corneal abrasions.”⁶

A more recent study by Dr. Moreno Menghini and colleagues showed no differences in healing of traumatic corneal abrasions between groups who received an eye patch, a contact lens, or no eye covering.⁷

Another longstanding myth that is less commonly seen now is the avoidance of use of narcotics for the treatment of acute, severe abdominal pain.

The long-term teaching was that by treating abdominal pain with narcotics, you could mask the important physical exam findings in patients presenting with an acute abdomen. The source of this myth wasn’t hard to uncover. The following are quotes from Cope’s Early Diagnosis of the Acute Abdomen 15th and 16th editions (these were the editions available back when I was a medical student in the early 1980s).

From the 15th edition: “If morphine be given, it is possible for a patient to die happy in the belief that he is on the road to recovery, and in some cases the medical attendant may for a time be induced to share the elusive hope.”⁸

An even stronger position was taken in the next edition of Cope’s text: “The patient cried out for relief, the relatives are insistent that something should be done, and the humane disciple of Aesculapius may think it is his first duty to diminish or banish the too obvious agony by administering a narcotic. Such a policy is a mistake. Though it may appear cruel, it is really kind to withhold morphine until a reasonable diagnosis has been made.”⁹

No controlled trials ever questioned this long-held belief until a study done by Dr. Alex Attard and colleagues published in 1992.¹⁰ In this study, 100 patients were evaluated by an admitting officer and given an intramuscular injection of either a narcotic or saline. Surgeons who subsequently followed the patients felt equally confident in diagnosis and management in both groups. The decision to operate or observe was incorrect in two patients in the narcotic group and nine in the saline group.

Dr. H. A. Amoli and colleagues studied whether administering morphine changed exam findings in patients with acute appendiciits.¹¹ In a randomized, double-blind study design, half the patients received morphine and half received saline. Patients were examined by surgeons not involved in their care before and after drug administration, and their pain intensity and signs were recorded at each visit. The administration of morphine did not alter clinical signs or physician management plans.

In a study by Dr. Steven Pace and colleagues of patients presenting with acute abdominal pain, intravenous morphine or placebo was administered in 71 patients early in their presentation to the ED.¹² There were no differences in accuracy of diagnosis between groups. Three diagnostic or management errors were made in each group.

I think the standard of care now for corneal abrasion treatment does not include eye patching. I also believe that the old teaching of no pain medication until the surgeon has examined the patient has also been replaced with appropriate pain management occurring early in the care plan for patients presenting with acute abdominal pain.

In the case of corneal abrasions, overwhelming data showing no benefit won out. I believe that the change in the management of acute abdominal pain was a combination of data along with advances in diagnostic imaging.

References

1. Wilkins. Emergency Medicine. 1989 Williams and Wilkins, Baltimore, Md.

2. Br Med J. 1960 Sep 3;2(5200):713.

3. Ophthalmology. 1995 Dec;102(12):1936-42.

4. Lancet. 1991 Mar 16;337(8742):643.

5. Eye (Lond). 1993;7:468-71.

6. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004764.

7. Ophthalmic Res. 2013;50(1):13-8.

8. Cope’s Early Diagnosis of the Acute Abdomen, 15th Edition, Oxford University Press, 1979.

9. Cope’s Early Diagnosis of the Acute Abdomen, 16th Edition, Oxford University Press, 1983.

10. BMJ. 1992 Sep 5;305(6853):554-6.

11. Emerg Med J. 2008 Sep;25(9):586-9.

12. Acad Emerg Med. 1996 Dec;3(12):1086-92.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

I appreciate the opportunity to share medical myths each month, hopefully to highlight topics where new knowledge and data may help change ways we approach common problems in medicine. I have been researching medical myths since the early 1990s, and some have actually evolved in such a way that they are no longer myths – that is, accepted practice now is very different than it was decades ago, and has incorporated updated research.

Some myths are timeless. The vitamin B12 myth I shared in this column last year continues to this day, despite evidence that has been present since the 1960s.

I will share with you two of my all-time favorite myths that have now been retired, where current practice now does not perpetuate these myths.

When I was in medical school, I was taught that the best way to treat a corneal abrasion was to patch the affected eye.¹ Pretty much everyone who was seen in an emergency department for a corneal abrasion before the 1990s left the ED with an eye patch. This standard approach was not based on any evidence of benefit of healing or decreased pain.

Dr. Harold Jackson reported in a study of patients with corneal abrasions published in 1960 that there was no difference in healing between eyes that were patched and eyes that were left unpatched.² The largest published study on eye patches for corneal abrasions involved 201 patients who were evaluated for corneal abrasions.³ The patients who did not receive an eye patch had less pain and quicker healing of the corneal abrasions. Other studies all showed no benefit to eye patches.^4,5

A Cochrane Review published in 2006 concluded: “Treating simple corneal abrasions with a patch does not improve healing rates on the first day post-injury and does not reduce pain. In addition, use of patches results in a loss of binocular vision. Therefore, it is recommended that patches should not be used for simple corneal abrasions.”⁶

A more recent study by Dr. Moreno Menghini and colleagues showed no differences in healing of traumatic corneal abrasions between groups who received an eye patch, a contact lens, or no eye covering.⁷

Another longstanding myth that is less commonly seen now is the avoidance of use of narcotics for the treatment of acute, severe abdominal pain.

The long-term teaching was that by treating abdominal pain with narcotics, you could mask the important physical exam findings in patients presenting with an acute abdomen. The source of this myth wasn’t hard to uncover. The following are quotes from Cope’s Early Diagnosis of the Acute Abdomen 15th and 16th editions (these were the editions available back when I was a medical student in the early 1980s).

From the 15th edition: “If morphine be given, it is possible for a patient to die happy in the belief that he is on the road to recovery, and in some cases the medical attendant may for a time be induced to share the elusive hope.”⁸

An even stronger position was taken in the next edition of Cope’s text: “The patient cried out for relief, the relatives are insistent that something should be done, and the humane disciple of Aesculapius may think it is his first duty to diminish or banish the too obvious agony by administering a narcotic. Such a policy is a mistake. Though it may appear cruel, it is really kind to withhold morphine until a reasonable diagnosis has been made.”⁹

No controlled trials ever questioned this long-held belief until a study done by Dr. Alex Attard and colleagues published in 1992.¹⁰ In this study, 100 patients were evaluated by an admitting officer and given an intramuscular injection of either a narcotic or saline. Surgeons who subsequently followed the patients felt equally confident in diagnosis and management in both groups. The decision to operate or observe was incorrect in two patients in the narcotic group and nine in the saline group.

Dr. H. A. Amoli and colleagues studied whether administering morphine changed exam findings in patients with acute appendiciits.¹¹ In a randomized, double-blind study design, half the patients received morphine and half received saline. Patients were examined by surgeons not involved in their care before and after drug administration, and their pain intensity and signs were recorded at each visit. The administration of morphine did not alter clinical signs or physician management plans.

In a study by Dr. Steven Pace and colleagues of patients presenting with acute abdominal pain, intravenous morphine or placebo was administered in 71 patients early in their presentation to the ED.¹² There were no differences in accuracy of diagnosis between groups. Three diagnostic or management errors were made in each group.

I think the standard of care now for corneal abrasion treatment does not include eye patching. I also believe that the old teaching of no pain medication until the surgeon has examined the patient has also been replaced with appropriate pain management occurring early in the care plan for patients presenting with acute abdominal pain.

In the case of corneal abrasions, overwhelming data showing no benefit won out. I believe that the change in the management of acute abdominal pain was a combination of data along with advances in diagnostic imaging.

References

1. Wilkins. Emergency Medicine. 1989 Williams and Wilkins, Baltimore, Md.

2. Br Med J. 1960 Sep 3;2(5200):713.

3. Ophthalmology. 1995 Dec;102(12):1936-42.

4. Lancet. 1991 Mar 16;337(8742):643.

5. Eye (Lond). 1993;7:468-71.

6. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004764.

7. Ophthalmic Res. 2013;50(1):13-8.

8. Cope’s Early Diagnosis of the Acute Abdomen, 15th Edition, Oxford University Press, 1979.

9. Cope’s Early Diagnosis of the Acute Abdomen, 16th Edition, Oxford University Press, 1983.

10. BMJ. 1992 Sep 5;305(6853):554-6.

11. Emerg Med J. 2008 Sep;25(9):586-9.

12. Acad Emerg Med. 1996 Dec;3(12):1086-92.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

I appreciate the opportunity to share medical myths each month, hopefully to highlight topics where new knowledge and data may help change ways we approach common problems in medicine. I have been researching medical myths since the early 1990s, and some have actually evolved in such a way that they are no longer myths – that is, accepted practice now is very different than it was decades ago, and has incorporated updated research.

Some myths are timeless. The vitamin B12 myth I shared in this column last year continues to this day, despite evidence that has been present since the 1960s.

I will share with you two of my all-time favorite myths that have now been retired, where current practice now does not perpetuate these myths.

When I was in medical school, I was taught that the best way to treat a corneal abrasion was to patch the affected eye.¹ Pretty much everyone who was seen in an emergency department for a corneal abrasion before the 1990s left the ED with an eye patch. This standard approach was not based on any evidence of benefit of healing or decreased pain.

Dr. Harold Jackson reported in a study of patients with corneal abrasions published in 1960 that there was no difference in healing between eyes that were patched and eyes that were left unpatched.² The largest published study on eye patches for corneal abrasions involved 201 patients who were evaluated for corneal abrasions.³ The patients who did not receive an eye patch had less pain and quicker healing of the corneal abrasions. Other studies all showed no benefit to eye patches.^4,5

A Cochrane Review published in 2006 concluded: “Treating simple corneal abrasions with a patch does not improve healing rates on the first day post-injury and does not reduce pain. In addition, use of patches results in a loss of binocular vision. Therefore, it is recommended that patches should not be used for simple corneal abrasions.”⁶

A more recent study by Dr. Moreno Menghini and colleagues showed no differences in healing of traumatic corneal abrasions between groups who received an eye patch, a contact lens, or no eye covering.⁷

Another longstanding myth that is less commonly seen now is the avoidance of use of narcotics for the treatment of acute, severe abdominal pain.

The long-term teaching was that by treating abdominal pain with narcotics, you could mask the important physical exam findings in patients presenting with an acute abdomen. The source of this myth wasn’t hard to uncover. The following are quotes from Cope’s Early Diagnosis of the Acute Abdomen 15th and 16th editions (these were the editions available back when I was a medical student in the early 1980s).

From the 15th edition: “If morphine be given, it is possible for a patient to die happy in the belief that he is on the road to recovery, and in some cases the medical attendant may for a time be induced to share the elusive hope.”⁸

An even stronger position was taken in the next edition of Cope’s text: “The patient cried out for relief, the relatives are insistent that something should be done, and the humane disciple of Aesculapius may think it is his first duty to diminish or banish the too obvious agony by administering a narcotic. Such a policy is a mistake. Though it may appear cruel, it is really kind to withhold morphine until a reasonable diagnosis has been made.”⁹

No controlled trials ever questioned this long-held belief until a study done by Dr. Alex Attard and colleagues published in 1992.¹⁰ In this study, 100 patients were evaluated by an admitting officer and given an intramuscular injection of either a narcotic or saline. Surgeons who subsequently followed the patients felt equally confident in diagnosis and management in both groups. The decision to operate or observe was incorrect in two patients in the narcotic group and nine in the saline group.

Dr. H. A. Amoli and colleagues studied whether administering morphine changed exam findings in patients with acute appendiciits.¹¹ In a randomized, double-blind study design, half the patients received morphine and half received saline. Patients were examined by surgeons not involved in their care before and after drug administration, and their pain intensity and signs were recorded at each visit. The administration of morphine did not alter clinical signs or physician management plans.

In a study by Dr. Steven Pace and colleagues of patients presenting with acute abdominal pain, intravenous morphine or placebo was administered in 71 patients early in their presentation to the ED.¹² There were no differences in accuracy of diagnosis between groups. Three diagnostic or management errors were made in each group.

I think the standard of care now for corneal abrasion treatment does not include eye patching. I also believe that the old teaching of no pain medication until the surgeon has examined the patient has also been replaced with appropriate pain management occurring early in the care plan for patients presenting with acute abdominal pain.

In the case of corneal abrasions, overwhelming data showing no benefit won out. I believe that the change in the management of acute abdominal pain was a combination of data along with advances in diagnostic imaging.

References

1. Wilkins. Emergency Medicine. 1989 Williams and Wilkins, Baltimore, Md.

2. Br Med J. 1960 Sep 3;2(5200):713.

3. Ophthalmology. 1995 Dec;102(12):1936-42.

4. Lancet. 1991 Mar 16;337(8742):643.

5. Eye (Lond). 1993;7:468-71.

6. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004764.

7. Ophthalmic Res. 2013;50(1):13-8.

8. Cope’s Early Diagnosis of the Acute Abdomen, 15th Edition, Oxford University Press, 1979.

9. Cope’s Early Diagnosis of the Acute Abdomen, 16th Edition, Oxford University Press, 1983.

10. BMJ. 1992 Sep 5;305(6853):554-6.

11. Emerg Med J. 2008 Sep;25(9):586-9.

12. Acad Emerg Med. 1996 Dec;3(12):1086-92.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

VANCOUVER – Women with epilepsy have fertility rates comparable with healthy women in the general population, according to results from the first prospective observational cohort study to make the comparison.

During the year-long Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study, 70% of women with epilepsy and 67% of healthy control women became pregnant, and there was no significant difference in the mean time to pregnancy between those with and without epilepsy (6 months vs. 9 months, respectively), Dr. Page Pennell reported at the annual meeting of the American Academy of Neurology.

Live births occurred in 82% of pregnancies of women with epilepsy and 80% of controls, while miscarriages occurred in 13% and 20%, respectively. Both of those rates are very similar to the general population. Another 5% of pregnancies in women with epilepsy were ectopic, terminated due to chromosomal abnormality, or lost to follow-up.

“These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy,” said Dr. Pennell, director of research for the division of epilepsy in the department of neurology at Brigham and Women’s Hospital in Boston. She is a primary investigator of the study along with Dr. Jacqueline French, professor of neurology at NYU Langone Medical Center and Dr. Cynthia Harden, system director of epilepsy services at Mount Sinai Beth Israel, both in New York.

“I think overall the findings are more in the light of myth busting. ... We don’t necessarily see a lot of problems with fertility, yet the literature suggests that the birth rates are much lower,” Dr. Harden said in an interview.

“It’s really the first solid evidence, and it’s nice because in a sea of bad news for women when it comes to family planning and achieving pregnancy and pregnancy outcomes, I think this was very positive to say that their ability to achieve pregnancy was no different than what was reported by a control population without epilepsy,” Dr. Katherine Noe, an epilepsy specialist at the Mayo Clinic in Scottsdale, Ariz., said when asked to comment on the study.

“There was certainly reason to be concerned,” said Dr. Noe, who was not involved in the study. “We have a lot of data saying that babies exposed to antiepileptic drugs are more likely to have malformations, and so you could have a baby that already early in pregnancy has severe malformations that would be more likely to end in spontaneous abortion.”

Dr. Noe said that pregnancy registry data indicate that women with epilepsy may be more likely to have a pregnancy that ends in a miscarriage. Investigators for several studies published in 2015 reported that women with epilepsy face greater risk for morbidity and adverse outcomes at the time of delivery and during pregnancy than women without epilepsy (JAMA Neurol. 2015;72[9]:981-8 and Lancet. 2016;386[10006]:1845–52). Women with epilepsy also have been thought to be more prone to infertility for various reasons, including menstrual irregularities, polycystic ovarian syndrome related to antiepileptic medications, and early menopause, she said.

Three previous studies had reported that women with epilepsy had birth rates as low as only one-quarter to one-third that of women without epilepsy. There have been many reasons reported for why that might be the case, including lower marriage rates, sexual dysfunction, lower libido (in both men and women with epilepsy), and increased number of anovulatory cycles, or greater choice to not become pregnant, Dr. Pennell said.

The WEPOD study enrolled 89 women with epilepsy and 109 healthy controls who were seeking to become pregnant and had stopped using contraception within 6 months of enrollment or were about to stop using it. The investigators excluded women with infertility, polycystic ovarian syndrome, endometriosis, endocrine disorder, and heavy smoking, or who were not in an exclusive heterosexual relationship with a significant other or spouse.

Participants received iPod touch devices with an app with which they tracked menses and intercourse, as well as antiepileptic drug use and seizures in women with epilepsy. “This was a particularly novel part of the study,” Dr. Harden said. It allowed the investigators to track adherence very well. Participants logged about 87% of their days in the app, and the investigators could see when the entries were made.

Women in both groups had a mean age of about 31 years and mean body mass index of about 25 kg/m². Overall, 52%-58% had undergone a prior pregnancy. Women with epilepsy, compared with controls, were less often Asian (17% vs. 6%) or African American (16% vs. 1%). The education level of participants was “fairly similar” between the groups, and slightly more women with epilepsy were unemployed (21% vs. 10%). Women with epilepsy also were more often married than were controls (89% vs. 75%).

During the study, 36% of women with epilepsy were still having seizures. At enrollment, most of the women’s seizure types were generalized (30%) or focal only (63%). Dr. Pennell noted that the antiseizure medications that the women were taking were typical for women of reproductive age: lamotrigine monotherapy (44%), levetiracetam monotherapy (28%), monotherapy with a strong enzyme-inducing drug (12%), other polytherapy (10%), polytherapy with a strong enzyme-inducing drug (6%), other monotherapy (3%), or no antiseizure medication (2%). A few women either added or stopped drugs during the study. A total of 18 women with epilepsy and 15 healthy controls dropped out.

As expected, age affected the likelihood of becoming pregnant, as well as number of prior pregnancies. Body mass index did not affect the likelihood of becoming pregnant, while white race and being married increased the likelihood.

In future analyses, the investigators are planning on checking whether ovulatory rates, frequency of intercourse, and time of intercourse had any impact on pregnancy, and in women with epilepsy, they will check the effect of the type of antiseizure medication and seizure-related factors.

“I think our findings will stand with future analyses.” Dr. Harden said. “The most interesting future findings may come from within the epilepsy group,” she said, noting that older antiepileptic medications have been previously associated with difficulty conceiving.

The WEPOD study was funded by the Milken Family Foundation, the Epilepsy Therapy Project, and the Epilepsy Foundation.

[email protected]

VANCOUVER – Women with epilepsy have fertility rates comparable with healthy women in the general population, according to results from the first prospective observational cohort study to make the comparison.

During the year-long Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study, 70% of women with epilepsy and 67% of healthy control women became pregnant, and there was no significant difference in the mean time to pregnancy between those with and without epilepsy (6 months vs. 9 months, respectively), Dr. Page Pennell reported at the annual meeting of the American Academy of Neurology.

Live births occurred in 82% of pregnancies of women with epilepsy and 80% of controls, while miscarriages occurred in 13% and 20%, respectively. Both of those rates are very similar to the general population. Another 5% of pregnancies in women with epilepsy were ectopic, terminated due to chromosomal abnormality, or lost to follow-up.

“These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy,” said Dr. Pennell, director of research for the division of epilepsy in the department of neurology at Brigham and Women’s Hospital in Boston. She is a primary investigator of the study along with Dr. Jacqueline French, professor of neurology at NYU Langone Medical Center and Dr. Cynthia Harden, system director of epilepsy services at Mount Sinai Beth Israel, both in New York.

“I think overall the findings are more in the light of myth busting. ... We don’t necessarily see a lot of problems with fertility, yet the literature suggests that the birth rates are much lower,” Dr. Harden said in an interview.

“It’s really the first solid evidence, and it’s nice because in a sea of bad news for women when it comes to family planning and achieving pregnancy and pregnancy outcomes, I think this was very positive to say that their ability to achieve pregnancy was no different than what was reported by a control population without epilepsy,” Dr. Katherine Noe, an epilepsy specialist at the Mayo Clinic in Scottsdale, Ariz., said when asked to comment on the study.

“There was certainly reason to be concerned,” said Dr. Noe, who was not involved in the study. “We have a lot of data saying that babies exposed to antiepileptic drugs are more likely to have malformations, and so you could have a baby that already early in pregnancy has severe malformations that would be more likely to end in spontaneous abortion.”

Dr. Noe said that pregnancy registry data indicate that women with epilepsy may be more likely to have a pregnancy that ends in a miscarriage. Investigators for several studies published in 2015 reported that women with epilepsy face greater risk for morbidity and adverse outcomes at the time of delivery and during pregnancy than women without epilepsy (JAMA Neurol. 2015;72[9]:981-8 and Lancet. 2016;386[10006]:1845–52). Women with epilepsy also have been thought to be more prone to infertility for various reasons, including menstrual irregularities, polycystic ovarian syndrome related to antiepileptic medications, and early menopause, she said.

Three previous studies had reported that women with epilepsy had birth rates as low as only one-quarter to one-third that of women without epilepsy. There have been many reasons reported for why that might be the case, including lower marriage rates, sexual dysfunction, lower libido (in both men and women with epilepsy), and increased number of anovulatory cycles, or greater choice to not become pregnant, Dr. Pennell said.

The WEPOD study enrolled 89 women with epilepsy and 109 healthy controls who were seeking to become pregnant and had stopped using contraception within 6 months of enrollment or were about to stop using it. The investigators excluded women with infertility, polycystic ovarian syndrome, endometriosis, endocrine disorder, and heavy smoking, or who were not in an exclusive heterosexual relationship with a significant other or spouse.

Participants received iPod touch devices with an app with which they tracked menses and intercourse, as well as antiepileptic drug use and seizures in women with epilepsy. “This was a particularly novel part of the study,” Dr. Harden said. It allowed the investigators to track adherence very well. Participants logged about 87% of their days in the app, and the investigators could see when the entries were made.

Women in both groups had a mean age of about 31 years and mean body mass index of about 25 kg/m². Overall, 52%-58% had undergone a prior pregnancy. Women with epilepsy, compared with controls, were less often Asian (17% vs. 6%) or African American (16% vs. 1%). The education level of participants was “fairly similar” between the groups, and slightly more women with epilepsy were unemployed (21% vs. 10%). Women with epilepsy also were more often married than were controls (89% vs. 75%).

During the study, 36% of women with epilepsy were still having seizures. At enrollment, most of the women’s seizure types were generalized (30%) or focal only (63%). Dr. Pennell noted that the antiseizure medications that the women were taking were typical for women of reproductive age: lamotrigine monotherapy (44%), levetiracetam monotherapy (28%), monotherapy with a strong enzyme-inducing drug (12%), other polytherapy (10%), polytherapy with a strong enzyme-inducing drug (6%), other monotherapy (3%), or no antiseizure medication (2%). A few women either added or stopped drugs during the study. A total of 18 women with epilepsy and 15 healthy controls dropped out.

As expected, age affected the likelihood of becoming pregnant, as well as number of prior pregnancies. Body mass index did not affect the likelihood of becoming pregnant, while white race and being married increased the likelihood.

In future analyses, the investigators are planning on checking whether ovulatory rates, frequency of intercourse, and time of intercourse had any impact on pregnancy, and in women with epilepsy, they will check the effect of the type of antiseizure medication and seizure-related factors.

“I think our findings will stand with future analyses.” Dr. Harden said. “The most interesting future findings may come from within the epilepsy group,” she said, noting that older antiepileptic medications have been previously associated with difficulty conceiving.

The WEPOD study was funded by the Milken Family Foundation, the Epilepsy Therapy Project, and the Epilepsy Foundation.

[email protected]

VANCOUVER – Women with epilepsy have fertility rates comparable with healthy women in the general population, according to results from the first prospective observational cohort study to make the comparison.

During the year-long Women With Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD) study, 70% of women with epilepsy and 67% of healthy control women became pregnant, and there was no significant difference in the mean time to pregnancy between those with and without epilepsy (6 months vs. 9 months, respectively), Dr. Page Pennell reported at the annual meeting of the American Academy of Neurology.

Live births occurred in 82% of pregnancies of women with epilepsy and 80% of controls, while miscarriages occurred in 13% and 20%, respectively. Both of those rates are very similar to the general population. Another 5% of pregnancies in women with epilepsy were ectopic, terminated due to chromosomal abnormality, or lost to follow-up.

“These findings should reassure women with epilepsy and clinicians when counseling women with epilepsy who are planning pregnancy,” said Dr. Pennell, director of research for the division of epilepsy in the department of neurology at Brigham and Women’s Hospital in Boston. She is a primary investigator of the study along with Dr. Jacqueline French, professor of neurology at NYU Langone Medical Center and Dr. Cynthia Harden, system director of epilepsy services at Mount Sinai Beth Israel, both in New York.

“I think overall the findings are more in the light of myth busting. ... We don’t necessarily see a lot of problems with fertility, yet the literature suggests that the birth rates are much lower,” Dr. Harden said in an interview.

“It’s really the first solid evidence, and it’s nice because in a sea of bad news for women when it comes to family planning and achieving pregnancy and pregnancy outcomes, I think this was very positive to say that their ability to achieve pregnancy was no different than what was reported by a control population without epilepsy,” Dr. Katherine Noe, an epilepsy specialist at the Mayo Clinic in Scottsdale, Ariz., said when asked to comment on the study.

“There was certainly reason to be concerned,” said Dr. Noe, who was not involved in the study. “We have a lot of data saying that babies exposed to antiepileptic drugs are more likely to have malformations, and so you could have a baby that already early in pregnancy has severe malformations that would be more likely to end in spontaneous abortion.”

Dr. Noe said that pregnancy registry data indicate that women with epilepsy may be more likely to have a pregnancy that ends in a miscarriage. Investigators for several studies published in 2015 reported that women with epilepsy face greater risk for morbidity and adverse outcomes at the time of delivery and during pregnancy than women without epilepsy (JAMA Neurol. 2015;72[9]:981-8 and Lancet. 2016;386[10006]:1845–52). Women with epilepsy also have been thought to be more prone to infertility for various reasons, including menstrual irregularities, polycystic ovarian syndrome related to antiepileptic medications, and early menopause, she said.

Three previous studies had reported that women with epilepsy had birth rates as low as only one-quarter to one-third that of women without epilepsy. There have been many reasons reported for why that might be the case, including lower marriage rates, sexual dysfunction, lower libido (in both men and women with epilepsy), and increased number of anovulatory cycles, or greater choice to not become pregnant, Dr. Pennell said.

The WEPOD study enrolled 89 women with epilepsy and 109 healthy controls who were seeking to become pregnant and had stopped using contraception within 6 months of enrollment or were about to stop using it. The investigators excluded women with infertility, polycystic ovarian syndrome, endometriosis, endocrine disorder, and heavy smoking, or who were not in an exclusive heterosexual relationship with a significant other or spouse.

Participants received iPod touch devices with an app with which they tracked menses and intercourse, as well as antiepileptic drug use and seizures in women with epilepsy. “This was a particularly novel part of the study,” Dr. Harden said. It allowed the investigators to track adherence very well. Participants logged about 87% of their days in the app, and the investigators could see when the entries were made.

Women in both groups had a mean age of about 31 years and mean body mass index of about 25 kg/m². Overall, 52%-58% had undergone a prior pregnancy. Women with epilepsy, compared with controls, were less often Asian (17% vs. 6%) or African American (16% vs. 1%). The education level of participants was “fairly similar” between the groups, and slightly more women with epilepsy were unemployed (21% vs. 10%). Women with epilepsy also were more often married than were controls (89% vs. 75%).

During the study, 36% of women with epilepsy were still having seizures. At enrollment, most of the women’s seizure types were generalized (30%) or focal only (63%). Dr. Pennell noted that the antiseizure medications that the women were taking were typical for women of reproductive age: lamotrigine monotherapy (44%), levetiracetam monotherapy (28%), monotherapy with a strong enzyme-inducing drug (12%), other polytherapy (10%), polytherapy with a strong enzyme-inducing drug (6%), other monotherapy (3%), or no antiseizure medication (2%). A few women either added or stopped drugs during the study. A total of 18 women with epilepsy and 15 healthy controls dropped out.

As expected, age affected the likelihood of becoming pregnant, as well as number of prior pregnancies. Body mass index did not affect the likelihood of becoming pregnant, while white race and being married increased the likelihood.

In future analyses, the investigators are planning on checking whether ovulatory rates, frequency of intercourse, and time of intercourse had any impact on pregnancy, and in women with epilepsy, they will check the effect of the type of antiseizure medication and seizure-related factors.

“I think our findings will stand with future analyses.” Dr. Harden said. “The most interesting future findings may come from within the epilepsy group,” she said, noting that older antiepileptic medications have been previously associated with difficulty conceiving.

The WEPOD study was funded by the Milken Family Foundation, the Epilepsy Therapy Project, and the Epilepsy Foundation.

[email protected]

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

[email protected]

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

[email protected]

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

[email protected]

The American College of Surgeons (ACS) is now accepting applications for the 2016 Claude H. Organ, Jr., MD, FACS, Traveling Fellowship. The deadline for all application materials is June 1.

The family and friends of the late Dr. Organ established an endowment through the ACS Foundation to provide funding for this fellowship, which is awarded annually to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than age 45 who is a member of one of these societies to attend an educational meeting or participate in an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The most recent fellow, Kathie-Ann Joseph, MD, MPH, FACS, associate professor of surgery, New York University School of Medicine, and chief of surgery, Bellevue Hospital Center, New York, NY, is researching how health care systems work in a major metropolitan area, with a focus on the ways that large hospitals systems manage care for underserved women.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted at facs.org/member-services/scholarships/special/organ. The 2016 awardee will be informed of the College’s decision by August 2016. Questions and application materials should be submitted to the attention of Kate Early, ACS Scholarships Administrator, at [email protected].

The American College of Surgeons (ACS) is now accepting applications for the 2016 Claude H. Organ, Jr., MD, FACS, Traveling Fellowship. The deadline for all application materials is June 1.

The family and friends of the late Dr. Organ established an endowment through the ACS Foundation to provide funding for this fellowship, which is awarded annually to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than age 45 who is a member of one of these societies to attend an educational meeting or participate in an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The most recent fellow, Kathie-Ann Joseph, MD, MPH, FACS, associate professor of surgery, New York University School of Medicine, and chief of surgery, Bellevue Hospital Center, New York, NY, is researching how health care systems work in a major metropolitan area, with a focus on the ways that large hospitals systems manage care for underserved women.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted at facs.org/member-services/scholarships/special/organ. The 2016 awardee will be informed of the College’s decision by August 2016. Questions and application materials should be submitted to the attention of Kate Early, ACS Scholarships Administrator, at [email protected].

The American College of Surgeons (ACS) is now accepting applications for the 2016 Claude H. Organ, Jr., MD, FACS, Traveling Fellowship. The deadline for all application materials is June 1.

The family and friends of the late Dr. Organ established an endowment through the ACS Foundation to provide funding for this fellowship, which is awarded annually to an outstanding young surgeon from the Society of Black Academic Surgeons, the Association of Women Surgeons, or the Surgical Section of the National Medical Association. The fellowship, in the amount of $5,000, enables a U.S. or Canadian Fellow or Associate Fellow younger than age 45 who is a member of one of these societies to attend an educational meeting or participate in an extended visit to an institution of his or her choice, tailored to his or her research interests.

Past awardees have used their fellowships to develop their careers in creative ways. The most recent fellow, Kathie-Ann Joseph, MD, MPH, FACS, associate professor of surgery, New York University School of Medicine, and chief of surgery, Bellevue Hospital Center, New York, NY, is researching how health care systems work in a major metropolitan area, with a focus on the ways that large hospitals systems manage care for underserved women.

The full requirements for the Claude H. Organ, Jr., MD, FACS, Traveling Fellowship are posted at facs.org/member-services/scholarships/special/organ. The 2016 awardee will be informed of the College’s decision by August 2016. Questions and application materials should be submitted to the attention of Kate Early, ACS Scholarships Administrator, at [email protected].

Have you ever run across a negative or even malicious comment about you or your practice on the web, in full view of the world? You’re certainly not alone.

Chances are it was on one of those doctor rating sites, whose supposedly “objective” evaluations are anything but fair or accurate; one curmudgeon, angry about something that usually has nothing to do with your clinical skills, can use his First Amendment–protected right to trash you unfairly, as thousands of satisfied patients remain silent.

What to do? You could hire one of the many companies in the rapidly burgeoning field of online reputation management; but that can cost hundreds to thousands of dollars per month for monitoring and intervention, and there are no guarantees of success.

A better solution is to generate your own search results – positive ones – that will overwhelm any negative comments that search engines might find. Start with the social networking sites. However you feel about networking, there’s no getting around the fact that personal pages on Facebook, LinkedIn, and Twitter rank very high on major search engines. (Some consultants say a favorable LinkedIn profile is particularly helpful because of that site’s reputation as a “professional” network.) Your community activities, charitable work, interesting hobbies – anything that casts you in a favorable light – need to be mentioned prominently in your network profiles.

You can also use Google’s profiling tool (https://plus.google.com/up/accounts/) to create a sterling bio, complete with links to URLs, photos, and anything else that shows you in the best possible light. And your Google profile will be at or near the top of any Google search.

Wikipedia articles also go to the top of most searches, so if you’re notable enough to merit mention in one – or to have one of your own – see that it is done, and updated regularly. You can’t do that yourself, however; Wikipedia’s conflict of interest rules forbid writing or editing content about yourself. Someone with a theoretically “neutral point of view” will have to do it.

If you don’t yet have a website, now would be a good time. As I’ve discussed many times, a professionally designed site will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created in a way that is readily visible to search engine users.

Leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your site. And remember that once it’s online, it’s online forever; consider the ramifications of anything you post on any site (yours or others) before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you posted yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Make your (noncontroversial) opinions known on Facebook and Twitter. If social networks are not your thing, add a blog to your web site and write about what you know, and what interests you. If you have expertise in a particular field, write about that.

Incidentally, if the URL for your web site is not your name, you should also register your name as a separate domain name – if only to be sure that a trickster, or someone with the same name and a bad reputation, doesn’t get it.

Set up an RSS news feed for yourself, so you’ll know immediately anytime your name pops up in news or gossip sites, or on blogs. If something untrue is posted about you, take action. Reputable news sites and blogs have their own reputations to protect, and so can usually be persuaded to correct anything that is demonstrably false. Try to get the error removed entirely, or corrected within the original article. An erratum on the last page of the next edition will be ignored, and will leave the false information online, intact.

Unfair comments on doctor rating sites are unlikely to be removed unless they are blatantly libelous; but there is nothing wrong with encouraging happy patients to write favorable reviews. Turnabout is fair play.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Have you ever run across a negative or even malicious comment about you or your practice on the web, in full view of the world? You’re certainly not alone.

Chances are it was on one of those doctor rating sites, whose supposedly “objective” evaluations are anything but fair or accurate; one curmudgeon, angry about something that usually has nothing to do with your clinical skills, can use his First Amendment–protected right to trash you unfairly, as thousands of satisfied patients remain silent.

What to do? You could hire one of the many companies in the rapidly burgeoning field of online reputation management; but that can cost hundreds to thousands of dollars per month for monitoring and intervention, and there are no guarantees of success.

A better solution is to generate your own search results – positive ones – that will overwhelm any negative comments that search engines might find. Start with the social networking sites. However you feel about networking, there’s no getting around the fact that personal pages on Facebook, LinkedIn, and Twitter rank very high on major search engines. (Some consultants say a favorable LinkedIn profile is particularly helpful because of that site’s reputation as a “professional” network.) Your community activities, charitable work, interesting hobbies – anything that casts you in a favorable light – need to be mentioned prominently in your network profiles.

You can also use Google’s profiling tool (https://plus.google.com/up/accounts/) to create a sterling bio, complete with links to URLs, photos, and anything else that shows you in the best possible light. And your Google profile will be at or near the top of any Google search.

Wikipedia articles also go to the top of most searches, so if you’re notable enough to merit mention in one – or to have one of your own – see that it is done, and updated regularly. You can’t do that yourself, however; Wikipedia’s conflict of interest rules forbid writing or editing content about yourself. Someone with a theoretically “neutral point of view” will have to do it.

If you don’t yet have a website, now would be a good time. As I’ve discussed many times, a professionally designed site will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created in a way that is readily visible to search engine users.

Leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your site. And remember that once it’s online, it’s online forever; consider the ramifications of anything you post on any site (yours or others) before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you posted yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Make your (noncontroversial) opinions known on Facebook and Twitter. If social networks are not your thing, add a blog to your web site and write about what you know, and what interests you. If you have expertise in a particular field, write about that.

Incidentally, if the URL for your web site is not your name, you should also register your name as a separate domain name – if only to be sure that a trickster, or someone with the same name and a bad reputation, doesn’t get it.

Set up an RSS news feed for yourself, so you’ll know immediately anytime your name pops up in news or gossip sites, or on blogs. If something untrue is posted about you, take action. Reputable news sites and blogs have their own reputations to protect, and so can usually be persuaded to correct anything that is demonstrably false. Try to get the error removed entirely, or corrected within the original article. An erratum on the last page of the next edition will be ignored, and will leave the false information online, intact.

Unfair comments on doctor rating sites are unlikely to be removed unless they are blatantly libelous; but there is nothing wrong with encouraging happy patients to write favorable reviews. Turnabout is fair play.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Have you ever run across a negative or even malicious comment about you or your practice on the web, in full view of the world? You’re certainly not alone.

Chances are it was on one of those doctor rating sites, whose supposedly “objective” evaluations are anything but fair or accurate; one curmudgeon, angry about something that usually has nothing to do with your clinical skills, can use his First Amendment–protected right to trash you unfairly, as thousands of satisfied patients remain silent.

What to do? You could hire one of the many companies in the rapidly burgeoning field of online reputation management; but that can cost hundreds to thousands of dollars per month for monitoring and intervention, and there are no guarantees of success.

A better solution is to generate your own search results – positive ones – that will overwhelm any negative comments that search engines might find. Start with the social networking sites. However you feel about networking, there’s no getting around the fact that personal pages on Facebook, LinkedIn, and Twitter rank very high on major search engines. (Some consultants say a favorable LinkedIn profile is particularly helpful because of that site’s reputation as a “professional” network.) Your community activities, charitable work, interesting hobbies – anything that casts you in a favorable light – need to be mentioned prominently in your network profiles.

You can also use Google’s profiling tool (https://plus.google.com/up/accounts/) to create a sterling bio, complete with links to URLs, photos, and anything else that shows you in the best possible light. And your Google profile will be at or near the top of any Google search.

Wikipedia articles also go to the top of most searches, so if you’re notable enough to merit mention in one – or to have one of your own – see that it is done, and updated regularly. You can’t do that yourself, however; Wikipedia’s conflict of interest rules forbid writing or editing content about yourself. Someone with a theoretically “neutral point of view” will have to do it.

If you don’t yet have a website, now would be a good time. As I’ve discussed many times, a professionally designed site will be far more attractive and polished than anything you could build yourself. Furthermore, an experienced designer will employ “search engine optimization” (SEO), meaning that content will be created in a way that is readily visible to search engine users.

Leave design and SEO to the pros, but don’t delegate the content itself; as captain of the ship you are responsible for all the facts and opinions on your site. And remember that once it’s online, it’s online forever; consider the ramifications of anything you post on any site (yours or others) before hitting the “send” button. “The most damaging item about you,” one consultant told me, “could well be something you posted yourself.” Just ask any of several prominent politicians who have famously sabotaged their own careers online.

That said, don’t be shy about creating content. Make your (noncontroversial) opinions known on Facebook and Twitter. If social networks are not your thing, add a blog to your web site and write about what you know, and what interests you. If you have expertise in a particular field, write about that.

Incidentally, if the URL for your web site is not your name, you should also register your name as a separate domain name – if only to be sure that a trickster, or someone with the same name and a bad reputation, doesn’t get it.

Set up an RSS news feed for yourself, so you’ll know immediately anytime your name pops up in news or gossip sites, or on blogs. If something untrue is posted about you, take action. Reputable news sites and blogs have their own reputations to protect, and so can usually be persuaded to correct anything that is demonstrably false. Try to get the error removed entirely, or corrected within the original article. An erratum on the last page of the next edition will be ignored, and will leave the false information online, intact.

Unfair comments on doctor rating sites are unlikely to be removed unless they are blatantly libelous; but there is nothing wrong with encouraging happy patients to write favorable reviews. Turnabout is fair play.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

[email protected]

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

[email protected]

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

[email protected]

VANCOUVER – A new American Academy of Neurology practice guideline on the efficacy and safety evidence for botulinum toxin treatment of blepharospasm, cervical dystonia, spasticity, and headache has updated the last recommendations published in 2008, but leaves some relevant clinical concerns and off-label uses unaddressed.

The 2016 update, published April 18 in Neurology, adds new individual evidence for the use of the four branded formulations of the two commercially available botulinum toxin serotypes, A and B, for the aforementioned indications rather than lumping all recommendations for botulinum toxin together as in the 2008 guidelines. However, questions remain on the differences between the different products in clinical practice, especially since the formulations show little clinical difference in head-to-head comparisons for some of the indications, especially for the serotype A formulations.

Jeff Evans/Frontline Medical News

In a press briefing on the new guidelines at the annual meeting of the American Academy of Neurology, guidelines coauthor Dr. Mark Hallett noted that nothing really surprised the experienced 14-member committee that put the guidelines together. “The reason that we chose these four different diseases is because we already had the sense that they were going to change in the particular ways that they did. We didn’t know exactly, of course, what was going to happen, but we had a sense that there were sufficient data that it was worth looking at them.”

For blepharospasm, the totality of evidence suggests that onabotulinumtoxinA (onaBoNT-A; Botox) and incobotulinumtoxinA (incoBoNT-A; Xeomin) injections should be considered and are probably safe and effective (level B recommendation), while abobotulinumtoxinA (aboBoNT-A; Dysport) may be considered (level C) and is possibly effective. The evidence shows that incoBoNT-A and onaBoNT-A have equivalent efficacy and aboBoNT-A and onaBoNT-A are possibly equivalent. There was not enough evidence to determine the efficacy of rimabotulinumtoxinB for blepharospasm (rimaBoNT-B; Myobloc).

The rigorousness of clinical trials in evaluating the efficacy and safety of botulinum toxin has evolved since the Food and Drug Administration approved onaBoNT-A and incoBoNT-A to treat blepharospasm, but no new trials have been conducted to give it a higher level of recommendation despite their well-known magnitude of benefit, said Dr. Hallett, chief of the National Institute of Neurological Disorders and Stroke medical neurology branch and its human motor control section.

New evidence added to the already well-established data on the effectiveness of botulinum toxin for cervical dystonia suggest that onaBoNT-A and incoBoNT-A are probably safe and effective and should be considered. In addition, aboBoNT-A and rimaBoNT-B have already proven effectiveness and safety and should be offered. The lack of class I studies for onaBoNT-A and incoBoNT-A led to the lower level of recommendation for them despite an extensive clinical history of their use in cervical dystonia, the guideline committee wrote (Neurology. 2016 Apr 18. doi: 10.1212/WNL.0000000000002560).

In adults with upper-limb spasticity, all three serotype A formulations – onaBoNT-A, aboBoNT-A, and incoBoNT-A – are effective and safe in reducing symptoms and improving passive limb function. All three achieved level A evidence to recommend that they should be offered. One comparative trial showed enough evidence to say that onaBoNT-A is probably superior to tizanidine for reducing upper-extremity tone and should be considered before it. RimaBoNT-B has level B evidence to advise that it should be considered and is probably safe and effective. None of the formulations have enough data to determine their efficacy on active limb function.

Fewer trials have examined the safety and effectiveness of botulinum toxin formulations for reducing lower leg spasticity in adults. The guidelines panel found enough evidence to recommend that aboBoNT-A and onaBoNT-A are safe and effective and should be offered (level A). There were no trials with high enough level of quality to determine whether incoBoNT-A or rimaBoNT-B were effective for lower-leg spasticity. None of the four agents had enough evidence to support their ability to improve active function associated with lower-limb spasticity.

At the press briefing, guidelines first author Dr. David M. Simpson expressed hope that a more refined methodology for evaluating spasticity might be achieved in future trials of botulinum toxin to detect the potentially subtle effects the agents may have on certain patients who are more likely to achieve benefits in active limb function. Currently, trials use a standardized set of outcomes to try to detect differences in patients with wide-ranging severity of symptoms and types of injury that led to spasticity. Dr. Simpson is professor of neurology at Mount Sinai in New York, as well as director of the neuromuscular diseases division and director of the clinical neurophysiology laboratories.

Positive results for onaBoNT-A in two pivotal trials in chronic migraine that were published since the last guidelines give the formulation the only FDA-approved indication for a botulinum toxin in chronic migraine and earned it a level A recommendation from the guidelines committee. However, in the trials it had a relatively small magnitude of efficacy in reducing the number of headache days by 15% versus placebo. The guidelines also advise not using onaBoNT-A in episodic migraine based on three negative trials. No high-quality trials have evaluated any formulation to change the overall 2008 guidelines’ advice that botulinum toxin is probably ineffective for treating chronic tension-type headaches.

Familiarity with appropriate dosing and side effects may allow clinicians to use the products off-label for indications in the guidelines for which clinical trials were not available, Dr. Richard L. Barbano of the movement disorders division at the University of Rochester noted in an editorial about the guidelines (Neurol Clin Pract. 2016 Apr 18. doi: 10.1212/CPJ.0000000000000244). “Off-label use is common in clinical practice. Little data exist to indicate that any of the different formulations, with attention to appropriate dosing and side effects, would not be effective in treating these other conditions. There are also a number of other neurologic conditions not discussed in the guideline in which botulinum toxin has shown efficacy, such as hemifacial spasm and other focal dystonias. Lack of sufficient high-level evidence to support a level A or B guideline recommendation does not negate their potential utility and likewise, there is little evidence to recommend one formulation over another.”

“In some circumstances where the drugs are relatively equivalent, some people prefer to stick with one so they get used to it more, and they can have more of a sense of what the dosing is, given that the doses may be different with the compounds and have different side effects,” Dr. Hallett said in an interview, noting that availability and price also might enter into a clinician’s decision on what to do.

Dr. Barbano also said that cost and value are becoming more important, and neurologists should consider when botulinum toxin therapy should be chosen among existing alternative treatment options, particularly for chronic migraine.

The guidelines are endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine and the American Society of Plastic Surgeons.

Dr. Hallett reported serving as chair of the Neurotoxin Institute Advisory Council and has received research grants from Allergan and Merz Pharmaceuticals. Dr. Simpson reported receiving research grants from and served as a consultant for Allergan, Ipsen, Merz Pharmaceuticals, and Acorda Therapeutics. Five other coauthors of the guidelines disclosed relationships with manufacturers of botulinum toxin formulations. Dr. Barbano reported serving on a scientific advisory board for Allergan and receiving research support from Allergan, Vaccinex, and Biotie.

[email protected]

VANCOUVER – A new American Academy of Neurology practice guideline on the efficacy and safety evidence for botulinum toxin treatment of blepharospasm, cervical dystonia, spasticity, and headache has updated the last recommendations published in 2008, but leaves some relevant clinical concerns and off-label uses unaddressed.

The 2016 update, published April 18 in Neurology, adds new individual evidence for the use of the four branded formulations of the two commercially available botulinum toxin serotypes, A and B, for the aforementioned indications rather than lumping all recommendations for botulinum toxin together as in the 2008 guidelines. However, questions remain on the differences between the different products in clinical practice, especially since the formulations show little clinical difference in head-to-head comparisons for some of the indications, especially for the serotype A formulations.

Jeff Evans/Frontline Medical News

In a press briefing on the new guidelines at the annual meeting of the American Academy of Neurology, guidelines coauthor Dr. Mark Hallett noted that nothing really surprised the experienced 14-member committee that put the guidelines together. “The reason that we chose these four different diseases is because we already had the sense that they were going to change in the particular ways that they did. We didn’t know exactly, of course, what was going to happen, but we had a sense that there were sufficient data that it was worth looking at them.”

For blepharospasm, the totality of evidence suggests that onabotulinumtoxinA (onaBoNT-A; Botox) and incobotulinumtoxinA (incoBoNT-A; Xeomin) injections should be considered and are probably safe and effective (level B recommendation), while abobotulinumtoxinA (aboBoNT-A; Dysport) may be considered (level C) and is possibly effective. The evidence shows that incoBoNT-A and onaBoNT-A have equivalent efficacy and aboBoNT-A and onaBoNT-A are possibly equivalent. There was not enough evidence to determine the efficacy of rimabotulinumtoxinB for blepharospasm (rimaBoNT-B; Myobloc).

The rigorousness of clinical trials in evaluating the efficacy and safety of botulinum toxin has evolved since the Food and Drug Administration approved onaBoNT-A and incoBoNT-A to treat blepharospasm, but no new trials have been conducted to give it a higher level of recommendation despite their well-known magnitude of benefit, said Dr. Hallett, chief of the National Institute of Neurological Disorders and Stroke medical neurology branch and its human motor control section.

New evidence added to the already well-established data on the effectiveness of botulinum toxin for cervical dystonia suggest that onaBoNT-A and incoBoNT-A are probably safe and effective and should be considered. In addition, aboBoNT-A and rimaBoNT-B have already proven effectiveness and safety and should be offered. The lack of class I studies for onaBoNT-A and incoBoNT-A led to the lower level of recommendation for them despite an extensive clinical history of their use in cervical dystonia, the guideline committee wrote (Neurology. 2016 Apr 18. doi: 10.1212/WNL.0000000000002560).

In adults with upper-limb spasticity, all three serotype A formulations – onaBoNT-A, aboBoNT-A, and incoBoNT-A – are effective and safe in reducing symptoms and improving passive limb function. All three achieved level A evidence to recommend that they should be offered. One comparative trial showed enough evidence to say that onaBoNT-A is probably superior to tizanidine for reducing upper-extremity tone and should be considered before it. RimaBoNT-B has level B evidence to advise that it should be considered and is probably safe and effective. None of the formulations have enough data to determine their efficacy on active limb function.

Fewer trials have examined the safety and effectiveness of botulinum toxin formulations for reducing lower leg spasticity in adults. The guidelines panel found enough evidence to recommend that aboBoNT-A and onaBoNT-A are safe and effective and should be offered (level A). There were no trials with high enough level of quality to determine whether incoBoNT-A or rimaBoNT-B were effective for lower-leg spasticity. None of the four agents had enough evidence to support their ability to improve active function associated with lower-limb spasticity.

At the press briefing, guidelines first author Dr. David M. Simpson expressed hope that a more refined methodology for evaluating spasticity might be achieved in future trials of botulinum toxin to detect the potentially subtle effects the agents may have on certain patients who are more likely to achieve benefits in active limb function. Currently, trials use a standardized set of outcomes to try to detect differences in patients with wide-ranging severity of symptoms and types of injury that led to spasticity. Dr. Simpson is professor of neurology at Mount Sinai in New York, as well as director of the neuromuscular diseases division and director of the clinical neurophysiology laboratories.

Positive results for onaBoNT-A in two pivotal trials in chronic migraine that were published since the last guidelines give the formulation the only FDA-approved indication for a botulinum toxin in chronic migraine and earned it a level A recommendation from the guidelines committee. However, in the trials it had a relatively small magnitude of efficacy in reducing the number of headache days by 15% versus placebo. The guidelines also advise not using onaBoNT-A in episodic migraine based on three negative trials. No high-quality trials have evaluated any formulation to change the overall 2008 guidelines’ advice that botulinum toxin is probably ineffective for treating chronic tension-type headaches.

Familiarity with appropriate dosing and side effects may allow clinicians to use the products off-label for indications in the guidelines for which clinical trials were not available, Dr. Richard L. Barbano of the movement disorders division at the University of Rochester noted in an editorial about the guidelines (Neurol Clin Pract. 2016 Apr 18. doi: 10.1212/CPJ.0000000000000244). “Off-label use is common in clinical practice. Little data exist to indicate that any of the different formulations, with attention to appropriate dosing and side effects, would not be effective in treating these other conditions. There are also a number of other neurologic conditions not discussed in the guideline in which botulinum toxin has shown efficacy, such as hemifacial spasm and other focal dystonias. Lack of sufficient high-level evidence to support a level A or B guideline recommendation does not negate their potential utility and likewise, there is little evidence to recommend one formulation over another.”

“In some circumstances where the drugs are relatively equivalent, some people prefer to stick with one so they get used to it more, and they can have more of a sense of what the dosing is, given that the doses may be different with the compounds and have different side effects,” Dr. Hallett said in an interview, noting that availability and price also might enter into a clinician’s decision on what to do.

Dr. Barbano also said that cost and value are becoming more important, and neurologists should consider when botulinum toxin therapy should be chosen among existing alternative treatment options, particularly for chronic migraine.

The guidelines are endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine and the American Society of Plastic Surgeons.

Dr. Hallett reported serving as chair of the Neurotoxin Institute Advisory Council and has received research grants from Allergan and Merz Pharmaceuticals. Dr. Simpson reported receiving research grants from and served as a consultant for Allergan, Ipsen, Merz Pharmaceuticals, and Acorda Therapeutics. Five other coauthors of the guidelines disclosed relationships with manufacturers of botulinum toxin formulations. Dr. Barbano reported serving on a scientific advisory board for Allergan and receiving research support from Allergan, Vaccinex, and Biotie.

[email protected]

VANCOUVER – A new American Academy of Neurology practice guideline on the efficacy and safety evidence for botulinum toxin treatment of blepharospasm, cervical dystonia, spasticity, and headache has updated the last recommendations published in 2008, but leaves some relevant clinical concerns and off-label uses unaddressed.

The 2016 update, published April 18 in Neurology, adds new individual evidence for the use of the four branded formulations of the two commercially available botulinum toxin serotypes, A and B, for the aforementioned indications rather than lumping all recommendations for botulinum toxin together as in the 2008 guidelines. However, questions remain on the differences between the different products in clinical practice, especially since the formulations show little clinical difference in head-to-head comparisons for some of the indications, especially for the serotype A formulations.

Jeff Evans/Frontline Medical News

In a press briefing on the new guidelines at the annual meeting of the American Academy of Neurology, guidelines coauthor Dr. Mark Hallett noted that nothing really surprised the experienced 14-member committee that put the guidelines together. “The reason that we chose these four different diseases is because we already had the sense that they were going to change in the particular ways that they did. We didn’t know exactly, of course, what was going to happen, but we had a sense that there were sufficient data that it was worth looking at them.”

For blepharospasm, the totality of evidence suggests that onabotulinumtoxinA (onaBoNT-A; Botox) and incobotulinumtoxinA (incoBoNT-A; Xeomin) injections should be considered and are probably safe and effective (level B recommendation), while abobotulinumtoxinA (aboBoNT-A; Dysport) may be considered (level C) and is possibly effective. The evidence shows that incoBoNT-A and onaBoNT-A have equivalent efficacy and aboBoNT-A and onaBoNT-A are possibly equivalent. There was not enough evidence to determine the efficacy of rimabotulinumtoxinB for blepharospasm (rimaBoNT-B; Myobloc).

The rigorousness of clinical trials in evaluating the efficacy and safety of botulinum toxin has evolved since the Food and Drug Administration approved onaBoNT-A and incoBoNT-A to treat blepharospasm, but no new trials have been conducted to give it a higher level of recommendation despite their well-known magnitude of benefit, said Dr. Hallett, chief of the National Institute of Neurological Disorders and Stroke medical neurology branch and its human motor control section.

New evidence added to the already well-established data on the effectiveness of botulinum toxin for cervical dystonia suggest that onaBoNT-A and incoBoNT-A are probably safe and effective and should be considered. In addition, aboBoNT-A and rimaBoNT-B have already proven effectiveness and safety and should be offered. The lack of class I studies for onaBoNT-A and incoBoNT-A led to the lower level of recommendation for them despite an extensive clinical history of their use in cervical dystonia, the guideline committee wrote (Neurology. 2016 Apr 18. doi: 10.1212/WNL.0000000000002560).

In adults with upper-limb spasticity, all three serotype A formulations – onaBoNT-A, aboBoNT-A, and incoBoNT-A – are effective and safe in reducing symptoms and improving passive limb function. All three achieved level A evidence to recommend that they should be offered. One comparative trial showed enough evidence to say that onaBoNT-A is probably superior to tizanidine for reducing upper-extremity tone and should be considered before it. RimaBoNT-B has level B evidence to advise that it should be considered and is probably safe and effective. None of the formulations have enough data to determine their efficacy on active limb function.

Fewer trials have examined the safety and effectiveness of botulinum toxin formulations for reducing lower leg spasticity in adults. The guidelines panel found enough evidence to recommend that aboBoNT-A and onaBoNT-A are safe and effective and should be offered (level A). There were no trials with high enough level of quality to determine whether incoBoNT-A or rimaBoNT-B were effective for lower-leg spasticity. None of the four agents had enough evidence to support their ability to improve active function associated with lower-limb spasticity.

At the press briefing, guidelines first author Dr. David M. Simpson expressed hope that a more refined methodology for evaluating spasticity might be achieved in future trials of botulinum toxin to detect the potentially subtle effects the agents may have on certain patients who are more likely to achieve benefits in active limb function. Currently, trials use a standardized set of outcomes to try to detect differences in patients with wide-ranging severity of symptoms and types of injury that led to spasticity. Dr. Simpson is professor of neurology at Mount Sinai in New York, as well as director of the neuromuscular diseases division and director of the clinical neurophysiology laboratories.

Positive results for onaBoNT-A in two pivotal trials in chronic migraine that were published since the last guidelines give the formulation the only FDA-approved indication for a botulinum toxin in chronic migraine and earned it a level A recommendation from the guidelines committee. However, in the trials it had a relatively small magnitude of efficacy in reducing the number of headache days by 15% versus placebo. The guidelines also advise not using onaBoNT-A in episodic migraine based on three negative trials. No high-quality trials have evaluated any formulation to change the overall 2008 guidelines’ advice that botulinum toxin is probably ineffective for treating chronic tension-type headaches.

Familiarity with appropriate dosing and side effects may allow clinicians to use the products off-label for indications in the guidelines for which clinical trials were not available, Dr. Richard L. Barbano of the movement disorders division at the University of Rochester noted in an editorial about the guidelines (Neurol Clin Pract. 2016 Apr 18. doi: 10.1212/CPJ.0000000000000244). “Off-label use is common in clinical practice. Little data exist to indicate that any of the different formulations, with attention to appropriate dosing and side effects, would not be effective in treating these other conditions. There are also a number of other neurologic conditions not discussed in the guideline in which botulinum toxin has shown efficacy, such as hemifacial spasm and other focal dystonias. Lack of sufficient high-level evidence to support a level A or B guideline recommendation does not negate their potential utility and likewise, there is little evidence to recommend one formulation over another.”

“In some circumstances where the drugs are relatively equivalent, some people prefer to stick with one so they get used to it more, and they can have more of a sense of what the dosing is, given that the doses may be different with the compounds and have different side effects,” Dr. Hallett said in an interview, noting that availability and price also might enter into a clinician’s decision on what to do.

Dr. Barbano also said that cost and value are becoming more important, and neurologists should consider when botulinum toxin therapy should be chosen among existing alternative treatment options, particularly for chronic migraine.

The guidelines are endorsed by the American Association of Neuromuscular & Electrodiagnostic Medicine and the American Society of Plastic Surgeons.

Dr. Hallett reported serving as chair of the Neurotoxin Institute Advisory Council and has received research grants from Allergan and Merz Pharmaceuticals. Dr. Simpson reported receiving research grants from and served as a consultant for Allergan, Ipsen, Merz Pharmaceuticals, and Acorda Therapeutics. Five other coauthors of the guidelines disclosed relationships with manufacturers of botulinum toxin formulations. Dr. Barbano reported serving on a scientific advisory board for Allergan and receiving research support from Allergan, Vaccinex, and Biotie.

[email protected]

From Genoa-QoL Healthcare and the University of Michigan College of Pharmacy, Ann Arbor, MI.

Abstract

• Objective: To review the Common Sense Model, a framework that can be used for understanding patients’ behavior, including taking or not taking medications as prescribed.
• Methods: Descriptive report.
• Results: Medication adherence, a critical component of achieving good patient outcomes and reducing medical costs, is dependent upon patient illness beliefs. The Common Sense Model holds that these beliefs can be categorized as illness identity, cause, consequence, control, and timeline. Effective communication is necessary to understand the beliefs that patients hold and help them understand their condition. Good communication also can allay fears and other emotions that can be disruptive to achieving good outcomes.
• Conclusion: Clinicians should seek to understand their patients’ illness beliefs and collaborate with them  to achieve desired health outcomes.

Clinical practice is based on scientific evidence, by which medical problems are diagnosed and treatment recommendations are made. However, the role of the patient may not be completely recognized as an integral part of the process of patient care. The impact of failing to adequately recognize the patient perspective is evident in medication nonadherence. Health psychology research can provide clinicians insight into patients’ perceptions and behavior. This paper reviews the Common Sense Model (CSM), a behavioral model that provides a framework that can be used in understanding patients’ behavior. In this paper I will discuss the model and how it can be a possible strategy for improving adherence.

Making the Case for CSM in Daily Practice

It can be difficult to realize that persons seeking medical attention would not take medications as prescribed by a physician. In fact, studies reveal that on average, 16.4% of prescribed medications will not be picked up from the pharmacy [1]. Of those patients who do pick up their medication, approximately 1 out of 4 will not take them as prescribed [2]. Such medication nonadherence leads to poor health outcomes and increased health care costs [3,4]. There are many reasons for medication nonadherence [5], and there is no single solution to improving medication adherence [6]. A Cochrane review of randomized controlled trials evaluating various interventions intended to enhance patient adherence to prescribed medications for medical conditions found them to have limited effectiveness. Interventions assessed included health and medication information, reminder calls, follow-up assessment of medication therapy, social support, and simplification of the treatment regimen [6]. In an exploratory study of patients with chronic health conditions, Kucukarslan et al found patients’ beliefs about their illness and their medication are integral to their health care decisions [7]. Their findings were consistent with the CSM, which is based on Leventhal’s theory of self-regulation.

Self-regulation theory states that rational people will make decisions to reduce their health threat. Patients’ perceptions of their selves and environments drives their behavior. So in the presence of a health threat, a person will seek to eliminate or reduce that threat. However, coping behavior is complex. A person may decide to follow the advice of his clinician, follow some other advice (from family, friends, advertising, etc.), or do nothing. The premise of self-regulation is that people will choose a common sense approach to their health threat [8]. Therefore, clinicians must understand their patients’ viewpoint of themselves and their health condition so they may help guide them toward healthy outcomes.

The Common Sense Model

The CSM is a framework for understanding patient behavior when faced with a health threat. It holds that patients form common sense representations of their illness using information from 5 domains [8]: (1) the identity of the illness (the label the patient gives to the condition and symptoms); (2) the cause of the illness; (3) the consequences of the illness (beliefs about how the illness will impact the patient’s well-being); (4) whether the illness can be controlled or cured; and (5) timeline (beliefs about how long the condition will last). A patient may either act to address the health threat or choose to ignore it. Patient emotions are proposed to have a role on patient behavior along with the 5 dimensions of illness perception.

Illness Identity

Illness identity is the label patients place on the health threat; it is most likely not the same as the signs and symptoms clinicians use. Therefore, the first misconnect between physician and patient may be in describing the illness. Chen et al studied illness identity as perceived by patients with hypertension [9,10]. Illness identity was defined as (1) hypertension-related symptoms, (2) symptoms experienced before and after their diagnosis; and (3) symptoms used to predict high blood pressure. Although hypertension is asymptomatic, patients do perceive symptoms such as headache associated with their hypertension. The researchers found those patients who identified more symptoms were more likely to believe that their symptoms caused the hypertension and were correspondingly less likely to use their medication. For them, when the headache subsides, so does the hypertension.

Physicians should find out how patients assess their health condition and provide them tools for evaluating their response to medication. In the case of hypertension, the physician could have the patient check their blood pressure with and without the headache to demonstrate that hypertension occurs even when the patient is not “symptomatic.” The point is to converse with the patient to learn how they view their condition. Clinicians should resist the “urge” to correct patients. Taking time to help patients better understand their condition is important. A misstep:

Patient: I can tell when my blood pressure is high. I get a pounding headache.

Doctor: High blood pressure is an asymptomatic condition. Your headaches are not caused by your high blood pressure.

Patients may choose to ignore the clinician if they feel strongly about how they define their illness. It is better to listen to the patient and offer steps to learn about their health condition. Here is a better response from the physician:

Doctor: You are telling me that you can tell when your blood pressure is high. So when your head aches your pressure is high, right?

Patient: Yes.

Doctor: Let me tell you more about high blood pressure. High blood pressure is also present without headaches...

Illness Causes

There are multiple causative factors patients may associate with their disease. Causes attributed to disease may be based on patient experiences, input from family and friends, and cultural factors. Causes may include emotional state, stress or worry, overwork, genetic predisposition, or environmental factors (eg, pollution). Jessop and Rutter found patients who perceive their condition as due to uncontrollable factors, such as chance, germs, or pollution, were less likely to take their medication [11]. Similar findings were published by Chen et al [9]. They found psychological factors, environmental risk factors (eg, smoking, diet), and even bad luck or chance associated with less likelihood of taking medications as prescribed. Clinicians should explore patients’ perceptions of causes of a condition. Patients strive to eliminate the perceived cause, thus eliminating the need to take medication. In some cultures, bad luck or chance drives patients’ decisions to not take medication, or they believe in fate and do not accept treatment. Whether they feel they can control their condition by eliminating the cause or have a fatalistic view that the cause of their condition is not within their control, the clinician must work with the patient to reduce the impact of misperceptions or significance of perceived causes.

Illness Consequence

Consequence associated with the health condition is an important factor in patient behavior [12]. Patients must understand the specific threats to their health if a condition is left untreated or uncontrolled. Patients’ view of illness consequence may be formed by their own perceived vulnerability or susceptibility and the perceived seriousness of the condition. For example, patients with hypertension should be informed about the impact of high blood pressure on their bodies and the consequence of disability from stroke, dependency on dialysis from kidney failure, or death. They may not consider themselves susceptible to illness since they “feel healthy” and may decide to delay treatment. Patients with conditions such as asthma or heart failure may believe they are cured when their symptoms abate and therefore believe they have no more need for medication. Such patients need education to understand that they are asymptomatic because they are well controlled with medication.

Illness Control

Patients may feel they can control their health condition by changing their behavior, changing their environment, and/or by taking prescribed medication. As discussed earlier, cause and control both work together to form patient beliefs and actions. Patients will take their medications as prescribed if they believe in the effectiveness of medication to control their condition [11,13–15]. Interestingly, Ross found those who felt they had more control over their illness were more likely not to take their medication as prescribed [12]. These persons are more likely to not want to become “dependent” on medication. Their  feeling was that they can make changes in their lives and thereby improve their health condition.

Physicians should invite patients’ thoughts as to what should be done to improve their health condition, and collaborate with the patient on an action plan for change if change is expected to improve/control the health condition. Follow-up to assess the patient’s health status longitudinally is necessary.

In this exchange, the patient feels he can control his hypertension on his own:

Doctor: I recommend that you start taking medication to control your blood pressure. Uncontrolled high blood pressure can lead to many health problems.

Patient: I am not ready to start taking medication.

Doctor: What are your reasons?

Patient:  I am under a lot of stress at work. Once I get control of this stress, my blood pressure will go down.

Doctor: Getting control of your stress at work is important. Let me tell you more about high blood pressure.

Patient: Okay.

Doctor: There is no one cause of your high blood pressure. Eliminating your work stress will most likely not reduce your blood pressure....

Timeline

Health conditions can be  acute, chronic, or cyclical (ie, seasonal); however, patients may have different perceptions of the duration of their health condition. In Kucukarslan et al, some patients did not believe their hypertension was a lifelong condition because they felt they would be able to cure it [7]. For example, as illustrated above, patients may believe that stress causes their hypertension, and if the stress could be controlled, then their blood pressure would normalize. Conversely, Ross et al found that patients who viewed their hypertension as a long-term condition were more likely to believe their medications were necessary and thus more likely to take their medication as prescribed [12]. A lifelong or chronic health condition is a difficult concept for patients to accept, especially ones who may view themselves as too young to have the condition.

Emotions

After being informed about their health condition, patients may feel emotions that are not apparent to the practitioner. These may include worry, depression, anger, anxiety, or fear. Emotions may impact their decision to take medication [12,14]. Listening for patients’ responses to health information provided by the clinician and letting patients know they have been heard will help allay strong negative emotions [16]. Good communication builds trust between the clinician and patient.

Conclusion

Patients receive medical advice from clinicians that may be inconsistent with their beliefs and understanding of their health condition. Studies of medication nonadherence find many factors contribute to it and no one tool to improve medication adherence exists. However, the consequence of medication nonadherence are great and include  include worsening condition, increased comorbid disease, and increased health care costs. Understanding patients’ beliefs about their health condition is an important step toward reducing medication nonadherence. The CSM provides a framework for clinicians to guide patients toward effective decision-making. Listening to the patient explain how they view their condition—how they define it, the causes, consequences, how to control it, and how long it will last or if it will progress—are important to the process of working with the patient manage their condition effectively. Clinicians’ reaction  to these perceptions are important, and dismissing them may alienate patients. Effective communication is necessary to understand patients’ perspectives and to help them manage their health condition.

Corresponding author: Suzan N. Kucukarslan, PhD, RPh, [email protected].

Financial disclosures: None.

From Genoa-QoL Healthcare and the University of Michigan College of Pharmacy, Ann Arbor, MI.

Abstract

• Objective: To review the Common Sense Model, a framework that can be used for understanding patients’ behavior, including taking or not taking medications as prescribed.
• Methods: Descriptive report.
• Results: Medication adherence, a critical component of achieving good patient outcomes and reducing medical costs, is dependent upon patient illness beliefs. The Common Sense Model holds that these beliefs can be categorized as illness identity, cause, consequence, control, and timeline. Effective communication is necessary to understand the beliefs that patients hold and help them understand their condition. Good communication also can allay fears and other emotions that can be disruptive to achieving good outcomes.
• Conclusion: Clinicians should seek to understand their patients’ illness beliefs and collaborate with them  to achieve desired health outcomes.

Clinical practice is based on scientific evidence, by which medical problems are diagnosed and treatment recommendations are made. However, the role of the patient may not be completely recognized as an integral part of the process of patient care. The impact of failing to adequately recognize the patient perspective is evident in medication nonadherence. Health psychology research can provide clinicians insight into patients’ perceptions and behavior. This paper reviews the Common Sense Model (CSM), a behavioral model that provides a framework that can be used in understanding patients’ behavior. In this paper I will discuss the model and how it can be a possible strategy for improving adherence.

Making the Case for CSM in Daily Practice

It can be difficult to realize that persons seeking medical attention would not take medications as prescribed by a physician. In fact, studies reveal that on average, 16.4% of prescribed medications will not be picked up from the pharmacy [1]. Of those patients who do pick up their medication, approximately 1 out of 4 will not take them as prescribed [2]. Such medication nonadherence leads to poor health outcomes and increased health care costs [3,4]. There are many reasons for medication nonadherence [5], and there is no single solution to improving medication adherence [6]. A Cochrane review of randomized controlled trials evaluating various interventions intended to enhance patient adherence to prescribed medications for medical conditions found them to have limited effectiveness. Interventions assessed included health and medication information, reminder calls, follow-up assessment of medication therapy, social support, and simplification of the treatment regimen [6]. In an exploratory study of patients with chronic health conditions, Kucukarslan et al found patients’ beliefs about their illness and their medication are integral to their health care decisions [7]. Their findings were consistent with the CSM, which is based on Leventhal’s theory of self-regulation.

Self-regulation theory states that rational people will make decisions to reduce their health threat. Patients’ perceptions of their selves and environments drives their behavior. So in the presence of a health threat, a person will seek to eliminate or reduce that threat. However, coping behavior is complex. A person may decide to follow the advice of his clinician, follow some other advice (from family, friends, advertising, etc.), or do nothing. The premise of self-regulation is that people will choose a common sense approach to their health threat [8]. Therefore, clinicians must understand their patients’ viewpoint of themselves and their health condition so they may help guide them toward healthy outcomes.

The Common Sense Model

The CSM is a framework for understanding patient behavior when faced with a health threat. It holds that patients form common sense representations of their illness using information from 5 domains [8]: (1) the identity of the illness (the label the patient gives to the condition and symptoms); (2) the cause of the illness; (3) the consequences of the illness (beliefs about how the illness will impact the patient’s well-being); (4) whether the illness can be controlled or cured; and (5) timeline (beliefs about how long the condition will last). A patient may either act to address the health threat or choose to ignore it. Patient emotions are proposed to have a role on patient behavior along with the 5 dimensions of illness perception.

Illness Identity

Illness identity is the label patients place on the health threat; it is most likely not the same as the signs and symptoms clinicians use. Therefore, the first misconnect between physician and patient may be in describing the illness. Chen et al studied illness identity as perceived by patients with hypertension [9,10]. Illness identity was defined as (1) hypertension-related symptoms, (2) symptoms experienced before and after their diagnosis; and (3) symptoms used to predict high blood pressure. Although hypertension is asymptomatic, patients do perceive symptoms such as headache associated with their hypertension. The researchers found those patients who identified more symptoms were more likely to believe that their symptoms caused the hypertension and were correspondingly less likely to use their medication. For them, when the headache subsides, so does the hypertension.

Physicians should find out how patients assess their health condition and provide them tools for evaluating their response to medication. In the case of hypertension, the physician could have the patient check their blood pressure with and without the headache to demonstrate that hypertension occurs even when the patient is not “symptomatic.” The point is to converse with the patient to learn how they view their condition. Clinicians should resist the “urge” to correct patients. Taking time to help patients better understand their condition is important. A misstep:

Patient: I can tell when my blood pressure is high. I get a pounding headache.

Doctor: High blood pressure is an asymptomatic condition. Your headaches are not caused by your high blood pressure.

Patients may choose to ignore the clinician if they feel strongly about how they define their illness. It is better to listen to the patient and offer steps to learn about their health condition. Here is a better response from the physician:

Doctor: You are telling me that you can tell when your blood pressure is high. So when your head aches your pressure is high, right?

Patient: Yes.

Doctor: Let me tell you more about high blood pressure. High blood pressure is also present without headaches...

Illness Causes

There are multiple causative factors patients may associate with their disease. Causes attributed to disease may be based on patient experiences, input from family and friends, and cultural factors. Causes may include emotional state, stress or worry, overwork, genetic predisposition, or environmental factors (eg, pollution). Jessop and Rutter found patients who perceive their condition as due to uncontrollable factors, such as chance, germs, or pollution, were less likely to take their medication [11]. Similar findings were published by Chen et al [9]. They found psychological factors, environmental risk factors (eg, smoking, diet), and even bad luck or chance associated with less likelihood of taking medications as prescribed. Clinicians should explore patients’ perceptions of causes of a condition. Patients strive to eliminate the perceived cause, thus eliminating the need to take medication. In some cultures, bad luck or chance drives patients’ decisions to not take medication, or they believe in fate and do not accept treatment. Whether they feel they can control their condition by eliminating the cause or have a fatalistic view that the cause of their condition is not within their control, the clinician must work with the patient to reduce the impact of misperceptions or significance of perceived causes.

Illness Consequence

Consequence associated with the health condition is an important factor in patient behavior [12]. Patients must understand the specific threats to their health if a condition is left untreated or uncontrolled. Patients’ view of illness consequence may be formed by their own perceived vulnerability or susceptibility and the perceived seriousness of the condition. For example, patients with hypertension should be informed about the impact of high blood pressure on their bodies and the consequence of disability from stroke, dependency on dialysis from kidney failure, or death. They may not consider themselves susceptible to illness since they “feel healthy” and may decide to delay treatment. Patients with conditions such as asthma or heart failure may believe they are cured when their symptoms abate and therefore believe they have no more need for medication. Such patients need education to understand that they are asymptomatic because they are well controlled with medication.

Illness Control

Patients may feel they can control their health condition by changing their behavior, changing their environment, and/or by taking prescribed medication. As discussed earlier, cause and control both work together to form patient beliefs and actions. Patients will take their medications as prescribed if they believe in the effectiveness of medication to control their condition [11,13–15]. Interestingly, Ross found those who felt they had more control over their illness were more likely not to take their medication as prescribed [12]. These persons are more likely to not want to become “dependent” on medication. Their  feeling was that they can make changes in their lives and thereby improve their health condition.

Physicians should invite patients’ thoughts as to what should be done to improve their health condition, and collaborate with the patient on an action plan for change if change is expected to improve/control the health condition. Follow-up to assess the patient’s health status longitudinally is necessary.

In this exchange, the patient feels he can control his hypertension on his own:

Doctor: I recommend that you start taking medication to control your blood pressure. Uncontrolled high blood pressure can lead to many health problems.

Patient: I am not ready to start taking medication.

Doctor: What are your reasons?

Patient:  I am under a lot of stress at work. Once I get control of this stress, my blood pressure will go down.

Doctor: Getting control of your stress at work is important. Let me tell you more about high blood pressure.

Patient: Okay.

Doctor: There is no one cause of your high blood pressure. Eliminating your work stress will most likely not reduce your blood pressure....

Timeline

Health conditions can be  acute, chronic, or cyclical (ie, seasonal); however, patients may have different perceptions of the duration of their health condition. In Kucukarslan et al, some patients did not believe their hypertension was a lifelong condition because they felt they would be able to cure it [7]. For example, as illustrated above, patients may believe that stress causes their hypertension, and if the stress could be controlled, then their blood pressure would normalize. Conversely, Ross et al found that patients who viewed their hypertension as a long-term condition were more likely to believe their medications were necessary and thus more likely to take their medication as prescribed [12]. A lifelong or chronic health condition is a difficult concept for patients to accept, especially ones who may view themselves as too young to have the condition.

Emotions

After being informed about their health condition, patients may feel emotions that are not apparent to the practitioner. These may include worry, depression, anger, anxiety, or fear. Emotions may impact their decision to take medication [12,14]. Listening for patients’ responses to health information provided by the clinician and letting patients know they have been heard will help allay strong negative emotions [16]. Good communication builds trust between the clinician and patient.

Conclusion

Patients receive medical advice from clinicians that may be inconsistent with their beliefs and understanding of their health condition. Studies of medication nonadherence find many factors contribute to it and no one tool to improve medication adherence exists. However, the consequence of medication nonadherence are great and include  include worsening condition, increased comorbid disease, and increased health care costs. Understanding patients’ beliefs about their health condition is an important step toward reducing medication nonadherence. The CSM provides a framework for clinicians to guide patients toward effective decision-making. Listening to the patient explain how they view their condition—how they define it, the causes, consequences, how to control it, and how long it will last or if it will progress—are important to the process of working with the patient manage their condition effectively. Clinicians’ reaction  to these perceptions are important, and dismissing them may alienate patients. Effective communication is necessary to understand patients’ perspectives and to help them manage their health condition.

Corresponding author: Suzan N. Kucukarslan, PhD, RPh, [email protected].

Financial disclosures: None.

From Genoa-QoL Healthcare and the University of Michigan College of Pharmacy, Ann Arbor, MI.

Abstract

• Objective: To review the Common Sense Model, a framework that can be used for understanding patients’ behavior, including taking or not taking medications as prescribed.
• Methods: Descriptive report.
• Results: Medication adherence, a critical component of achieving good patient outcomes and reducing medical costs, is dependent upon patient illness beliefs. The Common Sense Model holds that these beliefs can be categorized as illness identity, cause, consequence, control, and timeline. Effective communication is necessary to understand the beliefs that patients hold and help them understand their condition. Good communication also can allay fears and other emotions that can be disruptive to achieving good outcomes.
• Conclusion: Clinicians should seek to understand their patients’ illness beliefs and collaborate with them  to achieve desired health outcomes.

Clinical practice is based on scientific evidence, by which medical problems are diagnosed and treatment recommendations are made. However, the role of the patient may not be completely recognized as an integral part of the process of patient care. The impact of failing to adequately recognize the patient perspective is evident in medication nonadherence. Health psychology research can provide clinicians insight into patients’ perceptions and behavior. This paper reviews the Common Sense Model (CSM), a behavioral model that provides a framework that can be used in understanding patients’ behavior. In this paper I will discuss the model and how it can be a possible strategy for improving adherence.

Making the Case for CSM in Daily Practice

It can be difficult to realize that persons seeking medical attention would not take medications as prescribed by a physician. In fact, studies reveal that on average, 16.4% of prescribed medications will not be picked up from the pharmacy [1]. Of those patients who do pick up their medication, approximately 1 out of 4 will not take them as prescribed [2]. Such medication nonadherence leads to poor health outcomes and increased health care costs [3,4]. There are many reasons for medication nonadherence [5], and there is no single solution to improving medication adherence [6]. A Cochrane review of randomized controlled trials evaluating various interventions intended to enhance patient adherence to prescribed medications for medical conditions found them to have limited effectiveness. Interventions assessed included health and medication information, reminder calls, follow-up assessment of medication therapy, social support, and simplification of the treatment regimen [6]. In an exploratory study of patients with chronic health conditions, Kucukarslan et al found patients’ beliefs about their illness and their medication are integral to their health care decisions [7]. Their findings were consistent with the CSM, which is based on Leventhal’s theory of self-regulation.

Self-regulation theory states that rational people will make decisions to reduce their health threat. Patients’ perceptions of their selves and environments drives their behavior. So in the presence of a health threat, a person will seek to eliminate or reduce that threat. However, coping behavior is complex. A person may decide to follow the advice of his clinician, follow some other advice (from family, friends, advertising, etc.), or do nothing. The premise of self-regulation is that people will choose a common sense approach to their health threat [8]. Therefore, clinicians must understand their patients’ viewpoint of themselves and their health condition so they may help guide them toward healthy outcomes.

The Common Sense Model

The CSM is a framework for understanding patient behavior when faced with a health threat. It holds that patients form common sense representations of their illness using information from 5 domains [8]: (1) the identity of the illness (the label the patient gives to the condition and symptoms); (2) the cause of the illness; (3) the consequences of the illness (beliefs about how the illness will impact the patient’s well-being); (4) whether the illness can be controlled or cured; and (5) timeline (beliefs about how long the condition will last). A patient may either act to address the health threat or choose to ignore it. Patient emotions are proposed to have a role on patient behavior along with the 5 dimensions of illness perception.

Illness Identity

Illness identity is the label patients place on the health threat; it is most likely not the same as the signs and symptoms clinicians use. Therefore, the first misconnect between physician and patient may be in describing the illness. Chen et al studied illness identity as perceived by patients with hypertension [9,10]. Illness identity was defined as (1) hypertension-related symptoms, (2) symptoms experienced before and after their diagnosis; and (3) symptoms used to predict high blood pressure. Although hypertension is asymptomatic, patients do perceive symptoms such as headache associated with their hypertension. The researchers found those patients who identified more symptoms were more likely to believe that their symptoms caused the hypertension and were correspondingly less likely to use their medication. For them, when the headache subsides, so does the hypertension.

Physicians should find out how patients assess their health condition and provide them tools for evaluating their response to medication. In the case of hypertension, the physician could have the patient check their blood pressure with and without the headache to demonstrate that hypertension occurs even when the patient is not “symptomatic.” The point is to converse with the patient to learn how they view their condition. Clinicians should resist the “urge” to correct patients. Taking time to help patients better understand their condition is important. A misstep:

Patient: I can tell when my blood pressure is high. I get a pounding headache.

Doctor: High blood pressure is an asymptomatic condition. Your headaches are not caused by your high blood pressure.

Patients may choose to ignore the clinician if they feel strongly about how they define their illness. It is better to listen to the patient and offer steps to learn about their health condition. Here is a better response from the physician:

Doctor: You are telling me that you can tell when your blood pressure is high. So when your head aches your pressure is high, right?

Patient: Yes.

Doctor: Let me tell you more about high blood pressure. High blood pressure is also present without headaches...

Illness Causes

There are multiple causative factors patients may associate with their disease. Causes attributed to disease may be based on patient experiences, input from family and friends, and cultural factors. Causes may include emotional state, stress or worry, overwork, genetic predisposition, or environmental factors (eg, pollution). Jessop and Rutter found patients who perceive their condition as due to uncontrollable factors, such as chance, germs, or pollution, were less likely to take their medication [11]. Similar findings were published by Chen et al [9]. They found psychological factors, environmental risk factors (eg, smoking, diet), and even bad luck or chance associated with less likelihood of taking medications as prescribed. Clinicians should explore patients’ perceptions of causes of a condition. Patients strive to eliminate the perceived cause, thus eliminating the need to take medication. In some cultures, bad luck or chance drives patients’ decisions to not take medication, or they believe in fate and do not accept treatment. Whether they feel they can control their condition by eliminating the cause or have a fatalistic view that the cause of their condition is not within their control, the clinician must work with the patient to reduce the impact of misperceptions or significance of perceived causes.

Illness Consequence

Consequence associated with the health condition is an important factor in patient behavior [12]. Patients must understand the specific threats to their health if a condition is left untreated or uncontrolled. Patients’ view of illness consequence may be formed by their own perceived vulnerability or susceptibility and the perceived seriousness of the condition. For example, patients with hypertension should be informed about the impact of high blood pressure on their bodies and the consequence of disability from stroke, dependency on dialysis from kidney failure, or death. They may not consider themselves susceptible to illness since they “feel healthy” and may decide to delay treatment. Patients with conditions such as asthma or heart failure may believe they are cured when their symptoms abate and therefore believe they have no more need for medication. Such patients need education to understand that they are asymptomatic because they are well controlled with medication.

Illness Control

Patients may feel they can control their health condition by changing their behavior, changing their environment, and/or by taking prescribed medication. As discussed earlier, cause and control both work together to form patient beliefs and actions. Patients will take their medications as prescribed if they believe in the effectiveness of medication to control their condition [11,13–15]. Interestingly, Ross found those who felt they had more control over their illness were more likely not to take their medication as prescribed [12]. These persons are more likely to not want to become “dependent” on medication. Their  feeling was that they can make changes in their lives and thereby improve their health condition.

Physicians should invite patients’ thoughts as to what should be done to improve their health condition, and collaborate with the patient on an action plan for change if change is expected to improve/control the health condition. Follow-up to assess the patient’s health status longitudinally is necessary.

In this exchange, the patient feels he can control his hypertension on his own:

Doctor: I recommend that you start taking medication to control your blood pressure. Uncontrolled high blood pressure can lead to many health problems.

Patient: I am not ready to start taking medication.

Doctor: What are your reasons?

Patient:  I am under a lot of stress at work. Once I get control of this stress, my blood pressure will go down.

Doctor: Getting control of your stress at work is important. Let me tell you more about high blood pressure.

Patient: Okay.

Doctor: There is no one cause of your high blood pressure. Eliminating your work stress will most likely not reduce your blood pressure....

Timeline

Health conditions can be  acute, chronic, or cyclical (ie, seasonal); however, patients may have different perceptions of the duration of their health condition. In Kucukarslan et al, some patients did not believe their hypertension was a lifelong condition because they felt they would be able to cure it [7]. For example, as illustrated above, patients may believe that stress causes their hypertension, and if the stress could be controlled, then their blood pressure would normalize. Conversely, Ross et al found that patients who viewed their hypertension as a long-term condition were more likely to believe their medications were necessary and thus more likely to take their medication as prescribed [12]. A lifelong or chronic health condition is a difficult concept for patients to accept, especially ones who may view themselves as too young to have the condition.

Emotions

After being informed about their health condition, patients may feel emotions that are not apparent to the practitioner. These may include worry, depression, anger, anxiety, or fear. Emotions may impact their decision to take medication [12,14]. Listening for patients’ responses to health information provided by the clinician and letting patients know they have been heard will help allay strong negative emotions [16]. Good communication builds trust between the clinician and patient.

Conclusion

Patients receive medical advice from clinicians that may be inconsistent with their beliefs and understanding of their health condition. Studies of medication nonadherence find many factors contribute to it and no one tool to improve medication adherence exists. However, the consequence of medication nonadherence are great and include  include worsening condition, increased comorbid disease, and increased health care costs. Understanding patients’ beliefs about their health condition is an important step toward reducing medication nonadherence. The CSM provides a framework for clinicians to guide patients toward effective decision-making. Listening to the patient explain how they view their condition—how they define it, the causes, consequences, how to control it, and how long it will last or if it will progress—are important to the process of working with the patient manage their condition effectively. Clinicians’ reaction  to these perceptions are important, and dismissing them may alienate patients. Effective communication is necessary to understand patients’ perspectives and to help them manage their health condition.

Corresponding author: Suzan N. Kucukarslan, PhD, RPh, [email protected].

Financial disclosures: None.

From the Center for Patients and Families (Dr. Fagan, Ms. Wong, Ms. Morrison, Ms. Carnie), and the Division of Women’s Health and Gender Biology (Dr. Lewis-O’Connor), Brigham and Women’s Hospital, Boston, MA.

Abstract

• Objective: To describe and illustrate the phases of creating, recruiting, launching, and sustaining a successful Patient and Family Advisory Council (PFAC) in a hospital setting.
• Method: Descriptive report.
• Results: There are 4 stages in creating and establishing a PFAC: council preparation, patient/family advisor recruitment, council launch, and sustaining an established council. Each stage poses challenges that need to be addressed in order to progress to the next stage. The ability for hospital leadership to authentically partner with patient and family advisors is key to maintaining and sustaining PFACs.
• Conclusion: The success of a PFAC is based on leadership support, advisors’ commitment to their PFAC, and the ability to sustain the council. PFACs can promote patient- and family-centered care and shift the model of care from a prescribed model to one that embraces partnerships with patients while advancing care delivery. As patient- and family-centered care advances, it is important that best practices and resources for building and sustaining PFACs are developed and made available to ensure all hospitals have access to this valuable resource.

Throughout the country, families, patients, and health care professionals are working together in new ways, including within patient and family advisory councils (PFACs). First established in the 1990s, PFACs became widespread after patient-centeredness was identified by the Institute of Medicine as one of the 6 aims of quality health care [1]. PFACs were created to institutionalize a partnership between hospital leadership, clinicians, patients, and families to improve care delivery. Through this partnership, PFACs facilitate the sharing of patient perspectives and input on hospital policies and programs; serve as a resource to providers; and promote relationships between staff, patients, and family members [2]. PFACs also play an important role in promoting patient- and family-centered care, ensuring that patient needs and values are at the center of the care delivery system.

The BWH Center for Patients and Families includes the executive director, a project manager, and a senior patient advisor, who together oversee the PFACs. The project manager provides logistical support and is available as concerns arise, working closely with the senior patient advisor to ensure patient/family advisors are acclimated to their role and all PFACs run smoothly. The senior patient advisor is a volunteer advisor and patient advocate with long term experience creating and sustaining PFACs and mentoring patient/family advisors. Her role as a mentor includes attending PFAC meetings to model skills and behaviors for other advisors and working with them to ensure they are comfortable in their PFAC. Her advocacy work includes listening to and helping to articulate lived patient/family experiences as compelling narratives, which can be shared with hospital leadership and used as exemplars to spur change. Together, the team recruits and trains patient/family advisors, support all phases of PFAC development, and represent the patient/family voice within the hospital.

In this article, we describe and illustrate the 4 stages of creating and sustaining a successful PFAC to provide guidance and lessons learned to organizations seeking to develop this valuable resource. These stages are: (1) council preparation, (2) patient/family advisor recruitment, (3) council launch, and (4) sustaining an established council.

Council Preparation

Preparation of the PFAC occurs once hospital or service line leadership has identified a need for and is committed to having a PFAC. Leadership contacts the executive director of the  Center for Patients and Families to discuss the strategy and vision of the council. The executive director describes the attributes sought in an advisor and the core principles of patient- and family-centered care. This discussion includes recruitment methods, meeting logistics, and  who will  serve as council chair. The council chair should be in a leadership role and willing to champion the PFAC for their service line. The executive director discusses what is being planned with relevant clinicians and staff at a staff meeting in order to foster buy-in and involve them in the council recruitment process.

The BWH Center for Patients and Families has adapted Institute for Patient- and Family-Centered Care  recommendations for PFAC logistics and structure [3]. Councils generally meet monthly for 90 minutes excluding August and December. As volunteers, our advisors receive no monetary compensation but receive complimentary parking and are often provided meals. Advisors are asked to commit to a 3-year term with the understanding that personal issues can arise and their commitment may change; after their term, they are welcome to continue. We recommend to leadership that PFACs be comprised of no more than 1 staff member to every 4 advisors. This ratio seeks to address any potential power imbalance and promotes a feeling of ownership of their council . The project manager works with leadership in creating council guidelines, including the council’s goals, expectations, and each member’s role.

Patient/Family Advisor Recruitment

We ask service line providers and staff to nominate patients and family members they believe would be suitable advisors. The attributes we look for in an advisor include their ability to: (1) share personal experiences in ways that professional and support staff can learn from, (2) see the big picture of a challenge or scenario and give advice using the lens of the patient or family member, (3) be interested in more than one agenda item, (4) speak to multiple operational topics, (5) listen to other points of view and be empathetic, (6) connect with other advisors and staff, and (7) have a good sense of humor. Candidates with both positive and negative experiences are sought so that we can learn and improve from their experience [2].

To find advisors with these attributes, we ask providers to review their schedule and think about who they look forward to seeing or connect with on a personal level. This method has proven successful at producing candidates that have the attributes we seek. It is vital that the patients we recruit are able to see past their own personal experiences to understand broader objectives and how they fit into the bigger picture, enabling them to participate in a variety of projects and committees. There are no educational or specific skill requirements to become an advisor; the only requirement is that candidates must have experience as a patient or caregiver (family member) of a patient at BWH.

Recommended patients receive a letter notifying them that they have been nominated to be an advisor on a PFAC by their treating clinician. The project manager contacts potential advisors to see if they are interested and provides a brief description of PFACs and the role of patient/family advisors. The project manager emphasizes the importance of patient/family input to the hospital, describing the opportunities patient/family advisors have to contribute their expertise as a patient or caregiver to decisions and projects that will positively affect future patient care. Examples of past successful PFAC projects are shared to give a sense of the importance of the advisor role within the hospital and the appreciation hospital leadership has for PFAC contributions. The project manager reiterates that their clinician nominated them to the council to encourage the candidate to feel that their voice deserves to be heard.

Interested candidates are interviewed by phone by the team. Each candidate is asked the same questions: (1) How long have you been a patient in the clinic or unit?; (2) Describe your experiences in this clinic/service; and (3) Describe what works well and what could be improved in your care. During the interview, we listen to their personal narrative and their perspective on their care, which allows us to assess whether they have the attributes of a successful patient/family advisor. Candidate’s narratives illustrate how they would share their concerns, contribute to solutions, and if they have the ability to see beyond their own personal agenda. We also listen carefully for themes of tolerance, operational insight, empathy, and problem-solving capabilities. Interviews take about 15–20 minutes, depending on how many follow-up questions we have for the candidate and if they have questions for us.

After the phone interview, the team determines whether the candidate would be an appropriate patient/family advisor. If there are any concerns and more information is needed, the project manager reaches out to the staff and contacts the candidate to invite them for an in-person interview. Of the interviewed candidates, about 75% to 80% are invited to join. Candidates who are not chosen are generally unable to clearly articulate issues they see within the hospital/clinic, may have personal relationships with the staff (ie, friends with the physician), or cannot see pass their own issues and are inflexible in their thinking. Those not chosen receive a note thanking them for their time and interest. The candidates chosen to be advisors are on boarded through BWH volunteer services and must attend a 3-hour BWH volunteer orientation, be HIPAA compliant, and be cleared by occupational health before receiving their advisor ID badge and beginning service.

Council Launch

Once the advisors have been recruited and oriented, the council enters the launching stage, which lasts from the council’s first meeting until the 1-year anniversary. The first meeting agenda is designed to introduce staff and advisors to each other. Advisors each share their health care narratives and the staff shares their motivations for participating in the council. The council chair reviews the purpose and goals of the council.

During the first year, the council gains experience working together as a team. Council projects are initially chosen by the council chair and should be reasonably simple to accomplish and meaningful to advisors so that advisors recognize that their feedback is being heard and acted on. Example projects include creating clearer directional sign-age, assessing recliners for patient rooms, and providing feedback on patient handouts to ensure patient friendliness.

As the council advances, projects can be initiated by the advisors. This process is facilitated when an advisor is added as council co-chair, which usually occurs at the end of the first year. Projects often arise from similar concerns shared by advisors during the recruitment interview process.

Sustaining an Established Council

A council is considered established when it enters its second year and has named a patient advisor as a co-chair. Established councils have undertaken projects such as improving the layout of the whiteboards in patient rooms and providing feedback to staff on how to manage challenging patients. In addition, established councils may be tapped when service lines without a PFAC seek to gather advisor feedback for a project. For example, one of our established councils has provided feedback on two patient safety research projects.

Councils are sustained by continually engaging advisors in projects that are of value to them, both in their department and hospital-wide. Advisors should be given the opportunity to prioritize and set new council goals. One of the overarching goals for all our PFACs is to improve communication between patients and staff. Councils at this stage often participate in grand rounds or attend staff meetings to share their narratives, enabling providers to understand their perspective. The council can also be engaged in grant-funded research initiatives. Having PFACs involved in various projects allows advisors to bring their narratives to a wider audience and be a part of change from numerous avenues within the hospital.

Patient and Family Advisory Councils in Practice

BWH has 16 PFACs in various stages of growth. To illustrate the variety in council structure and function, we describe 3 PFACs below. Each has unique composition and goals based on the needs of service line leadership.

Shapiro Cardiovascular PFAC

The Shapiro Cardiovascular Center, a LEED silver-certified building and with private patient rooms that welcome family members to stay with their loved ones [4], opened in 2008. The chief nursing officer felt the care provided in this new space should promote and embody PFCC. With the assistance of the Center for Patients and Families, the associate chief nursing officer was charged with creating the Shapiro Cardiovascular PFAC. Launched in May 2011, this PFAC provides input to improve the patient experience for inpatient and ambulatory care housed in the Shapiro Center.

The Shapiro PFAC originally consisted of medical/surgical cardiac and heart transplant patients; renal transplant recipients and donors later joined. Initially, this council worked on patient/visitor guidelines for the inpatient units. As the council became more experienced, advisors interviewed nursing director candidates for cardiac surgery ICU and organized two PFCC nursing grand rounds. These grand rounds featured a panel of Shapiro advisors sharing their perspective of their hospital care and reflections on their healing process. This council has also provided feedback on hospital-wide projects, such as the refinement of a nursing fall prevention tool and the development of patient-informed measures of a successful surgery. As advisors became more experienced, they were recruited by the executive director to be part of other committees and research projects.

The Shapiro PFAC is one of the oldest councils at BWH, consisting of 12 advisors and 3 staff members, with most of the inaugural advisors remaining. Because the council chair has changed twice since 2011, this council does not have a formal advisor co-chair but the council remains a cohesive team as they work in partnership with the newest chair. To sustain this PFAC, leadership has consistently engaged the council in operational projects. For example, the associate chief nursing officer has suggested advisors be part of unit-based councils composed of staff nurses and educators who work to improve patient care within their unit. Advisors have also been invited to participate in staff and nursing director meetings to share their narratives and allow staff to reflect on the care they provide patients.

LGBTQ PFAC

In the fall of 2014, BWH held an educational Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ)  patient experience forum prompted by a complaint from the wife of a maternity patient that the care they received was not patient/family-centered. During this panel discussion, 4 LGBTQ patients described their care at BWH, including what went well and what their providers could have done better. There was an acknowledgement by a majority of providers in the audience that they did not receive training on inclusive care for LGBTQ patients and their families. The providers identified the need to be educated on LGBTQ issues and care concerns, and their desire to work towards creating a warm and inclusive environment that better serves LGBTQ patients. This organic request for education was met with enthusiasm from the panel participants and led to a commitment to form an LGBTQ PFAC at BWH.

The LGBTQ PFAC is co-chaired by the executive director of the Center for Patients and Families and a LGBTQ patient advisor who receives his care at BWH. It was important for this council to be co-led by an advisor from the beginning to acknowledge and validate LGBTQ experiences of care which had previously been marginalized. Because LGBTQ patients interact with all service lines at BWH, it made sense that a central operational leader with significant experience listening and responding to the patient voice co-leads the group. This council is composed of LGBTQ patients, their caregivers/partners/spouses, BWH LGBTQ staff that also receive healthcare from BWH, and LGBTQ academic stakeholders who provide historical contextualization to inform change.

The LGBTQ PFAC began the preparation phase in April 2015 and launched as a hospital-wide council in October 2015. This launch was widely publicized so that all BWH employees would know this council was created to elevate LGBTQ patients and caregivers into the mainstream hospital consciousness. The goals for this year are to partner with the existing LGBTQ employee group to create a standardized LGBTQ provider directory, educate staff on the healthcare needs of the community, and promote educational awareness, compassionate understanding, and improved care for transgender patients. As this council matures into the established stage, new projects will be taken on in line with the needs seen by members.

Women’s Health Council

The Women’s Health Council is a unique PFAC established in 2012. The council serves a population of trauma survivors cared for by the Coordinated Approach to Recovery and Empowerment (C.A.R.E.) clinic at BWH, also founded in 2012. Patients who receive care in this clinic have experienced violence and trauma, including domestic and sexual violence, child maltreatment, and human trafficking. Due to previous experience leading a PFAC, the C.A.R.E. Director understood the importance of patient input and engaged patients as advisors while forming the clinic.

The C.A.R.E. clinic serves both men and women but the majority of survivors served are female; thus, the patient advisors on its PFAC are all female. To recruit advisors, clinicians, and social workers at the clinic refer potential candidates to the C.A.R.E. Director, who then interviews them. The criteria for advisors for this council include being a female survivor of violence and trauma, being physically and mentally able to serve, and able to participate in a way that does not re-traumatize them. There are currently 14 advisors on the council with a goal to grow to 30 advisors. Experience has shown that members become busy with family, school and careers and may need to step away for short periods of time; thus, the council seeks to continually recruit to ensure robust membership.

Instead of the usual monthly scheduled meetings, this council holds “meetings on demand.” Advisors are polled via email to find a time in the near future that works for the group. The PFAC generally uses a web conferencing platform for their meetings and has an in-person meeting once or twice a year. Also unlike other councils, this council does not require their advisors to share their personal narratives; it is up to each advisor to decide what to share.

This council has accomplished numerous goals since its inception, including its first task of giving the C.A.R.E. clinic its name. The council has provided feedback on the development of the C.A.R.E. brochure and website and serves as key informants in all aspects of policy and procedures for the C.A.R.E. clinic. Additionally, they have provided input on how to create a safe environment for patients and screen patients to identify a victim of violence or human trafficking [5]. This council has been sustained by the strong community fostered by the director and projects led by the advisors, as each advisor has a vested interest in ensuring the clinic provides a safe environment for patients seeking care. This year, the council is hoping to host experts from the Boston Health Commission to share best practices in providing services to victims of abuse and violence.

Lessons Learned

The BWH Center for Patients and Families has encountered challenges when creating and sustaining PFACs, such as recruiting advisors from diverse ethnic, cultural, and economic backgrounds. Currently, our advisor population is primarily comprised of Caucasian patient/family members from middle and upper economic backgrounds, though it has increasingly diversified as the program has grown. We believe the lack of representation from other backgrounds is due to scheduling difficulties, the lack of payment for advisors, visibility of the PFAC program, and, potentially, cultural norms that promote deference to medical expertise. We have worked to increase PFAC diversity by asking providers to specifically seek out and nominate patients that will broaden our reach as a council.

Retaining and recruiting advisors after the PFACs have launched can also present a challenge. Some advisors have had to resign due to job demands, relocation, health issues, or the need to take care of family. To resolve this issue, we have asked PFAC chairs to continuously actively recruit advisors. By doing so, the councils gain new perspectives and ensure there are adequate number of advisors should a vacancy occur.

Sustaining PFACs once they are established requires time, effort, and commitment of leadership, advisors, and dedicated staff resources. The council needs to be continuously engaged in meaningful projects and feel that their participation is impactful and creates change. It is important that clinical leadership stays actively involved and attends all PFAC meetings. If there is a change in leadership as we experienced on our Shapiro PFAC, it is critical that the interim chair participates and supports the goal of the council. Regardless, leadership must show sustained enthusiasm for PFAC engagement and achievement.

Employing technology can also help sustain councils. Although we prefer in-person meetings, the option to attend meetings through online or phone conferencing should be made available to support advisors who are unable to attend in person. At this time, only one of our councils uses web conferencing, while several of our councils offer an option to call in via a conference line. The conference line has been beneficial in helping us retain and engage advisors who travel a significant distance to attend meetings.

We recognize that BWH has many resources available due to its status as a large, academic medical center in an urban center. Nonetheless, PFACs can play a vital role in hospitals no matter the setting, location, or size as long as there is buy in from hospital leadership. Although BWH has 16 PFACs, it is not necessary to have this many councils. Having one PFAC may be sufficient for smaller hospitals; the ideal number of councils depends on the size and complexity of the institution. Hospitals without a dedicated department like the Center for Patients and Families can create PFACs by partnering with volunteer services, patient engagement, or quality and safety departments. Existing departments with the capability to train advisors and provide meeting resources to support patient/family recruitment and engagement should be harnessed whenever possible. It is, however, important to have a dedicated staff member to serve as a point person for the advisors should they have any questions or concerns. Technology, such as web conferencing described above, can facilitate attendance by patient/family advisors who have limited time or resources and will be valuable for hospitals in a rural setting. The stages we have described are critical to the success of creating and sustaining a PFAC regardless of where they are developed and can be adapted to fit the unique needs and environments of any healthcare setting.

Conclusion

BWH’s Center for Patients and Families has created 16 PFACs since 2008, which are in various stages of development. Our PFACs are successful for many reasons, including a rigorous recruitment and interview process, leadership support, advisors’ commitment to their PFAC, and making modifications made based on lessons learned, as illustrated by the 3 PFACs discussed. We are able to sustain our councils by continually engagingadvisors, having leadership partner with advisors, setting feasible goals, and recruiting new advisors for a fresh perspective. PFACs promote patient- and family-centered care and can shift the model of care from a prescribed model to one that embraces collaboration with patients while advancing care delivery. As patient- and family-centered care advances, it is important that best practices for building and sustaining PFACs are developed and made available to ensure all hospitals have access to this valuable resource.

Corresponding author: Celene Wong, MHA, Center for Patients and Families, Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115, [email protected].

Financial disclosures: None.

From the Center for Patients and Families (Dr. Fagan, Ms. Wong, Ms. Morrison, Ms. Carnie), and the Division of Women’s Health and Gender Biology (Dr. Lewis-O’Connor), Brigham and Women’s Hospital, Boston, MA.

Abstract

• Objective: To describe and illustrate the phases of creating, recruiting, launching, and sustaining a successful Patient and Family Advisory Council (PFAC) in a hospital setting.
• Method: Descriptive report.
• Results: There are 4 stages in creating and establishing a PFAC: council preparation, patient/family advisor recruitment, council launch, and sustaining an established council. Each stage poses challenges that need to be addressed in order to progress to the next stage. The ability for hospital leadership to authentically partner with patient and family advisors is key to maintaining and sustaining PFACs.
• Conclusion: The success of a PFAC is based on leadership support, advisors’ commitment to their PFAC, and the ability to sustain the council. PFACs can promote patient- and family-centered care and shift the model of care from a prescribed model to one that embraces partnerships with patients while advancing care delivery. As patient- and family-centered care advances, it is important that best practices and resources for building and sustaining PFACs are developed and made available to ensure all hospitals have access to this valuable resource.

Throughout the country, families, patients, and health care professionals are working together in new ways, including within patient and family advisory councils (PFACs). First established in the 1990s, PFACs became widespread after patient-centeredness was identified by the Institute of Medicine as one of the 6 aims of quality health care [1]. PFACs were created to institutionalize a partnership between hospital leadership, clinicians, patients, and families to improve care delivery. Through this partnership, PFACs facilitate the sharing of patient perspectives and input on hospital policies and programs; serve as a resource to providers; and promote relationships between staff, patients, and family members [2]. PFACs also play an important role in promoting patient- and family-centered care, ensuring that patient needs and values are at the center of the care delivery system.

The BWH Center for Patients and Families includes the executive director, a project manager, and a senior patient advisor, who together oversee the PFACs. The project manager provides logistical support and is available as concerns arise, working closely with the senior patient advisor to ensure patient/family advisors are acclimated to their role and all PFACs run smoothly. The senior patient advisor is a volunteer advisor and patient advocate with long term experience creating and sustaining PFACs and mentoring patient/family advisors. Her role as a mentor includes attending PFAC meetings to model skills and behaviors for other advisors and working with them to ensure they are comfortable in their PFAC. Her advocacy work includes listening to and helping to articulate lived patient/family experiences as compelling narratives, which can be shared with hospital leadership and used as exemplars to spur change. Together, the team recruits and trains patient/family advisors, support all phases of PFAC development, and represent the patient/family voice within the hospital.

In this article, we describe and illustrate the 4 stages of creating and sustaining a successful PFAC to provide guidance and lessons learned to organizations seeking to develop this valuable resource. These stages are: (1) council preparation, (2) patient/family advisor recruitment, (3) council launch, and (4) sustaining an established council.

Council Preparation

Preparation of the PFAC occurs once hospital or service line leadership has identified a need for and is committed to having a PFAC. Leadership contacts the executive director of the  Center for Patients and Families to discuss the strategy and vision of the council. The executive director describes the attributes sought in an advisor and the core principles of patient- and family-centered care. This discussion includes recruitment methods, meeting logistics, and  who will  serve as council chair. The council chair should be in a leadership role and willing to champion the PFAC for their service line. The executive director discusses what is being planned with relevant clinicians and staff at a staff meeting in order to foster buy-in and involve them in the council recruitment process.

The BWH Center for Patients and Families has adapted Institute for Patient- and Family-Centered Care  recommendations for PFAC logistics and structure [3]. Councils generally meet monthly for 90 minutes excluding August and December. As volunteers, our advisors receive no monetary compensation but receive complimentary parking and are often provided meals. Advisors are asked to commit to a 3-year term with the understanding that personal issues can arise and their commitment may change; after their term, they are welcome to continue. We recommend to leadership that PFACs be comprised of no more than 1 staff member to every 4 advisors. This ratio seeks to address any potential power imbalance and promotes a feeling of ownership of their council . The project manager works with leadership in creating council guidelines, including the council’s goals, expectations, and each member’s role.

Patient/Family Advisor Recruitment

We ask service line providers and staff to nominate patients and family members they believe would be suitable advisors. The attributes we look for in an advisor include their ability to: (1) share personal experiences in ways that professional and support staff can learn from, (2) see the big picture of a challenge or scenario and give advice using the lens of the patient or family member, (3) be interested in more than one agenda item, (4) speak to multiple operational topics, (5) listen to other points of view and be empathetic, (6) connect with other advisors and staff, and (7) have a good sense of humor. Candidates with both positive and negative experiences are sought so that we can learn and improve from their experience [2].

To find advisors with these attributes, we ask providers to review their schedule and think about who they look forward to seeing or connect with on a personal level. This method has proven successful at producing candidates that have the attributes we seek. It is vital that the patients we recruit are able to see past their own personal experiences to understand broader objectives and how they fit into the bigger picture, enabling them to participate in a variety of projects and committees. There are no educational or specific skill requirements to become an advisor; the only requirement is that candidates must have experience as a patient or caregiver (family member) of a patient at BWH.

Recommended patients receive a letter notifying them that they have been nominated to be an advisor on a PFAC by their treating clinician. The project manager contacts potential advisors to see if they are interested and provides a brief description of PFACs and the role of patient/family advisors. The project manager emphasizes the importance of patient/family input to the hospital, describing the opportunities patient/family advisors have to contribute their expertise as a patient or caregiver to decisions and projects that will positively affect future patient care. Examples of past successful PFAC projects are shared to give a sense of the importance of the advisor role within the hospital and the appreciation hospital leadership has for PFAC contributions. The project manager reiterates that their clinician nominated them to the council to encourage the candidate to feel that their voice deserves to be heard.

Interested candidates are interviewed by phone by the team. Each candidate is asked the same questions: (1) How long have you been a patient in the clinic or unit?; (2) Describe your experiences in this clinic/service; and (3) Describe what works well and what could be improved in your care. During the interview, we listen to their personal narrative and their perspective on their care, which allows us to assess whether they have the attributes of a successful patient/family advisor. Candidate’s narratives illustrate how they would share their concerns, contribute to solutions, and if they have the ability to see beyond their own personal agenda. We also listen carefully for themes of tolerance, operational insight, empathy, and problem-solving capabilities. Interviews take about 15–20 minutes, depending on how many follow-up questions we have for the candidate and if they have questions for us.

After the phone interview, the team determines whether the candidate would be an appropriate patient/family advisor. If there are any concerns and more information is needed, the project manager reaches out to the staff and contacts the candidate to invite them for an in-person interview. Of the interviewed candidates, about 75% to 80% are invited to join. Candidates who are not chosen are generally unable to clearly articulate issues they see within the hospital/clinic, may have personal relationships with the staff (ie, friends with the physician), or cannot see pass their own issues and are inflexible in their thinking. Those not chosen receive a note thanking them for their time and interest. The candidates chosen to be advisors are on boarded through BWH volunteer services and must attend a 3-hour BWH volunteer orientation, be HIPAA compliant, and be cleared by occupational health before receiving their advisor ID badge and beginning service.

Council Launch

Once the advisors have been recruited and oriented, the council enters the launching stage, which lasts from the council’s first meeting until the 1-year anniversary. The first meeting agenda is designed to introduce staff and advisors to each other. Advisors each share their health care narratives and the staff shares their motivations for participating in the council. The council chair reviews the purpose and goals of the council.

During the first year, the council gains experience working together as a team. Council projects are initially chosen by the council chair and should be reasonably simple to accomplish and meaningful to advisors so that advisors recognize that their feedback is being heard and acted on. Example projects include creating clearer directional sign-age, assessing recliners for patient rooms, and providing feedback on patient handouts to ensure patient friendliness.

As the council advances, projects can be initiated by the advisors. This process is facilitated when an advisor is added as council co-chair, which usually occurs at the end of the first year. Projects often arise from similar concerns shared by advisors during the recruitment interview process.

Sustaining an Established Council

A council is considered established when it enters its second year and has named a patient advisor as a co-chair. Established councils have undertaken projects such as improving the layout of the whiteboards in patient rooms and providing feedback to staff on how to manage challenging patients. In addition, established councils may be tapped when service lines without a PFAC seek to gather advisor feedback for a project. For example, one of our established councils has provided feedback on two patient safety research projects.

Councils are sustained by continually engaging advisors in projects that are of value to them, both in their department and hospital-wide. Advisors should be given the opportunity to prioritize and set new council goals. One of the overarching goals for all our PFACs is to improve communication between patients and staff. Councils at this stage often participate in grand rounds or attend staff meetings to share their narratives, enabling providers to understand their perspective. The council can also be engaged in grant-funded research initiatives. Having PFACs involved in various projects allows advisors to bring their narratives to a wider audience and be a part of change from numerous avenues within the hospital.

Patient and Family Advisory Councils in Practice

BWH has 16 PFACs in various stages of growth. To illustrate the variety in council structure and function, we describe 3 PFACs below. Each has unique composition and goals based on the needs of service line leadership.

Shapiro Cardiovascular PFAC

The Shapiro Cardiovascular Center, a LEED silver-certified building and with private patient rooms that welcome family members to stay with their loved ones [4], opened in 2008. The chief nursing officer felt the care provided in this new space should promote and embody PFCC. With the assistance of the Center for Patients and Families, the associate chief nursing officer was charged with creating the Shapiro Cardiovascular PFAC. Launched in May 2011, this PFAC provides input to improve the patient experience for inpatient and ambulatory care housed in the Shapiro Center.

The Shapiro PFAC originally consisted of medical/surgical cardiac and heart transplant patients; renal transplant recipients and donors later joined. Initially, this council worked on patient/visitor guidelines for the inpatient units. As the council became more experienced, advisors interviewed nursing director candidates for cardiac surgery ICU and organized two PFCC nursing grand rounds. These grand rounds featured a panel of Shapiro advisors sharing their perspective of their hospital care and reflections on their healing process. This council has also provided feedback on hospital-wide projects, such as the refinement of a nursing fall prevention tool and the development of patient-informed measures of a successful surgery. As advisors became more experienced, they were recruited by the executive director to be part of other committees and research projects.

The Shapiro PFAC is one of the oldest councils at BWH, consisting of 12 advisors and 3 staff members, with most of the inaugural advisors remaining. Because the council chair has changed twice since 2011, this council does not have a formal advisor co-chair but the council remains a cohesive team as they work in partnership with the newest chair. To sustain this PFAC, leadership has consistently engaged the council in operational projects. For example, the associate chief nursing officer has suggested advisors be part of unit-based councils composed of staff nurses and educators who work to improve patient care within their unit. Advisors have also been invited to participate in staff and nursing director meetings to share their narratives and allow staff to reflect on the care they provide patients.

LGBTQ PFAC

In the fall of 2014, BWH held an educational Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ)  patient experience forum prompted by a complaint from the wife of a maternity patient that the care they received was not patient/family-centered. During this panel discussion, 4 LGBTQ patients described their care at BWH, including what went well and what their providers could have done better. There was an acknowledgement by a majority of providers in the audience that they did not receive training on inclusive care for LGBTQ patients and their families. The providers identified the need to be educated on LGBTQ issues and care concerns, and their desire to work towards creating a warm and inclusive environment that better serves LGBTQ patients. This organic request for education was met with enthusiasm from the panel participants and led to a commitment to form an LGBTQ PFAC at BWH.

The LGBTQ PFAC is co-chaired by the executive director of the Center for Patients and Families and a LGBTQ patient advisor who receives his care at BWH. It was important for this council to be co-led by an advisor from the beginning to acknowledge and validate LGBTQ experiences of care which had previously been marginalized. Because LGBTQ patients interact with all service lines at BWH, it made sense that a central operational leader with significant experience listening and responding to the patient voice co-leads the group. This council is composed of LGBTQ patients, their caregivers/partners/spouses, BWH LGBTQ staff that also receive healthcare from BWH, and LGBTQ academic stakeholders who provide historical contextualization to inform change.

The LGBTQ PFAC began the preparation phase in April 2015 and launched as a hospital-wide council in October 2015. This launch was widely publicized so that all BWH employees would know this council was created to elevate LGBTQ patients and caregivers into the mainstream hospital consciousness. The goals for this year are to partner with the existing LGBTQ employee group to create a standardized LGBTQ provider directory, educate staff on the healthcare needs of the community, and promote educational awareness, compassionate understanding, and improved care for transgender patients. As this council matures into the established stage, new projects will be taken on in line with the needs seen by members.

Women’s Health Council

The Women’s Health Council is a unique PFAC established in 2012. The council serves a population of trauma survivors cared for by the Coordinated Approach to Recovery and Empowerment (C.A.R.E.) clinic at BWH, also founded in 2012. Patients who receive care in this clinic have experienced violence and trauma, including domestic and sexual violence, child maltreatment, and human trafficking. Due to previous experience leading a PFAC, the C.A.R.E. Director understood the importance of patient input and engaged patients as advisors while forming the clinic.

The C.A.R.E. clinic serves both men and women but the majority of survivors served are female; thus, the patient advisors on its PFAC are all female. To recruit advisors, clinicians, and social workers at the clinic refer potential candidates to the C.A.R.E. Director, who then interviews them. The criteria for advisors for this council include being a female survivor of violence and trauma, being physically and mentally able to serve, and able to participate in a way that does not re-traumatize them. There are currently 14 advisors on the council with a goal to grow to 30 advisors. Experience has shown that members become busy with family, school and careers and may need to step away for short periods of time; thus, the council seeks to continually recruit to ensure robust membership.

Instead of the usual monthly scheduled meetings, this council holds “meetings on demand.” Advisors are polled via email to find a time in the near future that works for the group. The PFAC generally uses a web conferencing platform for their meetings and has an in-person meeting once or twice a year. Also unlike other councils, this council does not require their advisors to share their personal narratives; it is up to each advisor to decide what to share.

This council has accomplished numerous goals since its inception, including its first task of giving the C.A.R.E. clinic its name. The council has provided feedback on the development of the C.A.R.E. brochure and website and serves as key informants in all aspects of policy and procedures for the C.A.R.E. clinic. Additionally, they have provided input on how to create a safe environment for patients and screen patients to identify a victim of violence or human trafficking [5]. This council has been sustained by the strong community fostered by the director and projects led by the advisors, as each advisor has a vested interest in ensuring the clinic provides a safe environment for patients seeking care. This year, the council is hoping to host experts from the Boston Health Commission to share best practices in providing services to victims of abuse and violence.

Lessons Learned

The BWH Center for Patients and Families has encountered challenges when creating and sustaining PFACs, such as recruiting advisors from diverse ethnic, cultural, and economic backgrounds. Currently, our advisor population is primarily comprised of Caucasian patient/family members from middle and upper economic backgrounds, though it has increasingly diversified as the program has grown. We believe the lack of representation from other backgrounds is due to scheduling difficulties, the lack of payment for advisors, visibility of the PFAC program, and, potentially, cultural norms that promote deference to medical expertise. We have worked to increase PFAC diversity by asking providers to specifically seek out and nominate patients that will broaden our reach as a council.

Retaining and recruiting advisors after the PFACs have launched can also present a challenge. Some advisors have had to resign due to job demands, relocation, health issues, or the need to take care of family. To resolve this issue, we have asked PFAC chairs to continuously actively recruit advisors. By doing so, the councils gain new perspectives and ensure there are adequate number of advisors should a vacancy occur.

Sustaining PFACs once they are established requires time, effort, and commitment of leadership, advisors, and dedicated staff resources. The council needs to be continuously engaged in meaningful projects and feel that their participation is impactful and creates change. It is important that clinical leadership stays actively involved and attends all PFAC meetings. If there is a change in leadership as we experienced on our Shapiro PFAC, it is critical that the interim chair participates and supports the goal of the council. Regardless, leadership must show sustained enthusiasm for PFAC engagement and achievement.

Employing technology can also help sustain councils. Although we prefer in-person meetings, the option to attend meetings through online or phone conferencing should be made available to support advisors who are unable to attend in person. At this time, only one of our councils uses web conferencing, while several of our councils offer an option to call in via a conference line. The conference line has been beneficial in helping us retain and engage advisors who travel a significant distance to attend meetings.

We recognize that BWH has many resources available due to its status as a large, academic medical center in an urban center. Nonetheless, PFACs can play a vital role in hospitals no matter the setting, location, or size as long as there is buy in from hospital leadership. Although BWH has 16 PFACs, it is not necessary to have this many councils. Having one PFAC may be sufficient for smaller hospitals; the ideal number of councils depends on the size and complexity of the institution. Hospitals without a dedicated department like the Center for Patients and Families can create PFACs by partnering with volunteer services, patient engagement, or quality and safety departments. Existing departments with the capability to train advisors and provide meeting resources to support patient/family recruitment and engagement should be harnessed whenever possible. It is, however, important to have a dedicated staff member to serve as a point person for the advisors should they have any questions or concerns. Technology, such as web conferencing described above, can facilitate attendance by patient/family advisors who have limited time or resources and will be valuable for hospitals in a rural setting. The stages we have described are critical to the success of creating and sustaining a PFAC regardless of where they are developed and can be adapted to fit the unique needs and environments of any healthcare setting.

Conclusion

BWH’s Center for Patients and Families has created 16 PFACs since 2008, which are in various stages of development. Our PFACs are successful for many reasons, including a rigorous recruitment and interview process, leadership support, advisors’ commitment to their PFAC, and making modifications made based on lessons learned, as illustrated by the 3 PFACs discussed. We are able to sustain our councils by continually engagingadvisors, having leadership partner with advisors, setting feasible goals, and recruiting new advisors for a fresh perspective. PFACs promote patient- and family-centered care and can shift the model of care from a prescribed model to one that embraces collaboration with patients while advancing care delivery. As patient- and family-centered care advances, it is important that best practices for building and sustaining PFACs are developed and made available to ensure all hospitals have access to this valuable resource.

Corresponding author: Celene Wong, MHA, Center for Patients and Families, Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115, [email protected].

Financial disclosures: None.

From the Center for Patients and Families (Dr. Fagan, Ms. Wong, Ms. Morrison, Ms. Carnie), and the Division of Women’s Health and Gender Biology (Dr. Lewis-O’Connor), Brigham and Women’s Hospital, Boston, MA.

Abstract

• Objective: To describe and illustrate the phases of creating, recruiting, launching, and sustaining a successful Patient and Family Advisory Council (PFAC) in a hospital setting.
• Method: Descriptive report.
• Results: There are 4 stages in creating and establishing a PFAC: council preparation, patient/family advisor recruitment, council launch, and sustaining an established council. Each stage poses challenges that need to be addressed in order to progress to the next stage. The ability for hospital leadership to authentically partner with patient and family advisors is key to maintaining and sustaining PFACs.
• Conclusion: The success of a PFAC is based on leadership support, advisors’ commitment to their PFAC, and the ability to sustain the council. PFACs can promote patient- and family-centered care and shift the model of care from a prescribed model to one that embraces partnerships with patients while advancing care delivery. As patient- and family-centered care advances, it is important that best practices and resources for building and sustaining PFACs are developed and made available to ensure all hospitals have access to this valuable resource.

Throughout the country, families, patients, and health care professionals are working together in new ways, including within patient and family advisory councils (PFACs). First established in the 1990s, PFACs became widespread after patient-centeredness was identified by the Institute of Medicine as one of the 6 aims of quality health care [1]. PFACs were created to institutionalize a partnership between hospital leadership, clinicians, patients, and families to improve care delivery. Through this partnership, PFACs facilitate the sharing of patient perspectives and input on hospital policies and programs; serve as a resource to providers; and promote relationships between staff, patients, and family members [2]. PFACs also play an important role in promoting patient- and family-centered care, ensuring that patient needs and values are at the center of the care delivery system.

The BWH Center for Patients and Families includes the executive director, a project manager, and a senior patient advisor, who together oversee the PFACs. The project manager provides logistical support and is available as concerns arise, working closely with the senior patient advisor to ensure patient/family advisors are acclimated to their role and all PFACs run smoothly. The senior patient advisor is a volunteer advisor and patient advocate with long term experience creating and sustaining PFACs and mentoring patient/family advisors. Her role as a mentor includes attending PFAC meetings to model skills and behaviors for other advisors and working with them to ensure they are comfortable in their PFAC. Her advocacy work includes listening to and helping to articulate lived patient/family experiences as compelling narratives, which can be shared with hospital leadership and used as exemplars to spur change. Together, the team recruits and trains patient/family advisors, support all phases of PFAC development, and represent the patient/family voice within the hospital.

In this article, we describe and illustrate the 4 stages of creating and sustaining a successful PFAC to provide guidance and lessons learned to organizations seeking to develop this valuable resource. These stages are: (1) council preparation, (2) patient/family advisor recruitment, (3) council launch, and (4) sustaining an established council.

Council Preparation

Preparation of the PFAC occurs once hospital or service line leadership has identified a need for and is committed to having a PFAC. Leadership contacts the executive director of the  Center for Patients and Families to discuss the strategy and vision of the council. The executive director describes the attributes sought in an advisor and the core principles of patient- and family-centered care. This discussion includes recruitment methods, meeting logistics, and  who will  serve as council chair. The council chair should be in a leadership role and willing to champion the PFAC for their service line. The executive director discusses what is being planned with relevant clinicians and staff at a staff meeting in order to foster buy-in and involve them in the council recruitment process.

The BWH Center for Patients and Families has adapted Institute for Patient- and Family-Centered Care  recommendations for PFAC logistics and structure [3]. Councils generally meet monthly for 90 minutes excluding August and December. As volunteers, our advisors receive no monetary compensation but receive complimentary parking and are often provided meals. Advisors are asked to commit to a 3-year term with the understanding that personal issues can arise and their commitment may change; after their term, they are welcome to continue. We recommend to leadership that PFACs be comprised of no more than 1 staff member to every 4 advisors. This ratio seeks to address any potential power imbalance and promotes a feeling of ownership of their council . The project manager works with leadership in creating council guidelines, including the council’s goals, expectations, and each member’s role.

Patient/Family Advisor Recruitment

We ask service line providers and staff to nominate patients and family members they believe would be suitable advisors. The attributes we look for in an advisor include their ability to: (1) share personal experiences in ways that professional and support staff can learn from, (2) see the big picture of a challenge or scenario and give advice using the lens of the patient or family member, (3) be interested in more than one agenda item, (4) speak to multiple operational topics, (5) listen to other points of view and be empathetic, (6) connect with other advisors and staff, and (7) have a good sense of humor. Candidates with both positive and negative experiences are sought so that we can learn and improve from their experience [2].

To find advisors with these attributes, we ask providers to review their schedule and think about who they look forward to seeing or connect with on a personal level. This method has proven successful at producing candidates that have the attributes we seek. It is vital that the patients we recruit are able to see past their own personal experiences to understand broader objectives and how they fit into the bigger picture, enabling them to participate in a variety of projects and committees. There are no educational or specific skill requirements to become an advisor; the only requirement is that candidates must have experience as a patient or caregiver (family member) of a patient at BWH.

Recommended patients receive a letter notifying them that they have been nominated to be an advisor on a PFAC by their treating clinician. The project manager contacts potential advisors to see if they are interested and provides a brief description of PFACs and the role of patient/family advisors. The project manager emphasizes the importance of patient/family input to the hospital, describing the opportunities patient/family advisors have to contribute their expertise as a patient or caregiver to decisions and projects that will positively affect future patient care. Examples of past successful PFAC projects are shared to give a sense of the importance of the advisor role within the hospital and the appreciation hospital leadership has for PFAC contributions. The project manager reiterates that their clinician nominated them to the council to encourage the candidate to feel that their voice deserves to be heard.

Interested candidates are interviewed by phone by the team. Each candidate is asked the same questions: (1) How long have you been a patient in the clinic or unit?; (2) Describe your experiences in this clinic/service; and (3) Describe what works well and what could be improved in your care. During the interview, we listen to their personal narrative and their perspective on their care, which allows us to assess whether they have the attributes of a successful patient/family advisor. Candidate’s narratives illustrate how they would share their concerns, contribute to solutions, and if they have the ability to see beyond their own personal agenda. We also listen carefully for themes of tolerance, operational insight, empathy, and problem-solving capabilities. Interviews take about 15–20 minutes, depending on how many follow-up questions we have for the candidate and if they have questions for us.

After the phone interview, the team determines whether the candidate would be an appropriate patient/family advisor. If there are any concerns and more information is needed, the project manager reaches out to the staff and contacts the candidate to invite them for an in-person interview. Of the interviewed candidates, about 75% to 80% are invited to join. Candidates who are not chosen are generally unable to clearly articulate issues they see within the hospital/clinic, may have personal relationships with the staff (ie, friends with the physician), or cannot see pass their own issues and are inflexible in their thinking. Those not chosen receive a note thanking them for their time and interest. The candidates chosen to be advisors are on boarded through BWH volunteer services and must attend a 3-hour BWH volunteer orientation, be HIPAA compliant, and be cleared by occupational health before receiving their advisor ID badge and beginning service.

Council Launch

Once the advisors have been recruited and oriented, the council enters the launching stage, which lasts from the council’s first meeting until the 1-year anniversary. The first meeting agenda is designed to introduce staff and advisors to each other. Advisors each share their health care narratives and the staff shares their motivations for participating in the council. The council chair reviews the purpose and goals of the council.

During the first year, the council gains experience working together as a team. Council projects are initially chosen by the council chair and should be reasonably simple to accomplish and meaningful to advisors so that advisors recognize that their feedback is being heard and acted on. Example projects include creating clearer directional sign-age, assessing recliners for patient rooms, and providing feedback on patient handouts to ensure patient friendliness.

As the council advances, projects can be initiated by the advisors. This process is facilitated when an advisor is added as council co-chair, which usually occurs at the end of the first year. Projects often arise from similar concerns shared by advisors during the recruitment interview process.

Sustaining an Established Council

A council is considered established when it enters its second year and has named a patient advisor as a co-chair. Established councils have undertaken projects such as improving the layout of the whiteboards in patient rooms and providing feedback to staff on how to manage challenging patients. In addition, established councils may be tapped when service lines without a PFAC seek to gather advisor feedback for a project. For example, one of our established councils has provided feedback on two patient safety research projects.

Councils are sustained by continually engaging advisors in projects that are of value to them, both in their department and hospital-wide. Advisors should be given the opportunity to prioritize and set new council goals. One of the overarching goals for all our PFACs is to improve communication between patients and staff. Councils at this stage often participate in grand rounds or attend staff meetings to share their narratives, enabling providers to understand their perspective. The council can also be engaged in grant-funded research initiatives. Having PFACs involved in various projects allows advisors to bring their narratives to a wider audience and be a part of change from numerous avenues within the hospital.

Patient and Family Advisory Councils in Practice

BWH has 16 PFACs in various stages of growth. To illustrate the variety in council structure and function, we describe 3 PFACs below. Each has unique composition and goals based on the needs of service line leadership.

Shapiro Cardiovascular PFAC

The Shapiro Cardiovascular Center, a LEED silver-certified building and with private patient rooms that welcome family members to stay with their loved ones [4], opened in 2008. The chief nursing officer felt the care provided in this new space should promote and embody PFCC. With the assistance of the Center for Patients and Families, the associate chief nursing officer was charged with creating the Shapiro Cardiovascular PFAC. Launched in May 2011, this PFAC provides input to improve the patient experience for inpatient and ambulatory care housed in the Shapiro Center.

The Shapiro PFAC originally consisted of medical/surgical cardiac and heart transplant patients; renal transplant recipients and donors later joined. Initially, this council worked on patient/visitor guidelines for the inpatient units. As the council became more experienced, advisors interviewed nursing director candidates for cardiac surgery ICU and organized two PFCC nursing grand rounds. These grand rounds featured a panel of Shapiro advisors sharing their perspective of their hospital care and reflections on their healing process. This council has also provided feedback on hospital-wide projects, such as the refinement of a nursing fall prevention tool and the development of patient-informed measures of a successful surgery. As advisors became more experienced, they were recruited by the executive director to be part of other committees and research projects.

The Shapiro PFAC is one of the oldest councils at BWH, consisting of 12 advisors and 3 staff members, with most of the inaugural advisors remaining. Because the council chair has changed twice since 2011, this council does not have a formal advisor co-chair but the council remains a cohesive team as they work in partnership with the newest chair. To sustain this PFAC, leadership has consistently engaged the council in operational projects. For example, the associate chief nursing officer has suggested advisors be part of unit-based councils composed of staff nurses and educators who work to improve patient care within their unit. Advisors have also been invited to participate in staff and nursing director meetings to share their narratives and allow staff to reflect on the care they provide patients.

LGBTQ PFAC

In the fall of 2014, BWH held an educational Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ)  patient experience forum prompted by a complaint from the wife of a maternity patient that the care they received was not patient/family-centered. During this panel discussion, 4 LGBTQ patients described their care at BWH, including what went well and what their providers could have done better. There was an acknowledgement by a majority of providers in the audience that they did not receive training on inclusive care for LGBTQ patients and their families. The providers identified the need to be educated on LGBTQ issues and care concerns, and their desire to work towards creating a warm and inclusive environment that better serves LGBTQ patients. This organic request for education was met with enthusiasm from the panel participants and led to a commitment to form an LGBTQ PFAC at BWH.

The LGBTQ PFAC is co-chaired by the executive director of the Center for Patients and Families and a LGBTQ patient advisor who receives his care at BWH. It was important for this council to be co-led by an advisor from the beginning to acknowledge and validate LGBTQ experiences of care which had previously been marginalized. Because LGBTQ patients interact with all service lines at BWH, it made sense that a central operational leader with significant experience listening and responding to the patient voice co-leads the group. This council is composed of LGBTQ patients, their caregivers/partners/spouses, BWH LGBTQ staff that also receive healthcare from BWH, and LGBTQ academic stakeholders who provide historical contextualization to inform change.

The LGBTQ PFAC began the preparation phase in April 2015 and launched as a hospital-wide council in October 2015. This launch was widely publicized so that all BWH employees would know this council was created to elevate LGBTQ patients and caregivers into the mainstream hospital consciousness. The goals for this year are to partner with the existing LGBTQ employee group to create a standardized LGBTQ provider directory, educate staff on the healthcare needs of the community, and promote educational awareness, compassionate understanding, and improved care for transgender patients. As this council matures into the established stage, new projects will be taken on in line with the needs seen by members.

Women’s Health Council

The Women’s Health Council is a unique PFAC established in 2012. The council serves a population of trauma survivors cared for by the Coordinated Approach to Recovery and Empowerment (C.A.R.E.) clinic at BWH, also founded in 2012. Patients who receive care in this clinic have experienced violence and trauma, including domestic and sexual violence, child maltreatment, and human trafficking. Due to previous experience leading a PFAC, the C.A.R.E. Director understood the importance of patient input and engaged patients as advisors while forming the clinic.

The C.A.R.E. clinic serves both men and women but the majority of survivors served are female; thus, the patient advisors on its PFAC are all female. To recruit advisors, clinicians, and social workers at the clinic refer potential candidates to the C.A.R.E. Director, who then interviews them. The criteria for advisors for this council include being a female survivor of violence and trauma, being physically and mentally able to serve, and able to participate in a way that does not re-traumatize them. There are currently 14 advisors on the council with a goal to grow to 30 advisors. Experience has shown that members become busy with family, school and careers and may need to step away for short periods of time; thus, the council seeks to continually recruit to ensure robust membership.

Instead of the usual monthly scheduled meetings, this council holds “meetings on demand.” Advisors are polled via email to find a time in the near future that works for the group. The PFAC generally uses a web conferencing platform for their meetings and has an in-person meeting once or twice a year. Also unlike other councils, this council does not require their advisors to share their personal narratives; it is up to each advisor to decide what to share.

This council has accomplished numerous goals since its inception, including its first task of giving the C.A.R.E. clinic its name. The council has provided feedback on the development of the C.A.R.E. brochure and website and serves as key informants in all aspects of policy and procedures for the C.A.R.E. clinic. Additionally, they have provided input on how to create a safe environment for patients and screen patients to identify a victim of violence or human trafficking [5]. This council has been sustained by the strong community fostered by the director and projects led by the advisors, as each advisor has a vested interest in ensuring the clinic provides a safe environment for patients seeking care. This year, the council is hoping to host experts from the Boston Health Commission to share best practices in providing services to victims of abuse and violence.

Lessons Learned

The BWH Center for Patients and Families has encountered challenges when creating and sustaining PFACs, such as recruiting advisors from diverse ethnic, cultural, and economic backgrounds. Currently, our advisor population is primarily comprised of Caucasian patient/family members from middle and upper economic backgrounds, though it has increasingly diversified as the program has grown. We believe the lack of representation from other backgrounds is due to scheduling difficulties, the lack of payment for advisors, visibility of the PFAC program, and, potentially, cultural norms that promote deference to medical expertise. We have worked to increase PFAC diversity by asking providers to specifically seek out and nominate patients that will broaden our reach as a council.

Retaining and recruiting advisors after the PFACs have launched can also present a challenge. Some advisors have had to resign due to job demands, relocation, health issues, or the need to take care of family. To resolve this issue, we have asked PFAC chairs to continuously actively recruit advisors. By doing so, the councils gain new perspectives and ensure there are adequate number of advisors should a vacancy occur.

Sustaining PFACs once they are established requires time, effort, and commitment of leadership, advisors, and dedicated staff resources. The council needs to be continuously engaged in meaningful projects and feel that their participation is impactful and creates change. It is important that clinical leadership stays actively involved and attends all PFAC meetings. If there is a change in leadership as we experienced on our Shapiro PFAC, it is critical that the interim chair participates and supports the goal of the council. Regardless, leadership must show sustained enthusiasm for PFAC engagement and achievement.

Employing technology can also help sustain councils. Although we prefer in-person meetings, the option to attend meetings through online or phone conferencing should be made available to support advisors who are unable to attend in person. At this time, only one of our councils uses web conferencing, while several of our councils offer an option to call in via a conference line. The conference line has been beneficial in helping us retain and engage advisors who travel a significant distance to attend meetings.

We recognize that BWH has many resources available due to its status as a large, academic medical center in an urban center. Nonetheless, PFACs can play a vital role in hospitals no matter the setting, location, or size as long as there is buy in from hospital leadership. Although BWH has 16 PFACs, it is not necessary to have this many councils. Having one PFAC may be sufficient for smaller hospitals; the ideal number of councils depends on the size and complexity of the institution. Hospitals without a dedicated department like the Center for Patients and Families can create PFACs by partnering with volunteer services, patient engagement, or quality and safety departments. Existing departments with the capability to train advisors and provide meeting resources to support patient/family recruitment and engagement should be harnessed whenever possible. It is, however, important to have a dedicated staff member to serve as a point person for the advisors should they have any questions or concerns. Technology, such as web conferencing described above, can facilitate attendance by patient/family advisors who have limited time or resources and will be valuable for hospitals in a rural setting. The stages we have described are critical to the success of creating and sustaining a PFAC regardless of where they are developed and can be adapted to fit the unique needs and environments of any healthcare setting.

Conclusion

BWH’s Center for Patients and Families has created 16 PFACs since 2008, which are in various stages of development. Our PFACs are successful for many reasons, including a rigorous recruitment and interview process, leadership support, advisors’ commitment to their PFAC, and making modifications made based on lessons learned, as illustrated by the 3 PFACs discussed. We are able to sustain our councils by continually engagingadvisors, having leadership partner with advisors, setting feasible goals, and recruiting new advisors for a fresh perspective. PFACs promote patient- and family-centered care and can shift the model of care from a prescribed model to one that embraces collaboration with patients while advancing care delivery. As patient- and family-centered care advances, it is important that best practices for building and sustaining PFACs are developed and made available to ensure all hospitals have access to this valuable resource.

Corresponding author: Celene Wong, MHA, Center for Patients and Families, Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115, [email protected].

Financial disclosures: None.