Patient Satisfaction and Quality of Care: A Prospective Study at Outpatient Dermatology Clinics

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Patient Satisfaction and Quality of Care: A Prospective Study at Outpatient Dermatology Clinics

The Patient Protection and Affordable Care Act has increased the number of insured Americans by more than 20 million individuals.1 Approximately half of the newly insured have an income at or below 138% of the poverty level and are on average younger, sicker, and more likely to report poor to fair health compared to those individuals who already had health care coverage.2 Specialties such as dermatology are faced with the challenge of expanding access to these newly insured individuals while also improving quality of care.

Because of the complexity of defining quality in medicine, patient satisfaction is being used as a proxy for quality, with physicians evaluated and reimbursed based on patient satisfaction scores. Little research has been conducted to validate the relationship between patient satisfaction and quality; however, one study showed online reviews from patients on Yelp correlated with traditional markers of quality, such as mortality and readmission rates, lending credibility to the notion that patient satisfaction equates quality of care.3 Moreover, prospective studies have found positive correlations between patient satisfaction and compliance to therapy4,5; however, these studies may not give a complete picture of the relationship between patient satisfaction and quality of care, as other studies also have illustrated that, more often than not, factors extrinsic to actual medical care (eg, time spent in the waiting room) play a considerable role in patient satisfaction scores.6-9

When judging the quality of care that is provided, one study found that patients rate physicians based on interpersonal skills and not care delivered.8 Another important factor related to patient satisfaction is the anonymity of the surveys. Patients who have negative experiences are more likely to respond to online surveys than those who have positive experiences, skewing overall ratings.6 Additionally, because of Health Insurance Portability and Accountability Act regulations, physicians often are unable to respond directly to public patient reviews, resulting in an incomplete picture of the quality of care provided.

Ultimately, even if physicians do not agree that patient satisfaction correlates with quality of care, it is increasingly being used as a marker of such. Leading health care systems are embracing this new weight on patient satisfaction by increasing transparency and publishing patient satisfaction results online, allowing patients more access to physician reviews.

In dermatology, patient satisfaction serves an even more important role, as traditional markers of quality such as mortality and hospital readmission rates are not reasonable measures of patient care in this specialty, leaving patient satisfaction as one of the most accessible markers insurance companies and prospective patients can use to evaluate dermatologists. Furthermore, treatment modalities in dermatology often aim to improve quality of life, of which patient satisfaction arguably serves as an indicator. Ideally, patient satisfaction would allow physicians to identify areas where they may be better able to meet patients’ needs. However, patient satisfaction scores rarely are used as outcome measures in studies and are notoriously difficult to ascertain, as they tend to be inaccurate and may be unreliable in correlation with physician skill and training or may be skewed by patients’ desires to please their physicians.10 There also is a lack of standardized tools and scales to quantitatively judge outcomes in procedural surgeries.

Although patient satisfaction is being used as a measure of quality of care and is particularly necessary in a field such as dermatology that has outcome measures that are subjective in nature, there is a gap in the current literature regarding patient satisfaction and dermatology. To fill this gap, we conducted a prospective study of targeted interventions administered at outpatient dermatology clinics to determine if they resulted in statistically significant increases in patient satisfaction measures, particularly among Spanish-speaking patients.

Methods

We conducted a prospective study evaluating patient satisfaction in the outpatient dermatology clinics of LAC+USC Medical Center in Los Angeles, California, spanning over 1 year. During this time period, patients were randomly selected to participate and were asked to complete the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which asked patients to rate their care experience on a 5-point Likert scale (1=strongly agree; 5=strongly disagree). The survey was separated into the following 7 subscales or categories looking at different aspects of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with physician, and accessibility and convenience. Patients were given this survey both before and after targeted interventions to improve patient satisfaction were implemented. The targeted interventions were created based on literature review in the factors affecting patient satisfaction. The change in relative satisfaction was then determined using statistical analysis. The study was approved by the University of Southern California Health Science institutional review board.

 

 

Results

Of 470 patients surveyed, the average age was 49 years. Fifty percent of respondents were male, 70% self-identified as Hispanic, 45% spoke Spanish as their native language, and 69% reported a mean annual household income of less than $15,000. When scores were stratified, English-speaking patients were significantly more satisfied than Spanish-speaking patients in the categories of technical quality (P.0340), financial aspects (P.0301), interpersonal manner (P.0037), and time spent with physician (P.0059). Specifically, in the time spent with physician category, the lowest scores were found in females, patients aged 18 to 29 years, and patients with a mean annual household income less than $15,000. These demographics correlate well with many of the newly insured and intimate the need for improved patient satisfaction, particularly in this subset of patients.

After analyzing baseline patient satisfaction scores, we implemented targeted interventions such as creating a call tree, developing multilingual disease-specific patient handouts, instituting quarterly nursing in-services, which judged interpersonal and occupational nursing skills, and recruiting bilingual staff. These interventions were implemented simultaneously and were selected with the goal of reducing the impact of the language barrier between physicians and patients and increasing accessibility to clinics. Following approximately 3 months of these interventions, performance on many categories increased in our demographics that were lowest performing when we collected baseline data. In Spanish-speaking respondents, improvement in several categories approached statistical significance, including general satisfaction (P.110), interpersonal skills (P.080), and time spent with physician (P.096). When stratifying by income and age, patients with a mean annual household income less than $15,000 demonstrated an improved technical quality (P.066) subscale score, and participants aged 18 to 29 years showed improvement in both accessibility and convenience (P.053) and financial aspects (P.056) subscales.

Comment

The categories where improvements were found are noteworthy and suggest that certain aspects of care are more important than others. Although it seems intuitive that clinical acumen and training should be important contributors to patient satisfaction, one study that analyzed 1000 online comments regarding patient satisfaction with dermatologists on the website DrScore.com found that most comments concerned physician personality and interpersonal skills rather than medical judgment and acumen,4 suggesting that a patient’s perception of the character of the physician directly affects patient satisfaction scores. This notion was reiterated by other studies, including one that found that a patient’s perception of the physician’s kindness and empathy skills, is the most important measure of quality of care scores.8 Although this perception can be intimidating to some physicians, as certain interpersonal skills are difficult to change, it is reassuring to note that external environment and cues, such as the clinic building and staff, also seem to affect interpersonal ratings. As seen in our study, patient ratings of a physician’s interpersonal skills increased after educational materials for staff and patients were created and more bilingual staff was recruited. Other environmental changes, such as spending a few more minutes with patients and sitting down when talking to patients, are relatively easy to administer and can improve patient satisfaction scores.8

Although some of the scores in our study approached but did not reach statistical significance, likely because of a small sample size, they suggest that targeted interventions can improve patient satisfaction. They also suggested that targeted interventions are particularly useful in Spanish-speaking patients, younger patients, and patients from lower socioeconomic backgrounds, which are all characteristics of the newly insured under the Patient Protection and Affordable Health Care Act.

Our study also is unique in that dermatology as a specialty is lagging in quality improvement studies. In the few studies evaluating patient satisfaction in the literature, the care provided by dermatologists was painted in a positive light.6,11 One study evaluated 45 dermatology practices and reported average patient satisfaction scores of 3.46 and 4.72 of 5 on Yelp and ZocDoc, respectively.11 Another study looking at dermatologist ratings on DrScore.com found that the majority of patients were satisfied with the care they received.6

Although these studies seem encouraging, they have several limitations. First, their results were not stratified by patient demographics and therefore may not be generalizable to low-income populations that constitute much of the newly insured. Secondly, the observational nature and limited number of studies prohibit meaningful conclusions from being drawn and leave many questions unanswered. Additionally, although the raw patient satisfaction scores seem good, dermatology is lacking compared to the patient satisfaction scores within other specialties. A study of more than 28,000 Yelp reviews of 23 specialties found that dermatology ranked second to last, ahead of only psychiatry.7 Of course, given the observational nature of this study, it is impossible to generalize, as many confounders (eg, medical comorbidities, patient age) may have skewed the dermatology ranking. Regardless, there is always room for improvement, and luckily improving patient satisfaction is not an elusive goal.

Conclusion

As dermatologists, our interventions often improve quality of life; therefore, we are positioned to be leaders in the quality improvement field. Despite the numerous limitations of using patient satisfaction as a measure for quality of care, it is used by payers to determine reimbursement and patients to select providers. Encouraging initial data from our prospective study demonstrate that small interventions can increase patient satisfaction. Continued work to maximize patient satisfaction is needed to improve outcomes for our patients, help validate the quality of care being provided, and further solidify the importance of having insurers maintain sufficient dermatologists in their networks.

References
  1. Uberoi N, Finegold K, Gee E. Health insurance coverage and the Affordable Care Act, 2010-2016. US Department of Health & Human Services website. https://aspe.hhs.gov/system/files/pdf/187551/ACA2010-2016.pdf. Published March 3, 2016. Accessed May 18, 2018.
  2. Shatzer A, Long SK, Zuckerman S. Who are the newly insured as of early March 2014? Urban Institute Health Policy Center website. http://hrms.urban.org/briefs/Who-Are-the-Newly-Insured.html. Published May 22, 2014. Accessed May 18, 2018.
  3. Bardach NS, Asteria-Peñaloza R, Boscardin WJ, et al. The relationship between commercial website ratings and traditional hospital performance measures in the USA. BMJ Qual Saf. 2013;22:194-202.
  4. Kincey J, Bradshaw P, Ley P. Patient satisfaction and reported acceptance of medical advice in general practice. J R Coll Gen Pract. 1975;25:558-566.
  5. Francis V, Korsch BM, Morris MJ. Gaps in doctor-patient communication. patients’ response to medical advice. N Engl J Med. 1969;280:535-540.
  6. Ali ST, Feldman SR. Patient satisfaction in dermatology: a qualitative assessment. Dermatol Online J. 2014;20. pii:doj_21534.
  7. Internet study: highest educated & trained doctors get poorest online reviews. Vanguard Communications website. https://vanguard communications.net/best-online-doctor-reviews/. Published April 22, 2015. Accessed May 18, 2018.
  8. Uhas AA, Camacho FT, Feldman SR, et al. The relationship between physician friendliness and caring, and patient satisfaction: findings from an internet-based survey. Patient. 2008;1:91-96.
  9. Anderson RT, Camacho FT, Balkrishnan R. Willing to wait?: the influence of patient wait time on satisfaction with primary care. BMC Health Serv Res. 2007;7:31.
  10. Maibach HI, Gorouhi F. Evidence-Based Dermatology. 2nd ed. Shelton, CT: People’s Medical Publishing House-USA; 2011.
  11. Smith R, Lipoff J. Evaluation of dermatology practice online reviews. JAMA Dermatol. 2016;152:153-157.
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From the Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles.

The authors report no conflict of interest.

Correspondence: Sachi Patel, MD, LAC+USC Medical Center, General Hospital, 1200 N State St, Room 3250, Los Angeles, CA 90033 ([email protected]).

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From the Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles.

The authors report no conflict of interest.

Correspondence: Sachi Patel, MD, LAC+USC Medical Center, General Hospital, 1200 N State St, Room 3250, Los Angeles, CA 90033 ([email protected]).

Author and Disclosure Information

From the Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles.

The authors report no conflict of interest.

Correspondence: Sachi Patel, MD, LAC+USC Medical Center, General Hospital, 1200 N State St, Room 3250, Los Angeles, CA 90033 ([email protected]).

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The Patient Protection and Affordable Care Act has increased the number of insured Americans by more than 20 million individuals.1 Approximately half of the newly insured have an income at or below 138% of the poverty level and are on average younger, sicker, and more likely to report poor to fair health compared to those individuals who already had health care coverage.2 Specialties such as dermatology are faced with the challenge of expanding access to these newly insured individuals while also improving quality of care.

Because of the complexity of defining quality in medicine, patient satisfaction is being used as a proxy for quality, with physicians evaluated and reimbursed based on patient satisfaction scores. Little research has been conducted to validate the relationship between patient satisfaction and quality; however, one study showed online reviews from patients on Yelp correlated with traditional markers of quality, such as mortality and readmission rates, lending credibility to the notion that patient satisfaction equates quality of care.3 Moreover, prospective studies have found positive correlations between patient satisfaction and compliance to therapy4,5; however, these studies may not give a complete picture of the relationship between patient satisfaction and quality of care, as other studies also have illustrated that, more often than not, factors extrinsic to actual medical care (eg, time spent in the waiting room) play a considerable role in patient satisfaction scores.6-9

When judging the quality of care that is provided, one study found that patients rate physicians based on interpersonal skills and not care delivered.8 Another important factor related to patient satisfaction is the anonymity of the surveys. Patients who have negative experiences are more likely to respond to online surveys than those who have positive experiences, skewing overall ratings.6 Additionally, because of Health Insurance Portability and Accountability Act regulations, physicians often are unable to respond directly to public patient reviews, resulting in an incomplete picture of the quality of care provided.

Ultimately, even if physicians do not agree that patient satisfaction correlates with quality of care, it is increasingly being used as a marker of such. Leading health care systems are embracing this new weight on patient satisfaction by increasing transparency and publishing patient satisfaction results online, allowing patients more access to physician reviews.

In dermatology, patient satisfaction serves an even more important role, as traditional markers of quality such as mortality and hospital readmission rates are not reasonable measures of patient care in this specialty, leaving patient satisfaction as one of the most accessible markers insurance companies and prospective patients can use to evaluate dermatologists. Furthermore, treatment modalities in dermatology often aim to improve quality of life, of which patient satisfaction arguably serves as an indicator. Ideally, patient satisfaction would allow physicians to identify areas where they may be better able to meet patients’ needs. However, patient satisfaction scores rarely are used as outcome measures in studies and are notoriously difficult to ascertain, as they tend to be inaccurate and may be unreliable in correlation with physician skill and training or may be skewed by patients’ desires to please their physicians.10 There also is a lack of standardized tools and scales to quantitatively judge outcomes in procedural surgeries.

Although patient satisfaction is being used as a measure of quality of care and is particularly necessary in a field such as dermatology that has outcome measures that are subjective in nature, there is a gap in the current literature regarding patient satisfaction and dermatology. To fill this gap, we conducted a prospective study of targeted interventions administered at outpatient dermatology clinics to determine if they resulted in statistically significant increases in patient satisfaction measures, particularly among Spanish-speaking patients.

Methods

We conducted a prospective study evaluating patient satisfaction in the outpatient dermatology clinics of LAC+USC Medical Center in Los Angeles, California, spanning over 1 year. During this time period, patients were randomly selected to participate and were asked to complete the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which asked patients to rate their care experience on a 5-point Likert scale (1=strongly agree; 5=strongly disagree). The survey was separated into the following 7 subscales or categories looking at different aspects of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with physician, and accessibility and convenience. Patients were given this survey both before and after targeted interventions to improve patient satisfaction were implemented. The targeted interventions were created based on literature review in the factors affecting patient satisfaction. The change in relative satisfaction was then determined using statistical analysis. The study was approved by the University of Southern California Health Science institutional review board.

 

 

Results

Of 470 patients surveyed, the average age was 49 years. Fifty percent of respondents were male, 70% self-identified as Hispanic, 45% spoke Spanish as their native language, and 69% reported a mean annual household income of less than $15,000. When scores were stratified, English-speaking patients were significantly more satisfied than Spanish-speaking patients in the categories of technical quality (P.0340), financial aspects (P.0301), interpersonal manner (P.0037), and time spent with physician (P.0059). Specifically, in the time spent with physician category, the lowest scores were found in females, patients aged 18 to 29 years, and patients with a mean annual household income less than $15,000. These demographics correlate well with many of the newly insured and intimate the need for improved patient satisfaction, particularly in this subset of patients.

After analyzing baseline patient satisfaction scores, we implemented targeted interventions such as creating a call tree, developing multilingual disease-specific patient handouts, instituting quarterly nursing in-services, which judged interpersonal and occupational nursing skills, and recruiting bilingual staff. These interventions were implemented simultaneously and were selected with the goal of reducing the impact of the language barrier between physicians and patients and increasing accessibility to clinics. Following approximately 3 months of these interventions, performance on many categories increased in our demographics that were lowest performing when we collected baseline data. In Spanish-speaking respondents, improvement in several categories approached statistical significance, including general satisfaction (P.110), interpersonal skills (P.080), and time spent with physician (P.096). When stratifying by income and age, patients with a mean annual household income less than $15,000 demonstrated an improved technical quality (P.066) subscale score, and participants aged 18 to 29 years showed improvement in both accessibility and convenience (P.053) and financial aspects (P.056) subscales.

Comment

The categories where improvements were found are noteworthy and suggest that certain aspects of care are more important than others. Although it seems intuitive that clinical acumen and training should be important contributors to patient satisfaction, one study that analyzed 1000 online comments regarding patient satisfaction with dermatologists on the website DrScore.com found that most comments concerned physician personality and interpersonal skills rather than medical judgment and acumen,4 suggesting that a patient’s perception of the character of the physician directly affects patient satisfaction scores. This notion was reiterated by other studies, including one that found that a patient’s perception of the physician’s kindness and empathy skills, is the most important measure of quality of care scores.8 Although this perception can be intimidating to some physicians, as certain interpersonal skills are difficult to change, it is reassuring to note that external environment and cues, such as the clinic building and staff, also seem to affect interpersonal ratings. As seen in our study, patient ratings of a physician’s interpersonal skills increased after educational materials for staff and patients were created and more bilingual staff was recruited. Other environmental changes, such as spending a few more minutes with patients and sitting down when talking to patients, are relatively easy to administer and can improve patient satisfaction scores.8

Although some of the scores in our study approached but did not reach statistical significance, likely because of a small sample size, they suggest that targeted interventions can improve patient satisfaction. They also suggested that targeted interventions are particularly useful in Spanish-speaking patients, younger patients, and patients from lower socioeconomic backgrounds, which are all characteristics of the newly insured under the Patient Protection and Affordable Health Care Act.

Our study also is unique in that dermatology as a specialty is lagging in quality improvement studies. In the few studies evaluating patient satisfaction in the literature, the care provided by dermatologists was painted in a positive light.6,11 One study evaluated 45 dermatology practices and reported average patient satisfaction scores of 3.46 and 4.72 of 5 on Yelp and ZocDoc, respectively.11 Another study looking at dermatologist ratings on DrScore.com found that the majority of patients were satisfied with the care they received.6

Although these studies seem encouraging, they have several limitations. First, their results were not stratified by patient demographics and therefore may not be generalizable to low-income populations that constitute much of the newly insured. Secondly, the observational nature and limited number of studies prohibit meaningful conclusions from being drawn and leave many questions unanswered. Additionally, although the raw patient satisfaction scores seem good, dermatology is lacking compared to the patient satisfaction scores within other specialties. A study of more than 28,000 Yelp reviews of 23 specialties found that dermatology ranked second to last, ahead of only psychiatry.7 Of course, given the observational nature of this study, it is impossible to generalize, as many confounders (eg, medical comorbidities, patient age) may have skewed the dermatology ranking. Regardless, there is always room for improvement, and luckily improving patient satisfaction is not an elusive goal.

Conclusion

As dermatologists, our interventions often improve quality of life; therefore, we are positioned to be leaders in the quality improvement field. Despite the numerous limitations of using patient satisfaction as a measure for quality of care, it is used by payers to determine reimbursement and patients to select providers. Encouraging initial data from our prospective study demonstrate that small interventions can increase patient satisfaction. Continued work to maximize patient satisfaction is needed to improve outcomes for our patients, help validate the quality of care being provided, and further solidify the importance of having insurers maintain sufficient dermatologists in their networks.

The Patient Protection and Affordable Care Act has increased the number of insured Americans by more than 20 million individuals.1 Approximately half of the newly insured have an income at or below 138% of the poverty level and are on average younger, sicker, and more likely to report poor to fair health compared to those individuals who already had health care coverage.2 Specialties such as dermatology are faced with the challenge of expanding access to these newly insured individuals while also improving quality of care.

Because of the complexity of defining quality in medicine, patient satisfaction is being used as a proxy for quality, with physicians evaluated and reimbursed based on patient satisfaction scores. Little research has been conducted to validate the relationship between patient satisfaction and quality; however, one study showed online reviews from patients on Yelp correlated with traditional markers of quality, such as mortality and readmission rates, lending credibility to the notion that patient satisfaction equates quality of care.3 Moreover, prospective studies have found positive correlations between patient satisfaction and compliance to therapy4,5; however, these studies may not give a complete picture of the relationship between patient satisfaction and quality of care, as other studies also have illustrated that, more often than not, factors extrinsic to actual medical care (eg, time spent in the waiting room) play a considerable role in patient satisfaction scores.6-9

When judging the quality of care that is provided, one study found that patients rate physicians based on interpersonal skills and not care delivered.8 Another important factor related to patient satisfaction is the anonymity of the surveys. Patients who have negative experiences are more likely to respond to online surveys than those who have positive experiences, skewing overall ratings.6 Additionally, because of Health Insurance Portability and Accountability Act regulations, physicians often are unable to respond directly to public patient reviews, resulting in an incomplete picture of the quality of care provided.

Ultimately, even if physicians do not agree that patient satisfaction correlates with quality of care, it is increasingly being used as a marker of such. Leading health care systems are embracing this new weight on patient satisfaction by increasing transparency and publishing patient satisfaction results online, allowing patients more access to physician reviews.

In dermatology, patient satisfaction serves an even more important role, as traditional markers of quality such as mortality and hospital readmission rates are not reasonable measures of patient care in this specialty, leaving patient satisfaction as one of the most accessible markers insurance companies and prospective patients can use to evaluate dermatologists. Furthermore, treatment modalities in dermatology often aim to improve quality of life, of which patient satisfaction arguably serves as an indicator. Ideally, patient satisfaction would allow physicians to identify areas where they may be better able to meet patients’ needs. However, patient satisfaction scores rarely are used as outcome measures in studies and are notoriously difficult to ascertain, as they tend to be inaccurate and may be unreliable in correlation with physician skill and training or may be skewed by patients’ desires to please their physicians.10 There also is a lack of standardized tools and scales to quantitatively judge outcomes in procedural surgeries.

Although patient satisfaction is being used as a measure of quality of care and is particularly necessary in a field such as dermatology that has outcome measures that are subjective in nature, there is a gap in the current literature regarding patient satisfaction and dermatology. To fill this gap, we conducted a prospective study of targeted interventions administered at outpatient dermatology clinics to determine if they resulted in statistically significant increases in patient satisfaction measures, particularly among Spanish-speaking patients.

Methods

We conducted a prospective study evaluating patient satisfaction in the outpatient dermatology clinics of LAC+USC Medical Center in Los Angeles, California, spanning over 1 year. During this time period, patients were randomly selected to participate and were asked to complete the Short-Form Patient Satisfaction Questionnaire (PSQ-18), which asked patients to rate their care experience on a 5-point Likert scale (1=strongly agree; 5=strongly disagree). The survey was separated into the following 7 subscales or categories looking at different aspects of care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with physician, and accessibility and convenience. Patients were given this survey both before and after targeted interventions to improve patient satisfaction were implemented. The targeted interventions were created based on literature review in the factors affecting patient satisfaction. The change in relative satisfaction was then determined using statistical analysis. The study was approved by the University of Southern California Health Science institutional review board.

 

 

Results

Of 470 patients surveyed, the average age was 49 years. Fifty percent of respondents were male, 70% self-identified as Hispanic, 45% spoke Spanish as their native language, and 69% reported a mean annual household income of less than $15,000. When scores were stratified, English-speaking patients were significantly more satisfied than Spanish-speaking patients in the categories of technical quality (P.0340), financial aspects (P.0301), interpersonal manner (P.0037), and time spent with physician (P.0059). Specifically, in the time spent with physician category, the lowest scores were found in females, patients aged 18 to 29 years, and patients with a mean annual household income less than $15,000. These demographics correlate well with many of the newly insured and intimate the need for improved patient satisfaction, particularly in this subset of patients.

After analyzing baseline patient satisfaction scores, we implemented targeted interventions such as creating a call tree, developing multilingual disease-specific patient handouts, instituting quarterly nursing in-services, which judged interpersonal and occupational nursing skills, and recruiting bilingual staff. These interventions were implemented simultaneously and were selected with the goal of reducing the impact of the language barrier between physicians and patients and increasing accessibility to clinics. Following approximately 3 months of these interventions, performance on many categories increased in our demographics that were lowest performing when we collected baseline data. In Spanish-speaking respondents, improvement in several categories approached statistical significance, including general satisfaction (P.110), interpersonal skills (P.080), and time spent with physician (P.096). When stratifying by income and age, patients with a mean annual household income less than $15,000 demonstrated an improved technical quality (P.066) subscale score, and participants aged 18 to 29 years showed improvement in both accessibility and convenience (P.053) and financial aspects (P.056) subscales.

Comment

The categories where improvements were found are noteworthy and suggest that certain aspects of care are more important than others. Although it seems intuitive that clinical acumen and training should be important contributors to patient satisfaction, one study that analyzed 1000 online comments regarding patient satisfaction with dermatologists on the website DrScore.com found that most comments concerned physician personality and interpersonal skills rather than medical judgment and acumen,4 suggesting that a patient’s perception of the character of the physician directly affects patient satisfaction scores. This notion was reiterated by other studies, including one that found that a patient’s perception of the physician’s kindness and empathy skills, is the most important measure of quality of care scores.8 Although this perception can be intimidating to some physicians, as certain interpersonal skills are difficult to change, it is reassuring to note that external environment and cues, such as the clinic building and staff, also seem to affect interpersonal ratings. As seen in our study, patient ratings of a physician’s interpersonal skills increased after educational materials for staff and patients were created and more bilingual staff was recruited. Other environmental changes, such as spending a few more minutes with patients and sitting down when talking to patients, are relatively easy to administer and can improve patient satisfaction scores.8

Although some of the scores in our study approached but did not reach statistical significance, likely because of a small sample size, they suggest that targeted interventions can improve patient satisfaction. They also suggested that targeted interventions are particularly useful in Spanish-speaking patients, younger patients, and patients from lower socioeconomic backgrounds, which are all characteristics of the newly insured under the Patient Protection and Affordable Health Care Act.

Our study also is unique in that dermatology as a specialty is lagging in quality improvement studies. In the few studies evaluating patient satisfaction in the literature, the care provided by dermatologists was painted in a positive light.6,11 One study evaluated 45 dermatology practices and reported average patient satisfaction scores of 3.46 and 4.72 of 5 on Yelp and ZocDoc, respectively.11 Another study looking at dermatologist ratings on DrScore.com found that the majority of patients were satisfied with the care they received.6

Although these studies seem encouraging, they have several limitations. First, their results were not stratified by patient demographics and therefore may not be generalizable to low-income populations that constitute much of the newly insured. Secondly, the observational nature and limited number of studies prohibit meaningful conclusions from being drawn and leave many questions unanswered. Additionally, although the raw patient satisfaction scores seem good, dermatology is lacking compared to the patient satisfaction scores within other specialties. A study of more than 28,000 Yelp reviews of 23 specialties found that dermatology ranked second to last, ahead of only psychiatry.7 Of course, given the observational nature of this study, it is impossible to generalize, as many confounders (eg, medical comorbidities, patient age) may have skewed the dermatology ranking. Regardless, there is always room for improvement, and luckily improving patient satisfaction is not an elusive goal.

Conclusion

As dermatologists, our interventions often improve quality of life; therefore, we are positioned to be leaders in the quality improvement field. Despite the numerous limitations of using patient satisfaction as a measure for quality of care, it is used by payers to determine reimbursement and patients to select providers. Encouraging initial data from our prospective study demonstrate that small interventions can increase patient satisfaction. Continued work to maximize patient satisfaction is needed to improve outcomes for our patients, help validate the quality of care being provided, and further solidify the importance of having insurers maintain sufficient dermatologists in their networks.

References
  1. Uberoi N, Finegold K, Gee E. Health insurance coverage and the Affordable Care Act, 2010-2016. US Department of Health & Human Services website. https://aspe.hhs.gov/system/files/pdf/187551/ACA2010-2016.pdf. Published March 3, 2016. Accessed May 18, 2018.
  2. Shatzer A, Long SK, Zuckerman S. Who are the newly insured as of early March 2014? Urban Institute Health Policy Center website. http://hrms.urban.org/briefs/Who-Are-the-Newly-Insured.html. Published May 22, 2014. Accessed May 18, 2018.
  3. Bardach NS, Asteria-Peñaloza R, Boscardin WJ, et al. The relationship between commercial website ratings and traditional hospital performance measures in the USA. BMJ Qual Saf. 2013;22:194-202.
  4. Kincey J, Bradshaw P, Ley P. Patient satisfaction and reported acceptance of medical advice in general practice. J R Coll Gen Pract. 1975;25:558-566.
  5. Francis V, Korsch BM, Morris MJ. Gaps in doctor-patient communication. patients’ response to medical advice. N Engl J Med. 1969;280:535-540.
  6. Ali ST, Feldman SR. Patient satisfaction in dermatology: a qualitative assessment. Dermatol Online J. 2014;20. pii:doj_21534.
  7. Internet study: highest educated & trained doctors get poorest online reviews. Vanguard Communications website. https://vanguard communications.net/best-online-doctor-reviews/. Published April 22, 2015. Accessed May 18, 2018.
  8. Uhas AA, Camacho FT, Feldman SR, et al. The relationship between physician friendliness and caring, and patient satisfaction: findings from an internet-based survey. Patient. 2008;1:91-96.
  9. Anderson RT, Camacho FT, Balkrishnan R. Willing to wait?: the influence of patient wait time on satisfaction with primary care. BMC Health Serv Res. 2007;7:31.
  10. Maibach HI, Gorouhi F. Evidence-Based Dermatology. 2nd ed. Shelton, CT: People’s Medical Publishing House-USA; 2011.
  11. Smith R, Lipoff J. Evaluation of dermatology practice online reviews. JAMA Dermatol. 2016;152:153-157.
References
  1. Uberoi N, Finegold K, Gee E. Health insurance coverage and the Affordable Care Act, 2010-2016. US Department of Health & Human Services website. https://aspe.hhs.gov/system/files/pdf/187551/ACA2010-2016.pdf. Published March 3, 2016. Accessed May 18, 2018.
  2. Shatzer A, Long SK, Zuckerman S. Who are the newly insured as of early March 2014? Urban Institute Health Policy Center website. http://hrms.urban.org/briefs/Who-Are-the-Newly-Insured.html. Published May 22, 2014. Accessed May 18, 2018.
  3. Bardach NS, Asteria-Peñaloza R, Boscardin WJ, et al. The relationship between commercial website ratings and traditional hospital performance measures in the USA. BMJ Qual Saf. 2013;22:194-202.
  4. Kincey J, Bradshaw P, Ley P. Patient satisfaction and reported acceptance of medical advice in general practice. J R Coll Gen Pract. 1975;25:558-566.
  5. Francis V, Korsch BM, Morris MJ. Gaps in doctor-patient communication. patients’ response to medical advice. N Engl J Med. 1969;280:535-540.
  6. Ali ST, Feldman SR. Patient satisfaction in dermatology: a qualitative assessment. Dermatol Online J. 2014;20. pii:doj_21534.
  7. Internet study: highest educated & trained doctors get poorest online reviews. Vanguard Communications website. https://vanguard communications.net/best-online-doctor-reviews/. Published April 22, 2015. Accessed May 18, 2018.
  8. Uhas AA, Camacho FT, Feldman SR, et al. The relationship between physician friendliness and caring, and patient satisfaction: findings from an internet-based survey. Patient. 2008;1:91-96.
  9. Anderson RT, Camacho FT, Balkrishnan R. Willing to wait?: the influence of patient wait time on satisfaction with primary care. BMC Health Serv Res. 2007;7:31.
  10. Maibach HI, Gorouhi F. Evidence-Based Dermatology. 2nd ed. Shelton, CT: People’s Medical Publishing House-USA; 2011.
  11. Smith R, Lipoff J. Evaluation of dermatology practice online reviews. JAMA Dermatol. 2016;152:153-157.
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Patient Satisfaction and Quality of Care: A Prospective Study at Outpatient Dermatology Clinics
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Practice Points

  • It is becoming increasingly important, particularly in the field of dermatology, to both measure and work to improve patient satisfaction scores.
  • Preliminary research has found that simple interventions, such as providing disease-specific handouts and interpreter services, can improve satisfaction scores, making patient satisfaction an achievable goal.
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Cenobamate Reduces the Frequency of Partial-Onset Seizures

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Adjunctive treatment with the investigational drug reduces median seizure frequency, compared with placebo.

LOS ANGELES—Adjunctive treatment with an investigational antiepileptic drug (AED) reduces the median frequency of partial-onset seizures, according to trial results presented at the 70th Annual Meeting of the American Academy of Neurology.

“The results with cenobamate demonstrated a decrease in overall median seizure frequencies compared to placebo at all doses studied,” said study principal investigator Gregory Krauss, MD, Professor of Neurology at Johns Hopkins University in Baltimore.

Gregory Krauss, MD


To assess the efficacy, safety, and tolerability of adjunctive cenobamate (previously known as YKP3089) treatment for different types of partial-onset seizures, including simple partial motor seizures, complex partial seizures, and secondary generalized tonic-clonic seizures, investigators conducted an 18-week, randomized, double-blind, placebo-controlled, dose-response study.

After a prospective eight-week baseline period during which researchers documented patients’ seizures, patients were randomized to one of three doses of cenobamate or placebo. The trial included a six-week titration period and a 12-week maintenance phase.

The primary end point was median percent reduction from baseline in seizure frequency for the complete cohort. Researchers also assessed seizure frequency for each seizure type when those seizures were present at baseline.

Seizure Types

In all, 437 patients received 100 mg per day of cenobamate (n = 108), 200 mg per day of cenobamate (n = 110), 400 mg per day of cenobamate (n = 111), or placebo (n = 108). Patients’ average age was about 40, and patients had a median seizure frequency of between 8.4 and 11 seizures per month. Most patients had a history of complex partial seizures (78.9%) or secondary generalized tonic-clonic seizures (60.0%) and were receiving two or three concomitant AEDs.

Median seizure frequencies decreased for all doses of cenobamate (100 mg/day: 35.5%, 200 mg/day: 55.0%, and 400 mg/day: 55.0%), compared with placebo (24.0%). Median frequencies for simple partial seizures decreased with all doses of cenobamate (100 mg/day: 48.0%; 200 mg/day: 63.0%; and 400 mg/day: 58.5%), compared with placebo (7.0%). Median frequencies for complex partial seizures and secondary generalized tonic-clonic seizures decreased with 200 mg per day of cenobamate (55.0% and 91.0%, respectively) and 400 mg per day of cenobamate (60.0% and 78.0%, respectively), compared with placebo (28.5% and 33.0%, respectively).

Compared with patients who received placebo, patients who received cenobamate were more likely to have greater than 50% reductions and 100% reductions in seizure frequency, Dr. Krauss said.

Investigators Adjusted Titration

The most common adverse events were somnolence, dizziness, headache, and balance disorder. The percentage of patients with common adverse events increased with dose, and slightly more patients who received 400 mg per day of cenobamate dropped out of the trial, compared with patients who received lower doses, Dr. Krauss said. Some patients with adverse events in the 400 mg group required modest dose reductions, and some adverse events were related to titration, he said.

Two allergic reactions occurred during initial rapid titration of the drug. After rapid dose titration for the first 10% of patients in the trial, doses for the remaining patients were titrated more slowly. One patient in the fast titration group developed drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Two patients in the trial had the common morbilliform rash without systemic signs—one during fast titration and one during slower titration.

Most adverse events were mild to moderate, and there were no deaths. In all, 37 adverse events occurred in 28 patients, and the number of adverse events was comparable between placebo and cenobamate, Dr. Krauss said. The most common serious adverse events were seizures in four patients, ataxias in two patients, dizziness in two patients, nystagmus in two patients, and suicidal ideation in two patients.

SK Life Science, based in Fair Lawn, New Jersey, is developing cenobamate.

 

 

—Jake Remaly

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Adjunctive treatment with the investigational drug reduces median seizure frequency, compared with placebo.

Adjunctive treatment with the investigational drug reduces median seizure frequency, compared with placebo.

LOS ANGELES—Adjunctive treatment with an investigational antiepileptic drug (AED) reduces the median frequency of partial-onset seizures, according to trial results presented at the 70th Annual Meeting of the American Academy of Neurology.

“The results with cenobamate demonstrated a decrease in overall median seizure frequencies compared to placebo at all doses studied,” said study principal investigator Gregory Krauss, MD, Professor of Neurology at Johns Hopkins University in Baltimore.

Gregory Krauss, MD


To assess the efficacy, safety, and tolerability of adjunctive cenobamate (previously known as YKP3089) treatment for different types of partial-onset seizures, including simple partial motor seizures, complex partial seizures, and secondary generalized tonic-clonic seizures, investigators conducted an 18-week, randomized, double-blind, placebo-controlled, dose-response study.

After a prospective eight-week baseline period during which researchers documented patients’ seizures, patients were randomized to one of three doses of cenobamate or placebo. The trial included a six-week titration period and a 12-week maintenance phase.

The primary end point was median percent reduction from baseline in seizure frequency for the complete cohort. Researchers also assessed seizure frequency for each seizure type when those seizures were present at baseline.

Seizure Types

In all, 437 patients received 100 mg per day of cenobamate (n = 108), 200 mg per day of cenobamate (n = 110), 400 mg per day of cenobamate (n = 111), or placebo (n = 108). Patients’ average age was about 40, and patients had a median seizure frequency of between 8.4 and 11 seizures per month. Most patients had a history of complex partial seizures (78.9%) or secondary generalized tonic-clonic seizures (60.0%) and were receiving two or three concomitant AEDs.

Median seizure frequencies decreased for all doses of cenobamate (100 mg/day: 35.5%, 200 mg/day: 55.0%, and 400 mg/day: 55.0%), compared with placebo (24.0%). Median frequencies for simple partial seizures decreased with all doses of cenobamate (100 mg/day: 48.0%; 200 mg/day: 63.0%; and 400 mg/day: 58.5%), compared with placebo (7.0%). Median frequencies for complex partial seizures and secondary generalized tonic-clonic seizures decreased with 200 mg per day of cenobamate (55.0% and 91.0%, respectively) and 400 mg per day of cenobamate (60.0% and 78.0%, respectively), compared with placebo (28.5% and 33.0%, respectively).

Compared with patients who received placebo, patients who received cenobamate were more likely to have greater than 50% reductions and 100% reductions in seizure frequency, Dr. Krauss said.

Investigators Adjusted Titration

The most common adverse events were somnolence, dizziness, headache, and balance disorder. The percentage of patients with common adverse events increased with dose, and slightly more patients who received 400 mg per day of cenobamate dropped out of the trial, compared with patients who received lower doses, Dr. Krauss said. Some patients with adverse events in the 400 mg group required modest dose reductions, and some adverse events were related to titration, he said.

Two allergic reactions occurred during initial rapid titration of the drug. After rapid dose titration for the first 10% of patients in the trial, doses for the remaining patients were titrated more slowly. One patient in the fast titration group developed drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Two patients in the trial had the common morbilliform rash without systemic signs—one during fast titration and one during slower titration.

Most adverse events were mild to moderate, and there were no deaths. In all, 37 adverse events occurred in 28 patients, and the number of adverse events was comparable between placebo and cenobamate, Dr. Krauss said. The most common serious adverse events were seizures in four patients, ataxias in two patients, dizziness in two patients, nystagmus in two patients, and suicidal ideation in two patients.

SK Life Science, based in Fair Lawn, New Jersey, is developing cenobamate.

 

 

—Jake Remaly

LOS ANGELES—Adjunctive treatment with an investigational antiepileptic drug (AED) reduces the median frequency of partial-onset seizures, according to trial results presented at the 70th Annual Meeting of the American Academy of Neurology.

“The results with cenobamate demonstrated a decrease in overall median seizure frequencies compared to placebo at all doses studied,” said study principal investigator Gregory Krauss, MD, Professor of Neurology at Johns Hopkins University in Baltimore.

Gregory Krauss, MD


To assess the efficacy, safety, and tolerability of adjunctive cenobamate (previously known as YKP3089) treatment for different types of partial-onset seizures, including simple partial motor seizures, complex partial seizures, and secondary generalized tonic-clonic seizures, investigators conducted an 18-week, randomized, double-blind, placebo-controlled, dose-response study.

After a prospective eight-week baseline period during which researchers documented patients’ seizures, patients were randomized to one of three doses of cenobamate or placebo. The trial included a six-week titration period and a 12-week maintenance phase.

The primary end point was median percent reduction from baseline in seizure frequency for the complete cohort. Researchers also assessed seizure frequency for each seizure type when those seizures were present at baseline.

Seizure Types

In all, 437 patients received 100 mg per day of cenobamate (n = 108), 200 mg per day of cenobamate (n = 110), 400 mg per day of cenobamate (n = 111), or placebo (n = 108). Patients’ average age was about 40, and patients had a median seizure frequency of between 8.4 and 11 seizures per month. Most patients had a history of complex partial seizures (78.9%) or secondary generalized tonic-clonic seizures (60.0%) and were receiving two or three concomitant AEDs.

Median seizure frequencies decreased for all doses of cenobamate (100 mg/day: 35.5%, 200 mg/day: 55.0%, and 400 mg/day: 55.0%), compared with placebo (24.0%). Median frequencies for simple partial seizures decreased with all doses of cenobamate (100 mg/day: 48.0%; 200 mg/day: 63.0%; and 400 mg/day: 58.5%), compared with placebo (7.0%). Median frequencies for complex partial seizures and secondary generalized tonic-clonic seizures decreased with 200 mg per day of cenobamate (55.0% and 91.0%, respectively) and 400 mg per day of cenobamate (60.0% and 78.0%, respectively), compared with placebo (28.5% and 33.0%, respectively).

Compared with patients who received placebo, patients who received cenobamate were more likely to have greater than 50% reductions and 100% reductions in seizure frequency, Dr. Krauss said.

Investigators Adjusted Titration

The most common adverse events were somnolence, dizziness, headache, and balance disorder. The percentage of patients with common adverse events increased with dose, and slightly more patients who received 400 mg per day of cenobamate dropped out of the trial, compared with patients who received lower doses, Dr. Krauss said. Some patients with adverse events in the 400 mg group required modest dose reductions, and some adverse events were related to titration, he said.

Two allergic reactions occurred during initial rapid titration of the drug. After rapid dose titration for the first 10% of patients in the trial, doses for the remaining patients were titrated more slowly. One patient in the fast titration group developed drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Two patients in the trial had the common morbilliform rash without systemic signs—one during fast titration and one during slower titration.

Most adverse events were mild to moderate, and there were no deaths. In all, 37 adverse events occurred in 28 patients, and the number of adverse events was comparable between placebo and cenobamate, Dr. Krauss said. The most common serious adverse events were seizures in four patients, ataxias in two patients, dizziness in two patients, nystagmus in two patients, and suicidal ideation in two patients.

SK Life Science, based in Fair Lawn, New Jersey, is developing cenobamate.

 

 

—Jake Remaly

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Neuropilin-1 surpasses AFP as HCC diagnostic marker

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A transmembrane glycoprotein labeled neuropilin-1 may be a diagnostic biomarker for hepatocellular carcinoma.

In a series of experiments using HCC tissues and cell lines, as well as serum samples from patients with other malignancies or hepatitis, Jiafei Lin, MD, from Shanghai Jiaotong University, Shanghai, China, and colleagues found that neuropilin-1 (NRP1) was up-regulated in hepatocellular carcinoma (HCC) and promotes tumor growth.

“Notably, the concentrations of serum NRP1 in the HCC patients were much higher than those of hepatitis B, hepatitis C, cirrhosis, breast cancer, colon cancer, gastric cancer, and lung cancer patients,” they wrote in the journal Clinica Chimica Acta.

They also found that NRP1 has a high degree of sensitivity and specificity for HCC, and suggested that NRP1 could replace alpha fetoprotein (AFP) for early clinical diagnosis of HCC.

They first showed that NRP1 was directly regulated by TEAD, a family of transcription factors essential for developmental processes. The experiments in HCC cell lines showed that messenger RNA levels of NRP1 were increased when TEAD was overexpressed, and decreased when TEAD was knocked down. The experiments also suggested that TEAD binds directly to the promoter of NRP1 to stimulate its transcription in HCC cells.

The investigators then sought to demonstrate that NRP1 promotes tumor development and growth in HCC by testing expression of the protein in both normal liver and HCC tissue samples.

“NRP1 was found highly up-regulated in HCC tissues compared to normal tissues. Moreover, NRP1 was recruited to the membrane in HCC tissues, whereas this protein was not detected in normal tissues,” they wrote.

Furthermore, when they zeroed in on NRP1 using two different short hairpin RNAs to silence its expression, they found that knocking down NRP1 suppressed the viability of tumor cells and inhibited colony formation while also ramping up programmed cell death. Taken together, the data indicate that NRP1 is highly expressed in HCC and promotes tumorigenesis.

They then showed that NRP1 serum concentrations were significantly higher in samples from patients with HCC than in those from healthy individuals or patients with hepatitis B, hepatitis C, cirrhosis, breast cancer, colon cancer, gastric cancer, or lung cancer. In addition, higher NRP1 concentrations were significantly associated with higher HCC tumor stages.

The investigators then looked at the relationship between serum NRP1 and standard liver function markers in HCC, and found that NRP1 serum levels significantly correlated with gamma-glutamyltransferase, albumin, bile acid, ALT, AST, AFP, and prealbumin levels, but not total bilirubin or total protein levels.

Finally, they demonstrated that serum NRP1 is a better diagnostic marker than AFP, with an area under the receiver operating characteristic curve of 0.971, compared with 0.862 for AFP. At an NRP1 cutoff of 68 pg/mL, NRP1 had a sensitivity of 93.7%, and a specificity of 98.7%. Combining NRP1 with AFP only slightly improved the diagnostic accuracy.

“These results indicate that the single use of NRP1 is a promising choice for the diagnosis of HCC,” the investigators wrote.

They noted that the most of the study subjects were of Han Chinese origin, and that the results need to be validated in people of other ethnicities.

The study was supported by the National Natural Science Foundation of China. Potential conflicts of interest were not reported.

SOURCE: Lin J et al. Clin Chim Acta. 2018;485:158-65.

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A transmembrane glycoprotein labeled neuropilin-1 may be a diagnostic biomarker for hepatocellular carcinoma.

In a series of experiments using HCC tissues and cell lines, as well as serum samples from patients with other malignancies or hepatitis, Jiafei Lin, MD, from Shanghai Jiaotong University, Shanghai, China, and colleagues found that neuropilin-1 (NRP1) was up-regulated in hepatocellular carcinoma (HCC) and promotes tumor growth.

“Notably, the concentrations of serum NRP1 in the HCC patients were much higher than those of hepatitis B, hepatitis C, cirrhosis, breast cancer, colon cancer, gastric cancer, and lung cancer patients,” they wrote in the journal Clinica Chimica Acta.

They also found that NRP1 has a high degree of sensitivity and specificity for HCC, and suggested that NRP1 could replace alpha fetoprotein (AFP) for early clinical diagnosis of HCC.

They first showed that NRP1 was directly regulated by TEAD, a family of transcription factors essential for developmental processes. The experiments in HCC cell lines showed that messenger RNA levels of NRP1 were increased when TEAD was overexpressed, and decreased when TEAD was knocked down. The experiments also suggested that TEAD binds directly to the promoter of NRP1 to stimulate its transcription in HCC cells.

The investigators then sought to demonstrate that NRP1 promotes tumor development and growth in HCC by testing expression of the protein in both normal liver and HCC tissue samples.

“NRP1 was found highly up-regulated in HCC tissues compared to normal tissues. Moreover, NRP1 was recruited to the membrane in HCC tissues, whereas this protein was not detected in normal tissues,” they wrote.

Furthermore, when they zeroed in on NRP1 using two different short hairpin RNAs to silence its expression, they found that knocking down NRP1 suppressed the viability of tumor cells and inhibited colony formation while also ramping up programmed cell death. Taken together, the data indicate that NRP1 is highly expressed in HCC and promotes tumorigenesis.

They then showed that NRP1 serum concentrations were significantly higher in samples from patients with HCC than in those from healthy individuals or patients with hepatitis B, hepatitis C, cirrhosis, breast cancer, colon cancer, gastric cancer, or lung cancer. In addition, higher NRP1 concentrations were significantly associated with higher HCC tumor stages.

The investigators then looked at the relationship between serum NRP1 and standard liver function markers in HCC, and found that NRP1 serum levels significantly correlated with gamma-glutamyltransferase, albumin, bile acid, ALT, AST, AFP, and prealbumin levels, but not total bilirubin or total protein levels.

Finally, they demonstrated that serum NRP1 is a better diagnostic marker than AFP, with an area under the receiver operating characteristic curve of 0.971, compared with 0.862 for AFP. At an NRP1 cutoff of 68 pg/mL, NRP1 had a sensitivity of 93.7%, and a specificity of 98.7%. Combining NRP1 with AFP only slightly improved the diagnostic accuracy.

“These results indicate that the single use of NRP1 is a promising choice for the diagnosis of HCC,” the investigators wrote.

They noted that the most of the study subjects were of Han Chinese origin, and that the results need to be validated in people of other ethnicities.

The study was supported by the National Natural Science Foundation of China. Potential conflicts of interest were not reported.

SOURCE: Lin J et al. Clin Chim Acta. 2018;485:158-65.

A transmembrane glycoprotein labeled neuropilin-1 may be a diagnostic biomarker for hepatocellular carcinoma.

In a series of experiments using HCC tissues and cell lines, as well as serum samples from patients with other malignancies or hepatitis, Jiafei Lin, MD, from Shanghai Jiaotong University, Shanghai, China, and colleagues found that neuropilin-1 (NRP1) was up-regulated in hepatocellular carcinoma (HCC) and promotes tumor growth.

“Notably, the concentrations of serum NRP1 in the HCC patients were much higher than those of hepatitis B, hepatitis C, cirrhosis, breast cancer, colon cancer, gastric cancer, and lung cancer patients,” they wrote in the journal Clinica Chimica Acta.

They also found that NRP1 has a high degree of sensitivity and specificity for HCC, and suggested that NRP1 could replace alpha fetoprotein (AFP) for early clinical diagnosis of HCC.

They first showed that NRP1 was directly regulated by TEAD, a family of transcription factors essential for developmental processes. The experiments in HCC cell lines showed that messenger RNA levels of NRP1 were increased when TEAD was overexpressed, and decreased when TEAD was knocked down. The experiments also suggested that TEAD binds directly to the promoter of NRP1 to stimulate its transcription in HCC cells.

The investigators then sought to demonstrate that NRP1 promotes tumor development and growth in HCC by testing expression of the protein in both normal liver and HCC tissue samples.

“NRP1 was found highly up-regulated in HCC tissues compared to normal tissues. Moreover, NRP1 was recruited to the membrane in HCC tissues, whereas this protein was not detected in normal tissues,” they wrote.

Furthermore, when they zeroed in on NRP1 using two different short hairpin RNAs to silence its expression, they found that knocking down NRP1 suppressed the viability of tumor cells and inhibited colony formation while also ramping up programmed cell death. Taken together, the data indicate that NRP1 is highly expressed in HCC and promotes tumorigenesis.

They then showed that NRP1 serum concentrations were significantly higher in samples from patients with HCC than in those from healthy individuals or patients with hepatitis B, hepatitis C, cirrhosis, breast cancer, colon cancer, gastric cancer, or lung cancer. In addition, higher NRP1 concentrations were significantly associated with higher HCC tumor stages.

The investigators then looked at the relationship between serum NRP1 and standard liver function markers in HCC, and found that NRP1 serum levels significantly correlated with gamma-glutamyltransferase, albumin, bile acid, ALT, AST, AFP, and prealbumin levels, but not total bilirubin or total protein levels.

Finally, they demonstrated that serum NRP1 is a better diagnostic marker than AFP, with an area under the receiver operating characteristic curve of 0.971, compared with 0.862 for AFP. At an NRP1 cutoff of 68 pg/mL, NRP1 had a sensitivity of 93.7%, and a specificity of 98.7%. Combining NRP1 with AFP only slightly improved the diagnostic accuracy.

“These results indicate that the single use of NRP1 is a promising choice for the diagnosis of HCC,” the investigators wrote.

They noted that the most of the study subjects were of Han Chinese origin, and that the results need to be validated in people of other ethnicities.

The study was supported by the National Natural Science Foundation of China. Potential conflicts of interest were not reported.

SOURCE: Lin J et al. Clin Chim Acta. 2018;485:158-65.

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Key clinical point: The transmembrane glycoprotein neuropilin-1 may be a better diagnostic marker for hepatocellular carcinoma than alpha fetoprotein.

Major finding: Serum levels of neuropilin-1 were significantly higher in patients with HCC, compared with those with normal liver tissues, other liver diseases, or other malignancies.

Study details: A basic science investigation using HCC tissues and cell lines, as well as serum samples.

Disclosures: The study was supported by the National Natural Science Foundation of China. Potential conflicts of interest were not reported.

Source: Lin J et al. Clin Chim Acta. 2018;485:158-65.

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Surgical Procedures for Hidradenitis Suppurativa

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Surgical Procedures for Hidradenitis Suppurativa
In Collaboration with the Skin of Color Society

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that has a social and psychosocial impact on patients with skin of color.1 It is characterized by recurrent abscesses, draining sinus tracts, and scarring in the intertriginous skin folds. The lesions are difficult to treat and present with considerable frustration for both patients and physicians. Although current treatment ladders can delay procedures and surgical intervention,1 some believe that surgery should be introduced earlier in HS management.2 In this article, we review current procedures for the management of HS, including cryoinsufflation, incision and drainage, deroofing, skin tissue–saving excision with electrosurgical peeling, and wide surgical excision, along with various closure techniques.

Cryoinsufflation

First described in 2014, cryoinsufflation is a novel method for treating sinus tracts.3 Lesions initially are identified on physical examination. Prior to the procedure, local anesthesia is administered to the lesion.3 A 21-gauge needle is mounted onto a cryosurgical unit and inserted into the opening of the sinus tract. Liquid nitrogen is sprayed into the tract for 5 seconds, followed by a 3-second pause; the process is repeated 3 times. Patients return for treatment sessions monthly until the tract is obliterated. This procedure was first performed on 2 patients with satisfactory results.3

Since the initial report, the investigators made 2 changes to refine the procedure.4 First, systemic antibiotics should be prescribed 2 months prior to the procedure to clear the sinus tracts of infection. Furthermore, a 21-gauge, olive-tipped cannula is recommended in lieu of a 21-gauge needle to mitigate the risk of adverse events such as air embolism.4

Incision and Drainage

Incision and drainage provides rapid pain relief for tense fluctuant abscesses, but recurrence is common and the procedure costs are high.5 For drainage, wide circumferential local anesthesia is administered followed by incision.6 Pus is eliminated using digital pressure or saline rinses.2 Following the elimination of pus, the wound may need gauze packing or placement of a wick for a few days.6 The general belief is that incision and drainage should be used, if necessary, to rapidly relieve the patient’s pain; however, other surgical options should be considered if the patient has had multiple incision and drainage procedures.7 Currently there are no randomized controlled trials (RCTs) on incision and drainage procedures in HS abscesses.

Deroofing

In 1959, Mullins et al8 first described the deroofing procedure, which was refined to preserve the floor of the sinus tract in the 1980s.9,10 Culp10 and Brown et al9 theorized that preservation of the exposed floor of the sinus tract allowed for the epithelial cells from sweat glands and hair follicle remnants to rapidly reepithelialize the wound. In 2010, van der Zee et al11 performed a prospective study of 88 deroofed lesions in which the investigators removed keratinous debris and epithelial remnants of the floor due to concern for recurrence in this area if the tissues remained. Only 17% (15/88) of the lesions recurred at a median follow-up of 34 months.11

In Hurley stage I or II HS, deroofing remains the primary procedure for persistent nodules and sinus tracts.2 The lesion is identified on physical examination and local anesthesia is administered, first to the area surrounding the lesion, then to the lesion itself.11 A blunt probe is used to identify openings and search for connecting fistulas. After defining the sinus tract, the roof and wings created by the incision are removed.11,12 The material on the floor of the tract is scraped away, and the wound is left to heal by secondary intention.11 In general, deroofed lesions heal with cosmetically acceptable scars. We have used this procedure in skin of color patients with good results and no difficulties with healing. Controlled trials with long-term follow-up are lacking in this population.

Skin Tissue–Saving Excision With Electrosurgical Peeling

Skin tissue–saving excision with electrosurgical peeling was first introduced in 2015.13 Blok et al14 described the procedure as a promising alternative to wide surgical excision for Hurley stage II or III HS. The procedure saves healthy tissue while completely removing lesional tissue, leading to rapid wound healing, excellent cosmesis, and a low risk of contractures2,14; however, recurrence rates are higher than those seen in wide surgical excision.15 There are no known RCTs with long-term follow-up for HS patients treated with skin tissue–saving excision with electrosurgical peeling.

The procedure typically is performed under general anesthesia.14 First, the sinus tract is palpated on physical examination and probed to delineate the extent of the tract. Next, the roof of the tract is incised electrosurgically with a wire loop tip coupled to an electrosurgical generator.14 Consecutive tangential excisions are made until the floor of the sinus tract is reached. The process of incising sinus tracts followed by tangential peeling off of tissue continues until the entire area is clear of lesional and fibrotic tissue. The wound margins are probed for the presence and subsequent removal of residual sinus tracts. Lastly, the electrosurgical generator is used to achieve hemostasis, steroids are injected to prevent the formation of hypergranulation tissue, and the wound is left to heal by secondary intention.14 Following intervention, recurrence rates appear to be similar to wide surgical excision.13,14

 

 

Wide Surgical Excision

Wide excision is a widely established technique consisting of surgical excision of a lesion plus an area of surrounding disease-free tissue such as subcutaneous fat or a lateral margin of intertriginous skin.15 Similar to other surgical techniques, wide excision is considered in cases of severe disease when pharmacologic management cannot remedy extensive fibrosis or architectural loss. It typically is performed in Hurley stage II and III HS, with pathology extending to involve deeper structures inaccessible to more superficial surgical methods.2 Prominent areas of use include gluteal, axillary, perineal, and perianal HS lesions on which conservative treatments have little effect and depend on wide excision to provide successful postoperative results.16 Although retrospective and prospective studies exist on wide excision in HS, there continues to be a dearth of RCTs. Based on the available literature, the primary motive for wide excision is lower recurrence rates (13% overall compared to 22% and 27% for local excision and deroofing, respectively) and longer asymptomatic periods compared to more local techniques.7,17 Wide excision combined with continued aggressive medical management and dietary modifications currently is an efficacious treatment in providing functional long-term results.6 These benefits, however, are not without their drawbacks, as the more extensive nature of wide surgical excision predisposes patients to larger wounds, surgery-induced infection, and prolonged recovery periods.6,15 If preoperative measurements are not wisely assessed, the excision also can extend to involve neurovascular bundles and other vital structures, contributing to greater postoperative morbidity.15 Ultrasonography provides useful anatomic information in HS, such as location and extent of fistulous tracts and fluid collections; these findings can assist in guiding the width and depth of the excision itself to ensure the entire area of HS involvement is removed.18 Published data revealed that 204 of 255 (80%) patients were markedly satisfied with postoperative outcomes of wide excision,19 which gives credence to the idea that although the complications of wide excision may not be as favorable, the long-lasting improvements in quality of life make wide surgical excision a suggested first-line treatment in all stages of HS.16,20

Closure Techniques

The best skin closure method following surgical excision is controversial and not well established in literature. Options include healing by secondary intention, primary (suture-based) closure, skin grafts, and skin flaps. Each of these methods has had moderate success in multiple observational studies, and the choice should be made based on individualized assessment of the patient’s HS lesion characteristics, ability to adhere to recovery protocols, and relevant demographics. A systematic review by Mehdizadeh et al17 provided the following recurrence rates for techniques utilized after wide excision: primary closure, 15%; flaps, 8%; and grafting, 6%. Despite conflicting evidence, allowing wounds to heal by secondary intention is best, based on the author’s experience (I.H.H.).

Secondary Intention
Healing by secondary intention refers to a wound that is intentionally left open to be filled in with granulation tissue and eventual epithelization over time rather than being approximated and closed via sutures or staples as in primary intention. It is a well-established option in wound management and results in a longer but more comfortable period of convalescence in postsurgical HS management.20 Patients can add regular moist wound dressings (eg, silastic foam dressing) to manage the wound at home and continue normal activities for most of the healing period; however, the recovery period can become excessively long and painful, and there is a high risk of formation of retractile scar bands at and around the healing site.12 Strict adherence to wound-healing protocols is paramount to minimizing unwanted complications.21 Secondary intention often is used after wide local excision and has been demonstrated to yield positive functional and aesthetic results in multiple studies, especially in the more severe Hurley stage II or III cases.21,22 It can be successfully employed after laser treatment and in surgical defects of all sizes with little to no contractures or reduced range of motion.6 Ultimately, the choice to heal via secondary intention should be made after thorough assessment of patient needs and with ample education to ensure compliance.

Primary Closure
Primary closure is the suture-mediated closing technique that is most often used in wound closure for lower-grade HS cases, especially smaller excisions. However, it is associated with potential complications. If HS lesions are not effectively excised, disease can then recur at the periphery of the excision and wound dehiscence can manifest more readily, especially as wound size increases.23 Consequently, primary closure is associated with the highest recurrence rates among closure techniques.17 Avoiding primary closure in active disease also is recommended due to the potential of burying residual foci of inflammation.6 Finally, primary closures lack skin coverage and thus often are not viable options in most perianal and genital lesions that require more extensive reconstruction. Retrospective case series and case reports exist on primary excision, but further study is needed.

Skin Grafts
Skin grafting is a technique of surgically transplanting a piece of healthy skin from one body site to another. Skin grafts typically are used when primary closure or skin flaps are not feasible (eg, in large wounds) and also when shorter time to wound closure is a greater concern in patient recovery.2,24 Additionally, skin grafts can be employed on large flat surfaces of the body, such as the buttocks or thighs, for timely wound closure when wound contraction is less effective or wound healing is slow via epithelization. Types of skin graft techniques include split-thickness skin graft (STSG), full-thickness skin graft, and recycled skin graft. All 3 types have demonstrated acceptable functional and aesthetic results in observational studies and case reports, and thus deciding which technique to use should include individualized assessment.2,25 The STSG has several advantages over the full-thickness skin graft, including hairlessness (ie, without hair follicles), ease of harvest, and a less complicated transfer to contaminated lesional areas such as those in HS.26 Additionally, STSGs allow for closure of even the largest wounds with minimal risk of serious infection. Split-thickness skin grafts are considered one of the most efficacious tools for axilla reconstruction; however, they require prolonged immobilization of the arm, result in sequelae in donor sites, and do not always prevent retractile scars.26 The recycled skin graft technique can be used to treat chronic gluteal HS, but reliability and outcomes have not been reported. Skin grafting after excision is associated with increased pain, immobilization, prolonged hospitalization, and longer healing times compared to skin flaps.19 In a systematic review of wound healing techniques following wide excision, grafting was shown to have the lowest recurrence rate (6%) compared to skin flaps (8%) and primary closure (15%).17 The absence of hair follicles and sweat glands in STSGs may be advantageous in HS because both hair follicles and sweat glands are thought to play more roles in the pathogenesis of HS.18,24 Most studies on skin grafts are limited to case reports.

Skin Flaps
Skin flaps are similar to skin grafts in that healthy skin is transplanted from one site to another; the difference is that flaps maintain an intact blood supply, whereas skin grafts depend on growth of new blood vessels.12,13 The primary advantage of skin flaps is that they provide the best quality of skin due to the thick tissue coverage, which is an important concern, especially in aesthetic scenarios. Additionally, they have been shown to provide shorter healing times than grafts, primary closure, and secondary healing, which can be especially important when functional disability is a concern in the postoperative period.26 However, their use should be limited due to several complications owing to their blood supply, as there is a high risk of ischemia to distant portions of flaps, which often can progress to necrosis and hemorrhage during the harvesting process.2 Thus, skin flaps are incredibly difficult to use in larger wounds and often require debulking due to their thickness. Additionally, skin flaps are definitive by nature, which can pose an issue if HS recurs locally. Skin flaps are recommended only when their use is mandatory, such as in the coverage of important anatomic structures (eg, exposed neurovascular bundles and large vessels).2 Advances have been made in flap construction, and now several types of flaps are employed in several body areas with differing indications and recommendations.2,21 As with skin grafts, most studies in the literature are case reports; therefore, further investigation is needed.

Combination Reconstructions
Combination reconstructions refer to the simultaneous use of multiple closure or healing techniques. By combining 2 or more methods, surgeons can utilize the advantages of each technique to provide an individualized approach that can substantially diminish wound surface area and accelerate wound healing.2 For example, with the starlike technique, 5 equilateral triangles bordering a foci of axillary disease are excised in addition to the central foci, and the edges of each triangle are then sutured together to create a final scar of considerably smaller size. The starlike technique allows the wound to be partially sutured while leaving the remaining area to heal by secondary intention.2 There are a small number of case series and prospective studies on combined reconstructions in HS but no RCTs.

Conclusion

Many procedures exist as options for treatment of patients with HS. Deroofing and cryoinsufflation are options for localized Hurley stage I or II disease. For more severe Hurley stage II or III disease, skin tissue–saving excision with electrosurgical peeling or wide surgical excisions are preferred. Following excision, there are many options for wound closure, but our preference is to allow the wound to heal by secondary intention. It is imperative that dermatologists are informed on the different techniques for treating this disease to determine the best route of care for their patients.

References
  1. Smith MK, Nicholson CL, Parks-Miller A, et al. Hidradenitis suppurativa: an update on connecting the tracts. F1000Res. 2017;6:1272.
  2. Janse I, Bieniek A, Horvath B, et al. Surgical procedures in hidradenitis suppurativa. Dermatol Clin. 2016;34:97-109.
  3. Pagliarello C, Fabrizi G, Feliciani C, et al. Cryoinsufflation for Hurley stage II hidradenitis suppurativa: a useful treatment option when systemic therapies should be avoided. JAMA Dermatol. 2014;150:765-766.
  4. Pagliarello C, Fabrizi G, di Nuzzo S. Cryoinsufflation for hidradenitis suppurativa: technical refinement to prevent complications. Dermatol Surg. 2016;42:130-132.
  5. Ritz JP, Runkel N, Haier J, et al. Extent of surgery and recurrence rate of hidradenitis suppurativa. Int J Colorectal Dis. 1998;13:164-168.
  6. Danby FW, Hazen PG, Boer J. New and traditional surgical approaches to hidradenitis suppurativa. J Am Acad Dermatol. 2015;73(5, suppl 1):S62-S65.
  7. Ellis LZ. Hidradenitis suppurativa: surgical and other management techniques. Dermatol Surg. 2012;38:517-536.
  8. Mullins JF, McCash WB, Boudreau RF. Treatment of chronic hidradenitis suppurativa: surgical modification. Postgrad Med. 1959;26:805-808.
  9. Brown SC, Kazzazi N, Lord PH. Surgical treatment of perineal hidradenitis suppurativa with special reference to recognition of the perianal form. Br J Surg. 1986;73:978-980.
  10. Culp CE. Chronic hidradenitis suppurativa of the anal canal. a surgical skin disease. Dis Colon Rectum. 1983;26:669-676.
  11. van der Zee HH, Prens EP, Boer J. Deroofing: a tissue-saving surgical technique for the treatment of mild to moderate hidradenitis suppurativa lesions. J Am Acad Dermatol. 2010;63:475-480.
  12. Lin CH, Chang KP, Huang SH. Deroofing: an effective method for treating chronic diffuse hidradenitis suppurativa. Dermatol Surg. 2016;42:273-275.
  13. Blok JL, Boersma M, Terra JB, et al. Surgery under general anaes-thesia in severe hidradenitis suppurativa: a study of 363 primary operations in 113 patients. J Eur Acad Dermatol Venereol. 2015;29:1590-1597.
  14. Blok JL, Spoo JR, Leeman FW, et al. Skin-Tissue-sparing Excision with Electrosurgical Peeling (STEEP): a surgical treatment option for severe hidradenitis suppurativa Hurley stage II/III. J Eur Acad Dermatol Venereol. 2015;29:379-382.
  15. Saunte DML, Jemec GBE. Hidradenitis suppurativa: advances in diagnosis and treatment. JAMA. 2017;318:2019-2032.
  16. Maghsoudi H, Almasi H, Miri Bonjar MR. Men, main victims of hidradenitis suppurativa (a prospective cohort study). Int J Surg. 2018;50:6-10.
  17. Mehdizadeh A, Hazen PG, Bechara FG, et al. Recurrence of hidradenitis suppurativa after surgical management: a systematic review and meta-analysis. J Am Acad Dermatol. 2015;73(5, suppl 1):S70-S77.
  18. Wortsman X, Moreno C, Soto R, et al. Ultrasound in-depth characterization and staging of hidradenitis suppurativa. Dermatol Surg. 2013;39:1835-1842.
  19. Kofler L, Schweinzer K, Heister M, et al. Surgical treatment of hidradenitis suppurativa: an analysis of postoperative outcome, cosmetic results and quality of life in 255 patients [published online February 17, 2018]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.14892.
  20. Dini V, Oranges T, Rotella L, et al. Hidradenitis suppurativa and wound management. Int J Low Extrem Wounds. 2015;14:236-244.
  21. Humphries LS, Kueberuwa E, Beederman M, et al. Wide excision and healing by secondary intent for the surgical treatment of hidradenitis suppurativa: a single-center experience. J Plast Reconstr Aesthet Surg. 2016;69:554-566.
  22. Wollina U, Langner D, Heinig B, et al. Comorbidities, treatment, and outcome in severe anogenital inverse acne (hidradenitis suppurativa): a 15-year single center report. Int J Dermatol. 2017;56:109-115.
  23. Watson JD. Hidradenitis suppurativa—a clinical review. Br J Plast Surg. 1985;38:567-569.
  24. Sugio Y, Tomita K, Hosokawa K. Reconstruction after excision of hidradenitis suppurativa: are skin grafts better than flaps? Plast Reconstr Surg Glob Open. 2016;4:E1128.
  25. Burney RE. 35-year experience with surgical treatment of hidradenitis suppurativa. World J Surg. 2017;41:2723-2730.
  26. Nail-Barthelemy R, Stroumza N, Qassemyar Q, et al. Evaluation of the mobility of the shoulder and quality of life after perforator flaps for recalcitrant axillary hidradenitis [published online February 13, 2018]. Ann Chir Plast Esthet. pii:S0294-1260(18)30005-0. doi:10.1016/j.anplas.2018.01.003.
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Mr. Vellaichamy is from the Department of Dermatology, Wayne State University, Detroit, Michigan. Drs. Braunberger, Nahhas, and Hamzavi are from the Department of Dermatology, Henry Ford Hospital, Detroit.

Mr. Vellaichamy and Drs. Braunberger and Nahhas report no conflict of interest. Dr. Hamzavi received honoraria as an advisory board member for Aclaris Therapeutics, Inc. He also is a consultant for Pfizer Inc and an investigator for Allergan; The Estée Lauder Companies; Ferndale Pharma Group, Inc; and Johnson & Johnson Consumer Inc.

Correspondence: Iltefat H. Hamzavi, MD, Department of Dermatology, Henry Ford Hospital, 3031 W Grand Blvd, Detroit, MI 48202 ([email protected]).

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Mr. Vellaichamy is from the Department of Dermatology, Wayne State University, Detroit, Michigan. Drs. Braunberger, Nahhas, and Hamzavi are from the Department of Dermatology, Henry Ford Hospital, Detroit.

Mr. Vellaichamy and Drs. Braunberger and Nahhas report no conflict of interest. Dr. Hamzavi received honoraria as an advisory board member for Aclaris Therapeutics, Inc. He also is a consultant for Pfizer Inc and an investigator for Allergan; The Estée Lauder Companies; Ferndale Pharma Group, Inc; and Johnson & Johnson Consumer Inc.

Correspondence: Iltefat H. Hamzavi, MD, Department of Dermatology, Henry Ford Hospital, 3031 W Grand Blvd, Detroit, MI 48202 ([email protected]).

Author and Disclosure Information

 

Mr. Vellaichamy is from the Department of Dermatology, Wayne State University, Detroit, Michigan. Drs. Braunberger, Nahhas, and Hamzavi are from the Department of Dermatology, Henry Ford Hospital, Detroit.

Mr. Vellaichamy and Drs. Braunberger and Nahhas report no conflict of interest. Dr. Hamzavi received honoraria as an advisory board member for Aclaris Therapeutics, Inc. He also is a consultant for Pfizer Inc and an investigator for Allergan; The Estée Lauder Companies; Ferndale Pharma Group, Inc; and Johnson & Johnson Consumer Inc.

Correspondence: Iltefat H. Hamzavi, MD, Department of Dermatology, Henry Ford Hospital, 3031 W Grand Blvd, Detroit, MI 48202 ([email protected]).

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In Collaboration with the Skin of Color Society
In Collaboration with the Skin of Color Society

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that has a social and psychosocial impact on patients with skin of color.1 It is characterized by recurrent abscesses, draining sinus tracts, and scarring in the intertriginous skin folds. The lesions are difficult to treat and present with considerable frustration for both patients and physicians. Although current treatment ladders can delay procedures and surgical intervention,1 some believe that surgery should be introduced earlier in HS management.2 In this article, we review current procedures for the management of HS, including cryoinsufflation, incision and drainage, deroofing, skin tissue–saving excision with electrosurgical peeling, and wide surgical excision, along with various closure techniques.

Cryoinsufflation

First described in 2014, cryoinsufflation is a novel method for treating sinus tracts.3 Lesions initially are identified on physical examination. Prior to the procedure, local anesthesia is administered to the lesion.3 A 21-gauge needle is mounted onto a cryosurgical unit and inserted into the opening of the sinus tract. Liquid nitrogen is sprayed into the tract for 5 seconds, followed by a 3-second pause; the process is repeated 3 times. Patients return for treatment sessions monthly until the tract is obliterated. This procedure was first performed on 2 patients with satisfactory results.3

Since the initial report, the investigators made 2 changes to refine the procedure.4 First, systemic antibiotics should be prescribed 2 months prior to the procedure to clear the sinus tracts of infection. Furthermore, a 21-gauge, olive-tipped cannula is recommended in lieu of a 21-gauge needle to mitigate the risk of adverse events such as air embolism.4

Incision and Drainage

Incision and drainage provides rapid pain relief for tense fluctuant abscesses, but recurrence is common and the procedure costs are high.5 For drainage, wide circumferential local anesthesia is administered followed by incision.6 Pus is eliminated using digital pressure or saline rinses.2 Following the elimination of pus, the wound may need gauze packing or placement of a wick for a few days.6 The general belief is that incision and drainage should be used, if necessary, to rapidly relieve the patient’s pain; however, other surgical options should be considered if the patient has had multiple incision and drainage procedures.7 Currently there are no randomized controlled trials (RCTs) on incision and drainage procedures in HS abscesses.

Deroofing

In 1959, Mullins et al8 first described the deroofing procedure, which was refined to preserve the floor of the sinus tract in the 1980s.9,10 Culp10 and Brown et al9 theorized that preservation of the exposed floor of the sinus tract allowed for the epithelial cells from sweat glands and hair follicle remnants to rapidly reepithelialize the wound. In 2010, van der Zee et al11 performed a prospective study of 88 deroofed lesions in which the investigators removed keratinous debris and epithelial remnants of the floor due to concern for recurrence in this area if the tissues remained. Only 17% (15/88) of the lesions recurred at a median follow-up of 34 months.11

In Hurley stage I or II HS, deroofing remains the primary procedure for persistent nodules and sinus tracts.2 The lesion is identified on physical examination and local anesthesia is administered, first to the area surrounding the lesion, then to the lesion itself.11 A blunt probe is used to identify openings and search for connecting fistulas. After defining the sinus tract, the roof and wings created by the incision are removed.11,12 The material on the floor of the tract is scraped away, and the wound is left to heal by secondary intention.11 In general, deroofed lesions heal with cosmetically acceptable scars. We have used this procedure in skin of color patients with good results and no difficulties with healing. Controlled trials with long-term follow-up are lacking in this population.

Skin Tissue–Saving Excision With Electrosurgical Peeling

Skin tissue–saving excision with electrosurgical peeling was first introduced in 2015.13 Blok et al14 described the procedure as a promising alternative to wide surgical excision for Hurley stage II or III HS. The procedure saves healthy tissue while completely removing lesional tissue, leading to rapid wound healing, excellent cosmesis, and a low risk of contractures2,14; however, recurrence rates are higher than those seen in wide surgical excision.15 There are no known RCTs with long-term follow-up for HS patients treated with skin tissue–saving excision with electrosurgical peeling.

The procedure typically is performed under general anesthesia.14 First, the sinus tract is palpated on physical examination and probed to delineate the extent of the tract. Next, the roof of the tract is incised electrosurgically with a wire loop tip coupled to an electrosurgical generator.14 Consecutive tangential excisions are made until the floor of the sinus tract is reached. The process of incising sinus tracts followed by tangential peeling off of tissue continues until the entire area is clear of lesional and fibrotic tissue. The wound margins are probed for the presence and subsequent removal of residual sinus tracts. Lastly, the electrosurgical generator is used to achieve hemostasis, steroids are injected to prevent the formation of hypergranulation tissue, and the wound is left to heal by secondary intention.14 Following intervention, recurrence rates appear to be similar to wide surgical excision.13,14

 

 

Wide Surgical Excision

Wide excision is a widely established technique consisting of surgical excision of a lesion plus an area of surrounding disease-free tissue such as subcutaneous fat or a lateral margin of intertriginous skin.15 Similar to other surgical techniques, wide excision is considered in cases of severe disease when pharmacologic management cannot remedy extensive fibrosis or architectural loss. It typically is performed in Hurley stage II and III HS, with pathology extending to involve deeper structures inaccessible to more superficial surgical methods.2 Prominent areas of use include gluteal, axillary, perineal, and perianal HS lesions on which conservative treatments have little effect and depend on wide excision to provide successful postoperative results.16 Although retrospective and prospective studies exist on wide excision in HS, there continues to be a dearth of RCTs. Based on the available literature, the primary motive for wide excision is lower recurrence rates (13% overall compared to 22% and 27% for local excision and deroofing, respectively) and longer asymptomatic periods compared to more local techniques.7,17 Wide excision combined with continued aggressive medical management and dietary modifications currently is an efficacious treatment in providing functional long-term results.6 These benefits, however, are not without their drawbacks, as the more extensive nature of wide surgical excision predisposes patients to larger wounds, surgery-induced infection, and prolonged recovery periods.6,15 If preoperative measurements are not wisely assessed, the excision also can extend to involve neurovascular bundles and other vital structures, contributing to greater postoperative morbidity.15 Ultrasonography provides useful anatomic information in HS, such as location and extent of fistulous tracts and fluid collections; these findings can assist in guiding the width and depth of the excision itself to ensure the entire area of HS involvement is removed.18 Published data revealed that 204 of 255 (80%) patients were markedly satisfied with postoperative outcomes of wide excision,19 which gives credence to the idea that although the complications of wide excision may not be as favorable, the long-lasting improvements in quality of life make wide surgical excision a suggested first-line treatment in all stages of HS.16,20

Closure Techniques

The best skin closure method following surgical excision is controversial and not well established in literature. Options include healing by secondary intention, primary (suture-based) closure, skin grafts, and skin flaps. Each of these methods has had moderate success in multiple observational studies, and the choice should be made based on individualized assessment of the patient’s HS lesion characteristics, ability to adhere to recovery protocols, and relevant demographics. A systematic review by Mehdizadeh et al17 provided the following recurrence rates for techniques utilized after wide excision: primary closure, 15%; flaps, 8%; and grafting, 6%. Despite conflicting evidence, allowing wounds to heal by secondary intention is best, based on the author’s experience (I.H.H.).

Secondary Intention
Healing by secondary intention refers to a wound that is intentionally left open to be filled in with granulation tissue and eventual epithelization over time rather than being approximated and closed via sutures or staples as in primary intention. It is a well-established option in wound management and results in a longer but more comfortable period of convalescence in postsurgical HS management.20 Patients can add regular moist wound dressings (eg, silastic foam dressing) to manage the wound at home and continue normal activities for most of the healing period; however, the recovery period can become excessively long and painful, and there is a high risk of formation of retractile scar bands at and around the healing site.12 Strict adherence to wound-healing protocols is paramount to minimizing unwanted complications.21 Secondary intention often is used after wide local excision and has been demonstrated to yield positive functional and aesthetic results in multiple studies, especially in the more severe Hurley stage II or III cases.21,22 It can be successfully employed after laser treatment and in surgical defects of all sizes with little to no contractures or reduced range of motion.6 Ultimately, the choice to heal via secondary intention should be made after thorough assessment of patient needs and with ample education to ensure compliance.

Primary Closure
Primary closure is the suture-mediated closing technique that is most often used in wound closure for lower-grade HS cases, especially smaller excisions. However, it is associated with potential complications. If HS lesions are not effectively excised, disease can then recur at the periphery of the excision and wound dehiscence can manifest more readily, especially as wound size increases.23 Consequently, primary closure is associated with the highest recurrence rates among closure techniques.17 Avoiding primary closure in active disease also is recommended due to the potential of burying residual foci of inflammation.6 Finally, primary closures lack skin coverage and thus often are not viable options in most perianal and genital lesions that require more extensive reconstruction. Retrospective case series and case reports exist on primary excision, but further study is needed.

Skin Grafts
Skin grafting is a technique of surgically transplanting a piece of healthy skin from one body site to another. Skin grafts typically are used when primary closure or skin flaps are not feasible (eg, in large wounds) and also when shorter time to wound closure is a greater concern in patient recovery.2,24 Additionally, skin grafts can be employed on large flat surfaces of the body, such as the buttocks or thighs, for timely wound closure when wound contraction is less effective or wound healing is slow via epithelization. Types of skin graft techniques include split-thickness skin graft (STSG), full-thickness skin graft, and recycled skin graft. All 3 types have demonstrated acceptable functional and aesthetic results in observational studies and case reports, and thus deciding which technique to use should include individualized assessment.2,25 The STSG has several advantages over the full-thickness skin graft, including hairlessness (ie, without hair follicles), ease of harvest, and a less complicated transfer to contaminated lesional areas such as those in HS.26 Additionally, STSGs allow for closure of even the largest wounds with minimal risk of serious infection. Split-thickness skin grafts are considered one of the most efficacious tools for axilla reconstruction; however, they require prolonged immobilization of the arm, result in sequelae in donor sites, and do not always prevent retractile scars.26 The recycled skin graft technique can be used to treat chronic gluteal HS, but reliability and outcomes have not been reported. Skin grafting after excision is associated with increased pain, immobilization, prolonged hospitalization, and longer healing times compared to skin flaps.19 In a systematic review of wound healing techniques following wide excision, grafting was shown to have the lowest recurrence rate (6%) compared to skin flaps (8%) and primary closure (15%).17 The absence of hair follicles and sweat glands in STSGs may be advantageous in HS because both hair follicles and sweat glands are thought to play more roles in the pathogenesis of HS.18,24 Most studies on skin grafts are limited to case reports.

Skin Flaps
Skin flaps are similar to skin grafts in that healthy skin is transplanted from one site to another; the difference is that flaps maintain an intact blood supply, whereas skin grafts depend on growth of new blood vessels.12,13 The primary advantage of skin flaps is that they provide the best quality of skin due to the thick tissue coverage, which is an important concern, especially in aesthetic scenarios. Additionally, they have been shown to provide shorter healing times than grafts, primary closure, and secondary healing, which can be especially important when functional disability is a concern in the postoperative period.26 However, their use should be limited due to several complications owing to their blood supply, as there is a high risk of ischemia to distant portions of flaps, which often can progress to necrosis and hemorrhage during the harvesting process.2 Thus, skin flaps are incredibly difficult to use in larger wounds and often require debulking due to their thickness. Additionally, skin flaps are definitive by nature, which can pose an issue if HS recurs locally. Skin flaps are recommended only when their use is mandatory, such as in the coverage of important anatomic structures (eg, exposed neurovascular bundles and large vessels).2 Advances have been made in flap construction, and now several types of flaps are employed in several body areas with differing indications and recommendations.2,21 As with skin grafts, most studies in the literature are case reports; therefore, further investigation is needed.

Combination Reconstructions
Combination reconstructions refer to the simultaneous use of multiple closure or healing techniques. By combining 2 or more methods, surgeons can utilize the advantages of each technique to provide an individualized approach that can substantially diminish wound surface area and accelerate wound healing.2 For example, with the starlike technique, 5 equilateral triangles bordering a foci of axillary disease are excised in addition to the central foci, and the edges of each triangle are then sutured together to create a final scar of considerably smaller size. The starlike technique allows the wound to be partially sutured while leaving the remaining area to heal by secondary intention.2 There are a small number of case series and prospective studies on combined reconstructions in HS but no RCTs.

Conclusion

Many procedures exist as options for treatment of patients with HS. Deroofing and cryoinsufflation are options for localized Hurley stage I or II disease. For more severe Hurley stage II or III disease, skin tissue–saving excision with electrosurgical peeling or wide surgical excisions are preferred. Following excision, there are many options for wound closure, but our preference is to allow the wound to heal by secondary intention. It is imperative that dermatologists are informed on the different techniques for treating this disease to determine the best route of care for their patients.

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that has a social and psychosocial impact on patients with skin of color.1 It is characterized by recurrent abscesses, draining sinus tracts, and scarring in the intertriginous skin folds. The lesions are difficult to treat and present with considerable frustration for both patients and physicians. Although current treatment ladders can delay procedures and surgical intervention,1 some believe that surgery should be introduced earlier in HS management.2 In this article, we review current procedures for the management of HS, including cryoinsufflation, incision and drainage, deroofing, skin tissue–saving excision with electrosurgical peeling, and wide surgical excision, along with various closure techniques.

Cryoinsufflation

First described in 2014, cryoinsufflation is a novel method for treating sinus tracts.3 Lesions initially are identified on physical examination. Prior to the procedure, local anesthesia is administered to the lesion.3 A 21-gauge needle is mounted onto a cryosurgical unit and inserted into the opening of the sinus tract. Liquid nitrogen is sprayed into the tract for 5 seconds, followed by a 3-second pause; the process is repeated 3 times. Patients return for treatment sessions monthly until the tract is obliterated. This procedure was first performed on 2 patients with satisfactory results.3

Since the initial report, the investigators made 2 changes to refine the procedure.4 First, systemic antibiotics should be prescribed 2 months prior to the procedure to clear the sinus tracts of infection. Furthermore, a 21-gauge, olive-tipped cannula is recommended in lieu of a 21-gauge needle to mitigate the risk of adverse events such as air embolism.4

Incision and Drainage

Incision and drainage provides rapid pain relief for tense fluctuant abscesses, but recurrence is common and the procedure costs are high.5 For drainage, wide circumferential local anesthesia is administered followed by incision.6 Pus is eliminated using digital pressure or saline rinses.2 Following the elimination of pus, the wound may need gauze packing or placement of a wick for a few days.6 The general belief is that incision and drainage should be used, if necessary, to rapidly relieve the patient’s pain; however, other surgical options should be considered if the patient has had multiple incision and drainage procedures.7 Currently there are no randomized controlled trials (RCTs) on incision and drainage procedures in HS abscesses.

Deroofing

In 1959, Mullins et al8 first described the deroofing procedure, which was refined to preserve the floor of the sinus tract in the 1980s.9,10 Culp10 and Brown et al9 theorized that preservation of the exposed floor of the sinus tract allowed for the epithelial cells from sweat glands and hair follicle remnants to rapidly reepithelialize the wound. In 2010, van der Zee et al11 performed a prospective study of 88 deroofed lesions in which the investigators removed keratinous debris and epithelial remnants of the floor due to concern for recurrence in this area if the tissues remained. Only 17% (15/88) of the lesions recurred at a median follow-up of 34 months.11

In Hurley stage I or II HS, deroofing remains the primary procedure for persistent nodules and sinus tracts.2 The lesion is identified on physical examination and local anesthesia is administered, first to the area surrounding the lesion, then to the lesion itself.11 A blunt probe is used to identify openings and search for connecting fistulas. After defining the sinus tract, the roof and wings created by the incision are removed.11,12 The material on the floor of the tract is scraped away, and the wound is left to heal by secondary intention.11 In general, deroofed lesions heal with cosmetically acceptable scars. We have used this procedure in skin of color patients with good results and no difficulties with healing. Controlled trials with long-term follow-up are lacking in this population.

Skin Tissue–Saving Excision With Electrosurgical Peeling

Skin tissue–saving excision with electrosurgical peeling was first introduced in 2015.13 Blok et al14 described the procedure as a promising alternative to wide surgical excision for Hurley stage II or III HS. The procedure saves healthy tissue while completely removing lesional tissue, leading to rapid wound healing, excellent cosmesis, and a low risk of contractures2,14; however, recurrence rates are higher than those seen in wide surgical excision.15 There are no known RCTs with long-term follow-up for HS patients treated with skin tissue–saving excision with electrosurgical peeling.

The procedure typically is performed under general anesthesia.14 First, the sinus tract is palpated on physical examination and probed to delineate the extent of the tract. Next, the roof of the tract is incised electrosurgically with a wire loop tip coupled to an electrosurgical generator.14 Consecutive tangential excisions are made until the floor of the sinus tract is reached. The process of incising sinus tracts followed by tangential peeling off of tissue continues until the entire area is clear of lesional and fibrotic tissue. The wound margins are probed for the presence and subsequent removal of residual sinus tracts. Lastly, the electrosurgical generator is used to achieve hemostasis, steroids are injected to prevent the formation of hypergranulation tissue, and the wound is left to heal by secondary intention.14 Following intervention, recurrence rates appear to be similar to wide surgical excision.13,14

 

 

Wide Surgical Excision

Wide excision is a widely established technique consisting of surgical excision of a lesion plus an area of surrounding disease-free tissue such as subcutaneous fat or a lateral margin of intertriginous skin.15 Similar to other surgical techniques, wide excision is considered in cases of severe disease when pharmacologic management cannot remedy extensive fibrosis or architectural loss. It typically is performed in Hurley stage II and III HS, with pathology extending to involve deeper structures inaccessible to more superficial surgical methods.2 Prominent areas of use include gluteal, axillary, perineal, and perianal HS lesions on which conservative treatments have little effect and depend on wide excision to provide successful postoperative results.16 Although retrospective and prospective studies exist on wide excision in HS, there continues to be a dearth of RCTs. Based on the available literature, the primary motive for wide excision is lower recurrence rates (13% overall compared to 22% and 27% for local excision and deroofing, respectively) and longer asymptomatic periods compared to more local techniques.7,17 Wide excision combined with continued aggressive medical management and dietary modifications currently is an efficacious treatment in providing functional long-term results.6 These benefits, however, are not without their drawbacks, as the more extensive nature of wide surgical excision predisposes patients to larger wounds, surgery-induced infection, and prolonged recovery periods.6,15 If preoperative measurements are not wisely assessed, the excision also can extend to involve neurovascular bundles and other vital structures, contributing to greater postoperative morbidity.15 Ultrasonography provides useful anatomic information in HS, such as location and extent of fistulous tracts and fluid collections; these findings can assist in guiding the width and depth of the excision itself to ensure the entire area of HS involvement is removed.18 Published data revealed that 204 of 255 (80%) patients were markedly satisfied with postoperative outcomes of wide excision,19 which gives credence to the idea that although the complications of wide excision may not be as favorable, the long-lasting improvements in quality of life make wide surgical excision a suggested first-line treatment in all stages of HS.16,20

Closure Techniques

The best skin closure method following surgical excision is controversial and not well established in literature. Options include healing by secondary intention, primary (suture-based) closure, skin grafts, and skin flaps. Each of these methods has had moderate success in multiple observational studies, and the choice should be made based on individualized assessment of the patient’s HS lesion characteristics, ability to adhere to recovery protocols, and relevant demographics. A systematic review by Mehdizadeh et al17 provided the following recurrence rates for techniques utilized after wide excision: primary closure, 15%; flaps, 8%; and grafting, 6%. Despite conflicting evidence, allowing wounds to heal by secondary intention is best, based on the author’s experience (I.H.H.).

Secondary Intention
Healing by secondary intention refers to a wound that is intentionally left open to be filled in with granulation tissue and eventual epithelization over time rather than being approximated and closed via sutures or staples as in primary intention. It is a well-established option in wound management and results in a longer but more comfortable period of convalescence in postsurgical HS management.20 Patients can add regular moist wound dressings (eg, silastic foam dressing) to manage the wound at home and continue normal activities for most of the healing period; however, the recovery period can become excessively long and painful, and there is a high risk of formation of retractile scar bands at and around the healing site.12 Strict adherence to wound-healing protocols is paramount to minimizing unwanted complications.21 Secondary intention often is used after wide local excision and has been demonstrated to yield positive functional and aesthetic results in multiple studies, especially in the more severe Hurley stage II or III cases.21,22 It can be successfully employed after laser treatment and in surgical defects of all sizes with little to no contractures or reduced range of motion.6 Ultimately, the choice to heal via secondary intention should be made after thorough assessment of patient needs and with ample education to ensure compliance.

Primary Closure
Primary closure is the suture-mediated closing technique that is most often used in wound closure for lower-grade HS cases, especially smaller excisions. However, it is associated with potential complications. If HS lesions are not effectively excised, disease can then recur at the periphery of the excision and wound dehiscence can manifest more readily, especially as wound size increases.23 Consequently, primary closure is associated with the highest recurrence rates among closure techniques.17 Avoiding primary closure in active disease also is recommended due to the potential of burying residual foci of inflammation.6 Finally, primary closures lack skin coverage and thus often are not viable options in most perianal and genital lesions that require more extensive reconstruction. Retrospective case series and case reports exist on primary excision, but further study is needed.

Skin Grafts
Skin grafting is a technique of surgically transplanting a piece of healthy skin from one body site to another. Skin grafts typically are used when primary closure or skin flaps are not feasible (eg, in large wounds) and also when shorter time to wound closure is a greater concern in patient recovery.2,24 Additionally, skin grafts can be employed on large flat surfaces of the body, such as the buttocks or thighs, for timely wound closure when wound contraction is less effective or wound healing is slow via epithelization. Types of skin graft techniques include split-thickness skin graft (STSG), full-thickness skin graft, and recycled skin graft. All 3 types have demonstrated acceptable functional and aesthetic results in observational studies and case reports, and thus deciding which technique to use should include individualized assessment.2,25 The STSG has several advantages over the full-thickness skin graft, including hairlessness (ie, without hair follicles), ease of harvest, and a less complicated transfer to contaminated lesional areas such as those in HS.26 Additionally, STSGs allow for closure of even the largest wounds with minimal risk of serious infection. Split-thickness skin grafts are considered one of the most efficacious tools for axilla reconstruction; however, they require prolonged immobilization of the arm, result in sequelae in donor sites, and do not always prevent retractile scars.26 The recycled skin graft technique can be used to treat chronic gluteal HS, but reliability and outcomes have not been reported. Skin grafting after excision is associated with increased pain, immobilization, prolonged hospitalization, and longer healing times compared to skin flaps.19 In a systematic review of wound healing techniques following wide excision, grafting was shown to have the lowest recurrence rate (6%) compared to skin flaps (8%) and primary closure (15%).17 The absence of hair follicles and sweat glands in STSGs may be advantageous in HS because both hair follicles and sweat glands are thought to play more roles in the pathogenesis of HS.18,24 Most studies on skin grafts are limited to case reports.

Skin Flaps
Skin flaps are similar to skin grafts in that healthy skin is transplanted from one site to another; the difference is that flaps maintain an intact blood supply, whereas skin grafts depend on growth of new blood vessels.12,13 The primary advantage of skin flaps is that they provide the best quality of skin due to the thick tissue coverage, which is an important concern, especially in aesthetic scenarios. Additionally, they have been shown to provide shorter healing times than grafts, primary closure, and secondary healing, which can be especially important when functional disability is a concern in the postoperative period.26 However, their use should be limited due to several complications owing to their blood supply, as there is a high risk of ischemia to distant portions of flaps, which often can progress to necrosis and hemorrhage during the harvesting process.2 Thus, skin flaps are incredibly difficult to use in larger wounds and often require debulking due to their thickness. Additionally, skin flaps are definitive by nature, which can pose an issue if HS recurs locally. Skin flaps are recommended only when their use is mandatory, such as in the coverage of important anatomic structures (eg, exposed neurovascular bundles and large vessels).2 Advances have been made in flap construction, and now several types of flaps are employed in several body areas with differing indications and recommendations.2,21 As with skin grafts, most studies in the literature are case reports; therefore, further investigation is needed.

Combination Reconstructions
Combination reconstructions refer to the simultaneous use of multiple closure or healing techniques. By combining 2 or more methods, surgeons can utilize the advantages of each technique to provide an individualized approach that can substantially diminish wound surface area and accelerate wound healing.2 For example, with the starlike technique, 5 equilateral triangles bordering a foci of axillary disease are excised in addition to the central foci, and the edges of each triangle are then sutured together to create a final scar of considerably smaller size. The starlike technique allows the wound to be partially sutured while leaving the remaining area to heal by secondary intention.2 There are a small number of case series and prospective studies on combined reconstructions in HS but no RCTs.

Conclusion

Many procedures exist as options for treatment of patients with HS. Deroofing and cryoinsufflation are options for localized Hurley stage I or II disease. For more severe Hurley stage II or III disease, skin tissue–saving excision with electrosurgical peeling or wide surgical excisions are preferred. Following excision, there are many options for wound closure, but our preference is to allow the wound to heal by secondary intention. It is imperative that dermatologists are informed on the different techniques for treating this disease to determine the best route of care for their patients.

References
  1. Smith MK, Nicholson CL, Parks-Miller A, et al. Hidradenitis suppurativa: an update on connecting the tracts. F1000Res. 2017;6:1272.
  2. Janse I, Bieniek A, Horvath B, et al. Surgical procedures in hidradenitis suppurativa. Dermatol Clin. 2016;34:97-109.
  3. Pagliarello C, Fabrizi G, Feliciani C, et al. Cryoinsufflation for Hurley stage II hidradenitis suppurativa: a useful treatment option when systemic therapies should be avoided. JAMA Dermatol. 2014;150:765-766.
  4. Pagliarello C, Fabrizi G, di Nuzzo S. Cryoinsufflation for hidradenitis suppurativa: technical refinement to prevent complications. Dermatol Surg. 2016;42:130-132.
  5. Ritz JP, Runkel N, Haier J, et al. Extent of surgery and recurrence rate of hidradenitis suppurativa. Int J Colorectal Dis. 1998;13:164-168.
  6. Danby FW, Hazen PG, Boer J. New and traditional surgical approaches to hidradenitis suppurativa. J Am Acad Dermatol. 2015;73(5, suppl 1):S62-S65.
  7. Ellis LZ. Hidradenitis suppurativa: surgical and other management techniques. Dermatol Surg. 2012;38:517-536.
  8. Mullins JF, McCash WB, Boudreau RF. Treatment of chronic hidradenitis suppurativa: surgical modification. Postgrad Med. 1959;26:805-808.
  9. Brown SC, Kazzazi N, Lord PH. Surgical treatment of perineal hidradenitis suppurativa with special reference to recognition of the perianal form. Br J Surg. 1986;73:978-980.
  10. Culp CE. Chronic hidradenitis suppurativa of the anal canal. a surgical skin disease. Dis Colon Rectum. 1983;26:669-676.
  11. van der Zee HH, Prens EP, Boer J. Deroofing: a tissue-saving surgical technique for the treatment of mild to moderate hidradenitis suppurativa lesions. J Am Acad Dermatol. 2010;63:475-480.
  12. Lin CH, Chang KP, Huang SH. Deroofing: an effective method for treating chronic diffuse hidradenitis suppurativa. Dermatol Surg. 2016;42:273-275.
  13. Blok JL, Boersma M, Terra JB, et al. Surgery under general anaes-thesia in severe hidradenitis suppurativa: a study of 363 primary operations in 113 patients. J Eur Acad Dermatol Venereol. 2015;29:1590-1597.
  14. Blok JL, Spoo JR, Leeman FW, et al. Skin-Tissue-sparing Excision with Electrosurgical Peeling (STEEP): a surgical treatment option for severe hidradenitis suppurativa Hurley stage II/III. J Eur Acad Dermatol Venereol. 2015;29:379-382.
  15. Saunte DML, Jemec GBE. Hidradenitis suppurativa: advances in diagnosis and treatment. JAMA. 2017;318:2019-2032.
  16. Maghsoudi H, Almasi H, Miri Bonjar MR. Men, main victims of hidradenitis suppurativa (a prospective cohort study). Int J Surg. 2018;50:6-10.
  17. Mehdizadeh A, Hazen PG, Bechara FG, et al. Recurrence of hidradenitis suppurativa after surgical management: a systematic review and meta-analysis. J Am Acad Dermatol. 2015;73(5, suppl 1):S70-S77.
  18. Wortsman X, Moreno C, Soto R, et al. Ultrasound in-depth characterization and staging of hidradenitis suppurativa. Dermatol Surg. 2013;39:1835-1842.
  19. Kofler L, Schweinzer K, Heister M, et al. Surgical treatment of hidradenitis suppurativa: an analysis of postoperative outcome, cosmetic results and quality of life in 255 patients [published online February 17, 2018]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.14892.
  20. Dini V, Oranges T, Rotella L, et al. Hidradenitis suppurativa and wound management. Int J Low Extrem Wounds. 2015;14:236-244.
  21. Humphries LS, Kueberuwa E, Beederman M, et al. Wide excision and healing by secondary intent for the surgical treatment of hidradenitis suppurativa: a single-center experience. J Plast Reconstr Aesthet Surg. 2016;69:554-566.
  22. Wollina U, Langner D, Heinig B, et al. Comorbidities, treatment, and outcome in severe anogenital inverse acne (hidradenitis suppurativa): a 15-year single center report. Int J Dermatol. 2017;56:109-115.
  23. Watson JD. Hidradenitis suppurativa—a clinical review. Br J Plast Surg. 1985;38:567-569.
  24. Sugio Y, Tomita K, Hosokawa K. Reconstruction after excision of hidradenitis suppurativa: are skin grafts better than flaps? Plast Reconstr Surg Glob Open. 2016;4:E1128.
  25. Burney RE. 35-year experience with surgical treatment of hidradenitis suppurativa. World J Surg. 2017;41:2723-2730.
  26. Nail-Barthelemy R, Stroumza N, Qassemyar Q, et al. Evaluation of the mobility of the shoulder and quality of life after perforator flaps for recalcitrant axillary hidradenitis [published online February 13, 2018]. Ann Chir Plast Esthet. pii:S0294-1260(18)30005-0. doi:10.1016/j.anplas.2018.01.003.
References
  1. Smith MK, Nicholson CL, Parks-Miller A, et al. Hidradenitis suppurativa: an update on connecting the tracts. F1000Res. 2017;6:1272.
  2. Janse I, Bieniek A, Horvath B, et al. Surgical procedures in hidradenitis suppurativa. Dermatol Clin. 2016;34:97-109.
  3. Pagliarello C, Fabrizi G, Feliciani C, et al. Cryoinsufflation for Hurley stage II hidradenitis suppurativa: a useful treatment option when systemic therapies should be avoided. JAMA Dermatol. 2014;150:765-766.
  4. Pagliarello C, Fabrizi G, di Nuzzo S. Cryoinsufflation for hidradenitis suppurativa: technical refinement to prevent complications. Dermatol Surg. 2016;42:130-132.
  5. Ritz JP, Runkel N, Haier J, et al. Extent of surgery and recurrence rate of hidradenitis suppurativa. Int J Colorectal Dis. 1998;13:164-168.
  6. Danby FW, Hazen PG, Boer J. New and traditional surgical approaches to hidradenitis suppurativa. J Am Acad Dermatol. 2015;73(5, suppl 1):S62-S65.
  7. Ellis LZ. Hidradenitis suppurativa: surgical and other management techniques. Dermatol Surg. 2012;38:517-536.
  8. Mullins JF, McCash WB, Boudreau RF. Treatment of chronic hidradenitis suppurativa: surgical modification. Postgrad Med. 1959;26:805-808.
  9. Brown SC, Kazzazi N, Lord PH. Surgical treatment of perineal hidradenitis suppurativa with special reference to recognition of the perianal form. Br J Surg. 1986;73:978-980.
  10. Culp CE. Chronic hidradenitis suppurativa of the anal canal. a surgical skin disease. Dis Colon Rectum. 1983;26:669-676.
  11. van der Zee HH, Prens EP, Boer J. Deroofing: a tissue-saving surgical technique for the treatment of mild to moderate hidradenitis suppurativa lesions. J Am Acad Dermatol. 2010;63:475-480.
  12. Lin CH, Chang KP, Huang SH. Deroofing: an effective method for treating chronic diffuse hidradenitis suppurativa. Dermatol Surg. 2016;42:273-275.
  13. Blok JL, Boersma M, Terra JB, et al. Surgery under general anaes-thesia in severe hidradenitis suppurativa: a study of 363 primary operations in 113 patients. J Eur Acad Dermatol Venereol. 2015;29:1590-1597.
  14. Blok JL, Spoo JR, Leeman FW, et al. Skin-Tissue-sparing Excision with Electrosurgical Peeling (STEEP): a surgical treatment option for severe hidradenitis suppurativa Hurley stage II/III. J Eur Acad Dermatol Venereol. 2015;29:379-382.
  15. Saunte DML, Jemec GBE. Hidradenitis suppurativa: advances in diagnosis and treatment. JAMA. 2017;318:2019-2032.
  16. Maghsoudi H, Almasi H, Miri Bonjar MR. Men, main victims of hidradenitis suppurativa (a prospective cohort study). Int J Surg. 2018;50:6-10.
  17. Mehdizadeh A, Hazen PG, Bechara FG, et al. Recurrence of hidradenitis suppurativa after surgical management: a systematic review and meta-analysis. J Am Acad Dermatol. 2015;73(5, suppl 1):S70-S77.
  18. Wortsman X, Moreno C, Soto R, et al. Ultrasound in-depth characterization and staging of hidradenitis suppurativa. Dermatol Surg. 2013;39:1835-1842.
  19. Kofler L, Schweinzer K, Heister M, et al. Surgical treatment of hidradenitis suppurativa: an analysis of postoperative outcome, cosmetic results and quality of life in 255 patients [published online February 17, 2018]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.14892.
  20. Dini V, Oranges T, Rotella L, et al. Hidradenitis suppurativa and wound management. Int J Low Extrem Wounds. 2015;14:236-244.
  21. Humphries LS, Kueberuwa E, Beederman M, et al. Wide excision and healing by secondary intent for the surgical treatment of hidradenitis suppurativa: a single-center experience. J Plast Reconstr Aesthet Surg. 2016;69:554-566.
  22. Wollina U, Langner D, Heinig B, et al. Comorbidities, treatment, and outcome in severe anogenital inverse acne (hidradenitis suppurativa): a 15-year single center report. Int J Dermatol. 2017;56:109-115.
  23. Watson JD. Hidradenitis suppurativa—a clinical review. Br J Plast Surg. 1985;38:567-569.
  24. Sugio Y, Tomita K, Hosokawa K. Reconstruction after excision of hidradenitis suppurativa: are skin grafts better than flaps? Plast Reconstr Surg Glob Open. 2016;4:E1128.
  25. Burney RE. 35-year experience with surgical treatment of hidradenitis suppurativa. World J Surg. 2017;41:2723-2730.
  26. Nail-Barthelemy R, Stroumza N, Qassemyar Q, et al. Evaluation of the mobility of the shoulder and quality of life after perforator flaps for recalcitrant axillary hidradenitis [published online February 13, 2018]. Ann Chir Plast Esthet. pii:S0294-1260(18)30005-0. doi:10.1016/j.anplas.2018.01.003.
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  • Surgical intervention currently is the only definitive treatment for hidradenitis suppurativa (HS).
  • There is no consensus on the best surgical intervention for long-term outcomes in HS; rather, approach is based on clinical judgment dependent upon the location and severity of lesions.
  • After wide excision, allow wounds to heal by secondary intention.
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Migraine and menopause: Longitudinal study shows what to expect

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– What can women with migraine expect during the menopausal transition?

About 60% will experience a change in their headache pattern. And for 60% of that group, it’s a change for the worse, Yu-Chen Cheng, MD, reported at the annual meeting of the American Headache Society.

She presented a retrospective longitudinal study of 60 women with a preexisting history of migraine who were followed through the menopausal transition. All had long-term medical records available, including brain imaging results and hormonal laboratory data.

The impetus for the study was the fact that even though three-quarters of America’s estimated 38 million migraineurs are women, all of whom will eventually undergo menopause, the question of what happens to them headache-wise as they go through this process of permanent cessation of ovarian function has received little research attention.

©Eraxion/thinkstockphotos.com


“This longitudinal study addresses the pattern of change of migraine during menopausal transition, an important but underestimated and undermanaged issue. We need more awareness of this. We hope in the future that physicians can pay more attention to this and provide better treatment for our patients with impaired quality of life,” said Dr. Cheng, a neurologist and postdoctoral fellow at Massachusetts General Hospital and Harvard Medical School, Boston.

Of the 35 women who experienced a change in their migraine attacks in association with menopause, the change occurred perimenopausally or postmenopausally – that is, after the final menstrual period – in 84% of cases. Premenopausal change in migraine in women who hadn’t yet missed a menstrual period in the past 12 months was a less frequent event.

No significant demographic differences existed between the 35 women with migraine change during the menopausal transition and the 25 women whose headache pattern remained stable. However, there were significant differences between the two groups in terms of the change over time in serum estradiol and follicle-stimulating hormone (FSH) levels. The median estradiol level in women whose migraine pattern remained stable went from 29 pg/mL premenopausally to 16.5 pg/mL post menopause, a statistically nonsignificant difference. In contrast, the median estradiol in women who experienced a change in migraine pattern dropped from 52.6 pg/mL premenopausally to 22.5 pg/mL post menopause, which was a significant difference.

Similarly, the pre- to postmenopause change in median FSH from 38.6 to 62.8 IU/L in the stable migraine group didn’t attain statistical significance, while the bigger shift in the migraine change group – from 13.5 IU/L premenopausally to 62.2 IU/L post menopause, was statistically significant.

“So we can say there’s a greater hormonal change in the migraine change group for women in the menopausal transition,” the neurologist said. “This suggests the possibility that a significant steep decline in estradiol level may stimulate migraine change.”

Brain imaging findings in the two groups were similar: Nearly two-thirds of women in both groups had normal brain MRI results, while the rest had nonspecific findings.

Several female headache specialists in the audience rose to thank Dr. Cheng for shining new light on a major understudied issue with far-reaching quality-of-life implications. Could hormone replacement therapy possibly prevent worsening of migraine attacks in association with menopause? she was asked.

Dr. Cheng noted that hormone replacement therapy was used by about two-thirds of women whose migraines remained stable and a similar proportion of those whose headaches changed. But the study wasn’t designed or sized to examine any possible migraine-preventive effect of hormone therapy. That would properly be addressed in a large prospective study. Anecdotally, however, it has been her clinical impression as well as that of some of her fellow neurologists at Massachusetts General that hormone replacement therapy does seem to protect against worsening migraine attacks in menopause, she added.

Dr. Cheng reported having no financial conflicts regarding her National Institutes of Health–funded study.

[email protected]

SOURCE: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.

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– What can women with migraine expect during the menopausal transition?

About 60% will experience a change in their headache pattern. And for 60% of that group, it’s a change for the worse, Yu-Chen Cheng, MD, reported at the annual meeting of the American Headache Society.

She presented a retrospective longitudinal study of 60 women with a preexisting history of migraine who were followed through the menopausal transition. All had long-term medical records available, including brain imaging results and hormonal laboratory data.

The impetus for the study was the fact that even though three-quarters of America’s estimated 38 million migraineurs are women, all of whom will eventually undergo menopause, the question of what happens to them headache-wise as they go through this process of permanent cessation of ovarian function has received little research attention.

©Eraxion/thinkstockphotos.com


“This longitudinal study addresses the pattern of change of migraine during menopausal transition, an important but underestimated and undermanaged issue. We need more awareness of this. We hope in the future that physicians can pay more attention to this and provide better treatment for our patients with impaired quality of life,” said Dr. Cheng, a neurologist and postdoctoral fellow at Massachusetts General Hospital and Harvard Medical School, Boston.

Of the 35 women who experienced a change in their migraine attacks in association with menopause, the change occurred perimenopausally or postmenopausally – that is, after the final menstrual period – in 84% of cases. Premenopausal change in migraine in women who hadn’t yet missed a menstrual period in the past 12 months was a less frequent event.

No significant demographic differences existed between the 35 women with migraine change during the menopausal transition and the 25 women whose headache pattern remained stable. However, there were significant differences between the two groups in terms of the change over time in serum estradiol and follicle-stimulating hormone (FSH) levels. The median estradiol level in women whose migraine pattern remained stable went from 29 pg/mL premenopausally to 16.5 pg/mL post menopause, a statistically nonsignificant difference. In contrast, the median estradiol in women who experienced a change in migraine pattern dropped from 52.6 pg/mL premenopausally to 22.5 pg/mL post menopause, which was a significant difference.

Similarly, the pre- to postmenopause change in median FSH from 38.6 to 62.8 IU/L in the stable migraine group didn’t attain statistical significance, while the bigger shift in the migraine change group – from 13.5 IU/L premenopausally to 62.2 IU/L post menopause, was statistically significant.

“So we can say there’s a greater hormonal change in the migraine change group for women in the menopausal transition,” the neurologist said. “This suggests the possibility that a significant steep decline in estradiol level may stimulate migraine change.”

Brain imaging findings in the two groups were similar: Nearly two-thirds of women in both groups had normal brain MRI results, while the rest had nonspecific findings.

Several female headache specialists in the audience rose to thank Dr. Cheng for shining new light on a major understudied issue with far-reaching quality-of-life implications. Could hormone replacement therapy possibly prevent worsening of migraine attacks in association with menopause? she was asked.

Dr. Cheng noted that hormone replacement therapy was used by about two-thirds of women whose migraines remained stable and a similar proportion of those whose headaches changed. But the study wasn’t designed or sized to examine any possible migraine-preventive effect of hormone therapy. That would properly be addressed in a large prospective study. Anecdotally, however, it has been her clinical impression as well as that of some of her fellow neurologists at Massachusetts General that hormone replacement therapy does seem to protect against worsening migraine attacks in menopause, she added.

Dr. Cheng reported having no financial conflicts regarding her National Institutes of Health–funded study.

[email protected]

SOURCE: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.

 

– What can women with migraine expect during the menopausal transition?

About 60% will experience a change in their headache pattern. And for 60% of that group, it’s a change for the worse, Yu-Chen Cheng, MD, reported at the annual meeting of the American Headache Society.

She presented a retrospective longitudinal study of 60 women with a preexisting history of migraine who were followed through the menopausal transition. All had long-term medical records available, including brain imaging results and hormonal laboratory data.

The impetus for the study was the fact that even though three-quarters of America’s estimated 38 million migraineurs are women, all of whom will eventually undergo menopause, the question of what happens to them headache-wise as they go through this process of permanent cessation of ovarian function has received little research attention.

©Eraxion/thinkstockphotos.com


“This longitudinal study addresses the pattern of change of migraine during menopausal transition, an important but underestimated and undermanaged issue. We need more awareness of this. We hope in the future that physicians can pay more attention to this and provide better treatment for our patients with impaired quality of life,” said Dr. Cheng, a neurologist and postdoctoral fellow at Massachusetts General Hospital and Harvard Medical School, Boston.

Of the 35 women who experienced a change in their migraine attacks in association with menopause, the change occurred perimenopausally or postmenopausally – that is, after the final menstrual period – in 84% of cases. Premenopausal change in migraine in women who hadn’t yet missed a menstrual period in the past 12 months was a less frequent event.

No significant demographic differences existed between the 35 women with migraine change during the menopausal transition and the 25 women whose headache pattern remained stable. However, there were significant differences between the two groups in terms of the change over time in serum estradiol and follicle-stimulating hormone (FSH) levels. The median estradiol level in women whose migraine pattern remained stable went from 29 pg/mL premenopausally to 16.5 pg/mL post menopause, a statistically nonsignificant difference. In contrast, the median estradiol in women who experienced a change in migraine pattern dropped from 52.6 pg/mL premenopausally to 22.5 pg/mL post menopause, which was a significant difference.

Similarly, the pre- to postmenopause change in median FSH from 38.6 to 62.8 IU/L in the stable migraine group didn’t attain statistical significance, while the bigger shift in the migraine change group – from 13.5 IU/L premenopausally to 62.2 IU/L post menopause, was statistically significant.

“So we can say there’s a greater hormonal change in the migraine change group for women in the menopausal transition,” the neurologist said. “This suggests the possibility that a significant steep decline in estradiol level may stimulate migraine change.”

Brain imaging findings in the two groups were similar: Nearly two-thirds of women in both groups had normal brain MRI results, while the rest had nonspecific findings.

Several female headache specialists in the audience rose to thank Dr. Cheng for shining new light on a major understudied issue with far-reaching quality-of-life implications. Could hormone replacement therapy possibly prevent worsening of migraine attacks in association with menopause? she was asked.

Dr. Cheng noted that hormone replacement therapy was used by about two-thirds of women whose migraines remained stable and a similar proportion of those whose headaches changed. But the study wasn’t designed or sized to examine any possible migraine-preventive effect of hormone therapy. That would properly be addressed in a large prospective study. Anecdotally, however, it has been her clinical impression as well as that of some of her fellow neurologists at Massachusetts General that hormone replacement therapy does seem to protect against worsening migraine attacks in menopause, she added.

Dr. Cheng reported having no financial conflicts regarding her National Institutes of Health–funded study.

[email protected]

SOURCE: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.

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Key clinical point: For migraineurs, the menopausal transition is a time of change in headache pattern, often for the worse.

Major finding: Sixty percent of migraineurs experienced a change in headache pattern during the menopausal transition, and for 60% of them it involved worsening migraine intensity and/or frequency.

Study details: This retrospective longitudinal study followed 60 women with migraine before and through the menopausal transition.

Disclosures: The presenter reported having no financial conflicts regarding her National Institutes of Health–funded study.

Source: Cheng Y-C and Maleki N. Headache. 2018;58:71. Abstract OR16.

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Economic Stewardship in Acne Management

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We are fortunate to have plentiful acne treatment options available that cater to each patient’s clinical examination, predispositions, and triggers, but the choices are daunting amidst the vast prescription and over-the-counter (OTC) topicals available along with disparate insurance and cost nuances. In addition, when prescribing generic oral therapies, it is complicated to parse out regional differences in price, supply, and insurance coverage to advocate best for each patient and land upon the delicate balance between efficacy, safety, and financial stewardship, both at an individual and community level. I will outline some challenges and solutions to the management of acne amidst these complicated factors.

Oral Therapies

For isotretinoin, generic choices, cost, and tiering within insurance plans are perpetual moving targets despite the drug being the only member of its class.1 Prescriber resources include tandem searches of electronic medical record price estimates within each insurance formulary, individual pharmacy search engines, and compilation mobile applications such as GoodRx to select the most affordable version for each patient. As an example of a regional trend, isotretinoin generic coverage by one provider in Pennsylvania shifted earlier this year so that every patient, whether new to isotretinoin or midcourse, required a new prior authorization with more stringent coverage requirements including failure of 2 oral antibiotics. Swiftly thereafter, efforts across the state driven by the Pennsylvania Academy of Dermatology and Dermatologic Surgery and its members and fueled by poignant patient vignettes about fragmented and substandard patient care helped to reverse this policy and remove the prior authorization mandate.2

Tetracyclines have experienced broad cost swings, mostly based on disruption of manufacturing at the limited number of distribution sites in the United States. In 2011, a tetracycline shortage arose due to a major manufacturer’s recall3 and persisted with subsequent material shortages, as doxycycline became the preferred and cheaper member of the class. Doxycycline price tag hikes then occurred following Hurricane Sandy when an East Coast manufacturing site was damaged.3 Spironolactone backorder also has been frequent due to recent raw material shortages and delays in production,3 forcing pharmacies to refill small amounts of medication in various dosage forms despite patients owing the same copayment per prescription.

Topical Therapies

Topical retinoid prescription affordability has always been fraught with difficulty owing to age cutoffs because it is often restricted to patients younger than 25 or 40 years, depending on the plan,4,5 but the availability of adapalene gel 0.1% as an OTC preparation in 2016 has broadened retinoid access and use.6 Prescription benzoyl peroxide (BPO) products alone or in combination with retinoids or topical antibiotics (or other combination topical therapies) comprise a large number of branded prescriptions often not covered by insurance or are only affordable using proprietary and intermittently available coupon cards (eg, BPO-clindamycin, clindamycin-tretinoin, BPO-adapalene); therefore, prescribers tend to dispense the individual ingredients and instruct the patient to compound them at home. Furthermore, BPO products can be purchased in effective concentrations as OTC products, and patients looking to procure more affordable, albeit less effective, topical retinoids that also have less irritation potential reach for OTC nightly retinol creams nestled in the antiaging section of the pharmacy.7

Opportunities to be involved in the larger scaffold of patient advocacy also are plentiful at the state and national levels. For example, with the support of dermatology state societies and the American Academy of Dermatology Association, Pennsylvania House Bill 22118 and similar bills in other states call for reversal of the gag clause that prevents pharmacists from disclosing the best medication price to patients. Also guided by the American Academy of Dermatology Association, prior authorization model legislation to promote transparency across insurers in this haphazard process is emerging across the country.9,10

Final Thoughts

These examples of acne medication access and cost quandaries serve to embody the daily problem-solving that dermatologists execute as part of their growing administrative and economic duties. They also represent worthy efforts to consider on behalf of patients, their pocketbooks, and the prudent use of their dermatologists’ time.

References
  1. Borgonjen RJ, de Lange JA, van de Kerkhof PCM. Guideline-based clinical decision support in acne patients receiving isotretinoin: improving adherence and cost-effectiveness. J Eur Acad Dermatol Venereol. 2017;31:e440-e442.
  2. Oral isotretinoin therapy update. Highmark website. https://content.highmarkprc.com/Files/NewsletterNotices/HotTopics/ht-all-isotretinoin-therapy-update-051718.pdf. Published May 17, 2018. Accessed June 29, 2018.
  3. Drug shortages. US Food & Drug Administration website. https://www.fda.gov/drugs/drugsafety/drugshortages/default.htm. Updated June 19, 2018. Accessed June 19, 2018.
  4. Retinoids prior authorization criteria. Blue Cross and Blue Shield of Illinois website. https://www.bcbsil.com/provider/pdf/retinoids.pdf. Published March 2008. Accessed June 18, 2018.
  5. Davis SA, Huang KE, Feldman SR, et al. Trends in ambulatory health care usage for adult acne. J Cutan Med Surg. 2015;19:377-379.
  6. FDA approves Differin gel 0.1% for over-the-counter use to treat acne [press release]. Silver Spring, MD: US Food & Drug Administration; July 8, 2016.
  7. Rosamilia LL. Over-the-counter treatments for acne and rosacea. Semin Cutan Med Surg. 2016;35:87-95.
  8. An Act Providing for Consumer Prescription Drug Pricing Disclosure, HB 2211, Regular Sess (Pa 2018).
  9. An Act Providing for Preauthorizations Conducted by Utilization Review Entities Relating to Health Care Services, HB 1293, Regular Sess (Pa 2017).
  10. Step therapy legislation. American Academy of Dermatology website. https://www.aad.org/advocacy/state-policy/step-therapy-legislation. Accessed June 19, 2018.
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From the Department of Dermatology, Geisinger Health System Scenery Park, State College, Pennsylvania.

The author reports no conflict of interest.

Correspondence: Lorraine L. Rosamilia, MD, 200 Scenery Dr, 56-02, State College, PA 16801 ([email protected]).

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The author reports no conflict of interest.

Correspondence: Lorraine L. Rosamilia, MD, 200 Scenery Dr, 56-02, State College, PA 16801 ([email protected]).

Author and Disclosure Information

From the Department of Dermatology, Geisinger Health System Scenery Park, State College, Pennsylvania.

The author reports no conflict of interest.

Correspondence: Lorraine L. Rosamilia, MD, 200 Scenery Dr, 56-02, State College, PA 16801 ([email protected]).

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We are fortunate to have plentiful acne treatment options available that cater to each patient’s clinical examination, predispositions, and triggers, but the choices are daunting amidst the vast prescription and over-the-counter (OTC) topicals available along with disparate insurance and cost nuances. In addition, when prescribing generic oral therapies, it is complicated to parse out regional differences in price, supply, and insurance coverage to advocate best for each patient and land upon the delicate balance between efficacy, safety, and financial stewardship, both at an individual and community level. I will outline some challenges and solutions to the management of acne amidst these complicated factors.

Oral Therapies

For isotretinoin, generic choices, cost, and tiering within insurance plans are perpetual moving targets despite the drug being the only member of its class.1 Prescriber resources include tandem searches of electronic medical record price estimates within each insurance formulary, individual pharmacy search engines, and compilation mobile applications such as GoodRx to select the most affordable version for each patient. As an example of a regional trend, isotretinoin generic coverage by one provider in Pennsylvania shifted earlier this year so that every patient, whether new to isotretinoin or midcourse, required a new prior authorization with more stringent coverage requirements including failure of 2 oral antibiotics. Swiftly thereafter, efforts across the state driven by the Pennsylvania Academy of Dermatology and Dermatologic Surgery and its members and fueled by poignant patient vignettes about fragmented and substandard patient care helped to reverse this policy and remove the prior authorization mandate.2

Tetracyclines have experienced broad cost swings, mostly based on disruption of manufacturing at the limited number of distribution sites in the United States. In 2011, a tetracycline shortage arose due to a major manufacturer’s recall3 and persisted with subsequent material shortages, as doxycycline became the preferred and cheaper member of the class. Doxycycline price tag hikes then occurred following Hurricane Sandy when an East Coast manufacturing site was damaged.3 Spironolactone backorder also has been frequent due to recent raw material shortages and delays in production,3 forcing pharmacies to refill small amounts of medication in various dosage forms despite patients owing the same copayment per prescription.

Topical Therapies

Topical retinoid prescription affordability has always been fraught with difficulty owing to age cutoffs because it is often restricted to patients younger than 25 or 40 years, depending on the plan,4,5 but the availability of adapalene gel 0.1% as an OTC preparation in 2016 has broadened retinoid access and use.6 Prescription benzoyl peroxide (BPO) products alone or in combination with retinoids or topical antibiotics (or other combination topical therapies) comprise a large number of branded prescriptions often not covered by insurance or are only affordable using proprietary and intermittently available coupon cards (eg, BPO-clindamycin, clindamycin-tretinoin, BPO-adapalene); therefore, prescribers tend to dispense the individual ingredients and instruct the patient to compound them at home. Furthermore, BPO products can be purchased in effective concentrations as OTC products, and patients looking to procure more affordable, albeit less effective, topical retinoids that also have less irritation potential reach for OTC nightly retinol creams nestled in the antiaging section of the pharmacy.7

Opportunities to be involved in the larger scaffold of patient advocacy also are plentiful at the state and national levels. For example, with the support of dermatology state societies and the American Academy of Dermatology Association, Pennsylvania House Bill 22118 and similar bills in other states call for reversal of the gag clause that prevents pharmacists from disclosing the best medication price to patients. Also guided by the American Academy of Dermatology Association, prior authorization model legislation to promote transparency across insurers in this haphazard process is emerging across the country.9,10

Final Thoughts

These examples of acne medication access and cost quandaries serve to embody the daily problem-solving that dermatologists execute as part of their growing administrative and economic duties. They also represent worthy efforts to consider on behalf of patients, their pocketbooks, and the prudent use of their dermatologists’ time.

We are fortunate to have plentiful acne treatment options available that cater to each patient’s clinical examination, predispositions, and triggers, but the choices are daunting amidst the vast prescription and over-the-counter (OTC) topicals available along with disparate insurance and cost nuances. In addition, when prescribing generic oral therapies, it is complicated to parse out regional differences in price, supply, and insurance coverage to advocate best for each patient and land upon the delicate balance between efficacy, safety, and financial stewardship, both at an individual and community level. I will outline some challenges and solutions to the management of acne amidst these complicated factors.

Oral Therapies

For isotretinoin, generic choices, cost, and tiering within insurance plans are perpetual moving targets despite the drug being the only member of its class.1 Prescriber resources include tandem searches of electronic medical record price estimates within each insurance formulary, individual pharmacy search engines, and compilation mobile applications such as GoodRx to select the most affordable version for each patient. As an example of a regional trend, isotretinoin generic coverage by one provider in Pennsylvania shifted earlier this year so that every patient, whether new to isotretinoin or midcourse, required a new prior authorization with more stringent coverage requirements including failure of 2 oral antibiotics. Swiftly thereafter, efforts across the state driven by the Pennsylvania Academy of Dermatology and Dermatologic Surgery and its members and fueled by poignant patient vignettes about fragmented and substandard patient care helped to reverse this policy and remove the prior authorization mandate.2

Tetracyclines have experienced broad cost swings, mostly based on disruption of manufacturing at the limited number of distribution sites in the United States. In 2011, a tetracycline shortage arose due to a major manufacturer’s recall3 and persisted with subsequent material shortages, as doxycycline became the preferred and cheaper member of the class. Doxycycline price tag hikes then occurred following Hurricane Sandy when an East Coast manufacturing site was damaged.3 Spironolactone backorder also has been frequent due to recent raw material shortages and delays in production,3 forcing pharmacies to refill small amounts of medication in various dosage forms despite patients owing the same copayment per prescription.

Topical Therapies

Topical retinoid prescription affordability has always been fraught with difficulty owing to age cutoffs because it is often restricted to patients younger than 25 or 40 years, depending on the plan,4,5 but the availability of adapalene gel 0.1% as an OTC preparation in 2016 has broadened retinoid access and use.6 Prescription benzoyl peroxide (BPO) products alone or in combination with retinoids or topical antibiotics (or other combination topical therapies) comprise a large number of branded prescriptions often not covered by insurance or are only affordable using proprietary and intermittently available coupon cards (eg, BPO-clindamycin, clindamycin-tretinoin, BPO-adapalene); therefore, prescribers tend to dispense the individual ingredients and instruct the patient to compound them at home. Furthermore, BPO products can be purchased in effective concentrations as OTC products, and patients looking to procure more affordable, albeit less effective, topical retinoids that also have less irritation potential reach for OTC nightly retinol creams nestled in the antiaging section of the pharmacy.7

Opportunities to be involved in the larger scaffold of patient advocacy also are plentiful at the state and national levels. For example, with the support of dermatology state societies and the American Academy of Dermatology Association, Pennsylvania House Bill 22118 and similar bills in other states call for reversal of the gag clause that prevents pharmacists from disclosing the best medication price to patients. Also guided by the American Academy of Dermatology Association, prior authorization model legislation to promote transparency across insurers in this haphazard process is emerging across the country.9,10

Final Thoughts

These examples of acne medication access and cost quandaries serve to embody the daily problem-solving that dermatologists execute as part of their growing administrative and economic duties. They also represent worthy efforts to consider on behalf of patients, their pocketbooks, and the prudent use of their dermatologists’ time.

References
  1. Borgonjen RJ, de Lange JA, van de Kerkhof PCM. Guideline-based clinical decision support in acne patients receiving isotretinoin: improving adherence and cost-effectiveness. J Eur Acad Dermatol Venereol. 2017;31:e440-e442.
  2. Oral isotretinoin therapy update. Highmark website. https://content.highmarkprc.com/Files/NewsletterNotices/HotTopics/ht-all-isotretinoin-therapy-update-051718.pdf. Published May 17, 2018. Accessed June 29, 2018.
  3. Drug shortages. US Food & Drug Administration website. https://www.fda.gov/drugs/drugsafety/drugshortages/default.htm. Updated June 19, 2018. Accessed June 19, 2018.
  4. Retinoids prior authorization criteria. Blue Cross and Blue Shield of Illinois website. https://www.bcbsil.com/provider/pdf/retinoids.pdf. Published March 2008. Accessed June 18, 2018.
  5. Davis SA, Huang KE, Feldman SR, et al. Trends in ambulatory health care usage for adult acne. J Cutan Med Surg. 2015;19:377-379.
  6. FDA approves Differin gel 0.1% for over-the-counter use to treat acne [press release]. Silver Spring, MD: US Food & Drug Administration; July 8, 2016.
  7. Rosamilia LL. Over-the-counter treatments for acne and rosacea. Semin Cutan Med Surg. 2016;35:87-95.
  8. An Act Providing for Consumer Prescription Drug Pricing Disclosure, HB 2211, Regular Sess (Pa 2018).
  9. An Act Providing for Preauthorizations Conducted by Utilization Review Entities Relating to Health Care Services, HB 1293, Regular Sess (Pa 2017).
  10. Step therapy legislation. American Academy of Dermatology website. https://www.aad.org/advocacy/state-policy/step-therapy-legislation. Accessed June 19, 2018.
References
  1. Borgonjen RJ, de Lange JA, van de Kerkhof PCM. Guideline-based clinical decision support in acne patients receiving isotretinoin: improving adherence and cost-effectiveness. J Eur Acad Dermatol Venereol. 2017;31:e440-e442.
  2. Oral isotretinoin therapy update. Highmark website. https://content.highmarkprc.com/Files/NewsletterNotices/HotTopics/ht-all-isotretinoin-therapy-update-051718.pdf. Published May 17, 2018. Accessed June 29, 2018.
  3. Drug shortages. US Food & Drug Administration website. https://www.fda.gov/drugs/drugsafety/drugshortages/default.htm. Updated June 19, 2018. Accessed June 19, 2018.
  4. Retinoids prior authorization criteria. Blue Cross and Blue Shield of Illinois website. https://www.bcbsil.com/provider/pdf/retinoids.pdf. Published March 2008. Accessed June 18, 2018.
  5. Davis SA, Huang KE, Feldman SR, et al. Trends in ambulatory health care usage for adult acne. J Cutan Med Surg. 2015;19:377-379.
  6. FDA approves Differin gel 0.1% for over-the-counter use to treat acne [press release]. Silver Spring, MD: US Food & Drug Administration; July 8, 2016.
  7. Rosamilia LL. Over-the-counter treatments for acne and rosacea. Semin Cutan Med Surg. 2016;35:87-95.
  8. An Act Providing for Consumer Prescription Drug Pricing Disclosure, HB 2211, Regular Sess (Pa 2018).
  9. An Act Providing for Preauthorizations Conducted by Utilization Review Entities Relating to Health Care Services, HB 1293, Regular Sess (Pa 2017).
  10. Step therapy legislation. American Academy of Dermatology website. https://www.aad.org/advocacy/state-policy/step-therapy-legislation. Accessed June 19, 2018.
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ICD use curbed in hospitals named in federal lawsuit

Sometimes a stick works better than a carrot
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A 2005 update in Medicare reimbursement policy had a modest effect on the use of implantable cardioverter defibrillators for primary prevention, but it took a whistle-blower and a federal lawsuit to bring the numbers down substantially.

Usage dropped just slightly from 2007 to 2009, after Medicare updated its appropriate use criteria, Nihar R. Desai, MD, MPH, and his colleagues reported in JAMA. From 2010 to 2011, after the Department of Justice suit became public knowledge, the declines were significantly greater: 7.4% in hospitals that eventually settled for a total of $280 million, and 4.7% in hospitals that weren’t named in the suit.

The government launched the suit in 2010, after a whistle-blower used Medicare data to allege that many hospitals weren’t waiting the appropriate amount of time to implant an implantable cardioverter defibrillator (ICD) after a heart attack or coronary revascularization, wrote Dr. Desai of Yale University, New Haven, Conn., and his team. These procedures would have been against the 2005 Centers for Medicare & Medicaid Services National Coverage Determination (NCD), which required delaying implantation for 40 days after a heart attack and 90 days after a revascularization.

Just a year after the suit was filed, an independent investigator concluded that 22.5% of the ICDs implanted from 2006 to 2009 for primary prevention were not evidence based.

Dr. Desai and his coauthors used CMS data to examine changes in the proportion of primary-prevention ICD implantations at hospitals that eventually settled the suit, and those that did not. The study spanned 2007-2015 and comprised 1,809 U.S. hospitals in the National Cardiovascular Data Registry ICD Registry; of these, 452 hospitals that had done 99,591 procedures reached settlements.

After the steeper drops in 2010 and 2011, the number of procedures leveled off. From July 2011 to 2015, the proportions of ICDs not meeting the NCD criteria were similar and stable in both hospital settlement groups, with an annual change of −0.5% for settlement hospitals and −0.4% for nonsettlement hospitals, the team wrote.

Despite the changes, there was “persistent variation” among hospitals, with more than 14% of the primary-prevention ICDs not meeting NCD criteria at some of the worst-performing hospitals.

The decreases weren’t just in Medicare beneficiaries, though. Hospitals were rethinking this indication for ICD use in everyone, although the investigators found no evidence that the changing clinical landscape endangered the health of patients.

“The analyses of secondary prevention ICDs do not suggest that access to necessary procedures was negatively affected by the investigation. … These analyses offer some reassurance, but further research into hospital responses to the investigation could offer additional insights about possible unintended consequences,” the investigators wrote.

The study was sponsored by the Agency for Healthcare Research and Quality. Dr. Desai had no financial disclosures.

SOURCE: Desai NR et al. JAMA. 2018; 320: 63-71.

Body

 

The federal investigation into inappropriate use of implanted cardioverter defibrillators (ICDs) appeared to be highly effective, both in recovering costs and changing behavior at hospitals.

Even though individuals were not the focus of the investigation, many physicians sensed a new exposure to civil liability, if not criminal penalties, and felt accused of providing substandard care. Did this investigation have the intended effect of improving care?

The numbers suggest it did.

The observed decrease in use raises the question of whether appropriate ICDs were also avoided, a potential unintended consequence of the investigation. The study by Desai et al noted that ICD implantations for secondary prevention remained relatively stable during this period, suggesting that appropriate ICD use likely did not decline substantially.

The investigation also clearly showed the power of a large, financially intimidating legal action.

The mere announcement of the investigation appeared to have a large and immediate influence on prompting hospitals to limit inappropriate ICD implantation for primary prevention. As a form of audit and feedback, the Department of Justice investigation appeared to be highly effective in changing practice. Past studies of audit and feedback show relatively modest effects on changing physician behavior, although these studies did not involve allegations of fraud with financial penalties. Clearly, the reward or penalty attached to the feedback influences clinician behavior with penalties likely more effective in promoting change.

Paul A. Heidenreich, MD, professor of cardiovascular medicine at Stanford (Calif.) University, made these comments in an accompanying editorial (JAMA. 2018; 320:40-2).

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The federal investigation into inappropriate use of implanted cardioverter defibrillators (ICDs) appeared to be highly effective, both in recovering costs and changing behavior at hospitals.

Even though individuals were not the focus of the investigation, many physicians sensed a new exposure to civil liability, if not criminal penalties, and felt accused of providing substandard care. Did this investigation have the intended effect of improving care?

The numbers suggest it did.

The observed decrease in use raises the question of whether appropriate ICDs were also avoided, a potential unintended consequence of the investigation. The study by Desai et al noted that ICD implantations for secondary prevention remained relatively stable during this period, suggesting that appropriate ICD use likely did not decline substantially.

The investigation also clearly showed the power of a large, financially intimidating legal action.

The mere announcement of the investigation appeared to have a large and immediate influence on prompting hospitals to limit inappropriate ICD implantation for primary prevention. As a form of audit and feedback, the Department of Justice investigation appeared to be highly effective in changing practice. Past studies of audit and feedback show relatively modest effects on changing physician behavior, although these studies did not involve allegations of fraud with financial penalties. Clearly, the reward or penalty attached to the feedback influences clinician behavior with penalties likely more effective in promoting change.

Paul A. Heidenreich, MD, professor of cardiovascular medicine at Stanford (Calif.) University, made these comments in an accompanying editorial (JAMA. 2018; 320:40-2).

Body

 

The federal investigation into inappropriate use of implanted cardioverter defibrillators (ICDs) appeared to be highly effective, both in recovering costs and changing behavior at hospitals.

Even though individuals were not the focus of the investigation, many physicians sensed a new exposure to civil liability, if not criminal penalties, and felt accused of providing substandard care. Did this investigation have the intended effect of improving care?

The numbers suggest it did.

The observed decrease in use raises the question of whether appropriate ICDs were also avoided, a potential unintended consequence of the investigation. The study by Desai et al noted that ICD implantations for secondary prevention remained relatively stable during this period, suggesting that appropriate ICD use likely did not decline substantially.

The investigation also clearly showed the power of a large, financially intimidating legal action.

The mere announcement of the investigation appeared to have a large and immediate influence on prompting hospitals to limit inappropriate ICD implantation for primary prevention. As a form of audit and feedback, the Department of Justice investigation appeared to be highly effective in changing practice. Past studies of audit and feedback show relatively modest effects on changing physician behavior, although these studies did not involve allegations of fraud with financial penalties. Clearly, the reward or penalty attached to the feedback influences clinician behavior with penalties likely more effective in promoting change.

Paul A. Heidenreich, MD, professor of cardiovascular medicine at Stanford (Calif.) University, made these comments in an accompanying editorial (JAMA. 2018; 320:40-2).

Title
Sometimes a stick works better than a carrot
Sometimes a stick works better than a carrot

 

A 2005 update in Medicare reimbursement policy had a modest effect on the use of implantable cardioverter defibrillators for primary prevention, but it took a whistle-blower and a federal lawsuit to bring the numbers down substantially.

Usage dropped just slightly from 2007 to 2009, after Medicare updated its appropriate use criteria, Nihar R. Desai, MD, MPH, and his colleagues reported in JAMA. From 2010 to 2011, after the Department of Justice suit became public knowledge, the declines were significantly greater: 7.4% in hospitals that eventually settled for a total of $280 million, and 4.7% in hospitals that weren’t named in the suit.

The government launched the suit in 2010, after a whistle-blower used Medicare data to allege that many hospitals weren’t waiting the appropriate amount of time to implant an implantable cardioverter defibrillator (ICD) after a heart attack or coronary revascularization, wrote Dr. Desai of Yale University, New Haven, Conn., and his team. These procedures would have been against the 2005 Centers for Medicare & Medicaid Services National Coverage Determination (NCD), which required delaying implantation for 40 days after a heart attack and 90 days after a revascularization.

Just a year after the suit was filed, an independent investigator concluded that 22.5% of the ICDs implanted from 2006 to 2009 for primary prevention were not evidence based.

Dr. Desai and his coauthors used CMS data to examine changes in the proportion of primary-prevention ICD implantations at hospitals that eventually settled the suit, and those that did not. The study spanned 2007-2015 and comprised 1,809 U.S. hospitals in the National Cardiovascular Data Registry ICD Registry; of these, 452 hospitals that had done 99,591 procedures reached settlements.

After the steeper drops in 2010 and 2011, the number of procedures leveled off. From July 2011 to 2015, the proportions of ICDs not meeting the NCD criteria were similar and stable in both hospital settlement groups, with an annual change of −0.5% for settlement hospitals and −0.4% for nonsettlement hospitals, the team wrote.

Despite the changes, there was “persistent variation” among hospitals, with more than 14% of the primary-prevention ICDs not meeting NCD criteria at some of the worst-performing hospitals.

The decreases weren’t just in Medicare beneficiaries, though. Hospitals were rethinking this indication for ICD use in everyone, although the investigators found no evidence that the changing clinical landscape endangered the health of patients.

“The analyses of secondary prevention ICDs do not suggest that access to necessary procedures was negatively affected by the investigation. … These analyses offer some reassurance, but further research into hospital responses to the investigation could offer additional insights about possible unintended consequences,” the investigators wrote.

The study was sponsored by the Agency for Healthcare Research and Quality. Dr. Desai had no financial disclosures.

SOURCE: Desai NR et al. JAMA. 2018; 320: 63-71.

 

A 2005 update in Medicare reimbursement policy had a modest effect on the use of implantable cardioverter defibrillators for primary prevention, but it took a whistle-blower and a federal lawsuit to bring the numbers down substantially.

Usage dropped just slightly from 2007 to 2009, after Medicare updated its appropriate use criteria, Nihar R. Desai, MD, MPH, and his colleagues reported in JAMA. From 2010 to 2011, after the Department of Justice suit became public knowledge, the declines were significantly greater: 7.4% in hospitals that eventually settled for a total of $280 million, and 4.7% in hospitals that weren’t named in the suit.

The government launched the suit in 2010, after a whistle-blower used Medicare data to allege that many hospitals weren’t waiting the appropriate amount of time to implant an implantable cardioverter defibrillator (ICD) after a heart attack or coronary revascularization, wrote Dr. Desai of Yale University, New Haven, Conn., and his team. These procedures would have been against the 2005 Centers for Medicare & Medicaid Services National Coverage Determination (NCD), which required delaying implantation for 40 days after a heart attack and 90 days after a revascularization.

Just a year after the suit was filed, an independent investigator concluded that 22.5% of the ICDs implanted from 2006 to 2009 for primary prevention were not evidence based.

Dr. Desai and his coauthors used CMS data to examine changes in the proportion of primary-prevention ICD implantations at hospitals that eventually settled the suit, and those that did not. The study spanned 2007-2015 and comprised 1,809 U.S. hospitals in the National Cardiovascular Data Registry ICD Registry; of these, 452 hospitals that had done 99,591 procedures reached settlements.

After the steeper drops in 2010 and 2011, the number of procedures leveled off. From July 2011 to 2015, the proportions of ICDs not meeting the NCD criteria were similar and stable in both hospital settlement groups, with an annual change of −0.5% for settlement hospitals and −0.4% for nonsettlement hospitals, the team wrote.

Despite the changes, there was “persistent variation” among hospitals, with more than 14% of the primary-prevention ICDs not meeting NCD criteria at some of the worst-performing hospitals.

The decreases weren’t just in Medicare beneficiaries, though. Hospitals were rethinking this indication for ICD use in everyone, although the investigators found no evidence that the changing clinical landscape endangered the health of patients.

“The analyses of secondary prevention ICDs do not suggest that access to necessary procedures was negatively affected by the investigation. … These analyses offer some reassurance, but further research into hospital responses to the investigation could offer additional insights about possible unintended consequences,” the investigators wrote.

The study was sponsored by the Agency for Healthcare Research and Quality. Dr. Desai had no financial disclosures.

SOURCE: Desai NR et al. JAMA. 2018; 320: 63-71.

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Key clinical point: A federal lawsuit against hospitals changed the practice of using implantable cardioverter defibrillators for primary prevention.

Major finding: In the year after the Department of Justice lawsuit was announced, ICD for primary prevention use dropped 7.4% in hospitals that settled and dropped 4.7% in hospitals that were nonsettlers.

Study details: An analysis of data from the Centers for Medicare & Medicaid Services.

Disclosures: The Agency for Healthcare Research and Quality sponsored the study. Dr. Desai had no financial disclosures.

Source: Desai NR et al. JAMA. 2018; 320:63-71.

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Rapid venetoclax dose escalation aids relapsed CLL

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STOCKHOLM – Patients with chronic lymphocytic leukemia (CLL) who experience relapse after therapy with a B-cell receptor signaling inhibitor tend to have a swiftly progressive disease course that requires immediate intervention. For these patients, a rapid venetoclax dose-escalation protocol may be a safe way to quickly regain disease control, and possibly bridge to salvage therapies, investigators reported.

Of 15 patients with CLL who relapsed after treatment with a B-cell receptor inhibitor (BCRi), all were able to get to their target dose of venetoclax under close inpatient monitoring at a median of 12 days, compared with the 35 days usually required for venetoclax dose escalation, reported Farrukh T. Awan, MD, of Ohio State University Comprehensive Cancer Center in Columbus, and his colleagues.

Only two patients developed clinical tumor lysis syndrome (TLS), a common occurrence with venetoclax therapy, and this adverse event was manageable, Dr. Awan said at the annual congress of the European Hematology Association.

“The reason why we have been doing a slow ramp up on venetoclax is the original toxicity issues that we saw early on,” he said in an interview. “But unfortunately, a lot of patients are progressing on these new agents and have very rapid disease progression, and what we have seen is that if you stop the ibrutinib, the disease progresses very quickly, and by the time they can get up to the effective dose of venetoclax, they’re too sick to continue, or they might even die from disease progression.”

Neil Osterweil/MDedge News
Dr. Farrukh T. Awan


To combat this problem, Dr. Awan and his colleagues developed a rapid dose escalation protocol that would ramp up from 20 mg to 400 mg, with increases every 1 or 2 days depending on tolerability and incident TLS. Lab tests for TLS were evaluated every 4-8 hours.

All patients were closely monitored in the hospital, and all were started on allopurinol or other uric acid–lowering agents before starting on venetoclax.

The investigators reported safety and efficacy outcomes for the patients in a retrospective analysis.

The median age of the patients, 12 men and 3 women, was 65 years (range, 58-86 years). Seven patients had Eastern Cooperative Oncology Group Performance Status of 0, seven had an ECOG score of 1, and one had a score of 2-4.

Ten patients had most recently been treated with a BCRi, either a Bruton’s tyrosine kinase inhibitor (ibrutinib or acalabrutinib), idelalisib, or entospletinib. Three patients received ibrutinib plus chemotherapy, and two received rituximab and dexamethasone followed by rituximab maintenance.

The median time to full venetoclax dose was 12 days (range, 5-21 days) and all 15 patients reached the target dose. The mean length of stay during the ramp-up period was 9.5 days (range, 6-22 days).
 

The incidence of clinical TLS was 13.2%, occurring in two patients, one at the initial 20-mg dose, and one at the 200-mg dose level. Another five patients had asymptomatic TLS. Other treatment-related adverse events were anemia in seven patients, neutropenia in six patients, thrombocytopenia in five patients, and lung infection in one patient.

 

 

Twelve patients had a partial response, one had stable disease, and two had progressive disease. The mean time to best response was 71 days.

One-year progression-free survival was 49%, and 1-year overall survival was 68%.

The investigators found that for patients who still have some disease control with a BCRi, it may be possible to keep them on that drug while transitioning to venetoclax. The rapid dose escalation protocol should only be attempted in highly experience comprehensive cancer centers, Dr. Awan said.

“Under very close monitoring in an experienced inpatient setting, where the nurses are very used to doing this on a weekly basis in a very high volume center, I think that our data show that we could do this without affecting toxicity significantly or mortality,” he said.

Venetoclax therapy could buy enough time for patients to bridge to other options, such as chimeric antigen receptor (CAR) T-cell therapy or allogeneic stem cell transplant, he noted.

“But if we had waited 4 weeks, most of these patients would not have made it,” he said.

The study was internally funded. Dr. Awan reported research funding from Gilead, Pharmacyclics, AbbVie, and Janssen.

SOURCE: Koenig K et al. EHA Congress, Abstract PF357.

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STOCKHOLM – Patients with chronic lymphocytic leukemia (CLL) who experience relapse after therapy with a B-cell receptor signaling inhibitor tend to have a swiftly progressive disease course that requires immediate intervention. For these patients, a rapid venetoclax dose-escalation protocol may be a safe way to quickly regain disease control, and possibly bridge to salvage therapies, investigators reported.

Of 15 patients with CLL who relapsed after treatment with a B-cell receptor inhibitor (BCRi), all were able to get to their target dose of venetoclax under close inpatient monitoring at a median of 12 days, compared with the 35 days usually required for venetoclax dose escalation, reported Farrukh T. Awan, MD, of Ohio State University Comprehensive Cancer Center in Columbus, and his colleagues.

Only two patients developed clinical tumor lysis syndrome (TLS), a common occurrence with venetoclax therapy, and this adverse event was manageable, Dr. Awan said at the annual congress of the European Hematology Association.

“The reason why we have been doing a slow ramp up on venetoclax is the original toxicity issues that we saw early on,” he said in an interview. “But unfortunately, a lot of patients are progressing on these new agents and have very rapid disease progression, and what we have seen is that if you stop the ibrutinib, the disease progresses very quickly, and by the time they can get up to the effective dose of venetoclax, they’re too sick to continue, or they might even die from disease progression.”

Neil Osterweil/MDedge News
Dr. Farrukh T. Awan


To combat this problem, Dr. Awan and his colleagues developed a rapid dose escalation protocol that would ramp up from 20 mg to 400 mg, with increases every 1 or 2 days depending on tolerability and incident TLS. Lab tests for TLS were evaluated every 4-8 hours.

All patients were closely monitored in the hospital, and all were started on allopurinol or other uric acid–lowering agents before starting on venetoclax.

The investigators reported safety and efficacy outcomes for the patients in a retrospective analysis.

The median age of the patients, 12 men and 3 women, was 65 years (range, 58-86 years). Seven patients had Eastern Cooperative Oncology Group Performance Status of 0, seven had an ECOG score of 1, and one had a score of 2-4.

Ten patients had most recently been treated with a BCRi, either a Bruton’s tyrosine kinase inhibitor (ibrutinib or acalabrutinib), idelalisib, or entospletinib. Three patients received ibrutinib plus chemotherapy, and two received rituximab and dexamethasone followed by rituximab maintenance.

The median time to full venetoclax dose was 12 days (range, 5-21 days) and all 15 patients reached the target dose. The mean length of stay during the ramp-up period was 9.5 days (range, 6-22 days).
 

The incidence of clinical TLS was 13.2%, occurring in two patients, one at the initial 20-mg dose, and one at the 200-mg dose level. Another five patients had asymptomatic TLS. Other treatment-related adverse events were anemia in seven patients, neutropenia in six patients, thrombocytopenia in five patients, and lung infection in one patient.

 

 

Twelve patients had a partial response, one had stable disease, and two had progressive disease. The mean time to best response was 71 days.

One-year progression-free survival was 49%, and 1-year overall survival was 68%.

The investigators found that for patients who still have some disease control with a BCRi, it may be possible to keep them on that drug while transitioning to venetoclax. The rapid dose escalation protocol should only be attempted in highly experience comprehensive cancer centers, Dr. Awan said.

“Under very close monitoring in an experienced inpatient setting, where the nurses are very used to doing this on a weekly basis in a very high volume center, I think that our data show that we could do this without affecting toxicity significantly or mortality,” he said.

Venetoclax therapy could buy enough time for patients to bridge to other options, such as chimeric antigen receptor (CAR) T-cell therapy or allogeneic stem cell transplant, he noted.

“But if we had waited 4 weeks, most of these patients would not have made it,” he said.

The study was internally funded. Dr. Awan reported research funding from Gilead, Pharmacyclics, AbbVie, and Janssen.

SOURCE: Koenig K et al. EHA Congress, Abstract PF357.

 

STOCKHOLM – Patients with chronic lymphocytic leukemia (CLL) who experience relapse after therapy with a B-cell receptor signaling inhibitor tend to have a swiftly progressive disease course that requires immediate intervention. For these patients, a rapid venetoclax dose-escalation protocol may be a safe way to quickly regain disease control, and possibly bridge to salvage therapies, investigators reported.

Of 15 patients with CLL who relapsed after treatment with a B-cell receptor inhibitor (BCRi), all were able to get to their target dose of venetoclax under close inpatient monitoring at a median of 12 days, compared with the 35 days usually required for venetoclax dose escalation, reported Farrukh T. Awan, MD, of Ohio State University Comprehensive Cancer Center in Columbus, and his colleagues.

Only two patients developed clinical tumor lysis syndrome (TLS), a common occurrence with venetoclax therapy, and this adverse event was manageable, Dr. Awan said at the annual congress of the European Hematology Association.

“The reason why we have been doing a slow ramp up on venetoclax is the original toxicity issues that we saw early on,” he said in an interview. “But unfortunately, a lot of patients are progressing on these new agents and have very rapid disease progression, and what we have seen is that if you stop the ibrutinib, the disease progresses very quickly, and by the time they can get up to the effective dose of venetoclax, they’re too sick to continue, or they might even die from disease progression.”

Neil Osterweil/MDedge News
Dr. Farrukh T. Awan


To combat this problem, Dr. Awan and his colleagues developed a rapid dose escalation protocol that would ramp up from 20 mg to 400 mg, with increases every 1 or 2 days depending on tolerability and incident TLS. Lab tests for TLS were evaluated every 4-8 hours.

All patients were closely monitored in the hospital, and all were started on allopurinol or other uric acid–lowering agents before starting on venetoclax.

The investigators reported safety and efficacy outcomes for the patients in a retrospective analysis.

The median age of the patients, 12 men and 3 women, was 65 years (range, 58-86 years). Seven patients had Eastern Cooperative Oncology Group Performance Status of 0, seven had an ECOG score of 1, and one had a score of 2-4.

Ten patients had most recently been treated with a BCRi, either a Bruton’s tyrosine kinase inhibitor (ibrutinib or acalabrutinib), idelalisib, or entospletinib. Three patients received ibrutinib plus chemotherapy, and two received rituximab and dexamethasone followed by rituximab maintenance.

The median time to full venetoclax dose was 12 days (range, 5-21 days) and all 15 patients reached the target dose. The mean length of stay during the ramp-up period was 9.5 days (range, 6-22 days).
 

The incidence of clinical TLS was 13.2%, occurring in two patients, one at the initial 20-mg dose, and one at the 200-mg dose level. Another five patients had asymptomatic TLS. Other treatment-related adverse events were anemia in seven patients, neutropenia in six patients, thrombocytopenia in five patients, and lung infection in one patient.

 

 

Twelve patients had a partial response, one had stable disease, and two had progressive disease. The mean time to best response was 71 days.

One-year progression-free survival was 49%, and 1-year overall survival was 68%.

The investigators found that for patients who still have some disease control with a BCRi, it may be possible to keep them on that drug while transitioning to venetoclax. The rapid dose escalation protocol should only be attempted in highly experience comprehensive cancer centers, Dr. Awan said.

“Under very close monitoring in an experienced inpatient setting, where the nurses are very used to doing this on a weekly basis in a very high volume center, I think that our data show that we could do this without affecting toxicity significantly or mortality,” he said.

Venetoclax therapy could buy enough time for patients to bridge to other options, such as chimeric antigen receptor (CAR) T-cell therapy or allogeneic stem cell transplant, he noted.

“But if we had waited 4 weeks, most of these patients would not have made it,” he said.

The study was internally funded. Dr. Awan reported research funding from Gilead, Pharmacyclics, AbbVie, and Janssen.

SOURCE: Koenig K et al. EHA Congress, Abstract PF357.

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Key clinical point: Quick ramp up of venetoclax dosing in relapsed CLL appears safe.

Major finding: All patients reached the target dose of venetoclax, with only two cases of manageable clinical tumor lysis syndrome.

Study details: Retrospective analysis of outcomes for 15 patients with CLL who relapsed after treatment with a B-cell receptor signaling inhibitor.

Disclosures: The study was internally funded. Dr. Awan reported research funding from Gilead, Pharmacyclics, AbbVie, and Janssen.

Source: Koenig K et al. EHA Congress, Abstract PF357.

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When he was about 12, a now 41-year-old man noticed that the skin on his left chest was darkening. For several years afterward, the darkness spread and deepened, and the area became hairy. In young adulthood, he experienced occasional outbreaks of what looked like acne on the lesion; this eventually cleared.

He now finds the hairiness increasingly bothersome, so he shaves the worst parts of it. Upon consulting his primary care provider, he was assured that the lesion is “a birthmark.” Unsatisfied with this answer, the patient took the advice of a friend and decided to consult dermatology.

EXAMINATION
A polygonal, hyperpigmented, hypertrichotic patch covers most of the patient’s left pectoral area. The lateral margin is irregular but well-defined. There is obvious partial regrowth of the shaved hair on the lateral margin, but it stops abruptly at that point.

The breast and surrounding tissue appear normal. No areas of hyperpigmentation or hypertrichosis are seen elsewhere.

What is the diagnosis?

 

 

DISCUSSION
First described by William Becker in 1948 (and subsequently named for him), the Becker nevus (BN) received little research attention until a French study of 20,000 young men showed a prevalence of 0.5%. Nearly half of the subjects had first noticed the lesion before the age of 10—a somewhat surprising finding, since abundant evidence implicates androgens in its genesis. (This is supported by the condition’s predominance in males, the increased numbers of androgen receptors and melanocytes in the affected skin, and the prevalence of hypertrichosis.)

The researchers were also surprised to find that only 30% of the reported lesions occurred above the nipple, because the first descriptions of BN gave the impression that the shoulder and chest were most commonly affected. We now know that BN can also be found on arms and legs.

Usually a benign condition, BN can be associated with skeletal or soft-tissue deformities in the affected area (eg, ipsilateral breast hypoplasia). Malignancies—most notably melanoma—have also been reported with BN but are especially uncommon.

The differential includes the café-au-lait macules of neurofibromatosis, Albright disease, and congenital melanocytic nevus. The history of BN (ie, presentation, hypertrichosis, gender of patient, and distribution) usually allow a clinical diagnosis.

Treatment is limited to laser hair removal or laser removal or reduction of pigment.

TAKE-HOME LEARNING POINTS

  • Becker nevus (BN) is far more common in males than females.
  • BN typically manifests during puberty, which aligns with the suspected androgenic etiology.
  • Though the shoulders and chest are the most commonly affected areas, BNs can also appear on the flank, arms, or legs.
  • The lesions are rarely associated with serious pathology; hypoplasia of the ipsilateral breast is the most common of these complications.
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When he was about 12, a now 41-year-old man noticed that the skin on his left chest was darkening. For several years afterward, the darkness spread and deepened, and the area became hairy. In young adulthood, he experienced occasional outbreaks of what looked like acne on the lesion; this eventually cleared.

He now finds the hairiness increasingly bothersome, so he shaves the worst parts of it. Upon consulting his primary care provider, he was assured that the lesion is “a birthmark.” Unsatisfied with this answer, the patient took the advice of a friend and decided to consult dermatology.

EXAMINATION
A polygonal, hyperpigmented, hypertrichotic patch covers most of the patient’s left pectoral area. The lateral margin is irregular but well-defined. There is obvious partial regrowth of the shaved hair on the lateral margin, but it stops abruptly at that point.

The breast and surrounding tissue appear normal. No areas of hyperpigmentation or hypertrichosis are seen elsewhere.

What is the diagnosis?

 

 

DISCUSSION
First described by William Becker in 1948 (and subsequently named for him), the Becker nevus (BN) received little research attention until a French study of 20,000 young men showed a prevalence of 0.5%. Nearly half of the subjects had first noticed the lesion before the age of 10—a somewhat surprising finding, since abundant evidence implicates androgens in its genesis. (This is supported by the condition’s predominance in males, the increased numbers of androgen receptors and melanocytes in the affected skin, and the prevalence of hypertrichosis.)

The researchers were also surprised to find that only 30% of the reported lesions occurred above the nipple, because the first descriptions of BN gave the impression that the shoulder and chest were most commonly affected. We now know that BN can also be found on arms and legs.

Usually a benign condition, BN can be associated with skeletal or soft-tissue deformities in the affected area (eg, ipsilateral breast hypoplasia). Malignancies—most notably melanoma—have also been reported with BN but are especially uncommon.

The differential includes the café-au-lait macules of neurofibromatosis, Albright disease, and congenital melanocytic nevus. The history of BN (ie, presentation, hypertrichosis, gender of patient, and distribution) usually allow a clinical diagnosis.

Treatment is limited to laser hair removal or laser removal or reduction of pigment.

TAKE-HOME LEARNING POINTS

  • Becker nevus (BN) is far more common in males than females.
  • BN typically manifests during puberty, which aligns with the suspected androgenic etiology.
  • Though the shoulders and chest are the most commonly affected areas, BNs can also appear on the flank, arms, or legs.
  • The lesions are rarely associated with serious pathology; hypoplasia of the ipsilateral breast is the most common of these complications.

When he was about 12, a now 41-year-old man noticed that the skin on his left chest was darkening. For several years afterward, the darkness spread and deepened, and the area became hairy. In young adulthood, he experienced occasional outbreaks of what looked like acne on the lesion; this eventually cleared.

He now finds the hairiness increasingly bothersome, so he shaves the worst parts of it. Upon consulting his primary care provider, he was assured that the lesion is “a birthmark.” Unsatisfied with this answer, the patient took the advice of a friend and decided to consult dermatology.

EXAMINATION
A polygonal, hyperpigmented, hypertrichotic patch covers most of the patient’s left pectoral area. The lateral margin is irregular but well-defined. There is obvious partial regrowth of the shaved hair on the lateral margin, but it stops abruptly at that point.

The breast and surrounding tissue appear normal. No areas of hyperpigmentation or hypertrichosis are seen elsewhere.

What is the diagnosis?

 

 

DISCUSSION
First described by William Becker in 1948 (and subsequently named for him), the Becker nevus (BN) received little research attention until a French study of 20,000 young men showed a prevalence of 0.5%. Nearly half of the subjects had first noticed the lesion before the age of 10—a somewhat surprising finding, since abundant evidence implicates androgens in its genesis. (This is supported by the condition’s predominance in males, the increased numbers of androgen receptors and melanocytes in the affected skin, and the prevalence of hypertrichosis.)

The researchers were also surprised to find that only 30% of the reported lesions occurred above the nipple, because the first descriptions of BN gave the impression that the shoulder and chest were most commonly affected. We now know that BN can also be found on arms and legs.

Usually a benign condition, BN can be associated with skeletal or soft-tissue deformities in the affected area (eg, ipsilateral breast hypoplasia). Malignancies—most notably melanoma—have also been reported with BN but are especially uncommon.

The differential includes the café-au-lait macules of neurofibromatosis, Albright disease, and congenital melanocytic nevus. The history of BN (ie, presentation, hypertrichosis, gender of patient, and distribution) usually allow a clinical diagnosis.

Treatment is limited to laser hair removal or laser removal or reduction of pigment.

TAKE-HOME LEARNING POINTS

  • Becker nevus (BN) is far more common in males than females.
  • BN typically manifests during puberty, which aligns with the suspected androgenic etiology.
  • Though the shoulders and chest are the most commonly affected areas, BNs can also appear on the flank, arms, or legs.
  • The lesions are rarely associated with serious pathology; hypoplasia of the ipsilateral breast is the most common of these complications.
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New pediatric hypertension guidelines increased hypertension prevalence

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New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

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New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

New clinical guidelines for pediatric hypertension resulted in increased prevalence of hypertension and improved sensitivity in detecting target organ damage among at-risk youth, according to findings published in Pediatrics.

In a clinical practice guideline (CPG) published in 2017, the American Academy of Pediatrics updated its 2004 guideline to include new reference tables for BP values in addition to new definitions of elevated BP and hypertension, including absolute BP cutoff values for adolescents aged 13 years and older (Pediatrics. 2017 Sep;140[6]:e20173035). This was intended to “emulate the recently updated adult hypertension guidelines and to simplify the process of identifying and classifying hypertension in adolescents,” wrote Michael Khoury, MD, of the Heart Institute at Cincinnati Children’s Hospital Medical Center, and his coauthors.

To evaluate the impact of the new guidelines on the prevalence of hypertension and associations with target organ damage, the investigators used data from a study on obesity and type 2 diabetes in 364 patients aged 10-17 years; 59% were obese, and 30% had type 2 diabetes. Three groups were identified: patients with obesity and type 2 diabetes, patients with obesity but no type 2 diabetes, and healthy (“lean”) controls.

Patients fasted overnight for a minimum of 10 hours, after which body mass index was calculated, blood pressure was taken, and anthropometric, laboratory, echocardiography, and carotid assessments were performed. Average BP measurements were categorized according to the 2004 guideline and to the new CPG.

In carotid ultrasonography assessments, a composite of carotid intima-media thickness was formed from the average of three sites, and a composite carotid intima-media thickness greater than or equal to the 90th percentile of that measured in the lean patients, who were the controls, was considered abnormal. In echocardiography assessments, left ventricular mass (LVM) and LVM index were calculated. Elevated LVM was defined by the pediatric cutoff of LVM index greater than or equal to 38.6 g/m.

For diastolic function, tissue Doppler velocities under the 10th percentile and an average early left ventricular filling/peak early myocardial velocity ratio greater than or equal to the 90th percentile in controls were considered abnormal. Lastly, pulse wave velocity (PWV) was measured to determine arterial stiffness, and a PWV greater than or equal to the 90th percentile for the controls was considered abnormal.

BP classification under the new guideline resulted in an increased prevalence of hypertension at 13% (10% stage 1, 3% stage 2), compared with the 2004 guideline at 8% (6% stage 1, 2% stage 2), with a P value of .007.

Of the 75 patients classified as having elevated BP in the 2004 guideline, 19 (25%) were reclassified as having stage 1 hypertension under the CPG. These 19 patients were older, compared with patients who remained in the elevated blood pressure category (16.5 ± 0.9 vs. 15.5 ± 1.7 years; P = .02). The patients who were reclassified also had higher body mass indexes (38.8 ± 8.2 vs. 33.6 ± 7.4; P = .01) and diastolic blood pressures (76.5 mm Hg ± 8.7 vs. 62.1 ± 12.2 mm Hg; P less than .001), Dr. Khoury and his colleagues reported.

Reclassification to a higher BP category was associated with increased odds of an abnormal target organ damage (TOD) values, and both guidelines produced similar odds, “suggesting that the two guidelines produce similar associations with TOD,” the authors wrote. Reclassification based on the CPG definition accounted for 31% of patients with increased LVM, compared with 20% as defined in the 2004 guideline (P less than .001), and for 33% of patients with abnormal PWV, compared with 23% in the 2004 guideline, suggesting improved sensitivity of hypertension categorization in detecting LVM. A similar effect was seen in other measures of TOD, the authors noted.

The findings suggest that, combined with the increased prevalence of hypertension under the new guidelines, “the CPG may contribute to an increased detection of abnormal LVM and other measures of TOD,” the authors wrote. “This, in turn, may contribute to risk stratification in clinical decision making for youth presenting with BP concerns,” they concluded.

The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures.

SOURCE: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

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Key clinical point: New clinical guidelines for pediatric hypertension resulted in increased prevalence of the condition and improved sensitivity in detecting target organ damage.

Major finding: BP classification under the new guideline resulted in an increased hypertension prevalence of 13% versus 8% with the 2004 guideline (P = .007).

Study details: The impact of the new guidelines was evaluated using data on 364 patients aged 10-18 years in an obesity and type 2 diabetes mellitus trial.

Disclosures: The study was supported by a National Institutes of Health grant. The authors had no relevant disclosures to report.

Source: Khoury M et al. Pediatrics. 2018 Jul 5. doi: 10.1542/peds.2018-0245.

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