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Clinical Endpoints in PTCL: The Road Less Traveled



Release Date: August 1, 2017
Expiration Date: July 31, 2018
Note: This activity is no longer available for credit.
Agenda
Developing New Strategic Goals in PTCL (duration 27:00)
Andrei R. Shustov, MD
University of Washington School of Medicine
Fred Hutchinson Cancer Research Center
Seattle, WA, USA
PTCL as a Rare Disease: A Case of Overall Survival (duration 19:00)
Owen A. O’Connor, MD, PhD
Columbia University Medical Center
The New York Presbyterian Hospital
New York, NY, USA
Why Might Response Rates Differ Between the East and West? (duration 17:00)
Kensei Tobinai, MD, PhD
National Cancer Center Hospital
Tokyo, Japan
Provided by:
Original activity supported by an educational grant from:
Spectrum Pharmaceuticals
Learning Objectives
At the end of the activity, participants should be able to:
- Explain why progression-free survival is important when treating patients with PTCL
- Determine when overall survival is possible
- Describe the challenges of using matched control analysis in PTCL clinical trials
- Discuss why different response rates to therapy for PTCL may be seen in Asian patients versus North American or European patients and define the possible contributing factors
Target Audience
Hematologists, oncologists, and other clinicians and scientists with an interest in T-cell lymphoma
Statement of Need
This activity explores clinical endpoints in PTCL, the importance of choosing the appropriate ones and the possibility of achieving them. Global and regional differences in PTCL are also explored as they relate to response rates. The presentations highlight the challenges physicians face in treating PTCL patients and recent developments are discussed to help practitioners evaluate the utility of these endpoints in choosing appropriate treatments to improve outcomes in their patients with PTCL.
FACULTY
Faculty
Andrei R. Shustov, MD
Disclosures: Consulting fee: Celgene; BMS
Owen O’Connor, MD, PhD
Disclosures: Consulting fees: Mundipharma; Celgene; Contracted Research: Mundipharma; Spectrum; Celgene; Seattle Genetics; TG Therapeutics; ADCT; Trillium
Kensei Tobinai, MD, PhD
Disclosures: Honoraria: Eisai; HUYA Bioscience International; Janssen; Mundipharma; Takeda; Zenyaku Kogyo; Contracted research: Abbvie; Celgene; Chugai Pharma; Eisai; GlaxoSmithKline; Janssen; Kyowa Hakko Kirin; Mundipharma; Ono Pharmaceutical; SERVIER; Takeda
Permissions
Andrei Shustov presentation
- Slide 7: PTCL Prognosis Is Indicative of Diverse Biology
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 8: PTCL: Global Epidemiology
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 9: PTCL: USA Epidemiology (top half)
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 9: PTCL: USA Epidemiology (bottom half)
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slide 10: PTCL Prognosis: Histology x Race (USA)
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slide 12: PTCL Prognosis: Clinical Features (top right side)
- Reprinted with permission. © 2013 American Society of Clinical Oncology. All rights reserved.
- Slide 14: PTCL Prognosis: Molecular Classifiers (left side)
- Republished with permission of the American Society of Hematology, from Parilla Castellar ER, et al. Blood 2014;124:1473-1480
- Slide 14: PTCL Prognosis: Molecular Classifiers (right side)
- Republished with permission of the American Society of Hematology, from Iqbal J, et al. Blood 2014;123:2915-2923
- Slide 17: US Epidemiology of PTCL
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slides 18-19: Romidepsin in Relapsed/Refractory PTCL
- Reprinted with permission. © 2012 American Society of Clinical Oncology. All rights reserved.
- Slides 20-22, 25: Romidepsin in Elderly Patients
- Shustov A, et al. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma 2017 [Epub ahead of print]. Reprinted by permission of Taylor & Francis Ltd, http://www.tandfonline.com
- Slides 27-28: Belinostat in Relapsed/Refractory PTCL
- Reprinted with permission. © 2015 American Society of Clinical Oncology. All rights reserved.
Kensei Tobinai presentation
- Slide 7: Overall Survival of ATL Pts in JCOG 9801
- Reprinted with permission. © 2007 American Society of Clinical Oncology. All rights reserved.
Disclaimer
The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Hemedicus, the supporter, or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.



Release Date: August 1, 2017
Expiration Date: July 31, 2018
Note: This activity is no longer available for credit.
Agenda
Developing New Strategic Goals in PTCL (duration 27:00)
Andrei R. Shustov, MD
University of Washington School of Medicine
Fred Hutchinson Cancer Research Center
Seattle, WA, USA
PTCL as a Rare Disease: A Case of Overall Survival (duration 19:00)
Owen A. O’Connor, MD, PhD
Columbia University Medical Center
The New York Presbyterian Hospital
New York, NY, USA
Why Might Response Rates Differ Between the East and West? (duration 17:00)
Kensei Tobinai, MD, PhD
National Cancer Center Hospital
Tokyo, Japan
Provided by:
Original activity supported by an educational grant from:
Spectrum Pharmaceuticals
Learning Objectives
At the end of the activity, participants should be able to:
- Explain why progression-free survival is important when treating patients with PTCL
- Determine when overall survival is possible
- Describe the challenges of using matched control analysis in PTCL clinical trials
- Discuss why different response rates to therapy for PTCL may be seen in Asian patients versus North American or European patients and define the possible contributing factors
Target Audience
Hematologists, oncologists, and other clinicians and scientists with an interest in T-cell lymphoma
Statement of Need
This activity explores clinical endpoints in PTCL, the importance of choosing the appropriate ones and the possibility of achieving them. Global and regional differences in PTCL are also explored as they relate to response rates. The presentations highlight the challenges physicians face in treating PTCL patients and recent developments are discussed to help practitioners evaluate the utility of these endpoints in choosing appropriate treatments to improve outcomes in their patients with PTCL.
FACULTY
Faculty
Andrei R. Shustov, MD
Disclosures: Consulting fee: Celgene; BMS
Owen O’Connor, MD, PhD
Disclosures: Consulting fees: Mundipharma; Celgene; Contracted Research: Mundipharma; Spectrum; Celgene; Seattle Genetics; TG Therapeutics; ADCT; Trillium
Kensei Tobinai, MD, PhD
Disclosures: Honoraria: Eisai; HUYA Bioscience International; Janssen; Mundipharma; Takeda; Zenyaku Kogyo; Contracted research: Abbvie; Celgene; Chugai Pharma; Eisai; GlaxoSmithKline; Janssen; Kyowa Hakko Kirin; Mundipharma; Ono Pharmaceutical; SERVIER; Takeda
Permissions
Andrei Shustov presentation
- Slide 7: PTCL Prognosis Is Indicative of Diverse Biology
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 8: PTCL: Global Epidemiology
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 9: PTCL: USA Epidemiology (top half)
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 9: PTCL: USA Epidemiology (bottom half)
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slide 10: PTCL Prognosis: Histology x Race (USA)
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slide 12: PTCL Prognosis: Clinical Features (top right side)
- Reprinted with permission. © 2013 American Society of Clinical Oncology. All rights reserved.
- Slide 14: PTCL Prognosis: Molecular Classifiers (left side)
- Republished with permission of the American Society of Hematology, from Parilla Castellar ER, et al. Blood 2014;124:1473-1480
- Slide 14: PTCL Prognosis: Molecular Classifiers (right side)
- Republished with permission of the American Society of Hematology, from Iqbal J, et al. Blood 2014;123:2915-2923
- Slide 17: US Epidemiology of PTCL
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slides 18-19: Romidepsin in Relapsed/Refractory PTCL
- Reprinted with permission. © 2012 American Society of Clinical Oncology. All rights reserved.
- Slides 20-22, 25: Romidepsin in Elderly Patients
- Shustov A, et al. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma 2017 [Epub ahead of print]. Reprinted by permission of Taylor & Francis Ltd, http://www.tandfonline.com
- Slides 27-28: Belinostat in Relapsed/Refractory PTCL
- Reprinted with permission. © 2015 American Society of Clinical Oncology. All rights reserved.
Kensei Tobinai presentation
- Slide 7: Overall Survival of ATL Pts in JCOG 9801
- Reprinted with permission. © 2007 American Society of Clinical Oncology. All rights reserved.
Disclaimer
The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Hemedicus, the supporter, or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.



Release Date: August 1, 2017
Expiration Date: July 31, 2018
Note: This activity is no longer available for credit.
Agenda
Developing New Strategic Goals in PTCL (duration 27:00)
Andrei R. Shustov, MD
University of Washington School of Medicine
Fred Hutchinson Cancer Research Center
Seattle, WA, USA
PTCL as a Rare Disease: A Case of Overall Survival (duration 19:00)
Owen A. O’Connor, MD, PhD
Columbia University Medical Center
The New York Presbyterian Hospital
New York, NY, USA
Why Might Response Rates Differ Between the East and West? (duration 17:00)
Kensei Tobinai, MD, PhD
National Cancer Center Hospital
Tokyo, Japan
Provided by:
Original activity supported by an educational grant from:
Spectrum Pharmaceuticals
Learning Objectives
At the end of the activity, participants should be able to:
- Explain why progression-free survival is important when treating patients with PTCL
- Determine when overall survival is possible
- Describe the challenges of using matched control analysis in PTCL clinical trials
- Discuss why different response rates to therapy for PTCL may be seen in Asian patients versus North American or European patients and define the possible contributing factors
Target Audience
Hematologists, oncologists, and other clinicians and scientists with an interest in T-cell lymphoma
Statement of Need
This activity explores clinical endpoints in PTCL, the importance of choosing the appropriate ones and the possibility of achieving them. Global and regional differences in PTCL are also explored as they relate to response rates. The presentations highlight the challenges physicians face in treating PTCL patients and recent developments are discussed to help practitioners evaluate the utility of these endpoints in choosing appropriate treatments to improve outcomes in their patients with PTCL.
FACULTY
Faculty
Andrei R. Shustov, MD
Disclosures: Consulting fee: Celgene; BMS
Owen O’Connor, MD, PhD
Disclosures: Consulting fees: Mundipharma; Celgene; Contracted Research: Mundipharma; Spectrum; Celgene; Seattle Genetics; TG Therapeutics; ADCT; Trillium
Kensei Tobinai, MD, PhD
Disclosures: Honoraria: Eisai; HUYA Bioscience International; Janssen; Mundipharma; Takeda; Zenyaku Kogyo; Contracted research: Abbvie; Celgene; Chugai Pharma; Eisai; GlaxoSmithKline; Janssen; Kyowa Hakko Kirin; Mundipharma; Ono Pharmaceutical; SERVIER; Takeda
Permissions
Andrei Shustov presentation
- Slide 7: PTCL Prognosis Is Indicative of Diverse Biology
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 8: PTCL: Global Epidemiology
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 9: PTCL: USA Epidemiology (top half)
- Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
- Slide 9: PTCL: USA Epidemiology (bottom half)
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slide 10: PTCL Prognosis: Histology x Race (USA)
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slide 12: PTCL Prognosis: Clinical Features (top right side)
- Reprinted with permission. © 2013 American Society of Clinical Oncology. All rights reserved.
- Slide 14: PTCL Prognosis: Molecular Classifiers (left side)
- Republished with permission of the American Society of Hematology, from Parilla Castellar ER, et al. Blood 2014;124:1473-1480
- Slide 14: PTCL Prognosis: Molecular Classifiers (right side)
- Republished with permission of the American Society of Hematology, from Iqbal J, et al. Blood 2014;123:2915-2923
- Slide 17: US Epidemiology of PTCL
- Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
- Slides 18-19: Romidepsin in Relapsed/Refractory PTCL
- Reprinted with permission. © 2012 American Society of Clinical Oncology. All rights reserved.
- Slides 20-22, 25: Romidepsin in Elderly Patients
- Shustov A, et al. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma 2017 [Epub ahead of print]. Reprinted by permission of Taylor & Francis Ltd, http://www.tandfonline.com
- Slides 27-28: Belinostat in Relapsed/Refractory PTCL
- Reprinted with permission. © 2015 American Society of Clinical Oncology. All rights reserved.
Kensei Tobinai presentation
- Slide 7: Overall Survival of ATL Pts in JCOG 9801
- Reprinted with permission. © 2007 American Society of Clinical Oncology. All rights reserved.
Disclaimer
The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Hemedicus, the supporter, or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.
Risk of sexual dysfunction in diabetes is high, but treatments can help
SAN DIEGO –
This isn’t normal for men of that age, according to Hunter B. Wessells, MD.“It’s not just that they’re aging. It’s a 20-year acceleration of the aging process,” he said at the annual scientific sessions of the American Diabetes Association.
That’s not all. In some cases, men with diabetes may experience decreased libido that’s potentially caused by low testosterone, said Dr. Wessells, professor and Wilma Wise Nelson, Ole A. Nelson, and Mabel Wise Nelson Endowed Chair in Urology at the University of Washington, Seattle
Still, research findings offer useful insights into the frequency of sexual dysfunction in people with diabetes and the potential – and limitations – of available treatments, said Dr. Wessells.
In patients with well-controlled diabetes, “these conditions impact quality of life to a greater degree than complications like nephropathy, neuropathy, and retinopathy,” he said in an interview. “Thus, treatment of urological symptoms can be a high-yield endeavor.”
In both sexes, Dr. Wessells said, diabetes can disrupt the mechanism of desire, arousal, and orgasm by affecting a long list of bodily functions such as central nervous system stimulation, hormone activity, autonomic and somatic nerve activity, and processing of calcium ions and nitric acid.
In men, diabetes boosts the risk of erectile dysfunction to a larger extent than do related conditions such as obesity, heart disease, and depression. “But they are interrelated,” he said. “The primary mechanisms include the metabolic effects of high glucose, autonomic nerve damage, and microvascular disease.”
Low testosterone levels also can cause problems in patients with diabetes, he said. “Type 2 diabetes has greater effects on testosterone than type 1. It is most closely linked to weight in the type 1 population and affects only a small percentage.”
A 2017 systematic review and meta-analysis of 145 studies with more than 88,000 subjects (average age 55.8 ± 7.9 years) suggests that ED was more common in type 2 diabetes (66.3%) than type 1 diabetes (37.5%) after statistical adjustment to account for publication bias (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403).
A smaller analysis found that men with diabetes had almost four times the odds (odd ratio = 3.62) of ED compared with healthy controls (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403). Phosphodiesterase-5 inhibitors – such as sildenafil, vardenafil, and tadalafil – are one option for men with diabetes and ED, Dr. Wessells said. “They work pretty well, but men with diabetes tend to have more severe ED. They’re going to get better, but will they get better enough to be normal? That’s the question.”
A 2007 Cochrane Library analysis found that men with diabetes and ED gained from PDE5 inhibitors overall (Cochrane Database Syst Rev. 2007 Jan 24[1]:CD002187. doi: 10.1002/14651858.CD002187.pub3).
“They’re not going to do as well as the general population,” Dr. Wessells said, “but we should try these as first-line agents in absence of things like severe unstable cardiovascular disease and other risk factors.”
Second-line therapies, typically offered by urologists, include penile prostheses and injection therapy, he said. A 2014 analysis of previous research found that men with diabetes were “more than 50% more likely to be prescribed secondary ED treatments over the 2-year observation period, and more than twice as likely to undergo penile prosthesis surgery” (Int J Impot Res. 2014 May-Jun;26[3]:112-5).
As for women, a 2009 study found that of 424 sexually active women with type 1 diabetes (97% of whom were white), 35% showed signs of female sexual dysfunction (FSD). Of those with FSD, problems included loss of libido (57%); problems with orgasm (51%), lubrication (47%), and/or arousal (38%); and pain (21%) (Diabetes Care. 2009 May;32[5]:780-5).
Only one drug, flibanserin (Addyi), is approved for FSD in the United States. Its impact on patients with diabetes is unknown, Dr. Wessells said, and the drug has the potential for significant adverse events.
The good news: Research is providing insight into which men and women are more likely to develop sexual dysfunction, Dr. Wessells said.
Age is important in both genders. For women, depression and being married appear to be risk factors, he said. “This needs more exploration to help us understand how to intervene.”
And in men, he said, ED is linked to jumps in hemoglobin A1c, while men on intensive glycemic therapy have a lower risk.
“Maybe we can find out who needs to be targeted for earlier intervention,” he said. This is especially important for men because ED becomes more likely to be irreversible after just a few years, he said.
Dr. Wessells reports no relevant disclosures.
SAN DIEGO –
This isn’t normal for men of that age, according to Hunter B. Wessells, MD.“It’s not just that they’re aging. It’s a 20-year acceleration of the aging process,” he said at the annual scientific sessions of the American Diabetes Association.
That’s not all. In some cases, men with diabetes may experience decreased libido that’s potentially caused by low testosterone, said Dr. Wessells, professor and Wilma Wise Nelson, Ole A. Nelson, and Mabel Wise Nelson Endowed Chair in Urology at the University of Washington, Seattle
Still, research findings offer useful insights into the frequency of sexual dysfunction in people with diabetes and the potential – and limitations – of available treatments, said Dr. Wessells.
In patients with well-controlled diabetes, “these conditions impact quality of life to a greater degree than complications like nephropathy, neuropathy, and retinopathy,” he said in an interview. “Thus, treatment of urological symptoms can be a high-yield endeavor.”
In both sexes, Dr. Wessells said, diabetes can disrupt the mechanism of desire, arousal, and orgasm by affecting a long list of bodily functions such as central nervous system stimulation, hormone activity, autonomic and somatic nerve activity, and processing of calcium ions and nitric acid.
In men, diabetes boosts the risk of erectile dysfunction to a larger extent than do related conditions such as obesity, heart disease, and depression. “But they are interrelated,” he said. “The primary mechanisms include the metabolic effects of high glucose, autonomic nerve damage, and microvascular disease.”
Low testosterone levels also can cause problems in patients with diabetes, he said. “Type 2 diabetes has greater effects on testosterone than type 1. It is most closely linked to weight in the type 1 population and affects only a small percentage.”
A 2017 systematic review and meta-analysis of 145 studies with more than 88,000 subjects (average age 55.8 ± 7.9 years) suggests that ED was more common in type 2 diabetes (66.3%) than type 1 diabetes (37.5%) after statistical adjustment to account for publication bias (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403).
A smaller analysis found that men with diabetes had almost four times the odds (odd ratio = 3.62) of ED compared with healthy controls (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403). Phosphodiesterase-5 inhibitors – such as sildenafil, vardenafil, and tadalafil – are one option for men with diabetes and ED, Dr. Wessells said. “They work pretty well, but men with diabetes tend to have more severe ED. They’re going to get better, but will they get better enough to be normal? That’s the question.”
A 2007 Cochrane Library analysis found that men with diabetes and ED gained from PDE5 inhibitors overall (Cochrane Database Syst Rev. 2007 Jan 24[1]:CD002187. doi: 10.1002/14651858.CD002187.pub3).
“They’re not going to do as well as the general population,” Dr. Wessells said, “but we should try these as first-line agents in absence of things like severe unstable cardiovascular disease and other risk factors.”
Second-line therapies, typically offered by urologists, include penile prostheses and injection therapy, he said. A 2014 analysis of previous research found that men with diabetes were “more than 50% more likely to be prescribed secondary ED treatments over the 2-year observation period, and more than twice as likely to undergo penile prosthesis surgery” (Int J Impot Res. 2014 May-Jun;26[3]:112-5).
As for women, a 2009 study found that of 424 sexually active women with type 1 diabetes (97% of whom were white), 35% showed signs of female sexual dysfunction (FSD). Of those with FSD, problems included loss of libido (57%); problems with orgasm (51%), lubrication (47%), and/or arousal (38%); and pain (21%) (Diabetes Care. 2009 May;32[5]:780-5).
Only one drug, flibanserin (Addyi), is approved for FSD in the United States. Its impact on patients with diabetes is unknown, Dr. Wessells said, and the drug has the potential for significant adverse events.
The good news: Research is providing insight into which men and women are more likely to develop sexual dysfunction, Dr. Wessells said.
Age is important in both genders. For women, depression and being married appear to be risk factors, he said. “This needs more exploration to help us understand how to intervene.”
And in men, he said, ED is linked to jumps in hemoglobin A1c, while men on intensive glycemic therapy have a lower risk.
“Maybe we can find out who needs to be targeted for earlier intervention,” he said. This is especially important for men because ED becomes more likely to be irreversible after just a few years, he said.
Dr. Wessells reports no relevant disclosures.
SAN DIEGO –
This isn’t normal for men of that age, according to Hunter B. Wessells, MD.“It’s not just that they’re aging. It’s a 20-year acceleration of the aging process,” he said at the annual scientific sessions of the American Diabetes Association.
That’s not all. In some cases, men with diabetes may experience decreased libido that’s potentially caused by low testosterone, said Dr. Wessells, professor and Wilma Wise Nelson, Ole A. Nelson, and Mabel Wise Nelson Endowed Chair in Urology at the University of Washington, Seattle
Still, research findings offer useful insights into the frequency of sexual dysfunction in people with diabetes and the potential – and limitations – of available treatments, said Dr. Wessells.
In patients with well-controlled diabetes, “these conditions impact quality of life to a greater degree than complications like nephropathy, neuropathy, and retinopathy,” he said in an interview. “Thus, treatment of urological symptoms can be a high-yield endeavor.”
In both sexes, Dr. Wessells said, diabetes can disrupt the mechanism of desire, arousal, and orgasm by affecting a long list of bodily functions such as central nervous system stimulation, hormone activity, autonomic and somatic nerve activity, and processing of calcium ions and nitric acid.
In men, diabetes boosts the risk of erectile dysfunction to a larger extent than do related conditions such as obesity, heart disease, and depression. “But they are interrelated,” he said. “The primary mechanisms include the metabolic effects of high glucose, autonomic nerve damage, and microvascular disease.”
Low testosterone levels also can cause problems in patients with diabetes, he said. “Type 2 diabetes has greater effects on testosterone than type 1. It is most closely linked to weight in the type 1 population and affects only a small percentage.”
A 2017 systematic review and meta-analysis of 145 studies with more than 88,000 subjects (average age 55.8 ± 7.9 years) suggests that ED was more common in type 2 diabetes (66.3%) than type 1 diabetes (37.5%) after statistical adjustment to account for publication bias (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403).
A smaller analysis found that men with diabetes had almost four times the odds (odd ratio = 3.62) of ED compared with healthy controls (Diabet Med. 2017 Jul 18. doi: 10.1111/dme.13403). Phosphodiesterase-5 inhibitors – such as sildenafil, vardenafil, and tadalafil – are one option for men with diabetes and ED, Dr. Wessells said. “They work pretty well, but men with diabetes tend to have more severe ED. They’re going to get better, but will they get better enough to be normal? That’s the question.”
A 2007 Cochrane Library analysis found that men with diabetes and ED gained from PDE5 inhibitors overall (Cochrane Database Syst Rev. 2007 Jan 24[1]:CD002187. doi: 10.1002/14651858.CD002187.pub3).
“They’re not going to do as well as the general population,” Dr. Wessells said, “but we should try these as first-line agents in absence of things like severe unstable cardiovascular disease and other risk factors.”
Second-line therapies, typically offered by urologists, include penile prostheses and injection therapy, he said. A 2014 analysis of previous research found that men with diabetes were “more than 50% more likely to be prescribed secondary ED treatments over the 2-year observation period, and more than twice as likely to undergo penile prosthesis surgery” (Int J Impot Res. 2014 May-Jun;26[3]:112-5).
As for women, a 2009 study found that of 424 sexually active women with type 1 diabetes (97% of whom were white), 35% showed signs of female sexual dysfunction (FSD). Of those with FSD, problems included loss of libido (57%); problems with orgasm (51%), lubrication (47%), and/or arousal (38%); and pain (21%) (Diabetes Care. 2009 May;32[5]:780-5).
Only one drug, flibanserin (Addyi), is approved for FSD in the United States. Its impact on patients with diabetes is unknown, Dr. Wessells said, and the drug has the potential for significant adverse events.
The good news: Research is providing insight into which men and women are more likely to develop sexual dysfunction, Dr. Wessells said.
Age is important in both genders. For women, depression and being married appear to be risk factors, he said. “This needs more exploration to help us understand how to intervene.”
And in men, he said, ED is linked to jumps in hemoglobin A1c, while men on intensive glycemic therapy have a lower risk.
“Maybe we can find out who needs to be targeted for earlier intervention,” he said. This is especially important for men because ED becomes more likely to be irreversible after just a few years, he said.
Dr. Wessells reports no relevant disclosures.
EXPERT ANALYSIS AT THE ADA ANNUAL SCIENTIFIC SESSIONS
David Henry's JCSO podcast, July-August 2017
For the July-August issue of the Journal of Community and Supportive Oncology, the Editor-in-Chief, Dr David Henry, discusses a recap by Howard Burris, MD, of the top presentations at this year’s annual meeting of the American Society for Clinical Oncology, and a selection of articles on some of the key findings reported at the meeting. A number of articles, in keeping with the journal mission of delivering content that can inform or change daily practice in the community setting, provide ‘how-to’ clinical and supportive advice. They include an outline by Thomas J Smith of Johns Hopkins University of how to initiate goals-of-care conversations with patients and their family members; a review of managing polycythemia vera in the community oncology setting; a New Therapies feature on how immunotherapies are shaping the treatment of hematologic malignancies; and research articles on using Onodera’s Prognostic Nutritional Index to predict wound complications in patients with soft tissue sarcoma, and bone remodeling associated with CTLA-4 inhibition. A third research article assesses a multidisciplinary survivorship program in a group of predominantly Hispanic women with breast cancer. Also in the line-up for discussion are Case Reports, one on managing high-grade pleomorphic sarcoma in a patient with colon metastasis and another on intramedullary spinal cord and leptomeningeal metastases presenting as cauda equina syndrome in a patient with melanoma.
Listen to the podcast below.
For the July-August issue of the Journal of Community and Supportive Oncology, the Editor-in-Chief, Dr David Henry, discusses a recap by Howard Burris, MD, of the top presentations at this year’s annual meeting of the American Society for Clinical Oncology, and a selection of articles on some of the key findings reported at the meeting. A number of articles, in keeping with the journal mission of delivering content that can inform or change daily practice in the community setting, provide ‘how-to’ clinical and supportive advice. They include an outline by Thomas J Smith of Johns Hopkins University of how to initiate goals-of-care conversations with patients and their family members; a review of managing polycythemia vera in the community oncology setting; a New Therapies feature on how immunotherapies are shaping the treatment of hematologic malignancies; and research articles on using Onodera’s Prognostic Nutritional Index to predict wound complications in patients with soft tissue sarcoma, and bone remodeling associated with CTLA-4 inhibition. A third research article assesses a multidisciplinary survivorship program in a group of predominantly Hispanic women with breast cancer. Also in the line-up for discussion are Case Reports, one on managing high-grade pleomorphic sarcoma in a patient with colon metastasis and another on intramedullary spinal cord and leptomeningeal metastases presenting as cauda equina syndrome in a patient with melanoma.
Listen to the podcast below.
For the July-August issue of the Journal of Community and Supportive Oncology, the Editor-in-Chief, Dr David Henry, discusses a recap by Howard Burris, MD, of the top presentations at this year’s annual meeting of the American Society for Clinical Oncology, and a selection of articles on some of the key findings reported at the meeting. A number of articles, in keeping with the journal mission of delivering content that can inform or change daily practice in the community setting, provide ‘how-to’ clinical and supportive advice. They include an outline by Thomas J Smith of Johns Hopkins University of how to initiate goals-of-care conversations with patients and their family members; a review of managing polycythemia vera in the community oncology setting; a New Therapies feature on how immunotherapies are shaping the treatment of hematologic malignancies; and research articles on using Onodera’s Prognostic Nutritional Index to predict wound complications in patients with soft tissue sarcoma, and bone remodeling associated with CTLA-4 inhibition. A third research article assesses a multidisciplinary survivorship program in a group of predominantly Hispanic women with breast cancer. Also in the line-up for discussion are Case Reports, one on managing high-grade pleomorphic sarcoma in a patient with colon metastasis and another on intramedullary spinal cord and leptomeningeal metastases presenting as cauda equina syndrome in a patient with melanoma.
Listen to the podcast below.
2017 Update on contraception
According to the most recent data (2011–2013), 62% of women of childbearing age (15–44 years) use some method of contraception. Of these “contracepting” women, about 25% reported relying on permanent contraception, making it one of the most common methods of contraception used by women in the United States (FIGURE 1).1,2 Women either can choose to have a permanent contraception procedure performed immediately postpartum, which occurs after approximately 9% of all hospital deliveries in the United States,3 or at a time separate from pregnancy.
The most common methods of permanent contraception include partial salpingectomy at the time of cesarean delivery or within 24 hours after vaginal delivery and laparoscopic occlusive procedures at a time unrelated to the postpartum period.3 Hysteroscopic occlusion of the tubal ostia is a newer option, introduced in 2002; its worldwide use is concentrated in the United States, which accounts for 80% of sales based on revenue.4
Historically, for procedures remote from pregnancy, the laparoscopic approach evolved with less sophisticated laparoscopic equipment and limited visualization, which resulted in efficiency and safety being the primary goals of the procedure.5 Accordingly, rapid occlusive procedures were commonplace. However, advancement of laparoscopic technology related to insufflation systems, surgical equipment, and video capabilities did not change this practice.
Recent literature has suggested that complete fallopian tube removal provides additional benefits. With increasing knowledge about the origin of ovarian cancer, as well as increasing data to support the hypothesis that complete tubal excision results in increased ovarian cancer protection when compared with occlusive or partial salpingectomies, both the American College of Obstetricians and Gynecologists (ACOG)6 and the Society of Gynecologic Oncology (SGO)7 recommend discussing bilateral total salpingectomy with patients desiring permanent contraception. Although occlusive procedures decrease a woman’s lifetime risk of ovarian cancer by 24% to 34%,8,9 total salpingectomy likely reduces this risk by 49% to 65%.10,11
With this new evidence, McAlpine and colleagues initiated an educational campaign, targeting all ObGyns in British Columbia, which outlined the role of the fallopian tube in ovarian cancer and urged the consideration of total salpingectomy for permanent contraception in place of occlusive or partial salpingectomy procedures. They found that this one-time targeted education increased the use of total salpingectomy for permanent contraception from 0.5% at 2 years before the intervention to 33.3% by 2 years afterwards.12 On average, laparoscopic bilateral salpingectomy took 10 minutes longer to complete than occlusive procedures. Most importantly, they found no significant differences in complication rates, including hospital readmissions or blood transfusions.
Although our community can be applauded for the rapid uptake of concomitant bilateral salpingectomy at the time of benign hysterectomy,12,13 offering total salpingectomy for permanent contraception is far from common practice. Similarly, while multiple studies have been published to support the practice of opportunistic salpingectomy at the time of hysterectomy, little has been published about the use of bilateral salpingectomy for permanent contraception until this past year.
In this article, we review some of the first publications to focus specifically on the feasibility and safety profile of performing either immediate postpartum total salpingectomy or interval total salpingectomy in women desiring permanent contraception.
Family Planning experts are now strongly discouraging the use of terms like “sterilization,” “permanent sterilization,” and “tubal ligation” due to sterilization abuses that affected vulnerable and marginalized populations in the United States during the early-to mid-20th century.
In 1907, Indiana was the first state to enact a eugenics-based permanent sterilization law, which initiated an aggressive eugenics movement across the United States. This movement lasted for approximately 70 years and resulted in the sterilization of more than 60,000 women, men, and children against their will or without their knowledge. One of the major contributors to this movement was the state of California, which sterilized more than 20,000 women, men, and children.
They defined sterilization as a prophylactic measure that could simultaneously defend public health, preserve precious fiscal resources, and mitigate menace of the “unfit and feebleminded.” The US eugenics movement even inspired Hitler and the Nazi eugenics movement in Germany.
Because of these reproductive rights atrocities, a large counter movement to protect the rights of women, men, and children resulted in the creation of the Medicaid permanent sterilization consents that we still use today. Although some experts question whether the current Medicaid protective policy should be reevaluated, many are focused on the use of less offensive language when discussing the topic.
Current recommendations are to use the phrase “permanent contraception” or simply refer to the procedure name (salpingectomy, vasectomy, tubal occlusion, etc.) to move away from the connection to the eugenics movement.
Read about a total salpingectomy at delivery
Total salpingectomy: A viable option for permanent contraception after vaginal or at cesarean delivery
Shinar S, Blecher Y, Alpern S, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185-1189.
Danis RB, Della Badia CR, Richard SD. Postpartum permanent sterilization: could bilateral salpingectomy replace bilateral tubal ligation? J Minim Invasive Gynecol. 2016;23(6):928-932.
Shinar and colleagues presented a retrospective case series that included women undergoing permanent contraception procedures during cesarean delivery at a single tertiary medical center. The authors evaluated outcomes before and after a global hospital policy changed the preferred permanent contraception procedure from partial to total salpingectomy.
Details of the Shinar technique and outcomes
Of the 149 women included, 99 underwent partial salpingectomy via the modified Pomeroy technique and 50 underwent total salpingectomy using an electrothermal bipolar tissue-sealing instrument (Ligasure). The authors found no difference in operative times and similar rates of complications. Composite adverse outcomes, defined as surgery duration greater than 45 minutes, hemoglobin decline greater than 1.2 g/dL, need for blood transfusion, prolonged hospitalization, ICU admission, or re-laparotomy, were comparable and were reported as 30.3% and 36.0% in the partial and total salpingectomy groups, respectively, (P = .57).One major complication occurred in the total salpingectomy cohort; postoperatively the patient had hemodynamic instability and was found to have hemoperitoneum requiring exploratory laparotomy. Significant bleeding from the bilateral mesosalpinges was discovered, presumably directly related to the total salpingectomy.
Related article:
Hysteroscopic tubal occlusion: How new product labeling can be a resource for patient counseling
Details of Danis et al
Intuitively, performing salpingectomy at the time of cesarean delivery does not seem as significant a change in practice as would performing salpingectomy through a small periumbilical incision after vaginal delivery. However, Danis and colleagues did just that; they published a retrospective case series of total salpingectomy performed within 24 hours after a vaginal delivery at an urban, academic institution. They included all women admitted for full-term vaginal deliveries who desired permanent contraception, with no exclusion criteria related to body mass index (BMI). The authors reported on 80 women, including 64 (80%) who underwent partial salpingectomy via the modified Pomeroy or Parkland technique and 16 (20%) who underwent total salpingectomy. Most women had a BMI of less than 30 kg/m2; less than 15% of the women in each group had a BMI greater than 40 kg/m2.
The technique for total salpingectomy involved a 2- to 3-cm vertical incision at the level of the umbilicus, elevation of the entire fallopian tube with 2 Babcock clamps, followed by the development of 2 to 3 windows with monopolar electrocautery in the mesosalpinx and subsequent suture ligation with polyglactin 910 (Vicryl, Ethicon).
Major findings included slightly longer operative time in the total salpingectomy compared with the partial salpingectomy group (a finding consistent with other studies12,14,15) and no difference in complication rates. The average (SD) surgical time in the partial salpingectomy group was 59 (16) minutes, compared with 71 (6) minutes in the total salpingectomy group (P = .003). The authors reported 4 (6.3%) complications in the partial salpingectomy group--ileus, excessive bleeding from mesosalpinx, and incisional site hematoma--and no complications in the total salpingectomy group (P = .58).
These 2 studies, although small retrospective case series, demonstrate the feasibility of performing total salpingectomies with minimal operative time differences when compared with more traditional partial salpingectomy procedures. The re-laparotomy complication noted in the Shinar series cannot be dismissed, as this is a major morbidity, but it also should not dictate the conversation.
Overall, the need for blood transfusion or unintended major surgery after permanent contraception procedures is rare. In the U.S. Collaborative Review of Sterilization study, none of the 282 women who had a permanent contraception procedure performed via laparotomy experienced either of these outcomes.16 Only 1 of the 9,475 women (0.01%) having a laparoscopic procedure in this study required blood transfusion and 14 (0.15%) required reoperation secondary to a procedure complication.17 The complication reported in the Shinar study reminds us that the technique for salpingectomy in the postpartum period, whether partial or total, should be considered carefully, being mindful of the anatomical changes that occur in pregnancy.
While larger studies should be performed to confirm these initial findings, these 2 articles provide the reassurance that many providers may need before beginning to offer total salpingectomy procedures in the immediate postpartum period.
When women present for permanent contraception counseling, we must remember that our patients' needs are often far too diverse and dynamic to allow a universal counseling technique. Every provider likely has a counseling style, with a structure and language that has been altered and changed through years of practice, patient experiences, and new scientific technologies and data. Unfortunately, provider biases and past coercive practices also influence contraceptive counseling.
Historically, some providers used formulas related to a woman's age and parity to decide if she could have a permanent contraception procedure, possibly based on fears of patient regret. Such practices are an embarrassment to the principles of patient autonomy and empowerment, which should serve as the foundation for any contraceptive conversation. Studies of regret after permanent contraception procedures are often misinterpreted; although younger women experience higher rates of regret, the absolute rate still favors performing the procedure.1,2 When comparing women aged 30 or younger to those older than 30 years at the time of procedure, the vast majority (about 80%) of those 30 and younger do not express regret.1 Less than 5% of women who express regret access a reversal procedure.2,3 Our job as providers is to educate and allow women to understand the options--and with permanent contraception that also means explaining the potential for regret; however, empowering women does not mean limiting an opportunity for the majority to potentially impact the minority.
Our contraceptive counseling philosophy follows the shared decision-making model. This model informs the patient, tailors the conversation toward her priorities, and maintains patient autonomy, while empowering the patient to take control of her reproductive health and future. When a patient expresses the desire for permanent contraception, we ensure she understands the permanence of the procedure and offer information about other Tier 1 contraceptive options, including long-acting reversible methods and vasectomy. We use the evidence-based World Health Organization counseling table4,5 to assist with the discussion and provide vasectomy referral and further information about specific intrauterine devices or the contraceptive implant based on the woman's interests.
For women who desire a female permanent contraception procedure, we also provide information tables comparing laparoscopic tubal occlusion procedures, laparoscopic bilateral salpingectomy, and hysteroscopic tubal occlusion. These tables review how each procedure is performed; risks and benefits, including failure rates over time; and ovarian cancer protection estimates. Our office also has devised tables to inform women seeking permanent contraception immediately after delivery and unrelated to pregnancy. Ultimately, the woman can choose what makes the most sense for her at that specific time in her life, and as providers we must support and uphold that decision.
References
- Hills SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93(6):889-895.
- Curtis KM, Mohllajee AP, Peterson HB. Regret following female sterilization at a young age: a systematic review. Contraception. 2006;73(2):205-210.
- Schmidt JE, Hillis SD, Marchbanks PA, Jeng G, Peterson HB. Requesting information about and obtaining reversal after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Fertil Steril. 2000;74(5):892-898.
- Steiner MJ, Trussell J, Mehta N, Condon S, Subramaniam S, Bourne D. Communicating contraceptive effectiveness: a randomized controlled trial to inform a World Health Organization family planning handbook. Am J Obstet Gynecol. 2006;195(1):85-91.
- Steiner MJ, Trussell J, Johnson S. Communicating contraceptive effectiveness: an updated counseling chart. Am J Obstet Gynecol. 2007;197(1):118.
Read about interval permanent contraception
Feasibility of interval laparoscopic permanent contraception via bilateral salpingectomy
Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505-508.
In this retrospective study, authors used billing data to identify women undergoing interval laparoscopic permanent contraception at a single academic medical center. They educated physicians and patients about the potential benefits to ovarian cancer risk with total salpingectomy (similar to the educational initiative done in British Columbia) and discussed the requirement for the extra incision and more time for the surgery. From 2013 to 2015 use of salpingectomy for permanent contraception changed from 45% of the procedures to 85%, a fairly dramatic trend.18 With these data, the authors compared outcomes between the women receiving tubal occlusive procedures and women receiving bilateral salpingectomy.
Related article:
Risk-reducing salpingectomy at benign hysterectomy: Have surgeons embraced this practice?
Details of surgical time and complications
Tubal occlusion procedures were performed through 2 abdominal ports, and device placement was at the discretion of the provider. Bilateral salpingectomies were performed through 3 abdominal port sites with an electrothermal bipolar tissue-sealing instrument. A total of 149 procedures were identified, 68 tubal occlusions (19% Falope rings, 32% bipolar cautery, and 47% Filshie clips) and 81 bilateral salpingectomies.
The surgical time average (SD) was 6 minutes longer for the salpingectomies (44 [13] minutes vs 38 [15] minutes; P = .018). As would be expected, more experienced residents had shorter surgical times when compared with less experienced residents for both procedures (FIGURE 2).15 Similar rates of both immediate and short-term surgical complications were noted. One immediate complication was reported in each group, both of which were secondary to anesthesia issues.
Interestingly, short-term complications were lower in the salpingectomy group (4.9%) versus the tubal occlusion group (14.7%), although this difference was barely not statistically significant (P = .051). These complications included 1 incisional site infection requiring oral antibiotics and 3 cases of increased pain in the salpingectomy group and 4 incisional site infections with 6 patients reporting increased pain in the tubal occlusion group.
This retrospective analysis provides further reassurance regarding the safety of offering bilateral salpingectomy to patients desiring permanent contraception. This study again consistently demonstrates that bilateral salpingectomy increases the operative time, but only minimally, which is unlikely clinically significant, especially when considering the potential benefits from total salpingectomy (increased ovarian cancer protection, higher contraceptive efficacy, decreased ectopic pregnancy rates, reduced risk of future surgeries for such tubal pathology as hydrosalpinx, etc). The study also shows that educational initiatives targeted at providers likely will increase acceptability as well as uptake of this practice for permanent contraception.
Read about tube removal and ovarian reserve
Does total removal of the tubes affect ovarian reserve?
Ganer Herman H, Gluck O, Keidar R, et al. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017;doi: 10.1016/j.ajog.2017.04.028.
As acceptability of total salpingectomy for permanent contraception increases, one concern is that complete removal may alter blood supply to the ovary, resulting in decreased ovarian reserve and, subsequently, earlier menopause. Several studies have addressed the potential effect of salpingectomy on ovarian function when performed at the time of hysterectomy, most of which have noted no difference in anti-Müllerian hormone (AMH) levels and sonographic parameters following surgery.19 However, very little has been published to assess this same question when the salpingectomy is performed for the purpose of permanent contraception.
Ganer Herman and colleagues aimed to assess short-term ovarian reserve by measuring AMH levels preoperatively and 6 to 8 weeks postoperatively in patients undergoing partial or total salpingectomy at the time of elective cesarean delivery.
Related article:
Salpingectomy after vaginal hysterectomy: Technique, tips, and pearls
Details of the study
The study included women aged 18 to 45 who presented for elective cesarean delivery and who requested permanent contraception. Exclusion criteria included previous tubal surgery, emergent cesarean delivery, personal history of breast carcinoma, familial history of ovarian carcinoma, and BRCA carriage.
Women were randomly assigned at a 1:1 ratio to bilateral total salpingectomy or bilateral partial salpingectomy. A complete blood count and AMH level were drawn the night prior to surgery. Intraoperatively, after delivery and hysterotomy closure, partial salpingectomy, via the Parkland technique, or total salpingectomy, using a suture ligation technique, was performed.
Of the 46 women enrolled, follow-up was completed by 16 of 22 women (72%) in the total salpingectomy group and 18 of 24 women (75%) in the partial salpingectomy group. Patients in the total salpingectomy group were slightly older (mean age, 37 vs 34 years; P = .02), but otherwise all demographic and obstetric characteristics were comparable.
No differences were noted in preoperative and postoperative AMH levels between groups, with an average (SD) increase of 0.58 (0.98) ng/mL versus 0.39 (0.41) ng/mL in the total salpingectomy and partial salpingectomy groups, respectively (P = .45), consistent with known postpartum AMH level trends.
Other findings included an average 13-minute increase in operative time in the total salpingectomy cases, similar safety profile of the 2 methods as there were no postoperative complications during the study period, and no differences in postoperative hemoglobin levels.
This study was designed as a pilot trial to assess feasibility of enrollment, safety, and short-term ovarian reserve after salpingectomy for permanent contraception. Although the study is small and does not assess long-term effects, the findings are reassuring, especially in conjunction with other data.
A meta-analysis demonstrated no effect on ovarian reserve up to 18 months after salpingectomy based on AMH changes.19 A 5-year follow-up evaluation of 71 women undergoing total laparoscopic hysterectomy with bilateral salpingectomy also showed no effect on ovarian reserve as measured by multiple hormone levels including AMH and ultrasonographic findings.20 Thus, it is highly unlikely that a permanent contraception procedure that does not include removal of the uterus will have long-term ovarian reserve effects.
Additionally, consistent with other trials, Ganer Herman and colleagues demonstrate a slightly increased operative time and no increased complications. The surgical technique used in the study reflects the concern for postoperative bleeding from the mesosalpinx, and methods that ensure excellent hemostasis with suture ligation were used.
Conclusion
The studies reviewed in this article are some of the first to evaluate the feasibility and safety of opportunistic, or total, salpingectomy for permanent contraception since the ACOG and SGO recommendations were published. Just as our community has adopted the common practice of opportunistic salpingectomy at the time of hysterectomy, we should continue to advocate for a similar practice when discussing permanent contraception. Additionally, the Westberg study provides good evidence that educational initiatives can influence provider practices, which upholds the data published by McAlpine and colleagues in British Columbia. This information is promising and valuable.
Our universal goal as ObGyns is to provide the best reproductive health care possible based on the most recent evidence available. Continuing to advocate for opportunistic salpingectomy for permanent contraception purposes meets this goal and potentially provides significant noncontraceptive benefits.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Daniels K, Daugherty J, Jones J, Mosher W. Current contraceptive use and variation by selected characteristics among women aged 15-44: United States, 2011-2013. Natl Health Stat Report. 2015;86:1–14.
- Kavanaugh ML, Jerman J, Finer LB. Changes in use of long-acting reversible contraceptive methods among U.S. women, 2009-2012. Obstet Gynecol. 2015;126(5):17–927.
- Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril. 2010;94(1):1–6.
- Essure system for permanent birth control: Executive summary. Bayer Healthcare: Berlin, Germany; 2015:1–89. https://www.fda.gov/downloads/AdvisoryCommittees/UCM463460.pdf. Accessed July 19, 2017.
- Creinin MD, Zite N. Female tubal sterilization: the time has come to routinely consider removal. Obstet Gynecol. 2014;124(3):596–599.
- American College of Obstetrics and Gynecology Committee opinion no. 620: salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015;125(1):279–281.
- Society of Gynecologic Oncology website. SGO clinical practice statement: salpingectomy for ovarian cancer. https://www.sgo.org/clinical-practice/guidelines/sgo-clinical-practice-statement-salpingectomy-for-ovarian-cancer-prevention/. Published November 2013. Accessed July 21, 2017.
- Cibula D, Widschwendter M, Majek O, Dusek L. Tubal ligation and the risk of ovarian cancer: review and meta-analysis. Hum Reprod Update. 2011;17(1): 55–67.
- Sieh W, Salvador S, McGuire V, et al. Tubal ligation and risk of ovarian cancer subtypes: a pooled analysis of case-control studies. Int J Epidemiol. 2013;42(2): 579–589.
- Yoon SH, Kim SN, Shim SH, Kang SB, Lee SJ. Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: a meta-analysis. Eur J Cancer. 2016;55:38–46.
- Falconer H, Yin L, Grönberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015;107(2).
- McAlpine JN, Hanley GE, Woo MM, et al. Opportunistic salpingectomy: uptake, risks, and complications of a regional initiative for ovarian cancer prevention. Am J Obstet Gynecol. 2014;210(5):471e1–e11.
- Garcia C, Martin M, Tucker LY, et al. Experience with opportunistic salpingectomy in a large, community-based health system in the United States. Obstet Gynecol. 2016;128(2):277–283.
- Shinar S, Blecher Y, Alpern A, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185–1189.
- Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505–508.
- Layde PM, Peterson HB, Dicker RC, DeStefano F, Rubin GL, Ory HW. Risk factors for complications of interval tubal sterilization by laparotomy. Obstet Gynecol. 1983;62(2):180–184.
- Jamieson DJ, Hillis SD, Duerr A, Marchbanks PA, Costello C, Peterson HB. Complications of interval laparoscopic tubal sterilization: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 2000;96(6):997–1002.
- Westberg JM, Scott F, Cansino C, Creinin MD. Recent trends in incidence of different permanent female sterilization methods. Obstet Gynecol. 2016;127(suppl):127S.
- Mohamed AA, Yosef AH, James C, Al-Hussaini TK, Bedaiwy MA, Amer SAKS. Ovarian reserve after salpingectomy: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2017;96(7):795–803.
- Venturella R, Lico D, Borelli M, et al. 3 to 5 years later: long-term effects of prophylactic bilateral salpingectomy on ovarian function. J Minim Invasive Gynecol. 2017;24(1):145–150.
According to the most recent data (2011–2013), 62% of women of childbearing age (15–44 years) use some method of contraception. Of these “contracepting” women, about 25% reported relying on permanent contraception, making it one of the most common methods of contraception used by women in the United States (FIGURE 1).1,2 Women either can choose to have a permanent contraception procedure performed immediately postpartum, which occurs after approximately 9% of all hospital deliveries in the United States,3 or at a time separate from pregnancy.
The most common methods of permanent contraception include partial salpingectomy at the time of cesarean delivery or within 24 hours after vaginal delivery and laparoscopic occlusive procedures at a time unrelated to the postpartum period.3 Hysteroscopic occlusion of the tubal ostia is a newer option, introduced in 2002; its worldwide use is concentrated in the United States, which accounts for 80% of sales based on revenue.4
Historically, for procedures remote from pregnancy, the laparoscopic approach evolved with less sophisticated laparoscopic equipment and limited visualization, which resulted in efficiency and safety being the primary goals of the procedure.5 Accordingly, rapid occlusive procedures were commonplace. However, advancement of laparoscopic technology related to insufflation systems, surgical equipment, and video capabilities did not change this practice.
Recent literature has suggested that complete fallopian tube removal provides additional benefits. With increasing knowledge about the origin of ovarian cancer, as well as increasing data to support the hypothesis that complete tubal excision results in increased ovarian cancer protection when compared with occlusive or partial salpingectomies, both the American College of Obstetricians and Gynecologists (ACOG)6 and the Society of Gynecologic Oncology (SGO)7 recommend discussing bilateral total salpingectomy with patients desiring permanent contraception. Although occlusive procedures decrease a woman’s lifetime risk of ovarian cancer by 24% to 34%,8,9 total salpingectomy likely reduces this risk by 49% to 65%.10,11
With this new evidence, McAlpine and colleagues initiated an educational campaign, targeting all ObGyns in British Columbia, which outlined the role of the fallopian tube in ovarian cancer and urged the consideration of total salpingectomy for permanent contraception in place of occlusive or partial salpingectomy procedures. They found that this one-time targeted education increased the use of total salpingectomy for permanent contraception from 0.5% at 2 years before the intervention to 33.3% by 2 years afterwards.12 On average, laparoscopic bilateral salpingectomy took 10 minutes longer to complete than occlusive procedures. Most importantly, they found no significant differences in complication rates, including hospital readmissions or blood transfusions.
Although our community can be applauded for the rapid uptake of concomitant bilateral salpingectomy at the time of benign hysterectomy,12,13 offering total salpingectomy for permanent contraception is far from common practice. Similarly, while multiple studies have been published to support the practice of opportunistic salpingectomy at the time of hysterectomy, little has been published about the use of bilateral salpingectomy for permanent contraception until this past year.
In this article, we review some of the first publications to focus specifically on the feasibility and safety profile of performing either immediate postpartum total salpingectomy or interval total salpingectomy in women desiring permanent contraception.
Family Planning experts are now strongly discouraging the use of terms like “sterilization,” “permanent sterilization,” and “tubal ligation” due to sterilization abuses that affected vulnerable and marginalized populations in the United States during the early-to mid-20th century.
In 1907, Indiana was the first state to enact a eugenics-based permanent sterilization law, which initiated an aggressive eugenics movement across the United States. This movement lasted for approximately 70 years and resulted in the sterilization of more than 60,000 women, men, and children against their will or without their knowledge. One of the major contributors to this movement was the state of California, which sterilized more than 20,000 women, men, and children.
They defined sterilization as a prophylactic measure that could simultaneously defend public health, preserve precious fiscal resources, and mitigate menace of the “unfit and feebleminded.” The US eugenics movement even inspired Hitler and the Nazi eugenics movement in Germany.
Because of these reproductive rights atrocities, a large counter movement to protect the rights of women, men, and children resulted in the creation of the Medicaid permanent sterilization consents that we still use today. Although some experts question whether the current Medicaid protective policy should be reevaluated, many are focused on the use of less offensive language when discussing the topic.
Current recommendations are to use the phrase “permanent contraception” or simply refer to the procedure name (salpingectomy, vasectomy, tubal occlusion, etc.) to move away from the connection to the eugenics movement.
Read about a total salpingectomy at delivery
Total salpingectomy: A viable option for permanent contraception after vaginal or at cesarean delivery
Shinar S, Blecher Y, Alpern S, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185-1189.
Danis RB, Della Badia CR, Richard SD. Postpartum permanent sterilization: could bilateral salpingectomy replace bilateral tubal ligation? J Minim Invasive Gynecol. 2016;23(6):928-932.
Shinar and colleagues presented a retrospective case series that included women undergoing permanent contraception procedures during cesarean delivery at a single tertiary medical center. The authors evaluated outcomes before and after a global hospital policy changed the preferred permanent contraception procedure from partial to total salpingectomy.
Details of the Shinar technique and outcomes
Of the 149 women included, 99 underwent partial salpingectomy via the modified Pomeroy technique and 50 underwent total salpingectomy using an electrothermal bipolar tissue-sealing instrument (Ligasure). The authors found no difference in operative times and similar rates of complications. Composite adverse outcomes, defined as surgery duration greater than 45 minutes, hemoglobin decline greater than 1.2 g/dL, need for blood transfusion, prolonged hospitalization, ICU admission, or re-laparotomy, were comparable and were reported as 30.3% and 36.0% in the partial and total salpingectomy groups, respectively, (P = .57).One major complication occurred in the total salpingectomy cohort; postoperatively the patient had hemodynamic instability and was found to have hemoperitoneum requiring exploratory laparotomy. Significant bleeding from the bilateral mesosalpinges was discovered, presumably directly related to the total salpingectomy.
Related article:
Hysteroscopic tubal occlusion: How new product labeling can be a resource for patient counseling
Details of Danis et al
Intuitively, performing salpingectomy at the time of cesarean delivery does not seem as significant a change in practice as would performing salpingectomy through a small periumbilical incision after vaginal delivery. However, Danis and colleagues did just that; they published a retrospective case series of total salpingectomy performed within 24 hours after a vaginal delivery at an urban, academic institution. They included all women admitted for full-term vaginal deliveries who desired permanent contraception, with no exclusion criteria related to body mass index (BMI). The authors reported on 80 women, including 64 (80%) who underwent partial salpingectomy via the modified Pomeroy or Parkland technique and 16 (20%) who underwent total salpingectomy. Most women had a BMI of less than 30 kg/m2; less than 15% of the women in each group had a BMI greater than 40 kg/m2.
The technique for total salpingectomy involved a 2- to 3-cm vertical incision at the level of the umbilicus, elevation of the entire fallopian tube with 2 Babcock clamps, followed by the development of 2 to 3 windows with monopolar electrocautery in the mesosalpinx and subsequent suture ligation with polyglactin 910 (Vicryl, Ethicon).
Major findings included slightly longer operative time in the total salpingectomy compared with the partial salpingectomy group (a finding consistent with other studies12,14,15) and no difference in complication rates. The average (SD) surgical time in the partial salpingectomy group was 59 (16) minutes, compared with 71 (6) minutes in the total salpingectomy group (P = .003). The authors reported 4 (6.3%) complications in the partial salpingectomy group--ileus, excessive bleeding from mesosalpinx, and incisional site hematoma--and no complications in the total salpingectomy group (P = .58).
These 2 studies, although small retrospective case series, demonstrate the feasibility of performing total salpingectomies with minimal operative time differences when compared with more traditional partial salpingectomy procedures. The re-laparotomy complication noted in the Shinar series cannot be dismissed, as this is a major morbidity, but it also should not dictate the conversation.
Overall, the need for blood transfusion or unintended major surgery after permanent contraception procedures is rare. In the U.S. Collaborative Review of Sterilization study, none of the 282 women who had a permanent contraception procedure performed via laparotomy experienced either of these outcomes.16 Only 1 of the 9,475 women (0.01%) having a laparoscopic procedure in this study required blood transfusion and 14 (0.15%) required reoperation secondary to a procedure complication.17 The complication reported in the Shinar study reminds us that the technique for salpingectomy in the postpartum period, whether partial or total, should be considered carefully, being mindful of the anatomical changes that occur in pregnancy.
While larger studies should be performed to confirm these initial findings, these 2 articles provide the reassurance that many providers may need before beginning to offer total salpingectomy procedures in the immediate postpartum period.
When women present for permanent contraception counseling, we must remember that our patients' needs are often far too diverse and dynamic to allow a universal counseling technique. Every provider likely has a counseling style, with a structure and language that has been altered and changed through years of practice, patient experiences, and new scientific technologies and data. Unfortunately, provider biases and past coercive practices also influence contraceptive counseling.
Historically, some providers used formulas related to a woman's age and parity to decide if she could have a permanent contraception procedure, possibly based on fears of patient regret. Such practices are an embarrassment to the principles of patient autonomy and empowerment, which should serve as the foundation for any contraceptive conversation. Studies of regret after permanent contraception procedures are often misinterpreted; although younger women experience higher rates of regret, the absolute rate still favors performing the procedure.1,2 When comparing women aged 30 or younger to those older than 30 years at the time of procedure, the vast majority (about 80%) of those 30 and younger do not express regret.1 Less than 5% of women who express regret access a reversal procedure.2,3 Our job as providers is to educate and allow women to understand the options--and with permanent contraception that also means explaining the potential for regret; however, empowering women does not mean limiting an opportunity for the majority to potentially impact the minority.
Our contraceptive counseling philosophy follows the shared decision-making model. This model informs the patient, tailors the conversation toward her priorities, and maintains patient autonomy, while empowering the patient to take control of her reproductive health and future. When a patient expresses the desire for permanent contraception, we ensure she understands the permanence of the procedure and offer information about other Tier 1 contraceptive options, including long-acting reversible methods and vasectomy. We use the evidence-based World Health Organization counseling table4,5 to assist with the discussion and provide vasectomy referral and further information about specific intrauterine devices or the contraceptive implant based on the woman's interests.
For women who desire a female permanent contraception procedure, we also provide information tables comparing laparoscopic tubal occlusion procedures, laparoscopic bilateral salpingectomy, and hysteroscopic tubal occlusion. These tables review how each procedure is performed; risks and benefits, including failure rates over time; and ovarian cancer protection estimates. Our office also has devised tables to inform women seeking permanent contraception immediately after delivery and unrelated to pregnancy. Ultimately, the woman can choose what makes the most sense for her at that specific time in her life, and as providers we must support and uphold that decision.
References
- Hills SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93(6):889-895.
- Curtis KM, Mohllajee AP, Peterson HB. Regret following female sterilization at a young age: a systematic review. Contraception. 2006;73(2):205-210.
- Schmidt JE, Hillis SD, Marchbanks PA, Jeng G, Peterson HB. Requesting information about and obtaining reversal after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Fertil Steril. 2000;74(5):892-898.
- Steiner MJ, Trussell J, Mehta N, Condon S, Subramaniam S, Bourne D. Communicating contraceptive effectiveness: a randomized controlled trial to inform a World Health Organization family planning handbook. Am J Obstet Gynecol. 2006;195(1):85-91.
- Steiner MJ, Trussell J, Johnson S. Communicating contraceptive effectiveness: an updated counseling chart. Am J Obstet Gynecol. 2007;197(1):118.
Read about interval permanent contraception
Feasibility of interval laparoscopic permanent contraception via bilateral salpingectomy
Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505-508.
In this retrospective study, authors used billing data to identify women undergoing interval laparoscopic permanent contraception at a single academic medical center. They educated physicians and patients about the potential benefits to ovarian cancer risk with total salpingectomy (similar to the educational initiative done in British Columbia) and discussed the requirement for the extra incision and more time for the surgery. From 2013 to 2015 use of salpingectomy for permanent contraception changed from 45% of the procedures to 85%, a fairly dramatic trend.18 With these data, the authors compared outcomes between the women receiving tubal occlusive procedures and women receiving bilateral salpingectomy.
Related article:
Risk-reducing salpingectomy at benign hysterectomy: Have surgeons embraced this practice?
Details of surgical time and complications
Tubal occlusion procedures were performed through 2 abdominal ports, and device placement was at the discretion of the provider. Bilateral salpingectomies were performed through 3 abdominal port sites with an electrothermal bipolar tissue-sealing instrument. A total of 149 procedures were identified, 68 tubal occlusions (19% Falope rings, 32% bipolar cautery, and 47% Filshie clips) and 81 bilateral salpingectomies.
The surgical time average (SD) was 6 minutes longer for the salpingectomies (44 [13] minutes vs 38 [15] minutes; P = .018). As would be expected, more experienced residents had shorter surgical times when compared with less experienced residents for both procedures (FIGURE 2).15 Similar rates of both immediate and short-term surgical complications were noted. One immediate complication was reported in each group, both of which were secondary to anesthesia issues.
Interestingly, short-term complications were lower in the salpingectomy group (4.9%) versus the tubal occlusion group (14.7%), although this difference was barely not statistically significant (P = .051). These complications included 1 incisional site infection requiring oral antibiotics and 3 cases of increased pain in the salpingectomy group and 4 incisional site infections with 6 patients reporting increased pain in the tubal occlusion group.
This retrospective analysis provides further reassurance regarding the safety of offering bilateral salpingectomy to patients desiring permanent contraception. This study again consistently demonstrates that bilateral salpingectomy increases the operative time, but only minimally, which is unlikely clinically significant, especially when considering the potential benefits from total salpingectomy (increased ovarian cancer protection, higher contraceptive efficacy, decreased ectopic pregnancy rates, reduced risk of future surgeries for such tubal pathology as hydrosalpinx, etc). The study also shows that educational initiatives targeted at providers likely will increase acceptability as well as uptake of this practice for permanent contraception.
Read about tube removal and ovarian reserve
Does total removal of the tubes affect ovarian reserve?
Ganer Herman H, Gluck O, Keidar R, et al. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017;doi: 10.1016/j.ajog.2017.04.028.
As acceptability of total salpingectomy for permanent contraception increases, one concern is that complete removal may alter blood supply to the ovary, resulting in decreased ovarian reserve and, subsequently, earlier menopause. Several studies have addressed the potential effect of salpingectomy on ovarian function when performed at the time of hysterectomy, most of which have noted no difference in anti-Müllerian hormone (AMH) levels and sonographic parameters following surgery.19 However, very little has been published to assess this same question when the salpingectomy is performed for the purpose of permanent contraception.
Ganer Herman and colleagues aimed to assess short-term ovarian reserve by measuring AMH levels preoperatively and 6 to 8 weeks postoperatively in patients undergoing partial or total salpingectomy at the time of elective cesarean delivery.
Related article:
Salpingectomy after vaginal hysterectomy: Technique, tips, and pearls
Details of the study
The study included women aged 18 to 45 who presented for elective cesarean delivery and who requested permanent contraception. Exclusion criteria included previous tubal surgery, emergent cesarean delivery, personal history of breast carcinoma, familial history of ovarian carcinoma, and BRCA carriage.
Women were randomly assigned at a 1:1 ratio to bilateral total salpingectomy or bilateral partial salpingectomy. A complete blood count and AMH level were drawn the night prior to surgery. Intraoperatively, after delivery and hysterotomy closure, partial salpingectomy, via the Parkland technique, or total salpingectomy, using a suture ligation technique, was performed.
Of the 46 women enrolled, follow-up was completed by 16 of 22 women (72%) in the total salpingectomy group and 18 of 24 women (75%) in the partial salpingectomy group. Patients in the total salpingectomy group were slightly older (mean age, 37 vs 34 years; P = .02), but otherwise all demographic and obstetric characteristics were comparable.
No differences were noted in preoperative and postoperative AMH levels between groups, with an average (SD) increase of 0.58 (0.98) ng/mL versus 0.39 (0.41) ng/mL in the total salpingectomy and partial salpingectomy groups, respectively (P = .45), consistent with known postpartum AMH level trends.
Other findings included an average 13-minute increase in operative time in the total salpingectomy cases, similar safety profile of the 2 methods as there were no postoperative complications during the study period, and no differences in postoperative hemoglobin levels.
This study was designed as a pilot trial to assess feasibility of enrollment, safety, and short-term ovarian reserve after salpingectomy for permanent contraception. Although the study is small and does not assess long-term effects, the findings are reassuring, especially in conjunction with other data.
A meta-analysis demonstrated no effect on ovarian reserve up to 18 months after salpingectomy based on AMH changes.19 A 5-year follow-up evaluation of 71 women undergoing total laparoscopic hysterectomy with bilateral salpingectomy also showed no effect on ovarian reserve as measured by multiple hormone levels including AMH and ultrasonographic findings.20 Thus, it is highly unlikely that a permanent contraception procedure that does not include removal of the uterus will have long-term ovarian reserve effects.
Additionally, consistent with other trials, Ganer Herman and colleagues demonstrate a slightly increased operative time and no increased complications. The surgical technique used in the study reflects the concern for postoperative bleeding from the mesosalpinx, and methods that ensure excellent hemostasis with suture ligation were used.
Conclusion
The studies reviewed in this article are some of the first to evaluate the feasibility and safety of opportunistic, or total, salpingectomy for permanent contraception since the ACOG and SGO recommendations were published. Just as our community has adopted the common practice of opportunistic salpingectomy at the time of hysterectomy, we should continue to advocate for a similar practice when discussing permanent contraception. Additionally, the Westberg study provides good evidence that educational initiatives can influence provider practices, which upholds the data published by McAlpine and colleagues in British Columbia. This information is promising and valuable.
Our universal goal as ObGyns is to provide the best reproductive health care possible based on the most recent evidence available. Continuing to advocate for opportunistic salpingectomy for permanent contraception purposes meets this goal and potentially provides significant noncontraceptive benefits.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
According to the most recent data (2011–2013), 62% of women of childbearing age (15–44 years) use some method of contraception. Of these “contracepting” women, about 25% reported relying on permanent contraception, making it one of the most common methods of contraception used by women in the United States (FIGURE 1).1,2 Women either can choose to have a permanent contraception procedure performed immediately postpartum, which occurs after approximately 9% of all hospital deliveries in the United States,3 or at a time separate from pregnancy.
The most common methods of permanent contraception include partial salpingectomy at the time of cesarean delivery or within 24 hours after vaginal delivery and laparoscopic occlusive procedures at a time unrelated to the postpartum period.3 Hysteroscopic occlusion of the tubal ostia is a newer option, introduced in 2002; its worldwide use is concentrated in the United States, which accounts for 80% of sales based on revenue.4
Historically, for procedures remote from pregnancy, the laparoscopic approach evolved with less sophisticated laparoscopic equipment and limited visualization, which resulted in efficiency and safety being the primary goals of the procedure.5 Accordingly, rapid occlusive procedures were commonplace. However, advancement of laparoscopic technology related to insufflation systems, surgical equipment, and video capabilities did not change this practice.
Recent literature has suggested that complete fallopian tube removal provides additional benefits. With increasing knowledge about the origin of ovarian cancer, as well as increasing data to support the hypothesis that complete tubal excision results in increased ovarian cancer protection when compared with occlusive or partial salpingectomies, both the American College of Obstetricians and Gynecologists (ACOG)6 and the Society of Gynecologic Oncology (SGO)7 recommend discussing bilateral total salpingectomy with patients desiring permanent contraception. Although occlusive procedures decrease a woman’s lifetime risk of ovarian cancer by 24% to 34%,8,9 total salpingectomy likely reduces this risk by 49% to 65%.10,11
With this new evidence, McAlpine and colleagues initiated an educational campaign, targeting all ObGyns in British Columbia, which outlined the role of the fallopian tube in ovarian cancer and urged the consideration of total salpingectomy for permanent contraception in place of occlusive or partial salpingectomy procedures. They found that this one-time targeted education increased the use of total salpingectomy for permanent contraception from 0.5% at 2 years before the intervention to 33.3% by 2 years afterwards.12 On average, laparoscopic bilateral salpingectomy took 10 minutes longer to complete than occlusive procedures. Most importantly, they found no significant differences in complication rates, including hospital readmissions or blood transfusions.
Although our community can be applauded for the rapid uptake of concomitant bilateral salpingectomy at the time of benign hysterectomy,12,13 offering total salpingectomy for permanent contraception is far from common practice. Similarly, while multiple studies have been published to support the practice of opportunistic salpingectomy at the time of hysterectomy, little has been published about the use of bilateral salpingectomy for permanent contraception until this past year.
In this article, we review some of the first publications to focus specifically on the feasibility and safety profile of performing either immediate postpartum total salpingectomy or interval total salpingectomy in women desiring permanent contraception.
Family Planning experts are now strongly discouraging the use of terms like “sterilization,” “permanent sterilization,” and “tubal ligation” due to sterilization abuses that affected vulnerable and marginalized populations in the United States during the early-to mid-20th century.
In 1907, Indiana was the first state to enact a eugenics-based permanent sterilization law, which initiated an aggressive eugenics movement across the United States. This movement lasted for approximately 70 years and resulted in the sterilization of more than 60,000 women, men, and children against their will or without their knowledge. One of the major contributors to this movement was the state of California, which sterilized more than 20,000 women, men, and children.
They defined sterilization as a prophylactic measure that could simultaneously defend public health, preserve precious fiscal resources, and mitigate menace of the “unfit and feebleminded.” The US eugenics movement even inspired Hitler and the Nazi eugenics movement in Germany.
Because of these reproductive rights atrocities, a large counter movement to protect the rights of women, men, and children resulted in the creation of the Medicaid permanent sterilization consents that we still use today. Although some experts question whether the current Medicaid protective policy should be reevaluated, many are focused on the use of less offensive language when discussing the topic.
Current recommendations are to use the phrase “permanent contraception” or simply refer to the procedure name (salpingectomy, vasectomy, tubal occlusion, etc.) to move away from the connection to the eugenics movement.
Read about a total salpingectomy at delivery
Total salpingectomy: A viable option for permanent contraception after vaginal or at cesarean delivery
Shinar S, Blecher Y, Alpern S, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185-1189.
Danis RB, Della Badia CR, Richard SD. Postpartum permanent sterilization: could bilateral salpingectomy replace bilateral tubal ligation? J Minim Invasive Gynecol. 2016;23(6):928-932.
Shinar and colleagues presented a retrospective case series that included women undergoing permanent contraception procedures during cesarean delivery at a single tertiary medical center. The authors evaluated outcomes before and after a global hospital policy changed the preferred permanent contraception procedure from partial to total salpingectomy.
Details of the Shinar technique and outcomes
Of the 149 women included, 99 underwent partial salpingectomy via the modified Pomeroy technique and 50 underwent total salpingectomy using an electrothermal bipolar tissue-sealing instrument (Ligasure). The authors found no difference in operative times and similar rates of complications. Composite adverse outcomes, defined as surgery duration greater than 45 minutes, hemoglobin decline greater than 1.2 g/dL, need for blood transfusion, prolonged hospitalization, ICU admission, or re-laparotomy, were comparable and were reported as 30.3% and 36.0% in the partial and total salpingectomy groups, respectively, (P = .57).One major complication occurred in the total salpingectomy cohort; postoperatively the patient had hemodynamic instability and was found to have hemoperitoneum requiring exploratory laparotomy. Significant bleeding from the bilateral mesosalpinges was discovered, presumably directly related to the total salpingectomy.
Related article:
Hysteroscopic tubal occlusion: How new product labeling can be a resource for patient counseling
Details of Danis et al
Intuitively, performing salpingectomy at the time of cesarean delivery does not seem as significant a change in practice as would performing salpingectomy through a small periumbilical incision after vaginal delivery. However, Danis and colleagues did just that; they published a retrospective case series of total salpingectomy performed within 24 hours after a vaginal delivery at an urban, academic institution. They included all women admitted for full-term vaginal deliveries who desired permanent contraception, with no exclusion criteria related to body mass index (BMI). The authors reported on 80 women, including 64 (80%) who underwent partial salpingectomy via the modified Pomeroy or Parkland technique and 16 (20%) who underwent total salpingectomy. Most women had a BMI of less than 30 kg/m2; less than 15% of the women in each group had a BMI greater than 40 kg/m2.
The technique for total salpingectomy involved a 2- to 3-cm vertical incision at the level of the umbilicus, elevation of the entire fallopian tube with 2 Babcock clamps, followed by the development of 2 to 3 windows with monopolar electrocautery in the mesosalpinx and subsequent suture ligation with polyglactin 910 (Vicryl, Ethicon).
Major findings included slightly longer operative time in the total salpingectomy compared with the partial salpingectomy group (a finding consistent with other studies12,14,15) and no difference in complication rates. The average (SD) surgical time in the partial salpingectomy group was 59 (16) minutes, compared with 71 (6) minutes in the total salpingectomy group (P = .003). The authors reported 4 (6.3%) complications in the partial salpingectomy group--ileus, excessive bleeding from mesosalpinx, and incisional site hematoma--and no complications in the total salpingectomy group (P = .58).
These 2 studies, although small retrospective case series, demonstrate the feasibility of performing total salpingectomies with minimal operative time differences when compared with more traditional partial salpingectomy procedures. The re-laparotomy complication noted in the Shinar series cannot be dismissed, as this is a major morbidity, but it also should not dictate the conversation.
Overall, the need for blood transfusion or unintended major surgery after permanent contraception procedures is rare. In the U.S. Collaborative Review of Sterilization study, none of the 282 women who had a permanent contraception procedure performed via laparotomy experienced either of these outcomes.16 Only 1 of the 9,475 women (0.01%) having a laparoscopic procedure in this study required blood transfusion and 14 (0.15%) required reoperation secondary to a procedure complication.17 The complication reported in the Shinar study reminds us that the technique for salpingectomy in the postpartum period, whether partial or total, should be considered carefully, being mindful of the anatomical changes that occur in pregnancy.
While larger studies should be performed to confirm these initial findings, these 2 articles provide the reassurance that many providers may need before beginning to offer total salpingectomy procedures in the immediate postpartum period.
When women present for permanent contraception counseling, we must remember that our patients' needs are often far too diverse and dynamic to allow a universal counseling technique. Every provider likely has a counseling style, with a structure and language that has been altered and changed through years of practice, patient experiences, and new scientific technologies and data. Unfortunately, provider biases and past coercive practices also influence contraceptive counseling.
Historically, some providers used formulas related to a woman's age and parity to decide if she could have a permanent contraception procedure, possibly based on fears of patient regret. Such practices are an embarrassment to the principles of patient autonomy and empowerment, which should serve as the foundation for any contraceptive conversation. Studies of regret after permanent contraception procedures are often misinterpreted; although younger women experience higher rates of regret, the absolute rate still favors performing the procedure.1,2 When comparing women aged 30 or younger to those older than 30 years at the time of procedure, the vast majority (about 80%) of those 30 and younger do not express regret.1 Less than 5% of women who express regret access a reversal procedure.2,3 Our job as providers is to educate and allow women to understand the options--and with permanent contraception that also means explaining the potential for regret; however, empowering women does not mean limiting an opportunity for the majority to potentially impact the minority.
Our contraceptive counseling philosophy follows the shared decision-making model. This model informs the patient, tailors the conversation toward her priorities, and maintains patient autonomy, while empowering the patient to take control of her reproductive health and future. When a patient expresses the desire for permanent contraception, we ensure she understands the permanence of the procedure and offer information about other Tier 1 contraceptive options, including long-acting reversible methods and vasectomy. We use the evidence-based World Health Organization counseling table4,5 to assist with the discussion and provide vasectomy referral and further information about specific intrauterine devices or the contraceptive implant based on the woman's interests.
For women who desire a female permanent contraception procedure, we also provide information tables comparing laparoscopic tubal occlusion procedures, laparoscopic bilateral salpingectomy, and hysteroscopic tubal occlusion. These tables review how each procedure is performed; risks and benefits, including failure rates over time; and ovarian cancer protection estimates. Our office also has devised tables to inform women seeking permanent contraception immediately after delivery and unrelated to pregnancy. Ultimately, the woman can choose what makes the most sense for her at that specific time in her life, and as providers we must support and uphold that decision.
References
- Hills SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93(6):889-895.
- Curtis KM, Mohllajee AP, Peterson HB. Regret following female sterilization at a young age: a systematic review. Contraception. 2006;73(2):205-210.
- Schmidt JE, Hillis SD, Marchbanks PA, Jeng G, Peterson HB. Requesting information about and obtaining reversal after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Fertil Steril. 2000;74(5):892-898.
- Steiner MJ, Trussell J, Mehta N, Condon S, Subramaniam S, Bourne D. Communicating contraceptive effectiveness: a randomized controlled trial to inform a World Health Organization family planning handbook. Am J Obstet Gynecol. 2006;195(1):85-91.
- Steiner MJ, Trussell J, Johnson S. Communicating contraceptive effectiveness: an updated counseling chart. Am J Obstet Gynecol. 2007;197(1):118.
Read about interval permanent contraception
Feasibility of interval laparoscopic permanent contraception via bilateral salpingectomy
Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505-508.
In this retrospective study, authors used billing data to identify women undergoing interval laparoscopic permanent contraception at a single academic medical center. They educated physicians and patients about the potential benefits to ovarian cancer risk with total salpingectomy (similar to the educational initiative done in British Columbia) and discussed the requirement for the extra incision and more time for the surgery. From 2013 to 2015 use of salpingectomy for permanent contraception changed from 45% of the procedures to 85%, a fairly dramatic trend.18 With these data, the authors compared outcomes between the women receiving tubal occlusive procedures and women receiving bilateral salpingectomy.
Related article:
Risk-reducing salpingectomy at benign hysterectomy: Have surgeons embraced this practice?
Details of surgical time and complications
Tubal occlusion procedures were performed through 2 abdominal ports, and device placement was at the discretion of the provider. Bilateral salpingectomies were performed through 3 abdominal port sites with an electrothermal bipolar tissue-sealing instrument. A total of 149 procedures were identified, 68 tubal occlusions (19% Falope rings, 32% bipolar cautery, and 47% Filshie clips) and 81 bilateral salpingectomies.
The surgical time average (SD) was 6 minutes longer for the salpingectomies (44 [13] minutes vs 38 [15] minutes; P = .018). As would be expected, more experienced residents had shorter surgical times when compared with less experienced residents for both procedures (FIGURE 2).15 Similar rates of both immediate and short-term surgical complications were noted. One immediate complication was reported in each group, both of which were secondary to anesthesia issues.
Interestingly, short-term complications were lower in the salpingectomy group (4.9%) versus the tubal occlusion group (14.7%), although this difference was barely not statistically significant (P = .051). These complications included 1 incisional site infection requiring oral antibiotics and 3 cases of increased pain in the salpingectomy group and 4 incisional site infections with 6 patients reporting increased pain in the tubal occlusion group.
This retrospective analysis provides further reassurance regarding the safety of offering bilateral salpingectomy to patients desiring permanent contraception. This study again consistently demonstrates that bilateral salpingectomy increases the operative time, but only minimally, which is unlikely clinically significant, especially when considering the potential benefits from total salpingectomy (increased ovarian cancer protection, higher contraceptive efficacy, decreased ectopic pregnancy rates, reduced risk of future surgeries for such tubal pathology as hydrosalpinx, etc). The study also shows that educational initiatives targeted at providers likely will increase acceptability as well as uptake of this practice for permanent contraception.
Read about tube removal and ovarian reserve
Does total removal of the tubes affect ovarian reserve?
Ganer Herman H, Gluck O, Keidar R, et al. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017;doi: 10.1016/j.ajog.2017.04.028.
As acceptability of total salpingectomy for permanent contraception increases, one concern is that complete removal may alter blood supply to the ovary, resulting in decreased ovarian reserve and, subsequently, earlier menopause. Several studies have addressed the potential effect of salpingectomy on ovarian function when performed at the time of hysterectomy, most of which have noted no difference in anti-Müllerian hormone (AMH) levels and sonographic parameters following surgery.19 However, very little has been published to assess this same question when the salpingectomy is performed for the purpose of permanent contraception.
Ganer Herman and colleagues aimed to assess short-term ovarian reserve by measuring AMH levels preoperatively and 6 to 8 weeks postoperatively in patients undergoing partial or total salpingectomy at the time of elective cesarean delivery.
Related article:
Salpingectomy after vaginal hysterectomy: Technique, tips, and pearls
Details of the study
The study included women aged 18 to 45 who presented for elective cesarean delivery and who requested permanent contraception. Exclusion criteria included previous tubal surgery, emergent cesarean delivery, personal history of breast carcinoma, familial history of ovarian carcinoma, and BRCA carriage.
Women were randomly assigned at a 1:1 ratio to bilateral total salpingectomy or bilateral partial salpingectomy. A complete blood count and AMH level were drawn the night prior to surgery. Intraoperatively, after delivery and hysterotomy closure, partial salpingectomy, via the Parkland technique, or total salpingectomy, using a suture ligation technique, was performed.
Of the 46 women enrolled, follow-up was completed by 16 of 22 women (72%) in the total salpingectomy group and 18 of 24 women (75%) in the partial salpingectomy group. Patients in the total salpingectomy group were slightly older (mean age, 37 vs 34 years; P = .02), but otherwise all demographic and obstetric characteristics were comparable.
No differences were noted in preoperative and postoperative AMH levels between groups, with an average (SD) increase of 0.58 (0.98) ng/mL versus 0.39 (0.41) ng/mL in the total salpingectomy and partial salpingectomy groups, respectively (P = .45), consistent with known postpartum AMH level trends.
Other findings included an average 13-minute increase in operative time in the total salpingectomy cases, similar safety profile of the 2 methods as there were no postoperative complications during the study period, and no differences in postoperative hemoglobin levels.
This study was designed as a pilot trial to assess feasibility of enrollment, safety, and short-term ovarian reserve after salpingectomy for permanent contraception. Although the study is small and does not assess long-term effects, the findings are reassuring, especially in conjunction with other data.
A meta-analysis demonstrated no effect on ovarian reserve up to 18 months after salpingectomy based on AMH changes.19 A 5-year follow-up evaluation of 71 women undergoing total laparoscopic hysterectomy with bilateral salpingectomy also showed no effect on ovarian reserve as measured by multiple hormone levels including AMH and ultrasonographic findings.20 Thus, it is highly unlikely that a permanent contraception procedure that does not include removal of the uterus will have long-term ovarian reserve effects.
Additionally, consistent with other trials, Ganer Herman and colleagues demonstrate a slightly increased operative time and no increased complications. The surgical technique used in the study reflects the concern for postoperative bleeding from the mesosalpinx, and methods that ensure excellent hemostasis with suture ligation were used.
Conclusion
The studies reviewed in this article are some of the first to evaluate the feasibility and safety of opportunistic, or total, salpingectomy for permanent contraception since the ACOG and SGO recommendations were published. Just as our community has adopted the common practice of opportunistic salpingectomy at the time of hysterectomy, we should continue to advocate for a similar practice when discussing permanent contraception. Additionally, the Westberg study provides good evidence that educational initiatives can influence provider practices, which upholds the data published by McAlpine and colleagues in British Columbia. This information is promising and valuable.
Our universal goal as ObGyns is to provide the best reproductive health care possible based on the most recent evidence available. Continuing to advocate for opportunistic salpingectomy for permanent contraception purposes meets this goal and potentially provides significant noncontraceptive benefits.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Daniels K, Daugherty J, Jones J, Mosher W. Current contraceptive use and variation by selected characteristics among women aged 15-44: United States, 2011-2013. Natl Health Stat Report. 2015;86:1–14.
- Kavanaugh ML, Jerman J, Finer LB. Changes in use of long-acting reversible contraceptive methods among U.S. women, 2009-2012. Obstet Gynecol. 2015;126(5):17–927.
- Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril. 2010;94(1):1–6.
- Essure system for permanent birth control: Executive summary. Bayer Healthcare: Berlin, Germany; 2015:1–89. https://www.fda.gov/downloads/AdvisoryCommittees/UCM463460.pdf. Accessed July 19, 2017.
- Creinin MD, Zite N. Female tubal sterilization: the time has come to routinely consider removal. Obstet Gynecol. 2014;124(3):596–599.
- American College of Obstetrics and Gynecology Committee opinion no. 620: salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015;125(1):279–281.
- Society of Gynecologic Oncology website. SGO clinical practice statement: salpingectomy for ovarian cancer. https://www.sgo.org/clinical-practice/guidelines/sgo-clinical-practice-statement-salpingectomy-for-ovarian-cancer-prevention/. Published November 2013. Accessed July 21, 2017.
- Cibula D, Widschwendter M, Majek O, Dusek L. Tubal ligation and the risk of ovarian cancer: review and meta-analysis. Hum Reprod Update. 2011;17(1): 55–67.
- Sieh W, Salvador S, McGuire V, et al. Tubal ligation and risk of ovarian cancer subtypes: a pooled analysis of case-control studies. Int J Epidemiol. 2013;42(2): 579–589.
- Yoon SH, Kim SN, Shim SH, Kang SB, Lee SJ. Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: a meta-analysis. Eur J Cancer. 2016;55:38–46.
- Falconer H, Yin L, Grönberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015;107(2).
- McAlpine JN, Hanley GE, Woo MM, et al. Opportunistic salpingectomy: uptake, risks, and complications of a regional initiative for ovarian cancer prevention. Am J Obstet Gynecol. 2014;210(5):471e1–e11.
- Garcia C, Martin M, Tucker LY, et al. Experience with opportunistic salpingectomy in a large, community-based health system in the United States. Obstet Gynecol. 2016;128(2):277–283.
- Shinar S, Blecher Y, Alpern A, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185–1189.
- Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505–508.
- Layde PM, Peterson HB, Dicker RC, DeStefano F, Rubin GL, Ory HW. Risk factors for complications of interval tubal sterilization by laparotomy. Obstet Gynecol. 1983;62(2):180–184.
- Jamieson DJ, Hillis SD, Duerr A, Marchbanks PA, Costello C, Peterson HB. Complications of interval laparoscopic tubal sterilization: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 2000;96(6):997–1002.
- Westberg JM, Scott F, Cansino C, Creinin MD. Recent trends in incidence of different permanent female sterilization methods. Obstet Gynecol. 2016;127(suppl):127S.
- Mohamed AA, Yosef AH, James C, Al-Hussaini TK, Bedaiwy MA, Amer SAKS. Ovarian reserve after salpingectomy: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2017;96(7):795–803.
- Venturella R, Lico D, Borelli M, et al. 3 to 5 years later: long-term effects of prophylactic bilateral salpingectomy on ovarian function. J Minim Invasive Gynecol. 2017;24(1):145–150.
- Daniels K, Daugherty J, Jones J, Mosher W. Current contraceptive use and variation by selected characteristics among women aged 15-44: United States, 2011-2013. Natl Health Stat Report. 2015;86:1–14.
- Kavanaugh ML, Jerman J, Finer LB. Changes in use of long-acting reversible contraceptive methods among U.S. women, 2009-2012. Obstet Gynecol. 2015;126(5):17–927.
- Chan LM, Westhoff CL. Tubal sterilization trends in the United States. Fertil Steril. 2010;94(1):1–6.
- Essure system for permanent birth control: Executive summary. Bayer Healthcare: Berlin, Germany; 2015:1–89. https://www.fda.gov/downloads/AdvisoryCommittees/UCM463460.pdf. Accessed July 19, 2017.
- Creinin MD, Zite N. Female tubal sterilization: the time has come to routinely consider removal. Obstet Gynecol. 2014;124(3):596–599.
- American College of Obstetrics and Gynecology Committee opinion no. 620: salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015;125(1):279–281.
- Society of Gynecologic Oncology website. SGO clinical practice statement: salpingectomy for ovarian cancer. https://www.sgo.org/clinical-practice/guidelines/sgo-clinical-practice-statement-salpingectomy-for-ovarian-cancer-prevention/. Published November 2013. Accessed July 21, 2017.
- Cibula D, Widschwendter M, Majek O, Dusek L. Tubal ligation and the risk of ovarian cancer: review and meta-analysis. Hum Reprod Update. 2011;17(1): 55–67.
- Sieh W, Salvador S, McGuire V, et al. Tubal ligation and risk of ovarian cancer subtypes: a pooled analysis of case-control studies. Int J Epidemiol. 2013;42(2): 579–589.
- Yoon SH, Kim SN, Shim SH, Kang SB, Lee SJ. Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: a meta-analysis. Eur J Cancer. 2016;55:38–46.
- Falconer H, Yin L, Grönberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015;107(2).
- McAlpine JN, Hanley GE, Woo MM, et al. Opportunistic salpingectomy: uptake, risks, and complications of a regional initiative for ovarian cancer prevention. Am J Obstet Gynecol. 2014;210(5):471e1–e11.
- Garcia C, Martin M, Tucker LY, et al. Experience with opportunistic salpingectomy in a large, community-based health system in the United States. Obstet Gynecol. 2016;128(2):277–283.
- Shinar S, Blecher Y, Alpern A, et al. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017;295(5):1185–1189.
- Westberg J, Scott F, Creinin MD. Safety outcomes of female sterilization by salpingectomy and tubal occlusion. Contraception. 2017;95(5):505–508.
- Layde PM, Peterson HB, Dicker RC, DeStefano F, Rubin GL, Ory HW. Risk factors for complications of interval tubal sterilization by laparotomy. Obstet Gynecol. 1983;62(2):180–184.
- Jamieson DJ, Hillis SD, Duerr A, Marchbanks PA, Costello C, Peterson HB. Complications of interval laparoscopic tubal sterilization: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 2000;96(6):997–1002.
- Westberg JM, Scott F, Cansino C, Creinin MD. Recent trends in incidence of different permanent female sterilization methods. Obstet Gynecol. 2016;127(suppl):127S.
- Mohamed AA, Yosef AH, James C, Al-Hussaini TK, Bedaiwy MA, Amer SAKS. Ovarian reserve after salpingectomy: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2017;96(7):795–803.
- Venturella R, Lico D, Borelli M, et al. 3 to 5 years later: long-term effects of prophylactic bilateral salpingectomy on ovarian function. J Minim Invasive Gynecol. 2017;24(1):145–150.
What Therapy-Related Risks Can Patients With MS Tolerate?
NEW ORLEANS—Tolerance of risk related to current disease-modifying therapies (DMTs) on the part of patients with multiple sclerosis (MS) varies widely, according to results from a large national survey presented at the 31st Annual Meeting of the Consortium of MS Centers.
“We have therapies available with a wide range of risks,” said Sneha Natarajan, PhD, a research coordinator at the Mellen Center for MS Treatment and Research at the Cleveland Clinic. “Some of the risks are relatively minor, like injection-site reactions or flu-like symptoms, and some are as bad as progressive multifocal leukoencephalopathy [PML], which can be fatal. We do not know what kind of risks people tolerate.”
To address these questions, Dr. Natarajan and colleagues conducted a survey of participants in the North American Research Committee on MS Registry and visitors to the National MS Society website who reported having MS. The benefit of a hypothetical oral DMT was set at 50% reduction in clinical relapses and 30% reduction in disability progression. The researchers chose six risk scenarios to evaluate tolerance to the following six risks: infection, skin rash, kidney injury, thyroid injury, liver injury, and PML. Starting from a risk tolerance of 1:1,000, the risk was adjusted to identify the highest risk tolerated, ranging from “would take regardless of the risk of death” to “no acceptable risk.”
Dr. Natarajan and colleagues reported results from 3,371 survey respondents. The mean age was 55, 93% of participants were white, 61% of participants had relapsing-remitting MS, and 53% of participants were currently taking a DMT. Overall, respondents reported the highest risk tolerance for infection or thyroid risks (1:1,000 for both) and lowest risk tolerance for PML and kidney injury (1:1,000,000 for both). Males reported a higher risk tolerance to all six risks. Females reported a risk tolerance to skin rash that was similar to that of kidney injury and PML.
“There is a pattern to the risks that our patients accept,” Dr. Natarajan said. “I do not think a doctor would not recommend a therapy benefit because of a skin rash [risk], but he may need to address the concerns of the patient up front and have a talk with the patient.”
Researchers also found that current DMT users expressed increased risk tolerance for all outcomes, compared with those not using any DMT. Respondents who were older, those who were more disabled, and those taking infusion therapies also reported higher risk tolerance.
The National MS Society funded this study. Dr. Natarajan reported having no financial disclosures.
—Doug Brunk
NEW ORLEANS—Tolerance of risk related to current disease-modifying therapies (DMTs) on the part of patients with multiple sclerosis (MS) varies widely, according to results from a large national survey presented at the 31st Annual Meeting of the Consortium of MS Centers.
“We have therapies available with a wide range of risks,” said Sneha Natarajan, PhD, a research coordinator at the Mellen Center for MS Treatment and Research at the Cleveland Clinic. “Some of the risks are relatively minor, like injection-site reactions or flu-like symptoms, and some are as bad as progressive multifocal leukoencephalopathy [PML], which can be fatal. We do not know what kind of risks people tolerate.”
To address these questions, Dr. Natarajan and colleagues conducted a survey of participants in the North American Research Committee on MS Registry and visitors to the National MS Society website who reported having MS. The benefit of a hypothetical oral DMT was set at 50% reduction in clinical relapses and 30% reduction in disability progression. The researchers chose six risk scenarios to evaluate tolerance to the following six risks: infection, skin rash, kidney injury, thyroid injury, liver injury, and PML. Starting from a risk tolerance of 1:1,000, the risk was adjusted to identify the highest risk tolerated, ranging from “would take regardless of the risk of death” to “no acceptable risk.”
Dr. Natarajan and colleagues reported results from 3,371 survey respondents. The mean age was 55, 93% of participants were white, 61% of participants had relapsing-remitting MS, and 53% of participants were currently taking a DMT. Overall, respondents reported the highest risk tolerance for infection or thyroid risks (1:1,000 for both) and lowest risk tolerance for PML and kidney injury (1:1,000,000 for both). Males reported a higher risk tolerance to all six risks. Females reported a risk tolerance to skin rash that was similar to that of kidney injury and PML.
“There is a pattern to the risks that our patients accept,” Dr. Natarajan said. “I do not think a doctor would not recommend a therapy benefit because of a skin rash [risk], but he may need to address the concerns of the patient up front and have a talk with the patient.”
Researchers also found that current DMT users expressed increased risk tolerance for all outcomes, compared with those not using any DMT. Respondents who were older, those who were more disabled, and those taking infusion therapies also reported higher risk tolerance.
The National MS Society funded this study. Dr. Natarajan reported having no financial disclosures.
—Doug Brunk
NEW ORLEANS—Tolerance of risk related to current disease-modifying therapies (DMTs) on the part of patients with multiple sclerosis (MS) varies widely, according to results from a large national survey presented at the 31st Annual Meeting of the Consortium of MS Centers.
“We have therapies available with a wide range of risks,” said Sneha Natarajan, PhD, a research coordinator at the Mellen Center for MS Treatment and Research at the Cleveland Clinic. “Some of the risks are relatively minor, like injection-site reactions or flu-like symptoms, and some are as bad as progressive multifocal leukoencephalopathy [PML], which can be fatal. We do not know what kind of risks people tolerate.”
To address these questions, Dr. Natarajan and colleagues conducted a survey of participants in the North American Research Committee on MS Registry and visitors to the National MS Society website who reported having MS. The benefit of a hypothetical oral DMT was set at 50% reduction in clinical relapses and 30% reduction in disability progression. The researchers chose six risk scenarios to evaluate tolerance to the following six risks: infection, skin rash, kidney injury, thyroid injury, liver injury, and PML. Starting from a risk tolerance of 1:1,000, the risk was adjusted to identify the highest risk tolerated, ranging from “would take regardless of the risk of death” to “no acceptable risk.”
Dr. Natarajan and colleagues reported results from 3,371 survey respondents. The mean age was 55, 93% of participants were white, 61% of participants had relapsing-remitting MS, and 53% of participants were currently taking a DMT. Overall, respondents reported the highest risk tolerance for infection or thyroid risks (1:1,000 for both) and lowest risk tolerance for PML and kidney injury (1:1,000,000 for both). Males reported a higher risk tolerance to all six risks. Females reported a risk tolerance to skin rash that was similar to that of kidney injury and PML.
“There is a pattern to the risks that our patients accept,” Dr. Natarajan said. “I do not think a doctor would not recommend a therapy benefit because of a skin rash [risk], but he may need to address the concerns of the patient up front and have a talk with the patient.”
Researchers also found that current DMT users expressed increased risk tolerance for all outcomes, compared with those not using any DMT. Respondents who were older, those who were more disabled, and those taking infusion therapies also reported higher risk tolerance.
The National MS Society funded this study. Dr. Natarajan reported having no financial disclosures.
—Doug Brunk
When – and how – to do a full-thickness graft repair
NEW YORK – Though flap reconstruction can provide elegant solutions with very good cosmesis after Mohs surgery and other excisional procedures, skin grafts provide another set of options.
Both split and full thickness grafts have a place in the dermatologist’s repertoire, but some tips and tricks can make a full thickness graft an attractive option in many instances, according to Marc Brown, MD, professor of dermatology and oncology at the University of Rochester (N.Y.).
Speaking at the summer meeting of the American Academy of Dermatology, Dr. Brown said that retrospective studies have shown that patients are highly satisfied with the cosmesis of full thickness skin grafting for reconstruction post Mohs surgery – if they’re asked after enough time has passed for the graft to mature and the dermatologist to perform some of the tweaks that are occasionally necessary. “It takes time to get to that point, but the overall satisfaction improves over time,” he said.
Full thickness skin grafts may be a good option when flap coverage is suboptimal or infeasible, he said. Some other pros of opting for a full thickness graft are that better cosmesis can be achieved in certain cases, and the donor site can be sutured, allowing for quicker healing with less downtime. However, a full thickness graft is a thicker graft, with resulting high metabolic demand. To ensure good “take,” dermatologists must be mindful that the graft site has a good vascular supply. Also, he added, full thickness grafts often need thinning, and physicians shouldn’t be afraid of being aggressive.
Both to reduce unwanted bulk and to help with better graft take, subcutaneous fat should be stripped completely from the graft, Dr. Brown noted. “You should see nothing that looks yellow,” he said. Fine serrated scissors are an excellent defatting tool, and while expensive, “they’re worth the cost,” he added.
Areas to be considered for full thickness grafts include the nasal ala, the medial canthus of the eye, the upper eyelid, fingers, and the ear. Larger defects on the scalp or forehead may also be good candidates, and full thickness grafts can work well on the lower leg.
For smaller grafts – those less than 1 or 2 cm diameter – Dr. Brown said that the preauricular area can work well as a donor site for facial grafts, since there’s often extra tissue with little tension there. Patients who are worried about donor site cosmesis may prefer the postauricular area, though the result is usually very good in either case, he said. Other potential donor sites are the glabella, nasolabial area, and the eyelid.
When grafts of more than 2 cm diameter are needed, Dr. Brown said the lateral neck, the supraclavicular area, or the lateral chest area can provide a good match in color and texture to facial skin.
Other tips for surgical technique are to use an appropriately-sized nonadherent gauze pad as a template for exact graft sizing. Precision counts, said Dr. Brown: “Measure twice, cut once.”
A central basting suture can be used to hold the graft in place while getting started, and Dr. Brown often uses a bolster for grafts of less than 1 cm. “Bolsters are helpful to prevent bleeding and improve contact in larger grafts,” he added.
Sutures should be placed graft to skin – “up and under,” Dr. Brown noted. He uses rapid-absorbing chromic suture material, with silk on the outside for the tie-over bolster. It’s also important to avoid tension on the wound edge, and he advised always using a pressure bandage for 48-72 hours.
If there’s concern about blood supply when grafting over cartilage, Dr. Brown advises making a few 2-mm punch defects in the cartilage to boost blood supply and help with engraftment.
For larger grafts where hematoma formation might result in graft failure, he will place a few parallel incisions through the graft as a means of escape should there be significant bleeding. At about 1 week post procedure, the graft should be purplish-pink in color, and patients should be counseled about the appearance of the graft as healing progresses, he said.
Physicians can manage patient expectations by letting them know not to expect the best cosmesis right away. However, said Dr. Brown, if the graft remains thickened, there are lots of options. Intralesional triamcinolone injections can help with thinning, and can be used beginning about 3 months after the graft. Dermabrasion is another good option, but he likes to wait 4-6 months before performing this procedure.
With appropriate site selection, meticulous technique, and good patient communication, dermatologists can keep full thickness skin grafting in the repertoire of viable options for excellent cosmesis, and a valuable tool in their own right. “Skin grafts are not a failure of reconstruction,” Dr. Brown said.
Dr. Brown had no conflicts to disclose.
[email protected]
On Twitter @karioakes
NEW YORK – Though flap reconstruction can provide elegant solutions with very good cosmesis after Mohs surgery and other excisional procedures, skin grafts provide another set of options.
Both split and full thickness grafts have a place in the dermatologist’s repertoire, but some tips and tricks can make a full thickness graft an attractive option in many instances, according to Marc Brown, MD, professor of dermatology and oncology at the University of Rochester (N.Y.).
Speaking at the summer meeting of the American Academy of Dermatology, Dr. Brown said that retrospective studies have shown that patients are highly satisfied with the cosmesis of full thickness skin grafting for reconstruction post Mohs surgery – if they’re asked after enough time has passed for the graft to mature and the dermatologist to perform some of the tweaks that are occasionally necessary. “It takes time to get to that point, but the overall satisfaction improves over time,” he said.
Full thickness skin grafts may be a good option when flap coverage is suboptimal or infeasible, he said. Some other pros of opting for a full thickness graft are that better cosmesis can be achieved in certain cases, and the donor site can be sutured, allowing for quicker healing with less downtime. However, a full thickness graft is a thicker graft, with resulting high metabolic demand. To ensure good “take,” dermatologists must be mindful that the graft site has a good vascular supply. Also, he added, full thickness grafts often need thinning, and physicians shouldn’t be afraid of being aggressive.
Both to reduce unwanted bulk and to help with better graft take, subcutaneous fat should be stripped completely from the graft, Dr. Brown noted. “You should see nothing that looks yellow,” he said. Fine serrated scissors are an excellent defatting tool, and while expensive, “they’re worth the cost,” he added.
Areas to be considered for full thickness grafts include the nasal ala, the medial canthus of the eye, the upper eyelid, fingers, and the ear. Larger defects on the scalp or forehead may also be good candidates, and full thickness grafts can work well on the lower leg.
For smaller grafts – those less than 1 or 2 cm diameter – Dr. Brown said that the preauricular area can work well as a donor site for facial grafts, since there’s often extra tissue with little tension there. Patients who are worried about donor site cosmesis may prefer the postauricular area, though the result is usually very good in either case, he said. Other potential donor sites are the glabella, nasolabial area, and the eyelid.
When grafts of more than 2 cm diameter are needed, Dr. Brown said the lateral neck, the supraclavicular area, or the lateral chest area can provide a good match in color and texture to facial skin.
Other tips for surgical technique are to use an appropriately-sized nonadherent gauze pad as a template for exact graft sizing. Precision counts, said Dr. Brown: “Measure twice, cut once.”
A central basting suture can be used to hold the graft in place while getting started, and Dr. Brown often uses a bolster for grafts of less than 1 cm. “Bolsters are helpful to prevent bleeding and improve contact in larger grafts,” he added.
Sutures should be placed graft to skin – “up and under,” Dr. Brown noted. He uses rapid-absorbing chromic suture material, with silk on the outside for the tie-over bolster. It’s also important to avoid tension on the wound edge, and he advised always using a pressure bandage for 48-72 hours.
If there’s concern about blood supply when grafting over cartilage, Dr. Brown advises making a few 2-mm punch defects in the cartilage to boost blood supply and help with engraftment.
For larger grafts where hematoma formation might result in graft failure, he will place a few parallel incisions through the graft as a means of escape should there be significant bleeding. At about 1 week post procedure, the graft should be purplish-pink in color, and patients should be counseled about the appearance of the graft as healing progresses, he said.
Physicians can manage patient expectations by letting them know not to expect the best cosmesis right away. However, said Dr. Brown, if the graft remains thickened, there are lots of options. Intralesional triamcinolone injections can help with thinning, and can be used beginning about 3 months after the graft. Dermabrasion is another good option, but he likes to wait 4-6 months before performing this procedure.
With appropriate site selection, meticulous technique, and good patient communication, dermatologists can keep full thickness skin grafting in the repertoire of viable options for excellent cosmesis, and a valuable tool in their own right. “Skin grafts are not a failure of reconstruction,” Dr. Brown said.
Dr. Brown had no conflicts to disclose.
[email protected]
On Twitter @karioakes
NEW YORK – Though flap reconstruction can provide elegant solutions with very good cosmesis after Mohs surgery and other excisional procedures, skin grafts provide another set of options.
Both split and full thickness grafts have a place in the dermatologist’s repertoire, but some tips and tricks can make a full thickness graft an attractive option in many instances, according to Marc Brown, MD, professor of dermatology and oncology at the University of Rochester (N.Y.).
Speaking at the summer meeting of the American Academy of Dermatology, Dr. Brown said that retrospective studies have shown that patients are highly satisfied with the cosmesis of full thickness skin grafting for reconstruction post Mohs surgery – if they’re asked after enough time has passed for the graft to mature and the dermatologist to perform some of the tweaks that are occasionally necessary. “It takes time to get to that point, but the overall satisfaction improves over time,” he said.
Full thickness skin grafts may be a good option when flap coverage is suboptimal or infeasible, he said. Some other pros of opting for a full thickness graft are that better cosmesis can be achieved in certain cases, and the donor site can be sutured, allowing for quicker healing with less downtime. However, a full thickness graft is a thicker graft, with resulting high metabolic demand. To ensure good “take,” dermatologists must be mindful that the graft site has a good vascular supply. Also, he added, full thickness grafts often need thinning, and physicians shouldn’t be afraid of being aggressive.
Both to reduce unwanted bulk and to help with better graft take, subcutaneous fat should be stripped completely from the graft, Dr. Brown noted. “You should see nothing that looks yellow,” he said. Fine serrated scissors are an excellent defatting tool, and while expensive, “they’re worth the cost,” he added.
Areas to be considered for full thickness grafts include the nasal ala, the medial canthus of the eye, the upper eyelid, fingers, and the ear. Larger defects on the scalp or forehead may also be good candidates, and full thickness grafts can work well on the lower leg.
For smaller grafts – those less than 1 or 2 cm diameter – Dr. Brown said that the preauricular area can work well as a donor site for facial grafts, since there’s often extra tissue with little tension there. Patients who are worried about donor site cosmesis may prefer the postauricular area, though the result is usually very good in either case, he said. Other potential donor sites are the glabella, nasolabial area, and the eyelid.
When grafts of more than 2 cm diameter are needed, Dr. Brown said the lateral neck, the supraclavicular area, or the lateral chest area can provide a good match in color and texture to facial skin.
Other tips for surgical technique are to use an appropriately-sized nonadherent gauze pad as a template for exact graft sizing. Precision counts, said Dr. Brown: “Measure twice, cut once.”
A central basting suture can be used to hold the graft in place while getting started, and Dr. Brown often uses a bolster for grafts of less than 1 cm. “Bolsters are helpful to prevent bleeding and improve contact in larger grafts,” he added.
Sutures should be placed graft to skin – “up and under,” Dr. Brown noted. He uses rapid-absorbing chromic suture material, with silk on the outside for the tie-over bolster. It’s also important to avoid tension on the wound edge, and he advised always using a pressure bandage for 48-72 hours.
If there’s concern about blood supply when grafting over cartilage, Dr. Brown advises making a few 2-mm punch defects in the cartilage to boost blood supply and help with engraftment.
For larger grafts where hematoma formation might result in graft failure, he will place a few parallel incisions through the graft as a means of escape should there be significant bleeding. At about 1 week post procedure, the graft should be purplish-pink in color, and patients should be counseled about the appearance of the graft as healing progresses, he said.
Physicians can manage patient expectations by letting them know not to expect the best cosmesis right away. However, said Dr. Brown, if the graft remains thickened, there are lots of options. Intralesional triamcinolone injections can help with thinning, and can be used beginning about 3 months after the graft. Dermabrasion is another good option, but he likes to wait 4-6 months before performing this procedure.
With appropriate site selection, meticulous technique, and good patient communication, dermatologists can keep full thickness skin grafting in the repertoire of viable options for excellent cosmesis, and a valuable tool in their own right. “Skin grafts are not a failure of reconstruction,” Dr. Brown said.
Dr. Brown had no conflicts to disclose.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM the 2017 AAD SUMMER MEETING
Severity Weighting of Postoperative Adverse Events in Orthopedic Surgery
Take-Home Points
- Studies of AEs after orthopedic surgery commonly use composite AE outcomes.
- These types of outcomes treat AEs with different clinical significance similarly.
- This study created a single severity-weighted outcome that can be used to characterize the overall severity of a given patient’s postoperative course.
- Future studies may benefit from using this new severity-weighted outcome score.
Recently there has been an increase in the use of national databases for orthopedic surgery research.1-4 Studies commonly compare rates of postoperative adverse events (AEs) across different demographic, comorbidity, and procedural characteristics.5-23 Their conclusions often highlight different modifiable and/or nonmodifiable risk factors associated with the occurrence of postoperative events.
The several dozen AEs that have been investigated range from very severe (eg, death, myocardial infarction, coma) to less severe (eg, urinary tract infection [UTI], anemia requiring blood transfusion). A common approach for these studies is to consider many AEs together in the same analysis, asking a question such as, “What are risk factors for the occurrence of ‘adverse events’ after spine surgery?” Such studies test for associations with the occurrence of “any adverse event,” the occurrence of any “serious adverse event,” or similar composite outcomes. How common this type of study has become is indicated by the fact that in 2013 and 2014, at least 12 such studies were published in Clinical Orthopaedics and Related Research and the Journal of Bone and Joint Surgery,5-14,21-23 and many more in other orthopedic journals.15-20 However, there is a problem in using this type of composite outcome to perform such analyses: AEs with highly varying degrees of severity have identical impacts on the outcome variable, changing it from negative (“no adverse event”) to positive (“at least one adverse event”). As a result, the system may treat a very severe AE such as death and a very minor AE such as UTI similarly. Even in studies that use the slightly more specific composite outcome of “serious adverse events,” death and a nonlethal thromboembolic event would be treated similarly. Failure to differentiate these AEs in terms of their clinical significance detracts from the clinical applicability of conclusions drawn from studies using these types of composite AE outcomes.
In one of many examples that can be considered, a retrospective cohort study compared general and spinal anesthesia used in total knee arthroplasty.10 The rate of any AEs was higher with general anesthesia than with spinal anesthesia (12.34% vs 10.72%; P = .003). However, the only 2 specific AEs that had statistically significant differences were anemia requiring blood transfusion (6.07% vs 5.02%; P = .009) and superficial surgical-site infection (SSI; 0.92% vs 0.68%; P < .001). These 2 AEs are of relatively low severity; nevertheless, because these AEs are common, their differences constituted the majority of the difference in the rate of any AEs. In contrast, differences in the more severe AEs, such as death (0.11% vs 0.22%; P > .05), septic shock (0.14% vs 0.12%; P > .05), and myocardial infarction (0.20% vs 0.20%; P > .05), were small and not statistically significant. Had more weight been given to these more severe events, the outcome of the study likely would have been “no difference.”
To address this shortcoming in orthopedic research methodology, we created a severity-weighted outcome score that can be used to determine the overall “severity” of any given patient’s postoperative course. We also tested this novel outcome score for correlation with procedure type and patient characteristics using orthopedic patients from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP). Our intention is for database investigators to be able to use this outcome score in place of the composite outcomes that are dominating this type of research.
Methods
Generation of Severity Weights
Our method is described generally as utility weighting, assigning value weights reflective of overall impact to differing outcome states.24 Parallel methods have been used to generate the disability weights used to determine disability-adjusted life years for the Global Burden of Disease project25 and many other areas of health, economic, and policy research.
All orthopedic faculty members at 2 geographically disparate, large US academic institutions were invited to participate in a severity-weighting exercise. Each surgeon who agreed to participate performed the exercise independently.
- STEP 1: Please reorder the AE cards by your perception of “severity” for a patient experiencing that event after an orthopedic procedure.
- STEP 2: Once your cards are in order, please determine how many postoperative occurrences of each event you would “trade” for 1 patient experiencing postoperative death. Place this number of occurrences in the box in the upper right corner of each card.
- NOTES: As you consider each AE:
- Please consider an “average” occurrence of that AE, but note that in no case does the AE result in perioperative death.
- Please consider only the “severity” for the patient. (Do not consider the extent to which the event may be related to surgical error.)
- Please consider that the numbers you assign are relative to each other. Hence, if you would trade 20 of “event A” for 1 death, and if you would trade 40 of “event B” for 1 death, the implication is that you would trade 20 of “event A” for 40 of “event B.”
- You may readjust the order of your cards at any point.
Participants’ responses were recorded. For each number provided by each participant, the inverse (reciprocal) was taken and multiplied by 100%. This new number was taken to be the percentage severity of death that the given participant considered the given AE to embody. For example, as a hypothetical on one end of the spectrum, if a participant reported 1 (he/she would trade 1 AE X for 1 death), then the severity would be 1/1 × 100% = 100% of death, a very severe AE. Conversely, if a participant reported a very large number like 100,000 (he/she would trade 100,000 AEs X for 1 death), then the severity would be 1/100,000 × 100% = 0.001% of death, a very minor AE. More commonly, a participant will report a number like 25, which would translate to 4% of death (1/25 × 100% = 4%). For each AE, weights were then averaged across participants to derive a mean severity weight to be used to generate a novel composite outcome score.
Definition of Novel Composite Outcome Score
The novel composite outcome score would be expressed as a percentage to be interpreted as percentage severity of death, which we termed severity-weighted outcome relative to death (SWORD). For each patient, SWORD was defined as no AE (0%) or postoperative death (100%), with other AEs assigned mean severity weights based on faculty members’ survey responses. A patient with multiple AEs would be assigned the weight for the more severe AE. This method was chosen over summing the AE weights because in many cases the AEs were thought to overlap; hence, summing would be inappropriate. For example, generally a deep SSI would result in a return to the operating room, and one would not want to double-count this AE. Similarly, it would not make sense for a patient who died of a complication to have a SWORD of >100%, which would be the summing result.
Application to ACS-NSQIP Patients
ACS-NSQIP is a surgical registry that prospectively identifies patients undergoing major surgery at any of >500 institutions nationwide.26,27 Patients are characterized at baseline and are followed for AEs over the first 30 postoperative days.
First, mean SWORD was calculated and reported for patients undergoing each of the 8 procedures. Analysis of variance (ANOVA) was used to test for associations of mean SWORD with type of procedure both before and after multivariate adjustment for demographics (sex; age in years, <40, 40-49, 50-59, 60-69, 70-79, 80-89, ≥90) and comorbidities (diabetes, hypertension, chronic obstructive pulmonary disease, exertional dyspnea, end-stage renal disease, congestive heart failure).
Second, patients undergoing the procedure with the highest mean SWORD (hip fracture surgery) were examined in depth. Among only these patients, multivariate ANOVA was used to test for associations of mean SWORD with the same demographics and comorbidities.
All statistical tests were 2-tailed. Significance was set at α = 0.05 (P < .05).
All 23 institution A faculty members (100%) and 24 (89%) of the 27 institution B faculty members completed the exercise.
In the ACS-NSQIP database, 85,109 patients were identified on the basis of the initial inclusion criteria.
Results
Figure 1 shows mean severity weights and standard errors generated from faculty responses. Mean (standard error) severity weight for UTI was 0.23% (0.08%); blood transfusion, 0.28% (0.09%); pneumonia, 0.55% (0.15%); hospital readmission, 0.59% (0.23%); wound dehiscence, 0.64% (0.17%); deep vein thrombosis, 0.64% (0.19%); superficial SSI, 0.68% (0.23%); return to operating room, 0.91% (0.29%); progressive renal insufficiency, 0.93% (0.27%); graft/prosthesis/flap failure, 1.20% (0.34%); unplanned intubation, 1.38% (0.53%); deep SSI, 1.45% (0.38%); failure to wean from ventilator, 1.45% (0.48%); organ/space SSI, 1.76% (0.46%); sepsis without shock, 1.77% (0.42%); peripheral nerve injury, 1.83% (0.47%); pulmonary embolism, 2.99% (0.76%); acute renal failure, 3.95% (0.85%); myocardial infarction, 4.16% (0.98%); septic shock, 7.17% (1.36%); stroke, 8.73% (1.74%); cardiac arrest requiring cardiopulmonary resuscitation, 9.97% (2.46%); and coma, 15.14% (3.04%).
Among ACS-NSQIP patients, mean SWORD ranged from 0.2% (elective anterior cervical decompression and fusion) to 6.0% (hip fracture surgery) (Figure 2).
Discussion
The use of national databases in studies has become increasingly common in orthopedic surgery.1-4
The academic orthopedic surgeons who participated in our severity-weighting exercise thought the various AEs have markedly different severities. The least severe AE (UTI) was considered 0.23% as severe as postoperative death, with other events spanning the range up to 15.14% as severe as death. This wide range of severities demonstrates the problem with composite outcomes that implicitly consider all AEs similarly severe. Use of these markedly disparate weights in the development of SWORD enables this outcome to be more clinically applicable than outcomes such as “any adverse events.”
SWORD was highly associated with procedure type both before and after adjustment for demographics and comorbidities. Among patients undergoing the highest SWORD procedure (hip fracture surgery), SWORD was also associated with age, sex, and 4 of 6 tested comorbidities. Together, our findings show how SWORD is intended to be used in studies: to identify demographic, comorbidity, and procedural risk factors for an adverse postoperative course. We propose that researchers use our weighted outcome as their primary outcome—it is more meaningful than the simpler composite outcomes commonly used.
Outside orthopedic surgery, a small series of studies has addressed severity weighting of postoperative AEs.25,28-30 However, their approach was very different, as they were not designed to generate weights that could be transferred to future studies; rather, they simply compared severities of postoperative courses for patients within each individual study. In each study, a review of each original patient record was required, as the severity of each patient’s postoperative course was characterized according to the degree of any postoperative intervention—from no intervention to minor interventions such as placement of an intravenous catheter and major interventions such as endoscopic, radiologic, and surgical procedures. Only after the degree of intervention was defined could an outcome score be assigned to a given patient. However, databases do not depict the degree of intervention with nearly enough detail for this type of approach; they typically identify only occurrence or nonoccurrence of each event. Our work, which arose independently from this body of literature, enables an entirely different type of analysis. SWORD, which is not based on degree of intervention but on perceived severity of an “average” event, enables direct application of severity weights to large databases that store simple information on occurrence and nonoccurrence of specific AEs.
This study had several limitations. Most significantly, the generated severity weights were based on the surgeons’ subjective perceptions of severity, not on definitive assessments of the impacts of specific AEs on actual patients. We did not query the specialists who treat the complications or who present data on the costs and disabilities that may arise from these AEs. In addition, to develop our severity weighting scale, we queried faculty at only 2 institutions. A survey of surgeons throughout the United States would be more representative and would minimize selection bias. This is a potential research area. Another limitation is that scoring was subjective, based on surgeons’ perceptions of patients—in contrast to the Global Burden of Disease project, in which severity was based more objectively on epidemiologic data from >150 countries.
Orthopedic database research itself has often-noted limitations, including inability to sufficiently control for confounders, potential inaccuracies in data coding, limited follow-up, and lack of orthopedic-specific outcomes.1-4,31-33 However, this research also has much to offer, has increased tremendously over the past several years, and is expected to continue to expand. Many of the limitations of database studies cannot be entirely reversed. In providing a system for weighting postoperative AEs, our study fills a methodologic void. Future studies in orthopedics may benefit from using the severity-weighted outcome score presented here. Other fields with growth in database research may consider using similar methods to create severity-weighting systems of their own.
Am J Orthop. 2017;46(4):E235-E243. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Bohl DD, Basques BA, Golinvaux NS, Baumgaertner MR, Grauer JN. Nationwide Inpatient Sample and National Surgical Quality Improvement Program give different results in hip fracture studies. Clin Orthop Relat Res. 2014;472(6):1672-1680.
2. Bohl DD, Russo GS, Basques BA, et al. Variations in data collection methods between national databases affect study results: a comparison of the Nationwide Inpatient Sample and National Surgical Quality Improvement Program databases for lumbar spine fusion procedures. J Bone Joint Surg Am. 2014;96(23):e193.
3. Bohl DD, Grauer JN, Leopold SS. Editor’s spotlight/Take 5: Nationwide Inpatient Sample and National Surgical Quality Improvement Program give different results in hip fracture studies. Clin Orthop Relat Res. 2014;472(6):1667-1671.
4. Levin PE. Apples, oranges, and national databases: commentary on an article by Daniel D. Bohl, MPH, et al.: “Variations in data collection methods between national databases affect study results: a comparison of the Nationwide Inpatient Sample and National Surgical Quality Improvement Program databases for lumbar spine fusion procedures.” J Bone Joint Surg Am. 2014;96(23):e198.
5. Duchman KR, Gao Y, Pugely AJ, Martin CT, Callaghan JJ. Differences in short-term complications between unicompartmental and total knee arthroplasty: a propensity score matched analysis. J Bone Joint Surg Am. 2014;96(16):1387-1394.
6. Edelstein AI, Lovecchio FC, Saha S, Hsu WK, Kim JY. Impact of resident involvement on orthopaedic surgery outcomes: an analysis of 30,628 patients from the American College of Surgeons National Surgical Quality Improvement Program database. J Bone Joint Surg Am. 2014;96(15):e131.
7. Belmont PJ Jr, Goodman GP, Waterman BR, Bader JO, Schoenfeld AJ. Thirty-day postoperative complications and mortality following total knee arthroplasty: incidence and risk factors among a national sample of 15,321 patients. J Bone Joint Surg Am. 2014;96(1):20-26.
8. Martin CT, Pugely AJ, Gao Y, Mendoza-Lattes S. Thirty-day morbidity after single-level anterior cervical discectomy and fusion: identification of risk factors and emphasis on the safety of outpatient procedures. J Bone Joint Surg Am. 2014;96(15):1288-1294.
9. Martin CT, Pugely AJ, Gao Y, Wolf BR. Risk factors for thirty-day morbidity and mortality following knee arthroscopy: a review of 12,271 patients from the National Surgical Quality Improvement Program database. J Bone Joint Surg Am. 2013;95(14):e98 1-10.
10. Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013;95(3):193-199.
11. Odum SM, Springer BD. In-hospital complication rates and associated factors after simultaneous bilateral versus unilateral total knee arthroplasty. J Bone Joint Surg Am. 2014;96(13):1058-1065.
12. Yoshihara H, Yoneoka D. Trends in the incidence and in-hospital outcomes of elective major orthopaedic surgery in patients eighty years of age and older in the United States from 2000 to 2009. J Bone Joint Surg Am. 2014;96(14):1185-1191.
13. Lin CA, Kuo AC, Takemoto S. Comorbidities and perioperative complications in HIV-positive patients undergoing primary total hip and knee arthroplasty. J Bone Joint Surg Am. 2013;95(11):1028-1036.
14. Mednick RE, Alvi HM, Krishnan V, Lovecchio F, Manning DW. Factors affecting readmission rates following primary total hip arthroplasty. J Bone Joint Surg Am. 2014;96(14):1201-1209.
15. Pugely AJ, Martin CT, Gao Y, Ilgenfritz R, Weinstein SL. The incidence and risk factors for short-term morbidity and mortality in pediatric deformity spinal surgery: an analysis of the NSQIP pediatric database. Spine. 2014;39(15):1225-1234.
16. Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Resident involvement does not influence complication after total hip arthroplasty: an analysis of 13,109 cases. J Arthroplasty. 2014;29(10):1919-1924.
17. Belmont PJ Jr, Goodman GP, Hamilton W, Waterman BR, Bader JO, Schoenfeld AJ. Morbidity and mortality in the thirty-day period following total hip arthroplasty: risk factors and incidence. J Arthroplasty. 2014;29(10):2025-2030.
18. Bohl DD, Fu MC, Golinvaux NS, Basques BA, Gruskay JA, Grauer JN. The “July effect” in primary total hip and knee arthroplasty: analysis of 21,434 cases from the ACS-NSQIP database. J Arthroplasty. 2014;29(7):1332-1338.
19. Bohl DD, Fu MC, Gruskay JA, Basques BA, Golinvaux NS, Grauer JN. “July effect” in elective spine surgery: analysis of the American College of Surgeons National Surgical Quality Improvement Program database. Spine. 2014;39(7):603-611.
20. Babu R, Thomas S, Hazzard MA, et al. Morbidity, mortality, and health care costs for patients undergoing spine surgery following the ACGME resident duty-hour reform: clinical article. J Neurosurg Spine. 2014;21(4):502-515.
21. Lovecchio F, Beal M, Kwasny M, Manning D. Do patients with insulin-dependent and noninsulin-dependent diabetes have different risks for complications after arthroplasty? Clin Orthop Relat Res. 2014;472(11):3570-3575.
22. Pugely AJ, Gao Y, Martin CT, Callagh JJ, Weinstein SL, Marsh JL. The effect of resident participation on short-term outcomes after orthopaedic surgery. Clin Orthop Relat Res. 2014;472(7):2290-2300.
23. Easterlin MC, Chang DG, Talamini M, Chang DC. Older age increases short-term surgical complications after primary knee arthroplasty. Clin Orthop Relat Res. 2013;471(8):2611-2620.
24. Morimoto T, Fukui T. Utilities measured by rating scale, time trade-off, and standard gamble: review and reference for health care professionals. J Epidemiology. 2002;12(2):160-178.
25. Salomon JA, Vos T, Hogan DR, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2129-2143.
26. American College of Surgeons National Surgical Quality Improvement Program. User Guide for the 2011 Participant Use Data File. https://www.facs.org/~/media/files/quality%20programs/nsqip/ug11.ashx. Published October 2012. Accessed December 1, 2013.
27. Molina CS, Thakore RV, Blumer A, Obremskey WT, Sethi MK. Use of the National Surgical Quality Improvement Program in orthopaedic surgery. Clin Orthop Relat Res. 2015;473(5):1574-1581.
28. Strasberg SM, Hall BL. Postoperative Morbidity Index: a quantitative measure of severity of postoperative complications. J Am Coll Surg. 2011;213(5):616-626.
29. Beilan J, Strakosha R, Palacios DA, Rosser CJ. The Postoperative Morbidity Index: a quantitative weighing of postoperative complications applied to urological procedures. BMC Urol. 2014;14:1.
30. Porembka MR, Hall BL, Hirbe M, Strasberg SM. Quantitative weighting of postoperative complications based on the Accordion Severity Grading System: demonstration of potential impact using the American College of Surgeons National Surgical Quality Improvement Program. J Am Coll Surg. 2010;210(3):286-298.
31. Golinvaux NS, Bohl DD, Basques BA, Fu MC, Gardner EC, Grauer JN. Limitations of administrative databases in spine research: a study in obesity. Spine J. 2014;14(12):2923-2928.
32. Golinvaux NS, Bohl DD, Basques BA, Grauer JN. Administrative database concerns: accuracy of International Classification of Diseases, Ninth Revision coding is poor for preoperative anemia in patients undergoing spinal fusion. Spine. 2014;39(24):2019-2023.
33. Bekkers S, Bot AG, Makarawung D, Neuhaus V, Ring D. The National Hospital Discharge Survey and Nationwide Inpatient Sample: the databases used affect results in THA research. Clin Orthop Relat Res. 2014;472(11):3441-3449.
Take-Home Points
- Studies of AEs after orthopedic surgery commonly use composite AE outcomes.
- These types of outcomes treat AEs with different clinical significance similarly.
- This study created a single severity-weighted outcome that can be used to characterize the overall severity of a given patient’s postoperative course.
- Future studies may benefit from using this new severity-weighted outcome score.
Recently there has been an increase in the use of national databases for orthopedic surgery research.1-4 Studies commonly compare rates of postoperative adverse events (AEs) across different demographic, comorbidity, and procedural characteristics.5-23 Their conclusions often highlight different modifiable and/or nonmodifiable risk factors associated with the occurrence of postoperative events.
The several dozen AEs that have been investigated range from very severe (eg, death, myocardial infarction, coma) to less severe (eg, urinary tract infection [UTI], anemia requiring blood transfusion). A common approach for these studies is to consider many AEs together in the same analysis, asking a question such as, “What are risk factors for the occurrence of ‘adverse events’ after spine surgery?” Such studies test for associations with the occurrence of “any adverse event,” the occurrence of any “serious adverse event,” or similar composite outcomes. How common this type of study has become is indicated by the fact that in 2013 and 2014, at least 12 such studies were published in Clinical Orthopaedics and Related Research and the Journal of Bone and Joint Surgery,5-14,21-23 and many more in other orthopedic journals.15-20 However, there is a problem in using this type of composite outcome to perform such analyses: AEs with highly varying degrees of severity have identical impacts on the outcome variable, changing it from negative (“no adverse event”) to positive (“at least one adverse event”). As a result, the system may treat a very severe AE such as death and a very minor AE such as UTI similarly. Even in studies that use the slightly more specific composite outcome of “serious adverse events,” death and a nonlethal thromboembolic event would be treated similarly. Failure to differentiate these AEs in terms of their clinical significance detracts from the clinical applicability of conclusions drawn from studies using these types of composite AE outcomes.
In one of many examples that can be considered, a retrospective cohort study compared general and spinal anesthesia used in total knee arthroplasty.10 The rate of any AEs was higher with general anesthesia than with spinal anesthesia (12.34% vs 10.72%; P = .003). However, the only 2 specific AEs that had statistically significant differences were anemia requiring blood transfusion (6.07% vs 5.02%; P = .009) and superficial surgical-site infection (SSI; 0.92% vs 0.68%; P < .001). These 2 AEs are of relatively low severity; nevertheless, because these AEs are common, their differences constituted the majority of the difference in the rate of any AEs. In contrast, differences in the more severe AEs, such as death (0.11% vs 0.22%; P > .05), septic shock (0.14% vs 0.12%; P > .05), and myocardial infarction (0.20% vs 0.20%; P > .05), were small and not statistically significant. Had more weight been given to these more severe events, the outcome of the study likely would have been “no difference.”
To address this shortcoming in orthopedic research methodology, we created a severity-weighted outcome score that can be used to determine the overall “severity” of any given patient’s postoperative course. We also tested this novel outcome score for correlation with procedure type and patient characteristics using orthopedic patients from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP). Our intention is for database investigators to be able to use this outcome score in place of the composite outcomes that are dominating this type of research.
Methods
Generation of Severity Weights
Our method is described generally as utility weighting, assigning value weights reflective of overall impact to differing outcome states.24 Parallel methods have been used to generate the disability weights used to determine disability-adjusted life years for the Global Burden of Disease project25 and many other areas of health, economic, and policy research.
All orthopedic faculty members at 2 geographically disparate, large US academic institutions were invited to participate in a severity-weighting exercise. Each surgeon who agreed to participate performed the exercise independently.
- STEP 1: Please reorder the AE cards by your perception of “severity” for a patient experiencing that event after an orthopedic procedure.
- STEP 2: Once your cards are in order, please determine how many postoperative occurrences of each event you would “trade” for 1 patient experiencing postoperative death. Place this number of occurrences in the box in the upper right corner of each card.
- NOTES: As you consider each AE:
- Please consider an “average” occurrence of that AE, but note that in no case does the AE result in perioperative death.
- Please consider only the “severity” for the patient. (Do not consider the extent to which the event may be related to surgical error.)
- Please consider that the numbers you assign are relative to each other. Hence, if you would trade 20 of “event A” for 1 death, and if you would trade 40 of “event B” for 1 death, the implication is that you would trade 20 of “event A” for 40 of “event B.”
- You may readjust the order of your cards at any point.
Participants’ responses were recorded. For each number provided by each participant, the inverse (reciprocal) was taken and multiplied by 100%. This new number was taken to be the percentage severity of death that the given participant considered the given AE to embody. For example, as a hypothetical on one end of the spectrum, if a participant reported 1 (he/she would trade 1 AE X for 1 death), then the severity would be 1/1 × 100% = 100% of death, a very severe AE. Conversely, if a participant reported a very large number like 100,000 (he/she would trade 100,000 AEs X for 1 death), then the severity would be 1/100,000 × 100% = 0.001% of death, a very minor AE. More commonly, a participant will report a number like 25, which would translate to 4% of death (1/25 × 100% = 4%). For each AE, weights were then averaged across participants to derive a mean severity weight to be used to generate a novel composite outcome score.
Definition of Novel Composite Outcome Score
The novel composite outcome score would be expressed as a percentage to be interpreted as percentage severity of death, which we termed severity-weighted outcome relative to death (SWORD). For each patient, SWORD was defined as no AE (0%) or postoperative death (100%), with other AEs assigned mean severity weights based on faculty members’ survey responses. A patient with multiple AEs would be assigned the weight for the more severe AE. This method was chosen over summing the AE weights because in many cases the AEs were thought to overlap; hence, summing would be inappropriate. For example, generally a deep SSI would result in a return to the operating room, and one would not want to double-count this AE. Similarly, it would not make sense for a patient who died of a complication to have a SWORD of >100%, which would be the summing result.
Application to ACS-NSQIP Patients
ACS-NSQIP is a surgical registry that prospectively identifies patients undergoing major surgery at any of >500 institutions nationwide.26,27 Patients are characterized at baseline and are followed for AEs over the first 30 postoperative days.
First, mean SWORD was calculated and reported for patients undergoing each of the 8 procedures. Analysis of variance (ANOVA) was used to test for associations of mean SWORD with type of procedure both before and after multivariate adjustment for demographics (sex; age in years, <40, 40-49, 50-59, 60-69, 70-79, 80-89, ≥90) and comorbidities (diabetes, hypertension, chronic obstructive pulmonary disease, exertional dyspnea, end-stage renal disease, congestive heart failure).
Second, patients undergoing the procedure with the highest mean SWORD (hip fracture surgery) were examined in depth. Among only these patients, multivariate ANOVA was used to test for associations of mean SWORD with the same demographics and comorbidities.
All statistical tests were 2-tailed. Significance was set at α = 0.05 (P < .05).
All 23 institution A faculty members (100%) and 24 (89%) of the 27 institution B faculty members completed the exercise.
In the ACS-NSQIP database, 85,109 patients were identified on the basis of the initial inclusion criteria.
Results
Figure 1 shows mean severity weights and standard errors generated from faculty responses. Mean (standard error) severity weight for UTI was 0.23% (0.08%); blood transfusion, 0.28% (0.09%); pneumonia, 0.55% (0.15%); hospital readmission, 0.59% (0.23%); wound dehiscence, 0.64% (0.17%); deep vein thrombosis, 0.64% (0.19%); superficial SSI, 0.68% (0.23%); return to operating room, 0.91% (0.29%); progressive renal insufficiency, 0.93% (0.27%); graft/prosthesis/flap failure, 1.20% (0.34%); unplanned intubation, 1.38% (0.53%); deep SSI, 1.45% (0.38%); failure to wean from ventilator, 1.45% (0.48%); organ/space SSI, 1.76% (0.46%); sepsis without shock, 1.77% (0.42%); peripheral nerve injury, 1.83% (0.47%); pulmonary embolism, 2.99% (0.76%); acute renal failure, 3.95% (0.85%); myocardial infarction, 4.16% (0.98%); septic shock, 7.17% (1.36%); stroke, 8.73% (1.74%); cardiac arrest requiring cardiopulmonary resuscitation, 9.97% (2.46%); and coma, 15.14% (3.04%).
Among ACS-NSQIP patients, mean SWORD ranged from 0.2% (elective anterior cervical decompression and fusion) to 6.0% (hip fracture surgery) (Figure 2).
Discussion
The use of national databases in studies has become increasingly common in orthopedic surgery.1-4
The academic orthopedic surgeons who participated in our severity-weighting exercise thought the various AEs have markedly different severities. The least severe AE (UTI) was considered 0.23% as severe as postoperative death, with other events spanning the range up to 15.14% as severe as death. This wide range of severities demonstrates the problem with composite outcomes that implicitly consider all AEs similarly severe. Use of these markedly disparate weights in the development of SWORD enables this outcome to be more clinically applicable than outcomes such as “any adverse events.”
SWORD was highly associated with procedure type both before and after adjustment for demographics and comorbidities. Among patients undergoing the highest SWORD procedure (hip fracture surgery), SWORD was also associated with age, sex, and 4 of 6 tested comorbidities. Together, our findings show how SWORD is intended to be used in studies: to identify demographic, comorbidity, and procedural risk factors for an adverse postoperative course. We propose that researchers use our weighted outcome as their primary outcome—it is more meaningful than the simpler composite outcomes commonly used.
Outside orthopedic surgery, a small series of studies has addressed severity weighting of postoperative AEs.25,28-30 However, their approach was very different, as they were not designed to generate weights that could be transferred to future studies; rather, they simply compared severities of postoperative courses for patients within each individual study. In each study, a review of each original patient record was required, as the severity of each patient’s postoperative course was characterized according to the degree of any postoperative intervention—from no intervention to minor interventions such as placement of an intravenous catheter and major interventions such as endoscopic, radiologic, and surgical procedures. Only after the degree of intervention was defined could an outcome score be assigned to a given patient. However, databases do not depict the degree of intervention with nearly enough detail for this type of approach; they typically identify only occurrence or nonoccurrence of each event. Our work, which arose independently from this body of literature, enables an entirely different type of analysis. SWORD, which is not based on degree of intervention but on perceived severity of an “average” event, enables direct application of severity weights to large databases that store simple information on occurrence and nonoccurrence of specific AEs.
This study had several limitations. Most significantly, the generated severity weights were based on the surgeons’ subjective perceptions of severity, not on definitive assessments of the impacts of specific AEs on actual patients. We did not query the specialists who treat the complications or who present data on the costs and disabilities that may arise from these AEs. In addition, to develop our severity weighting scale, we queried faculty at only 2 institutions. A survey of surgeons throughout the United States would be more representative and would minimize selection bias. This is a potential research area. Another limitation is that scoring was subjective, based on surgeons’ perceptions of patients—in contrast to the Global Burden of Disease project, in which severity was based more objectively on epidemiologic data from >150 countries.
Orthopedic database research itself has often-noted limitations, including inability to sufficiently control for confounders, potential inaccuracies in data coding, limited follow-up, and lack of orthopedic-specific outcomes.1-4,31-33 However, this research also has much to offer, has increased tremendously over the past several years, and is expected to continue to expand. Many of the limitations of database studies cannot be entirely reversed. In providing a system for weighting postoperative AEs, our study fills a methodologic void. Future studies in orthopedics may benefit from using the severity-weighted outcome score presented here. Other fields with growth in database research may consider using similar methods to create severity-weighting systems of their own.
Am J Orthop. 2017;46(4):E235-E243. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
Take-Home Points
- Studies of AEs after orthopedic surgery commonly use composite AE outcomes.
- These types of outcomes treat AEs with different clinical significance similarly.
- This study created a single severity-weighted outcome that can be used to characterize the overall severity of a given patient’s postoperative course.
- Future studies may benefit from using this new severity-weighted outcome score.
Recently there has been an increase in the use of national databases for orthopedic surgery research.1-4 Studies commonly compare rates of postoperative adverse events (AEs) across different demographic, comorbidity, and procedural characteristics.5-23 Their conclusions often highlight different modifiable and/or nonmodifiable risk factors associated with the occurrence of postoperative events.
The several dozen AEs that have been investigated range from very severe (eg, death, myocardial infarction, coma) to less severe (eg, urinary tract infection [UTI], anemia requiring blood transfusion). A common approach for these studies is to consider many AEs together in the same analysis, asking a question such as, “What are risk factors for the occurrence of ‘adverse events’ after spine surgery?” Such studies test for associations with the occurrence of “any adverse event,” the occurrence of any “serious adverse event,” or similar composite outcomes. How common this type of study has become is indicated by the fact that in 2013 and 2014, at least 12 such studies were published in Clinical Orthopaedics and Related Research and the Journal of Bone and Joint Surgery,5-14,21-23 and many more in other orthopedic journals.15-20 However, there is a problem in using this type of composite outcome to perform such analyses: AEs with highly varying degrees of severity have identical impacts on the outcome variable, changing it from negative (“no adverse event”) to positive (“at least one adverse event”). As a result, the system may treat a very severe AE such as death and a very minor AE such as UTI similarly. Even in studies that use the slightly more specific composite outcome of “serious adverse events,” death and a nonlethal thromboembolic event would be treated similarly. Failure to differentiate these AEs in terms of their clinical significance detracts from the clinical applicability of conclusions drawn from studies using these types of composite AE outcomes.
In one of many examples that can be considered, a retrospective cohort study compared general and spinal anesthesia used in total knee arthroplasty.10 The rate of any AEs was higher with general anesthesia than with spinal anesthesia (12.34% vs 10.72%; P = .003). However, the only 2 specific AEs that had statistically significant differences were anemia requiring blood transfusion (6.07% vs 5.02%; P = .009) and superficial surgical-site infection (SSI; 0.92% vs 0.68%; P < .001). These 2 AEs are of relatively low severity; nevertheless, because these AEs are common, their differences constituted the majority of the difference in the rate of any AEs. In contrast, differences in the more severe AEs, such as death (0.11% vs 0.22%; P > .05), septic shock (0.14% vs 0.12%; P > .05), and myocardial infarction (0.20% vs 0.20%; P > .05), were small and not statistically significant. Had more weight been given to these more severe events, the outcome of the study likely would have been “no difference.”
To address this shortcoming in orthopedic research methodology, we created a severity-weighted outcome score that can be used to determine the overall “severity” of any given patient’s postoperative course. We also tested this novel outcome score for correlation with procedure type and patient characteristics using orthopedic patients from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP). Our intention is for database investigators to be able to use this outcome score in place of the composite outcomes that are dominating this type of research.
Methods
Generation of Severity Weights
Our method is described generally as utility weighting, assigning value weights reflective of overall impact to differing outcome states.24 Parallel methods have been used to generate the disability weights used to determine disability-adjusted life years for the Global Burden of Disease project25 and many other areas of health, economic, and policy research.
All orthopedic faculty members at 2 geographically disparate, large US academic institutions were invited to participate in a severity-weighting exercise. Each surgeon who agreed to participate performed the exercise independently.
- STEP 1: Please reorder the AE cards by your perception of “severity” for a patient experiencing that event after an orthopedic procedure.
- STEP 2: Once your cards are in order, please determine how many postoperative occurrences of each event you would “trade” for 1 patient experiencing postoperative death. Place this number of occurrences in the box in the upper right corner of each card.
- NOTES: As you consider each AE:
- Please consider an “average” occurrence of that AE, but note that in no case does the AE result in perioperative death.
- Please consider only the “severity” for the patient. (Do not consider the extent to which the event may be related to surgical error.)
- Please consider that the numbers you assign are relative to each other. Hence, if you would trade 20 of “event A” for 1 death, and if you would trade 40 of “event B” for 1 death, the implication is that you would trade 20 of “event A” for 40 of “event B.”
- You may readjust the order of your cards at any point.
Participants’ responses were recorded. For each number provided by each participant, the inverse (reciprocal) was taken and multiplied by 100%. This new number was taken to be the percentage severity of death that the given participant considered the given AE to embody. For example, as a hypothetical on one end of the spectrum, if a participant reported 1 (he/she would trade 1 AE X for 1 death), then the severity would be 1/1 × 100% = 100% of death, a very severe AE. Conversely, if a participant reported a very large number like 100,000 (he/she would trade 100,000 AEs X for 1 death), then the severity would be 1/100,000 × 100% = 0.001% of death, a very minor AE. More commonly, a participant will report a number like 25, which would translate to 4% of death (1/25 × 100% = 4%). For each AE, weights were then averaged across participants to derive a mean severity weight to be used to generate a novel composite outcome score.
Definition of Novel Composite Outcome Score
The novel composite outcome score would be expressed as a percentage to be interpreted as percentage severity of death, which we termed severity-weighted outcome relative to death (SWORD). For each patient, SWORD was defined as no AE (0%) or postoperative death (100%), with other AEs assigned mean severity weights based on faculty members’ survey responses. A patient with multiple AEs would be assigned the weight for the more severe AE. This method was chosen over summing the AE weights because in many cases the AEs were thought to overlap; hence, summing would be inappropriate. For example, generally a deep SSI would result in a return to the operating room, and one would not want to double-count this AE. Similarly, it would not make sense for a patient who died of a complication to have a SWORD of >100%, which would be the summing result.
Application to ACS-NSQIP Patients
ACS-NSQIP is a surgical registry that prospectively identifies patients undergoing major surgery at any of >500 institutions nationwide.26,27 Patients are characterized at baseline and are followed for AEs over the first 30 postoperative days.
First, mean SWORD was calculated and reported for patients undergoing each of the 8 procedures. Analysis of variance (ANOVA) was used to test for associations of mean SWORD with type of procedure both before and after multivariate adjustment for demographics (sex; age in years, <40, 40-49, 50-59, 60-69, 70-79, 80-89, ≥90) and comorbidities (diabetes, hypertension, chronic obstructive pulmonary disease, exertional dyspnea, end-stage renal disease, congestive heart failure).
Second, patients undergoing the procedure with the highest mean SWORD (hip fracture surgery) were examined in depth. Among only these patients, multivariate ANOVA was used to test for associations of mean SWORD with the same demographics and comorbidities.
All statistical tests were 2-tailed. Significance was set at α = 0.05 (P < .05).
All 23 institution A faculty members (100%) and 24 (89%) of the 27 institution B faculty members completed the exercise.
In the ACS-NSQIP database, 85,109 patients were identified on the basis of the initial inclusion criteria.
Results
Figure 1 shows mean severity weights and standard errors generated from faculty responses. Mean (standard error) severity weight for UTI was 0.23% (0.08%); blood transfusion, 0.28% (0.09%); pneumonia, 0.55% (0.15%); hospital readmission, 0.59% (0.23%); wound dehiscence, 0.64% (0.17%); deep vein thrombosis, 0.64% (0.19%); superficial SSI, 0.68% (0.23%); return to operating room, 0.91% (0.29%); progressive renal insufficiency, 0.93% (0.27%); graft/prosthesis/flap failure, 1.20% (0.34%); unplanned intubation, 1.38% (0.53%); deep SSI, 1.45% (0.38%); failure to wean from ventilator, 1.45% (0.48%); organ/space SSI, 1.76% (0.46%); sepsis without shock, 1.77% (0.42%); peripheral nerve injury, 1.83% (0.47%); pulmonary embolism, 2.99% (0.76%); acute renal failure, 3.95% (0.85%); myocardial infarction, 4.16% (0.98%); septic shock, 7.17% (1.36%); stroke, 8.73% (1.74%); cardiac arrest requiring cardiopulmonary resuscitation, 9.97% (2.46%); and coma, 15.14% (3.04%).
Among ACS-NSQIP patients, mean SWORD ranged from 0.2% (elective anterior cervical decompression and fusion) to 6.0% (hip fracture surgery) (Figure 2).
Discussion
The use of national databases in studies has become increasingly common in orthopedic surgery.1-4
The academic orthopedic surgeons who participated in our severity-weighting exercise thought the various AEs have markedly different severities. The least severe AE (UTI) was considered 0.23% as severe as postoperative death, with other events spanning the range up to 15.14% as severe as death. This wide range of severities demonstrates the problem with composite outcomes that implicitly consider all AEs similarly severe. Use of these markedly disparate weights in the development of SWORD enables this outcome to be more clinically applicable than outcomes such as “any adverse events.”
SWORD was highly associated with procedure type both before and after adjustment for demographics and comorbidities. Among patients undergoing the highest SWORD procedure (hip fracture surgery), SWORD was also associated with age, sex, and 4 of 6 tested comorbidities. Together, our findings show how SWORD is intended to be used in studies: to identify demographic, comorbidity, and procedural risk factors for an adverse postoperative course. We propose that researchers use our weighted outcome as their primary outcome—it is more meaningful than the simpler composite outcomes commonly used.
Outside orthopedic surgery, a small series of studies has addressed severity weighting of postoperative AEs.25,28-30 However, their approach was very different, as they were not designed to generate weights that could be transferred to future studies; rather, they simply compared severities of postoperative courses for patients within each individual study. In each study, a review of each original patient record was required, as the severity of each patient’s postoperative course was characterized according to the degree of any postoperative intervention—from no intervention to minor interventions such as placement of an intravenous catheter and major interventions such as endoscopic, radiologic, and surgical procedures. Only after the degree of intervention was defined could an outcome score be assigned to a given patient. However, databases do not depict the degree of intervention with nearly enough detail for this type of approach; they typically identify only occurrence or nonoccurrence of each event. Our work, which arose independently from this body of literature, enables an entirely different type of analysis. SWORD, which is not based on degree of intervention but on perceived severity of an “average” event, enables direct application of severity weights to large databases that store simple information on occurrence and nonoccurrence of specific AEs.
This study had several limitations. Most significantly, the generated severity weights were based on the surgeons’ subjective perceptions of severity, not on definitive assessments of the impacts of specific AEs on actual patients. We did not query the specialists who treat the complications or who present data on the costs and disabilities that may arise from these AEs. In addition, to develop our severity weighting scale, we queried faculty at only 2 institutions. A survey of surgeons throughout the United States would be more representative and would minimize selection bias. This is a potential research area. Another limitation is that scoring was subjective, based on surgeons’ perceptions of patients—in contrast to the Global Burden of Disease project, in which severity was based more objectively on epidemiologic data from >150 countries.
Orthopedic database research itself has often-noted limitations, including inability to sufficiently control for confounders, potential inaccuracies in data coding, limited follow-up, and lack of orthopedic-specific outcomes.1-4,31-33 However, this research also has much to offer, has increased tremendously over the past several years, and is expected to continue to expand. Many of the limitations of database studies cannot be entirely reversed. In providing a system for weighting postoperative AEs, our study fills a methodologic void. Future studies in orthopedics may benefit from using the severity-weighted outcome score presented here. Other fields with growth in database research may consider using similar methods to create severity-weighting systems of their own.
Am J Orthop. 2017;46(4):E235-E243. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Bohl DD, Basques BA, Golinvaux NS, Baumgaertner MR, Grauer JN. Nationwide Inpatient Sample and National Surgical Quality Improvement Program give different results in hip fracture studies. Clin Orthop Relat Res. 2014;472(6):1672-1680.
2. Bohl DD, Russo GS, Basques BA, et al. Variations in data collection methods between national databases affect study results: a comparison of the Nationwide Inpatient Sample and National Surgical Quality Improvement Program databases for lumbar spine fusion procedures. J Bone Joint Surg Am. 2014;96(23):e193.
3. Bohl DD, Grauer JN, Leopold SS. Editor’s spotlight/Take 5: Nationwide Inpatient Sample and National Surgical Quality Improvement Program give different results in hip fracture studies. Clin Orthop Relat Res. 2014;472(6):1667-1671.
4. Levin PE. Apples, oranges, and national databases: commentary on an article by Daniel D. Bohl, MPH, et al.: “Variations in data collection methods between national databases affect study results: a comparison of the Nationwide Inpatient Sample and National Surgical Quality Improvement Program databases for lumbar spine fusion procedures.” J Bone Joint Surg Am. 2014;96(23):e198.
5. Duchman KR, Gao Y, Pugely AJ, Martin CT, Callaghan JJ. Differences in short-term complications between unicompartmental and total knee arthroplasty: a propensity score matched analysis. J Bone Joint Surg Am. 2014;96(16):1387-1394.
6. Edelstein AI, Lovecchio FC, Saha S, Hsu WK, Kim JY. Impact of resident involvement on orthopaedic surgery outcomes: an analysis of 30,628 patients from the American College of Surgeons National Surgical Quality Improvement Program database. J Bone Joint Surg Am. 2014;96(15):e131.
7. Belmont PJ Jr, Goodman GP, Waterman BR, Bader JO, Schoenfeld AJ. Thirty-day postoperative complications and mortality following total knee arthroplasty: incidence and risk factors among a national sample of 15,321 patients. J Bone Joint Surg Am. 2014;96(1):20-26.
8. Martin CT, Pugely AJ, Gao Y, Mendoza-Lattes S. Thirty-day morbidity after single-level anterior cervical discectomy and fusion: identification of risk factors and emphasis on the safety of outpatient procedures. J Bone Joint Surg Am. 2014;96(15):1288-1294.
9. Martin CT, Pugely AJ, Gao Y, Wolf BR. Risk factors for thirty-day morbidity and mortality following knee arthroscopy: a review of 12,271 patients from the National Surgical Quality Improvement Program database. J Bone Joint Surg Am. 2013;95(14):e98 1-10.
10. Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013;95(3):193-199.
11. Odum SM, Springer BD. In-hospital complication rates and associated factors after simultaneous bilateral versus unilateral total knee arthroplasty. J Bone Joint Surg Am. 2014;96(13):1058-1065.
12. Yoshihara H, Yoneoka D. Trends in the incidence and in-hospital outcomes of elective major orthopaedic surgery in patients eighty years of age and older in the United States from 2000 to 2009. J Bone Joint Surg Am. 2014;96(14):1185-1191.
13. Lin CA, Kuo AC, Takemoto S. Comorbidities and perioperative complications in HIV-positive patients undergoing primary total hip and knee arthroplasty. J Bone Joint Surg Am. 2013;95(11):1028-1036.
14. Mednick RE, Alvi HM, Krishnan V, Lovecchio F, Manning DW. Factors affecting readmission rates following primary total hip arthroplasty. J Bone Joint Surg Am. 2014;96(14):1201-1209.
15. Pugely AJ, Martin CT, Gao Y, Ilgenfritz R, Weinstein SL. The incidence and risk factors for short-term morbidity and mortality in pediatric deformity spinal surgery: an analysis of the NSQIP pediatric database. Spine. 2014;39(15):1225-1234.
16. Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Resident involvement does not influence complication after total hip arthroplasty: an analysis of 13,109 cases. J Arthroplasty. 2014;29(10):1919-1924.
17. Belmont PJ Jr, Goodman GP, Hamilton W, Waterman BR, Bader JO, Schoenfeld AJ. Morbidity and mortality in the thirty-day period following total hip arthroplasty: risk factors and incidence. J Arthroplasty. 2014;29(10):2025-2030.
18. Bohl DD, Fu MC, Golinvaux NS, Basques BA, Gruskay JA, Grauer JN. The “July effect” in primary total hip and knee arthroplasty: analysis of 21,434 cases from the ACS-NSQIP database. J Arthroplasty. 2014;29(7):1332-1338.
19. Bohl DD, Fu MC, Gruskay JA, Basques BA, Golinvaux NS, Grauer JN. “July effect” in elective spine surgery: analysis of the American College of Surgeons National Surgical Quality Improvement Program database. Spine. 2014;39(7):603-611.
20. Babu R, Thomas S, Hazzard MA, et al. Morbidity, mortality, and health care costs for patients undergoing spine surgery following the ACGME resident duty-hour reform: clinical article. J Neurosurg Spine. 2014;21(4):502-515.
21. Lovecchio F, Beal M, Kwasny M, Manning D. Do patients with insulin-dependent and noninsulin-dependent diabetes have different risks for complications after arthroplasty? Clin Orthop Relat Res. 2014;472(11):3570-3575.
22. Pugely AJ, Gao Y, Martin CT, Callagh JJ, Weinstein SL, Marsh JL. The effect of resident participation on short-term outcomes after orthopaedic surgery. Clin Orthop Relat Res. 2014;472(7):2290-2300.
23. Easterlin MC, Chang DG, Talamini M, Chang DC. Older age increases short-term surgical complications after primary knee arthroplasty. Clin Orthop Relat Res. 2013;471(8):2611-2620.
24. Morimoto T, Fukui T. Utilities measured by rating scale, time trade-off, and standard gamble: review and reference for health care professionals. J Epidemiology. 2002;12(2):160-178.
25. Salomon JA, Vos T, Hogan DR, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2129-2143.
26. American College of Surgeons National Surgical Quality Improvement Program. User Guide for the 2011 Participant Use Data File. https://www.facs.org/~/media/files/quality%20programs/nsqip/ug11.ashx. Published October 2012. Accessed December 1, 2013.
27. Molina CS, Thakore RV, Blumer A, Obremskey WT, Sethi MK. Use of the National Surgical Quality Improvement Program in orthopaedic surgery. Clin Orthop Relat Res. 2015;473(5):1574-1581.
28. Strasberg SM, Hall BL. Postoperative Morbidity Index: a quantitative measure of severity of postoperative complications. J Am Coll Surg. 2011;213(5):616-626.
29. Beilan J, Strakosha R, Palacios DA, Rosser CJ. The Postoperative Morbidity Index: a quantitative weighing of postoperative complications applied to urological procedures. BMC Urol. 2014;14:1.
30. Porembka MR, Hall BL, Hirbe M, Strasberg SM. Quantitative weighting of postoperative complications based on the Accordion Severity Grading System: demonstration of potential impact using the American College of Surgeons National Surgical Quality Improvement Program. J Am Coll Surg. 2010;210(3):286-298.
31. Golinvaux NS, Bohl DD, Basques BA, Fu MC, Gardner EC, Grauer JN. Limitations of administrative databases in spine research: a study in obesity. Spine J. 2014;14(12):2923-2928.
32. Golinvaux NS, Bohl DD, Basques BA, Grauer JN. Administrative database concerns: accuracy of International Classification of Diseases, Ninth Revision coding is poor for preoperative anemia in patients undergoing spinal fusion. Spine. 2014;39(24):2019-2023.
33. Bekkers S, Bot AG, Makarawung D, Neuhaus V, Ring D. The National Hospital Discharge Survey and Nationwide Inpatient Sample: the databases used affect results in THA research. Clin Orthop Relat Res. 2014;472(11):3441-3449.
1. Bohl DD, Basques BA, Golinvaux NS, Baumgaertner MR, Grauer JN. Nationwide Inpatient Sample and National Surgical Quality Improvement Program give different results in hip fracture studies. Clin Orthop Relat Res. 2014;472(6):1672-1680.
2. Bohl DD, Russo GS, Basques BA, et al. Variations in data collection methods between national databases affect study results: a comparison of the Nationwide Inpatient Sample and National Surgical Quality Improvement Program databases for lumbar spine fusion procedures. J Bone Joint Surg Am. 2014;96(23):e193.
3. Bohl DD, Grauer JN, Leopold SS. Editor’s spotlight/Take 5: Nationwide Inpatient Sample and National Surgical Quality Improvement Program give different results in hip fracture studies. Clin Orthop Relat Res. 2014;472(6):1667-1671.
4. Levin PE. Apples, oranges, and national databases: commentary on an article by Daniel D. Bohl, MPH, et al.: “Variations in data collection methods between national databases affect study results: a comparison of the Nationwide Inpatient Sample and National Surgical Quality Improvement Program databases for lumbar spine fusion procedures.” J Bone Joint Surg Am. 2014;96(23):e198.
5. Duchman KR, Gao Y, Pugely AJ, Martin CT, Callaghan JJ. Differences in short-term complications between unicompartmental and total knee arthroplasty: a propensity score matched analysis. J Bone Joint Surg Am. 2014;96(16):1387-1394.
6. Edelstein AI, Lovecchio FC, Saha S, Hsu WK, Kim JY. Impact of resident involvement on orthopaedic surgery outcomes: an analysis of 30,628 patients from the American College of Surgeons National Surgical Quality Improvement Program database. J Bone Joint Surg Am. 2014;96(15):e131.
7. Belmont PJ Jr, Goodman GP, Waterman BR, Bader JO, Schoenfeld AJ. Thirty-day postoperative complications and mortality following total knee arthroplasty: incidence and risk factors among a national sample of 15,321 patients. J Bone Joint Surg Am. 2014;96(1):20-26.
8. Martin CT, Pugely AJ, Gao Y, Mendoza-Lattes S. Thirty-day morbidity after single-level anterior cervical discectomy and fusion: identification of risk factors and emphasis on the safety of outpatient procedures. J Bone Joint Surg Am. 2014;96(15):1288-1294.
9. Martin CT, Pugely AJ, Gao Y, Wolf BR. Risk factors for thirty-day morbidity and mortality following knee arthroscopy: a review of 12,271 patients from the National Surgical Quality Improvement Program database. J Bone Joint Surg Am. 2013;95(14):e98 1-10.
10. Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013;95(3):193-199.
11. Odum SM, Springer BD. In-hospital complication rates and associated factors after simultaneous bilateral versus unilateral total knee arthroplasty. J Bone Joint Surg Am. 2014;96(13):1058-1065.
12. Yoshihara H, Yoneoka D. Trends in the incidence and in-hospital outcomes of elective major orthopaedic surgery in patients eighty years of age and older in the United States from 2000 to 2009. J Bone Joint Surg Am. 2014;96(14):1185-1191.
13. Lin CA, Kuo AC, Takemoto S. Comorbidities and perioperative complications in HIV-positive patients undergoing primary total hip and knee arthroplasty. J Bone Joint Surg Am. 2013;95(11):1028-1036.
14. Mednick RE, Alvi HM, Krishnan V, Lovecchio F, Manning DW. Factors affecting readmission rates following primary total hip arthroplasty. J Bone Joint Surg Am. 2014;96(14):1201-1209.
15. Pugely AJ, Martin CT, Gao Y, Ilgenfritz R, Weinstein SL. The incidence and risk factors for short-term morbidity and mortality in pediatric deformity spinal surgery: an analysis of the NSQIP pediatric database. Spine. 2014;39(15):1225-1234.
16. Haughom BD, Schairer WW, Hellman MD, Yi PH, Levine BR. Resident involvement does not influence complication after total hip arthroplasty: an analysis of 13,109 cases. J Arthroplasty. 2014;29(10):1919-1924.
17. Belmont PJ Jr, Goodman GP, Hamilton W, Waterman BR, Bader JO, Schoenfeld AJ. Morbidity and mortality in the thirty-day period following total hip arthroplasty: risk factors and incidence. J Arthroplasty. 2014;29(10):2025-2030.
18. Bohl DD, Fu MC, Golinvaux NS, Basques BA, Gruskay JA, Grauer JN. The “July effect” in primary total hip and knee arthroplasty: analysis of 21,434 cases from the ACS-NSQIP database. J Arthroplasty. 2014;29(7):1332-1338.
19. Bohl DD, Fu MC, Gruskay JA, Basques BA, Golinvaux NS, Grauer JN. “July effect” in elective spine surgery: analysis of the American College of Surgeons National Surgical Quality Improvement Program database. Spine. 2014;39(7):603-611.
20. Babu R, Thomas S, Hazzard MA, et al. Morbidity, mortality, and health care costs for patients undergoing spine surgery following the ACGME resident duty-hour reform: clinical article. J Neurosurg Spine. 2014;21(4):502-515.
21. Lovecchio F, Beal M, Kwasny M, Manning D. Do patients with insulin-dependent and noninsulin-dependent diabetes have different risks for complications after arthroplasty? Clin Orthop Relat Res. 2014;472(11):3570-3575.
22. Pugely AJ, Gao Y, Martin CT, Callagh JJ, Weinstein SL, Marsh JL. The effect of resident participation on short-term outcomes after orthopaedic surgery. Clin Orthop Relat Res. 2014;472(7):2290-2300.
23. Easterlin MC, Chang DG, Talamini M, Chang DC. Older age increases short-term surgical complications after primary knee arthroplasty. Clin Orthop Relat Res. 2013;471(8):2611-2620.
24. Morimoto T, Fukui T. Utilities measured by rating scale, time trade-off, and standard gamble: review and reference for health care professionals. J Epidemiology. 2002;12(2):160-178.
25. Salomon JA, Vos T, Hogan DR, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2129-2143.
26. American College of Surgeons National Surgical Quality Improvement Program. User Guide for the 2011 Participant Use Data File. https://www.facs.org/~/media/files/quality%20programs/nsqip/ug11.ashx. Published October 2012. Accessed December 1, 2013.
27. Molina CS, Thakore RV, Blumer A, Obremskey WT, Sethi MK. Use of the National Surgical Quality Improvement Program in orthopaedic surgery. Clin Orthop Relat Res. 2015;473(5):1574-1581.
28. Strasberg SM, Hall BL. Postoperative Morbidity Index: a quantitative measure of severity of postoperative complications. J Am Coll Surg. 2011;213(5):616-626.
29. Beilan J, Strakosha R, Palacios DA, Rosser CJ. The Postoperative Morbidity Index: a quantitative weighing of postoperative complications applied to urological procedures. BMC Urol. 2014;14:1.
30. Porembka MR, Hall BL, Hirbe M, Strasberg SM. Quantitative weighting of postoperative complications based on the Accordion Severity Grading System: demonstration of potential impact using the American College of Surgeons National Surgical Quality Improvement Program. J Am Coll Surg. 2010;210(3):286-298.
31. Golinvaux NS, Bohl DD, Basques BA, Fu MC, Gardner EC, Grauer JN. Limitations of administrative databases in spine research: a study in obesity. Spine J. 2014;14(12):2923-2928.
32. Golinvaux NS, Bohl DD, Basques BA, Grauer JN. Administrative database concerns: accuracy of International Classification of Diseases, Ninth Revision coding is poor for preoperative anemia in patients undergoing spinal fusion. Spine. 2014;39(24):2019-2023.
33. Bekkers S, Bot AG, Makarawung D, Neuhaus V, Ring D. The National Hospital Discharge Survey and Nationwide Inpatient Sample: the databases used affect results in THA research. Clin Orthop Relat Res. 2014;472(11):3441-3449.
Concussion: Evaluation and management
Concussion, also known as mild traumatic brain injury, affects more than 600 adults per 100,000 each year and is commonly treated by nonneurologists.1 Public attention to concussion has been increasing, particularly to concussion sustained during sports. Coincident with this increased attention, the diagnosis of concussion continues to increase in the outpatient setting. Thus, a review of the topic is timely.
ACCELERATION OF THE BRAIN DUE TO TRAUMA
The definition of concussion has changed considerably over the years. It is currently defined as a pathophysiologic process that results from an acceleration or deceleration of the brain induced by trauma.2 It is largely a temporary, functional problem, as opposed to a gross structural injury.2–5
The acceleration of the brain that results in a concussion is usually initiated by a direct blow to the head, although direct impact is not required.6 As the brain rotates, different areas accelerate at different rates, resulting in a shear strain imparted to the parenchyma.
This shear strain causes deformation of axonal membranes and opening of membrane-associated sodium-potassium channels. This in turn leads to release of excitatory neurotransmitters, ultimately culminating in a wave of neuronal depolarization and a spreading depression-like phenomenon that may mediate the loss of consciousness, posttraumatic amnesia, confusion, and many of the other immediate signs and symptoms associated with concussion.
The sudden metabolic demand created by the massive excitatory phenomena triggers an increased utilization of glucose to restore cellular homeostasis. At the same time, cerebral blood flow decreases after concussion, which, in the setting of increased glucose demand, leads to an “energy crisis”: an increased need for adenosine triphosphate with a concomitant decreased delivery of glucose.7 This mismatch between energy demand and supply is thought to underlie the most common signs and symptoms of concussion.
ASSESSMENT
History
The history of present illness is essential to a diagnosis of concussion. In the classic scenario, an otherwise asymptomatic person sustains some trauma to the head that is followed immediately by the signs and symptoms of concussion.
Many of these signs and symptoms are nonspecific and may occur without concussion or other trauma.8,9 Thus, the diagnosis of concussion cannot be made on the basis of symptoms alone, but only in the overall context of history, physical examination, and, at times, additional clinical assessments.
The symptoms of concussion should gradually improve. While they may be exacerbated by certain activities or stimuli, the overall trend should be one of symptom improvement. If symptoms are worsening over time, alternative explanations for the patient’s symptoms should be considered.
Physical examination
A thorough neurologic examination should be conducted in all patients with suspected concussion and include the following.
A mental status examination should include assessment of attention, memory, and recall. Orientation is normal except in the most acute examinations.
Cranial nerve examination must include careful assessment of eye-movement control, including smooth pursuit and saccades. However, even in patients with prominent subjective dizziness, considerable experience may be needed to actually demonstrate abnormalities.
Balance testing. Balance demands careful assessment and, especially for young athletes, this testing should be more difficult than the tandem gait and eyes-closed, feet-together tests.
Standard strength, sensory, reflex, and coordination testing is usually normal.
Any focal neurologic findings should prompt consideration of other causes or of a more serious injury and should lead to further evaluation, including brain imaging.
Diagnostic tests
Current clinical brain imaging cannot diagnose a concussion. The purpose of neuroimaging is to assess for other etiologies or injuries, such as hemorrhage or contusion, that may cause similar symptoms but require different management.
Several guidelines are available to assess the need for imaging in the setting of recent trauma, of which 2 are typically used10–12:
The Canadian CT Head Rule10 states that computed tomography (CT) is indicated in any of the following situations:
- The patient fails to reach a Glasgow Coma Scale score of 15—on a scale of 3 (worst) to 15 (best)—within 2 hours
- There is a suspected open skull fracture
- There is any sign of basal skull fracture
- The patient has 2 or more episodes of vomiting
- The patient is 65 or older
- The patient has retrograde amnesia (ie, cannot remember events that occurred before the injury) for 30 minutes or more
- The mechanism of injury was dangerous (eg, a pedestrian was struck by a motor vehicle, or the patient fell from > 3 feet or > 5 stairs).
The New Orleans Criteria11 state that a patient warrants CT of the head if any of the following is present:
- Severe headache
- Vomiting
- Age over 60
- Drug or alcohol intoxication
- Deficit in short-term memory
- Physical evidence of trauma above the clavicles
- Seizure.
Caveats: these imaging guidelines apply to adults; those for pediatric patients differ.12 Also, because they were designed for use in an emergency department, their utility in clinical practice outside the emergency department is unclear.
Electroencephalography is not necessary in the evaluation of concussion unless a seizure disorder is believed to be the cause of the injury.
Concussion in athletes
Athletes who participate in contact and collision sports are at higher risk of concussion than the nonathletic population. Therefore, specific assessments of symptoms, balance, oculomotor function, cognitive function, and reaction time have been developed for athletes.
Ideally, these measures are taken at preseason baseline, so that they are available for comparison with postinjury assessments after a known or suspected concussion. These assessments can be used to help make the diagnosis of concussion in cases that are unclear and to help monitor recovery. Objective measures of injury are especially useful for athletes who may be reluctant to report symptoms in order to return to play.
Like most medical tests, these assessments need to be properly interpreted in the overall context of the medical history and physical examination by those who know how to administer them. It is important to remember that the natural history of concussion recovery differs between sport-related concussion and concussion that occurs outside of sports.8
MANAGEMENT
The symptoms and signs after concussion are so variable and multidimensional that they make a generally applicable treatment hard to define.
Rest: Physical and cognitive
Treatment depends on the specifics of the injury, but there are common recommendations for the acute days after injury. Lacking hard data, the consensus among experts is that patients should undergo a period of physical and cognitive rest.13,14 Exactly what “rest” means and how long it should last are unknown, leading to a wide variation in its application.
Rest aids recovery but also may have adverse effects: fatigue, diurnal sleep disruption, reactive depression, anxiety, and physiologic deconditioning.15,16 Many guidelines recommend physical and cognitive rest until symptoms resolve,14 but this is likely too cautious. Even without a concussion, inactivity is associated with many of the nonspecific symptoms also associated with concussion. As recovery progresses, the somatic symptoms of concussion improve, while emotional symptoms worsen, likely in part due to prolonged rest.17
We recommend a period of rest lasting 3 to 5 days after injury, followed by a gradual resumption of both physical and cognitive activities as tolerated, remaining below the level at which symptoms are exacerbated.
Not surprisingly, many guidelines for returning to physical activity are focused on athletes. Yet the same principles apply to management of concussion in the general population who exercise: light physical activity (typically walking or stationary bicycling), followed by more vigorous aerobic activity, followed by some resistance activities. Mild aerobic exercise (to below the threshold of symptoms) may speed recovery from refractive postconcussion syndrome, even in those who did not exercise before the injury.18
Athletes require specific and strict instructions to avoid increased trauma to the head during the gradual increase of physical activities. The National Collegiate Athletic Association has published an algorithm for a gradual return to sport-specific training that is echoed in recent consensus statements on concussion.19 Once aerobic reconditioning produces no symptoms, then noncontact, sport-specific activities are begun, followed by contact activities. We have patients return to the clinic once they are symptom-free for repeat evaluation before clearing them for high-risk activities (eg, skiing, bicycling) or contact sports (eg, basketball, soccer, football, ice hockey).
Cognitive rest
While physical rest is fairly straightforward, cognitive rest is more challenging. The concept of cognitive rest is hard to define and even harder to enforce. Patients are often told to minimize any activities that require attention or concentration. This often includes, but is not limited to, avoiding reading, texting, playing video games, and using computers.13
In the modern world, full avoidance of these activities is difficult and can be profoundly socially isolating. Further, complete cognitive rest may be associated with symptoms of its own.15,16,20 Still, some reasonable limitation of cognitive activities, at least initially, is likely beneficial.21 For patients engaged in school or academic work, often the daily schedule needs to be adjusted and accommodations made to help them return to a full academic schedule and level of activity. It is reasonable to have patients return gradually to work or school rather than attempt to immediately return to their preinjury level.
With these interventions, most patients have full resolution of their symptoms and return to preinjury levels of performance.
TREATING SOMATIC SYMPTOMS
Posttraumatic headache
Posttraumatic headache is the most common sequela of concussion.22 Surprisingly, it is more common after concussion than after moderate or severe traumatic brain injury.23 A prior history of headache, particularly migraine, is a known risk factor for development of posttraumatic headache.24
Posttraumatic headache is usually further defined by headache type using the International Classification of Headache Disorders criteria (www.ichd-3.org). Migraine or probable migraine is the most common type of posttraumatic headache; tension headache is less common.25
Analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) are often used initially by patients to treat posttraumatic headache. One study found that 70% of patients used acetaminophen or an NSAID.26
Treating early with effective therapy is the most important tenet of posttraumatic headache treatment, since 80% of those who self-treat have incomplete relief, and almost all of them are using over-the-counter products.27 Overuse of over-the-counter abortive medications can lead to medication overuse headache, also known as rebound headache, thus complicating the treatment of posttraumatic headache.26
Earlier treatment with a preventive medication can often limit the need for and overuse of over-the-counter analgesics and can minimize the occurrence of subsequent medication overuse headache. However, in pediatric populations, nonpharmacologic interventions such as rest and sleep hygiene are typically used first, then medications after 4 to 6 weeks if this is ineffective.
A number of medications have been studied for prophylactic treatment of posttraumatic headache, including topiramate, amitriptyline, and divalproex sodium,28–30 but there is little compelling evidence for use of one over the other. If posttraumatic headache is migrainous, beta-blockers, calcium-channel blockers, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibtors, and gabapentin are other prophylactic medication options under the appropriate circumstances.27,31,32 In adults, we have clinically had success with nortriptyline 20 mg or gabapentin 300 mg at night as an initial prophylactic headache medication, increasing as tolerated or until pain is controlled, though there are no high-quality data to guide this decision.
The ideal prophylactic medication depends on headache type, patient tolerance, comorbidities, allergies, and medication sensitivities. Gabapentin, amitriptyline, and nortriptyline can produce sedation, which can help those suffering from sleep disturbance.
If a provider is not comfortable prescribing these medications or doesn’t prescribe them regularly, the patient should be referred to a concussion or headache specialist more familiar with their use.
In some patients, even some athletes, headache may be related to a cervical strain injury—whiplash—that should be treated with an NSAID (or acetaminophen), perhaps with a short course of a muscle relaxant in adults, and with physical therapy.32
Some patients have chronic headache despite oral medications.26 Therefore, alternatives to oral medications and complementary therapies should be considered. Especially for protracted cases requiring more complicated headache management or injectable treatments, patients should be referred to a pain clinic, headache specialist, or concussion specialist.
Dizziness
Dizziness is also common after concussion. But what the patient means by dizziness requires a little probing. Some have paroxysms of vertigo. This typically represents a peripheral vestibular injury, usually benign paroxysmal positional vertigo. The latter can be elicited with a Hallpike maneuver and treated in the office with the Epley maneuver.33
Usually, dizziness is a subjective sense of poor coordination, gait instability, or dysequilibrium. Patients may also complain of associated nausea and motion sensitivity. This may all be secondary to a mechanism in the middle or inner ear or the brain. Patients should be encouraged to begin movement—gradually and safely—to help the vestibular system accommodate, which it will do with gradual stimulation. It usually resolves spontaneously.
Specific treatment is unfortunately limited. There is no established benefit from vestibular suppressants such as meclizine. Vestibular rehabilitation may accelerate improvement and decrease symptoms.33 Referral for a comprehensive balance assessment or to vestibular therapy (a subset of physical therapy) should be considered and is something we typically undertake in our clinic if there is no recovery from dizziness 4 to 6 weeks after the concussion.
Visual symptoms can contribute to dizziness. Convergence spasm or convergence insufficiency (both related to muscle spasm of the eye) can occur after concussion, with some studies estimating that up to 69% of patients have these symptoms.34 This can interfere with visual tracking and contribute to a feeling of dysequilibrium.34 Referral to a concussion specialist or vestibular rehabilitation physical therapist can be helpful in treating this issue if it does not resolve spontaneously.
Orthostasis and lightheadedness also contribute to dizziness and are associated with cerebrovascular autoregulation. Available data suggest that dysregulation of neurovascular coupling, cerebral vasoreactivity, and cerebral autoregulation contribute to some of the chronic symptoms of concussion, including dizziness. A gradual return to exercise may help regulate cerebral blood flow and improve this type of dizziness.35
Sleep disturbance
Sleep disturbance is common after concussion, but the form is variable: insomnia, excessive daytime somnolence, and alteration of the sleep-wake cycle are all seen and may themselves affect recovery.36
Sleep hygiene education should be the first intervention for postconcussive sleep issues. For example, the patient should be encouraged to do the following:
- Minimize “screen time” an hour before going to bed: cell phone, tablet, and computer screens emit a wavelength of light that suppresses endogenous melatonin release37,38
- Go to bed and wake up at the same time each day
- Minimize or avoid caffeine, nicotine, and alcohol
- Avoid naps.39
Melatonin is a safe and effective treatment that could be added.40 In addition, some studies suggest that melatonin may improve recovery from traumatic brain injury.41,42
Mild exercise (to below the threshold of causing or exacerbating symptoms) may also improve sleep quality.
Amitriptyline or nortriptyline may reduce headache frequency and intensity and also help treat insomnia.
Trazodone is recommended by some as a first-line agent,39 but we usually reserve it for protracted insomnia refractory to the above treatments.
Benzodiazepines should be avoided, as they reduce arousal, impair cognition, and exacerbate motor impairments.43
Emotional symptoms
Acute-onset anxiety or depression often occurs after concussion.44,45 There is abundant evidence that emotional effects of injury may be the most significant factor in recovery.46 A preinjury history of anxiety may be a prognostic factor.9 Patients with a history of anxiety or depression are more likely to develop emotional symptoms after a concussion, but emotional problems may develop in any patient after a concussion.47,48
The circumstances under which an injury is sustained may be traumatic (eg, car accident, assault), leading to an acute stress reaction or disorder and, if untreated, may result in a more chronic condition—posttraumatic stress disorder. Moreover, the injury and subsequent symptoms may have repercussions in many aspects of the patient’s life, leading to further psychologic stress (eg, loss of wages or the inability to handle normal work, school, and family responsibilities).
Referral to a therapist trained in skills-based psychotherapy (eg, cognitive-behavioral therapy, exposure-based treatment) is often helpful.
Pharmacologic treatment can be a useful adjunct. Several studies have shown that selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants may improve depression after concussion.49 The prescription of antidepressants, however, is best left to providers with experience in treating anxiety and depression.
As with sleep disorders after concussion, benzodiazepines should be avoided, as they can impair cognition.43
Cognitive problems
Cognitive problems are also common after concussion. Patients complain about everyday experiences of forgetfulness, distractibility, loss of concentration, and mental fatigue. Although patients often subjectively perceive these symptoms as quite limiting, the impairments can be difficult to demonstrate in office testing.
A program of gradual increase in mental activity, parallel to recovery of physical capacity, should be undertaken. Most patients make a gradual recovery within a few weeks.50
When cognitive symptoms cause significant school or vocational problems or become persistent, patients should be referred to a specialty clinic. As with most of the consequences of concussion, there are few established treatments. When cognitive difficulties persist, it is important to consider the complications of concussion mentioned above: headache, pain, sleep disturbance, and anxiety, all of which may cause subjective cognitive problems and are treatable.
If cognitive symptoms are prolonged despite improvement of other issues like headache and sleep disturbance, a low-dose stimulant medication such as amphetamine salts or methylphenidate may be useful for symptoms of poor attention.49 They should be only a temporary measure after concussion to carry the patient through a cognitively challenging period, unless there was a history of attention-deficit disorder before the injury. A variety of other agents, including amantadine,51 have been proposed based on limited studies; all are off-label uses. Before considering these types of interventions, referral to a specialist or a specialty program would be appropriate.
IF SYMPTOMS PERSIST
With the interventions suggested above, most patients with concussion have a resolution of symptoms and can return to preinjury levels of performance. But some have prolonged symptoms and sequelae. Approximately 10% of athletes have persistent signs and symptoms of concussion beyond 2 weeks. If concussion is not sport-related, most patients recover completely within the first 3 months, but up to 33% may have symptoms beyond that.52
Four types of patients have persistent symptoms:
Patients who sustained a high-force mechanism of injury. These patients simply need more time and accommodation.
Patients who sustained multiple concussions. These patients may also need more time and accommodation.
Patients with an underlying neurologic condition, recognized prior to injury or not, may have delayed or incomplete recovery. Even aging may be an “underlying condition” in concussion.
Patients whose symptoms from an apparently single mild concussion do not resolve despite appropriate treatments may have identifiable factors, but intractable pain (usually headache) or significant emotional disturbance or both are common. Once established and persistent, this is difficult to treat. Referral to a specialty practice is appropriate, but even in that setting effective treatment may be elusive.
PATIENT EDUCATION
Most important for patient education is reassurance. Ultimately, concussion is a self-limited phenomenon, and reinforcing this is helpful for patients. If concussion is not sport-related, most patients recover completely within 3 months.
The next important tenet in patient education is that they should rest for 3 to 5 days, then resume gradual physical and cognitive activities. If resuming activities too soon results in symptoms, then they should rest for a day and gradually resume activity. If their recovery is prolonged (ie, longer than 6 weeks), they likely need to be referred to a concussion specialist.
- Cassidy JD, Carroll LJ, Peloso PM, et al; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med 2004; (suppl):28–60.
- Shaw NA. The neurophysiology of concussion. Prog Neurobiol 2002; 67:281–344.
- Denny-Brown DE, Russell WR. Experimental concussion: (section of neurology). Proc R Soc Med 1941; 34:691–692.
- Ommaya AK, Gennarelli TA. Cerebral concussion and traumatic unconsciousness. Correlation of experimental and clinical observations of blunt head injuries. Brain 1974; 97:633–654.
- Houlburn AHS, Edin MA. Mechanics of head injuries. Lancet 1943; 242:438–441.
- Gennarelli TA, Adams JH, Graham DI. Acceleration induced head injury in the monkey. I. The model, its mechanical and physiological correlates. Acta Neuropathol Suppl 1981; 7:23–25.
- Giza CC, Hovda DA. The neurometabolic cascade of concussion. J Athl Train 2001; 36:228–235.
- Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics 2009; 123:114–123.
- Iverson GL, Silverberg ND, Mannix R, et al. Factors associated with concussion-like symptom reporting in high school athletes. JAMA Pediatr 2015; 169:1132–1140.
- Stiell IG, Wells GA, Vandemheen K. et al. The Canadian CT head rule for patients with minor head injury. Lancet 2001; 357:1391–1396.
- Haydel MJ, Preston CA, Mills TJ, Luber S, Blaudeau E, DeBlieux PMC. Indications for computed tomography in patients with minor head injury. N Engl J Med 2000; 343:100–105.
- Kuppermann N, Holmes JF, Dayan PS, et al; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically important brain injuries after head trauma: a prospective cohort study. Lancet 2009; 374:1160–1170.
- McCrory P, Meeuwisse W, Johnston K, et al. Consensus Statement on Concussion in Sport: the 3rd International Conference on Concussion in Sport held in Zurich, November 2008. Br J Sports Med 2009; 43(suppl 1):i76–i90.
- DeMatteo C, Stazyk K, Singh SK, et al; Ontario Neurotrauma Foundation. Development of a conservative protocol to return children and youth to activity following concussive injury. Clin Pediatr (Phila) 2015; 54:152–163.
- Willer B, Leddy JJ. Management of concussion and post-concussion syndrome. Curr Treat Options Neurol 2006; 8:415–426.
- DiFazio M, Silverberg ND, Kirkwood MW, Bernier R, Iverson GL. Prolonged activity restriction after concussion: are we worsening outcomes? Clin Pediatr (Phila) 2016; 55:443–451.
- Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics 2015; 135:213–223.
- Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med 2010; 20:21–27.
- McCrory P, Meeuwisse WH, Aubry M, et al. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med 2013; 47:250–258.
- Buckley TA, Munkasy BA, Clouse BP. Acute cognitive and physical rest may not improve concussion recovery time. J Head Trauma Rehabil 2016; 31:233–241.
- Brown NJ, Mannix RC, O'Brien MJ, Gostine D, Collins MW, Meehan WP 3rd. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics 2014; 133:e299–e304.
- Packard RC. Epidemiology and pathogenesis of posttraumatic headache. J Head Trauma Rehabil 1999; 14:9–21.
- Couch JR, Bearss C. Chronic daily headache in the posttrauma syndrome: relation to extent of head injury. Headache 2001; 41:559–564.
- Lucas S, Hoffman JM, Bell KR, Dikmen S. A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia 2014; 34:93–102.
- Lucas S, Hoffman JM, Bell KR, Walker W, Dikmen S. Characterization of headache after traumatic brain injury. Cephalalgia 2012; 32:600–606.
- DiTommaso C, Hoffman JM, Lucas S, Dikmen S, Temkin N, Bell KR. Medication usage patterns for headache treatment after mild traumatic brain injury. Headache 2014; 54:511–519.
- Lucas S. Characterization and management of headache after mild traumatic brain injury. In: Kobeissy FH, ed. Brain Neurotrauma: Molecular, Neuropsychological, and Rehabilitation Aspects. Boca Raton, FL: CRC Press/Taylor & Franis Group; 2015:145–154.
- Erickson JC. Treatment outcomes of chronic post-traumatic headaches after mild head trauma in US soldiers: an observational study. Headache 2011; 51:932–944.
- Tyler GS, McNeely HE, Dick ML. Treatment of post-traumatic headache with amitriptyline. Headache 1980; 20:213–216.
- Packard RC. Treatment of chronic daily posttraumatic headache with divalproex sodium. Headache 2000; 40:736–739.
- Kacperski J, Arthur T. Management of post-traumatic headaches in children and adolescents. Headache 2016; 56:36–48.
- Lenaerts ME, Couch JR, Couch JR. Posttraumatic headache. Curr Treat Options Neurol 2004; 6:507–517.
- Valovich McLeod TC, Hale TD. Vestibular and balance issues following sport-related concussion. Brain Inj 2015; 29:175–184.
- Master CL, Cheiman M, Gallaway M, et al. Vision diagnoses are common after concussion in adolescents. Clin Pediatr (Phila) 2016; 55:260–267.
- Tan CO, Meehan WP 3rd, Iverson GL, Taylor JA. Cerebrovascular regulation, exercise and mild traumatic brain injury. Neurology 2014; 83:1665–1672.
- Mahmood O, Rapport LJ, Hanks RA, Fichtenberg NL. Neuropsychological performance and sleep disturbance following traumatic brain injury. J Head Trauma Rehabil 2004; 19:378–390.
- Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Markey SP. Light suppresses melatonin secretion in humans. Science 1980; 210:1267–1269.
- Figueiro MG, Wood B, Plitnick B, Rea MS. The impact of light from computer monitors on melatonin levels in college students. Neuro Endocrinol Lett 2011; 32:158–163.
- Rao V, Rollings P. Sleep disturbances following traumatic brain injury. Curr Treat Options Neurol 2002; 4:77–87.
- Samantaray S, Das A, Thakore NP, et al. Therapeutic potential of melatonin in traumatic central nervous system injury. J Pineal Res 2009; 47:134–142.
- Ding K, Xu J, Wang H, Zhang L, Wu Y, Li T. Melatonin protects the brain from apoptosis by enhancement of autophagy after traumatic brain injury in mice. Neurochem Int 2015; 91:46–54.
- Babaee A, Eftekhar-Vaghefi SH, Asadi-Shekaari M, et al. Melatonin treatment reduces astrogliosis and apoptosis in rats with traumatic brain injury. Iran J Basic Med Sci 2015; 18:867–872.
- Arciniegas DB, Anderson CA, Topkoff J, McAllister TW. Mild traumatic brain injury: a neuropsychiatric approach to diagnosis, evaluation, and treatment. Neuropsychiatr Dis Treat 2005; 1:311–327.
- O’Donnell ML, Creamer M, Pattison P, Atkin C. Psychiatric morbidity following injury. Am J Psychiatry 2004; 161:507–514.
- Dikmen SS, Bombardier CH, Machamer JE, Fann JR, Temkin NR. Natural history of depression in traumatic brain injury. Arch Phys Med Rehabil 2004; 85:1457–1464.
- Massey JS, Meares S, Batchelor J, Bryant RA. An exploratory study of the association of acute posttraumatic stress, depression, and pain to cognitive functioning in mild traumatic brain injury. Neuropsychology 2015; 29:530–542.
- Meares S, Shores EA, Taylor AJ, et al. The prospective course of postconcussion syndrome: the role of mild traumatic brain injury. Neuropsychology 2011; 25:454–465.
- Solomon GS, Kuhn AW, Zuckerman SL. Depression as a modifying factor in sport-related concussion: a critical review of the literature. Phys Sportsmed 2016; 44:14–19.
- Neurobehavioral Guidelines Working Group; Warden DL, Gordon B, McAllister TW, et al. Guidelines for the pharmacologic treatment of neurobehavioral sequelae of traumatic brain injury. J Neurotrauma 2006; 23:1468–1501.
- Dikmen S, McLean A, Temkin N. Neuropsychological and psychosocial consequences of minor head injury. J Neurol Neurosurg Psychiatry 1986; 49:1227–1232.
- Reddy CC, Collins M, Lovell M, Kontos AP. Efficacy of amantadine treatment on symptoms and neurocognitive performance among adolescents following sports-related concussion. J Head Trauma Rehabil 2013; 28:260–265.
- Leddy JJ, Sandhu H, Sodhi V, Baker JG, Willer B. Rehabilitation of concussion and post-concussion syndrome. Sports Health 2012; 4:147–154.
Concussion, also known as mild traumatic brain injury, affects more than 600 adults per 100,000 each year and is commonly treated by nonneurologists.1 Public attention to concussion has been increasing, particularly to concussion sustained during sports. Coincident with this increased attention, the diagnosis of concussion continues to increase in the outpatient setting. Thus, a review of the topic is timely.
ACCELERATION OF THE BRAIN DUE TO TRAUMA
The definition of concussion has changed considerably over the years. It is currently defined as a pathophysiologic process that results from an acceleration or deceleration of the brain induced by trauma.2 It is largely a temporary, functional problem, as opposed to a gross structural injury.2–5
The acceleration of the brain that results in a concussion is usually initiated by a direct blow to the head, although direct impact is not required.6 As the brain rotates, different areas accelerate at different rates, resulting in a shear strain imparted to the parenchyma.
This shear strain causes deformation of axonal membranes and opening of membrane-associated sodium-potassium channels. This in turn leads to release of excitatory neurotransmitters, ultimately culminating in a wave of neuronal depolarization and a spreading depression-like phenomenon that may mediate the loss of consciousness, posttraumatic amnesia, confusion, and many of the other immediate signs and symptoms associated with concussion.
The sudden metabolic demand created by the massive excitatory phenomena triggers an increased utilization of glucose to restore cellular homeostasis. At the same time, cerebral blood flow decreases after concussion, which, in the setting of increased glucose demand, leads to an “energy crisis”: an increased need for adenosine triphosphate with a concomitant decreased delivery of glucose.7 This mismatch between energy demand and supply is thought to underlie the most common signs and symptoms of concussion.
ASSESSMENT
History
The history of present illness is essential to a diagnosis of concussion. In the classic scenario, an otherwise asymptomatic person sustains some trauma to the head that is followed immediately by the signs and symptoms of concussion.
Many of these signs and symptoms are nonspecific and may occur without concussion or other trauma.8,9 Thus, the diagnosis of concussion cannot be made on the basis of symptoms alone, but only in the overall context of history, physical examination, and, at times, additional clinical assessments.
The symptoms of concussion should gradually improve. While they may be exacerbated by certain activities or stimuli, the overall trend should be one of symptom improvement. If symptoms are worsening over time, alternative explanations for the patient’s symptoms should be considered.
Physical examination
A thorough neurologic examination should be conducted in all patients with suspected concussion and include the following.
A mental status examination should include assessment of attention, memory, and recall. Orientation is normal except in the most acute examinations.
Cranial nerve examination must include careful assessment of eye-movement control, including smooth pursuit and saccades. However, even in patients with prominent subjective dizziness, considerable experience may be needed to actually demonstrate abnormalities.
Balance testing. Balance demands careful assessment and, especially for young athletes, this testing should be more difficult than the tandem gait and eyes-closed, feet-together tests.
Standard strength, sensory, reflex, and coordination testing is usually normal.
Any focal neurologic findings should prompt consideration of other causes or of a more serious injury and should lead to further evaluation, including brain imaging.
Diagnostic tests
Current clinical brain imaging cannot diagnose a concussion. The purpose of neuroimaging is to assess for other etiologies or injuries, such as hemorrhage or contusion, that may cause similar symptoms but require different management.
Several guidelines are available to assess the need for imaging in the setting of recent trauma, of which 2 are typically used10–12:
The Canadian CT Head Rule10 states that computed tomography (CT) is indicated in any of the following situations:
- The patient fails to reach a Glasgow Coma Scale score of 15—on a scale of 3 (worst) to 15 (best)—within 2 hours
- There is a suspected open skull fracture
- There is any sign of basal skull fracture
- The patient has 2 or more episodes of vomiting
- The patient is 65 or older
- The patient has retrograde amnesia (ie, cannot remember events that occurred before the injury) for 30 minutes or more
- The mechanism of injury was dangerous (eg, a pedestrian was struck by a motor vehicle, or the patient fell from > 3 feet or > 5 stairs).
The New Orleans Criteria11 state that a patient warrants CT of the head if any of the following is present:
- Severe headache
- Vomiting
- Age over 60
- Drug or alcohol intoxication
- Deficit in short-term memory
- Physical evidence of trauma above the clavicles
- Seizure.
Caveats: these imaging guidelines apply to adults; those for pediatric patients differ.12 Also, because they were designed for use in an emergency department, their utility in clinical practice outside the emergency department is unclear.
Electroencephalography is not necessary in the evaluation of concussion unless a seizure disorder is believed to be the cause of the injury.
Concussion in athletes
Athletes who participate in contact and collision sports are at higher risk of concussion than the nonathletic population. Therefore, specific assessments of symptoms, balance, oculomotor function, cognitive function, and reaction time have been developed for athletes.
Ideally, these measures are taken at preseason baseline, so that they are available for comparison with postinjury assessments after a known or suspected concussion. These assessments can be used to help make the diagnosis of concussion in cases that are unclear and to help monitor recovery. Objective measures of injury are especially useful for athletes who may be reluctant to report symptoms in order to return to play.
Like most medical tests, these assessments need to be properly interpreted in the overall context of the medical history and physical examination by those who know how to administer them. It is important to remember that the natural history of concussion recovery differs between sport-related concussion and concussion that occurs outside of sports.8
MANAGEMENT
The symptoms and signs after concussion are so variable and multidimensional that they make a generally applicable treatment hard to define.
Rest: Physical and cognitive
Treatment depends on the specifics of the injury, but there are common recommendations for the acute days after injury. Lacking hard data, the consensus among experts is that patients should undergo a period of physical and cognitive rest.13,14 Exactly what “rest” means and how long it should last are unknown, leading to a wide variation in its application.
Rest aids recovery but also may have adverse effects: fatigue, diurnal sleep disruption, reactive depression, anxiety, and physiologic deconditioning.15,16 Many guidelines recommend physical and cognitive rest until symptoms resolve,14 but this is likely too cautious. Even without a concussion, inactivity is associated with many of the nonspecific symptoms also associated with concussion. As recovery progresses, the somatic symptoms of concussion improve, while emotional symptoms worsen, likely in part due to prolonged rest.17
We recommend a period of rest lasting 3 to 5 days after injury, followed by a gradual resumption of both physical and cognitive activities as tolerated, remaining below the level at which symptoms are exacerbated.
Not surprisingly, many guidelines for returning to physical activity are focused on athletes. Yet the same principles apply to management of concussion in the general population who exercise: light physical activity (typically walking or stationary bicycling), followed by more vigorous aerobic activity, followed by some resistance activities. Mild aerobic exercise (to below the threshold of symptoms) may speed recovery from refractive postconcussion syndrome, even in those who did not exercise before the injury.18
Athletes require specific and strict instructions to avoid increased trauma to the head during the gradual increase of physical activities. The National Collegiate Athletic Association has published an algorithm for a gradual return to sport-specific training that is echoed in recent consensus statements on concussion.19 Once aerobic reconditioning produces no symptoms, then noncontact, sport-specific activities are begun, followed by contact activities. We have patients return to the clinic once they are symptom-free for repeat evaluation before clearing them for high-risk activities (eg, skiing, bicycling) or contact sports (eg, basketball, soccer, football, ice hockey).
Cognitive rest
While physical rest is fairly straightforward, cognitive rest is more challenging. The concept of cognitive rest is hard to define and even harder to enforce. Patients are often told to minimize any activities that require attention or concentration. This often includes, but is not limited to, avoiding reading, texting, playing video games, and using computers.13
In the modern world, full avoidance of these activities is difficult and can be profoundly socially isolating. Further, complete cognitive rest may be associated with symptoms of its own.15,16,20 Still, some reasonable limitation of cognitive activities, at least initially, is likely beneficial.21 For patients engaged in school or academic work, often the daily schedule needs to be adjusted and accommodations made to help them return to a full academic schedule and level of activity. It is reasonable to have patients return gradually to work or school rather than attempt to immediately return to their preinjury level.
With these interventions, most patients have full resolution of their symptoms and return to preinjury levels of performance.
TREATING SOMATIC SYMPTOMS
Posttraumatic headache
Posttraumatic headache is the most common sequela of concussion.22 Surprisingly, it is more common after concussion than after moderate or severe traumatic brain injury.23 A prior history of headache, particularly migraine, is a known risk factor for development of posttraumatic headache.24
Posttraumatic headache is usually further defined by headache type using the International Classification of Headache Disorders criteria (www.ichd-3.org). Migraine or probable migraine is the most common type of posttraumatic headache; tension headache is less common.25
Analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) are often used initially by patients to treat posttraumatic headache. One study found that 70% of patients used acetaminophen or an NSAID.26
Treating early with effective therapy is the most important tenet of posttraumatic headache treatment, since 80% of those who self-treat have incomplete relief, and almost all of them are using over-the-counter products.27 Overuse of over-the-counter abortive medications can lead to medication overuse headache, also known as rebound headache, thus complicating the treatment of posttraumatic headache.26
Earlier treatment with a preventive medication can often limit the need for and overuse of over-the-counter analgesics and can minimize the occurrence of subsequent medication overuse headache. However, in pediatric populations, nonpharmacologic interventions such as rest and sleep hygiene are typically used first, then medications after 4 to 6 weeks if this is ineffective.
A number of medications have been studied for prophylactic treatment of posttraumatic headache, including topiramate, amitriptyline, and divalproex sodium,28–30 but there is little compelling evidence for use of one over the other. If posttraumatic headache is migrainous, beta-blockers, calcium-channel blockers, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibtors, and gabapentin are other prophylactic medication options under the appropriate circumstances.27,31,32 In adults, we have clinically had success with nortriptyline 20 mg or gabapentin 300 mg at night as an initial prophylactic headache medication, increasing as tolerated or until pain is controlled, though there are no high-quality data to guide this decision.
The ideal prophylactic medication depends on headache type, patient tolerance, comorbidities, allergies, and medication sensitivities. Gabapentin, amitriptyline, and nortriptyline can produce sedation, which can help those suffering from sleep disturbance.
If a provider is not comfortable prescribing these medications or doesn’t prescribe them regularly, the patient should be referred to a concussion or headache specialist more familiar with their use.
In some patients, even some athletes, headache may be related to a cervical strain injury—whiplash—that should be treated with an NSAID (or acetaminophen), perhaps with a short course of a muscle relaxant in adults, and with physical therapy.32
Some patients have chronic headache despite oral medications.26 Therefore, alternatives to oral medications and complementary therapies should be considered. Especially for protracted cases requiring more complicated headache management or injectable treatments, patients should be referred to a pain clinic, headache specialist, or concussion specialist.
Dizziness
Dizziness is also common after concussion. But what the patient means by dizziness requires a little probing. Some have paroxysms of vertigo. This typically represents a peripheral vestibular injury, usually benign paroxysmal positional vertigo. The latter can be elicited with a Hallpike maneuver and treated in the office with the Epley maneuver.33
Usually, dizziness is a subjective sense of poor coordination, gait instability, or dysequilibrium. Patients may also complain of associated nausea and motion sensitivity. This may all be secondary to a mechanism in the middle or inner ear or the brain. Patients should be encouraged to begin movement—gradually and safely—to help the vestibular system accommodate, which it will do with gradual stimulation. It usually resolves spontaneously.
Specific treatment is unfortunately limited. There is no established benefit from vestibular suppressants such as meclizine. Vestibular rehabilitation may accelerate improvement and decrease symptoms.33 Referral for a comprehensive balance assessment or to vestibular therapy (a subset of physical therapy) should be considered and is something we typically undertake in our clinic if there is no recovery from dizziness 4 to 6 weeks after the concussion.
Visual symptoms can contribute to dizziness. Convergence spasm or convergence insufficiency (both related to muscle spasm of the eye) can occur after concussion, with some studies estimating that up to 69% of patients have these symptoms.34 This can interfere with visual tracking and contribute to a feeling of dysequilibrium.34 Referral to a concussion specialist or vestibular rehabilitation physical therapist can be helpful in treating this issue if it does not resolve spontaneously.
Orthostasis and lightheadedness also contribute to dizziness and are associated with cerebrovascular autoregulation. Available data suggest that dysregulation of neurovascular coupling, cerebral vasoreactivity, and cerebral autoregulation contribute to some of the chronic symptoms of concussion, including dizziness. A gradual return to exercise may help regulate cerebral blood flow and improve this type of dizziness.35
Sleep disturbance
Sleep disturbance is common after concussion, but the form is variable: insomnia, excessive daytime somnolence, and alteration of the sleep-wake cycle are all seen and may themselves affect recovery.36
Sleep hygiene education should be the first intervention for postconcussive sleep issues. For example, the patient should be encouraged to do the following:
- Minimize “screen time” an hour before going to bed: cell phone, tablet, and computer screens emit a wavelength of light that suppresses endogenous melatonin release37,38
- Go to bed and wake up at the same time each day
- Minimize or avoid caffeine, nicotine, and alcohol
- Avoid naps.39
Melatonin is a safe and effective treatment that could be added.40 In addition, some studies suggest that melatonin may improve recovery from traumatic brain injury.41,42
Mild exercise (to below the threshold of causing or exacerbating symptoms) may also improve sleep quality.
Amitriptyline or nortriptyline may reduce headache frequency and intensity and also help treat insomnia.
Trazodone is recommended by some as a first-line agent,39 but we usually reserve it for protracted insomnia refractory to the above treatments.
Benzodiazepines should be avoided, as they reduce arousal, impair cognition, and exacerbate motor impairments.43
Emotional symptoms
Acute-onset anxiety or depression often occurs after concussion.44,45 There is abundant evidence that emotional effects of injury may be the most significant factor in recovery.46 A preinjury history of anxiety may be a prognostic factor.9 Patients with a history of anxiety or depression are more likely to develop emotional symptoms after a concussion, but emotional problems may develop in any patient after a concussion.47,48
The circumstances under which an injury is sustained may be traumatic (eg, car accident, assault), leading to an acute stress reaction or disorder and, if untreated, may result in a more chronic condition—posttraumatic stress disorder. Moreover, the injury and subsequent symptoms may have repercussions in many aspects of the patient’s life, leading to further psychologic stress (eg, loss of wages or the inability to handle normal work, school, and family responsibilities).
Referral to a therapist trained in skills-based psychotherapy (eg, cognitive-behavioral therapy, exposure-based treatment) is often helpful.
Pharmacologic treatment can be a useful adjunct. Several studies have shown that selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants may improve depression after concussion.49 The prescription of antidepressants, however, is best left to providers with experience in treating anxiety and depression.
As with sleep disorders after concussion, benzodiazepines should be avoided, as they can impair cognition.43
Cognitive problems
Cognitive problems are also common after concussion. Patients complain about everyday experiences of forgetfulness, distractibility, loss of concentration, and mental fatigue. Although patients often subjectively perceive these symptoms as quite limiting, the impairments can be difficult to demonstrate in office testing.
A program of gradual increase in mental activity, parallel to recovery of physical capacity, should be undertaken. Most patients make a gradual recovery within a few weeks.50
When cognitive symptoms cause significant school or vocational problems or become persistent, patients should be referred to a specialty clinic. As with most of the consequences of concussion, there are few established treatments. When cognitive difficulties persist, it is important to consider the complications of concussion mentioned above: headache, pain, sleep disturbance, and anxiety, all of which may cause subjective cognitive problems and are treatable.
If cognitive symptoms are prolonged despite improvement of other issues like headache and sleep disturbance, a low-dose stimulant medication such as amphetamine salts or methylphenidate may be useful for symptoms of poor attention.49 They should be only a temporary measure after concussion to carry the patient through a cognitively challenging period, unless there was a history of attention-deficit disorder before the injury. A variety of other agents, including amantadine,51 have been proposed based on limited studies; all are off-label uses. Before considering these types of interventions, referral to a specialist or a specialty program would be appropriate.
IF SYMPTOMS PERSIST
With the interventions suggested above, most patients with concussion have a resolution of symptoms and can return to preinjury levels of performance. But some have prolonged symptoms and sequelae. Approximately 10% of athletes have persistent signs and symptoms of concussion beyond 2 weeks. If concussion is not sport-related, most patients recover completely within the first 3 months, but up to 33% may have symptoms beyond that.52
Four types of patients have persistent symptoms:
Patients who sustained a high-force mechanism of injury. These patients simply need more time and accommodation.
Patients who sustained multiple concussions. These patients may also need more time and accommodation.
Patients with an underlying neurologic condition, recognized prior to injury or not, may have delayed or incomplete recovery. Even aging may be an “underlying condition” in concussion.
Patients whose symptoms from an apparently single mild concussion do not resolve despite appropriate treatments may have identifiable factors, but intractable pain (usually headache) or significant emotional disturbance or both are common. Once established and persistent, this is difficult to treat. Referral to a specialty practice is appropriate, but even in that setting effective treatment may be elusive.
PATIENT EDUCATION
Most important for patient education is reassurance. Ultimately, concussion is a self-limited phenomenon, and reinforcing this is helpful for patients. If concussion is not sport-related, most patients recover completely within 3 months.
The next important tenet in patient education is that they should rest for 3 to 5 days, then resume gradual physical and cognitive activities. If resuming activities too soon results in symptoms, then they should rest for a day and gradually resume activity. If their recovery is prolonged (ie, longer than 6 weeks), they likely need to be referred to a concussion specialist.
Concussion, also known as mild traumatic brain injury, affects more than 600 adults per 100,000 each year and is commonly treated by nonneurologists.1 Public attention to concussion has been increasing, particularly to concussion sustained during sports. Coincident with this increased attention, the diagnosis of concussion continues to increase in the outpatient setting. Thus, a review of the topic is timely.
ACCELERATION OF THE BRAIN DUE TO TRAUMA
The definition of concussion has changed considerably over the years. It is currently defined as a pathophysiologic process that results from an acceleration or deceleration of the brain induced by trauma.2 It is largely a temporary, functional problem, as opposed to a gross structural injury.2–5
The acceleration of the brain that results in a concussion is usually initiated by a direct blow to the head, although direct impact is not required.6 As the brain rotates, different areas accelerate at different rates, resulting in a shear strain imparted to the parenchyma.
This shear strain causes deformation of axonal membranes and opening of membrane-associated sodium-potassium channels. This in turn leads to release of excitatory neurotransmitters, ultimately culminating in a wave of neuronal depolarization and a spreading depression-like phenomenon that may mediate the loss of consciousness, posttraumatic amnesia, confusion, and many of the other immediate signs and symptoms associated with concussion.
The sudden metabolic demand created by the massive excitatory phenomena triggers an increased utilization of glucose to restore cellular homeostasis. At the same time, cerebral blood flow decreases after concussion, which, in the setting of increased glucose demand, leads to an “energy crisis”: an increased need for adenosine triphosphate with a concomitant decreased delivery of glucose.7 This mismatch between energy demand and supply is thought to underlie the most common signs and symptoms of concussion.
ASSESSMENT
History
The history of present illness is essential to a diagnosis of concussion. In the classic scenario, an otherwise asymptomatic person sustains some trauma to the head that is followed immediately by the signs and symptoms of concussion.
Many of these signs and symptoms are nonspecific and may occur without concussion or other trauma.8,9 Thus, the diagnosis of concussion cannot be made on the basis of symptoms alone, but only in the overall context of history, physical examination, and, at times, additional clinical assessments.
The symptoms of concussion should gradually improve. While they may be exacerbated by certain activities or stimuli, the overall trend should be one of symptom improvement. If symptoms are worsening over time, alternative explanations for the patient’s symptoms should be considered.
Physical examination
A thorough neurologic examination should be conducted in all patients with suspected concussion and include the following.
A mental status examination should include assessment of attention, memory, and recall. Orientation is normal except in the most acute examinations.
Cranial nerve examination must include careful assessment of eye-movement control, including smooth pursuit and saccades. However, even in patients with prominent subjective dizziness, considerable experience may be needed to actually demonstrate abnormalities.
Balance testing. Balance demands careful assessment and, especially for young athletes, this testing should be more difficult than the tandem gait and eyes-closed, feet-together tests.
Standard strength, sensory, reflex, and coordination testing is usually normal.
Any focal neurologic findings should prompt consideration of other causes or of a more serious injury and should lead to further evaluation, including brain imaging.
Diagnostic tests
Current clinical brain imaging cannot diagnose a concussion. The purpose of neuroimaging is to assess for other etiologies or injuries, such as hemorrhage or contusion, that may cause similar symptoms but require different management.
Several guidelines are available to assess the need for imaging in the setting of recent trauma, of which 2 are typically used10–12:
The Canadian CT Head Rule10 states that computed tomography (CT) is indicated in any of the following situations:
- The patient fails to reach a Glasgow Coma Scale score of 15—on a scale of 3 (worst) to 15 (best)—within 2 hours
- There is a suspected open skull fracture
- There is any sign of basal skull fracture
- The patient has 2 or more episodes of vomiting
- The patient is 65 or older
- The patient has retrograde amnesia (ie, cannot remember events that occurred before the injury) for 30 minutes or more
- The mechanism of injury was dangerous (eg, a pedestrian was struck by a motor vehicle, or the patient fell from > 3 feet or > 5 stairs).
The New Orleans Criteria11 state that a patient warrants CT of the head if any of the following is present:
- Severe headache
- Vomiting
- Age over 60
- Drug or alcohol intoxication
- Deficit in short-term memory
- Physical evidence of trauma above the clavicles
- Seizure.
Caveats: these imaging guidelines apply to adults; those for pediatric patients differ.12 Also, because they were designed for use in an emergency department, their utility in clinical practice outside the emergency department is unclear.
Electroencephalography is not necessary in the evaluation of concussion unless a seizure disorder is believed to be the cause of the injury.
Concussion in athletes
Athletes who participate in contact and collision sports are at higher risk of concussion than the nonathletic population. Therefore, specific assessments of symptoms, balance, oculomotor function, cognitive function, and reaction time have been developed for athletes.
Ideally, these measures are taken at preseason baseline, so that they are available for comparison with postinjury assessments after a known or suspected concussion. These assessments can be used to help make the diagnosis of concussion in cases that are unclear and to help monitor recovery. Objective measures of injury are especially useful for athletes who may be reluctant to report symptoms in order to return to play.
Like most medical tests, these assessments need to be properly interpreted in the overall context of the medical history and physical examination by those who know how to administer them. It is important to remember that the natural history of concussion recovery differs between sport-related concussion and concussion that occurs outside of sports.8
MANAGEMENT
The symptoms and signs after concussion are so variable and multidimensional that they make a generally applicable treatment hard to define.
Rest: Physical and cognitive
Treatment depends on the specifics of the injury, but there are common recommendations for the acute days after injury. Lacking hard data, the consensus among experts is that patients should undergo a period of physical and cognitive rest.13,14 Exactly what “rest” means and how long it should last are unknown, leading to a wide variation in its application.
Rest aids recovery but also may have adverse effects: fatigue, diurnal sleep disruption, reactive depression, anxiety, and physiologic deconditioning.15,16 Many guidelines recommend physical and cognitive rest until symptoms resolve,14 but this is likely too cautious. Even without a concussion, inactivity is associated with many of the nonspecific symptoms also associated with concussion. As recovery progresses, the somatic symptoms of concussion improve, while emotional symptoms worsen, likely in part due to prolonged rest.17
We recommend a period of rest lasting 3 to 5 days after injury, followed by a gradual resumption of both physical and cognitive activities as tolerated, remaining below the level at which symptoms are exacerbated.
Not surprisingly, many guidelines for returning to physical activity are focused on athletes. Yet the same principles apply to management of concussion in the general population who exercise: light physical activity (typically walking or stationary bicycling), followed by more vigorous aerobic activity, followed by some resistance activities. Mild aerobic exercise (to below the threshold of symptoms) may speed recovery from refractive postconcussion syndrome, even in those who did not exercise before the injury.18
Athletes require specific and strict instructions to avoid increased trauma to the head during the gradual increase of physical activities. The National Collegiate Athletic Association has published an algorithm for a gradual return to sport-specific training that is echoed in recent consensus statements on concussion.19 Once aerobic reconditioning produces no symptoms, then noncontact, sport-specific activities are begun, followed by contact activities. We have patients return to the clinic once they are symptom-free for repeat evaluation before clearing them for high-risk activities (eg, skiing, bicycling) or contact sports (eg, basketball, soccer, football, ice hockey).
Cognitive rest
While physical rest is fairly straightforward, cognitive rest is more challenging. The concept of cognitive rest is hard to define and even harder to enforce. Patients are often told to minimize any activities that require attention or concentration. This often includes, but is not limited to, avoiding reading, texting, playing video games, and using computers.13
In the modern world, full avoidance of these activities is difficult and can be profoundly socially isolating. Further, complete cognitive rest may be associated with symptoms of its own.15,16,20 Still, some reasonable limitation of cognitive activities, at least initially, is likely beneficial.21 For patients engaged in school or academic work, often the daily schedule needs to be adjusted and accommodations made to help them return to a full academic schedule and level of activity. It is reasonable to have patients return gradually to work or school rather than attempt to immediately return to their preinjury level.
With these interventions, most patients have full resolution of their symptoms and return to preinjury levels of performance.
TREATING SOMATIC SYMPTOMS
Posttraumatic headache
Posttraumatic headache is the most common sequela of concussion.22 Surprisingly, it is more common after concussion than after moderate or severe traumatic brain injury.23 A prior history of headache, particularly migraine, is a known risk factor for development of posttraumatic headache.24
Posttraumatic headache is usually further defined by headache type using the International Classification of Headache Disorders criteria (www.ichd-3.org). Migraine or probable migraine is the most common type of posttraumatic headache; tension headache is less common.25
Analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) are often used initially by patients to treat posttraumatic headache. One study found that 70% of patients used acetaminophen or an NSAID.26
Treating early with effective therapy is the most important tenet of posttraumatic headache treatment, since 80% of those who self-treat have incomplete relief, and almost all of them are using over-the-counter products.27 Overuse of over-the-counter abortive medications can lead to medication overuse headache, also known as rebound headache, thus complicating the treatment of posttraumatic headache.26
Earlier treatment with a preventive medication can often limit the need for and overuse of over-the-counter analgesics and can minimize the occurrence of subsequent medication overuse headache. However, in pediatric populations, nonpharmacologic interventions such as rest and sleep hygiene are typically used first, then medications after 4 to 6 weeks if this is ineffective.
A number of medications have been studied for prophylactic treatment of posttraumatic headache, including topiramate, amitriptyline, and divalproex sodium,28–30 but there is little compelling evidence for use of one over the other. If posttraumatic headache is migrainous, beta-blockers, calcium-channel blockers, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibtors, and gabapentin are other prophylactic medication options under the appropriate circumstances.27,31,32 In adults, we have clinically had success with nortriptyline 20 mg or gabapentin 300 mg at night as an initial prophylactic headache medication, increasing as tolerated or until pain is controlled, though there are no high-quality data to guide this decision.
The ideal prophylactic medication depends on headache type, patient tolerance, comorbidities, allergies, and medication sensitivities. Gabapentin, amitriptyline, and nortriptyline can produce sedation, which can help those suffering from sleep disturbance.
If a provider is not comfortable prescribing these medications or doesn’t prescribe them regularly, the patient should be referred to a concussion or headache specialist more familiar with their use.
In some patients, even some athletes, headache may be related to a cervical strain injury—whiplash—that should be treated with an NSAID (or acetaminophen), perhaps with a short course of a muscle relaxant in adults, and with physical therapy.32
Some patients have chronic headache despite oral medications.26 Therefore, alternatives to oral medications and complementary therapies should be considered. Especially for protracted cases requiring more complicated headache management or injectable treatments, patients should be referred to a pain clinic, headache specialist, or concussion specialist.
Dizziness
Dizziness is also common after concussion. But what the patient means by dizziness requires a little probing. Some have paroxysms of vertigo. This typically represents a peripheral vestibular injury, usually benign paroxysmal positional vertigo. The latter can be elicited with a Hallpike maneuver and treated in the office with the Epley maneuver.33
Usually, dizziness is a subjective sense of poor coordination, gait instability, or dysequilibrium. Patients may also complain of associated nausea and motion sensitivity. This may all be secondary to a mechanism in the middle or inner ear or the brain. Patients should be encouraged to begin movement—gradually and safely—to help the vestibular system accommodate, which it will do with gradual stimulation. It usually resolves spontaneously.
Specific treatment is unfortunately limited. There is no established benefit from vestibular suppressants such as meclizine. Vestibular rehabilitation may accelerate improvement and decrease symptoms.33 Referral for a comprehensive balance assessment or to vestibular therapy (a subset of physical therapy) should be considered and is something we typically undertake in our clinic if there is no recovery from dizziness 4 to 6 weeks after the concussion.
Visual symptoms can contribute to dizziness. Convergence spasm or convergence insufficiency (both related to muscle spasm of the eye) can occur after concussion, with some studies estimating that up to 69% of patients have these symptoms.34 This can interfere with visual tracking and contribute to a feeling of dysequilibrium.34 Referral to a concussion specialist or vestibular rehabilitation physical therapist can be helpful in treating this issue if it does not resolve spontaneously.
Orthostasis and lightheadedness also contribute to dizziness and are associated with cerebrovascular autoregulation. Available data suggest that dysregulation of neurovascular coupling, cerebral vasoreactivity, and cerebral autoregulation contribute to some of the chronic symptoms of concussion, including dizziness. A gradual return to exercise may help regulate cerebral blood flow and improve this type of dizziness.35
Sleep disturbance
Sleep disturbance is common after concussion, but the form is variable: insomnia, excessive daytime somnolence, and alteration of the sleep-wake cycle are all seen and may themselves affect recovery.36
Sleep hygiene education should be the first intervention for postconcussive sleep issues. For example, the patient should be encouraged to do the following:
- Minimize “screen time” an hour before going to bed: cell phone, tablet, and computer screens emit a wavelength of light that suppresses endogenous melatonin release37,38
- Go to bed and wake up at the same time each day
- Minimize or avoid caffeine, nicotine, and alcohol
- Avoid naps.39
Melatonin is a safe and effective treatment that could be added.40 In addition, some studies suggest that melatonin may improve recovery from traumatic brain injury.41,42
Mild exercise (to below the threshold of causing or exacerbating symptoms) may also improve sleep quality.
Amitriptyline or nortriptyline may reduce headache frequency and intensity and also help treat insomnia.
Trazodone is recommended by some as a first-line agent,39 but we usually reserve it for protracted insomnia refractory to the above treatments.
Benzodiazepines should be avoided, as they reduce arousal, impair cognition, and exacerbate motor impairments.43
Emotional symptoms
Acute-onset anxiety or depression often occurs after concussion.44,45 There is abundant evidence that emotional effects of injury may be the most significant factor in recovery.46 A preinjury history of anxiety may be a prognostic factor.9 Patients with a history of anxiety or depression are more likely to develop emotional symptoms after a concussion, but emotional problems may develop in any patient after a concussion.47,48
The circumstances under which an injury is sustained may be traumatic (eg, car accident, assault), leading to an acute stress reaction or disorder and, if untreated, may result in a more chronic condition—posttraumatic stress disorder. Moreover, the injury and subsequent symptoms may have repercussions in many aspects of the patient’s life, leading to further psychologic stress (eg, loss of wages or the inability to handle normal work, school, and family responsibilities).
Referral to a therapist trained in skills-based psychotherapy (eg, cognitive-behavioral therapy, exposure-based treatment) is often helpful.
Pharmacologic treatment can be a useful adjunct. Several studies have shown that selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants may improve depression after concussion.49 The prescription of antidepressants, however, is best left to providers with experience in treating anxiety and depression.
As with sleep disorders after concussion, benzodiazepines should be avoided, as they can impair cognition.43
Cognitive problems
Cognitive problems are also common after concussion. Patients complain about everyday experiences of forgetfulness, distractibility, loss of concentration, and mental fatigue. Although patients often subjectively perceive these symptoms as quite limiting, the impairments can be difficult to demonstrate in office testing.
A program of gradual increase in mental activity, parallel to recovery of physical capacity, should be undertaken. Most patients make a gradual recovery within a few weeks.50
When cognitive symptoms cause significant school or vocational problems or become persistent, patients should be referred to a specialty clinic. As with most of the consequences of concussion, there are few established treatments. When cognitive difficulties persist, it is important to consider the complications of concussion mentioned above: headache, pain, sleep disturbance, and anxiety, all of which may cause subjective cognitive problems and are treatable.
If cognitive symptoms are prolonged despite improvement of other issues like headache and sleep disturbance, a low-dose stimulant medication such as amphetamine salts or methylphenidate may be useful for symptoms of poor attention.49 They should be only a temporary measure after concussion to carry the patient through a cognitively challenging period, unless there was a history of attention-deficit disorder before the injury. A variety of other agents, including amantadine,51 have been proposed based on limited studies; all are off-label uses. Before considering these types of interventions, referral to a specialist or a specialty program would be appropriate.
IF SYMPTOMS PERSIST
With the interventions suggested above, most patients with concussion have a resolution of symptoms and can return to preinjury levels of performance. But some have prolonged symptoms and sequelae. Approximately 10% of athletes have persistent signs and symptoms of concussion beyond 2 weeks. If concussion is not sport-related, most patients recover completely within the first 3 months, but up to 33% may have symptoms beyond that.52
Four types of patients have persistent symptoms:
Patients who sustained a high-force mechanism of injury. These patients simply need more time and accommodation.
Patients who sustained multiple concussions. These patients may also need more time and accommodation.
Patients with an underlying neurologic condition, recognized prior to injury or not, may have delayed or incomplete recovery. Even aging may be an “underlying condition” in concussion.
Patients whose symptoms from an apparently single mild concussion do not resolve despite appropriate treatments may have identifiable factors, but intractable pain (usually headache) or significant emotional disturbance or both are common. Once established and persistent, this is difficult to treat. Referral to a specialty practice is appropriate, but even in that setting effective treatment may be elusive.
PATIENT EDUCATION
Most important for patient education is reassurance. Ultimately, concussion is a self-limited phenomenon, and reinforcing this is helpful for patients. If concussion is not sport-related, most patients recover completely within 3 months.
The next important tenet in patient education is that they should rest for 3 to 5 days, then resume gradual physical and cognitive activities. If resuming activities too soon results in symptoms, then they should rest for a day and gradually resume activity. If their recovery is prolonged (ie, longer than 6 weeks), they likely need to be referred to a concussion specialist.
- Cassidy JD, Carroll LJ, Peloso PM, et al; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med 2004; (suppl):28–60.
- Shaw NA. The neurophysiology of concussion. Prog Neurobiol 2002; 67:281–344.
- Denny-Brown DE, Russell WR. Experimental concussion: (section of neurology). Proc R Soc Med 1941; 34:691–692.
- Ommaya AK, Gennarelli TA. Cerebral concussion and traumatic unconsciousness. Correlation of experimental and clinical observations of blunt head injuries. Brain 1974; 97:633–654.
- Houlburn AHS, Edin MA. Mechanics of head injuries. Lancet 1943; 242:438–441.
- Gennarelli TA, Adams JH, Graham DI. Acceleration induced head injury in the monkey. I. The model, its mechanical and physiological correlates. Acta Neuropathol Suppl 1981; 7:23–25.
- Giza CC, Hovda DA. The neurometabolic cascade of concussion. J Athl Train 2001; 36:228–235.
- Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics 2009; 123:114–123.
- Iverson GL, Silverberg ND, Mannix R, et al. Factors associated with concussion-like symptom reporting in high school athletes. JAMA Pediatr 2015; 169:1132–1140.
- Stiell IG, Wells GA, Vandemheen K. et al. The Canadian CT head rule for patients with minor head injury. Lancet 2001; 357:1391–1396.
- Haydel MJ, Preston CA, Mills TJ, Luber S, Blaudeau E, DeBlieux PMC. Indications for computed tomography in patients with minor head injury. N Engl J Med 2000; 343:100–105.
- Kuppermann N, Holmes JF, Dayan PS, et al; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically important brain injuries after head trauma: a prospective cohort study. Lancet 2009; 374:1160–1170.
- McCrory P, Meeuwisse W, Johnston K, et al. Consensus Statement on Concussion in Sport: the 3rd International Conference on Concussion in Sport held in Zurich, November 2008. Br J Sports Med 2009; 43(suppl 1):i76–i90.
- DeMatteo C, Stazyk K, Singh SK, et al; Ontario Neurotrauma Foundation. Development of a conservative protocol to return children and youth to activity following concussive injury. Clin Pediatr (Phila) 2015; 54:152–163.
- Willer B, Leddy JJ. Management of concussion and post-concussion syndrome. Curr Treat Options Neurol 2006; 8:415–426.
- DiFazio M, Silverberg ND, Kirkwood MW, Bernier R, Iverson GL. Prolonged activity restriction after concussion: are we worsening outcomes? Clin Pediatr (Phila) 2016; 55:443–451.
- Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics 2015; 135:213–223.
- Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med 2010; 20:21–27.
- McCrory P, Meeuwisse WH, Aubry M, et al. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med 2013; 47:250–258.
- Buckley TA, Munkasy BA, Clouse BP. Acute cognitive and physical rest may not improve concussion recovery time. J Head Trauma Rehabil 2016; 31:233–241.
- Brown NJ, Mannix RC, O'Brien MJ, Gostine D, Collins MW, Meehan WP 3rd. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics 2014; 133:e299–e304.
- Packard RC. Epidemiology and pathogenesis of posttraumatic headache. J Head Trauma Rehabil 1999; 14:9–21.
- Couch JR, Bearss C. Chronic daily headache in the posttrauma syndrome: relation to extent of head injury. Headache 2001; 41:559–564.
- Lucas S, Hoffman JM, Bell KR, Dikmen S. A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia 2014; 34:93–102.
- Lucas S, Hoffman JM, Bell KR, Walker W, Dikmen S. Characterization of headache after traumatic brain injury. Cephalalgia 2012; 32:600–606.
- DiTommaso C, Hoffman JM, Lucas S, Dikmen S, Temkin N, Bell KR. Medication usage patterns for headache treatment after mild traumatic brain injury. Headache 2014; 54:511–519.
- Lucas S. Characterization and management of headache after mild traumatic brain injury. In: Kobeissy FH, ed. Brain Neurotrauma: Molecular, Neuropsychological, and Rehabilitation Aspects. Boca Raton, FL: CRC Press/Taylor & Franis Group; 2015:145–154.
- Erickson JC. Treatment outcomes of chronic post-traumatic headaches after mild head trauma in US soldiers: an observational study. Headache 2011; 51:932–944.
- Tyler GS, McNeely HE, Dick ML. Treatment of post-traumatic headache with amitriptyline. Headache 1980; 20:213–216.
- Packard RC. Treatment of chronic daily posttraumatic headache with divalproex sodium. Headache 2000; 40:736–739.
- Kacperski J, Arthur T. Management of post-traumatic headaches in children and adolescents. Headache 2016; 56:36–48.
- Lenaerts ME, Couch JR, Couch JR. Posttraumatic headache. Curr Treat Options Neurol 2004; 6:507–517.
- Valovich McLeod TC, Hale TD. Vestibular and balance issues following sport-related concussion. Brain Inj 2015; 29:175–184.
- Master CL, Cheiman M, Gallaway M, et al. Vision diagnoses are common after concussion in adolescents. Clin Pediatr (Phila) 2016; 55:260–267.
- Tan CO, Meehan WP 3rd, Iverson GL, Taylor JA. Cerebrovascular regulation, exercise and mild traumatic brain injury. Neurology 2014; 83:1665–1672.
- Mahmood O, Rapport LJ, Hanks RA, Fichtenberg NL. Neuropsychological performance and sleep disturbance following traumatic brain injury. J Head Trauma Rehabil 2004; 19:378–390.
- Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Markey SP. Light suppresses melatonin secretion in humans. Science 1980; 210:1267–1269.
- Figueiro MG, Wood B, Plitnick B, Rea MS. The impact of light from computer monitors on melatonin levels in college students. Neuro Endocrinol Lett 2011; 32:158–163.
- Rao V, Rollings P. Sleep disturbances following traumatic brain injury. Curr Treat Options Neurol 2002; 4:77–87.
- Samantaray S, Das A, Thakore NP, et al. Therapeutic potential of melatonin in traumatic central nervous system injury. J Pineal Res 2009; 47:134–142.
- Ding K, Xu J, Wang H, Zhang L, Wu Y, Li T. Melatonin protects the brain from apoptosis by enhancement of autophagy after traumatic brain injury in mice. Neurochem Int 2015; 91:46–54.
- Babaee A, Eftekhar-Vaghefi SH, Asadi-Shekaari M, et al. Melatonin treatment reduces astrogliosis and apoptosis in rats with traumatic brain injury. Iran J Basic Med Sci 2015; 18:867–872.
- Arciniegas DB, Anderson CA, Topkoff J, McAllister TW. Mild traumatic brain injury: a neuropsychiatric approach to diagnosis, evaluation, and treatment. Neuropsychiatr Dis Treat 2005; 1:311–327.
- O’Donnell ML, Creamer M, Pattison P, Atkin C. Psychiatric morbidity following injury. Am J Psychiatry 2004; 161:507–514.
- Dikmen SS, Bombardier CH, Machamer JE, Fann JR, Temkin NR. Natural history of depression in traumatic brain injury. Arch Phys Med Rehabil 2004; 85:1457–1464.
- Massey JS, Meares S, Batchelor J, Bryant RA. An exploratory study of the association of acute posttraumatic stress, depression, and pain to cognitive functioning in mild traumatic brain injury. Neuropsychology 2015; 29:530–542.
- Meares S, Shores EA, Taylor AJ, et al. The prospective course of postconcussion syndrome: the role of mild traumatic brain injury. Neuropsychology 2011; 25:454–465.
- Solomon GS, Kuhn AW, Zuckerman SL. Depression as a modifying factor in sport-related concussion: a critical review of the literature. Phys Sportsmed 2016; 44:14–19.
- Neurobehavioral Guidelines Working Group; Warden DL, Gordon B, McAllister TW, et al. Guidelines for the pharmacologic treatment of neurobehavioral sequelae of traumatic brain injury. J Neurotrauma 2006; 23:1468–1501.
- Dikmen S, McLean A, Temkin N. Neuropsychological and psychosocial consequences of minor head injury. J Neurol Neurosurg Psychiatry 1986; 49:1227–1232.
- Reddy CC, Collins M, Lovell M, Kontos AP. Efficacy of amantadine treatment on symptoms and neurocognitive performance among adolescents following sports-related concussion. J Head Trauma Rehabil 2013; 28:260–265.
- Leddy JJ, Sandhu H, Sodhi V, Baker JG, Willer B. Rehabilitation of concussion and post-concussion syndrome. Sports Health 2012; 4:147–154.
- Cassidy JD, Carroll LJ, Peloso PM, et al; WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. Incidence, risk factors and prevention of mild traumatic brain injury: results of the WHO Collaborating Centre Task Force on Mild Traumatic Brain Injury. J Rehabil Med 2004; (suppl):28–60.
- Shaw NA. The neurophysiology of concussion. Prog Neurobiol 2002; 67:281–344.
- Denny-Brown DE, Russell WR. Experimental concussion: (section of neurology). Proc R Soc Med 1941; 34:691–692.
- Ommaya AK, Gennarelli TA. Cerebral concussion and traumatic unconsciousness. Correlation of experimental and clinical observations of blunt head injuries. Brain 1974; 97:633–654.
- Houlburn AHS, Edin MA. Mechanics of head injuries. Lancet 1943; 242:438–441.
- Gennarelli TA, Adams JH, Graham DI. Acceleration induced head injury in the monkey. I. The model, its mechanical and physiological correlates. Acta Neuropathol Suppl 1981; 7:23–25.
- Giza CC, Hovda DA. The neurometabolic cascade of concussion. J Athl Train 2001; 36:228–235.
- Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics 2009; 123:114–123.
- Iverson GL, Silverberg ND, Mannix R, et al. Factors associated with concussion-like symptom reporting in high school athletes. JAMA Pediatr 2015; 169:1132–1140.
- Stiell IG, Wells GA, Vandemheen K. et al. The Canadian CT head rule for patients with minor head injury. Lancet 2001; 357:1391–1396.
- Haydel MJ, Preston CA, Mills TJ, Luber S, Blaudeau E, DeBlieux PMC. Indications for computed tomography in patients with minor head injury. N Engl J Med 2000; 343:100–105.
- Kuppermann N, Holmes JF, Dayan PS, et al; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically important brain injuries after head trauma: a prospective cohort study. Lancet 2009; 374:1160–1170.
- McCrory P, Meeuwisse W, Johnston K, et al. Consensus Statement on Concussion in Sport: the 3rd International Conference on Concussion in Sport held in Zurich, November 2008. Br J Sports Med 2009; 43(suppl 1):i76–i90.
- DeMatteo C, Stazyk K, Singh SK, et al; Ontario Neurotrauma Foundation. Development of a conservative protocol to return children and youth to activity following concussive injury. Clin Pediatr (Phila) 2015; 54:152–163.
- Willer B, Leddy JJ. Management of concussion and post-concussion syndrome. Curr Treat Options Neurol 2006; 8:415–426.
- DiFazio M, Silverberg ND, Kirkwood MW, Bernier R, Iverson GL. Prolonged activity restriction after concussion: are we worsening outcomes? Clin Pediatr (Phila) 2016; 55:443–451.
- Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics 2015; 135:213–223.
- Leddy JJ, Kozlowski K, Donnelly JP, Pendergast DR, Epstein LH, Willer B. A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Clin J Sport Med 2010; 20:21–27.
- McCrory P, Meeuwisse WH, Aubry M, et al. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med 2013; 47:250–258.
- Buckley TA, Munkasy BA, Clouse BP. Acute cognitive and physical rest may not improve concussion recovery time. J Head Trauma Rehabil 2016; 31:233–241.
- Brown NJ, Mannix RC, O'Brien MJ, Gostine D, Collins MW, Meehan WP 3rd. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics 2014; 133:e299–e304.
- Packard RC. Epidemiology and pathogenesis of posttraumatic headache. J Head Trauma Rehabil 1999; 14:9–21.
- Couch JR, Bearss C. Chronic daily headache in the posttrauma syndrome: relation to extent of head injury. Headache 2001; 41:559–564.
- Lucas S, Hoffman JM, Bell KR, Dikmen S. A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia 2014; 34:93–102.
- Lucas S, Hoffman JM, Bell KR, Walker W, Dikmen S. Characterization of headache after traumatic brain injury. Cephalalgia 2012; 32:600–606.
- DiTommaso C, Hoffman JM, Lucas S, Dikmen S, Temkin N, Bell KR. Medication usage patterns for headache treatment after mild traumatic brain injury. Headache 2014; 54:511–519.
- Lucas S. Characterization and management of headache after mild traumatic brain injury. In: Kobeissy FH, ed. Brain Neurotrauma: Molecular, Neuropsychological, and Rehabilitation Aspects. Boca Raton, FL: CRC Press/Taylor & Franis Group; 2015:145–154.
- Erickson JC. Treatment outcomes of chronic post-traumatic headaches after mild head trauma in US soldiers: an observational study. Headache 2011; 51:932–944.
- Tyler GS, McNeely HE, Dick ML. Treatment of post-traumatic headache with amitriptyline. Headache 1980; 20:213–216.
- Packard RC. Treatment of chronic daily posttraumatic headache with divalproex sodium. Headache 2000; 40:736–739.
- Kacperski J, Arthur T. Management of post-traumatic headaches in children and adolescents. Headache 2016; 56:36–48.
- Lenaerts ME, Couch JR, Couch JR. Posttraumatic headache. Curr Treat Options Neurol 2004; 6:507–517.
- Valovich McLeod TC, Hale TD. Vestibular and balance issues following sport-related concussion. Brain Inj 2015; 29:175–184.
- Master CL, Cheiman M, Gallaway M, et al. Vision diagnoses are common after concussion in adolescents. Clin Pediatr (Phila) 2016; 55:260–267.
- Tan CO, Meehan WP 3rd, Iverson GL, Taylor JA. Cerebrovascular regulation, exercise and mild traumatic brain injury. Neurology 2014; 83:1665–1672.
- Mahmood O, Rapport LJ, Hanks RA, Fichtenberg NL. Neuropsychological performance and sleep disturbance following traumatic brain injury. J Head Trauma Rehabil 2004; 19:378–390.
- Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Markey SP. Light suppresses melatonin secretion in humans. Science 1980; 210:1267–1269.
- Figueiro MG, Wood B, Plitnick B, Rea MS. The impact of light from computer monitors on melatonin levels in college students. Neuro Endocrinol Lett 2011; 32:158–163.
- Rao V, Rollings P. Sleep disturbances following traumatic brain injury. Curr Treat Options Neurol 2002; 4:77–87.
- Samantaray S, Das A, Thakore NP, et al. Therapeutic potential of melatonin in traumatic central nervous system injury. J Pineal Res 2009; 47:134–142.
- Ding K, Xu J, Wang H, Zhang L, Wu Y, Li T. Melatonin protects the brain from apoptosis by enhancement of autophagy after traumatic brain injury in mice. Neurochem Int 2015; 91:46–54.
- Babaee A, Eftekhar-Vaghefi SH, Asadi-Shekaari M, et al. Melatonin treatment reduces astrogliosis and apoptosis in rats with traumatic brain injury. Iran J Basic Med Sci 2015; 18:867–872.
- Arciniegas DB, Anderson CA, Topkoff J, McAllister TW. Mild traumatic brain injury: a neuropsychiatric approach to diagnosis, evaluation, and treatment. Neuropsychiatr Dis Treat 2005; 1:311–327.
- O’Donnell ML, Creamer M, Pattison P, Atkin C. Psychiatric morbidity following injury. Am J Psychiatry 2004; 161:507–514.
- Dikmen SS, Bombardier CH, Machamer JE, Fann JR, Temkin NR. Natural history of depression in traumatic brain injury. Arch Phys Med Rehabil 2004; 85:1457–1464.
- Massey JS, Meares S, Batchelor J, Bryant RA. An exploratory study of the association of acute posttraumatic stress, depression, and pain to cognitive functioning in mild traumatic brain injury. Neuropsychology 2015; 29:530–542.
- Meares S, Shores EA, Taylor AJ, et al. The prospective course of postconcussion syndrome: the role of mild traumatic brain injury. Neuropsychology 2011; 25:454–465.
- Solomon GS, Kuhn AW, Zuckerman SL. Depression as a modifying factor in sport-related concussion: a critical review of the literature. Phys Sportsmed 2016; 44:14–19.
- Neurobehavioral Guidelines Working Group; Warden DL, Gordon B, McAllister TW, et al. Guidelines for the pharmacologic treatment of neurobehavioral sequelae of traumatic brain injury. J Neurotrauma 2006; 23:1468–1501.
- Dikmen S, McLean A, Temkin N. Neuropsychological and psychosocial consequences of minor head injury. J Neurol Neurosurg Psychiatry 1986; 49:1227–1232.
- Reddy CC, Collins M, Lovell M, Kontos AP. Efficacy of amantadine treatment on symptoms and neurocognitive performance among adolescents following sports-related concussion. J Head Trauma Rehabil 2013; 28:260–265.
- Leddy JJ, Sandhu H, Sodhi V, Baker JG, Willer B. Rehabilitation of concussion and post-concussion syndrome. Sports Health 2012; 4:147–154.
KEY POINTS
- Concussion results from a traumatic acceleration of the brain that leads to a metabolic mismatch, with an increased demand for adenosine triphosphate but decreased blood flow to the brain. This “energy crisis” results in variable signs and symptoms, most commonly headache, dizziness, sleep disturbance, cognitive problems, and emotional difficulties.
- Initial therapy involves several days of cognitive and physical rest, followed by a gradual return to physical and cognitive activities.
- There is no direct treatment for the physiology of concussion, but early treatment of symptoms and education about recovery and accommodations aids functional recovery.
Improving Veteran Engagement With Mental Health Care
The VA is intent on reducing and preventing veteran deaths by suicide. Most veteran who die by suicide, however, did not get treatment from the VHA, emphasizing the need for improved outreach to those veterans who are not part of the VA health care system.
I will begin by reviewing some reasons why veterans do not go to the VHA or to other mental health treatment centers and how we can change that. I am well aware that the health care providers at the DoD and VHA—including myself—feel overwhelmed by the influx of patients already at their doorstep. Thus, many providers are ambivalent about bringing in more patients when timely access remains a challenge. However, it is critical to engage patients in care to try to improve their lives and, hopefully, bring down the suicide rate.
Another critical issue then is hiring additional clinical providers and administrative staff. More providers are essential for timely patient care. If phones are not answered and patients cannot make appointments, they become frustrated and give up, especially if they already are ambivalent about seeking treatment.
Mental Health Service Experiences
Active-duty service members’ experience of the mental health service ranges from helpful to humiliating. Why is this? The helpful part is easy. The military has hundreds of finely trained professional mental health care providers who try their best to help the soldiers, marines, airmen, and sailors recover from the stress of combat or from providing humanitarian assistance. They use up-to-date therapeutic techniques and medication.
At the humiliating end of the spectrum, many service members are sent to behavioral health for “clearance” before they are administratively separated, ie, discharged without benefits. The separation may be for a variety of administrative discharges, such as a personality disorder; other mental health or medical disorders; or less than honorable discharges. The labels of the discharge vary in the different services, but the disappointment remains.
If the service member is enrolled in a drug and alcohol program (eg, the Army Substance Alcohol Program), the standard is total abstinence. If a service member fails to achieve abstinence, he or she may be discharged without benefits. The denial of benefits is controversial but is still the standard. I recommend a harm reduction model, eg, less drinking or drug use, which may be more achievable in many cases.
The waiting room of a military mental health or behavioral health clinic usually is occupied with service members who are facing a variety of discharges from the military (considered “losers”). Sitting in a crowded waiting room, sometimes for hours, can be humiliating.
To be clear, the clinic experience is not always humiliating. At many Wounded Warrior clinics, the environment is more welcoming. For example, at the National Intrepid Center of Excellence and other specialty clinics, the atmosphere is much more therapeutic.
Significantly, the negative feelings from the routine military clinics often translate into reluctance to go to a mental health clinic at the VHA or elsewhere. To reduce the stigma, the military has switched from using the term mental health to behavioral health, but a name change does not really change the stigma.
Ending the Stigma
To reduce the stigma, DoD has deployed many public service announcements (PSAs). These often have positive messages, such as: It is a sign of strength to accept help; Being mentally injured is like having a broken leg; I am a 3-star general, I have PTSD, and I got help—you can too. Unfortunately, these messages do not resonate with many service members: They have seen many of their friends discharged after seeking mental health services (although that may not have been the actual reason for their discharge). Hoping for a promotion may lead to avoidance of care out of fear that treatment will lead to being passed over for promotion.
Reluctance
When service members come to the VA, it is often with a defeatist attitude. “My wife said I need to come, or she will divorce me.” “I cannot concentrate in school, and I am failing classes.” “My girlfriend threw me out, and I have no place to live.” There is an initial interview with a mental health provider—often after a long waiting period. Often the veteran does not return for a follow-up.
Unquestionably, psychiatric and psychological treatments benefit service members—but the treatments also have drawbacks. Psychiatric medications, although potentially helpful often cause weight gain and sexual adverse effects. Trauma-based therapies deliberately force service members to reexperience the trauma. Reliving the traumatic experience is inherently painful. Additionally, there may be practical concerns, such as getting to the clinic, traffic, and parking.
Solutions
So how do we engage the veteran? There are several well-established practices. I am a big supporter of all veteran outreach. The veteran service organizations (VSOs) are well established but traditionally appeal to older veterans. However, VSOs are working to reach younger veterans in the context of outreach or sporting activities. Peer outreach also works well with veterans in or out of the VA system connecting with their fellow veterans. I favor engaging veterans through baseball games, kayaking, picnics, and other athletic/social activities. These are nonthreatening ways to engage the veteran and his or her family. Using animals, especially dogs and horses, also is a good way to connect.
Clinical Strategies
When I treat veterans who are ambivalent—which the younger ones usually are—I ask where they live, then when or where did they serve, and what was their military occupational specialty. In other words, I ask them about their strengths.
Besides the standard depression and PTSD symptoms, I ask about sexual health, knowing that it often is a major concern. I describe the wide range of PTSD treatments, using the “3 buckets” model to describe them. The 3 buckets are psychiatric medication, talking therapies, and everything else. The last bucket includes exercise, yoga, meditation, animal-assisted therapies, and others, such as transcranial magnetic stimulation and stellate ganglion block.
Veterans often are more comfortable with the last bucket, as it allows them more options. With this knowledge the service members have more tools, so they feel less helpless and more in charge of their health care.
Conclusion
There are many reasons why service members do not seek mental health care. Stigma is one that is often cited. Also, they often associate mental health treatment with humiliation. We have a duty to change that paradigm.
The VA is intent on reducing and preventing veteran deaths by suicide. Most veteran who die by suicide, however, did not get treatment from the VHA, emphasizing the need for improved outreach to those veterans who are not part of the VA health care system.
I will begin by reviewing some reasons why veterans do not go to the VHA or to other mental health treatment centers and how we can change that. I am well aware that the health care providers at the DoD and VHA—including myself—feel overwhelmed by the influx of patients already at their doorstep. Thus, many providers are ambivalent about bringing in more patients when timely access remains a challenge. However, it is critical to engage patients in care to try to improve their lives and, hopefully, bring down the suicide rate.
Another critical issue then is hiring additional clinical providers and administrative staff. More providers are essential for timely patient care. If phones are not answered and patients cannot make appointments, they become frustrated and give up, especially if they already are ambivalent about seeking treatment.
Mental Health Service Experiences
Active-duty service members’ experience of the mental health service ranges from helpful to humiliating. Why is this? The helpful part is easy. The military has hundreds of finely trained professional mental health care providers who try their best to help the soldiers, marines, airmen, and sailors recover from the stress of combat or from providing humanitarian assistance. They use up-to-date therapeutic techniques and medication.
At the humiliating end of the spectrum, many service members are sent to behavioral health for “clearance” before they are administratively separated, ie, discharged without benefits. The separation may be for a variety of administrative discharges, such as a personality disorder; other mental health or medical disorders; or less than honorable discharges. The labels of the discharge vary in the different services, but the disappointment remains.
If the service member is enrolled in a drug and alcohol program (eg, the Army Substance Alcohol Program), the standard is total abstinence. If a service member fails to achieve abstinence, he or she may be discharged without benefits. The denial of benefits is controversial but is still the standard. I recommend a harm reduction model, eg, less drinking or drug use, which may be more achievable in many cases.
The waiting room of a military mental health or behavioral health clinic usually is occupied with service members who are facing a variety of discharges from the military (considered “losers”). Sitting in a crowded waiting room, sometimes for hours, can be humiliating.
To be clear, the clinic experience is not always humiliating. At many Wounded Warrior clinics, the environment is more welcoming. For example, at the National Intrepid Center of Excellence and other specialty clinics, the atmosphere is much more therapeutic.
Significantly, the negative feelings from the routine military clinics often translate into reluctance to go to a mental health clinic at the VHA or elsewhere. To reduce the stigma, the military has switched from using the term mental health to behavioral health, but a name change does not really change the stigma.
Ending the Stigma
To reduce the stigma, DoD has deployed many public service announcements (PSAs). These often have positive messages, such as: It is a sign of strength to accept help; Being mentally injured is like having a broken leg; I am a 3-star general, I have PTSD, and I got help—you can too. Unfortunately, these messages do not resonate with many service members: They have seen many of their friends discharged after seeking mental health services (although that may not have been the actual reason for their discharge). Hoping for a promotion may lead to avoidance of care out of fear that treatment will lead to being passed over for promotion.
Reluctance
When service members come to the VA, it is often with a defeatist attitude. “My wife said I need to come, or she will divorce me.” “I cannot concentrate in school, and I am failing classes.” “My girlfriend threw me out, and I have no place to live.” There is an initial interview with a mental health provider—often after a long waiting period. Often the veteran does not return for a follow-up.
Unquestionably, psychiatric and psychological treatments benefit service members—but the treatments also have drawbacks. Psychiatric medications, although potentially helpful often cause weight gain and sexual adverse effects. Trauma-based therapies deliberately force service members to reexperience the trauma. Reliving the traumatic experience is inherently painful. Additionally, there may be practical concerns, such as getting to the clinic, traffic, and parking.
Solutions
So how do we engage the veteran? There are several well-established practices. I am a big supporter of all veteran outreach. The veteran service organizations (VSOs) are well established but traditionally appeal to older veterans. However, VSOs are working to reach younger veterans in the context of outreach or sporting activities. Peer outreach also works well with veterans in or out of the VA system connecting with their fellow veterans. I favor engaging veterans through baseball games, kayaking, picnics, and other athletic/social activities. These are nonthreatening ways to engage the veteran and his or her family. Using animals, especially dogs and horses, also is a good way to connect.
Clinical Strategies
When I treat veterans who are ambivalent—which the younger ones usually are—I ask where they live, then when or where did they serve, and what was their military occupational specialty. In other words, I ask them about their strengths.
Besides the standard depression and PTSD symptoms, I ask about sexual health, knowing that it often is a major concern. I describe the wide range of PTSD treatments, using the “3 buckets” model to describe them. The 3 buckets are psychiatric medication, talking therapies, and everything else. The last bucket includes exercise, yoga, meditation, animal-assisted therapies, and others, such as transcranial magnetic stimulation and stellate ganglion block.
Veterans often are more comfortable with the last bucket, as it allows them more options. With this knowledge the service members have more tools, so they feel less helpless and more in charge of their health care.
Conclusion
There are many reasons why service members do not seek mental health care. Stigma is one that is often cited. Also, they often associate mental health treatment with humiliation. We have a duty to change that paradigm.
The VA is intent on reducing and preventing veteran deaths by suicide. Most veteran who die by suicide, however, did not get treatment from the VHA, emphasizing the need for improved outreach to those veterans who are not part of the VA health care system.
I will begin by reviewing some reasons why veterans do not go to the VHA or to other mental health treatment centers and how we can change that. I am well aware that the health care providers at the DoD and VHA—including myself—feel overwhelmed by the influx of patients already at their doorstep. Thus, many providers are ambivalent about bringing in more patients when timely access remains a challenge. However, it is critical to engage patients in care to try to improve their lives and, hopefully, bring down the suicide rate.
Another critical issue then is hiring additional clinical providers and administrative staff. More providers are essential for timely patient care. If phones are not answered and patients cannot make appointments, they become frustrated and give up, especially if they already are ambivalent about seeking treatment.
Mental Health Service Experiences
Active-duty service members’ experience of the mental health service ranges from helpful to humiliating. Why is this? The helpful part is easy. The military has hundreds of finely trained professional mental health care providers who try their best to help the soldiers, marines, airmen, and sailors recover from the stress of combat or from providing humanitarian assistance. They use up-to-date therapeutic techniques and medication.
At the humiliating end of the spectrum, many service members are sent to behavioral health for “clearance” before they are administratively separated, ie, discharged without benefits. The separation may be for a variety of administrative discharges, such as a personality disorder; other mental health or medical disorders; or less than honorable discharges. The labels of the discharge vary in the different services, but the disappointment remains.
If the service member is enrolled in a drug and alcohol program (eg, the Army Substance Alcohol Program), the standard is total abstinence. If a service member fails to achieve abstinence, he or she may be discharged without benefits. The denial of benefits is controversial but is still the standard. I recommend a harm reduction model, eg, less drinking or drug use, which may be more achievable in many cases.
The waiting room of a military mental health or behavioral health clinic usually is occupied with service members who are facing a variety of discharges from the military (considered “losers”). Sitting in a crowded waiting room, sometimes for hours, can be humiliating.
To be clear, the clinic experience is not always humiliating. At many Wounded Warrior clinics, the environment is more welcoming. For example, at the National Intrepid Center of Excellence and other specialty clinics, the atmosphere is much more therapeutic.
Significantly, the negative feelings from the routine military clinics often translate into reluctance to go to a mental health clinic at the VHA or elsewhere. To reduce the stigma, the military has switched from using the term mental health to behavioral health, but a name change does not really change the stigma.
Ending the Stigma
To reduce the stigma, DoD has deployed many public service announcements (PSAs). These often have positive messages, such as: It is a sign of strength to accept help; Being mentally injured is like having a broken leg; I am a 3-star general, I have PTSD, and I got help—you can too. Unfortunately, these messages do not resonate with many service members: They have seen many of their friends discharged after seeking mental health services (although that may not have been the actual reason for their discharge). Hoping for a promotion may lead to avoidance of care out of fear that treatment will lead to being passed over for promotion.
Reluctance
When service members come to the VA, it is often with a defeatist attitude. “My wife said I need to come, or she will divorce me.” “I cannot concentrate in school, and I am failing classes.” “My girlfriend threw me out, and I have no place to live.” There is an initial interview with a mental health provider—often after a long waiting period. Often the veteran does not return for a follow-up.
Unquestionably, psychiatric and psychological treatments benefit service members—but the treatments also have drawbacks. Psychiatric medications, although potentially helpful often cause weight gain and sexual adverse effects. Trauma-based therapies deliberately force service members to reexperience the trauma. Reliving the traumatic experience is inherently painful. Additionally, there may be practical concerns, such as getting to the clinic, traffic, and parking.
Solutions
So how do we engage the veteran? There are several well-established practices. I am a big supporter of all veteran outreach. The veteran service organizations (VSOs) are well established but traditionally appeal to older veterans. However, VSOs are working to reach younger veterans in the context of outreach or sporting activities. Peer outreach also works well with veterans in or out of the VA system connecting with their fellow veterans. I favor engaging veterans through baseball games, kayaking, picnics, and other athletic/social activities. These are nonthreatening ways to engage the veteran and his or her family. Using animals, especially dogs and horses, also is a good way to connect.
Clinical Strategies
When I treat veterans who are ambivalent—which the younger ones usually are—I ask where they live, then when or where did they serve, and what was their military occupational specialty. In other words, I ask them about their strengths.
Besides the standard depression and PTSD symptoms, I ask about sexual health, knowing that it often is a major concern. I describe the wide range of PTSD treatments, using the “3 buckets” model to describe them. The 3 buckets are psychiatric medication, talking therapies, and everything else. The last bucket includes exercise, yoga, meditation, animal-assisted therapies, and others, such as transcranial magnetic stimulation and stellate ganglion block.
Veterans often are more comfortable with the last bucket, as it allows them more options. With this knowledge the service members have more tools, so they feel less helpless and more in charge of their health care.
Conclusion
There are many reasons why service members do not seek mental health care. Stigma is one that is often cited. Also, they often associate mental health treatment with humiliation. We have a duty to change that paradigm.
Understanding the bell-ringing of concussion
We well recall, back in the day, getting our “bell rung” from some form of sports-related head contact. If we could count the coach’s fingers clearly, run fast and straight, and know the plays, we could happily go back into the game. There was little additional thought given to short-term or lasting effects. I recall hearing tales from my grandfather, a boxing enthusiast, of retired punch-drunk fighters working as bouncers and greeters at sports-focused restaurants and clubs. I certainly didn’t draw any link to a few episodes of personally feeling spacey or dizzy after playing football.
But now, as parents, we are all highly tuned in to the issue of wrongly minimized “minor” head contact and concussion in our children playing sports. There is a growing research-based understanding of the mechanisms of concussion, which remains a clinical syndrome diagnosed on the basis of symptoms and sometimes subtle objective findings that occur in the appropriate environmental context. Intracranial brain impact sets the stage for locally spreading firing of neurons outside their usual pattern. This can result in a diffuse jamming of some normal electrochemical pathways of cognitive function, as well as create additional mismatch between neuronal metabolic needs and the local blood flow providing oxygen and nutrients. This disruption in autoregulation of blood flow sets the stage for enhanced brain sensitivity to any second injurious event, even a minimal one. Hence the aggressive implementation of enforced rest and recovery time for athletes and others with concussion.
It is critical to realize that the patient may not have had a loss of consciousness. Equally important is to consider the need for imaging and protection of patients who are not recovering as expected in 7 to 10 days, as well as for initial imaging of those with severe head impact or baseline neurologic disease, the aged, and those on anticoagulation.
We well recall, back in the day, getting our “bell rung” from some form of sports-related head contact. If we could count the coach’s fingers clearly, run fast and straight, and know the plays, we could happily go back into the game. There was little additional thought given to short-term or lasting effects. I recall hearing tales from my grandfather, a boxing enthusiast, of retired punch-drunk fighters working as bouncers and greeters at sports-focused restaurants and clubs. I certainly didn’t draw any link to a few episodes of personally feeling spacey or dizzy after playing football.
But now, as parents, we are all highly tuned in to the issue of wrongly minimized “minor” head contact and concussion in our children playing sports. There is a growing research-based understanding of the mechanisms of concussion, which remains a clinical syndrome diagnosed on the basis of symptoms and sometimes subtle objective findings that occur in the appropriate environmental context. Intracranial brain impact sets the stage for locally spreading firing of neurons outside their usual pattern. This can result in a diffuse jamming of some normal electrochemical pathways of cognitive function, as well as create additional mismatch between neuronal metabolic needs and the local blood flow providing oxygen and nutrients. This disruption in autoregulation of blood flow sets the stage for enhanced brain sensitivity to any second injurious event, even a minimal one. Hence the aggressive implementation of enforced rest and recovery time for athletes and others with concussion.
It is critical to realize that the patient may not have had a loss of consciousness. Equally important is to consider the need for imaging and protection of patients who are not recovering as expected in 7 to 10 days, as well as for initial imaging of those with severe head impact or baseline neurologic disease, the aged, and those on anticoagulation.
We well recall, back in the day, getting our “bell rung” from some form of sports-related head contact. If we could count the coach’s fingers clearly, run fast and straight, and know the plays, we could happily go back into the game. There was little additional thought given to short-term or lasting effects. I recall hearing tales from my grandfather, a boxing enthusiast, of retired punch-drunk fighters working as bouncers and greeters at sports-focused restaurants and clubs. I certainly didn’t draw any link to a few episodes of personally feeling spacey or dizzy after playing football.
But now, as parents, we are all highly tuned in to the issue of wrongly minimized “minor” head contact and concussion in our children playing sports. There is a growing research-based understanding of the mechanisms of concussion, which remains a clinical syndrome diagnosed on the basis of symptoms and sometimes subtle objective findings that occur in the appropriate environmental context. Intracranial brain impact sets the stage for locally spreading firing of neurons outside their usual pattern. This can result in a diffuse jamming of some normal electrochemical pathways of cognitive function, as well as create additional mismatch between neuronal metabolic needs and the local blood flow providing oxygen and nutrients. This disruption in autoregulation of blood flow sets the stage for enhanced brain sensitivity to any second injurious event, even a minimal one. Hence the aggressive implementation of enforced rest and recovery time for athletes and others with concussion.
It is critical to realize that the patient may not have had a loss of consciousness. Equally important is to consider the need for imaging and protection of patients who are not recovering as expected in 7 to 10 days, as well as for initial imaging of those with severe head impact or baseline neurologic disease, the aged, and those on anticoagulation.