Surgery

When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”

Micah Young/istockphoto.com

How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.” What factors will you be considering when you try to decide between what is likely to be several competing SARS-CoV-2 vaccines?

Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?

In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.

For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.

Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.

The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”

Micah Young/istockphoto.com

How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.” What factors will you be considering when you try to decide between what is likely to be several competing SARS-CoV-2 vaccines?

Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?

In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.

For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.

Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.

The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

When the pandemic was just emerging from its infancy and we were just beginning to think about social distancing, I was sitting around enjoying an adult beverage and some gluten free (not my choice) snacks with some friends. A retired nurse who had just celebrated her 80th birthday said, “I can’t wait until they’ve developed a vaccine.” A former electrical engineer sitting just short of 2 meters to her left responded, “Don’t save me a place near the front of the line for something that is being developed in a program called Warp Speed.”

Micah Young/istockphoto.com

How do you feel about the potential SARS-CoV-2 vaccine? Are you going to roll up your sleeve as soon as the vaccine becomes available in your community? What are you going to suggest to your patients, your children? I suspect many of you will answer, “It depends.” What factors will you be considering when you try to decide between what is likely to be several competing SARS-CoV-2 vaccines?

Will it make any difference to you which biochemical-immune-bending strategy is being used to make the vaccine? All of them will probably be the result of a clever sounding but novel technique, all of them with a track record that is measured in months and not years. Will you be swayed by how large the trials were? Or how long the follow-up lasted? How effective must the vaccine be to convince you that it is worth receiving or recommending? Do you have the tools and experience to make a decision like that? I know I don’t. And should you and I even be put in a position to make that decision?

In the past, you and I may have relied on the Centers for Disease Control and Prevention for advice. But given the somewhat murky and stormy relationship between the CDC and the president, the vaccine recommendation may be issued by the White House and not the CDC.

For those of us who were practicing medicine during the Swine Flu fiasco of 1976, the pace and the politics surrounding the development of a SARS-CoV-2 vaccine has a discomforting déjà vu quality about it. The fact that like this year 1976 was an election year that infused the development process with a sense of urgency above and beyond any of the concerns about the pandemic that never happened. Although causality was never proven, there was a surge in Guillain-Barré syndrome cases that had been linked temporally to the vaccine.

Of course, our pandemic is real, and it would be imprudent to wait a year or more to watch for long-term vaccine sequelae. However, I am more than a little concerned that fast tracking the development process may result in unfortunate consequences in the short term that could have been avoided with a more measured approach to trialing the vaccines.

The sad reality is that as a nation we tend to be impatient. We are drawn to quick fixes that come in a vial or a capsule. We are learning that simple measures like mask wearing and social distancing can make a difference in slowing the spread of the virus. It would be tragic to rush a vaccine into production that at best turns out to simply be an expensive alternative to the measures that we know work or at worst injures more of us than it saves.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

From the Department of Surgery, Washington University School of Medicine, St. Louis, MO.

Abstract

Background: Patients undergoing colorectal surgery are at high risk for postoperative venous thromboembolism (VTE). Early ambulation has been encouraged to lower rates of VTE, but evidence demonstrating its effectiveness outside of a bundle is limited.

Objective: To create a multidisciplinary ambulation protocol in an effort to reduce postoperative VTE.

Methods: A single-center, retrospective, comparative study of patients who underwent colectomy or proctectomy was conducted. Outcomes of patients operated on prior to protocol implementation were compared with a cohort after implementation. The intervention studied was the implementation of a multidisciplinary ambulation protocol. The primary endpoint was postoperative VTE.

Results: There was no difference between the pre-intervention group (n = 1762) and the postintervention group (n = 253) in terms of sex, race, origin, emergency status, operative time, and the majority of medical comorbidities (with the exception of smoking status and congestive heart failure). After the protocol was implemented, ambulation rates on postoperative days 0, 1, and 2 improved from 36.4%, 47.3%, and 50.2% to 36.8%, 74.7%, and 82.6%, respectively The VTE rate in the pre-intervention group was 2.7% versus a rate of 0.4% in the postintervention group (P = 0.02).

Conclusion: Creation of an ambulation protocol is associated with a significant reduction in VTE. Commitment from patients, families, nurses, physician extenders, and physicians is critical to the success of the program.

Keywords: VTE; pulmonary embolism; deep vein thrombosis; postoperative; quality improvement.

Postoperative venous thromboembolism (VTE) is a significant source of morbidity, mortality, and cost.^1,2 Colorectal surgery patients are at particularly high risk for VTE due to positioning during surgery, pelvic dissection, and other conditions often found in these patients, such as cancer and inflammatory bowel disease.³ A National Surgical Quality Improvement Program (NSQIP) analysis demonstrated an overall rate of VTE in colorectal surgery patients of 2.4%, although other studies have demonstrated rates up to 9%, even in those receiving appropriate chemoprophylaxis.^4-6 Many of these VTEs occur in the postdischarge setting. In a NSQIP study of colorectal surgery patients, the rate of VTE between discharge and 30 days was 0.47%.⁷ The cost burdenfor a postoperative VTE has been estimated to be more than $18,000.⁸

Studies from NSQIP have identified multiple factors associated with VTE in colorectal surgery patients, but NSQIP does not record ambulation as a standard variable.⁹ Multiple strategies have been implemented to reduce postoperative VTE. Often, these studies focus on increasing compliance with appropriate chemoprophylaxis, risk stratification, or bundling multiple strategies.^10,11 However, despite the fact that postsurgical ambulation is widely encouraged and recommended by the American Society of Colon and Rectal Surgeons clinical practice guidelines, there is little evidence demonstrating the role of ambulation alone in the reduction of VTE.^4,12 The purpose of this study was to create a multidisciplinary protocol to increase postoperative ambulation and evaluate its effect on VTE.

Methods

Setting

This study was conducted at a single academic tertiary care center.

Patients and Outcome Measures

All patients undergoing colectomy or proctectomy by surgeons in the section of colon and rectal surgery at a single institution between January 2011 and March 2017 were included. Colectomy and proctectomy were defined by CPT codes 44140, 44141, 44143, 44144, 44145, 44146, 44147, 44150, 44151, 44155, 44156, 44157, 44158, 44160, 44204, 44205, 44206, 44207, 44208, 44210, 44211, 44212, 44213, 45110, 45111, 45112, 45113, 45114, 45116, 45119, 45120, 45121, 45123, 45126, 45160, 45395, and 45397. The primary outcome of VTE within 30 days, including deep venous thrombosis (DVT) and pulmonary embolism (PE), was measured using institution-specific data from NSQIP in both the pre-intervention and postintervention setting. The occurrence of both DVT and PE in 1 patient was counted as a single event of VTE. Ambulation rate on postoperative day (POD) 0, 1, and 2 was calculated by NSQIP in the pre-intervention setting (our institution-specific NSQIP recorded ambulation data for an unrelated project) and by review of the electronic health record in the postintervention setting, as this institution-specific variable was no longer being collected. Ambulation was defined as getting out of bed and taking at least 1 step. The threshold for ambulating each day was once on POD 0 and twice on PODs 1 and 2. Patients with missing ambulation data were excluded from the analysis. Both prior to and throughout the intervention, all patients were given VTE chemoprophylaxis with either low-dose unfractionated heparin or low-molecular-weight heparin prior to induction of anesthesia, with chemoprophylaxis extending an additional 21 days after discharge (unless specifically contraindicated); sequential compression devices; and standard orders to ambulate 3 times daily from POD 0 as part of the standard Enhanced Recovery After Surgery protocol.

Analysis

Statistical analysis was performed using univariate analysis. Chi-square test and univariate logistic regression were used to determine the association between ambulation rates and VTE in the pre-intervention group. Chi-square test was also used to compare ambulation and VTE rates between the pre-intervention and postintervention groups. Plan-Do-Study-Act (PDSA) cycle fidelity (the degree to which a PDSA cycle is carried out in accordance with the guiding principles of its use) was measured by recording the ambulation rates both before and after the intervention.¹³ Statistical analysis was performed using SAS Version 9.4 (SAS Institute, Cary, NC). This study was reviewed by the Washington University School of Medicine Institutional Review Board and deemed to be quality improvement, not human subjects research, and therefore did not require formal approval.

A total of 1762 patients were identified during the pre-intervention period. The overall VTE rate in the pre-intervention group was 2.7% (n = 48), with 39 DVTs (2.2%) and 13 PEs (0.7%). Pre-intervention ambulation data were available on 590 patients. Baseline ambulation rates on PODs 0, 1, and 2 were 36.4% (213/590), 47.3% (279/590), and 50.2% (296/590), respectively. Patients who did not ambulate on POD 0 had a VTE rate of 4.3%, as compared to 0.9% in those who did ambulate (Table 1). Patients who did not ambulate twice on POD 1 had a VTE rate of 4.8%, compared to 1.1% in those who did ambulate (odds ratio [OR], 4.66; 95% confidence interval [CI], 1.34 to 16.28). Patients who did not ambulate twice on POD 2 had a VTE rate of 5.4%, compared to 0.7% in those who did. Finally, those who ambulated twice on both PODs 1 and 2 had a 0% rate of VTE, compared to 4.9% in those who did not ambulate on both PODs.

Ambulation Protocol

After baseline outcome rates had been established, a multidisciplinary team of medical assistants, nurses, nurse practitioners, and physicians worked together to identify all processes that involved postoperative ambulation. Given the significant differences in VTE rates between patients who ambulated and those that did not, we created a multidisciplinary ambulation protocol using the PDSA method.¹⁴ Multiple points of patient contact were chosen for intervention, and the ambulation protocol was implemented in June 2018 and continued for 7 months.

Patients were observed from their initial office visit with a surgeon, during the preoperative education encounter, and in the operating room and on the surgical ward until discharge. Representatives from multiple disciplines who encountered patients at various times in the process, including medical assistants, patient care technicians, nurses, nurse practitioners, physical therapists, and physicians, participated in a kick-off meeting to identify difficulties they encounter when encouraging patient ambulation. The following 4 areas were identified.

Barriers to Patient Ambulation

Patient Expectations. Patients did not appear to have a clear expectation of what their ambulation goals were postoperatively, despite the fact that each patient is given an operative pathway booklet that includes their goals for each day, including ambulation. The consensus was that patients were overwhelmed with the amount of information and, oftentimes, the severity of their diagnosis, so the information regarding ambulation was not retained. Nurses commented that patients frequently stated that they did not think their surgeon wanted them to get out of bed postoperatively.

Electronic Orders. There was confusion within the nursing staff regarding orders in the electronic health record compared to physician expectations. Orders stated patients should ambulate 3 times daily, but did not specify on which postoperative day this should start. Often, nursing verbal sign-out from the post-anesthesia care unit (PACU) would be an order for bedrest, despite no clear origin of this order. This created confusion among the nursing staff as to what the appropriate ambulation orders should be.

Nursing Workflow. The initial state of the nursing workflow was not conducive to evaluating for, or assisting with, ambulation. With no set time to assist and evaluate patients for ambulation, it turned into a task nurses needed to accomplish when they had extra time. With increasing demands of charting in the electronic health record, nurses often had to skip ambulation in order to accomplish other tasks.

Family Expectations. In addition to patient expectations, family members often had expectations that were not congruent with the planned postoperative course. Nurses stated family members would often tell them that they did not feel that their family member should be ambulating so soon after surgery. Often these family members had not attended preoperative education sessions with the patient. This was compounded by the uncertainty among the nursing staff regarding what exactly the ambulation orders were.

Interventions

Targeted interventions were created to address these 4 barriers to ambulation identified by staff.

Preoperative Education. Although all elective patients received a printed operative pathway booklet describing daily goals, including ambulation, patients still did not have a sufficient understanding of what was expected of them. The education session was modified to increase the time spent on both the expectation for and the rationale behind ambulation. That section of the education session ended with a verbal commitment and read-back of the expectations for ambulation by the patient.

Clarification of Electronic Orders. Postoperative orders within the colorectal standard pathway were changed, including specific time frames and frequency, to match the information provided in the patient education booklet. These orders were for ambulation within 4 hours of arrival to the floor, and the orders also noted that no patient should be on bedrest unless explicitly stated. From POD 1, all patients were to ambulate at least twice daily for the remainder of the hospital stay (patients were encouraged to walk 4 times daily, but we set a minimum expectation of twice daily for the order set). These orders were clarified with in-person meetings with the nursing staff and leadership from the PACU and the colorectal surgical ward.

Adjusted Nursing Workflow. Nurses were interviewed and asked to create a plan regarding how they could better incorporate ambulation into their daily workflow. Ambulation assessment was incorporated into the twice-per-shift recording of vital signs and patient safety assessment. This was recorded into the electronic health record at the same time as the patients’ vital signs. This allowed nurses to keep track of which patients would need extra assistance in ambulation and which patients were doing well on their own with the assistance of family. It also helped focus the resources of physical therapy and the single ambulation technician on the floor and to assist patients who needed more assistance.

Creation of Ambulation Encouragement Signs. The authors discovered that despite patients being told preoperatively about ambulation expectations, friends and family are not always included in these conversations. As nurses frequently cited both patients and family as reasons patients thought they should not walk, multiple signs inviting patients to take an active role in their recovery by ambulating were created and placed around the unit. The signs outlined the expectations of being out of bed and taking at least 1 step on the day of surgery and walking at least 4 times per day thereafter. In addition, we addressed frequently asked questions around issues such as walking with intravenous poles and urinary catheters. The posters were signed by all staff colorectal surgeons.

Results

Over the course of 7 months (June 2018 to December 2018), 253 postintervention patients were identified (Table 2). There was no difference between the pre-intervention group (n = 1762) and the postintervention group in terms of sex, race, origin, emergency status, operative time, and the majority of medical comorbidities (with the exception of smoking status and congestive heart failure). The postintervention group was slightly older (60 versus 57 years) and had a higher percentage of patients with an American Society of Anesthesiologists physical status score greater than 2 (66.8% versus 51.2%). The postintervention group also had higher rates of both malignancy (53.4% versus 33.3%) and inflammatory bowel disease (18.2% versus 14.4%).

The fidelity of the PDSA cycle was measured by pre-intervention and postintervention ambulation rates. Ambulation rates on POD 0, 1, and 2 improved from 36.4%, 47.3%, and 50.2% to 36.8%, 74.7%, and 82.6%, respectively (Table 3). The VTE rate decreased from 2.7% to 0.4% (P = 0.02), with 1 DVT and 0 PEs. It should be noted that the only patient who developed a VTE postintervention did not ambulate on PODs 0, 1, or 2.

Discussion

Postoperative VTE is a severe complication for postoperative colorectal surgery patients. Previous studies have demonstrated that increasing ambulation is associated with a lower rate of overall complications, and, when incorporated into a bundle, is associated with decreased rates of VTE.^11,15 However, this is the first study to our knowledge demonstrating that creation of an ambulation protocol alone is associated with a decrease in VTE.

Analysis of pre-intervention data demonstrated a strong association between ambulation and an absence of VTE. No patient who ambulated on PODs 0, 1, and 2 developed a VTE. Based on those results, we moved forward with creating the ambulation protocol. While ambulation stayed stable on POD 0, there were 60% and 65% increases on PODs 1 and 2, respectively. Nurses cited late arrival to the floor for second and third start cases as the primary difficulty in getting patients to ambulate more on POD 0.

We believe the key to the success of the ambulation protocol was its multidisciplinary nature. Certainly, the easiest way to create an ambulation protocol is to change the postoperative orders to state patients must walk 4 times per day. However, if the nursing staff is unable or unwilling to carry out these orders, the orders serve little purpose. In order to make lasting changes, all stakeholders in the process must be identified. In our case, stakeholders included surgery and nursing leadership, surgeons, nurse practitioners, nurses, medical assistants, physical therapists, patient care technicians, and patients. This is where we utilized kaizen, a core principle of Lean methodology that empowers employees at the level of the work being carried out to propose ideas for improvement.¹⁶ From the beginning of the patient experience, the health care practitioners who were carrying out each step of the process were best able to identify the problems and create solutions. In addition, stakeholders were given regular updates regarding how their efforts were increasing ambulation rates and the results at the end of the study period.

This study also demonstrates that, in a health care system increasingly focused on both quality and cost, significant improvements in quality can be made without increasing cost or resource utilization. Early in the process, it was proposed that the only way to increase the ambulation rate would be to increase the number of physical therapists, nurses, and nursing assistants. However, after identifying the root causes of the problem, the solutions had more to do with improving workflow and fixing problem areas identified by the staff.

In addition to having a positive effect on the outcome studied, collaborative projects such as this between physicians and nurses may lead to increased nursing job satisfaction. A meta-analysis of 31 studies identified nurse-physician collaboration and autonomy as 2 factors that correlate most strongly with nursing satisfaction.¹⁷ A Cochrane review also suggests that practice-based interprofessional collaboration may lead to improved health care processes and outcomes.¹⁸

This study has several limitations. Pre-intervention ambulation rates were abstracted from institution-specific NSQIP data, and missing data were excluded from analysis. Also, due to the retrospective collection of the pre-intervention data, the distance of ambulation could not be quantified. The bar for ambulation is low, as patients were only required to get out of bed and walk 1 step. However, we feel that getting out of bed and taking even 1 step is substantially better than complete bedrest. It is likely that once patients cross the threshold of taking 1 step, they are more likely to ambulate. An area of future study may be to more precisely define the relationship between the quantity of ambulation in steps and its effect on VTE. Finally, we acknowledge that while there is no direct increase in costs, implementing an ambulation protocol does take time from all who participate in the project.

Conclusion

Creation of an ambulation protocol is associated with a decrease in postoperative VTE rates in colorectal surgery patients. A multidisciplinary approach is critical to identify the underlying problems and propose effective solutions. Further studies are required to better correlate the distance of ambulation and its effect on VTE. However, this study shows that even a minimum of 1 step is associated with decreased VTE rates.

Corresponding author: Aneel Damle, MD, MBA, Colon & Rectal Surgery Associates, 3433 Broadway St. NE, Suite 115, Minneapolis, MN 55413; [email protected].

Financial disclosures: None.

From the Department of Surgery, Washington University School of Medicine, St. Louis, MO.

Abstract

Background: Patients undergoing colorectal surgery are at high risk for postoperative venous thromboembolism (VTE). Early ambulation has been encouraged to lower rates of VTE, but evidence demonstrating its effectiveness outside of a bundle is limited.

Objective: To create a multidisciplinary ambulation protocol in an effort to reduce postoperative VTE.

Methods: A single-center, retrospective, comparative study of patients who underwent colectomy or proctectomy was conducted. Outcomes of patients operated on prior to protocol implementation were compared with a cohort after implementation. The intervention studied was the implementation of a multidisciplinary ambulation protocol. The primary endpoint was postoperative VTE.

Results: There was no difference between the pre-intervention group (n = 1762) and the postintervention group (n = 253) in terms of sex, race, origin, emergency status, operative time, and the majority of medical comorbidities (with the exception of smoking status and congestive heart failure). After the protocol was implemented, ambulation rates on postoperative days 0, 1, and 2 improved from 36.4%, 47.3%, and 50.2% to 36.8%, 74.7%, and 82.6%, respectively The VTE rate in the pre-intervention group was 2.7% versus a rate of 0.4% in the postintervention group (P = 0.02).

Conclusion: Creation of an ambulation protocol is associated with a significant reduction in VTE. Commitment from patients, families, nurses, physician extenders, and physicians is critical to the success of the program.

Keywords: VTE; pulmonary embolism; deep vein thrombosis; postoperative; quality improvement.

Postoperative venous thromboembolism (VTE) is a significant source of morbidity, mortality, and cost.^1,2 Colorectal surgery patients are at particularly high risk for VTE due to positioning during surgery, pelvic dissection, and other conditions often found in these patients, such as cancer and inflammatory bowel disease.³ A National Surgical Quality Improvement Program (NSQIP) analysis demonstrated an overall rate of VTE in colorectal surgery patients of 2.4%, although other studies have demonstrated rates up to 9%, even in those receiving appropriate chemoprophylaxis.^4-6 Many of these VTEs occur in the postdischarge setting. In a NSQIP study of colorectal surgery patients, the rate of VTE between discharge and 30 days was 0.47%.⁷ The cost burdenfor a postoperative VTE has been estimated to be more than $18,000.⁸

Studies from NSQIP have identified multiple factors associated with VTE in colorectal surgery patients, but NSQIP does not record ambulation as a standard variable.⁹ Multiple strategies have been implemented to reduce postoperative VTE. Often, these studies focus on increasing compliance with appropriate chemoprophylaxis, risk stratification, or bundling multiple strategies.^10,11 However, despite the fact that postsurgical ambulation is widely encouraged and recommended by the American Society of Colon and Rectal Surgeons clinical practice guidelines, there is little evidence demonstrating the role of ambulation alone in the reduction of VTE.^4,12 The purpose of this study was to create a multidisciplinary protocol to increase postoperative ambulation and evaluate its effect on VTE.

Methods

Setting

This study was conducted at a single academic tertiary care center.

Patients and Outcome Measures

All patients undergoing colectomy or proctectomy by surgeons in the section of colon and rectal surgery at a single institution between January 2011 and March 2017 were included. Colectomy and proctectomy were defined by CPT codes 44140, 44141, 44143, 44144, 44145, 44146, 44147, 44150, 44151, 44155, 44156, 44157, 44158, 44160, 44204, 44205, 44206, 44207, 44208, 44210, 44211, 44212, 44213, 45110, 45111, 45112, 45113, 45114, 45116, 45119, 45120, 45121, 45123, 45126, 45160, 45395, and 45397. The primary outcome of VTE within 30 days, including deep venous thrombosis (DVT) and pulmonary embolism (PE), was measured using institution-specific data from NSQIP in both the pre-intervention and postintervention setting. The occurrence of both DVT and PE in 1 patient was counted as a single event of VTE. Ambulation rate on postoperative day (POD) 0, 1, and 2 was calculated by NSQIP in the pre-intervention setting (our institution-specific NSQIP recorded ambulation data for an unrelated project) and by review of the electronic health record in the postintervention setting, as this institution-specific variable was no longer being collected. Ambulation was defined as getting out of bed and taking at least 1 step. The threshold for ambulating each day was once on POD 0 and twice on PODs 1 and 2. Patients with missing ambulation data were excluded from the analysis. Both prior to and throughout the intervention, all patients were given VTE chemoprophylaxis with either low-dose unfractionated heparin or low-molecular-weight heparin prior to induction of anesthesia, with chemoprophylaxis extending an additional 21 days after discharge (unless specifically contraindicated); sequential compression devices; and standard orders to ambulate 3 times daily from POD 0 as part of the standard Enhanced Recovery After Surgery protocol.

Analysis

Statistical analysis was performed using univariate analysis. Chi-square test and univariate logistic regression were used to determine the association between ambulation rates and VTE in the pre-intervention group. Chi-square test was also used to compare ambulation and VTE rates between the pre-intervention and postintervention groups. Plan-Do-Study-Act (PDSA) cycle fidelity (the degree to which a PDSA cycle is carried out in accordance with the guiding principles of its use) was measured by recording the ambulation rates both before and after the intervention.¹³ Statistical analysis was performed using SAS Version 9.4 (SAS Institute, Cary, NC). This study was reviewed by the Washington University School of Medicine Institutional Review Board and deemed to be quality improvement, not human subjects research, and therefore did not require formal approval.

A total of 1762 patients were identified during the pre-intervention period. The overall VTE rate in the pre-intervention group was 2.7% (n = 48), with 39 DVTs (2.2%) and 13 PEs (0.7%). Pre-intervention ambulation data were available on 590 patients. Baseline ambulation rates on PODs 0, 1, and 2 were 36.4% (213/590), 47.3% (279/590), and 50.2% (296/590), respectively. Patients who did not ambulate on POD 0 had a VTE rate of 4.3%, as compared to 0.9% in those who did ambulate (Table 1). Patients who did not ambulate twice on POD 1 had a VTE rate of 4.8%, compared to 1.1% in those who did ambulate (odds ratio [OR], 4.66; 95% confidence interval [CI], 1.34 to 16.28). Patients who did not ambulate twice on POD 2 had a VTE rate of 5.4%, compared to 0.7% in those who did. Finally, those who ambulated twice on both PODs 1 and 2 had a 0% rate of VTE, compared to 4.9% in those who did not ambulate on both PODs.

Ambulation Protocol

After baseline outcome rates had been established, a multidisciplinary team of medical assistants, nurses, nurse practitioners, and physicians worked together to identify all processes that involved postoperative ambulation. Given the significant differences in VTE rates between patients who ambulated and those that did not, we created a multidisciplinary ambulation protocol using the PDSA method.¹⁴ Multiple points of patient contact were chosen for intervention, and the ambulation protocol was implemented in June 2018 and continued for 7 months.

Patients were observed from their initial office visit with a surgeon, during the preoperative education encounter, and in the operating room and on the surgical ward until discharge. Representatives from multiple disciplines who encountered patients at various times in the process, including medical assistants, patient care technicians, nurses, nurse practitioners, physical therapists, and physicians, participated in a kick-off meeting to identify difficulties they encounter when encouraging patient ambulation. The following 4 areas were identified.

Barriers to Patient Ambulation

Patient Expectations. Patients did not appear to have a clear expectation of what their ambulation goals were postoperatively, despite the fact that each patient is given an operative pathway booklet that includes their goals for each day, including ambulation. The consensus was that patients were overwhelmed with the amount of information and, oftentimes, the severity of their diagnosis, so the information regarding ambulation was not retained. Nurses commented that patients frequently stated that they did not think their surgeon wanted them to get out of bed postoperatively.

Electronic Orders. There was confusion within the nursing staff regarding orders in the electronic health record compared to physician expectations. Orders stated patients should ambulate 3 times daily, but did not specify on which postoperative day this should start. Often, nursing verbal sign-out from the post-anesthesia care unit (PACU) would be an order for bedrest, despite no clear origin of this order. This created confusion among the nursing staff as to what the appropriate ambulation orders should be.

Nursing Workflow. The initial state of the nursing workflow was not conducive to evaluating for, or assisting with, ambulation. With no set time to assist and evaluate patients for ambulation, it turned into a task nurses needed to accomplish when they had extra time. With increasing demands of charting in the electronic health record, nurses often had to skip ambulation in order to accomplish other tasks.

Family Expectations. In addition to patient expectations, family members often had expectations that were not congruent with the planned postoperative course. Nurses stated family members would often tell them that they did not feel that their family member should be ambulating so soon after surgery. Often these family members had not attended preoperative education sessions with the patient. This was compounded by the uncertainty among the nursing staff regarding what exactly the ambulation orders were.

Interventions

Targeted interventions were created to address these 4 barriers to ambulation identified by staff.

Preoperative Education. Although all elective patients received a printed operative pathway booklet describing daily goals, including ambulation, patients still did not have a sufficient understanding of what was expected of them. The education session was modified to increase the time spent on both the expectation for and the rationale behind ambulation. That section of the education session ended with a verbal commitment and read-back of the expectations for ambulation by the patient.

Clarification of Electronic Orders. Postoperative orders within the colorectal standard pathway were changed, including specific time frames and frequency, to match the information provided in the patient education booklet. These orders were for ambulation within 4 hours of arrival to the floor, and the orders also noted that no patient should be on bedrest unless explicitly stated. From POD 1, all patients were to ambulate at least twice daily for the remainder of the hospital stay (patients were encouraged to walk 4 times daily, but we set a minimum expectation of twice daily for the order set). These orders were clarified with in-person meetings with the nursing staff and leadership from the PACU and the colorectal surgical ward.

Adjusted Nursing Workflow. Nurses were interviewed and asked to create a plan regarding how they could better incorporate ambulation into their daily workflow. Ambulation assessment was incorporated into the twice-per-shift recording of vital signs and patient safety assessment. This was recorded into the electronic health record at the same time as the patients’ vital signs. This allowed nurses to keep track of which patients would need extra assistance in ambulation and which patients were doing well on their own with the assistance of family. It also helped focus the resources of physical therapy and the single ambulation technician on the floor and to assist patients who needed more assistance.

Creation of Ambulation Encouragement Signs. The authors discovered that despite patients being told preoperatively about ambulation expectations, friends and family are not always included in these conversations. As nurses frequently cited both patients and family as reasons patients thought they should not walk, multiple signs inviting patients to take an active role in their recovery by ambulating were created and placed around the unit. The signs outlined the expectations of being out of bed and taking at least 1 step on the day of surgery and walking at least 4 times per day thereafter. In addition, we addressed frequently asked questions around issues such as walking with intravenous poles and urinary catheters. The posters were signed by all staff colorectal surgeons.

Results

Over the course of 7 months (June 2018 to December 2018), 253 postintervention patients were identified (Table 2). There was no difference between the pre-intervention group (n = 1762) and the postintervention group in terms of sex, race, origin, emergency status, operative time, and the majority of medical comorbidities (with the exception of smoking status and congestive heart failure). The postintervention group was slightly older (60 versus 57 years) and had a higher percentage of patients with an American Society of Anesthesiologists physical status score greater than 2 (66.8% versus 51.2%). The postintervention group also had higher rates of both malignancy (53.4% versus 33.3%) and inflammatory bowel disease (18.2% versus 14.4%).

The fidelity of the PDSA cycle was measured by pre-intervention and postintervention ambulation rates. Ambulation rates on POD 0, 1, and 2 improved from 36.4%, 47.3%, and 50.2% to 36.8%, 74.7%, and 82.6%, respectively (Table 3). The VTE rate decreased from 2.7% to 0.4% (P = 0.02), with 1 DVT and 0 PEs. It should be noted that the only patient who developed a VTE postintervention did not ambulate on PODs 0, 1, or 2.

Discussion

Postoperative VTE is a severe complication for postoperative colorectal surgery patients. Previous studies have demonstrated that increasing ambulation is associated with a lower rate of overall complications, and, when incorporated into a bundle, is associated with decreased rates of VTE.^11,15 However, this is the first study to our knowledge demonstrating that creation of an ambulation protocol alone is associated with a decrease in VTE.

Analysis of pre-intervention data demonstrated a strong association between ambulation and an absence of VTE. No patient who ambulated on PODs 0, 1, and 2 developed a VTE. Based on those results, we moved forward with creating the ambulation protocol. While ambulation stayed stable on POD 0, there were 60% and 65% increases on PODs 1 and 2, respectively. Nurses cited late arrival to the floor for second and third start cases as the primary difficulty in getting patients to ambulate more on POD 0.

We believe the key to the success of the ambulation protocol was its multidisciplinary nature. Certainly, the easiest way to create an ambulation protocol is to change the postoperative orders to state patients must walk 4 times per day. However, if the nursing staff is unable or unwilling to carry out these orders, the orders serve little purpose. In order to make lasting changes, all stakeholders in the process must be identified. In our case, stakeholders included surgery and nursing leadership, surgeons, nurse practitioners, nurses, medical assistants, physical therapists, patient care technicians, and patients. This is where we utilized kaizen, a core principle of Lean methodology that empowers employees at the level of the work being carried out to propose ideas for improvement.¹⁶ From the beginning of the patient experience, the health care practitioners who were carrying out each step of the process were best able to identify the problems and create solutions. In addition, stakeholders were given regular updates regarding how their efforts were increasing ambulation rates and the results at the end of the study period.

This study also demonstrates that, in a health care system increasingly focused on both quality and cost, significant improvements in quality can be made without increasing cost or resource utilization. Early in the process, it was proposed that the only way to increase the ambulation rate would be to increase the number of physical therapists, nurses, and nursing assistants. However, after identifying the root causes of the problem, the solutions had more to do with improving workflow and fixing problem areas identified by the staff.

In addition to having a positive effect on the outcome studied, collaborative projects such as this between physicians and nurses may lead to increased nursing job satisfaction. A meta-analysis of 31 studies identified nurse-physician collaboration and autonomy as 2 factors that correlate most strongly with nursing satisfaction.¹⁷ A Cochrane review also suggests that practice-based interprofessional collaboration may lead to improved health care processes and outcomes.¹⁸

This study has several limitations. Pre-intervention ambulation rates were abstracted from institution-specific NSQIP data, and missing data were excluded from analysis. Also, due to the retrospective collection of the pre-intervention data, the distance of ambulation could not be quantified. The bar for ambulation is low, as patients were only required to get out of bed and walk 1 step. However, we feel that getting out of bed and taking even 1 step is substantially better than complete bedrest. It is likely that once patients cross the threshold of taking 1 step, they are more likely to ambulate. An area of future study may be to more precisely define the relationship between the quantity of ambulation in steps and its effect on VTE. Finally, we acknowledge that while there is no direct increase in costs, implementing an ambulation protocol does take time from all who participate in the project.

Conclusion

Creation of an ambulation protocol is associated with a decrease in postoperative VTE rates in colorectal surgery patients. A multidisciplinary approach is critical to identify the underlying problems and propose effective solutions. Further studies are required to better correlate the distance of ambulation and its effect on VTE. However, this study shows that even a minimum of 1 step is associated with decreased VTE rates.

Corresponding author: Aneel Damle, MD, MBA, Colon & Rectal Surgery Associates, 3433 Broadway St. NE, Suite 115, Minneapolis, MN 55413; [email protected].

Financial disclosures: None.

From the Department of Surgery, Washington University School of Medicine, St. Louis, MO.

Abstract

Background: Patients undergoing colorectal surgery are at high risk for postoperative venous thromboembolism (VTE). Early ambulation has been encouraged to lower rates of VTE, but evidence demonstrating its effectiveness outside of a bundle is limited.

Objective: To create a multidisciplinary ambulation protocol in an effort to reduce postoperative VTE.

Methods: A single-center, retrospective, comparative study of patients who underwent colectomy or proctectomy was conducted. Outcomes of patients operated on prior to protocol implementation were compared with a cohort after implementation. The intervention studied was the implementation of a multidisciplinary ambulation protocol. The primary endpoint was postoperative VTE.

Results: There was no difference between the pre-intervention group (n = 1762) and the postintervention group (n = 253) in terms of sex, race, origin, emergency status, operative time, and the majority of medical comorbidities (with the exception of smoking status and congestive heart failure). After the protocol was implemented, ambulation rates on postoperative days 0, 1, and 2 improved from 36.4%, 47.3%, and 50.2% to 36.8%, 74.7%, and 82.6%, respectively The VTE rate in the pre-intervention group was 2.7% versus a rate of 0.4% in the postintervention group (P = 0.02).

Conclusion: Creation of an ambulation protocol is associated with a significant reduction in VTE. Commitment from patients, families, nurses, physician extenders, and physicians is critical to the success of the program.

Keywords: VTE; pulmonary embolism; deep vein thrombosis; postoperative; quality improvement.

Postoperative venous thromboembolism (VTE) is a significant source of morbidity, mortality, and cost.^1,2 Colorectal surgery patients are at particularly high risk for VTE due to positioning during surgery, pelvic dissection, and other conditions often found in these patients, such as cancer and inflammatory bowel disease.³ A National Surgical Quality Improvement Program (NSQIP) analysis demonstrated an overall rate of VTE in colorectal surgery patients of 2.4%, although other studies have demonstrated rates up to 9%, even in those receiving appropriate chemoprophylaxis.^4-6 Many of these VTEs occur in the postdischarge setting. In a NSQIP study of colorectal surgery patients, the rate of VTE between discharge and 30 days was 0.47%.⁷ The cost burdenfor a postoperative VTE has been estimated to be more than $18,000.⁸

Studies from NSQIP have identified multiple factors associated with VTE in colorectal surgery patients, but NSQIP does not record ambulation as a standard variable.⁹ Multiple strategies have been implemented to reduce postoperative VTE. Often, these studies focus on increasing compliance with appropriate chemoprophylaxis, risk stratification, or bundling multiple strategies.^10,11 However, despite the fact that postsurgical ambulation is widely encouraged and recommended by the American Society of Colon and Rectal Surgeons clinical practice guidelines, there is little evidence demonstrating the role of ambulation alone in the reduction of VTE.^4,12 The purpose of this study was to create a multidisciplinary protocol to increase postoperative ambulation and evaluate its effect on VTE.

Methods

Setting

This study was conducted at a single academic tertiary care center.

Patients and Outcome Measures

All patients undergoing colectomy or proctectomy by surgeons in the section of colon and rectal surgery at a single institution between January 2011 and March 2017 were included. Colectomy and proctectomy were defined by CPT codes 44140, 44141, 44143, 44144, 44145, 44146, 44147, 44150, 44151, 44155, 44156, 44157, 44158, 44160, 44204, 44205, 44206, 44207, 44208, 44210, 44211, 44212, 44213, 45110, 45111, 45112, 45113, 45114, 45116, 45119, 45120, 45121, 45123, 45126, 45160, 45395, and 45397. The primary outcome of VTE within 30 days, including deep venous thrombosis (DVT) and pulmonary embolism (PE), was measured using institution-specific data from NSQIP in both the pre-intervention and postintervention setting. The occurrence of both DVT and PE in 1 patient was counted as a single event of VTE. Ambulation rate on postoperative day (POD) 0, 1, and 2 was calculated by NSQIP in the pre-intervention setting (our institution-specific NSQIP recorded ambulation data for an unrelated project) and by review of the electronic health record in the postintervention setting, as this institution-specific variable was no longer being collected. Ambulation was defined as getting out of bed and taking at least 1 step. The threshold for ambulating each day was once on POD 0 and twice on PODs 1 and 2. Patients with missing ambulation data were excluded from the analysis. Both prior to and throughout the intervention, all patients were given VTE chemoprophylaxis with either low-dose unfractionated heparin or low-molecular-weight heparin prior to induction of anesthesia, with chemoprophylaxis extending an additional 21 days after discharge (unless specifically contraindicated); sequential compression devices; and standard orders to ambulate 3 times daily from POD 0 as part of the standard Enhanced Recovery After Surgery protocol.

Analysis

Statistical analysis was performed using univariate analysis. Chi-square test and univariate logistic regression were used to determine the association between ambulation rates and VTE in the pre-intervention group. Chi-square test was also used to compare ambulation and VTE rates between the pre-intervention and postintervention groups. Plan-Do-Study-Act (PDSA) cycle fidelity (the degree to which a PDSA cycle is carried out in accordance with the guiding principles of its use) was measured by recording the ambulation rates both before and after the intervention.¹³ Statistical analysis was performed using SAS Version 9.4 (SAS Institute, Cary, NC). This study was reviewed by the Washington University School of Medicine Institutional Review Board and deemed to be quality improvement, not human subjects research, and therefore did not require formal approval.

A total of 1762 patients were identified during the pre-intervention period. The overall VTE rate in the pre-intervention group was 2.7% (n = 48), with 39 DVTs (2.2%) and 13 PEs (0.7%). Pre-intervention ambulation data were available on 590 patients. Baseline ambulation rates on PODs 0, 1, and 2 were 36.4% (213/590), 47.3% (279/590), and 50.2% (296/590), respectively. Patients who did not ambulate on POD 0 had a VTE rate of 4.3%, as compared to 0.9% in those who did ambulate (Table 1). Patients who did not ambulate twice on POD 1 had a VTE rate of 4.8%, compared to 1.1% in those who did ambulate (odds ratio [OR], 4.66; 95% confidence interval [CI], 1.34 to 16.28). Patients who did not ambulate twice on POD 2 had a VTE rate of 5.4%, compared to 0.7% in those who did. Finally, those who ambulated twice on both PODs 1 and 2 had a 0% rate of VTE, compared to 4.9% in those who did not ambulate on both PODs.

Ambulation Protocol

After baseline outcome rates had been established, a multidisciplinary team of medical assistants, nurses, nurse practitioners, and physicians worked together to identify all processes that involved postoperative ambulation. Given the significant differences in VTE rates between patients who ambulated and those that did not, we created a multidisciplinary ambulation protocol using the PDSA method.¹⁴ Multiple points of patient contact were chosen for intervention, and the ambulation protocol was implemented in June 2018 and continued for 7 months.

Patients were observed from their initial office visit with a surgeon, during the preoperative education encounter, and in the operating room and on the surgical ward until discharge. Representatives from multiple disciplines who encountered patients at various times in the process, including medical assistants, patient care technicians, nurses, nurse practitioners, physical therapists, and physicians, participated in a kick-off meeting to identify difficulties they encounter when encouraging patient ambulation. The following 4 areas were identified.

Barriers to Patient Ambulation

Patient Expectations. Patients did not appear to have a clear expectation of what their ambulation goals were postoperatively, despite the fact that each patient is given an operative pathway booklet that includes their goals for each day, including ambulation. The consensus was that patients were overwhelmed with the amount of information and, oftentimes, the severity of their diagnosis, so the information regarding ambulation was not retained. Nurses commented that patients frequently stated that they did not think their surgeon wanted them to get out of bed postoperatively.

Electronic Orders. There was confusion within the nursing staff regarding orders in the electronic health record compared to physician expectations. Orders stated patients should ambulate 3 times daily, but did not specify on which postoperative day this should start. Often, nursing verbal sign-out from the post-anesthesia care unit (PACU) would be an order for bedrest, despite no clear origin of this order. This created confusion among the nursing staff as to what the appropriate ambulation orders should be.

Nursing Workflow. The initial state of the nursing workflow was not conducive to evaluating for, or assisting with, ambulation. With no set time to assist and evaluate patients for ambulation, it turned into a task nurses needed to accomplish when they had extra time. With increasing demands of charting in the electronic health record, nurses often had to skip ambulation in order to accomplish other tasks.

Family Expectations. In addition to patient expectations, family members often had expectations that were not congruent with the planned postoperative course. Nurses stated family members would often tell them that they did not feel that their family member should be ambulating so soon after surgery. Often these family members had not attended preoperative education sessions with the patient. This was compounded by the uncertainty among the nursing staff regarding what exactly the ambulation orders were.

Interventions

Targeted interventions were created to address these 4 barriers to ambulation identified by staff.

Preoperative Education. Although all elective patients received a printed operative pathway booklet describing daily goals, including ambulation, patients still did not have a sufficient understanding of what was expected of them. The education session was modified to increase the time spent on both the expectation for and the rationale behind ambulation. That section of the education session ended with a verbal commitment and read-back of the expectations for ambulation by the patient.

Clarification of Electronic Orders. Postoperative orders within the colorectal standard pathway were changed, including specific time frames and frequency, to match the information provided in the patient education booklet. These orders were for ambulation within 4 hours of arrival to the floor, and the orders also noted that no patient should be on bedrest unless explicitly stated. From POD 1, all patients were to ambulate at least twice daily for the remainder of the hospital stay (patients were encouraged to walk 4 times daily, but we set a minimum expectation of twice daily for the order set). These orders were clarified with in-person meetings with the nursing staff and leadership from the PACU and the colorectal surgical ward.

Adjusted Nursing Workflow. Nurses were interviewed and asked to create a plan regarding how they could better incorporate ambulation into their daily workflow. Ambulation assessment was incorporated into the twice-per-shift recording of vital signs and patient safety assessment. This was recorded into the electronic health record at the same time as the patients’ vital signs. This allowed nurses to keep track of which patients would need extra assistance in ambulation and which patients were doing well on their own with the assistance of family. It also helped focus the resources of physical therapy and the single ambulation technician on the floor and to assist patients who needed more assistance.

Creation of Ambulation Encouragement Signs. The authors discovered that despite patients being told preoperatively about ambulation expectations, friends and family are not always included in these conversations. As nurses frequently cited both patients and family as reasons patients thought they should not walk, multiple signs inviting patients to take an active role in their recovery by ambulating were created and placed around the unit. The signs outlined the expectations of being out of bed and taking at least 1 step on the day of surgery and walking at least 4 times per day thereafter. In addition, we addressed frequently asked questions around issues such as walking with intravenous poles and urinary catheters. The posters were signed by all staff colorectal surgeons.

Results

Over the course of 7 months (June 2018 to December 2018), 253 postintervention patients were identified (Table 2). There was no difference between the pre-intervention group (n = 1762) and the postintervention group in terms of sex, race, origin, emergency status, operative time, and the majority of medical comorbidities (with the exception of smoking status and congestive heart failure). The postintervention group was slightly older (60 versus 57 years) and had a higher percentage of patients with an American Society of Anesthesiologists physical status score greater than 2 (66.8% versus 51.2%). The postintervention group also had higher rates of both malignancy (53.4% versus 33.3%) and inflammatory bowel disease (18.2% versus 14.4%).

The fidelity of the PDSA cycle was measured by pre-intervention and postintervention ambulation rates. Ambulation rates on POD 0, 1, and 2 improved from 36.4%, 47.3%, and 50.2% to 36.8%, 74.7%, and 82.6%, respectively (Table 3). The VTE rate decreased from 2.7% to 0.4% (P = 0.02), with 1 DVT and 0 PEs. It should be noted that the only patient who developed a VTE postintervention did not ambulate on PODs 0, 1, or 2.

Discussion

Postoperative VTE is a severe complication for postoperative colorectal surgery patients. Previous studies have demonstrated that increasing ambulation is associated with a lower rate of overall complications, and, when incorporated into a bundle, is associated with decreased rates of VTE.^11,15 However, this is the first study to our knowledge demonstrating that creation of an ambulation protocol alone is associated with a decrease in VTE.

Analysis of pre-intervention data demonstrated a strong association between ambulation and an absence of VTE. No patient who ambulated on PODs 0, 1, and 2 developed a VTE. Based on those results, we moved forward with creating the ambulation protocol. While ambulation stayed stable on POD 0, there were 60% and 65% increases on PODs 1 and 2, respectively. Nurses cited late arrival to the floor for second and third start cases as the primary difficulty in getting patients to ambulate more on POD 0.

We believe the key to the success of the ambulation protocol was its multidisciplinary nature. Certainly, the easiest way to create an ambulation protocol is to change the postoperative orders to state patients must walk 4 times per day. However, if the nursing staff is unable or unwilling to carry out these orders, the orders serve little purpose. In order to make lasting changes, all stakeholders in the process must be identified. In our case, stakeholders included surgery and nursing leadership, surgeons, nurse practitioners, nurses, medical assistants, physical therapists, patient care technicians, and patients. This is where we utilized kaizen, a core principle of Lean methodology that empowers employees at the level of the work being carried out to propose ideas for improvement.¹⁶ From the beginning of the patient experience, the health care practitioners who were carrying out each step of the process were best able to identify the problems and create solutions. In addition, stakeholders were given regular updates regarding how their efforts were increasing ambulation rates and the results at the end of the study period.

This study also demonstrates that, in a health care system increasingly focused on both quality and cost, significant improvements in quality can be made without increasing cost or resource utilization. Early in the process, it was proposed that the only way to increase the ambulation rate would be to increase the number of physical therapists, nurses, and nursing assistants. However, after identifying the root causes of the problem, the solutions had more to do with improving workflow and fixing problem areas identified by the staff.

In addition to having a positive effect on the outcome studied, collaborative projects such as this between physicians and nurses may lead to increased nursing job satisfaction. A meta-analysis of 31 studies identified nurse-physician collaboration and autonomy as 2 factors that correlate most strongly with nursing satisfaction.¹⁷ A Cochrane review also suggests that practice-based interprofessional collaboration may lead to improved health care processes and outcomes.¹⁸

This study has several limitations. Pre-intervention ambulation rates were abstracted from institution-specific NSQIP data, and missing data were excluded from analysis. Also, due to the retrospective collection of the pre-intervention data, the distance of ambulation could not be quantified. The bar for ambulation is low, as patients were only required to get out of bed and walk 1 step. However, we feel that getting out of bed and taking even 1 step is substantially better than complete bedrest. It is likely that once patients cross the threshold of taking 1 step, they are more likely to ambulate. An area of future study may be to more precisely define the relationship between the quantity of ambulation in steps and its effect on VTE. Finally, we acknowledge that while there is no direct increase in costs, implementing an ambulation protocol does take time from all who participate in the project.

Conclusion

Creation of an ambulation protocol is associated with a decrease in postoperative VTE rates in colorectal surgery patients. A multidisciplinary approach is critical to identify the underlying problems and propose effective solutions. Further studies are required to better correlate the distance of ambulation and its effect on VTE. However, this study shows that even a minimum of 1 step is associated with decreased VTE rates.

Corresponding author: Aneel Damle, MD, MBA, Colon & Rectal Surgery Associates, 3433 Broadway St. NE, Suite 115, Minneapolis, MN 55413; [email protected].

Financial disclosures: None.

One of the take-away messages from a review of multisystem inflammatory syndrome in children (MIS-C) is that clinicians treating this condition “need to be comfortable with uncertainty,” Melissa Hazen, MD, said at a synthesis of multiple published case series and personal experience summarized at the virtual Pediatric Hospital Medicine meeting.

She emphasized MIS-C patient care “requires flexibility,” and she advised clinicians managing these patients to open the lines of communication with the many specialists who often are required to deal with complications affecting an array of organ systems.

MIS-C might best be understood as the most serious manifestation of an immune-mediated response to COVID-19 infection that ranges from transient mild symptoms to the life-threatening multiple organ involvement that characterizes this newly recognized threat. Although “most children who encounter this pathogen only develop mild disease,” the spectrum of the disease can move in a subset of patients to a “Kawasaki-like illness” without hemodynamic instability and then to MIS-C “with highly elevated systemic inflammatory markers and multiple organ involvement,” explained Dr. Hazen, an attending physician in the rheumatology program at Boston Children’s Hospital.

A reliable profile of MIS-C is only beginning to emerge from the series of published case series, most of which have only recently reached publication, according to Dr. Hazen. In general, the description of the most common symptoms and their course has been relatively consistent.

In 186 cases of MIS-C collected in a study funded by the Centers for Disease Control and Prevention, 148 (80%) were admitted to intensive care, 90 patients (48%) received vasoactive support, 37 (20%) received mechanical ventilation, and 4 (2%) died.¹ The median age was 8 years (range, 3-13 years) in this study. The case definition was fever for at least 24 hours, laboratory evidence of inflammation, multisystem organ involvement, and evidence of COVID-19 infection. In this cohort of 186 children, 92% had gastrointestinal, 80% had cardiovascular, 76% had hematologic, and 70% had respiratory system involvement.

In a different series of 95 cases collected in New York State, 79 (80%) were admitted to intensive care, 61 (62%) received vasoactive support, 10 (10%) received mechanical ventilation, 4 (4%) received extracorporeal membrane oxygenation (ECMO), and 2 (2%) died. ² Thirty-one percent patients were aged 0-5 years, 42% were 6-12 years, and 26% were 13-20 years of age. In that series, for which the case definition was elevation of two or more inflammatory markers, virologic evidence of COVID-19 infection, 80% had gastrointestinal system involvement, and 53% had evidence of myocarditis.

In both of these series, as well as others published and unpublished, the peak in MIS-C cases has occurred about 3 to 4 weeks after peak COVID-19 activity, according to Diana Lee, MD, a pediatrician at Icahn School of Medicine at Mount Sinai, New York. This pattern, reported by others, was observed in New York State, where 230 cases of MIS-C were collected from the beginning of May until the end of June, which reflected this 3- to 4-week delay in peak incidence.

“This does seem to be a rare syndrome since this [group of] 230 cases is amongst the entire population of children in New York State. So, yes, we should be keeping this in mind in our differential, but we should not forget all the other reasons that children can have a fever,” she said.

Both Dr. Hazen and Dr. Lee cautioned that MIS-C, despite a general consistency among published studies, remains a moving target in regard to how it is being characterized. In a 2-day period in May, the CDC, the World Health Organization, and New York State all issued descriptions of MIS-C, employing compatible but slightly different terminology and diagnostic criteria. Many questions regarding optimal methods of diagnosis, treatment, and follow-up remain unanswered.

Questions regarding the risk to the cardiovascular system, one of the organs most commonly affected in MIS-C, are among the most urgent. It is not now clear how best to monitor cardiovascular involvement, how to intervene, and how to follow patients in the postinfection period, according to Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital.

“The most frequent complication we have seen is ventricular dysfunction, which occurs in about half of these patients,” he reported. “Usually it is in the mild to moderate range, but occasionally patients have an ejection fraction of less than 40%.”

Coronary abnormalities, typically in the form of dilations or small aneurysms, occur in 10%-20% of children with MIS-C, according to Dr. Friedman. Giant aneurysms have been reported.

“Some of these findings can progress including in both the acute phase and, particularly for the coronary aneurysms, in the subacute phase. We recommend echocardiograms and EKGs at diagnosis and at 1-2 weeks to recheck coronary size or sooner if there are clinical indications,” Dr. Friedman advised.

Protocols like these are constantly under review as more information becomes available. There are as yet no guidelines, and practice differs across institutions, according to the investigators summarizing this information.

None of the speakers had any relevant financial disclosures.

References

1. Feldstein LR et al. Multisystem inflammatory syndrome in U.S. children and adolescents. N Engl J Med. 2020;383:334-46.

2. Dufort EM et al. Multisystem inflammatory syndrome in children in New York State. N Engl J Med 2020;383:347-58.

One of the take-away messages from a review of multisystem inflammatory syndrome in children (MIS-C) is that clinicians treating this condition “need to be comfortable with uncertainty,” Melissa Hazen, MD, said at a synthesis of multiple published case series and personal experience summarized at the virtual Pediatric Hospital Medicine meeting.

She emphasized MIS-C patient care “requires flexibility,” and she advised clinicians managing these patients to open the lines of communication with the many specialists who often are required to deal with complications affecting an array of organ systems.

MIS-C might best be understood as the most serious manifestation of an immune-mediated response to COVID-19 infection that ranges from transient mild symptoms to the life-threatening multiple organ involvement that characterizes this newly recognized threat. Although “most children who encounter this pathogen only develop mild disease,” the spectrum of the disease can move in a subset of patients to a “Kawasaki-like illness” without hemodynamic instability and then to MIS-C “with highly elevated systemic inflammatory markers and multiple organ involvement,” explained Dr. Hazen, an attending physician in the rheumatology program at Boston Children’s Hospital.

A reliable profile of MIS-C is only beginning to emerge from the series of published case series, most of which have only recently reached publication, according to Dr. Hazen. In general, the description of the most common symptoms and their course has been relatively consistent.

In 186 cases of MIS-C collected in a study funded by the Centers for Disease Control and Prevention, 148 (80%) were admitted to intensive care, 90 patients (48%) received vasoactive support, 37 (20%) received mechanical ventilation, and 4 (2%) died.¹ The median age was 8 years (range, 3-13 years) in this study. The case definition was fever for at least 24 hours, laboratory evidence of inflammation, multisystem organ involvement, and evidence of COVID-19 infection. In this cohort of 186 children, 92% had gastrointestinal, 80% had cardiovascular, 76% had hematologic, and 70% had respiratory system involvement.

In a different series of 95 cases collected in New York State, 79 (80%) were admitted to intensive care, 61 (62%) received vasoactive support, 10 (10%) received mechanical ventilation, 4 (4%) received extracorporeal membrane oxygenation (ECMO), and 2 (2%) died. ² Thirty-one percent patients were aged 0-5 years, 42% were 6-12 years, and 26% were 13-20 years of age. In that series, for which the case definition was elevation of two or more inflammatory markers, virologic evidence of COVID-19 infection, 80% had gastrointestinal system involvement, and 53% had evidence of myocarditis.

In both of these series, as well as others published and unpublished, the peak in MIS-C cases has occurred about 3 to 4 weeks after peak COVID-19 activity, according to Diana Lee, MD, a pediatrician at Icahn School of Medicine at Mount Sinai, New York. This pattern, reported by others, was observed in New York State, where 230 cases of MIS-C were collected from the beginning of May until the end of June, which reflected this 3- to 4-week delay in peak incidence.

“This does seem to be a rare syndrome since this [group of] 230 cases is amongst the entire population of children in New York State. So, yes, we should be keeping this in mind in our differential, but we should not forget all the other reasons that children can have a fever,” she said.

Both Dr. Hazen and Dr. Lee cautioned that MIS-C, despite a general consistency among published studies, remains a moving target in regard to how it is being characterized. In a 2-day period in May, the CDC, the World Health Organization, and New York State all issued descriptions of MIS-C, employing compatible but slightly different terminology and diagnostic criteria. Many questions regarding optimal methods of diagnosis, treatment, and follow-up remain unanswered.

Questions regarding the risk to the cardiovascular system, one of the organs most commonly affected in MIS-C, are among the most urgent. It is not now clear how best to monitor cardiovascular involvement, how to intervene, and how to follow patients in the postinfection period, according to Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital.

“The most frequent complication we have seen is ventricular dysfunction, which occurs in about half of these patients,” he reported. “Usually it is in the mild to moderate range, but occasionally patients have an ejection fraction of less than 40%.”

Coronary abnormalities, typically in the form of dilations or small aneurysms, occur in 10%-20% of children with MIS-C, according to Dr. Friedman. Giant aneurysms have been reported.

“Some of these findings can progress including in both the acute phase and, particularly for the coronary aneurysms, in the subacute phase. We recommend echocardiograms and EKGs at diagnosis and at 1-2 weeks to recheck coronary size or sooner if there are clinical indications,” Dr. Friedman advised.

Protocols like these are constantly under review as more information becomes available. There are as yet no guidelines, and practice differs across institutions, according to the investigators summarizing this information.

None of the speakers had any relevant financial disclosures.

References

1. Feldstein LR et al. Multisystem inflammatory syndrome in U.S. children and adolescents. N Engl J Med. 2020;383:334-46.

2. Dufort EM et al. Multisystem inflammatory syndrome in children in New York State. N Engl J Med 2020;383:347-58.

One of the take-away messages from a review of multisystem inflammatory syndrome in children (MIS-C) is that clinicians treating this condition “need to be comfortable with uncertainty,” Melissa Hazen, MD, said at a synthesis of multiple published case series and personal experience summarized at the virtual Pediatric Hospital Medicine meeting.

She emphasized MIS-C patient care “requires flexibility,” and she advised clinicians managing these patients to open the lines of communication with the many specialists who often are required to deal with complications affecting an array of organ systems.

MIS-C might best be understood as the most serious manifestation of an immune-mediated response to COVID-19 infection that ranges from transient mild symptoms to the life-threatening multiple organ involvement that characterizes this newly recognized threat. Although “most children who encounter this pathogen only develop mild disease,” the spectrum of the disease can move in a subset of patients to a “Kawasaki-like illness” without hemodynamic instability and then to MIS-C “with highly elevated systemic inflammatory markers and multiple organ involvement,” explained Dr. Hazen, an attending physician in the rheumatology program at Boston Children’s Hospital.

A reliable profile of MIS-C is only beginning to emerge from the series of published case series, most of which have only recently reached publication, according to Dr. Hazen. In general, the description of the most common symptoms and their course has been relatively consistent.

In 186 cases of MIS-C collected in a study funded by the Centers for Disease Control and Prevention, 148 (80%) were admitted to intensive care, 90 patients (48%) received vasoactive support, 37 (20%) received mechanical ventilation, and 4 (2%) died.¹ The median age was 8 years (range, 3-13 years) in this study. The case definition was fever for at least 24 hours, laboratory evidence of inflammation, multisystem organ involvement, and evidence of COVID-19 infection. In this cohort of 186 children, 92% had gastrointestinal, 80% had cardiovascular, 76% had hematologic, and 70% had respiratory system involvement.

In a different series of 95 cases collected in New York State, 79 (80%) were admitted to intensive care, 61 (62%) received vasoactive support, 10 (10%) received mechanical ventilation, 4 (4%) received extracorporeal membrane oxygenation (ECMO), and 2 (2%) died. ² Thirty-one percent patients were aged 0-5 years, 42% were 6-12 years, and 26% were 13-20 years of age. In that series, for which the case definition was elevation of two or more inflammatory markers, virologic evidence of COVID-19 infection, 80% had gastrointestinal system involvement, and 53% had evidence of myocarditis.

In both of these series, as well as others published and unpublished, the peak in MIS-C cases has occurred about 3 to 4 weeks after peak COVID-19 activity, according to Diana Lee, MD, a pediatrician at Icahn School of Medicine at Mount Sinai, New York. This pattern, reported by others, was observed in New York State, where 230 cases of MIS-C were collected from the beginning of May until the end of June, which reflected this 3- to 4-week delay in peak incidence.

“This does seem to be a rare syndrome since this [group of] 230 cases is amongst the entire population of children in New York State. So, yes, we should be keeping this in mind in our differential, but we should not forget all the other reasons that children can have a fever,” she said.

Both Dr. Hazen and Dr. Lee cautioned that MIS-C, despite a general consistency among published studies, remains a moving target in regard to how it is being characterized. In a 2-day period in May, the CDC, the World Health Organization, and New York State all issued descriptions of MIS-C, employing compatible but slightly different terminology and diagnostic criteria. Many questions regarding optimal methods of diagnosis, treatment, and follow-up remain unanswered.

Questions regarding the risk to the cardiovascular system, one of the organs most commonly affected in MIS-C, are among the most urgent. It is not now clear how best to monitor cardiovascular involvement, how to intervene, and how to follow patients in the postinfection period, according to Kevin G. Friedman, MD, a pediatrician at Harvard Medical School, Boston, and an attending physician in the department of cardiology at Boston Children’s Hospital.

“The most frequent complication we have seen is ventricular dysfunction, which occurs in about half of these patients,” he reported. “Usually it is in the mild to moderate range, but occasionally patients have an ejection fraction of less than 40%.”

Coronary abnormalities, typically in the form of dilations or small aneurysms, occur in 10%-20% of children with MIS-C, according to Dr. Friedman. Giant aneurysms have been reported.

“Some of these findings can progress including in both the acute phase and, particularly for the coronary aneurysms, in the subacute phase. We recommend echocardiograms and EKGs at diagnosis and at 1-2 weeks to recheck coronary size or sooner if there are clinical indications,” Dr. Friedman advised.

Protocols like these are constantly under review as more information becomes available. There are as yet no guidelines, and practice differs across institutions, according to the investigators summarizing this information.

None of the speakers had any relevant financial disclosures.

References

1. Feldstein LR et al. Multisystem inflammatory syndrome in U.S. children and adolescents. N Engl J Med. 2020;383:334-46.

2. Dufort EM et al. Multisystem inflammatory syndrome in children in New York State. N Engl J Med 2020;383:347-58.

Vulvar intraepithelial neoplasia (VIN) is a distressing condition that may require painful and disfiguring treatments. It is particularly problematic because more than a quarter of patients will experience recurrence of their disease after primary therapy. In this column we will explore the risk factors for recurrence, recommendations for early detection, and options to minimize its incidence.

VIN was traditionally characterized in three stages (I, II, III). However, as it became better understood that the previously named VIN I was not, in fact, a precursor for malignancy, but rather a benign manifestation of low-risk human papillomavirus (HPV) infection, it was removed from consideration as VIN. Furthermore, our understanding of VIN grew to recognize that there were two developmental pathways to vulvar neoplasia and malignancy. The first was via high-risk HPV infection, often with tobacco exposure as an accelerating factor, and typically among younger women. This has been named “usual type VIN” (uVIN). The second arises in the background of lichen sclerosus in older women and is named “differentiated type VIN” (dVIN). This type carries with it a higher risk for progression to cancer, coexisting in approximately 80% of cases of invasive squamous cell carcinoma. In addition, the progression to cancer appears to occur more quickly for dVIN lesions (22 months compared with 41 months in uVIN).¹

While observation of VIN can be considered for young, asymptomatic women, it is not universally recommended because the risk of progression to cancer is approximately 8% (5% for uVIN and 33% for dVIN).^1,2 Both subtypes of VIN can be treated with similar interventions including surgical excision (typically a wide local excision), ablative therapies (such as CO₂ laser) or topical medical therapy such as imiquimod or 5-fluorouracil. Excisional surgery remains the mainstay of therapy for VIN because it provides clinicians with certainty regarding the possibility of occult invasive disease (false-negative biopsies), and adequacy of margin status. However, given the proximity of this disease to vital structures such as the clitoris, urethral meatus, and anal verge, as well as issues with wound healing, and difficulty with reapproximation of vulvar tissues – particularly when large or multifocal disease is present – sometimes multimodal treatments or medical therapies are preferred to spare disfigurement or sexual, bladder, or bowel dysfunction.

Excision of VIN need not be deeper than the epidermis, although including a limited degree of dermis protects against incomplete resection of occult, coexisting early invasive disease. However, wide margins should ideally be at least 10 mm. This can prove to be a challenging goal for multiple reasons. First, while there are visual stigmata of VIN, its true extent can be determined only microscopically. In addition, the disease may be multifocal. Furthermore, particularly where it encroaches upon the anus, clitoris, or urethral meatus, resection margins may be limited because of the desire to preserve function of adjacent structures. The application of 2%-5% acetic acid in the operating room prior to marking the planned borders of excision can optimize the likelihood that the incisions will encompass the microscopic extent of VIN. As it does with cervical dysplasia, acetic acid is thought to cause reversible coagulation of nuclear proteins and cytokeratins, which are more abundant in dysplastic lesions, thus appearing white to the surgeon’s eye.

However, even with the surgeon’s best attempts to excise all disease, approximately half of VIN excisions will have positive margins. Fortunately, not all of these patients will go on to develop recurrent dysplasia. In fact, less than half of women with positive margins on excision will develop recurrent VIN disease.² This incomplete incidence of recurrence may be in part due to an ablative effect of inflammation at the cut skin edges. Therefore, provided that there is no macroscopic disease remaining, close observation, rather than immediate reexcision, is recommended.

Positive excisional margins are a major risk factor for recurrence, carrying an eightfold increased risk, and also are associated with a more rapid onset of recurrence than for those with negative margins. Other predisposing risk factors for recurrence include advancing age, coexistence of dysplasia at other lower genital sites (including vaginal and cervical), immunosuppressive conditions or therapies (especially steroid use), HPV exposure, and the presence of lichen sclerosus.² Continued tobacco use is a modifiable risk factor that has been shown to be associated with an increased recurrence risk of VIN. We should take the opportunity in the postoperative and surveillance period to educate our patients regarding the importance of smoking cessation in modifying their risk for recurrent or new disease.

HPV infection may not be a modifiable risk factor, but certainly can be prevented by encouraging the adoption of HPV vaccination.

Topical steroids used to treat lichen sclerosus can improve symptoms of this vulvar dystrophy as well as decrease the incidence of recurrent dVIN and invasive vulvar cancer. Treatment should continue until the skin has normalized its appearance and texture. This may involve chronic long-term therapy.³

Recognizing that more than a quarter of patients will recur, the recommended posttreatment follow-up for VIN is at 6 months, 12 months, and then annually. It should include close inspection of the vulva with consideration of application of topical 2%-5% acetic acid (I typically apply this with a soaked gauze sponge) and vulvar colposcopy (a hand-held magnification glass works well for this purpose). Patients should be counseled regarding their high risk for recurrence, informed of typical symptoms, and encouraged to perform regular vulva self-inspection (with use of a hand mirror).

For patients at the highest risk for recurrence (older patients, patients with positive excisional margins, HPV coinfection, lichen sclerosus, tobacco use, and immunosuppression), I recommend 6 monthly follow-up surveillance for 5 years. Most (75%) of recurrences will occur with the first 43 months after diagnosis with half occurring in the first 18 months.² Patients who have had positive margins on their excisional specimen are at the highest risk for an earlier recurrence.

VIN is an insidious disease with a high recurrence rate. It is challenging to completely resect with negative margins. Patients with a history of VIN should receive close observation in the years following their excision, particularly if resection margins were positive, and clinicians should attempt to modify risk factors wherever possible, paying particularly close attention to older postmenopausal women with a history of lichen sclerosus as progression to malignancy is highest for these women.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email Dr. Rossi at [email protected].

References

1. Pathology. 2016 Jun 1;48(4)291-302.

2. Gynecol Oncol. 2018 Jan;148(1):126-31.

3. JAMA Dermatol. 2015 Oct;151(10):1061-7.

Vulvar intraepithelial neoplasia (VIN) is a distressing condition that may require painful and disfiguring treatments. It is particularly problematic because more than a quarter of patients will experience recurrence of their disease after primary therapy. In this column we will explore the risk factors for recurrence, recommendations for early detection, and options to minimize its incidence.

VIN was traditionally characterized in three stages (I, II, III). However, as it became better understood that the previously named VIN I was not, in fact, a precursor for malignancy, but rather a benign manifestation of low-risk human papillomavirus (HPV) infection, it was removed from consideration as VIN. Furthermore, our understanding of VIN grew to recognize that there were two developmental pathways to vulvar neoplasia and malignancy. The first was via high-risk HPV infection, often with tobacco exposure as an accelerating factor, and typically among younger women. This has been named “usual type VIN” (uVIN). The second arises in the background of lichen sclerosus in older women and is named “differentiated type VIN” (dVIN). This type carries with it a higher risk for progression to cancer, coexisting in approximately 80% of cases of invasive squamous cell carcinoma. In addition, the progression to cancer appears to occur more quickly for dVIN lesions (22 months compared with 41 months in uVIN).¹

While observation of VIN can be considered for young, asymptomatic women, it is not universally recommended because the risk of progression to cancer is approximately 8% (5% for uVIN and 33% for dVIN).^1,2 Both subtypes of VIN can be treated with similar interventions including surgical excision (typically a wide local excision), ablative therapies (such as CO₂ laser) or topical medical therapy such as imiquimod or 5-fluorouracil. Excisional surgery remains the mainstay of therapy for VIN because it provides clinicians with certainty regarding the possibility of occult invasive disease (false-negative biopsies), and adequacy of margin status. However, given the proximity of this disease to vital structures such as the clitoris, urethral meatus, and anal verge, as well as issues with wound healing, and difficulty with reapproximation of vulvar tissues – particularly when large or multifocal disease is present – sometimes multimodal treatments or medical therapies are preferred to spare disfigurement or sexual, bladder, or bowel dysfunction.

Excision of VIN need not be deeper than the epidermis, although including a limited degree of dermis protects against incomplete resection of occult, coexisting early invasive disease. However, wide margins should ideally be at least 10 mm. This can prove to be a challenging goal for multiple reasons. First, while there are visual stigmata of VIN, its true extent can be determined only microscopically. In addition, the disease may be multifocal. Furthermore, particularly where it encroaches upon the anus, clitoris, or urethral meatus, resection margins may be limited because of the desire to preserve function of adjacent structures. The application of 2%-5% acetic acid in the operating room prior to marking the planned borders of excision can optimize the likelihood that the incisions will encompass the microscopic extent of VIN. As it does with cervical dysplasia, acetic acid is thought to cause reversible coagulation of nuclear proteins and cytokeratins, which are more abundant in dysplastic lesions, thus appearing white to the surgeon’s eye.

However, even with the surgeon’s best attempts to excise all disease, approximately half of VIN excisions will have positive margins. Fortunately, not all of these patients will go on to develop recurrent dysplasia. In fact, less than half of women with positive margins on excision will develop recurrent VIN disease.² This incomplete incidence of recurrence may be in part due to an ablative effect of inflammation at the cut skin edges. Therefore, provided that there is no macroscopic disease remaining, close observation, rather than immediate reexcision, is recommended.

Positive excisional margins are a major risk factor for recurrence, carrying an eightfold increased risk, and also are associated with a more rapid onset of recurrence than for those with negative margins. Other predisposing risk factors for recurrence include advancing age, coexistence of dysplasia at other lower genital sites (including vaginal and cervical), immunosuppressive conditions or therapies (especially steroid use), HPV exposure, and the presence of lichen sclerosus.² Continued tobacco use is a modifiable risk factor that has been shown to be associated with an increased recurrence risk of VIN. We should take the opportunity in the postoperative and surveillance period to educate our patients regarding the importance of smoking cessation in modifying their risk for recurrent or new disease.

HPV infection may not be a modifiable risk factor, but certainly can be prevented by encouraging the adoption of HPV vaccination.

Topical steroids used to treat lichen sclerosus can improve symptoms of this vulvar dystrophy as well as decrease the incidence of recurrent dVIN and invasive vulvar cancer. Treatment should continue until the skin has normalized its appearance and texture. This may involve chronic long-term therapy.³

Recognizing that more than a quarter of patients will recur, the recommended posttreatment follow-up for VIN is at 6 months, 12 months, and then annually. It should include close inspection of the vulva with consideration of application of topical 2%-5% acetic acid (I typically apply this with a soaked gauze sponge) and vulvar colposcopy (a hand-held magnification glass works well for this purpose). Patients should be counseled regarding their high risk for recurrence, informed of typical symptoms, and encouraged to perform regular vulva self-inspection (with use of a hand mirror).

For patients at the highest risk for recurrence (older patients, patients with positive excisional margins, HPV coinfection, lichen sclerosus, tobacco use, and immunosuppression), I recommend 6 monthly follow-up surveillance for 5 years. Most (75%) of recurrences will occur with the first 43 months after diagnosis with half occurring in the first 18 months.² Patients who have had positive margins on their excisional specimen are at the highest risk for an earlier recurrence.

VIN is an insidious disease with a high recurrence rate. It is challenging to completely resect with negative margins. Patients with a history of VIN should receive close observation in the years following their excision, particularly if resection margins were positive, and clinicians should attempt to modify risk factors wherever possible, paying particularly close attention to older postmenopausal women with a history of lichen sclerosus as progression to malignancy is highest for these women.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email Dr. Rossi at [email protected].

References

1. Pathology. 2016 Jun 1;48(4)291-302.

2. Gynecol Oncol. 2018 Jan;148(1):126-31.

3. JAMA Dermatol. 2015 Oct;151(10):1061-7.

Vulvar intraepithelial neoplasia (VIN) is a distressing condition that may require painful and disfiguring treatments. It is particularly problematic because more than a quarter of patients will experience recurrence of their disease after primary therapy. In this column we will explore the risk factors for recurrence, recommendations for early detection, and options to minimize its incidence.

VIN was traditionally characterized in three stages (I, II, III). However, as it became better understood that the previously named VIN I was not, in fact, a precursor for malignancy, but rather a benign manifestation of low-risk human papillomavirus (HPV) infection, it was removed from consideration as VIN. Furthermore, our understanding of VIN grew to recognize that there were two developmental pathways to vulvar neoplasia and malignancy. The first was via high-risk HPV infection, often with tobacco exposure as an accelerating factor, and typically among younger women. This has been named “usual type VIN” (uVIN). The second arises in the background of lichen sclerosus in older women and is named “differentiated type VIN” (dVIN). This type carries with it a higher risk for progression to cancer, coexisting in approximately 80% of cases of invasive squamous cell carcinoma. In addition, the progression to cancer appears to occur more quickly for dVIN lesions (22 months compared with 41 months in uVIN).¹

While observation of VIN can be considered for young, asymptomatic women, it is not universally recommended because the risk of progression to cancer is approximately 8% (5% for uVIN and 33% for dVIN).^1,2 Both subtypes of VIN can be treated with similar interventions including surgical excision (typically a wide local excision), ablative therapies (such as CO₂ laser) or topical medical therapy such as imiquimod or 5-fluorouracil. Excisional surgery remains the mainstay of therapy for VIN because it provides clinicians with certainty regarding the possibility of occult invasive disease (false-negative biopsies), and adequacy of margin status. However, given the proximity of this disease to vital structures such as the clitoris, urethral meatus, and anal verge, as well as issues with wound healing, and difficulty with reapproximation of vulvar tissues – particularly when large or multifocal disease is present – sometimes multimodal treatments or medical therapies are preferred to spare disfigurement or sexual, bladder, or bowel dysfunction.

Excision of VIN need not be deeper than the epidermis, although including a limited degree of dermis protects against incomplete resection of occult, coexisting early invasive disease. However, wide margins should ideally be at least 10 mm. This can prove to be a challenging goal for multiple reasons. First, while there are visual stigmata of VIN, its true extent can be determined only microscopically. In addition, the disease may be multifocal. Furthermore, particularly where it encroaches upon the anus, clitoris, or urethral meatus, resection margins may be limited because of the desire to preserve function of adjacent structures. The application of 2%-5% acetic acid in the operating room prior to marking the planned borders of excision can optimize the likelihood that the incisions will encompass the microscopic extent of VIN. As it does with cervical dysplasia, acetic acid is thought to cause reversible coagulation of nuclear proteins and cytokeratins, which are more abundant in dysplastic lesions, thus appearing white to the surgeon’s eye.

However, even with the surgeon’s best attempts to excise all disease, approximately half of VIN excisions will have positive margins. Fortunately, not all of these patients will go on to develop recurrent dysplasia. In fact, less than half of women with positive margins on excision will develop recurrent VIN disease.² This incomplete incidence of recurrence may be in part due to an ablative effect of inflammation at the cut skin edges. Therefore, provided that there is no macroscopic disease remaining, close observation, rather than immediate reexcision, is recommended.

Positive excisional margins are a major risk factor for recurrence, carrying an eightfold increased risk, and also are associated with a more rapid onset of recurrence than for those with negative margins. Other predisposing risk factors for recurrence include advancing age, coexistence of dysplasia at other lower genital sites (including vaginal and cervical), immunosuppressive conditions or therapies (especially steroid use), HPV exposure, and the presence of lichen sclerosus.² Continued tobacco use is a modifiable risk factor that has been shown to be associated with an increased recurrence risk of VIN. We should take the opportunity in the postoperative and surveillance period to educate our patients regarding the importance of smoking cessation in modifying their risk for recurrent or new disease.

HPV infection may not be a modifiable risk factor, but certainly can be prevented by encouraging the adoption of HPV vaccination.

Topical steroids used to treat lichen sclerosus can improve symptoms of this vulvar dystrophy as well as decrease the incidence of recurrent dVIN and invasive vulvar cancer. Treatment should continue until the skin has normalized its appearance and texture. This may involve chronic long-term therapy.³

Recognizing that more than a quarter of patients will recur, the recommended posttreatment follow-up for VIN is at 6 months, 12 months, and then annually. It should include close inspection of the vulva with consideration of application of topical 2%-5% acetic acid (I typically apply this with a soaked gauze sponge) and vulvar colposcopy (a hand-held magnification glass works well for this purpose). Patients should be counseled regarding their high risk for recurrence, informed of typical symptoms, and encouraged to perform regular vulva self-inspection (with use of a hand mirror).

For patients at the highest risk for recurrence (older patients, patients with positive excisional margins, HPV coinfection, lichen sclerosus, tobacco use, and immunosuppression), I recommend 6 monthly follow-up surveillance for 5 years. Most (75%) of recurrences will occur with the first 43 months after diagnosis with half occurring in the first 18 months.² Patients who have had positive margins on their excisional specimen are at the highest risk for an earlier recurrence.

VIN is an insidious disease with a high recurrence rate. It is challenging to completely resect with negative margins. Patients with a history of VIN should receive close observation in the years following their excision, particularly if resection margins were positive, and clinicians should attempt to modify risk factors wherever possible, paying particularly close attention to older postmenopausal women with a history of lichen sclerosus as progression to malignancy is highest for these women.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email Dr. Rossi at [email protected].

References

1. Pathology. 2016 Jun 1;48(4)291-302.

2. Gynecol Oncol. 2018 Jan;148(1):126-31.

3. JAMA Dermatol. 2015 Oct;151(10):1061-7.

All infants born to a cohort of 31 COVID-19–positive mothers tested negative for the virus during the height of the New York surge, according to a study out of New York-Presbyterian Hospital.

South_agency/Getty Images

“It is suggested in the cumulative data that the virus does not confer additional risk to the fetus during labor or during the early postnatal period in both preterm and term infants,” concluded Jeffrey Perlman, MB ChB, and colleagues in Pediatrics.

But other experts suggest substantial gaps remain in our understanding of maternal transmission of SARS-CoV-2.

“Much more needs to be known,” Munish Gupta, MD, and colleagues from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, said in an accompanying editorial.

The prospective study is the first to describe a cohort of U.S. COVID-19–related deliveries, with the prior neonatal impact of COVID-19 “almost exclusively” reported from China, noted the authors. They included a cohort of 326 women who were tested for SARS-CoV-2 on admission to labor and delivery at New York-Presbyterian Hospital between March 22 and April 15th, 2020. Of the 31 (10%) mothers who tested positive, 15 (48%) were asymptomatic and 16 (52%) were symptomatic.

Two babies were born prematurely (one by Cesarean) and were isolated in negative pressure rooms with continuous positive airway pressure. Both were moved out of isolation after two negative test results and “have exhibited an unremarkable clinical course,” the authors reported.

The other 29 term babies were cared for in their mothers’ rooms, with breastfeeding allowed, if desired. These babies and their mothers were discharged from the hospital between 24 and 48 hours after delivery.

“Visitor restriction for mothers who were positive for COVID-19 included 14 days of no visitation from the start of symptoms,” noted the team.

They added “since the prepublication release there have been a total of 47 mothers positive for COVID-19, resulting in 47 infants; 4 have been admitted to neonatal intensive care. In addition, 32 other infants have been tested for a variety of indications within the unit. All infants test results have been negative.”

The brief report outlined the institution’s checklist for delivery preparedness in either the operating room or labor delivery room, including personal protective equipment, resuscitation, transportation to the neonatal intensive care unit, and early postresuscitation care. “Suspected or confirmed COVID-19 alone in an otherwise uncomplicated pregnancy is not an indication for the resuscitation team or the neonatal fellow,” they noted, adding delivery room preparation and management should include contact precautions. “With scrupulous attention to infectious precautions, horizontal viral transmission should be minimized,” they advised.

Dr. Perlman and associates emphasized that rapid turnaround SARSCoV-2 testing is “crucial to minimize the likelihood of a provider becoming infected and/or infecting the infant.”

Although the findings are “clearly reassuring,” Dr. Gupta and colleagues have reservations. “To what extent does this report address concerns for infection risk with a rooming-in approach to care?” they asked in their accompanying editorial. “The answer is likely some, but not much.”

Many questions remain, they said, including: “What precautions were used to minimize infection risk during the postbirth hospital course? What was the approach to skin-to-skin care and direct mother-newborn contact? Were restrictions placed on family members? Were changes made to routine interventions such as hearing screens or circumcisions? What practices were in place around environmental cleaning? Most important, how did the newborns do after discharge?”

The current uncertainty around neonatal COVID-19 infection risk has led to “disparate” variations in care recommendations, they pointed out. Whereas China’s consensus guidelines recommend a 14-day separation of COVID-19–positive mothers from their healthy infants, a practice supported by the American Academy of Pediatrics “when possible,” the Italian Society of Neonatology, the Royal College of Paediatrics and Child Health, and the Canadian Paediatric Society advise “rooming-in and breastfeeding with appropriate infection prevention measures.”

Dr. Gupta and colleagues pointed to the following as at least three “critical and time-sensitive needs for research around neonatal care and outcomes related to COVID-19”:

• Studies need to have much larger sample sizes and include diverse populations. This will allow for reliable measurement of outcomes.
• Descriptions of care practices must be in detail, especially about infection prevention; these should be presented in a way to compare the efficacy of different approaches.
• There needs to be follow-up information on outcomes of both the mother and the neonate after the birth hospitalization.

Asked to comment, Lillian Beard, MD, of George Washington University in Washington welcomed the data as “good news.”

SOURCE: Perlman J et al. Pediatrics. 2020;146(2):e20201567.

All infants born to a cohort of 31 COVID-19–positive mothers tested negative for the virus during the height of the New York surge, according to a study out of New York-Presbyterian Hospital.

South_agency/Getty Images

“It is suggested in the cumulative data that the virus does not confer additional risk to the fetus during labor or during the early postnatal period in both preterm and term infants,” concluded Jeffrey Perlman, MB ChB, and colleagues in Pediatrics.

But other experts suggest substantial gaps remain in our understanding of maternal transmission of SARS-CoV-2.

“Much more needs to be known,” Munish Gupta, MD, and colleagues from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, said in an accompanying editorial.

The prospective study is the first to describe a cohort of U.S. COVID-19–related deliveries, with the prior neonatal impact of COVID-19 “almost exclusively” reported from China, noted the authors. They included a cohort of 326 women who were tested for SARS-CoV-2 on admission to labor and delivery at New York-Presbyterian Hospital between March 22 and April 15th, 2020. Of the 31 (10%) mothers who tested positive, 15 (48%) were asymptomatic and 16 (52%) were symptomatic.

Two babies were born prematurely (one by Cesarean) and were isolated in negative pressure rooms with continuous positive airway pressure. Both were moved out of isolation after two negative test results and “have exhibited an unremarkable clinical course,” the authors reported.

The other 29 term babies were cared for in their mothers’ rooms, with breastfeeding allowed, if desired. These babies and their mothers were discharged from the hospital between 24 and 48 hours after delivery.

“Visitor restriction for mothers who were positive for COVID-19 included 14 days of no visitation from the start of symptoms,” noted the team.

They added “since the prepublication release there have been a total of 47 mothers positive for COVID-19, resulting in 47 infants; 4 have been admitted to neonatal intensive care. In addition, 32 other infants have been tested for a variety of indications within the unit. All infants test results have been negative.”

The brief report outlined the institution’s checklist for delivery preparedness in either the operating room or labor delivery room, including personal protective equipment, resuscitation, transportation to the neonatal intensive care unit, and early postresuscitation care. “Suspected or confirmed COVID-19 alone in an otherwise uncomplicated pregnancy is not an indication for the resuscitation team or the neonatal fellow,” they noted, adding delivery room preparation and management should include contact precautions. “With scrupulous attention to infectious precautions, horizontal viral transmission should be minimized,” they advised.

Dr. Perlman and associates emphasized that rapid turnaround SARSCoV-2 testing is “crucial to minimize the likelihood of a provider becoming infected and/or infecting the infant.”

Although the findings are “clearly reassuring,” Dr. Gupta and colleagues have reservations. “To what extent does this report address concerns for infection risk with a rooming-in approach to care?” they asked in their accompanying editorial. “The answer is likely some, but not much.”

Many questions remain, they said, including: “What precautions were used to minimize infection risk during the postbirth hospital course? What was the approach to skin-to-skin care and direct mother-newborn contact? Were restrictions placed on family members? Were changes made to routine interventions such as hearing screens or circumcisions? What practices were in place around environmental cleaning? Most important, how did the newborns do after discharge?”

The current uncertainty around neonatal COVID-19 infection risk has led to “disparate” variations in care recommendations, they pointed out. Whereas China’s consensus guidelines recommend a 14-day separation of COVID-19–positive mothers from their healthy infants, a practice supported by the American Academy of Pediatrics “when possible,” the Italian Society of Neonatology, the Royal College of Paediatrics and Child Health, and the Canadian Paediatric Society advise “rooming-in and breastfeeding with appropriate infection prevention measures.”

Dr. Gupta and colleagues pointed to the following as at least three “critical and time-sensitive needs for research around neonatal care and outcomes related to COVID-19”:

• Studies need to have much larger sample sizes and include diverse populations. This will allow for reliable measurement of outcomes.
• Descriptions of care practices must be in detail, especially about infection prevention; these should be presented in a way to compare the efficacy of different approaches.
• There needs to be follow-up information on outcomes of both the mother and the neonate after the birth hospitalization.

Asked to comment, Lillian Beard, MD, of George Washington University in Washington welcomed the data as “good news.”

SOURCE: Perlman J et al. Pediatrics. 2020;146(2):e20201567.

All infants born to a cohort of 31 COVID-19–positive mothers tested negative for the virus during the height of the New York surge, according to a study out of New York-Presbyterian Hospital.

South_agency/Getty Images

“It is suggested in the cumulative data that the virus does not confer additional risk to the fetus during labor or during the early postnatal period in both preterm and term infants,” concluded Jeffrey Perlman, MB ChB, and colleagues in Pediatrics.

But other experts suggest substantial gaps remain in our understanding of maternal transmission of SARS-CoV-2.

“Much more needs to be known,” Munish Gupta, MD, and colleagues from Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, said in an accompanying editorial.

The prospective study is the first to describe a cohort of U.S. COVID-19–related deliveries, with the prior neonatal impact of COVID-19 “almost exclusively” reported from China, noted the authors. They included a cohort of 326 women who were tested for SARS-CoV-2 on admission to labor and delivery at New York-Presbyterian Hospital between March 22 and April 15th, 2020. Of the 31 (10%) mothers who tested positive, 15 (48%) were asymptomatic and 16 (52%) were symptomatic.

Two babies were born prematurely (one by Cesarean) and were isolated in negative pressure rooms with continuous positive airway pressure. Both were moved out of isolation after two negative test results and “have exhibited an unremarkable clinical course,” the authors reported.

The other 29 term babies were cared for in their mothers’ rooms, with breastfeeding allowed, if desired. These babies and their mothers were discharged from the hospital between 24 and 48 hours after delivery.

“Visitor restriction for mothers who were positive for COVID-19 included 14 days of no visitation from the start of symptoms,” noted the team.

They added “since the prepublication release there have been a total of 47 mothers positive for COVID-19, resulting in 47 infants; 4 have been admitted to neonatal intensive care. In addition, 32 other infants have been tested for a variety of indications within the unit. All infants test results have been negative.”

The brief report outlined the institution’s checklist for delivery preparedness in either the operating room or labor delivery room, including personal protective equipment, resuscitation, transportation to the neonatal intensive care unit, and early postresuscitation care. “Suspected or confirmed COVID-19 alone in an otherwise uncomplicated pregnancy is not an indication for the resuscitation team or the neonatal fellow,” they noted, adding delivery room preparation and management should include contact precautions. “With scrupulous attention to infectious precautions, horizontal viral transmission should be minimized,” they advised.

Dr. Perlman and associates emphasized that rapid turnaround SARSCoV-2 testing is “crucial to minimize the likelihood of a provider becoming infected and/or infecting the infant.”

Although the findings are “clearly reassuring,” Dr. Gupta and colleagues have reservations. “To what extent does this report address concerns for infection risk with a rooming-in approach to care?” they asked in their accompanying editorial. “The answer is likely some, but not much.”

Many questions remain, they said, including: “What precautions were used to minimize infection risk during the postbirth hospital course? What was the approach to skin-to-skin care and direct mother-newborn contact? Were restrictions placed on family members? Were changes made to routine interventions such as hearing screens or circumcisions? What practices were in place around environmental cleaning? Most important, how did the newborns do after discharge?”

The current uncertainty around neonatal COVID-19 infection risk has led to “disparate” variations in care recommendations, they pointed out. Whereas China’s consensus guidelines recommend a 14-day separation of COVID-19–positive mothers from their healthy infants, a practice supported by the American Academy of Pediatrics “when possible,” the Italian Society of Neonatology, the Royal College of Paediatrics and Child Health, and the Canadian Paediatric Society advise “rooming-in and breastfeeding with appropriate infection prevention measures.”

Dr. Gupta and colleagues pointed to the following as at least three “critical and time-sensitive needs for research around neonatal care and outcomes related to COVID-19”:

• Studies need to have much larger sample sizes and include diverse populations. This will allow for reliable measurement of outcomes.
• Descriptions of care practices must be in detail, especially about infection prevention; these should be presented in a way to compare the efficacy of different approaches.
• There needs to be follow-up information on outcomes of both the mother and the neonate after the birth hospitalization.

Asked to comment, Lillian Beard, MD, of George Washington University in Washington welcomed the data as “good news.”

SOURCE: Perlman J et al. Pediatrics. 2020;146(2):e20201567.

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but the proportion of women occupying leadership roles in medicine remains low, according to an update provided at the virtual Pediatric Hospital Medicine.

In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.

“No matter how you slice it, women are underrepresented in leadership positions,” he noted.

The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.

According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.

Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.

“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.

The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.

“There is certainly no shortage of capable women,” he noted.

Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.

The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”

Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”

However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.

In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”

There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.

Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.

“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.

“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.

Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.

“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.

Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.

Dr. Chiang reported no potential conflicts of interest relevant to this study.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

[email protected]

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

[email protected]

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

[email protected]

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

[email protected]

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

[email protected]

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

[email protected]

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at [email protected].

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at [email protected].

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

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The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at [email protected].

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.