Surgery

The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.^1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.³ As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.⁴ Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.^1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.⁶

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.⁷ In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.⁸ Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.^9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.^12-15

Continue to: Know the pathology’s characteristics...

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

• Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
• Bag volume: the total volume a bag can accommodate when completely full
• Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
• Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
• Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
• Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
• Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.^16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.^1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.³ As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.⁴ Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.^1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.⁶

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.⁷ In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.⁸ Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.^9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.^12-15

Continue to: Know the pathology’s characteristics...

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

• Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
• Bag volume: the total volume a bag can accommodate when completely full
• Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
• Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
• Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
• Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
• Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.^16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.^1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.³ As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.⁴ Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.^1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.⁶

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.⁷ In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.⁸ Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.^9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.^12-15

Continue to: Know the pathology’s characteristics...

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

• Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
• Bag volume: the total volume a bag can accommodate when completely full
• Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
• Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
• Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
• Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
• Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.^16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

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.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

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.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

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.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Hysterectomies performed using an abdominal surgical approach or in women with endometriosis are more likely to carry an increased risk of bowel injury, according to recent results published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Cici R. Zhu, MD, of the department of obstetrics and gynecology at the University of Ottawa, and colleagues retrospectively studied the incidence of bowel injury in women participating in the American College of Surgeons National Surgical Quality Improvement Program who underwent hysterectomy for a benign surgical indication between 2012 and 2016.

“Although the absolute incidence is low, bowel injuries are among the most devastating complications of hysterectomy, as they can lead to a wide range of complications, including peritonitis, abscess formation, enterocutaneous fistula, sepsis, and even death,” Dr. Zhu and colleagues wrote. “Secondary bowel surgeries are often required, and associated ileostomies and colostomies can be distressing to patients. This not only severely affects quality of life, but the resultant readmissions, reoperations, and prolonged hospitalizations can impose a substantial economic toll on the health care system.”

Overall, 155,557 women were included in the study. The cohort consisted of women who were a mean age of 48 years and had a mean body mass index (BMI) of 31 kg/m². The researchers evaluated whether baseline characteristics, clinical, and surgical variables impacted the incidence of bowel injury. They analyzed data of participant age, race (White vs. non-White), BMI, comorbid conditions (smoking, diabetes, chronic obstructive pulmonary disease, hypertension, and bleeding disorder), American Society of Anesthesiologists (ASA) classification, surgical approach (abdominal, laparoscopic, or vaginal), hysterectomy type (total or subtotal), lysis of adhesions, operation time, and admission type. Indication for hysterectomy was also evaluated, which included uterine leiomyoma (32.9%), menstrual disorders (22.0%), genital prolapse (13.1%), endometriosis (6.8%) and pelvic pain (3.8%).
 

Endometriosis, abdominal approach raise risk

There were 610 cases of bowel injury observed in the study, for an overall injury rate of 0.39%. A majority of the repairs were done during surgery (82.3%), with the remainder performed within 30 days of hysterectomy. Women with endometriosis had the most frequent incidence of bowel injury (0.59%), but it also occurred in women with uterine leiomyomas (0.47%), pain (0.24%), menstrual disorders (0.20%), genital prolapse (0.18%) and other indications (0.56%).

Dr. Zhu and colleagues found risk of bowel injury was higher among women 55 years and older, compared with women aged younger than 40 years (odds ratio, 1.66; 95% confidence interval, 1.28-2.15); in non-White women, compared with White women (OR, 1.92; 95% CI, 1.62-2.28); and in women with class 3 obesity, compared with women at a normal BMI (OR, 1.81; 95 CI, 1.40-2.34). Other risk factors for bowel injury included hypertension (OR, 1.39; 95% CI, 1.17-1.64) and ASA III, IV, and V classification, compared with ASA I classification (OR, 1.92; 95% CI, 1.43-2.58).

Researchers noted there was a statistically significant difference in rates of bowel injury between hysterectomy indications (P < .001). When compared with endometriosis, there were lower odds of bowel injury among women with uterine leiomyomas (adjusted odds ratio, 0.44; 95% confidence interval, 0.33-0.59), genital prolapse (aOR, 0.41; 95% CI, 0.25-0.67), and menstrual disorder (aOR, 0.33; 95% CI, 0.23-0.48).

Surgical factors also impacted the risk for bowel injury. In hysterectomies where the abdominal approach was used, there was an over-tenfold risk of bowel injury, compared with when a vaginal approach was used (OR, 10.80; 95% CI, 7.31-15.95). Lysis of lesions carried an increased risk of bowel injury (OR, 3.11; 95% CI, 2.20-4.40), and a subtotal hysterectomy increased the risk of bowel injury, compared with when a total hysterectomy was performed (OR, 1.76; 95% CI, 1.42-2.18).

The researchers acknowledged the lack of detailed clinical information on surgical indications, severity of bowel injury, and training of the surgeons and surgical team, and potential for missing information may limit the application of the study findings.
 

Findings must be cautiously interpreted

Kate Stampler, DO, assistant program director of minimally invasive gynecologic robotic surgery at Einstein Healthcare Network in Philadelphia, said in an interview that the study by Zhu et al. is a good reminder of the patient and surgical risk factors that can occur that affect outcomes of hysterectomy.

“In my clinical practice, I have not seen a significant difference in route of hysterectomy and bowel injury, however, this must be interpreted carefully in the context of an infrequent complication and as an MIS [minimally invasive surgery]-trained surgeon performing various complex cases,” she said. Other reports in the literature have not identified a difference in the rate of bowel injury based on surgical approach, but the study by Zhu et al. is “unique to the literature in its large sample size,” she explained.

“I would encourage less experienced surgeons to operate with a higher-volume assistant surgeon if the end result means being able to perform an MIS approach, or appropriately offer referral if feasible to another surgeon for best practices. A thorough informed consent of the available route of hysterectomy is integral to good surgical care and allows for shared decision making for the patient,” Dr. Stampler said. “Additionally, participation in a large quality reporting system such as ACS National Surgical Quality Improvement Program database should be considered broadly and we should strive for overall high-value care.”

Regarding endometriosis being a risk factor for bowel injury during hysterectomy, Dr. Stampler noted that severe endometriosis poses a significant challenge for gynecologic surgeons. “Loss of anatomic planes due to dense adhesions and fibrosis, in addition to deep infiltrating lesions, can add significant time, complexity, and risk to the procedure. This can be compounded in a scenario with less experienced surgeons and unplanned disease at the time of surgery.”

Dr. Stampler also applauded the paper for highlighting the differences in White and non-White patient outcomes for hysterectomy, and emphasized that it is not new information. “Their call to continue to address the social determinants of health in an effort to minimize risk and maximize safety for our patients of color is of critical importance now more than ever. While the hypothesis for this study was not meant to address this challenge specifically, the data should serve as a striking reminder that while several factors may be playing a role in surgical complications, ongoing systemic racism is a component that needs dedicated time and attention.”

Dr. Zhu and three coauthors reported no relevant financial disclosures. One coauthor received support from the University of Ottawa Clinical Research Chair in Reproductive Population Health and Health Services, the Canadian Institutes for Health Research, and Physicians’ Services Incorporated Foundation to conduct this research. Two other coauthors reported financial relationships with various pharmaceutical and medical technology companies. Dr. Stampler reported no relevant conflicts of interest.

SOURCE: Zhu CR et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004007.

Hysterectomies performed using an abdominal surgical approach or in women with endometriosis are more likely to carry an increased risk of bowel injury, according to recent results published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Cici R. Zhu, MD, of the department of obstetrics and gynecology at the University of Ottawa, and colleagues retrospectively studied the incidence of bowel injury in women participating in the American College of Surgeons National Surgical Quality Improvement Program who underwent hysterectomy for a benign surgical indication between 2012 and 2016.

“Although the absolute incidence is low, bowel injuries are among the most devastating complications of hysterectomy, as they can lead to a wide range of complications, including peritonitis, abscess formation, enterocutaneous fistula, sepsis, and even death,” Dr. Zhu and colleagues wrote. “Secondary bowel surgeries are often required, and associated ileostomies and colostomies can be distressing to patients. This not only severely affects quality of life, but the resultant readmissions, reoperations, and prolonged hospitalizations can impose a substantial economic toll on the health care system.”

Overall, 155,557 women were included in the study. The cohort consisted of women who were a mean age of 48 years and had a mean body mass index (BMI) of 31 kg/m². The researchers evaluated whether baseline characteristics, clinical, and surgical variables impacted the incidence of bowel injury. They analyzed data of participant age, race (White vs. non-White), BMI, comorbid conditions (smoking, diabetes, chronic obstructive pulmonary disease, hypertension, and bleeding disorder), American Society of Anesthesiologists (ASA) classification, surgical approach (abdominal, laparoscopic, or vaginal), hysterectomy type (total or subtotal), lysis of adhesions, operation time, and admission type. Indication for hysterectomy was also evaluated, which included uterine leiomyoma (32.9%), menstrual disorders (22.0%), genital prolapse (13.1%), endometriosis (6.8%) and pelvic pain (3.8%).
 

Endometriosis, abdominal approach raise risk

There were 610 cases of bowel injury observed in the study, for an overall injury rate of 0.39%. A majority of the repairs were done during surgery (82.3%), with the remainder performed within 30 days of hysterectomy. Women with endometriosis had the most frequent incidence of bowel injury (0.59%), but it also occurred in women with uterine leiomyomas (0.47%), pain (0.24%), menstrual disorders (0.20%), genital prolapse (0.18%) and other indications (0.56%).

Dr. Zhu and colleagues found risk of bowel injury was higher among women 55 years and older, compared with women aged younger than 40 years (odds ratio, 1.66; 95% confidence interval, 1.28-2.15); in non-White women, compared with White women (OR, 1.92; 95% CI, 1.62-2.28); and in women with class 3 obesity, compared with women at a normal BMI (OR, 1.81; 95 CI, 1.40-2.34). Other risk factors for bowel injury included hypertension (OR, 1.39; 95% CI, 1.17-1.64) and ASA III, IV, and V classification, compared with ASA I classification (OR, 1.92; 95% CI, 1.43-2.58).

Researchers noted there was a statistically significant difference in rates of bowel injury between hysterectomy indications (P < .001). When compared with endometriosis, there were lower odds of bowel injury among women with uterine leiomyomas (adjusted odds ratio, 0.44; 95% confidence interval, 0.33-0.59), genital prolapse (aOR, 0.41; 95% CI, 0.25-0.67), and menstrual disorder (aOR, 0.33; 95% CI, 0.23-0.48).

Surgical factors also impacted the risk for bowel injury. In hysterectomies where the abdominal approach was used, there was an over-tenfold risk of bowel injury, compared with when a vaginal approach was used (OR, 10.80; 95% CI, 7.31-15.95). Lysis of lesions carried an increased risk of bowel injury (OR, 3.11; 95% CI, 2.20-4.40), and a subtotal hysterectomy increased the risk of bowel injury, compared with when a total hysterectomy was performed (OR, 1.76; 95% CI, 1.42-2.18).

The researchers acknowledged the lack of detailed clinical information on surgical indications, severity of bowel injury, and training of the surgeons and surgical team, and potential for missing information may limit the application of the study findings.
 

Findings must be cautiously interpreted

Kate Stampler, DO, assistant program director of minimally invasive gynecologic robotic surgery at Einstein Healthcare Network in Philadelphia, said in an interview that the study by Zhu et al. is a good reminder of the patient and surgical risk factors that can occur that affect outcomes of hysterectomy.

“In my clinical practice, I have not seen a significant difference in route of hysterectomy and bowel injury, however, this must be interpreted carefully in the context of an infrequent complication and as an MIS [minimally invasive surgery]-trained surgeon performing various complex cases,” she said. Other reports in the literature have not identified a difference in the rate of bowel injury based on surgical approach, but the study by Zhu et al. is “unique to the literature in its large sample size,” she explained.

“I would encourage less experienced surgeons to operate with a higher-volume assistant surgeon if the end result means being able to perform an MIS approach, or appropriately offer referral if feasible to another surgeon for best practices. A thorough informed consent of the available route of hysterectomy is integral to good surgical care and allows for shared decision making for the patient,” Dr. Stampler said. “Additionally, participation in a large quality reporting system such as ACS National Surgical Quality Improvement Program database should be considered broadly and we should strive for overall high-value care.”

Regarding endometriosis being a risk factor for bowel injury during hysterectomy, Dr. Stampler noted that severe endometriosis poses a significant challenge for gynecologic surgeons. “Loss of anatomic planes due to dense adhesions and fibrosis, in addition to deep infiltrating lesions, can add significant time, complexity, and risk to the procedure. This can be compounded in a scenario with less experienced surgeons and unplanned disease at the time of surgery.”

Dr. Stampler also applauded the paper for highlighting the differences in White and non-White patient outcomes for hysterectomy, and emphasized that it is not new information. “Their call to continue to address the social determinants of health in an effort to minimize risk and maximize safety for our patients of color is of critical importance now more than ever. While the hypothesis for this study was not meant to address this challenge specifically, the data should serve as a striking reminder that while several factors may be playing a role in surgical complications, ongoing systemic racism is a component that needs dedicated time and attention.”

Dr. Zhu and three coauthors reported no relevant financial disclosures. One coauthor received support from the University of Ottawa Clinical Research Chair in Reproductive Population Health and Health Services, the Canadian Institutes for Health Research, and Physicians’ Services Incorporated Foundation to conduct this research. Two other coauthors reported financial relationships with various pharmaceutical and medical technology companies. Dr. Stampler reported no relevant conflicts of interest.

SOURCE: Zhu CR et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004007.

Hysterectomies performed using an abdominal surgical approach or in women with endometriosis are more likely to carry an increased risk of bowel injury, according to recent results published in Obstetrics & Gynecology.

U.S. Air Force photo by Staff Sgt. Ciara Gosier

Cici R. Zhu, MD, of the department of obstetrics and gynecology at the University of Ottawa, and colleagues retrospectively studied the incidence of bowel injury in women participating in the American College of Surgeons National Surgical Quality Improvement Program who underwent hysterectomy for a benign surgical indication between 2012 and 2016.

“Although the absolute incidence is low, bowel injuries are among the most devastating complications of hysterectomy, as they can lead to a wide range of complications, including peritonitis, abscess formation, enterocutaneous fistula, sepsis, and even death,” Dr. Zhu and colleagues wrote. “Secondary bowel surgeries are often required, and associated ileostomies and colostomies can be distressing to patients. This not only severely affects quality of life, but the resultant readmissions, reoperations, and prolonged hospitalizations can impose a substantial economic toll on the health care system.”

Overall, 155,557 women were included in the study. The cohort consisted of women who were a mean age of 48 years and had a mean body mass index (BMI) of 31 kg/m². The researchers evaluated whether baseline characteristics, clinical, and surgical variables impacted the incidence of bowel injury. They analyzed data of participant age, race (White vs. non-White), BMI, comorbid conditions (smoking, diabetes, chronic obstructive pulmonary disease, hypertension, and bleeding disorder), American Society of Anesthesiologists (ASA) classification, surgical approach (abdominal, laparoscopic, or vaginal), hysterectomy type (total or subtotal), lysis of adhesions, operation time, and admission type. Indication for hysterectomy was also evaluated, which included uterine leiomyoma (32.9%), menstrual disorders (22.0%), genital prolapse (13.1%), endometriosis (6.8%) and pelvic pain (3.8%).
 

Endometriosis, abdominal approach raise risk

There were 610 cases of bowel injury observed in the study, for an overall injury rate of 0.39%. A majority of the repairs were done during surgery (82.3%), with the remainder performed within 30 days of hysterectomy. Women with endometriosis had the most frequent incidence of bowel injury (0.59%), but it also occurred in women with uterine leiomyomas (0.47%), pain (0.24%), menstrual disorders (0.20%), genital prolapse (0.18%) and other indications (0.56%).

Dr. Zhu and colleagues found risk of bowel injury was higher among women 55 years and older, compared with women aged younger than 40 years (odds ratio, 1.66; 95% confidence interval, 1.28-2.15); in non-White women, compared with White women (OR, 1.92; 95% CI, 1.62-2.28); and in women with class 3 obesity, compared with women at a normal BMI (OR, 1.81; 95 CI, 1.40-2.34). Other risk factors for bowel injury included hypertension (OR, 1.39; 95% CI, 1.17-1.64) and ASA III, IV, and V classification, compared with ASA I classification (OR, 1.92; 95% CI, 1.43-2.58).

Researchers noted there was a statistically significant difference in rates of bowel injury between hysterectomy indications (P < .001). When compared with endometriosis, there were lower odds of bowel injury among women with uterine leiomyomas (adjusted odds ratio, 0.44; 95% confidence interval, 0.33-0.59), genital prolapse (aOR, 0.41; 95% CI, 0.25-0.67), and menstrual disorder (aOR, 0.33; 95% CI, 0.23-0.48).

Surgical factors also impacted the risk for bowel injury. In hysterectomies where the abdominal approach was used, there was an over-tenfold risk of bowel injury, compared with when a vaginal approach was used (OR, 10.80; 95% CI, 7.31-15.95). Lysis of lesions carried an increased risk of bowel injury (OR, 3.11; 95% CI, 2.20-4.40), and a subtotal hysterectomy increased the risk of bowel injury, compared with when a total hysterectomy was performed (OR, 1.76; 95% CI, 1.42-2.18).

The researchers acknowledged the lack of detailed clinical information on surgical indications, severity of bowel injury, and training of the surgeons and surgical team, and potential for missing information may limit the application of the study findings.
 

Findings must be cautiously interpreted

Kate Stampler, DO, assistant program director of minimally invasive gynecologic robotic surgery at Einstein Healthcare Network in Philadelphia, said in an interview that the study by Zhu et al. is a good reminder of the patient and surgical risk factors that can occur that affect outcomes of hysterectomy.

“In my clinical practice, I have not seen a significant difference in route of hysterectomy and bowel injury, however, this must be interpreted carefully in the context of an infrequent complication and as an MIS [minimally invasive surgery]-trained surgeon performing various complex cases,” she said. Other reports in the literature have not identified a difference in the rate of bowel injury based on surgical approach, but the study by Zhu et al. is “unique to the literature in its large sample size,” she explained.

“I would encourage less experienced surgeons to operate with a higher-volume assistant surgeon if the end result means being able to perform an MIS approach, or appropriately offer referral if feasible to another surgeon for best practices. A thorough informed consent of the available route of hysterectomy is integral to good surgical care and allows for shared decision making for the patient,” Dr. Stampler said. “Additionally, participation in a large quality reporting system such as ACS National Surgical Quality Improvement Program database should be considered broadly and we should strive for overall high-value care.”

Regarding endometriosis being a risk factor for bowel injury during hysterectomy, Dr. Stampler noted that severe endometriosis poses a significant challenge for gynecologic surgeons. “Loss of anatomic planes due to dense adhesions and fibrosis, in addition to deep infiltrating lesions, can add significant time, complexity, and risk to the procedure. This can be compounded in a scenario with less experienced surgeons and unplanned disease at the time of surgery.”

Dr. Stampler also applauded the paper for highlighting the differences in White and non-White patient outcomes for hysterectomy, and emphasized that it is not new information. “Their call to continue to address the social determinants of health in an effort to minimize risk and maximize safety for our patients of color is of critical importance now more than ever. While the hypothesis for this study was not meant to address this challenge specifically, the data should serve as a striking reminder that while several factors may be playing a role in surgical complications, ongoing systemic racism is a component that needs dedicated time and attention.”

Dr. Zhu and three coauthors reported no relevant financial disclosures. One coauthor received support from the University of Ottawa Clinical Research Chair in Reproductive Population Health and Health Services, the Canadian Institutes for Health Research, and Physicians’ Services Incorporated Foundation to conduct this research. Two other coauthors reported financial relationships with various pharmaceutical and medical technology companies. Dr. Stampler reported no relevant conflicts of interest.

SOURCE: Zhu CR et al. Obstet Gynecol. 2020 Oct. doi: 10.1097/AOG.0000000000004007.

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at [email protected].

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at [email protected].

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at [email protected].

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

Patrick J. Culligan, MD: We all know that burnout is an important problem among surgeons. In fact, it seems that, in the United States, we are working longer hours than ever before, and that higher education correlates with less balance in life. This dysfunction seems to start in school, when we are encouraged to be competitive, and overwork just becomes another way to compete. It’s very easy to get swept up in the traditional model of academic medicine, the engine of which is competition and overwork.

My impression of our younger colleagues, however, is that many of them are not attracted to the traditional ivory tower research model of academic advancement to which many in previous generations aspired. They seem more concerned with work-life balance as their measure of success rather than the classic metrics of money and prestige. Everyone still needs role models and mentors, though, and that’s where all of you come in. I asked each of you to be on this panel because I admire you for your varying approaches to work-life balance while achieving success as gynecologic surgeons. I thought others in the field might be inspired by hearing your stories.

Cultivating your passions

Kristie Greene, MD: What I have come to learn and appreciate is a really simple point: you do not have to do everything. Determining who you want to be both personally and professionally is step 1.

Granted, answering the question, “Who do I want to be?” is not as simple as it sounds. Many factors figure into the decisions we make in our personal and professional lives. Also, it is not a question we often stop and ask ourselves. From early on, we are placed on an escalator moving up through medical school, residency, fellowship, good job, better job, etc. We are so accustomed to being competitive, to winning, and to wanting to be the best that we sometimes forget to ask ourselves, “What is it exactly that I want, and why? What is my endpoint? And does it make me happy?”

Multitasking is regarded as a talent. As much as we would like to believe that we can do everything at the same time and do it all well, we actually can’t. A friend of mine made me read a book a couple of years ago, called Feeling Good, by David Burns. The book encourages you to consider the different tasks you do in a day and rate how good you are at each of them on a scale of 1 to 10. It then asks you to think about how much enjoyment you derive from each of the tasks and about why you are doing the ones that bring you little to no enjoyment.

I ultimately decided that, for me professionally, the most important thing was my interest in global health. So I decided to do whatever it took to make this happen. But you don’t get something for nothing, and everything comes with sacrifices.

Continue to: Charles Rardin, MD...

Charles Rardin, MD: How exactly did you decide that you were going to focus your career toward pursuing international health? How did you know it was more important? And how did you overcome some of those obstacles?

Dr. Greene: You have to ask the hard question again about what brings you the most joy professionally and personally. That was the easy part of it for me because global health has always been that source of happiness and fulfillment for me. The more challenging parts are the sacrifices and hard choices that come with it. With global health, it can be difficult to balance the demands of a clinical practice.

All of our jobs are a business. I am still struggling with the money part of it. For my husband and I, that meant we had to start small—do what we could afford. But then it blossomed into something that was involving residents, fellows, and med students, which requires far more funding than we had. So I reached out to family. Most of our families donate to different organizations or charities every year, so why not donate to a loved one for something they are passionate about?

At the University of South Florida (USF), we set up a fund, a foundation for global health, which helps support our work abroad as well as the costs associated with involvement of our trainees. Right now, what we have is still small potatoes to a country, but we are making it happen by starting at a small level and growing it.

Beyond the money aspect, traveling abroad means less involvement in meetings, missed opportunities to teach courses that might interest me, and time away from my family. I guess my advice on this whole thing is that you can make things happen if they are important enough to you, and if you are willing to make sacrifices in other areas because you can’t have it all.

Making time for you

Dr. Culligan: So you have found what is important to you, and you have found a way to make it happen. But you are faced with more work; you have given yourself additional work on top of your regular work. How do you make time for a personal life?

Catherine Matthews, MD: In preparing for this discussion, I decided to break down my advice into 3 buckets: The first bucket is discovering and knowing your authentic self. The second is building a community, which I’ll elaborate on. And the third, which we have discussed, is to let go of the money.

Dr. Culligan: I love the concept of the authentic self, but how does that jive with a tendency to strive for perfection? We all think we can do it all. How do we narrow down to what really matters?

Dr. Matthews: We often focus on the things that bring us happiness and what we are good at, but it’s the things that make us unhappy that tend to bring us down. It’s the presence of unhappiness, not the absence of happiness, that seems to be the undoing of many, including myself.

None of us are born with dramatic insight. It is experience that leads to insight. People who are actually present are able to gain insight through observation. A person becomes a better surgeon by observing the outcome of doing a stitch this way versus that; you learn how to do it by seeing what it looks like afterward.

Finding our authentic selves happens in much the same way. Having the presence of mind to ask the right questions, such as, “How am I feeling while I’m doing this?” leads to insights into the true self.

Continue to: It takes a village...

Dr. Greene: Catherine mentioned community earlier, and that is extremely important. The people who surround us can have a huge impact on the way we perceive things, including ourselves. Having a mix of people in our lives—some who practice medicine and others who don’t—helps us stay balanced and answer some of the tough questions. Catherine, for example, has helped me in various stages of my career to ask myself meaningful questions and get real answers.

Dr. Rardin: Part of finding balance is luck, and part of it is making a choice between money and everything else. In considering my first job out of training, I knew that money had the potential to distract me from what was important to me. So I chose a position that was almost entirely salaried so that the decisions I made clinically, surgically, and regarding work-life balance would be less likely to directly impact what was important to me.

Sally Huber, MD: I am still in the “getting there” phase of my life, but one thing I have found is that getting my family involved and excited about what I do has made them much more accepting of when I have longer work days or work to do on the weekend. My spouse has become quite involved with what I have been doing with transgender health in Atlanta. It has been a great bonding experience; she shares my passions, and together we are creating something about which we both can be proud.

When work invades home life

Dr. Culligan: That is great. Sally, I think when we talked, you were just learning about the necessity of mental separation and of not taking your work home with you, which is so hard for all of us with all of our devices.

Dr. Huber: Yes, this year has been about seeing what works best as far as being efficient at work and having quality time at home. At the end of every day I ask myself, “What worked well today? What didn’t work well? What else can I do to maximize time with my family?” I am slowly becoming more efficient, but it has been a challenge. During fellowship, your day is pretty set, but once you are practicing on your own, your hours and responsibilities are completely different, and you have to figure out what works best for you, your values, and your expectations of private life. It takes some time, and I am still figuring it out.

Dr. Culligan: How often would you say that you bring work home? I try hard once I am home to quit working, but sometimes on the weekends I break that rule.

Dr. Matthews: I must say that I do feel like there are certain times when I am better at that than others. Work comes in waves with pressing deadlines. If I averaged it out, probably a third of the time I have some email or some conference call or something that I have got to do at home. I do really try to limit the obligations that I have after 5:30 or 6:00 pm. I resent intrusions after that time. As far as weekends, I delegate about one weekend every 2 months to work, instead of doing a little bit every weekend.

Dr. Greene: I agree. I try hard to make 5:30 to 7:30 pm unequivocal time for a family dinner and time for my kids. During that time, I do not have my phone near me so I can’t look at email or texts. I try not to schedule conference calls. I try to be there to read books to my kids at night. Then if I need to do work, I do it later at night, which interferes with time with my spouse, and is not ideal, but that’s what happens.

Dr. Matthews: One of the things that I think is a huge part of work-life balance is work-related travel. When you are present at work on a consistent basis, the work does not pile up to the extent that it does when you are absent on a trip. When you come back, you invariably pay the price by seeing more patients and doing more surgery. Then it becomes a stressful event.

My advice to young people is to be very thoughtful about planning trips, especially distant ones. You do not want to sit on a plane all day when you could be doing something more productive. If I could have done something differently in my mid-career, I would have traveled less.

Continue to: Prioritizing “out of office” time...

Dr. Greene: How do you all mentally separate yourself from work, so that when you are on vacation with your family you are not thinking about the office, the patients, and all of the things on your to-do list?

Dr. Rardin: I don’t have a great answer for that except that it is about being present. You have to decide that now is the time when I am home, now is the time when I am a parent, now is the time when I am a boy scout leader, etc. I guess maybe it’s a skill, or maybe it’s about making something a priority. Work will always be waiting for you when you turn your attention back to it.

Dr. Matthews: Kristie, the answer to your question goes back to community. Partners in a practice cover for each other. You have to trust them to take care of things so that you can relax during your time away.

Some people recommend not scheduling challenging cases right before going away because invariably something goes wrong, and then you are asking, “Why did I schedule 3 colpopexies before getting on a plane?”

Dr. Rardin: Yes, I completely agree with all of that. Personally, I feel fortunate that I can compartmentalize pretty well. When I am home with my kids, I allow myself to shed some of the doctor/surgeon/leadership persona; I am able to be goofy and completely non–doctor-like. It works to help me leave work behind.

Dr. Matthews: Other things you can do include setting up an out-of-office notice on your email that says when you will be back and what to do in case of urgent matters. This basically says to the world, “Don’t expect to hear from me until X date.” It removes the expectation that you will respond sooner. Otherwise, we would all be on our smartphones all the time and not enjoying our time away.

What I wish I knew then

Dr. Culligan: How would you complete the sentence, “I wish they had told me X when I was embarking on my career?”

Dr. Rardin: I keep coming back to the phrase, “Don’t do anything that you can reasonably pay someone else to do.” By that I mean, if you don’t get energy from housework, consider spending some of your money to get help with the housework. Resolve to make a relatively small expenditure to maximize the quality of the time that you give to yourself and your family. Those are the sorts of things that I think can go a long way.

Dr. Culligan: Charley, your wife is an ObGyn. How do you navigate a dual medical career household? What advice do you have for others?

Dr. Rardin: When I was going into fellowship, we had a conversation about how hard it is for both people in a relationship to have an academic fire in the belly and to be truly engaged in climbing the academic ladder. We made a decision that Jane would go into private practice. There has got to be some give and take in a dual medical relationship; a lot of sacrifices and compromises need to happen. We are fortunate in that there are complementary aspects to our jobs. We both spend about the same number of nights away from the house, but my travel is more in chunks and hers is overnight calls for labor and delivery. We have different ways of (briefly) single-parenting, and you have to come up with ways to handle the domestic chores.

Dr. Matthews: I wish someone had explained to me that the people you work with are much more important than the place. The human connection is what defines your experience, much more than any ego-driven outcome.

Dr. Greene: I wish someone had explained to me the competing aspects of academic medicine. The cards are stacked in a way that make it difficult for you to win. For example, you may love to teach and may be really good at it, but if you let your students handle too many cases, your relative value units plummet and then the hospital is on your back. There are the interests of people, and there are the interests of the business. Everything is a balance, and it’s really tricky.

Dr. Huber: Luckily, Pat counselled me as I was finishing my fellowship about the importance of negotiating a good contract, of being pushy and knowing what you want out of it and knowing what your limitations are. I joined a private practice that had 3 different physical locations. If I had to drive to all of them, as they wanted, it would have meant up to a one-and-a-half-hour commute. But I pushed to stay in one location and to put that extra hour to better use. I am glad I did, but it was terrifying at the time because I didn’t want to lose the offer. I know people that did not do that and took the first thing they got. Now, they are driving all over the place or they have these crazy hours or terrible call responsibilities that if they had just been a little firmer, they probably could have gotten out of. As they start trying to find work-life balance, they are already handicapped.

Continue to: Passions outside the office...

Passions outside the office

Dr. Culligan: One thing I would like to touch on is what is going on in each of your personal lives because all of you have interesting stories to tell outside of what you do professionally. What drives you other than medicine?

Dr. Rardin: I am the father of 3 boys. The oldest one just got his Eagle Scout rank yesterday in Boy Scouts. I would be a woodworker if I wasn’t in medicine. I am a Deacon at church. And I love to spend my downtime reading with my family in front of the fireplace.

Dr. Matthews: For me, it’s music. When my husband and I first met, he asked me if I played a musical instrument. I said I played the cello in primary school. He said, “Great, go rent a cello.” I was never at all interested in playing the cello by myself, but because he plays guitar and piano we became able to play a lot of music together. Our son, Alexander, plays drums. We now have a family band.

In addition, I do yoga. I would never have labeled myself an anxious person, but I learned through this process that I am and need to manage it. It took a lot of years to figure that out. If I don’t leave myself an hour each day to go to a yoga class, I am not a happy person and neither is anyone around me. Also, I get tremendous pleasure from reading books and magazines as opposed to watching a screen.

Dr. Greene: I have found that my passions outside of work often change depending on my stage of life. Right now, I have two young babies and so my life outside of work revolves around them. Before the babies, my dad, who lives in Buffalo, was ill. So for awhile, we were flying to Buffalo almost every weekend that I was not on call. I would say, in general what fuels me is connecting with the people I love as often as I can. A typical night involves me and my husband going for a walk with our kids and dog after dinner and talking to each other. We connect with neighbors and chat on the front porch. It doesn’t really matter what we are doing; it is about being surrounded by people who matter.

Dr. Huber: It’s similar for me. Having a child completely shifts your world view. My goal every day is to give my daughter her first feeding in the morning and to get home as soon as possible at the end of the day to do her last feeding and put her to sleep. She crawled for the first time yesterday, and I was so excited that I could be there for that.

Also, I love being outdoors. I love hiking and camping. Going on a hike and being outside with nature is my way of decompressing.

Continue to: Thinking about upcoming generations...

Dr. Matthews: One other thing I would like to propose is looking at what can we do to make the profession better for the next generation. As a group, our profession is somewhat inflexible. We tend to fall into the trap of, “since this is the way we have always done it this is how we should continue doing it.” The OR still starts at 7:00 or 7:30 am, ignoring the need for school drop-offs, etc. We are not innovative about flexibility in the work week. Honestly, it does not work well for many people, patients and physicians alike. Flexible scheduling should be something that is on the table for both men and women who are trying to balance being full-time parents and full-time surgeons. We need to create an environment in which it is okay for you to spend 10 years instead of 6 as an assistant professor because you are also a young parent, and it will not count against you when you come up for promotion.

Dr. Culligan: I agree with you, Catherine. Full “Professor” is a nice title, but it means time away from family and a lot of other things. Each of us has to decide whether it is worth it, especially since it often does not come with any extra money.

Dr. Huber: A question on a recent survey of residents asked, “Do you see yourself going into private practice or academic medicine when you’ve completed your residency?” When I was a resident, everyone wanted to go into academic medicine, but now it seems like more and more residents have their sights set on private practice because that is where they see the opportunities to create work-life balance.

In the academic world, you have to try to get a promotion in X number of years, and get X number of publications, and be a great teacher, doctor, and administrator all at the same time. I am wondering if we are going to start seeing more and more residents and fellows going into private or hospital-owned practice where there aren’t those added expectations.

Dr. Rardin: I agree, and we are back to what we said in the beginning about doing an honest assessment of what is meaningful and important. We are all trained to try to reach for that shiny brass ring, but do we really want that brass ring? Will it be an asset or a hindrance once we get it? It is okay to be honest and say, “I really don’t want that promotion. I would rather spend more time with my family.” ●

© TRENDOBJECTS/SHUTTERSTOCK

I often say that there are both “guardrail” days and very good days when it comes to the ins and outs of health care builds and product launches. The process is much like starting down the path of a country road in the middle of a blizzard—unless you have dependable wipers and a good defrost system, that path can get murky very quickly. With this article I hope to offer my counsel to inventors, featuring a few of my prior launches as well as case studies of health care launches I was not involved with, and sharing the lessons learned and hurdles that were overcome. I encourage all entrepreneurs to act on their ideas because, in the world of health care startups, the only failure is not acting on an invention.

Case study 1: Cerezyme

Today, Cerezyme is indicated for patients with Gaucher, which is a lysosomal storage disorder. Cerezyme’s first-generation product, called Ceredase, was a human tissue-derived protein that we extracted from human placentas. At the time, the concept of moving this program forward was denied by the Board of Directors because they said that even if you could collect enough placentas to make the enzyme, it would be too expensive to manufacture. In fact, early scale-up modeling for manufacturing the protein demonstrated that Genzyme would need 4 tons of placentas per Gaucher patient per year.

Gaucher is a severe, early-onset disease that has a significant negative outcome for patients. Patients with Gaucher are in dire need of treatment. Genzyme went forward with the Ceredase program by financing it through the families of patients with the disease, by starting an LLC separate from the business and funding the initial clinical trial and the development of the protein through the families of Gaucher patients. That approach was a successful endeavor. A great example of a creative capital structure to advance a program.

This was in the late 1980s/early 1990s, and at the height of the AIDS challenge. Genzyme based the manufacturing in Lille, France, and we cryopreserved placentas in the United States and Europe and shipped them to Lille to be processed into therapy. Genzyme eventually received approval for Ceredase from the US Food and Drug Administration (FDA) and the European Medicines Agency. At the height of the placenta collection, we were gathering about 10% to 15% of the placentas in the United States and 30% to 40% of the placentas in Europe. Resources supply became an issue until we developed a recombinant form of the protein, accomplished by using a manufacturing system called a CHO cell line.

This is a very good success story: If this invention was not pursued, Gaucher patients would not benefit from the treatment today. In addition, there are a plethora of patients with different lysosomal storage disorders treated with additional proteins that have been aided by us going through the entire development, manufacturing, and global commercialization process. We figured out how to manufacture and deliver the treatment, working through multiple countries’ political systems, and today the therapy is paid for by insurance and government systems on a worldwide basis.

Continue to: Case study 2...

Case study 2: ThinPrep

I like to use the approval of ThinPrep as an example of avoiding a false negative—a stoppage in the development of the product or drug for the wrong reasons. False negatives, in my mind, occur when you are developing a technology and you run into issues during the clinical phase and/or with FDA approval, or with a technical failure or you run out of capital prior to knowing whether or not the innovation actually works. In the case of ThinPrep, a poorly run clinical trial almost resulted in a false negative.

The company at the time was Cytyc, and an initial clinical study presented to the FDA yielded a neutral-negative outcome. The FDA said that there were not enough data to show the differentiation from the current Pap smear standard of care.

The founders of the company at that time had inherited the study protocol from a prior leadership team, so they had to finish the trial with the initial protocol. Given the FDA’s advisement, they developed a new trial. It took the persistence of these two founders, who mortgaged their homes and spent their personal dollars to take this through the next wave of clinical development. In the end it was successful. The revised clinical trial yielded an approval for ThinPrep, which is now considered a standard of care.

The use of ThinPrep reduced cervical cancer deaths by 40% from preapproval. The challenging path from clinical development to eventual commercial launch and physician leadership in advancing patient care makes the story of ThinPrep a great example of not allowing an early false negative of a poorly designed and run clinical trial stop important innovation.

Case study 3: Cologuard

The development of Cologuard is a case study demonstrating that, sometimes, when your first attempt does not work, you need to have the persistence to raise additional capital and/or use a slightly different technical approach. The approval story of Cologuard is important to share because it is an important cancer screening diagnostic, using DNA from stool samples to test for colon cancer, giving access to important colon cancer screening to many patients. Currently, caregivers are only scraping the surface with Cologuard’s ability to screen the population. There are many more patients that need access to the test, and I believe they will get it in the years ahead.

Cologuard went through a first- and second-generational technical failure. They could not get the test’s specificity and sensitivity to be at the level of a screening tool; there were too many false-positive results. With the third iteration came the technical breakthrough, and a very large, expensive study was conducted—one the leadership team was criticized for. However, that study yielded the data that achieved a New England Journal of Medicine article, and reimbursement support across the country. The combination of the right technical team and the right leadership team, who planned a proper commercial launch, with a CEO that supported the extensive clinical study, has resulted in the fourth generation of Cologuard—an important breakthrough offering a very useful new standard of care in colon cancer detection and screening.

Continue to: Pearls for moving your innovations forward...

Pearls for moving your innovations forward

Because of my experience in undergoing health care start-ups, and contributing to several of those advancements of innovation, many inventors approach me for advice on their paths from idea to full-concept company. Here are a few of my lessons learned.

Consider purpose, not financial gain, first and foremost. Financial gain is typically the by-product or outcome of a standard-of-care breakthrough for inventors, but it’s a very hard road. Pursue your invention for advancing patient care and moving a new standard of care forward in health care versus financial gain at the end.

Determine whether your invention is a product or a company, or potentially, not capitalizable at all. Figure this out early. Analyze your idea to make sure it is sound and truly novel. Analyze the competition and to make sure it is sound and truly novel. Analyze the competition and the market dynamics to support a new product. Can the development path be defined very clearly to raise capital? Is your innovation a big enough breakthrough in the market with several current products to actually make a difference in patient outcomes (and eventually achieve product reimbursement)? The creation of a company may be the right strategy if the innovation can support a differentiated enough breakthrough where you can actually support all the infrastructure to build the business. If you find that the market is not there to support and develop your idea to eventual success, backing off early is important to preserve invested capital.

Protect early. Is your invention patentable, or has someone else already thought of the idea? What kind of patent(s) are appropriate? Where, geographically, do you want to protect your invention? Find a good patent attorney in your local area, early in the process, to help you answer all of these critical questions. Patents are expensive to file and maintain, but it is not expensive to do a literature search to find out if your idea is novel. A provisional patent, which would be your first step, is an important cost-effective step.

Capital is out there. If your invention or idea deserves capital, it is available. I will address raising capital in more detail in the next section.

Consider regulatory and manufacturing as achievable hurdles. Inventors often get tripped up here, considering the regulatory hurdles and manufacturing too challenging and abandoning their ideas because the risk is too great. Regulatory and manufacturing are very important aspects of health care standard-of-care builds. Cutting corners is not an option. That said, regulatory and manufacturing should not stop you. Challenges often can be worked through as long as the clinical need is there, and the clinical data support bringing that technology forward.

Consider corporate partnerships. I am a fan of corporate partners. But which ones should you target, and when and why? Corporate partnerships can bring significant capital, which is great, but there is enough investor capital out there that you should not pursue a corporate partner just for capital. The main benefit of a corporate partner is enterprise intellect. They typically know more about the field that you are entering than the investors or a small company leadership team.

Establish and listen to advisors. When thinking about who to trust, research their track record. Advisors who have gone through this process before, and specifically in your product area, are important to have access to.

Persistence is key. I have observed a tremendous “compression of innovation” in the health care areas that I have been involved with—human tissue-derived proteins, robotic surgery, stem cell therapy, and digital health (which is still in its infancy). For each of these breakthrough categories, early on, it appeared that it couldn’t be done. However, after the first 2 or 3 major breakthroughs in each one of these areas, a compression of innovation occurred. For instance, after approximately 15 years of protein development, we came out with the recombinant manufacturing systems for proteins. Very quickly, within 10 years, there were more than 70 proteins on the market. The persistence of the inventors to overcome early obstacles in each of these health care areas was critical to future success in each area.

Continue to: Raising capital...

Raising capital

There are different investors who specialize in different types of investment opportunities. The first phase of raising capital is the seed round—where there is typically early data, or even no data and just a concept. From this seed round forward, there is less risk as you develop your technology; thus, there are different investors that support different stages of development and that specialize in different types of investing. It is important to target the right investors and raise enough capital to be able to go achieve multiple operational milestones. Otherwise, when you go through your first round of capital, or the Series A or B financing rounds, there may not be a set of investors out there to fund the company moving forward. Health care investors will make it known that they invest in certain rounds of capital. You can determine who those investors are by doing a search online.

A mistake health care inventors can make is not taking enough capital from investors, because they are concerned about dilution. I advise investors not to focus on dilution but rather on, how big can you make “the pie” (value of the company) worth? The entire process is about bringing a true product through to a new standard-of-care curve.

Trust is the most important thing to earn with investors, and there is zero tolerance for a lack of trust. Share your vision as the inventor with investors, who want to know where this category could be in the next 5 or 10 years. Clinical data will always win, and health care investors and industry leaders should be focused on executing the most robust clinical data to demonstrate the clearest potential clinical outcome. Investors will follow a good plan that has been developed to achieve FDA approval, successful commercialization or “go to market” launch, and eventual reimbursement to support a true standard-of-care change.

Failure is defined by inaction

The 3 case studies that I have shared were success stories because the ideas and inventions were acted upon. When I was at Genzyme, we built the company up to more than $1 billion in revenue. We commercialized proteins in over 50 countries. Most importantly, many patients benefited from the innovation. If you have an invention and an idea, act on it—and surround yourself with great people in every discipline. Having the right people and team is extremely important. ●

© TRENDOBJECTS/SHUTTERSTOCK

I often say that there are both “guardrail” days and very good days when it comes to the ins and outs of health care builds and product launches. The process is much like starting down the path of a country road in the middle of a blizzard—unless you have dependable wipers and a good defrost system, that path can get murky very quickly. With this article I hope to offer my counsel to inventors, featuring a few of my prior launches as well as case studies of health care launches I was not involved with, and sharing the lessons learned and hurdles that were overcome. I encourage all entrepreneurs to act on their ideas because, in the world of health care startups, the only failure is not acting on an invention.

Case study 1: Cerezyme

Today, Cerezyme is indicated for patients with Gaucher, which is a lysosomal storage disorder. Cerezyme’s first-generation product, called Ceredase, was a human tissue-derived protein that we extracted from human placentas. At the time, the concept of moving this program forward was denied by the Board of Directors because they said that even if you could collect enough placentas to make the enzyme, it would be too expensive to manufacture. In fact, early scale-up modeling for manufacturing the protein demonstrated that Genzyme would need 4 tons of placentas per Gaucher patient per year.

Gaucher is a severe, early-onset disease that has a significant negative outcome for patients. Patients with Gaucher are in dire need of treatment. Genzyme went forward with the Ceredase program by financing it through the families of patients with the disease, by starting an LLC separate from the business and funding the initial clinical trial and the development of the protein through the families of Gaucher patients. That approach was a successful endeavor. A great example of a creative capital structure to advance a program.

This was in the late 1980s/early 1990s, and at the height of the AIDS challenge. Genzyme based the manufacturing in Lille, France, and we cryopreserved placentas in the United States and Europe and shipped them to Lille to be processed into therapy. Genzyme eventually received approval for Ceredase from the US Food and Drug Administration (FDA) and the European Medicines Agency. At the height of the placenta collection, we were gathering about 10% to 15% of the placentas in the United States and 30% to 40% of the placentas in Europe. Resources supply became an issue until we developed a recombinant form of the protein, accomplished by using a manufacturing system called a CHO cell line.

This is a very good success story: If this invention was not pursued, Gaucher patients would not benefit from the treatment today. In addition, there are a plethora of patients with different lysosomal storage disorders treated with additional proteins that have been aided by us going through the entire development, manufacturing, and global commercialization process. We figured out how to manufacture and deliver the treatment, working through multiple countries’ political systems, and today the therapy is paid for by insurance and government systems on a worldwide basis.

Continue to: Case study 2...

Case study 2: ThinPrep

I like to use the approval of ThinPrep as an example of avoiding a false negative—a stoppage in the development of the product or drug for the wrong reasons. False negatives, in my mind, occur when you are developing a technology and you run into issues during the clinical phase and/or with FDA approval, or with a technical failure or you run out of capital prior to knowing whether or not the innovation actually works. In the case of ThinPrep, a poorly run clinical trial almost resulted in a false negative.

The company at the time was Cytyc, and an initial clinical study presented to the FDA yielded a neutral-negative outcome. The FDA said that there were not enough data to show the differentiation from the current Pap smear standard of care.

The founders of the company at that time had inherited the study protocol from a prior leadership team, so they had to finish the trial with the initial protocol. Given the FDA’s advisement, they developed a new trial. It took the persistence of these two founders, who mortgaged their homes and spent their personal dollars to take this through the next wave of clinical development. In the end it was successful. The revised clinical trial yielded an approval for ThinPrep, which is now considered a standard of care.

The use of ThinPrep reduced cervical cancer deaths by 40% from preapproval. The challenging path from clinical development to eventual commercial launch and physician leadership in advancing patient care makes the story of ThinPrep a great example of not allowing an early false negative of a poorly designed and run clinical trial stop important innovation.

Case study 3: Cologuard

The development of Cologuard is a case study demonstrating that, sometimes, when your first attempt does not work, you need to have the persistence to raise additional capital and/or use a slightly different technical approach. The approval story of Cologuard is important to share because it is an important cancer screening diagnostic, using DNA from stool samples to test for colon cancer, giving access to important colon cancer screening to many patients. Currently, caregivers are only scraping the surface with Cologuard’s ability to screen the population. There are many more patients that need access to the test, and I believe they will get it in the years ahead.

Cologuard went through a first- and second-generational technical failure. They could not get the test’s specificity and sensitivity to be at the level of a screening tool; there were too many false-positive results. With the third iteration came the technical breakthrough, and a very large, expensive study was conducted—one the leadership team was criticized for. However, that study yielded the data that achieved a New England Journal of Medicine article, and reimbursement support across the country. The combination of the right technical team and the right leadership team, who planned a proper commercial launch, with a CEO that supported the extensive clinical study, has resulted in the fourth generation of Cologuard—an important breakthrough offering a very useful new standard of care in colon cancer detection and screening.

Continue to: Pearls for moving your innovations forward...

Pearls for moving your innovations forward

Because of my experience in undergoing health care start-ups, and contributing to several of those advancements of innovation, many inventors approach me for advice on their paths from idea to full-concept company. Here are a few of my lessons learned.

Consider purpose, not financial gain, first and foremost. Financial gain is typically the by-product or outcome of a standard-of-care breakthrough for inventors, but it’s a very hard road. Pursue your invention for advancing patient care and moving a new standard of care forward in health care versus financial gain at the end.

Determine whether your invention is a product or a company, or potentially, not capitalizable at all. Figure this out early. Analyze your idea to make sure it is sound and truly novel. Analyze the competition and to make sure it is sound and truly novel. Analyze the competition and the market dynamics to support a new product. Can the development path be defined very clearly to raise capital? Is your innovation a big enough breakthrough in the market with several current products to actually make a difference in patient outcomes (and eventually achieve product reimbursement)? The creation of a company may be the right strategy if the innovation can support a differentiated enough breakthrough where you can actually support all the infrastructure to build the business. If you find that the market is not there to support and develop your idea to eventual success, backing off early is important to preserve invested capital.

Protect early. Is your invention patentable, or has someone else already thought of the idea? What kind of patent(s) are appropriate? Where, geographically, do you want to protect your invention? Find a good patent attorney in your local area, early in the process, to help you answer all of these critical questions. Patents are expensive to file and maintain, but it is not expensive to do a literature search to find out if your idea is novel. A provisional patent, which would be your first step, is an important cost-effective step.

Capital is out there. If your invention or idea deserves capital, it is available. I will address raising capital in more detail in the next section.

Consider regulatory and manufacturing as achievable hurdles. Inventors often get tripped up here, considering the regulatory hurdles and manufacturing too challenging and abandoning their ideas because the risk is too great. Regulatory and manufacturing are very important aspects of health care standard-of-care builds. Cutting corners is not an option. That said, regulatory and manufacturing should not stop you. Challenges often can be worked through as long as the clinical need is there, and the clinical data support bringing that technology forward.

Consider corporate partnerships. I am a fan of corporate partners. But which ones should you target, and when and why? Corporate partnerships can bring significant capital, which is great, but there is enough investor capital out there that you should not pursue a corporate partner just for capital. The main benefit of a corporate partner is enterprise intellect. They typically know more about the field that you are entering than the investors or a small company leadership team.

Establish and listen to advisors. When thinking about who to trust, research their track record. Advisors who have gone through this process before, and specifically in your product area, are important to have access to.

Persistence is key. I have observed a tremendous “compression of innovation” in the health care areas that I have been involved with—human tissue-derived proteins, robotic surgery, stem cell therapy, and digital health (which is still in its infancy). For each of these breakthrough categories, early on, it appeared that it couldn’t be done. However, after the first 2 or 3 major breakthroughs in each one of these areas, a compression of innovation occurred. For instance, after approximately 15 years of protein development, we came out with the recombinant manufacturing systems for proteins. Very quickly, within 10 years, there were more than 70 proteins on the market. The persistence of the inventors to overcome early obstacles in each of these health care areas was critical to future success in each area.

Continue to: Raising capital...

Raising capital

There are different investors who specialize in different types of investment opportunities. The first phase of raising capital is the seed round—where there is typically early data, or even no data and just a concept. From this seed round forward, there is less risk as you develop your technology; thus, there are different investors that support different stages of development and that specialize in different types of investing. It is important to target the right investors and raise enough capital to be able to go achieve multiple operational milestones. Otherwise, when you go through your first round of capital, or the Series A or B financing rounds, there may not be a set of investors out there to fund the company moving forward. Health care investors will make it known that they invest in certain rounds of capital. You can determine who those investors are by doing a search online.

A mistake health care inventors can make is not taking enough capital from investors, because they are concerned about dilution. I advise investors not to focus on dilution but rather on, how big can you make “the pie” (value of the company) worth? The entire process is about bringing a true product through to a new standard-of-care curve.

Trust is the most important thing to earn with investors, and there is zero tolerance for a lack of trust. Share your vision as the inventor with investors, who want to know where this category could be in the next 5 or 10 years. Clinical data will always win, and health care investors and industry leaders should be focused on executing the most robust clinical data to demonstrate the clearest potential clinical outcome. Investors will follow a good plan that has been developed to achieve FDA approval, successful commercialization or “go to market” launch, and eventual reimbursement to support a true standard-of-care change.

Failure is defined by inaction

The 3 case studies that I have shared were success stories because the ideas and inventions were acted upon. When I was at Genzyme, we built the company up to more than $1 billion in revenue. We commercialized proteins in over 50 countries. Most importantly, many patients benefited from the innovation. If you have an invention and an idea, act on it—and surround yourself with great people in every discipline. Having the right people and team is extremely important. ●

© TRENDOBJECTS/SHUTTERSTOCK

I often say that there are both “guardrail” days and very good days when it comes to the ins and outs of health care builds and product launches. The process is much like starting down the path of a country road in the middle of a blizzard—unless you have dependable wipers and a good defrost system, that path can get murky very quickly. With this article I hope to offer my counsel to inventors, featuring a few of my prior launches as well as case studies of health care launches I was not involved with, and sharing the lessons learned and hurdles that were overcome. I encourage all entrepreneurs to act on their ideas because, in the world of health care startups, the only failure is not acting on an invention.

Case study 1: Cerezyme

Today, Cerezyme is indicated for patients with Gaucher, which is a lysosomal storage disorder. Cerezyme’s first-generation product, called Ceredase, was a human tissue-derived protein that we extracted from human placentas. At the time, the concept of moving this program forward was denied by the Board of Directors because they said that even if you could collect enough placentas to make the enzyme, it would be too expensive to manufacture. In fact, early scale-up modeling for manufacturing the protein demonstrated that Genzyme would need 4 tons of placentas per Gaucher patient per year.

Gaucher is a severe, early-onset disease that has a significant negative outcome for patients. Patients with Gaucher are in dire need of treatment. Genzyme went forward with the Ceredase program by financing it through the families of patients with the disease, by starting an LLC separate from the business and funding the initial clinical trial and the development of the protein through the families of Gaucher patients. That approach was a successful endeavor. A great example of a creative capital structure to advance a program.

This was in the late 1980s/early 1990s, and at the height of the AIDS challenge. Genzyme based the manufacturing in Lille, France, and we cryopreserved placentas in the United States and Europe and shipped them to Lille to be processed into therapy. Genzyme eventually received approval for Ceredase from the US Food and Drug Administration (FDA) and the European Medicines Agency. At the height of the placenta collection, we were gathering about 10% to 15% of the placentas in the United States and 30% to 40% of the placentas in Europe. Resources supply became an issue until we developed a recombinant form of the protein, accomplished by using a manufacturing system called a CHO cell line.

This is a very good success story: If this invention was not pursued, Gaucher patients would not benefit from the treatment today. In addition, there are a plethora of patients with different lysosomal storage disorders treated with additional proteins that have been aided by us going through the entire development, manufacturing, and global commercialization process. We figured out how to manufacture and deliver the treatment, working through multiple countries’ political systems, and today the therapy is paid for by insurance and government systems on a worldwide basis.

Continue to: Case study 2...

Case study 2: ThinPrep

I like to use the approval of ThinPrep as an example of avoiding a false negative—a stoppage in the development of the product or drug for the wrong reasons. False negatives, in my mind, occur when you are developing a technology and you run into issues during the clinical phase and/or with FDA approval, or with a technical failure or you run out of capital prior to knowing whether or not the innovation actually works. In the case of ThinPrep, a poorly run clinical trial almost resulted in a false negative.

The company at the time was Cytyc, and an initial clinical study presented to the FDA yielded a neutral-negative outcome. The FDA said that there were not enough data to show the differentiation from the current Pap smear standard of care.

The founders of the company at that time had inherited the study protocol from a prior leadership team, so they had to finish the trial with the initial protocol. Given the FDA’s advisement, they developed a new trial. It took the persistence of these two founders, who mortgaged their homes and spent their personal dollars to take this through the next wave of clinical development. In the end it was successful. The revised clinical trial yielded an approval for ThinPrep, which is now considered a standard of care.

The use of ThinPrep reduced cervical cancer deaths by 40% from preapproval. The challenging path from clinical development to eventual commercial launch and physician leadership in advancing patient care makes the story of ThinPrep a great example of not allowing an early false negative of a poorly designed and run clinical trial stop important innovation.

Case study 3: Cologuard

The development of Cologuard is a case study demonstrating that, sometimes, when your first attempt does not work, you need to have the persistence to raise additional capital and/or use a slightly different technical approach. The approval story of Cologuard is important to share because it is an important cancer screening diagnostic, using DNA from stool samples to test for colon cancer, giving access to important colon cancer screening to many patients. Currently, caregivers are only scraping the surface with Cologuard’s ability to screen the population. There are many more patients that need access to the test, and I believe they will get it in the years ahead.

Cologuard went through a first- and second-generational technical failure. They could not get the test’s specificity and sensitivity to be at the level of a screening tool; there were too many false-positive results. With the third iteration came the technical breakthrough, and a very large, expensive study was conducted—one the leadership team was criticized for. However, that study yielded the data that achieved a New England Journal of Medicine article, and reimbursement support across the country. The combination of the right technical team and the right leadership team, who planned a proper commercial launch, with a CEO that supported the extensive clinical study, has resulted in the fourth generation of Cologuard—an important breakthrough offering a very useful new standard of care in colon cancer detection and screening.

Continue to: Pearls for moving your innovations forward...

Pearls for moving your innovations forward

Because of my experience in undergoing health care start-ups, and contributing to several of those advancements of innovation, many inventors approach me for advice on their paths from idea to full-concept company. Here are a few of my lessons learned.

Consider purpose, not financial gain, first and foremost. Financial gain is typically the by-product or outcome of a standard-of-care breakthrough for inventors, but it’s a very hard road. Pursue your invention for advancing patient care and moving a new standard of care forward in health care versus financial gain at the end.

Determine whether your invention is a product or a company, or potentially, not capitalizable at all. Figure this out early. Analyze your idea to make sure it is sound and truly novel. Analyze the competition and to make sure it is sound and truly novel. Analyze the competition and the market dynamics to support a new product. Can the development path be defined very clearly to raise capital? Is your innovation a big enough breakthrough in the market with several current products to actually make a difference in patient outcomes (and eventually achieve product reimbursement)? The creation of a company may be the right strategy if the innovation can support a differentiated enough breakthrough where you can actually support all the infrastructure to build the business. If you find that the market is not there to support and develop your idea to eventual success, backing off early is important to preserve invested capital.

Protect early. Is your invention patentable, or has someone else already thought of the idea? What kind of patent(s) are appropriate? Where, geographically, do you want to protect your invention? Find a good patent attorney in your local area, early in the process, to help you answer all of these critical questions. Patents are expensive to file and maintain, but it is not expensive to do a literature search to find out if your idea is novel. A provisional patent, which would be your first step, is an important cost-effective step.

Capital is out there. If your invention or idea deserves capital, it is available. I will address raising capital in more detail in the next section.

Consider regulatory and manufacturing as achievable hurdles. Inventors often get tripped up here, considering the regulatory hurdles and manufacturing too challenging and abandoning their ideas because the risk is too great. Regulatory and manufacturing are very important aspects of health care standard-of-care builds. Cutting corners is not an option. That said, regulatory and manufacturing should not stop you. Challenges often can be worked through as long as the clinical need is there, and the clinical data support bringing that technology forward.

Consider corporate partnerships. I am a fan of corporate partners. But which ones should you target, and when and why? Corporate partnerships can bring significant capital, which is great, but there is enough investor capital out there that you should not pursue a corporate partner just for capital. The main benefit of a corporate partner is enterprise intellect. They typically know more about the field that you are entering than the investors or a small company leadership team.

Establish and listen to advisors. When thinking about who to trust, research their track record. Advisors who have gone through this process before, and specifically in your product area, are important to have access to.

Persistence is key. I have observed a tremendous “compression of innovation” in the health care areas that I have been involved with—human tissue-derived proteins, robotic surgery, stem cell therapy, and digital health (which is still in its infancy). For each of these breakthrough categories, early on, it appeared that it couldn’t be done. However, after the first 2 or 3 major breakthroughs in each one of these areas, a compression of innovation occurred. For instance, after approximately 15 years of protein development, we came out with the recombinant manufacturing systems for proteins. Very quickly, within 10 years, there were more than 70 proteins on the market. The persistence of the inventors to overcome early obstacles in each of these health care areas was critical to future success in each area.

Continue to: Raising capital...

Raising capital

There are different investors who specialize in different types of investment opportunities. The first phase of raising capital is the seed round—where there is typically early data, or even no data and just a concept. From this seed round forward, there is less risk as you develop your technology; thus, there are different investors that support different stages of development and that specialize in different types of investing. It is important to target the right investors and raise enough capital to be able to go achieve multiple operational milestones. Otherwise, when you go through your first round of capital, or the Series A or B financing rounds, there may not be a set of investors out there to fund the company moving forward. Health care investors will make it known that they invest in certain rounds of capital. You can determine who those investors are by doing a search online.

A mistake health care inventors can make is not taking enough capital from investors, because they are concerned about dilution. I advise investors not to focus on dilution but rather on, how big can you make “the pie” (value of the company) worth? The entire process is about bringing a true product through to a new standard-of-care curve.

Trust is the most important thing to earn with investors, and there is zero tolerance for a lack of trust. Share your vision as the inventor with investors, who want to know where this category could be in the next 5 or 10 years. Clinical data will always win, and health care investors and industry leaders should be focused on executing the most robust clinical data to demonstrate the clearest potential clinical outcome. Investors will follow a good plan that has been developed to achieve FDA approval, successful commercialization or “go to market” launch, and eventual reimbursement to support a true standard-of-care change.

Failure is defined by inaction

The 3 case studies that I have shared were success stories because the ideas and inventions were acted upon. When I was at Genzyme, we built the company up to more than $1 billion in revenue. We commercialized proteins in over 50 countries. Most importantly, many patients benefited from the innovation. If you have an invention and an idea, act on it—and surround yourself with great people in every discipline. Having the right people and team is extremely important. ●