BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.

This was an unexpected result.

Bruce Jancin/Frontline Medical News

BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.

This was an unexpected result.

Bruce Jancin/Frontline Medical News

BARCELONA – Bag-mask ventilation for airway management during resuscitation of patients with out-of-hospital cardiac arrest was considerably less safe and yet no more effective than endotracheal intubation in a large randomized trial, Frederic Adnet, MD, reported at the annual congress of the European Society of Cardiology.

This was an unexpected result.

Bruce Jancin/Frontline Medical News

Gynecologic surgeons who trained in the early 1990s may feel that the practice of gynecologic surgery seemed simpler back then. There were really only 2 ways to perform a hysterectomy: vaginally (TVH—total vaginal hysterectomy) and abdominally (TAH—total abdominal hysterectomy). Global endometrial ablation devices were not an established treatment for abnormal uterine bleeding, and therapeutic advancements such as hormonally laden intrauterine devices, vaginal mesh kits, and surgical robots did not exist. The options in the surgical toolbox were limited, and the general expectation in residency was long hours. During that period, consistent exposure to the operating room and case volume allowed one to graduate confidant in one’s surgical skills.

Illustration: Kimberly Martens for OBG Management

The changing landscape of gynecologic surgery

Fast-forward to 2017. Now, so many variables affect the ability to produce a well-trained gynecologic surgeon. In fact, in 2015 Guntupalli and colleagues studied the preparedness of ObGyn residents for fellowship training in the 4 subspecialties of female pelvic medicine and reconstructive surgery, gynecologic oncology, maternal-fetal medicine, and reproductive endocrinology-infertility.¹ Through a validated survey of fellowship program directors, the authors found that only 20% of first-year fellows were able to perform a vaginal hysterectomy independently, and 46%, an abdominal hysterectomy. Barely 50% of first-year fellows in all subspecialties studied could independently set up a retractor for laparotomy and appropriately pack and mobilize the bowel for pelvic surgery.¹

Today the hysterectomy procedure has become the proverbial alphabet soup. Trainees are confronted with having to learn not only the TVH and the TAH but also the LAVH (laparoscopic-assisted vaginal hysterectomy), LSH (laparoscopic supracervical hysterectomy), TLH (total laparoscopic hysterectomy), and RALH (robot-assisted laparoscopic hysterectomy).² With a mandated 80-hour residency workweek restriction and an increasing number of minimally invasive hysterectomies performed nationally, a perfect storm exists for critically evaluating the current paradigm of resident and fellow surgical training.³

One may wonder if current controversies surrounding many of the technologic advancements in gynecologic surgery result from inadequate training and too many treatment options or from flaws in the actual devices. A “see one, do one, teach one” approach to assimilating surgical skills is no longer an accepted approach, and although the “10,000-hour rule” of focused practice to attain expertise makes sense, how can a trainee gain enough exposure to achieve competency?

Related article:
The Extracorporeal C-Incision Tissue Extraction (ExCITE) technique

Simulation: A creditable training tactic

This is where simulation—whether low or high fidelity—potentially can fill in some of those training gaps. Simulation in medicine is a proven instructional design strategy in which learning is an active and experiential process. Studies clearly have shown that simulation-based medical education (SBME) with deliberate practice is superior to traditional clinical medical education in achieving specific clinical skill acquisition goals.⁴

This special Update on minimally invasive gynecologic surgery offers a 30,000-foot overview of the current state of simulation in gynecologic surgical training. Equally important to this conversation is the process by which a trained individual can obtain the appropriate credentials and subsequent privileging to perform various surgical procedures. Simulation has begun to play a significant role not only in an individual’s initial credentialing and privileging in surgery but also in maintaining those privileges.

Read about the evolving role of simulation in gyn surgery training.

Simulation's evolving role in gyn surgery training

Recently, the traditional model of gynecologic surgical training has been impacted by the exponential growth of technology (surgical devices), increased surgical options, and the limited work hours of trainees. As a result, simulation-based medical education has been identified as a potential solution to address deficits in surgical training. Fortunately, all modalities of surgery are now amenable to improvements in surgical education via simulation.⁵

Although basic skill training in the standard areas of hand-eye coordination, tissue handling, and instrument use still is prerequisite, the integration of both low- and high-fidelity simulation technologies--with enhanced functionality--now allows for a more comprehensive approach to understanding surgical anatomy. In addition, simulation training provides the opportunity for independent practice of full surgical procedures and, in many instances, offers objective and instantaneous assessment feedback for the learner. This discussion highlights some of the relevant literature on simulation training and the impact of surgical simulation on hysteroscopy and laparoscopy. 

Box trainers and virtual reality simulators in hysteroscopy training 

Hysteroscopic surgery allows direct endoscopic visualization of the uterine cavity for both diagnostic and therapeutic purposes. While the majority of these procedures are generally low risk, operative hysteroscopic experience minimizes the possibility of significant procedure-related complications, such as uterine perforation.⁵ The literature repeatedly shows that significant differences exist in skill and sense of preparedness between the novice or inexperienced surgeon (resident trainee) and the expert in hysteroscopic surgery.^6-8

Both low- and high-fidelity hysteroscopic simulators can be used to fine-tune operator skills. Low-fidelity simulators such as box trainers, which focus on skills like endometrial ablation and hysteroscopic resection with energy, have been shown to measurably improve performance, and they are well-received by participants. Low-fidelity simulations that incorporate vegetable/fruit or animal models (for example, porcine bladders and cattle uteri) have also been employed with success.⁹

On the high-fidelity end, surgical trainees can now experience hysteroscopic surgery simulation through virtual reality simulators, which have evolved with improvements in technology (FIGURE 1). Many high-fidelity simulators have been developed, and technical skill and theoretical knowledge improve with their use. Overall, trainees have provided positive feedback regarding the realism and training capacity afforded by virtual reality simultors.^10,11

Various simulators are equipped with complete training curriculums that focus on essential surgical skills. Common troubleshooting techniques taught via simulator include establishing and maintaining clear views, detecting and coagulating bleeding sources, fluid management and handling, and instrument failure. Learners can perform these sessions repeatedly, independent of their respective starting skill level. On completion of simulation training, the trainee is given objective performance assessments on economy of motion, visualization, safety, fluid handling, and other skills. 

Related article:
ExCITE: Minimally invasive tissue extraction made simple with simulation

Learning the complexities of laparoscopy through simulation

Laparoscopic surgery (both conventional and robot assisted) allows for a minimally invasive, cost-effective, and rapid-recovery approach to the management of many common gynecologic conditions. In both approaches, the learning curve to reach competency is steep. Conventional laparoscopy requires unique surgical skills, including adapting to a 2-dimensional field with altered depth perception; this creates challenges in spatial reasoning and achieving proficiency in video-eye-hand coordination as a result of the fulcrum effect inherent in laparoscopic instrumentation. This is further complicated by the essential dexterity required to complete dissections and suturing.^12,13

Robot-assisted laparoscopic surgery requires significant modifications to adapt to a 3-dimensional view. In addition, this approach incorporates another level of complexity (and challenge to attaining mastery), namely, using remotely controlled multiple instrument arms with no tactile feedback.

Importantly, some residency training programs are structured unevenly, emphasizing one or the other surgical modality.¹⁴ As a result, this propagates certain skills--or lack thereof--on graduation, and thus highlights potential areas of laparoscopic training that need to be improved and enhanced. 

Increasing the learning potential 

The growing integration of low- and high-fidelity simulation training in laparoscopic surgery has led to improved skill acquisition.^12,13,15,16 A well-established low-fidelity simulation model is the Fundamentals of Laparoscopic Surgery module, through which trainees are taught vital psychomotor skills via a validated box trainer that is also supported by a cognitive component (FIGURE 2).^17,18

The advent of laparoscopic virtual reality training systems has raised the learning potential further, even for experienced surgeons. Some benefits of virtual reality simulation in conventional laparoscopy include education on an interactive 3D pelvis, step-by-step procedural guidance, a comprehensive return of performance metrics on vital laparoscopic skills, and the incorporation of advanced skills such as laparoscopic suturing, complex dissections, and lysis of adhesions.

In the arena of robot-assisted procedures, simulation modules are available for learning fundamental skill development in hand-eye coordination, depth perception, bimanual manipulation, camera navigation, and wrist articulation.

In both conventional and robot-assisted laparoscopy simulation pathways, complete procedural curriculums (for example, hysterectomy with adnexectomy) are available. Thus, learners can start a procedure or technique at a point applicable to them, practice repeatedly until competency, and eventually become proficient (FIGURE 3).

Generally, high-fidelity computerized simulators provide a comprehensive performance report on completion of training, along with a complete recording of the trainee's encounter during accruement of skill. Most importantly, laparoscopic training via simulation has been validated to translate into improved operating room performance by impacting operating times, safety profiles, and surgical skill growth.^15,19 

Related article:
Complete colpectomy & colpocleisis: Model for simulation

Simulation is a mainstream training tool

The skills gap between expert surgeons and new trainees continues to widen. A comprehensive educational pathway that provides an optimistic safety profile, abides by time constraints, and elevates skill sets will fall to simulation-based surgical training.20,21 Surgical competence is defined not simply by observation and Halstedian technique but by a combination of cognitive and behavioral abilities as well as perceptual and psychomotor skills. It is impractical to expect current learners to become proficient in visuospatial and tactile perception and to demonstrate technical competency without supplementing their training.22-24 Ultimately, as experience with both low- and high-fidelity surgical simulation grows, the predictive validity of this type of training pathway will become more readily apparent. In other words, improved performance in the simulated environment will translate into improved performance in the operating room.

Read about how gyn surgery simulation is being incorporated into credentialing and privileging

Incorporating gyn surgery simulation into credentialing and privileging

Over the last 25 years surgeons have seen unprecedented changes in technology that have revolutionized our surgical approaches to common gynecologic conditions. In the past, granting surgical privileges was pretty straightforward. Surgeons were granted privileges based on successfully completing their training, and subsequent renewal of those privileges was based on not having any significant misadventures or complications. With the advent of laparoscopy, hysteroscopy, and then robot-assisted surgery, training surgeons and verifying their competency has become much more complicated. The variety of surgical approaches now being taught coupled with reduced resident training time and decreasing case volumes have significantly impacted the traditional methodologies of surgical training.^25,26

Related article:
How the AAGL is trying to improve outcomes for patients undergoing robot-assisted gynecologic surgery

High-tech surgery demands high-tech training

The development of high-tech surgical approaches has been accompanied by the natural development of simulation models to help with training. Initially, inanimate models, animal labs, and cadavers were used. Over the last 15 years, several innovative companies have developed virtual reality simulation platforms for laparoscopy, hysteroscopy, and even robotics.²⁷ These virtual reality simulators allow students to develop the psychomotor skills necessary to perform minimally invasive procedures and to practice those skills until they can demonstrate proficiency before operating on a live patient.

Most would agree that the key to learning a surgical skill is to "practice, practice, practice."²⁸ Many studies have shown that improvement in surgical outcomes is clearly related to a surgeon's case volume.^29,30 But with case volumes decreased, simulation has evolved as the best training alternative. Current surgical simulators enable a student to engage in "deliberate practice"; that is, to have tasks with well-defined goals, to be motivated to improve, and to receive immediate feedback along with opportunities for repetition and refinements of performance.

Simulation allows students to try different surgical techniques and to use "deliberate practice" avoidance of errors in a controlled, safe situation that provides immediate performance feedback.³¹ Currently, virtual reality simulators are available for hysteroscopy, laparoscopy, and robot-assisted gynecologic applications. Early models focused solely on developing a learner's psychomotor skills necessary to safely perform minimally invasive surgeries. Newer simulators add a cognitive component to help students learn specific procedures, such as adnexectomy and hysterectomy.³²

Based on the aviation simulator training model, the AAGL endorsed a Gynecologic Robotic Surgery Credentialing and Privileging Guideline in 2014; this guidance relies heavily on simulation for initial training as well as for subsequent annual recertification.³³ Many institutions, including the MultiCare Health System in Tacoma, Washington, require all surgeons--even high-volume surgeons--to demonstrate proficiency annually by passing required robotic simulation exercises at least 2 times consecutively in order to maintain robotic surgery privileges.³⁴

A work-around for a simulation drawback

Using simulation for recertification has been criticized because, although it can confirm that a surgeon is skilled enough to operate the tool, it does not evaluate surgical judgment or technique. In response, crowdsourced review of an individual surgeon's surgical videos has proven to be a useful, dependable way to give a surgeon direct feedback regarding his or her performance on a live patient.³⁵ Many institutions now use this technology not only for initial training but also for helping surgeons improve with direct feedback from master surgeon reviewers. Other institutions have considered replacing annual re-credentialing case volume requirements with this technology, which actually assesses competence in a more accurate way.³⁶

Related article:
Flight plan for robotic surgery credentialing: New AAGL guidelines

A new flight plan

The bottom line is that the training and annual recertification of future surgeons now mimics closely the pathway that all airplane pilots are required to follow.

Initial training will require mastery of surgical techniques using a simulator before taking a "solo flight" on a live patient.

Maintenance of privileges now requires either large case volumes or skills testing on a simulator. Many institutions now also require an annual "check ride," such as a crowdsourced video review of a surgeon's cases, as described above.

Re-credentialing. Just as the "see one, do one, teach one" model is now part of our historical legacy, re-credentialing simply by avoiding misadventures and staying out of trouble will go the way of paper medical records. Our future will certainly require an annual objective evaluation of good surgical judgment and surgical technique proficiency. Surgical simulation will be the norm for all of us.  

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Gynecologic surgeons who trained in the early 1990s may feel that the practice of gynecologic surgery seemed simpler back then. There were really only 2 ways to perform a hysterectomy: vaginally (TVH—total vaginal hysterectomy) and abdominally (TAH—total abdominal hysterectomy). Global endometrial ablation devices were not an established treatment for abnormal uterine bleeding, and therapeutic advancements such as hormonally laden intrauterine devices, vaginal mesh kits, and surgical robots did not exist. The options in the surgical toolbox were limited, and the general expectation in residency was long hours. During that period, consistent exposure to the operating room and case volume allowed one to graduate confidant in one’s surgical skills.

Illustration: Kimberly Martens for OBG Management

The changing landscape of gynecologic surgery

Fast-forward to 2017. Now, so many variables affect the ability to produce a well-trained gynecologic surgeon. In fact, in 2015 Guntupalli and colleagues studied the preparedness of ObGyn residents for fellowship training in the 4 subspecialties of female pelvic medicine and reconstructive surgery, gynecologic oncology, maternal-fetal medicine, and reproductive endocrinology-infertility.¹ Through a validated survey of fellowship program directors, the authors found that only 20% of first-year fellows were able to perform a vaginal hysterectomy independently, and 46%, an abdominal hysterectomy. Barely 50% of first-year fellows in all subspecialties studied could independently set up a retractor for laparotomy and appropriately pack and mobilize the bowel for pelvic surgery.¹

Today the hysterectomy procedure has become the proverbial alphabet soup. Trainees are confronted with having to learn not only the TVH and the TAH but also the LAVH (laparoscopic-assisted vaginal hysterectomy), LSH (laparoscopic supracervical hysterectomy), TLH (total laparoscopic hysterectomy), and RALH (robot-assisted laparoscopic hysterectomy).² With a mandated 80-hour residency workweek restriction and an increasing number of minimally invasive hysterectomies performed nationally, a perfect storm exists for critically evaluating the current paradigm of resident and fellow surgical training.³

One may wonder if current controversies surrounding many of the technologic advancements in gynecologic surgery result from inadequate training and too many treatment options or from flaws in the actual devices. A “see one, do one, teach one” approach to assimilating surgical skills is no longer an accepted approach, and although the “10,000-hour rule” of focused practice to attain expertise makes sense, how can a trainee gain enough exposure to achieve competency?

Related article:
The Extracorporeal C-Incision Tissue Extraction (ExCITE) technique

Simulation: A creditable training tactic

This is where simulation—whether low or high fidelity—potentially can fill in some of those training gaps. Simulation in medicine is a proven instructional design strategy in which learning is an active and experiential process. Studies clearly have shown that simulation-based medical education (SBME) with deliberate practice is superior to traditional clinical medical education in achieving specific clinical skill acquisition goals.⁴

This special Update on minimally invasive gynecologic surgery offers a 30,000-foot overview of the current state of simulation in gynecologic surgical training. Equally important to this conversation is the process by which a trained individual can obtain the appropriate credentials and subsequent privileging to perform various surgical procedures. Simulation has begun to play a significant role not only in an individual’s initial credentialing and privileging in surgery but also in maintaining those privileges.

Read about the evolving role of simulation in gyn surgery training.

Simulation's evolving role in gyn surgery training

Recently, the traditional model of gynecologic surgical training has been impacted by the exponential growth of technology (surgical devices), increased surgical options, and the limited work hours of trainees. As a result, simulation-based medical education has been identified as a potential solution to address deficits in surgical training. Fortunately, all modalities of surgery are now amenable to improvements in surgical education via simulation.⁵

Although basic skill training in the standard areas of hand-eye coordination, tissue handling, and instrument use still is prerequisite, the integration of both low- and high-fidelity simulation technologies--with enhanced functionality--now allows for a more comprehensive approach to understanding surgical anatomy. In addition, simulation training provides the opportunity for independent practice of full surgical procedures and, in many instances, offers objective and instantaneous assessment feedback for the learner. This discussion highlights some of the relevant literature on simulation training and the impact of surgical simulation on hysteroscopy and laparoscopy. 

Box trainers and virtual reality simulators in hysteroscopy training 

Hysteroscopic surgery allows direct endoscopic visualization of the uterine cavity for both diagnostic and therapeutic purposes. While the majority of these procedures are generally low risk, operative hysteroscopic experience minimizes the possibility of significant procedure-related complications, such as uterine perforation.⁵ The literature repeatedly shows that significant differences exist in skill and sense of preparedness between the novice or inexperienced surgeon (resident trainee) and the expert in hysteroscopic surgery.^6-8

Both low- and high-fidelity hysteroscopic simulators can be used to fine-tune operator skills. Low-fidelity simulators such as box trainers, which focus on skills like endometrial ablation and hysteroscopic resection with energy, have been shown to measurably improve performance, and they are well-received by participants. Low-fidelity simulations that incorporate vegetable/fruit or animal models (for example, porcine bladders and cattle uteri) have also been employed with success.⁹

On the high-fidelity end, surgical trainees can now experience hysteroscopic surgery simulation through virtual reality simulators, which have evolved with improvements in technology (FIGURE 1). Many high-fidelity simulators have been developed, and technical skill and theoretical knowledge improve with their use. Overall, trainees have provided positive feedback regarding the realism and training capacity afforded by virtual reality simultors.^10,11

Various simulators are equipped with complete training curriculums that focus on essential surgical skills. Common troubleshooting techniques taught via simulator include establishing and maintaining clear views, detecting and coagulating bleeding sources, fluid management and handling, and instrument failure. Learners can perform these sessions repeatedly, independent of their respective starting skill level. On completion of simulation training, the trainee is given objective performance assessments on economy of motion, visualization, safety, fluid handling, and other skills. 

Related article:
ExCITE: Minimally invasive tissue extraction made simple with simulation

Learning the complexities of laparoscopy through simulation

Laparoscopic surgery (both conventional and robot assisted) allows for a minimally invasive, cost-effective, and rapid-recovery approach to the management of many common gynecologic conditions. In both approaches, the learning curve to reach competency is steep. Conventional laparoscopy requires unique surgical skills, including adapting to a 2-dimensional field with altered depth perception; this creates challenges in spatial reasoning and achieving proficiency in video-eye-hand coordination as a result of the fulcrum effect inherent in laparoscopic instrumentation. This is further complicated by the essential dexterity required to complete dissections and suturing.^12,13

Robot-assisted laparoscopic surgery requires significant modifications to adapt to a 3-dimensional view. In addition, this approach incorporates another level of complexity (and challenge to attaining mastery), namely, using remotely controlled multiple instrument arms with no tactile feedback.

Importantly, some residency training programs are structured unevenly, emphasizing one or the other surgical modality.¹⁴ As a result, this propagates certain skills--or lack thereof--on graduation, and thus highlights potential areas of laparoscopic training that need to be improved and enhanced. 

Increasing the learning potential 

The growing integration of low- and high-fidelity simulation training in laparoscopic surgery has led to improved skill acquisition.^12,13,15,16 A well-established low-fidelity simulation model is the Fundamentals of Laparoscopic Surgery module, through which trainees are taught vital psychomotor skills via a validated box trainer that is also supported by a cognitive component (FIGURE 2).^17,18

The advent of laparoscopic virtual reality training systems has raised the learning potential further, even for experienced surgeons. Some benefits of virtual reality simulation in conventional laparoscopy include education on an interactive 3D pelvis, step-by-step procedural guidance, a comprehensive return of performance metrics on vital laparoscopic skills, and the incorporation of advanced skills such as laparoscopic suturing, complex dissections, and lysis of adhesions.

In the arena of robot-assisted procedures, simulation modules are available for learning fundamental skill development in hand-eye coordination, depth perception, bimanual manipulation, camera navigation, and wrist articulation.

In both conventional and robot-assisted laparoscopy simulation pathways, complete procedural curriculums (for example, hysterectomy with adnexectomy) are available. Thus, learners can start a procedure or technique at a point applicable to them, practice repeatedly until competency, and eventually become proficient (FIGURE 3).

Generally, high-fidelity computerized simulators provide a comprehensive performance report on completion of training, along with a complete recording of the trainee's encounter during accruement of skill. Most importantly, laparoscopic training via simulation has been validated to translate into improved operating room performance by impacting operating times, safety profiles, and surgical skill growth.^15,19 

Related article:
Complete colpectomy & colpocleisis: Model for simulation

Simulation is a mainstream training tool

The skills gap between expert surgeons and new trainees continues to widen. A comprehensive educational pathway that provides an optimistic safety profile, abides by time constraints, and elevates skill sets will fall to simulation-based surgical training.20,21 Surgical competence is defined not simply by observation and Halstedian technique but by a combination of cognitive and behavioral abilities as well as perceptual and psychomotor skills. It is impractical to expect current learners to become proficient in visuospatial and tactile perception and to demonstrate technical competency without supplementing their training.22-24 Ultimately, as experience with both low- and high-fidelity surgical simulation grows, the predictive validity of this type of training pathway will become more readily apparent. In other words, improved performance in the simulated environment will translate into improved performance in the operating room.

Read about how gyn surgery simulation is being incorporated into credentialing and privileging

Incorporating gyn surgery simulation into credentialing and privileging

Over the last 25 years surgeons have seen unprecedented changes in technology that have revolutionized our surgical approaches to common gynecologic conditions. In the past, granting surgical privileges was pretty straightforward. Surgeons were granted privileges based on successfully completing their training, and subsequent renewal of those privileges was based on not having any significant misadventures or complications. With the advent of laparoscopy, hysteroscopy, and then robot-assisted surgery, training surgeons and verifying their competency has become much more complicated. The variety of surgical approaches now being taught coupled with reduced resident training time and decreasing case volumes have significantly impacted the traditional methodologies of surgical training.^25,26

Related article:
How the AAGL is trying to improve outcomes for patients undergoing robot-assisted gynecologic surgery

High-tech surgery demands high-tech training

The development of high-tech surgical approaches has been accompanied by the natural development of simulation models to help with training. Initially, inanimate models, animal labs, and cadavers were used. Over the last 15 years, several innovative companies have developed virtual reality simulation platforms for laparoscopy, hysteroscopy, and even robotics.²⁷ These virtual reality simulators allow students to develop the psychomotor skills necessary to perform minimally invasive procedures and to practice those skills until they can demonstrate proficiency before operating on a live patient.

Most would agree that the key to learning a surgical skill is to "practice, practice, practice."²⁸ Many studies have shown that improvement in surgical outcomes is clearly related to a surgeon's case volume.^29,30 But with case volumes decreased, simulation has evolved as the best training alternative. Current surgical simulators enable a student to engage in "deliberate practice"; that is, to have tasks with well-defined goals, to be motivated to improve, and to receive immediate feedback along with opportunities for repetition and refinements of performance.

Simulation allows students to try different surgical techniques and to use "deliberate practice" avoidance of errors in a controlled, safe situation that provides immediate performance feedback.³¹ Currently, virtual reality simulators are available for hysteroscopy, laparoscopy, and robot-assisted gynecologic applications. Early models focused solely on developing a learner's psychomotor skills necessary to safely perform minimally invasive surgeries. Newer simulators add a cognitive component to help students learn specific procedures, such as adnexectomy and hysterectomy.³²

Based on the aviation simulator training model, the AAGL endorsed a Gynecologic Robotic Surgery Credentialing and Privileging Guideline in 2014; this guidance relies heavily on simulation for initial training as well as for subsequent annual recertification.³³ Many institutions, including the MultiCare Health System in Tacoma, Washington, require all surgeons--even high-volume surgeons--to demonstrate proficiency annually by passing required robotic simulation exercises at least 2 times consecutively in order to maintain robotic surgery privileges.³⁴

A work-around for a simulation drawback

Using simulation for recertification has been criticized because, although it can confirm that a surgeon is skilled enough to operate the tool, it does not evaluate surgical judgment or technique. In response, crowdsourced review of an individual surgeon's surgical videos has proven to be a useful, dependable way to give a surgeon direct feedback regarding his or her performance on a live patient.³⁵ Many institutions now use this technology not only for initial training but also for helping surgeons improve with direct feedback from master surgeon reviewers. Other institutions have considered replacing annual re-credentialing case volume requirements with this technology, which actually assesses competence in a more accurate way.³⁶

Related article:
Flight plan for robotic surgery credentialing: New AAGL guidelines

A new flight plan

The bottom line is that the training and annual recertification of future surgeons now mimics closely the pathway that all airplane pilots are required to follow.

Initial training will require mastery of surgical techniques using a simulator before taking a "solo flight" on a live patient.

Maintenance of privileges now requires either large case volumes or skills testing on a simulator. Many institutions now also require an annual "check ride," such as a crowdsourced video review of a surgeon's cases, as described above.

Re-credentialing. Just as the "see one, do one, teach one" model is now part of our historical legacy, re-credentialing simply by avoiding misadventures and staying out of trouble will go the way of paper medical records. Our future will certainly require an annual objective evaluation of good surgical judgment and surgical technique proficiency. Surgical simulation will be the norm for all of us.  

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Gynecologic surgeons who trained in the early 1990s may feel that the practice of gynecologic surgery seemed simpler back then. There were really only 2 ways to perform a hysterectomy: vaginally (TVH—total vaginal hysterectomy) and abdominally (TAH—total abdominal hysterectomy). Global endometrial ablation devices were not an established treatment for abnormal uterine bleeding, and therapeutic advancements such as hormonally laden intrauterine devices, vaginal mesh kits, and surgical robots did not exist. The options in the surgical toolbox were limited, and the general expectation in residency was long hours. During that period, consistent exposure to the operating room and case volume allowed one to graduate confidant in one’s surgical skills.

Illustration: Kimberly Martens for OBG Management

The changing landscape of gynecologic surgery

Fast-forward to 2017. Now, so many variables affect the ability to produce a well-trained gynecologic surgeon. In fact, in 2015 Guntupalli and colleagues studied the preparedness of ObGyn residents for fellowship training in the 4 subspecialties of female pelvic medicine and reconstructive surgery, gynecologic oncology, maternal-fetal medicine, and reproductive endocrinology-infertility.¹ Through a validated survey of fellowship program directors, the authors found that only 20% of first-year fellows were able to perform a vaginal hysterectomy independently, and 46%, an abdominal hysterectomy. Barely 50% of first-year fellows in all subspecialties studied could independently set up a retractor for laparotomy and appropriately pack and mobilize the bowel for pelvic surgery.¹

Today the hysterectomy procedure has become the proverbial alphabet soup. Trainees are confronted with having to learn not only the TVH and the TAH but also the LAVH (laparoscopic-assisted vaginal hysterectomy), LSH (laparoscopic supracervical hysterectomy), TLH (total laparoscopic hysterectomy), and RALH (robot-assisted laparoscopic hysterectomy).² With a mandated 80-hour residency workweek restriction and an increasing number of minimally invasive hysterectomies performed nationally, a perfect storm exists for critically evaluating the current paradigm of resident and fellow surgical training.³

One may wonder if current controversies surrounding many of the technologic advancements in gynecologic surgery result from inadequate training and too many treatment options or from flaws in the actual devices. A “see one, do one, teach one” approach to assimilating surgical skills is no longer an accepted approach, and although the “10,000-hour rule” of focused practice to attain expertise makes sense, how can a trainee gain enough exposure to achieve competency?

Related article:
The Extracorporeal C-Incision Tissue Extraction (ExCITE) technique

Simulation: A creditable training tactic

This is where simulation—whether low or high fidelity—potentially can fill in some of those training gaps. Simulation in medicine is a proven instructional design strategy in which learning is an active and experiential process. Studies clearly have shown that simulation-based medical education (SBME) with deliberate practice is superior to traditional clinical medical education in achieving specific clinical skill acquisition goals.⁴

This special Update on minimally invasive gynecologic surgery offers a 30,000-foot overview of the current state of simulation in gynecologic surgical training. Equally important to this conversation is the process by which a trained individual can obtain the appropriate credentials and subsequent privileging to perform various surgical procedures. Simulation has begun to play a significant role not only in an individual’s initial credentialing and privileging in surgery but also in maintaining those privileges.

Read about the evolving role of simulation in gyn surgery training.

Simulation's evolving role in gyn surgery training

Recently, the traditional model of gynecologic surgical training has been impacted by the exponential growth of technology (surgical devices), increased surgical options, and the limited work hours of trainees. As a result, simulation-based medical education has been identified as a potential solution to address deficits in surgical training. Fortunately, all modalities of surgery are now amenable to improvements in surgical education via simulation.⁵

Although basic skill training in the standard areas of hand-eye coordination, tissue handling, and instrument use still is prerequisite, the integration of both low- and high-fidelity simulation technologies--with enhanced functionality--now allows for a more comprehensive approach to understanding surgical anatomy. In addition, simulation training provides the opportunity for independent practice of full surgical procedures and, in many instances, offers objective and instantaneous assessment feedback for the learner. This discussion highlights some of the relevant literature on simulation training and the impact of surgical simulation on hysteroscopy and laparoscopy. 

Box trainers and virtual reality simulators in hysteroscopy training 

Hysteroscopic surgery allows direct endoscopic visualization of the uterine cavity for both diagnostic and therapeutic purposes. While the majority of these procedures are generally low risk, operative hysteroscopic experience minimizes the possibility of significant procedure-related complications, such as uterine perforation.⁵ The literature repeatedly shows that significant differences exist in skill and sense of preparedness between the novice or inexperienced surgeon (resident trainee) and the expert in hysteroscopic surgery.^6-8

Both low- and high-fidelity hysteroscopic simulators can be used to fine-tune operator skills. Low-fidelity simulators such as box trainers, which focus on skills like endometrial ablation and hysteroscopic resection with energy, have been shown to measurably improve performance, and they are well-received by participants. Low-fidelity simulations that incorporate vegetable/fruit or animal models (for example, porcine bladders and cattle uteri) have also been employed with success.⁹

On the high-fidelity end, surgical trainees can now experience hysteroscopic surgery simulation through virtual reality simulators, which have evolved with improvements in technology (FIGURE 1). Many high-fidelity simulators have been developed, and technical skill and theoretical knowledge improve with their use. Overall, trainees have provided positive feedback regarding the realism and training capacity afforded by virtual reality simultors.^10,11

Various simulators are equipped with complete training curriculums that focus on essential surgical skills. Common troubleshooting techniques taught via simulator include establishing and maintaining clear views, detecting and coagulating bleeding sources, fluid management and handling, and instrument failure. Learners can perform these sessions repeatedly, independent of their respective starting skill level. On completion of simulation training, the trainee is given objective performance assessments on economy of motion, visualization, safety, fluid handling, and other skills. 

Related article:
ExCITE: Minimally invasive tissue extraction made simple with simulation

Learning the complexities of laparoscopy through simulation

Laparoscopic surgery (both conventional and robot assisted) allows for a minimally invasive, cost-effective, and rapid-recovery approach to the management of many common gynecologic conditions. In both approaches, the learning curve to reach competency is steep. Conventional laparoscopy requires unique surgical skills, including adapting to a 2-dimensional field with altered depth perception; this creates challenges in spatial reasoning and achieving proficiency in video-eye-hand coordination as a result of the fulcrum effect inherent in laparoscopic instrumentation. This is further complicated by the essential dexterity required to complete dissections and suturing.^12,13

Robot-assisted laparoscopic surgery requires significant modifications to adapt to a 3-dimensional view. In addition, this approach incorporates another level of complexity (and challenge to attaining mastery), namely, using remotely controlled multiple instrument arms with no tactile feedback.

Importantly, some residency training programs are structured unevenly, emphasizing one or the other surgical modality.¹⁴ As a result, this propagates certain skills--or lack thereof--on graduation, and thus highlights potential areas of laparoscopic training that need to be improved and enhanced. 

Increasing the learning potential 

The growing integration of low- and high-fidelity simulation training in laparoscopic surgery has led to improved skill acquisition.^12,13,15,16 A well-established low-fidelity simulation model is the Fundamentals of Laparoscopic Surgery module, through which trainees are taught vital psychomotor skills via a validated box trainer that is also supported by a cognitive component (FIGURE 2).^17,18

The advent of laparoscopic virtual reality training systems has raised the learning potential further, even for experienced surgeons. Some benefits of virtual reality simulation in conventional laparoscopy include education on an interactive 3D pelvis, step-by-step procedural guidance, a comprehensive return of performance metrics on vital laparoscopic skills, and the incorporation of advanced skills such as laparoscopic suturing, complex dissections, and lysis of adhesions.

In the arena of robot-assisted procedures, simulation modules are available for learning fundamental skill development in hand-eye coordination, depth perception, bimanual manipulation, camera navigation, and wrist articulation.

In both conventional and robot-assisted laparoscopy simulation pathways, complete procedural curriculums (for example, hysterectomy with adnexectomy) are available. Thus, learners can start a procedure or technique at a point applicable to them, practice repeatedly until competency, and eventually become proficient (FIGURE 3).

Generally, high-fidelity computerized simulators provide a comprehensive performance report on completion of training, along with a complete recording of the trainee's encounter during accruement of skill. Most importantly, laparoscopic training via simulation has been validated to translate into improved operating room performance by impacting operating times, safety profiles, and surgical skill growth.^15,19 

Related article:
Complete colpectomy & colpocleisis: Model for simulation

Simulation is a mainstream training tool

The skills gap between expert surgeons and new trainees continues to widen. A comprehensive educational pathway that provides an optimistic safety profile, abides by time constraints, and elevates skill sets will fall to simulation-based surgical training.20,21 Surgical competence is defined not simply by observation and Halstedian technique but by a combination of cognitive and behavioral abilities as well as perceptual and psychomotor skills. It is impractical to expect current learners to become proficient in visuospatial and tactile perception and to demonstrate technical competency without supplementing their training.22-24 Ultimately, as experience with both low- and high-fidelity surgical simulation grows, the predictive validity of this type of training pathway will become more readily apparent. In other words, improved performance in the simulated environment will translate into improved performance in the operating room.

Read about how gyn surgery simulation is being incorporated into credentialing and privileging

Incorporating gyn surgery simulation into credentialing and privileging

Over the last 25 years surgeons have seen unprecedented changes in technology that have revolutionized our surgical approaches to common gynecologic conditions. In the past, granting surgical privileges was pretty straightforward. Surgeons were granted privileges based on successfully completing their training, and subsequent renewal of those privileges was based on not having any significant misadventures or complications. With the advent of laparoscopy, hysteroscopy, and then robot-assisted surgery, training surgeons and verifying their competency has become much more complicated. The variety of surgical approaches now being taught coupled with reduced resident training time and decreasing case volumes have significantly impacted the traditional methodologies of surgical training.^25,26

Related article:
How the AAGL is trying to improve outcomes for patients undergoing robot-assisted gynecologic surgery

High-tech surgery demands high-tech training

The development of high-tech surgical approaches has been accompanied by the natural development of simulation models to help with training. Initially, inanimate models, animal labs, and cadavers were used. Over the last 15 years, several innovative companies have developed virtual reality simulation platforms for laparoscopy, hysteroscopy, and even robotics.²⁷ These virtual reality simulators allow students to develop the psychomotor skills necessary to perform minimally invasive procedures and to practice those skills until they can demonstrate proficiency before operating on a live patient.

Most would agree that the key to learning a surgical skill is to "practice, practice, practice."²⁸ Many studies have shown that improvement in surgical outcomes is clearly related to a surgeon's case volume.^29,30 But with case volumes decreased, simulation has evolved as the best training alternative. Current surgical simulators enable a student to engage in "deliberate practice"; that is, to have tasks with well-defined goals, to be motivated to improve, and to receive immediate feedback along with opportunities for repetition and refinements of performance.

Simulation allows students to try different surgical techniques and to use "deliberate practice" avoidance of errors in a controlled, safe situation that provides immediate performance feedback.³¹ Currently, virtual reality simulators are available for hysteroscopy, laparoscopy, and robot-assisted gynecologic applications. Early models focused solely on developing a learner's psychomotor skills necessary to safely perform minimally invasive surgeries. Newer simulators add a cognitive component to help students learn specific procedures, such as adnexectomy and hysterectomy.³²

Based on the aviation simulator training model, the AAGL endorsed a Gynecologic Robotic Surgery Credentialing and Privileging Guideline in 2014; this guidance relies heavily on simulation for initial training as well as for subsequent annual recertification.³³ Many institutions, including the MultiCare Health System in Tacoma, Washington, require all surgeons--even high-volume surgeons--to demonstrate proficiency annually by passing required robotic simulation exercises at least 2 times consecutively in order to maintain robotic surgery privileges.³⁴

A work-around for a simulation drawback

Using simulation for recertification has been criticized because, although it can confirm that a surgeon is skilled enough to operate the tool, it does not evaluate surgical judgment or technique. In response, crowdsourced review of an individual surgeon's surgical videos has proven to be a useful, dependable way to give a surgeon direct feedback regarding his or her performance on a live patient.³⁵ Many institutions now use this technology not only for initial training but also for helping surgeons improve with direct feedback from master surgeon reviewers. Other institutions have considered replacing annual re-credentialing case volume requirements with this technology, which actually assesses competence in a more accurate way.³⁶

Related article:
Flight plan for robotic surgery credentialing: New AAGL guidelines

A new flight plan

The bottom line is that the training and annual recertification of future surgeons now mimics closely the pathway that all airplane pilots are required to follow.

Initial training will require mastery of surgical techniques using a simulator before taking a "solo flight" on a live patient.

Maintenance of privileges now requires either large case volumes or skills testing on a simulator. Many institutions now also require an annual "check ride," such as a crowdsourced video review of a surgeon's cases, as described above.

Re-credentialing. Just as the "see one, do one, teach one" model is now part of our historical legacy, re-credentialing simply by avoiding misadventures and staying out of trouble will go the way of paper medical records. Our future will certainly require an annual objective evaluation of good surgical judgment and surgical technique proficiency. Surgical simulation will be the norm for all of us.  

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Uninsured patients made up a smaller share of the average physician’s practice in 2016 than in 2012, according to a survey by the American Medical Association.

For the average practice in 2016, 6.1% of patients were uninsured, compared with 6.9% in 2012. That significant drop of 0.8 percentage points was accompanied by significant increases in the number of patients covered by Medicaid and by private insurance, the AMA said in a report released Oct. 30.

“The overall picture from new physician-reported data is of more patients covered and fewer uninsured, but the findings also indicate that the improvement along those lines was concentrated in states that expanded their Medicaid programs under the ACA,” said David O. Barbe, MD, AMA president.

[email protected]

Uninsured patients made up a smaller share of the average physician’s practice in 2016 than in 2012, according to a survey by the American Medical Association.

For the average practice in 2016, 6.1% of patients were uninsured, compared with 6.9% in 2012. That significant drop of 0.8 percentage points was accompanied by significant increases in the number of patients covered by Medicaid and by private insurance, the AMA said in a report released Oct. 30.

“The overall picture from new physician-reported data is of more patients covered and fewer uninsured, but the findings also indicate that the improvement along those lines was concentrated in states that expanded their Medicaid programs under the ACA,” said David O. Barbe, MD, AMA president.

[email protected]

Uninsured patients made up a smaller share of the average physician’s practice in 2016 than in 2012, according to a survey by the American Medical Association.

For the average practice in 2016, 6.1% of patients were uninsured, compared with 6.9% in 2012. That significant drop of 0.8 percentage points was accompanied by significant increases in the number of patients covered by Medicaid and by private insurance, the AMA said in a report released Oct. 30.

“The overall picture from new physician-reported data is of more patients covered and fewer uninsured, but the findings also indicate that the improvement along those lines was concentrated in states that expanded their Medicaid programs under the ACA,” said David O. Barbe, MD, AMA president.

[email protected]

Mortality from systemic lupus erythematosus has declined since 1968 in the United States, but not as markedly as rates of death from other causes, according to a study in Annals of Internal Medicine.

Furthermore, systemic lupus erythematosus (SLE) mortality varied significantly by sex, race, and geographic region, noted Eric Y. Yen, MD, and his associates at the University of California, Los Angeles. Mortality from SLE was highest among females, black individuals, and those who lived in the South. Multivariable analyses confirmed that sex, race, and geographic region were independent risk factors for SLE mortality and that race modified relationships among SLE mortality, sex, and geographic region.

wildpixel/Thinkstock

Mortality from systemic lupus erythematosus has declined since 1968 in the United States, but not as markedly as rates of death from other causes, according to a study in Annals of Internal Medicine.

Furthermore, systemic lupus erythematosus (SLE) mortality varied significantly by sex, race, and geographic region, noted Eric Y. Yen, MD, and his associates at the University of California, Los Angeles. Mortality from SLE was highest among females, black individuals, and those who lived in the South. Multivariable analyses confirmed that sex, race, and geographic region were independent risk factors for SLE mortality and that race modified relationships among SLE mortality, sex, and geographic region.

wildpixel/Thinkstock

Mortality from systemic lupus erythematosus has declined since 1968 in the United States, but not as markedly as rates of death from other causes, according to a study in Annals of Internal Medicine.

Furthermore, systemic lupus erythematosus (SLE) mortality varied significantly by sex, race, and geographic region, noted Eric Y. Yen, MD, and his associates at the University of California, Los Angeles. Mortality from SLE was highest among females, black individuals, and those who lived in the South. Multivariable analyses confirmed that sex, race, and geographic region were independent risk factors for SLE mortality and that race modified relationships among SLE mortality, sex, and geographic region.

wildpixel/Thinkstock

It is no surprise that the law is playing an ever more important role in the practice of medicine. Concerns about legal issues are a source of stress for ObGyns, including increasing worries about the economics of professional liability, the anxiety of defending a legal claim, and ambiguity about what is required for compliance.¹ In this article my goal is to demystify some of the most important legal principles affecting your practice and provide suggestions for avoiding legal problems.

Medical malpractice: A form of negligence

Most ObGyns instinctively think first of medical malpractice when “legal problems” are mentioned—not an unreasonable response because obstetrics has a high incidence of malpractice claims. In one study, 77% of the American College of Obstetricians and Gynecologists (ACOG) Fellows reported that they have been sued.²

At its core, malpractice is a form of negligence, or, medical practice that falls below the quality of care that a reasonably careful practitioner would provide under the circumstances. When practice falls below that “standard of care,” and it causes injury, there may be malpractice liability. Insurance usually covers the cost of defending malpractice lawsuits and paying liability (although liability is the result of a minority of malpractice suits). There are, however, collateral consequences, including the time, stress, and disruption associated with defending the suit. In addition, malpractice may trigger review by the institutions with which the physician is associated, or in extreme cases, by licensing authorities. Large malpractice settlements or verdicts must be reported to the National Practitioner Database (sometimes colloquially referred to the “problem physician” database) or a similar state database.
 

Related article:
Who is liable when a surgical error occurs?

Regulation and reimbursement (“compliance”) policies

The practice of medicine is closely regulated by federal and state bodies. Many regulations apply through reimbursement policies related to Medicare and Medicaid. While malpractice liability may, at worst, result in a financial award (with the cost of defense and any award paid by insurance), regulatory problems may result in a number of unpleasant consequences, most of which are not covered by insurance. In addition to loss of reimbursement, civil penalties (even criminalpenalties in extreme cases), loss of hospital privileges, licensure discipline, and loss of Medicare-Medicaid eligibility may result from regulatory noncompliance.³

There are multivolume sets discussing these legal requirements, so here we will look only at a tiny tip of the regulatory iceberg by mentioning some common regulatory areas.

Fraud and abuse laws refer to a bundle of federal (and some state) statutes and regulations that are intended to ensure that public-funded programs such as Medicare and Medicaid are not cheated or overpaying for services. It is a violation to provide low-quality services to government-funded programs. Proper payment and coding and ensuring that services were actually performed by the professional listed (not someone else) are examples of traps for the unwary. Submitting inaccurate records may result in action to recover incorrect payments and in civil penalties. In extreme cases where there is intentional misrepresentation, there have been criminal charges and loss of future Medicare-Medicaid eligibility.

Anti-kickback, self-referral, and Stark limitations are intended to avoid unnecessary or overpriced services. When someone is receiving a benefit for ordering or recommending a product or service, it is reasonable to expect that an incentive might affect the decision to order it, likely resulting in unnecessary or suboptimal services. It is illegal to receive a kickback for using, ordering, or recommending a product or service (a pharmaceutical company could not pay a physician $10 for each prescription written for its product). It is also illegal for physicians to refer patients to other entities in which they have a financial interest (a physician could not refer a patient to a lab in which the physician has partial ownership). The Stark laws and state prohibitions on self-referral have complex series of “safe harbor” exceptions in an ocean of prohibitions.⁴

HIPAA and confidentiality regulations are intended to protect patient privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has extensive regulations concerning both privacy and security. The medical community is well-versed in HIPAA regulations and sensitive (perhaps hypersensitive) to its requirements. Most states have patient privacy regulations that apply in addition to HIPAA and are commonly less well known.

Protecting patient confidentiality is an ethical, legal, and licensure obligation. Protecting patient confidentiality is, therefore, general duty and not tied to a specific federal program.⁵

Related article:
Patient with a breast mass: Why did she pursue litigation?

Insurance Fraud is the private side of fraud and abuse. Submitting private insurance claims that are false or a misrepresentation of service is generally a violation of the contract between the provider and the insurance company. It may also be a crime—it is, after all, a form of theft. Serious fraud may result in the loss of the license to practice.

The False Claims Act and Whistleblower laws make it a civil offense (and, in extreme cases, a criminal offense), to present to the government a false claim for payment of services. It may be false in the sense that the service was not provided or in the sense that service was of inadequate quality. These statutes (both federal and state) also allow for a private whistleblower to receive some of the proceeds if he or she helps the government recoup wrongful payments. Disgruntled former employees are a common source of whistleblowing.⁶

Abuse-reporting statutes are part of every state’s law but vary considerably. They require certain professions, including physicians, to report known or suspected abuse of children, dependent adults, and often, other groups. The failure to make required reports can result in civil liability or even (rarely) criminal charges.

Read about how organizational law affects ObGyns.

How organizational and commercial law affects ObGyns

Physicians are generally members of organizations that are engaged in the business of health care (even nonprofit organizations have business interests). There are 2 major legal building blocks of these business relationships: contracts and agency.⁷

Contracts are agreements between 2 or more persons or entities that carry with them legally enforceable obligations. The 3 common elements are an offer by one party, acceptance by another, and consideration (exchanging one thing of value for another). Contracts are binding in the sense that, if there is a breach of the promise by one party, the other party may seek monetary damages for the loss of the benefit of the bargain (and in limited circumstances, require that the contract be performed).

Agency is essentially the mechanism that allows a person to legally work for or on behalf of another. A “principal” authorizes an agent to take actions for, and bind, the principal. All employment, partnership, and “agent” relationships create an agency. The principal is generally responsible for the actions of the agent—at least within the scope of the agent’s authority. For example, the principal is responsible for the torts (civil liability resulting from the breach of a socially imposed duty, but generally not arising from a contract) of an agent doing the principal’s business. The agent has the obligation to act in good faith for the benefit of the principal and to abide by the instructions of the principal.

Corporate structures

There are a variety of corporate organizational structures; the basic types are corporations, partnerships, and unincorporated associations. These generally are available to nonprofit and for-profit organizations. As a general matter, corporations limit the owners’ personal liability; partnerships have tax advantages. A number of laws now allow the creation of entities that have both liability and tax advantages (subchapter S corporations, limited liability companies, and limited liability partnerships).

Other areas of business law

Employment law, which now affects almost every aspect of hiring, dismissal, payment, and fringe benefits, is not a single law but a series of state and federal statutes, regulations, and court decisions.⁸

Competition is regulated through a number of antitrust laws as well as fair business practices. These affect the ability of health care entities to merge, fix prices, and split markets.⁹

There are literally hundreds of other laws that affect the way health care entities can operate. Conducting a careful compliance review is of considerable importance.¹⁰

Read about the dos and don’ts of preventive law.

Dos and don’ts of preventive law

The business of medicine is subject to many laws and keeping track of all of these is generally beyond the expertise of the ObGyn. Here are a few practical suggestions for thriving in this legal milieu.

Understanding the law

DO establish an ongoing relationship with an attorney you can trust who is knowledgeable in health law. Consult with this attorney not only on an as-needed basis but also for an “annual checkup” of legal issues affecting your practice.

DON’T guess what the law is. Laws vary from state to state and change frequently. Taking curbstone advice or suggestions from a podcast is a good way to develop problems.

Error reduction

DO take risk management seriously. Implement plans to improve patient safety and reduce errors.¹¹

DON’T ignore angry or hostile patients. Their hostility may be directed at you—an undesirable state. The same goes for disgruntled (or former) employees, who may become whistleblowers.

Insurance

DO review your insurance coverage annually, preferably with an expert or your attorney. Insurance policies and your insurance needs change frequently.

DON’T assume you have all the insurance you need or that insurance will cover all legal claims arising from your practice. Intentional torts, some antitrust claims, licensure discipline, and civil fines, for example, may not be covered.

Informed consent and ethics

DO use the informed consent process as a means of improving communication between you and your patients to address their concerns and discuss expectations. Autonomy is a basic ethical value of medicine and informed consent helps to achieve that goal.

DON’T ignore ethics. Ethical obligations are not just essential to maintaining a license, hospital privileges, and professional standing.¹² They also help guide you toward good practice that avoids liability.

Related articles:
Informed consent: The more you know, the more you and your patient are protected

Compliance, disputes, and arbitration

DO engage in continuing compliance review. That includes understanding the contracts and professional arrangements in which you practice and all of the requirements of third-party payers (especially government entities). There are a wide range of other compliance obligations that require ongoing attention.

DON’T sign arbitration agreements without understanding exactly what you are agreeing to. There are advantages to arbitration,¹³ but there are disadvantages, too.¹⁴ The courts generally enforce arbitration agreements, even ones that are unfair or one-sided.¹⁵

The law need not be a mystery or the enemy. Preventive law, like preventive medicine, can make all the difference.¹⁶

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It is no surprise that the law is playing an ever more important role in the practice of medicine. Concerns about legal issues are a source of stress for ObGyns, including increasing worries about the economics of professional liability, the anxiety of defending a legal claim, and ambiguity about what is required for compliance.¹ In this article my goal is to demystify some of the most important legal principles affecting your practice and provide suggestions for avoiding legal problems.

Medical malpractice: A form of negligence

Most ObGyns instinctively think first of medical malpractice when “legal problems” are mentioned—not an unreasonable response because obstetrics has a high incidence of malpractice claims. In one study, 77% of the American College of Obstetricians and Gynecologists (ACOG) Fellows reported that they have been sued.²

At its core, malpractice is a form of negligence, or, medical practice that falls below the quality of care that a reasonably careful practitioner would provide under the circumstances. When practice falls below that “standard of care,” and it causes injury, there may be malpractice liability. Insurance usually covers the cost of defending malpractice lawsuits and paying liability (although liability is the result of a minority of malpractice suits). There are, however, collateral consequences, including the time, stress, and disruption associated with defending the suit. In addition, malpractice may trigger review by the institutions with which the physician is associated, or in extreme cases, by licensing authorities. Large malpractice settlements or verdicts must be reported to the National Practitioner Database (sometimes colloquially referred to the “problem physician” database) or a similar state database.
 

Related article:
Who is liable when a surgical error occurs?

Regulation and reimbursement (“compliance”) policies

The practice of medicine is closely regulated by federal and state bodies. Many regulations apply through reimbursement policies related to Medicare and Medicaid. While malpractice liability may, at worst, result in a financial award (with the cost of defense and any award paid by insurance), regulatory problems may result in a number of unpleasant consequences, most of which are not covered by insurance. In addition to loss of reimbursement, civil penalties (even criminalpenalties in extreme cases), loss of hospital privileges, licensure discipline, and loss of Medicare-Medicaid eligibility may result from regulatory noncompliance.³

There are multivolume sets discussing these legal requirements, so here we will look only at a tiny tip of the regulatory iceberg by mentioning some common regulatory areas.

Fraud and abuse laws refer to a bundle of federal (and some state) statutes and regulations that are intended to ensure that public-funded programs such as Medicare and Medicaid are not cheated or overpaying for services. It is a violation to provide low-quality services to government-funded programs. Proper payment and coding and ensuring that services were actually performed by the professional listed (not someone else) are examples of traps for the unwary. Submitting inaccurate records may result in action to recover incorrect payments and in civil penalties. In extreme cases where there is intentional misrepresentation, there have been criminal charges and loss of future Medicare-Medicaid eligibility.

Anti-kickback, self-referral, and Stark limitations are intended to avoid unnecessary or overpriced services. When someone is receiving a benefit for ordering or recommending a product or service, it is reasonable to expect that an incentive might affect the decision to order it, likely resulting in unnecessary or suboptimal services. It is illegal to receive a kickback for using, ordering, or recommending a product or service (a pharmaceutical company could not pay a physician $10 for each prescription written for its product). It is also illegal for physicians to refer patients to other entities in which they have a financial interest (a physician could not refer a patient to a lab in which the physician has partial ownership). The Stark laws and state prohibitions on self-referral have complex series of “safe harbor” exceptions in an ocean of prohibitions.⁴

HIPAA and confidentiality regulations are intended to protect patient privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has extensive regulations concerning both privacy and security. The medical community is well-versed in HIPAA regulations and sensitive (perhaps hypersensitive) to its requirements. Most states have patient privacy regulations that apply in addition to HIPAA and are commonly less well known.

Protecting patient confidentiality is an ethical, legal, and licensure obligation. Protecting patient confidentiality is, therefore, general duty and not tied to a specific federal program.⁵

Related article:
Patient with a breast mass: Why did she pursue litigation?

Insurance Fraud is the private side of fraud and abuse. Submitting private insurance claims that are false or a misrepresentation of service is generally a violation of the contract between the provider and the insurance company. It may also be a crime—it is, after all, a form of theft. Serious fraud may result in the loss of the license to practice.

The False Claims Act and Whistleblower laws make it a civil offense (and, in extreme cases, a criminal offense), to present to the government a false claim for payment of services. It may be false in the sense that the service was not provided or in the sense that service was of inadequate quality. These statutes (both federal and state) also allow for a private whistleblower to receive some of the proceeds if he or she helps the government recoup wrongful payments. Disgruntled former employees are a common source of whistleblowing.⁶

Abuse-reporting statutes are part of every state’s law but vary considerably. They require certain professions, including physicians, to report known or suspected abuse of children, dependent adults, and often, other groups. The failure to make required reports can result in civil liability or even (rarely) criminal charges.

Read about how organizational law affects ObGyns.

How organizational and commercial law affects ObGyns

Physicians are generally members of organizations that are engaged in the business of health care (even nonprofit organizations have business interests). There are 2 major legal building blocks of these business relationships: contracts and agency.⁷

Contracts are agreements between 2 or more persons or entities that carry with them legally enforceable obligations. The 3 common elements are an offer by one party, acceptance by another, and consideration (exchanging one thing of value for another). Contracts are binding in the sense that, if there is a breach of the promise by one party, the other party may seek monetary damages for the loss of the benefit of the bargain (and in limited circumstances, require that the contract be performed).

Agency is essentially the mechanism that allows a person to legally work for or on behalf of another. A “principal” authorizes an agent to take actions for, and bind, the principal. All employment, partnership, and “agent” relationships create an agency. The principal is generally responsible for the actions of the agent—at least within the scope of the agent’s authority. For example, the principal is responsible for the torts (civil liability resulting from the breach of a socially imposed duty, but generally not arising from a contract) of an agent doing the principal’s business. The agent has the obligation to act in good faith for the benefit of the principal and to abide by the instructions of the principal.

Corporate structures

There are a variety of corporate organizational structures; the basic types are corporations, partnerships, and unincorporated associations. These generally are available to nonprofit and for-profit organizations. As a general matter, corporations limit the owners’ personal liability; partnerships have tax advantages. A number of laws now allow the creation of entities that have both liability and tax advantages (subchapter S corporations, limited liability companies, and limited liability partnerships).

Other areas of business law

Employment law, which now affects almost every aspect of hiring, dismissal, payment, and fringe benefits, is not a single law but a series of state and federal statutes, regulations, and court decisions.⁸

Competition is regulated through a number of antitrust laws as well as fair business practices. These affect the ability of health care entities to merge, fix prices, and split markets.⁹

There are literally hundreds of other laws that affect the way health care entities can operate. Conducting a careful compliance review is of considerable importance.¹⁰

Read about the dos and don’ts of preventive law.

Dos and don’ts of preventive law

The business of medicine is subject to many laws and keeping track of all of these is generally beyond the expertise of the ObGyn. Here are a few practical suggestions for thriving in this legal milieu.

Understanding the law

DO establish an ongoing relationship with an attorney you can trust who is knowledgeable in health law. Consult with this attorney not only on an as-needed basis but also for an “annual checkup” of legal issues affecting your practice.

DON’T guess what the law is. Laws vary from state to state and change frequently. Taking curbstone advice or suggestions from a podcast is a good way to develop problems.

Error reduction

DO take risk management seriously. Implement plans to improve patient safety and reduce errors.¹¹

DON’T ignore angry or hostile patients. Their hostility may be directed at you—an undesirable state. The same goes for disgruntled (or former) employees, who may become whistleblowers.

Insurance

DO review your insurance coverage annually, preferably with an expert or your attorney. Insurance policies and your insurance needs change frequently.

DON’T assume you have all the insurance you need or that insurance will cover all legal claims arising from your practice. Intentional torts, some antitrust claims, licensure discipline, and civil fines, for example, may not be covered.

Informed consent and ethics

DO use the informed consent process as a means of improving communication between you and your patients to address their concerns and discuss expectations. Autonomy is a basic ethical value of medicine and informed consent helps to achieve that goal.

DON’T ignore ethics. Ethical obligations are not just essential to maintaining a license, hospital privileges, and professional standing.¹² They also help guide you toward good practice that avoids liability.

Related articles:
Informed consent: The more you know, the more you and your patient are protected

Compliance, disputes, and arbitration

DO engage in continuing compliance review. That includes understanding the contracts and professional arrangements in which you practice and all of the requirements of third-party payers (especially government entities). There are a wide range of other compliance obligations that require ongoing attention.

DON’T sign arbitration agreements without understanding exactly what you are agreeing to. There are advantages to arbitration,¹³ but there are disadvantages, too.¹⁴ The courts generally enforce arbitration agreements, even ones that are unfair or one-sided.¹⁵

The law need not be a mystery or the enemy. Preventive law, like preventive medicine, can make all the difference.¹⁶

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It is no surprise that the law is playing an ever more important role in the practice of medicine. Concerns about legal issues are a source of stress for ObGyns, including increasing worries about the economics of professional liability, the anxiety of defending a legal claim, and ambiguity about what is required for compliance.¹ In this article my goal is to demystify some of the most important legal principles affecting your practice and provide suggestions for avoiding legal problems.

Medical malpractice: A form of negligence

Most ObGyns instinctively think first of medical malpractice when “legal problems” are mentioned—not an unreasonable response because obstetrics has a high incidence of malpractice claims. In one study, 77% of the American College of Obstetricians and Gynecologists (ACOG) Fellows reported that they have been sued.²

At its core, malpractice is a form of negligence, or, medical practice that falls below the quality of care that a reasonably careful practitioner would provide under the circumstances. When practice falls below that “standard of care,” and it causes injury, there may be malpractice liability. Insurance usually covers the cost of defending malpractice lawsuits and paying liability (although liability is the result of a minority of malpractice suits). There are, however, collateral consequences, including the time, stress, and disruption associated with defending the suit. In addition, malpractice may trigger review by the institutions with which the physician is associated, or in extreme cases, by licensing authorities. Large malpractice settlements or verdicts must be reported to the National Practitioner Database (sometimes colloquially referred to the “problem physician” database) or a similar state database.
 

Related article:
Who is liable when a surgical error occurs?

Regulation and reimbursement (“compliance”) policies

The practice of medicine is closely regulated by federal and state bodies. Many regulations apply through reimbursement policies related to Medicare and Medicaid. While malpractice liability may, at worst, result in a financial award (with the cost of defense and any award paid by insurance), regulatory problems may result in a number of unpleasant consequences, most of which are not covered by insurance. In addition to loss of reimbursement, civil penalties (even criminalpenalties in extreme cases), loss of hospital privileges, licensure discipline, and loss of Medicare-Medicaid eligibility may result from regulatory noncompliance.³

There are multivolume sets discussing these legal requirements, so here we will look only at a tiny tip of the regulatory iceberg by mentioning some common regulatory areas.

Fraud and abuse laws refer to a bundle of federal (and some state) statutes and regulations that are intended to ensure that public-funded programs such as Medicare and Medicaid are not cheated or overpaying for services. It is a violation to provide low-quality services to government-funded programs. Proper payment and coding and ensuring that services were actually performed by the professional listed (not someone else) are examples of traps for the unwary. Submitting inaccurate records may result in action to recover incorrect payments and in civil penalties. In extreme cases where there is intentional misrepresentation, there have been criminal charges and loss of future Medicare-Medicaid eligibility.

Anti-kickback, self-referral, and Stark limitations are intended to avoid unnecessary or overpriced services. When someone is receiving a benefit for ordering or recommending a product or service, it is reasonable to expect that an incentive might affect the decision to order it, likely resulting in unnecessary or suboptimal services. It is illegal to receive a kickback for using, ordering, or recommending a product or service (a pharmaceutical company could not pay a physician $10 for each prescription written for its product). It is also illegal for physicians to refer patients to other entities in which they have a financial interest (a physician could not refer a patient to a lab in which the physician has partial ownership). The Stark laws and state prohibitions on self-referral have complex series of “safe harbor” exceptions in an ocean of prohibitions.⁴

HIPAA and confidentiality regulations are intended to protect patient privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has extensive regulations concerning both privacy and security. The medical community is well-versed in HIPAA regulations and sensitive (perhaps hypersensitive) to its requirements. Most states have patient privacy regulations that apply in addition to HIPAA and are commonly less well known.

Protecting patient confidentiality is an ethical, legal, and licensure obligation. Protecting patient confidentiality is, therefore, general duty and not tied to a specific federal program.⁵

Related article:
Patient with a breast mass: Why did she pursue litigation?

Insurance Fraud is the private side of fraud and abuse. Submitting private insurance claims that are false or a misrepresentation of service is generally a violation of the contract between the provider and the insurance company. It may also be a crime—it is, after all, a form of theft. Serious fraud may result in the loss of the license to practice.

The False Claims Act and Whistleblower laws make it a civil offense (and, in extreme cases, a criminal offense), to present to the government a false claim for payment of services. It may be false in the sense that the service was not provided or in the sense that service was of inadequate quality. These statutes (both federal and state) also allow for a private whistleblower to receive some of the proceeds if he or she helps the government recoup wrongful payments. Disgruntled former employees are a common source of whistleblowing.⁶

Abuse-reporting statutes are part of every state’s law but vary considerably. They require certain professions, including physicians, to report known or suspected abuse of children, dependent adults, and often, other groups. The failure to make required reports can result in civil liability or even (rarely) criminal charges.

Read about how organizational law affects ObGyns.

How organizational and commercial law affects ObGyns

Physicians are generally members of organizations that are engaged in the business of health care (even nonprofit organizations have business interests). There are 2 major legal building blocks of these business relationships: contracts and agency.⁷

Contracts are agreements between 2 or more persons or entities that carry with them legally enforceable obligations. The 3 common elements are an offer by one party, acceptance by another, and consideration (exchanging one thing of value for another). Contracts are binding in the sense that, if there is a breach of the promise by one party, the other party may seek monetary damages for the loss of the benefit of the bargain (and in limited circumstances, require that the contract be performed).

Agency is essentially the mechanism that allows a person to legally work for or on behalf of another. A “principal” authorizes an agent to take actions for, and bind, the principal. All employment, partnership, and “agent” relationships create an agency. The principal is generally responsible for the actions of the agent—at least within the scope of the agent’s authority. For example, the principal is responsible for the torts (civil liability resulting from the breach of a socially imposed duty, but generally not arising from a contract) of an agent doing the principal’s business. The agent has the obligation to act in good faith for the benefit of the principal and to abide by the instructions of the principal.

Corporate structures

There are a variety of corporate organizational structures; the basic types are corporations, partnerships, and unincorporated associations. These generally are available to nonprofit and for-profit organizations. As a general matter, corporations limit the owners’ personal liability; partnerships have tax advantages. A number of laws now allow the creation of entities that have both liability and tax advantages (subchapter S corporations, limited liability companies, and limited liability partnerships).

Other areas of business law

Employment law, which now affects almost every aspect of hiring, dismissal, payment, and fringe benefits, is not a single law but a series of state and federal statutes, regulations, and court decisions.⁸

Competition is regulated through a number of antitrust laws as well as fair business practices. These affect the ability of health care entities to merge, fix prices, and split markets.⁹

There are literally hundreds of other laws that affect the way health care entities can operate. Conducting a careful compliance review is of considerable importance.¹⁰

Read about the dos and don’ts of preventive law.

Dos and don’ts of preventive law

The business of medicine is subject to many laws and keeping track of all of these is generally beyond the expertise of the ObGyn. Here are a few practical suggestions for thriving in this legal milieu.

Understanding the law

DO establish an ongoing relationship with an attorney you can trust who is knowledgeable in health law. Consult with this attorney not only on an as-needed basis but also for an “annual checkup” of legal issues affecting your practice.

DON’T guess what the law is. Laws vary from state to state and change frequently. Taking curbstone advice or suggestions from a podcast is a good way to develop problems.

Error reduction

DO take risk management seriously. Implement plans to improve patient safety and reduce errors.¹¹

DON’T ignore angry or hostile patients. Their hostility may be directed at you—an undesirable state. The same goes for disgruntled (or former) employees, who may become whistleblowers.

Insurance

DO review your insurance coverage annually, preferably with an expert or your attorney. Insurance policies and your insurance needs change frequently.

DON’T assume you have all the insurance you need or that insurance will cover all legal claims arising from your practice. Intentional torts, some antitrust claims, licensure discipline, and civil fines, for example, may not be covered.

Informed consent and ethics

DO use the informed consent process as a means of improving communication between you and your patients to address their concerns and discuss expectations. Autonomy is a basic ethical value of medicine and informed consent helps to achieve that goal.

DON’T ignore ethics. Ethical obligations are not just essential to maintaining a license, hospital privileges, and professional standing.¹² They also help guide you toward good practice that avoids liability.

Related articles:
Informed consent: The more you know, the more you and your patient are protected

Compliance, disputes, and arbitration

DO engage in continuing compliance review. That includes understanding the contracts and professional arrangements in which you practice and all of the requirements of third-party payers (especially government entities). There are a wide range of other compliance obligations that require ongoing attention.

DON’T sign arbitration agreements without understanding exactly what you are agreeing to. There are advantages to arbitration,¹³ but there are disadvantages, too.¹⁴ The courts generally enforce arbitration agreements, even ones that are unfair or one-sided.¹⁵

The law need not be a mystery or the enemy. Preventive law, like preventive medicine, can make all the difference.¹⁶

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

TORONTO – Patients who received an influenza vaccination but still required hospitalization for H1N1 influenza had better outcomes, compared with unvaccinated patients, according to findings from a retrospective study.

In the hospital, vaccinated patients had significantly lower rates of acute kidney injury (6% vs. 35%; P = .038) and were more likely to be satisfactorily managed with noninvasive mechanical ventilation (41% vs. 6%; P = .004).

Debra Beck/ Frontline Medical News

TORONTO – Patients who received an influenza vaccination but still required hospitalization for H1N1 influenza had better outcomes, compared with unvaccinated patients, according to findings from a retrospective study.

In the hospital, vaccinated patients had significantly lower rates of acute kidney injury (6% vs. 35%; P = .038) and were more likely to be satisfactorily managed with noninvasive mechanical ventilation (41% vs. 6%; P = .004).

Debra Beck/ Frontline Medical News

TORONTO – Patients who received an influenza vaccination but still required hospitalization for H1N1 influenza had better outcomes, compared with unvaccinated patients, according to findings from a retrospective study.

In the hospital, vaccinated patients had significantly lower rates of acute kidney injury (6% vs. 35%; P = .038) and were more likely to be satisfactorily managed with noninvasive mechanical ventilation (41% vs. 6%; P = .004).

Debra Beck/ Frontline Medical News

EXPERT COMMENTARY

 A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.¹ Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.

Related article:
2017 Update on menopause

Details of the study

A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.

All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).

Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).

Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).

With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).

Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

Study strengths and weaknesses

The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.

The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

 A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.¹ Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.

Related article:
2017 Update on menopause

Details of the study

A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.

All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).

Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).

Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).

With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).

Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

Study strengths and weaknesses

The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.

The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

EXPERT COMMENTARY

 A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.¹ Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.

Related article:
2017 Update on menopause

Details of the study

A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.

All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).

Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).

Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).

With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).

Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?

Study strengths and weaknesses

The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.

The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

LONDON—Transient epileptic amnesia (TEA) does not appear to increase the risk of Alzheimer’s disease, according to a study presented at the 2017 Alzheimer’s Association International Conference. Persistent memory problems are common in patients with TEA, but the prevalence of dementia in these patients may not exceed that in the general population, the researchers noted.

TEA is a type of adult-onset temporal lobe epilepsy characterized by recurring amnestic seizures. Interictal memory deficits, such as autobiographic amnesia and accelerated long-term forgetting, are common. Short-term follow-up after initiating anticonvulsant medication suggests good seizure control and stable cognition. Recent case reports, however, have raised concerns that TEA may be a prodrome of Alzheimer’s disease.

Investigating Clinical and Cognitive Outcomes

To evaluate the basis for these concerns, Sharon A. Savage, PhD, Lecturer in Aging and Dementia at the University of Exeter Medical School in the United Kingdom, and colleagues investigated clinical and cognitive outcomes of patients with TEA over 10 to 20 years. They also assessed evidence of increased risk of Alzheimer’s disease.

The researchers studied two cohorts of patients with TEA. The first cohort included 10 patients followed up at 10 years and 20 years. The second cohort included 42 patients followed up at 10 years. At baseline, both cohorts were compared with age- and IQ-matched healthy controls. Researchers also recorded Alzheimer’s disease diagnoses among participants with TEA and compared the prevalence of Alzheimer’s disease in the study populations with published prevalence rates.

In a subset of patients, Dr. Savage and colleagues assessed cognitive ability using the National Adult Reading Test or the Wechsler Abbreviated Scale of Intelligence. They assessed objective memory using the Logical Memory story 1, Rey Complex Figure, and the Recognition Memory Test. Additional testing examined naming, verbal fluency, and problem solving.

Fifty patients completed neuropsychologic review (mean age at baseline, 66). At last follow-up, clinical information was available for nine patients from Cohort 1 and 37 patients from Cohort 2.

Controls Performed Similarly to TEA Cohorts

At 20 years, no cases of Alzheimer’s disease were reported in Cohort 1. One participant in that group developed vascular dementia, and four died. Four patients in Cohort 2 had Alzheimer’s disease at 10 years, and 15 patients died, including one patient with Alzheimer’s disease.

When TEA data were compared with data from healthy controls, general cognitive ability among patients with TEA was above average with no decline at 10 and 20 years. In addition, significant change from baseline was observed at 10 years for story recall, recognition memory, verbal fluency, and problem solving. Overall, approximately one-third of patients with TEA remained stable or improved on individual test scores at 10 years.

At 20 years, general cognitive ability remained above average for patients with TEA, compared with controls. Performance was not significantly reduced on more than one memory measure per participant.

Researchers concluded that memory problems may continue in TEA despite effective cessation of seizures. Some patients may remain stable over 10 to 20 years, and others may decline. Additional changes in executive function may also develop over time in some patients, the researchers added.

“The prognosis of TEA appears relatively benign,” said Dr. Savage and colleagues. Patients in both TEA cohorts performed similarly to healthy controls on the majority of tests. In addition, life expectancy did not appear to decrease, and seizures were generally well controlled.

—Erica Tricarico

LONDON—Transient epileptic amnesia (TEA) does not appear to increase the risk of Alzheimer’s disease, according to a study presented at the 2017 Alzheimer’s Association International Conference. Persistent memory problems are common in patients with TEA, but the prevalence of dementia in these patients may not exceed that in the general population, the researchers noted.

TEA is a type of adult-onset temporal lobe epilepsy characterized by recurring amnestic seizures. Interictal memory deficits, such as autobiographic amnesia and accelerated long-term forgetting, are common. Short-term follow-up after initiating anticonvulsant medication suggests good seizure control and stable cognition. Recent case reports, however, have raised concerns that TEA may be a prodrome of Alzheimer’s disease.

Investigating Clinical and Cognitive Outcomes

To evaluate the basis for these concerns, Sharon A. Savage, PhD, Lecturer in Aging and Dementia at the University of Exeter Medical School in the United Kingdom, and colleagues investigated clinical and cognitive outcomes of patients with TEA over 10 to 20 years. They also assessed evidence of increased risk of Alzheimer’s disease.

The researchers studied two cohorts of patients with TEA. The first cohort included 10 patients followed up at 10 years and 20 years. The second cohort included 42 patients followed up at 10 years. At baseline, both cohorts were compared with age- and IQ-matched healthy controls. Researchers also recorded Alzheimer’s disease diagnoses among participants with TEA and compared the prevalence of Alzheimer’s disease in the study populations with published prevalence rates.

In a subset of patients, Dr. Savage and colleagues assessed cognitive ability using the National Adult Reading Test or the Wechsler Abbreviated Scale of Intelligence. They assessed objective memory using the Logical Memory story 1, Rey Complex Figure, and the Recognition Memory Test. Additional testing examined naming, verbal fluency, and problem solving.

Fifty patients completed neuropsychologic review (mean age at baseline, 66). At last follow-up, clinical information was available for nine patients from Cohort 1 and 37 patients from Cohort 2.

Controls Performed Similarly to TEA Cohorts

At 20 years, no cases of Alzheimer’s disease were reported in Cohort 1. One participant in that group developed vascular dementia, and four died. Four patients in Cohort 2 had Alzheimer’s disease at 10 years, and 15 patients died, including one patient with Alzheimer’s disease.

When TEA data were compared with data from healthy controls, general cognitive ability among patients with TEA was above average with no decline at 10 and 20 years. In addition, significant change from baseline was observed at 10 years for story recall, recognition memory, verbal fluency, and problem solving. Overall, approximately one-third of patients with TEA remained stable or improved on individual test scores at 10 years.

At 20 years, general cognitive ability remained above average for patients with TEA, compared with controls. Performance was not significantly reduced on more than one memory measure per participant.

Researchers concluded that memory problems may continue in TEA despite effective cessation of seizures. Some patients may remain stable over 10 to 20 years, and others may decline. Additional changes in executive function may also develop over time in some patients, the researchers added.

“The prognosis of TEA appears relatively benign,” said Dr. Savage and colleagues. Patients in both TEA cohorts performed similarly to healthy controls on the majority of tests. In addition, life expectancy did not appear to decrease, and seizures were generally well controlled.

—Erica Tricarico

LONDON—Transient epileptic amnesia (TEA) does not appear to increase the risk of Alzheimer’s disease, according to a study presented at the 2017 Alzheimer’s Association International Conference. Persistent memory problems are common in patients with TEA, but the prevalence of dementia in these patients may not exceed that in the general population, the researchers noted.

TEA is a type of adult-onset temporal lobe epilepsy characterized by recurring amnestic seizures. Interictal memory deficits, such as autobiographic amnesia and accelerated long-term forgetting, are common. Short-term follow-up after initiating anticonvulsant medication suggests good seizure control and stable cognition. Recent case reports, however, have raised concerns that TEA may be a prodrome of Alzheimer’s disease.

Investigating Clinical and Cognitive Outcomes

To evaluate the basis for these concerns, Sharon A. Savage, PhD, Lecturer in Aging and Dementia at the University of Exeter Medical School in the United Kingdom, and colleagues investigated clinical and cognitive outcomes of patients with TEA over 10 to 20 years. They also assessed evidence of increased risk of Alzheimer’s disease.

The researchers studied two cohorts of patients with TEA. The first cohort included 10 patients followed up at 10 years and 20 years. The second cohort included 42 patients followed up at 10 years. At baseline, both cohorts were compared with age- and IQ-matched healthy controls. Researchers also recorded Alzheimer’s disease diagnoses among participants with TEA and compared the prevalence of Alzheimer’s disease in the study populations with published prevalence rates.

In a subset of patients, Dr. Savage and colleagues assessed cognitive ability using the National Adult Reading Test or the Wechsler Abbreviated Scale of Intelligence. They assessed objective memory using the Logical Memory story 1, Rey Complex Figure, and the Recognition Memory Test. Additional testing examined naming, verbal fluency, and problem solving.

Fifty patients completed neuropsychologic review (mean age at baseline, 66). At last follow-up, clinical information was available for nine patients from Cohort 1 and 37 patients from Cohort 2.

Controls Performed Similarly to TEA Cohorts

At 20 years, no cases of Alzheimer’s disease were reported in Cohort 1. One participant in that group developed vascular dementia, and four died. Four patients in Cohort 2 had Alzheimer’s disease at 10 years, and 15 patients died, including one patient with Alzheimer’s disease.

When TEA data were compared with data from healthy controls, general cognitive ability among patients with TEA was above average with no decline at 10 and 20 years. In addition, significant change from baseline was observed at 10 years for story recall, recognition memory, verbal fluency, and problem solving. Overall, approximately one-third of patients with TEA remained stable or improved on individual test scores at 10 years.

At 20 years, general cognitive ability remained above average for patients with TEA, compared with controls. Performance was not significantly reduced on more than one memory measure per participant.

Researchers concluded that memory problems may continue in TEA despite effective cessation of seizures. Some patients may remain stable over 10 to 20 years, and others may decline. Additional changes in executive function may also develop over time in some patients, the researchers added.

“The prognosis of TEA appears relatively benign,” said Dr. Savage and colleagues. Patients in both TEA cohorts performed similarly to healthy controls on the majority of tests. In addition, life expectancy did not appear to decrease, and seizures were generally well controlled.

—Erica Tricarico

Endoscopists who performed endoscopic retrograde cholangiopancreatography (ERCP) at high-volume centers had a 60% greater odds of procedure success compared with those at low-volume centers, according to the results of a systematic review and meta-analysis.

High-volume endoscopists also had a 30% lower odds of performing ERCP that led to adverse events such as pancreatitis, perforation, and bleeding, reported Rajesh N. Keswani, MD, MS, of Northwestern University, Chicago, and his associates. High-volume centers themselves also were associated with a significantly higher odds of successful ERCP (odds ratio, 2.0; 95% CI, 1.6 to 2.5), although they were not associated with a significantly lower risk of adverse events, the reviewers wrote. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.002).

Diagnostic ERCP has fallen sevenfold in the past 30 years while therapeutic use has increased 30-fold, the researchers noted. Therapeutic use spans several complex pancreaticobiliary conditions, including chronic pancreatitis, malignant jaundice, and complications of liver transplantation. This shift from diagnostic to therapeutic has naturally increased the complexity of ERCP, the need for expert endoscopy, and the potential risk of adverse events. “As health care continues to shift toward rewarding value rather than volume, it will be increasingly important to deliver care that is effective and efficient,” the reviewers wrote. “Thus, understanding factors associated with unsuccessful interventions, such as a failed ERCP, will be of critical importance to payers and patients (Clin Gastroenterol Hepatol. 2017 Jun 7;218:237-45).

Therefore, they searched MEDLINE, EMBASE, and the Cochrane register of controlled trials for prospective and retrospective studies published through January 2017. In all, the researchers identified 13 studies that stratified outcomes by volume per endoscopist or center. These studies comprised 59,437 procedures and patients. Definitions of low volume varied by study, ranging from less than 25 to less than 156 annual ERCPs per endoscopist and from less than 87 to less than 200 annual ERCPs per center. Endoscopists who achieved this threshold were significantly more likely to perform successful ERCPs than were low-volume endoscopists (OR, 1.6; 95% CI, 1.2 to 2.1), and were significantly less likely to have patients develop pancreatitis, perforation, or bleeding after ERCP (OR, 0.7; 95% CI, 0.5 to 0.8).

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

“Given these compelling findings, we propose that providers and payers consider consolidating ERCP to high-volume endoscopists and centers to improve ERCP outcomes and value,” the reviewers wrote. Minimum thresholds for endoscopists and centers to maintain ERCP skills and optimize outcomes have not been defined, they noted. Intuitively, there is no “critical volume threshold” at which “outcomes suddenly improve,” but the studies in this analysis used widely varying definitions of low volume, they added. It also remains unclear whether a low-volume endoscopist can achieve optimal outcomes at a high-volume center, or vice versa, they said. They recommended studies to better define procedure success and the appropriate use of ERCP in therapeutic settings.

One reviewer acknowledged support from the University of Colorado Department of Medicine Outstanding Early Career Faculty Program. The reviewers reported having no conflicts of interest.

Endoscopists who performed endoscopic retrograde cholangiopancreatography (ERCP) at high-volume centers had a 60% greater odds of procedure success compared with those at low-volume centers, according to the results of a systematic review and meta-analysis.

High-volume endoscopists also had a 30% lower odds of performing ERCP that led to adverse events such as pancreatitis, perforation, and bleeding, reported Rajesh N. Keswani, MD, MS, of Northwestern University, Chicago, and his associates. High-volume centers themselves also were associated with a significantly higher odds of successful ERCP (odds ratio, 2.0; 95% CI, 1.6 to 2.5), although they were not associated with a significantly lower risk of adverse events, the reviewers wrote. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.002).

Diagnostic ERCP has fallen sevenfold in the past 30 years while therapeutic use has increased 30-fold, the researchers noted. Therapeutic use spans several complex pancreaticobiliary conditions, including chronic pancreatitis, malignant jaundice, and complications of liver transplantation. This shift from diagnostic to therapeutic has naturally increased the complexity of ERCP, the need for expert endoscopy, and the potential risk of adverse events. “As health care continues to shift toward rewarding value rather than volume, it will be increasingly important to deliver care that is effective and efficient,” the reviewers wrote. “Thus, understanding factors associated with unsuccessful interventions, such as a failed ERCP, will be of critical importance to payers and patients (Clin Gastroenterol Hepatol. 2017 Jun 7;218:237-45).

Therefore, they searched MEDLINE, EMBASE, and the Cochrane register of controlled trials for prospective and retrospective studies published through January 2017. In all, the researchers identified 13 studies that stratified outcomes by volume per endoscopist or center. These studies comprised 59,437 procedures and patients. Definitions of low volume varied by study, ranging from less than 25 to less than 156 annual ERCPs per endoscopist and from less than 87 to less than 200 annual ERCPs per center. Endoscopists who achieved this threshold were significantly more likely to perform successful ERCPs than were low-volume endoscopists (OR, 1.6; 95% CI, 1.2 to 2.1), and were significantly less likely to have patients develop pancreatitis, perforation, or bleeding after ERCP (OR, 0.7; 95% CI, 0.5 to 0.8).

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

“Given these compelling findings, we propose that providers and payers consider consolidating ERCP to high-volume endoscopists and centers to improve ERCP outcomes and value,” the reviewers wrote. Minimum thresholds for endoscopists and centers to maintain ERCP skills and optimize outcomes have not been defined, they noted. Intuitively, there is no “critical volume threshold” at which “outcomes suddenly improve,” but the studies in this analysis used widely varying definitions of low volume, they added. It also remains unclear whether a low-volume endoscopist can achieve optimal outcomes at a high-volume center, or vice versa, they said. They recommended studies to better define procedure success and the appropriate use of ERCP in therapeutic settings.

One reviewer acknowledged support from the University of Colorado Department of Medicine Outstanding Early Career Faculty Program. The reviewers reported having no conflicts of interest.

Endoscopists who performed endoscopic retrograde cholangiopancreatography (ERCP) at high-volume centers had a 60% greater odds of procedure success compared with those at low-volume centers, according to the results of a systematic review and meta-analysis.

High-volume endoscopists also had a 30% lower odds of performing ERCP that led to adverse events such as pancreatitis, perforation, and bleeding, reported Rajesh N. Keswani, MD, MS, of Northwestern University, Chicago, and his associates. High-volume centers themselves also were associated with a significantly higher odds of successful ERCP (odds ratio, 2.0; 95% CI, 1.6 to 2.5), although they were not associated with a significantly lower risk of adverse events, the reviewers wrote. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.002).

Diagnostic ERCP has fallen sevenfold in the past 30 years while therapeutic use has increased 30-fold, the researchers noted. Therapeutic use spans several complex pancreaticobiliary conditions, including chronic pancreatitis, malignant jaundice, and complications of liver transplantation. This shift from diagnostic to therapeutic has naturally increased the complexity of ERCP, the need for expert endoscopy, and the potential risk of adverse events. “As health care continues to shift toward rewarding value rather than volume, it will be increasingly important to deliver care that is effective and efficient,” the reviewers wrote. “Thus, understanding factors associated with unsuccessful interventions, such as a failed ERCP, will be of critical importance to payers and patients (Clin Gastroenterol Hepatol. 2017 Jun 7;218:237-45).

Therefore, they searched MEDLINE, EMBASE, and the Cochrane register of controlled trials for prospective and retrospective studies published through January 2017. In all, the researchers identified 13 studies that stratified outcomes by volume per endoscopist or center. These studies comprised 59,437 procedures and patients. Definitions of low volume varied by study, ranging from less than 25 to less than 156 annual ERCPs per endoscopist and from less than 87 to less than 200 annual ERCPs per center. Endoscopists who achieved this threshold were significantly more likely to perform successful ERCPs than were low-volume endoscopists (OR, 1.6; 95% CI, 1.2 to 2.1), and were significantly less likely to have patients develop pancreatitis, perforation, or bleeding after ERCP (OR, 0.7; 95% CI, 0.5 to 0.8).

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

“Given these compelling findings, we propose that providers and payers consider consolidating ERCP to high-volume endoscopists and centers to improve ERCP outcomes and value,” the reviewers wrote. Minimum thresholds for endoscopists and centers to maintain ERCP skills and optimize outcomes have not been defined, they noted. Intuitively, there is no “critical volume threshold” at which “outcomes suddenly improve,” but the studies in this analysis used widely varying definitions of low volume, they added. It also remains unclear whether a low-volume endoscopist can achieve optimal outcomes at a high-volume center, or vice versa, they said. They recommended studies to better define procedure success and the appropriate use of ERCP in therapeutic settings.

One reviewer acknowledged support from the University of Colorado Department of Medicine Outstanding Early Career Faculty Program. The reviewers reported having no conflicts of interest.

ORLANDO – Probiotics are safe and effective for treating functional abdominal pain in children, based on findings from a meta-analysis of 11 randomized studies with a total of 790 patients.

“We think there is pretty strong evidence” for the efficacy of probiotics, and “by any analysis you can throw at them probiotics are safe,” Gordon Morris, MD, said at the World Congress of Gastroenterology at ACG 2017. “The evidence is of moderate and high quality,” added Dr. Morris, a pediatric gastroenterologist at the University of Central Lancashire in Preston, England.

The most widely studied probiotic in the analysis was Lactobacillus reuteri, used in six of the studies with a total of 405 randomized patients. The next most commonly studied agent was Lactobacillus rhamnosus GG, the focus of four studies and tested in a total of 270 randomized patients. Both microbes showed statistically significant and clinically meaningful levels of pain reduction when compared with placebo in subgroup analyses, said Dr. Morris, who performed the meta-analysis as a Cochrane Review Groups systematic review.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

ORLANDO – Probiotics are safe and effective for treating functional abdominal pain in children, based on findings from a meta-analysis of 11 randomized studies with a total of 790 patients.

“We think there is pretty strong evidence” for the efficacy of probiotics, and “by any analysis you can throw at them probiotics are safe,” Gordon Morris, MD, said at the World Congress of Gastroenterology at ACG 2017. “The evidence is of moderate and high quality,” added Dr. Morris, a pediatric gastroenterologist at the University of Central Lancashire in Preston, England.

The most widely studied probiotic in the analysis was Lactobacillus reuteri, used in six of the studies with a total of 405 randomized patients. The next most commonly studied agent was Lactobacillus rhamnosus GG, the focus of four studies and tested in a total of 270 randomized patients. Both microbes showed statistically significant and clinically meaningful levels of pain reduction when compared with placebo in subgroup analyses, said Dr. Morris, who performed the meta-analysis as a Cochrane Review Groups systematic review.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

ORLANDO – Probiotics are safe and effective for treating functional abdominal pain in children, based on findings from a meta-analysis of 11 randomized studies with a total of 790 patients.

“We think there is pretty strong evidence” for the efficacy of probiotics, and “by any analysis you can throw at them probiotics are safe,” Gordon Morris, MD, said at the World Congress of Gastroenterology at ACG 2017. “The evidence is of moderate and high quality,” added Dr. Morris, a pediatric gastroenterologist at the University of Central Lancashire in Preston, England.

The most widely studied probiotic in the analysis was Lactobacillus reuteri, used in six of the studies with a total of 405 randomized patients. The next most commonly studied agent was Lactobacillus rhamnosus GG, the focus of four studies and tested in a total of 270 randomized patients. Both microbes showed statistically significant and clinically meaningful levels of pain reduction when compared with placebo in subgroup analyses, said Dr. Morris, who performed the meta-analysis as a Cochrane Review Groups systematic review.

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler