Surgery

The management of symptomatic uterine fibroids in the patient desiring conservative surgical therapy can be challenging at times. The advent of robot-assisted laparoscopy has provided surgeons with an enabling tool and patients with the option for a minimally invasive approach to myomectomy.

This month’s video was produced in order to demonstrate a systematic approach to the robot-assisted laparoscopic myomectomy in patients who are candidates. The example case is removal of a 5-cm, intrauterine posterior myoma in a 39-year-old woman (G3P1021) with heavy menstrual bleeding who desires future fertility.

Key objectives of the video include:

Also integrated into this video is the application of the ExCITE technique—a manual cold knife tissue extraction technique utilizing an extracorporeal semi-circle “C-incision” approach—for tissue extraction. This technique was featured in an earlier installment of the video channel.¹

I hope that you find this month’s video helpful to your surgical practice.

Vidyard Video

 

Share your thoughts on this video! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The management of symptomatic uterine fibroids in the patient desiring conservative surgical therapy can be challenging at times. The advent of robot-assisted laparoscopy has provided surgeons with an enabling tool and patients with the option for a minimally invasive approach to myomectomy.

This month’s video was produced in order to demonstrate a systematic approach to the robot-assisted laparoscopic myomectomy in patients who are candidates. The example case is removal of a 5-cm, intrauterine posterior myoma in a 39-year-old woman (G3P1021) with heavy menstrual bleeding who desires future fertility.

Key objectives of the video include:

Also integrated into this video is the application of the ExCITE technique—a manual cold knife tissue extraction technique utilizing an extracorporeal semi-circle “C-incision” approach—for tissue extraction. This technique was featured in an earlier installment of the video channel.¹

I hope that you find this month’s video helpful to your surgical practice.

Vidyard Video

 

Share your thoughts on this video! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The management of symptomatic uterine fibroids in the patient desiring conservative surgical therapy can be challenging at times. The advent of robot-assisted laparoscopy has provided surgeons with an enabling tool and patients with the option for a minimally invasive approach to myomectomy.

This month’s video was produced in order to demonstrate a systematic approach to the robot-assisted laparoscopic myomectomy in patients who are candidates. The example case is removal of a 5-cm, intrauterine posterior myoma in a 39-year-old woman (G3P1021) with heavy menstrual bleeding who desires future fertility.

Key objectives of the video include:

Also integrated into this video is the application of the ExCITE technique—a manual cold knife tissue extraction technique utilizing an extracorporeal semi-circle “C-incision” approach—for tissue extraction. This technique was featured in an earlier installment of the video channel.¹

I hope that you find this month’s video helpful to your surgical practice.

Vidyard Video

 

Share your thoughts on this video! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

NEW YORK (Reuters Health) - About one in 20 bariatric surgery patients are readmitted to the hospital within 30 days of having the procedure, according to new findings.

Readmissions are increasingly being used as a quality metric for surgical procedures, Dr. John Morton of Stanford University in California and colleagues note in their report, published online March 19 in the American Journal of Surgery.

"While (the Centers for Medicare and Medicaid Services) has not addressed bariatric surgery readmissions to date, other payors have made readmissions a priority," they add. "Data regarding bariatric surgery readmissions are critical to help better understand and drive quality improvement in this area.

"To investigate the prevalence, causes and risk factors for readmission following bariatric surgery, the researchers looked at data from the 2012 American College of Surgeons National Surgical Quality Improvement Program Public Use File dataset on nearly 18,300 bariatric patients, of whom 55% had laparoscopic Roux-en-Y gastric bypass (LRYGB), 10% had laparoscopic adjustable gastric banding (LAGB), and 35% had laparoscopic sleeve gastrectomy (LSG).

There were 955 readmissions (5.22%), most commonly for gastrointestinal causes (45%), dietary reasons (34%) and bleeding (7%). Readmission rates were nearly 7% for LRYGB; just under 2% for LAGB; and 4% for LSG.

The patients who were readmitted had a significantly longer average operating time (132 vs. 115 minutes) and length of stay (2.76 days vs. 2.23). Forty percent had a complication, versus 4% of patients who were not readmitted. Patients who were readmitted were also more likely to have a body mass index above 50, preoperative diabetes, chronic obstructive pulmonary disease, and hypertension.

Factors independently associated with readmission included African-American race (odds ratio, 1.53), complication (OR, 11.3) and resident involvement (OR, 0.53).

"Other studies have also demonstrated similar predictors of readmission and have also demonstrated that length of stay may also play a role in readmission rates," Dr. Morton and his team state. "This study helps demonstrate that bariatric surgery readmissions are prevalent and potentially preventable."

NEW YORK (Reuters Health) - About one in 20 bariatric surgery patients are readmitted to the hospital within 30 days of having the procedure, according to new findings.

Readmissions are increasingly being used as a quality metric for surgical procedures, Dr. John Morton of Stanford University in California and colleagues note in their report, published online March 19 in the American Journal of Surgery.

"While (the Centers for Medicare and Medicaid Services) has not addressed bariatric surgery readmissions to date, other payors have made readmissions a priority," they add. "Data regarding bariatric surgery readmissions are critical to help better understand and drive quality improvement in this area.

"To investigate the prevalence, causes and risk factors for readmission following bariatric surgery, the researchers looked at data from the 2012 American College of Surgeons National Surgical Quality Improvement Program Public Use File dataset on nearly 18,300 bariatric patients, of whom 55% had laparoscopic Roux-en-Y gastric bypass (LRYGB), 10% had laparoscopic adjustable gastric banding (LAGB), and 35% had laparoscopic sleeve gastrectomy (LSG).

There were 955 readmissions (5.22%), most commonly for gastrointestinal causes (45%), dietary reasons (34%) and bleeding (7%). Readmission rates were nearly 7% for LRYGB; just under 2% for LAGB; and 4% for LSG.

The patients who were readmitted had a significantly longer average operating time (132 vs. 115 minutes) and length of stay (2.76 days vs. 2.23). Forty percent had a complication, versus 4% of patients who were not readmitted. Patients who were readmitted were also more likely to have a body mass index above 50, preoperative diabetes, chronic obstructive pulmonary disease, and hypertension.

Factors independently associated with readmission included African-American race (odds ratio, 1.53), complication (OR, 11.3) and resident involvement (OR, 0.53).

"Other studies have also demonstrated similar predictors of readmission and have also demonstrated that length of stay may also play a role in readmission rates," Dr. Morton and his team state. "This study helps demonstrate that bariatric surgery readmissions are prevalent and potentially preventable."

NEW YORK (Reuters Health) - About one in 20 bariatric surgery patients are readmitted to the hospital within 30 days of having the procedure, according to new findings.

Readmissions are increasingly being used as a quality metric for surgical procedures, Dr. John Morton of Stanford University in California and colleagues note in their report, published online March 19 in the American Journal of Surgery.

"While (the Centers for Medicare and Medicaid Services) has not addressed bariatric surgery readmissions to date, other payors have made readmissions a priority," they add. "Data regarding bariatric surgery readmissions are critical to help better understand and drive quality improvement in this area.

"To investigate the prevalence, causes and risk factors for readmission following bariatric surgery, the researchers looked at data from the 2012 American College of Surgeons National Surgical Quality Improvement Program Public Use File dataset on nearly 18,300 bariatric patients, of whom 55% had laparoscopic Roux-en-Y gastric bypass (LRYGB), 10% had laparoscopic adjustable gastric banding (LAGB), and 35% had laparoscopic sleeve gastrectomy (LSG).

There were 955 readmissions (5.22%), most commonly for gastrointestinal causes (45%), dietary reasons (34%) and bleeding (7%). Readmission rates were nearly 7% for LRYGB; just under 2% for LAGB; and 4% for LSG.

The patients who were readmitted had a significantly longer average operating time (132 vs. 115 minutes) and length of stay (2.76 days vs. 2.23). Forty percent had a complication, versus 4% of patients who were not readmitted. Patients who were readmitted were also more likely to have a body mass index above 50, preoperative diabetes, chronic obstructive pulmonary disease, and hypertension.

Factors independently associated with readmission included African-American race (odds ratio, 1.53), complication (OR, 11.3) and resident involvement (OR, 0.53).

"Other studies have also demonstrated similar predictors of readmission and have also demonstrated that length of stay may also play a role in readmission rates," Dr. Morton and his team state. "This study helps demonstrate that bariatric surgery readmissions are prevalent and potentially preventable."

Cesarean delivery is one of the most common surgical procedures in women, with rates of 30% or more in the United States.¹ As a result, the rate is rising for cesarean scar defect—the presence of a “niche” at the site of cesarean delivery scar—with the reported prevalence between 24% and 70% in a random population of women with at least one cesarean delivery.² Other terms for cesarean scar defect include a niche, isthmocele, uteroperitoneal fistula, and diverticulum.^1–9

Formation of cesarean scar defect

Cesarean scar defect forms after cesarean delivery, at the site of hysterotomy, on the anterior wall of the uterine isthmus (FIGURE 1). While this is the typical location, the defect has also been found at the endocervical canal and mid-uterine body. Improper healing of the cesarean incision leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site. The exact reason why a niche develops has not yet been determined; however, there are several hypotheses, broken down by pregnancy-related and patient-related factors. Surgical techniques that may increase the chance of niche development include low (cervical) hysterotomy, single-layer uterine wall closure, use of locking sutures, closure of hysterotomy with endometrial-sparing technique, and multiple cesarean deliveries.^3,4 Patients with medical conditions that may impact wound healing (such as diabetes and smoking) may be at increased risk for niche formation.

Viewed hysteroscopically, the defect appears as a concave shape in the anterior uterine wall; to the inexperienced eye, it may resemble a second cavity (FIGURE 2).

Pelvic pain and other serious consequences

The presence of fibrotic tissue in the niche acts like a valve, leading to the accumulation of blood in this reservoir-like area. A niche thus can cause delayed menstruation through the cervix, resulting in abnormal bleeding, pelvic pain, vaginal discharge, dysmenorrhea, dyspareunia, and infertility. Accumulated blood in this area can ultimately degrade cervical mucus and sperm quality, as well as inhibit sperm transport, a proposed mechanism of infertility.^5,6 Women with a niche who conceive are at potential risk for cesarean scar ectopic pregnancy, with the embryo implanting in the pouch and subsequently growing and developing improperly.

Read about evaluation and treatment.

Evaluation and treatment

Patients presenting with the symptoms de-scribed above who have had a prior cesarean delivery should be evaluated for a cesarean scar defect.⁹ The best time to assess for the abnormality is after the patient’s menstrual cycle, when the endometrial lining is at its thinnest and recently menstruated blood has collected in the defect (this can highlight the niche on imaging). Transvaginal ultrasonography (FIGURE 3) or saline-infusion sonohysterogram serve as a first-line test for in-office diagnosis.⁷ Magnetic resonance imaging (MRI), 3-D ultrasonography, and hysteroscopy are additional useful imaging modalities that can aid in the diagnosis.

Treatments for cesarean scar defect vary dramatically and include hormonal therapy, hysteroscopic resection, vaginal or laparoscopic repair, and hysterectomy. Nonsurgical treatment should be reserved for women who desire a noninvasive approach, as the evidence for symptom resolution is limited.⁸

To promote fertility and decrease symptoms, the abnormal, fibrotic tissue must be removed. In our experience, since 2003, we have found that use of a laparoscopic approach is best for women desiring future fertility and that hysteroscopic resection is best for women whose childbearing is completed.⁹ Our management is dictated by the patient’s fertility plans, since there is concern that cesarean scar defect in a gravid uterus presents a risk for uterine rupture. The laparoscopic approach allows the defect to be repaired and the integrity of the myometrium restored.⁹

Read about techniques for repair.

Techniques for repairing cesarean scar defect

For hysteroscopic resection of a niche, the uterus is distended and the intrauterine defect is visualized hysteroscopically, as seen in FIGURE 2. Using a bipolar or unipolar resectoscope, resect the fibrotic tissue of the defect and endometrial-like glands present within the niche. The goal of this relatively quick procedure is to open up the reservoir and facilitate the complete drainage of menstrual blood, thus alleviating the patient’s symptoms.Postoperatively, follow the patient for symptom resolution, and evaluate for defect resolution with transvaginal ultrasonography.

For a laparoscopic repair, first identify the niche hysteroscopically. At the same time as hysteroscopic examination of the cavity, the defect can be evaluated laparoscopically (FIGURE 4). The light from the hysteroscope can be visualized easily laparoscopically because of the thinned myometrium in the area of the defect. Map out the niche by transvaginally passing a cervical dilator into the defect in the uterine cavity (FIGURE 5). Again, given the thinning of this segment of the uterus, the dilator can be easily visualized laparoscopically. Be cautious when placing this dilator, as there is often overlying bladder. Prevent incidental cystotomy by gently advancing the dilator into the defect only until the niche can be adequately detected.⁹At this point, develop a bladder flap by opening the vesicovaginal and vesicocervical space, mobilizing the bladder inferiorly (FIGURE 6). With the guide of the dilator mapping out the defect (FIGURE 7), excise the fibrotic edges of the niche with thermal energy (monopolar cautery or CO₂ laser) or sharp dissection (FIGURE 8). This leaves healthy myometrial tissue margins. Reapproximate these margins with absorbable suture (2-0 polyglactin 910 [Vicryl]) in an interrupted or running fashion, in 2 layers⁹ (FIGURE 9). Following the laparoscopic repair, perform hysteroscopic evaluation of the uterine cavity to assure complete resolution of the defect (FIGURE 10). With the hysteroscope in place, perform concurrent laparoscopic assessment of the repair. Check for impermeability by assuring no hysteroscopic fluid escapes at the site of repaired hysterotomy.⁹

Postoperative care requires following the patient for symptom resolution and counseling regarding future fertility plans. We recommend that patients wait 6 months following the procedure before attempting conception.

When it comes to recommendations regarding preventing cesarean scar defects, additional randomized controlled trials need to be performed to evaluate various surgical techniques. At this time, there is no conclusive evidence that one method of hysterotomy closure is superior to another in preventing cesarean scar defect.

Symptoms often resolve with repair

When a patient with a prior cesarean delivery presents with symptoms of abnormal uterine bleeding, vaginal discharge, dysmenorrhea, dyspareunia, pelvic pain, or infertility that remain unexplained, consider cesarean scar defect as the culprit. Once a diagnosis of niche has been confirmed, the treatment approach should be dictated by the patient’s plans for future fertility. Hysteroscopic resection has been reported to have a 92% to 100% success rate for resolving symptoms of pain and bleeding, while 75% of patients undergoing laparoscopic niche repair for infertility achieved pregnancy.^10,11 In our practice, a majority of patients experience symptom relief and go on to carry healthy pregnancies.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Cesarean delivery is one of the most common surgical procedures in women, with rates of 30% or more in the United States.¹ As a result, the rate is rising for cesarean scar defect—the presence of a “niche” at the site of cesarean delivery scar—with the reported prevalence between 24% and 70% in a random population of women with at least one cesarean delivery.² Other terms for cesarean scar defect include a niche, isthmocele, uteroperitoneal fistula, and diverticulum.^1–9

Formation of cesarean scar defect

Cesarean scar defect forms after cesarean delivery, at the site of hysterotomy, on the anterior wall of the uterine isthmus (FIGURE 1). While this is the typical location, the defect has also been found at the endocervical canal and mid-uterine body. Improper healing of the cesarean incision leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site. The exact reason why a niche develops has not yet been determined; however, there are several hypotheses, broken down by pregnancy-related and patient-related factors. Surgical techniques that may increase the chance of niche development include low (cervical) hysterotomy, single-layer uterine wall closure, use of locking sutures, closure of hysterotomy with endometrial-sparing technique, and multiple cesarean deliveries.^3,4 Patients with medical conditions that may impact wound healing (such as diabetes and smoking) may be at increased risk for niche formation.

Viewed hysteroscopically, the defect appears as a concave shape in the anterior uterine wall; to the inexperienced eye, it may resemble a second cavity (FIGURE 2).

Pelvic pain and other serious consequences

The presence of fibrotic tissue in the niche acts like a valve, leading to the accumulation of blood in this reservoir-like area. A niche thus can cause delayed menstruation through the cervix, resulting in abnormal bleeding, pelvic pain, vaginal discharge, dysmenorrhea, dyspareunia, and infertility. Accumulated blood in this area can ultimately degrade cervical mucus and sperm quality, as well as inhibit sperm transport, a proposed mechanism of infertility.^5,6 Women with a niche who conceive are at potential risk for cesarean scar ectopic pregnancy, with the embryo implanting in the pouch and subsequently growing and developing improperly.

Read about evaluation and treatment.

Evaluation and treatment

Patients presenting with the symptoms de-scribed above who have had a prior cesarean delivery should be evaluated for a cesarean scar defect.⁹ The best time to assess for the abnormality is after the patient’s menstrual cycle, when the endometrial lining is at its thinnest and recently menstruated blood has collected in the defect (this can highlight the niche on imaging). Transvaginal ultrasonography (FIGURE 3) or saline-infusion sonohysterogram serve as a first-line test for in-office diagnosis.⁷ Magnetic resonance imaging (MRI), 3-D ultrasonography, and hysteroscopy are additional useful imaging modalities that can aid in the diagnosis.

Treatments for cesarean scar defect vary dramatically and include hormonal therapy, hysteroscopic resection, vaginal or laparoscopic repair, and hysterectomy. Nonsurgical treatment should be reserved for women who desire a noninvasive approach, as the evidence for symptom resolution is limited.⁸

To promote fertility and decrease symptoms, the abnormal, fibrotic tissue must be removed. In our experience, since 2003, we have found that use of a laparoscopic approach is best for women desiring future fertility and that hysteroscopic resection is best for women whose childbearing is completed.⁹ Our management is dictated by the patient’s fertility plans, since there is concern that cesarean scar defect in a gravid uterus presents a risk for uterine rupture. The laparoscopic approach allows the defect to be repaired and the integrity of the myometrium restored.⁹

Read about techniques for repair.

Techniques for repairing cesarean scar defect

For hysteroscopic resection of a niche, the uterus is distended and the intrauterine defect is visualized hysteroscopically, as seen in FIGURE 2. Using a bipolar or unipolar resectoscope, resect the fibrotic tissue of the defect and endometrial-like glands present within the niche. The goal of this relatively quick procedure is to open up the reservoir and facilitate the complete drainage of menstrual blood, thus alleviating the patient’s symptoms.Postoperatively, follow the patient for symptom resolution, and evaluate for defect resolution with transvaginal ultrasonography.

For a laparoscopic repair, first identify the niche hysteroscopically. At the same time as hysteroscopic examination of the cavity, the defect can be evaluated laparoscopically (FIGURE 4). The light from the hysteroscope can be visualized easily laparoscopically because of the thinned myometrium in the area of the defect. Map out the niche by transvaginally passing a cervical dilator into the defect in the uterine cavity (FIGURE 5). Again, given the thinning of this segment of the uterus, the dilator can be easily visualized laparoscopically. Be cautious when placing this dilator, as there is often overlying bladder. Prevent incidental cystotomy by gently advancing the dilator into the defect only until the niche can be adequately detected.⁹At this point, develop a bladder flap by opening the vesicovaginal and vesicocervical space, mobilizing the bladder inferiorly (FIGURE 6). With the guide of the dilator mapping out the defect (FIGURE 7), excise the fibrotic edges of the niche with thermal energy (monopolar cautery or CO₂ laser) or sharp dissection (FIGURE 8). This leaves healthy myometrial tissue margins. Reapproximate these margins with absorbable suture (2-0 polyglactin 910 [Vicryl]) in an interrupted or running fashion, in 2 layers⁹ (FIGURE 9). Following the laparoscopic repair, perform hysteroscopic evaluation of the uterine cavity to assure complete resolution of the defect (FIGURE 10). With the hysteroscope in place, perform concurrent laparoscopic assessment of the repair. Check for impermeability by assuring no hysteroscopic fluid escapes at the site of repaired hysterotomy.⁹

Postoperative care requires following the patient for symptom resolution and counseling regarding future fertility plans. We recommend that patients wait 6 months following the procedure before attempting conception.

When it comes to recommendations regarding preventing cesarean scar defects, additional randomized controlled trials need to be performed to evaluate various surgical techniques. At this time, there is no conclusive evidence that one method of hysterotomy closure is superior to another in preventing cesarean scar defect.

Symptoms often resolve with repair

When a patient with a prior cesarean delivery presents with symptoms of abnormal uterine bleeding, vaginal discharge, dysmenorrhea, dyspareunia, pelvic pain, or infertility that remain unexplained, consider cesarean scar defect as the culprit. Once a diagnosis of niche has been confirmed, the treatment approach should be dictated by the patient’s plans for future fertility. Hysteroscopic resection has been reported to have a 92% to 100% success rate for resolving symptoms of pain and bleeding, while 75% of patients undergoing laparoscopic niche repair for infertility achieved pregnancy.^10,11 In our practice, a majority of patients experience symptom relief and go on to carry healthy pregnancies.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Cesarean delivery is one of the most common surgical procedures in women, with rates of 30% or more in the United States.¹ As a result, the rate is rising for cesarean scar defect—the presence of a “niche” at the site of cesarean delivery scar—with the reported prevalence between 24% and 70% in a random population of women with at least one cesarean delivery.² Other terms for cesarean scar defect include a niche, isthmocele, uteroperitoneal fistula, and diverticulum.^1–9

Formation of cesarean scar defect

Cesarean scar defect forms after cesarean delivery, at the site of hysterotomy, on the anterior wall of the uterine isthmus (FIGURE 1). While this is the typical location, the defect has also been found at the endocervical canal and mid-uterine body. Improper healing of the cesarean incision leads to thinning of the anterior uterine wall, which creates an indentation and fluid-filled pouch at the cesarean scar site. The exact reason why a niche develops has not yet been determined; however, there are several hypotheses, broken down by pregnancy-related and patient-related factors. Surgical techniques that may increase the chance of niche development include low (cervical) hysterotomy, single-layer uterine wall closure, use of locking sutures, closure of hysterotomy with endometrial-sparing technique, and multiple cesarean deliveries.^3,4 Patients with medical conditions that may impact wound healing (such as diabetes and smoking) may be at increased risk for niche formation.

Viewed hysteroscopically, the defect appears as a concave shape in the anterior uterine wall; to the inexperienced eye, it may resemble a second cavity (FIGURE 2).

Pelvic pain and other serious consequences

The presence of fibrotic tissue in the niche acts like a valve, leading to the accumulation of blood in this reservoir-like area. A niche thus can cause delayed menstruation through the cervix, resulting in abnormal bleeding, pelvic pain, vaginal discharge, dysmenorrhea, dyspareunia, and infertility. Accumulated blood in this area can ultimately degrade cervical mucus and sperm quality, as well as inhibit sperm transport, a proposed mechanism of infertility.^5,6 Women with a niche who conceive are at potential risk for cesarean scar ectopic pregnancy, with the embryo implanting in the pouch and subsequently growing and developing improperly.

Read about evaluation and treatment.

Evaluation and treatment

Patients presenting with the symptoms de-scribed above who have had a prior cesarean delivery should be evaluated for a cesarean scar defect.⁹ The best time to assess for the abnormality is after the patient’s menstrual cycle, when the endometrial lining is at its thinnest and recently menstruated blood has collected in the defect (this can highlight the niche on imaging). Transvaginal ultrasonography (FIGURE 3) or saline-infusion sonohysterogram serve as a first-line test for in-office diagnosis.⁷ Magnetic resonance imaging (MRI), 3-D ultrasonography, and hysteroscopy are additional useful imaging modalities that can aid in the diagnosis.

Treatments for cesarean scar defect vary dramatically and include hormonal therapy, hysteroscopic resection, vaginal or laparoscopic repair, and hysterectomy. Nonsurgical treatment should be reserved for women who desire a noninvasive approach, as the evidence for symptom resolution is limited.⁸

To promote fertility and decrease symptoms, the abnormal, fibrotic tissue must be removed. In our experience, since 2003, we have found that use of a laparoscopic approach is best for women desiring future fertility and that hysteroscopic resection is best for women whose childbearing is completed.⁹ Our management is dictated by the patient’s fertility plans, since there is concern that cesarean scar defect in a gravid uterus presents a risk for uterine rupture. The laparoscopic approach allows the defect to be repaired and the integrity of the myometrium restored.⁹

Read about techniques for repair.

Techniques for repairing cesarean scar defect

For hysteroscopic resection of a niche, the uterus is distended and the intrauterine defect is visualized hysteroscopically, as seen in FIGURE 2. Using a bipolar or unipolar resectoscope, resect the fibrotic tissue of the defect and endometrial-like glands present within the niche. The goal of this relatively quick procedure is to open up the reservoir and facilitate the complete drainage of menstrual blood, thus alleviating the patient’s symptoms.Postoperatively, follow the patient for symptom resolution, and evaluate for defect resolution with transvaginal ultrasonography.

For a laparoscopic repair, first identify the niche hysteroscopically. At the same time as hysteroscopic examination of the cavity, the defect can be evaluated laparoscopically (FIGURE 4). The light from the hysteroscope can be visualized easily laparoscopically because of the thinned myometrium in the area of the defect. Map out the niche by transvaginally passing a cervical dilator into the defect in the uterine cavity (FIGURE 5). Again, given the thinning of this segment of the uterus, the dilator can be easily visualized laparoscopically. Be cautious when placing this dilator, as there is often overlying bladder. Prevent incidental cystotomy by gently advancing the dilator into the defect only until the niche can be adequately detected.⁹At this point, develop a bladder flap by opening the vesicovaginal and vesicocervical space, mobilizing the bladder inferiorly (FIGURE 6). With the guide of the dilator mapping out the defect (FIGURE 7), excise the fibrotic edges of the niche with thermal energy (monopolar cautery or CO₂ laser) or sharp dissection (FIGURE 8). This leaves healthy myometrial tissue margins. Reapproximate these margins with absorbable suture (2-0 polyglactin 910 [Vicryl]) in an interrupted or running fashion, in 2 layers⁹ (FIGURE 9). Following the laparoscopic repair, perform hysteroscopic evaluation of the uterine cavity to assure complete resolution of the defect (FIGURE 10). With the hysteroscope in place, perform concurrent laparoscopic assessment of the repair. Check for impermeability by assuring no hysteroscopic fluid escapes at the site of repaired hysterotomy.⁹

Postoperative care requires following the patient for symptom resolution and counseling regarding future fertility plans. We recommend that patients wait 6 months following the procedure before attempting conception.

When it comes to recommendations regarding preventing cesarean scar defects, additional randomized controlled trials need to be performed to evaluate various surgical techniques. At this time, there is no conclusive evidence that one method of hysterotomy closure is superior to another in preventing cesarean scar defect.

Symptoms often resolve with repair

When a patient with a prior cesarean delivery presents with symptoms of abnormal uterine bleeding, vaginal discharge, dysmenorrhea, dyspareunia, pelvic pain, or infertility that remain unexplained, consider cesarean scar defect as the culprit. Once a diagnosis of niche has been confirmed, the treatment approach should be dictated by the patient’s plans for future fertility. Hysteroscopic resection has been reported to have a 92% to 100% success rate for resolving symptoms of pain and bleeding, while 75% of patients undergoing laparoscopic niche repair for infertility achieved pregnancy.^10,11 In our practice, a majority of patients experience symptom relief and go on to carry healthy pregnancies.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, james.wright@ndorms.ox.ac.uk.


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, james.wright@ndorms.ox.ac.uk.


Funding/support: RB Salter Chair in Paediatric Surgical Research.

From the Hospital for Sick Children, Toronto, ON.

Abstract

• Objective: To describe the iterative and adaptive process used in implementing strategies to reduce surgical site infections (SSI) in a pediatric academic health science center.
• Methods: A multidisciplinary group was tasked with implementing strategies to reduce SSI with a focus on evaluating the use of a guideline for the use of prophylactic antibiotics and determining the rate of SSI.
• Results: The task force initially addressed surgical preparation solution, hair removal, oxygenation, and normothermia. The task force subsequently revised a guideline for the use of prophylactic antibiotics and implemented the guideline iteratively with multiple strategies including audit and feedback, communication and dissemination, and computerised order entry. The appropriate use of the guideline was associated with a 30% reduction in the rate of SSI.
• Conclusion: Using iterative and adaptive strategies over many years, the SSI rate was reduced by 30%.

Improving quality of care is a prime concern for clinicians, patients, families, and health systems [1]. Quality improvement methods are used widely in medicine for studying and addressing problems with care and have successfully addressed gaps in quality. The challenges include defining quality, obtaining complete and accurate data about quality, developing meaningful and cost-effective interventions to improve quality, and to successfully change clinician’s behaviour with commensurate improvement in quality of care.

Quality improvement in health care involves effecting and assessing change in a setting of complexity and uncertainty. Whereas the randomized trial may be used to measure the effectiveness of a particular treatment, quality improvement implementation involves an iterative and adaptive process in response to local events as the implementation proceeds [2]. These context-specific iterative changes to the implementation process are the fuzzy elements of change. This article describes a quality improvement initative to to reduce surgical site infections at an academic health science center with a focus on the fuzziness inherent in the process and our iterative responses to local events.

Setting

The Hospital for Sick Children (Sickkids) is a childrens’ academic health science center in Toronto, Ontario, Canada. The largest children’s hospital in Canada, with 8000 health care professionals, scientists, trainees, administrative and support staff, it has approximately 300 beds, 15,000 inpatient admissions, 12,000 surgical procedures, 70,000 emergency visits, and 300,000 outpatient visits annually. The hospital is a Level 1 trauma unit and performs the full spectrum of pediatric surgical care including transplant and cardiac procedures. The hospital and physician staffs are affiliated with the University of Toronto. The hospital has 16 theatre operating rooms, with 11 perioperative divisions and departments.

The departmental and divisional structure of the hospital, which emulates the university organizational structure, does not represent the size and level of clinical activity of the groups. For example, the department of otolaryngology, head and neck surgery has 5 surgeons whereas the division of orthopedics (as one of 6 divisions in the department of surgery) has 9 orthopedic surgeons. Furthermore, a divisional and departmental structure arguably does not match the institutional operational aims related to patient care delivery. Thus, in 2007 the 3 departments of surgery, the departments of critical care, anaesthesia and pain medicine, and dentistry were clustered together as “perioperative services,” reporting to a chief of perioperative services who in turn reported directly to the CEO. The chief of perioperative services, responsible for all operational issues, was concurrently the surgeon-in-chief.

Physicians at Sickkids are not paid fee-for-service. Each division/department receives compensation according to their specific speciality on a full-time equivalent (FTE) basis. While clinical and academic productivity is measured, physicians do not receive activity-based compensation. The perioperative service chiefs have primary responsibility for the clinical operations and academic activity. A perioperative care unit (POCU) executive has primarily responsibility for policy and financial oversight of the operating rooms.

As this was primarily a quality improvement initiative, we obtained institutional approval through that process.

Defining the Target for Quality improvement

To determine shared objectives for quality improvement, the surgeon-in-chief organized a daylong retreat in 2005 of all physicians (of the 11 divisions and departments that was later called perioperative services), nurses, and other disciplines involved in delivering surgical care. All scheduled clinics and OR activity were cancelled. The start and end of the retreat day matched the nursing day shift with a voluntary social event at the end. In the morning after meeting together, the 3 disciplines of nursing, surgery and anaesthesia met to discuss speciality-specific issues. In the afternoon, the 3 disciplines reconvened in small multidisciplinary groups of 8 to 10 individuals to discuss the objectives for improvement using the Institute of Medicine framework [1]. Outcomes of the small group discussions were presented to, and discussed by, the entire group, and those initiatives that achieved general endorsement were approved. A report summarising all recommendations arising from the day was widely circulated for comment. Recommendations were grouped, where appropriate, and assigned to task forces. Task forces were multidisciplinary groups co-led by 2 disciplines, with specific objectives arising from the retreat recommendations with measurable goals and a timeline of 12 to 18 months for completion of the recommendations.

The retreat of the perioperative services group recognized that many aspects of high quality care were hampered by variable diagnoses, comorbidities, and multiple and complex interventions with a critical lack of easily measured and cogent outcomes. The 4 areas that were relevant to all disciplines, most amenable to evaluation, and where significant quality gains were perceived to be necessary and possible were safety, perioperative pain, access to surgery, and surgical site infection (SSI). This paper reports on the SSI QI program.

Initial Task Force Work

An SSI task force initially addressed surgical preparation solution, hair clipping, oxygenation and normothermia. All razors were physically removed from the ORs and replaced by electric clippers. Multi-use proviodine preparation solution was replaced by single-use 70% isopropyl alcohol with 2% chlorhexidene (except for open wounds and neonates). Pilot studies of patients arriving in the POCU revealed that hypoxia was not an issue and normothermia was seldom an issue. Thereafter the prime focus shifted to the use of prophylactic antibiotics to reduce SSI.

Compliance with Antibiotic Prophylaxis Guideline

Guideline Update Process

A guideline for the use of prophylactic antibiotics to prevent SSI had been in place at Sickkids for many years. However, a chart review revealed only 40% of patients were receiving the correct drug, dose, duration, and time of administration relative to the incision, and few patients were receiving appropriate intraoperative top-ups [3]. In addition, the existing guideline was incomplete for all specialities and procedures, did not consider the issue of beta-lactam antibiotic allergy, and had no specific dosing for neonates. Therefore, the guideline needed to be updated and be more comprehensive before any attempts to increase compliance with the guideline was initiated. The infection control specialist and pharmacist reviewed evidence-based guidelines from the literature on adults to create a guideline comprehensive for speciality and procedure with specific dosing for neonates and alternative antibiotics for patients allergic to penicillin [3]. Updating the guidelines took almost a year.

The next step was to seek endorsement of all the surgical subspecialities. The guidelines were circulated to all specialities for comments. While a few specialists provided minor comments, as discussed further below, this step did not result in substantive feedback and again took almost a year.

The final guidelines were discussed at multiple meetings of the members of perioperative services and approved by the hospital drug and therapeutics committee. A date was set to introduce the new guideline and announced at departmental meetings, in emails, and on banners in the OR.

The revised guidelines replaced the old guidelines on the e-formulary. Hard copies were attached to the anaesthetic machine in each OR and the need for antibiotics was made part of the “time-out” before commencement of the procedure.

Early Monitoring of Guideline Use

To monitor the use of the guidelines, the use of an antibiotic and the timing related to the surgical incision became part of charting by nurses. Nurses charted many aspects of the surgical procedure through a surgical information management system (SIS, Alpharetta, GA). While documentation of the specific drug and dose was considered important information, the additional charting burden for nurses was considered to be too great. Thus the compromise was to chart if a drug was given and the time of administration to allow determination if the drug was given within an hour of the surgical incision.

Early results from monitoring of antibiotic administration revealed that drugs often were given well in advance of the 1-hour target. To address this issue, first, antibiotics given “on call to OR” was eliminated (because the duration from the call to go to the OR and until the surgical incision was never less than 1 hour) and thereafter all antibiotics were given in the OR. Second, due to prolonged anesthetic times prior to surgical start for complex cases, anesthetists changed their practise to give antibiotics as one of the final steps prior to start of surgery.

The next step was to monitor the use and timing of antibiotics by surgical division/department automatically using data from SIS. Concurrent with the efforts to improve the use of prophylactic antibiotic, a score card had been created to monitor quality and efficiency activities within perioperative services. The use and timing of prophylactic antibiotics became part of that monthly report. While the appropriate use of antibiotics improved over 6 months, a repeat audit revealed that compliance with the guideline for patients to receive, or not receive, antibiotics was only moderately improved [5]. Furthermore, whereas the guideline stated that antibiotics were needed only intra-operatively for the majority of procedures, antibiotics were extended postoperatively for periods ranging from 24 to 72 hours.

Addressing Compliance Issues

First, semi-annual mandatory lectures were presented to residents and fellows delineating the importance of the guidelines, with a specific focus on correct duration of antibiotics. Furthermore a “stop warning” was added to the computerized physician order entry system (orders are completed almost exclusively by house staff). In addition, we introduced an individual audit and feedback mechanism (see below).

Automated Audit and Feedback Process and Results

Each surgeon and anesthetist received an automated email the morning after the procedure detailing whether antibiotics had been indicated and whether they had been given or held appropriately. To accomplish this required that all surgical procedures (entered on SIS by the nurses) were matched to the guidelines. With the assistance of each division and department, each SIS procedural code was matched to the guideline as to whether antibiotics were indicated or not. In the case of multiple procedures, if any of the procedures warranted antibiotics then antibiotics were indicated for that patient. The automatic email sent to the staff acknowledged potential errors due to incorrect matching of the surgical procedure to guideline, incorrect charting by nurses, and incorrect indication of the guideline to receive (or not receive) antibiotics.

The response to this email had several impacts. First, the response identified many errors related to matching of SIS procedure to guidelines. Second, the email served as impetus to improve nurse charting. Third, through the automated emails we determined that some patients were on antibiotics for a pre-existing infection. Thus a separate notation in the SIS charting by the nursing staff was added to indicate a pre-existing infection (to prevent an automated email). Fourth, while circulation of the guidelines to all divisions and departments had provided little feedback to the final draft of guideline, responses to the emails resulted in refinement of ambiguities in guideline related to procedure description, and in some cases changes to the guideline based on the use of antibiotics. Fifth, the emails improved compliance with the guideline [3].

While audit and feedback resulted in a substantial rise in the appropriate use and timing of antibiotics, the nurses were often harassed about their charting, placing them in the uncomfortable position of seen to be enforcing the guideline. Also, some surgeons vehemently disliked the emails, pointing to occasional inaccuracies of the emails. Finally, the audit and feedback provided feedback after the surgical event, and while increasing attention on the guideline, did nothing for the individual patient. An alternative proposed strategy was that at the time of SIS charting of the procedure that SIS could serve as a decision tool and indicate whether antibiotics were indicated, and indicate the correct antibiotic. However SIS is proprietary software and we were unable to make the necessary programming changes.

Measuring SSI Rate

Concurrently with focusing on the process measures of the appropriate use of antibiotics, we also developed a mechanism to measure SSI [4]. Prior to this quality improvement initiative, the existing mechanism to measure institutional SSI was based on daily visits to surgical wards by infection control practitioners (ICPs) supplemented by identification of patients by positive wound cultures in microbiology. Due to the expense of active monitoring across all surgical disciplines, this program had been restricted to neurosurgery, cardiac surgery, and spine surgery (areas of high risk for SSI identified in the past). Because the hospital did not have the resources to expand ICP monitoring to all surgical areas, an alternative strategy of using health record coders was explored as a means to provide comprehensive rates of SSI for all disciplines.

The first step in using health records as a means to identify SSI was to perform a review of all SSIs identified by health records in the 3 priority areas monitored by the ICPs. All health records identified “SSI” were reviewed by a surgeon to determine which were and were not SSI, according to the Centers for Disease Control criteria [5]. The review identified that the International Classification of Disease (ICD−10) coding for SSI included, in addition to SSI, multiple types of infections such as sepsis and central line infections. The review also identified that the health record coders had no specific criteria and therefore were variable in how they coded “SSI.” The review identified that the ICPs missed some true infections that were identified by health record coders.

To address the ambiguity of ICD coding, extension codes to the ICD codes were added to code specifically for SSI. To address the lack of criteria for SSI, the health record coders were trained by ICPs to use Centers for Disease Control criteria for SSI [5]. While both of these steps improved the identification of SSI by health record coders, a subsequent chart audit identified false positive and false negative recording of SSI by both ICPs and health record coders. The task force accepted that no method was completely accurate and that health record coding for SSI was financially feasible and provided SSI rates for all surgical disciplines. The task force concluded that health record coding would serve the purpose of monitoring trends in SSIs.

Impact of Guideline Compliance

The final step in the quality improvement initiative of reducing SSI was to evaluate trends in use of prophylactic antibiotics and the relationship with SSI. Through the multiple iterative strategies described above, the administration of an antibiotic within an hour of the incision increased to over 80% of patients. To evaluate the impact of guideline compliance, approximately 9000 procedures were reviewed over a 21-month period [4]. In the approximately 4500 patients who had a guideline-based indication to receive antibiotics, the 80% who received correct administration of an antibiotic within 1 hour of the incision had a reduction in the rate of SSI by one third compared with the 20% who didn’t receive antibiotics. Of the approximately 4500 patients who did not have an indication for antibiotics, 80% did not receive antibiotics (20% did receive despite no indication) and had a (statistically insignificant) lower rate of SSI compared to the 20% who received antibiotics inappropriately. In summary, only 50% of children having surgery had an indication for antibiotics, and not receiving antibiotics saved money, reduced antibiotic exposure, and did not increase the rate of SSI. In the 50% of patients who received antibiotics according to the guidelines the rate of SSI was reduced by 30% [6].

Discussion

Duration of Project

The total duration of the Sickkids effort to measure and reduce the rate of SSI and thereby improve the quality of surgical care took almost 8 years. The duration, which ideally should have been about one quarter of that time, was due to multiple issues. First, there were many simultaneous competing demands to improve quality in other IOM domains such as safety and efficiency. Second, no one on the task force had protected time and thus meetings could be no more than monthly because people could not complete tasks in a shorter time frame. Third, many of the steps relied on wider physician involvement such as reviewing the revised guidelines. The physicians were slow to respond and only after all 9 surgical disciplines had signed off on the guidelines could implementation proceed. Finally, many of the important issues came up only after implementation of a specific step. For example, the recognition of the need for an individual audit and feedback mechanism created the need of mapping the procedures to guidelines to SIS procedures, a process that took more than a year to complete. Also the responses to the emails created the need for revisions to the guideline with subsequent delays for re-approval with hospital and IT support for eformulary changes.

Success Factors and Impediments

The factors that in retrospect seem critical to effecting positive change started with a general endorsement of the perioperative services group for improving quality and specifically SSI. The retreat and an open forum involving multiple disciplines was critical in creating a mandate for change. Second, the task force not only had multiple and key discipline representation for each aspect of the change management strategy, but the task force members were passionate about the importance of reducing SSI. Third, the multiple strategies used for change needed to be adaptive and iterative to new findings as they arose. While the task force attempted to anticipate barriers to change, only once the quality initiative started did the task force truly understand the barriers and respond in turn. Finally, the need for relentless energy by the leaders and task force was critical to seeing the project to completion.

While the appropriate use of antibiotics increased with a reduction in SSI, several aspects of this initiative were not successful. First, despite the surgeon-in-chief’s semi-annual lectures, this initiative did not successfully engage the majority of the house staff manifested by their continued habit of prescribing postoperative antibiotics for hours to days despite the guideline advice. Second, because nurses were tasked with asking about and recording the use of antibiotics, an unintended consequence was that they took the brunt of disgruntled physicians. Despite all our attempts, many nurses felt this initiative brought negative responses of physicians toward their charting duties. Third, while audit and feedback was an important strategy to improve guideline compliance, many physicians saw the daily emails in response to noncompliance with the guidelines as intrusive and irritating. Also we could not program SIS to make it a decision support in real time rather than documenting an event after the fact and, thereby, not enhancing care for that individual patient. Finally, we adopted a strategy of health record coding for SSI due to the prohibitive expenses of a comprehensive active monitoring strategies by ICPs.

Exportability

The strategies used in this quality improvement project to reduce SSI may be exportable to other hospitals with similar results. However, the emphasis on which element of change management strategy is most important would likely vary by context [2,6]. The elements most essential for success were a mechanism to develop group buy-in, a dedicated multidisciplinary task force with leader(s) with relentless commitment to achieving meaningful change, and a mechanism to evaluate both the process measures and the final outcome. The elements of change would vary by site and including consideration of the mechanism for physician compensation, commitment of physicians to institutional initiatives to enhance quality, and institutional resources to support quality initiatives.

None of the observed changes in this quality improvement initiative can be confidently attributed to any of the specific interventions. The interventions were completed in stages, but most importantly were constantly changed, emphasized and de-emphasized according to the responses. This is the fuzzy nature of change whereby leaders take reasonable steps to effect change but have to constantly adapt to barriers to change. While a specific change strategy generalizable to all contexts would be ideal, in the end at an institutional level, positive change is the ultimate aim rather than determining which interventions are effective. This response to events as they arise as illustrated in our quality improvement journey, is the fuzzy side of change management.

Conclusion

In conclusion, through a long period with a multitude of strategies, use of a guideline for prophylactic antibiotics increased and was associated with a reduction in SSI. Future directions need to consider cost-effective strategies to actively monitor SSI and testing of other strategies to reduce SSI. Institutions embarking on change need to consider that initiatives will likely need to adapt to specific contextual responses.

Corresponding author: James G. Wright, MD, PMH, FRCS, Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford Botnar Research Centre,
Windmill Road, Oxford, OX3 7LD, UK, james.wright@ndorms.ox.ac.uk.


Funding/support: RB Salter Chair in Paediatric Surgical Research.

With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?

Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.

Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.

This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.

Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.¹ In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?

Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.

Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.

Proactive steps surgeons can take

Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.

Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.

We need juries that can understand the science so they truly can decide on cases involving complex technologies.

Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.

Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.

Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.² I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.

Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.

We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.

We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.

Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.

We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.

Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.³ The future of this technology is now uncertain as well.

I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.

According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”

That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.

Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”⁴ She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”⁴

We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”^4,5

No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.

It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.

It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.

To that end, we must ask ourselves, will we:

• honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”⁶
• “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”⁶
• zealously advocate for our patients to ensure we can offer them the very best therapies
• honor and respect the sacred trust patients place in us when we take them to the operating room
• lead or be led?

This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?

I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.

I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”⁶

I do believe we will.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?

Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.

Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.

This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.

Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.¹ In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?

Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.

Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.

Proactive steps surgeons can take

Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.

Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.

We need juries that can understand the science so they truly can decide on cases involving complex technologies.

Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.

Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.

Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.² I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.

Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.

We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.

We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.

Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.

We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.

Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.³ The future of this technology is now uncertain as well.

I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.

According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”

That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.

Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”⁴ She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”⁴

We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”^4,5

No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.

It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.

It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.

To that end, we must ask ourselves, will we:

• honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”⁶
• “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”⁶
• zealously advocate for our patients to ensure we can offer them the very best therapies
• honor and respect the sacred trust patients place in us when we take them to the operating room
• lead or be led?

This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?

I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.

I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”⁶

I do believe we will.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

With the decision by Astora Women’s Health to discontinue operations as of March 31, 2016, we have lost midurethral slings and pelvic organ prolapse repair mesh, technologies and kits that have been among the most widely used and studied (Steve Blum, Senior Vice President and General Manager, Astora Women’s Health, and Kathie J. Lenzen, Senior Vice President and General Manager, Endo Device Operations, e-mail communication to physician customers, February 29, 2016). US Food and Drug Administration (FDA)−mandated 522 postmarket surveillance studies on these products have stopped enrolling patients, and we will therefore never glean the full science from fully enrolled and completed studies. This is a horrible precedent. How did this happen, and what do we need to do now to prevent further loss of helpful innovative technologies that benefit our patients with pelvic floor disorders?

Liability challenges precipitated shut downEndo Pharmaceuticals, the parent company of Astora (previously American Medical Systems Women’s Health division), last year offered $1.5 billion to settle a majority of its pending mesh litigation cases. I was told that the company wanted to put all of the negative noise from the relentless plaintiff attorney public media campaign behind it and refocus its attention on helping women with pelvic floor disorders.

Over the past year, 4 interested and capable buyers have been in discussions with the company to purchase and continue its product line. The company’s recent decision to not sell its product line and discontinue all operations was based on “the current legal environment and the ongoing challenges associated with vaginal mesh product liability” (Astora Women’s Health, e-mail communication to physician customers, February 29, 2016). If it had chosen to sell its product line, the company always would have remained a potential deep-pocketed codefendant in any future litigation against the company that purchased its products, technologies, and intellectual properties.

This is a frightening scenario that threatens existing companies that want to remain in the prolapse and incontinence product space. This is a threat to all future innovation for pelvic floor disorder therapies, and it discourages anyone or any company to invest in innovative products that may help our patients. In addition, it is a threat to our mission as physicians and surgeons to provide the very best therapies to our patients who deserve and expect us to do so.

Let me be crystal clear: Currently available midurethral slings are also in the crosshairs of plaintiff attorneys, and we are at risk of losing them as well if we do not act quickly, decisively, and as a unified force. More than 60% of the mesh lawsuits have been against midurethral slings, not the prolapse mesh kits focused on in the FDA Public Health notice of July 2011.¹ In their class action lawsuits, plaintiff attorneys lumped together any procedure involving mesh in the pelvis to increase the number of their patient clients involved, which can drive up settlement awards, and they succeeded. In 2014, 128,030 sling procedures for incontinence were performed. Does anyone truly believe that the scientific literature supports that these patients would have been best served by 128,030 Burch procedures?

Some believe that Endo Pharmaceuticals’ placement of $1.5 billion in settlement funds was an error, “threw blood in the water,” and led to what has happened. Some believe that companies should fight every lawsuit to win and not settle. By the companies winning cases, the plaintiff attorneys lose their incentives to advertise and file more cases, as they only receive money if they win (or get a settlement) and are out of pocket for their costs and time if they lose.

Plaintiff attorneys have a responsibility to zealously advocate for their patient clients. Defense attorneys have a responsibility to zealously defend their corporate clients. We surgeons must realize that we have a responsibility to zealously advocate for our patients and do whatever is needed to best serve them and to protect the use (and development) of innovative products and therapies that give them value and a better quality of life.

Proactive steps surgeons can take

Implement expert oversight for litigation. Some of the large plaintiff awards were assisted by expert testimony based on a highly questionable scientific foundation. Judges give expert witnesses great latitude in their testimony, relying on the jury to discern the truth. I recommend that professional societies, such as the American College of Obstetricians and Gynecologists (ACOG), AmericanUrological Association (AUA), American Urogynecologic Society (AUGS), Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), and Society of Gynecologic Surgeons (SGS), establish a panel to review and carefully evaluate plaintiff expert testimony that has a questionable scientific foundation. If such a panel finds the scientific basis of testimony to be biased, untruthful, or unethical, the societies must publicly reprimand and sanction these experts. Only then would these experts no longer be used by the plaintiff attorneys.

Such an expert panel also could serve to educate the judges in federal and state courts on real science and not manufactured opinions.

We need juries that can understand the science so they truly can decide on cases involving complex technologies.

Support professional leadership efforts. I am encouraged that AUGS is working to establish guidelines for the management of mesh complications. I have seen cases in which a small amount of mesh exposure, best treated by limited local excision of the exposed mesh, instead has been treated by complete excision of every polypropylene fiber placed, resulting in an unnecessarily morbid surgery that leaves a scarred and small vagina. Notably, some of the surgeons who excise every polypropylene fiber are also working as plaintiff experts, who may then testify that the scarred, small vagina was caused by the mesh and the implanting surgeon.

Our professional society leadership and volunteer committees, especially from AUGS, have done a tremendous amount of work in assisting with the FDA-required 522 postmarket surveillance study research design; establishing a Pelvic Floor Disorders Registry (http://www.pfdr.org/) and a sling registry; and developing credentialing guidelines for sacrocolpopexy, transvaginal mesh, and slings. They deserve our gratitude and our participation in the registries. It would be a tragedy if all of this work does not lead to fully enrolled and completed 522 studies so that we can scientifically make decisions on products before any more treatment options are removed from the market.

Use video to scrutinize surgical outcomes data. The surgical literature shows extreme variance in outcomes and complications for vaginal mesh surgery, including exposure rates from 1% to 20% with the same mesh products. This only can be explained by depth of surgical dissection and implanting technique. Surgical outcomes have been shown to be related directly to surgical volumes and experience.² I propose that going forward, any authors who publish their study outcomes and complication data on a surgical procedure must submit a surgical video that demonstrates exactly how the surgery was done.

Best serve the patient. We all need to rigorously follow our own surgery results, improve our techniques, and keep within our surgical skill sets. We need to share our outcome and complication data with our patients during the informed consent process, since we, and not the surgical literature, are performing their surgeries.

We need to be transparent and respectful of our colleagues with different skill sets, putting what is best for patients ahead of everything else. We must be mindful of our inherent biases toward surgeries we are personally very good at and comfortable with. We must respect that other surgeons may achieve better clinical outcomes than us with the same surgery. We need to teach each other the best reproducible surgical techniques to maximize outcomes and minimize complications.

We must humbly accept that not every surgeon can do every surgery (and should not try). If a patient would be best served with a surgery we are not skilled in, we must refer that patient to a colleague who is.

Encourage industry’s part in training. As new technologies are developed, we must be brutally honest with ourselves about whether or not we have the skill sets to use them. Industry must gauge the complexity of the surgical skill set necessary to use their products and limit attendance at their teaching labs to surgeons who have the skills required to obtain good outcomes and minimize complications.

We have reached the tipping pointWe have seen the enemy, and it is us. We now need to advocate zealously for our patients. We will succeed only if we keep what is best for our patients at the forefront of everything we do. We must today decide to lead or be led. If we do not lead, we will be led by others—to places that may not best serve our patients. Make no mistake, this is a tipping point. The future of midurethral slings and potential future innovations lie in our hands right now.

Notably, just days prior to Astora’s letter to its physician customers announcing the decision to discontinue all of its operations, the transobturator postanal sling system (TOPAS) for fecal incontinence, a product in the pipeline at Astora, received 3 unanimous 8-0 votes from an FDA device advisory panel on safety, efficacy, and benefit outweighing risk.³ The future of this technology is now uncertain as well.

I ask Endo Pharmaceuticals to reconsider abandoning all of its products and intellectual properties. I ask it to entertain discussions with large companies that want its technologies and intellectual properties and can indemnify it from future litigation. While there never is a guarantee of complete indemnification and the company does have a fiduciary responsibility to its shareholders, industry also has a responsibility to patients and surgeons to allow helpful technologies to persist.

According to Astora’s letter to its physician customers, “Patient health has always been our number one priority. As such, the business closure has been expedited so that you and your patients have the opportunity to assess alternative treatment options as soon as possible.”

That letter was dated February 29. I do not feel that 31 days’ notice is enough time for surgeons to assess—let alone learn and master—new treatment options. It would have been helpful if Endo Pharmaceuticals had given more notice and would at least have allowed other interested companies the option to purchase useful technologies and intellectual property to mitigate its rapid departure from the space. The company remains in the health care arena with its pharmaceutical products, and how it behaves leaving the surgical space will be noted and impact its brand and reputation.

Lessons from the morcellation situationHow quickly the power morcellator disappeared is a lesson to note very carefully, and it has important parallels to what we now face. I highly recommend that you read and study Lisa Rosenbaum’s article in New England Journal of Medicine, “N-of-1 policymaking—tragedy, trade-offs, and the demise of morcellation.”⁴ She eloquently discusses how decisions to terminate technologies based on passionate anecdotal stories and media campaigns, and not scientific study, does not serve the greater good. She explores lessons learned from the silicone breast implant saga as well, stating “the tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.”⁴

We need a calmer, less emotional, and balanced scientific approach to evaluate technologies. We need to consider what harm is done by not allowing new technologies to be adequately studied, improved, and implemented. Dr. Rosenbaum discusses what Cass Sunstein and Timur Kuran call the “availability cascade,” “a phenomenon whereby stories inform public perceptions and anyone challenging those perceptions is vilified.”^4,5

No technology will ever be risk free, and there always will be some risks and complications that could be significant and chilling. However, patient autonomy requires a full discussion of a risk/benefit ratio that is based on science, and these scientific data must be allowed to be collected and learned. There even can be more significant and chilling complications from not using a technology as well.

It is challenging to speak science to emotion that is driven by tragic outcomes, but we can remain compassionate as we seek the science that will serve the greater good. Condemning proponents of carefully studied and properly implemented technologies as immoral is neither helpful nor constructive. Crushing the ability to thoroughly and scientifically study new technologies is not in the best interest of our patients with pelvic floor disorders.

It is time to reawaken the better angels of our natureWill we do the necessary work now no matter how uncomfortable it may make us feel? Or will we be intimidated and remain silent and disjointed? Will we participate in the registries and follow best clinical practice and credentialing guidelines? Will we hold ourselves and our colleagues accountable? It is time to remember why we became surgeons, and to start acting on our convictions.

To that end, we must ask ourselves, will we:

• honor the Hippocratic Oath that we took in medical school and “respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow”⁶
• “not be ashamed to say ‘I know not,’ nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery”⁶
• zealously advocate for our patients to ensure we can offer them the very best therapies
• honor and respect the sacred trust patients place in us when we take them to the operating room
• lead or be led?

This is personal for me. My mother struggled with pelvic floor disorders. I always felt it grossly unfair that women who chose to give us life could suffer for the rest of theirs for that decision. These women deserve our very best. The 40 million women with pelvic floor disorders deserve—and expect—that we lead. Will we?

I am hopeful that we will. I believe we will rise to today’s challenges and protect and fight for our patients. I believe that years from now we will look back and be proud that we did the right thing, and in so doing protected and encouraged innovations that significantly enhanced the quality of our patients’ lives. I believe patients will recognize our genuine efforts and in so doing give our profession the respect and trust that I feel has been diminished.

I believe we will draw the needed courage and resolve from the oath we recited in medical school and remember that, “If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.”⁶

I do believe we will.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.