Commentary

Uterine myomas cause heavy menstrual bleeding and other clinically significant symptoms in 35%-50% of affected women and have been shown to be the leading indication for hysterectomy in the United States among women aged 35-54 years.

Research has shown that a significant number of women who undergo hysterectomy for treatment of fibroids later regret the loss of their uterus and have other concerns and complications. Other options for therapy include various pharmacologic treatments, a progestin-releasing intrauterine device, uterine artery embolization, endometrial ablation, MRI-guided focused ultrasound surgery, and myomectomy performed laparoscopically, robotically, or hysteroscopically.

Myomectomy seems largely to preserve fertility, but rates of recurrence and additional procedures for bleeding and myoma symptoms are still high – upward of 30% in some studies. Overall, we need other more efficacious and minimally invasive options.

Radiofrequency volumetric thermal ablation (RFVTA) achieved through the Acessa System (Halt Medical) has been the newest addition to our armamentarium for treatment of symptomatic fibroids. It is suitable for every type of fibroid except for type 0 pedunculated intracavitary fibroids and type 7 pedunculated subserosal fibroids, which is significant because deep intramural fibroids have been difficult to target and treat by other methods.

Three-year outcome data show sustained improvements in fibroid symptoms and quality of life, with an incidence of recurrences and additional procedures – approximately 11% – that appears to be substantially lower than for other uterine-sparing fibroid treatments. In addition, while the technology is not indicated for women seeking future childbearing, successful pregnancies are being reported, suggesting that full-term pregnancies – and vaginal delivery in some cases – may be possible after RFVTA.

The principles

Radiofrequency ablation has been used for years in the treatment of liver and kidney tumors. The basic concept is that volumetric thermal ablation results in coagulative necrosis.

The Acessa System, approved by the Food and Drug Administration in late 2012, was designed to treat fibroids, which have much firmer tissue than the tissues being targeted in other radiofrequency ablation procedures. It uses a specially designed intrauterine ultrasound probe and radiofrequency probe, and it combines three fundamental gynecologic skills: Laparoscopy using two trocars and requiring no special suturing skills; ultrasound using a laparoscopic ultrasound probe to scan and manipulate; and probe placement under laparoscopic ultrasound guidance.

Specifically, the system allows for percutaneous, laparoscopic ultrasound–guided radiofrequency ablation of fibroids with a disposable 3.4-mm handpiece coupled to a dual-function radiofrequency generator. The handpiece contains a retractable array of electrodes, so that the fibroid may be ablated with one electrode or with the deployed electrode array.

The generator controls and monitors the ablation with real-time feedback from thermocouples. It monitors and displays the temperature at each needle tip, the average temperature of the array, and the return temperatures on two dispersive electrode pads that are placed on the anterior thighs. The electrode pads are designed to reduce the incidence of pad burns, which are a complication with other radiofrequency ablation devices. The system will automatically stop treatment if either of the pad thermocouples registers a skin temperature greater than 40° C (JSLS. 2014 Apr-Jun;18[2]:182-90).

The outcomes

Laparoscopic ultrasound–guided RFVTA has been studied in five prospective trials, including one multicenter international trial of 135 premenopausal women – the pivotal trial for FDA clearance – in which 104 women were followed for 3 years and found to have prolonged symptom relief and improved quality of life.

At baseline, the women had symptomatic uterine myomas and moderate to severe heavy menstrual bleeding measured by alkaline hematin analysis of returned sanitary products. Their mean symptom severity scores on the Uterine Fibroid Symptom and Quality-of-Life Questionnaire (UFS-QOL) decreased significantly from baseline to 3 months and changed little after that, for a total change of –32.6 over the study period.

The cumulative repeat intervention rate at 3 years was 11%, with 14 of the 135 participants having repeat interventions to treat bleeding and myoma symptoms. Seven of these women were found to have adenomyosis (J Minim Invasive Gynecol. 2014 Sep-Oct;21[5]:767-74).

The surprisingly low reintervention rates may stem from the benefits of direct contact imaging of the uterus. A comparison of images from the pivotal trial has shown that intraoperative ultrasound detected more than twice as many fibroids as did preoperative transvaginal ultrasound, and about one-third more than preoperative MRIs (J Minim Invasive Gynecol. 2013 Nov-Dec;20[6]:770-4).

Interestingly, four women became pregnant over the study’s 3-year follow-up, despite the inclusion requirement that women desire uterine conservation but not future childbearing.

We have followed reproductive outcomes in women after RFVTA of symptomatic fibroids in other studies as well. In our most recent analysis, presented in November at the 2015 American Association of Gynecologic Laparoscopists Global Congress, we identified 10 pregnancies among participants of the five prospective trials.

Of 232 women enrolled in premarket RFVTA studies – trials in which completing childbearing and continuing contraception were requirements – six conceived at 3.5-15 months post ablation. The number of myomas treated ranged from one to seven and included multiple types and dimensions. Five of these six women delivered full-term healthy babies – one by vaginal delivery and four by cesarean section. The sixth patient had a spontaneous abortion in the first trimester.

Of 43 women who participated in two randomized clinical trials undertaken after FDA clearance, four conceived at 4-23.5 months post ablation. Three of these women had uneventful, full-term pregnancies with vaginal births. The fourth had a cesarean section at 38 weeks.

Considering the theoretical advantages of the Acessa procedure – that it is less damaging to healthy myometrium – and the outcomes reported thus far, it appears likely that Acessa will be preferable to myomectomy. Early results from an ongoing 5-year German study that randomized 50 women to RFVTA or laparoscopic myomectomy show that RFVTA resulted in the treatment of more fibroids and involved a significantly shorter hospital stay and post-operative recovery (Int J Gynaecol Obstet. 2014 Jun;125[3]:261-5).

The technique

The patient is pretreated with a nonsteroidal anti-inflammatory agent and prophylactic antibiotic. She is placed in a supine position with arms tucked, and a single-toothed tenaculum is placed on the cervix from 12 to 6 o’clock, without any instrument for manipulation of the uterus. The system’s dispersive electrode pads are placed symmetrically just above the patella on the anterior thighs; asymmetrical placement could potentially increase the risk of a pad burn.

Two standard laparoscopic ports are placed. A 5-mm trocar for the camera and video laparoscope is placed through the umbilicus or at a supraumbilical or left upper–quadrant level, depending on the patient’s anatomy, her surgical history, and the size of the uterus. A thorough visual inspection of the abdomen should be performed to look for unsuspected findings.

A 10-mm trocar is then placed at the level of the top of the fundus for the intra-abdominal ultrasound probe. Laparoscopic ultrasound is used to survey the entire uterus, map the fibroids, and plan an approach. Once the fibroid to be treated first is identified, the ability to stabilize the uterus accordingly is assessed, and the dimensions of the fibroid are taken. The dimensions will be used by the surgeon with a volume algorithm to calculate the length of ablation time based on the size of the fibroid and electrode deployment.

Under ultrasound guidance, the Acessa radiofrequency ablation handpiece is inserted percutaneously at 12, 3, 6, or 9 o’clock relative to the ultrasound trocar, based on the location of the target fibroid. The uterus must be stabilized, with the handpiece and ultrasound probe parallel and in plane. The handpiece is then inserted 1 cm into the target fibroid through the uterine serosal surface, utilizing a combination of laparoscopic and ultrasound views. Care must be taken to use gentle rotation and minimal downward pressure as the tip of the handpiece is quite sharp.

The location of the tip is confirmed by laparoscopic ultrasound, and the 7-needle electrode array can then be deployed to the ablation site. All three dimensions of the fibroid should be viewed for placement and deployment of the electrodes. Care is taken to avoid large blood vessels and ensure that the electrodes are confined within the fibroid and within the uterus.

Radiofrequency ablation is carried out with a low-voltage, high-frequency alternating current. The radiofrequency waves heat the tissue to an average temperature of 95° C for a length of time determined by a treatment algorithm. The wattage automatically adjusts to maintain the treatment temperature for the calculated duration of ablation.

Small fibroids can be treated in a manual mode without deployment of the electrode array at a current output of 15 W.

At the conclusion of the ablation, the electrodes are withdrawn into the handpiece, the generator is changed to coagulation mode, and the handpiece is slowly withdrawn under ultrasound visualization. The tract is simultaneously coagulated. A bit of additional coagulation is facilitated by pausing at the serosal surface.

Additional fibroids can be ablated through another insertion of the handpiece, either through the same tract or through a new tract.

Larger fibroids may require multiple ablations. The maximum size of ablation is about 5 cm, so it is important to plan the treatment of larger fibroids. This can be accomplished by carefully scanning large fibroids and visualizing the number of overlapping ablations needed to treat the entire volume. I ask my assistant to record the size and location of each ablation; I find this helpful both for organizing the treatment of large fibroids and for dictating the operative report.

It is important to appreciate that treatment of one area can make it difficult to visualize nearby fibroids with ultrasound. The effect dissipates in about 30-45 minutes. It is one reason why having a fibroid map prior to treatment is so important.

Once all fibroids are treated, a final inspection is performed. We usually use a suction irrigator to clean out whatever small amounts of blood are present, and the laparoscopic and port sites are closed in standard fashion.

Patients are seen 1 week postoperatively and are instructed to call in cases of pain, fever, bleeding, or chills. Most patients require only NSAIDs for pain relief and return to work in 2-7 days.

Many patients experience a slightly heavier than normal first menses after treatment. Pelvic rest is recommended for 3 weeks as a precaution, and avoidance of intrauterine procedures is advised because the uterus will be soft and thus may be easily perforated. Patients who have had type 1, type 2, or type 2-5 fibroids ablated may experience drainage for several weeks as the fibroid tissue is reabsorbed.

Dr. Berman is interim chairman of Wayne State University’s department of obstetrics and gynecology and interim specialist-in-chief for obstetrics and gynecology at the Detroit Medical Center. He was a principal investigator of the 3-year outcome study of Acessa sponsored by Halt Medical. He is a consultant for Halt Medical and directs physician training in the use of Acessa.

Uterine myomas cause heavy menstrual bleeding and other clinically significant symptoms in 35%-50% of affected women and have been shown to be the leading indication for hysterectomy in the United States among women aged 35-54 years.

Research has shown that a significant number of women who undergo hysterectomy for treatment of fibroids later regret the loss of their uterus and have other concerns and complications. Other options for therapy include various pharmacologic treatments, a progestin-releasing intrauterine device, uterine artery embolization, endometrial ablation, MRI-guided focused ultrasound surgery, and myomectomy performed laparoscopically, robotically, or hysteroscopically.

Myomectomy seems largely to preserve fertility, but rates of recurrence and additional procedures for bleeding and myoma symptoms are still high – upward of 30% in some studies. Overall, we need other more efficacious and minimally invasive options.

Radiofrequency volumetric thermal ablation (RFVTA) achieved through the Acessa System (Halt Medical) has been the newest addition to our armamentarium for treatment of symptomatic fibroids. It is suitable for every type of fibroid except for type 0 pedunculated intracavitary fibroids and type 7 pedunculated subserosal fibroids, which is significant because deep intramural fibroids have been difficult to target and treat by other methods.

Three-year outcome data show sustained improvements in fibroid symptoms and quality of life, with an incidence of recurrences and additional procedures – approximately 11% – that appears to be substantially lower than for other uterine-sparing fibroid treatments. In addition, while the technology is not indicated for women seeking future childbearing, successful pregnancies are being reported, suggesting that full-term pregnancies – and vaginal delivery in some cases – may be possible after RFVTA.

The principles

Radiofrequency ablation has been used for years in the treatment of liver and kidney tumors. The basic concept is that volumetric thermal ablation results in coagulative necrosis.

The Acessa System, approved by the Food and Drug Administration in late 2012, was designed to treat fibroids, which have much firmer tissue than the tissues being targeted in other radiofrequency ablation procedures. It uses a specially designed intrauterine ultrasound probe and radiofrequency probe, and it combines three fundamental gynecologic skills: Laparoscopy using two trocars and requiring no special suturing skills; ultrasound using a laparoscopic ultrasound probe to scan and manipulate; and probe placement under laparoscopic ultrasound guidance.

Specifically, the system allows for percutaneous, laparoscopic ultrasound–guided radiofrequency ablation of fibroids with a disposable 3.4-mm handpiece coupled to a dual-function radiofrequency generator. The handpiece contains a retractable array of electrodes, so that the fibroid may be ablated with one electrode or with the deployed electrode array.

The generator controls and monitors the ablation with real-time feedback from thermocouples. It monitors and displays the temperature at each needle tip, the average temperature of the array, and the return temperatures on two dispersive electrode pads that are placed on the anterior thighs. The electrode pads are designed to reduce the incidence of pad burns, which are a complication with other radiofrequency ablation devices. The system will automatically stop treatment if either of the pad thermocouples registers a skin temperature greater than 40° C (JSLS. 2014 Apr-Jun;18[2]:182-90).

The outcomes

Laparoscopic ultrasound–guided RFVTA has been studied in five prospective trials, including one multicenter international trial of 135 premenopausal women – the pivotal trial for FDA clearance – in which 104 women were followed for 3 years and found to have prolonged symptom relief and improved quality of life.

At baseline, the women had symptomatic uterine myomas and moderate to severe heavy menstrual bleeding measured by alkaline hematin analysis of returned sanitary products. Their mean symptom severity scores on the Uterine Fibroid Symptom and Quality-of-Life Questionnaire (UFS-QOL) decreased significantly from baseline to 3 months and changed little after that, for a total change of –32.6 over the study period.

The cumulative repeat intervention rate at 3 years was 11%, with 14 of the 135 participants having repeat interventions to treat bleeding and myoma symptoms. Seven of these women were found to have adenomyosis (J Minim Invasive Gynecol. 2014 Sep-Oct;21[5]:767-74).

The surprisingly low reintervention rates may stem from the benefits of direct contact imaging of the uterus. A comparison of images from the pivotal trial has shown that intraoperative ultrasound detected more than twice as many fibroids as did preoperative transvaginal ultrasound, and about one-third more than preoperative MRIs (J Minim Invasive Gynecol. 2013 Nov-Dec;20[6]:770-4).

Interestingly, four women became pregnant over the study’s 3-year follow-up, despite the inclusion requirement that women desire uterine conservation but not future childbearing.

We have followed reproductive outcomes in women after RFVTA of symptomatic fibroids in other studies as well. In our most recent analysis, presented in November at the 2015 American Association of Gynecologic Laparoscopists Global Congress, we identified 10 pregnancies among participants of the five prospective trials.

Of 232 women enrolled in premarket RFVTA studies – trials in which completing childbearing and continuing contraception were requirements – six conceived at 3.5-15 months post ablation. The number of myomas treated ranged from one to seven and included multiple types and dimensions. Five of these six women delivered full-term healthy babies – one by vaginal delivery and four by cesarean section. The sixth patient had a spontaneous abortion in the first trimester.

Of 43 women who participated in two randomized clinical trials undertaken after FDA clearance, four conceived at 4-23.5 months post ablation. Three of these women had uneventful, full-term pregnancies with vaginal births. The fourth had a cesarean section at 38 weeks.

Considering the theoretical advantages of the Acessa procedure – that it is less damaging to healthy myometrium – and the outcomes reported thus far, it appears likely that Acessa will be preferable to myomectomy. Early results from an ongoing 5-year German study that randomized 50 women to RFVTA or laparoscopic myomectomy show that RFVTA resulted in the treatment of more fibroids and involved a significantly shorter hospital stay and post-operative recovery (Int J Gynaecol Obstet. 2014 Jun;125[3]:261-5).

The technique

The patient is pretreated with a nonsteroidal anti-inflammatory agent and prophylactic antibiotic. She is placed in a supine position with arms tucked, and a single-toothed tenaculum is placed on the cervix from 12 to 6 o’clock, without any instrument for manipulation of the uterus. The system’s dispersive electrode pads are placed symmetrically just above the patella on the anterior thighs; asymmetrical placement could potentially increase the risk of a pad burn.

Two standard laparoscopic ports are placed. A 5-mm trocar for the camera and video laparoscope is placed through the umbilicus or at a supraumbilical or left upper–quadrant level, depending on the patient’s anatomy, her surgical history, and the size of the uterus. A thorough visual inspection of the abdomen should be performed to look for unsuspected findings.

A 10-mm trocar is then placed at the level of the top of the fundus for the intra-abdominal ultrasound probe. Laparoscopic ultrasound is used to survey the entire uterus, map the fibroids, and plan an approach. Once the fibroid to be treated first is identified, the ability to stabilize the uterus accordingly is assessed, and the dimensions of the fibroid are taken. The dimensions will be used by the surgeon with a volume algorithm to calculate the length of ablation time based on the size of the fibroid and electrode deployment.

Under ultrasound guidance, the Acessa radiofrequency ablation handpiece is inserted percutaneously at 12, 3, 6, or 9 o’clock relative to the ultrasound trocar, based on the location of the target fibroid. The uterus must be stabilized, with the handpiece and ultrasound probe parallel and in plane. The handpiece is then inserted 1 cm into the target fibroid through the uterine serosal surface, utilizing a combination of laparoscopic and ultrasound views. Care must be taken to use gentle rotation and minimal downward pressure as the tip of the handpiece is quite sharp.

The location of the tip is confirmed by laparoscopic ultrasound, and the 7-needle electrode array can then be deployed to the ablation site. All three dimensions of the fibroid should be viewed for placement and deployment of the electrodes. Care is taken to avoid large blood vessels and ensure that the electrodes are confined within the fibroid and within the uterus.

Radiofrequency ablation is carried out with a low-voltage, high-frequency alternating current. The radiofrequency waves heat the tissue to an average temperature of 95° C for a length of time determined by a treatment algorithm. The wattage automatically adjusts to maintain the treatment temperature for the calculated duration of ablation.

Small fibroids can be treated in a manual mode without deployment of the electrode array at a current output of 15 W.

At the conclusion of the ablation, the electrodes are withdrawn into the handpiece, the generator is changed to coagulation mode, and the handpiece is slowly withdrawn under ultrasound visualization. The tract is simultaneously coagulated. A bit of additional coagulation is facilitated by pausing at the serosal surface.

Additional fibroids can be ablated through another insertion of the handpiece, either through the same tract or through a new tract.

Larger fibroids may require multiple ablations. The maximum size of ablation is about 5 cm, so it is important to plan the treatment of larger fibroids. This can be accomplished by carefully scanning large fibroids and visualizing the number of overlapping ablations needed to treat the entire volume. I ask my assistant to record the size and location of each ablation; I find this helpful both for organizing the treatment of large fibroids and for dictating the operative report.

It is important to appreciate that treatment of one area can make it difficult to visualize nearby fibroids with ultrasound. The effect dissipates in about 30-45 minutes. It is one reason why having a fibroid map prior to treatment is so important.

Once all fibroids are treated, a final inspection is performed. We usually use a suction irrigator to clean out whatever small amounts of blood are present, and the laparoscopic and port sites are closed in standard fashion.

Patients are seen 1 week postoperatively and are instructed to call in cases of pain, fever, bleeding, or chills. Most patients require only NSAIDs for pain relief and return to work in 2-7 days.

Many patients experience a slightly heavier than normal first menses after treatment. Pelvic rest is recommended for 3 weeks as a precaution, and avoidance of intrauterine procedures is advised because the uterus will be soft and thus may be easily perforated. Patients who have had type 1, type 2, or type 2-5 fibroids ablated may experience drainage for several weeks as the fibroid tissue is reabsorbed.

Dr. Berman is interim chairman of Wayne State University’s department of obstetrics and gynecology and interim specialist-in-chief for obstetrics and gynecology at the Detroit Medical Center. He was a principal investigator of the 3-year outcome study of Acessa sponsored by Halt Medical. He is a consultant for Halt Medical and directs physician training in the use of Acessa.

Uterine myomas cause heavy menstrual bleeding and other clinically significant symptoms in 35%-50% of affected women and have been shown to be the leading indication for hysterectomy in the United States among women aged 35-54 years.

Research has shown that a significant number of women who undergo hysterectomy for treatment of fibroids later regret the loss of their uterus and have other concerns and complications. Other options for therapy include various pharmacologic treatments, a progestin-releasing intrauterine device, uterine artery embolization, endometrial ablation, MRI-guided focused ultrasound surgery, and myomectomy performed laparoscopically, robotically, or hysteroscopically.

Myomectomy seems largely to preserve fertility, but rates of recurrence and additional procedures for bleeding and myoma symptoms are still high – upward of 30% in some studies. Overall, we need other more efficacious and minimally invasive options.

Radiofrequency volumetric thermal ablation (RFVTA) achieved through the Acessa System (Halt Medical) has been the newest addition to our armamentarium for treatment of symptomatic fibroids. It is suitable for every type of fibroid except for type 0 pedunculated intracavitary fibroids and type 7 pedunculated subserosal fibroids, which is significant because deep intramural fibroids have been difficult to target and treat by other methods.

Three-year outcome data show sustained improvements in fibroid symptoms and quality of life, with an incidence of recurrences and additional procedures – approximately 11% – that appears to be substantially lower than for other uterine-sparing fibroid treatments. In addition, while the technology is not indicated for women seeking future childbearing, successful pregnancies are being reported, suggesting that full-term pregnancies – and vaginal delivery in some cases – may be possible after RFVTA.

The principles

Radiofrequency ablation has been used for years in the treatment of liver and kidney tumors. The basic concept is that volumetric thermal ablation results in coagulative necrosis.

The Acessa System, approved by the Food and Drug Administration in late 2012, was designed to treat fibroids, which have much firmer tissue than the tissues being targeted in other radiofrequency ablation procedures. It uses a specially designed intrauterine ultrasound probe and radiofrequency probe, and it combines three fundamental gynecologic skills: Laparoscopy using two trocars and requiring no special suturing skills; ultrasound using a laparoscopic ultrasound probe to scan and manipulate; and probe placement under laparoscopic ultrasound guidance.

Specifically, the system allows for percutaneous, laparoscopic ultrasound–guided radiofrequency ablation of fibroids with a disposable 3.4-mm handpiece coupled to a dual-function radiofrequency generator. The handpiece contains a retractable array of electrodes, so that the fibroid may be ablated with one electrode or with the deployed electrode array.

The generator controls and monitors the ablation with real-time feedback from thermocouples. It monitors and displays the temperature at each needle tip, the average temperature of the array, and the return temperatures on two dispersive electrode pads that are placed on the anterior thighs. The electrode pads are designed to reduce the incidence of pad burns, which are a complication with other radiofrequency ablation devices. The system will automatically stop treatment if either of the pad thermocouples registers a skin temperature greater than 40° C (JSLS. 2014 Apr-Jun;18[2]:182-90).

The outcomes

Laparoscopic ultrasound–guided RFVTA has been studied in five prospective trials, including one multicenter international trial of 135 premenopausal women – the pivotal trial for FDA clearance – in which 104 women were followed for 3 years and found to have prolonged symptom relief and improved quality of life.

At baseline, the women had symptomatic uterine myomas and moderate to severe heavy menstrual bleeding measured by alkaline hematin analysis of returned sanitary products. Their mean symptom severity scores on the Uterine Fibroid Symptom and Quality-of-Life Questionnaire (UFS-QOL) decreased significantly from baseline to 3 months and changed little after that, for a total change of –32.6 over the study period.

The cumulative repeat intervention rate at 3 years was 11%, with 14 of the 135 participants having repeat interventions to treat bleeding and myoma symptoms. Seven of these women were found to have adenomyosis (J Minim Invasive Gynecol. 2014 Sep-Oct;21[5]:767-74).

The surprisingly low reintervention rates may stem from the benefits of direct contact imaging of the uterus. A comparison of images from the pivotal trial has shown that intraoperative ultrasound detected more than twice as many fibroids as did preoperative transvaginal ultrasound, and about one-third more than preoperative MRIs (J Minim Invasive Gynecol. 2013 Nov-Dec;20[6]:770-4).

Interestingly, four women became pregnant over the study’s 3-year follow-up, despite the inclusion requirement that women desire uterine conservation but not future childbearing.

We have followed reproductive outcomes in women after RFVTA of symptomatic fibroids in other studies as well. In our most recent analysis, presented in November at the 2015 American Association of Gynecologic Laparoscopists Global Congress, we identified 10 pregnancies among participants of the five prospective trials.

Of 232 women enrolled in premarket RFVTA studies – trials in which completing childbearing and continuing contraception were requirements – six conceived at 3.5-15 months post ablation. The number of myomas treated ranged from one to seven and included multiple types and dimensions. Five of these six women delivered full-term healthy babies – one by vaginal delivery and four by cesarean section. The sixth patient had a spontaneous abortion in the first trimester.

Of 43 women who participated in two randomized clinical trials undertaken after FDA clearance, four conceived at 4-23.5 months post ablation. Three of these women had uneventful, full-term pregnancies with vaginal births. The fourth had a cesarean section at 38 weeks.

Considering the theoretical advantages of the Acessa procedure – that it is less damaging to healthy myometrium – and the outcomes reported thus far, it appears likely that Acessa will be preferable to myomectomy. Early results from an ongoing 5-year German study that randomized 50 women to RFVTA or laparoscopic myomectomy show that RFVTA resulted in the treatment of more fibroids and involved a significantly shorter hospital stay and post-operative recovery (Int J Gynaecol Obstet. 2014 Jun;125[3]:261-5).

The technique

The patient is pretreated with a nonsteroidal anti-inflammatory agent and prophylactic antibiotic. She is placed in a supine position with arms tucked, and a single-toothed tenaculum is placed on the cervix from 12 to 6 o’clock, without any instrument for manipulation of the uterus. The system’s dispersive electrode pads are placed symmetrically just above the patella on the anterior thighs; asymmetrical placement could potentially increase the risk of a pad burn.

Two standard laparoscopic ports are placed. A 5-mm trocar for the camera and video laparoscope is placed through the umbilicus or at a supraumbilical or left upper–quadrant level, depending on the patient’s anatomy, her surgical history, and the size of the uterus. A thorough visual inspection of the abdomen should be performed to look for unsuspected findings.

A 10-mm trocar is then placed at the level of the top of the fundus for the intra-abdominal ultrasound probe. Laparoscopic ultrasound is used to survey the entire uterus, map the fibroids, and plan an approach. Once the fibroid to be treated first is identified, the ability to stabilize the uterus accordingly is assessed, and the dimensions of the fibroid are taken. The dimensions will be used by the surgeon with a volume algorithm to calculate the length of ablation time based on the size of the fibroid and electrode deployment.

Under ultrasound guidance, the Acessa radiofrequency ablation handpiece is inserted percutaneously at 12, 3, 6, or 9 o’clock relative to the ultrasound trocar, based on the location of the target fibroid. The uterus must be stabilized, with the handpiece and ultrasound probe parallel and in plane. The handpiece is then inserted 1 cm into the target fibroid through the uterine serosal surface, utilizing a combination of laparoscopic and ultrasound views. Care must be taken to use gentle rotation and minimal downward pressure as the tip of the handpiece is quite sharp.

The location of the tip is confirmed by laparoscopic ultrasound, and the 7-needle electrode array can then be deployed to the ablation site. All three dimensions of the fibroid should be viewed for placement and deployment of the electrodes. Care is taken to avoid large blood vessels and ensure that the electrodes are confined within the fibroid and within the uterus.

Radiofrequency ablation is carried out with a low-voltage, high-frequency alternating current. The radiofrequency waves heat the tissue to an average temperature of 95° C for a length of time determined by a treatment algorithm. The wattage automatically adjusts to maintain the treatment temperature for the calculated duration of ablation.

Small fibroids can be treated in a manual mode without deployment of the electrode array at a current output of 15 W.

At the conclusion of the ablation, the electrodes are withdrawn into the handpiece, the generator is changed to coagulation mode, and the handpiece is slowly withdrawn under ultrasound visualization. The tract is simultaneously coagulated. A bit of additional coagulation is facilitated by pausing at the serosal surface.

Additional fibroids can be ablated through another insertion of the handpiece, either through the same tract or through a new tract.

Larger fibroids may require multiple ablations. The maximum size of ablation is about 5 cm, so it is important to plan the treatment of larger fibroids. This can be accomplished by carefully scanning large fibroids and visualizing the number of overlapping ablations needed to treat the entire volume. I ask my assistant to record the size and location of each ablation; I find this helpful both for organizing the treatment of large fibroids and for dictating the operative report.

It is important to appreciate that treatment of one area can make it difficult to visualize nearby fibroids with ultrasound. The effect dissipates in about 30-45 minutes. It is one reason why having a fibroid map prior to treatment is so important.

Once all fibroids are treated, a final inspection is performed. We usually use a suction irrigator to clean out whatever small amounts of blood are present, and the laparoscopic and port sites are closed in standard fashion.

Patients are seen 1 week postoperatively and are instructed to call in cases of pain, fever, bleeding, or chills. Most patients require only NSAIDs for pain relief and return to work in 2-7 days.

Many patients experience a slightly heavier than normal first menses after treatment. Pelvic rest is recommended for 3 weeks as a precaution, and avoidance of intrauterine procedures is advised because the uterus will be soft and thus may be easily perforated. Patients who have had type 1, type 2, or type 2-5 fibroids ablated may experience drainage for several weeks as the fibroid tissue is reabsorbed.

Dr. Berman is interim chairman of Wayne State University’s department of obstetrics and gynecology and interim specialist-in-chief for obstetrics and gynecology at the Detroit Medical Center. He was a principal investigator of the 3-year outcome study of Acessa sponsored by Halt Medical. He is a consultant for Halt Medical and directs physician training in the use of Acessa.

While some physicians prefer a narrower clinic focus, the wide variety and complexity of the care provided by family physicians is precisely what drew many of us to the specialty. We enjoy caring for patients of all ages who see us for the diagnosis and treatment of acute illnesses, management of chronic diseases, preventive care, and behavioral and mental health concerns.

The quantity, variety, and complexity of the care we provide has been well-documented in the literature. In a study performed by the Wisconsin Research Network,¹ 29 family physicians reported addressing an average of 3.05 problems per patient during 572 office visits. A chart review confirmed physician self-report: 2.82 problems were recorded on average for each visit. For patients older than age 65, an average of 3.88 problems were addressed at each visit. For patients with diabetes, the average was 4.60.

Using data from the 2000 National Ambulatory Medical Care Survey, Katerndahl et al² estimated the complexity of patient encounters in family practice, cardiology, and psychiatry. They used a formula that took into account the per-patient number of reasons for each visit, diagnoses, and body systems examined, and the variability and diversity of each of these factors. After adjusting the results for length of visit, they found the complexity of care provided per hour by family physicians was 33% higher than that of cardiologists and 5 times higher than that of psychiatrists.

The topics in this issue are a terrific illustration of the breadth of family medicine. Peripheral neuropathy, which we see almost daily, is difficult to diagnose and treat. Prolotherapy is an up-and-coming dextrose injection therapy for tendinopathies and joint pain that shows promise, and patients are likely to start asking us about it. Home apnea monitors are used frequently for newborns—but how effective are they, and when can you tell parents to discontinue their use?

The complexity of care provided per hour by family physicians is 33% higher than that of cardiologists and 5 times higher than that of psychiatrists.

It seems that vaccine recommendations change every year, and this issue’s Practice Alert covers the latest on meningococcal immunization. This month’s PURL answers the question: Do we really need to “bridge” patients with atrial fibrillation from warfarin to low molecular weight heparin immediately before and after a surgical procedure?

The authors and editors of The Journal of Family Practice constantly strive to bring you the most up-to-date information to support your work as a master of the complexity of primary care practice.

While some physicians prefer a narrower clinic focus, the wide variety and complexity of the care provided by family physicians is precisely what drew many of us to the specialty. We enjoy caring for patients of all ages who see us for the diagnosis and treatment of acute illnesses, management of chronic diseases, preventive care, and behavioral and mental health concerns.

The quantity, variety, and complexity of the care we provide has been well-documented in the literature. In a study performed by the Wisconsin Research Network,¹ 29 family physicians reported addressing an average of 3.05 problems per patient during 572 office visits. A chart review confirmed physician self-report: 2.82 problems were recorded on average for each visit. For patients older than age 65, an average of 3.88 problems were addressed at each visit. For patients with diabetes, the average was 4.60.

Using data from the 2000 National Ambulatory Medical Care Survey, Katerndahl et al² estimated the complexity of patient encounters in family practice, cardiology, and psychiatry. They used a formula that took into account the per-patient number of reasons for each visit, diagnoses, and body systems examined, and the variability and diversity of each of these factors. After adjusting the results for length of visit, they found the complexity of care provided per hour by family physicians was 33% higher than that of cardiologists and 5 times higher than that of psychiatrists.

The topics in this issue are a terrific illustration of the breadth of family medicine. Peripheral neuropathy, which we see almost daily, is difficult to diagnose and treat. Prolotherapy is an up-and-coming dextrose injection therapy for tendinopathies and joint pain that shows promise, and patients are likely to start asking us about it. Home apnea monitors are used frequently for newborns—but how effective are they, and when can you tell parents to discontinue their use?

The complexity of care provided per hour by family physicians is 33% higher than that of cardiologists and 5 times higher than that of psychiatrists.

It seems that vaccine recommendations change every year, and this issue’s Practice Alert covers the latest on meningococcal immunization. This month’s PURL answers the question: Do we really need to “bridge” patients with atrial fibrillation from warfarin to low molecular weight heparin immediately before and after a surgical procedure?

The authors and editors of The Journal of Family Practice constantly strive to bring you the most up-to-date information to support your work as a master of the complexity of primary care practice.

While some physicians prefer a narrower clinic focus, the wide variety and complexity of the care provided by family physicians is precisely what drew many of us to the specialty. We enjoy caring for patients of all ages who see us for the diagnosis and treatment of acute illnesses, management of chronic diseases, preventive care, and behavioral and mental health concerns.

The quantity, variety, and complexity of the care we provide has been well-documented in the literature. In a study performed by the Wisconsin Research Network,¹ 29 family physicians reported addressing an average of 3.05 problems per patient during 572 office visits. A chart review confirmed physician self-report: 2.82 problems were recorded on average for each visit. For patients older than age 65, an average of 3.88 problems were addressed at each visit. For patients with diabetes, the average was 4.60.

Using data from the 2000 National Ambulatory Medical Care Survey, Katerndahl et al² estimated the complexity of patient encounters in family practice, cardiology, and psychiatry. They used a formula that took into account the per-patient number of reasons for each visit, diagnoses, and body systems examined, and the variability and diversity of each of these factors. After adjusting the results for length of visit, they found the complexity of care provided per hour by family physicians was 33% higher than that of cardiologists and 5 times higher than that of psychiatrists.

The topics in this issue are a terrific illustration of the breadth of family medicine. Peripheral neuropathy, which we see almost daily, is difficult to diagnose and treat. Prolotherapy is an up-and-coming dextrose injection therapy for tendinopathies and joint pain that shows promise, and patients are likely to start asking us about it. Home apnea monitors are used frequently for newborns—but how effective are they, and when can you tell parents to discontinue their use?

The complexity of care provided per hour by family physicians is 33% higher than that of cardiologists and 5 times higher than that of psychiatrists.

It seems that vaccine recommendations change every year, and this issue’s Practice Alert covers the latest on meningococcal immunization. This month’s PURL answers the question: Do we really need to “bridge” patients with atrial fibrillation from warfarin to low molecular weight heparin immediately before and after a surgical procedure?

The authors and editors of The Journal of Family Practice constantly strive to bring you the most up-to-date information to support your work as a master of the complexity of primary care practice.

In this issue of the Journal, Millstein et al provide an elegant, practical, and up-to-date review of insulin pump therapy (also known as continuous subcutaneous insulin infusion), emphasizing its benefits and comparing it with multiple daily insulin injections.¹

See related article

NOT FOR EVERYONE

While insulin pumps make the lives of many patients much easier, we should be careful when generalizing their indications. These devices have been with us for 4 decades, during which they have progressively been made more precise and more intelligent—and smaller. The technology may be attractive to some patients but undesirable to others (Table 1).

Many healthcare providers are unfamiliar with pump technology, and some are intimidated by it because it involves a dynamic device-user interface that is more complex than that of other concealed programmed devices such as pacemakers. Inadequate glycemic management is complex and may result from factors such as fear of hypoglycemia, difficulty with insulin dose adjustment, and poor math skills.²

Unfortunately, some patients are given a pump without proper screening and education, and they tend to call the pump manufacturer’s help line or their provider often for help with technical problems. Selecting the right patient for this technology is more important than the converse.

Indications for an insulin pump vary by country. In some countries, a pump is started as soon as type 1 diabetes is diagnosed. In the United States, the indications are very rigorous and restrictive, especially for patients with type 2 diabetes, in whom a lack of endogenous insulin production must first be proved.

There is no question that a pump should be offered to every patient with type 1 diabetes who demonstrates good motivation to improve his or her glucose control, but only after a rigorous education program. This option is too costly to be tried just to see if the patient likes it.

ADVERSE EVENTS WITH INSULIN PUMPS: MORE DATA NEEDED

A worrisome aspect of continuous subcutaneous insulin infusion at a population level is a lack of information on the root causes of adverse events (diabetic ketoacidosis or severe hypoglycemia) in patients who use it. These events may be serious and sometimes even fatal.

Outside of a controlled environment, it is difficult to ascertain whether an adverse event represents device error or user error, since pumps contain different components (electronic, mechanical, and pharmacologic) that interface with the human user.³ How adverse events are tracked or categorized is unclear, and given the risks associated with this technology, better postmarketing evaluation is needed. Furthermore, we do not know if the precision of insulin delivery decreases over the life of a pump.

While most pump manufacturers have good customer service and make every effort to provide the patient with a replacement pump in case of failure, we do not know if anyone maintains a database of such failures or adverse events, and if those failures can be analyzed to improve safety.³

INTERFACES ARE NOT STANDARD

When one buys a new car, little time is needed to learn how to operate it because most cars use the same basic features.

The situation is different with insulin pumps. To compete with each other, pump manufacturers create different looks, different insulin delivery methods, and different ways of administering a bolus. Switching from one pump to another is difficult without detailed education on the “bells and whistles” of the new pump.

Most patients use just a few features of the pump. They look at it as more of a convenience. They sometimes forget they are wearing it, and even forget to take a bolus before a meal.

PATIENT SATISFACTION DEPENDS ON THE PATIENT

For years, we thought insulin pumps were better at improving hypoglycemia awareness. But in a prospective study, multiple daily injections with frequent self-monitoring of blood glucose provided identical outcomes without worsening hemoglobin A_1c compared with continuous infusion with real-time continuous glucose monitoring, although satisfaction with treatment was better in the latter group.⁴

Patients’ satisfaction with continuous subcutaneous insulin infusion depends on their baseline hemoglobin A_1c level. Patients with relatively low hemoglobin A_1c tend to take an active approach to self-care, describe the pump as a tool for meeting glycemic goals, and say the pump makes them feel more normal. Patients with high hemoglobin A_1c tend to have a more passive approach to their self-care and have more negative experiences with the pump. Women are more concerned than men with the effect of the pump on body image and social acceptance.⁵

DOLLARS AND CENTS

According to 2012 estimates, 29 million Americans had diabetes mellitus, of whom 1.25 million had type 1. The direct medical costs of diabetes are estimated at $176 billion, of which 12% covers overall pharmacy costs.⁶ About 31% of adults with diabetes use insulin.⁷

For a device that costs $6,000, has a life span of only 4 years, and requires supplies that cost $300 per month, rigorous interpretation of superiority data would be needed to confirm that this technology would have a positive impact on public health if every insulin-using patient with diabetes were to say yes to it. It is true that switching from multiple daily injections to a pump leads to a significant reduction in insulin expenditures in patients with type 2 diabetes, according to a retrospective analysis of claims data.⁸

However, not all studies comparing pumps and multiple daily injections in type 2 diabetes have shown an advantage of one over the other in terms of a reduction in fasting glucose, hemoglobin A_1c, or incidence of hypoglycemia.⁹ A meta-analysis¹⁰ found that the two therapies had similar effects on glycemic control and hypoglycemia. Continuous infusion had a more favorable effect in adults with type 1 diabetes.¹⁰

Neither continuous infusion nor multiple daily injections can mimic physiologic endogenous insulin secretion. Endogenous insulin is secreted into the portal system, and its main site of action is the liver. As a result, there is more hepatic glucose uptake and thus a lower peripheral plasma insulin concentration with endogenous secretion than with systemic administration. Endogenous insulin secretion also suppresses hepatic glucose production and reduces the risk of hypoglycemia.¹¹

PROGRESS, BUT NOT PERFECTION

Diabetes mellitus constitutes a big burden on patients and on society. The discovery of insulin was a giant leap forward; the insulin pump was another great advance. We are getting closer to an integrated bionic pancreas. We are far from achieving a perfect system, but we are much better off than we were 50 or 80 years ago. And although insulin pump technology is sophisticated and precise, it still interfaces with a human user, and the human user still must press its buttons.

In this issue of the Journal, Millstein et al provide an elegant, practical, and up-to-date review of insulin pump therapy (also known as continuous subcutaneous insulin infusion), emphasizing its benefits and comparing it with multiple daily insulin injections.¹

See related article

NOT FOR EVERYONE

While insulin pumps make the lives of many patients much easier, we should be careful when generalizing their indications. These devices have been with us for 4 decades, during which they have progressively been made more precise and more intelligent—and smaller. The technology may be attractive to some patients but undesirable to others (Table 1).

Many healthcare providers are unfamiliar with pump technology, and some are intimidated by it because it involves a dynamic device-user interface that is more complex than that of other concealed programmed devices such as pacemakers. Inadequate glycemic management is complex and may result from factors such as fear of hypoglycemia, difficulty with insulin dose adjustment, and poor math skills.²

Unfortunately, some patients are given a pump without proper screening and education, and they tend to call the pump manufacturer’s help line or their provider often for help with technical problems. Selecting the right patient for this technology is more important than the converse.

Indications for an insulin pump vary by country. In some countries, a pump is started as soon as type 1 diabetes is diagnosed. In the United States, the indications are very rigorous and restrictive, especially for patients with type 2 diabetes, in whom a lack of endogenous insulin production must first be proved.

There is no question that a pump should be offered to every patient with type 1 diabetes who demonstrates good motivation to improve his or her glucose control, but only after a rigorous education program. This option is too costly to be tried just to see if the patient likes it.

ADVERSE EVENTS WITH INSULIN PUMPS: MORE DATA NEEDED

A worrisome aspect of continuous subcutaneous insulin infusion at a population level is a lack of information on the root causes of adverse events (diabetic ketoacidosis or severe hypoglycemia) in patients who use it. These events may be serious and sometimes even fatal.

Outside of a controlled environment, it is difficult to ascertain whether an adverse event represents device error or user error, since pumps contain different components (electronic, mechanical, and pharmacologic) that interface with the human user.³ How adverse events are tracked or categorized is unclear, and given the risks associated with this technology, better postmarketing evaluation is needed. Furthermore, we do not know if the precision of insulin delivery decreases over the life of a pump.

While most pump manufacturers have good customer service and make every effort to provide the patient with a replacement pump in case of failure, we do not know if anyone maintains a database of such failures or adverse events, and if those failures can be analyzed to improve safety.³

INTERFACES ARE NOT STANDARD

When one buys a new car, little time is needed to learn how to operate it because most cars use the same basic features.

The situation is different with insulin pumps. To compete with each other, pump manufacturers create different looks, different insulin delivery methods, and different ways of administering a bolus. Switching from one pump to another is difficult without detailed education on the “bells and whistles” of the new pump.

Most patients use just a few features of the pump. They look at it as more of a convenience. They sometimes forget they are wearing it, and even forget to take a bolus before a meal.

PATIENT SATISFACTION DEPENDS ON THE PATIENT

For years, we thought insulin pumps were better at improving hypoglycemia awareness. But in a prospective study, multiple daily injections with frequent self-monitoring of blood glucose provided identical outcomes without worsening hemoglobin A_1c compared with continuous infusion with real-time continuous glucose monitoring, although satisfaction with treatment was better in the latter group.⁴

Patients’ satisfaction with continuous subcutaneous insulin infusion depends on their baseline hemoglobin A_1c level. Patients with relatively low hemoglobin A_1c tend to take an active approach to self-care, describe the pump as a tool for meeting glycemic goals, and say the pump makes them feel more normal. Patients with high hemoglobin A_1c tend to have a more passive approach to their self-care and have more negative experiences with the pump. Women are more concerned than men with the effect of the pump on body image and social acceptance.⁵

DOLLARS AND CENTS

According to 2012 estimates, 29 million Americans had diabetes mellitus, of whom 1.25 million had type 1. The direct medical costs of diabetes are estimated at $176 billion, of which 12% covers overall pharmacy costs.⁶ About 31% of adults with diabetes use insulin.⁷

For a device that costs $6,000, has a life span of only 4 years, and requires supplies that cost $300 per month, rigorous interpretation of superiority data would be needed to confirm that this technology would have a positive impact on public health if every insulin-using patient with diabetes were to say yes to it. It is true that switching from multiple daily injections to a pump leads to a significant reduction in insulin expenditures in patients with type 2 diabetes, according to a retrospective analysis of claims data.⁸

However, not all studies comparing pumps and multiple daily injections in type 2 diabetes have shown an advantage of one over the other in terms of a reduction in fasting glucose, hemoglobin A_1c, or incidence of hypoglycemia.⁹ A meta-analysis¹⁰ found that the two therapies had similar effects on glycemic control and hypoglycemia. Continuous infusion had a more favorable effect in adults with type 1 diabetes.¹⁰

Neither continuous infusion nor multiple daily injections can mimic physiologic endogenous insulin secretion. Endogenous insulin is secreted into the portal system, and its main site of action is the liver. As a result, there is more hepatic glucose uptake and thus a lower peripheral plasma insulin concentration with endogenous secretion than with systemic administration. Endogenous insulin secretion also suppresses hepatic glucose production and reduces the risk of hypoglycemia.¹¹

PROGRESS, BUT NOT PERFECTION

Diabetes mellitus constitutes a big burden on patients and on society. The discovery of insulin was a giant leap forward; the insulin pump was another great advance. We are getting closer to an integrated bionic pancreas. We are far from achieving a perfect system, but we are much better off than we were 50 or 80 years ago. And although insulin pump technology is sophisticated and precise, it still interfaces with a human user, and the human user still must press its buttons.

In this issue of the Journal, Millstein et al provide an elegant, practical, and up-to-date review of insulin pump therapy (also known as continuous subcutaneous insulin infusion), emphasizing its benefits and comparing it with multiple daily insulin injections.¹

See related article

NOT FOR EVERYONE

While insulin pumps make the lives of many patients much easier, we should be careful when generalizing their indications. These devices have been with us for 4 decades, during which they have progressively been made more precise and more intelligent—and smaller. The technology may be attractive to some patients but undesirable to others (Table 1).

Many healthcare providers are unfamiliar with pump technology, and some are intimidated by it because it involves a dynamic device-user interface that is more complex than that of other concealed programmed devices such as pacemakers. Inadequate glycemic management is complex and may result from factors such as fear of hypoglycemia, difficulty with insulin dose adjustment, and poor math skills.²

Unfortunately, some patients are given a pump without proper screening and education, and they tend to call the pump manufacturer’s help line or their provider often for help with technical problems. Selecting the right patient for this technology is more important than the converse.

Indications for an insulin pump vary by country. In some countries, a pump is started as soon as type 1 diabetes is diagnosed. In the United States, the indications are very rigorous and restrictive, especially for patients with type 2 diabetes, in whom a lack of endogenous insulin production must first be proved.

There is no question that a pump should be offered to every patient with type 1 diabetes who demonstrates good motivation to improve his or her glucose control, but only after a rigorous education program. This option is too costly to be tried just to see if the patient likes it.

ADVERSE EVENTS WITH INSULIN PUMPS: MORE DATA NEEDED

A worrisome aspect of continuous subcutaneous insulin infusion at a population level is a lack of information on the root causes of adverse events (diabetic ketoacidosis or severe hypoglycemia) in patients who use it. These events may be serious and sometimes even fatal.

Outside of a controlled environment, it is difficult to ascertain whether an adverse event represents device error or user error, since pumps contain different components (electronic, mechanical, and pharmacologic) that interface with the human user.³ How adverse events are tracked or categorized is unclear, and given the risks associated with this technology, better postmarketing evaluation is needed. Furthermore, we do not know if the precision of insulin delivery decreases over the life of a pump.

While most pump manufacturers have good customer service and make every effort to provide the patient with a replacement pump in case of failure, we do not know if anyone maintains a database of such failures or adverse events, and if those failures can be analyzed to improve safety.³

INTERFACES ARE NOT STANDARD

When one buys a new car, little time is needed to learn how to operate it because most cars use the same basic features.

The situation is different with insulin pumps. To compete with each other, pump manufacturers create different looks, different insulin delivery methods, and different ways of administering a bolus. Switching from one pump to another is difficult without detailed education on the “bells and whistles” of the new pump.

Most patients use just a few features of the pump. They look at it as more of a convenience. They sometimes forget they are wearing it, and even forget to take a bolus before a meal.

PATIENT SATISFACTION DEPENDS ON THE PATIENT

For years, we thought insulin pumps were better at improving hypoglycemia awareness. But in a prospective study, multiple daily injections with frequent self-monitoring of blood glucose provided identical outcomes without worsening hemoglobin A_1c compared with continuous infusion with real-time continuous glucose monitoring, although satisfaction with treatment was better in the latter group.⁴

Patients’ satisfaction with continuous subcutaneous insulin infusion depends on their baseline hemoglobin A_1c level. Patients with relatively low hemoglobin A_1c tend to take an active approach to self-care, describe the pump as a tool for meeting glycemic goals, and say the pump makes them feel more normal. Patients with high hemoglobin A_1c tend to have a more passive approach to their self-care and have more negative experiences with the pump. Women are more concerned than men with the effect of the pump on body image and social acceptance.⁵

DOLLARS AND CENTS

According to 2012 estimates, 29 million Americans had diabetes mellitus, of whom 1.25 million had type 1. The direct medical costs of diabetes are estimated at $176 billion, of which 12% covers overall pharmacy costs.⁶ About 31% of adults with diabetes use insulin.⁷

For a device that costs $6,000, has a life span of only 4 years, and requires supplies that cost $300 per month, rigorous interpretation of superiority data would be needed to confirm that this technology would have a positive impact on public health if every insulin-using patient with diabetes were to say yes to it. It is true that switching from multiple daily injections to a pump leads to a significant reduction in insulin expenditures in patients with type 2 diabetes, according to a retrospective analysis of claims data.⁸

However, not all studies comparing pumps and multiple daily injections in type 2 diabetes have shown an advantage of one over the other in terms of a reduction in fasting glucose, hemoglobin A_1c, or incidence of hypoglycemia.⁹ A meta-analysis¹⁰ found that the two therapies had similar effects on glycemic control and hypoglycemia. Continuous infusion had a more favorable effect in adults with type 1 diabetes.¹⁰

Neither continuous infusion nor multiple daily injections can mimic physiologic endogenous insulin secretion. Endogenous insulin is secreted into the portal system, and its main site of action is the liver. As a result, there is more hepatic glucose uptake and thus a lower peripheral plasma insulin concentration with endogenous secretion than with systemic administration. Endogenous insulin secretion also suppresses hepatic glucose production and reduces the risk of hypoglycemia.¹¹

PROGRESS, BUT NOT PERFECTION

Diabetes mellitus constitutes a big burden on patients and on society. The discovery of insulin was a giant leap forward; the insulin pump was another great advance. We are getting closer to an integrated bionic pancreas. We are far from achieving a perfect system, but we are much better off than we were 50 or 80 years ago. And although insulin pump technology is sophisticated and precise, it still interfaces with a human user, and the human user still must press its buttons.

When you finish reading this column … on second thought, stop now and read the Oct. 17, 2015, opinion piece titled “Overselling Breast-Feeding.” You will discover a well-researched and thoughtfully crafted article by Courtney Jung, a political science professor at the University of Toronto, in which she dares to carefully dissect one of our most revered sacred cows. The result is a convincing argument for rethinking how we present and promote breastfeeding. I won’t attempt to reconstruct her rationale. You can read it for yourself. But, I suspect that if you spend any part of your day trying to help new parents navigate the choppy waters of those first 6 months, you will find what she has to say strikes more than a few familiar chords.

Like most of you, what I learned about breastfeeding came as on the job training. Marilyn and I started our family while I was still in medical school, giving me the advantage of having watched the process bump along twice before I found myself on the frontline of private practice. I had been taught in school about all the advantages breast milk, but it didn’t take long in the real world to discover that breastfeeding could have a dark side.

I had to become a chameleon. I needed to be strong advocate for the advantages of breast milk and support new mothers as they tried to match the American Academy of Pediatrics’ guidelines. However, there were situations in which despite everyone’s best efforts, the handwriting on the wall said, “This isn’t working.” Then it was time to change my colors and convincingly convey the new truth that even a baby that isn’t breastfed is going to be fine. That a woman who doesn’t breastfeed can and will be a mother every bit as good as one who doesn’t breastfed her baby for 6 months or a year.

©Jupiterimages/thinkstockphotos.com

The tension between the party line and reality became so great that in frustration I decided to write my third book about breastfeeding. The result was “The Maternity Leave Breastfeeding Plan” (New York: Simon and Schuster, 2002). The watered-down title was chosen by the publisher. The subtitle, “How to Enjoy Nursing for 3 Months and Go Back to Work Guilt-Free,” was a better reflection of my message that there can be some serious challenges to breastfeeding and not to worry if it doesn’t work. Surprisingly, it found itself on a La Leche League list of recommended books – that is until someone in the organization actually read it.

Although I had always harbored doubts that many of the studies purporting to show the advantages of breastfeeding were poorly controlled, in 2002, I couldn’t find any data to support my concerns. But over the last decade those studies have begun to emerge and Professor Jung has found them and included them in her new book, “Lactivism: How Feminists and Fundamentalists, Hippies and Yuppies, and Physicians and Politicians Made Breastfeeding Big Business and Bad Policy” (New York: Basic Books, 2015).

It will be interesting to see how her observations play to the wider audience it deserves. The discussions may be lively and heated, and public opinion may shift a bit. But what won’t change is that those of us who deal with mothers and babies in a very personal way will still have to struggle with promoting a good product that isn’t always easy to obtain.

Breast milk is good … but it isn’t always better or best.

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

When you finish reading this column … on second thought, stop now and read the Oct. 17, 2015, opinion piece titled “Overselling Breast-Feeding.” You will discover a well-researched and thoughtfully crafted article by Courtney Jung, a political science professor at the University of Toronto, in which she dares to carefully dissect one of our most revered sacred cows. The result is a convincing argument for rethinking how we present and promote breastfeeding. I won’t attempt to reconstruct her rationale. You can read it for yourself. But, I suspect that if you spend any part of your day trying to help new parents navigate the choppy waters of those first 6 months, you will find what she has to say strikes more than a few familiar chords.

Like most of you, what I learned about breastfeeding came as on the job training. Marilyn and I started our family while I was still in medical school, giving me the advantage of having watched the process bump along twice before I found myself on the frontline of private practice. I had been taught in school about all the advantages breast milk, but it didn’t take long in the real world to discover that breastfeeding could have a dark side.

I had to become a chameleon. I needed to be strong advocate for the advantages of breast milk and support new mothers as they tried to match the American Academy of Pediatrics’ guidelines. However, there were situations in which despite everyone’s best efforts, the handwriting on the wall said, “This isn’t working.” Then it was time to change my colors and convincingly convey the new truth that even a baby that isn’t breastfed is going to be fine. That a woman who doesn’t breastfeed can and will be a mother every bit as good as one who doesn’t breastfed her baby for 6 months or a year.

©Jupiterimages/thinkstockphotos.com

The tension between the party line and reality became so great that in frustration I decided to write my third book about breastfeeding. The result was “The Maternity Leave Breastfeeding Plan” (New York: Simon and Schuster, 2002). The watered-down title was chosen by the publisher. The subtitle, “How to Enjoy Nursing for 3 Months and Go Back to Work Guilt-Free,” was a better reflection of my message that there can be some serious challenges to breastfeeding and not to worry if it doesn’t work. Surprisingly, it found itself on a La Leche League list of recommended books – that is until someone in the organization actually read it.

Although I had always harbored doubts that many of the studies purporting to show the advantages of breastfeeding were poorly controlled, in 2002, I couldn’t find any data to support my concerns. But over the last decade those studies have begun to emerge and Professor Jung has found them and included them in her new book, “Lactivism: How Feminists and Fundamentalists, Hippies and Yuppies, and Physicians and Politicians Made Breastfeeding Big Business and Bad Policy” (New York: Basic Books, 2015).

It will be interesting to see how her observations play to the wider audience it deserves. The discussions may be lively and heated, and public opinion may shift a bit. But what won’t change is that those of us who deal with mothers and babies in a very personal way will still have to struggle with promoting a good product that isn’t always easy to obtain.

Breast milk is good … but it isn’t always better or best.

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

When you finish reading this column … on second thought, stop now and read the Oct. 17, 2015, opinion piece titled “Overselling Breast-Feeding.” You will discover a well-researched and thoughtfully crafted article by Courtney Jung, a political science professor at the University of Toronto, in which she dares to carefully dissect one of our most revered sacred cows. The result is a convincing argument for rethinking how we present and promote breastfeeding. I won’t attempt to reconstruct her rationale. You can read it for yourself. But, I suspect that if you spend any part of your day trying to help new parents navigate the choppy waters of those first 6 months, you will find what she has to say strikes more than a few familiar chords.

Like most of you, what I learned about breastfeeding came as on the job training. Marilyn and I started our family while I was still in medical school, giving me the advantage of having watched the process bump along twice before I found myself on the frontline of private practice. I had been taught in school about all the advantages breast milk, but it didn’t take long in the real world to discover that breastfeeding could have a dark side.

I had to become a chameleon. I needed to be strong advocate for the advantages of breast milk and support new mothers as they tried to match the American Academy of Pediatrics’ guidelines. However, there were situations in which despite everyone’s best efforts, the handwriting on the wall said, “This isn’t working.” Then it was time to change my colors and convincingly convey the new truth that even a baby that isn’t breastfed is going to be fine. That a woman who doesn’t breastfeed can and will be a mother every bit as good as one who doesn’t breastfed her baby for 6 months or a year.

©Jupiterimages/thinkstockphotos.com

The tension between the party line and reality became so great that in frustration I decided to write my third book about breastfeeding. The result was “The Maternity Leave Breastfeeding Plan” (New York: Simon and Schuster, 2002). The watered-down title was chosen by the publisher. The subtitle, “How to Enjoy Nursing for 3 Months and Go Back to Work Guilt-Free,” was a better reflection of my message that there can be some serious challenges to breastfeeding and not to worry if it doesn’t work. Surprisingly, it found itself on a La Leche League list of recommended books – that is until someone in the organization actually read it.

Although I had always harbored doubts that many of the studies purporting to show the advantages of breastfeeding were poorly controlled, in 2002, I couldn’t find any data to support my concerns. But over the last decade those studies have begun to emerge and Professor Jung has found them and included them in her new book, “Lactivism: How Feminists and Fundamentalists, Hippies and Yuppies, and Physicians and Politicians Made Breastfeeding Big Business and Bad Policy” (New York: Basic Books, 2015).

It will be interesting to see how her observations play to the wider audience it deserves. The discussions may be lively and heated, and public opinion may shift a bit. But what won’t change is that those of us who deal with mothers and babies in a very personal way will still have to struggle with promoting a good product that isn’t always easy to obtain.

Breast milk is good … but it isn’t always better or best.

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

Imagine yourself in a small community hospital standing at the bedside of a tiny preemie waiting for the neonatal transport team to return your call for help.

With one eye shifting between the clock and the oximeter, you have the other one looking out the window hoping that the predicted snow and freezing rain will hold out for another hour. You have done everything you can do, but clearly it’s not going to be enough to rescue this little person who had the misfortune of exiting the birth canal several months too early.

You have been able to insert an umbilical vein catheter and miraculously have threaded an endotracheal tube into a trachea that looked no bigger than a piece of spaghetti, or maybe you have failed and the nurses are taking turns bagging. The transport team returns your call for help and with apologies reports that they are tied up with a similar scenario further south; they predict that it may be an hour and a half before they will be able to get back to their hospital, which is a half hour down the road from you.

They suggest some things that you have already done. Should you wait for more skilled hands and their equipment or transport the patient yourself and get on the road before it becomes a skating rink? There is an antique transport isolette gathering dust in the storage room down the hall, and the local fire department ambulance crew with whom you are on a first-name basis is always ready to help. Is it time to gather the troops and tell them, “Let’s roll!” ?

If you have ever lived through a similar scenario, you may find a recent study interesting (Ann Intern Med. 2015;163[9]:681-90). What these investigators found was that for adults who had suffered major trauma, stroke, respiratory failure, and acute myocardial infarction, those who were transported by crews with basic life support (BLS) skills had significantly better long-term survival and neurologic outcomes than did those victims transported by crews with advanced life support (ALS) skills.

In the flurry of comments that circulated following the release of the study were a few questions about the methodology, but most commentators were searching for an explanation. Was critical time lost by the ALS crews doing stuff when the better course of action would have been to get the ambulance rolling to the hospital and more definitive care? Does the temptation to do things because you can do them sometimes cloud the decision-making process?

Although I have lived the scenario I described, it is less likely to happen now. Backup teams from other institutions may be activated. The teams are so well equipped and trained that the gaps between their capabilities and the neonatal intensive care unit have narrowed, but there is no question that they remain and are significant.

The other thing that hasn’t changed is the weather here in Maine. While we have beautiful summers that prompt us to put “Vacationland” on our license plates, our winters are a challenge. In addition to the patient’s condition and the availability of resources, the decision of whether to invest time in stabilization or get moving toward the referral center also must include the risk to the patient and staff who will be traveling on weather-threatened roads.

On the other hand, we can’t ignore the elephant that occasionally finds its way into the room when decisions are made about how thoroughly a critically ill patient is stabilized and how speedily he is transferred. And, that ponderous pachyderm is the hot potato factor and sometimes answers to its acronym, NIMBY (“not in my back yard”). You know as well as I do that despite the Emergency Medical Treatment and Active Labor Act (EMTALA) regulations, there are cases when a patient is hustled out the door without being appropriately stabilized primarily to avoid having that patient die in the referring hospital. We must continue to ask ourselves if we have done everything that we can do to stabilize the patient before we say, “Let’s roll!”

William G. Wilkoff, M.D., practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

Imagine yourself in a small community hospital standing at the bedside of a tiny preemie waiting for the neonatal transport team to return your call for help.

With one eye shifting between the clock and the oximeter, you have the other one looking out the window hoping that the predicted snow and freezing rain will hold out for another hour. You have done everything you can do, but clearly it’s not going to be enough to rescue this little person who had the misfortune of exiting the birth canal several months too early.

You have been able to insert an umbilical vein catheter and miraculously have threaded an endotracheal tube into a trachea that looked no bigger than a piece of spaghetti, or maybe you have failed and the nurses are taking turns bagging. The transport team returns your call for help and with apologies reports that they are tied up with a similar scenario further south; they predict that it may be an hour and a half before they will be able to get back to their hospital, which is a half hour down the road from you.

They suggest some things that you have already done. Should you wait for more skilled hands and their equipment or transport the patient yourself and get on the road before it becomes a skating rink? There is an antique transport isolette gathering dust in the storage room down the hall, and the local fire department ambulance crew with whom you are on a first-name basis is always ready to help. Is it time to gather the troops and tell them, “Let’s roll!” ?

If you have ever lived through a similar scenario, you may find a recent study interesting (Ann Intern Med. 2015;163[9]:681-90). What these investigators found was that for adults who had suffered major trauma, stroke, respiratory failure, and acute myocardial infarction, those who were transported by crews with basic life support (BLS) skills had significantly better long-term survival and neurologic outcomes than did those victims transported by crews with advanced life support (ALS) skills.

In the flurry of comments that circulated following the release of the study were a few questions about the methodology, but most commentators were searching for an explanation. Was critical time lost by the ALS crews doing stuff when the better course of action would have been to get the ambulance rolling to the hospital and more definitive care? Does the temptation to do things because you can do them sometimes cloud the decision-making process?

Although I have lived the scenario I described, it is less likely to happen now. Backup teams from other institutions may be activated. The teams are so well equipped and trained that the gaps between their capabilities and the neonatal intensive care unit have narrowed, but there is no question that they remain and are significant.

The other thing that hasn’t changed is the weather here in Maine. While we have beautiful summers that prompt us to put “Vacationland” on our license plates, our winters are a challenge. In addition to the patient’s condition and the availability of resources, the decision of whether to invest time in stabilization or get moving toward the referral center also must include the risk to the patient and staff who will be traveling on weather-threatened roads.

On the other hand, we can’t ignore the elephant that occasionally finds its way into the room when decisions are made about how thoroughly a critically ill patient is stabilized and how speedily he is transferred. And, that ponderous pachyderm is the hot potato factor and sometimes answers to its acronym, NIMBY (“not in my back yard”). You know as well as I do that despite the Emergency Medical Treatment and Active Labor Act (EMTALA) regulations, there are cases when a patient is hustled out the door without being appropriately stabilized primarily to avoid having that patient die in the referring hospital. We must continue to ask ourselves if we have done everything that we can do to stabilize the patient before we say, “Let’s roll!”

William G. Wilkoff, M.D., practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

Imagine yourself in a small community hospital standing at the bedside of a tiny preemie waiting for the neonatal transport team to return your call for help.

With one eye shifting between the clock and the oximeter, you have the other one looking out the window hoping that the predicted snow and freezing rain will hold out for another hour. You have done everything you can do, but clearly it’s not going to be enough to rescue this little person who had the misfortune of exiting the birth canal several months too early.

You have been able to insert an umbilical vein catheter and miraculously have threaded an endotracheal tube into a trachea that looked no bigger than a piece of spaghetti, or maybe you have failed and the nurses are taking turns bagging. The transport team returns your call for help and with apologies reports that they are tied up with a similar scenario further south; they predict that it may be an hour and a half before they will be able to get back to their hospital, which is a half hour down the road from you.

They suggest some things that you have already done. Should you wait for more skilled hands and their equipment or transport the patient yourself and get on the road before it becomes a skating rink? There is an antique transport isolette gathering dust in the storage room down the hall, and the local fire department ambulance crew with whom you are on a first-name basis is always ready to help. Is it time to gather the troops and tell them, “Let’s roll!” ?

If you have ever lived through a similar scenario, you may find a recent study interesting (Ann Intern Med. 2015;163[9]:681-90). What these investigators found was that for adults who had suffered major trauma, stroke, respiratory failure, and acute myocardial infarction, those who were transported by crews with basic life support (BLS) skills had significantly better long-term survival and neurologic outcomes than did those victims transported by crews with advanced life support (ALS) skills.

In the flurry of comments that circulated following the release of the study were a few questions about the methodology, but most commentators were searching for an explanation. Was critical time lost by the ALS crews doing stuff when the better course of action would have been to get the ambulance rolling to the hospital and more definitive care? Does the temptation to do things because you can do them sometimes cloud the decision-making process?

Although I have lived the scenario I described, it is less likely to happen now. Backup teams from other institutions may be activated. The teams are so well equipped and trained that the gaps between their capabilities and the neonatal intensive care unit have narrowed, but there is no question that they remain and are significant.

The other thing that hasn’t changed is the weather here in Maine. While we have beautiful summers that prompt us to put “Vacationland” on our license plates, our winters are a challenge. In addition to the patient’s condition and the availability of resources, the decision of whether to invest time in stabilization or get moving toward the referral center also must include the risk to the patient and staff who will be traveling on weather-threatened roads.

On the other hand, we can’t ignore the elephant that occasionally finds its way into the room when decisions are made about how thoroughly a critically ill patient is stabilized and how speedily he is transferred. And, that ponderous pachyderm is the hot potato factor and sometimes answers to its acronym, NIMBY (“not in my back yard”). You know as well as I do that despite the Emergency Medical Treatment and Active Labor Act (EMTALA) regulations, there are cases when a patient is hustled out the door without being appropriately stabilized primarily to avoid having that patient die in the referring hospital. We must continue to ask ourselves if we have done everything that we can do to stabilize the patient before we say, “Let’s roll!”

William G. Wilkoff, M.D., practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

Design thinking isn’t only for products such as the Apple watch. It is a methodology used to improve customer experiences not only with products but also with services. Much in the same way that the SOAP note shaped our thinking about diagnosis and treatment, design thinking provides a scaffold to help us better understand the needs and wants of customers, or in our case, patients.

Design thinking uses specific tools and methodologies to understand experiences from others’ perspectives. From its roots in Silicon Valley, design thinking has grown steadily in its influence. Its first high priests were people such as Steve Jobs and David Kelly, who famously designed the computer mouse. The principles learned or applied to increasingly complicated products and services led to the growth of an entire industry in Palo Alto, Calif., with companies such as IDEO and gurus such as IDEO CEO and President Tim Brown of Stanford (Calif.) University has an entire graduate school program on design thinking called d.school while Coursera offers online courses on design thinking.

The principles are simple: The better you understand your customers and their needs, the better you can design your services. There are many toolkits that are available for you to try for free. Empathy Mapping is an easy one you could apply to your practice to enhance your patients’ experience.

The idea behind this technique is to immerse yourself in your patient’s world. Pick a time when your practice is closed. Then take a journey through your office as if you were a patient. It’s important that you keep the experience as close to reality as possible. Start before you even arrive at your office. What is the experience like driving to your office? Do patients have to fight traffic to get to you? Is parking easy to find? How far must they walk from their car to get to your office? What is your check-in process like? Are patients greeted by name? Are they first handed paperwork to complete? Or are they introduced and warmly welcomed to your practice first?

What’s the experience like in the waiting room? Take note of not only what your patients see but also what they hear, smell, touch, and say. What experience does your furniture give patients? What type of magazines are available to them? Do you have Wi-Fi? Is there a television? If so, is it showing simply an advertisement, or is it something that your patients would connect with? Is there music playing?

Using the same process, continue your journey through an entire patient visit. Make note of what the experience is like walking back to your exam rooms. What do your patients see and smell while sitting in an exam room waiting for you? Does it smell of isopropyl alcohol? Is it cold or hot? What’s it like to sit in your room wearing nothing but a patient gown? Are there instruments such as cryo guns that could be intimidating to patients? All of these factors can be modified and thus “designed” to optimize the experience for your patients. Continue this journey including a physical exam and discussion with the doctor and other providers and assistants.

This is a great exercise not only for you but more importantly for your staff. Ask your staff to take notes as they walk through the same empathy mapping journey. It will give them an entirely new and valuable perspective on what it’s like to be a patient in your office. Once you’ve completed your empathy mapping, sit with your team and brainstorm about opportunities to improve the experience for your patients. Ask yourselves what things surprised you. What things do you feel could have the largest impact on your patients’ experience in your office? In what ways can you modify the spaces in your office to optimize your patients’ experience?

Having done this exercise in my own clinic, I found it highly impactful. It gave me a deeper understanding of and appreciation for my patients and caused me to make several minor but important changes in my exam room and to my and my staff’s interactions with patients. I hope you have a similarly informative experience.

If you’re interested in learning more about design thinking, then check out the following books and articles:

• “Change by Design: How Design Thinking Transforms Organization and Inspires Innovation,” by Tim Brown (New York: Harper Business, 2009).

• “The Art of Innovation,” by Tom Kelley (New York: A Currency Book, Doubleday, Random House, 2001).

• Design Thinking Comes of Age, by Jon Kolko (Harv Bus Rev. Sep 2015;pp 66-71).

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Design thinking isn’t only for products such as the Apple watch. It is a methodology used to improve customer experiences not only with products but also with services. Much in the same way that the SOAP note shaped our thinking about diagnosis and treatment, design thinking provides a scaffold to help us better understand the needs and wants of customers, or in our case, patients.

Design thinking uses specific tools and methodologies to understand experiences from others’ perspectives. From its roots in Silicon Valley, design thinking has grown steadily in its influence. Its first high priests were people such as Steve Jobs and David Kelly, who famously designed the computer mouse. The principles learned or applied to increasingly complicated products and services led to the growth of an entire industry in Palo Alto, Calif., with companies such as IDEO and gurus such as IDEO CEO and President Tim Brown of Stanford (Calif.) University has an entire graduate school program on design thinking called d.school while Coursera offers online courses on design thinking.

The principles are simple: The better you understand your customers and their needs, the better you can design your services. There are many toolkits that are available for you to try for free. Empathy Mapping is an easy one you could apply to your practice to enhance your patients’ experience.

The idea behind this technique is to immerse yourself in your patient’s world. Pick a time when your practice is closed. Then take a journey through your office as if you were a patient. It’s important that you keep the experience as close to reality as possible. Start before you even arrive at your office. What is the experience like driving to your office? Do patients have to fight traffic to get to you? Is parking easy to find? How far must they walk from their car to get to your office? What is your check-in process like? Are patients greeted by name? Are they first handed paperwork to complete? Or are they introduced and warmly welcomed to your practice first?

What’s the experience like in the waiting room? Take note of not only what your patients see but also what they hear, smell, touch, and say. What experience does your furniture give patients? What type of magazines are available to them? Do you have Wi-Fi? Is there a television? If so, is it showing simply an advertisement, or is it something that your patients would connect with? Is there music playing?

Using the same process, continue your journey through an entire patient visit. Make note of what the experience is like walking back to your exam rooms. What do your patients see and smell while sitting in an exam room waiting for you? Does it smell of isopropyl alcohol? Is it cold or hot? What’s it like to sit in your room wearing nothing but a patient gown? Are there instruments such as cryo guns that could be intimidating to patients? All of these factors can be modified and thus “designed” to optimize the experience for your patients. Continue this journey including a physical exam and discussion with the doctor and other providers and assistants.

This is a great exercise not only for you but more importantly for your staff. Ask your staff to take notes as they walk through the same empathy mapping journey. It will give them an entirely new and valuable perspective on what it’s like to be a patient in your office. Once you’ve completed your empathy mapping, sit with your team and brainstorm about opportunities to improve the experience for your patients. Ask yourselves what things surprised you. What things do you feel could have the largest impact on your patients’ experience in your office? In what ways can you modify the spaces in your office to optimize your patients’ experience?

Having done this exercise in my own clinic, I found it highly impactful. It gave me a deeper understanding of and appreciation for my patients and caused me to make several minor but important changes in my exam room and to my and my staff’s interactions with patients. I hope you have a similarly informative experience.

If you’re interested in learning more about design thinking, then check out the following books and articles:

• “Change by Design: How Design Thinking Transforms Organization and Inspires Innovation,” by Tim Brown (New York: Harper Business, 2009).

• “The Art of Innovation,” by Tom Kelley (New York: A Currency Book, Doubleday, Random House, 2001).

• Design Thinking Comes of Age, by Jon Kolko (Harv Bus Rev. Sep 2015;pp 66-71).

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.

Design thinking isn’t only for products such as the Apple watch. It is a methodology used to improve customer experiences not only with products but also with services. Much in the same way that the SOAP note shaped our thinking about diagnosis and treatment, design thinking provides a scaffold to help us better understand the needs and wants of customers, or in our case, patients.

Design thinking uses specific tools and methodologies to understand experiences from others’ perspectives. From its roots in Silicon Valley, design thinking has grown steadily in its influence. Its first high priests were people such as Steve Jobs and David Kelly, who famously designed the computer mouse. The principles learned or applied to increasingly complicated products and services led to the growth of an entire industry in Palo Alto, Calif., with companies such as IDEO and gurus such as IDEO CEO and President Tim Brown of Stanford (Calif.) University has an entire graduate school program on design thinking called d.school while Coursera offers online courses on design thinking.

The principles are simple: The better you understand your customers and their needs, the better you can design your services. There are many toolkits that are available for you to try for free. Empathy Mapping is an easy one you could apply to your practice to enhance your patients’ experience.

The idea behind this technique is to immerse yourself in your patient’s world. Pick a time when your practice is closed. Then take a journey through your office as if you were a patient. It’s important that you keep the experience as close to reality as possible. Start before you even arrive at your office. What is the experience like driving to your office? Do patients have to fight traffic to get to you? Is parking easy to find? How far must they walk from their car to get to your office? What is your check-in process like? Are patients greeted by name? Are they first handed paperwork to complete? Or are they introduced and warmly welcomed to your practice first?

What’s the experience like in the waiting room? Take note of not only what your patients see but also what they hear, smell, touch, and say. What experience does your furniture give patients? What type of magazines are available to them? Do you have Wi-Fi? Is there a television? If so, is it showing simply an advertisement, or is it something that your patients would connect with? Is there music playing?

Using the same process, continue your journey through an entire patient visit. Make note of what the experience is like walking back to your exam rooms. What do your patients see and smell while sitting in an exam room waiting for you? Does it smell of isopropyl alcohol? Is it cold or hot? What’s it like to sit in your room wearing nothing but a patient gown? Are there instruments such as cryo guns that could be intimidating to patients? All of these factors can be modified and thus “designed” to optimize the experience for your patients. Continue this journey including a physical exam and discussion with the doctor and other providers and assistants.

This is a great exercise not only for you but more importantly for your staff. Ask your staff to take notes as they walk through the same empathy mapping journey. It will give them an entirely new and valuable perspective on what it’s like to be a patient in your office. Once you’ve completed your empathy mapping, sit with your team and brainstorm about opportunities to improve the experience for your patients. Ask yourselves what things surprised you. What things do you feel could have the largest impact on your patients’ experience in your office? In what ways can you modify the spaces in your office to optimize your patients’ experience?

Having done this exercise in my own clinic, I found it highly impactful. It gave me a deeper understanding of and appreciation for my patients and caused me to make several minor but important changes in my exam room and to my and my staff’s interactions with patients. I hope you have a similarly informative experience.

If you’re interested in learning more about design thinking, then check out the following books and articles:

• “Change by Design: How Design Thinking Transforms Organization and Inspires Innovation,” by Tim Brown (New York: Harper Business, 2009).

• “The Art of Innovation,” by Tom Kelley (New York: A Currency Book, Doubleday, Random House, 2001).

• Design Thinking Comes of Age, by Jon Kolko (Harv Bus Rev. Sep 2015;pp 66-71).

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego, and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter.