Bedside Ultrasound for Pulsatile Hand Mass

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A 23-year-old man, who initially presented to an outside hospital’s ED for evaluation and treatment of a stab wound, presented to our ED two months later with a pulsatile hand mass.

Case

A 23-year-old man presented to an outside hospital’s ED for evaluation of a wound on his right hand, which he sustained after he accidentally stabbed himself with a steak knife. At presentation, the patient’s vital signs were: heart rate, 90 beats/min; respiratory rate, 16 breaths/min; blood pressure, 150/92 mm Hg; and temperature, 98.1°F. Oxygen saturation was 98% on room air. Examination revealed a laceration on the patient’s right hand measuring 2 cm in length. The emergency physician (EP) closed the wound using four nylon sutures and administered a Boostrix shot. The patient was discharged home with a prescription for cephalexin capsule 500 mg to be taken four times daily for 5 days. He was instructed to return in 10 days for suture removal, but failed to follow-up.

The patient presented to our ED two months after the initial injury for evaluation of a 1.5-cm round pulsatile mass on his right palm, at the base of the middle finger, from which exuded a small amount of sanguineous fluid. The patient complained of numbness and difficulty extending his right index and middle fingers.

Figure. Ultrasound image of the patient’s right hand demonstrating the classic yin-yang sign consistent with a pseudoaneurysm.
Figure. Ultrasound image of the patient’s right hand demonstrating the classic yin-yang sign consistent with a pseudoaneurysm.
An X-ray of the hand showed no fracture, gas, or foreign bodies. The differential diagnosis included a hematoma, abscess, retained foreign body, incision cyst, fibroma, and lipoma. Due to the pulsatile nature of the mass, the EP performed a point-of-care (POC) ultrasound of the patient’s right hand, which included non-Doppler and Doppler imaging. The non-Doppler study revealed a pulsatile mass with heterogeneous echogenicity (Video 1); the Doppler study showed pulsatile-flow through the neck of the mass (Video 2); and a still ultrasound image (Figure) demonstrated a classic yin-yang sign consistent with a pseudoaneurysm.

Discussion

Palmar Pseudoaneurysms

A pseudoaneurysm, also referred to as a traumatic aneurysm, develops when a tear of the vessel wall and hemorrhage is contained by a thin-walled capsule, typically following traumatic perforation of the arterial wall. Unlike a true aneurysm, a pseudo­aneurysm does not contain all three layers of intima, media, and adventitia. Thin walls lead to inevitable expansion over time; in some cases, a patient will present with a soft-tissue mass years after the initial injury. Compression of nearby structures can cause neuropathy, peripheral edema, venous thrombosis, arterial occlusion or emboli, and even bone erosion.1,2

Hand pseudoaneurysms are more likely to occur on the palmar surface, involving the superficial palmar arch,3 and are due to a penetrating injury or repetitive microtrauma. Hypothenar hammer syndrome occurs when repetitive microtrauma is applied to the ulnar artery as it passes under the hook of the hamate bone into the hand. This condition is also referred to as “hammer hand syndrome” because it frequently occurs in laborers such as mechanics, carpenters, and machinists as a result of repetitive palm trauma. Cases have also been reported in baseball players and cooks who also expose their hands to repetitive trauma.3 Likewise, elderly patients who use walking canes can also present with bilateral hammer hand syndrome,3 and patients who need crutches for a prolonged period of time may also develop axillary artery aneurysms.1,2

Although rare, there have also been cases of spontaneous hand pseudoaneurysms in patients on anticoagulation therapy;4,5 however, pseudoaneurysms are not an absolute contraindication to initiating or continuing use of anticoagulants.

Evaluation

Physical Examination. The patient’s mass in this case was clearly pulsatile on examination, but physical examination alone is not a reliable indicator of pseudoaneurysm, as patients may present only with soft-tissue swelling, pain, erythema, or neurological symptoms.3,6,7

Ultrasound Imaging. In the emergency setting, POC ultrasound should be performed to evaluate any soft-tissue hand mass, especially in the context of trauma or any neurovascular findings, since palmar pseudoaneurysms can easily be confused with an abscess, foreign body, cyst, or even a tendon tear.6 Ultrasound studies using the linear vascular probe should always be done before any attempt to incise and drain the mass.

Three ultrasound characteristics of pseudoaneurysms include expansile pulsatility, turbulent flow with a classic yin-yang sign on Doppler, and a hematoma with variable echogenicity. Variable echogenicity may represent separate episodes of bleeding and rebleeding.8 A “to-and-fro” spectral waveform is pathognomonic for palmar pseudoaneurysms.8

Computed Tomography and Magnetic Resonance Angiography. Definitive imaging for operative management includes computed tomography or magnetic resonance angiography to assess for the exact location and presence of collateral circulation.

 

 

Treatment

Treatment of pseudoaneurysms includes conservative compression therapy, surgical excision, or anastomosis, and more recently, ultrasound-guided thrombin injection (UGTI).

Compression Therapy. Compression therapy is often used for femoral artery pseudoaneurysms that develop after iatrogenic injury. However, this technique is time consuming, is uncomfortable for patients, is not effective in treating large pseudoaneurysms, and is contraindicated in patients on anticoagulation therapy. Compression therapy also has a high-failure rate of resolving pseudoaneurysms. Traditionally, surgical excision or anastomosis has been the definitive treatment for palmar pseudoaneurysms.

Ultrasound-Guided Thrombin Injection. A more recent treatment option is UGTI, which is usually performed by an interventional radiologist. Although there is no consensus on exact dose of thrombin for this procedure, the literature describes UGTI to treat both the radial and ulnar arteries.9,10 One study of 83 pseudoaneurysms demonstrated a relationship between the size of the palmar pseudoaneurysm and the number of thrombin injections required to resolve it. Depending on the size of the palmar pseudoaneurysm, the effective thrombin doses ranged from 200 to 2,500 U. Regarding adverse effects and events from treatment, this study reported one case of transient distal ischemia.11

Intravascular balloon occlusion of the pseudoaneurysm neck has also been recommended for UGTI in the femoral artery if the neck is greater than 1 mm, but there is currently nothing in the literature describing its use in palmar pseudoaneurysms.12

Complications

There are more descriptions of palmar, radial, and ulnar pseudoaneurysms in critical care patients due to the frequent, but necessary, use of invasive lines. Emergency physicians frequently place radial or femoral arterial lines for hemodynamic monitoring in critically ill patients. However, the incidence of pseudoaneurysms and its sequelae from these lines are not usually observed in the ED setting.

Radial arterial lines may cause thrombosis in 19% to 57% of cases, and local infection in 1% to 18% of cases.10 In a study of 12,500 patients with radial artery catheters, the rate of radial pseudoaneurysm was only 0.05%.11 Although this is a small complication rate, pseudoaneurysms can lead to significant loss of function. To decrease the number of attempts and penetrating injuries to the arteries, ultrasound guidance for these procedures in the ED is strongly recommended. In addition to decreasing the risk of developing a pseudoaneurysm, ultrasound-guidance decreases the discomfort level of the patient and reduces the risk of bleeding, hematoma formation, and infection. Arterial line placement in the ED using ultrasound guidance decreases the risk of developing pseudoaneurysms and their sequelae, such as distal embolization.

Case Conclusion

The patient in this case underwent an arterial duplex study, which found a partially thrombosed right superficial palmar arch pseudoaneurysm measuring 1.91 cm x 2.08 cm, with an active flow area measuring 0.58 cm x 0.68 cm. The flow to the index finger medial artery and middle finger lateral artery was also diminished. The patient was discharged home with a bulky soft dressing and underwent excision and repair by hand surgery 3 days later. At the 1-month postoperative follow-up visit, the patient had full sensation but mildly decreased range of motion in his fingers.

Summary

Hand pseudoaneurysms are often associated with penetrating injuries—as demonstrated in our case—or repetitive microtrauma. Hand pseudoaneurysms can present with minimal findings such as isolated soft-tissue swelling, pain, or neuropathy. The EP should consider vascular pathology in the differential for patients who present with posttraumatic neuropathy. Regarding imaging studies, ultrasound is the best imaging modality to assess for pseudoaneurysms, and EPs should have a low threshold for its use at bedside—especially prior to attempting any invasive procedure. Patients with a confirmed pseudoaneurysm should be referred to a hand or vascular surgeon for surgical repair, or to an interventional radiologist for UGTI.

References

1. Newton EJ, Arora S. Peripheral vascular injury. In: Marx JA, Hockberger RS, Walls RM, et al, eds. Rosen’s Emergency Medicine Concepts and Clinical Practice. Vol 1. 8th ed. Philadelphia, PA: Elsevier Saunders; 2014:502.

2. Aufderheide TP. Peripheral arteriovascular disease. In: Marx JA, Hockberger RS, Walls RM, et al, eds. Rosen’s Emergency Medicine Concepts and Clinical Practice. Vol 1. 8th ed. 2014:1147-1149.

3. Anderson SE, De Monaco D, Buechler U, et al. Imaging features of pseudoaneurysms of the hand in children and adults. AJR Am J Roentgenol. 2003;180(3):659-664. doi:10.2214/ajr.180.3.1800659.

4. Shah S, Powell-Brett S, Garnham A. Pseudoaneurysm: an unusual cause of post-traumatic hand swelling. BMJ Case Rep. 2015;2015. pii: bcr2014208750. doi:10.1136/bcr-2014-208750.

5. Kitamura A, Mukohara N. Spontaneous pseudoaneurysm of the hand. Ann Vasc Surg. 2014;28(3):739.e1-e3. doi:10.1016/j.avsg.2013.04.033.

6. Huang SW, Wei TS, Liu SY, Wang WT. Spontaneous totally thrombosed pseudoaneurysm mimicking a tendon tear of the wrist. Orthopedics. 2010;33(10):776. doi:10.3928/01477447-20100826-23.

7. Belyayev L, Rich NM, McKay P, Nesti L, Wind G. Traumatic ulnar artery pseudoaneurysm following a grenade blast: report of a case. Mil Med. 2015;180(6):e725-e727. doi:10.7205/MILMED-D-14-00400.

8. Pero T, Herrick J. Pseudoaneurysm of the radial artery diagnosed by bedside ultrasound. West J Emerg Med. 2009;10(2):89-91.

9. Bosman A, Veger HTC, Doornink F, Hedeman Joosten PPA. A pseudoaneurysm of the deep palmar arch after penetrating trauma to the hand: successful exclusion by ultrasound guided percutaneous thrombin injection. EJVES Short Rep. 2016;31:9-11. doi:10.1016/j.ejvssr.2016.03.002.

10. Komorowska-Timek E, Teruya TH, Abou-Zamzam AM Jr, Papa D, Ballard JL. Treatment of radial and ulnar artery pseudoaneurysms using percutaneous thrombin injection. J Hand Surg. 2004;29A(5):936-942. doi:10.1016/j.jhsa.2004.05.009.

11. Falk PS, Scuderi PE, Sherertz RJ, Motsinger SM. Infected radial artery pseudoaneurysms occurring after percutaneous cannulation. Chest. 1992;101(2):490-495.

12. Kang SS, Labropoulos N, Mansour MA, et al. Expanded indications for ultrasound-guided thrombin injection of pseudoaneurysms. J Vasc Surg. 2000;31(2):289-298.

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Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

Dr Xiao is a resident, department of emergency medicine, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan. Dr Brackney is an emergency medicine clinical faculty member, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.

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Dr Xiao is a resident, department of emergency medicine, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan. Dr Brackney is an emergency medicine clinical faculty member, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.

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Authors’ Disclosure Statement: The authors report no actual or potential conflict of interest in relation to this article.

Dr Xiao is a resident, department of emergency medicine, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan. Dr Brackney is an emergency medicine clinical faculty member, Oakland University William Beaumont School of Medicine, Royal Oak, Michigan.

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A 23-year-old man, who initially presented to an outside hospital’s ED for evaluation and treatment of a stab wound, presented to our ED two months later with a pulsatile hand mass.
A 23-year-old man, who initially presented to an outside hospital’s ED for evaluation and treatment of a stab wound, presented to our ED two months later with a pulsatile hand mass.

Case

A 23-year-old man presented to an outside hospital’s ED for evaluation of a wound on his right hand, which he sustained after he accidentally stabbed himself with a steak knife. At presentation, the patient’s vital signs were: heart rate, 90 beats/min; respiratory rate, 16 breaths/min; blood pressure, 150/92 mm Hg; and temperature, 98.1°F. Oxygen saturation was 98% on room air. Examination revealed a laceration on the patient’s right hand measuring 2 cm in length. The emergency physician (EP) closed the wound using four nylon sutures and administered a Boostrix shot. The patient was discharged home with a prescription for cephalexin capsule 500 mg to be taken four times daily for 5 days. He was instructed to return in 10 days for suture removal, but failed to follow-up.

The patient presented to our ED two months after the initial injury for evaluation of a 1.5-cm round pulsatile mass on his right palm, at the base of the middle finger, from which exuded a small amount of sanguineous fluid. The patient complained of numbness and difficulty extending his right index and middle fingers.

Figure. Ultrasound image of the patient’s right hand demonstrating the classic yin-yang sign consistent with a pseudoaneurysm.
Figure. Ultrasound image of the patient’s right hand demonstrating the classic yin-yang sign consistent with a pseudoaneurysm.
An X-ray of the hand showed no fracture, gas, or foreign bodies. The differential diagnosis included a hematoma, abscess, retained foreign body, incision cyst, fibroma, and lipoma. Due to the pulsatile nature of the mass, the EP performed a point-of-care (POC) ultrasound of the patient’s right hand, which included non-Doppler and Doppler imaging. The non-Doppler study revealed a pulsatile mass with heterogeneous echogenicity (Video 1); the Doppler study showed pulsatile-flow through the neck of the mass (Video 2); and a still ultrasound image (Figure) demonstrated a classic yin-yang sign consistent with a pseudoaneurysm.

Discussion

Palmar Pseudoaneurysms

A pseudoaneurysm, also referred to as a traumatic aneurysm, develops when a tear of the vessel wall and hemorrhage is contained by a thin-walled capsule, typically following traumatic perforation of the arterial wall. Unlike a true aneurysm, a pseudo­aneurysm does not contain all three layers of intima, media, and adventitia. Thin walls lead to inevitable expansion over time; in some cases, a patient will present with a soft-tissue mass years after the initial injury. Compression of nearby structures can cause neuropathy, peripheral edema, venous thrombosis, arterial occlusion or emboli, and even bone erosion.1,2

Hand pseudoaneurysms are more likely to occur on the palmar surface, involving the superficial palmar arch,3 and are due to a penetrating injury or repetitive microtrauma. Hypothenar hammer syndrome occurs when repetitive microtrauma is applied to the ulnar artery as it passes under the hook of the hamate bone into the hand. This condition is also referred to as “hammer hand syndrome” because it frequently occurs in laborers such as mechanics, carpenters, and machinists as a result of repetitive palm trauma. Cases have also been reported in baseball players and cooks who also expose their hands to repetitive trauma.3 Likewise, elderly patients who use walking canes can also present with bilateral hammer hand syndrome,3 and patients who need crutches for a prolonged period of time may also develop axillary artery aneurysms.1,2

Although rare, there have also been cases of spontaneous hand pseudoaneurysms in patients on anticoagulation therapy;4,5 however, pseudoaneurysms are not an absolute contraindication to initiating or continuing use of anticoagulants.

Evaluation

Physical Examination. The patient’s mass in this case was clearly pulsatile on examination, but physical examination alone is not a reliable indicator of pseudoaneurysm, as patients may present only with soft-tissue swelling, pain, erythema, or neurological symptoms.3,6,7

Ultrasound Imaging. In the emergency setting, POC ultrasound should be performed to evaluate any soft-tissue hand mass, especially in the context of trauma or any neurovascular findings, since palmar pseudoaneurysms can easily be confused with an abscess, foreign body, cyst, or even a tendon tear.6 Ultrasound studies using the linear vascular probe should always be done before any attempt to incise and drain the mass.

Three ultrasound characteristics of pseudoaneurysms include expansile pulsatility, turbulent flow with a classic yin-yang sign on Doppler, and a hematoma with variable echogenicity. Variable echogenicity may represent separate episodes of bleeding and rebleeding.8 A “to-and-fro” spectral waveform is pathognomonic for palmar pseudoaneurysms.8

Computed Tomography and Magnetic Resonance Angiography. Definitive imaging for operative management includes computed tomography or magnetic resonance angiography to assess for the exact location and presence of collateral circulation.

 

 

Treatment

Treatment of pseudoaneurysms includes conservative compression therapy, surgical excision, or anastomosis, and more recently, ultrasound-guided thrombin injection (UGTI).

Compression Therapy. Compression therapy is often used for femoral artery pseudoaneurysms that develop after iatrogenic injury. However, this technique is time consuming, is uncomfortable for patients, is not effective in treating large pseudoaneurysms, and is contraindicated in patients on anticoagulation therapy. Compression therapy also has a high-failure rate of resolving pseudoaneurysms. Traditionally, surgical excision or anastomosis has been the definitive treatment for palmar pseudoaneurysms.

Ultrasound-Guided Thrombin Injection. A more recent treatment option is UGTI, which is usually performed by an interventional radiologist. Although there is no consensus on exact dose of thrombin for this procedure, the literature describes UGTI to treat both the radial and ulnar arteries.9,10 One study of 83 pseudoaneurysms demonstrated a relationship between the size of the palmar pseudoaneurysm and the number of thrombin injections required to resolve it. Depending on the size of the palmar pseudoaneurysm, the effective thrombin doses ranged from 200 to 2,500 U. Regarding adverse effects and events from treatment, this study reported one case of transient distal ischemia.11

Intravascular balloon occlusion of the pseudoaneurysm neck has also been recommended for UGTI in the femoral artery if the neck is greater than 1 mm, but there is currently nothing in the literature describing its use in palmar pseudoaneurysms.12

Complications

There are more descriptions of palmar, radial, and ulnar pseudoaneurysms in critical care patients due to the frequent, but necessary, use of invasive lines. Emergency physicians frequently place radial or femoral arterial lines for hemodynamic monitoring in critically ill patients. However, the incidence of pseudoaneurysms and its sequelae from these lines are not usually observed in the ED setting.

Radial arterial lines may cause thrombosis in 19% to 57% of cases, and local infection in 1% to 18% of cases.10 In a study of 12,500 patients with radial artery catheters, the rate of radial pseudoaneurysm was only 0.05%.11 Although this is a small complication rate, pseudoaneurysms can lead to significant loss of function. To decrease the number of attempts and penetrating injuries to the arteries, ultrasound guidance for these procedures in the ED is strongly recommended. In addition to decreasing the risk of developing a pseudoaneurysm, ultrasound-guidance decreases the discomfort level of the patient and reduces the risk of bleeding, hematoma formation, and infection. Arterial line placement in the ED using ultrasound guidance decreases the risk of developing pseudoaneurysms and their sequelae, such as distal embolization.

Case Conclusion

The patient in this case underwent an arterial duplex study, which found a partially thrombosed right superficial palmar arch pseudoaneurysm measuring 1.91 cm x 2.08 cm, with an active flow area measuring 0.58 cm x 0.68 cm. The flow to the index finger medial artery and middle finger lateral artery was also diminished. The patient was discharged home with a bulky soft dressing and underwent excision and repair by hand surgery 3 days later. At the 1-month postoperative follow-up visit, the patient had full sensation but mildly decreased range of motion in his fingers.

Summary

Hand pseudoaneurysms are often associated with penetrating injuries—as demonstrated in our case—or repetitive microtrauma. Hand pseudoaneurysms can present with minimal findings such as isolated soft-tissue swelling, pain, or neuropathy. The EP should consider vascular pathology in the differential for patients who present with posttraumatic neuropathy. Regarding imaging studies, ultrasound is the best imaging modality to assess for pseudoaneurysms, and EPs should have a low threshold for its use at bedside—especially prior to attempting any invasive procedure. Patients with a confirmed pseudoaneurysm should be referred to a hand or vascular surgeon for surgical repair, or to an interventional radiologist for UGTI.

Case

A 23-year-old man presented to an outside hospital’s ED for evaluation of a wound on his right hand, which he sustained after he accidentally stabbed himself with a steak knife. At presentation, the patient’s vital signs were: heart rate, 90 beats/min; respiratory rate, 16 breaths/min; blood pressure, 150/92 mm Hg; and temperature, 98.1°F. Oxygen saturation was 98% on room air. Examination revealed a laceration on the patient’s right hand measuring 2 cm in length. The emergency physician (EP) closed the wound using four nylon sutures and administered a Boostrix shot. The patient was discharged home with a prescription for cephalexin capsule 500 mg to be taken four times daily for 5 days. He was instructed to return in 10 days for suture removal, but failed to follow-up.

The patient presented to our ED two months after the initial injury for evaluation of a 1.5-cm round pulsatile mass on his right palm, at the base of the middle finger, from which exuded a small amount of sanguineous fluid. The patient complained of numbness and difficulty extending his right index and middle fingers.

Figure. Ultrasound image of the patient’s right hand demonstrating the classic yin-yang sign consistent with a pseudoaneurysm.
Figure. Ultrasound image of the patient’s right hand demonstrating the classic yin-yang sign consistent with a pseudoaneurysm.
An X-ray of the hand showed no fracture, gas, or foreign bodies. The differential diagnosis included a hematoma, abscess, retained foreign body, incision cyst, fibroma, and lipoma. Due to the pulsatile nature of the mass, the EP performed a point-of-care (POC) ultrasound of the patient’s right hand, which included non-Doppler and Doppler imaging. The non-Doppler study revealed a pulsatile mass with heterogeneous echogenicity (Video 1); the Doppler study showed pulsatile-flow through the neck of the mass (Video 2); and a still ultrasound image (Figure) demonstrated a classic yin-yang sign consistent with a pseudoaneurysm.

Discussion

Palmar Pseudoaneurysms

A pseudoaneurysm, also referred to as a traumatic aneurysm, develops when a tear of the vessel wall and hemorrhage is contained by a thin-walled capsule, typically following traumatic perforation of the arterial wall. Unlike a true aneurysm, a pseudo­aneurysm does not contain all three layers of intima, media, and adventitia. Thin walls lead to inevitable expansion over time; in some cases, a patient will present with a soft-tissue mass years after the initial injury. Compression of nearby structures can cause neuropathy, peripheral edema, venous thrombosis, arterial occlusion or emboli, and even bone erosion.1,2

Hand pseudoaneurysms are more likely to occur on the palmar surface, involving the superficial palmar arch,3 and are due to a penetrating injury or repetitive microtrauma. Hypothenar hammer syndrome occurs when repetitive microtrauma is applied to the ulnar artery as it passes under the hook of the hamate bone into the hand. This condition is also referred to as “hammer hand syndrome” because it frequently occurs in laborers such as mechanics, carpenters, and machinists as a result of repetitive palm trauma. Cases have also been reported in baseball players and cooks who also expose their hands to repetitive trauma.3 Likewise, elderly patients who use walking canes can also present with bilateral hammer hand syndrome,3 and patients who need crutches for a prolonged period of time may also develop axillary artery aneurysms.1,2

Although rare, there have also been cases of spontaneous hand pseudoaneurysms in patients on anticoagulation therapy;4,5 however, pseudoaneurysms are not an absolute contraindication to initiating or continuing use of anticoagulants.

Evaluation

Physical Examination. The patient’s mass in this case was clearly pulsatile on examination, but physical examination alone is not a reliable indicator of pseudoaneurysm, as patients may present only with soft-tissue swelling, pain, erythema, or neurological symptoms.3,6,7

Ultrasound Imaging. In the emergency setting, POC ultrasound should be performed to evaluate any soft-tissue hand mass, especially in the context of trauma or any neurovascular findings, since palmar pseudoaneurysms can easily be confused with an abscess, foreign body, cyst, or even a tendon tear.6 Ultrasound studies using the linear vascular probe should always be done before any attempt to incise and drain the mass.

Three ultrasound characteristics of pseudoaneurysms include expansile pulsatility, turbulent flow with a classic yin-yang sign on Doppler, and a hematoma with variable echogenicity. Variable echogenicity may represent separate episodes of bleeding and rebleeding.8 A “to-and-fro” spectral waveform is pathognomonic for palmar pseudoaneurysms.8

Computed Tomography and Magnetic Resonance Angiography. Definitive imaging for operative management includes computed tomography or magnetic resonance angiography to assess for the exact location and presence of collateral circulation.

 

 

Treatment

Treatment of pseudoaneurysms includes conservative compression therapy, surgical excision, or anastomosis, and more recently, ultrasound-guided thrombin injection (UGTI).

Compression Therapy. Compression therapy is often used for femoral artery pseudoaneurysms that develop after iatrogenic injury. However, this technique is time consuming, is uncomfortable for patients, is not effective in treating large pseudoaneurysms, and is contraindicated in patients on anticoagulation therapy. Compression therapy also has a high-failure rate of resolving pseudoaneurysms. Traditionally, surgical excision or anastomosis has been the definitive treatment for palmar pseudoaneurysms.

Ultrasound-Guided Thrombin Injection. A more recent treatment option is UGTI, which is usually performed by an interventional radiologist. Although there is no consensus on exact dose of thrombin for this procedure, the literature describes UGTI to treat both the radial and ulnar arteries.9,10 One study of 83 pseudoaneurysms demonstrated a relationship between the size of the palmar pseudoaneurysm and the number of thrombin injections required to resolve it. Depending on the size of the palmar pseudoaneurysm, the effective thrombin doses ranged from 200 to 2,500 U. Regarding adverse effects and events from treatment, this study reported one case of transient distal ischemia.11

Intravascular balloon occlusion of the pseudoaneurysm neck has also been recommended for UGTI in the femoral artery if the neck is greater than 1 mm, but there is currently nothing in the literature describing its use in palmar pseudoaneurysms.12

Complications

There are more descriptions of palmar, radial, and ulnar pseudoaneurysms in critical care patients due to the frequent, but necessary, use of invasive lines. Emergency physicians frequently place radial or femoral arterial lines for hemodynamic monitoring in critically ill patients. However, the incidence of pseudoaneurysms and its sequelae from these lines are not usually observed in the ED setting.

Radial arterial lines may cause thrombosis in 19% to 57% of cases, and local infection in 1% to 18% of cases.10 In a study of 12,500 patients with radial artery catheters, the rate of radial pseudoaneurysm was only 0.05%.11 Although this is a small complication rate, pseudoaneurysms can lead to significant loss of function. To decrease the number of attempts and penetrating injuries to the arteries, ultrasound guidance for these procedures in the ED is strongly recommended. In addition to decreasing the risk of developing a pseudoaneurysm, ultrasound-guidance decreases the discomfort level of the patient and reduces the risk of bleeding, hematoma formation, and infection. Arterial line placement in the ED using ultrasound guidance decreases the risk of developing pseudoaneurysms and their sequelae, such as distal embolization.

Case Conclusion

The patient in this case underwent an arterial duplex study, which found a partially thrombosed right superficial palmar arch pseudoaneurysm measuring 1.91 cm x 2.08 cm, with an active flow area measuring 0.58 cm x 0.68 cm. The flow to the index finger medial artery and middle finger lateral artery was also diminished. The patient was discharged home with a bulky soft dressing and underwent excision and repair by hand surgery 3 days later. At the 1-month postoperative follow-up visit, the patient had full sensation but mildly decreased range of motion in his fingers.

Summary

Hand pseudoaneurysms are often associated with penetrating injuries—as demonstrated in our case—or repetitive microtrauma. Hand pseudoaneurysms can present with minimal findings such as isolated soft-tissue swelling, pain, or neuropathy. The EP should consider vascular pathology in the differential for patients who present with posttraumatic neuropathy. Regarding imaging studies, ultrasound is the best imaging modality to assess for pseudoaneurysms, and EPs should have a low threshold for its use at bedside—especially prior to attempting any invasive procedure. Patients with a confirmed pseudoaneurysm should be referred to a hand or vascular surgeon for surgical repair, or to an interventional radiologist for UGTI.

References

1. Newton EJ, Arora S. Peripheral vascular injury. In: Marx JA, Hockberger RS, Walls RM, et al, eds. Rosen’s Emergency Medicine Concepts and Clinical Practice. Vol 1. 8th ed. Philadelphia, PA: Elsevier Saunders; 2014:502.

2. Aufderheide TP. Peripheral arteriovascular disease. In: Marx JA, Hockberger RS, Walls RM, et al, eds. Rosen’s Emergency Medicine Concepts and Clinical Practice. Vol 1. 8th ed. 2014:1147-1149.

3. Anderson SE, De Monaco D, Buechler U, et al. Imaging features of pseudoaneurysms of the hand in children and adults. AJR Am J Roentgenol. 2003;180(3):659-664. doi:10.2214/ajr.180.3.1800659.

4. Shah S, Powell-Brett S, Garnham A. Pseudoaneurysm: an unusual cause of post-traumatic hand swelling. BMJ Case Rep. 2015;2015. pii: bcr2014208750. doi:10.1136/bcr-2014-208750.

5. Kitamura A, Mukohara N. Spontaneous pseudoaneurysm of the hand. Ann Vasc Surg. 2014;28(3):739.e1-e3. doi:10.1016/j.avsg.2013.04.033.

6. Huang SW, Wei TS, Liu SY, Wang WT. Spontaneous totally thrombosed pseudoaneurysm mimicking a tendon tear of the wrist. Orthopedics. 2010;33(10):776. doi:10.3928/01477447-20100826-23.

7. Belyayev L, Rich NM, McKay P, Nesti L, Wind G. Traumatic ulnar artery pseudoaneurysm following a grenade blast: report of a case. Mil Med. 2015;180(6):e725-e727. doi:10.7205/MILMED-D-14-00400.

8. Pero T, Herrick J. Pseudoaneurysm of the radial artery diagnosed by bedside ultrasound. West J Emerg Med. 2009;10(2):89-91.

9. Bosman A, Veger HTC, Doornink F, Hedeman Joosten PPA. A pseudoaneurysm of the deep palmar arch after penetrating trauma to the hand: successful exclusion by ultrasound guided percutaneous thrombin injection. EJVES Short Rep. 2016;31:9-11. doi:10.1016/j.ejvssr.2016.03.002.

10. Komorowska-Timek E, Teruya TH, Abou-Zamzam AM Jr, Papa D, Ballard JL. Treatment of radial and ulnar artery pseudoaneurysms using percutaneous thrombin injection. J Hand Surg. 2004;29A(5):936-942. doi:10.1016/j.jhsa.2004.05.009.

11. Falk PS, Scuderi PE, Sherertz RJ, Motsinger SM. Infected radial artery pseudoaneurysms occurring after percutaneous cannulation. Chest. 1992;101(2):490-495.

12. Kang SS, Labropoulos N, Mansour MA, et al. Expanded indications for ultrasound-guided thrombin injection of pseudoaneurysms. J Vasc Surg. 2000;31(2):289-298.

References

1. Newton EJ, Arora S. Peripheral vascular injury. In: Marx JA, Hockberger RS, Walls RM, et al, eds. Rosen’s Emergency Medicine Concepts and Clinical Practice. Vol 1. 8th ed. Philadelphia, PA: Elsevier Saunders; 2014:502.

2. Aufderheide TP. Peripheral arteriovascular disease. In: Marx JA, Hockberger RS, Walls RM, et al, eds. Rosen’s Emergency Medicine Concepts and Clinical Practice. Vol 1. 8th ed. 2014:1147-1149.

3. Anderson SE, De Monaco D, Buechler U, et al. Imaging features of pseudoaneurysms of the hand in children and adults. AJR Am J Roentgenol. 2003;180(3):659-664. doi:10.2214/ajr.180.3.1800659.

4. Shah S, Powell-Brett S, Garnham A. Pseudoaneurysm: an unusual cause of post-traumatic hand swelling. BMJ Case Rep. 2015;2015. pii: bcr2014208750. doi:10.1136/bcr-2014-208750.

5. Kitamura A, Mukohara N. Spontaneous pseudoaneurysm of the hand. Ann Vasc Surg. 2014;28(3):739.e1-e3. doi:10.1016/j.avsg.2013.04.033.

6. Huang SW, Wei TS, Liu SY, Wang WT. Spontaneous totally thrombosed pseudoaneurysm mimicking a tendon tear of the wrist. Orthopedics. 2010;33(10):776. doi:10.3928/01477447-20100826-23.

7. Belyayev L, Rich NM, McKay P, Nesti L, Wind G. Traumatic ulnar artery pseudoaneurysm following a grenade blast: report of a case. Mil Med. 2015;180(6):e725-e727. doi:10.7205/MILMED-D-14-00400.

8. Pero T, Herrick J. Pseudoaneurysm of the radial artery diagnosed by bedside ultrasound. West J Emerg Med. 2009;10(2):89-91.

9. Bosman A, Veger HTC, Doornink F, Hedeman Joosten PPA. A pseudoaneurysm of the deep palmar arch after penetrating trauma to the hand: successful exclusion by ultrasound guided percutaneous thrombin injection. EJVES Short Rep. 2016;31:9-11. doi:10.1016/j.ejvssr.2016.03.002.

10. Komorowska-Timek E, Teruya TH, Abou-Zamzam AM Jr, Papa D, Ballard JL. Treatment of radial and ulnar artery pseudoaneurysms using percutaneous thrombin injection. J Hand Surg. 2004;29A(5):936-942. doi:10.1016/j.jhsa.2004.05.009.

11. Falk PS, Scuderi PE, Sherertz RJ, Motsinger SM. Infected radial artery pseudoaneurysms occurring after percutaneous cannulation. Chest. 1992;101(2):490-495.

12. Kang SS, Labropoulos N, Mansour MA, et al. Expanded indications for ultrasound-guided thrombin injection of pseudoaneurysms. J Vasc Surg. 2000;31(2):289-298.

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Balloon pulmonary angioplasty for CTEPH improves heart failure symptoms

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– Balloon pulmonary angioplasty provides meaningful improvements in functional capacity for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for surgical pulmonary thromboendarterectomy, according to a single-center experience with 15 consecutive patients that was presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

The treatment of choice for CTEPH is pulmonary thromboendarterectomy (PTE), but “a huge percentage of the population with CTEPH” is not eligible or does not undergo surgical treatment, which was the impetus to initiate this intervention, reported Riyaz Bashir, MD, director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at Temple University, Philadelphia.

Ted Bosworth/MDedge News
Dr. Riyaz Bashir
Much of the experience with balloon pulmonary angioplasty (BPA) for CTEPH comes from outside the United States, particularly Japan, where this procedure has been associated with improved survival, compared with historical untreated controls, according to Dr. Bashir. He cited registry data showing that more than 80% of CTEPH patients are not surgical candidates and up to 40% of those who are candidates still fail to undergo PTE for other reasons.

There have now been 15 CTEPH patients treated with BPA by Dr. Bashir and his team at Temple University. He reported 6-month outcome data on the first 13 patients, all of whom had a history of pulmonary embolism. Three of the patients had a prior PTE.

The primary outcome of interest in this series was functional improvement. Unlike PTE, immediate improvement in hemodynamics is not typically observed immediately after the procedure, but these measures do improve incrementally over time, Dr. Bashir reported. This is reflected in progressive improvements in the 6-minute walk test and in New York Heart Association (NYHA) functional class.

Of the 13 patients treated so far, 6 (46%) were in NYHA class IV and only 2 (15%) were in NYHA class II prior to BPA. Six months after BPA, the proportions had reversed. At that point, seven patients (54%) were in class II and two (15%) in class IV. The remaining patients at both time points were in NYHA class III. Similar improvements were seen in the 6-minute walk test, which typically tracks with NYHA class.

Describing the first case, performed about 2 years ago, Dr. Bashir explained that a tight stenosis in the right lower pulmonary artery of a 44-year-old woman was reached with a multipurpose guiding catheter through femoral access. A 5-mm balloon was used to dilate the stenosis and create a pulsatile flow.

 

 


“The goal is not to raise the mean arterial pressure above 35 mm Hg, because this has been associated with significant peripheral edema,” Dr. Bashir explained.

In this patient, progressive improvements in pulmonary pressure, cardiac index, and other hemodynamics were associated with progressive shrinking of the right ventricle over 6 months of follow-up. The walk test improved from 216 m prior to BPA to 421 m at her most recent evaluation.

The average age in the 13 patients treated so far was 55 years, and 75% are males. The mean left ventricular ejection fraction (LVEF) was 55%. According to Dr. Bashir, most patients required at least two treatment sessions and some have required up to four.

There have been two complications – one patient developed hemoptysis that required a brief intubation and the other involved perfusion edema – and no deaths in this series so far, he said.

The outcomes so far, which Dr. Bashir characterized as “an early experience,” provide evidence that BPA is “safe and feasible” for patients with CTEPH who are not surgical candidates. At Dr. Bashir’s institution, where PTE is commonly performed in patients with CTEPH (Dr. Bashir reported that 134 cases were performed over the period of time in which these 15 cases of BPA were performed), there is a plan to compare functional outcomes in CTEPH patients managed with these two different approaches.

Dr. Bashir reported no financial relationships relevant to this study.

SOURCE: Bashir R. CRT 2018

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– Balloon pulmonary angioplasty provides meaningful improvements in functional capacity for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for surgical pulmonary thromboendarterectomy, according to a single-center experience with 15 consecutive patients that was presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

The treatment of choice for CTEPH is pulmonary thromboendarterectomy (PTE), but “a huge percentage of the population with CTEPH” is not eligible or does not undergo surgical treatment, which was the impetus to initiate this intervention, reported Riyaz Bashir, MD, director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at Temple University, Philadelphia.

Ted Bosworth/MDedge News
Dr. Riyaz Bashir
Much of the experience with balloon pulmonary angioplasty (BPA) for CTEPH comes from outside the United States, particularly Japan, where this procedure has been associated with improved survival, compared with historical untreated controls, according to Dr. Bashir. He cited registry data showing that more than 80% of CTEPH patients are not surgical candidates and up to 40% of those who are candidates still fail to undergo PTE for other reasons.

There have now been 15 CTEPH patients treated with BPA by Dr. Bashir and his team at Temple University. He reported 6-month outcome data on the first 13 patients, all of whom had a history of pulmonary embolism. Three of the patients had a prior PTE.

The primary outcome of interest in this series was functional improvement. Unlike PTE, immediate improvement in hemodynamics is not typically observed immediately after the procedure, but these measures do improve incrementally over time, Dr. Bashir reported. This is reflected in progressive improvements in the 6-minute walk test and in New York Heart Association (NYHA) functional class.

Of the 13 patients treated so far, 6 (46%) were in NYHA class IV and only 2 (15%) were in NYHA class II prior to BPA. Six months after BPA, the proportions had reversed. At that point, seven patients (54%) were in class II and two (15%) in class IV. The remaining patients at both time points were in NYHA class III. Similar improvements were seen in the 6-minute walk test, which typically tracks with NYHA class.

Describing the first case, performed about 2 years ago, Dr. Bashir explained that a tight stenosis in the right lower pulmonary artery of a 44-year-old woman was reached with a multipurpose guiding catheter through femoral access. A 5-mm balloon was used to dilate the stenosis and create a pulsatile flow.

 

 


“The goal is not to raise the mean arterial pressure above 35 mm Hg, because this has been associated with significant peripheral edema,” Dr. Bashir explained.

In this patient, progressive improvements in pulmonary pressure, cardiac index, and other hemodynamics were associated with progressive shrinking of the right ventricle over 6 months of follow-up. The walk test improved from 216 m prior to BPA to 421 m at her most recent evaluation.

The average age in the 13 patients treated so far was 55 years, and 75% are males. The mean left ventricular ejection fraction (LVEF) was 55%. According to Dr. Bashir, most patients required at least two treatment sessions and some have required up to four.

There have been two complications – one patient developed hemoptysis that required a brief intubation and the other involved perfusion edema – and no deaths in this series so far, he said.

The outcomes so far, which Dr. Bashir characterized as “an early experience,” provide evidence that BPA is “safe and feasible” for patients with CTEPH who are not surgical candidates. At Dr. Bashir’s institution, where PTE is commonly performed in patients with CTEPH (Dr. Bashir reported that 134 cases were performed over the period of time in which these 15 cases of BPA were performed), there is a plan to compare functional outcomes in CTEPH patients managed with these two different approaches.

Dr. Bashir reported no financial relationships relevant to this study.

SOURCE: Bashir R. CRT 2018

 

– Balloon pulmonary angioplasty provides meaningful improvements in functional capacity for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not candidates for surgical pulmonary thromboendarterectomy, according to a single-center experience with 15 consecutive patients that was presented at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.

The treatment of choice for CTEPH is pulmonary thromboendarterectomy (PTE), but “a huge percentage of the population with CTEPH” is not eligible or does not undergo surgical treatment, which was the impetus to initiate this intervention, reported Riyaz Bashir, MD, director of vascular and endovascular medicine at Temple University Hospital and professor of medicine at Temple University, Philadelphia.

Ted Bosworth/MDedge News
Dr. Riyaz Bashir
Much of the experience with balloon pulmonary angioplasty (BPA) for CTEPH comes from outside the United States, particularly Japan, where this procedure has been associated with improved survival, compared with historical untreated controls, according to Dr. Bashir. He cited registry data showing that more than 80% of CTEPH patients are not surgical candidates and up to 40% of those who are candidates still fail to undergo PTE for other reasons.

There have now been 15 CTEPH patients treated with BPA by Dr. Bashir and his team at Temple University. He reported 6-month outcome data on the first 13 patients, all of whom had a history of pulmonary embolism. Three of the patients had a prior PTE.

The primary outcome of interest in this series was functional improvement. Unlike PTE, immediate improvement in hemodynamics is not typically observed immediately after the procedure, but these measures do improve incrementally over time, Dr. Bashir reported. This is reflected in progressive improvements in the 6-minute walk test and in New York Heart Association (NYHA) functional class.

Of the 13 patients treated so far, 6 (46%) were in NYHA class IV and only 2 (15%) were in NYHA class II prior to BPA. Six months after BPA, the proportions had reversed. At that point, seven patients (54%) were in class II and two (15%) in class IV. The remaining patients at both time points were in NYHA class III. Similar improvements were seen in the 6-minute walk test, which typically tracks with NYHA class.

Describing the first case, performed about 2 years ago, Dr. Bashir explained that a tight stenosis in the right lower pulmonary artery of a 44-year-old woman was reached with a multipurpose guiding catheter through femoral access. A 5-mm balloon was used to dilate the stenosis and create a pulsatile flow.

 

 


“The goal is not to raise the mean arterial pressure above 35 mm Hg, because this has been associated with significant peripheral edema,” Dr. Bashir explained.

In this patient, progressive improvements in pulmonary pressure, cardiac index, and other hemodynamics were associated with progressive shrinking of the right ventricle over 6 months of follow-up. The walk test improved from 216 m prior to BPA to 421 m at her most recent evaluation.

The average age in the 13 patients treated so far was 55 years, and 75% are males. The mean left ventricular ejection fraction (LVEF) was 55%. According to Dr. Bashir, most patients required at least two treatment sessions and some have required up to four.

There have been two complications – one patient developed hemoptysis that required a brief intubation and the other involved perfusion edema – and no deaths in this series so far, he said.

The outcomes so far, which Dr. Bashir characterized as “an early experience,” provide evidence that BPA is “safe and feasible” for patients with CTEPH who are not surgical candidates. At Dr. Bashir’s institution, where PTE is commonly performed in patients with CTEPH (Dr. Bashir reported that 134 cases were performed over the period of time in which these 15 cases of BPA were performed), there is a plan to compare functional outcomes in CTEPH patients managed with these two different approaches.

Dr. Bashir reported no financial relationships relevant to this study.

SOURCE: Bashir R. CRT 2018

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Key clinical point: Balloon pulmonary angioplasty has clinical benefits in chronic thromboembolic pulmonary hypertension (CTEPH) patients not candidates for surgery.

Major finding: At baseline, only 30% of CTEPH patients were at or below NYHA class II, rising to 65% 6 months after balloon pulmonary angioplasty.

Data source: Single-center review of 15 patients.

Disclosures: Dr. Bashir reports no financial relationships relevant to this study.

Source: Bashir R. CRT 2018

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Failure to find cancer earlier; patient dies: $4.69M verdict

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Failure to find cancer earlier; patient dies: $4.69M verdict

Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

 

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

 

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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

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Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

 

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

 

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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

Failure to find cancer earlier; patient dies: $4.69M verdict

On July 19, a 26-year-old woman presented to the emergency department (ED) with abnormal vaginal bleeding 3 months after giving birth. She was found to have endometrial thickening and an elevated ß human chorionic gonadotropin level. An ObGyn (Dr. A) assumed that the patient was having a miscarriage and sent her home.

On July 30, when the patient returned to the ED with continued bleeding, lesions on her cervix and urethra were discovered. A second ObGyn, Dr. B, addressed the bleeding, removed the lesion, and ordered testing. On August 17, the patient saw a third ObGyn (Dr. C), who did not conduct an examination.

Days later, the patient suffered a brain hemorrhage that was suspicious for hemorrhagic metastasis. After that, stage IV choriocarcinoma was identified. Although she underwent chemotherapy, the patient died 18 months later.

ESTATE'S CLAIM: All 3 ObGyns failed to take a proper history, conduct adequate examinations, and order appropriate testing. Even at stage IV, 75% of patients with choriocarcinoma survive past 5 years. The stroke rendered chemotherapy less effective and substantially contributed to the patient's death. Failure to diagnose the cancer before the stroke allowed the disease to progress beyond the point at which the patient's life could be saved.

DEFENDANTS' DEFENSE: The ObGyns and hospital claimed that appropriate care was provided and that they were not negligent in failing to consider the diagnosis of a very rare form of cancer.

VERDICT: A $4.69 million New Jersey verdict was returned, with all 3 physicians held partially liable.

 

Hot speculum burns patient: $547,090 award

A 54-year-old woman underwent a hysterectomy performed at a government-operated hospital. After she was anesthetized and unconscious, a second-year resident took a speculum that had been placed in the sterile field by a nurse, and inserted it in the patient's vagina.

When the patient awoke from surgery, she discovered significant burns to her vaginal area, perineum, anus, and buttocks.

PATIENT'S CLAIM: The speculum had just been removed from the autoclave and was very hot. The patient incurred substantial medical bills to treat her injuries and was unable to work for several months. She sued the hospital and resident, alleging error by the nurse in placing the hot speculum in the sterile field without cooling it or advising the resident that it was still hot. The resident was blamed for using the speculum without confirming that it was hot.

DEFENDANTS' DEFENSE: The resident claimed that she reasonably relied on the nurse to not place a hot instrument in the surgical field without first cooling it. The hospital, representing the nurse, denied fault, blaming the resident for not checking the speculum.

VERDICT: A $547,090 Louisiana verdict was awarded by a judge against the resident and the hospital, but it was halved by comparative fault to $273,545.

 

Surgeon's breast exam insufficient: $375,000 verdict

After a woman in her early 40s found a lump in her left breast, she underwent a radiographic study, which a radiologist interpreted as showing a 3-mm cyst. Without performing additional tests, a general surgeon immediately scheduled her for surgery.

On May 17, the radiologist performed an ultrasound-guided needle-localized biopsy and found a nodule. The patient was immediately sent to the operating room where the surgeon performed a segmental resection of the nodule.

On May 24, the patient presented to the surgeon's office for a postoperative visit. She told the nurse that the palpable mass was still there. The nurse examined the mass, told the patient that the incision was healing nicely, and suggested follow-up in a month.

Four months later, the patient sought a second opinion. On September 15, she underwent a diagnostic mammogram, ultrasound, and biopsy. The biopsy was positive for invasive ductal carcinoma. On September 30, magnetic resonance imaging and a second biopsy further confirmed the diagnosis. On November 2, she underwent a segmental mastectomy with sentinel lymph node biopsy. The pathology report noted a 3-cm invasive ductal carcinoma with necrosis. The patient underwent chemotherapy and radiation treatment.

PATIENT'S CLAIM: She sued the general surgeon, radiologist, and surgical center, alleging that her breast cancer went undiagnosed. Prior to trial, the radiologist and surgical center were dismissed from the case.  
The surgeon failed to perform a thorough physical examination and nodal evaluation of the left breast and axilla. His substandard methods to diagnose and treat the patient's breast cancer delayed proper treatment and significantly altered the outcome.

PHYSICIAN'S CLAIM: The surgeon's treatment met the standard of care. The outcome and treatment were not significantly changed by the delay. 

VERDICT: A $375,000 Pennsylvania verdict was returned.

 

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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

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Failure to find cancer earlier; patient dies: $4.69M verdict
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Checkpoint inhibition less toxic than antiangiogenic therapy in NSCLC

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Checkpoint blockade is associated with reduced toxicity when compared with antiangiogenic therapies for the treatment of advanced non–small-cell lung cancer, a systematic review and meta-analysis suggests.

In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.

For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.



The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.

The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.

Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.

“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.

 

 


This study was supported by the China Medical University Beigang Hospital.

SOURCE: Hsu C et al. NCCN poster 13

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Checkpoint blockade is associated with reduced toxicity when compared with antiangiogenic therapies for the treatment of advanced non–small-cell lung cancer, a systematic review and meta-analysis suggests.

In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.

For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.



The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.

The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.

Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.

“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.

 

 


This study was supported by the China Medical University Beigang Hospital.

SOURCE: Hsu C et al. NCCN poster 13

 

Checkpoint blockade is associated with reduced toxicity when compared with antiangiogenic therapies for the treatment of advanced non–small-cell lung cancer, a systematic review and meta-analysis suggests.

In 16,810 patients from 37 trials included in the analysis, first-line treatment with nivolumab or pembrolizumab, compared with first-line sorafenib plus platinum doublets, for example, was associated with less combined direct and indirect toxicity (odds ratios, 0.08 and 0.12, respectively), Chin-Chuan Hung, MD, and her colleagues reported in a poster at the annual conference of the National Comprehensive Cancer Network.

For subsequent therapy, nivolumab showed lower risk than most antiangiogenic therapies, particularly combination ramucirumab and docetaxel (OR, 0.06), said Dr. Hung of China Medical University Hospital in Taichung, Taiwan.



The findings are notable because tolerability is an essential selection criterion for patients with advanced stage disease, and while checkpoint inhibitors – including nivolumab, pembrolizumab, and atezolizumab – and antiangiogenic agents – including bevacizumab, ramucirumab, and nintedanib – have become the treatments of choice, direct comparisons with respect to tolerability are lacking, she noted.

The investigators performed a systematic review using Bayesian-model network meta-analysis of studies conducted through July 2017 comparing first-line and subsequent regimens containing chemotherapy, antiangiogenic therapy, and/or immune checkpoint inhibitors. Chemotherapy agents studied included cisplatin, carboplatin, oxaliplatin, gemcitabine, paclitaxel, docetaxel, and pemetrexed; antiangiogenic agents included bevacizumab, aflibercept, ramucirumab, nintedanib, axitinib, sorafenib, vandetanib, and sunitinib; and immune checkpoint inhibitors included ipilimumab, pembrolizumab, nivolumab, and atezolizumab.

Direct and indirect data for all grade 3-5 adverse events were combined using random-effects network meta-analysis.

“The results indicated that [checkpoint] inhibitors can be preferred choices for less toxicity to treat advanced stage NSCLC compared with antiangiogenic therapies in first-line and subsequent settings,” Dr. Hung and her associates concluded.

 

 


This study was supported by the China Medical University Beigang Hospital.

SOURCE: Hsu C et al. NCCN poster 13

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REPORTING FROM THE NCCN ANNUAL CONFERENCE

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Key clinical point: Checkpoint blockade appears less toxic than antiangiogenic therapies in advanced NSCLC

Major finding: Less toxicity was seen with first-line nivolumab or pembrolizumab vs. sorafenib + platinum doublets (odds ratios, 0.08 and 0.12, respectively).

Study details: A systematic review and meta-analysis of 37 trials involving 16,810 patients.

Disclosures: The study was supported by the China Medical University Beigang Hospital.

Source: Hsu C et al. NCCN poster 13.

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Obesity in adults continues to rise

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Obesity and severe obesity rose significantly in adults but not in children from 2007 to 2016, according to data from the National Health and Nutrition Examination Survey.

The age-standardized prevalence of obesity – defined as a body mass index of 30 or more – among adults aged 20 years and over increased from 33.7% for the 2-year period of 2007-2008 to 39.6% in 2015-2016, while the prevalence of severe obesity – defined as a body mass index of 40 kg/m2 or more – went from 5.7% to 7.7% over that same period, Craig M. Hales, MD, and his associates at the Centers for Disease Control and Prevention in Hyattsville, Md., and Atlanta said in a research letter published in JAMA.

The prevalence of obesity in children aged 2-19 years – defined as BMI at or above the sex-specific 95th percentile – increased, but not significantly, from 16.8% in 2007-2008 to 18.5% in 2015-2016, with most of that increase coming in the last 2 years. Severe obesity – BMI at or above 120% of the sex-specific 95th percentile – rose from 4.9% to 5.6% over those 10 years, but the last 2-year period saw the rate drop from 6% in 2013-2014, the investigators reported.

For the most recent reporting period, boys were more likely than girls to be obese (19.1% vs. 17.8%) and severely obese (6.3% vs. 4.9%), and both obesity and severe obesity were more common with increasing age. Obesity prevalence went from 13.9% in those aged 2-5 years to 20.6% in 12- to 19-year-olds, and severe obesity was 1.8% in the youngest group and 7.7% in the oldest, with the middle-age group (6-11 years) in the middle in both categories, they said

Among the adults, obesity was more common in women than men (41.1% vs. 37.9%) for 2015-2016, as was severe obesity (9.7% vs. 5.6%). Obesity and severe obesity were both highest in those aged 40-59 years, but obesity prevalence was lowest in the younger group (20-39 years) and severe obesity was least common in the older group (60 years and older), Dr. Hales and his associates said.

The analysis involved 16,875 children and 27,449 adults over the 10-year period. The investigators did not report any conflicts of interest.

AGA patient education materials can help your patients better understand how to manage and discuss obesity, including lifestyle, pharmacological and endoscopic treatment options. Learn more at www.gastro.org/patientInfo/topic/obesity.

SOURCE: Hales CM et al. JAMA 2018 Mar 23. doi: 10.1001/jama.2018.3060.

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Obesity and severe obesity rose significantly in adults but not in children from 2007 to 2016, according to data from the National Health and Nutrition Examination Survey.

The age-standardized prevalence of obesity – defined as a body mass index of 30 or more – among adults aged 20 years and over increased from 33.7% for the 2-year period of 2007-2008 to 39.6% in 2015-2016, while the prevalence of severe obesity – defined as a body mass index of 40 kg/m2 or more – went from 5.7% to 7.7% over that same period, Craig M. Hales, MD, and his associates at the Centers for Disease Control and Prevention in Hyattsville, Md., and Atlanta said in a research letter published in JAMA.

The prevalence of obesity in children aged 2-19 years – defined as BMI at or above the sex-specific 95th percentile – increased, but not significantly, from 16.8% in 2007-2008 to 18.5% in 2015-2016, with most of that increase coming in the last 2 years. Severe obesity – BMI at or above 120% of the sex-specific 95th percentile – rose from 4.9% to 5.6% over those 10 years, but the last 2-year period saw the rate drop from 6% in 2013-2014, the investigators reported.

For the most recent reporting period, boys were more likely than girls to be obese (19.1% vs. 17.8%) and severely obese (6.3% vs. 4.9%), and both obesity and severe obesity were more common with increasing age. Obesity prevalence went from 13.9% in those aged 2-5 years to 20.6% in 12- to 19-year-olds, and severe obesity was 1.8% in the youngest group and 7.7% in the oldest, with the middle-age group (6-11 years) in the middle in both categories, they said

Among the adults, obesity was more common in women than men (41.1% vs. 37.9%) for 2015-2016, as was severe obesity (9.7% vs. 5.6%). Obesity and severe obesity were both highest in those aged 40-59 years, but obesity prevalence was lowest in the younger group (20-39 years) and severe obesity was least common in the older group (60 years and older), Dr. Hales and his associates said.

The analysis involved 16,875 children and 27,449 adults over the 10-year period. The investigators did not report any conflicts of interest.

AGA patient education materials can help your patients better understand how to manage and discuss obesity, including lifestyle, pharmacological and endoscopic treatment options. Learn more at www.gastro.org/patientInfo/topic/obesity.

SOURCE: Hales CM et al. JAMA 2018 Mar 23. doi: 10.1001/jama.2018.3060.

 

Obesity and severe obesity rose significantly in adults but not in children from 2007 to 2016, according to data from the National Health and Nutrition Examination Survey.

The age-standardized prevalence of obesity – defined as a body mass index of 30 or more – among adults aged 20 years and over increased from 33.7% for the 2-year period of 2007-2008 to 39.6% in 2015-2016, while the prevalence of severe obesity – defined as a body mass index of 40 kg/m2 or more – went from 5.7% to 7.7% over that same period, Craig M. Hales, MD, and his associates at the Centers for Disease Control and Prevention in Hyattsville, Md., and Atlanta said in a research letter published in JAMA.

The prevalence of obesity in children aged 2-19 years – defined as BMI at or above the sex-specific 95th percentile – increased, but not significantly, from 16.8% in 2007-2008 to 18.5% in 2015-2016, with most of that increase coming in the last 2 years. Severe obesity – BMI at or above 120% of the sex-specific 95th percentile – rose from 4.9% to 5.6% over those 10 years, but the last 2-year period saw the rate drop from 6% in 2013-2014, the investigators reported.

For the most recent reporting period, boys were more likely than girls to be obese (19.1% vs. 17.8%) and severely obese (6.3% vs. 4.9%), and both obesity and severe obesity were more common with increasing age. Obesity prevalence went from 13.9% in those aged 2-5 years to 20.6% in 12- to 19-year-olds, and severe obesity was 1.8% in the youngest group and 7.7% in the oldest, with the middle-age group (6-11 years) in the middle in both categories, they said

Among the adults, obesity was more common in women than men (41.1% vs. 37.9%) for 2015-2016, as was severe obesity (9.7% vs. 5.6%). Obesity and severe obesity were both highest in those aged 40-59 years, but obesity prevalence was lowest in the younger group (20-39 years) and severe obesity was least common in the older group (60 years and older), Dr. Hales and his associates said.

The analysis involved 16,875 children and 27,449 adults over the 10-year period. The investigators did not report any conflicts of interest.

AGA patient education materials can help your patients better understand how to manage and discuss obesity, including lifestyle, pharmacological and endoscopic treatment options. Learn more at www.gastro.org/patientInfo/topic/obesity.

SOURCE: Hales CM et al. JAMA 2018 Mar 23. doi: 10.1001/jama.2018.3060.

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Greater Occipital Nerve Block Proves Effective

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J Am Board Fam Med; 2018 Mar-Apr; Allen, et al

Greater occipital nerve (GON) block seems to be an effective option for acute management of migraine headache, with promising reductions in pain scores, a recent study found. This retrospective cohort study was undertaken between January 2009 and August 2014 and included patients who underwent at least 1 GON block and attended at least 1 follow-up appointment. Change in the 11-point numeric pain rating scale (NPRS) was used to assess the response to GON block. A total of 562 patients met inclusion criteria; 423 were women (75%); mean age was 58.6 ± 16.7 years. Response was defined as “minimal” (less than 30% NPRS point reduction), “moderate” (31% to 50% NPRS point reduction), or “significant” ( greater than 50% NPRS point reduction). Researchers found:

  • Of total patients, 459 (82%) rated their response to GON block as moderate or significant.
  • No statistically significant relationship existed between previous treatment regimens and response to GON block.
  • GON block was equally effective across the different age and sex groups.

Greater occipital nerve block for acute treatment of migraine headache: A large retrospective cohort study. J Am Board Fam Med. 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188.

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J Am Board Fam Med; 2018 Mar-Apr; Allen, et al
J Am Board Fam Med; 2018 Mar-Apr; Allen, et al

Greater occipital nerve (GON) block seems to be an effective option for acute management of migraine headache, with promising reductions in pain scores, a recent study found. This retrospective cohort study was undertaken between January 2009 and August 2014 and included patients who underwent at least 1 GON block and attended at least 1 follow-up appointment. Change in the 11-point numeric pain rating scale (NPRS) was used to assess the response to GON block. A total of 562 patients met inclusion criteria; 423 were women (75%); mean age was 58.6 ± 16.7 years. Response was defined as “minimal” (less than 30% NPRS point reduction), “moderate” (31% to 50% NPRS point reduction), or “significant” ( greater than 50% NPRS point reduction). Researchers found:

  • Of total patients, 459 (82%) rated their response to GON block as moderate or significant.
  • No statistically significant relationship existed between previous treatment regimens and response to GON block.
  • GON block was equally effective across the different age and sex groups.

Greater occipital nerve block for acute treatment of migraine headache: A large retrospective cohort study. J Am Board Fam Med. 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188.

Greater occipital nerve (GON) block seems to be an effective option for acute management of migraine headache, with promising reductions in pain scores, a recent study found. This retrospective cohort study was undertaken between January 2009 and August 2014 and included patients who underwent at least 1 GON block and attended at least 1 follow-up appointment. Change in the 11-point numeric pain rating scale (NPRS) was used to assess the response to GON block. A total of 562 patients met inclusion criteria; 423 were women (75%); mean age was 58.6 ± 16.7 years. Response was defined as “minimal” (less than 30% NPRS point reduction), “moderate” (31% to 50% NPRS point reduction), or “significant” ( greater than 50% NPRS point reduction). Researchers found:

  • Of total patients, 459 (82%) rated their response to GON block as moderate or significant.
  • No statistically significant relationship existed between previous treatment regimens and response to GON block.
  • GON block was equally effective across the different age and sex groups.

Greater occipital nerve block for acute treatment of migraine headache: A large retrospective cohort study. J Am Board Fam Med. 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188.

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Brain Diffusion Abnormalities in Children Examined

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AJNR Am J Neuroradiol; ePub 2018 Mar 15; Santoro, et al

A recent study identifies early cerebral diffusion changes in children with tension-type and migraine-type headaches compared with controls. The hypothesized mechanisms of nociception in migraine-type and tension-type headaches may explain the findings as a precursor to structural changes seen in adult patients with chronic headache. Patients evaluated for tension-type or migraine-type headache without aura from May 2014 to July 2016 in a single center were retrospectively reviewed. Thirty-two patients with tension-type headache and 23 with migraine-type headache at an average of 4 months after diagnosis were enrolled. All patients underwent diffusion weighted imaging at 3T before the start of pharmacotherapy. Researchers found:

  • There were no significant differences in regional brain volumes between the groups.
  • Patients with tension-type and migraine-type headaches showed significantly increased apparent diffusion coefficient (ADC) in the hippocampus and brain stem compared with controls.
  • Additionally, only patients with migraine-type headache showed significantly increased ADC in the thalamus and a trend toward increased ADC in the amygdala compared with controls.

Brain diffusion abnormalities in children with tension-type and migraine-type headaches. [Published online ahead of print March 15, 2018]. AJNR Am J Neuroradiol. doi:10.3174/ajnr.A5582.

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AJNR Am J Neuroradiol; ePub 2018 Mar 15; Santoro, et al
AJNR Am J Neuroradiol; ePub 2018 Mar 15; Santoro, et al

A recent study identifies early cerebral diffusion changes in children with tension-type and migraine-type headaches compared with controls. The hypothesized mechanisms of nociception in migraine-type and tension-type headaches may explain the findings as a precursor to structural changes seen in adult patients with chronic headache. Patients evaluated for tension-type or migraine-type headache without aura from May 2014 to July 2016 in a single center were retrospectively reviewed. Thirty-two patients with tension-type headache and 23 with migraine-type headache at an average of 4 months after diagnosis were enrolled. All patients underwent diffusion weighted imaging at 3T before the start of pharmacotherapy. Researchers found:

  • There were no significant differences in regional brain volumes between the groups.
  • Patients with tension-type and migraine-type headaches showed significantly increased apparent diffusion coefficient (ADC) in the hippocampus and brain stem compared with controls.
  • Additionally, only patients with migraine-type headache showed significantly increased ADC in the thalamus and a trend toward increased ADC in the amygdala compared with controls.

Brain diffusion abnormalities in children with tension-type and migraine-type headaches. [Published online ahead of print March 15, 2018]. AJNR Am J Neuroradiol. doi:10.3174/ajnr.A5582.

A recent study identifies early cerebral diffusion changes in children with tension-type and migraine-type headaches compared with controls. The hypothesized mechanisms of nociception in migraine-type and tension-type headaches may explain the findings as a precursor to structural changes seen in adult patients with chronic headache. Patients evaluated for tension-type or migraine-type headache without aura from May 2014 to July 2016 in a single center were retrospectively reviewed. Thirty-two patients with tension-type headache and 23 with migraine-type headache at an average of 4 months after diagnosis were enrolled. All patients underwent diffusion weighted imaging at 3T before the start of pharmacotherapy. Researchers found:

  • There were no significant differences in regional brain volumes between the groups.
  • Patients with tension-type and migraine-type headaches showed significantly increased apparent diffusion coefficient (ADC) in the hippocampus and brain stem compared with controls.
  • Additionally, only patients with migraine-type headache showed significantly increased ADC in the thalamus and a trend toward increased ADC in the amygdala compared with controls.

Brain diffusion abnormalities in children with tension-type and migraine-type headaches. [Published online ahead of print March 15, 2018]. AJNR Am J Neuroradiol. doi:10.3174/ajnr.A5582.

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Migraine Linked with Otolaryngologic Symptoms

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Migraine Linked with Otolaryngologic Symptoms
Otolaryngol Head Neck Surg; ePub 2018 Mar 20; Schulz, et al

Migraine disease has a higher prevalence in an otolaryngologic cohort than in the general population, according to a recent study, presenting with a high rate of sinonasal and otologic symptoms that may be due to or exacerbated by migraines. In a cross-sectional study utilizing the CHEER (Creating Healthcare Excellence through Education and Research) network, patients were recruited in 14 CHEER sites between June 2015 and March 2017. Those included were aged 18 years or older and had been seen for any concern that was not head and neck cancer. Patients with any history of brain abnormality or headaches that began within 2 weeks of a medical illness, trauma, or head injury were excluded. If they screened positive on the Migraine Assessment Tool (MAT+), the subjects also filled out questionnaires for sinonasal, otologic, and migraine-specific symptoms. Researchers found:

  • Of 1458 patients screened, 235 (16.1%) screened positive for migraine (MAT+), which is higher than the general population (13%).
  • The MAT+ group was significantly younger (47.2 vs 55.6 years of age) and predominantly women (80.0% vs 55.9%).

Patterns of migraine disease in otolaryngology: A CHEER network study. [Published online ahead of print March 20, 2018]. Otolaryngol Head Neck Surg. doi:10.1177/0194599818764387.

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Otolaryngol Head Neck Surg; ePub 2018 Mar 20; Schulz, et al
Otolaryngol Head Neck Surg; ePub 2018 Mar 20; Schulz, et al

Migraine disease has a higher prevalence in an otolaryngologic cohort than in the general population, according to a recent study, presenting with a high rate of sinonasal and otologic symptoms that may be due to or exacerbated by migraines. In a cross-sectional study utilizing the CHEER (Creating Healthcare Excellence through Education and Research) network, patients were recruited in 14 CHEER sites between June 2015 and March 2017. Those included were aged 18 years or older and had been seen for any concern that was not head and neck cancer. Patients with any history of brain abnormality or headaches that began within 2 weeks of a medical illness, trauma, or head injury were excluded. If they screened positive on the Migraine Assessment Tool (MAT+), the subjects also filled out questionnaires for sinonasal, otologic, and migraine-specific symptoms. Researchers found:

  • Of 1458 patients screened, 235 (16.1%) screened positive for migraine (MAT+), which is higher than the general population (13%).
  • The MAT+ group was significantly younger (47.2 vs 55.6 years of age) and predominantly women (80.0% vs 55.9%).

Patterns of migraine disease in otolaryngology: A CHEER network study. [Published online ahead of print March 20, 2018]. Otolaryngol Head Neck Surg. doi:10.1177/0194599818764387.

Migraine disease has a higher prevalence in an otolaryngologic cohort than in the general population, according to a recent study, presenting with a high rate of sinonasal and otologic symptoms that may be due to or exacerbated by migraines. In a cross-sectional study utilizing the CHEER (Creating Healthcare Excellence through Education and Research) network, patients were recruited in 14 CHEER sites between June 2015 and March 2017. Those included were aged 18 years or older and had been seen for any concern that was not head and neck cancer. Patients with any history of brain abnormality or headaches that began within 2 weeks of a medical illness, trauma, or head injury were excluded. If they screened positive on the Migraine Assessment Tool (MAT+), the subjects also filled out questionnaires for sinonasal, otologic, and migraine-specific symptoms. Researchers found:

  • Of 1458 patients screened, 235 (16.1%) screened positive for migraine (MAT+), which is higher than the general population (13%).
  • The MAT+ group was significantly younger (47.2 vs 55.6 years of age) and predominantly women (80.0% vs 55.9%).

Patterns of migraine disease in otolaryngology: A CHEER network study. [Published online ahead of print March 20, 2018]. Otolaryngol Head Neck Surg. doi:10.1177/0194599818764387.

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It costs what?! How we can educate residents and students on how much things cost

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It costs what?! How we can educate residents and students on how much things cost

Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.1 Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes2:

  • effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
  • efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
  • equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
  • patient-centeredness: meeting patient needs and preferences and providing education and support
  • safety: actual or potential bodily harm
  • timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

  • patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
  • health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
  • society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.3

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.4

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

 

 

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.5 When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.6 This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”7

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

 

 

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

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

References
  1. Wieand E, Lagrew DC Jr. Value-based payment: what does it mean, and how can ObGyns get out ahead? OBG Manag. 2018;30(1):17–19, 25–26.
  2. Agency for Healthcare Research and Quality. The six domains of health care quality. https://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html. Reviewed March 2016. Accessed March 22, 2018.
  3. Centers for Medicare and Medicaid Services. Better care. Smarter spending. Healthier people: paying providers for value, not volume. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html. Published January 26, 2015. Accessed March 22, 2018.
  4. Society for Human Resource Management. Managing health care costs. https://www.shrm.org/resourcesandtools/tools-and-samples/toolkits/pages/managinghealthcarecosts.aspx. Published January 11, 2017. Accessed March 18, 2018.
  5. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, Long-Acting Reversible Contraception Working Group. ACOG Committee Opinion No. 642: Increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol. 2015;126(4):e44–e48.
  6. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 375: Brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 pt 1):447–448.
  7. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 537: Reprocessed single-use devices. Obstet Gynecol. 2012;120(4):974–976.
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Dr. Woodland is Chair, Department of Obstetrics and Gynecology, Reading Hospital, Tower Health, Reading, Pennsylvania.

The authors report no financial relationships relevant to this article.

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The authors report no financial relationships relevant to this article.

Author and Disclosure Information

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Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.1 Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes2:

  • effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
  • efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
  • equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
  • patient-centeredness: meeting patient needs and preferences and providing education and support
  • safety: actual or potential bodily harm
  • timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

  • patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
  • health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
  • society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.3

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.4

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

 

 

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.5 When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.6 This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”7

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

 

 

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

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

Why are you ordering a CBC on the patient when her white blood cell count, hemoglobin, and platelets have been stable for the past 3 days?” sternly inquired the attending gynecologic oncologist. “Don’t order tests without any clinical indication. If she is infected or bleeding, there will be signs and thus an indication to order a CBC. The physical exam is your test.” There was an authoritative pause before he invoked the “value-based care” maxim.

For many residents who graduated in the past decade, education in value-based care and alternative payment models (APMs) was cobbled together from experience, demonstrated by attendings who labeled it as such, and from rare didactic education classroom sessions and inpatient environments.

In today’s health care environment, professional survival requires the ability to successfully deliver high-value care to patients. Attendings often illustrate and champion how to do this by using patient care to highlight the definition: Value = Quality ÷ Cost.

For residency education programs to create the ObGyns of the future, they must teach trainees what they will be evaluated on and held accountable for.1 Today’s clinicians will have to take responsibility for reigning in health care costs from the fee-for-service era, which in the United States have snowballed into one of the unhealthiest cost-to-outcomes ratios worldwide. Residents will be required to understand not only value but also areas in which they can influence the cost of care and how their outcome metrics are valued.

Modifiable factors in value-based care

As mentioned, value is defined by the equation, Value = Quality ÷ Cost. The granularity of these terms helps clarify the depth and the multitude of levels that clinicians can modify and influence to achieve the highest value.

Quality, as defined by the National Academy of Medicine, includes2:

  • effectiveness: providing care processes and achieving outcomes as supported by scientific evidence
  • efficiency: maximizing the quality of a comparable unit of health care delivered or unit of health benefit achieved for a given unit of health care resources used
  • equity: providing health care of equal quality to those who may differ in personal characteristics other than their clinical condition or preferences for care
  • patient-centeredness: meeting patient needs and preferences and providing education and support
  • safety: actual or potential bodily harm
  • timeliness: obtaining needed care while minimizing delays.

From electronic health records, which were mandated in the Patient Protection and Affordable Care Act of 2010, offices, hospitals, and medical systems have gained robust databases of mineable information. Even data abstraction from paper records has been made easier, allowing better reflection of practitioner-based delivery of care.

Understanding cost breakdown in the overall value equation

With regard to value-based care, cost is generally related to money. When broadly explored, however, cost can be broken down into cost to the patient, the health care system, and society this way:

  • patient: time spent receiving evaluation and management from a clinician; money spent for family care needs while undergoing management; money spent for procedures and tests; wages lost due to appointments
  • health system: preventive services versus costly emergency room visit; community-based interventions to improve population health
  • society: cost to tax payers; equitable distribution of vital resources (for example, vaccines); prevention of iatrogenic antibiotic resistance.

To understand how physicians are paid, it is important to see how payers value our services. The Centers for Medicare and Medicaid Services states that it is “promoting value-based care as part of its larger quality strategy to reform how health care is delivered and paid for.” In 2018, the US Department of Health and Human Services is striving to have half of Medicare payments in APMs.3

It is the physician’s responsibility to recognize that costs to the patient, payer, health system, and society can compete with and directly influence the outcome of each other. For example, because the patient pays an insurance premium to participate in a risk pool where cost-sharing is the primary cost-containment strategy, poor-value interventions can directly translate into increased premiums, copayments, or deductibles for the entire pool.4

By clearly identifying the different variables involved in the value-based care equation, residents can better understand their responsibility in their day-to-day work in medicine to address value, not just quality or cost. Clarifying the tenets of value-based care will help guide educators in identifying “teaching moments” and organizing didactic sessions focused on practical implementation of value.

Less is more

In our opening anecdote, the attending shows how curbing overuse of resources can increase the value of care delivered. But that example illustrates only one of the many levels on which educators can help residents understand their impact on value. A multidisciplinary education that incorporates outpatient and inpatient pharmacists, social workers, occupational therapists, pelvic floor physiotherapists, office staff, billing specialists, operating room (OR) technologists, and others can be beneficial in learning how to deliver high-value care.

Read about selecting value-based interventions at work.

 

 

Value-based interventions at work

In the discussion that follows, we illustrate how residents can identify, evaluate, and put into practice value-based interventions that can occur at multiple levels.

Antibiotic selection. Resident choices for outpatient antibiotics can severely affect patient adherence. Subtle differences in the formulation of certain antibiotics affect the price and thus pose a significant potential obstacle. Judicious use of inexpensive drug formulations with fewer dosing frequencies can help patients engage in their own care.

Knowing the pharmacologic difference between doxycycline hyclate and doxycycline monohydrate, for example, is to know the difference between esoteric salts—undeniably worthless information with regard to successfully treating a patient’s infection. Knowing that one formula is on the bargain formulary at the patient’s local pharmacy, or that one drug requires twice-daily dosing versus 4-times-daily dosing, however, can mean the difference between the patient’s adherence or nonadherence to your expert recommendation.

Contraception options. Contraceptives pose a challenge with respect to value because of the myriad delivery systems, doses, and generic formulations available. There are dozens of oral contraceptive pills (OCPs) on the market that vary in their dosing, phasic nature (monophasic, multiphasic), iron content in the hormone-free week, and different progestogens for different conditions (such as drospirenone for androgen excess).

When weighing contraceptive options, the clinician must look at value not only from a cost perspective but also from an effectiveness perspective. The desired outcome in this scenario is preventing unwanted pregnancy with ideal or typical contraceptive use at the most inexpensive price point. When working within the value equation, the clinician must individualize the prescribed contraceptive to one that is most acceptable to the patient and that optimizes the various costs and quality measures. “Cost” can mean the cost of OCPs, menstrual control products, backup contraception, failed or unwanted pregnancy management, or suffering lost wages from missed days of work from, for example, dysmenorrhea. “Quality” can mean a low contraceptive failure rate, predictable cyclicality, the need for patient administration and the risk of forgetting, and the need for backup contraceptives.

In comparing the subdermal contraceptive implant (which can cost up to $1,300 every 3 years, equivalent to $36.11 per month) with OCPs (which can cost as low as $324 for 3 years for an ethinyl estradiol and norgestimate combination, or $9 per month), the OCPs significantly outweigh the implant in terms of cost. When comparing failure rates, the degree of patient intervention, and decreased use of menstrual control products due to amenorrhea, the subdermal contraceptive wins. As we know, long-acting reversible contraception (LARC), including the intrauterine device (IUD) and subdermal implant, is the most effective but often the most expensive contraceptive option.5 When cost is evaluated from a global perspective, as highlighted by the adage “an IUD is cheaper than a baby,” the LARC’s value is derived from its overall high effectiveness and low cost.

If the patient elects to choose OCPs, the clinician should direct the prescription to a pharmacy that has discounted generic pills on its formulary. Generic OCPs have a low- cost burden without loss of efficacy, thus providing maximal value.6 This requires an intimate knowledge of the local pharmacies and what their formularies provide. Sometimes the patient will need to drive out of her way to access cost-effective, quality medications, or the high-value option.

Surgery considerations. Judicious instrument selection in the OR can decrease overall operative costs. While most advanced sealing and cutting instrumentation is for single use, for example, it also can be reprocessed for reuse. Although the cost of reprocessed, single-use instruments is lower, studies evaluating the quality of these instruments “found a significant rate of physical defects, performance issues, or improper decontamination.”7

Marketing largely has driven physician choice in the use of certain vessel sealing and cutting devices, but there has yet to be evidence that using any one device actually improves performance or outcomes, such as length of surgery, blood loss, or postoperative complications. Technology companies that create these instruments likely will have to start designing studies to test performance and outcomes as they relate to their devices to persuade hospital systems that using their products improves outcomes and reduces costs.

While learning laparoscopic hysterectomy, residents may see that some attending surgeons can complete the entire procedure with monopolar scissors, bipolar forceps, and laparoscopic needle drivers, while other surgeons use those instruments plus others, such as a LigaSure instrument or a Harmonic scalpel. With outcomes being the same between these surgeons, it is reasonable for hospitals to audit each surgeon using the Value = Quality ÷ Cost equation and to seek data to describe why the latter surgeon requires additional instrumentation.

Residency training poses a unique opportunity for physicians to learn numerous ways to perform the same procedure so they can fill their armamentarium with various effective techniques. Residency also should be a time in which proficiency with basic surgical instrumentation is emphasized. Attending physicians can help residents improve their skills, for example, by having them use only one advanced sealing and cutting device, or no device at all. This practice will make the trainee better able to adapt to situations in which an advanced device may fail or be unavailable. Future performance metrics may evaluate the physician’s cost effectiveness with regard to single-use instruments during routine surgical procedures.

Standardized order sets. Evidence-based order sets help in the management of pneumonia, sepsis, deep vein thrombosis prophylaxis, and numerous other conditions. In the era of computerized physician order entry systems (CPOEs), a resident needs to enter just a few clicks to order all necessary tests, interventions, and imaging studies for a condition. In one fell swoop, orders are placed not only for admission but also for the patient’s entire hospitalization. The paradox of the order set is that it uses a template to deliver individualized patient-centered care.

In the age of enhanced recovery pathways after surgery, we see patients who undergo a hysterectomy being discharged home directly from the postoperative anesthesia care unit (PACU). Generally, follow-up laboratory testing is not ordered on an outpatient basis. If, however, the patient needs to remain in the hospital for social reasons (such as delayed PACU transfer, transportation, weather), she receives the standardized orders from the post hysterectomy order set: a morning complete blood count ($55) with a basic metabolic panel ($45). As an academic exercise, the order set may help residents learn which orders they must consider when admitting a postoperative hysterectomy patient, but overuse of order sets can be a setback for a value-based care system.

Read about evaluating competence and individualizing care.

 

 

Evaluating competence in value-based care

Research is an integral component of all residency programs accredited by the Accreditation Council for Graduate Medical Education (ACGME). The implementation of value-based care—with all its nuances, quality metrics, and cost parameters—creates a space for resident-led studies to contribute to peer education. The ACGME’s Obstetrics and Gynecology Milestones project was developed to assess the development of ObGyn residents’ competence as they progress through training. Despite national laws tying reimbursements to value-based care, there is no mention of value as it relates to the basic formula, Value = Quality ÷ Cost, in the project.

With the nuances that value-based care offers, it would behoove the Council on Resident Education in Obstetrics and Gynecology of the American College of Obstetricians and Gynecologists to incorporate a method of evaluation to determine competence in this evolving field.

Care also must be individualized

Academic ObGyns and instructors should focus their pedagogy not only on value-based care but also on individualized care that will maximize desired outcomes for each patient. Incorporating multidisciplinary didactics, focused research, and a 360-degree evaluation in the residency curriculum will create new ObGyns who are known for successfully delivering high-value care.

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

References
  1. Wieand E, Lagrew DC Jr. Value-based payment: what does it mean, and how can ObGyns get out ahead? OBG Manag. 2018;30(1):17–19, 25–26.
  2. Agency for Healthcare Research and Quality. The six domains of health care quality. https://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html. Reviewed March 2016. Accessed March 22, 2018.
  3. Centers for Medicare and Medicaid Services. Better care. Smarter spending. Healthier people: paying providers for value, not volume. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html. Published January 26, 2015. Accessed March 22, 2018.
  4. Society for Human Resource Management. Managing health care costs. https://www.shrm.org/resourcesandtools/tools-and-samples/toolkits/pages/managinghealthcarecosts.aspx. Published January 11, 2017. Accessed March 18, 2018.
  5. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, Long-Acting Reversible Contraception Working Group. ACOG Committee Opinion No. 642: Increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol. 2015;126(4):e44–e48.
  6. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 375: Brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 pt 1):447–448.
  7. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 537: Reprocessed single-use devices. Obstet Gynecol. 2012;120(4):974–976.
References
  1. Wieand E, Lagrew DC Jr. Value-based payment: what does it mean, and how can ObGyns get out ahead? OBG Manag. 2018;30(1):17–19, 25–26.
  2. Agency for Healthcare Research and Quality. The six domains of health care quality. https://www.ahrq.gov/professionals/quality-patient-safety/talkingquality/create/sixdomains.html. Reviewed March 2016. Accessed March 22, 2018.
  3. Centers for Medicare and Medicaid Services. Better care. Smarter spending. Healthier people: paying providers for value, not volume. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-01-26-3.html. Published January 26, 2015. Accessed March 22, 2018.
  4. Society for Human Resource Management. Managing health care costs. https://www.shrm.org/resourcesandtools/tools-and-samples/toolkits/pages/managinghealthcarecosts.aspx. Published January 11, 2017. Accessed March 18, 2018.
  5. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice, Long-Acting Reversible Contraception Working Group. ACOG Committee Opinion No. 642: Increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol. 2015;126(4):e44–e48.
  6. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 375: Brand versus generic oral contraceptives. Obstet Gynecol. 2007;110(2 pt 1):447–448.
  7. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 537: Reprocessed single-use devices. Obstet Gynecol. 2012;120(4):974–976.
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The Right Choice? Mixed feelings about a recent informed consent court decision

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On June 20, 2017, the Supreme Court of Pennsylvania ruled on a case that may have significant implications for surgical informed consent.

Although the legal complexities of the case might be interesting to some, what got my attention was the question of whether a surgeon can delegate the informed consent discussion with a patient to someone else.

Dr. Peter Angelos
The case, Shinal v. Toms, involved a malpractice claim arising from a neurosurgical procedure. Megan Shinal had met with Steven Toms, MD, to discuss removal of a benign pituitary tumor (“Shinal vs. Toms: It is now harder to get informed consent,” ACS Surgery News, Sept. 10, 2017). Apparently several options for the surgical approach were discussed at that consultation and Ms. Shinal had reportedly agreed to have surgery.

A few weeks later, the patient had a phone conversation with Dr. Tom’s physician assistant (PA) who answered several additional questions Ms. Shinal had about the surgery. Approximately one month later, the patient met with the same PA and had a preoperative history and physical examination and the informed consent form was signed.

About 2 weeks after that, the patient had an open craniotomy with total resection of the tumor. Unfortunately, the procedure was complicated by bleeding that resulted in stroke, brain injury, and partial blindness. Ms. Shinal and her husband sued Dr. Toms for malpractice, and included in the suit was a claim that Dr. Toms failed to obtain informed consent from Ms. Shinal.

At the original trial, the jury was instructed by the judge to consider information given to Ms. Shinal both by Dr. Toms and his PA as included in the informed consent process. The jury found in favor of Dr. Toms and the patient then appealed to the Pennsylvania Superior Court which upheld the decision. The case was then appealed to the Pennsylvania Supreme Court, which specifically addressed the issue of whether the informed consent discussion must be performed by the surgeon or can be delegated to others.

Several groups, including the American Medical Association, filed briefs in the case supporting Dr. Tom’s claim that the information that is conveyed in the informed consent process is what is important rather than exactly who provides that information to the patient. For many, this case seemed to be relatively straightforward. The surgeon had discussed the operation with the patient, she had agreed, and then in several additional conversations with the surgeon’s PA, the patient’s additional questions had been answered and the patient had willingly signed the informed consent document.

 

 


However, in a surprise to many, the Pennsylvania Supreme Court decision stated that “a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patients’ informed consent. Informed consent requires direct communication between physician and patient and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.” Based on this finding, the case was sent back to the trial court for a new trial.

Although legal scholars may debate the legal basis of this opinion and the ramifications for future cases, I am more interested in the ethical issues that it raises. Although, in recent decades, I have become increasingly accustomed to the idea of medical care by teams, there is something almost nostalgic about this decision. It suggests to me that at least four of the seven Pennsylvania Supreme Court justices believe that there is something so special about surgical informed consent that it must involve a direct conversation between the patient and the surgeon.

This view seems ever more foreign in an environment in which we increasingly talk about processes of care and systems errors rather than individual relationships and individual responsibility. Although the supremely hierarchical concept of the surgeon as the “captain of the ship” has largely been replaced by the team approach, it is nevertheless true that, in an elective case, the patient would not be in the operating room but for the relationship and trust that the patient has in the surgeon.

As I contemplate this court case, I see how it may add to the challenges of providing surgical care to patients and how it may further the delays to see some surgeons. However, it also reemphasizes for me that informed consent for surgery is less about the information that is transferred to the patient and much more about the relationship in which a patient places his or her trust in the surgeon. The emphasis that this court ruling places on the direct relationship between a surgeon and a patient is a refreshing reminder of the personal responsibility that surgeons have for their patients’ outcomes.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

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On June 20, 2017, the Supreme Court of Pennsylvania ruled on a case that may have significant implications for surgical informed consent.

Although the legal complexities of the case might be interesting to some, what got my attention was the question of whether a surgeon can delegate the informed consent discussion with a patient to someone else.

Dr. Peter Angelos
The case, Shinal v. Toms, involved a malpractice claim arising from a neurosurgical procedure. Megan Shinal had met with Steven Toms, MD, to discuss removal of a benign pituitary tumor (“Shinal vs. Toms: It is now harder to get informed consent,” ACS Surgery News, Sept. 10, 2017). Apparently several options for the surgical approach were discussed at that consultation and Ms. Shinal had reportedly agreed to have surgery.

A few weeks later, the patient had a phone conversation with Dr. Tom’s physician assistant (PA) who answered several additional questions Ms. Shinal had about the surgery. Approximately one month later, the patient met with the same PA and had a preoperative history and physical examination and the informed consent form was signed.

About 2 weeks after that, the patient had an open craniotomy with total resection of the tumor. Unfortunately, the procedure was complicated by bleeding that resulted in stroke, brain injury, and partial blindness. Ms. Shinal and her husband sued Dr. Toms for malpractice, and included in the suit was a claim that Dr. Toms failed to obtain informed consent from Ms. Shinal.

At the original trial, the jury was instructed by the judge to consider information given to Ms. Shinal both by Dr. Toms and his PA as included in the informed consent process. The jury found in favor of Dr. Toms and the patient then appealed to the Pennsylvania Superior Court which upheld the decision. The case was then appealed to the Pennsylvania Supreme Court, which specifically addressed the issue of whether the informed consent discussion must be performed by the surgeon or can be delegated to others.

Several groups, including the American Medical Association, filed briefs in the case supporting Dr. Tom’s claim that the information that is conveyed in the informed consent process is what is important rather than exactly who provides that information to the patient. For many, this case seemed to be relatively straightforward. The surgeon had discussed the operation with the patient, she had agreed, and then in several additional conversations with the surgeon’s PA, the patient’s additional questions had been answered and the patient had willingly signed the informed consent document.

 

 


However, in a surprise to many, the Pennsylvania Supreme Court decision stated that “a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patients’ informed consent. Informed consent requires direct communication between physician and patient and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.” Based on this finding, the case was sent back to the trial court for a new trial.

Although legal scholars may debate the legal basis of this opinion and the ramifications for future cases, I am more interested in the ethical issues that it raises. Although, in recent decades, I have become increasingly accustomed to the idea of medical care by teams, there is something almost nostalgic about this decision. It suggests to me that at least four of the seven Pennsylvania Supreme Court justices believe that there is something so special about surgical informed consent that it must involve a direct conversation between the patient and the surgeon.

This view seems ever more foreign in an environment in which we increasingly talk about processes of care and systems errors rather than individual relationships and individual responsibility. Although the supremely hierarchical concept of the surgeon as the “captain of the ship” has largely been replaced by the team approach, it is nevertheless true that, in an elective case, the patient would not be in the operating room but for the relationship and trust that the patient has in the surgeon.

As I contemplate this court case, I see how it may add to the challenges of providing surgical care to patients and how it may further the delays to see some surgeons. However, it also reemphasizes for me that informed consent for surgery is less about the information that is transferred to the patient and much more about the relationship in which a patient places his or her trust in the surgeon. The emphasis that this court ruling places on the direct relationship between a surgeon and a patient is a refreshing reminder of the personal responsibility that surgeons have for their patients’ outcomes.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

 

On June 20, 2017, the Supreme Court of Pennsylvania ruled on a case that may have significant implications for surgical informed consent.

Although the legal complexities of the case might be interesting to some, what got my attention was the question of whether a surgeon can delegate the informed consent discussion with a patient to someone else.

Dr. Peter Angelos
The case, Shinal v. Toms, involved a malpractice claim arising from a neurosurgical procedure. Megan Shinal had met with Steven Toms, MD, to discuss removal of a benign pituitary tumor (“Shinal vs. Toms: It is now harder to get informed consent,” ACS Surgery News, Sept. 10, 2017). Apparently several options for the surgical approach were discussed at that consultation and Ms. Shinal had reportedly agreed to have surgery.

A few weeks later, the patient had a phone conversation with Dr. Tom’s physician assistant (PA) who answered several additional questions Ms. Shinal had about the surgery. Approximately one month later, the patient met with the same PA and had a preoperative history and physical examination and the informed consent form was signed.

About 2 weeks after that, the patient had an open craniotomy with total resection of the tumor. Unfortunately, the procedure was complicated by bleeding that resulted in stroke, brain injury, and partial blindness. Ms. Shinal and her husband sued Dr. Toms for malpractice, and included in the suit was a claim that Dr. Toms failed to obtain informed consent from Ms. Shinal.

At the original trial, the jury was instructed by the judge to consider information given to Ms. Shinal both by Dr. Toms and his PA as included in the informed consent process. The jury found in favor of Dr. Toms and the patient then appealed to the Pennsylvania Superior Court which upheld the decision. The case was then appealed to the Pennsylvania Supreme Court, which specifically addressed the issue of whether the informed consent discussion must be performed by the surgeon or can be delegated to others.

Several groups, including the American Medical Association, filed briefs in the case supporting Dr. Tom’s claim that the information that is conveyed in the informed consent process is what is important rather than exactly who provides that information to the patient. For many, this case seemed to be relatively straightforward. The surgeon had discussed the operation with the patient, she had agreed, and then in several additional conversations with the surgeon’s PA, the patient’s additional questions had been answered and the patient had willingly signed the informed consent document.

 

 


However, in a surprise to many, the Pennsylvania Supreme Court decision stated that “a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patients’ informed consent. Informed consent requires direct communication between physician and patient and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patient’s informed consent belongs solely to the physician.” Based on this finding, the case was sent back to the trial court for a new trial.

Although legal scholars may debate the legal basis of this opinion and the ramifications for future cases, I am more interested in the ethical issues that it raises. Although, in recent decades, I have become increasingly accustomed to the idea of medical care by teams, there is something almost nostalgic about this decision. It suggests to me that at least four of the seven Pennsylvania Supreme Court justices believe that there is something so special about surgical informed consent that it must involve a direct conversation between the patient and the surgeon.

This view seems ever more foreign in an environment in which we increasingly talk about processes of care and systems errors rather than individual relationships and individual responsibility. Although the supremely hierarchical concept of the surgeon as the “captain of the ship” has largely been replaced by the team approach, it is nevertheless true that, in an elective case, the patient would not be in the operating room but for the relationship and trust that the patient has in the surgeon.

As I contemplate this court case, I see how it may add to the challenges of providing surgical care to patients and how it may further the delays to see some surgeons. However, it also reemphasizes for me that informed consent for surgery is less about the information that is transferred to the patient and much more about the relationship in which a patient places his or her trust in the surgeon. The emphasis that this court ruling places on the direct relationship between a surgeon and a patient is a refreshing reminder of the personal responsibility that surgeons have for their patients’ outcomes.

Dr. Angelos is the Linda Kohler Anderson Professor of Surgery and Surgical Ethics, chief of endocrine surgery, and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.

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