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Official Newspaper of the American College of Surgeons
Sequential laser therapy clears basal cell carcinomas
BOSTON – Sequential application of pulsed dye and Nd:YAG lasers is safe and effective for treating small basal cell carcinomas, based on data from a prospective study of patients with nodular and superficial BCC subtypes on the trunk and extremities.
The findings were presented at the annual meeting of the American Society for Laser Medicine and Surgery.
In a study of 10 patients with BCC, 7 of the 12 lesions treated with pulsed dye laser followed by Nd:YAG laser showed completed clinical and histologic clearance, said Dr. H. Ray Jalian of Massachusetts General Hospital in Boston.
"Targeting the microvasculature of BCC offers a promising new treatment approach. These tumors have large caliber feeding vessels; oftentimes these vessels are larger than the surrounding stroma," he said.
Data from a previous study (Lasers Surg. Med. 2009;41:417-42) showed a 92% regression rate of BCC lesions smaller than 1.5 cm treated with a 595 nm pulsed dye laser, Dr. Jalian noted.
The rationale for the sequential laser therapy is that pulsed dye laser energy is well absorbed by hemoglobin, which generates methemoglobin that in turn absorbs 1064 nm Nd:YAG energy, allowing the energy to penetrate to deep vessels.
"We hypothesized that targeting the vasculature of basal cells at two levels may be able to selectively destroy deeper vessels and perhaps achieve a higher cure rate," he said.
The investigators conducted a prospective study with 10 patients who had a total of 13 BCC of nodular and superficial subtypes on the trunk and extremities (1 patient with a single lesion was not available for follow-up).
The treated lesions were less than 2 cm with clearly visible margins that would be suitable for treatment with standard surgical excision. Patients with scars or infections in the area to be treated were excluded, as were those who were immunocompromised or pregnant.
The participants underwent four laser treatments 2-4 weeks apart with a 585-nm PDL set for a 7-mm spot size, 8-J/cm2, 2-ms pulse duration, followed by a 1064-nm Nd:YAG laser set with a 7-mm spot, 40-J/cm2, 15-ms pulse duration.
A total of 7 of the 12 lesions available for follow-up were completely cleared on both clinical and histologic evaluation. Of the eight tumors under 1 cm in size, six were completely cleared by sequential laser therapy,
Of the four patients with 5 lesions with residual disease after four laser sessions, three were on anticoagulation therapy with aspirin, and one with warfarin.
"We did see a clearance of the nodular component in most cases, but there was persistent residual superficial BCC in these patients," Dr. Jalian said.
Anticoagulation may hamper the laser effect by reducing laser-induced vascular injury, he noted.
Treatment-related side effects included erythema, scarring, and hyperpigmentation. Erythema and scarring decreased from the first treatment to the last follow-up visit, while hyperpigmentation increased slightly from the first to the third treatment, and then plateaued.
Biopsy scars improved with sequential treatments, Dr. Jalian noted.
Possible explanations for the lower success rate treating BCC compared to previous studies include the use of a slightly lower wavelength laser (585 vs. 595), and lower energy settings (8 J/cm2 for 2 ms, vs. 15 J/cm2 for 3 ms), and by mix of histologic subtypes, said Dr. Jalian.
"Superficial subtypes present in residual lesions suggest there may be a different vascular pattern in these lesions."
The findings also suggest that anticoagulation therapy may need to be suspended before treatment with pulsed dye, Nd:YAG, and other vascular-specific lasers, he added.
The study was internally supported. Dr. Jalian reported having no financial disclosures.
BOSTON – Sequential application of pulsed dye and Nd:YAG lasers is safe and effective for treating small basal cell carcinomas, based on data from a prospective study of patients with nodular and superficial BCC subtypes on the trunk and extremities.
The findings were presented at the annual meeting of the American Society for Laser Medicine and Surgery.
In a study of 10 patients with BCC, 7 of the 12 lesions treated with pulsed dye laser followed by Nd:YAG laser showed completed clinical and histologic clearance, said Dr. H. Ray Jalian of Massachusetts General Hospital in Boston.
"Targeting the microvasculature of BCC offers a promising new treatment approach. These tumors have large caliber feeding vessels; oftentimes these vessels are larger than the surrounding stroma," he said.
Data from a previous study (Lasers Surg. Med. 2009;41:417-42) showed a 92% regression rate of BCC lesions smaller than 1.5 cm treated with a 595 nm pulsed dye laser, Dr. Jalian noted.
The rationale for the sequential laser therapy is that pulsed dye laser energy is well absorbed by hemoglobin, which generates methemoglobin that in turn absorbs 1064 nm Nd:YAG energy, allowing the energy to penetrate to deep vessels.
"We hypothesized that targeting the vasculature of basal cells at two levels may be able to selectively destroy deeper vessels and perhaps achieve a higher cure rate," he said.
The investigators conducted a prospective study with 10 patients who had a total of 13 BCC of nodular and superficial subtypes on the trunk and extremities (1 patient with a single lesion was not available for follow-up).
The treated lesions were less than 2 cm with clearly visible margins that would be suitable for treatment with standard surgical excision. Patients with scars or infections in the area to be treated were excluded, as were those who were immunocompromised or pregnant.
The participants underwent four laser treatments 2-4 weeks apart with a 585-nm PDL set for a 7-mm spot size, 8-J/cm2, 2-ms pulse duration, followed by a 1064-nm Nd:YAG laser set with a 7-mm spot, 40-J/cm2, 15-ms pulse duration.
A total of 7 of the 12 lesions available for follow-up were completely cleared on both clinical and histologic evaluation. Of the eight tumors under 1 cm in size, six were completely cleared by sequential laser therapy,
Of the four patients with 5 lesions with residual disease after four laser sessions, three were on anticoagulation therapy with aspirin, and one with warfarin.
"We did see a clearance of the nodular component in most cases, but there was persistent residual superficial BCC in these patients," Dr. Jalian said.
Anticoagulation may hamper the laser effect by reducing laser-induced vascular injury, he noted.
Treatment-related side effects included erythema, scarring, and hyperpigmentation. Erythema and scarring decreased from the first treatment to the last follow-up visit, while hyperpigmentation increased slightly from the first to the third treatment, and then plateaued.
Biopsy scars improved with sequential treatments, Dr. Jalian noted.
Possible explanations for the lower success rate treating BCC compared to previous studies include the use of a slightly lower wavelength laser (585 vs. 595), and lower energy settings (8 J/cm2 for 2 ms, vs. 15 J/cm2 for 3 ms), and by mix of histologic subtypes, said Dr. Jalian.
"Superficial subtypes present in residual lesions suggest there may be a different vascular pattern in these lesions."
The findings also suggest that anticoagulation therapy may need to be suspended before treatment with pulsed dye, Nd:YAG, and other vascular-specific lasers, he added.
The study was internally supported. Dr. Jalian reported having no financial disclosures.
BOSTON – Sequential application of pulsed dye and Nd:YAG lasers is safe and effective for treating small basal cell carcinomas, based on data from a prospective study of patients with nodular and superficial BCC subtypes on the trunk and extremities.
The findings were presented at the annual meeting of the American Society for Laser Medicine and Surgery.
In a study of 10 patients with BCC, 7 of the 12 lesions treated with pulsed dye laser followed by Nd:YAG laser showed completed clinical and histologic clearance, said Dr. H. Ray Jalian of Massachusetts General Hospital in Boston.
"Targeting the microvasculature of BCC offers a promising new treatment approach. These tumors have large caliber feeding vessels; oftentimes these vessels are larger than the surrounding stroma," he said.
Data from a previous study (Lasers Surg. Med. 2009;41:417-42) showed a 92% regression rate of BCC lesions smaller than 1.5 cm treated with a 595 nm pulsed dye laser, Dr. Jalian noted.
The rationale for the sequential laser therapy is that pulsed dye laser energy is well absorbed by hemoglobin, which generates methemoglobin that in turn absorbs 1064 nm Nd:YAG energy, allowing the energy to penetrate to deep vessels.
"We hypothesized that targeting the vasculature of basal cells at two levels may be able to selectively destroy deeper vessels and perhaps achieve a higher cure rate," he said.
The investigators conducted a prospective study with 10 patients who had a total of 13 BCC of nodular and superficial subtypes on the trunk and extremities (1 patient with a single lesion was not available for follow-up).
The treated lesions were less than 2 cm with clearly visible margins that would be suitable for treatment with standard surgical excision. Patients with scars or infections in the area to be treated were excluded, as were those who were immunocompromised or pregnant.
The participants underwent four laser treatments 2-4 weeks apart with a 585-nm PDL set for a 7-mm spot size, 8-J/cm2, 2-ms pulse duration, followed by a 1064-nm Nd:YAG laser set with a 7-mm spot, 40-J/cm2, 15-ms pulse duration.
A total of 7 of the 12 lesions available for follow-up were completely cleared on both clinical and histologic evaluation. Of the eight tumors under 1 cm in size, six were completely cleared by sequential laser therapy,
Of the four patients with 5 lesions with residual disease after four laser sessions, three were on anticoagulation therapy with aspirin, and one with warfarin.
"We did see a clearance of the nodular component in most cases, but there was persistent residual superficial BCC in these patients," Dr. Jalian said.
Anticoagulation may hamper the laser effect by reducing laser-induced vascular injury, he noted.
Treatment-related side effects included erythema, scarring, and hyperpigmentation. Erythema and scarring decreased from the first treatment to the last follow-up visit, while hyperpigmentation increased slightly from the first to the third treatment, and then plateaued.
Biopsy scars improved with sequential treatments, Dr. Jalian noted.
Possible explanations for the lower success rate treating BCC compared to previous studies include the use of a slightly lower wavelength laser (585 vs. 595), and lower energy settings (8 J/cm2 for 2 ms, vs. 15 J/cm2 for 3 ms), and by mix of histologic subtypes, said Dr. Jalian.
"Superficial subtypes present in residual lesions suggest there may be a different vascular pattern in these lesions."
The findings also suggest that anticoagulation therapy may need to be suspended before treatment with pulsed dye, Nd:YAG, and other vascular-specific lasers, he added.
The study was internally supported. Dr. Jalian reported having no financial disclosures.
AT LASER 2013
Major finding: Seven of 12 basal cell carcinomas treated with sequential lasers showed complete clinical and histologic clearance.
Data source: Prospective case series of 10 patients with 13 BCC lesions.
Disclosures: The study was internally supported. Dr. Jalian reported having no financial disclosures.
'Slow Mohs' advised for lentigo maligna
MAUI, HAWAII – "Slow Mohs" has gained near-universal acceptance among skin cancer specialists as a definitive surgical technique for complete removal of lentigo maligna melanoma while simultaneously sparing normal tissue, according to Dr. Ellen Marmur of Mount Sinai School of Medicine, New York.
The big advantage that slow Mohs has over standard wide local excision with 0.5- to 1-cm margins is a 5-year cure rate approaching 100%. In contrast, standard excision has a recurrence rate of up to 20%, she said at the Hawaii Dermatology Seminar, sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Slow Mohs is a modified form of Mohs micrographic surgery. The surgery compares with conventional Mohs: It is staged, margin-controlled excision. But in slow Mohs, rush permanent sections are sent off to the pathologist rather than the frozen sections integral to conventional Mohs.
Dr. Marmur relies upon slow Mohs, with "bread-loafing" of the central tumor by the pathologist, because the permanent sections better preserve the tumor’s microscopic features. Interpreting atypical melanocytes in frozen sections can be quite a challenge. However, she added, some Mohs surgeons have found that using rapid immunostains also markedly improves the sensitivity and specificity of frozen sections in lentigo maligna surgery.
Slow Mohs takes place over the course of days, she said. "Basically, you do your Wood’s lamp to define the lesion diameter, you measure out your margins, you excise the tumor, pack the area with a bandage, and send the patient home. You rush your pathology, and you don’t do any reconstruction until you get the margins clear."
A pathology report that comes back stating narrow margins are present is "a heart stopper," she added.
"You have the option of observing the area if the margin is clear but the tumor was close to the margin. That’s a good approach for an elderly patient or when the lentigo maligna was in a cosmetically important area."
Lentigo maligna melanoma accounts for 4% of all cases of melanoma. It typically arises on sun-damaged skin in individuals in their 70s or older. Common sites include the malar area, forehead, nose, and temple. The differential diagnosis includes seborrheic keratosis, pigmented actinic keratosis, and pigmented nevus.
Lentigo maligna becomes lentigo maligna melanoma when malignant melanoma cells invade the dermis and deeper appendages. Roughly 5% of lentigo malignas eventually progress to invasive melanoma, according to Dr. Marmur. Typically, a lentigo maligna undergoes extended gradual horizontal growth before beginning a vertical growth phase.
"It spreads like an oil slick for many years," Dr. Marmur said at the seminar.
Established treatment modalities for patients who aren’t surgical candidates include cryotherapy, radiotherapy, and topical imiquimod 5%. All have disadvantages, including high 5-year recurrence rates.
Dr. Marmur noted that a newer nonsurgical therapy drawing considerable interest involves off-label use of topical combination therapy with imiquimod and tazarotene gel. The concept is to use the topical retinoid to disrupt the stratum corneum in order to enhance imiquimod penetration, thereby achieving a greater inflammatory response than possible with imiquimod alone.
Initial data have been published by researchers at the University of Utah, Salt Lake City. They randomized 90 patients with 91 lentigo malignas to imiquimod 5% cream applied 5 days per week for 3 months or to the imiquimod regimen plus tazarotene 0.1% gel on the other 2 days per week. After 3 months of topical therapy, patients underwent conservative staged excision with frozen section analysis with Melan A immunostaining to confirm negative margins.
Of those treated with dual topical therapy for 3 months, 29 of 37 lesions (78%) had complete responses with no residual lentigo maligna at the time of staged excision. So did 27 of 42 (64%) treated with imiquimod alone (Arch. Dermatol. 2012;148:592-6).
The modest difference in outcome was not significant (P = .17). Nevertheless, the Utah investigators wrote that topical pretreatment appears to reduce surgical defect sizes, an important consideration in lentigo maligna because the lesions are often large and located on cosmetically sensitive facial sites. At the patient’s first visit, the researchers saucerize the entire tumor to remove all visible evidence of lentigo maligna and nip in the bud any invasive element that might be present. One month later, after the wound has healed by secondary intention, the patient begins topical imiquimod therapy 5 days per week. If no inflammation is observed, tazarotene gel is added on the other 2 days per week. After 3 months of topical therapy, the patient goes off treatment for 2 months so the inflammatory response can subside. Then a staged excision is performed with 2-mm margins around the perimeter of the original tumor outline.
"This is an interesting thought, but it’s still not considered standard of care," Dr. Marmur commented in describing the Utah research.
Session chair Dr. Allan C. Halpern, chief of the dermatology service at Memorial Sloan-Kettering Cancer Center in New York, said he and his colleagues, like the Utah group, are using a lot of topical imiquimod as adjunctive therapy for lentigo maligna.
"Because we’re a referral center, we see all those patients whose melanomas unfortunately do recur at the edge of large surgeries. We see a lot of patients whose local surgeons have chased around their faces for a certain amount of time. So I think the general concept of the cure rates of surgery is a bit overstated. I’m not trying to sell an off-label use of a drug, but I think sometimes imiquimod can be very helpful," Dr. Halpern said.
He offered a clinical pearl in diagnosing lentigo maligna: Consider a broad shave biopsy of a suspicious lesion rather than a deeper, smaller-diameter biopsy.
"Sampling errors are a real problem with lentigo maligna. We learned early on that if you take a large lentigo maligna and do multiple biopsies of the same lesion and send them to what we think are our very expert pathologists, on average, we get two or three back that were melanoma and two or three back that were pigmented actinic keratoses. The sampling error tends to be more in the horizontal than in the depth for these very early lesions," according to Dr. Halpern.
Dr. Marmur and Dr. Halpern reported having no relevant financial interests. SDEF and this news organization are owned by the same parent company.
MAUI, HAWAII – "Slow Mohs" has gained near-universal acceptance among skin cancer specialists as a definitive surgical technique for complete removal of lentigo maligna melanoma while simultaneously sparing normal tissue, according to Dr. Ellen Marmur of Mount Sinai School of Medicine, New York.
The big advantage that slow Mohs has over standard wide local excision with 0.5- to 1-cm margins is a 5-year cure rate approaching 100%. In contrast, standard excision has a recurrence rate of up to 20%, she said at the Hawaii Dermatology Seminar, sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Slow Mohs is a modified form of Mohs micrographic surgery. The surgery compares with conventional Mohs: It is staged, margin-controlled excision. But in slow Mohs, rush permanent sections are sent off to the pathologist rather than the frozen sections integral to conventional Mohs.
Dr. Marmur relies upon slow Mohs, with "bread-loafing" of the central tumor by the pathologist, because the permanent sections better preserve the tumor’s microscopic features. Interpreting atypical melanocytes in frozen sections can be quite a challenge. However, she added, some Mohs surgeons have found that using rapid immunostains also markedly improves the sensitivity and specificity of frozen sections in lentigo maligna surgery.
Slow Mohs takes place over the course of days, she said. "Basically, you do your Wood’s lamp to define the lesion diameter, you measure out your margins, you excise the tumor, pack the area with a bandage, and send the patient home. You rush your pathology, and you don’t do any reconstruction until you get the margins clear."
A pathology report that comes back stating narrow margins are present is "a heart stopper," she added.
"You have the option of observing the area if the margin is clear but the tumor was close to the margin. That’s a good approach for an elderly patient or when the lentigo maligna was in a cosmetically important area."
Lentigo maligna melanoma accounts for 4% of all cases of melanoma. It typically arises on sun-damaged skin in individuals in their 70s or older. Common sites include the malar area, forehead, nose, and temple. The differential diagnosis includes seborrheic keratosis, pigmented actinic keratosis, and pigmented nevus.
Lentigo maligna becomes lentigo maligna melanoma when malignant melanoma cells invade the dermis and deeper appendages. Roughly 5% of lentigo malignas eventually progress to invasive melanoma, according to Dr. Marmur. Typically, a lentigo maligna undergoes extended gradual horizontal growth before beginning a vertical growth phase.
"It spreads like an oil slick for many years," Dr. Marmur said at the seminar.
Established treatment modalities for patients who aren’t surgical candidates include cryotherapy, radiotherapy, and topical imiquimod 5%. All have disadvantages, including high 5-year recurrence rates.
Dr. Marmur noted that a newer nonsurgical therapy drawing considerable interest involves off-label use of topical combination therapy with imiquimod and tazarotene gel. The concept is to use the topical retinoid to disrupt the stratum corneum in order to enhance imiquimod penetration, thereby achieving a greater inflammatory response than possible with imiquimod alone.
Initial data have been published by researchers at the University of Utah, Salt Lake City. They randomized 90 patients with 91 lentigo malignas to imiquimod 5% cream applied 5 days per week for 3 months or to the imiquimod regimen plus tazarotene 0.1% gel on the other 2 days per week. After 3 months of topical therapy, patients underwent conservative staged excision with frozen section analysis with Melan A immunostaining to confirm negative margins.
Of those treated with dual topical therapy for 3 months, 29 of 37 lesions (78%) had complete responses with no residual lentigo maligna at the time of staged excision. So did 27 of 42 (64%) treated with imiquimod alone (Arch. Dermatol. 2012;148:592-6).
The modest difference in outcome was not significant (P = .17). Nevertheless, the Utah investigators wrote that topical pretreatment appears to reduce surgical defect sizes, an important consideration in lentigo maligna because the lesions are often large and located on cosmetically sensitive facial sites. At the patient’s first visit, the researchers saucerize the entire tumor to remove all visible evidence of lentigo maligna and nip in the bud any invasive element that might be present. One month later, after the wound has healed by secondary intention, the patient begins topical imiquimod therapy 5 days per week. If no inflammation is observed, tazarotene gel is added on the other 2 days per week. After 3 months of topical therapy, the patient goes off treatment for 2 months so the inflammatory response can subside. Then a staged excision is performed with 2-mm margins around the perimeter of the original tumor outline.
"This is an interesting thought, but it’s still not considered standard of care," Dr. Marmur commented in describing the Utah research.
Session chair Dr. Allan C. Halpern, chief of the dermatology service at Memorial Sloan-Kettering Cancer Center in New York, said he and his colleagues, like the Utah group, are using a lot of topical imiquimod as adjunctive therapy for lentigo maligna.
"Because we’re a referral center, we see all those patients whose melanomas unfortunately do recur at the edge of large surgeries. We see a lot of patients whose local surgeons have chased around their faces for a certain amount of time. So I think the general concept of the cure rates of surgery is a bit overstated. I’m not trying to sell an off-label use of a drug, but I think sometimes imiquimod can be very helpful," Dr. Halpern said.
He offered a clinical pearl in diagnosing lentigo maligna: Consider a broad shave biopsy of a suspicious lesion rather than a deeper, smaller-diameter biopsy.
"Sampling errors are a real problem with lentigo maligna. We learned early on that if you take a large lentigo maligna and do multiple biopsies of the same lesion and send them to what we think are our very expert pathologists, on average, we get two or three back that were melanoma and two or three back that were pigmented actinic keratoses. The sampling error tends to be more in the horizontal than in the depth for these very early lesions," according to Dr. Halpern.
Dr. Marmur and Dr. Halpern reported having no relevant financial interests. SDEF and this news organization are owned by the same parent company.
MAUI, HAWAII – "Slow Mohs" has gained near-universal acceptance among skin cancer specialists as a definitive surgical technique for complete removal of lentigo maligna melanoma while simultaneously sparing normal tissue, according to Dr. Ellen Marmur of Mount Sinai School of Medicine, New York.
The big advantage that slow Mohs has over standard wide local excision with 0.5- to 1-cm margins is a 5-year cure rate approaching 100%. In contrast, standard excision has a recurrence rate of up to 20%, she said at the Hawaii Dermatology Seminar, sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Slow Mohs is a modified form of Mohs micrographic surgery. The surgery compares with conventional Mohs: It is staged, margin-controlled excision. But in slow Mohs, rush permanent sections are sent off to the pathologist rather than the frozen sections integral to conventional Mohs.
Dr. Marmur relies upon slow Mohs, with "bread-loafing" of the central tumor by the pathologist, because the permanent sections better preserve the tumor’s microscopic features. Interpreting atypical melanocytes in frozen sections can be quite a challenge. However, she added, some Mohs surgeons have found that using rapid immunostains also markedly improves the sensitivity and specificity of frozen sections in lentigo maligna surgery.
Slow Mohs takes place over the course of days, she said. "Basically, you do your Wood’s lamp to define the lesion diameter, you measure out your margins, you excise the tumor, pack the area with a bandage, and send the patient home. You rush your pathology, and you don’t do any reconstruction until you get the margins clear."
A pathology report that comes back stating narrow margins are present is "a heart stopper," she added.
"You have the option of observing the area if the margin is clear but the tumor was close to the margin. That’s a good approach for an elderly patient or when the lentigo maligna was in a cosmetically important area."
Lentigo maligna melanoma accounts for 4% of all cases of melanoma. It typically arises on sun-damaged skin in individuals in their 70s or older. Common sites include the malar area, forehead, nose, and temple. The differential diagnosis includes seborrheic keratosis, pigmented actinic keratosis, and pigmented nevus.
Lentigo maligna becomes lentigo maligna melanoma when malignant melanoma cells invade the dermis and deeper appendages. Roughly 5% of lentigo malignas eventually progress to invasive melanoma, according to Dr. Marmur. Typically, a lentigo maligna undergoes extended gradual horizontal growth before beginning a vertical growth phase.
"It spreads like an oil slick for many years," Dr. Marmur said at the seminar.
Established treatment modalities for patients who aren’t surgical candidates include cryotherapy, radiotherapy, and topical imiquimod 5%. All have disadvantages, including high 5-year recurrence rates.
Dr. Marmur noted that a newer nonsurgical therapy drawing considerable interest involves off-label use of topical combination therapy with imiquimod and tazarotene gel. The concept is to use the topical retinoid to disrupt the stratum corneum in order to enhance imiquimod penetration, thereby achieving a greater inflammatory response than possible with imiquimod alone.
Initial data have been published by researchers at the University of Utah, Salt Lake City. They randomized 90 patients with 91 lentigo malignas to imiquimod 5% cream applied 5 days per week for 3 months or to the imiquimod regimen plus tazarotene 0.1% gel on the other 2 days per week. After 3 months of topical therapy, patients underwent conservative staged excision with frozen section analysis with Melan A immunostaining to confirm negative margins.
Of those treated with dual topical therapy for 3 months, 29 of 37 lesions (78%) had complete responses with no residual lentigo maligna at the time of staged excision. So did 27 of 42 (64%) treated with imiquimod alone (Arch. Dermatol. 2012;148:592-6).
The modest difference in outcome was not significant (P = .17). Nevertheless, the Utah investigators wrote that topical pretreatment appears to reduce surgical defect sizes, an important consideration in lentigo maligna because the lesions are often large and located on cosmetically sensitive facial sites. At the patient’s first visit, the researchers saucerize the entire tumor to remove all visible evidence of lentigo maligna and nip in the bud any invasive element that might be present. One month later, after the wound has healed by secondary intention, the patient begins topical imiquimod therapy 5 days per week. If no inflammation is observed, tazarotene gel is added on the other 2 days per week. After 3 months of topical therapy, the patient goes off treatment for 2 months so the inflammatory response can subside. Then a staged excision is performed with 2-mm margins around the perimeter of the original tumor outline.
"This is an interesting thought, but it’s still not considered standard of care," Dr. Marmur commented in describing the Utah research.
Session chair Dr. Allan C. Halpern, chief of the dermatology service at Memorial Sloan-Kettering Cancer Center in New York, said he and his colleagues, like the Utah group, are using a lot of topical imiquimod as adjunctive therapy for lentigo maligna.
"Because we’re a referral center, we see all those patients whose melanomas unfortunately do recur at the edge of large surgeries. We see a lot of patients whose local surgeons have chased around their faces for a certain amount of time. So I think the general concept of the cure rates of surgery is a bit overstated. I’m not trying to sell an off-label use of a drug, but I think sometimes imiquimod can be very helpful," Dr. Halpern said.
He offered a clinical pearl in diagnosing lentigo maligna: Consider a broad shave biopsy of a suspicious lesion rather than a deeper, smaller-diameter biopsy.
"Sampling errors are a real problem with lentigo maligna. We learned early on that if you take a large lentigo maligna and do multiple biopsies of the same lesion and send them to what we think are our very expert pathologists, on average, we get two or three back that were melanoma and two or three back that were pigmented actinic keratoses. The sampling error tends to be more in the horizontal than in the depth for these very early lesions," according to Dr. Halpern.
Dr. Marmur and Dr. Halpern reported having no relevant financial interests. SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
FDA advisory panel nixes approval of drug-device for liver metastases
SILVER SPRING, MD. – The risks outweigh any possible benefits of treatment with a drug-device combination that delivers melphalan directly to the livers of patients with liver metastases from ocular melanoma, a Food and Drug Administration advisory panel concluded in a 16-0 vote.
At a meeting of the FDA’s Oncologic Drugs Advisory Committee, several panelists said that the treatment was promising but should remain investigational, given its marked toxicity and lack of effect on overall survival.
The Melblez Kit is a combination of melphalan and the Delcath Hepatic Delivery System, which includes two catheters and an extracorporeal hemofiltration component. The catheter is used to administer high doses of the chemotherapy drug directly to the liver via the hepatic artery, and the hemofiltration component lowers the drug level before the blood is returned to the systemic circulation, according to the manufacturer, Delcath Systems. Patients are hospitalized for about 4 days for the procedure, which takes about 3 hours and is performed at 4-week intervals under general anesthesia.
There are no FDA-approved treatments for patients with unresectable metastatic ocular melanoma to the liver, which is the indication under FDA review.
Treatment with the kit was associated with antitumor activity, but it also was associated with fatal and life-threatening adverse reactions. There was a trend towards a detrimental effect on survival, and the risk evaluation and mitigation strategy (REMS) proposed by the company to address those risks "will not improve the observed benefit-risk profile," Dr. Geoffrey Kim, a medical officer in the FDA’s office of hematology and oncology products, told the panel.
In an open-label, randomized multicenter phase-III study conducted between 2006 and 2010 in the United States, the device was used to treat 44 patients. Their outcomes were compared with those of 49 matched patients given the best alternative care (BAC). All patients had surgically unresectable hepatic-dominant metastatic ocular or cutaneous melanoma (89% had ocular melanoma, and almost half were treated at the National Cancer Institute). Subjects were treated until their hepatic disease progressed. The dose administered with the Melblez Kit was 3.0 mg/kg for a median of three treatment cycles and a median of 120 days; best alternative care included systemic chemotherapy in 49% of patients and intrahepatic chemotherapy in 22%.
The primary end point, median hepatic progression-free survival (hPFS) was 7 months among those on the device, compared with 1.6 months among those on BAC, a statistically significant difference that represented a 61% reduction in risk (hazard ratio, 0.39), according to the company. The median overall PFS was 4.8 months among those treated with the device, compared with 1.6 months among those on BAC, also a statistically significant difference.
Overall survival was comparable: 9.8 months in the device-treated group and 9.9 months in those on best alternative care. Further, almost 80% of patients in the Melblez Kit arm had a serious adverse event and almost 70% had a grade-4 adverse event. With best alternative care, the rate of serious adverse events was 16% and the rate of grade-4 events was 2%. No patients on best alternative care died because of an adverse event. Three patients treated with the drug-device died from adverse events.
The adverse reactions in a combined population of 121 patients in the phase-III and phase-II studies and in 28 patients in the BAC arm who crossed over to treatment with the device included toxic deaths in 7% (including cases of hepatic failure, streptococcal sepsis, and GI hemorrhage), cerebral infarction in 4%, MI in 2%, and grade-4 bone marrow suppression with a median time to recovery of more than 1 week in more than 70%. About half had to be rehospitalized for an adverse event.
For a cancer treatment, this safety profile "is unprecedented, in terms of the toxicity," Dr. Richard Pazdur, director of the FDA’s office of hematology and oncology products, remarked.
After the vote, panel member Dr. Louis Diehl, professor of medicine at Duke University, Durham, N.C., said that progression-free survival is valued in studies as an indicator of improved quality of life and it can be an early marker of increased survival. "Unfortunately, this treatment has an increase in morbidity and an increase in mortality and I can’t see from the survival curve that it will ever translate into an improvement in survival."
Delcath did not issue a response after the panel’s vote.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting, although a panelist may occasionally be given a waiver. At this meeting, two panelists who had expertise in the topic were given waivers (one panelist is the principal investigator in a study of a competing device and the other works at a medical center where a study of a competing device is being conducted).
About 2,000 cases of ocular melanoma are diagnosed annually in the United States and about 50% metastasize, most often to the liver, according to Delcath. In Europe and Australia, the company markets the device for a broad range of liver metastases, not just those caused by ocular melanoma, according to the company.
SILVER SPRING, MD. – The risks outweigh any possible benefits of treatment with a drug-device combination that delivers melphalan directly to the livers of patients with liver metastases from ocular melanoma, a Food and Drug Administration advisory panel concluded in a 16-0 vote.
At a meeting of the FDA’s Oncologic Drugs Advisory Committee, several panelists said that the treatment was promising but should remain investigational, given its marked toxicity and lack of effect on overall survival.
The Melblez Kit is a combination of melphalan and the Delcath Hepatic Delivery System, which includes two catheters and an extracorporeal hemofiltration component. The catheter is used to administer high doses of the chemotherapy drug directly to the liver via the hepatic artery, and the hemofiltration component lowers the drug level before the blood is returned to the systemic circulation, according to the manufacturer, Delcath Systems. Patients are hospitalized for about 4 days for the procedure, which takes about 3 hours and is performed at 4-week intervals under general anesthesia.
There are no FDA-approved treatments for patients with unresectable metastatic ocular melanoma to the liver, which is the indication under FDA review.
Treatment with the kit was associated with antitumor activity, but it also was associated with fatal and life-threatening adverse reactions. There was a trend towards a detrimental effect on survival, and the risk evaluation and mitigation strategy (REMS) proposed by the company to address those risks "will not improve the observed benefit-risk profile," Dr. Geoffrey Kim, a medical officer in the FDA’s office of hematology and oncology products, told the panel.
In an open-label, randomized multicenter phase-III study conducted between 2006 and 2010 in the United States, the device was used to treat 44 patients. Their outcomes were compared with those of 49 matched patients given the best alternative care (BAC). All patients had surgically unresectable hepatic-dominant metastatic ocular or cutaneous melanoma (89% had ocular melanoma, and almost half were treated at the National Cancer Institute). Subjects were treated until their hepatic disease progressed. The dose administered with the Melblez Kit was 3.0 mg/kg for a median of three treatment cycles and a median of 120 days; best alternative care included systemic chemotherapy in 49% of patients and intrahepatic chemotherapy in 22%.
The primary end point, median hepatic progression-free survival (hPFS) was 7 months among those on the device, compared with 1.6 months among those on BAC, a statistically significant difference that represented a 61% reduction in risk (hazard ratio, 0.39), according to the company. The median overall PFS was 4.8 months among those treated with the device, compared with 1.6 months among those on BAC, also a statistically significant difference.
Overall survival was comparable: 9.8 months in the device-treated group and 9.9 months in those on best alternative care. Further, almost 80% of patients in the Melblez Kit arm had a serious adverse event and almost 70% had a grade-4 adverse event. With best alternative care, the rate of serious adverse events was 16% and the rate of grade-4 events was 2%. No patients on best alternative care died because of an adverse event. Three patients treated with the drug-device died from adverse events.
The adverse reactions in a combined population of 121 patients in the phase-III and phase-II studies and in 28 patients in the BAC arm who crossed over to treatment with the device included toxic deaths in 7% (including cases of hepatic failure, streptococcal sepsis, and GI hemorrhage), cerebral infarction in 4%, MI in 2%, and grade-4 bone marrow suppression with a median time to recovery of more than 1 week in more than 70%. About half had to be rehospitalized for an adverse event.
For a cancer treatment, this safety profile "is unprecedented, in terms of the toxicity," Dr. Richard Pazdur, director of the FDA’s office of hematology and oncology products, remarked.
After the vote, panel member Dr. Louis Diehl, professor of medicine at Duke University, Durham, N.C., said that progression-free survival is valued in studies as an indicator of improved quality of life and it can be an early marker of increased survival. "Unfortunately, this treatment has an increase in morbidity and an increase in mortality and I can’t see from the survival curve that it will ever translate into an improvement in survival."
Delcath did not issue a response after the panel’s vote.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting, although a panelist may occasionally be given a waiver. At this meeting, two panelists who had expertise in the topic were given waivers (one panelist is the principal investigator in a study of a competing device and the other works at a medical center where a study of a competing device is being conducted).
About 2,000 cases of ocular melanoma are diagnosed annually in the United States and about 50% metastasize, most often to the liver, according to Delcath. In Europe and Australia, the company markets the device for a broad range of liver metastases, not just those caused by ocular melanoma, according to the company.
SILVER SPRING, MD. – The risks outweigh any possible benefits of treatment with a drug-device combination that delivers melphalan directly to the livers of patients with liver metastases from ocular melanoma, a Food and Drug Administration advisory panel concluded in a 16-0 vote.
At a meeting of the FDA’s Oncologic Drugs Advisory Committee, several panelists said that the treatment was promising but should remain investigational, given its marked toxicity and lack of effect on overall survival.
The Melblez Kit is a combination of melphalan and the Delcath Hepatic Delivery System, which includes two catheters and an extracorporeal hemofiltration component. The catheter is used to administer high doses of the chemotherapy drug directly to the liver via the hepatic artery, and the hemofiltration component lowers the drug level before the blood is returned to the systemic circulation, according to the manufacturer, Delcath Systems. Patients are hospitalized for about 4 days for the procedure, which takes about 3 hours and is performed at 4-week intervals under general anesthesia.
There are no FDA-approved treatments for patients with unresectable metastatic ocular melanoma to the liver, which is the indication under FDA review.
Treatment with the kit was associated with antitumor activity, but it also was associated with fatal and life-threatening adverse reactions. There was a trend towards a detrimental effect on survival, and the risk evaluation and mitigation strategy (REMS) proposed by the company to address those risks "will not improve the observed benefit-risk profile," Dr. Geoffrey Kim, a medical officer in the FDA’s office of hematology and oncology products, told the panel.
In an open-label, randomized multicenter phase-III study conducted between 2006 and 2010 in the United States, the device was used to treat 44 patients. Their outcomes were compared with those of 49 matched patients given the best alternative care (BAC). All patients had surgically unresectable hepatic-dominant metastatic ocular or cutaneous melanoma (89% had ocular melanoma, and almost half were treated at the National Cancer Institute). Subjects were treated until their hepatic disease progressed. The dose administered with the Melblez Kit was 3.0 mg/kg for a median of three treatment cycles and a median of 120 days; best alternative care included systemic chemotherapy in 49% of patients and intrahepatic chemotherapy in 22%.
The primary end point, median hepatic progression-free survival (hPFS) was 7 months among those on the device, compared with 1.6 months among those on BAC, a statistically significant difference that represented a 61% reduction in risk (hazard ratio, 0.39), according to the company. The median overall PFS was 4.8 months among those treated with the device, compared with 1.6 months among those on BAC, also a statistically significant difference.
Overall survival was comparable: 9.8 months in the device-treated group and 9.9 months in those on best alternative care. Further, almost 80% of patients in the Melblez Kit arm had a serious adverse event and almost 70% had a grade-4 adverse event. With best alternative care, the rate of serious adverse events was 16% and the rate of grade-4 events was 2%. No patients on best alternative care died because of an adverse event. Three patients treated with the drug-device died from adverse events.
The adverse reactions in a combined population of 121 patients in the phase-III and phase-II studies and in 28 patients in the BAC arm who crossed over to treatment with the device included toxic deaths in 7% (including cases of hepatic failure, streptococcal sepsis, and GI hemorrhage), cerebral infarction in 4%, MI in 2%, and grade-4 bone marrow suppression with a median time to recovery of more than 1 week in more than 70%. About half had to be rehospitalized for an adverse event.
For a cancer treatment, this safety profile "is unprecedented, in terms of the toxicity," Dr. Richard Pazdur, director of the FDA’s office of hematology and oncology products, remarked.
After the vote, panel member Dr. Louis Diehl, professor of medicine at Duke University, Durham, N.C., said that progression-free survival is valued in studies as an indicator of improved quality of life and it can be an early marker of increased survival. "Unfortunately, this treatment has an increase in morbidity and an increase in mortality and I can’t see from the survival curve that it will ever translate into an improvement in survival."
Delcath did not issue a response after the panel’s vote.
The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting, although a panelist may occasionally be given a waiver. At this meeting, two panelists who had expertise in the topic were given waivers (one panelist is the principal investigator in a study of a competing device and the other works at a medical center where a study of a competing device is being conducted).
About 2,000 cases of ocular melanoma are diagnosed annually in the United States and about 50% metastasize, most often to the liver, according to Delcath. In Europe and Australia, the company markets the device for a broad range of liver metastases, not just those caused by ocular melanoma, according to the company.
AT AN FDA ADVISORY PANEL MEETING
Palliative Care Competencies for Surgeons
Most surgeons are familiar with the Accreditation Council for Graduate Medical Education’s core competencies. However, many likely view them as an onerous set of requirements that have no tangible impact on their day-to-day surgical practice. When I talk to my surgical colleagues about palliative care competencies for surgeons, typical responses include: "That doesn’t apply to me, I don’t treat cancer patients" or "I don’t do much end-of-life care."
The fact is, palliative care isn’t just for cancer patients or those at the end of life. In 2003, the Surgeons Palliative Care Workgroup of the American College of Surgeons (ACS) established core competencies in two basic elements of palliative care—pain management and communication skills—to be essential for all surgeons. Rather than seeing these as yet another list of "to do" items, these competencies represent the very essence of what it means to be a surgeon.
The good news: Many surgeons routinely demonstrate proficiency in these core competencies without even thinking about it. It is time for us to take our rightful place among the better recognized members of the palliative care community. We are, as described by Dr. Charles von Gunten, Provost of the Institute for Palliative Medicine, primary palliative care providers. According to his definition, primary palliative care refers to the "basic skills and competencies necessary to relieve pain and other distressing symptoms." The application of basic palliative care principles to surgery is a fundamental component of good surgical clinical care.
Palliative care is provided throughout the course of a patient’s care, from diagnosis to the end of life. Surgeons are routinely engaged throughout the spectrum of care. Before a knife is ever raised to skin, surgeons utilize their communication skills to establish the covenant that forms the basis of every surgeon-patient relationship. Furthermore, it is through competent and compassionate communication that surgical plans are formed. Every surgeon is familiar with the process of informed consent which is the truest demonstration of surgical communication competency as we discuss a proposed procedure and its anticipated benefits (and risks) in a way that is patient specific, patient focused.
Unfortunately, recent literature suggests that our non-procedural colleagues do not always recognize or appreciate the communication that occurs between a surgeon and his/her patient. This lack of understanding is manifest in an editorial in the by Amy S. Kelley, "Treatment intensity at end of life – time to act on the evidence" (Lancet;2011;378:1364-5), in which she states: "... surgical procedures are highly reimbursed and, therefore, surgeons and hospitals are often financially motivated to operate regardless of the patient\'s preferences or goals. " In other words, there is at least the perception of surgeons as practitioners who "cut first and ask questions later."
Our first challenge is that we need to increase awareness regarding surgical communication competency to other members of the patient’s care team. It is our responsibility to inform other clinicians about these communications lest we continue to be regarded as technicians who operate without regard for patient preferences or goals.
The second palliative care core competency for surgeons is pain management. Surgeons are uniquely aware of the complexities of pain experienced by our patients. We are routinely called to apply surgical procedures for the relief of pain and, in the process, create pain (albeit temporary in most cases). Therefore, relief of suffering represents a core principle of surgical care and the responsibility to provide adequate pain control is ours primarily. Unfortunately, basic principles of pain management are often not routinely taught during surgical training.
Our second challenge is that we need to rededicate ourselves to excellence in pain management. "Surgical Palliative Care: A Resident’s Guide" is a free resource published by the Educational Division of the ACS that includes essential information on pain and other symptom management as well as a variety of key aspects of palliative care relative to surgical trainees and practicing surgeons alike.
Competencies in communication and pain management not only represent the two basic elements of palliative care for all surgeons, they embody the very basis of excellent surgical care.
Bridget N. Fahy, MD, FACS is an Assistant Professor of Surgery with Weill Cornell Medical College and an Attending Surgeon with The Methodist Hospital Department of Surgery. Her clinical practice is divided between the surgical management of solid organ malignancies and palliative care. She recently earned board certification in Hospice and Palliative Medicine. In addition to her clinical practice, she also serves as the Physician Leader of the Bioethics Program at The Methodist Hospital. Dr Fahy has no conflicts of interest to disclose.
Most surgeons are familiar with the Accreditation Council for Graduate Medical Education’s core competencies. However, many likely view them as an onerous set of requirements that have no tangible impact on their day-to-day surgical practice. When I talk to my surgical colleagues about palliative care competencies for surgeons, typical responses include: "That doesn’t apply to me, I don’t treat cancer patients" or "I don’t do much end-of-life care."
The fact is, palliative care isn’t just for cancer patients or those at the end of life. In 2003, the Surgeons Palliative Care Workgroup of the American College of Surgeons (ACS) established core competencies in two basic elements of palliative care—pain management and communication skills—to be essential for all surgeons. Rather than seeing these as yet another list of "to do" items, these competencies represent the very essence of what it means to be a surgeon.
The good news: Many surgeons routinely demonstrate proficiency in these core competencies without even thinking about it. It is time for us to take our rightful place among the better recognized members of the palliative care community. We are, as described by Dr. Charles von Gunten, Provost of the Institute for Palliative Medicine, primary palliative care providers. According to his definition, primary palliative care refers to the "basic skills and competencies necessary to relieve pain and other distressing symptoms." The application of basic palliative care principles to surgery is a fundamental component of good surgical clinical care.
Palliative care is provided throughout the course of a patient’s care, from diagnosis to the end of life. Surgeons are routinely engaged throughout the spectrum of care. Before a knife is ever raised to skin, surgeons utilize their communication skills to establish the covenant that forms the basis of every surgeon-patient relationship. Furthermore, it is through competent and compassionate communication that surgical plans are formed. Every surgeon is familiar with the process of informed consent which is the truest demonstration of surgical communication competency as we discuss a proposed procedure and its anticipated benefits (and risks) in a way that is patient specific, patient focused.
Unfortunately, recent literature suggests that our non-procedural colleagues do not always recognize or appreciate the communication that occurs between a surgeon and his/her patient. This lack of understanding is manifest in an editorial in the by Amy S. Kelley, "Treatment intensity at end of life – time to act on the evidence" (Lancet;2011;378:1364-5), in which she states: "... surgical procedures are highly reimbursed and, therefore, surgeons and hospitals are often financially motivated to operate regardless of the patient\'s preferences or goals. " In other words, there is at least the perception of surgeons as practitioners who "cut first and ask questions later."
Our first challenge is that we need to increase awareness regarding surgical communication competency to other members of the patient’s care team. It is our responsibility to inform other clinicians about these communications lest we continue to be regarded as technicians who operate without regard for patient preferences or goals.
The second palliative care core competency for surgeons is pain management. Surgeons are uniquely aware of the complexities of pain experienced by our patients. We are routinely called to apply surgical procedures for the relief of pain and, in the process, create pain (albeit temporary in most cases). Therefore, relief of suffering represents a core principle of surgical care and the responsibility to provide adequate pain control is ours primarily. Unfortunately, basic principles of pain management are often not routinely taught during surgical training.
Our second challenge is that we need to rededicate ourselves to excellence in pain management. "Surgical Palliative Care: A Resident’s Guide" is a free resource published by the Educational Division of the ACS that includes essential information on pain and other symptom management as well as a variety of key aspects of palliative care relative to surgical trainees and practicing surgeons alike.
Competencies in communication and pain management not only represent the two basic elements of palliative care for all surgeons, they embody the very basis of excellent surgical care.
Bridget N. Fahy, MD, FACS is an Assistant Professor of Surgery with Weill Cornell Medical College and an Attending Surgeon with The Methodist Hospital Department of Surgery. Her clinical practice is divided between the surgical management of solid organ malignancies and palliative care. She recently earned board certification in Hospice and Palliative Medicine. In addition to her clinical practice, she also serves as the Physician Leader of the Bioethics Program at The Methodist Hospital. Dr Fahy has no conflicts of interest to disclose.
Most surgeons are familiar with the Accreditation Council for Graduate Medical Education’s core competencies. However, many likely view them as an onerous set of requirements that have no tangible impact on their day-to-day surgical practice. When I talk to my surgical colleagues about palliative care competencies for surgeons, typical responses include: "That doesn’t apply to me, I don’t treat cancer patients" or "I don’t do much end-of-life care."
The fact is, palliative care isn’t just for cancer patients or those at the end of life. In 2003, the Surgeons Palliative Care Workgroup of the American College of Surgeons (ACS) established core competencies in two basic elements of palliative care—pain management and communication skills—to be essential for all surgeons. Rather than seeing these as yet another list of "to do" items, these competencies represent the very essence of what it means to be a surgeon.
The good news: Many surgeons routinely demonstrate proficiency in these core competencies without even thinking about it. It is time for us to take our rightful place among the better recognized members of the palliative care community. We are, as described by Dr. Charles von Gunten, Provost of the Institute for Palliative Medicine, primary palliative care providers. According to his definition, primary palliative care refers to the "basic skills and competencies necessary to relieve pain and other distressing symptoms." The application of basic palliative care principles to surgery is a fundamental component of good surgical clinical care.
Palliative care is provided throughout the course of a patient’s care, from diagnosis to the end of life. Surgeons are routinely engaged throughout the spectrum of care. Before a knife is ever raised to skin, surgeons utilize their communication skills to establish the covenant that forms the basis of every surgeon-patient relationship. Furthermore, it is through competent and compassionate communication that surgical plans are formed. Every surgeon is familiar with the process of informed consent which is the truest demonstration of surgical communication competency as we discuss a proposed procedure and its anticipated benefits (and risks) in a way that is patient specific, patient focused.
Unfortunately, recent literature suggests that our non-procedural colleagues do not always recognize or appreciate the communication that occurs between a surgeon and his/her patient. This lack of understanding is manifest in an editorial in the by Amy S. Kelley, "Treatment intensity at end of life – time to act on the evidence" (Lancet;2011;378:1364-5), in which she states: "... surgical procedures are highly reimbursed and, therefore, surgeons and hospitals are often financially motivated to operate regardless of the patient\'s preferences or goals. " In other words, there is at least the perception of surgeons as practitioners who "cut first and ask questions later."
Our first challenge is that we need to increase awareness regarding surgical communication competency to other members of the patient’s care team. It is our responsibility to inform other clinicians about these communications lest we continue to be regarded as technicians who operate without regard for patient preferences or goals.
The second palliative care core competency for surgeons is pain management. Surgeons are uniquely aware of the complexities of pain experienced by our patients. We are routinely called to apply surgical procedures for the relief of pain and, in the process, create pain (albeit temporary in most cases). Therefore, relief of suffering represents a core principle of surgical care and the responsibility to provide adequate pain control is ours primarily. Unfortunately, basic principles of pain management are often not routinely taught during surgical training.
Our second challenge is that we need to rededicate ourselves to excellence in pain management. "Surgical Palliative Care: A Resident’s Guide" is a free resource published by the Educational Division of the ACS that includes essential information on pain and other symptom management as well as a variety of key aspects of palliative care relative to surgical trainees and practicing surgeons alike.
Competencies in communication and pain management not only represent the two basic elements of palliative care for all surgeons, they embody the very basis of excellent surgical care.
Bridget N. Fahy, MD, FACS is an Assistant Professor of Surgery with Weill Cornell Medical College and an Attending Surgeon with The Methodist Hospital Department of Surgery. Her clinical practice is divided between the surgical management of solid organ malignancies and palliative care. She recently earned board certification in Hospice and Palliative Medicine. In addition to her clinical practice, she also serves as the Physician Leader of the Bioethics Program at The Methodist Hospital. Dr Fahy has no conflicts of interest to disclose.
More than 100 hospitals participate in ACS NSQIP CMS Hospital Compare
A total of 102 hospitals now are participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) and the Centers for Medicare & Medicaid Services (CMS) collaborative pilot project that allows ACS NSQIP hospitals to voluntarily report surgical performance measures on the CMS Hospital Compare website. On April 18, the results of the second reporting period were posted to the Hospital Compare website. Since the initial reporting period ended in October 2012, 23 additional hospitals have volunteered to publicly report their ACS NSQIP performance measures. View the results for the 102 hospitals.
Participating hospitals may report results for one or any combination of three National Quality Forum (NQF)–endorsed surgical measures: elderly surgical outcomes, colon surgical outcomes, and lower-extremity bypass surgical outcomes.
Registration is open for the next reporting period scheduled for October 2013. View additional information at http://site.acsnsqip.org/ regarding this initiative and registration procedures.
A total of 102 hospitals now are participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) and the Centers for Medicare & Medicaid Services (CMS) collaborative pilot project that allows ACS NSQIP hospitals to voluntarily report surgical performance measures on the CMS Hospital Compare website. On April 18, the results of the second reporting period were posted to the Hospital Compare website. Since the initial reporting period ended in October 2012, 23 additional hospitals have volunteered to publicly report their ACS NSQIP performance measures. View the results for the 102 hospitals.
Participating hospitals may report results for one or any combination of three National Quality Forum (NQF)–endorsed surgical measures: elderly surgical outcomes, colon surgical outcomes, and lower-extremity bypass surgical outcomes.
Registration is open for the next reporting period scheduled for October 2013. View additional information at http://site.acsnsqip.org/ regarding this initiative and registration procedures.
A total of 102 hospitals now are participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) and the Centers for Medicare & Medicaid Services (CMS) collaborative pilot project that allows ACS NSQIP hospitals to voluntarily report surgical performance measures on the CMS Hospital Compare website. On April 18, the results of the second reporting period were posted to the Hospital Compare website. Since the initial reporting period ended in October 2012, 23 additional hospitals have volunteered to publicly report their ACS NSQIP performance measures. View the results for the 102 hospitals.
Participating hospitals may report results for one or any combination of three National Quality Forum (NQF)–endorsed surgical measures: elderly surgical outcomes, colon surgical outcomes, and lower-extremity bypass surgical outcomes.
Registration is open for the next reporting period scheduled for October 2013. View additional information at http://site.acsnsqip.org/ regarding this initiative and registration procedures.
Surgeon well-being: A resource for surgeons
The practice of surgery provides significant privileges and rewards, but with accompanying responsibilities and challenges. As surgeons become more experienced and mature professionally, some of the most difficult issues they face fall outside the realm of patient care and medical knowledge. At times, behavioral, physical, judgment and impairment issues may damage and derail a surgeon’s ability to practice safely and effectively. Most surgeons know colleagues whose careers have been limited by these issues; some have personal experience. To help surgeons develop a better understanding of these problems, the American College of Surgeons (ACS) Board of Governors Committee on Physician Competency and Health has posted Being Well and Staying Competent: Challenges for the Surgeon on the members-only Web portal at www.efacs.org.
Ongoing concern
In the past, the expectation was that surgeons dealing with fatigue, illness, and other issues that can lead to impairment could, and should, "tough it out". The occasional acknowledgement of human frailty was mostly limited to cautionary tales of surgeons who were considered not resilient enough to meet the demands of surgical practice. Impairment and how to address it is rarely a component of surgical training; hence, most surgeons are far more comfortable managing a bowel obstruction than an impaired colleague. Additionally, surgeons may not realize that some of the personality traits we value in ourselves and our colleagues (compulsiveness, a heightened sense of responsibility, perfectionism) may predispose them to dysfunction and impairment. Consequently, situations and behaviors that are detrimental to patient care and surgeon wellbeing are sometimes ignored and rationalized.
The Governors’ Committee on Competency and Health has been studying these issues since 2008, when, with the support of the College, the committee commissioned a survey of the Fellows, asking about personal characteristics, practice situations, quality of life, professional satisfaction, issues relating to fatigue, and other topics. Most surgeons described good quality of life, and nearly three-quarters stated that, given the choice, they would again choose surgery as a career. Nonetheless, the large-scale response of nearly 8,000 Fellows reflected significant rates of burnout, depression, and other issues related to professional satisfaction and work-life balance.
Another survey performed in 2010 had a somewhat different focus, with questions addressing interpersonal relationships, work-life balance, coping mechanisms, and substance abuse. Responses to this study corroborated previous findings but also demonstrated high rates of substance abuse. Surgeons who reported making a major medical mistake in the three months prior to completing the survey were much more likely to offer responses indicating burnout, particularly emotional exhaustion and depersonalization, regardless of whether the patient was harmed.
A new resource
The committee examined the survey results carefully and solicited feedback, questions, and concerns from Fellows and decided to develop a readily available resource that Fellows could use to both identify and address these concerns. A previous pamphlet on The Impaired Surgeon was published in 1992 through the ACS Committee on Physicians’ Health (the precursor to the current committee) and revised in 1995. This resource primarily dealt with impairment due to alcohol or substance abuse. The evidence from the surveys and our personal experience suggested that the challenges facing surgeons are more wide-ranging. Discussion among committee members about the complexities of the identified problems led to the topic selections for Being Well and Staying Competent: Challenges for the Surgeon.
The committee members who contributed to this resource acknowledge that few of them are experts in these areas, but are surgeons with practical experience who are aware of the challenges and seek to offer assistance. Topics explored in the document include surgeon burnout, substance abuse, sleep deprivation, age impairment, the disruptive physician, boundaries, and credentialing issues.
The committee chose to post the document on ACS Portal to provide rapid access to this resource in a digital format. In addition, select sections of the resource are serving as the basis of a series of article in the ACS Bulletin, http://bulletin.facs.org/.
The practice of surgery provides significant privileges and rewards, but with accompanying responsibilities and challenges. As surgeons become more experienced and mature professionally, some of the most difficult issues they face fall outside the realm of patient care and medical knowledge. At times, behavioral, physical, judgment and impairment issues may damage and derail a surgeon’s ability to practice safely and effectively. Most surgeons know colleagues whose careers have been limited by these issues; some have personal experience. To help surgeons develop a better understanding of these problems, the American College of Surgeons (ACS) Board of Governors Committee on Physician Competency and Health has posted Being Well and Staying Competent: Challenges for the Surgeon on the members-only Web portal at www.efacs.org.
Ongoing concern
In the past, the expectation was that surgeons dealing with fatigue, illness, and other issues that can lead to impairment could, and should, "tough it out". The occasional acknowledgement of human frailty was mostly limited to cautionary tales of surgeons who were considered not resilient enough to meet the demands of surgical practice. Impairment and how to address it is rarely a component of surgical training; hence, most surgeons are far more comfortable managing a bowel obstruction than an impaired colleague. Additionally, surgeons may not realize that some of the personality traits we value in ourselves and our colleagues (compulsiveness, a heightened sense of responsibility, perfectionism) may predispose them to dysfunction and impairment. Consequently, situations and behaviors that are detrimental to patient care and surgeon wellbeing are sometimes ignored and rationalized.
The Governors’ Committee on Competency and Health has been studying these issues since 2008, when, with the support of the College, the committee commissioned a survey of the Fellows, asking about personal characteristics, practice situations, quality of life, professional satisfaction, issues relating to fatigue, and other topics. Most surgeons described good quality of life, and nearly three-quarters stated that, given the choice, they would again choose surgery as a career. Nonetheless, the large-scale response of nearly 8,000 Fellows reflected significant rates of burnout, depression, and other issues related to professional satisfaction and work-life balance.
Another survey performed in 2010 had a somewhat different focus, with questions addressing interpersonal relationships, work-life balance, coping mechanisms, and substance abuse. Responses to this study corroborated previous findings but also demonstrated high rates of substance abuse. Surgeons who reported making a major medical mistake in the three months prior to completing the survey were much more likely to offer responses indicating burnout, particularly emotional exhaustion and depersonalization, regardless of whether the patient was harmed.
A new resource
The committee examined the survey results carefully and solicited feedback, questions, and concerns from Fellows and decided to develop a readily available resource that Fellows could use to both identify and address these concerns. A previous pamphlet on The Impaired Surgeon was published in 1992 through the ACS Committee on Physicians’ Health (the precursor to the current committee) and revised in 1995. This resource primarily dealt with impairment due to alcohol or substance abuse. The evidence from the surveys and our personal experience suggested that the challenges facing surgeons are more wide-ranging. Discussion among committee members about the complexities of the identified problems led to the topic selections for Being Well and Staying Competent: Challenges for the Surgeon.
The committee members who contributed to this resource acknowledge that few of them are experts in these areas, but are surgeons with practical experience who are aware of the challenges and seek to offer assistance. Topics explored in the document include surgeon burnout, substance abuse, sleep deprivation, age impairment, the disruptive physician, boundaries, and credentialing issues.
The committee chose to post the document on ACS Portal to provide rapid access to this resource in a digital format. In addition, select sections of the resource are serving as the basis of a series of article in the ACS Bulletin, http://bulletin.facs.org/.
The practice of surgery provides significant privileges and rewards, but with accompanying responsibilities and challenges. As surgeons become more experienced and mature professionally, some of the most difficult issues they face fall outside the realm of patient care and medical knowledge. At times, behavioral, physical, judgment and impairment issues may damage and derail a surgeon’s ability to practice safely and effectively. Most surgeons know colleagues whose careers have been limited by these issues; some have personal experience. To help surgeons develop a better understanding of these problems, the American College of Surgeons (ACS) Board of Governors Committee on Physician Competency and Health has posted Being Well and Staying Competent: Challenges for the Surgeon on the members-only Web portal at www.efacs.org.
Ongoing concern
In the past, the expectation was that surgeons dealing with fatigue, illness, and other issues that can lead to impairment could, and should, "tough it out". The occasional acknowledgement of human frailty was mostly limited to cautionary tales of surgeons who were considered not resilient enough to meet the demands of surgical practice. Impairment and how to address it is rarely a component of surgical training; hence, most surgeons are far more comfortable managing a bowel obstruction than an impaired colleague. Additionally, surgeons may not realize that some of the personality traits we value in ourselves and our colleagues (compulsiveness, a heightened sense of responsibility, perfectionism) may predispose them to dysfunction and impairment. Consequently, situations and behaviors that are detrimental to patient care and surgeon wellbeing are sometimes ignored and rationalized.
The Governors’ Committee on Competency and Health has been studying these issues since 2008, when, with the support of the College, the committee commissioned a survey of the Fellows, asking about personal characteristics, practice situations, quality of life, professional satisfaction, issues relating to fatigue, and other topics. Most surgeons described good quality of life, and nearly three-quarters stated that, given the choice, they would again choose surgery as a career. Nonetheless, the large-scale response of nearly 8,000 Fellows reflected significant rates of burnout, depression, and other issues related to professional satisfaction and work-life balance.
Another survey performed in 2010 had a somewhat different focus, with questions addressing interpersonal relationships, work-life balance, coping mechanisms, and substance abuse. Responses to this study corroborated previous findings but also demonstrated high rates of substance abuse. Surgeons who reported making a major medical mistake in the three months prior to completing the survey were much more likely to offer responses indicating burnout, particularly emotional exhaustion and depersonalization, regardless of whether the patient was harmed.
A new resource
The committee examined the survey results carefully and solicited feedback, questions, and concerns from Fellows and decided to develop a readily available resource that Fellows could use to both identify and address these concerns. A previous pamphlet on The Impaired Surgeon was published in 1992 through the ACS Committee on Physicians’ Health (the precursor to the current committee) and revised in 1995. This resource primarily dealt with impairment due to alcohol or substance abuse. The evidence from the surveys and our personal experience suggested that the challenges facing surgeons are more wide-ranging. Discussion among committee members about the complexities of the identified problems led to the topic selections for Being Well and Staying Competent: Challenges for the Surgeon.
The committee members who contributed to this resource acknowledge that few of them are experts in these areas, but are surgeons with practical experience who are aware of the challenges and seek to offer assistance. Topics explored in the document include surgeon burnout, substance abuse, sleep deprivation, age impairment, the disruptive physician, boundaries, and credentialing issues.
The committee chose to post the document on ACS Portal to provide rapid access to this resource in a digital format. In addition, select sections of the resource are serving as the basis of a series of article in the ACS Bulletin, http://bulletin.facs.org/.
Save Your Tickets
To me the most daunting of speaking assignments is the after-dinner presentation. By the time the speech begins, the audience has been well fed, and many have emptied their wine glasses and refilled them several times. Bedtime is approaching, and the often somnolent listeners are nowhere near the peak of their powers of comprehension.
I have heard many such presentations, usually at surgical meetings and several from notable, even famous, personalities who had considerable wisdom to convey. Unfortunately, although I do remember the names of many of the speakers, their messages, if they were captured by the memory circuits of my brain, have since escaped me. There is one notable exception: a talk entitled "Tickets" given by Dr. Jerry Shuck, who was then professor and chairman of surgery at Case Western Reserve University. The occasion was the annual dinner of Surgical Biology Club III that is held during the American College of Surgeons fall Congress. This meeting occurred in the mid-1980s soon after I had assumed a major administrative responsibility as chair of a department of surgery. At the time I was the definition of a young, unseasoned, and inexperienced leader. The wisdom so unexpectedly imparted that evening goes to the core of exemplary leadership and has served me well over many years. In fact, I consider the message I received so important that it became a central tenet of a publication I wrote on surgical leadership several years later (Rikkers LF: Surgical leadership: lessons learned. Surgery 2004;140:717-24).
Virtually all surgeons are expected to be leaders. This responsibility may be limited to leading their operating room team or as extensive as guiding a large multidisciplinary health care team or a major academic department of surgery. Unfortunately leadership skills are not a component of the curriculum of most surgical residencies. Many surgeons have leadership responsibilities suddenly thrust upon them, and they are often ill-prepared. Courses in leadership offered nationally are usually expensive both in the cost of participating as well as time away from work. An exception is the ACS’s Surgeons As Leaders course that is conducted over a 3-day span. Thus, whenever a pearl regarding this challenging responsibility that we all face unexpectedly appears, it is essential to tuck it away into the recesses of one’s brain so that it can be quickly mobilized when needed. That evening at the Surgical Biology Club III dinner so many years ago was one such opportunity for me.
Shuck’s thesis was that a leader is presented with a gift of tickets when taking on a new position. In a sense, the tickets represent the goodwill freely given from the institution and the unit led at the beginning of one’s term. This is often defined as the "honeymoon period." Subsequent success or failure of the leader is greatly dependent on how these tickets are spent. Unfortunately, there are hard and fast rules of this ticket game that must be adhered to. Most importantly, once tickets are spent, they cannot be replenished. Second, one is never told exactly how many tickets he or she has been given. The bottom line is that one must be extremely careful in how the tickets are used. In other words, throughout the course of one’s leadership, issues and battles that require expenditure of tickets must be carefully chosen. Ticket spendthrifts tend to squander their tickets on relatively insignificant concerns early in their tenure with none left when a truly game-changing matter arises. A key concept that must be understood early on by inexperienced leaders is that most apparent crises are not crises at all. The tincture of time resolves or modulates most of them. Careful study followed by benign neglect is a wise course in many cases. Immediate and decisive action not preceded by detailed analysis, although occasionally merited, usually results in an unwise and unnecessary disbursement of tickets. The supposed crisis of today is often forgotten by tomorrow, even by those who were embroiled in it.
Another important notion for the unseasoned leader to grasp is the fact that we live in a gray world and that black or white issues are quite uncommon. The art of compromise, so poorly understood by our present national leaders, can be a crucial ticket saver. Rapid, definitive, and possibly risky decision-making is warranted only when one’s most cherished values are threatened. However, such instances should be infrequently encountered even during a long career in leadership. One absolute in ticket spending is to never waste tickets on those things that cannot be changed. The Alcoholics Anonymous serenity prayer provides sage advice for successful leadership: "God, grant me the serenity to accept the things I cannot change, the courage to change the things I can, and wisdom to know the difference."
In my personal leadership odyssey as a department chair that spanned 24 years, I confronted only two controversies that merited expenditure of my valuable tickets. When it was all over, no one could tell me how many I had left, but I am happy to pass the residual on to my successor. He may need them in the increasingly complex world in which surgeons live.
So the next time you purposely or inadvertently happen upon an after-dinner presentation, refuse that second glass of wine and tune your antenna into whatever rare bit of wisdom might be forthcoming. Although I can promise nothing, you just might gain an insight that will serve you well the rest of your life.
To me the most daunting of speaking assignments is the after-dinner presentation. By the time the speech begins, the audience has been well fed, and many have emptied their wine glasses and refilled them several times. Bedtime is approaching, and the often somnolent listeners are nowhere near the peak of their powers of comprehension.
I have heard many such presentations, usually at surgical meetings and several from notable, even famous, personalities who had considerable wisdom to convey. Unfortunately, although I do remember the names of many of the speakers, their messages, if they were captured by the memory circuits of my brain, have since escaped me. There is one notable exception: a talk entitled "Tickets" given by Dr. Jerry Shuck, who was then professor and chairman of surgery at Case Western Reserve University. The occasion was the annual dinner of Surgical Biology Club III that is held during the American College of Surgeons fall Congress. This meeting occurred in the mid-1980s soon after I had assumed a major administrative responsibility as chair of a department of surgery. At the time I was the definition of a young, unseasoned, and inexperienced leader. The wisdom so unexpectedly imparted that evening goes to the core of exemplary leadership and has served me well over many years. In fact, I consider the message I received so important that it became a central tenet of a publication I wrote on surgical leadership several years later (Rikkers LF: Surgical leadership: lessons learned. Surgery 2004;140:717-24).
Virtually all surgeons are expected to be leaders. This responsibility may be limited to leading their operating room team or as extensive as guiding a large multidisciplinary health care team or a major academic department of surgery. Unfortunately leadership skills are not a component of the curriculum of most surgical residencies. Many surgeons have leadership responsibilities suddenly thrust upon them, and they are often ill-prepared. Courses in leadership offered nationally are usually expensive both in the cost of participating as well as time away from work. An exception is the ACS’s Surgeons As Leaders course that is conducted over a 3-day span. Thus, whenever a pearl regarding this challenging responsibility that we all face unexpectedly appears, it is essential to tuck it away into the recesses of one’s brain so that it can be quickly mobilized when needed. That evening at the Surgical Biology Club III dinner so many years ago was one such opportunity for me.
Shuck’s thesis was that a leader is presented with a gift of tickets when taking on a new position. In a sense, the tickets represent the goodwill freely given from the institution and the unit led at the beginning of one’s term. This is often defined as the "honeymoon period." Subsequent success or failure of the leader is greatly dependent on how these tickets are spent. Unfortunately, there are hard and fast rules of this ticket game that must be adhered to. Most importantly, once tickets are spent, they cannot be replenished. Second, one is never told exactly how many tickets he or she has been given. The bottom line is that one must be extremely careful in how the tickets are used. In other words, throughout the course of one’s leadership, issues and battles that require expenditure of tickets must be carefully chosen. Ticket spendthrifts tend to squander their tickets on relatively insignificant concerns early in their tenure with none left when a truly game-changing matter arises. A key concept that must be understood early on by inexperienced leaders is that most apparent crises are not crises at all. The tincture of time resolves or modulates most of them. Careful study followed by benign neglect is a wise course in many cases. Immediate and decisive action not preceded by detailed analysis, although occasionally merited, usually results in an unwise and unnecessary disbursement of tickets. The supposed crisis of today is often forgotten by tomorrow, even by those who were embroiled in it.
Another important notion for the unseasoned leader to grasp is the fact that we live in a gray world and that black or white issues are quite uncommon. The art of compromise, so poorly understood by our present national leaders, can be a crucial ticket saver. Rapid, definitive, and possibly risky decision-making is warranted only when one’s most cherished values are threatened. However, such instances should be infrequently encountered even during a long career in leadership. One absolute in ticket spending is to never waste tickets on those things that cannot be changed. The Alcoholics Anonymous serenity prayer provides sage advice for successful leadership: "God, grant me the serenity to accept the things I cannot change, the courage to change the things I can, and wisdom to know the difference."
In my personal leadership odyssey as a department chair that spanned 24 years, I confronted only two controversies that merited expenditure of my valuable tickets. When it was all over, no one could tell me how many I had left, but I am happy to pass the residual on to my successor. He may need them in the increasingly complex world in which surgeons live.
So the next time you purposely or inadvertently happen upon an after-dinner presentation, refuse that second glass of wine and tune your antenna into whatever rare bit of wisdom might be forthcoming. Although I can promise nothing, you just might gain an insight that will serve you well the rest of your life.
To me the most daunting of speaking assignments is the after-dinner presentation. By the time the speech begins, the audience has been well fed, and many have emptied their wine glasses and refilled them several times. Bedtime is approaching, and the often somnolent listeners are nowhere near the peak of their powers of comprehension.
I have heard many such presentations, usually at surgical meetings and several from notable, even famous, personalities who had considerable wisdom to convey. Unfortunately, although I do remember the names of many of the speakers, their messages, if they were captured by the memory circuits of my brain, have since escaped me. There is one notable exception: a talk entitled "Tickets" given by Dr. Jerry Shuck, who was then professor and chairman of surgery at Case Western Reserve University. The occasion was the annual dinner of Surgical Biology Club III that is held during the American College of Surgeons fall Congress. This meeting occurred in the mid-1980s soon after I had assumed a major administrative responsibility as chair of a department of surgery. At the time I was the definition of a young, unseasoned, and inexperienced leader. The wisdom so unexpectedly imparted that evening goes to the core of exemplary leadership and has served me well over many years. In fact, I consider the message I received so important that it became a central tenet of a publication I wrote on surgical leadership several years later (Rikkers LF: Surgical leadership: lessons learned. Surgery 2004;140:717-24).
Virtually all surgeons are expected to be leaders. This responsibility may be limited to leading their operating room team or as extensive as guiding a large multidisciplinary health care team or a major academic department of surgery. Unfortunately leadership skills are not a component of the curriculum of most surgical residencies. Many surgeons have leadership responsibilities suddenly thrust upon them, and they are often ill-prepared. Courses in leadership offered nationally are usually expensive both in the cost of participating as well as time away from work. An exception is the ACS’s Surgeons As Leaders course that is conducted over a 3-day span. Thus, whenever a pearl regarding this challenging responsibility that we all face unexpectedly appears, it is essential to tuck it away into the recesses of one’s brain so that it can be quickly mobilized when needed. That evening at the Surgical Biology Club III dinner so many years ago was one such opportunity for me.
Shuck’s thesis was that a leader is presented with a gift of tickets when taking on a new position. In a sense, the tickets represent the goodwill freely given from the institution and the unit led at the beginning of one’s term. This is often defined as the "honeymoon period." Subsequent success or failure of the leader is greatly dependent on how these tickets are spent. Unfortunately, there are hard and fast rules of this ticket game that must be adhered to. Most importantly, once tickets are spent, they cannot be replenished. Second, one is never told exactly how many tickets he or she has been given. The bottom line is that one must be extremely careful in how the tickets are used. In other words, throughout the course of one’s leadership, issues and battles that require expenditure of tickets must be carefully chosen. Ticket spendthrifts tend to squander their tickets on relatively insignificant concerns early in their tenure with none left when a truly game-changing matter arises. A key concept that must be understood early on by inexperienced leaders is that most apparent crises are not crises at all. The tincture of time resolves or modulates most of them. Careful study followed by benign neglect is a wise course in many cases. Immediate and decisive action not preceded by detailed analysis, although occasionally merited, usually results in an unwise and unnecessary disbursement of tickets. The supposed crisis of today is often forgotten by tomorrow, even by those who were embroiled in it.
Another important notion for the unseasoned leader to grasp is the fact that we live in a gray world and that black or white issues are quite uncommon. The art of compromise, so poorly understood by our present national leaders, can be a crucial ticket saver. Rapid, definitive, and possibly risky decision-making is warranted only when one’s most cherished values are threatened. However, such instances should be infrequently encountered even during a long career in leadership. One absolute in ticket spending is to never waste tickets on those things that cannot be changed. The Alcoholics Anonymous serenity prayer provides sage advice for successful leadership: "God, grant me the serenity to accept the things I cannot change, the courage to change the things I can, and wisdom to know the difference."
In my personal leadership odyssey as a department chair that spanned 24 years, I confronted only two controversies that merited expenditure of my valuable tickets. When it was all over, no one could tell me how many I had left, but I am happy to pass the residual on to my successor. He may need them in the increasingly complex world in which surgeons live.
So the next time you purposely or inadvertently happen upon an after-dinner presentation, refuse that second glass of wine and tune your antenna into whatever rare bit of wisdom might be forthcoming. Although I can promise nothing, you just might gain an insight that will serve you well the rest of your life.
ACS Division of Education presents new Transition to Practice Program
The American College of Surgeons (ACS) Division of Education has introduced the new ACS Transition to Practice Program in General Surgery. Through this program, residents making the transition to independent practice will:
• Obtain enhanced autonomous experience in broad-based general surgery
• Increase their competence and confidence in clinical matters
• Gain exposure to aspects of practice management
• Experience mentoring with notable practicing surgeons
• Participate in experiential learning tailored to individual needs
The following institutions will offer the ACS Transition to Practice Program starting in July 2013:
Gundersen Lutheran Health System, LaCrosse, WI
Mercer University School of Medicine/Medical Center of Central Georgia, Macon
Ohio State University Wexner Medical Center, Columbus
University of Louisville School of Medicine, KY
University of Tennessee College of Medicine, Chattanooga
ACS Executive Director David B. Hoyt, MD, FACS, offers an overview of the ACS Transition to Practice Program in his "Looking Forward" column in the February 2013 Bulletin of the American College of Surgeons. To view the article, go to http://bulletin.facs.org/2013/02/looking-forward-february-2013. For additional information, please contact the Division of Education at 312-202-5491 or [email protected].
The American College of Surgeons (ACS) Division of Education has introduced the new ACS Transition to Practice Program in General Surgery. Through this program, residents making the transition to independent practice will:
• Obtain enhanced autonomous experience in broad-based general surgery
• Increase their competence and confidence in clinical matters
• Gain exposure to aspects of practice management
• Experience mentoring with notable practicing surgeons
• Participate in experiential learning tailored to individual needs
The following institutions will offer the ACS Transition to Practice Program starting in July 2013:
Gundersen Lutheran Health System, LaCrosse, WI
Mercer University School of Medicine/Medical Center of Central Georgia, Macon
Ohio State University Wexner Medical Center, Columbus
University of Louisville School of Medicine, KY
University of Tennessee College of Medicine, Chattanooga
ACS Executive Director David B. Hoyt, MD, FACS, offers an overview of the ACS Transition to Practice Program in his "Looking Forward" column in the February 2013 Bulletin of the American College of Surgeons. To view the article, go to http://bulletin.facs.org/2013/02/looking-forward-february-2013. For additional information, please contact the Division of Education at 312-202-5491 or [email protected].
The American College of Surgeons (ACS) Division of Education has introduced the new ACS Transition to Practice Program in General Surgery. Through this program, residents making the transition to independent practice will:
• Obtain enhanced autonomous experience in broad-based general surgery
• Increase their competence and confidence in clinical matters
• Gain exposure to aspects of practice management
• Experience mentoring with notable practicing surgeons
• Participate in experiential learning tailored to individual needs
The following institutions will offer the ACS Transition to Practice Program starting in July 2013:
Gundersen Lutheran Health System, LaCrosse, WI
Mercer University School of Medicine/Medical Center of Central Georgia, Macon
Ohio State University Wexner Medical Center, Columbus
University of Louisville School of Medicine, KY
University of Tennessee College of Medicine, Chattanooga
ACS Executive Director David B. Hoyt, MD, FACS, offers an overview of the ACS Transition to Practice Program in his "Looking Forward" column in the February 2013 Bulletin of the American College of Surgeons. To view the article, go to http://bulletin.facs.org/2013/02/looking-forward-february-2013. For additional information, please contact the Division of Education at 312-202-5491 or [email protected].
ACS releases primer on bundled payment
The American College of Surgeons (ACS) recently released the Surgeons and Bundled Payment Models: A Primer for Understanding Alternative Physician Payment Approaches, which summarizes the concept of bundled payment and the effect bundled payment policies could have on surgical practices.
Given the increased focus on bundled payment as an approach to payment reform, the ACS General Surgery Coding and Reimbursement Committee formed a workgroup to develop a process for creating clinically coherent bundled payment models and analyzing the potential opportunities and barriers. The workgroup was composed of surgeon experts in quality and coding and reimbursement and was tasked with: (1) determining the resources and expertise necessary for developing clinically coherent surgical bundles; (2) developing general principles regarding the selection, optimal structure, and function of surgical bundles; (3) providing robust guidelines about which procedures or condition characteristics must be present to construct a usable bundle; and (4) providing insight about which characteristics might make a procedure or condition a poor candidate for a bundled payment model.
In addition to the workgroup findings, the primer provides an overview of existing bundled payment programs at Geisinger Health System in Pennsylvania and BlueCross BlueShield of Massachusetts, as well as common issues to consider when developing a bundle. To access this members-only resource, go to http://efacs.org/advocacy and use your ACS issued username and password.
The American College of Surgeons (ACS) recently released the Surgeons and Bundled Payment Models: A Primer for Understanding Alternative Physician Payment Approaches, which summarizes the concept of bundled payment and the effect bundled payment policies could have on surgical practices.
Given the increased focus on bundled payment as an approach to payment reform, the ACS General Surgery Coding and Reimbursement Committee formed a workgroup to develop a process for creating clinically coherent bundled payment models and analyzing the potential opportunities and barriers. The workgroup was composed of surgeon experts in quality and coding and reimbursement and was tasked with: (1) determining the resources and expertise necessary for developing clinically coherent surgical bundles; (2) developing general principles regarding the selection, optimal structure, and function of surgical bundles; (3) providing robust guidelines about which procedures or condition characteristics must be present to construct a usable bundle; and (4) providing insight about which characteristics might make a procedure or condition a poor candidate for a bundled payment model.
In addition to the workgroup findings, the primer provides an overview of existing bundled payment programs at Geisinger Health System in Pennsylvania and BlueCross BlueShield of Massachusetts, as well as common issues to consider when developing a bundle. To access this members-only resource, go to http://efacs.org/advocacy and use your ACS issued username and password.
The American College of Surgeons (ACS) recently released the Surgeons and Bundled Payment Models: A Primer for Understanding Alternative Physician Payment Approaches, which summarizes the concept of bundled payment and the effect bundled payment policies could have on surgical practices.
Given the increased focus on bundled payment as an approach to payment reform, the ACS General Surgery Coding and Reimbursement Committee formed a workgroup to develop a process for creating clinically coherent bundled payment models and analyzing the potential opportunities and barriers. The workgroup was composed of surgeon experts in quality and coding and reimbursement and was tasked with: (1) determining the resources and expertise necessary for developing clinically coherent surgical bundles; (2) developing general principles regarding the selection, optimal structure, and function of surgical bundles; (3) providing robust guidelines about which procedures or condition characteristics must be present to construct a usable bundle; and (4) providing insight about which characteristics might make a procedure or condition a poor candidate for a bundled payment model.
In addition to the workgroup findings, the primer provides an overview of existing bundled payment programs at Geisinger Health System in Pennsylvania and BlueCross BlueShield of Massachusetts, as well as common issues to consider when developing a bundle. To access this members-only resource, go to http://efacs.org/advocacy and use your ACS issued username and password.
Study shows ACS NSQIP data more useful than administrative data in tracking readmissions
A study published in the March issue of the Journal of the American College of Surgeons (JACS) shows that data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) may be more useful than administrative records in accurately tracking and evaluating information on hospital readmissions. Accurate monitoring of the causes of readmissions is becoming increasingly relevant as The Centers for Medicare & Medicaid Services (CMS) seeks to publicly report on readmission rates and has even begun withholding payment for readmissions involving certain hospital-acquired complications.
"If we’re going to try to reduce readmissions and improve care for surgical patients, we have to know why they are being readmitted," said the study’s senior author, Karl Y. Bilimoria, MD, FACS, assistant professor of surgery and director of the surgical outcomes and quality improvement center at Northwestern University, Chicago, IL. "The CMS readmission data do not reliably offer that [information] to hospitals, and the more granular you can get with the information, the more actionable it will be locally for quality improvement and reduction of readmissions."
Currently, more than one in 10 surgical patients experiences complications requiring hospital readmission, according to a 2012 study also published in JACS.*
Comparisons of data
Most hospitals use their own clinical patient records and administrative data to determine how patients fare after a surgical procedure. However, this approach has its limitations. Clinical patient records are considered the gold standard of patient tracking because the treating physician or other health care professional records the information in real time. However, internal review of patient records does not allow hospitals to compare their results with those of other institutions.
Administrative data are provided for billing purposes only and usually by someone with no clinical training. Furthermore, administrative records do not provide reasons for readmissions or indicate whether a readmission was planned or unplanned.
Hospitals participating in ACS NSQIP may review clinical patient data and compare their outcomes with those at other hospitals in the database, and in January 2011, ACS NSQIP began collecting key data on the frequency and causes of readmissions.
In their study, Dr. Bilimoria and the Northwestern research team sought to determine whether the information in ACS NSQIP accurately reflected patient medical records and how the information compared with administrative data.
Data analysis
The surgeons examined data on 1,748 patients in Northwestern Memorial Hospital’s ACS NSQIP database. Nearly 70 percent of the patients had operations that required a hospital stay, and nearly all came to the hospital able to function independently. Approximately 7.5 percent were readmitted within 30 days of their operations.
The investigators then assessed the accuracy of the ACS NSQIP data by comparing it with the readmission data in the patients’ medical records—a comparison that yielded a rate of 99.8 percent agreement with the patients’ charts. Only two readmissions were not captured in the ACS NSQIP data.
Additionally, two readmissions were misclassified because the patients were readmitted through the emergency department (ED), and patients who come through the ED are not always recognized as a readmission. The difference highlights the need for comparing sources of information in order to improve the quality of surgical patient care and tracking. "Since seeing that inconsistency, we’ve been able to correct it," Dr. Bilimoria said.
ACS NSQIP also had a 95.7 percent agreement with the patient charts on tracking whether the readmission was planned or unplanned and nearly 80 percent agreement on the cause of the readmissions.
Whereas the study found 99.5 percent agreement between the administrative data and patient charts on recording readmissions, agreement was significantly lower on the reasons behind the readmission (55.1 percent).
"Historically, the most used source of readmission data has been administrative data," the authors wrote. However, Dr. Bilimoria said, "ACS NSQIP is as reliable as going through a chart. It’s certainly a better source than administrative data.
"It’s the type of data you can use to identify opportunities for improvement," Dr. Bilimoria added.
Data at work
Surgeons at Northwestern Memorial Hospital have used the data to improve their surgical site infection and urinary tract infection rates for surgical patients. "We keep an eye on all outcomes," Dr. Bilimoria said. "If we’re average on one quality of care standard, we can recognize it and work toward becoming excellent."
Other study participants are all affiliated with Northwestern Memorial Hospital and include Morgan M. Sellers; Ryan P. Merkow, MD; Amy Halverson, MD, FACS; Keiki Hinami, MD; Rachel R. Kelz, MD, MSCE, FACS; and David J. Bentrem, MD, FACS.
*Kassin, MT, Owen RM, Perez, SD. Risk factors for 30-day hospital readmission among general surgery patients. J Am Coll Surg. 2012;Sep:215(3):322-330.
A study published in the March issue of the Journal of the American College of Surgeons (JACS) shows that data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) may be more useful than administrative records in accurately tracking and evaluating information on hospital readmissions. Accurate monitoring of the causes of readmissions is becoming increasingly relevant as The Centers for Medicare & Medicaid Services (CMS) seeks to publicly report on readmission rates and has even begun withholding payment for readmissions involving certain hospital-acquired complications.
"If we’re going to try to reduce readmissions and improve care for surgical patients, we have to know why they are being readmitted," said the study’s senior author, Karl Y. Bilimoria, MD, FACS, assistant professor of surgery and director of the surgical outcomes and quality improvement center at Northwestern University, Chicago, IL. "The CMS readmission data do not reliably offer that [information] to hospitals, and the more granular you can get with the information, the more actionable it will be locally for quality improvement and reduction of readmissions."
Currently, more than one in 10 surgical patients experiences complications requiring hospital readmission, according to a 2012 study also published in JACS.*
Comparisons of data
Most hospitals use their own clinical patient records and administrative data to determine how patients fare after a surgical procedure. However, this approach has its limitations. Clinical patient records are considered the gold standard of patient tracking because the treating physician or other health care professional records the information in real time. However, internal review of patient records does not allow hospitals to compare their results with those of other institutions.
Administrative data are provided for billing purposes only and usually by someone with no clinical training. Furthermore, administrative records do not provide reasons for readmissions or indicate whether a readmission was planned or unplanned.
Hospitals participating in ACS NSQIP may review clinical patient data and compare their outcomes with those at other hospitals in the database, and in January 2011, ACS NSQIP began collecting key data on the frequency and causes of readmissions.
In their study, Dr. Bilimoria and the Northwestern research team sought to determine whether the information in ACS NSQIP accurately reflected patient medical records and how the information compared with administrative data.
Data analysis
The surgeons examined data on 1,748 patients in Northwestern Memorial Hospital’s ACS NSQIP database. Nearly 70 percent of the patients had operations that required a hospital stay, and nearly all came to the hospital able to function independently. Approximately 7.5 percent were readmitted within 30 days of their operations.
The investigators then assessed the accuracy of the ACS NSQIP data by comparing it with the readmission data in the patients’ medical records—a comparison that yielded a rate of 99.8 percent agreement with the patients’ charts. Only two readmissions were not captured in the ACS NSQIP data.
Additionally, two readmissions were misclassified because the patients were readmitted through the emergency department (ED), and patients who come through the ED are not always recognized as a readmission. The difference highlights the need for comparing sources of information in order to improve the quality of surgical patient care and tracking. "Since seeing that inconsistency, we’ve been able to correct it," Dr. Bilimoria said.
ACS NSQIP also had a 95.7 percent agreement with the patient charts on tracking whether the readmission was planned or unplanned and nearly 80 percent agreement on the cause of the readmissions.
Whereas the study found 99.5 percent agreement between the administrative data and patient charts on recording readmissions, agreement was significantly lower on the reasons behind the readmission (55.1 percent).
"Historically, the most used source of readmission data has been administrative data," the authors wrote. However, Dr. Bilimoria said, "ACS NSQIP is as reliable as going through a chart. It’s certainly a better source than administrative data.
"It’s the type of data you can use to identify opportunities for improvement," Dr. Bilimoria added.
Data at work
Surgeons at Northwestern Memorial Hospital have used the data to improve their surgical site infection and urinary tract infection rates for surgical patients. "We keep an eye on all outcomes," Dr. Bilimoria said. "If we’re average on one quality of care standard, we can recognize it and work toward becoming excellent."
Other study participants are all affiliated with Northwestern Memorial Hospital and include Morgan M. Sellers; Ryan P. Merkow, MD; Amy Halverson, MD, FACS; Keiki Hinami, MD; Rachel R. Kelz, MD, MSCE, FACS; and David J. Bentrem, MD, FACS.
*Kassin, MT, Owen RM, Perez, SD. Risk factors for 30-day hospital readmission among general surgery patients. J Am Coll Surg. 2012;Sep:215(3):322-330.
A study published in the March issue of the Journal of the American College of Surgeons (JACS) shows that data collected through the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) may be more useful than administrative records in accurately tracking and evaluating information on hospital readmissions. Accurate monitoring of the causes of readmissions is becoming increasingly relevant as The Centers for Medicare & Medicaid Services (CMS) seeks to publicly report on readmission rates and has even begun withholding payment for readmissions involving certain hospital-acquired complications.
"If we’re going to try to reduce readmissions and improve care for surgical patients, we have to know why they are being readmitted," said the study’s senior author, Karl Y. Bilimoria, MD, FACS, assistant professor of surgery and director of the surgical outcomes and quality improvement center at Northwestern University, Chicago, IL. "The CMS readmission data do not reliably offer that [information] to hospitals, and the more granular you can get with the information, the more actionable it will be locally for quality improvement and reduction of readmissions."
Currently, more than one in 10 surgical patients experiences complications requiring hospital readmission, according to a 2012 study also published in JACS.*
Comparisons of data
Most hospitals use their own clinical patient records and administrative data to determine how patients fare after a surgical procedure. However, this approach has its limitations. Clinical patient records are considered the gold standard of patient tracking because the treating physician or other health care professional records the information in real time. However, internal review of patient records does not allow hospitals to compare their results with those of other institutions.
Administrative data are provided for billing purposes only and usually by someone with no clinical training. Furthermore, administrative records do not provide reasons for readmissions or indicate whether a readmission was planned or unplanned.
Hospitals participating in ACS NSQIP may review clinical patient data and compare their outcomes with those at other hospitals in the database, and in January 2011, ACS NSQIP began collecting key data on the frequency and causes of readmissions.
In their study, Dr. Bilimoria and the Northwestern research team sought to determine whether the information in ACS NSQIP accurately reflected patient medical records and how the information compared with administrative data.
Data analysis
The surgeons examined data on 1,748 patients in Northwestern Memorial Hospital’s ACS NSQIP database. Nearly 70 percent of the patients had operations that required a hospital stay, and nearly all came to the hospital able to function independently. Approximately 7.5 percent were readmitted within 30 days of their operations.
The investigators then assessed the accuracy of the ACS NSQIP data by comparing it with the readmission data in the patients’ medical records—a comparison that yielded a rate of 99.8 percent agreement with the patients’ charts. Only two readmissions were not captured in the ACS NSQIP data.
Additionally, two readmissions were misclassified because the patients were readmitted through the emergency department (ED), and patients who come through the ED are not always recognized as a readmission. The difference highlights the need for comparing sources of information in order to improve the quality of surgical patient care and tracking. "Since seeing that inconsistency, we’ve been able to correct it," Dr. Bilimoria said.
ACS NSQIP also had a 95.7 percent agreement with the patient charts on tracking whether the readmission was planned or unplanned and nearly 80 percent agreement on the cause of the readmissions.
Whereas the study found 99.5 percent agreement between the administrative data and patient charts on recording readmissions, agreement was significantly lower on the reasons behind the readmission (55.1 percent).
"Historically, the most used source of readmission data has been administrative data," the authors wrote. However, Dr. Bilimoria said, "ACS NSQIP is as reliable as going through a chart. It’s certainly a better source than administrative data.
"It’s the type of data you can use to identify opportunities for improvement," Dr. Bilimoria added.
Data at work
Surgeons at Northwestern Memorial Hospital have used the data to improve their surgical site infection and urinary tract infection rates for surgical patients. "We keep an eye on all outcomes," Dr. Bilimoria said. "If we’re average on one quality of care standard, we can recognize it and work toward becoming excellent."
Other study participants are all affiliated with Northwestern Memorial Hospital and include Morgan M. Sellers; Ryan P. Merkow, MD; Amy Halverson, MD, FACS; Keiki Hinami, MD; Rachel R. Kelz, MD, MSCE, FACS; and David J. Bentrem, MD, FACS.
*Kassin, MT, Owen RM, Perez, SD. Risk factors for 30-day hospital readmission among general surgery patients. J Am Coll Surg. 2012;Sep:215(3):322-330.