Sherry Boschert

SAN FRANCISCO – The foundational beliefs of American Indian and Alaska Native communities play a key role in innovative substance abuse treatment programs, research has shown.

That’s a novel finding that could challenge conventional notions of culturally based care, Dr. Douglas K. Novins said at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In an ongoing study, he conducted hour-long interviews with 20 administrators and 15 focus groups with clinicians lasting 90 minutes each at 18 alcohol and substance abuse treatment programs serving American Indian and Alaska Native communities. The programs were chosen by an advisory board on the basis of their reputations for innovative services and to ensure a diversity of programs in the study.

Dr. Novins and his associates found that the programs included traditional practices and Western models of treatment, as has been reported in previous studies. The traditional practices might include crafts or jewelry making, drumming, singing, or fishing by bringing in tribal elders or Native American occupational therapists. The Western element typically included something similar to 12-step programs. That merging of 12-step approaches and traditional practices has been controversial among some American Indian and Alaska Native people.

The new finding is the emphasis that these programs place on the foundational beliefs of their cultures – the importance of community and family, meaningful relationships with clients and respect for clients, a homelike atmosphere in the program setting, and an open door policy that never turns clients away (Psychiatr. Serv. 2012;63:686-92).

These core values validate and incorporate the world view of American Indian and Alaska Native cultures, which see individuals as contained in a circle of family, within a circle of community, within a circle of the spirit world. "Many Native peoples will tell you that substance abuse is a sign of broken circles," said Dr. Novins of the University of Colorado, Aurora.

Previous research suggests that the long history of multigenerational traumas experienced by Native Americans as their cultures have been eradicated by nonnatives is a primary cause of substance abuse, he said. Almost all the programs studied incorporate Wellbriety (a treatment model that tries to merge 12-step treatment approaches with Native American beliefs and culture), but the programs made informal adjustments as they went along, Dr. Novins said. They addressed the historical trauma of Native Americans and incorporated culturally specific images, medicine wheels, and circles.

There are many challenges to basing treatment on the fundamental beliefs and values of Native peoples. The open-door policy, especially, "is tough if you come from an allopathic place," he said. Cultural competence in this regard means not turning away someone who comes to you without an appointment. You see them or ask them to wait until you’re done with what you’re doing, and then see them. It means that when a client telephones to say the police are at his house and he wants you to come talk to them, you go, he said.

The great diversity of Native tribes and their general lack of resources also create challenges to disseminating these innovative treatment models. There is great pressure to implement evidence-based practices, clinician burnout is a problem, and the socioeconomic hurdles might seem insurmountable. The success of substance abuse treatment programs might depend on blending evidence-based practices with the Native American cultural emphasis on community, family, relationships, and respect, Dr. Novins said.

Ten of the programs in the study are on reservations, three are in nonreservation rural areas, and five are in urban areas, where most Native American people live today. Only approximately 2% of the Indian Health Service budget goes to urban areas, Dr. Novins noted.

Participants in the study’s interviews received up to $300 worth of educational and clinical materials of each program’s choosing.

The investigators now are finishing the final phase of the study – a survey of 193 tribal substance abuse and treatment programs across the United States.

Dr. Novins reported that he had no relevant financial disclosures. The National Institute on Drug Abuse is funding this research.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – The foundational beliefs of American Indian and Alaska Native communities play a key role in innovative substance abuse treatment programs, research has shown.

That’s a novel finding that could challenge conventional notions of culturally based care, Dr. Douglas K. Novins said at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In an ongoing study, he conducted hour-long interviews with 20 administrators and 15 focus groups with clinicians lasting 90 minutes each at 18 alcohol and substance abuse treatment programs serving American Indian and Alaska Native communities. The programs were chosen by an advisory board on the basis of their reputations for innovative services and to ensure a diversity of programs in the study.

Dr. Novins and his associates found that the programs included traditional practices and Western models of treatment, as has been reported in previous studies. The traditional practices might include crafts or jewelry making, drumming, singing, or fishing by bringing in tribal elders or Native American occupational therapists. The Western element typically included something similar to 12-step programs. That merging of 12-step approaches and traditional practices has been controversial among some American Indian and Alaska Native people.

The new finding is the emphasis that these programs place on the foundational beliefs of their cultures – the importance of community and family, meaningful relationships with clients and respect for clients, a homelike atmosphere in the program setting, and an open door policy that never turns clients away (Psychiatr. Serv. 2012;63:686-92).

These core values validate and incorporate the world view of American Indian and Alaska Native cultures, which see individuals as contained in a circle of family, within a circle of community, within a circle of the spirit world. "Many Native peoples will tell you that substance abuse is a sign of broken circles," said Dr. Novins of the University of Colorado, Aurora.

Previous research suggests that the long history of multigenerational traumas experienced by Native Americans as their cultures have been eradicated by nonnatives is a primary cause of substance abuse, he said. Almost all the programs studied incorporate Wellbriety (a treatment model that tries to merge 12-step treatment approaches with Native American beliefs and culture), but the programs made informal adjustments as they went along, Dr. Novins said. They addressed the historical trauma of Native Americans and incorporated culturally specific images, medicine wheels, and circles.

There are many challenges to basing treatment on the fundamental beliefs and values of Native peoples. The open-door policy, especially, "is tough if you come from an allopathic place," he said. Cultural competence in this regard means not turning away someone who comes to you without an appointment. You see them or ask them to wait until you’re done with what you’re doing, and then see them. It means that when a client telephones to say the police are at his house and he wants you to come talk to them, you go, he said.

The great diversity of Native tribes and their general lack of resources also create challenges to disseminating these innovative treatment models. There is great pressure to implement evidence-based practices, clinician burnout is a problem, and the socioeconomic hurdles might seem insurmountable. The success of substance abuse treatment programs might depend on blending evidence-based practices with the Native American cultural emphasis on community, family, relationships, and respect, Dr. Novins said.

Ten of the programs in the study are on reservations, three are in nonreservation rural areas, and five are in urban areas, where most Native American people live today. Only approximately 2% of the Indian Health Service budget goes to urban areas, Dr. Novins noted.

Participants in the study’s interviews received up to $300 worth of educational and clinical materials of each program’s choosing.

The investigators now are finishing the final phase of the study – a survey of 193 tribal substance abuse and treatment programs across the United States.

Dr. Novins reported that he had no relevant financial disclosures. The National Institute on Drug Abuse is funding this research.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – The foundational beliefs of American Indian and Alaska Native communities play a key role in innovative substance abuse treatment programs, research has shown.

That’s a novel finding that could challenge conventional notions of culturally based care, Dr. Douglas K. Novins said at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

In an ongoing study, he conducted hour-long interviews with 20 administrators and 15 focus groups with clinicians lasting 90 minutes each at 18 alcohol and substance abuse treatment programs serving American Indian and Alaska Native communities. The programs were chosen by an advisory board on the basis of their reputations for innovative services and to ensure a diversity of programs in the study.

Dr. Novins and his associates found that the programs included traditional practices and Western models of treatment, as has been reported in previous studies. The traditional practices might include crafts or jewelry making, drumming, singing, or fishing by bringing in tribal elders or Native American occupational therapists. The Western element typically included something similar to 12-step programs. That merging of 12-step approaches and traditional practices has been controversial among some American Indian and Alaska Native people.

The new finding is the emphasis that these programs place on the foundational beliefs of their cultures – the importance of community and family, meaningful relationships with clients and respect for clients, a homelike atmosphere in the program setting, and an open door policy that never turns clients away (Psychiatr. Serv. 2012;63:686-92).

These core values validate and incorporate the world view of American Indian and Alaska Native cultures, which see individuals as contained in a circle of family, within a circle of community, within a circle of the spirit world. "Many Native peoples will tell you that substance abuse is a sign of broken circles," said Dr. Novins of the University of Colorado, Aurora.

Previous research suggests that the long history of multigenerational traumas experienced by Native Americans as their cultures have been eradicated by nonnatives is a primary cause of substance abuse, he said. Almost all the programs studied incorporate Wellbriety (a treatment model that tries to merge 12-step treatment approaches with Native American beliefs and culture), but the programs made informal adjustments as they went along, Dr. Novins said. They addressed the historical trauma of Native Americans and incorporated culturally specific images, medicine wheels, and circles.

There are many challenges to basing treatment on the fundamental beliefs and values of Native peoples. The open-door policy, especially, "is tough if you come from an allopathic place," he said. Cultural competence in this regard means not turning away someone who comes to you without an appointment. You see them or ask them to wait until you’re done with what you’re doing, and then see them. It means that when a client telephones to say the police are at his house and he wants you to come talk to them, you go, he said.

The great diversity of Native tribes and their general lack of resources also create challenges to disseminating these innovative treatment models. There is great pressure to implement evidence-based practices, clinician burnout is a problem, and the socioeconomic hurdles might seem insurmountable. The success of substance abuse treatment programs might depend on blending evidence-based practices with the Native American cultural emphasis on community, family, relationships, and respect, Dr. Novins said.

Ten of the programs in the study are on reservations, three are in nonreservation rural areas, and five are in urban areas, where most Native American people live today. Only approximately 2% of the Indian Health Service budget goes to urban areas, Dr. Novins noted.

Participants in the study’s interviews received up to $300 worth of educational and clinical materials of each program’s choosing.

The investigators now are finishing the final phase of the study – a survey of 193 tribal substance abuse and treatment programs across the United States.

Dr. Novins reported that he had no relevant financial disclosures. The National Institute on Drug Abuse is funding this research.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A phase II/III clinical trial of adding cetuximab to chemoradiotherapy for localized esophageal cancer was stopped early when interim results showed greater toxicity, less completion of chemoradiotherapy, and worse survival with cetuximab.

Patients had been randomized to potentially curative treatment with cisplatin, capecitabine, and radiation, with or without cetuximab (Erbitux). Six months of follow-up on 258 patients found significantly lower median overall survival in the cetuximab arm compared with the control group (22.1 months vs. 25.4 months) and fewer patients free of treatment failure (66% vs. 77%), Dr. Thomas Crosby reported at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology (ASCO).

Sherry Boschert/IMNG Medical Media

The number of patients lost to follow-up before 26 weeks was similar between groups: 10 in the cetuximab group and 8 in the control group, he added.

Significantly fewer patients in the cetuximab arm were able to receive the full protocol dose of radiotherapy compared with the control arm (75% vs. 86%) and to complete all four cycles of cisplatin and capecitabine at full doses (77% vs. 90%) or reduced doses (69% vs. 85%), reported Dr. Crosby of Velindre Hospital, Cardiff, Wales.

The cetuximab group also showed significantly higher rates of grade 3 or 4 nonhematologic toxicities (78%) compared with the control arm (63%), primarily because of increases in cardiac toxicities (6% vs. 2%), dermatologic toxicities (22% vs. 4%), and metabolic toxicities (24% vs. 11%).

"The addition of cetuximab cannot be recommended to standard definitive chemoradiotherapy in the treatment of unselected patients with esophageal cancer," Dr. Crosby said.

All patients were to receive four cycles of cisplatin 60 mg/m² on day 1 and capecitabine 625 mg/m² daily on days 1-21, with cycles three and four given concurrently with radiotherapy (60 Gy in 25 fractions). The cetuximab group also received 400 mg/m² of the drug on day 1 of cycle three, followed by cetuximab 250 mg/m² weekly.

Patients in the multicenter study, known as the SCOPE 1 trial, had a median age of 67 years in both groups.

Survival outcomes associated with chemoradiotherapy for localized, poor-prognosis esophageal cancer in SCOPE 1 were better than results previously reported in trials of radiotherapy or surgery for these cancers, he noted. Future research should look at improving definitive chemoradiotherapy by identifying biomarkers to help select patients for treatment and incorporating newer radiology techniques to intensify treatment, he suggested.

Definitive chemoradiotherapy is used in the United Kingdom predominantly for patients with esophageal cancer who are not candidates for surgery and is considered a standard of care for patients with localized squamous cell carcinoma of the esophagus, Dr. Crosby said.

Other previous studies have reported that cetuximab improved outcomes when added to chemotherapy for advanced colorectal or head and neck cancers, and when added to radiotherapy for localized squamous cell carcinomas of the head and neck, he said. A separate study recently reported worse outcomes when cetuximab was added to first-line chemotherapy for gastric cancer.

Dr. Crosby reported having no relevant financial disclosures. Cetuximab is a product of ImClone, a subsidiary of Eli Lilly and Bristol-Myers Squibb, that is licensed to Merck KGaA for marketing outside the United States. Some of his associates reported receiving research funding from Merck, AstraZeneca, or Roche.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A phase II/III clinical trial of adding cetuximab to chemoradiotherapy for localized esophageal cancer was stopped early when interim results showed greater toxicity, less completion of chemoradiotherapy, and worse survival with cetuximab.

Patients had been randomized to potentially curative treatment with cisplatin, capecitabine, and radiation, with or without cetuximab (Erbitux). Six months of follow-up on 258 patients found significantly lower median overall survival in the cetuximab arm compared with the control group (22.1 months vs. 25.4 months) and fewer patients free of treatment failure (66% vs. 77%), Dr. Thomas Crosby reported at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology (ASCO).

Sherry Boschert/IMNG Medical Media

The number of patients lost to follow-up before 26 weeks was similar between groups: 10 in the cetuximab group and 8 in the control group, he added.

Significantly fewer patients in the cetuximab arm were able to receive the full protocol dose of radiotherapy compared with the control arm (75% vs. 86%) and to complete all four cycles of cisplatin and capecitabine at full doses (77% vs. 90%) or reduced doses (69% vs. 85%), reported Dr. Crosby of Velindre Hospital, Cardiff, Wales.

The cetuximab group also showed significantly higher rates of grade 3 or 4 nonhematologic toxicities (78%) compared with the control arm (63%), primarily because of increases in cardiac toxicities (6% vs. 2%), dermatologic toxicities (22% vs. 4%), and metabolic toxicities (24% vs. 11%).

"The addition of cetuximab cannot be recommended to standard definitive chemoradiotherapy in the treatment of unselected patients with esophageal cancer," Dr. Crosby said.

All patients were to receive four cycles of cisplatin 60 mg/m² on day 1 and capecitabine 625 mg/m² daily on days 1-21, with cycles three and four given concurrently with radiotherapy (60 Gy in 25 fractions). The cetuximab group also received 400 mg/m² of the drug on day 1 of cycle three, followed by cetuximab 250 mg/m² weekly.

Patients in the multicenter study, known as the SCOPE 1 trial, had a median age of 67 years in both groups.

Survival outcomes associated with chemoradiotherapy for localized, poor-prognosis esophageal cancer in SCOPE 1 were better than results previously reported in trials of radiotherapy or surgery for these cancers, he noted. Future research should look at improving definitive chemoradiotherapy by identifying biomarkers to help select patients for treatment and incorporating newer radiology techniques to intensify treatment, he suggested.

Definitive chemoradiotherapy is used in the United Kingdom predominantly for patients with esophageal cancer who are not candidates for surgery and is considered a standard of care for patients with localized squamous cell carcinoma of the esophagus, Dr. Crosby said.

Other previous studies have reported that cetuximab improved outcomes when added to chemotherapy for advanced colorectal or head and neck cancers, and when added to radiotherapy for localized squamous cell carcinomas of the head and neck, he said. A separate study recently reported worse outcomes when cetuximab was added to first-line chemotherapy for gastric cancer.

Dr. Crosby reported having no relevant financial disclosures. Cetuximab is a product of ImClone, a subsidiary of Eli Lilly and Bristol-Myers Squibb, that is licensed to Merck KGaA for marketing outside the United States. Some of his associates reported receiving research funding from Merck, AstraZeneca, or Roche.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A phase II/III clinical trial of adding cetuximab to chemoradiotherapy for localized esophageal cancer was stopped early when interim results showed greater toxicity, less completion of chemoradiotherapy, and worse survival with cetuximab.

Patients had been randomized to potentially curative treatment with cisplatin, capecitabine, and radiation, with or without cetuximab (Erbitux). Six months of follow-up on 258 patients found significantly lower median overall survival in the cetuximab arm compared with the control group (22.1 months vs. 25.4 months) and fewer patients free of treatment failure (66% vs. 77%), Dr. Thomas Crosby reported at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology (ASCO).

Sherry Boschert/IMNG Medical Media

The number of patients lost to follow-up before 26 weeks was similar between groups: 10 in the cetuximab group and 8 in the control group, he added.

Significantly fewer patients in the cetuximab arm were able to receive the full protocol dose of radiotherapy compared with the control arm (75% vs. 86%) and to complete all four cycles of cisplatin and capecitabine at full doses (77% vs. 90%) or reduced doses (69% vs. 85%), reported Dr. Crosby of Velindre Hospital, Cardiff, Wales.

The cetuximab group also showed significantly higher rates of grade 3 or 4 nonhematologic toxicities (78%) compared with the control arm (63%), primarily because of increases in cardiac toxicities (6% vs. 2%), dermatologic toxicities (22% vs. 4%), and metabolic toxicities (24% vs. 11%).

"The addition of cetuximab cannot be recommended to standard definitive chemoradiotherapy in the treatment of unselected patients with esophageal cancer," Dr. Crosby said.

All patients were to receive four cycles of cisplatin 60 mg/m² on day 1 and capecitabine 625 mg/m² daily on days 1-21, with cycles three and four given concurrently with radiotherapy (60 Gy in 25 fractions). The cetuximab group also received 400 mg/m² of the drug on day 1 of cycle three, followed by cetuximab 250 mg/m² weekly.

Patients in the multicenter study, known as the SCOPE 1 trial, had a median age of 67 years in both groups.

Survival outcomes associated with chemoradiotherapy for localized, poor-prognosis esophageal cancer in SCOPE 1 were better than results previously reported in trials of radiotherapy or surgery for these cancers, he noted. Future research should look at improving definitive chemoradiotherapy by identifying biomarkers to help select patients for treatment and incorporating newer radiology techniques to intensify treatment, he suggested.

Definitive chemoradiotherapy is used in the United Kingdom predominantly for patients with esophageal cancer who are not candidates for surgery and is considered a standard of care for patients with localized squamous cell carcinoma of the esophagus, Dr. Crosby said.

Other previous studies have reported that cetuximab improved outcomes when added to chemotherapy for advanced colorectal or head and neck cancers, and when added to radiotherapy for localized squamous cell carcinomas of the head and neck, he said. A separate study recently reported worse outcomes when cetuximab was added to first-line chemotherapy for gastric cancer.

Dr. Crosby reported having no relevant financial disclosures. Cetuximab is a product of ImClone, a subsidiary of Eli Lilly and Bristol-Myers Squibb, that is licensed to Merck KGaA for marketing outside the United States. Some of his associates reported receiving research funding from Merck, AstraZeneca, or Roche.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A phase III clinical trial of an experimental monoclonal antibody for patients failing first-line treatment of metastatic gastric or gastroesophageal junction adenocarcinoma increased median overall survival to 5.2 months, compared with 3.8 months on placebo.

The difference was statistically significant and the treatment effect generally was consistent across major subgroups of the 355 patients in the international, prospective, double-blind trial. At 6 months, 42% of patients on ramucirumab and 32% on placebo were alive. At 12 months, 18% on ramucirumab and 11% on placebo were alive, Dr. Charles S. Fuchs and his associates reported in a poster presentation at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy American Society of Clinical Oncology

Ramucirumab is a fully human IgG1 monoclonal antibody receptor antagonist designed to inhibit the receptor for vascular endothelial cell growth factor (VEGF), which is believed to contribute to gastric cancer pathogenesis.

The study randomized 238 patients to second-line treatment with IV ramucirumab 8 mg/kg plus best supportive care or placebo plus best supportive care every 2 weeks until disease progression, unacceptable toxicity, or death. All patients had shown disease progression within 4 months of treatment for metastatic disease or within 6 months of adjuvant therapy using first-line regimens containing platinum and/or fluoropyrimidine.

Among secondary outcomes, patients in the ramucirumab group showed a significantly longer interval to disease progression – 2.1 months, compared with 1.3 months on placebo – the intent-to-treat analysis found. At 12 weeks, 40% of patients in the ramucirumab group and 16% on placebo showed no disease progression, reported Dr. Fuchs, director of the gastrointestinal cancer center at the Dana Farber Cancer Institute, Boston.

Overall, 49% of patients on ramucirumab showed a complete or partial response or stable disease, compared with 23% on placebo, a significant difference.

Two patients in each group did not receive the drug or placebo. Among 351 patients who did, the proportions that died because of an adverse event were similar between groups – 11% on ramucirumab and 13% on placebo. The two groups did not differ significantly in rates of most individual adverse events, most commonly fatigue, abdominal pain, decreased appetite, or vomiting. Hypertension was more likely to develop in the ramucirumab group than the placebo group (16% vs. 8%), and grade 3 or higher hypertension was more common on ramucirumab (8% vs. 3% on placebo), though no patients on ramucirumab developed grade 4 hypertension.

No unexpected or new findings regarding safety were seen, Dr. Fuchs reported. Hypertension is one of the adverse events generally associated with antiangiogenic agents and therapeutic antibodies. Rates did not differ between groups for other adverse events of special interest with these agents, including bleeding/hemorrhage, arteriothromboembolic or venous thrombolic events, proteinuria, GI perforation, fistula, and others.

Patient characteristics were similar between the groups at baseline.

The study enrolled patients at 120 centers in 30 countries on six continents.

Ramucirumab is a potential new second-line treatment for patients with metastatic adenocarcinoma of the stomach or the gastroesophageal junction, Dr. Fuchs suggested.

The symposium was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

The study was funded by ImClone Systems, a subsidiary of Eli Lilly and Co., which is developing ramucirumab. Some of Dr. Fuchs’ associates in the study disclosed employment or other financial relationships with ImClone Systems and stock ownership in Eli Lilly. Dr. Fuchs has been an advisor to Amgen, Bayer, Bristol-Myers Squibb, Genentech, Infinity Pharmaceuticals, Metamark Genetics, Momenta Pharmaceuticals, Pfizer, Roche, and Sanofi.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A phase III clinical trial of an experimental monoclonal antibody for patients failing first-line treatment of metastatic gastric or gastroesophageal junction adenocarcinoma increased median overall survival to 5.2 months, compared with 3.8 months on placebo.

The difference was statistically significant and the treatment effect generally was consistent across major subgroups of the 355 patients in the international, prospective, double-blind trial. At 6 months, 42% of patients on ramucirumab and 32% on placebo were alive. At 12 months, 18% on ramucirumab and 11% on placebo were alive, Dr. Charles S. Fuchs and his associates reported in a poster presentation at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy American Society of Clinical Oncology

Ramucirumab is a fully human IgG1 monoclonal antibody receptor antagonist designed to inhibit the receptor for vascular endothelial cell growth factor (VEGF), which is believed to contribute to gastric cancer pathogenesis.

The study randomized 238 patients to second-line treatment with IV ramucirumab 8 mg/kg plus best supportive care or placebo plus best supportive care every 2 weeks until disease progression, unacceptable toxicity, or death. All patients had shown disease progression within 4 months of treatment for metastatic disease or within 6 months of adjuvant therapy using first-line regimens containing platinum and/or fluoropyrimidine.

Among secondary outcomes, patients in the ramucirumab group showed a significantly longer interval to disease progression – 2.1 months, compared with 1.3 months on placebo – the intent-to-treat analysis found. At 12 weeks, 40% of patients in the ramucirumab group and 16% on placebo showed no disease progression, reported Dr. Fuchs, director of the gastrointestinal cancer center at the Dana Farber Cancer Institute, Boston.

Overall, 49% of patients on ramucirumab showed a complete or partial response or stable disease, compared with 23% on placebo, a significant difference.

Two patients in each group did not receive the drug or placebo. Among 351 patients who did, the proportions that died because of an adverse event were similar between groups – 11% on ramucirumab and 13% on placebo. The two groups did not differ significantly in rates of most individual adverse events, most commonly fatigue, abdominal pain, decreased appetite, or vomiting. Hypertension was more likely to develop in the ramucirumab group than the placebo group (16% vs. 8%), and grade 3 or higher hypertension was more common on ramucirumab (8% vs. 3% on placebo), though no patients on ramucirumab developed grade 4 hypertension.

No unexpected or new findings regarding safety were seen, Dr. Fuchs reported. Hypertension is one of the adverse events generally associated with antiangiogenic agents and therapeutic antibodies. Rates did not differ between groups for other adverse events of special interest with these agents, including bleeding/hemorrhage, arteriothromboembolic or venous thrombolic events, proteinuria, GI perforation, fistula, and others.

Patient characteristics were similar between the groups at baseline.

The study enrolled patients at 120 centers in 30 countries on six continents.

Ramucirumab is a potential new second-line treatment for patients with metastatic adenocarcinoma of the stomach or the gastroesophageal junction, Dr. Fuchs suggested.

The symposium was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

The study was funded by ImClone Systems, a subsidiary of Eli Lilly and Co., which is developing ramucirumab. Some of Dr. Fuchs’ associates in the study disclosed employment or other financial relationships with ImClone Systems and stock ownership in Eli Lilly. Dr. Fuchs has been an advisor to Amgen, Bayer, Bristol-Myers Squibb, Genentech, Infinity Pharmaceuticals, Metamark Genetics, Momenta Pharmaceuticals, Pfizer, Roche, and Sanofi.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A phase III clinical trial of an experimental monoclonal antibody for patients failing first-line treatment of metastatic gastric or gastroesophageal junction adenocarcinoma increased median overall survival to 5.2 months, compared with 3.8 months on placebo.

The difference was statistically significant and the treatment effect generally was consistent across major subgroups of the 355 patients in the international, prospective, double-blind trial. At 6 months, 42% of patients on ramucirumab and 32% on placebo were alive. At 12 months, 18% on ramucirumab and 11% on placebo were alive, Dr. Charles S. Fuchs and his associates reported in a poster presentation at a meeting on gastrointestinal cancers sponsored by the American Society of Clinical Oncology (ASCO).

Courtesy American Society of Clinical Oncology

Ramucirumab is a fully human IgG1 monoclonal antibody receptor antagonist designed to inhibit the receptor for vascular endothelial cell growth factor (VEGF), which is believed to contribute to gastric cancer pathogenesis.

The study randomized 238 patients to second-line treatment with IV ramucirumab 8 mg/kg plus best supportive care or placebo plus best supportive care every 2 weeks until disease progression, unacceptable toxicity, or death. All patients had shown disease progression within 4 months of treatment for metastatic disease or within 6 months of adjuvant therapy using first-line regimens containing platinum and/or fluoropyrimidine.

Among secondary outcomes, patients in the ramucirumab group showed a significantly longer interval to disease progression – 2.1 months, compared with 1.3 months on placebo – the intent-to-treat analysis found. At 12 weeks, 40% of patients in the ramucirumab group and 16% on placebo showed no disease progression, reported Dr. Fuchs, director of the gastrointestinal cancer center at the Dana Farber Cancer Institute, Boston.

Overall, 49% of patients on ramucirumab showed a complete or partial response or stable disease, compared with 23% on placebo, a significant difference.

Two patients in each group did not receive the drug or placebo. Among 351 patients who did, the proportions that died because of an adverse event were similar between groups – 11% on ramucirumab and 13% on placebo. The two groups did not differ significantly in rates of most individual adverse events, most commonly fatigue, abdominal pain, decreased appetite, or vomiting. Hypertension was more likely to develop in the ramucirumab group than the placebo group (16% vs. 8%), and grade 3 or higher hypertension was more common on ramucirumab (8% vs. 3% on placebo), though no patients on ramucirumab developed grade 4 hypertension.

No unexpected or new findings regarding safety were seen, Dr. Fuchs reported. Hypertension is one of the adverse events generally associated with antiangiogenic agents and therapeutic antibodies. Rates did not differ between groups for other adverse events of special interest with these agents, including bleeding/hemorrhage, arteriothromboembolic or venous thrombolic events, proteinuria, GI perforation, fistula, and others.

Patient characteristics were similar between the groups at baseline.

The study enrolled patients at 120 centers in 30 countries on six continents.

Ramucirumab is a potential new second-line treatment for patients with metastatic adenocarcinoma of the stomach or the gastroesophageal junction, Dr. Fuchs suggested.

The symposium was cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

The study was funded by ImClone Systems, a subsidiary of Eli Lilly and Co., which is developing ramucirumab. Some of Dr. Fuchs’ associates in the study disclosed employment or other financial relationships with ImClone Systems and stock ownership in Eli Lilly. Dr. Fuchs has been an advisor to Amgen, Bayer, Bristol-Myers Squibb, Genentech, Infinity Pharmaceuticals, Metamark Genetics, Momenta Pharmaceuticals, Pfizer, Roche, and Sanofi.

[email protected]

On Twitter @sherryboschert

SAN DIEGO – The aviation industry does it to ensure safe flights. The manufacturing industry does it to track its complex system of suppliers. The banking industry does it to view financial histories. Now, oncologists are using computer technology and complex systems management to pioneer improvements in the quality and efficiency of cancer care.

The goal is a health care system that aligns science, informatics, incentives, and culture so that new knowledge is captured as an integral by-product of delivering health care, Dr. Allen S. Lichter said at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).

The project was influenced by the Institute of Medicine’s September 2012 consensus report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America."

"Right now, as with most medical specialties, the majority of things we do are based on consensus or good solid hunches, not on solid, level 1 clinical trial evidence," said Dr. Lichter, ASCO Chief Executive Officer. An iterative, "learning" system should help fill those gaps by using real-time data to improve recommendations, he said.

The ASCO Cancer Learning Intelligence Network for Quality (Cancer LINQ) project is a first step to creating a "continuously learning" system. Another system, being developed by eviti Inc., aims to assimilate evidence-based data into clinical decision-making and treatment plans via a Web-based platform.

The eviti system incorporates existing guidelines and recommendations to provide clinical decision support, Dr. Yu-Ning Wong reported at the symposium. A recent pilot study used the eviti platform to process 596 treatment plans for patients with non–small cell lung cancer. The plans were submitted for preauthorization to seven insurers in 43 states between January 2011 and May 2012, said Dr. Wong, an oncologist at Fox Chase Cancer Center, Philadelphia.

Using the eviti system, the treatment plans were compared with a library of evidence-based standards drawn from multiple sources, including ASCO, the National Cancer Institute, the Food and Drug Administration, the American Society of Hematology, other organizations, and the peer-reviewed medical literature. For the 255 cases that matched an evidence-based regimen, the system issued a preauthorization code. The remaining 341 cases either were reviewed by a nurse (214 cases) or underwent a peer-to-peer review by an oncologist (127 cases), Dr. Wong said.

The nurse reconciled minor variances between the treatment plan and the evidence base in 132 cases, which then received preauthorization for treatment, and recommended a medically justified variance from recommended treatments in 82 cases, 76 of which were approved by payers. The oncologist reviewer convinced 23 treating oncologists to change to an evidence-based treatment plan, resulting in preauthorization. Medically justified variances were recommended in 49 cases, 46 of which were approved by payers. Another 55 treatment plans were neither evidence-based nor considered a medically justified variance by the reviewing oncologist, and were denied preauthorization.

In all, 91% of patients ended up with an evidence-based treatment plan (69%) or a recommendation for a medically justified variance (22%), and 89% of cases received a preauthorization code, Dr. Wong said.

Multiple reports in the literature suggest that 30%-40% of oncology treatments deviate from evidence-based standards, similar to the final 31% rate in the eviti study. It’s unclear whether decision-support systems such as eviti will reduce practice variations over time; clinician and administrator acceptance is under study, as is use of the system for other tumor types.

The Cancer LINQ project includes a decision-support feature similar to eviti’s, but also aggregates clinical data from any electronic health record system, assesses compliance with quality measures, and analyzes trends in treatments and outcomes, Dr. Lichter said. With a click, Cancer LINQ can generate a report on how a particular physician is meeting any of 10 measures in ASCO’s Quality Oncology Practice Initiative (QOPI) certification program.

Cancer LINQ is "the son or daughter of QOPI," with "the ability to measure quality in the oncology practice, measure outcomes, and report in real time and provide new methods for data exploration and hypothesis generation," he said. "We believe the real-time collection of quality and outcomes data will allow the system to learn," resulting in continuously and quickly updated recommendations.

"We do not have to write an interface between our system and every one of the dozen or so electronic health record [EHR] systems that are used in the oncology community," Dr. Lichter said. The Cancer LINQ prototype was able to grab and conform clinical data from four different EHR systems. Cancer LINQ also goes beyond EHRs and can accept billing data, pharmacy data, and imaging data.

The Cancer LINQ prototype is just the first step, and ASCO will need partners or support to tackle the challenges and the cost of developing a final product and disseminating it. "We piloted QOPI for almost 4 years before we released it to the public, so this is not something that will be done next month," he said. "We will be mining the lessons from the prototype for many, many months and years to come."

So many groups and companies now are developing or offering computerized quality-improvement systems in health care that it’s bound to become confusing for clinicians to decide which ones to pursue, Dr. Lichter said in an interview. Eventually, some consolidation in the industry will be needed.

Dr. Lichter reported having no financial disclosures. Dr. Wong has been an unpaid consultant to eviti.

[email protected]

On Twitter @sherryboschert

SAN DIEGO – The aviation industry does it to ensure safe flights. The manufacturing industry does it to track its complex system of suppliers. The banking industry does it to view financial histories. Now, oncologists are using computer technology and complex systems management to pioneer improvements in the quality and efficiency of cancer care.

The goal is a health care system that aligns science, informatics, incentives, and culture so that new knowledge is captured as an integral by-product of delivering health care, Dr. Allen S. Lichter said at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).

The project was influenced by the Institute of Medicine’s September 2012 consensus report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America."

"Right now, as with most medical specialties, the majority of things we do are based on consensus or good solid hunches, not on solid, level 1 clinical trial evidence," said Dr. Lichter, ASCO Chief Executive Officer. An iterative, "learning" system should help fill those gaps by using real-time data to improve recommendations, he said.

The ASCO Cancer Learning Intelligence Network for Quality (Cancer LINQ) project is a first step to creating a "continuously learning" system. Another system, being developed by eviti Inc., aims to assimilate evidence-based data into clinical decision-making and treatment plans via a Web-based platform.

The eviti system incorporates existing guidelines and recommendations to provide clinical decision support, Dr. Yu-Ning Wong reported at the symposium. A recent pilot study used the eviti platform to process 596 treatment plans for patients with non–small cell lung cancer. The plans were submitted for preauthorization to seven insurers in 43 states between January 2011 and May 2012, said Dr. Wong, an oncologist at Fox Chase Cancer Center, Philadelphia.

Using the eviti system, the treatment plans were compared with a library of evidence-based standards drawn from multiple sources, including ASCO, the National Cancer Institute, the Food and Drug Administration, the American Society of Hematology, other organizations, and the peer-reviewed medical literature. For the 255 cases that matched an evidence-based regimen, the system issued a preauthorization code. The remaining 341 cases either were reviewed by a nurse (214 cases) or underwent a peer-to-peer review by an oncologist (127 cases), Dr. Wong said.

The nurse reconciled minor variances between the treatment plan and the evidence base in 132 cases, which then received preauthorization for treatment, and recommended a medically justified variance from recommended treatments in 82 cases, 76 of which were approved by payers. The oncologist reviewer convinced 23 treating oncologists to change to an evidence-based treatment plan, resulting in preauthorization. Medically justified variances were recommended in 49 cases, 46 of which were approved by payers. Another 55 treatment plans were neither evidence-based nor considered a medically justified variance by the reviewing oncologist, and were denied preauthorization.

In all, 91% of patients ended up with an evidence-based treatment plan (69%) or a recommendation for a medically justified variance (22%), and 89% of cases received a preauthorization code, Dr. Wong said.

Multiple reports in the literature suggest that 30%-40% of oncology treatments deviate from evidence-based standards, similar to the final 31% rate in the eviti study. It’s unclear whether decision-support systems such as eviti will reduce practice variations over time; clinician and administrator acceptance is under study, as is use of the system for other tumor types.

The Cancer LINQ project includes a decision-support feature similar to eviti’s, but also aggregates clinical data from any electronic health record system, assesses compliance with quality measures, and analyzes trends in treatments and outcomes, Dr. Lichter said. With a click, Cancer LINQ can generate a report on how a particular physician is meeting any of 10 measures in ASCO’s Quality Oncology Practice Initiative (QOPI) certification program.

Cancer LINQ is "the son or daughter of QOPI," with "the ability to measure quality in the oncology practice, measure outcomes, and report in real time and provide new methods for data exploration and hypothesis generation," he said. "We believe the real-time collection of quality and outcomes data will allow the system to learn," resulting in continuously and quickly updated recommendations.

"We do not have to write an interface between our system and every one of the dozen or so electronic health record [EHR] systems that are used in the oncology community," Dr. Lichter said. The Cancer LINQ prototype was able to grab and conform clinical data from four different EHR systems. Cancer LINQ also goes beyond EHRs and can accept billing data, pharmacy data, and imaging data.

The Cancer LINQ prototype is just the first step, and ASCO will need partners or support to tackle the challenges and the cost of developing a final product and disseminating it. "We piloted QOPI for almost 4 years before we released it to the public, so this is not something that will be done next month," he said. "We will be mining the lessons from the prototype for many, many months and years to come."

So many groups and companies now are developing or offering computerized quality-improvement systems in health care that it’s bound to become confusing for clinicians to decide which ones to pursue, Dr. Lichter said in an interview. Eventually, some consolidation in the industry will be needed.

Dr. Lichter reported having no financial disclosures. Dr. Wong has been an unpaid consultant to eviti.

[email protected]

On Twitter @sherryboschert

SAN DIEGO – The aviation industry does it to ensure safe flights. The manufacturing industry does it to track its complex system of suppliers. The banking industry does it to view financial histories. Now, oncologists are using computer technology and complex systems management to pioneer improvements in the quality and efficiency of cancer care.

The goal is a health care system that aligns science, informatics, incentives, and culture so that new knowledge is captured as an integral by-product of delivering health care, Dr. Allen S. Lichter said at a symposium on quality care sponsored by the American Society of Clinical Oncology (ASCO).

The project was influenced by the Institute of Medicine’s September 2012 consensus report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America."

"Right now, as with most medical specialties, the majority of things we do are based on consensus or good solid hunches, not on solid, level 1 clinical trial evidence," said Dr. Lichter, ASCO Chief Executive Officer. An iterative, "learning" system should help fill those gaps by using real-time data to improve recommendations, he said.

The ASCO Cancer Learning Intelligence Network for Quality (Cancer LINQ) project is a first step to creating a "continuously learning" system. Another system, being developed by eviti Inc., aims to assimilate evidence-based data into clinical decision-making and treatment plans via a Web-based platform.

The eviti system incorporates existing guidelines and recommendations to provide clinical decision support, Dr. Yu-Ning Wong reported at the symposium. A recent pilot study used the eviti platform to process 596 treatment plans for patients with non–small cell lung cancer. The plans were submitted for preauthorization to seven insurers in 43 states between January 2011 and May 2012, said Dr. Wong, an oncologist at Fox Chase Cancer Center, Philadelphia.

Using the eviti system, the treatment plans were compared with a library of evidence-based standards drawn from multiple sources, including ASCO, the National Cancer Institute, the Food and Drug Administration, the American Society of Hematology, other organizations, and the peer-reviewed medical literature. For the 255 cases that matched an evidence-based regimen, the system issued a preauthorization code. The remaining 341 cases either were reviewed by a nurse (214 cases) or underwent a peer-to-peer review by an oncologist (127 cases), Dr. Wong said.

The nurse reconciled minor variances between the treatment plan and the evidence base in 132 cases, which then received preauthorization for treatment, and recommended a medically justified variance from recommended treatments in 82 cases, 76 of which were approved by payers. The oncologist reviewer convinced 23 treating oncologists to change to an evidence-based treatment plan, resulting in preauthorization. Medically justified variances were recommended in 49 cases, 46 of which were approved by payers. Another 55 treatment plans were neither evidence-based nor considered a medically justified variance by the reviewing oncologist, and were denied preauthorization.

In all, 91% of patients ended up with an evidence-based treatment plan (69%) or a recommendation for a medically justified variance (22%), and 89% of cases received a preauthorization code, Dr. Wong said.

Multiple reports in the literature suggest that 30%-40% of oncology treatments deviate from evidence-based standards, similar to the final 31% rate in the eviti study. It’s unclear whether decision-support systems such as eviti will reduce practice variations over time; clinician and administrator acceptance is under study, as is use of the system for other tumor types.

The Cancer LINQ project includes a decision-support feature similar to eviti’s, but also aggregates clinical data from any electronic health record system, assesses compliance with quality measures, and analyzes trends in treatments and outcomes, Dr. Lichter said. With a click, Cancer LINQ can generate a report on how a particular physician is meeting any of 10 measures in ASCO’s Quality Oncology Practice Initiative (QOPI) certification program.

Cancer LINQ is "the son or daughter of QOPI," with "the ability to measure quality in the oncology practice, measure outcomes, and report in real time and provide new methods for data exploration and hypothesis generation," he said. "We believe the real-time collection of quality and outcomes data will allow the system to learn," resulting in continuously and quickly updated recommendations.

"We do not have to write an interface between our system and every one of the dozen or so electronic health record [EHR] systems that are used in the oncology community," Dr. Lichter said. The Cancer LINQ prototype was able to grab and conform clinical data from four different EHR systems. Cancer LINQ also goes beyond EHRs and can accept billing data, pharmacy data, and imaging data.

The Cancer LINQ prototype is just the first step, and ASCO will need partners or support to tackle the challenges and the cost of developing a final product and disseminating it. "We piloted QOPI for almost 4 years before we released it to the public, so this is not something that will be done next month," he said. "We will be mining the lessons from the prototype for many, many months and years to come."

So many groups and companies now are developing or offering computerized quality-improvement systems in health care that it’s bound to become confusing for clinicians to decide which ones to pursue, Dr. Lichter said in an interview. Eventually, some consolidation in the industry will be needed.

Dr. Lichter reported having no financial disclosures. Dr. Wong has been an unpaid consultant to eviti.

[email protected]

On Twitter @sherryboschert

Results of a phase III trial support a common clinical practice – giving docetaxel as second-line chemotherapy to patients with advanced adenocarcinomas of the stomach or esophagus that progressed after first-line chemotherapy.

The randomized, controlled, open-label study showed significantly longer overall survival in 84 patients who received docetaxel (a median of 5.2 months), compared with 84 patients who received only "active symptom control" as second-line therapy (3.6 months), Dr. Hugo Ford reported. Active symptom control could include anything that the treating clinicians felt might be appropriate to manage symptoms, including radiotherapy, steroids, and supportive medications.

The finding bolsters previous, weaker evidence of survival benefit from second-line chemotherapy in these patients. Perhaps more important, though, is the current study’s finding of improved quality of life in patients who underwent second-line chemotherapy with docetaxel, compared with no second-line chemotherapy, he said.

Although scores for global quality of life and function did not differ significantly between groups, pain scores were significantly better in the treatment group than the control group, Dr. Ford said during a press briefing sponsored by the American Society for Clinical Oncology (ASCO).

"This is the first trial to show a quality of life benefit" from second-line chemotherapy in patients with esophagogastric cancer, "which is a very important finding in terms of informing patients about the likely benefits of the treatment we’re offering them," added Dr. Ford, director of cancer services at Addenbrooke’s Hospital, Cambridge, England. "Docetaxel should be a standard second-line treatment for esophagogastric adenocarcinoma."

He will present the findings in San Francisco on Jan. 24 at a meeting on gastrointestinal cancers sponsored by ASCO.

Clinicians in the United States and Europe commonly give second-line chemotherapy to patients with advanced esophagogastric cancers that progress after first-line treatment, despite a lack of strong evidence for the practice. Without second-line chemotherapy, the median survival time of patients who relapse after first-line chemotherapy for advanced esophagogastric adenocarcinoma is 3-4 months, previous data suggest.

Two separate trials recently reported small survival benefits from second-line chemotherapy using other drugs. A German study using irinotecan was too small (only 40 patients) to be considered robust evidence, Dr. Ford said. A Korean study used either irinotecan or docetaxel for second-line therapy but included only gastric cancers in patients who were Asian and younger and fitter than patients normally seen in U.S. practices, he added.

Paclitaxel also is used commonly as second-line chemotherapy for esophagogastric cancers and similar to docetaxel. Although there are no randomized data showing benefits from second-line paclitaxel, compared with supportive care, "one would be reasonable extrapolating a benefit there," he said.

The current trial enrolled patients with locally advanced or metastatic esophagogastric cancer who had a performance status of 0-2 and whose cancer had progressed within 6 months of first-line chemotherapy with platinum/fluoropyrimidine. Patients randomized to second-line docetaxel received IV 75 mg/m² every 3 weeks for up to six cycles.

Only 19 patients in the docetaxel group completed six cycles of the chemotherapy (23%); the median number of cycles was three per patient. Disease progression and toxicity were the main reasons for not completing six cycles. Grade 4 toxicity occurred in 18 patients on docetaxel (21%).

Nearly a third of patients in the docetaxel group received either one round or no chemotherapy, which points to the generally poor prognosis with this aggressive disease and the fact that a significant number of patients will not benefit from chemotherapy, Dr. Ford said.

"For me, it makes the case that in those people that are benefitting from chemotherapy, the benefits are probably more marked even than we saw in the trial," he said.

The study was unable to identify any subgroup as being less likely to benefit from second-line chemotherapy. Future studies may try to find ways to identify patients who won’t benefit from the treatment, he said.

"Docetaxel should be standard second-line treatment for esophagogastric adenocarcinoma, and we think it’s likely to be the standard arm against which future treatments should be compared," Dr. Ford said.

After second-line chemotherapy, 7% of patients had a partial response, and 46% had stable disease.

The median age in the study was 65 years, and 81% of patients were male. The performance status at randomization was 0 in 27% of patients, 1 in 57%, and 2 in 15%. A total of 46% of cancers were in the stomach, 34% were in the esophagogastric junction, and 20% were in the esophagus. The disease had metastasized in 86% of patients.

Disease progression occurred during primary chemotherapy in 43% of patients, within 3 months of finishing primary chemotherapy in 28%, and between 3 and 6 months after primary chemotherapy in 29% of patients.

Dr. Ford and his associates now are analyzing cost-effectiveness data collected during the study.

Approximately 39,000 new cases of esophagogastric cancer are diagnosed each year in the United States and 1.5 million cases worldwide, most commonly adenocarcinomas. All patients with esophagogastric adenocarcinoma who present with advanced disease and 60%-70% of patients who present with local disease will relapse after first-line chemotherapy.

The gastrointestinal cancers meeting, where Dr. Ford will present the results, is cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

The charity Cancer Research UK funded the study. Sanofi-Aventis, which makes docetaxel, provided the drug for free. Some of Dr. Ford’s associates in the study have been consultants or advisers to Sanofi and/or received honoraria or research funding from the company.

Results of a phase III trial support a common clinical practice – giving docetaxel as second-line chemotherapy to patients with advanced adenocarcinomas of the stomach or esophagus that progressed after first-line chemotherapy.

The randomized, controlled, open-label study showed significantly longer overall survival in 84 patients who received docetaxel (a median of 5.2 months), compared with 84 patients who received only "active symptom control" as second-line therapy (3.6 months), Dr. Hugo Ford reported. Active symptom control could include anything that the treating clinicians felt might be appropriate to manage symptoms, including radiotherapy, steroids, and supportive medications.

The finding bolsters previous, weaker evidence of survival benefit from second-line chemotherapy in these patients. Perhaps more important, though, is the current study’s finding of improved quality of life in patients who underwent second-line chemotherapy with docetaxel, compared with no second-line chemotherapy, he said.

Although scores for global quality of life and function did not differ significantly between groups, pain scores were significantly better in the treatment group than the control group, Dr. Ford said during a press briefing sponsored by the American Society for Clinical Oncology (ASCO).

"This is the first trial to show a quality of life benefit" from second-line chemotherapy in patients with esophagogastric cancer, "which is a very important finding in terms of informing patients about the likely benefits of the treatment we’re offering them," added Dr. Ford, director of cancer services at Addenbrooke’s Hospital, Cambridge, England. "Docetaxel should be a standard second-line treatment for esophagogastric adenocarcinoma."

He will present the findings in San Francisco on Jan. 24 at a meeting on gastrointestinal cancers sponsored by ASCO.

Clinicians in the United States and Europe commonly give second-line chemotherapy to patients with advanced esophagogastric cancers that progress after first-line treatment, despite a lack of strong evidence for the practice. Without second-line chemotherapy, the median survival time of patients who relapse after first-line chemotherapy for advanced esophagogastric adenocarcinoma is 3-4 months, previous data suggest.

Two separate trials recently reported small survival benefits from second-line chemotherapy using other drugs. A German study using irinotecan was too small (only 40 patients) to be considered robust evidence, Dr. Ford said. A Korean study used either irinotecan or docetaxel for second-line therapy but included only gastric cancers in patients who were Asian and younger and fitter than patients normally seen in U.S. practices, he added.

Paclitaxel also is used commonly as second-line chemotherapy for esophagogastric cancers and similar to docetaxel. Although there are no randomized data showing benefits from second-line paclitaxel, compared with supportive care, "one would be reasonable extrapolating a benefit there," he said.

The current trial enrolled patients with locally advanced or metastatic esophagogastric cancer who had a performance status of 0-2 and whose cancer had progressed within 6 months of first-line chemotherapy with platinum/fluoropyrimidine. Patients randomized to second-line docetaxel received IV 75 mg/m² every 3 weeks for up to six cycles.

Only 19 patients in the docetaxel group completed six cycles of the chemotherapy (23%); the median number of cycles was three per patient. Disease progression and toxicity were the main reasons for not completing six cycles. Grade 4 toxicity occurred in 18 patients on docetaxel (21%).

Nearly a third of patients in the docetaxel group received either one round or no chemotherapy, which points to the generally poor prognosis with this aggressive disease and the fact that a significant number of patients will not benefit from chemotherapy, Dr. Ford said.

"For me, it makes the case that in those people that are benefitting from chemotherapy, the benefits are probably more marked even than we saw in the trial," he said.

The study was unable to identify any subgroup as being less likely to benefit from second-line chemotherapy. Future studies may try to find ways to identify patients who won’t benefit from the treatment, he said.

"Docetaxel should be standard second-line treatment for esophagogastric adenocarcinoma, and we think it’s likely to be the standard arm against which future treatments should be compared," Dr. Ford said.

After second-line chemotherapy, 7% of patients had a partial response, and 46% had stable disease.

The median age in the study was 65 years, and 81% of patients were male. The performance status at randomization was 0 in 27% of patients, 1 in 57%, and 2 in 15%. A total of 46% of cancers were in the stomach, 34% were in the esophagogastric junction, and 20% were in the esophagus. The disease had metastasized in 86% of patients.

Disease progression occurred during primary chemotherapy in 43% of patients, within 3 months of finishing primary chemotherapy in 28%, and between 3 and 6 months after primary chemotherapy in 29% of patients.

Dr. Ford and his associates now are analyzing cost-effectiveness data collected during the study.

Approximately 39,000 new cases of esophagogastric cancer are diagnosed each year in the United States and 1.5 million cases worldwide, most commonly adenocarcinomas. All patients with esophagogastric adenocarcinoma who present with advanced disease and 60%-70% of patients who present with local disease will relapse after first-line chemotherapy.

The gastrointestinal cancers meeting, where Dr. Ford will present the results, is cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

The charity Cancer Research UK funded the study. Sanofi-Aventis, which makes docetaxel, provided the drug for free. Some of Dr. Ford’s associates in the study have been consultants or advisers to Sanofi and/or received honoraria or research funding from the company.

Results of a phase III trial support a common clinical practice – giving docetaxel as second-line chemotherapy to patients with advanced adenocarcinomas of the stomach or esophagus that progressed after first-line chemotherapy.

The randomized, controlled, open-label study showed significantly longer overall survival in 84 patients who received docetaxel (a median of 5.2 months), compared with 84 patients who received only "active symptom control" as second-line therapy (3.6 months), Dr. Hugo Ford reported. Active symptom control could include anything that the treating clinicians felt might be appropriate to manage symptoms, including radiotherapy, steroids, and supportive medications.

The finding bolsters previous, weaker evidence of survival benefit from second-line chemotherapy in these patients. Perhaps more important, though, is the current study’s finding of improved quality of life in patients who underwent second-line chemotherapy with docetaxel, compared with no second-line chemotherapy, he said.

Although scores for global quality of life and function did not differ significantly between groups, pain scores were significantly better in the treatment group than the control group, Dr. Ford said during a press briefing sponsored by the American Society for Clinical Oncology (ASCO).

"This is the first trial to show a quality of life benefit" from second-line chemotherapy in patients with esophagogastric cancer, "which is a very important finding in terms of informing patients about the likely benefits of the treatment we’re offering them," added Dr. Ford, director of cancer services at Addenbrooke’s Hospital, Cambridge, England. "Docetaxel should be a standard second-line treatment for esophagogastric adenocarcinoma."

He will present the findings in San Francisco on Jan. 24 at a meeting on gastrointestinal cancers sponsored by ASCO.

Clinicians in the United States and Europe commonly give second-line chemotherapy to patients with advanced esophagogastric cancers that progress after first-line treatment, despite a lack of strong evidence for the practice. Without second-line chemotherapy, the median survival time of patients who relapse after first-line chemotherapy for advanced esophagogastric adenocarcinoma is 3-4 months, previous data suggest.

Two separate trials recently reported small survival benefits from second-line chemotherapy using other drugs. A German study using irinotecan was too small (only 40 patients) to be considered robust evidence, Dr. Ford said. A Korean study used either irinotecan or docetaxel for second-line therapy but included only gastric cancers in patients who were Asian and younger and fitter than patients normally seen in U.S. practices, he added.

Paclitaxel also is used commonly as second-line chemotherapy for esophagogastric cancers and similar to docetaxel. Although there are no randomized data showing benefits from second-line paclitaxel, compared with supportive care, "one would be reasonable extrapolating a benefit there," he said.

The current trial enrolled patients with locally advanced or metastatic esophagogastric cancer who had a performance status of 0-2 and whose cancer had progressed within 6 months of first-line chemotherapy with platinum/fluoropyrimidine. Patients randomized to second-line docetaxel received IV 75 mg/m² every 3 weeks for up to six cycles.

Only 19 patients in the docetaxel group completed six cycles of the chemotherapy (23%); the median number of cycles was three per patient. Disease progression and toxicity were the main reasons for not completing six cycles. Grade 4 toxicity occurred in 18 patients on docetaxel (21%).

Nearly a third of patients in the docetaxel group received either one round or no chemotherapy, which points to the generally poor prognosis with this aggressive disease and the fact that a significant number of patients will not benefit from chemotherapy, Dr. Ford said.

"For me, it makes the case that in those people that are benefitting from chemotherapy, the benefits are probably more marked even than we saw in the trial," he said.

The study was unable to identify any subgroup as being less likely to benefit from second-line chemotherapy. Future studies may try to find ways to identify patients who won’t benefit from the treatment, he said.

"Docetaxel should be standard second-line treatment for esophagogastric adenocarcinoma, and we think it’s likely to be the standard arm against which future treatments should be compared," Dr. Ford said.

After second-line chemotherapy, 7% of patients had a partial response, and 46% had stable disease.

The median age in the study was 65 years, and 81% of patients were male. The performance status at randomization was 0 in 27% of patients, 1 in 57%, and 2 in 15%. A total of 46% of cancers were in the stomach, 34% were in the esophagogastric junction, and 20% were in the esophagus. The disease had metastasized in 86% of patients.

Disease progression occurred during primary chemotherapy in 43% of patients, within 3 months of finishing primary chemotherapy in 28%, and between 3 and 6 months after primary chemotherapy in 29% of patients.

Dr. Ford and his associates now are analyzing cost-effectiveness data collected during the study.

Approximately 39,000 new cases of esophagogastric cancer are diagnosed each year in the United States and 1.5 million cases worldwide, most commonly adenocarcinomas. All patients with esophagogastric adenocarcinoma who present with advanced disease and 60%-70% of patients who present with local disease will relapse after first-line chemotherapy.

The gastrointestinal cancers meeting, where Dr. Ford will present the results, is cosponsored by ASCO, the American Gastroenterological Association Institute, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

The charity Cancer Research UK funded the study. Sanofi-Aventis, which makes docetaxel, provided the drug for free. Some of Dr. Ford’s associates in the study have been consultants or advisers to Sanofi and/or received honoraria or research funding from the company.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

From Hollywood to Washington, care at the end of life increasingly is part of the national conversation.

As more than 70 million baby boomers (Americans born between 1946 and 1964) approach the end of their life spans, the cultural, clinical and socioeconomic impacts of end-of-life care have become high-profile topics. The French film "Amour," which depicts the challenges faced by an octogenarian couple after the wife has a series of strokes, has received an Academy Award Best Picture nomination. The Institute of Medicine will convene a panel of experts on Feb. 22-24 in Washington to examine the state of end-of-life care. The goal of the IOM Committee on Transforming End of Life Care is to produce a consensus report by 2014 to address end-of-life care. "Coordinated, expert, compassionate care for people dying from chronic diseases continues to challenge the American health care system," according to the IOM’s online announcement of the meeting.

In addition, the Coalition to Transform Advanced Care is hosting a National Summit on Advanced Illness Care on Jan. 29-30 in Washington. The Coalition includes a wide range of constituencies including the IOM, the American Heart Association, the American Academy of Hospice and Palliative Medicine, and the American Geriatrics Society, as well as insurers, health systems, patient advocacy groups, and others.

As policy issues are discussed and begin to take shape, outcomes research focused on end-of-life care will increasingly gain importance. In the area of cancer care, here are some of the highlights of such research presented at a Quality Care Symposium sponsored by the American Society of Clinical Oncology in December 2012 in San Diego.

Palliative care teams: A palliative care team formed by Dr. Allen R. Chen and his associates at Johns Hopkins’s comprehensive cancer center helped change patient and family decisions regarding end-of-life care during a 4-year period and decreased use of intensive or invasive procedures in the last 6 months of life.

The team offered inpatient and clinic consultations and didactic sessions to physicians to improve how they discuss end-of-life issues with patients, plus support for family meetings to discuss and document the goals of care, said Dr. Chen, associate professor of oncology and pediatrics at Johns Hopkins University, Baltimore.

Of the 525 oncology patients who died in the cancer center while hospitalized from 2008 through 2011, the proportion who chose to have do-not-resuscitate (DNR) orders, withdrew ICU support, or chose comfort care instead of more aggressive care increased from 81% to 95% over the course of the 4 years, a statistically significant difference, he reported.

The rate of ICU care during patients’ final hospitalizations did not change significantly, but the proportion of patients who were put on mechanical ventilation for more than 14 days decreased significantly from 10% to 5%. These earlier withdrawals of care did not increase the risk of death, Dr. Chen said – the rate of survival to discharge from the oncology ICU did not change significantly.

The investigators now are looking for ways to minimize ICU visits at the end of life, he said. The presence of advanced cancer, being on a cardiac monitor, or needing supplemental oxygen foreshadowed critical illness in patients in the study. "We want to facilitate the difficult discussion" about end-of-life care choices "before critical care is needed," he said. So far, their efforts haven’t resulted in decreased use of ICU services at the end of life.

Minimizing surgical risks: One of the first comprehensive analyses of surgical outcomes in patients with disseminated cancer found that the risk of death increases greatly with emergency surgery.

John Pesavento, a medical student at Creighton University, Omaha, Neb., and his associates analyzed preoperative and postoperative data from the American College of Surgeon’s National Surgical Quality Improvement Program database on move than 147,000 patients who underwent surgical procedures between 2005 and 2008.

Eight of the 10 most common procedures resulted in significantly higher 30-day mortality rates in the cancer patients as compared with the same surgeries in patients who did not have disseminated cancer.

Comparing patients with and without disseminated cancer, 30-day mortality rates were 21% and 15%, respectively, after exploration of the abdomen, 15% and 9% after removal of the small bowel, 11% and 6% after colon removal, 11% and 5% after colostomy, 10% and 5% after partial removal of the colon, 10% and 0.5% after cholecystectomy, 1.8% and 0.9% after repair of a bowel opening, and 1% and 0.1% after mastectomy, he reported. The most common operations in patients with disseminated cancer were partial removal of the colon (in 11%), partial removal of the liver (9%), partial removal of the intestine (5%), and abdominal exploration (5%), he reported in a poster presentation.

When done as emergency procedures, however, 7 of the top 10 surgeries led to significantly higher 30-day mortality rates for disseminated cancer patients. Death rates in patients with disseminated cancer were 44% for emergency surgery and 12% for nonemergent surgery to explore the abdomen; the respective rates were 33% and 6% after bowel-to-bowel fusion, 31% and 4% after removal of the colon, 28% and 10% after removal of the small intestine, 23% and 5% after cholecystectomy, 22% and 7% after partial removal of the colon, and 19% and 9% after colostomy.

The findings should help physicians counsel their patients with disseminated cancer to help them decide whether it’s worth undergoing surgery – especially emergency surgery – given the higher risks of death, Mr. Pesavento said.

Physicians’ attitudes and education: In a separate study, 16 urologists and four primary care physicians who were undergoing surgical training in urology were interviewed about their attitudes regarding end-of-life care for men dying of prostate cancer. They viewed current end-of-life care as shoddily organized and poorly integrated, and said that ideal outcomes should be defined by patients’ own values and preferences, Dr. Jonathan Bergman and his associates reported in a poster presentation.

The physicians said that, ideally, a multidisciplinary team would care for dying patients, but respondents varied in the degree to which they saw themselves participating, reported Dr. Bergman of the University of California, Los Angeles.

The findings suggest that physician education about end-of-life care needs improvement, and that clinicians should be guided to deliver end-of-life care that is patient-centered and congruent with patients’ values, he said.

Dying in the hospital: Among 2,621 patients with solid tumors, those who had contact with a specialist palliative care team more than a month before their deaths were less likely to die in the hospital (16%) than were patients who had later or no contact with the team (20%), J. Brian Cassel, Ph.D., reported in a poster presentation.

Dr. Cassel and his associates analyzed claims data on the last 6 months of life for 3,128 adults with cancer who had at least one contact with the Virginia Commonwealth University cancer center in Richmond between January 2009 and July 2011. The data set included patients who had solid tumors, underwent bone marrow transfer, or had other hematologic malignancies.

The findings provided a snapshot of end-of-life care at the university, where 32% of the cancer patients were admitted to the hospital within their last 30 days of life, 19% had at least one readmission during their last 6 months of life, and 15% died in the hospital. Chemotherapy was given to 11% in their last month of life, and to 7% in their last 2 weeks of life, said Dr. Cassel of the university.

The specialist palliative care team made contact with 28% of patients a median of 6-10 days before the death of patients with bone marrow transfer or other nonhematologic malignancies and a median of 25 days before the death of patients with solid tumors.

Chemotherapy at the end of life: Patients with hematologic malignancies were significantly more likely to get chemotherapy in the last 30 days of life (38%) compared with patients with solid tumors (8%), Dr. Alma Rodriguez and her associates reported in a poster presentation.

The investigators reviewed data on 7,399 patients who received care for a solid tumor or hematological malignancy at the University of Texas M.D. Anderson Cancer Center, Houston, and died between December 2010 and May 2012. Overall, 14% of patients received chemotherapy within the last 30 days of life.

Of the 1,262 patients who died in the hospital, 44% received chemotherapy within the last 30 days of life, compared with 7% of the 6,137 patients who died in other locations, reported Dr. Rodriguez, professor of medicine at the cancer center.

Chemotherapy within the last 30 days of life was 3 times more likely in patients with metastatic solid tumors, 14 times more likely in patients with nonrelapsed hematologic malignancy, and 36 times more likely in patients with historical or current relapse of hematologic malignancy.

Patients 65 years or older were 38% less likely than were younger patients to get chemotherapy within the last 30 days of life. Patients with one or more comorbidity (most frequently heart failure and coronary artery diseases) were 28% less likely to get chemotherapy within the last 30 days of life as compared with patients without comorbidities.

"As oncologists, we must communicate clearly with our patients about realistic goals of treatment and the likelihood of life-threatening complications of chemotherapy," Dr. Rodriguez said in the poster.

Outpatient palliative care: Dr. Kavitha Ramchandran and her associates at Stanford (Calif.) University studied their system’s electronic medical records to look at the use of palliative care in outpatient clinics from January through September 2012. The number of palliative care contacts with outpatient clinic patients increased from 10 in January to 45 in September. The number of physicians referring outpatients to palliative care increased from 6 in January to 21 in September, she said in a poster presentation.

More than 65% of patients who were referred for palliative care were younger than 65 years, said Dr. Ramchandran of the university. Most patients had only one visit with palliative care (41%) or two visits (23%).

The findings suggest that outpatient palliative care is a growing specialty, she suggested. The data are not mature enough to assess any impact on the quality of end-of-life care or on the efficiency of care, she added.

Dr. Chen and Mr. Pesavento reported having no financial disclosures. Dr. Ramchandran’s study was funded in part by the Stanford Corporate Partners Fund and by various Stanford departments. No financial disclosures were available for the other presenters.

Suicide attempts or ideation were a problem in 43% of autistic children compared with 14% of depressed nonautistic children and 0.5% of children with neither depression nor autism, in a prospective study of 1,012 children.

Mothers of the children rated 165 items on the Pediatric Behavior Scale from "not at all a problem" to "very often a problem." Suicide ideation and attempts were considered a problem if they occurred anywhere from sometimes to very often.

"Because suicide ideation and attempts in autism are significantly higher than the norm, all children with autism should be screened for suicide ideation or attempts," Angela A. Gorman, Ph.D., said at a poster presentation at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Among the 179 autistic children, 77% of those with suicide ideation or attempts were depressed, but only 28% of those with depression had suicide ideation or attempts. Among autistic children without depression, 95% had no suicide ideation or attempts, reported Dr. Gorman, a clinical psychologist in the department of psychiatry at Pennsylvania State College of Medicine, Hershey, and her associates.

The autistic children ranged in age from 1 to 16 years; 68% had high-function autism (defined as an IQ of 80 or higher), and the rest had low-functioning autism. The 35 nonautistic children with depression ranged in age from 8 to 16 years, and the 186 typical children were 6-12 years old.

Males comprised 84% of the autistic group, 26% of the nonautistic depressed group, and 44% of the typical group. The proportions of parents whose occupations were professional or managerial (indicating higher socioeconomic status) were 37% in the autistic group, 51% in the nonautistic with depression, and 51% in the typical group. The study cohort came mainly from rural, central Pennsylvania, where white children made up 92% of the autistic group, 94% of the nonautistic with depression, and 78% of the typical group.

The study assessed numerous variables to identify multiple risk factors in children with autism. Suicide ideation or attempts were more common in autistic males (15%) than females (7%); children with nonprofessional parents (16%), compared with those with professional parents (10%); black or Hispanic children (28%), compared with white or Asian children (13%); and in youths aged 10-16 years (32%), compared with those aged 1-9 years (10%).

Rates of suicide ideation or attempts increased with the number of risk factors, with rates of 11%-71% in children with two to four of these demographic risk factors (male sex, lower socioeconomic status, black or Hispanic race/ethnicity, and older age), Dr. Morgan reported.

Higher rates of suicide ideation or attempts also were seen in autistic children whose mothers reported that the child had been teased (19%) than in those who were not teased, in those who were depressed (26%), compared with nondepressed (5%), and in those with behavior problems (24%), compared with children without behavior problems (7%).

Rates of suicide ideation or attempts increased from 6% to 46% in autistic children with one to three of these comorbidity risk factors (teasing, depression, or behavior problems).

Screening for suicidality is especially important for children with these demographic and comorbidity risk factors, because the children’s risk might be reduced by interventions focused on teasing, mood, behavior problems, depression, and adversities related to race or socioeconomic status, Dr. Morgan said.

Factors that were not associated with suicide ideation and attempts in autistic children included IQ, the severity of autism, attention deficit, hyperactivity, psychosis, eating disturbances, or excessive sleep.

The study "reminds us that there’s the issue of ‘diagnostic overshadowing’ that can occur with patients – kids and adults – who are on the autism spectrum," she said. "We have to remember that these individuals also suffer from other disorders" and that symptoms of depression, suicidal ideation, and suicide behaviors should not be overlooked.

Because the study relied on parental reports, it provides a better understanding of how children with autism are perceived by their parents, but more research is needed to discern whether the children truly were considering and attempting to kill themselves or whether some of these were attempts by the autistic children to communicate something else.

"It’s important to screen more thoroughly when we have patients on the autism spectrum and make sure that we’re really understanding what’s going on with them," she said.

The investigators hope to expand their research to include other clinical sites, especially more urban sites, with a greater diversity of children.

Previous studies have shown depressed mood in 54% of children with high-functioning autism and 42% of children with low-functioning autism, she said. The current study appears to be the first to investigate suicidal ideation and attempts in autistic children.

Dr. Gorman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

Suicide attempts or ideation were a problem in 43% of autistic children compared with 14% of depressed nonautistic children and 0.5% of children with neither depression nor autism, in a prospective study of 1,012 children.

Mothers of the children rated 165 items on the Pediatric Behavior Scale from "not at all a problem" to "very often a problem." Suicide ideation and attempts were considered a problem if they occurred anywhere from sometimes to very often.

"Because suicide ideation and attempts in autism are significantly higher than the norm, all children with autism should be screened for suicide ideation or attempts," Angela A. Gorman, Ph.D., said at a poster presentation at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Among the 179 autistic children, 77% of those with suicide ideation or attempts were depressed, but only 28% of those with depression had suicide ideation or attempts. Among autistic children without depression, 95% had no suicide ideation or attempts, reported Dr. Gorman, a clinical psychologist in the department of psychiatry at Pennsylvania State College of Medicine, Hershey, and her associates.

The autistic children ranged in age from 1 to 16 years; 68% had high-function autism (defined as an IQ of 80 or higher), and the rest had low-functioning autism. The 35 nonautistic children with depression ranged in age from 8 to 16 years, and the 186 typical children were 6-12 years old.

Males comprised 84% of the autistic group, 26% of the nonautistic depressed group, and 44% of the typical group. The proportions of parents whose occupations were professional or managerial (indicating higher socioeconomic status) were 37% in the autistic group, 51% in the nonautistic with depression, and 51% in the typical group. The study cohort came mainly from rural, central Pennsylvania, where white children made up 92% of the autistic group, 94% of the nonautistic with depression, and 78% of the typical group.

The study assessed numerous variables to identify multiple risk factors in children with autism. Suicide ideation or attempts were more common in autistic males (15%) than females (7%); children with nonprofessional parents (16%), compared with those with professional parents (10%); black or Hispanic children (28%), compared with white or Asian children (13%); and in youths aged 10-16 years (32%), compared with those aged 1-9 years (10%).

Rates of suicide ideation or attempts increased with the number of risk factors, with rates of 11%-71% in children with two to four of these demographic risk factors (male sex, lower socioeconomic status, black or Hispanic race/ethnicity, and older age), Dr. Morgan reported.

Higher rates of suicide ideation or attempts also were seen in autistic children whose mothers reported that the child had been teased (19%) than in those who were not teased, in those who were depressed (26%), compared with nondepressed (5%), and in those with behavior problems (24%), compared with children without behavior problems (7%).

Rates of suicide ideation or attempts increased from 6% to 46% in autistic children with one to three of these comorbidity risk factors (teasing, depression, or behavior problems).

Screening for suicidality is especially important for children with these demographic and comorbidity risk factors, because the children’s risk might be reduced by interventions focused on teasing, mood, behavior problems, depression, and adversities related to race or socioeconomic status, Dr. Morgan said.

Factors that were not associated with suicide ideation and attempts in autistic children included IQ, the severity of autism, attention deficit, hyperactivity, psychosis, eating disturbances, or excessive sleep.

The study "reminds us that there’s the issue of ‘diagnostic overshadowing’ that can occur with patients – kids and adults – who are on the autism spectrum," she said. "We have to remember that these individuals also suffer from other disorders" and that symptoms of depression, suicidal ideation, and suicide behaviors should not be overlooked.

Because the study relied on parental reports, it provides a better understanding of how children with autism are perceived by their parents, but more research is needed to discern whether the children truly were considering and attempting to kill themselves or whether some of these were attempts by the autistic children to communicate something else.

"It’s important to screen more thoroughly when we have patients on the autism spectrum and make sure that we’re really understanding what’s going on with them," she said.

The investigators hope to expand their research to include other clinical sites, especially more urban sites, with a greater diversity of children.

Previous studies have shown depressed mood in 54% of children with high-functioning autism and 42% of children with low-functioning autism, she said. The current study appears to be the first to investigate suicidal ideation and attempts in autistic children.

Dr. Gorman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

Suicide attempts or ideation were a problem in 43% of autistic children compared with 14% of depressed nonautistic children and 0.5% of children with neither depression nor autism, in a prospective study of 1,012 children.

Mothers of the children rated 165 items on the Pediatric Behavior Scale from "not at all a problem" to "very often a problem." Suicide ideation and attempts were considered a problem if they occurred anywhere from sometimes to very often.

"Because suicide ideation and attempts in autism are significantly higher than the norm, all children with autism should be screened for suicide ideation or attempts," Angela A. Gorman, Ph.D., said at a poster presentation at the annual meeting of the American Academy of Child and Adolescent Psychiatry.

Among the 179 autistic children, 77% of those with suicide ideation or attempts were depressed, but only 28% of those with depression had suicide ideation or attempts. Among autistic children without depression, 95% had no suicide ideation or attempts, reported Dr. Gorman, a clinical psychologist in the department of psychiatry at Pennsylvania State College of Medicine, Hershey, and her associates.

The autistic children ranged in age from 1 to 16 years; 68% had high-function autism (defined as an IQ of 80 or higher), and the rest had low-functioning autism. The 35 nonautistic children with depression ranged in age from 8 to 16 years, and the 186 typical children were 6-12 years old.

Males comprised 84% of the autistic group, 26% of the nonautistic depressed group, and 44% of the typical group. The proportions of parents whose occupations were professional or managerial (indicating higher socioeconomic status) were 37% in the autistic group, 51% in the nonautistic with depression, and 51% in the typical group. The study cohort came mainly from rural, central Pennsylvania, where white children made up 92% of the autistic group, 94% of the nonautistic with depression, and 78% of the typical group.

The study assessed numerous variables to identify multiple risk factors in children with autism. Suicide ideation or attempts were more common in autistic males (15%) than females (7%); children with nonprofessional parents (16%), compared with those with professional parents (10%); black or Hispanic children (28%), compared with white or Asian children (13%); and in youths aged 10-16 years (32%), compared with those aged 1-9 years (10%).

Rates of suicide ideation or attempts increased with the number of risk factors, with rates of 11%-71% in children with two to four of these demographic risk factors (male sex, lower socioeconomic status, black or Hispanic race/ethnicity, and older age), Dr. Morgan reported.

Higher rates of suicide ideation or attempts also were seen in autistic children whose mothers reported that the child had been teased (19%) than in those who were not teased, in those who were depressed (26%), compared with nondepressed (5%), and in those with behavior problems (24%), compared with children without behavior problems (7%).

Rates of suicide ideation or attempts increased from 6% to 46% in autistic children with one to three of these comorbidity risk factors (teasing, depression, or behavior problems).

Screening for suicidality is especially important for children with these demographic and comorbidity risk factors, because the children’s risk might be reduced by interventions focused on teasing, mood, behavior problems, depression, and adversities related to race or socioeconomic status, Dr. Morgan said.

Factors that were not associated with suicide ideation and attempts in autistic children included IQ, the severity of autism, attention deficit, hyperactivity, psychosis, eating disturbances, or excessive sleep.

The study "reminds us that there’s the issue of ‘diagnostic overshadowing’ that can occur with patients – kids and adults – who are on the autism spectrum," she said. "We have to remember that these individuals also suffer from other disorders" and that symptoms of depression, suicidal ideation, and suicide behaviors should not be overlooked.

Because the study relied on parental reports, it provides a better understanding of how children with autism are perceived by their parents, but more research is needed to discern whether the children truly were considering and attempting to kill themselves or whether some of these were attempts by the autistic children to communicate something else.

"It’s important to screen more thoroughly when we have patients on the autism spectrum and make sure that we’re really understanding what’s going on with them," she said.

The investigators hope to expand their research to include other clinical sites, especially more urban sites, with a greater diversity of children.

Previous studies have shown depressed mood in 54% of children with high-functioning autism and 42% of children with low-functioning autism, she said. The current study appears to be the first to investigate suicidal ideation and attempts in autistic children.

Dr. Gorman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

DENVER – Do you need a stethoscope, a blood pressure monitor, or a tool to assess cardiac rhythms? There are apps for that. In fact, by recent count there are more than 200,000 applications of technology – or "apps" – available for smartphones or tablet devices, and they’re being used more and more for medical purposes.

Need a convenient way to look up drug interactions, pediatric dosing, or clinical decision rules from guidelines? Or how about a translator, a light to examine a finicky infant’s throat, or a "white board" to draw a picture for your patient? Yup – they’re all in apps, and chances are you already may be using some of these.

Dr. Joshua S. Broder expects an exponential increase in the use of apps in medicine as smartphones and tablets continue to proliferate, but their accuracy needs to be verified and potential problems need to be addressed, he said at the annual meeting of the American College of Emergency Physicians.

Apps will be used increasingly for bedside diagnosis and measurement of hemoglobin or other physiologic parameters. "Some of these tests may be taken over by smartphones in the near future," according to Dr. Broder of Duke University, Durham, N.C.

On the other hand, he cautioned, how do you sterilize a smartphone as you move from one hospital room or patient to another, so that you avoid transmitting infection? There are few independent studies so far testing the accuracy and reliability of medical apps, most of which were designed for lay consumers, not physicians.

The Food and Drug Administration is "very interested" in regulating any apps that might substitute for proven technologies such as stethoscopes or that physicians use as accessories to medical devices that already are regulated, he said. The FDA described its approach to deciding which mobile technology to regulate in a draft report in July 2012.

Even the basic functions of smartphones can be convenient in clinical practice, such as taking photos or videos and transmitting information by text or e-mail, but make sure you protect patient privacy and autonomy in ways that maintain trust and comply with HIPAA, Dr. Broder said.

The Duke University Health System has resolved any issues with HIPAA so that it’s safe for physicians to transmit images and video as long as they’re not sent outside the system. Talk to the HIPAA compliance officer at your medical center to establish the ground rules, he said. You can refresh your memory about which parts of data are considered by HIPAA to be protected information via a University of Miami site.

Dr. Broder reviewed some smartphone functions and apps that may be helpful and others that are not yet ready for medical prime time. Many are available for no cost or for as nominal fee. One study of health and fitness apps suggests that apps costing $0.99 or more tend to be higher quality and more trustworthy than less-expensive ones, he noted (J. Med. Internet Res. 2012;14:e72).

• Sleep: One of his residents swears by "smart alarm clock" apps that claim to use a smartphone’s accelerometer to assess where you are in your sleep cycle (based on your movements in bed) to wake you at a time that will leave you feeling less fatigued. You may set for 6 a.m., but the alarm may wake you at 5:45 a.m. Apps like Sleep Cycle ($0.99) and Sleep as Android have some underlying sleep science behind them, but no independent studies have verified their claims.

• CPR: The accelerometer also is used in the free app PocketCPR to give real-time feedback during CPR on the rate and depth of compression. Its has not been cleared by the FDA for use in humans, however, so the app warns that it’s meant for practice only. One prospective, randomized trial in 1,586 cardiac arrests that happened outside of hospitals found that use by emergency services personnel did not significantly change the likelihood of return of spontaneous circulation or other outcomes (BMJ 2011;342:d512).

• Chest: If you’re trying to teach students and residents about heart and lung sounds, or if you still get confused between mitral regurgitation and aortic stenosis, you might want to have a digital stethoscope app handy. These apps interpret heart and lung sounds heard typically through your smartphone’s microphone, which may not be good enough for clinical use. The Thinklabs Stethoscope app at $70 is pricey, compared with others, but it records sounds directly via the smartphone or through an attached electronic stethoscope.

A case that turns an iPhone into an ECG device has been submitted to the FDA for approval. The AliveCor iPhone ECG is expected to sell for between $100 and $200, compared with the usual price tag of thousands of dollars for conventional ECG machines, according to PC Magazine.

One small prospective study of experimental software that programs an iPhone to detect atrial fibrillation by placing a patient’s finger over the camera lens showed it was 98% sensitive and nearly 100% specific in detecting atrial fibrillation (IEEE Trans. Biomed. Eng. 2012 [doi:10.1109/TBME.2012.2208112]).

• Translation: When your hospital’s interpreter isn’t available, a free app like Google Translate can help. You can write or speak in one language and your device will write and say the message in a wide selection of language. You’ll need a wireless Internet connection for some translation apps.

• Eye chart: Your office has an eye chart, but you can’t find it. Pull up an app like the free EyeChart on your smartphone or tablet.

• Light: You want to inspect a patient’s sore throat, but the light in the exam room is broken. Use the flash on your smartphone camera, or use one of many free "flashlight" apps that turn the smartphone screen into a light source. Be sure to turn it off when you’re done, though, or your battery will run down quickly.

• Ultrasound: The miniaturization of ultrasound devices continues, with systems like the Mobisante MoblUS that attaches a probe to show images on your smartphone screen.

• Skin: For better evaluation of skin lesions, turn your iPhone into a dermatoscope by using the DermScope app ($4.99) and attaching the phone to the DermScope hardware (sold separately).

• Decision support: The PediStat app ($2.99 and up) makes it easy to determine the right pediatric drug dosing, among other features. The free Calculate (Medical Calculator) by QxMD app provides quick intuitive guides to common decision rules and can be customized by medical specialty.

• Drugs: Look up drug dosing, side effects, interactions and other information on free apps from Micromedex and others.

• Photos/videos: These apps are handy for documenting and sharing the appearance of a wound, a patient’s range of motion, or performance on a neurologic exam. Anyone who thinks they see uvula deviation in the throat of a struggling 3-year-old can snap a photo or video for review with other health care providers, medical students, or parents and avoid having to repeat the exam. Images of a wound problem after surgery can be sent to the surgeon when he or she is out of town.

Dr. Broder particularly finds the video useful for children having "pseudoseizures" whose parents demand a neurologic consult, even though the seizure event probably won’t be happening when the neurologist arrives. A video shows the neurologist exactly what Dr. Broder saw. (See the Dos and Don’ts for using photos and videos below.)

Once you’ve got an image or data you want to transmit, avoid texting as first-line means of communication because texts typically are not encrypted. Be careful when e-mailing to make sure it’s going to the correct address and only that address. Use e-mail options such as "confirm delivery" or "request read receipt," and add a sentence to the e-mail saying, "Please delete once no longer necessary for patient care," he advised.

Always document in the patient’s chart that you obtained patient consent and describe what was sent and who received it. Describe any images you send.

Don’t leave images on your portable devices. They’re easily lost, and most have inadequate encryption. Make images part of the medical record by uploading to the patient’s record, printing and scanning, or describing them clearly in the medical record. Then delete them from your device.

Store images and data in "cloud" computing sites with caution, Dr. Broder said. Services such as Google Drive or Dropbox allow sharing of very large files but provide no assurances about the quality of encryption or security. Cloud sites may be best used for giving patients access to instructions, instructional videos, reference papers, anatomic diagrams, etc.

The FDA approved the free Centricity Radiology Mobile Access app, which lets you view CT and MRI images on your iPhone if the images are stored in a GE Centricity PACS (picture archiving and communication system) platform – which may include 20% of U.S. radiology images, according to the company.

Sherry Boschert/IMNG Medical Media A screen shot shows the Centricity Radiology Mobile Access app.

The free CloudOn app lets you use MS Office software (including Word, Excel, and Powerpoint) on an iPad.

Various screen replicators that allow you to remotely access your computer desktop from your mobile device (such as ones by Citrix, or Splashtop Remote Desktop) all have the same problem, Dr. Broder said – they’re too clunky and not "touchscreen friendly."

And one final word on an underappreciated perk of medical apps on smartphones: When your medical director stops by, wanting to talk about your productivity, pull out your smartphone to show the data you’ve entered about patient encounters in your free iRVU app, which calculates total RVUs, charges, and average charge per encounter, among other features.

This list only begins to scratch the surface of app use in medicine. Other apps are available for immunization schedules, dictation, infectious disease guides, and teaching aids. Journals provide content to portable devices through apps, and some medical societies offer multifaceted apps such as ACEP Mobile.

Apps on smartphones and tablets will become part of daily medical practice, Dr. Broder predicted, but physicians need to be conscious about their limitations and potential problems as well as their assets.

Click here to view a video interview with Dr. Broder.

Dos and Don’ts for Medical Images on Smartphones

Do:

Obtain consent to acquire images or transmit them for the patient’s medical benefit.

Explain to the patient and get consent for any other intended use, such as education or publication.

Tell the patient what you will do with images when their use is completed – delete them or upload them to the medical record.

Confirm receipt if you send to other health care providers.

Specify in your message what that provider should do with the image.

Document in the patient’s chart that consent was obtained, what was sent, who received it, and content of the images.

Don’t:

Obtain images covertly.

Send to any unnecessary recipients.

Show images to anyone for fun.

Post to social media sites.

Blog about "funny" patient encounters.

Dr. Broder owns stock in Apple.

DENVER – Do you need a stethoscope, a blood pressure monitor, or a tool to assess cardiac rhythms? There are apps for that. In fact, by recent count there are more than 200,000 applications of technology – or "apps" – available for smartphones or tablet devices, and they’re being used more and more for medical purposes.

Need a convenient way to look up drug interactions, pediatric dosing, or clinical decision rules from guidelines? Or how about a translator, a light to examine a finicky infant’s throat, or a "white board" to draw a picture for your patient? Yup – they’re all in apps, and chances are you already may be using some of these.

Dr. Joshua S. Broder expects an exponential increase in the use of apps in medicine as smartphones and tablets continue to proliferate, but their accuracy needs to be verified and potential problems need to be addressed, he said at the annual meeting of the American College of Emergency Physicians.

Apps will be used increasingly for bedside diagnosis and measurement of hemoglobin or other physiologic parameters. "Some of these tests may be taken over by smartphones in the near future," according to Dr. Broder of Duke University, Durham, N.C.

On the other hand, he cautioned, how do you sterilize a smartphone as you move from one hospital room or patient to another, so that you avoid transmitting infection? There are few independent studies so far testing the accuracy and reliability of medical apps, most of which were designed for lay consumers, not physicians.

The Food and Drug Administration is "very interested" in regulating any apps that might substitute for proven technologies such as stethoscopes or that physicians use as accessories to medical devices that already are regulated, he said. The FDA described its approach to deciding which mobile technology to regulate in a draft report in July 2012.

Even the basic functions of smartphones can be convenient in clinical practice, such as taking photos or videos and transmitting information by text or e-mail, but make sure you protect patient privacy and autonomy in ways that maintain trust and comply with HIPAA, Dr. Broder said.

The Duke University Health System has resolved any issues with HIPAA so that it’s safe for physicians to transmit images and video as long as they’re not sent outside the system. Talk to the HIPAA compliance officer at your medical center to establish the ground rules, he said. You can refresh your memory about which parts of data are considered by HIPAA to be protected information via a University of Miami site.

Dr. Broder reviewed some smartphone functions and apps that may be helpful and others that are not yet ready for medical prime time. Many are available for no cost or for as nominal fee. One study of health and fitness apps suggests that apps costing $0.99 or more tend to be higher quality and more trustworthy than less-expensive ones, he noted (J. Med. Internet Res. 2012;14:e72).

• Sleep: One of his residents swears by "smart alarm clock" apps that claim to use a smartphone’s accelerometer to assess where you are in your sleep cycle (based on your movements in bed) to wake you at a time that will leave you feeling less fatigued. You may set for 6 a.m., but the alarm may wake you at 5:45 a.m. Apps like Sleep Cycle ($0.99) and Sleep as Android have some underlying sleep science behind them, but no independent studies have verified their claims.

• CPR: The accelerometer also is used in the free app PocketCPR to give real-time feedback during CPR on the rate and depth of compression. Its has not been cleared by the FDA for use in humans, however, so the app warns that it’s meant for practice only. One prospective, randomized trial in 1,586 cardiac arrests that happened outside of hospitals found that use by emergency services personnel did not significantly change the likelihood of return of spontaneous circulation or other outcomes (BMJ 2011;342:d512).

• Chest: If you’re trying to teach students and residents about heart and lung sounds, or if you still get confused between mitral regurgitation and aortic stenosis, you might want to have a digital stethoscope app handy. These apps interpret heart and lung sounds heard typically through your smartphone’s microphone, which may not be good enough for clinical use. The Thinklabs Stethoscope app at $70 is pricey, compared with others, but it records sounds directly via the smartphone or through an attached electronic stethoscope.

A case that turns an iPhone into an ECG device has been submitted to the FDA for approval. The AliveCor iPhone ECG is expected to sell for between $100 and $200, compared with the usual price tag of thousands of dollars for conventional ECG machines, according to PC Magazine.

One small prospective study of experimental software that programs an iPhone to detect atrial fibrillation by placing a patient’s finger over the camera lens showed it was 98% sensitive and nearly 100% specific in detecting atrial fibrillation (IEEE Trans. Biomed. Eng. 2012 [doi:10.1109/TBME.2012.2208112]).

• Translation: When your hospital’s interpreter isn’t available, a free app like Google Translate can help. You can write or speak in one language and your device will write and say the message in a wide selection of language. You’ll need a wireless Internet connection for some translation apps.

• Eye chart: Your office has an eye chart, but you can’t find it. Pull up an app like the free EyeChart on your smartphone or tablet.

• Light: You want to inspect a patient’s sore throat, but the light in the exam room is broken. Use the flash on your smartphone camera, or use one of many free "flashlight" apps that turn the smartphone screen into a light source. Be sure to turn it off when you’re done, though, or your battery will run down quickly.

• Ultrasound: The miniaturization of ultrasound devices continues, with systems like the Mobisante MoblUS that attaches a probe to show images on your smartphone screen.

• Skin: For better evaluation of skin lesions, turn your iPhone into a dermatoscope by using the DermScope app ($4.99) and attaching the phone to the DermScope hardware (sold separately).

• Decision support: The PediStat app ($2.99 and up) makes it easy to determine the right pediatric drug dosing, among other features. The free Calculate (Medical Calculator) by QxMD app provides quick intuitive guides to common decision rules and can be customized by medical specialty.

• Drugs: Look up drug dosing, side effects, interactions and other information on free apps from Micromedex and others.

• Photos/videos: These apps are handy for documenting and sharing the appearance of a wound, a patient’s range of motion, or performance on a neurologic exam. Anyone who thinks they see uvula deviation in the throat of a struggling 3-year-old can snap a photo or video for review with other health care providers, medical students, or parents and avoid having to repeat the exam. Images of a wound problem after surgery can be sent to the surgeon when he or she is out of town.

Dr. Broder particularly finds the video useful for children having "pseudoseizures" whose parents demand a neurologic consult, even though the seizure event probably won’t be happening when the neurologist arrives. A video shows the neurologist exactly what Dr. Broder saw. (See the Dos and Don’ts for using photos and videos below.)

Once you’ve got an image or data you want to transmit, avoid texting as first-line means of communication because texts typically are not encrypted. Be careful when e-mailing to make sure it’s going to the correct address and only that address. Use e-mail options such as "confirm delivery" or "request read receipt," and add a sentence to the e-mail saying, "Please delete once no longer necessary for patient care," he advised.

Always document in the patient’s chart that you obtained patient consent and describe what was sent and who received it. Describe any images you send.

Don’t leave images on your portable devices. They’re easily lost, and most have inadequate encryption. Make images part of the medical record by uploading to the patient’s record, printing and scanning, or describing them clearly in the medical record. Then delete them from your device.

Store images and data in "cloud" computing sites with caution, Dr. Broder said. Services such as Google Drive or Dropbox allow sharing of very large files but provide no assurances about the quality of encryption or security. Cloud sites may be best used for giving patients access to instructions, instructional videos, reference papers, anatomic diagrams, etc.

The FDA approved the free Centricity Radiology Mobile Access app, which lets you view CT and MRI images on your iPhone if the images are stored in a GE Centricity PACS (picture archiving and communication system) platform – which may include 20% of U.S. radiology images, according to the company.

Sherry Boschert/IMNG Medical Media A screen shot shows the Centricity Radiology Mobile Access app.

The free CloudOn app lets you use MS Office software (including Word, Excel, and Powerpoint) on an iPad.

Various screen replicators that allow you to remotely access your computer desktop from your mobile device (such as ones by Citrix, or Splashtop Remote Desktop) all have the same problem, Dr. Broder said – they’re too clunky and not "touchscreen friendly."

And one final word on an underappreciated perk of medical apps on smartphones: When your medical director stops by, wanting to talk about your productivity, pull out your smartphone to show the data you’ve entered about patient encounters in your free iRVU app, which calculates total RVUs, charges, and average charge per encounter, among other features.

This list only begins to scratch the surface of app use in medicine. Other apps are available for immunization schedules, dictation, infectious disease guides, and teaching aids. Journals provide content to portable devices through apps, and some medical societies offer multifaceted apps such as ACEP Mobile.

Apps on smartphones and tablets will become part of daily medical practice, Dr. Broder predicted, but physicians need to be conscious about their limitations and potential problems as well as their assets.

Click here to view a video interview with Dr. Broder.

Dos and Don’ts for Medical Images on Smartphones

Do:

Obtain consent to acquire images or transmit them for the patient’s medical benefit.

Explain to the patient and get consent for any other intended use, such as education or publication.

Tell the patient what you will do with images when their use is completed – delete them or upload them to the medical record.

Confirm receipt if you send to other health care providers.

Specify in your message what that provider should do with the image.

Document in the patient’s chart that consent was obtained, what was sent, who received it, and content of the images.

Don’t:

Obtain images covertly.

Send to any unnecessary recipients.

Show images to anyone for fun.

Post to social media sites.

Blog about "funny" patient encounters.

Dr. Broder owns stock in Apple.

DENVER – Do you need a stethoscope, a blood pressure monitor, or a tool to assess cardiac rhythms? There are apps for that. In fact, by recent count there are more than 200,000 applications of technology – or "apps" – available for smartphones or tablet devices, and they’re being used more and more for medical purposes.

Need a convenient way to look up drug interactions, pediatric dosing, or clinical decision rules from guidelines? Or how about a translator, a light to examine a finicky infant’s throat, or a "white board" to draw a picture for your patient? Yup – they’re all in apps, and chances are you already may be using some of these.

Dr. Joshua S. Broder expects an exponential increase in the use of apps in medicine as smartphones and tablets continue to proliferate, but their accuracy needs to be verified and potential problems need to be addressed, he said at the annual meeting of the American College of Emergency Physicians.

Apps will be used increasingly for bedside diagnosis and measurement of hemoglobin or other physiologic parameters. "Some of these tests may be taken over by smartphones in the near future," according to Dr. Broder of Duke University, Durham, N.C.

On the other hand, he cautioned, how do you sterilize a smartphone as you move from one hospital room or patient to another, so that you avoid transmitting infection? There are few independent studies so far testing the accuracy and reliability of medical apps, most of which were designed for lay consumers, not physicians.

The Food and Drug Administration is "very interested" in regulating any apps that might substitute for proven technologies such as stethoscopes or that physicians use as accessories to medical devices that already are regulated, he said. The FDA described its approach to deciding which mobile technology to regulate in a draft report in July 2012.

Even the basic functions of smartphones can be convenient in clinical practice, such as taking photos or videos and transmitting information by text or e-mail, but make sure you protect patient privacy and autonomy in ways that maintain trust and comply with HIPAA, Dr. Broder said.

The Duke University Health System has resolved any issues with HIPAA so that it’s safe for physicians to transmit images and video as long as they’re not sent outside the system. Talk to the HIPAA compliance officer at your medical center to establish the ground rules, he said. You can refresh your memory about which parts of data are considered by HIPAA to be protected information via a University of Miami site.

Dr. Broder reviewed some smartphone functions and apps that may be helpful and others that are not yet ready for medical prime time. Many are available for no cost or for as nominal fee. One study of health and fitness apps suggests that apps costing $0.99 or more tend to be higher quality and more trustworthy than less-expensive ones, he noted (J. Med. Internet Res. 2012;14:e72).

• Sleep: One of his residents swears by "smart alarm clock" apps that claim to use a smartphone’s accelerometer to assess where you are in your sleep cycle (based on your movements in bed) to wake you at a time that will leave you feeling less fatigued. You may set for 6 a.m., but the alarm may wake you at 5:45 a.m. Apps like Sleep Cycle ($0.99) and Sleep as Android have some underlying sleep science behind them, but no independent studies have verified their claims.

• CPR: The accelerometer also is used in the free app PocketCPR to give real-time feedback during CPR on the rate and depth of compression. Its has not been cleared by the FDA for use in humans, however, so the app warns that it’s meant for practice only. One prospective, randomized trial in 1,586 cardiac arrests that happened outside of hospitals found that use by emergency services personnel did not significantly change the likelihood of return of spontaneous circulation or other outcomes (BMJ 2011;342:d512).

• Chest: If you’re trying to teach students and residents about heart and lung sounds, or if you still get confused between mitral regurgitation and aortic stenosis, you might want to have a digital stethoscope app handy. These apps interpret heart and lung sounds heard typically through your smartphone’s microphone, which may not be good enough for clinical use. The Thinklabs Stethoscope app at $70 is pricey, compared with others, but it records sounds directly via the smartphone or through an attached electronic stethoscope.

A case that turns an iPhone into an ECG device has been submitted to the FDA for approval. The AliveCor iPhone ECG is expected to sell for between $100 and $200, compared with the usual price tag of thousands of dollars for conventional ECG machines, according to PC Magazine.

One small prospective study of experimental software that programs an iPhone to detect atrial fibrillation by placing a patient’s finger over the camera lens showed it was 98% sensitive and nearly 100% specific in detecting atrial fibrillation (IEEE Trans. Biomed. Eng. 2012 [doi:10.1109/TBME.2012.2208112]).

• Translation: When your hospital’s interpreter isn’t available, a free app like Google Translate can help. You can write or speak in one language and your device will write and say the message in a wide selection of language. You’ll need a wireless Internet connection for some translation apps.

• Eye chart: Your office has an eye chart, but you can’t find it. Pull up an app like the free EyeChart on your smartphone or tablet.

• Light: You want to inspect a patient’s sore throat, but the light in the exam room is broken. Use the flash on your smartphone camera, or use one of many free "flashlight" apps that turn the smartphone screen into a light source. Be sure to turn it off when you’re done, though, or your battery will run down quickly.

• Ultrasound: The miniaturization of ultrasound devices continues, with systems like the Mobisante MoblUS that attaches a probe to show images on your smartphone screen.

• Skin: For better evaluation of skin lesions, turn your iPhone into a dermatoscope by using the DermScope app ($4.99) and attaching the phone to the DermScope hardware (sold separately).

• Decision support: The PediStat app ($2.99 and up) makes it easy to determine the right pediatric drug dosing, among other features. The free Calculate (Medical Calculator) by QxMD app provides quick intuitive guides to common decision rules and can be customized by medical specialty.

• Drugs: Look up drug dosing, side effects, interactions and other information on free apps from Micromedex and others.

• Photos/videos: These apps are handy for documenting and sharing the appearance of a wound, a patient’s range of motion, or performance on a neurologic exam. Anyone who thinks they see uvula deviation in the throat of a struggling 3-year-old can snap a photo or video for review with other health care providers, medical students, or parents and avoid having to repeat the exam. Images of a wound problem after surgery can be sent to the surgeon when he or she is out of town.

Dr. Broder particularly finds the video useful for children having "pseudoseizures" whose parents demand a neurologic consult, even though the seizure event probably won’t be happening when the neurologist arrives. A video shows the neurologist exactly what Dr. Broder saw. (See the Dos and Don’ts for using photos and videos below.)

Once you’ve got an image or data you want to transmit, avoid texting as first-line means of communication because texts typically are not encrypted. Be careful when e-mailing to make sure it’s going to the correct address and only that address. Use e-mail options such as "confirm delivery" or "request read receipt," and add a sentence to the e-mail saying, "Please delete once no longer necessary for patient care," he advised.

Always document in the patient’s chart that you obtained patient consent and describe what was sent and who received it. Describe any images you send.

Don’t leave images on your portable devices. They’re easily lost, and most have inadequate encryption. Make images part of the medical record by uploading to the patient’s record, printing and scanning, or describing them clearly in the medical record. Then delete them from your device.

Store images and data in "cloud" computing sites with caution, Dr. Broder said. Services such as Google Drive or Dropbox allow sharing of very large files but provide no assurances about the quality of encryption or security. Cloud sites may be best used for giving patients access to instructions, instructional videos, reference papers, anatomic diagrams, etc.

The FDA approved the free Centricity Radiology Mobile Access app, which lets you view CT and MRI images on your iPhone if the images are stored in a GE Centricity PACS (picture archiving and communication system) platform – which may include 20% of U.S. radiology images, according to the company.

Sherry Boschert/IMNG Medical Media A screen shot shows the Centricity Radiology Mobile Access app.

The free CloudOn app lets you use MS Office software (including Word, Excel, and Powerpoint) on an iPad.

Various screen replicators that allow you to remotely access your computer desktop from your mobile device (such as ones by Citrix, or Splashtop Remote Desktop) all have the same problem, Dr. Broder said – they’re too clunky and not "touchscreen friendly."

And one final word on an underappreciated perk of medical apps on smartphones: When your medical director stops by, wanting to talk about your productivity, pull out your smartphone to show the data you’ve entered about patient encounters in your free iRVU app, which calculates total RVUs, charges, and average charge per encounter, among other features.

This list only begins to scratch the surface of app use in medicine. Other apps are available for immunization schedules, dictation, infectious disease guides, and teaching aids. Journals provide content to portable devices through apps, and some medical societies offer multifaceted apps such as ACEP Mobile.

Apps on smartphones and tablets will become part of daily medical practice, Dr. Broder predicted, but physicians need to be conscious about their limitations and potential problems as well as their assets.

Click here to view a video interview with Dr. Broder.

Dos and Don’ts for Medical Images on Smartphones

Do:

Obtain consent to acquire images or transmit them for the patient’s medical benefit.

Explain to the patient and get consent for any other intended use, such as education or publication.

Tell the patient what you will do with images when their use is completed – delete them or upload them to the medical record.

Confirm receipt if you send to other health care providers.

Specify in your message what that provider should do with the image.

Document in the patient’s chart that consent was obtained, what was sent, who received it, and content of the images.

Don’t:

Obtain images covertly.

Send to any unnecessary recipients.

Show images to anyone for fun.

Post to social media sites.

Blog about "funny" patient encounters.

Dr. Broder owns stock in Apple.

SAN FRANCISCO – Dr. Margaret D. Weiss had hoped that the group psychotherapy program she started for students with attention-deficit/hyperactivity disorder at the University of British Columbia might be more successful than some similar groups she’d heard about elsewhere with disappointing outcomes.

Her hopes were dashed, but some lessons were learned.

Despite a high rate of dropouts from the program, some students showed improvements. For other students, however, the group just confirmed their conviction that they were failures. In one group, for example, participants came to agreement in the very first session that they were all hopeless losers, and that psychiatrists and psychologists were stupid because they kept telling the students to do things that they had been trying to do for 20 years with little success.

©thinkstockphotos.com

The moral of that story is that "with college students, you have to do CBT [cognitive-behavioral therapy] first," she said at the annual meeting of the American Academy of Child and Adolescent Psychiatry. If the students don’t gain some confidence through hands-on CBT-like groups that teach executive function skills, group therapy is not going to work, said Dr. Weiss, head of the ADHD clinic at the university, in Vancouver.

Her program has made some adjustments that could improve chances for success, she said. In Canada, all college students with ADHD are entitled to accommodations and student disability services. However, now students at her institution will be told that in order to get the ADHD accommodations, they must take a required course of CBT and group therapy.

"It’s got to be on campus and scheduled so that they’ll come," and it must be highly structured, with an emphasis on praising the students’ efforts, not their achievements, she said.

Contact with other students who have ADHD might be especially important for college students with the disorder, Dr. Weiss said. Group psychotherapy can be very effective for lonely students. College students with ADHD who live away from home are more likely to have trouble managing activities of daily living, dealing with the distractions of dormitories and partying, falling behind academically and being unable to catch up, and negotiating the world of dating. They are at greater risk of loneliness, emotional dysregulation, self-medication, arguing with teachers, and becoming addicted to computers.

In one survey of 1,638 college students, 68 of whom had ADHD, the students with ADHD reported greater concerns about academic performance and depressive symptoms during the transition to college, Dr. Weiss said. Treatment with medication alone does not seem to diminish ADHD symptoms or improve student adjustment to college, multiple studies have shown. Programs that carry forward the skills-based training that children with ADHD receive are needed for college students to succeed.

"Pills do not build skills," she said.

Typically, children with ADHD are followed in pediatrics and psychiatry until they reach age 18 and then are "abandoned" at a key point in life when they face intense challenges – leaving home, learning to drive, and dealing with peer drug use, the complexities of dating, and the increased demand for executive function in college, Dr. Weiss said.

"Treatment in childhood does not mitigate adult outcomes without ongoing follow-up," she said. "Early intervention for ADHD is forever." College students with ADHD need to be engaged in treatment before they fail.

An estimated 2%-8% of college students have clinically significant levels of ADHD symptoms, studies have shown, and 25% of college students with disabilities are diagnosed with ADHD. There have been few studies of assessment methods, however, and nearly no controlled studies of psychopharmacological, psychosocial, or educational interventions, Dr. Weiss said. Good measures of outcomes have not been developed in these cases, but at least college students can self-report on whether they’re doing well, getting to class on time, and taking notes, for example.

Research also is needed not only on college students with ADHD who are struggling, but on the resiliency of young people with ADHD who make it to college, she added. Studies should investigate the competencies of students with ADHD who have achieved success against the odds.

"If you read the early longitudinal follow-up studies" of students with ADHD, "you wouldn’t think that anybody got to college," she noted. In the modern era of disability services and accommodations, longitudinal outcomes might change. In the future, all colleges and universities will recognize ADHD in their students, and multimodal, multidisciplinary treatment of ADHD in college will be the norm, Dr. Weiss predicted.

"One of the biggest handicaps to adulthood is not having a college education. If we can give these kids a college education, then we have done a great deal for their future as adults," she said. When students get to the point where they can specialize in their passion, ADHD becomes less of a handicap.

Dr. Weiss reported that she has had financial relationships with Eli Lilly, Purdue Pharma, Janssen Pharmaceuticals, and Shire.

SAN FRANCISCO – Dr. Margaret D. Weiss had hoped that the group psychotherapy program she started for students with attention-deficit/hyperactivity disorder at the University of British Columbia might be more successful than some similar groups she’d heard about elsewhere with disappointing outcomes.

Her hopes were dashed, but some lessons were learned.

Despite a high rate of dropouts from the program, some students showed improvements. For other students, however, the group just confirmed their conviction that they were failures. In one group, for example, participants came to agreement in the very first session that they were all hopeless losers, and that psychiatrists and psychologists were stupid because they kept telling the students to do things that they had been trying to do for 20 years with little success.

©thinkstockphotos.com

The moral of that story is that "with college students, you have to do CBT [cognitive-behavioral therapy] first," she said at the annual meeting of the American Academy of Child and Adolescent Psychiatry. If the students don’t gain some confidence through hands-on CBT-like groups that teach executive function skills, group therapy is not going to work, said Dr. Weiss, head of the ADHD clinic at the university, in Vancouver.

Her program has made some adjustments that could improve chances for success, she said. In Canada, all college students with ADHD are entitled to accommodations and student disability services. However, now students at her institution will be told that in order to get the ADHD accommodations, they must take a required course of CBT and group therapy.

"It’s got to be on campus and scheduled so that they’ll come," and it must be highly structured, with an emphasis on praising the students’ efforts, not their achievements, she said.

Contact with other students who have ADHD might be especially important for college students with the disorder, Dr. Weiss said. Group psychotherapy can be very effective for lonely students. College students with ADHD who live away from home are more likely to have trouble managing activities of daily living, dealing with the distractions of dormitories and partying, falling behind academically and being unable to catch up, and negotiating the world of dating. They are at greater risk of loneliness, emotional dysregulation, self-medication, arguing with teachers, and becoming addicted to computers.

In one survey of 1,638 college students, 68 of whom had ADHD, the students with ADHD reported greater concerns about academic performance and depressive symptoms during the transition to college, Dr. Weiss said. Treatment with medication alone does not seem to diminish ADHD symptoms or improve student adjustment to college, multiple studies have shown. Programs that carry forward the skills-based training that children with ADHD receive are needed for college students to succeed.

"Pills do not build skills," she said.

Typically, children with ADHD are followed in pediatrics and psychiatry until they reach age 18 and then are "abandoned" at a key point in life when they face intense challenges – leaving home, learning to drive, and dealing with peer drug use, the complexities of dating, and the increased demand for executive function in college, Dr. Weiss said.

"Treatment in childhood does not mitigate adult outcomes without ongoing follow-up," she said. "Early intervention for ADHD is forever." College students with ADHD need to be engaged in treatment before they fail.

An estimated 2%-8% of college students have clinically significant levels of ADHD symptoms, studies have shown, and 25% of college students with disabilities are diagnosed with ADHD. There have been few studies of assessment methods, however, and nearly no controlled studies of psychopharmacological, psychosocial, or educational interventions, Dr. Weiss said. Good measures of outcomes have not been developed in these cases, but at least college students can self-report on whether they’re doing well, getting to class on time, and taking notes, for example.

Research also is needed not only on college students with ADHD who are struggling, but on the resiliency of young people with ADHD who make it to college, she added. Studies should investigate the competencies of students with ADHD who have achieved success against the odds.

"If you read the early longitudinal follow-up studies" of students with ADHD, "you wouldn’t think that anybody got to college," she noted. In the modern era of disability services and accommodations, longitudinal outcomes might change. In the future, all colleges and universities will recognize ADHD in their students, and multimodal, multidisciplinary treatment of ADHD in college will be the norm, Dr. Weiss predicted.

"One of the biggest handicaps to adulthood is not having a college education. If we can give these kids a college education, then we have done a great deal for their future as adults," she said. When students get to the point where they can specialize in their passion, ADHD becomes less of a handicap.

Dr. Weiss reported that she has had financial relationships with Eli Lilly, Purdue Pharma, Janssen Pharmaceuticals, and Shire.

SAN FRANCISCO – Dr. Margaret D. Weiss had hoped that the group psychotherapy program she started for students with attention-deficit/hyperactivity disorder at the University of British Columbia might be more successful than some similar groups she’d heard about elsewhere with disappointing outcomes.

Her hopes were dashed, but some lessons were learned.

Despite a high rate of dropouts from the program, some students showed improvements. For other students, however, the group just confirmed their conviction that they were failures. In one group, for example, participants came to agreement in the very first session that they were all hopeless losers, and that psychiatrists and psychologists were stupid because they kept telling the students to do things that they had been trying to do for 20 years with little success.

©thinkstockphotos.com

The moral of that story is that "with college students, you have to do CBT [cognitive-behavioral therapy] first," she said at the annual meeting of the American Academy of Child and Adolescent Psychiatry. If the students don’t gain some confidence through hands-on CBT-like groups that teach executive function skills, group therapy is not going to work, said Dr. Weiss, head of the ADHD clinic at the university, in Vancouver.

Her program has made some adjustments that could improve chances for success, she said. In Canada, all college students with ADHD are entitled to accommodations and student disability services. However, now students at her institution will be told that in order to get the ADHD accommodations, they must take a required course of CBT and group therapy.

"It’s got to be on campus and scheduled so that they’ll come," and it must be highly structured, with an emphasis on praising the students’ efforts, not their achievements, she said.

Contact with other students who have ADHD might be especially important for college students with the disorder, Dr. Weiss said. Group psychotherapy can be very effective for lonely students. College students with ADHD who live away from home are more likely to have trouble managing activities of daily living, dealing with the distractions of dormitories and partying, falling behind academically and being unable to catch up, and negotiating the world of dating. They are at greater risk of loneliness, emotional dysregulation, self-medication, arguing with teachers, and becoming addicted to computers.

In one survey of 1,638 college students, 68 of whom had ADHD, the students with ADHD reported greater concerns about academic performance and depressive symptoms during the transition to college, Dr. Weiss said. Treatment with medication alone does not seem to diminish ADHD symptoms or improve student adjustment to college, multiple studies have shown. Programs that carry forward the skills-based training that children with ADHD receive are needed for college students to succeed.

"Pills do not build skills," she said.

Typically, children with ADHD are followed in pediatrics and psychiatry until they reach age 18 and then are "abandoned" at a key point in life when they face intense challenges – leaving home, learning to drive, and dealing with peer drug use, the complexities of dating, and the increased demand for executive function in college, Dr. Weiss said.

"Treatment in childhood does not mitigate adult outcomes without ongoing follow-up," she said. "Early intervention for ADHD is forever." College students with ADHD need to be engaged in treatment before they fail.

An estimated 2%-8% of college students have clinically significant levels of ADHD symptoms, studies have shown, and 25% of college students with disabilities are diagnosed with ADHD. There have been few studies of assessment methods, however, and nearly no controlled studies of psychopharmacological, psychosocial, or educational interventions, Dr. Weiss said. Good measures of outcomes have not been developed in these cases, but at least college students can self-report on whether they’re doing well, getting to class on time, and taking notes, for example.

Research also is needed not only on college students with ADHD who are struggling, but on the resiliency of young people with ADHD who make it to college, she added. Studies should investigate the competencies of students with ADHD who have achieved success against the odds.

"If you read the early longitudinal follow-up studies" of students with ADHD, "you wouldn’t think that anybody got to college," she noted. In the modern era of disability services and accommodations, longitudinal outcomes might change. In the future, all colleges and universities will recognize ADHD in their students, and multimodal, multidisciplinary treatment of ADHD in college will be the norm, Dr. Weiss predicted.

"One of the biggest handicaps to adulthood is not having a college education. If we can give these kids a college education, then we have done a great deal for their future as adults," she said. When students get to the point where they can specialize in their passion, ADHD becomes less of a handicap.

Dr. Weiss reported that she has had financial relationships with Eli Lilly, Purdue Pharma, Janssen Pharmaceuticals, and Shire.