Christine Kilgore

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.

"Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more," said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research "actually align very well with components of the meaningful use requirements."

The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.

"As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention," Dr. Nash said at the annual meeting of the Society of Behavioral Medicine. But "we really don’t know, though, what the optimal content and format of the [summary] might be."

The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.

The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.

Physicians reported using the summaries in a number of ways. "Some routinely print and review the [summary] with their patients, essentially every time," Dr. Nash said. "Others rarely even see or discuss it with their patients because these tasks are handled by someone else."

The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.

Most physicians "reported a lot of confusion on the part of their patients," said Dr. Nash, an instructor of family and community medicine at Baylor.

Mismatches between language and reading level also concerned physicians, as did privacy. "Some [physicians] were very concerned about showing potentially sensitive information on the patients’ records if it would automatically appear on the summary," Dr. Nash said.

Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.

Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.

The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.

Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.

Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.

Dr. Nash reported that she had no disclosures to make.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D., of Elliot Hospital in Manchester, N.H.

"The more comprehensive the approach, the more adherence can be improved," she said at the annual meeting of the Society of Behavioral Medicine.

Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that "nonadherence with headache medication regimens is common," said Dr. Rains, who has reviewed the literature on headache treatment compliance and empirically based adherence enhancing strategies.

"And patients who don’t take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache," said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital.

One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.

Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to "wait to see if it’s a migraine or if it’s severe," she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.

This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others. "And remember, repetition increases retention," she said.

Moreover, "the way we engage is important," Dr. Rains said. Adherence increases "not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they’re doing well."

She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. "At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you’ve been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan."

Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients’ motivation for treatment often shifts over time, Dr. Rains said.

She suggested using the following strategies:

• Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. "Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens]," she said.

• Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.

• Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side-effects. Differentiating current treatment from past failures is key, she said.

• Predict a positive but realistic outcome.

• Associate any positive outcome to the patient’s behavior and perseverance.

There is no sure way to assess and track adherence accurately, but more objective, multimodal measures are best, Dr. Rains said.

Face-to-face interviewing is the most widely used tool but also the least reliable, as "self-reporting actually overestimates adherence by 30%, compared with more objective monitoring," she said. Diaries and questionnaires are better, and electronic measures are better still. "Yet, even the most objective measures are not entirely reliable," she said. "Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of their visit."

Mechanical and electronic tools can "remind" patients to take a preset dose and track their use, but these tools do not address a patient’s conscious decision to alter a regimen, she warned.

This is why "a comprehensive, ongoing approach to assessing adherence is important," she said. Physicians generally respond to treatment failures by altering their recommendations for drug choice or for dosing rather than assessing adherence, and this, she emphasized, is a mistake. "All patients," she said, "are candidates for adherence facilitation."

Dr. Rains reported that she had no relevant disclosures.

WASHINGTON – Most of the gene variations identified thus far as risk factors for type 2 diabetes also appear to increase risk for gestational diabetes – a trend that reaffirms the importance of taking family histories in obstetrical practice, Dr. Alan R. Shuldiner said.

Hundreds of candidate genes for type 2 diabetes have been analyzed in association studies over the past several years, and more recently, whole genome approaches have identified close to 40 genes with variations that increase the risk of type 2 diabetes, he explained at the meeting.

Moreover, “most of these genetic variants that have also been looked at in [studies of] gestational diabetes all seem to increase risk there as well,” Dr. Shuldiner added.

While the utility of genetic screening in obstetrics needs to be investigated, it's clear that “people who have a family history of type 2 diabetes are probably at increased risk for gestational diabetes,” he said in an interview.

“From a genetic point of view, recent research reaffirms the importance of clinicians asking about family history,” said Dr. Shuldiner, who directs the program in personalized medicine and chairs the division of endocrinology, diabetes, and nutrition at the University of Maryland, Baltimore.

“Until recently, we really didn't know [about this interface],” he said. “It was possible that the genetic factors contributing to gestational diabetes would be very different and distinct from those contributing to type 2 diabetes. So far, that appears not to be the case.”

Most recently, an analysis of more than 5,500 pregnant women participating in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study demonstrated that a common maternal variant of the TCF7L2 gene is associated with a higher risk of gestational diabetes, as defined by the new International Association of Diabetes and Pregnancy Study Groupshand thus a higher risk of adverse pregnancy outcomes, he told meeting participants.

The risk-conferring variants of the TCF7L2 gene appear to be associated with impaired beta-cell function rather than insulin resistance, he noted.

An earlier report on TCF7L2 polymorphisms and progression to diabetes from the Diabetes Prevention Program Research Group showed that patients with the TCF7L2 variant are at increased risk of developing diabetes but “may be superresponders to lifestyle interventions,” Dr. Shuldiner said.

It is findings like these that may, with further research, lead to future recommendations for genetic screening.

Growing evidence on the effects of mutations in the glucokinase (GCK) gene, which appear to account for approximately 5% of gestational diabetes cases in white mothers, may similarly drive screening efforts in the future, he said. (Glucokinase is an enzyme present in pancreatic beta cells required for proper glucose sensing and insulin secretion.)

In a small study conducted in the United Kingdom, maternal hyperglycemia due to a GCK mutation – with no GCK mutation in the fetus – has been shown to result in higher birth weights, while inheritance by the fetus of a paternal GCK mutation appears to result in significant reductions in birth weight.

“Screening for GCK mutations could potentially be useful in guiding therapy so that the baby has a normal birth weight,” said Dr. Shuldiner, also John L. Whitehurst Professor of Medicine and professor of physiology. “The data so far suggest that if both mom and the fetus have a GCK mutation, you may want to forego treatment [with oral hypoglycemic agents or insulin], and even put mom on a high-carbohydrate diet, because the baby needs a high glucose level.”

Glucokinase mutations are also associated with maturity-onset diabetes of the young (MODY), which begins before the age of 25 and which we “now know is a heterogeneous group of disorders” resulting in mutations in any of at least eight different genes, he said.

In fact, many experts refer to MODY as being either “glucokinase diabetes” (resulting from mutations in the gene that encodes the glycolytic enzyme glucokinase) or “transcription factor diabetes” (resulting from mutations in genes that encode various transcription factors).

Unlike GCK MODY, transcription factor MODY is characterized by hyperglycemia that progressively worsens and often requires treatment with oral hypoglycemic agents or insulin, he said.

Research on the genetics of diabetes is “still in its early days,” said Dr. Shuldiner. The genetic loci associated with type 2 diabetes – and often gestational diabetes – are believed to be responsible for no more than 10% of total genetic susceptibility.

“There may be many rare variants [not detected through the association studies performed thus far] involved, and it's certainly possible that the genetic variants already identified may interact in important ways with lifestyle factors and ultimately with diabetes risk,” he noted.

Dr. Shuldiner reported that he had no relevant financial disclosures.

WASHINGTON – Most of the gene variations identified thus far as risk factors for type 2 diabetes also appear to increase risk for gestational diabetes – a trend that reaffirms the importance of taking family histories in obstetrical practice, Dr. Alan R. Shuldiner said.

Hundreds of candidate genes for type 2 diabetes have been analyzed in association studies over the past several years, and more recently, whole genome approaches have identified close to 40 genes with variations that increase the risk of type 2 diabetes, he explained at the meeting.

Moreover, “most of these genetic variants that have also been looked at in [studies of] gestational diabetes all seem to increase risk there as well,” Dr. Shuldiner added.

While the utility of genetic screening in obstetrics needs to be investigated, it's clear that “people who have a family history of type 2 diabetes are probably at increased risk for gestational diabetes,” he said in an interview.

“From a genetic point of view, recent research reaffirms the importance of clinicians asking about family history,” said Dr. Shuldiner, who directs the program in personalized medicine and chairs the division of endocrinology, diabetes, and nutrition at the University of Maryland, Baltimore.

“Until recently, we really didn't know [about this interface],” he said. “It was possible that the genetic factors contributing to gestational diabetes would be very different and distinct from those contributing to type 2 diabetes. So far, that appears not to be the case.”

Most recently, an analysis of more than 5,500 pregnant women participating in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study demonstrated that a common maternal variant of the TCF7L2 gene is associated with a higher risk of gestational diabetes, as defined by the new International Association of Diabetes and Pregnancy Study Groupshand thus a higher risk of adverse pregnancy outcomes, he told meeting participants.

The risk-conferring variants of the TCF7L2 gene appear to be associated with impaired beta-cell function rather than insulin resistance, he noted.

An earlier report on TCF7L2 polymorphisms and progression to diabetes from the Diabetes Prevention Program Research Group showed that patients with the TCF7L2 variant are at increased risk of developing diabetes but “may be superresponders to lifestyle interventions,” Dr. Shuldiner said.

It is findings like these that may, with further research, lead to future recommendations for genetic screening.

Growing evidence on the effects of mutations in the glucokinase (GCK) gene, which appear to account for approximately 5% of gestational diabetes cases in white mothers, may similarly drive screening efforts in the future, he said. (Glucokinase is an enzyme present in pancreatic beta cells required for proper glucose sensing and insulin secretion.)

In a small study conducted in the United Kingdom, maternal hyperglycemia due to a GCK mutation – with no GCK mutation in the fetus – has been shown to result in higher birth weights, while inheritance by the fetus of a paternal GCK mutation appears to result in significant reductions in birth weight.

“Screening for GCK mutations could potentially be useful in guiding therapy so that the baby has a normal birth weight,” said Dr. Shuldiner, also John L. Whitehurst Professor of Medicine and professor of physiology. “The data so far suggest that if both mom and the fetus have a GCK mutation, you may want to forego treatment [with oral hypoglycemic agents or insulin], and even put mom on a high-carbohydrate diet, because the baby needs a high glucose level.”

Glucokinase mutations are also associated with maturity-onset diabetes of the young (MODY), which begins before the age of 25 and which we “now know is a heterogeneous group of disorders” resulting in mutations in any of at least eight different genes, he said.

In fact, many experts refer to MODY as being either “glucokinase diabetes” (resulting from mutations in the gene that encodes the glycolytic enzyme glucokinase) or “transcription factor diabetes” (resulting from mutations in genes that encode various transcription factors).

Unlike GCK MODY, transcription factor MODY is characterized by hyperglycemia that progressively worsens and often requires treatment with oral hypoglycemic agents or insulin, he said.

Research on the genetics of diabetes is “still in its early days,” said Dr. Shuldiner. The genetic loci associated with type 2 diabetes – and often gestational diabetes – are believed to be responsible for no more than 10% of total genetic susceptibility.

“There may be many rare variants [not detected through the association studies performed thus far] involved, and it's certainly possible that the genetic variants already identified may interact in important ways with lifestyle factors and ultimately with diabetes risk,” he noted.

Dr. Shuldiner reported that he had no relevant financial disclosures.

WASHINGTON – Most of the gene variations identified thus far as risk factors for type 2 diabetes also appear to increase risk for gestational diabetes – a trend that reaffirms the importance of taking family histories in obstetrical practice, Dr. Alan R. Shuldiner said.

Hundreds of candidate genes for type 2 diabetes have been analyzed in association studies over the past several years, and more recently, whole genome approaches have identified close to 40 genes with variations that increase the risk of type 2 diabetes, he explained at the meeting.

Moreover, “most of these genetic variants that have also been looked at in [studies of] gestational diabetes all seem to increase risk there as well,” Dr. Shuldiner added.

While the utility of genetic screening in obstetrics needs to be investigated, it's clear that “people who have a family history of type 2 diabetes are probably at increased risk for gestational diabetes,” he said in an interview.

“From a genetic point of view, recent research reaffirms the importance of clinicians asking about family history,” said Dr. Shuldiner, who directs the program in personalized medicine and chairs the division of endocrinology, diabetes, and nutrition at the University of Maryland, Baltimore.

“Until recently, we really didn't know [about this interface],” he said. “It was possible that the genetic factors contributing to gestational diabetes would be very different and distinct from those contributing to type 2 diabetes. So far, that appears not to be the case.”

Most recently, an analysis of more than 5,500 pregnant women participating in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study demonstrated that a common maternal variant of the TCF7L2 gene is associated with a higher risk of gestational diabetes, as defined by the new International Association of Diabetes and Pregnancy Study Groupshand thus a higher risk of adverse pregnancy outcomes, he told meeting participants.

The risk-conferring variants of the TCF7L2 gene appear to be associated with impaired beta-cell function rather than insulin resistance, he noted.

An earlier report on TCF7L2 polymorphisms and progression to diabetes from the Diabetes Prevention Program Research Group showed that patients with the TCF7L2 variant are at increased risk of developing diabetes but “may be superresponders to lifestyle interventions,” Dr. Shuldiner said.

It is findings like these that may, with further research, lead to future recommendations for genetic screening.

Growing evidence on the effects of mutations in the glucokinase (GCK) gene, which appear to account for approximately 5% of gestational diabetes cases in white mothers, may similarly drive screening efforts in the future, he said. (Glucokinase is an enzyme present in pancreatic beta cells required for proper glucose sensing and insulin secretion.)

In a small study conducted in the United Kingdom, maternal hyperglycemia due to a GCK mutation – with no GCK mutation in the fetus – has been shown to result in higher birth weights, while inheritance by the fetus of a paternal GCK mutation appears to result in significant reductions in birth weight.

“Screening for GCK mutations could potentially be useful in guiding therapy so that the baby has a normal birth weight,” said Dr. Shuldiner, also John L. Whitehurst Professor of Medicine and professor of physiology. “The data so far suggest that if both mom and the fetus have a GCK mutation, you may want to forego treatment [with oral hypoglycemic agents or insulin], and even put mom on a high-carbohydrate diet, because the baby needs a high glucose level.”

Glucokinase mutations are also associated with maturity-onset diabetes of the young (MODY), which begins before the age of 25 and which we “now know is a heterogeneous group of disorders” resulting in mutations in any of at least eight different genes, he said.

In fact, many experts refer to MODY as being either “glucokinase diabetes” (resulting from mutations in the gene that encodes the glycolytic enzyme glucokinase) or “transcription factor diabetes” (resulting from mutations in genes that encode various transcription factors).

Unlike GCK MODY, transcription factor MODY is characterized by hyperglycemia that progressively worsens and often requires treatment with oral hypoglycemic agents or insulin, he said.

Research on the genetics of diabetes is “still in its early days,” said Dr. Shuldiner. The genetic loci associated with type 2 diabetes – and often gestational diabetes – are believed to be responsible for no more than 10% of total genetic susceptibility.

“There may be many rare variants [not detected through the association studies performed thus far] involved, and it's certainly possible that the genetic variants already identified may interact in important ways with lifestyle factors and ultimately with diabetes risk,” he noted.

Dr. Shuldiner reported that he had no relevant financial disclosures.

WASHINGTON – Radical prostatectomy did not significantly reduce the overall rate of all-cause or disease-specific death compared with observation at 12 years in men with clinically localized prostate cancer who participated in the Prostate Cancer Intervention Versus Observation Trial (PIVOT), chief investigator Dr. Timothy J. Wilt has reported.

The surgery does, however, appear to have benefited men with higher prostate-specific antigen (PSA) scores and those with higher-risk disease, Dr. Wilt said.

The yet-to-be-published main results of the PIVOT trial offer a different take on the value of radical prostatectomy from the recently published results of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), a pre–PSA-era trial that showed a significant overall benefit to surgery, even in men with tumors deemed to be low-risk.

In the PIVOT trial, which enrolled men whose cancer was detected in the early-PSA era, those with lower PSA levels or tumors categorized as low risk clearly gained no benefit from surgery, said Dr. Wilt, professor of medicine at the University of Minnesota, Minneapolis, and core investigator of the Department of Veterans Affairs’ Center for Chronic Disease Outcomes Research.

"Surgery did not reduce mortality [overall and disease specific] more than observation in men with low-PSA or low-risk prostate cancer, but our results do suggest a benefit for surgery in higher-PSA or higher-risk groups," Dr. Wilt reported at the annual meeting of the American Urological Association.

Initiated in 1994, the PIVOT trial randomized 731 men at medical centers across the United States to receive radical prostatectomy (281) or watchful waiting, with palliative care for symptoms. To be eligible, patients had to be 75 years or younger, with clinically localized prostate cancer and a PSA value less than 50 ng/mL.

Their mean age was 67 years, and nearly one-third were African American. Approximately 85% described themselves as fully active. Their mean and median PSA scores were 10.2 ng/mL and 7.8 ng/mL, respectively. Using tumor risk categorizations that incorporated PSA values, Gleason scores, and tumor stage, approximately 43% had low-risk tumors, 36% had intermediate-risk tumors, and 21% had high-risk tumors.

Investigators completed enrollment in 2002 and followed patients through 2010 (with a median follow-up of 10 years), determining cumulative rates of death at specific time points through intention-to-treat analysis. The new findings come from the final, 12-year analysis.

At the 12-year mark, 354 of the 731 men (48.4%) had died, with absolute reductions in all-cause and disease-specific mortality of approximately 3% in the radical prostatectomy group compared with observation. Specifically, the absolute reduction in all-cause mortality was 2.9% (a hazard ratio of 0.88), and the absolute reduction in prostate cancer mortality was 2.7% (HR, 0.63), values that are not statistically significant, Dr. Wilt said.

The effect of surgery on all-cause and disease-specific mortality did not vary by age, race, self-perceived health status, or the presence of comorbidities. There was also no significant effect of surgery on death rates when men were categorized solely by their Gleason scores (6 or less vs. 7-10).

Prostate cancer mortality did, however, "vary substantially by tumor risk category, ranging from 3% in the low-risk category to 13% in high risk," Dr. Wilt said.

In men with low-risk disease, there was an absolute difference in prostate cancer mortality between the treatment groups of 1.4% in favor of observation. But in men with high-risk disease, the absolute difference was 8.4%, in favor of surgery, a difference that is significant but appears to be of "borderline" statistical significance, Dr. Wilt said after the meeting.

"That’s why we say that our results suggest that there might be a benefit in men with high-risk disease," he said.

One factor challenging the PIVOT trial analyses is variation in some of the pathology readings. While the impact of surgery on prostate cancer mortality for the high-risk group was "consistent whether local or central pathology readings were used [in the sub-analysis]," the benefit of surgery on prostate cancer mortality and all-cause mortality for the intermediate-risk group varied depending on whether local or central pathology readings were employed in the risk categorization and subanalysis, he said.

The impact of surgery was seen most clearly in the PSA-level subgroup. "We consistently found that surgery did not reduce [either all-cause or disease-specific] mortality for men with PSA levels less than or equal to 10, and we consistently found that radical prostatectomy reduced both overall and disease-specific mortality in men with PSAs above 10," he said in the interview.

"Overall, we’re most confident in our findings regarding men with low PSA, low-stage, or low-risk disease," he emphasized.

In men with PSA levels of 10 ng/mL or less, the difference in absolute risk for all-cause mortality was 2.7%, in favor of observation.

Among men whose PSA levels were greater than 10 ng/mL, those randomized to receive radical prostatectomy had a statistically significant 13.2% absolute reduction in all-cause mortality compared with the watchful waiting group, which means that "about 8 men would have to be treated to prevent 1 death in about 12 years," he said after the meeting.

The men enrolled in the PIVOT trial are different from those in the SPCG-4 for various reasons, Dr. Wilt noted. For one, the majority of patients in the Scandinavian trial were diagnosed through palpable tumors or significant urinary obstruction symptoms. "So they had more advanced disease, even though it was still considered clinically localized," he said.

While the PIVOT enrollees are more representative of men being diagnosed and treated in the United States, there still are differences between the early era of PSA testing – the mid-late 1990s, when many of the PIVOT participants were enrolled – and current times, when "nearly all men, for better or for worse, are getting multiple PSA tests and having smaller tumors found earlier," he said.

"The risk of overdiagnosis in the PIVOT study is high, and it’s much higher today," Dr. Wilt said after the meeting. "As we move further and further to finding smaller and smaller tumors that have a very good long-term prognosis even with no treatment ... the risk of overdiagnosis becomes even greater than what we [see in PIVOT.]"

This study was supported by the Department of Veteran Affairs, the Agency for Healthcare Research and Quality, and the National Cancer Institute. Dr. Wilt reported that he had nothing to disclose.

WASHINGTON – Radical prostatectomy did not significantly reduce the overall rate of all-cause or disease-specific death compared with observation at 12 years in men with clinically localized prostate cancer who participated in the Prostate Cancer Intervention Versus Observation Trial (PIVOT), chief investigator Dr. Timothy J. Wilt has reported.

The surgery does, however, appear to have benefited men with higher prostate-specific antigen (PSA) scores and those with higher-risk disease, Dr. Wilt said.

The yet-to-be-published main results of the PIVOT trial offer a different take on the value of radical prostatectomy from the recently published results of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), a pre–PSA-era trial that showed a significant overall benefit to surgery, even in men with tumors deemed to be low-risk.

In the PIVOT trial, which enrolled men whose cancer was detected in the early-PSA era, those with lower PSA levels or tumors categorized as low risk clearly gained no benefit from surgery, said Dr. Wilt, professor of medicine at the University of Minnesota, Minneapolis, and core investigator of the Department of Veterans Affairs’ Center for Chronic Disease Outcomes Research.

"Surgery did not reduce mortality [overall and disease specific] more than observation in men with low-PSA or low-risk prostate cancer, but our results do suggest a benefit for surgery in higher-PSA or higher-risk groups," Dr. Wilt reported at the annual meeting of the American Urological Association.

Initiated in 1994, the PIVOT trial randomized 731 men at medical centers across the United States to receive radical prostatectomy (281) or watchful waiting, with palliative care for symptoms. To be eligible, patients had to be 75 years or younger, with clinically localized prostate cancer and a PSA value less than 50 ng/mL.

Their mean age was 67 years, and nearly one-third were African American. Approximately 85% described themselves as fully active. Their mean and median PSA scores were 10.2 ng/mL and 7.8 ng/mL, respectively. Using tumor risk categorizations that incorporated PSA values, Gleason scores, and tumor stage, approximately 43% had low-risk tumors, 36% had intermediate-risk tumors, and 21% had high-risk tumors.

Investigators completed enrollment in 2002 and followed patients through 2010 (with a median follow-up of 10 years), determining cumulative rates of death at specific time points through intention-to-treat analysis. The new findings come from the final, 12-year analysis.

At the 12-year mark, 354 of the 731 men (48.4%) had died, with absolute reductions in all-cause and disease-specific mortality of approximately 3% in the radical prostatectomy group compared with observation. Specifically, the absolute reduction in all-cause mortality was 2.9% (a hazard ratio of 0.88), and the absolute reduction in prostate cancer mortality was 2.7% (HR, 0.63), values that are not statistically significant, Dr. Wilt said.

The effect of surgery on all-cause and disease-specific mortality did not vary by age, race, self-perceived health status, or the presence of comorbidities. There was also no significant effect of surgery on death rates when men were categorized solely by their Gleason scores (6 or less vs. 7-10).

Prostate cancer mortality did, however, "vary substantially by tumor risk category, ranging from 3% in the low-risk category to 13% in high risk," Dr. Wilt said.

In men with low-risk disease, there was an absolute difference in prostate cancer mortality between the treatment groups of 1.4% in favor of observation. But in men with high-risk disease, the absolute difference was 8.4%, in favor of surgery, a difference that is significant but appears to be of "borderline" statistical significance, Dr. Wilt said after the meeting.

"That’s why we say that our results suggest that there might be a benefit in men with high-risk disease," he said.

One factor challenging the PIVOT trial analyses is variation in some of the pathology readings. While the impact of surgery on prostate cancer mortality for the high-risk group was "consistent whether local or central pathology readings were used [in the sub-analysis]," the benefit of surgery on prostate cancer mortality and all-cause mortality for the intermediate-risk group varied depending on whether local or central pathology readings were employed in the risk categorization and subanalysis, he said.

The impact of surgery was seen most clearly in the PSA-level subgroup. "We consistently found that surgery did not reduce [either all-cause or disease-specific] mortality for men with PSA levels less than or equal to 10, and we consistently found that radical prostatectomy reduced both overall and disease-specific mortality in men with PSAs above 10," he said in the interview.

"Overall, we’re most confident in our findings regarding men with low PSA, low-stage, or low-risk disease," he emphasized.

In men with PSA levels of 10 ng/mL or less, the difference in absolute risk for all-cause mortality was 2.7%, in favor of observation.

Among men whose PSA levels were greater than 10 ng/mL, those randomized to receive radical prostatectomy had a statistically significant 13.2% absolute reduction in all-cause mortality compared with the watchful waiting group, which means that "about 8 men would have to be treated to prevent 1 death in about 12 years," he said after the meeting.

The men enrolled in the PIVOT trial are different from those in the SPCG-4 for various reasons, Dr. Wilt noted. For one, the majority of patients in the Scandinavian trial were diagnosed through palpable tumors or significant urinary obstruction symptoms. "So they had more advanced disease, even though it was still considered clinically localized," he said.

While the PIVOT enrollees are more representative of men being diagnosed and treated in the United States, there still are differences between the early era of PSA testing – the mid-late 1990s, when many of the PIVOT participants were enrolled – and current times, when "nearly all men, for better or for worse, are getting multiple PSA tests and having smaller tumors found earlier," he said.

"The risk of overdiagnosis in the PIVOT study is high, and it’s much higher today," Dr. Wilt said after the meeting. "As we move further and further to finding smaller and smaller tumors that have a very good long-term prognosis even with no treatment ... the risk of overdiagnosis becomes even greater than what we [see in PIVOT.]"

This study was supported by the Department of Veteran Affairs, the Agency for Healthcare Research and Quality, and the National Cancer Institute. Dr. Wilt reported that he had nothing to disclose.

WASHINGTON – Radical prostatectomy did not significantly reduce the overall rate of all-cause or disease-specific death compared with observation at 12 years in men with clinically localized prostate cancer who participated in the Prostate Cancer Intervention Versus Observation Trial (PIVOT), chief investigator Dr. Timothy J. Wilt has reported.

The surgery does, however, appear to have benefited men with higher prostate-specific antigen (PSA) scores and those with higher-risk disease, Dr. Wilt said.

The yet-to-be-published main results of the PIVOT trial offer a different take on the value of radical prostatectomy from the recently published results of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), a pre–PSA-era trial that showed a significant overall benefit to surgery, even in men with tumors deemed to be low-risk.

In the PIVOT trial, which enrolled men whose cancer was detected in the early-PSA era, those with lower PSA levels or tumors categorized as low risk clearly gained no benefit from surgery, said Dr. Wilt, professor of medicine at the University of Minnesota, Minneapolis, and core investigator of the Department of Veterans Affairs’ Center for Chronic Disease Outcomes Research.

"Surgery did not reduce mortality [overall and disease specific] more than observation in men with low-PSA or low-risk prostate cancer, but our results do suggest a benefit for surgery in higher-PSA or higher-risk groups," Dr. Wilt reported at the annual meeting of the American Urological Association.

Initiated in 1994, the PIVOT trial randomized 731 men at medical centers across the United States to receive radical prostatectomy (281) or watchful waiting, with palliative care for symptoms. To be eligible, patients had to be 75 years or younger, with clinically localized prostate cancer and a PSA value less than 50 ng/mL.

Their mean age was 67 years, and nearly one-third were African American. Approximately 85% described themselves as fully active. Their mean and median PSA scores were 10.2 ng/mL and 7.8 ng/mL, respectively. Using tumor risk categorizations that incorporated PSA values, Gleason scores, and tumor stage, approximately 43% had low-risk tumors, 36% had intermediate-risk tumors, and 21% had high-risk tumors.

Investigators completed enrollment in 2002 and followed patients through 2010 (with a median follow-up of 10 years), determining cumulative rates of death at specific time points through intention-to-treat analysis. The new findings come from the final, 12-year analysis.

At the 12-year mark, 354 of the 731 men (48.4%) had died, with absolute reductions in all-cause and disease-specific mortality of approximately 3% in the radical prostatectomy group compared with observation. Specifically, the absolute reduction in all-cause mortality was 2.9% (a hazard ratio of 0.88), and the absolute reduction in prostate cancer mortality was 2.7% (HR, 0.63), values that are not statistically significant, Dr. Wilt said.

The effect of surgery on all-cause and disease-specific mortality did not vary by age, race, self-perceived health status, or the presence of comorbidities. There was also no significant effect of surgery on death rates when men were categorized solely by their Gleason scores (6 or less vs. 7-10).

Prostate cancer mortality did, however, "vary substantially by tumor risk category, ranging from 3% in the low-risk category to 13% in high risk," Dr. Wilt said.

In men with low-risk disease, there was an absolute difference in prostate cancer mortality between the treatment groups of 1.4% in favor of observation. But in men with high-risk disease, the absolute difference was 8.4%, in favor of surgery, a difference that is significant but appears to be of "borderline" statistical significance, Dr. Wilt said after the meeting.

"That’s why we say that our results suggest that there might be a benefit in men with high-risk disease," he said.

One factor challenging the PIVOT trial analyses is variation in some of the pathology readings. While the impact of surgery on prostate cancer mortality for the high-risk group was "consistent whether local or central pathology readings were used [in the sub-analysis]," the benefit of surgery on prostate cancer mortality and all-cause mortality for the intermediate-risk group varied depending on whether local or central pathology readings were employed in the risk categorization and subanalysis, he said.

The impact of surgery was seen most clearly in the PSA-level subgroup. "We consistently found that surgery did not reduce [either all-cause or disease-specific] mortality for men with PSA levels less than or equal to 10, and we consistently found that radical prostatectomy reduced both overall and disease-specific mortality in men with PSAs above 10," he said in the interview.

"Overall, we’re most confident in our findings regarding men with low PSA, low-stage, or low-risk disease," he emphasized.

In men with PSA levels of 10 ng/mL or less, the difference in absolute risk for all-cause mortality was 2.7%, in favor of observation.

Among men whose PSA levels were greater than 10 ng/mL, those randomized to receive radical prostatectomy had a statistically significant 13.2% absolute reduction in all-cause mortality compared with the watchful waiting group, which means that "about 8 men would have to be treated to prevent 1 death in about 12 years," he said after the meeting.

The men enrolled in the PIVOT trial are different from those in the SPCG-4 for various reasons, Dr. Wilt noted. For one, the majority of patients in the Scandinavian trial were diagnosed through palpable tumors or significant urinary obstruction symptoms. "So they had more advanced disease, even though it was still considered clinically localized," he said.

While the PIVOT enrollees are more representative of men being diagnosed and treated in the United States, there still are differences between the early era of PSA testing – the mid-late 1990s, when many of the PIVOT participants were enrolled – and current times, when "nearly all men, for better or for worse, are getting multiple PSA tests and having smaller tumors found earlier," he said.

"The risk of overdiagnosis in the PIVOT study is high, and it’s much higher today," Dr. Wilt said after the meeting. "As we move further and further to finding smaller and smaller tumors that have a very good long-term prognosis even with no treatment ... the risk of overdiagnosis becomes even greater than what we [see in PIVOT.]"

This study was supported by the Department of Veteran Affairs, the Agency for Healthcare Research and Quality, and the National Cancer Institute. Dr. Wilt reported that he had nothing to disclose.

WASHINGTON – Radical prostatectomy did not significantly reduce the overall rate of all-cause or disease-specific death compared with observation at 12 years in men with clinically localized prostate cancer who participated in the Prostate Cancer Intervention Versus Observation Trial (PIVOT), chief investigator Dr. Timothy J. Wilt has reported.

The surgery does, however, appear to have benefited men with higher prostate-specific antigen (PSA) scores and those with higher-risk disease, Dr. Wilt said.

The yet-to-be-published main results of the PIVOT trial offer a different take on the value of radical prostatectomy from the recently published results of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), a pre–PSA-era trial that showed a significant overall benefit to surgery, even in men with tumors deemed to be low-risk.

In the PIVOT trial, which enrolled men whose cancer was detected in the early-PSA era, those with lower PSA levels or tumors categorized as low risk clearly gained no benefit from surgery, said Dr. Wilt, professor of medicine at the University of Minnesota, Minneapolis, and core investigator of the Department of Veterans Affairs’ Center for Chronic Disease Outcomes Research.

"Surgery did not reduce mortality [overall and disease specific] more than observation in men with low-PSA or low-risk prostate cancer, but our results do suggest a benefit for surgery in higher-PSA or higher-risk groups," Dr. Wilt reported at the annual meeting of the American Urological Association.

Initiated in 1994, the PIVOT trial randomized 731 men at medical centers across the United States to receive radical prostatectomy (281) or watchful waiting, with palliative care for symptoms. To be eligible, patients had to be 75 years or younger, with clinically localized prostate cancer and a PSA value less than 50 ng/mL.

Their mean age was 67 years, and nearly one-third were African American. Approximately 85% described themselves as fully active. Their mean and median PSA scores were 10.2 ng/mL and 7.8 ng/mL, respectively. Using tumor risk categorizations that incorporated PSA values, Gleason scores, and tumor stage, approximately 43% had low-risk tumors, 36% had intermediate-risk tumors, and 21% had high-risk tumors.

Investigators completed enrollment in 2002 and followed patients through 2010 (with a median follow-up of 10 years), determining cumulative rates of death at specific time points through intention-to-treat analysis. The new findings come from the final, 12-year analysis.

At the 12-year mark, 354 of the 731 men (48.4%) had died, with absolute reductions in all-cause and disease-specific mortality of approximately 3% in the radical prostatectomy group compared with observation. Specifically, the absolute reduction in all-cause mortality was 2.9% (a hazard ratio of 0.88), and the absolute reduction in prostate cancer mortality was 2.7% (HR, 0.63), values that are not statistically significant, Dr. Wilt said.

The effect of surgery on all-cause and disease-specific mortality did not vary by age, race, self-perceived health status, or the presence of comorbidities. There was also no significant effect of surgery on death rates when men were categorized solely by their Gleason scores (6 or less vs. 7-10).

Prostate cancer mortality did, however, "vary substantially by tumor risk category, ranging from 3% in the low-risk category to 13% in high risk," Dr. Wilt said.

In men with low-risk disease, there was an absolute difference in prostate cancer mortality between the treatment groups of 1.4% in favor of observation. But in men with high-risk disease, the absolute difference was 8.4%, in favor of surgery, a difference that is significant but appears to be of "borderline" statistical significance, Dr. Wilt said after the meeting.

"That’s why we say that our results suggest that there might be a benefit in men with high-risk disease," he said.

One factor challenging the PIVOT trial analyses is variation in some of the pathology readings. While the impact of surgery on prostate cancer mortality for the high-risk group was "consistent whether local or central pathology readings were used [in the sub-analysis]," the benefit of surgery on prostate cancer mortality and all-cause mortality for the intermediate-risk group varied depending on whether local or central pathology readings were employed in the risk categorization and subanalysis, he said.

The impact of surgery was seen most clearly in the PSA-level subgroup. "We consistently found that surgery did not reduce [either all-cause or disease-specific] mortality for men with PSA levels less than or equal to 10, and we consistently found that radical prostatectomy reduced both overall and disease-specific mortality in men with PSAs above 10," he said in the interview.

"Overall, we’re most confident in our findings regarding men with low PSA, low-stage, or low-risk disease," he emphasized.

In men with PSA levels of 10 ng/mL or less, the difference in absolute risk for all-cause mortality was 2.7%, in favor of observation.

Among men whose PSA levels were greater than 10 ng/mL, those randomized to receive radical prostatectomy had a statistically significant 13.2% absolute reduction in all-cause mortality compared with the watchful waiting group, which means that "about 8 men would have to be treated to prevent 1 death in about 12 years," he said after the meeting.

The men enrolled in the PIVOT trial are different from those in the SPCG-4 for various reasons, Dr. Wilt noted. For one, the majority of patients in the Scandinavian trial were diagnosed through palpable tumors or significant urinary obstruction symptoms. "So they had more advanced disease, even though it was still considered clinically localized," he said.

While the PIVOT enrollees are more representative of men being diagnosed and treated in the United States, there still are differences between the early era of PSA testing – the mid-late 1990s, when many of the PIVOT participants were enrolled – and current times, when "nearly all men, for better or for worse, are getting multiple PSA tests and having smaller tumors found earlier," he said.

"The risk of overdiagnosis in the PIVOT study is high, and it’s much higher today," Dr. Wilt said after the meeting. "As we move further and further to finding smaller and smaller tumors that have a very good long-term prognosis even with no treatment ... the risk of overdiagnosis becomes even greater than what we [see in PIVOT.]"

This study was supported by the Department of Veteran Affairs, the Agency for Healthcare Research and Quality, and the National Cancer Institute. Dr. Wilt reported that he had nothing to disclose.

WASHINGTON – Radical prostatectomy did not significantly reduce the overall rate of all-cause or disease-specific death compared with observation at 12 years in men with clinically localized prostate cancer who participated in the Prostate Cancer Intervention Versus Observation Trial (PIVOT), chief investigator Dr. Timothy J. Wilt has reported.

The surgery does, however, appear to have benefited men with higher prostate-specific antigen (PSA) scores and those with higher-risk disease, Dr. Wilt said.

The yet-to-be-published main results of the PIVOT trial offer a different take on the value of radical prostatectomy from the recently published results of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), a pre–PSA-era trial that showed a significant overall benefit to surgery, even in men with tumors deemed to be low-risk.

In the PIVOT trial, which enrolled men whose cancer was detected in the early-PSA era, those with lower PSA levels or tumors categorized as low risk clearly gained no benefit from surgery, said Dr. Wilt, professor of medicine at the University of Minnesota, Minneapolis, and core investigator of the Department of Veterans Affairs’ Center for Chronic Disease Outcomes Research.

"Surgery did not reduce mortality [overall and disease specific] more than observation in men with low-PSA or low-risk prostate cancer, but our results do suggest a benefit for surgery in higher-PSA or higher-risk groups," Dr. Wilt reported at the annual meeting of the American Urological Association.

Initiated in 1994, the PIVOT trial randomized 731 men at medical centers across the United States to receive radical prostatectomy (281) or watchful waiting, with palliative care for symptoms. To be eligible, patients had to be 75 years or younger, with clinically localized prostate cancer and a PSA value less than 50 ng/mL.

Their mean age was 67 years, and nearly one-third were African American. Approximately 85% described themselves as fully active. Their mean and median PSA scores were 10.2 ng/mL and 7.8 ng/mL, respectively. Using tumor risk categorizations that incorporated PSA values, Gleason scores, and tumor stage, approximately 43% had low-risk tumors, 36% had intermediate-risk tumors, and 21% had high-risk tumors.

Investigators completed enrollment in 2002 and followed patients through 2010 (with a median follow-up of 10 years), determining cumulative rates of death at specific time points through intention-to-treat analysis. The new findings come from the final, 12-year analysis.

At the 12-year mark, 354 of the 731 men (48.4%) had died, with absolute reductions in all-cause and disease-specific mortality of approximately 3% in the radical prostatectomy group compared with observation. Specifically, the absolute reduction in all-cause mortality was 2.9% (a hazard ratio of 0.88), and the absolute reduction in prostate cancer mortality was 2.7% (HR, 0.63), values that are not statistically significant, Dr. Wilt said.

The effect of surgery on all-cause and disease-specific mortality did not vary by age, race, self-perceived health status, or the presence of comorbidities. There was also no significant effect of surgery on death rates when men were categorized solely by their Gleason scores (6 or less vs. 7-10).

Prostate cancer mortality did, however, "vary substantially by tumor risk category, ranging from 3% in the low-risk category to 13% in high risk," Dr. Wilt said.

In men with low-risk disease, there was an absolute difference in prostate cancer mortality between the treatment groups of 1.4% in favor of observation. But in men with high-risk disease, the absolute difference was 8.4%, in favor of surgery, a difference that is significant but appears to be of "borderline" statistical significance, Dr. Wilt said after the meeting.

"That’s why we say that our results suggest that there might be a benefit in men with high-risk disease," he said.

One factor challenging the PIVOT trial analyses is variation in some of the pathology readings. While the impact of surgery on prostate cancer mortality for the high-risk group was "consistent whether local or central pathology readings were used [in the sub-analysis]," the benefit of surgery on prostate cancer mortality and all-cause mortality for the intermediate-risk group varied depending on whether local or central pathology readings were employed in the risk categorization and subanalysis, he said.

The impact of surgery was seen most clearly in the PSA-level subgroup. "We consistently found that surgery did not reduce [either all-cause or disease-specific] mortality for men with PSA levels less than or equal to 10, and we consistently found that radical prostatectomy reduced both overall and disease-specific mortality in men with PSAs above 10," he said in the interview.

"Overall, we’re most confident in our findings regarding men with low PSA, low-stage, or low-risk disease," he emphasized.

In men with PSA levels of 10 ng/mL or less, the difference in absolute risk for all-cause mortality was 2.7%, in favor of observation.

Among men whose PSA levels were greater than 10 ng/mL, those randomized to receive radical prostatectomy had a statistically significant 13.2% absolute reduction in all-cause mortality compared with the watchful waiting group, which means that "about 8 men would have to be treated to prevent 1 death in about 12 years," he said after the meeting.

The men enrolled in the PIVOT trial are different from those in the SPCG-4 for various reasons, Dr. Wilt noted. For one, the majority of patients in the Scandinavian trial were diagnosed through palpable tumors or significant urinary obstruction symptoms. "So they had more advanced disease, even though it was still considered clinically localized," he said.

While the PIVOT enrollees are more representative of men being diagnosed and treated in the United States, there still are differences between the early era of PSA testing – the mid-late 1990s, when many of the PIVOT participants were enrolled – and current times, when "nearly all men, for better or for worse, are getting multiple PSA tests and having smaller tumors found earlier," he said.

"The risk of overdiagnosis in the PIVOT study is high, and it’s much higher today," Dr. Wilt said after the meeting. "As we move further and further to finding smaller and smaller tumors that have a very good long-term prognosis even with no treatment ... the risk of overdiagnosis becomes even greater than what we [see in PIVOT.]"

This study was supported by the Department of Veteran Affairs, the Agency for Healthcare Research and Quality, and the National Cancer Institute. Dr. Wilt reported that he had nothing to disclose.

WASHINGTON – Radical prostatectomy did not significantly reduce the overall rate of all-cause or disease-specific death compared with observation at 12 years in men with clinically localized prostate cancer who participated in the Prostate Cancer Intervention Versus Observation Trial (PIVOT), chief investigator Dr. Timothy J. Wilt has reported.

The surgery does, however, appear to have benefited men with higher prostate-specific antigen (PSA) scores and those with higher-risk disease, Dr. Wilt said.

The yet-to-be-published main results of the PIVOT trial offer a different take on the value of radical prostatectomy from the recently published results of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), a pre–PSA-era trial that showed a significant overall benefit to surgery, even in men with tumors deemed to be low-risk.

In the PIVOT trial, which enrolled men whose cancer was detected in the early-PSA era, those with lower PSA levels or tumors categorized as low risk clearly gained no benefit from surgery, said Dr. Wilt, professor of medicine at the University of Minnesota, Minneapolis, and core investigator of the Department of Veterans Affairs’ Center for Chronic Disease Outcomes Research.

"Surgery did not reduce mortality [overall and disease specific] more than observation in men with low-PSA or low-risk prostate cancer, but our results do suggest a benefit for surgery in higher-PSA or higher-risk groups," Dr. Wilt reported at the annual meeting of the American Urological Association.

Initiated in 1994, the PIVOT trial randomized 731 men at medical centers across the United States to receive radical prostatectomy (281) or watchful waiting, with palliative care for symptoms. To be eligible, patients had to be 75 years or younger, with clinically localized prostate cancer and a PSA value less than 50 ng/mL.

Their mean age was 67 years, and nearly one-third were African American. Approximately 85% described themselves as fully active. Their mean and median PSA scores were 10.2 ng/mL and 7.8 ng/mL, respectively. Using tumor risk categorizations that incorporated PSA values, Gleason scores, and tumor stage, approximately 43% had low-risk tumors, 36% had intermediate-risk tumors, and 21% had high-risk tumors.

Investigators completed enrollment in 2002 and followed patients through 2010 (with a median follow-up of 10 years), determining cumulative rates of death at specific time points through intention-to-treat analysis. The new findings come from the final, 12-year analysis.

At the 12-year mark, 354 of the 731 men (48.4%) had died, with absolute reductions in all-cause and disease-specific mortality of approximately 3% in the radical prostatectomy group compared with observation. Specifically, the absolute reduction in all-cause mortality was 2.9% (a hazard ratio of 0.88), and the absolute reduction in prostate cancer mortality was 2.7% (HR, 0.63), values that are not statistically significant, Dr. Wilt said.

The effect of surgery on all-cause and disease-specific mortality did not vary by age, race, self-perceived health status, or the presence of comorbidities. There was also no significant effect of surgery on death rates when men were categorized solely by their Gleason scores (6 or less vs. 7-10).

Prostate cancer mortality did, however, "vary substantially by tumor risk category, ranging from 3% in the low-risk category to 13% in high risk," Dr. Wilt said.

In men with low-risk disease, there was an absolute difference in prostate cancer mortality between the treatment groups of 1.4% in favor of observation. But in men with high-risk disease, the absolute difference was 8.4%, in favor of surgery, a difference that is significant but appears to be of "borderline" statistical significance, Dr. Wilt said after the meeting.

"That’s why we say that our results suggest that there might be a benefit in men with high-risk disease," he said.

One factor challenging the PIVOT trial analyses is variation in some of the pathology readings. While the impact of surgery on prostate cancer mortality for the high-risk group was "consistent whether local or central pathology readings were used [in the sub-analysis]," the benefit of surgery on prostate cancer mortality and all-cause mortality for the intermediate-risk group varied depending on whether local or central pathology readings were employed in the risk categorization and subanalysis, he said.

The impact of surgery was seen most clearly in the PSA-level subgroup. "We consistently found that surgery did not reduce [either all-cause or disease-specific] mortality for men with PSA levels less than or equal to 10, and we consistently found that radical prostatectomy reduced both overall and disease-specific mortality in men with PSAs above 10," he said in the interview.

"Overall, we’re most confident in our findings regarding men with low PSA, low-stage, or low-risk disease," he emphasized.

In men with PSA levels of 10 ng/mL or less, the difference in absolute risk for all-cause mortality was 2.7%, in favor of observation.

Among men whose PSA levels were greater than 10 ng/mL, those randomized to receive radical prostatectomy had a statistically significant 13.2% absolute reduction in all-cause mortality compared with the watchful waiting group, which means that "about 8 men would have to be treated to prevent 1 death in about 12 years," he said after the meeting.

The men enrolled in the PIVOT trial are different from those in the SPCG-4 for various reasons, Dr. Wilt noted. For one, the majority of patients in the Scandinavian trial were diagnosed through palpable tumors or significant urinary obstruction symptoms. "So they had more advanced disease, even though it was still considered clinically localized," he said.

While the PIVOT enrollees are more representative of men being diagnosed and treated in the United States, there still are differences between the early era of PSA testing – the mid-late 1990s, when many of the PIVOT participants were enrolled – and current times, when "nearly all men, for better or for worse, are getting multiple PSA tests and having smaller tumors found earlier," he said.

"The risk of overdiagnosis in the PIVOT study is high, and it’s much higher today," Dr. Wilt said after the meeting. "As we move further and further to finding smaller and smaller tumors that have a very good long-term prognosis even with no treatment ... the risk of overdiagnosis becomes even greater than what we [see in PIVOT.]"

This study was supported by the Department of Veteran Affairs, the Agency for Healthcare Research and Quality, and the National Cancer Institute. Dr. Wilt reported that he had nothing to disclose.