Heidi Splete

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

“Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention,” said Dr. John Iskander, who presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two vaccine surveillance mechanisms supported by the CDC.

“The data encompass the first 11 months of the U.S. experience with Gardasil,” said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

“Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine,” Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March 2007, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event reporting rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8, 2007. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9–26 years (the age range used in prelicensure clinical trials).

“A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination,” Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), fever (11%), nausea (11%), and headache (11%). Similarly, the most commonly reported symptoms associated with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13–16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. “Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope,” Dr. Iskander noted. Many of the frequently reported adverse events are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, 2007, but no claims alleging injuries as a result of HPV4 had been filed as of June 7, 2007, Dr. Iskander reported. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The CDC's VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006 and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline, said Dr. Lauri Markowitz, a member of ACIP's HPV working group. If the GSK vaccine, HPV-008 (Cervarix), is approved by FDA, the working group will review data and discuss including vaccine preference, and whether doses of the two could be interchangeable.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

“Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention,” said Dr. John Iskander, who presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two vaccine surveillance mechanisms supported by the CDC.

“The data encompass the first 11 months of the U.S. experience with Gardasil,” said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

“Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine,” Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March 2007, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event reporting rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8, 2007. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9–26 years (the age range used in prelicensure clinical trials).

“A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination,” Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), fever (11%), nausea (11%), and headache (11%). Similarly, the most commonly reported symptoms associated with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13–16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. “Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope,” Dr. Iskander noted. Many of the frequently reported adverse events are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, 2007, but no claims alleging injuries as a result of HPV4 had been filed as of June 7, 2007, Dr. Iskander reported. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The CDC's VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006 and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline, said Dr. Lauri Markowitz, a member of ACIP's HPV working group. If the GSK vaccine, HPV-008 (Cervarix), is approved by FDA, the working group will review data and discuss including vaccine preference, and whether doses of the two could be interchangeable.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

“Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention,” said Dr. John Iskander, who presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two vaccine surveillance mechanisms supported by the CDC.

“The data encompass the first 11 months of the U.S. experience with Gardasil,” said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

“Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine,” Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March 2007, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event reporting rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8, 2007. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9–26 years (the age range used in prelicensure clinical trials).

“A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination,” Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), fever (11%), nausea (11%), and headache (11%). Similarly, the most commonly reported symptoms associated with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13–16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. “Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope,” Dr. Iskander noted. Many of the frequently reported adverse events are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, 2007, but no claims alleging injuries as a result of HPV4 had been filed as of June 7, 2007, Dr. Iskander reported. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The CDC's VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006 and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline, said Dr. Lauri Markowitz, a member of ACIP's HPV working group. If the GSK vaccine, HPV-008 (Cervarix), is approved by FDA, the working group will review data and discuss including vaccine preference, and whether doses of the two could be interchangeable.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu.

The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination do include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

The committee also voted to include the new hepatitis A recommendations for prophylaxis and for travel in the CDC's Vaccines for Children program.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu.

The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination do include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

The committee also voted to include the new hepatitis A recommendations for prophylaxis and for travel in the CDC's Vaccines for Children program.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu.

The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination do include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

The committee also voted to include the new hepatitis A recommendations for prophylaxis and for travel in the CDC's Vaccines for Children program.

WASHINGTON – Insomnia is a disorder of hyperarousal rather than one of sleep deprivation, Thomas Roth, Ph.D., said at the annual meeting of the American Academy of Clinical Psychiatrists.

“Mothers of newborn babies don't have insomnia; they simply don't have adequate opportunities for sleep,” said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

Because 90% of people with insomnia have other comorbid conditions, insomnia was seen as a symptom rather than an independent disorder until 2005. That's when the National Institute of Mental Health declared that insomnia met the criteria for a disorder, which include impairment in function and quality of life that is associated with specific symptoms and rooted in physiology.

To meet the diagnostic criteria for insomnia, a person must report one or more of the following symptoms: difficulty falling asleep, difficulty staying asleep, or nonrestorative sleep.

When treating a patient who complains of chronic sleep problems, be sure to ask these several key questions, Dr. Roth said in an interview:

▸ What is the nature of the nighttime sleep problems (difficulty falling asleep, difficulty staying asleep)?

▸ What is the nature of daytime consequences (daytime sleepiness, impaired function)?

▸ What are the frequency and duration of symptoms?

▸ Does the patient have any comorbid medical or psychiatric conditions?

Prevalence data are limited, but about 30% of the general population has some type of disturbed sleep, Dr. Roth said.

Many patients with insomnia report that the daytime impairment and distress resulting from insomnia are more frustrating for them than their difficulty sleeping at night.

Chronic pain is a common comorbidity in insomnia patients. In addition, people with insomnia are significantly more likely to develop comorbid psychiatric disorders.

Dr. Roth cited a recent study from his laboratory in which the researchers evaluated 1,000 people who had never had a psychiatric disease and found that 240 met criteria for insomnia. At a follow-up 3.5 years later, the people with insomnia had 4.5 times the risk of developing a psychiatric disorder.

Treatment of insomnia remains a challenge, but recognition of the role of hyperarousal and the frequency of comorbidities allows for new therapeutic targets, including some sedating antidepressants.

WASHINGTON – Insomnia is a disorder of hyperarousal rather than one of sleep deprivation, Thomas Roth, Ph.D., said at the annual meeting of the American Academy of Clinical Psychiatrists.

“Mothers of newborn babies don't have insomnia; they simply don't have adequate opportunities for sleep,” said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

Because 90% of people with insomnia have other comorbid conditions, insomnia was seen as a symptom rather than an independent disorder until 2005. That's when the National Institute of Mental Health declared that insomnia met the criteria for a disorder, which include impairment in function and quality of life that is associated with specific symptoms and rooted in physiology.

To meet the diagnostic criteria for insomnia, a person must report one or more of the following symptoms: difficulty falling asleep, difficulty staying asleep, or nonrestorative sleep.

When treating a patient who complains of chronic sleep problems, be sure to ask these several key questions, Dr. Roth said in an interview:

▸ What is the nature of the nighttime sleep problems (difficulty falling asleep, difficulty staying asleep)?

▸ What is the nature of daytime consequences (daytime sleepiness, impaired function)?

▸ What are the frequency and duration of symptoms?

▸ Does the patient have any comorbid medical or psychiatric conditions?

Prevalence data are limited, but about 30% of the general population has some type of disturbed sleep, Dr. Roth said.

Many patients with insomnia report that the daytime impairment and distress resulting from insomnia are more frustrating for them than their difficulty sleeping at night.

Chronic pain is a common comorbidity in insomnia patients. In addition, people with insomnia are significantly more likely to develop comorbid psychiatric disorders.

Dr. Roth cited a recent study from his laboratory in which the researchers evaluated 1,000 people who had never had a psychiatric disease and found that 240 met criteria for insomnia. At a follow-up 3.5 years later, the people with insomnia had 4.5 times the risk of developing a psychiatric disorder.

Treatment of insomnia remains a challenge, but recognition of the role of hyperarousal and the frequency of comorbidities allows for new therapeutic targets, including some sedating antidepressants.

WASHINGTON – Insomnia is a disorder of hyperarousal rather than one of sleep deprivation, Thomas Roth, Ph.D., said at the annual meeting of the American Academy of Clinical Psychiatrists.

“Mothers of newborn babies don't have insomnia; they simply don't have adequate opportunities for sleep,” said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

Because 90% of people with insomnia have other comorbid conditions, insomnia was seen as a symptom rather than an independent disorder until 2005. That's when the National Institute of Mental Health declared that insomnia met the criteria for a disorder, which include impairment in function and quality of life that is associated with specific symptoms and rooted in physiology.

To meet the diagnostic criteria for insomnia, a person must report one or more of the following symptoms: difficulty falling asleep, difficulty staying asleep, or nonrestorative sleep.

When treating a patient who complains of chronic sleep problems, be sure to ask these several key questions, Dr. Roth said in an interview:

▸ What is the nature of the nighttime sleep problems (difficulty falling asleep, difficulty staying asleep)?

▸ What is the nature of daytime consequences (daytime sleepiness, impaired function)?

▸ What are the frequency and duration of symptoms?

▸ Does the patient have any comorbid medical or psychiatric conditions?

Prevalence data are limited, but about 30% of the general population has some type of disturbed sleep, Dr. Roth said.

Many patients with insomnia report that the daytime impairment and distress resulting from insomnia are more frustrating for them than their difficulty sleeping at night.

Chronic pain is a common comorbidity in insomnia patients. In addition, people with insomnia are significantly more likely to develop comorbid psychiatric disorders.

Dr. Roth cited a recent study from his laboratory in which the researchers evaluated 1,000 people who had never had a psychiatric disease and found that 240 met criteria for insomnia. At a follow-up 3.5 years later, the people with insomnia had 4.5 times the risk of developing a psychiatric disorder.

Treatment of insomnia remains a challenge, but recognition of the role of hyperarousal and the frequency of comorbidities allows for new therapeutic targets, including some sedating antidepressants.

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

"Adding technology gives you the opportunity to improve patient safety," but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA) (Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

PIMedications (17 questions).

PIHandoffs and transitions (11 questions).

PISurgery and invasive procedures, sedation, and anesthesia (6 questions).

PIPersonnel qualifications and competency (10 questions).

PIPractice management and culture (22 questions).

PIPatient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from "unaware or aware but no activity to implement" to "fully implemented everywhere."

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. "Even among practices with EHRs, 30% used paper lab forms," Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients. The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

"We are almost paper chartless," Ms. Schon said. "But what we want to do is make sure that we are managing our patient population effectively."

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to practice size, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

"Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it," Ms. Schon said.

"We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient," she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

"That's an area where you still have to rely on a piece of paper and a conversation," Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

"We are the health care safety net for our community," Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

"Adding technology gives you the opportunity to improve patient safety," but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA) (Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

PIMedications (17 questions).

PIHandoffs and transitions (11 questions).

PISurgery and invasive procedures, sedation, and anesthesia (6 questions).

PIPersonnel qualifications and competency (10 questions).

PIPractice management and culture (22 questions).

PIPatient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from "unaware or aware but no activity to implement" to "fully implemented everywhere."

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. "Even among practices with EHRs, 30% used paper lab forms," Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients. The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

"We are almost paper chartless," Ms. Schon said. "But what we want to do is make sure that we are managing our patient population effectively."

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to practice size, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

"Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it," Ms. Schon said.

"We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient," she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

"That's an area where you still have to rely on a piece of paper and a conversation," Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

"We are the health care safety net for our community," Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

"Adding technology gives you the opportunity to improve patient safety," but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA) (Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

PIMedications (17 questions).

PIHandoffs and transitions (11 questions).

PISurgery and invasive procedures, sedation, and anesthesia (6 questions).

PIPersonnel qualifications and competency (10 questions).

PIPractice management and culture (22 questions).

PIPatient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from "unaware or aware but no activity to implement" to "fully implemented everywhere."

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. "Even among practices with EHRs, 30% used paper lab forms," Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients. The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

"We are almost paper chartless," Ms. Schon said. "But what we want to do is make sure that we are managing our patient population effectively."

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to practice size, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

"Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it," Ms. Schon said.

"We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient," she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

"That's an area where you still have to rely on a piece of paper and a conversation," Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

"We are the health care safety net for our community," Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

WASHINGTON — Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

WASHINGTON — Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

WASHINGTON — Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

Disuse of hormone therapy might have fueled a significant drop in breast cancer detection rates in recent years, but a plateau in screening mammography among women older than 45 years also contributed to the decline, according to new data from an American Cancer Society study published in Breast Cancer Research.

To assess women's breast cancer trends over the period before the results of the Women's Health Initiative brought to light the possibility of a link between hormone therapy and an increased risk of breast cancer, Dr. Ahmedin Jemal and colleagues at the American Cancer Society reviewed data from the nine oldest Surveillance, Epidemiology, and End Results cancer registries (Breast Cancer Res. 2007;9:R28 [Epub doi:10.1186/1186/bcr1672]).

Based on these registries, 394,891 invasive and 59,837 in situ breast cancer cases were diagnosed in U.S. women aged 40 years and older from 1975 through 2003.

Age-specific incidence of invasive breast cancer declined in all 5-year age brackets for women aged 45 years and older between 1999 and 2003, although the degree of the decline varied among the age groups. The decrease in breast cancer incidence among most women younger than 60 years or older than 69 years began in 1998 or 1999. By contrast, the decrease in breast cancer incidence among women aged 60–64 years and 65–69 years occurred from 2002 to 2003 (the most recent year for which data are available). The largest percentage decreases occurred from 2002 to 2003 among women aged 55–59 years (11.3%), 60–64 years (10.6%), and 65–69 years (14.3%).

A joint analysis of tumor size and stage showed that overall, the incidence of small tumors (2 cm or less) decreased by 4.1% per year from 2000 through 2003 and the incidence of localized disease decreased by 3.1% per year from 1999 through 2003. No decrease in the incidence of larger tumors or advanced-stage disease was found during these periods. Also, in situ disease rates were stable from 2000 through 2003 after increasing since 1981.

Trend data based on receptor status showed an annual increase in the incidence of both estrogen receptor-positive tumors and progestin receptor-positive tumors from 1990 to 2000, followed by a 9.1% drop from 2002 to 2003 for both of these types. Estrogen receptor-negative and progestin receptor-negative tumors also showed their largest overall decreases in incidence, 4.8% and 6.9% respectively, between 2002 and 2003.

The drop in incidence that began in 1998 coincides with a plateau in screening mammography, and the types of cancers detected by mammography were the types that had a decrease in incidence (small tumors and localized disease). Data from the National Health Interview Survey show that the percentage of women aged 40 years and older who reported having a mammogram within the past 2 years was 70.3% in 1999, 70.4% in 2000, and 69.5% in 2003.

“Typically, incidence rates decrease when the penetrance of a screening test reaches a plateau due to a reduced pool of undiagnosed prevalent cases,” the researchers wrote.

The sharp declines in breast cancer from 2002 to 2003 that were reported at a breast cancer symposium sponsored by the Cancer Therapy and Research Center last year might have been due in part to a reduced use of hormone therapy in response to data from the Women's Health Initiative that linked hormone therapy to an increased risk of breast cancer. The sharp drop was observed mainly in estrogen receptor-positive tumors in a subset of women aged 50–69 years.

“Clearly there are many of us who feel that [the] drop in breast cancer detection rate has many factors,” Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said in an interview. But from a clinical standpoint, the findings represent a decline in detection, not necessarily an absence of cancer cases.

Clinically, the findings represent a decline in detection, not necessarily an absence of cancer cases. DR. LICHTENFELD

Disuse of hormone therapy might have fueled a significant drop in breast cancer detection rates in recent years, but a plateau in screening mammography among women older than 45 years also contributed to the decline, according to new data from an American Cancer Society study published in Breast Cancer Research.

To assess women's breast cancer trends over the period before the results of the Women's Health Initiative brought to light the possibility of a link between hormone therapy and an increased risk of breast cancer, Dr. Ahmedin Jemal and colleagues at the American Cancer Society reviewed data from the nine oldest Surveillance, Epidemiology, and End Results cancer registries (Breast Cancer Res. 2007;9:R28 [Epub doi:10.1186/1186/bcr1672]).

Based on these registries, 394,891 invasive and 59,837 in situ breast cancer cases were diagnosed in U.S. women aged 40 years and older from 1975 through 2003.

Age-specific incidence of invasive breast cancer declined in all 5-year age brackets for women aged 45 years and older between 1999 and 2003, although the degree of the decline varied among the age groups. The decrease in breast cancer incidence among most women younger than 60 years or older than 69 years began in 1998 or 1999. By contrast, the decrease in breast cancer incidence among women aged 60–64 years and 65–69 years occurred from 2002 to 2003 (the most recent year for which data are available). The largest percentage decreases occurred from 2002 to 2003 among women aged 55–59 years (11.3%), 60–64 years (10.6%), and 65–69 years (14.3%).

A joint analysis of tumor size and stage showed that overall, the incidence of small tumors (2 cm or less) decreased by 4.1% per year from 2000 through 2003 and the incidence of localized disease decreased by 3.1% per year from 1999 through 2003. No decrease in the incidence of larger tumors or advanced-stage disease was found during these periods. Also, in situ disease rates were stable from 2000 through 2003 after increasing since 1981.

Trend data based on receptor status showed an annual increase in the incidence of both estrogen receptor-positive tumors and progestin receptor-positive tumors from 1990 to 2000, followed by a 9.1% drop from 2002 to 2003 for both of these types. Estrogen receptor-negative and progestin receptor-negative tumors also showed their largest overall decreases in incidence, 4.8% and 6.9% respectively, between 2002 and 2003.

The drop in incidence that began in 1998 coincides with a plateau in screening mammography, and the types of cancers detected by mammography were the types that had a decrease in incidence (small tumors and localized disease). Data from the National Health Interview Survey show that the percentage of women aged 40 years and older who reported having a mammogram within the past 2 years was 70.3% in 1999, 70.4% in 2000, and 69.5% in 2003.

“Typically, incidence rates decrease when the penetrance of a screening test reaches a plateau due to a reduced pool of undiagnosed prevalent cases,” the researchers wrote.

The sharp declines in breast cancer from 2002 to 2003 that were reported at a breast cancer symposium sponsored by the Cancer Therapy and Research Center last year might have been due in part to a reduced use of hormone therapy in response to data from the Women's Health Initiative that linked hormone therapy to an increased risk of breast cancer. The sharp drop was observed mainly in estrogen receptor-positive tumors in a subset of women aged 50–69 years.

“Clearly there are many of us who feel that [the] drop in breast cancer detection rate has many factors,” Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said in an interview. But from a clinical standpoint, the findings represent a decline in detection, not necessarily an absence of cancer cases.

Clinically, the findings represent a decline in detection, not necessarily an absence of cancer cases. DR. LICHTENFELD

Disuse of hormone therapy might have fueled a significant drop in breast cancer detection rates in recent years, but a plateau in screening mammography among women older than 45 years also contributed to the decline, according to new data from an American Cancer Society study published in Breast Cancer Research.

To assess women's breast cancer trends over the period before the results of the Women's Health Initiative brought to light the possibility of a link between hormone therapy and an increased risk of breast cancer, Dr. Ahmedin Jemal and colleagues at the American Cancer Society reviewed data from the nine oldest Surveillance, Epidemiology, and End Results cancer registries (Breast Cancer Res. 2007;9:R28 [Epub doi:10.1186/1186/bcr1672]).

Based on these registries, 394,891 invasive and 59,837 in situ breast cancer cases were diagnosed in U.S. women aged 40 years and older from 1975 through 2003.

Age-specific incidence of invasive breast cancer declined in all 5-year age brackets for women aged 45 years and older between 1999 and 2003, although the degree of the decline varied among the age groups. The decrease in breast cancer incidence among most women younger than 60 years or older than 69 years began in 1998 or 1999. By contrast, the decrease in breast cancer incidence among women aged 60–64 years and 65–69 years occurred from 2002 to 2003 (the most recent year for which data are available). The largest percentage decreases occurred from 2002 to 2003 among women aged 55–59 years (11.3%), 60–64 years (10.6%), and 65–69 years (14.3%).

A joint analysis of tumor size and stage showed that overall, the incidence of small tumors (2 cm or less) decreased by 4.1% per year from 2000 through 2003 and the incidence of localized disease decreased by 3.1% per year from 1999 through 2003. No decrease in the incidence of larger tumors or advanced-stage disease was found during these periods. Also, in situ disease rates were stable from 2000 through 2003 after increasing since 1981.

Trend data based on receptor status showed an annual increase in the incidence of both estrogen receptor-positive tumors and progestin receptor-positive tumors from 1990 to 2000, followed by a 9.1% drop from 2002 to 2003 for both of these types. Estrogen receptor-negative and progestin receptor-negative tumors also showed their largest overall decreases in incidence, 4.8% and 6.9% respectively, between 2002 and 2003.

The drop in incidence that began in 1998 coincides with a plateau in screening mammography, and the types of cancers detected by mammography were the types that had a decrease in incidence (small tumors and localized disease). Data from the National Health Interview Survey show that the percentage of women aged 40 years and older who reported having a mammogram within the past 2 years was 70.3% in 1999, 70.4% in 2000, and 69.5% in 2003.

“Typically, incidence rates decrease when the penetrance of a screening test reaches a plateau due to a reduced pool of undiagnosed prevalent cases,” the researchers wrote.

The sharp declines in breast cancer from 2002 to 2003 that were reported at a breast cancer symposium sponsored by the Cancer Therapy and Research Center last year might have been due in part to a reduced use of hormone therapy in response to data from the Women's Health Initiative that linked hormone therapy to an increased risk of breast cancer. The sharp drop was observed mainly in estrogen receptor-positive tumors in a subset of women aged 50–69 years.

“Clearly there are many of us who feel that [the] drop in breast cancer detection rate has many factors,” Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said in an interview. But from a clinical standpoint, the findings represent a decline in detection, not necessarily an absence of cancer cases.

Clinically, the findings represent a decline in detection, not necessarily an absence of cancer cases. DR. LICHTENFELD

WASHINGTON — High blood pressure remains a real and growing problem that, if left untreated, could increase in prevalence by 60% over the next 2 decades, Dr. Richard Roberts said at a press briefing on hypertension.

“If action is not taken soon, both in the [United States] and around the world, there will be significant public health consequences,” said Dr. Roberts, a family physician and professor in the department of family medicine at the University of Wisconsin, Madison.

Dr. Roberts spoke on behalf of a coalition of 14 medical groups and voluntary health organizations that commissioned a report to compile the latest information about high blood pressure and its impact on health care systems. The report, “High Blood Pressure and Health Policy: Where We Are and Where We Need to Go Next,” serves as a call to action for health policy makers and physicians.

Citing data from the National Health and Nutrition Examination Survey (NHANES), the report documents that the prevalence of high blood pressure in adults in the United States increased from 25% in 1988–1994 to 29% in 1999–2002. In addition, the growing problem of high blood pressure in children is expected to contribute to the overall increase in prevalence over the next 20 years.

“What makes this such a serious threat is that it can't be prevented easily nor diagnosed and treated easily. It's a tough disease,” Dr. Roberts said. “I'm a family doctor in the trenches doing this every day, and it's probably one of the toughest things that we struggle with.”

The report, which was sponsored by an unrestricted educational grant from Novartis AG, calls for an international effort to address five public policy goals:

▸ Recognize that high blood pressure is a global health priority.

▸ Achieve global consensus on standards for managing high blood pressure.

▸ Empower family doctors to be the first lines of defense against high blood pressure on a global level.

▸ Educate patients about treatment options and acknowledge the difficulties of adhering to lifestyle changes and medication regimens.

▸ Conduct long-term clinical and epidemiologic studies on the costs and benefits of aggressively treating high blood pressure based on emerging trends and scientific research.

“More than 90% of us will have high blood pressure if we live long enough,” Dr. Michael A. Weber, professor of medicine at the State University of New York, Brooklyn, said during the briefing.

“The good news is, we can do plenty about it,” he said.

Losing weight and becoming more physically active are among the best ways to keep hypertension from developing, especially for young people. But for many people, regular adherence to medication may be necessary to keep their blood pressure at a healthy level, said Dr. Weber, chair of the American Society of Hypertension's Specialist Program and one of the coauthors of the report.

He suggested that patients would benefit from more education about the condition. “You don't know when you have high blood pressure; it is a totally asymptomatic condition. The only way you know you have high blood pressure is to have it measured, and if it is high, you must get it under control,” he said.

“The effort is worth it,” he emphasized. “When we treat high blood pressure well, we can reduce the probability of heart attacks by 40%–50%.”

Similarly, keeping high blood pressure under control can reduce the incidence of stroke and cut down on the number of patients who will eventually require kidney dialysis.

“If all of us work together, we can take a big bite out of this enormous problem,” concluded Dr. Weber, who serves as a consultant for several pharmaceutical companies including Novartis and Merck & Co.

WASHINGTON — High blood pressure remains a real and growing problem that, if left untreated, could increase in prevalence by 60% over the next 2 decades, Dr. Richard Roberts said at a press briefing on hypertension.

“If action is not taken soon, both in the [United States] and around the world, there will be significant public health consequences,” said Dr. Roberts, a family physician and professor in the department of family medicine at the University of Wisconsin, Madison.

Dr. Roberts spoke on behalf of a coalition of 14 medical groups and voluntary health organizations that commissioned a report to compile the latest information about high blood pressure and its impact on health care systems. The report, “High Blood Pressure and Health Policy: Where We Are and Where We Need to Go Next,” serves as a call to action for health policy makers and physicians.

Citing data from the National Health and Nutrition Examination Survey (NHANES), the report documents that the prevalence of high blood pressure in adults in the United States increased from 25% in 1988–1994 to 29% in 1999–2002. In addition, the growing problem of high blood pressure in children is expected to contribute to the overall increase in prevalence over the next 20 years.

“What makes this such a serious threat is that it can't be prevented easily nor diagnosed and treated easily. It's a tough disease,” Dr. Roberts said. “I'm a family doctor in the trenches doing this every day, and it's probably one of the toughest things that we struggle with.”

The report, which was sponsored by an unrestricted educational grant from Novartis AG, calls for an international effort to address five public policy goals:

▸ Recognize that high blood pressure is a global health priority.

▸ Achieve global consensus on standards for managing high blood pressure.

▸ Empower family doctors to be the first lines of defense against high blood pressure on a global level.

▸ Educate patients about treatment options and acknowledge the difficulties of adhering to lifestyle changes and medication regimens.

▸ Conduct long-term clinical and epidemiologic studies on the costs and benefits of aggressively treating high blood pressure based on emerging trends and scientific research.

“More than 90% of us will have high blood pressure if we live long enough,” Dr. Michael A. Weber, professor of medicine at the State University of New York, Brooklyn, said during the briefing.

“The good news is, we can do plenty about it,” he said.

Losing weight and becoming more physically active are among the best ways to keep hypertension from developing, especially for young people. But for many people, regular adherence to medication may be necessary to keep their blood pressure at a healthy level, said Dr. Weber, chair of the American Society of Hypertension's Specialist Program and one of the coauthors of the report.

He suggested that patients would benefit from more education about the condition. “You don't know when you have high blood pressure; it is a totally asymptomatic condition. The only way you know you have high blood pressure is to have it measured, and if it is high, you must get it under control,” he said.

“The effort is worth it,” he emphasized. “When we treat high blood pressure well, we can reduce the probability of heart attacks by 40%–50%.”

Similarly, keeping high blood pressure under control can reduce the incidence of stroke and cut down on the number of patients who will eventually require kidney dialysis.

“If all of us work together, we can take a big bite out of this enormous problem,” concluded Dr. Weber, who serves as a consultant for several pharmaceutical companies including Novartis and Merck & Co.

WASHINGTON — High blood pressure remains a real and growing problem that, if left untreated, could increase in prevalence by 60% over the next 2 decades, Dr. Richard Roberts said at a press briefing on hypertension.

“If action is not taken soon, both in the [United States] and around the world, there will be significant public health consequences,” said Dr. Roberts, a family physician and professor in the department of family medicine at the University of Wisconsin, Madison.

Dr. Roberts spoke on behalf of a coalition of 14 medical groups and voluntary health organizations that commissioned a report to compile the latest information about high blood pressure and its impact on health care systems. The report, “High Blood Pressure and Health Policy: Where We Are and Where We Need to Go Next,” serves as a call to action for health policy makers and physicians.

Citing data from the National Health and Nutrition Examination Survey (NHANES), the report documents that the prevalence of high blood pressure in adults in the United States increased from 25% in 1988–1994 to 29% in 1999–2002. In addition, the growing problem of high blood pressure in children is expected to contribute to the overall increase in prevalence over the next 20 years.

“What makes this such a serious threat is that it can't be prevented easily nor diagnosed and treated easily. It's a tough disease,” Dr. Roberts said. “I'm a family doctor in the trenches doing this every day, and it's probably one of the toughest things that we struggle with.”

The report, which was sponsored by an unrestricted educational grant from Novartis AG, calls for an international effort to address five public policy goals:

▸ Recognize that high blood pressure is a global health priority.

▸ Achieve global consensus on standards for managing high blood pressure.

▸ Empower family doctors to be the first lines of defense against high blood pressure on a global level.

▸ Educate patients about treatment options and acknowledge the difficulties of adhering to lifestyle changes and medication regimens.

▸ Conduct long-term clinical and epidemiologic studies on the costs and benefits of aggressively treating high blood pressure based on emerging trends and scientific research.

“More than 90% of us will have high blood pressure if we live long enough,” Dr. Michael A. Weber, professor of medicine at the State University of New York, Brooklyn, said during the briefing.

“The good news is, we can do plenty about it,” he said.

Losing weight and becoming more physically active are among the best ways to keep hypertension from developing, especially for young people. But for many people, regular adherence to medication may be necessary to keep their blood pressure at a healthy level, said Dr. Weber, chair of the American Society of Hypertension's Specialist Program and one of the coauthors of the report.

He suggested that patients would benefit from more education about the condition. “You don't know when you have high blood pressure; it is a totally asymptomatic condition. The only way you know you have high blood pressure is to have it measured, and if it is high, you must get it under control,” he said.

“The effort is worth it,” he emphasized. “When we treat high blood pressure well, we can reduce the probability of heart attacks by 40%–50%.”

Similarly, keeping high blood pressure under control can reduce the incidence of stroke and cut down on the number of patients who will eventually require kidney dialysis.

“If all of us work together, we can take a big bite out of this enormous problem,” concluded Dr. Weber, who serves as a consultant for several pharmaceutical companies including Novartis and Merck & Co.

WASHINGTON — Patient safety problems in hospitals often stem from a lack of teamwork and poor communication, James Battles, Ph.D., said at a conference sponsored by the National Patient Safety Foundation.

“In health care, if we don't have good teamwork, patients die,” said Dr. Battles, the senior service fellow for patient safety at the Agency for Healthcare Research and Quality (AHRQ).

“Teamwork is not unique to health care, and what we know about teamwork research comes from a number of disciplines, namely the military,” he said.

In the wake of “To Err Is Human,” the 1999 Institute of Medicine report that raised awareness of medical errors and called for better teamwork among physicians, AHRQ partnered with the Department of Defense to develop a teamwork training program. The resulting Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program was designed to help doctors and hospitals integrate teamwork principles into their daily activities as a way to reduce clinical errors and to improve patient outcomes, patient satisfaction, and hospital staff satisfaction.

Poor communication and other teamwork issues usually are to blame when a serious medical error occurs in a hospital, case studies have shown.

“There is a growing scientific body of literature that indicates that medical teamwork can improve the quality of the clinical process,” Dr. Battles said.

One key characteristic of successful teams is a shared mental model, which means that members of the team are “on the same page” and have a mutual sense of trust and a sense of being part of a team working toward a common goal. Each member of a successful team knows his or her role. And the most successful teams have supportive leadership.

Physicians can download materials from the AHRQ Web site and customize them to suit their practices. TeamSTEPPS became widely available in November 2006, and about 50 medical centers across the United States have used the program to improve teamwork and patient safety in their facilities, Dr. Battles said.

TeamSTEPPS offers ways to transform hospital culture by addressing the root causes of serious safety problems, particularly failures of communication.

“The program offers an excellent model and thorough instruction on how an institution can alter [its] culture and support enhanced teamwork,” Dr. Mark V. Williams, professor of medicine at Emory University in Atlanta and director of the Emory Hospital Medicine Unit, said in an interview.

“It especially empowers nurses and other health care staff to speak up and alert their colleagues and physicians when patient safety is at risk,” said Dr. Williams, who is evaluating the TeamSTEPPS program for possible use at Emory.

Key team events that make up the TeamSTEPPS program include briefs, huddles, debriefs, and conflict resolution, Heidi King, director of DOD's Healthcare Team Coordination Program, said at the meeting.

A brief is a short gathering of caregivers to review what is scheduled for the day. Topics include assignments, a review of relevant patient data, plans for specific patients, staff availability and workload, and resources.

“The idea is that we are creating words that people can use, when we say 'get together for a brief or a huddle,' everyone knows what is meant,” Ms. King said. “What we call the 'huddle' is for problem solving and to reestablish situation awareness. An example of a huddle: When a core care team, such as a surgical team or ob.gyn. team, meets for a quick review prior to a specific procedure.”

The debriefing is the step in which quality improvement occurs. Team members meet after the procedure or the next day to review events, even if everything went well the previous day. “This is where patient safety needs to take place, on the front lines of patient care,” Ms. King said.

A debriefing may include conflict resolution. The TeamSTEPPS material offers a constructive approach to resolving conflicts among team members in a four-step process called the DESC:

▸ Describe the specific situation or behavior that caused conflict.

▸ Express how the situation made you feel and what your concerns are.

▸ Suggest alternatives and seek agreement.

▸ Consequences should be stated in terms of the impact on team goals.

The outcomes of the training can be measured by improvements in four core skill areas: leadership, situation monitoring, mutual support, and communication.

Program participants develop a combination of knowledge (of the shared goals), attitudes (of mutual trust and support), and skills (related to accuracy, efficiency, and safety) that ultimately improve patient safety, Ms. King said.

“The big thing is sustaining the changes in attitude,” Ms. King said. “Implement the training in one section of the hospital, start monitoring what is going on, and communicate about what is working and not working, and then expand the training to other areas of the hospital,” she advised.

To change a hospital culture with teamwork training, create opportunities for team members to practice what they learned, and celebrate success as a way to promote progress, she added.

Barriers to good teamwork include inconsistency in team activity, lack of information sharing, hierarchy, defensiveness, varying communication styles, overwork, misinterpretation of cues, and confusion about one's role. The TeamSTEPPS strategies of better communication through briefs and huddles, as well as through feedback, patient advocacy, and mutual support, can combat these problems, Ms. King said, and result in mutual trust, improved performance, and patient safety.

Developing a team mentality is easier said than done. “We all train separately, and we come together and are expected to work together,” she acknowledged.

But physicians can learn the concept of better teamwork as a way to improve patient safety, said Dr. Alison Clay, who participates in TeamSTEPPS at Duke University in Durham, N.C.

TeamSTEPPS at Duke began in the pediatric ICU and it has spread to the operating room. “We are taking it to different parts of the hospital,” said Dr. Clay, an internist with appointments to the departments of surgery, and of internal medicine and pulmonary critical care at Duke. The program is likely to move next to the hospital wards and hospitalists and attending physicians, and then to clinics, she said.

The program starts with lectures and conversation and then proceeds to use of simulations and a debriefing to assess how the participants worked as a team.

Dr. Clay has participated in the TeamSTEPPS curriculum, and she has trained to coach others in teamwork building in her role as the capstone course director for fourth-year medical students.

Dr. Clay has a unique perspective on patient safety: She was a victim of a medical error at Duke when she arrived at the emergency department as a patient and went into respiratory arrest after being given a medication meant for the patient across the hall.

“That's why communication is important,” said Dr. Clay, who has shared her experience as a patient to emphasize the need for better patient safety measures.

“Concurrent with TeamSTEPPS, [there] are other efforts to teach safety involving all members of the team,” Dr. Clay noted. “People have to … be open to the concept [of] using better teamwork to solve the problem.”

For more information about TeamSTEPPS or to review and order materials, visit www.ahrq.gov/qual/teamstepps

WASHINGTON — Patient safety problems in hospitals often stem from a lack of teamwork and poor communication, James Battles, Ph.D., said at a conference sponsored by the National Patient Safety Foundation.

“In health care, if we don't have good teamwork, patients die,” said Dr. Battles, the senior service fellow for patient safety at the Agency for Healthcare Research and Quality (AHRQ).

“Teamwork is not unique to health care, and what we know about teamwork research comes from a number of disciplines, namely the military,” he said.

In the wake of “To Err Is Human,” the 1999 Institute of Medicine report that raised awareness of medical errors and called for better teamwork among physicians, AHRQ partnered with the Department of Defense to develop a teamwork training program. The resulting Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program was designed to help doctors and hospitals integrate teamwork principles into their daily activities as a way to reduce clinical errors and to improve patient outcomes, patient satisfaction, and hospital staff satisfaction.

Poor communication and other teamwork issues usually are to blame when a serious medical error occurs in a hospital, case studies have shown.

“There is a growing scientific body of literature that indicates that medical teamwork can improve the quality of the clinical process,” Dr. Battles said.

One key characteristic of successful teams is a shared mental model, which means that members of the team are “on the same page” and have a mutual sense of trust and a sense of being part of a team working toward a common goal. Each member of a successful team knows his or her role. And the most successful teams have supportive leadership.

Physicians can download materials from the AHRQ Web site and customize them to suit their practices. TeamSTEPPS became widely available in November 2006, and about 50 medical centers across the United States have used the program to improve teamwork and patient safety in their facilities, Dr. Battles said.

TeamSTEPPS offers ways to transform hospital culture by addressing the root causes of serious safety problems, particularly failures of communication.

“The program offers an excellent model and thorough instruction on how an institution can alter [its] culture and support enhanced teamwork,” Dr. Mark V. Williams, professor of medicine at Emory University in Atlanta and director of the Emory Hospital Medicine Unit, said in an interview.

“It especially empowers nurses and other health care staff to speak up and alert their colleagues and physicians when patient safety is at risk,” said Dr. Williams, who is evaluating the TeamSTEPPS program for possible use at Emory.

Key team events that make up the TeamSTEPPS program include briefs, huddles, debriefs, and conflict resolution, Heidi King, director of DOD's Healthcare Team Coordination Program, said at the meeting.

A brief is a short gathering of caregivers to review what is scheduled for the day. Topics include assignments, a review of relevant patient data, plans for specific patients, staff availability and workload, and resources.

“The idea is that we are creating words that people can use, when we say 'get together for a brief or a huddle,' everyone knows what is meant,” Ms. King said. “What we call the 'huddle' is for problem solving and to reestablish situation awareness. An example of a huddle: When a core care team, such as a surgical team or ob.gyn. team, meets for a quick review prior to a specific procedure.”

The debriefing is the step in which quality improvement occurs. Team members meet after the procedure or the next day to review events, even if everything went well the previous day. “This is where patient safety needs to take place, on the front lines of patient care,” Ms. King said.

A debriefing may include conflict resolution. The TeamSTEPPS material offers a constructive approach to resolving conflicts among team members in a four-step process called the DESC:

▸ Describe the specific situation or behavior that caused conflict.

▸ Express how the situation made you feel and what your concerns are.

▸ Suggest alternatives and seek agreement.

▸ Consequences should be stated in terms of the impact on team goals.

The outcomes of the training can be measured by improvements in four core skill areas: leadership, situation monitoring, mutual support, and communication.

Program participants develop a combination of knowledge (of the shared goals), attitudes (of mutual trust and support), and skills (related to accuracy, efficiency, and safety) that ultimately improve patient safety, Ms. King said.

“The big thing is sustaining the changes in attitude,” Ms. King said. “Implement the training in one section of the hospital, start monitoring what is going on, and communicate about what is working and not working, and then expand the training to other areas of the hospital,” she advised.

To change a hospital culture with teamwork training, create opportunities for team members to practice what they learned, and celebrate success as a way to promote progress, she added.

Barriers to good teamwork include inconsistency in team activity, lack of information sharing, hierarchy, defensiveness, varying communication styles, overwork, misinterpretation of cues, and confusion about one's role. The TeamSTEPPS strategies of better communication through briefs and huddles, as well as through feedback, patient advocacy, and mutual support, can combat these problems, Ms. King said, and result in mutual trust, improved performance, and patient safety.

Developing a team mentality is easier said than done. “We all train separately, and we come together and are expected to work together,” she acknowledged.

But physicians can learn the concept of better teamwork as a way to improve patient safety, said Dr. Alison Clay, who participates in TeamSTEPPS at Duke University in Durham, N.C.

TeamSTEPPS at Duke began in the pediatric ICU and it has spread to the operating room. “We are taking it to different parts of the hospital,” said Dr. Clay, an internist with appointments to the departments of surgery, and of internal medicine and pulmonary critical care at Duke. The program is likely to move next to the hospital wards and hospitalists and attending physicians, and then to clinics, she said.

The program starts with lectures and conversation and then proceeds to use of simulations and a debriefing to assess how the participants worked as a team.

Dr. Clay has participated in the TeamSTEPPS curriculum, and she has trained to coach others in teamwork building in her role as the capstone course director for fourth-year medical students.

Dr. Clay has a unique perspective on patient safety: She was a victim of a medical error at Duke when she arrived at the emergency department as a patient and went into respiratory arrest after being given a medication meant for the patient across the hall.

“That's why communication is important,” said Dr. Clay, who has shared her experience as a patient to emphasize the need for better patient safety measures.

“Concurrent with TeamSTEPPS, [there] are other efforts to teach safety involving all members of the team,” Dr. Clay noted. “People have to … be open to the concept [of] using better teamwork to solve the problem.”

For more information about TeamSTEPPS or to review and order materials, visit www.ahrq.gov/qual/teamstepps

WASHINGTON — Patient safety problems in hospitals often stem from a lack of teamwork and poor communication, James Battles, Ph.D., said at a conference sponsored by the National Patient Safety Foundation.

“In health care, if we don't have good teamwork, patients die,” said Dr. Battles, the senior service fellow for patient safety at the Agency for Healthcare Research and Quality (AHRQ).

“Teamwork is not unique to health care, and what we know about teamwork research comes from a number of disciplines, namely the military,” he said.

In the wake of “To Err Is Human,” the 1999 Institute of Medicine report that raised awareness of medical errors and called for better teamwork among physicians, AHRQ partnered with the Department of Defense to develop a teamwork training program. The resulting Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program was designed to help doctors and hospitals integrate teamwork principles into their daily activities as a way to reduce clinical errors and to improve patient outcomes, patient satisfaction, and hospital staff satisfaction.

Poor communication and other teamwork issues usually are to blame when a serious medical error occurs in a hospital, case studies have shown.

“There is a growing scientific body of literature that indicates that medical teamwork can improve the quality of the clinical process,” Dr. Battles said.

One key characteristic of successful teams is a shared mental model, which means that members of the team are “on the same page” and have a mutual sense of trust and a sense of being part of a team working toward a common goal. Each member of a successful team knows his or her role. And the most successful teams have supportive leadership.

Physicians can download materials from the AHRQ Web site and customize them to suit their practices. TeamSTEPPS became widely available in November 2006, and about 50 medical centers across the United States have used the program to improve teamwork and patient safety in their facilities, Dr. Battles said.

TeamSTEPPS offers ways to transform hospital culture by addressing the root causes of serious safety problems, particularly failures of communication.

“The program offers an excellent model and thorough instruction on how an institution can alter [its] culture and support enhanced teamwork,” Dr. Mark V. Williams, professor of medicine at Emory University in Atlanta and director of the Emory Hospital Medicine Unit, said in an interview.

“It especially empowers nurses and other health care staff to speak up and alert their colleagues and physicians when patient safety is at risk,” said Dr. Williams, who is evaluating the TeamSTEPPS program for possible use at Emory.

Key team events that make up the TeamSTEPPS program include briefs, huddles, debriefs, and conflict resolution, Heidi King, director of DOD's Healthcare Team Coordination Program, said at the meeting.

A brief is a short gathering of caregivers to review what is scheduled for the day. Topics include assignments, a review of relevant patient data, plans for specific patients, staff availability and workload, and resources.

“The idea is that we are creating words that people can use, when we say 'get together for a brief or a huddle,' everyone knows what is meant,” Ms. King said. “What we call the 'huddle' is for problem solving and to reestablish situation awareness. An example of a huddle: When a core care team, such as a surgical team or ob.gyn. team, meets for a quick review prior to a specific procedure.”

The debriefing is the step in which quality improvement occurs. Team members meet after the procedure or the next day to review events, even if everything went well the previous day. “This is where patient safety needs to take place, on the front lines of patient care,” Ms. King said.

A debriefing may include conflict resolution. The TeamSTEPPS material offers a constructive approach to resolving conflicts among team members in a four-step process called the DESC:

▸ Describe the specific situation or behavior that caused conflict.

▸ Express how the situation made you feel and what your concerns are.

▸ Suggest alternatives and seek agreement.

▸ Consequences should be stated in terms of the impact on team goals.

The outcomes of the training can be measured by improvements in four core skill areas: leadership, situation monitoring, mutual support, and communication.

Program participants develop a combination of knowledge (of the shared goals), attitudes (of mutual trust and support), and skills (related to accuracy, efficiency, and safety) that ultimately improve patient safety, Ms. King said.

“The big thing is sustaining the changes in attitude,” Ms. King said. “Implement the training in one section of the hospital, start monitoring what is going on, and communicate about what is working and not working, and then expand the training to other areas of the hospital,” she advised.

To change a hospital culture with teamwork training, create opportunities for team members to practice what they learned, and celebrate success as a way to promote progress, she added.

Barriers to good teamwork include inconsistency in team activity, lack of information sharing, hierarchy, defensiveness, varying communication styles, overwork, misinterpretation of cues, and confusion about one's role. The TeamSTEPPS strategies of better communication through briefs and huddles, as well as through feedback, patient advocacy, and mutual support, can combat these problems, Ms. King said, and result in mutual trust, improved performance, and patient safety.

Developing a team mentality is easier said than done. “We all train separately, and we come together and are expected to work together,” she acknowledged.

But physicians can learn the concept of better teamwork as a way to improve patient safety, said Dr. Alison Clay, who participates in TeamSTEPPS at Duke University in Durham, N.C.

TeamSTEPPS at Duke began in the pediatric ICU and it has spread to the operating room. “We are taking it to different parts of the hospital,” said Dr. Clay, an internist with appointments to the departments of surgery, and of internal medicine and pulmonary critical care at Duke. The program is likely to move next to the hospital wards and hospitalists and attending physicians, and then to clinics, she said.

The program starts with lectures and conversation and then proceeds to use of simulations and a debriefing to assess how the participants worked as a team.

Dr. Clay has participated in the TeamSTEPPS curriculum, and she has trained to coach others in teamwork building in her role as the capstone course director for fourth-year medical students.

Dr. Clay has a unique perspective on patient safety: She was a victim of a medical error at Duke when she arrived at the emergency department as a patient and went into respiratory arrest after being given a medication meant for the patient across the hall.

“That's why communication is important,” said Dr. Clay, who has shared her experience as a patient to emphasize the need for better patient safety measures.

“Concurrent with TeamSTEPPS, [there] are other efforts to teach safety involving all members of the team,” Dr. Clay noted. “People have to … be open to the concept [of] using better teamwork to solve the problem.”

For more information about TeamSTEPPS or to review and order materials, visit www.ahrq.gov/qual/teamstepps

Disuse of hormone therapy might have fueled a significant drop in breast cancer detection rates in recent years, but a plateau in screening mammography among women older than 45 years also contributed to the decline, according to new data from an American Cancer Society study published in Breast Cancer Research.

To assess women's breast cancer trends over the period before the results of the Women's Health Initiative brought to light the possibility of a link between hormone therapy and an increased risk of breast cancer, Dr. Ahmedin Jemal and colleagues at the American Cancer Society reviewed data from the nine oldest Surveillance, Epidemiology, and End Results cancer registries (Breast Cancer Res. 2007;9:R28 [Epub doi:10.1186/1186/bcr1672]).

Based on these registries, the researchers found that 394,891 invasive and 59,837 in situ breast cancer cases were diagnosed in U.S. women aged 40 years and older from 1975 through 2003.

Age-specific incidence of invasive breast cancer declined in all 5-year age brackets for women aged 45 years and older between 1999 and 2003, although the degree of the decline varied among the age groups. The decrease in breast cancer incidence among most women younger than 60 years or older than 69 years began in 1998 or 1999. By contrast, the decrease in breast cancer incidence among women aged 60–64 years and 65–69 years occurred from 2002 to 2003 (the most recent year for which data are available). The largest percentage decreases occurred from 2002 to 2003 among women aged 55–59 years (11.3%), 60–64 years (10.6%), and 65–69 years (14.3%).

A joint analysis of tumor size and stage showed that overall, the incidence of small tumors (2 cm or less) decreased by 4.1% per year from 2000 through 2003 and the incidence of localized disease decreased by 3.1% per year from 1999 through 2003. No decrease in the incidence of larger tumors or advanced-stage disease was found during these periods.

Also, in situ disease rates were stable from 2000 through 2003 after increasing since 1981.

Trend data based on receptor status showed an annual increase in the incidence of both estrogen receptor-positive tumors and progestin receptor-positive tumors from 1990 to 2000, followed by a 9.1% drop from 2002 to 2003 for both of these types. Estrogen receptor-negative and progestin receptor-negative tumors also showed their largest overall decreases in incidence, 4.8% and 6.9% respectively, between 2002 and 2003.

Two patterns of breast cancer trends emerged from the study.

First, the drop in incidence that began in 1998 coincides with a plateau in screening mammography, and the types of cancers detected by mammography were the types that had a decrease in incidence (small tumors and localized disease). Data from the National Health Interview Survey show that the percentage of women aged 40 years and older who reported having a mammogram within the past 2 years was 70.3% in 1999, 70.4% in 2000, and 69.5% in 2003.

“Typically, incidence rates decrease when the penetrance of a screening test reaches a plateau due to a reduced pool of undiagnosed prevalent cases,” the researchers wrote.

Second, the sharp declines in breast cancer from 2002 to 2003 that were reported at a breast cancer symposium sponsored by the Cancer Therapy and Research Center last year might have been due in part to a reduced use of hormone therapy in response to data from the Women's Health Initiative that linked hormone therapy to an increased risk of breast cancer. The sharp drop was observed mainly in estrogen receptor-positive tumors in a subset of women aged 50–69 years.

“Clearly there are many of us who feel that [the] drop in breast cancer detection rate has many factors,” Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said in an interview.

“You can't dismiss the impact of stopping hormones on the decreased detection of breast cancer, but the current article supports what we know, which is that the incidence of mammography is also declining,” he said.

But from a clinical standpoint, the findings represent a decline in detection, not necessarily an absence of cancer cases.

“I don't know any experts that think that breast cancer has gone away; there are breast cancers that have not been detected,” Dr. Lichtenfeld said.

The decline in the numbers of women having mammograms might include a lack of access or a woman's belief that if she has had one mammogram, she doesn't need additional mammograms, he noted. “The falloff in detection is much greater than one would have expected from hormones alone.”

'The falloff in detection is much greater than one would have expected from hormones alone.' DR. LICHTENFELD

Disuse of hormone therapy might have fueled a significant drop in breast cancer detection rates in recent years, but a plateau in screening mammography among women older than 45 years also contributed to the decline, according to new data from an American Cancer Society study published in Breast Cancer Research.

To assess women's breast cancer trends over the period before the results of the Women's Health Initiative brought to light the possibility of a link between hormone therapy and an increased risk of breast cancer, Dr. Ahmedin Jemal and colleagues at the American Cancer Society reviewed data from the nine oldest Surveillance, Epidemiology, and End Results cancer registries (Breast Cancer Res. 2007;9:R28 [Epub doi:10.1186/1186/bcr1672]).

Based on these registries, the researchers found that 394,891 invasive and 59,837 in situ breast cancer cases were diagnosed in U.S. women aged 40 years and older from 1975 through 2003.

Age-specific incidence of invasive breast cancer declined in all 5-year age brackets for women aged 45 years and older between 1999 and 2003, although the degree of the decline varied among the age groups. The decrease in breast cancer incidence among most women younger than 60 years or older than 69 years began in 1998 or 1999. By contrast, the decrease in breast cancer incidence among women aged 60–64 years and 65–69 years occurred from 2002 to 2003 (the most recent year for which data are available). The largest percentage decreases occurred from 2002 to 2003 among women aged 55–59 years (11.3%), 60–64 years (10.6%), and 65–69 years (14.3%).

A joint analysis of tumor size and stage showed that overall, the incidence of small tumors (2 cm or less) decreased by 4.1% per year from 2000 through 2003 and the incidence of localized disease decreased by 3.1% per year from 1999 through 2003. No decrease in the incidence of larger tumors or advanced-stage disease was found during these periods.

Also, in situ disease rates were stable from 2000 through 2003 after increasing since 1981.

Trend data based on receptor status showed an annual increase in the incidence of both estrogen receptor-positive tumors and progestin receptor-positive tumors from 1990 to 2000, followed by a 9.1% drop from 2002 to 2003 for both of these types. Estrogen receptor-negative and progestin receptor-negative tumors also showed their largest overall decreases in incidence, 4.8% and 6.9% respectively, between 2002 and 2003.

Two patterns of breast cancer trends emerged from the study.

First, the drop in incidence that began in 1998 coincides with a plateau in screening mammography, and the types of cancers detected by mammography were the types that had a decrease in incidence (small tumors and localized disease). Data from the National Health Interview Survey show that the percentage of women aged 40 years and older who reported having a mammogram within the past 2 years was 70.3% in 1999, 70.4% in 2000, and 69.5% in 2003.

“Typically, incidence rates decrease when the penetrance of a screening test reaches a plateau due to a reduced pool of undiagnosed prevalent cases,” the researchers wrote.

Second, the sharp declines in breast cancer from 2002 to 2003 that were reported at a breast cancer symposium sponsored by the Cancer Therapy and Research Center last year might have been due in part to a reduced use of hormone therapy in response to data from the Women's Health Initiative that linked hormone therapy to an increased risk of breast cancer. The sharp drop was observed mainly in estrogen receptor-positive tumors in a subset of women aged 50–69 years.

“Clearly there are many of us who feel that [the] drop in breast cancer detection rate has many factors,” Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said in an interview.

“You can't dismiss the impact of stopping hormones on the decreased detection of breast cancer, but the current article supports what we know, which is that the incidence of mammography is also declining,” he said.

But from a clinical standpoint, the findings represent a decline in detection, not necessarily an absence of cancer cases.

“I don't know any experts that think that breast cancer has gone away; there are breast cancers that have not been detected,” Dr. Lichtenfeld said.

The decline in the numbers of women having mammograms might include a lack of access or a woman's belief that if she has had one mammogram, she doesn't need additional mammograms, he noted. “The falloff in detection is much greater than one would have expected from hormones alone.”

'The falloff in detection is much greater than one would have expected from hormones alone.' DR. LICHTENFELD

Disuse of hormone therapy might have fueled a significant drop in breast cancer detection rates in recent years, but a plateau in screening mammography among women older than 45 years also contributed to the decline, according to new data from an American Cancer Society study published in Breast Cancer Research.

To assess women's breast cancer trends over the period before the results of the Women's Health Initiative brought to light the possibility of a link between hormone therapy and an increased risk of breast cancer, Dr. Ahmedin Jemal and colleagues at the American Cancer Society reviewed data from the nine oldest Surveillance, Epidemiology, and End Results cancer registries (Breast Cancer Res. 2007;9:R28 [Epub doi:10.1186/1186/bcr1672]).

Based on these registries, the researchers found that 394,891 invasive and 59,837 in situ breast cancer cases were diagnosed in U.S. women aged 40 years and older from 1975 through 2003.

Age-specific incidence of invasive breast cancer declined in all 5-year age brackets for women aged 45 years and older between 1999 and 2003, although the degree of the decline varied among the age groups. The decrease in breast cancer incidence among most women younger than 60 years or older than 69 years began in 1998 or 1999. By contrast, the decrease in breast cancer incidence among women aged 60–64 years and 65–69 years occurred from 2002 to 2003 (the most recent year for which data are available). The largest percentage decreases occurred from 2002 to 2003 among women aged 55–59 years (11.3%), 60–64 years (10.6%), and 65–69 years (14.3%).

A joint analysis of tumor size and stage showed that overall, the incidence of small tumors (2 cm or less) decreased by 4.1% per year from 2000 through 2003 and the incidence of localized disease decreased by 3.1% per year from 1999 through 2003. No decrease in the incidence of larger tumors or advanced-stage disease was found during these periods.

Also, in situ disease rates were stable from 2000 through 2003 after increasing since 1981.

Trend data based on receptor status showed an annual increase in the incidence of both estrogen receptor-positive tumors and progestin receptor-positive tumors from 1990 to 2000, followed by a 9.1% drop from 2002 to 2003 for both of these types. Estrogen receptor-negative and progestin receptor-negative tumors also showed their largest overall decreases in incidence, 4.8% and 6.9% respectively, between 2002 and 2003.

Two patterns of breast cancer trends emerged from the study.

First, the drop in incidence that began in 1998 coincides with a plateau in screening mammography, and the types of cancers detected by mammography were the types that had a decrease in incidence (small tumors and localized disease). Data from the National Health Interview Survey show that the percentage of women aged 40 years and older who reported having a mammogram within the past 2 years was 70.3% in 1999, 70.4% in 2000, and 69.5% in 2003.

“Typically, incidence rates decrease when the penetrance of a screening test reaches a plateau due to a reduced pool of undiagnosed prevalent cases,” the researchers wrote.

Second, the sharp declines in breast cancer from 2002 to 2003 that were reported at a breast cancer symposium sponsored by the Cancer Therapy and Research Center last year might have been due in part to a reduced use of hormone therapy in response to data from the Women's Health Initiative that linked hormone therapy to an increased risk of breast cancer. The sharp drop was observed mainly in estrogen receptor-positive tumors in a subset of women aged 50–69 years.

“Clearly there are many of us who feel that [the] drop in breast cancer detection rate has many factors,” Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said in an interview.

“You can't dismiss the impact of stopping hormones on the decreased detection of breast cancer, but the current article supports what we know, which is that the incidence of mammography is also declining,” he said.

But from a clinical standpoint, the findings represent a decline in detection, not necessarily an absence of cancer cases.

“I don't know any experts that think that breast cancer has gone away; there are breast cancers that have not been detected,” Dr. Lichtenfeld said.

The decline in the numbers of women having mammograms might include a lack of access or a woman's belief that if she has had one mammogram, she doesn't need additional mammograms, he noted. “The falloff in detection is much greater than one would have expected from hormones alone.”

'The falloff in detection is much greater than one would have expected from hormones alone.' DR. LICHTENFELD

LAS VEGAS — Imaging techniques can help to confirm stress fractures and distinguish them from other conditions, Dr. Christopher Beaulieu said at a symposium on emergency medicine sponsored by Stanford University.

“I don't call it a stress fracture unless I can point to the fracture line on the image, otherwise [it is] a stress reaction or stress response,” said Dr. Beaulieu of Stanford (Calif.) University. A stress reaction or response can be diagnosed if MR or other imaging shows periosteal or marrow edema without a fracture line.

If a stress fracture is confirmed, the patient must take time off from the offending activity to allow the bone to heal, but if a fracture has not occurred, the patient may be able to continue activities with modifications to prevent a full fracture.

Stress injuries to bone occur when the skeleton is unable to withstand submaximal forces acting over time, and they fall into two categories: stress (or fatigue) fractures and insufficiency fractures. Stress fractures occur when normal bones are subjected to abnormal forces, and they are common in new athletes and in military recruits. Insufficiency fractures occur when abnormal bones can't sustain normal forces, and they occur primarily in patients with bone conditions such as osteoporosis or Paget's disease.

A clinical history of overuse is the key to a stress fracture diagnosis. Risk factors for stress fractures include increased mileage, running on a hard surface, and a poor choice of shoes. Biomechanics and bone mineral density also contribute to stress fractures, as do female gender, amenorrhea, and poor nutrition or eating disorders.

To maximize the imaging of a possible stress fracture, use local coils and high quality T2-weighted imaging, Dr. Beaulieu said. “A high-quality localized image, a negative scan almost entirely excludes a significant bony stress injury.” A fat suppression image also helps in identifying a stress fracture.

MRI of a stress fracture in a runner shows a low-signal fracture line (red arrows).

MRI with fat suppression shows edema around the low-signal fracture. Photos courtesy Dr. Christopher Beaulieu

LAS VEGAS — Imaging techniques can help to confirm stress fractures and distinguish them from other conditions, Dr. Christopher Beaulieu said at a symposium on emergency medicine sponsored by Stanford University.

“I don't call it a stress fracture unless I can point to the fracture line on the image, otherwise [it is] a stress reaction or stress response,” said Dr. Beaulieu of Stanford (Calif.) University. A stress reaction or response can be diagnosed if MR or other imaging shows periosteal or marrow edema without a fracture line.

If a stress fracture is confirmed, the patient must take time off from the offending activity to allow the bone to heal, but if a fracture has not occurred, the patient may be able to continue activities with modifications to prevent a full fracture.

Stress injuries to bone occur when the skeleton is unable to withstand submaximal forces acting over time, and they fall into two categories: stress (or fatigue) fractures and insufficiency fractures. Stress fractures occur when normal bones are subjected to abnormal forces, and they are common in new athletes and in military recruits. Insufficiency fractures occur when abnormal bones can't sustain normal forces, and they occur primarily in patients with bone conditions such as osteoporosis or Paget's disease.

A clinical history of overuse is the key to a stress fracture diagnosis. Risk factors for stress fractures include increased mileage, running on a hard surface, and a poor choice of shoes. Biomechanics and bone mineral density also contribute to stress fractures, as do female gender, amenorrhea, and poor nutrition or eating disorders.

To maximize the imaging of a possible stress fracture, use local coils and high quality T2-weighted imaging, Dr. Beaulieu said. “A high-quality localized image, a negative scan almost entirely excludes a significant bony stress injury.” A fat suppression image also helps in identifying a stress fracture.

MRI of a stress fracture in a runner shows a low-signal fracture line (red arrows).

MRI with fat suppression shows edema around the low-signal fracture. Photos courtesy Dr. Christopher Beaulieu

LAS VEGAS — Imaging techniques can help to confirm stress fractures and distinguish them from other conditions, Dr. Christopher Beaulieu said at a symposium on emergency medicine sponsored by Stanford University.

“I don't call it a stress fracture unless I can point to the fracture line on the image, otherwise [it is] a stress reaction or stress response,” said Dr. Beaulieu of Stanford (Calif.) University. A stress reaction or response can be diagnosed if MR or other imaging shows periosteal or marrow edema without a fracture line.

If a stress fracture is confirmed, the patient must take time off from the offending activity to allow the bone to heal, but if a fracture has not occurred, the patient may be able to continue activities with modifications to prevent a full fracture.

Stress injuries to bone occur when the skeleton is unable to withstand submaximal forces acting over time, and they fall into two categories: stress (or fatigue) fractures and insufficiency fractures. Stress fractures occur when normal bones are subjected to abnormal forces, and they are common in new athletes and in military recruits. Insufficiency fractures occur when abnormal bones can't sustain normal forces, and they occur primarily in patients with bone conditions such as osteoporosis or Paget's disease.

A clinical history of overuse is the key to a stress fracture diagnosis. Risk factors for stress fractures include increased mileage, running on a hard surface, and a poor choice of shoes. Biomechanics and bone mineral density also contribute to stress fractures, as do female gender, amenorrhea, and poor nutrition or eating disorders.

To maximize the imaging of a possible stress fracture, use local coils and high quality T2-weighted imaging, Dr. Beaulieu said. “A high-quality localized image, a negative scan almost entirely excludes a significant bony stress injury.” A fat suppression image also helps in identifying a stress fracture.

MRI of a stress fracture in a runner shows a low-signal fracture line (red arrows).

MRI with fat suppression shows edema around the low-signal fracture. Photos courtesy Dr. Christopher Beaulieu