Sherry Boschert

LAS VEGAS – Topical tar therapy for psoriasis may be making a comeback thanks to more user-friendly formulations.

That trend is happening in Europe and may be replicated in the United States, Dr. Linda Stein Gold said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

"Topical therapy is the bread and butter of psoriasis treatment," and coal tar has been used for centuries to control the symptoms of plaque psoriasis, said Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit. The Goeckerman regimen, a combination of topical tar and ultraviolet light therapy in use since the 1920s, proved "exceptionally" effective and durable, she noted, with an average time of 18 days to 90% clearing of psoriatic lesions and 90% of patients remaining clear for up to 8 months.

But tar therapy was time consuming, a logistical hassle, and aesthetically unpleasing, and its use declined in recent decades with the advent of systemic biologic medications. "People weren’t using tar before because it’s messy and it smelled. Now we have some better options," Dr. Stein Gold said.

One of the newer topical solutions is a transparent gel of 15% liquor carbonis distillate (LCD), the equivalent of 2.3% coal tar (Psorent, NeoStrata Co.). "It doesn’t discolor bleached hair" when used for scalp psoriasis, it is quick-drying, and it comes in bottles with "dab-on" applicators so that patients don’t have to come in contact with it, she said.

In a controlled comparison with calcipotriol cream in 12 weeks of treatment of 60 adults with moderate plaque psoriasis, the LCD solution was more effective and led to fewer relapses 6 weeks after treatment. Among 55 patients with complete data, mean Psoriasis Area Severity Index (PASI) scores improved by 58% in the LCD solution group and 37% in the calcipotriol group, a significant difference (J. Am. Acad. Dermatol. 2009;60 [issue 3, suppl. 1]:Ab174 [doi: 10.1016/j.jaad.2008.11.757]).

A 75% improvement in PASI scores was seen in 11 of 27 (41%) of the LCD solution group and none of the 28 patients on calcipotriol. A 50% improvement in PASI scores was seen in 18 of 27 (67%) in the LCD group and 10 of 28 (36%) in the calcipotriol group. These differences between groups were statistically significant.

Among 42 patients with Physician Global Assessment (PGA) scores 6 weeks after treatment, the PGA scores worsened to baseline in 5 of 22 patients (23%) in the LCD solution group and in 14 of 20 patients (70%) in the calcipotriol group, again a significant difference.

A separate study compared the LCD solution in combination with UVB therapy on one side of the body with UVB light therapy alone on the other side of the body in 12 patients in 4 weeks of therapy. "Very quickly, the combo therapy gets more rapid and complete efficacy compared with UVB alone," said Dr. Stein Gold (J. Drugs. Dermatol. 2009;8 [4]:351-7).

Another relatively user-friendly product is an over-the-counter 2% coal tar formulation in a foam base (Scytera, Promius Pharma). The foam is "a much more cosmetically elegant" treatment compared with older tar therapies, she said. It spreads easily, dries quickly, and has an acceptable fragrance, Dr. Stein Gold added.

In a randomized, observer-blind study of 38 patients with chronic plaque-type psoriasis, two lesions on each patient were treated for 8 weeks with a 1% coal tar foam or calcipotriol cream. The treatments appeared to be comparably effective. More patients reported itching, unpleasant odor or staining with the tar foam than with calcipotriol cream, but the foam is considerably less expensive, the investigators noted (B. J. Dermatol. 2003;149[2]:350-53).

"Tar is something we probably should look at again," Dr. Stein Gold said.

Other useful topical therapies include corticosteroids, she said. While studies with objective measures of atrophy have proved that potent topical corticosteroids do lead to thinning of the skin over time, often this effect is not clinically noticeable, and it reverses over time once treatment is stopped.

Topical vitamin D is complementary to topical steroids for psoriasis therapy and helps counteract some of the side effects of topical steroids on skin.

Dr. Stein Gold said she has had financial associations with Leo Pharma, Medicis Pharmaceutical Corp., Stiefel Laboratories, Galderma, and Novartis. SDEF and this news organization are owned by Elsevier.

LAS VEGAS – Topical tar therapy for psoriasis may be making a comeback thanks to more user-friendly formulations.

That trend is happening in Europe and may be replicated in the United States, Dr. Linda Stein Gold said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

"Topical therapy is the bread and butter of psoriasis treatment," and coal tar has been used for centuries to control the symptoms of plaque psoriasis, said Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit. The Goeckerman regimen, a combination of topical tar and ultraviolet light therapy in use since the 1920s, proved "exceptionally" effective and durable, she noted, with an average time of 18 days to 90% clearing of psoriatic lesions and 90% of patients remaining clear for up to 8 months.

But tar therapy was time consuming, a logistical hassle, and aesthetically unpleasing, and its use declined in recent decades with the advent of systemic biologic medications. "People weren’t using tar before because it’s messy and it smelled. Now we have some better options," Dr. Stein Gold said.

One of the newer topical solutions is a transparent gel of 15% liquor carbonis distillate (LCD), the equivalent of 2.3% coal tar (Psorent, NeoStrata Co.). "It doesn’t discolor bleached hair" when used for scalp psoriasis, it is quick-drying, and it comes in bottles with "dab-on" applicators so that patients don’t have to come in contact with it, she said.

In a controlled comparison with calcipotriol cream in 12 weeks of treatment of 60 adults with moderate plaque psoriasis, the LCD solution was more effective and led to fewer relapses 6 weeks after treatment. Among 55 patients with complete data, mean Psoriasis Area Severity Index (PASI) scores improved by 58% in the LCD solution group and 37% in the calcipotriol group, a significant difference (J. Am. Acad. Dermatol. 2009;60 [issue 3, suppl. 1]:Ab174 [doi: 10.1016/j.jaad.2008.11.757]).

A 75% improvement in PASI scores was seen in 11 of 27 (41%) of the LCD solution group and none of the 28 patients on calcipotriol. A 50% improvement in PASI scores was seen in 18 of 27 (67%) in the LCD group and 10 of 28 (36%) in the calcipotriol group. These differences between groups were statistically significant.

Among 42 patients with Physician Global Assessment (PGA) scores 6 weeks after treatment, the PGA scores worsened to baseline in 5 of 22 patients (23%) in the LCD solution group and in 14 of 20 patients (70%) in the calcipotriol group, again a significant difference.

A separate study compared the LCD solution in combination with UVB therapy on one side of the body with UVB light therapy alone on the other side of the body in 12 patients in 4 weeks of therapy. "Very quickly, the combo therapy gets more rapid and complete efficacy compared with UVB alone," said Dr. Stein Gold (J. Drugs. Dermatol. 2009;8 [4]:351-7).

Another relatively user-friendly product is an over-the-counter 2% coal tar formulation in a foam base (Scytera, Promius Pharma). The foam is "a much more cosmetically elegant" treatment compared with older tar therapies, she said. It spreads easily, dries quickly, and has an acceptable fragrance, Dr. Stein Gold added.

In a randomized, observer-blind study of 38 patients with chronic plaque-type psoriasis, two lesions on each patient were treated for 8 weeks with a 1% coal tar foam or calcipotriol cream. The treatments appeared to be comparably effective. More patients reported itching, unpleasant odor or staining with the tar foam than with calcipotriol cream, but the foam is considerably less expensive, the investigators noted (B. J. Dermatol. 2003;149[2]:350-53).

"Tar is something we probably should look at again," Dr. Stein Gold said.

Other useful topical therapies include corticosteroids, she said. While studies with objective measures of atrophy have proved that potent topical corticosteroids do lead to thinning of the skin over time, often this effect is not clinically noticeable, and it reverses over time once treatment is stopped.

Topical vitamin D is complementary to topical steroids for psoriasis therapy and helps counteract some of the side effects of topical steroids on skin.

Dr. Stein Gold said she has had financial associations with Leo Pharma, Medicis Pharmaceutical Corp., Stiefel Laboratories, Galderma, and Novartis. SDEF and this news organization are owned by Elsevier.

LAS VEGAS – Topical tar therapy for psoriasis may be making a comeback thanks to more user-friendly formulations.

That trend is happening in Europe and may be replicated in the United States, Dr. Linda Stein Gold said at a dermatology seminar sponsored by Skin Disease Education Foundation (SDEF).

"Topical therapy is the bread and butter of psoriasis treatment," and coal tar has been used for centuries to control the symptoms of plaque psoriasis, said Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit. The Goeckerman regimen, a combination of topical tar and ultraviolet light therapy in use since the 1920s, proved "exceptionally" effective and durable, she noted, with an average time of 18 days to 90% clearing of psoriatic lesions and 90% of patients remaining clear for up to 8 months.

But tar therapy was time consuming, a logistical hassle, and aesthetically unpleasing, and its use declined in recent decades with the advent of systemic biologic medications. "People weren’t using tar before because it’s messy and it smelled. Now we have some better options," Dr. Stein Gold said.

One of the newer topical solutions is a transparent gel of 15% liquor carbonis distillate (LCD), the equivalent of 2.3% coal tar (Psorent, NeoStrata Co.). "It doesn’t discolor bleached hair" when used for scalp psoriasis, it is quick-drying, and it comes in bottles with "dab-on" applicators so that patients don’t have to come in contact with it, she said.

In a controlled comparison with calcipotriol cream in 12 weeks of treatment of 60 adults with moderate plaque psoriasis, the LCD solution was more effective and led to fewer relapses 6 weeks after treatment. Among 55 patients with complete data, mean Psoriasis Area Severity Index (PASI) scores improved by 58% in the LCD solution group and 37% in the calcipotriol group, a significant difference (J. Am. Acad. Dermatol. 2009;60 [issue 3, suppl. 1]:Ab174 [doi: 10.1016/j.jaad.2008.11.757]).

A 75% improvement in PASI scores was seen in 11 of 27 (41%) of the LCD solution group and none of the 28 patients on calcipotriol. A 50% improvement in PASI scores was seen in 18 of 27 (67%) in the LCD group and 10 of 28 (36%) in the calcipotriol group. These differences between groups were statistically significant.

Among 42 patients with Physician Global Assessment (PGA) scores 6 weeks after treatment, the PGA scores worsened to baseline in 5 of 22 patients (23%) in the LCD solution group and in 14 of 20 patients (70%) in the calcipotriol group, again a significant difference.

A separate study compared the LCD solution in combination with UVB therapy on one side of the body with UVB light therapy alone on the other side of the body in 12 patients in 4 weeks of therapy. "Very quickly, the combo therapy gets more rapid and complete efficacy compared with UVB alone," said Dr. Stein Gold (J. Drugs. Dermatol. 2009;8 [4]:351-7).

Another relatively user-friendly product is an over-the-counter 2% coal tar formulation in a foam base (Scytera, Promius Pharma). The foam is "a much more cosmetically elegant" treatment compared with older tar therapies, she said. It spreads easily, dries quickly, and has an acceptable fragrance, Dr. Stein Gold added.

In a randomized, observer-blind study of 38 patients with chronic plaque-type psoriasis, two lesions on each patient were treated for 8 weeks with a 1% coal tar foam or calcipotriol cream. The treatments appeared to be comparably effective. More patients reported itching, unpleasant odor or staining with the tar foam than with calcipotriol cream, but the foam is considerably less expensive, the investigators noted (B. J. Dermatol. 2003;149[2]:350-53).

"Tar is something we probably should look at again," Dr. Stein Gold said.

Other useful topical therapies include corticosteroids, she said. While studies with objective measures of atrophy have proved that potent topical corticosteroids do lead to thinning of the skin over time, often this effect is not clinically noticeable, and it reverses over time once treatment is stopped.

Topical vitamin D is complementary to topical steroids for psoriasis therapy and helps counteract some of the side effects of topical steroids on skin.

Dr. Stein Gold said she has had financial associations with Leo Pharma, Medicis Pharmaceutical Corp., Stiefel Laboratories, Galderma, and Novartis. SDEF and this news organization are owned by Elsevier.

SAN DIEGO – The risks for 30-day postoperative mortality and morbidity were lower in those whose general anesthesia contained nitrous oxide compared with matched patients who got intraoperative air, in a retrospective study of 37,609 adults undergoing major noncardiac surgery.

These findings contradict those of some previous reports, according to Dr. Ayako Shiba of the Cleveland Clinic.

She and her associates analyzed data on 37,609 procedures performed at the clinic between 2005 and 2009, and matched 12,773 patients who received nitrous oxide with 12,773 who did not get nitrous oxide by type of surgery and by a propensity score based on potential confounding variables at baseline.

They found no significant association between intraoperative administration of nitrous oxide and 30-day mortality, she reported at the annual meeting of the American Society of Anesthesiologists. In the nitrous oxide group, 0.6% died within 30 days compared with 0.8% in the air group (P = .08).

In a composite of in-hospital morbidity and mortality, the odds were significantly lower in the nitrous oxide group (8.2%) compared with the air group (9%), with an odds ratio of 0.90 in the nitrous oxide group (P = .017).

A secondary analysis looking at individual morbidities found that the risk for pulmonary/respiratory complications was significantly lower in the nitrous oxide group than in the air group (1.6% vs. 2.7%, P less than .001). Risks did not differ between groups for other individual morbidity categories, however, such as cardiac, hemorrhagic, infectious, neurologic, peripheral vascular, urinary/renal, or wound disruption, or for in-hospital mortality.

Dr. Shiba speculated that the lower rates of complications in the nitrous oxide group may have resulted from lower inspired oxygen concentrations – a direct beneficial effect of nitrous oxide – or a decrease in the use of volatile anesthetic agents.

A previous study – a randomized, controlled trial of 2,050 patients undergoing major surgery – reported that there were fewer complications in patients who did not receive perioperative nitrous oxide (Anesthesiology 2007;107:221-31).That study inspired an editorial titled, "Is It Time to Retire High-Concentration Nitrous Oxide?" (Anesthesiology 2007;107:200-1).

Although nitrous oxide has been used widely in clinical anesthesia for more than 150 years, concerns about the drug’s metabolic side effects, postoperative nausea and vomiting, and the greenhouse-gas effect have led to decreased usage in recent years, she said. An informal poll of the audience at her presentation showed that approximately three-quarters of those in attendance still use nitrous oxide as some component of anesthesia, and one-quarter have stopped using it completely.

"Considering all of the available data, we conclude that insufficient evidence supports the theory that nitrous oxide use increases the risk of either serious complications or mortality in surgical patients," she said.

The study excluded patients who needed emergency surgery or were American Society of Anesthesiology class V or VI. Pediatric cases and patients who were not under general anesthesia also were excluded.

Dr. Shiba said she has no relevant conflicts of interest.

SAN DIEGO – The risks for 30-day postoperative mortality and morbidity were lower in those whose general anesthesia contained nitrous oxide compared with matched patients who got intraoperative air, in a retrospective study of 37,609 adults undergoing major noncardiac surgery.

These findings contradict those of some previous reports, according to Dr. Ayako Shiba of the Cleveland Clinic.

She and her associates analyzed data on 37,609 procedures performed at the clinic between 2005 and 2009, and matched 12,773 patients who received nitrous oxide with 12,773 who did not get nitrous oxide by type of surgery and by a propensity score based on potential confounding variables at baseline.

They found no significant association between intraoperative administration of nitrous oxide and 30-day mortality, she reported at the annual meeting of the American Society of Anesthesiologists. In the nitrous oxide group, 0.6% died within 30 days compared with 0.8% in the air group (P = .08).

In a composite of in-hospital morbidity and mortality, the odds were significantly lower in the nitrous oxide group (8.2%) compared with the air group (9%), with an odds ratio of 0.90 in the nitrous oxide group (P = .017).

A secondary analysis looking at individual morbidities found that the risk for pulmonary/respiratory complications was significantly lower in the nitrous oxide group than in the air group (1.6% vs. 2.7%, P less than .001). Risks did not differ between groups for other individual morbidity categories, however, such as cardiac, hemorrhagic, infectious, neurologic, peripheral vascular, urinary/renal, or wound disruption, or for in-hospital mortality.

Dr. Shiba speculated that the lower rates of complications in the nitrous oxide group may have resulted from lower inspired oxygen concentrations – a direct beneficial effect of nitrous oxide – or a decrease in the use of volatile anesthetic agents.

A previous study – a randomized, controlled trial of 2,050 patients undergoing major surgery – reported that there were fewer complications in patients who did not receive perioperative nitrous oxide (Anesthesiology 2007;107:221-31).That study inspired an editorial titled, "Is It Time to Retire High-Concentration Nitrous Oxide?" (Anesthesiology 2007;107:200-1).

Although nitrous oxide has been used widely in clinical anesthesia for more than 150 years, concerns about the drug’s metabolic side effects, postoperative nausea and vomiting, and the greenhouse-gas effect have led to decreased usage in recent years, she said. An informal poll of the audience at her presentation showed that approximately three-quarters of those in attendance still use nitrous oxide as some component of anesthesia, and one-quarter have stopped using it completely.

"Considering all of the available data, we conclude that insufficient evidence supports the theory that nitrous oxide use increases the risk of either serious complications or mortality in surgical patients," she said.

The study excluded patients who needed emergency surgery or were American Society of Anesthesiology class V or VI. Pediatric cases and patients who were not under general anesthesia also were excluded.

Dr. Shiba said she has no relevant conflicts of interest.

SAN DIEGO – The risks for 30-day postoperative mortality and morbidity were lower in those whose general anesthesia contained nitrous oxide compared with matched patients who got intraoperative air, in a retrospective study of 37,609 adults undergoing major noncardiac surgery.

These findings contradict those of some previous reports, according to Dr. Ayako Shiba of the Cleveland Clinic.

She and her associates analyzed data on 37,609 procedures performed at the clinic between 2005 and 2009, and matched 12,773 patients who received nitrous oxide with 12,773 who did not get nitrous oxide by type of surgery and by a propensity score based on potential confounding variables at baseline.

They found no significant association between intraoperative administration of nitrous oxide and 30-day mortality, she reported at the annual meeting of the American Society of Anesthesiologists. In the nitrous oxide group, 0.6% died within 30 days compared with 0.8% in the air group (P = .08).

In a composite of in-hospital morbidity and mortality, the odds were significantly lower in the nitrous oxide group (8.2%) compared with the air group (9%), with an odds ratio of 0.90 in the nitrous oxide group (P = .017).

A secondary analysis looking at individual morbidities found that the risk for pulmonary/respiratory complications was significantly lower in the nitrous oxide group than in the air group (1.6% vs. 2.7%, P less than .001). Risks did not differ between groups for other individual morbidity categories, however, such as cardiac, hemorrhagic, infectious, neurologic, peripheral vascular, urinary/renal, or wound disruption, or for in-hospital mortality.

Dr. Shiba speculated that the lower rates of complications in the nitrous oxide group may have resulted from lower inspired oxygen concentrations – a direct beneficial effect of nitrous oxide – or a decrease in the use of volatile anesthetic agents.

A previous study – a randomized, controlled trial of 2,050 patients undergoing major surgery – reported that there were fewer complications in patients who did not receive perioperative nitrous oxide (Anesthesiology 2007;107:221-31).That study inspired an editorial titled, "Is It Time to Retire High-Concentration Nitrous Oxide?" (Anesthesiology 2007;107:200-1).

Although nitrous oxide has been used widely in clinical anesthesia for more than 150 years, concerns about the drug’s metabolic side effects, postoperative nausea and vomiting, and the greenhouse-gas effect have led to decreased usage in recent years, she said. An informal poll of the audience at her presentation showed that approximately three-quarters of those in attendance still use nitrous oxide as some component of anesthesia, and one-quarter have stopped using it completely.

"Considering all of the available data, we conclude that insufficient evidence supports the theory that nitrous oxide use increases the risk of either serious complications or mortality in surgical patients," she said.

The study excluded patients who needed emergency surgery or were American Society of Anesthesiology class V or VI. Pediatric cases and patients who were not under general anesthesia also were excluded.

Dr. Shiba said she has no relevant conflicts of interest.

SAN FRANCISCO – Looking for signs of intimate partner violence between parents of pediatric patients may or may not help the parents, but the effects of that violence on children are so profound that physicians must ask about it, a clinical report from the American Academy of Pediatrics concludes.

The lead author of the report, Dr. Jonathan D. Thackeray, highlighted it in a plenary session at the academy’s national meeting because the recommendations didn’t get the attention they deserved when published earlier this year, he said (Pediatrics 2010;125:1094-1100).At the time, the report was overshadowed by another article in the same issue of the journal – the academy’s policy statement on ritual genital cutting of female minors (Pediatrics 2010;125:1088-93).

Approximately 29% of U.S. children in dual-parent households (15.5 million children) were exposed to intimate partner violence in the previous year, and 13% of children (7 million) were in households with severe intimate partner violence, results of a 2006 study suggest (Journal of Fam. Psychol. 2006;20:137-42).

Those findings probably underestimate the problem because that survey did not include children living with single parents, grandparents, or same-sex parents, noted Dr. Thackeray of Ohio State University. "If you look for intimate partner violence, you will find it," he said.

There’s overwhelming evidence that children who are exposed to intimate partner violence face increased risk for child maltreatment and medical, behavioral, and mental health problems in both the short and long terms, added Dr. Thackeray, clinical director of the Child Assessment Center, Center for Child and Family Advocacy at Nationwide Children’s Hospital, Columbus, Ohio.

When either child maltreatment or intimate partner violence is present in a family, the other will be present in 30%-60% of cases, data suggest. When intimate partner violence affects a parent, the child’s risk of neglect or emotional abuse doubles and the risk of physical abuse more than triples. The violence also may cause injury to the child.

In the long run, adults who report childhood exposure to intimate partner violence in the family had a sixfold increased risk for emotional abuse or substance abuse, a fivefold increased risk for physical neglect or physical abuse, and a threefold higher risk for sexual abuse or incarceration of family members (Violence Vict. 2002;17:3-17). The more often they witnessed intimate partner violence as a child, the more likely they were as adults to report alcoholism, illicit or IV drug use, or depression.

The academy’s clinical report, produced by members of its Committee on Child Abuse and Neglect and Committee on Injury, Violence, and Poison Prevention, echoes endorsements of intimate partner violence screening by most major medical organizations.

These contrast somewhat with guidelines by government bodies concluding that there’s insufficient evidence to recommend for or against routine screening of women for intimate partner violence. Both the U.S. Preventive Services Task Force (Ann. Fam. Med. 2004;2:156-60) and the Canadian Task Force on Preventive Health Care (CMAJ 2003;169:582-4) concluded that there’s insufficient evidence to recommend for or against routine screening of women for intimate partner violence.

Various studies report finding intimate partner violence affecting 15%-41% of women screened, but have not shown that screening and detection make a significant difference in the odds of intimate partner violence recurring or in quality of life during 18 months of follow-up. That may be a sign that current interventions for women who screen positive for intimate partner violence are ineffective, Dr. Thackeray said.

There’s little evidence of benefit from referring women to community resources or from home visits, but "neither of these interventions directly address the child," he noted. More research is needed on interventions for the child exposed to intimate partner violence, he added.

On the flip side, studies also have found no indication that screening for intimate partner violence increases the risk for short-term harm or adverse events such as reprisal, family disruption, psychological effects, or involvement of child protective services.

The academy’s clinical report recommends screening either verbally or through self-administered written assessment, and points clinicians toward validated written screening tools. Once a patient discloses abuse on a self-administered assessment, it’s important to follow up in a gentle, nonjudgmental discussion away from children, family, friends, and the suspected abuser. The report offers resources and suggestions for referrals and safety plans that can be offered to parents dealing with intimate partner violence.

Dr. Thackeray said he has no pertinent conflicts of interest.

SAN FRANCISCO – Looking for signs of intimate partner violence between parents of pediatric patients may or may not help the parents, but the effects of that violence on children are so profound that physicians must ask about it, a clinical report from the American Academy of Pediatrics concludes.

The lead author of the report, Dr. Jonathan D. Thackeray, highlighted it in a plenary session at the academy’s national meeting because the recommendations didn’t get the attention they deserved when published earlier this year, he said (Pediatrics 2010;125:1094-1100).At the time, the report was overshadowed by another article in the same issue of the journal – the academy’s policy statement on ritual genital cutting of female minors (Pediatrics 2010;125:1088-93).

Approximately 29% of U.S. children in dual-parent households (15.5 million children) were exposed to intimate partner violence in the previous year, and 13% of children (7 million) were in households with severe intimate partner violence, results of a 2006 study suggest (Journal of Fam. Psychol. 2006;20:137-42).

Those findings probably underestimate the problem because that survey did not include children living with single parents, grandparents, or same-sex parents, noted Dr. Thackeray of Ohio State University. "If you look for intimate partner violence, you will find it," he said.

There’s overwhelming evidence that children who are exposed to intimate partner violence face increased risk for child maltreatment and medical, behavioral, and mental health problems in both the short and long terms, added Dr. Thackeray, clinical director of the Child Assessment Center, Center for Child and Family Advocacy at Nationwide Children’s Hospital, Columbus, Ohio.

When either child maltreatment or intimate partner violence is present in a family, the other will be present in 30%-60% of cases, data suggest. When intimate partner violence affects a parent, the child’s risk of neglect or emotional abuse doubles and the risk of physical abuse more than triples. The violence also may cause injury to the child.

In the long run, adults who report childhood exposure to intimate partner violence in the family had a sixfold increased risk for emotional abuse or substance abuse, a fivefold increased risk for physical neglect or physical abuse, and a threefold higher risk for sexual abuse or incarceration of family members (Violence Vict. 2002;17:3-17). The more often they witnessed intimate partner violence as a child, the more likely they were as adults to report alcoholism, illicit or IV drug use, or depression.

The academy’s clinical report, produced by members of its Committee on Child Abuse and Neglect and Committee on Injury, Violence, and Poison Prevention, echoes endorsements of intimate partner violence screening by most major medical organizations.

These contrast somewhat with guidelines by government bodies concluding that there’s insufficient evidence to recommend for or against routine screening of women for intimate partner violence. Both the U.S. Preventive Services Task Force (Ann. Fam. Med. 2004;2:156-60) and the Canadian Task Force on Preventive Health Care (CMAJ 2003;169:582-4) concluded that there’s insufficient evidence to recommend for or against routine screening of women for intimate partner violence.

Various studies report finding intimate partner violence affecting 15%-41% of women screened, but have not shown that screening and detection make a significant difference in the odds of intimate partner violence recurring or in quality of life during 18 months of follow-up. That may be a sign that current interventions for women who screen positive for intimate partner violence are ineffective, Dr. Thackeray said.

There’s little evidence of benefit from referring women to community resources or from home visits, but "neither of these interventions directly address the child," he noted. More research is needed on interventions for the child exposed to intimate partner violence, he added.

On the flip side, studies also have found no indication that screening for intimate partner violence increases the risk for short-term harm or adverse events such as reprisal, family disruption, psychological effects, or involvement of child protective services.

The academy’s clinical report recommends screening either verbally or through self-administered written assessment, and points clinicians toward validated written screening tools. Once a patient discloses abuse on a self-administered assessment, it’s important to follow up in a gentle, nonjudgmental discussion away from children, family, friends, and the suspected abuser. The report offers resources and suggestions for referrals and safety plans that can be offered to parents dealing with intimate partner violence.

Dr. Thackeray said he has no pertinent conflicts of interest.

SAN FRANCISCO – Looking for signs of intimate partner violence between parents of pediatric patients may or may not help the parents, but the effects of that violence on children are so profound that physicians must ask about it, a clinical report from the American Academy of Pediatrics concludes.

The lead author of the report, Dr. Jonathan D. Thackeray, highlighted it in a plenary session at the academy’s national meeting because the recommendations didn’t get the attention they deserved when published earlier this year, he said (Pediatrics 2010;125:1094-1100).At the time, the report was overshadowed by another article in the same issue of the journal – the academy’s policy statement on ritual genital cutting of female minors (Pediatrics 2010;125:1088-93).

Approximately 29% of U.S. children in dual-parent households (15.5 million children) were exposed to intimate partner violence in the previous year, and 13% of children (7 million) were in households with severe intimate partner violence, results of a 2006 study suggest (Journal of Fam. Psychol. 2006;20:137-42).

Those findings probably underestimate the problem because that survey did not include children living with single parents, grandparents, or same-sex parents, noted Dr. Thackeray of Ohio State University. "If you look for intimate partner violence, you will find it," he said.

There’s overwhelming evidence that children who are exposed to intimate partner violence face increased risk for child maltreatment and medical, behavioral, and mental health problems in both the short and long terms, added Dr. Thackeray, clinical director of the Child Assessment Center, Center for Child and Family Advocacy at Nationwide Children’s Hospital, Columbus, Ohio.

When either child maltreatment or intimate partner violence is present in a family, the other will be present in 30%-60% of cases, data suggest. When intimate partner violence affects a parent, the child’s risk of neglect or emotional abuse doubles and the risk of physical abuse more than triples. The violence also may cause injury to the child.

In the long run, adults who report childhood exposure to intimate partner violence in the family had a sixfold increased risk for emotional abuse or substance abuse, a fivefold increased risk for physical neglect or physical abuse, and a threefold higher risk for sexual abuse or incarceration of family members (Violence Vict. 2002;17:3-17). The more often they witnessed intimate partner violence as a child, the more likely they were as adults to report alcoholism, illicit or IV drug use, or depression.

The academy’s clinical report, produced by members of its Committee on Child Abuse and Neglect and Committee on Injury, Violence, and Poison Prevention, echoes endorsements of intimate partner violence screening by most major medical organizations.

These contrast somewhat with guidelines by government bodies concluding that there’s insufficient evidence to recommend for or against routine screening of women for intimate partner violence. Both the U.S. Preventive Services Task Force (Ann. Fam. Med. 2004;2:156-60) and the Canadian Task Force on Preventive Health Care (CMAJ 2003;169:582-4) concluded that there’s insufficient evidence to recommend for or against routine screening of women for intimate partner violence.

Various studies report finding intimate partner violence affecting 15%-41% of women screened, but have not shown that screening and detection make a significant difference in the odds of intimate partner violence recurring or in quality of life during 18 months of follow-up. That may be a sign that current interventions for women who screen positive for intimate partner violence are ineffective, Dr. Thackeray said.

There’s little evidence of benefit from referring women to community resources or from home visits, but "neither of these interventions directly address the child," he noted. More research is needed on interventions for the child exposed to intimate partner violence, he added.

On the flip side, studies also have found no indication that screening for intimate partner violence increases the risk for short-term harm or adverse events such as reprisal, family disruption, psychological effects, or involvement of child protective services.

The academy’s clinical report recommends screening either verbally or through self-administered written assessment, and points clinicians toward validated written screening tools. Once a patient discloses abuse on a self-administered assessment, it’s important to follow up in a gentle, nonjudgmental discussion away from children, family, friends, and the suspected abuser. The report offers resources and suggestions for referrals and safety plans that can be offered to parents dealing with intimate partner violence.

Dr. Thackeray said he has no pertinent conflicts of interest.

SAN FRANCISCO – The principles of “risk communication” can help physicians answer parents' questions about environmental risks to health.

Dr. Maida P. Galvez employed these principles to demonstrate how she addresses a common parental question these days: Are plastics dangerous? Whether discussing plastics or other topics, it's helpful to craft clear and concise messages in advance using straightforward language, she said.

Develop a maximum of three key messages. For each of those messages, prepare three supporting facts, advised Dr. Galvez of Mount Sinai School of Medicine's Center for Children's Environmental Health and Disease Prevention Research, New York.

In the three key messages, first define the exposure to the potential environmental risk, then explain what is known about potential health effects, and finally offer action items for families, she said.

Many parents have heard of potential health risks from phthalates or bisphenol A in plastics. They may ask physicians how to tell if toys contain phthalates. Are bottles with bisphenol A harmful? What health effects should they look for?

Utilizing the lessons in risk communication, a physician might first define the exposure to these substances by saying that phthalates and bisphenol A are plasticizers that are added to common products because they add flexibility and durability, Dr. Galvez said.

Summarizing what is known about potential health effects, the physician might then say that concerns have been raised about the potential for health effects based on animal studies and growing evidence that the U.S. population is universally exposed to phthalates and bisphenol A.

If families want to take action, given the concerns raised by animal studies and limited human studies, they can take a precautionary approach and choose alternatives to products that may contain these plasticizers, she said.

That simple one-two-three messaging can be fleshed out with the supporting facts if there's time and interest from the parents.

Phthalates are found in personal hygiene products like cosmetics, shampoos, fragrances, and nail polish, as well as in food packaging, medical tubing, children's toys, and vinyl products. Bisphenol A is found in hard plastic items like sports water bottles, baby bottles, canned foods, and dental sealants. These two plasticizers can leach from the products, exposing humans through ingestion, inhalation, or dermal absorption.

Phthalates and bisphenol A are known to have hormonal activity, and thus are often referred to as endocrine disruptors. Studies suggest they are ubiquitous in the U.S. population, with higher exposure levels in children and teens than in adults.

In animal studies, exposure to these plasticizers can affect birth outcomes, especially the reproductive tract in newborn males. Human studies are assessing potential links between plasticizers and early puberty, obesity, asthma, and male infertility.

What can parents do? “Keep it simple,” Dr. Galvez said. “Less is more. Especially in pregnancy, simplify your routine, and simplify the number of products you're using.”

Look for products free of phthalates and bisphenol A. If labels don't provide the needed information, look at recycling symbols: numbers 3, 6, and 7 should be avoided, but numbers 1, 2, 4, and 5 should be okay, she said. Her institution created a 2-inch by 3.5-inch “Pocket Guide to Plastics” that physicians may want to distribute to patients. Copies can be requested by e-mailing Dr. Luz Claudio at Luz.Claudio@mssm.edu

Similar fact sheets can be downloaded from the Web site of the Pediatric Environmental Health Specialty Units at www.aoec.org/PEHSU/facts.html

To avoid plasticizers, don't put plastic items in the microwave or dishwasher because heat promotes leaching. When possible, choose safer alternatives to plasticizer-containing products, such as fresh fruits and vegetables instead of canned food, breast milk instead of canned infant formulas, foods in glass containers instead of plastic, and water bottles made of stainless steel, Dr. Galvez recommended.

Dr. Galvez said that she has no pertinent conflicts of interest.

Recycling symbols and numbers on packaging show which products have safe amounts of plasticizers.

Source Sherry Boschert/Elsevier Global Medical News

SAN FRANCISCO – The principles of “risk communication” can help physicians answer parents' questions about environmental risks to health.

Dr. Maida P. Galvez employed these principles to demonstrate how she addresses a common parental question these days: Are plastics dangerous? Whether discussing plastics or other topics, it's helpful to craft clear and concise messages in advance using straightforward language, she said.

Develop a maximum of three key messages. For each of those messages, prepare three supporting facts, advised Dr. Galvez of Mount Sinai School of Medicine's Center for Children's Environmental Health and Disease Prevention Research, New York.

In the three key messages, first define the exposure to the potential environmental risk, then explain what is known about potential health effects, and finally offer action items for families, she said.

Many parents have heard of potential health risks from phthalates or bisphenol A in plastics. They may ask physicians how to tell if toys contain phthalates. Are bottles with bisphenol A harmful? What health effects should they look for?

Utilizing the lessons in risk communication, a physician might first define the exposure to these substances by saying that phthalates and bisphenol A are plasticizers that are added to common products because they add flexibility and durability, Dr. Galvez said.

Summarizing what is known about potential health effects, the physician might then say that concerns have been raised about the potential for health effects based on animal studies and growing evidence that the U.S. population is universally exposed to phthalates and bisphenol A.

If families want to take action, given the concerns raised by animal studies and limited human studies, they can take a precautionary approach and choose alternatives to products that may contain these plasticizers, she said.

That simple one-two-three messaging can be fleshed out with the supporting facts if there's time and interest from the parents.

Phthalates are found in personal hygiene products like cosmetics, shampoos, fragrances, and nail polish, as well as in food packaging, medical tubing, children's toys, and vinyl products. Bisphenol A is found in hard plastic items like sports water bottles, baby bottles, canned foods, and dental sealants. These two plasticizers can leach from the products, exposing humans through ingestion, inhalation, or dermal absorption.

Phthalates and bisphenol A are known to have hormonal activity, and thus are often referred to as endocrine disruptors. Studies suggest they are ubiquitous in the U.S. population, with higher exposure levels in children and teens than in adults.

In animal studies, exposure to these plasticizers can affect birth outcomes, especially the reproductive tract in newborn males. Human studies are assessing potential links between plasticizers and early puberty, obesity, asthma, and male infertility.

What can parents do? “Keep it simple,” Dr. Galvez said. “Less is more. Especially in pregnancy, simplify your routine, and simplify the number of products you're using.”

Look for products free of phthalates and bisphenol A. If labels don't provide the needed information, look at recycling symbols: numbers 3, 6, and 7 should be avoided, but numbers 1, 2, 4, and 5 should be okay, she said. Her institution created a 2-inch by 3.5-inch “Pocket Guide to Plastics” that physicians may want to distribute to patients. Copies can be requested by e-mailing Dr. Luz Claudio at Luz.Claudio@mssm.edu

Similar fact sheets can be downloaded from the Web site of the Pediatric Environmental Health Specialty Units at www.aoec.org/PEHSU/facts.html

To avoid plasticizers, don't put plastic items in the microwave or dishwasher because heat promotes leaching. When possible, choose safer alternatives to plasticizer-containing products, such as fresh fruits and vegetables instead of canned food, breast milk instead of canned infant formulas, foods in glass containers instead of plastic, and water bottles made of stainless steel, Dr. Galvez recommended.

Dr. Galvez said that she has no pertinent conflicts of interest.

Recycling symbols and numbers on packaging show which products have safe amounts of plasticizers.

Source Sherry Boschert/Elsevier Global Medical News

SAN FRANCISCO – The principles of “risk communication” can help physicians answer parents' questions about environmental risks to health.

Dr. Maida P. Galvez employed these principles to demonstrate how she addresses a common parental question these days: Are plastics dangerous? Whether discussing plastics or other topics, it's helpful to craft clear and concise messages in advance using straightforward language, she said.

Develop a maximum of three key messages. For each of those messages, prepare three supporting facts, advised Dr. Galvez of Mount Sinai School of Medicine's Center for Children's Environmental Health and Disease Prevention Research, New York.

In the three key messages, first define the exposure to the potential environmental risk, then explain what is known about potential health effects, and finally offer action items for families, she said.

Many parents have heard of potential health risks from phthalates or bisphenol A in plastics. They may ask physicians how to tell if toys contain phthalates. Are bottles with bisphenol A harmful? What health effects should they look for?

Utilizing the lessons in risk communication, a physician might first define the exposure to these substances by saying that phthalates and bisphenol A are plasticizers that are added to common products because they add flexibility and durability, Dr. Galvez said.

Summarizing what is known about potential health effects, the physician might then say that concerns have been raised about the potential for health effects based on animal studies and growing evidence that the U.S. population is universally exposed to phthalates and bisphenol A.

If families want to take action, given the concerns raised by animal studies and limited human studies, they can take a precautionary approach and choose alternatives to products that may contain these plasticizers, she said.

That simple one-two-three messaging can be fleshed out with the supporting facts if there's time and interest from the parents.

Phthalates are found in personal hygiene products like cosmetics, shampoos, fragrances, and nail polish, as well as in food packaging, medical tubing, children's toys, and vinyl products. Bisphenol A is found in hard plastic items like sports water bottles, baby bottles, canned foods, and dental sealants. These two plasticizers can leach from the products, exposing humans through ingestion, inhalation, or dermal absorption.

Phthalates and bisphenol A are known to have hormonal activity, and thus are often referred to as endocrine disruptors. Studies suggest they are ubiquitous in the U.S. population, with higher exposure levels in children and teens than in adults.

In animal studies, exposure to these plasticizers can affect birth outcomes, especially the reproductive tract in newborn males. Human studies are assessing potential links between plasticizers and early puberty, obesity, asthma, and male infertility.

What can parents do? “Keep it simple,” Dr. Galvez said. “Less is more. Especially in pregnancy, simplify your routine, and simplify the number of products you're using.”

Look for products free of phthalates and bisphenol A. If labels don't provide the needed information, look at recycling symbols: numbers 3, 6, and 7 should be avoided, but numbers 1, 2, 4, and 5 should be okay, she said. Her institution created a 2-inch by 3.5-inch “Pocket Guide to Plastics” that physicians may want to distribute to patients. Copies can be requested by e-mailing Dr. Luz Claudio at Luz.Claudio@mssm.edu

Similar fact sheets can be downloaded from the Web site of the Pediatric Environmental Health Specialty Units at www.aoec.org/PEHSU/facts.html

To avoid plasticizers, don't put plastic items in the microwave or dishwasher because heat promotes leaching. When possible, choose safer alternatives to plasticizer-containing products, such as fresh fruits and vegetables instead of canned food, breast milk instead of canned infant formulas, foods in glass containers instead of plastic, and water bottles made of stainless steel, Dr. Galvez recommended.

Dr. Galvez said that she has no pertinent conflicts of interest.

Recycling symbols and numbers on packaging show which products have safe amounts of plasticizers.

Source Sherry Boschert/Elsevier Global Medical News

SAN FRANCISCO – Use of light-based therapy for acne is increasing, despite a lack of proof that it works.

“Light-based therapy has become very popular as there is increasing public demand for nonpharmacologic options,” Dr. Christina Kim said at the meeting.

Dermatologists like light-based therapy for acne for a few reasons. It offers an alternative to isotretinoin for women who are concerned about the drug's teratogenicity. As a nonantibiotic alternative, light-based therapy does not contribute to the emergence of antibiotic resistance. Patient adherence to topical therapies is low, said Dr. Kim, a dermatologist at the University of California, Los Angeles.

“However, the efficacy of light-based therapy has not been proven,” she added. That's mostly because, unlike new medications, the Food and Drug Administration requires medical devices to be proven only safe, not efficacious. she said.

Light-based therapy works, theoretically, because light with a wavelength of 400-700 nm reacts with endogenous porphyrins to create reactive oxygen species that are toxic to Propionibacterium acnes. This effect is enhanced with the photosensitizing agent aminolevulinic acid.

Longer wavelengths with deeper penetration may damage the sebaceous glands and provide a more effective therapy, but the safety of that strategy is unknown. “It's not clear if that's 100% safe – to permanently destroy your sebaceous gland,” she said.

Dr. Kim said she has no pertinent conflicts of interest.

SAN FRANCISCO – Use of light-based therapy for acne is increasing, despite a lack of proof that it works.

“Light-based therapy has become very popular as there is increasing public demand for nonpharmacologic options,” Dr. Christina Kim said at the meeting.

Dermatologists like light-based therapy for acne for a few reasons. It offers an alternative to isotretinoin for women who are concerned about the drug's teratogenicity. As a nonantibiotic alternative, light-based therapy does not contribute to the emergence of antibiotic resistance. Patient adherence to topical therapies is low, said Dr. Kim, a dermatologist at the University of California, Los Angeles.

“However, the efficacy of light-based therapy has not been proven,” she added. That's mostly because, unlike new medications, the Food and Drug Administration requires medical devices to be proven only safe, not efficacious. she said.

Light-based therapy works, theoretically, because light with a wavelength of 400-700 nm reacts with endogenous porphyrins to create reactive oxygen species that are toxic to Propionibacterium acnes. This effect is enhanced with the photosensitizing agent aminolevulinic acid.

Longer wavelengths with deeper penetration may damage the sebaceous glands and provide a more effective therapy, but the safety of that strategy is unknown. “It's not clear if that's 100% safe – to permanently destroy your sebaceous gland,” she said.

Dr. Kim said she has no pertinent conflicts of interest.

SAN FRANCISCO – Use of light-based therapy for acne is increasing, despite a lack of proof that it works.

“Light-based therapy has become very popular as there is increasing public demand for nonpharmacologic options,” Dr. Christina Kim said at the meeting.

Dermatologists like light-based therapy for acne for a few reasons. It offers an alternative to isotretinoin for women who are concerned about the drug's teratogenicity. As a nonantibiotic alternative, light-based therapy does not contribute to the emergence of antibiotic resistance. Patient adherence to topical therapies is low, said Dr. Kim, a dermatologist at the University of California, Los Angeles.

“However, the efficacy of light-based therapy has not been proven,” she added. That's mostly because, unlike new medications, the Food and Drug Administration requires medical devices to be proven only safe, not efficacious. she said.

Light-based therapy works, theoretically, because light with a wavelength of 400-700 nm reacts with endogenous porphyrins to create reactive oxygen species that are toxic to Propionibacterium acnes. This effect is enhanced with the photosensitizing agent aminolevulinic acid.

Longer wavelengths with deeper penetration may damage the sebaceous glands and provide a more effective therapy, but the safety of that strategy is unknown. “It's not clear if that's 100% safe – to permanently destroy your sebaceous gland,” she said.

Dr. Kim said she has no pertinent conflicts of interest.

SAN FRANCISCO – A new report compiled by eight cardiology and imaging specialty organizations updates 4-year-old recommendations on when to use (or not use) cardiac CT imaging.

The eight societies hope that the recommendations will help inform clinicians and patients who are considering cardiac CT and also will guide insurers and third-party payers in setting rational reimbursement policies for cardiac CT.

The report, released by the American College of Cardiology, was endorsed by the ACC Foundation, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance.

The appropriate use criteria cover two tests: cardiac CT angiography using contrast, x-ray, or dye; and noncontrast CT scanning for calcium scoring, used to detect calcium deposits in the arteries (J. Am. Coll. Cardiol. 2010 Oct. 25 [doi: 10.1016/j.jacc.2010.07.005]).

CT angiography was considered appropriate for diagnosis and risk assessment in patients with symptoms of possible heart disease who have a low to intermediate risk of a heart problem, or in situations where the diagnosis of heart disease is uncertain after other tests are performed.

Calcium scanning was considered appropriate in patients without heart symptoms who have an intermediate risk of heart disease, or in selected patients with low risk (especially women or younger men) with a family history of heart problems.

Cardiac CT would not be appropriate for general screening in asymptomatic patients, or in patients with known heart problems or a high risk for heart disease, or for routine repeat testing, the report concludes. Adding the test when patients have high risk for heart disease or existing heart problems does not add any useful clinical information, Dr. Allen J. Taylor said in a statement released by the ACC. Dr. Taylor is chair of the report's writing committee and professor of medicine at Georgetown University, Washington.

The report also judged the usefulness of cardiac CT to be “uncertain” in some clinical scenarios, and the authors emphasized repeatedly that this does not mean that the test is inappropriate or that insurers should not reimburse for its use in these situations. An “uncertain” indication may require individual physician judgment and understanding of the patient to decide whether cardiac CT might help.

Tables in the report list 60 indications deemed appropriate, 52 rated as uncertain, and 55 considered inappropriate for cardiac CT. Clinical scenarios included acute and chronic chest pain, testing in symptomatic and asymptomatic patients, heart failure, preoperative risk assessment before either cardiac or noncardiac surgery, testing in the setting of prior test results (such as exercise testing, stress imaging procedures, or coronary calcium scores), prior revascularization, and evaluation of cardiac structure and function.

The document replaces the original 2006 criteria that were created when cardiac CT was relatively new (J. Am. Coll. Cardiol. 2006;48:1475-97).

The process to create the new criteria combined evidence-based medicine and practice experience. A seven-member writing group developed clinical scenarios that were scored by a 19-member technical panel on a 1-9 scale to reflect their judgements of appropriate use of cardiac CT, inappropriate use, or uncertainty about the appropriateness of use.

In the real world, no physicians or facilities will have 100% of their cardiac CT procedure fall within the “appropriate” indications, the report notes. But if a physician or facility has a higher rate of inappropriate procedures than the national average, they may want to examine their patterns of care.

For the first time, the report considered CT angiography in patients with heart failure and normal, as well as abnormal, left ventricular ejection fraction (LVEF), with ratings of appropriate or uncertain. The only appropriate scenarios covered patients with reduced LVEF who had low or intermediate pretest probability of coronary artery disease.

CT angiography was considered a potential option as part of preoperative evaluations for patients undergoing heart surgery for noncoronary indications such as valve replacement, and was considered appropriate in patients with intermediate pretest risk for coronary artery disease, and of uncertain appropriateness if the pretest risk was low. Coronary CT angiography was never considered appropriate for evaluations before noncardiac surgery.

Imaging for evaluation of left main coronary stents was deemed appropriate, and was considered uncertain for any coronary stents measuring 3 mm in diameter or larger that had been in place at least 2 years.

The evaluation of cardiac structure and function is considered a strength of cardiac CT imaging. For the first time, the report rated cardiac CT as appropriate in patients with suspected arrhythmogenic right ventricular dysplasia, and as uncertain for evaluation of myocardial viability when other imaging modalities are inadequate or contraindicated.

Using cardiac CT before electrophysiologic procedures for anatomical mapping, or prior to repeat sternotomy in reoperative cardiac surgery, also was rated appropriate.

The report attempts to align its language and definitions with those in the ACC's 2009 appropriate use criteria for cardiac radionuclide imaging (J. Am. Coll. Cardiol. 2009;53:2201-29).

Creation of the report was funded by the American College of Cardiology Foundation and by the other professional societies. Dr. Taylor reported that he has been a consultant to Abbott Laboratories and has received research funds from Abbott and Resverlogix Corp. Others on the writing or technical committees and a panel of reviewers involved in the report declared potential conflicts of interest that are listed in the report.

View on the News

Report Will Change Practice, Payment

At our institution, we will be incorporating the new practices and sharing them with our referring physicians. We will be advocating more calcium scoring in asymptomatic intermediate-risk patients, as this indication is now considered appropriate based upon more available science and validation studies. The criteria expand to stents and bypass grafts, and this will open doors for patients and clinicians.

Cardiologists will continue to increase their use of cardiac CT because of the very high negative predictive power of cardiac CT, whereby a negative test effectively rules out obstructive coronary artery disease. This obviates the need in these cases for the more expensive options of both nuclear imaging and invasive angiography. Using cardiac CT first (or early) in the course of patient management has been shown to be a more cost-effective algorithm for patient treatment. Large HMOs are also incorporating cardiac CT into their practices, expediting cardiac work-ups with a more accurate and less expensive test.

This report certainly helps the case for reimbursement, since many radiology benefit managers who control approvals for certain payers (such as Blue Cross/Blue Shield) can incorporate these criteria into their approval process. These criteria are specific for different cases and presentations, so it is very pertinent to payers who can choose to pay for these specific cases.

MATTHEW J. BUDOFF, M.D., is president of the Society of Cardiovascular Computed Tomography, which helped develop the report. He is a professor of medicine at the University of California, Los Angeles, and director of cardiac CT at Harbor-UCLA Medical Center, Torrance, Calif. Dr. Budoff has been a speaker for General Electric and an expert witness in CT scanning.

Vitals

SAN FRANCISCO – A new report compiled by eight cardiology and imaging specialty organizations updates 4-year-old recommendations on when to use (or not use) cardiac CT imaging.

The eight societies hope that the recommendations will help inform clinicians and patients who are considering cardiac CT and also will guide insurers and third-party payers in setting rational reimbursement policies for cardiac CT.

The report, released by the American College of Cardiology, was endorsed by the ACC Foundation, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance.

The appropriate use criteria cover two tests: cardiac CT angiography using contrast, x-ray, or dye; and noncontrast CT scanning for calcium scoring, used to detect calcium deposits in the arteries (J. Am. Coll. Cardiol. 2010 Oct. 25 [doi: 10.1016/j.jacc.2010.07.005]).

CT angiography was considered appropriate for diagnosis and risk assessment in patients with symptoms of possible heart disease who have a low to intermediate risk of a heart problem, or in situations where the diagnosis of heart disease is uncertain after other tests are performed.

Calcium scanning was considered appropriate in patients without heart symptoms who have an intermediate risk of heart disease, or in selected patients with low risk (especially women or younger men) with a family history of heart problems.

Cardiac CT would not be appropriate for general screening in asymptomatic patients, or in patients with known heart problems or a high risk for heart disease, or for routine repeat testing, the report concludes. Adding the test when patients have high risk for heart disease or existing heart problems does not add any useful clinical information, Dr. Allen J. Taylor said in a statement released by the ACC. Dr. Taylor is chair of the report's writing committee and professor of medicine at Georgetown University, Washington.

The report also judged the usefulness of cardiac CT to be “uncertain” in some clinical scenarios, and the authors emphasized repeatedly that this does not mean that the test is inappropriate or that insurers should not reimburse for its use in these situations. An “uncertain” indication may require individual physician judgment and understanding of the patient to decide whether cardiac CT might help.

Tables in the report list 60 indications deemed appropriate, 52 rated as uncertain, and 55 considered inappropriate for cardiac CT. Clinical scenarios included acute and chronic chest pain, testing in symptomatic and asymptomatic patients, heart failure, preoperative risk assessment before either cardiac or noncardiac surgery, testing in the setting of prior test results (such as exercise testing, stress imaging procedures, or coronary calcium scores), prior revascularization, and evaluation of cardiac structure and function.

The document replaces the original 2006 criteria that were created when cardiac CT was relatively new (J. Am. Coll. Cardiol. 2006;48:1475-97).

The process to create the new criteria combined evidence-based medicine and practice experience. A seven-member writing group developed clinical scenarios that were scored by a 19-member technical panel on a 1-9 scale to reflect their judgements of appropriate use of cardiac CT, inappropriate use, or uncertainty about the appropriateness of use.

In the real world, no physicians or facilities will have 100% of their cardiac CT procedure fall within the “appropriate” indications, the report notes. But if a physician or facility has a higher rate of inappropriate procedures than the national average, they may want to examine their patterns of care.

For the first time, the report considered CT angiography in patients with heart failure and normal, as well as abnormal, left ventricular ejection fraction (LVEF), with ratings of appropriate or uncertain. The only appropriate scenarios covered patients with reduced LVEF who had low or intermediate pretest probability of coronary artery disease.

CT angiography was considered a potential option as part of preoperative evaluations for patients undergoing heart surgery for noncoronary indications such as valve replacement, and was considered appropriate in patients with intermediate pretest risk for coronary artery disease, and of uncertain appropriateness if the pretest risk was low. Coronary CT angiography was never considered appropriate for evaluations before noncardiac surgery.

Imaging for evaluation of left main coronary stents was deemed appropriate, and was considered uncertain for any coronary stents measuring 3 mm in diameter or larger that had been in place at least 2 years.

The evaluation of cardiac structure and function is considered a strength of cardiac CT imaging. For the first time, the report rated cardiac CT as appropriate in patients with suspected arrhythmogenic right ventricular dysplasia, and as uncertain for evaluation of myocardial viability when other imaging modalities are inadequate or contraindicated.

Using cardiac CT before electrophysiologic procedures for anatomical mapping, or prior to repeat sternotomy in reoperative cardiac surgery, also was rated appropriate.

The report attempts to align its language and definitions with those in the ACC's 2009 appropriate use criteria for cardiac radionuclide imaging (J. Am. Coll. Cardiol. 2009;53:2201-29).

Creation of the report was funded by the American College of Cardiology Foundation and by the other professional societies. Dr. Taylor reported that he has been a consultant to Abbott Laboratories and has received research funds from Abbott and Resverlogix Corp. Others on the writing or technical committees and a panel of reviewers involved in the report declared potential conflicts of interest that are listed in the report.

View on the News

Report Will Change Practice, Payment

At our institution, we will be incorporating the new practices and sharing them with our referring physicians. We will be advocating more calcium scoring in asymptomatic intermediate-risk patients, as this indication is now considered appropriate based upon more available science and validation studies. The criteria expand to stents and bypass grafts, and this will open doors for patients and clinicians.

Cardiologists will continue to increase their use of cardiac CT because of the very high negative predictive power of cardiac CT, whereby a negative test effectively rules out obstructive coronary artery disease. This obviates the need in these cases for the more expensive options of both nuclear imaging and invasive angiography. Using cardiac CT first (or early) in the course of patient management has been shown to be a more cost-effective algorithm for patient treatment. Large HMOs are also incorporating cardiac CT into their practices, expediting cardiac work-ups with a more accurate and less expensive test.

This report certainly helps the case for reimbursement, since many radiology benefit managers who control approvals for certain payers (such as Blue Cross/Blue Shield) can incorporate these criteria into their approval process. These criteria are specific for different cases and presentations, so it is very pertinent to payers who can choose to pay for these specific cases.

MATTHEW J. BUDOFF, M.D., is president of the Society of Cardiovascular Computed Tomography, which helped develop the report. He is a professor of medicine at the University of California, Los Angeles, and director of cardiac CT at Harbor-UCLA Medical Center, Torrance, Calif. Dr. Budoff has been a speaker for General Electric and an expert witness in CT scanning.

Vitals

SAN FRANCISCO – A new report compiled by eight cardiology and imaging specialty organizations updates 4-year-old recommendations on when to use (or not use) cardiac CT imaging.

The eight societies hope that the recommendations will help inform clinicians and patients who are considering cardiac CT and also will guide insurers and third-party payers in setting rational reimbursement policies for cardiac CT.

The report, released by the American College of Cardiology, was endorsed by the ACC Foundation, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance.

The appropriate use criteria cover two tests: cardiac CT angiography using contrast, x-ray, or dye; and noncontrast CT scanning for calcium scoring, used to detect calcium deposits in the arteries (J. Am. Coll. Cardiol. 2010 Oct. 25 [doi: 10.1016/j.jacc.2010.07.005]).

CT angiography was considered appropriate for diagnosis and risk assessment in patients with symptoms of possible heart disease who have a low to intermediate risk of a heart problem, or in situations where the diagnosis of heart disease is uncertain after other tests are performed.

Calcium scanning was considered appropriate in patients without heart symptoms who have an intermediate risk of heart disease, or in selected patients with low risk (especially women or younger men) with a family history of heart problems.

Cardiac CT would not be appropriate for general screening in asymptomatic patients, or in patients with known heart problems or a high risk for heart disease, or for routine repeat testing, the report concludes. Adding the test when patients have high risk for heart disease or existing heart problems does not add any useful clinical information, Dr. Allen J. Taylor said in a statement released by the ACC. Dr. Taylor is chair of the report's writing committee and professor of medicine at Georgetown University, Washington.

The report also judged the usefulness of cardiac CT to be “uncertain” in some clinical scenarios, and the authors emphasized repeatedly that this does not mean that the test is inappropriate or that insurers should not reimburse for its use in these situations. An “uncertain” indication may require individual physician judgment and understanding of the patient to decide whether cardiac CT might help.

Tables in the report list 60 indications deemed appropriate, 52 rated as uncertain, and 55 considered inappropriate for cardiac CT. Clinical scenarios included acute and chronic chest pain, testing in symptomatic and asymptomatic patients, heart failure, preoperative risk assessment before either cardiac or noncardiac surgery, testing in the setting of prior test results (such as exercise testing, stress imaging procedures, or coronary calcium scores), prior revascularization, and evaluation of cardiac structure and function.

The document replaces the original 2006 criteria that were created when cardiac CT was relatively new (J. Am. Coll. Cardiol. 2006;48:1475-97).

The process to create the new criteria combined evidence-based medicine and practice experience. A seven-member writing group developed clinical scenarios that were scored by a 19-member technical panel on a 1-9 scale to reflect their judgements of appropriate use of cardiac CT, inappropriate use, or uncertainty about the appropriateness of use.

In the real world, no physicians or facilities will have 100% of their cardiac CT procedure fall within the “appropriate” indications, the report notes. But if a physician or facility has a higher rate of inappropriate procedures than the national average, they may want to examine their patterns of care.

For the first time, the report considered CT angiography in patients with heart failure and normal, as well as abnormal, left ventricular ejection fraction (LVEF), with ratings of appropriate or uncertain. The only appropriate scenarios covered patients with reduced LVEF who had low or intermediate pretest probability of coronary artery disease.

CT angiography was considered a potential option as part of preoperative evaluations for patients undergoing heart surgery for noncoronary indications such as valve replacement, and was considered appropriate in patients with intermediate pretest risk for coronary artery disease, and of uncertain appropriateness if the pretest risk was low. Coronary CT angiography was never considered appropriate for evaluations before noncardiac surgery.

Imaging for evaluation of left main coronary stents was deemed appropriate, and was considered uncertain for any coronary stents measuring 3 mm in diameter or larger that had been in place at least 2 years.

The evaluation of cardiac structure and function is considered a strength of cardiac CT imaging. For the first time, the report rated cardiac CT as appropriate in patients with suspected arrhythmogenic right ventricular dysplasia, and as uncertain for evaluation of myocardial viability when other imaging modalities are inadequate or contraindicated.

Using cardiac CT before electrophysiologic procedures for anatomical mapping, or prior to repeat sternotomy in reoperative cardiac surgery, also was rated appropriate.

The report attempts to align its language and definitions with those in the ACC's 2009 appropriate use criteria for cardiac radionuclide imaging (J. Am. Coll. Cardiol. 2009;53:2201-29).

Creation of the report was funded by the American College of Cardiology Foundation and by the other professional societies. Dr. Taylor reported that he has been a consultant to Abbott Laboratories and has received research funds from Abbott and Resverlogix Corp. Others on the writing or technical committees and a panel of reviewers involved in the report declared potential conflicts of interest that are listed in the report.

View on the News

Report Will Change Practice, Payment

At our institution, we will be incorporating the new practices and sharing them with our referring physicians. We will be advocating more calcium scoring in asymptomatic intermediate-risk patients, as this indication is now considered appropriate based upon more available science and validation studies. The criteria expand to stents and bypass grafts, and this will open doors for patients and clinicians.

Cardiologists will continue to increase their use of cardiac CT because of the very high negative predictive power of cardiac CT, whereby a negative test effectively rules out obstructive coronary artery disease. This obviates the need in these cases for the more expensive options of both nuclear imaging and invasive angiography. Using cardiac CT first (or early) in the course of patient management has been shown to be a more cost-effective algorithm for patient treatment. Large HMOs are also incorporating cardiac CT into their practices, expediting cardiac work-ups with a more accurate and less expensive test.

This report certainly helps the case for reimbursement, since many radiology benefit managers who control approvals for certain payers (such as Blue Cross/Blue Shield) can incorporate these criteria into their approval process. These criteria are specific for different cases and presentations, so it is very pertinent to payers who can choose to pay for these specific cases.

MATTHEW J. BUDOFF, M.D., is president of the Society of Cardiovascular Computed Tomography, which helped develop the report. He is a professor of medicine at the University of California, Los Angeles, and director of cardiac CT at Harbor-UCLA Medical Center, Torrance, Calif. Dr. Budoff has been a speaker for General Electric and an expert witness in CT scanning.

Vitals

SAN DIEGO – Perioperative vascular complications may be the largest emerging epidemic in cardiology, and tackling it will require a shift in medical culture to demand larger clinical trials, according to Dr. Philip J. Devereaux.

Each year, 500,000-900,000 patients who undergo noncardiac surgery worldwide die from perioperative cardiac complications or develop nonfatal myocardial infarction, or nonfatal cardiac arrest. At the same time, the number of noncardiac surgeries is increasing, according to research by Dr. Devereaux, a clinical epidemiologist and biostatistician at McMaster University, Hamilton, Ont. (CMAJ 2005;173:627-34).

Speaking at the annual meeting of the American Society of Anesthesiologists, he associated these trends with perioperative medicine's overreliance on small clinical trials and lack of scrutiny regarding the large treatment effects reported by such trials.

"I personally am more concerned about small randomized, controlled trials than I am about observational studies," he said. "The reason is, people question the observational studies. People believe randomized, controlled trials. They're powerful when they're large. When they're not large, they're incredibly likely to mislead."

Small clinical trials dominate perioperative medicine, he said. Physicians who provide perioperative medicine should demand large clinical trials to help guide their decision making, just as large studies have informed other areas of cardiovascular medicine.

"This fundamentally is a cultural shift," he noted. "Twenty-five years ago in cardiology there wasn't a single large, randomized, controlled trial. Yet, today, almost every other week in some journal there is a large cardiology trial," said Dr. Devereaux, adding that such a standard could be a reality for perioperative medicine, too, if the demand were there.

In the meantime, however, he and his associates have developed the Absolute Fragility Index (AFI) to help physicians assess trial results. They hope to publish an article about it soon. The AFI is the minimum number of patients in the treatment group who would be required to switch from not having an "event" (such as an MI) to having an event in order for the results to be considered nonsignificant, as opposed to significant.

For example, he compared two hypothetical randomized, double-blind, placebo-controlled trials of a drug to prevent MI. In the first trial of 200 patients, one in the treatment group and nine in the placebo group develop MIs, a significant difference (P = .02). In the second trial of 8,000 patients, 200 in the treatment group and 250 on placebo develop MIs, a significant difference between groups that has the same P value as the first trial (P = .02). In the first trial, however, if just one more patient in the treatment group had had an MI, the difference between groups would have been nonsignificant, whereas it would take nine additional MIs in the treatment group of the second trial to consider the difference nonsignificant. The first trial had an AFI of 1, and the second trial had an AFI of 9.

"If your trial hinges on one or two patients switching events, it doesn't matter what the P value is. You should be extremely cautious about believing it," he said. And yet most trials in perioperative medicine have an AFI of 1 or 2.

Considering the AFI is more than just an academic exercise, he added. Previous studies of the most highly cited randomized trials in leading medical journals have shown that 16% were later substantively contradicted, and another 16% were shown to have extremely exaggerated treatment effects. The one identifiable factor that could explain these errors was the small size of the initial studies, he said.

Dr. Devereaux's interest in an AFI grew from his experience as a co–primary investigator in the POISE-1 (Perioperative Ischemic Evaluation) trial, the largest randomized, controlled study of cardiac outcomes in patients undergoing noncardiac surgery. Guidelines on the use of perioperative beta-blockers in noncardiac surgery had been based on a separate randomized trial of 112 patients in which two patients in the beta-blocker group and nine in the control group died, a statistically significant difference (P = .02). However, in the POISE-1 trial involving 8,351 patients, more patients died in the beta-blocker group (129) than in the placebo group (97), also a statistically significant difference (P = .03) (Lancet 2008;371:1839-47).

"I thought, there is something fundamentally wrong with how we understand statistics and how we're interpreting results" if these studies are considered equally significant, he said. "Some might say our dose was not safe, and I agree. But to believe that the other trial demonstrates that their dose is safe is foolish."

Clinicians and researchers need to start collaborating and thinking big and internationally about perioperative medicine in order to move the medical culture to large trials, Dr. Devereaux said. "We owe it to patients to be confident about our results."

Dr. Devereaux reported having no relevant conflicts of interest.

SAN DIEGO – Perioperative vascular complications may be the largest emerging epidemic in cardiology, and tackling it will require a shift in medical culture to demand larger clinical trials, according to Dr. Philip J. Devereaux.

Each year, 500,000-900,000 patients who undergo noncardiac surgery worldwide die from perioperative cardiac complications or develop nonfatal myocardial infarction, or nonfatal cardiac arrest. At the same time, the number of noncardiac surgeries is increasing, according to research by Dr. Devereaux, a clinical epidemiologist and biostatistician at McMaster University, Hamilton, Ont. (CMAJ 2005;173:627-34).

Speaking at the annual meeting of the American Society of Anesthesiologists, he associated these trends with perioperative medicine's overreliance on small clinical trials and lack of scrutiny regarding the large treatment effects reported by such trials.

"I personally am more concerned about small randomized, controlled trials than I am about observational studies," he said. "The reason is, people question the observational studies. People believe randomized, controlled trials. They're powerful when they're large. When they're not large, they're incredibly likely to mislead."

Small clinical trials dominate perioperative medicine, he said. Physicians who provide perioperative medicine should demand large clinical trials to help guide their decision making, just as large studies have informed other areas of cardiovascular medicine.

"This fundamentally is a cultural shift," he noted. "Twenty-five years ago in cardiology there wasn't a single large, randomized, controlled trial. Yet, today, almost every other week in some journal there is a large cardiology trial," said Dr. Devereaux, adding that such a standard could be a reality for perioperative medicine, too, if the demand were there.

In the meantime, however, he and his associates have developed the Absolute Fragility Index (AFI) to help physicians assess trial results. They hope to publish an article about it soon. The AFI is the minimum number of patients in the treatment group who would be required to switch from not having an "event" (such as an MI) to having an event in order for the results to be considered nonsignificant, as opposed to significant.

For example, he compared two hypothetical randomized, double-blind, placebo-controlled trials of a drug to prevent MI. In the first trial of 200 patients, one in the treatment group and nine in the placebo group develop MIs, a significant difference (P = .02). In the second trial of 8,000 patients, 200 in the treatment group and 250 on placebo develop MIs, a significant difference between groups that has the same P value as the first trial (P = .02). In the first trial, however, if just one more patient in the treatment group had had an MI, the difference between groups would have been nonsignificant, whereas it would take nine additional MIs in the treatment group of the second trial to consider the difference nonsignificant. The first trial had an AFI of 1, and the second trial had an AFI of 9.

"If your trial hinges on one or two patients switching events, it doesn't matter what the P value is. You should be extremely cautious about believing it," he said. And yet most trials in perioperative medicine have an AFI of 1 or 2.

Considering the AFI is more than just an academic exercise, he added. Previous studies of the most highly cited randomized trials in leading medical journals have shown that 16% were later substantively contradicted, and another 16% were shown to have extremely exaggerated treatment effects. The one identifiable factor that could explain these errors was the small size of the initial studies, he said.

Dr. Devereaux's interest in an AFI grew from his experience as a co–primary investigator in the POISE-1 (Perioperative Ischemic Evaluation) trial, the largest randomized, controlled study of cardiac outcomes in patients undergoing noncardiac surgery. Guidelines on the use of perioperative beta-blockers in noncardiac surgery had been based on a separate randomized trial of 112 patients in which two patients in the beta-blocker group and nine in the control group died, a statistically significant difference (P = .02). However, in the POISE-1 trial involving 8,351 patients, more patients died in the beta-blocker group (129) than in the placebo group (97), also a statistically significant difference (P = .03) (Lancet 2008;371:1839-47).

"I thought, there is something fundamentally wrong with how we understand statistics and how we're interpreting results" if these studies are considered equally significant, he said. "Some might say our dose was not safe, and I agree. But to believe that the other trial demonstrates that their dose is safe is foolish."

Clinicians and researchers need to start collaborating and thinking big and internationally about perioperative medicine in order to move the medical culture to large trials, Dr. Devereaux said. "We owe it to patients to be confident about our results."

Dr. Devereaux reported having no relevant conflicts of interest.

SAN DIEGO – Perioperative vascular complications may be the largest emerging epidemic in cardiology, and tackling it will require a shift in medical culture to demand larger clinical trials, according to Dr. Philip J. Devereaux.

Each year, 500,000-900,000 patients who undergo noncardiac surgery worldwide die from perioperative cardiac complications or develop nonfatal myocardial infarction, or nonfatal cardiac arrest. At the same time, the number of noncardiac surgeries is increasing, according to research by Dr. Devereaux, a clinical epidemiologist and biostatistician at McMaster University, Hamilton, Ont. (CMAJ 2005;173:627-34).

Speaking at the annual meeting of the American Society of Anesthesiologists, he associated these trends with perioperative medicine's overreliance on small clinical trials and lack of scrutiny regarding the large treatment effects reported by such trials.

"I personally am more concerned about small randomized, controlled trials than I am about observational studies," he said. "The reason is, people question the observational studies. People believe randomized, controlled trials. They're powerful when they're large. When they're not large, they're incredibly likely to mislead."

Small clinical trials dominate perioperative medicine, he said. Physicians who provide perioperative medicine should demand large clinical trials to help guide their decision making, just as large studies have informed other areas of cardiovascular medicine.

"This fundamentally is a cultural shift," he noted. "Twenty-five years ago in cardiology there wasn't a single large, randomized, controlled trial. Yet, today, almost every other week in some journal there is a large cardiology trial," said Dr. Devereaux, adding that such a standard could be a reality for perioperative medicine, too, if the demand were there.

In the meantime, however, he and his associates have developed the Absolute Fragility Index (AFI) to help physicians assess trial results. They hope to publish an article about it soon. The AFI is the minimum number of patients in the treatment group who would be required to switch from not having an "event" (such as an MI) to having an event in order for the results to be considered nonsignificant, as opposed to significant.

For example, he compared two hypothetical randomized, double-blind, placebo-controlled trials of a drug to prevent MI. In the first trial of 200 patients, one in the treatment group and nine in the placebo group develop MIs, a significant difference (P = .02). In the second trial of 8,000 patients, 200 in the treatment group and 250 on placebo develop MIs, a significant difference between groups that has the same P value as the first trial (P = .02). In the first trial, however, if just one more patient in the treatment group had had an MI, the difference between groups would have been nonsignificant, whereas it would take nine additional MIs in the treatment group of the second trial to consider the difference nonsignificant. The first trial had an AFI of 1, and the second trial had an AFI of 9.

"If your trial hinges on one or two patients switching events, it doesn't matter what the P value is. You should be extremely cautious about believing it," he said. And yet most trials in perioperative medicine have an AFI of 1 or 2.

Considering the AFI is more than just an academic exercise, he added. Previous studies of the most highly cited randomized trials in leading medical journals have shown that 16% were later substantively contradicted, and another 16% were shown to have extremely exaggerated treatment effects. The one identifiable factor that could explain these errors was the small size of the initial studies, he said.

Dr. Devereaux's interest in an AFI grew from his experience as a co–primary investigator in the POISE-1 (Perioperative Ischemic Evaluation) trial, the largest randomized, controlled study of cardiac outcomes in patients undergoing noncardiac surgery. Guidelines on the use of perioperative beta-blockers in noncardiac surgery had been based on a separate randomized trial of 112 patients in which two patients in the beta-blocker group and nine in the control group died, a statistically significant difference (P = .02). However, in the POISE-1 trial involving 8,351 patients, more patients died in the beta-blocker group (129) than in the placebo group (97), also a statistically significant difference (P = .03) (Lancet 2008;371:1839-47).

"I thought, there is something fundamentally wrong with how we understand statistics and how we're interpreting results" if these studies are considered equally significant, he said. "Some might say our dose was not safe, and I agree. But to believe that the other trial demonstrates that their dose is safe is foolish."

Clinicians and researchers need to start collaborating and thinking big and internationally about perioperative medicine in order to move the medical culture to large trials, Dr. Devereaux said. "We owe it to patients to be confident about our results."

Dr. Devereaux reported having no relevant conflicts of interest.

SAN DIEGO – Perioperative vascular complications may be the largest emerging epidemic in cardiology, and tackling it will require a shift in medical culture to demand larger clinical trials, according to Dr. Philip J. Devereaux.

Each year, 500,000-900,000 patients who undergo noncardiac surgery worldwide die from perioperative cardiac complications or develop nonfatal myocardial infarction, or nonfatal cardiac arrest. At the same time, the number of noncardiac surgeries is increasing, according to research by Dr. Devereaux, a clinical epidemiologist and biostatistician at McMaster University, Hamilton, Ont. (CMAJ 2005;173:627-34).

Speaking at the annual meeting of the American Society of Anesthesiologists, he associated these trends with perioperative medicine's overreliance on small clinical trials and lack of scrutiny regarding the large treatment effects reported by such trials.

"I personally am more concerned about small randomized, controlled trials than I am about observational studies," he said. "The reason is, people question the observational studies. People believe randomized, controlled trials. They're powerful when they're large. When they're not large, they're incredibly likely to mislead."

Small clinical trials dominate perioperative medicine, he said. Physicians who provide perioperative medicine should demand large clinical trials to help guide their decision making, just as large studies have informed other areas of cardiovascular medicine.

"This fundamentally is a cultural shift," he noted. "Twenty-five years ago in cardiology there wasn't a single large, randomized, controlled trial. Yet, today, almost every other week in some journal there is a large cardiology trial," said Dr. Devereaux, adding that such a standard could be a reality for perioperative medicine, too, if the demand were there.

In the meantime, however, he and his associates have developed the Absolute Fragility Index (AFI) to help physicians assess trial results. They hope to publish an article about it soon. The AFI is the minimum number of patients in the treatment group who would be required to switch from not having an "event" (such as an MI) to having an event in order for the results to be considered nonsignificant, as opposed to significant.

For example, he compared two hypothetical randomized, double-blind, placebo-controlled trials of a drug to prevent MI. In the first trial of 200 patients, one in the treatment group and nine in the placebo group develop MIs, a significant difference (P = .02). In the second trial of 8,000 patients, 200 in the treatment group and 250 on placebo develop MIs, a significant difference between groups that has the same P value as the first trial (P = .02). In the first trial, however, if just one more patient in the treatment group had had an MI, the difference between groups would have been nonsignificant, whereas it would take nine additional MIs in the treatment group of the second trial to consider the difference nonsignificant. The first trial had an AFI of 1, and the second trial had an AFI of 9.

"If your trial hinges on one or two patients switching events, it doesn't matter what the P value is. You should be extremely cautious about believing it," he said. And yet most trials in perioperative medicine have an AFI of 1 or 2.

Considering the AFI is more than just an academic exercise, he added. Previous studies of the most highly cited randomized trials in leading medical journals have shown that 16% were later substantively contradicted, and another 16% were shown to have extremely exaggerated treatment effects. The one identifiable factor that could explain these errors was the small size of the initial studies, he said.

Dr. Devereaux's interest in an AFI grew from his experience as a co–primary investigator in the POISE-1 (Perioperative Ischemic Evaluation) trial, the largest randomized, controlled study of cardiac outcomes in patients undergoing noncardiac surgery. Guidelines on the use of perioperative beta-blockers in noncardiac surgery had been based on a separate randomized trial of 112 patients in which two patients in the beta-blocker group and nine in the control group died, a statistically significant difference (P = .02). However, in the POISE-1 trial involving 8,351 patients, more patients died in the beta-blocker group (129) than in the placebo group (97), also a statistically significant difference (P = .03) (Lancet 2008;371:1839-47).

"I thought, there is something fundamentally wrong with how we understand statistics and how we're interpreting results" if these studies are considered equally significant, he said. "Some might say our dose was not safe, and I agree. But to believe that the other trial demonstrates that their dose is safe is foolish."

Clinicians and researchers need to start collaborating and thinking big and internationally about perioperative medicine in order to move the medical culture to large trials, Dr. Devereaux said. "We owe it to patients to be confident about our results."

Dr. Devereaux reported having no relevant conflicts of interest.

SAN DIEGO – Perioperative vascular complications may be the largest emerging epidemic in cardiology, and tackling it will require a shift in medical culture to demand larger clinical trials, according to Dr. Philip J. Devereaux.

Each year, 500,000-900,000 patients who undergo noncardiac surgery worldwide die from perioperative cardiac complications or develop nonfatal myocardial infarction, or nonfatal cardiac arrest. At the same time, the number of noncardiac surgeries is increasing, according to research by Dr. Devereaux, a clinical epidemiologist and biostatistician at McMaster University, Hamilton, Ont. (CMAJ 2005;173:627-34).

Speaking at the annual meeting of the American Society of Anesthesiologists, he associated these trends with perioperative medicine's overreliance on small clinical trials and lack of scrutiny regarding the large treatment effects reported by such trials.

"I personally am more concerned about small randomized, controlled trials than I am about observational studies," he said. "The reason is, people question the observational studies. People believe randomized, controlled trials. They're powerful when they're large. When they're not large, they're incredibly likely to mislead."

Small clinical trials dominate perioperative medicine, he said. Physicians who provide perioperative medicine should demand large clinical trials to help guide their decision making, just as large studies have informed other areas of cardiovascular medicine.

"This fundamentally is a cultural shift," he noted. "Twenty-five years ago in cardiology there wasn't a single large, randomized, controlled trial. Yet, today, almost every other week in some journal there is a large cardiology trial," said Dr. Devereaux, adding that such a standard could be a reality for perioperative medicine, too, if the demand were there.

In the meantime, however, he and his associates have developed the Absolute Fragility Index (AFI) to help physicians assess trial results. They hope to publish an article about it soon. The AFI is the minimum number of patients in the treatment group who would be required to switch from not having an "event" (such as an MI) to having an event in order for the results to be considered nonsignificant, as opposed to significant.

For example, he compared two hypothetical randomized, double-blind, placebo-controlled trials of a drug to prevent MI. In the first trial of 200 patients, one in the treatment group and nine in the placebo group develop MIs, a significant difference (P = .02). In the second trial of 8,000 patients, 200 in the treatment group and 250 on placebo develop MIs, a significant difference between groups that has the same P value as the first trial (P = .02). In the first trial, however, if just one more patient in the treatment group had had an MI, the difference between groups would have been nonsignificant, whereas it would take nine additional MIs in the treatment group of the second trial to consider the difference nonsignificant. The first trial had an AFI of 1, and the second trial had an AFI of 9.

"If your trial hinges on one or two patients switching events, it doesn't matter what the P value is. You should be extremely cautious about believing it," he said. And yet most trials in perioperative medicine have an AFI of 1 or 2.

Considering the AFI is more than just an academic exercise, he added. Previous studies of the most highly cited randomized trials in leading medical journals have shown that 16% were later substantively contradicted, and another 16% were shown to have extremely exaggerated treatment effects. The one identifiable factor that could explain these errors was the small size of the initial studies, he said.

Dr. Devereaux's interest in an AFI grew from his experience as a co–primary investigator in the POISE-1 (Perioperative Ischemic Evaluation) trial, the largest randomized, controlled study of cardiac outcomes in patients undergoing noncardiac surgery. Guidelines on the use of perioperative beta-blockers in noncardiac surgery had been based on a separate randomized trial of 112 patients in which two patients in the beta-blocker group and nine in the control group died, a statistically significant difference (P = .02). However, in the POISE-1 trial involving 8,351 patients, more patients died in the beta-blocker group (129) than in the placebo group (97), also a statistically significant difference (P = .03) (Lancet 2008;371:1839-47).

"I thought, there is something fundamentally wrong with how we understand statistics and how we're interpreting results" if these studies are considered equally significant, he said. "Some might say our dose was not safe, and I agree. But to believe that the other trial demonstrates that their dose is safe is foolish."

Clinicians and researchers need to start collaborating and thinking big and internationally about perioperative medicine in order to move the medical culture to large trials, Dr. Devereaux said. "We owe it to patients to be confident about our results."

Dr. Devereaux reported having no relevant conflicts of interest.

SAN DIEGO – Perioperative vascular complications may be the largest emerging epidemic in cardiology, and tackling it will require a shift in medical culture to demand larger clinical trials, according to Dr. Philip J. Devereaux.

Each year, 500,000-900,000 patients who undergo noncardiac surgery worldwide die from perioperative cardiac complications or develop nonfatal myocardial infarction, or nonfatal cardiac arrest. At the same time, the number of noncardiac surgeries is increasing, according to research by Dr. Devereaux, a clinical epidemiologist and biostatistician at McMaster University, Hamilton, Ont. (CMAJ 2005;173:627-34).

Speaking at the annual meeting of the American Society of Anesthesiologists, he associated these trends with perioperative medicine's overreliance on small clinical trials and lack of scrutiny regarding the large treatment effects reported by such trials.

"I personally am more concerned about small randomized, controlled trials than I am about observational studies," he said. "The reason is, people question the observational studies. People believe randomized, controlled trials. They're powerful when they're large. When they're not large, they're incredibly likely to mislead."

Small clinical trials dominate perioperative medicine, he said. Physicians who provide perioperative medicine should demand large clinical trials to help guide their decision making, just as large studies have informed other areas of cardiovascular medicine.

"This fundamentally is a cultural shift," he noted. "Twenty-five years ago in cardiology there wasn't a single large, randomized, controlled trial. Yet, today, almost every other week in some journal there is a large cardiology trial," said Dr. Devereaux, adding that such a standard could be a reality for perioperative medicine, too, if the demand were there.

In the meantime, however, he and his associates have developed the Absolute Fragility Index (AFI) to help physicians assess trial results. They hope to publish an article about it soon. The AFI is the minimum number of patients in the treatment group who would be required to switch from not having an "event" (such as an MI) to having an event in order for the results to be considered nonsignificant, as opposed to significant.

For example, he compared two hypothetical randomized, double-blind, placebo-controlled trials of a drug to prevent MI. In the first trial of 200 patients, one in the treatment group and nine in the placebo group develop MIs, a significant difference (P = .02). In the second trial of 8,000 patients, 200 in the treatment group and 250 on placebo develop MIs, a significant difference between groups that has the same P value as the first trial (P = .02). In the first trial, however, if just one more patient in the treatment group had had an MI, the difference between groups would have been nonsignificant, whereas it would take nine additional MIs in the treatment group of the second trial to consider the difference nonsignificant. The first trial had an AFI of 1, and the second trial had an AFI of 9.

"If your trial hinges on one or two patients switching events, it doesn't matter what the P value is. You should be extremely cautious about believing it," he said. And yet most trials in perioperative medicine have an AFI of 1 or 2.

Considering the AFI is more than just an academic exercise, he added. Previous studies of the most highly cited randomized trials in leading medical journals have shown that 16% were later substantively contradicted, and another 16% were shown to have extremely exaggerated treatment effects. The one identifiable factor that could explain these errors was the small size of the initial studies, he said.

Dr. Devereaux's interest in an AFI grew from his experience as a co–primary investigator in the POISE-1 (Perioperative Ischemic Evaluation) trial, the largest randomized, controlled study of cardiac outcomes in patients undergoing noncardiac surgery. Guidelines on the use of perioperative beta-blockers in noncardiac surgery had been based on a separate randomized trial of 112 patients in which two patients in the beta-blocker group and nine in the control group died, a statistically significant difference (P = .02). However, in the POISE-1 trial involving 8,351 patients, more patients died in the beta-blocker group (129) than in the placebo group (97), also a statistically significant difference (P = .03) (Lancet 2008;371:1839-47).

"I thought, there is something fundamentally wrong with how we understand statistics and how we're interpreting results" if these studies are considered equally significant, he said. "Some might say our dose was not safe, and I agree. But to believe that the other trial demonstrates that their dose is safe is foolish."

Clinicians and researchers need to start collaborating and thinking big and internationally about perioperative medicine in order to move the medical culture to large trials, Dr. Devereaux said. "We owe it to patients to be confident about our results."

Dr. Devereaux reported having no relevant conflicts of interest.

SAN DIEGO – A single dose of dexamethasone given before outpatient laparoscopic cholecystectomy significantly improved measures of postoperative recovery and length of hospitalization, as well as quality of life after discharge, compared with placebo.

The findings of this randomized, double-blind study support previous studies suggesting that preoperative small-dose steroid therapy enhanced recovery, Dr. Glenn S. Murphy and his associates reported at the Annual Meeting of the American Society of Anesthesiologists.

The current study randomized patients undergoing elective laparoscopic cholecystectomy to receive either 8 mg dexamethasone or saline placebo 60 minutes before incision. All patients were expected to have same-day discharge, and all caregivers and patients were blinded to group assignment. The surgical procedures were standardized, as were fluid administration, ventilation, and anesthesia management using propofol, sevoflurane, rocuronium, fentanyl, and/or ondansetron.

The staff measured nausea, vomiting, pain, and fatigue preoperatively and at discharge from the postanesthesia care unit (PACU) and the ambulatory surgery unit (ASU). They recorded analgesic requirements during the hospitalization, and the length of time required to meet criteria for discharge from the PACU and ASU.

In addition, health status was assessed at baseline immediately prior to surgery using a previously validated 40-item scoring system, and patients took home another copy of this quality-of-recovery survey (QoR-40) to be completed 24 hours after discharge from the ASU.

Photo credit: (c)2010 American College of Surgeons/Elsevier

At baseline, the 56 patients in the dexamethasone group did not differ significantly from the 59 in the placebo group in terms of age, sex, height, weight, ASA physical status, history of smoking or drinking, hypertension, asthma, sleep apnea, or thyroid disease. Complete data were not available for five patients who were dropped from the analysis.

In the ASU, the dexamethasone group has less nausea, fatigue, and treatment of emetic symptoms, compared with the control group. In the PACU, the dexamethasone group had lower pain scores and less nausea, treatment of emetic symptoms, and need for analgesics. The dexamethasone patients had a 55 minute shorter stay in the ASU and were in the hospital 70 minutes less was than the control group, said Dr. Murphy of Northwestern University, Chicago.

The QoR-40 scores did not differ significantly between groups before surgery, but on postoperative day 1, the median global score in the control group was significantly lower (score of 161), compared with the dexamethasone group (score of 178), reflecting a worse quality of recovery in the control group, he said.

Three of the individual dimensions measured by the QoR-40 scored significantly lower in the control group, compared with the dexamethasone group postoperatively: emotional state (35 vs. 41), physical comfort (45 vs. 51), and pain (26 vs. 31). Scores for psychological support and physical independence did not differ significantly between groups.

Laparoscopic cholecystectomy is one of the most common elective surgical procedures in the United States, and up to 80% of patients may be discharged from the hospital on the day of surgery, data suggest. Investigators have looked to small-dose steroid therapy as a way to attenuate physiologic responses to minimally invasive surgery that can impair recovery and delay discharge, such as metabolic, hormonal, inflammatory, and immune responses activated by the surgery. Dexamethasone, a potent corticosteroid, has a biological half-life of 24-36 hours.

Dr. Murphy has been a consultant for Schering-Plough, which markets products containing dexamethasone.

SAN DIEGO – A single dose of dexamethasone given before outpatient laparoscopic cholecystectomy significantly improved measures of postoperative recovery and length of hospitalization, as well as quality of life after discharge, compared with placebo.

The findings of this randomized, double-blind study support previous studies suggesting that preoperative small-dose steroid therapy enhanced recovery, Dr. Glenn S. Murphy and his associates reported at the Annual Meeting of the American Society of Anesthesiologists.

The current study randomized patients undergoing elective laparoscopic cholecystectomy to receive either 8 mg dexamethasone or saline placebo 60 minutes before incision. All patients were expected to have same-day discharge, and all caregivers and patients were blinded to group assignment. The surgical procedures were standardized, as were fluid administration, ventilation, and anesthesia management using propofol, sevoflurane, rocuronium, fentanyl, and/or ondansetron.

The staff measured nausea, vomiting, pain, and fatigue preoperatively and at discharge from the postanesthesia care unit (PACU) and the ambulatory surgery unit (ASU). They recorded analgesic requirements during the hospitalization, and the length of time required to meet criteria for discharge from the PACU and ASU.

In addition, health status was assessed at baseline immediately prior to surgery using a previously validated 40-item scoring system, and patients took home another copy of this quality-of-recovery survey (QoR-40) to be completed 24 hours after discharge from the ASU.

Photo credit: (c)2010 American College of Surgeons/Elsevier

At baseline, the 56 patients in the dexamethasone group did not differ significantly from the 59 in the placebo group in terms of age, sex, height, weight, ASA physical status, history of smoking or drinking, hypertension, asthma, sleep apnea, or thyroid disease. Complete data were not available for five patients who were dropped from the analysis.

In the ASU, the dexamethasone group has less nausea, fatigue, and treatment of emetic symptoms, compared with the control group. In the PACU, the dexamethasone group had lower pain scores and less nausea, treatment of emetic symptoms, and need for analgesics. The dexamethasone patients had a 55 minute shorter stay in the ASU and were in the hospital 70 minutes less was than the control group, said Dr. Murphy of Northwestern University, Chicago.

The QoR-40 scores did not differ significantly between groups before surgery, but on postoperative day 1, the median global score in the control group was significantly lower (score of 161), compared with the dexamethasone group (score of 178), reflecting a worse quality of recovery in the control group, he said.

Three of the individual dimensions measured by the QoR-40 scored significantly lower in the control group, compared with the dexamethasone group postoperatively: emotional state (35 vs. 41), physical comfort (45 vs. 51), and pain (26 vs. 31). Scores for psychological support and physical independence did not differ significantly between groups.

Laparoscopic cholecystectomy is one of the most common elective surgical procedures in the United States, and up to 80% of patients may be discharged from the hospital on the day of surgery, data suggest. Investigators have looked to small-dose steroid therapy as a way to attenuate physiologic responses to minimally invasive surgery that can impair recovery and delay discharge, such as metabolic, hormonal, inflammatory, and immune responses activated by the surgery. Dexamethasone, a potent corticosteroid, has a biological half-life of 24-36 hours.

Dr. Murphy has been a consultant for Schering-Plough, which markets products containing dexamethasone.

SAN DIEGO – A single dose of dexamethasone given before outpatient laparoscopic cholecystectomy significantly improved measures of postoperative recovery and length of hospitalization, as well as quality of life after discharge, compared with placebo.

The findings of this randomized, double-blind study support previous studies suggesting that preoperative small-dose steroid therapy enhanced recovery, Dr. Glenn S. Murphy and his associates reported at the Annual Meeting of the American Society of Anesthesiologists.

The current study randomized patients undergoing elective laparoscopic cholecystectomy to receive either 8 mg dexamethasone or saline placebo 60 minutes before incision. All patients were expected to have same-day discharge, and all caregivers and patients were blinded to group assignment. The surgical procedures were standardized, as were fluid administration, ventilation, and anesthesia management using propofol, sevoflurane, rocuronium, fentanyl, and/or ondansetron.

The staff measured nausea, vomiting, pain, and fatigue preoperatively and at discharge from the postanesthesia care unit (PACU) and the ambulatory surgery unit (ASU). They recorded analgesic requirements during the hospitalization, and the length of time required to meet criteria for discharge from the PACU and ASU.

In addition, health status was assessed at baseline immediately prior to surgery using a previously validated 40-item scoring system, and patients took home another copy of this quality-of-recovery survey (QoR-40) to be completed 24 hours after discharge from the ASU.

Photo credit: (c)2010 American College of Surgeons/Elsevier

At baseline, the 56 patients in the dexamethasone group did not differ significantly from the 59 in the placebo group in terms of age, sex, height, weight, ASA physical status, history of smoking or drinking, hypertension, asthma, sleep apnea, or thyroid disease. Complete data were not available for five patients who were dropped from the analysis.

In the ASU, the dexamethasone group has less nausea, fatigue, and treatment of emetic symptoms, compared with the control group. In the PACU, the dexamethasone group had lower pain scores and less nausea, treatment of emetic symptoms, and need for analgesics. The dexamethasone patients had a 55 minute shorter stay in the ASU and were in the hospital 70 minutes less was than the control group, said Dr. Murphy of Northwestern University, Chicago.

The QoR-40 scores did not differ significantly between groups before surgery, but on postoperative day 1, the median global score in the control group was significantly lower (score of 161), compared with the dexamethasone group (score of 178), reflecting a worse quality of recovery in the control group, he said.

Three of the individual dimensions measured by the QoR-40 scored significantly lower in the control group, compared with the dexamethasone group postoperatively: emotional state (35 vs. 41), physical comfort (45 vs. 51), and pain (26 vs. 31). Scores for psychological support and physical independence did not differ significantly between groups.

Laparoscopic cholecystectomy is one of the most common elective surgical procedures in the United States, and up to 80% of patients may be discharged from the hospital on the day of surgery, data suggest. Investigators have looked to small-dose steroid therapy as a way to attenuate physiologic responses to minimally invasive surgery that can impair recovery and delay discharge, such as metabolic, hormonal, inflammatory, and immune responses activated by the surgery. Dexamethasone, a potent corticosteroid, has a biological half-life of 24-36 hours.

Dr. Murphy has been a consultant for Schering-Plough, which markets products containing dexamethasone.

SAN DIEGO – A single dose of dexamethasone given before outpatient laparoscopic cholecystectomy significantly improved measures of postoperative recovery and length of hospitalization, as well as quality of life after discharge, compared with placebo.

The findings of this randomized, double-blind study support previous studies suggesting that preoperative small-dose steroid therapy enhanced recovery, Dr. Glenn S. Murphy and his associates reported at the Annual Meeting of the American Society of Anesthesiologists.

The current study randomized patients undergoing elective laparoscopic cholecystectomy to receive either 8 mg dexamethasone or saline placebo 60 minutes before incision. All patients were expected to have same-day discharge, and all caregivers and patients were blinded to group assignment. The surgical procedures were standardized, as were fluid administration, ventilation, and anesthesia management using propofol, sevoflurane, rocuronium, fentanyl, and/or ondansetron.

The staff measured nausea, vomiting, pain, and fatigue preoperatively and at discharge from the postanesthesia care unit (PACU) and the ambulatory surgery unit (ASU). They recorded analgesic requirements during the hospitalization, and the length of time required to meet criteria for discharge from the PACU and ASU.

In addition, health status was assessed at baseline immediately prior to surgery using a previously validated 40-item scoring system, and patients took home another copy of this quality-of-recovery survey (QoR-40) to be completed 24 hours after discharge from the ASU.

Photo credit: (c)2010 American College of Surgeons/Elsevier

At baseline, the 56 patients in the dexamethasone group did not differ significantly from the 59 in the placebo group in terms of age, sex, height, weight, ASA physical status, history of smoking or drinking, hypertension, asthma, sleep apnea, or thyroid disease. Complete data were not available for five patients who were dropped from the analysis.

In the ASU, the dexamethasone group has less nausea, fatigue, and treatment of emetic symptoms, compared with the control group. In the PACU, the dexamethasone group had lower pain scores and less nausea, treatment of emetic symptoms, and need for analgesics. The dexamethasone patients had a 55 minute shorter stay in the ASU and were in the hospital 70 minutes less was than the control group, said Dr. Murphy of Northwestern University, Chicago.

The QoR-40 scores did not differ significantly between groups before surgery, but on postoperative day 1, the median global score in the control group was significantly lower (score of 161), compared with the dexamethasone group (score of 178), reflecting a worse quality of recovery in the control group, he said.

Three of the individual dimensions measured by the QoR-40 scored significantly lower in the control group, compared with the dexamethasone group postoperatively: emotional state (35 vs. 41), physical comfort (45 vs. 51), and pain (26 vs. 31). Scores for psychological support and physical independence did not differ significantly between groups.

Laparoscopic cholecystectomy is one of the most common elective surgical procedures in the United States, and up to 80% of patients may be discharged from the hospital on the day of surgery, data suggest. Investigators have looked to small-dose steroid therapy as a way to attenuate physiologic responses to minimally invasive surgery that can impair recovery and delay discharge, such as metabolic, hormonal, inflammatory, and immune responses activated by the surgery. Dexamethasone, a potent corticosteroid, has a biological half-life of 24-36 hours.

Dr. Murphy has been a consultant for Schering-Plough, which markets products containing dexamethasone.

SAN DIEGO – A single dose of dexamethasone given before outpatient laparoscopic cholecystectomy significantly improved measures of postoperative recovery and length of hospitalization, as well as quality of life after discharge, compared with placebo.

The findings of this randomized, double-blind study support previous studies suggesting that preoperative small-dose steroid therapy enhanced recovery, Dr. Glenn S. Murphy and his associates reported at the Annual Meeting of the American Society of Anesthesiologists.

The current study randomized patients undergoing elective laparoscopic cholecystectomy to receive either 8 mg dexamethasone or saline placebo 60 minutes before incision. All patients were expected to have same-day discharge, and all caregivers and patients were blinded to group assignment. The surgical procedures were standardized, as were fluid administration, ventilation, and anesthesia management using propofol, sevoflurane, rocuronium, fentanyl, and/or ondansetron.

The staff measured nausea, vomiting, pain, and fatigue preoperatively and at discharge from the postanesthesia care unit (PACU) and the ambulatory surgery unit (ASU). They recorded analgesic requirements during the hospitalization, and the length of time required to meet criteria for discharge from the PACU and ASU.

In addition, health status was assessed at baseline immediately prior to surgery using a previously validated 40-item scoring system, and patients took home another copy of this quality-of-recovery survey (QoR-40) to be completed 24 hours after discharge from the ASU.

Photo credit: (c)2010 American College of Surgeons/Elsevier

At baseline, the 56 patients in the dexamethasone group did not differ significantly from the 59 in the placebo group in terms of age, sex, height, weight, ASA physical status, history of smoking or drinking, hypertension, asthma, sleep apnea, or thyroid disease. Complete data were not available for five patients who were dropped from the analysis.

In the ASU, the dexamethasone group has less nausea, fatigue, and treatment of emetic symptoms, compared with the control group. In the PACU, the dexamethasone group had lower pain scores and less nausea, treatment of emetic symptoms, and need for analgesics. The dexamethasone patients had a 55 minute shorter stay in the ASU and were in the hospital 70 minutes less was than the control group, said Dr. Murphy of Northwestern University, Chicago.

The QoR-40 scores did not differ significantly between groups before surgery, but on postoperative day 1, the median global score in the control group was significantly lower (score of 161), compared with the dexamethasone group (score of 178), reflecting a worse quality of recovery in the control group, he said.

Three of the individual dimensions measured by the QoR-40 scored significantly lower in the control group, compared with the dexamethasone group postoperatively: emotional state (35 vs. 41), physical comfort (45 vs. 51), and pain (26 vs. 31). Scores for psychological support and physical independence did not differ significantly between groups.

Laparoscopic cholecystectomy is one of the most common elective surgical procedures in the United States, and up to 80% of patients may be discharged from the hospital on the day of surgery, data suggest. Investigators have looked to small-dose steroid therapy as a way to attenuate physiologic responses to minimally invasive surgery that can impair recovery and delay discharge, such as metabolic, hormonal, inflammatory, and immune responses activated by the surgery. Dexamethasone, a potent corticosteroid, has a biological half-life of 24-36 hours.

Dr. Murphy has been a consultant for Schering-Plough, which markets products containing dexamethasone.

SAN DIEGO – A single dose of dexamethasone given before outpatient laparoscopic cholecystectomy significantly improved measures of postoperative recovery and length of hospitalization, as well as quality of life after discharge, compared with placebo.

The findings of this randomized, double-blind study support previous studies suggesting that preoperative small-dose steroid therapy enhanced recovery, Dr. Glenn S. Murphy and his associates reported at the Annual Meeting of the American Society of Anesthesiologists.

The current study randomized patients undergoing elective laparoscopic cholecystectomy to receive either 8 mg dexamethasone or saline placebo 60 minutes before incision. All patients were expected to have same-day discharge, and all caregivers and patients were blinded to group assignment. The surgical procedures were standardized, as were fluid administration, ventilation, and anesthesia management using propofol, sevoflurane, rocuronium, fentanyl, and/or ondansetron.

The staff measured nausea, vomiting, pain, and fatigue preoperatively and at discharge from the postanesthesia care unit (PACU) and the ambulatory surgery unit (ASU). They recorded analgesic requirements during the hospitalization, and the length of time required to meet criteria for discharge from the PACU and ASU.

In addition, health status was assessed at baseline immediately prior to surgery using a previously validated 40-item scoring system, and patients took home another copy of this quality-of-recovery survey (QoR-40) to be completed 24 hours after discharge from the ASU.

Photo credit: (c)2010 American College of Surgeons/Elsevier

At baseline, the 56 patients in the dexamethasone group did not differ significantly from the 59 in the placebo group in terms of age, sex, height, weight, ASA physical status, history of smoking or drinking, hypertension, asthma, sleep apnea, or thyroid disease. Complete data were not available for five patients who were dropped from the analysis.

In the ASU, the dexamethasone group has less nausea, fatigue, and treatment of emetic symptoms, compared with the control group. In the PACU, the dexamethasone group had lower pain scores and less nausea, treatment of emetic symptoms, and need for analgesics. The dexamethasone patients had a 55 minute shorter stay in the ASU and were in the hospital 70 minutes less was than the control group, said Dr. Murphy of Northwestern University, Chicago.

The QoR-40 scores did not differ significantly between groups before surgery, but on postoperative day 1, the median global score in the control group was significantly lower (score of 161), compared with the dexamethasone group (score of 178), reflecting a worse quality of recovery in the control group, he said.

Three of the individual dimensions measured by the QoR-40 scored significantly lower in the control group, compared with the dexamethasone group postoperatively: emotional state (35 vs. 41), physical comfort (45 vs. 51), and pain (26 vs. 31). Scores for psychological support and physical independence did not differ significantly between groups.

Laparoscopic cholecystectomy is one of the most common elective surgical procedures in the United States, and up to 80% of patients may be discharged from the hospital on the day of surgery, data suggest. Investigators have looked to small-dose steroid therapy as a way to attenuate physiologic responses to minimally invasive surgery that can impair recovery and delay discharge, such as metabolic, hormonal, inflammatory, and immune responses activated by the surgery. Dexamethasone, a potent corticosteroid, has a biological half-life of 24-36 hours.

Dr. Murphy has been a consultant for Schering-Plough, which markets products containing dexamethasone.