Damian McNamara

ORLANDO — Consider a diagnosis other than nonalcoholic fatty liver disease when an obese child or adolescent presents with elevated levels of the liver enzyme alanine aminotransferase.

Dr. Daniel Preud'Homme and colleagues reviewed the medical records of 372 children and adolescents who were referred for evaluation and management of obesity to the pediatric healthy life center at the University of South Alabama, Mobile. A complete metabolic profile for each patient included liver testing with serum ALT measurements. Mean age was 14 years; mean body mass index was 39 kg/m

Of the 113 patients with abnormally high ALT (greater than 48 U/L), 8 (7%) were diagnosed with a condition other than nonalcoholic fatty liver disease, said Dr. Preud'Homme, a pediatric gastroenterologist at the university.

The index case was a 13-year-old girl who had four abnormally high ALT assays over 2 years. The results were attributed to her obesity only, when in fact she had autoimmune hepatitis type 1, Dr. Preud'Homme said during a poster presentation at the annual meeting of the American College of Gastroenterology.

Two other patients with abnormally high ALT levels had smooth muscle antibody-positive and antinuclear antibody-positive assays consistent with autoimmune hepatitis type 1. This finding supports a need for a more comprehensive evaluation in any patient with elevated ALT levels, obese or not, Dr. Preud' Homme said. He recommended testing for all liver diseases, performing an ultrasound, and, in some cases, taking biopsies.

Two other patients had indeterminate biopsies, and Dr. Preud'Homme said he plans to closely follow these patients and repeat the biopsies. Another two originally assumed to have fatty liver disease were diagnosed with alpha-1 antitrypsin deficiency. One child was diagnosed with Wilson's disease, a rare, inherited condition in which a patient cannot fully metabolize copper.

“If we assume ALT is elevated because [of obesity], we are likely to miss other diseases. The percentage is high enough to warrant not ignoring it,” he said.

ORLANDO — Consider a diagnosis other than nonalcoholic fatty liver disease when an obese child or adolescent presents with elevated levels of the liver enzyme alanine aminotransferase.

Dr. Daniel Preud'Homme and colleagues reviewed the medical records of 372 children and adolescents who were referred for evaluation and management of obesity to the pediatric healthy life center at the University of South Alabama, Mobile. A complete metabolic profile for each patient included liver testing with serum ALT measurements. Mean age was 14 years; mean body mass index was 39 kg/m

Of the 113 patients with abnormally high ALT (greater than 48 U/L), 8 (7%) were diagnosed with a condition other than nonalcoholic fatty liver disease, said Dr. Preud'Homme, a pediatric gastroenterologist at the university.

The index case was a 13-year-old girl who had four abnormally high ALT assays over 2 years. The results were attributed to her obesity only, when in fact she had autoimmune hepatitis type 1, Dr. Preud'Homme said during a poster presentation at the annual meeting of the American College of Gastroenterology.

Two other patients with abnormally high ALT levels had smooth muscle antibody-positive and antinuclear antibody-positive assays consistent with autoimmune hepatitis type 1. This finding supports a need for a more comprehensive evaluation in any patient with elevated ALT levels, obese or not, Dr. Preud' Homme said. He recommended testing for all liver diseases, performing an ultrasound, and, in some cases, taking biopsies.

Two other patients had indeterminate biopsies, and Dr. Preud'Homme said he plans to closely follow these patients and repeat the biopsies. Another two originally assumed to have fatty liver disease were diagnosed with alpha-1 antitrypsin deficiency. One child was diagnosed with Wilson's disease, a rare, inherited condition in which a patient cannot fully metabolize copper.

“If we assume ALT is elevated because [of obesity], we are likely to miss other diseases. The percentage is high enough to warrant not ignoring it,” he said.

ORLANDO — Consider a diagnosis other than nonalcoholic fatty liver disease when an obese child or adolescent presents with elevated levels of the liver enzyme alanine aminotransferase.

Dr. Daniel Preud'Homme and colleagues reviewed the medical records of 372 children and adolescents who were referred for evaluation and management of obesity to the pediatric healthy life center at the University of South Alabama, Mobile. A complete metabolic profile for each patient included liver testing with serum ALT measurements. Mean age was 14 years; mean body mass index was 39 kg/m

Of the 113 patients with abnormally high ALT (greater than 48 U/L), 8 (7%) were diagnosed with a condition other than nonalcoholic fatty liver disease, said Dr. Preud'Homme, a pediatric gastroenterologist at the university.

The index case was a 13-year-old girl who had four abnormally high ALT assays over 2 years. The results were attributed to her obesity only, when in fact she had autoimmune hepatitis type 1, Dr. Preud'Homme said during a poster presentation at the annual meeting of the American College of Gastroenterology.

Two other patients with abnormally high ALT levels had smooth muscle antibody-positive and antinuclear antibody-positive assays consistent with autoimmune hepatitis type 1. This finding supports a need for a more comprehensive evaluation in any patient with elevated ALT levels, obese or not, Dr. Preud' Homme said. He recommended testing for all liver diseases, performing an ultrasound, and, in some cases, taking biopsies.

Two other patients had indeterminate biopsies, and Dr. Preud'Homme said he plans to closely follow these patients and repeat the biopsies. Another two originally assumed to have fatty liver disease were diagnosed with alpha-1 antitrypsin deficiency. One child was diagnosed with Wilson's disease, a rare, inherited condition in which a patient cannot fully metabolize copper.

“If we assume ALT is elevated because [of obesity], we are likely to miss other diseases. The percentage is high enough to warrant not ignoring it,” he said.

ORLANDO — A short survey that assesses compliance with a gluten-free diet among adults with celiac disease has been validated.

Scores on the Celiac Dietary Adherence Test corresponded better with an independent dietician's assessment of adherence than does the standard serum test, the IgA tissue transglutaminase titer, according to the results of an analysis of data obtained from 200 people with biopsy-proven celiac disease.

The survey “is a clinically relevant, easily administered, seven-item point of care evaluation of gluten-free diet adherence. We hope it will be a useful tool in clinical and research settings,” said Dr. Daniel Leffler, director of clinical research at the Celiac Center, Beth Israel Deaconess Medical Center, Boston.

Celiac disease affects up to 1% of the general population worldwide (Nutr. Clin. Care. 2005;8:54–69). Its increasing prevalence is outpacing the number of adequately trained dieticians. The short survey may be especially useful in areas where access to a dietician is limited, said Dr. Leffer, who presented the results at the annual meeting of the American College of Gastroenterology on behalf of the study's lead investigator, Dr. Shailaja Jamma, and associates.

Adherence to diet is important because a gluten-free diet is the only effective strategy for managing celiac disease, Dr. Leffler said.

An expert panel of gastroenterologists, dieticians, and psychologists, as well as focus panels of people with celiac disease, created an initial 80-item survey. They agreed on factors in five domains: symptoms, perceived adherence, reasons for adherence, self-efficacy, and disease-specific knowledge.

An initial cohort of 150 patients completed the survey and had IgA tissue transglutaminase titers measured. The survey was then pared down to 40 items and administered to a second cohort of 50 others with celiac disease to confirm its validity.

This process resulted in a seven-item survey that has 89% accuracy in predicting gluten-free diet adherence, Dr. Leffler reported.

The Celiac Dietary Adherence Test asks patients to respond to the following questions and statements, and uses a table to rate the responses and obtain a total score that reflects the likelihood of adherence to the gluten-free diet:

▸ Have you been bothered by low energy level during the past 4 weeks?

▸ Have you been bothered by headaches during the past 4 weeks?

▸ I am able to follow a gluten-free diet when dining outside my home.

▸ Before I do something I carefully consider the consequences.

▸ I do not consider myself a failure.

▸ How important to your health are accidental gluten exposures?

▸ Over the past 4 weeks how many times have you eaten foods containing gluten on purpose?

The score on the tool highly correlated with dietician evaluation at 3 months: 0.771 among the first cohort of patients and 0.764 among the second group (using a Pearson's correlation coefficient area under the curve calculation).

The IgA tissue transglutaminase assay, in contrast, correlated less with the dietician, at 0.647. Dr. Leffler commented that “serologic tests are generally good for diagnosis, but unfortunately, few lines of testing suggest they're as good for ongoing monitoring.”

ORLANDO — A short survey that assesses compliance with a gluten-free diet among adults with celiac disease has been validated.

Scores on the Celiac Dietary Adherence Test corresponded better with an independent dietician's assessment of adherence than does the standard serum test, the IgA tissue transglutaminase titer, according to the results of an analysis of data obtained from 200 people with biopsy-proven celiac disease.

The survey “is a clinically relevant, easily administered, seven-item point of care evaluation of gluten-free diet adherence. We hope it will be a useful tool in clinical and research settings,” said Dr. Daniel Leffler, director of clinical research at the Celiac Center, Beth Israel Deaconess Medical Center, Boston.

Celiac disease affects up to 1% of the general population worldwide (Nutr. Clin. Care. 2005;8:54–69). Its increasing prevalence is outpacing the number of adequately trained dieticians. The short survey may be especially useful in areas where access to a dietician is limited, said Dr. Leffer, who presented the results at the annual meeting of the American College of Gastroenterology on behalf of the study's lead investigator, Dr. Shailaja Jamma, and associates.

Adherence to diet is important because a gluten-free diet is the only effective strategy for managing celiac disease, Dr. Leffler said.

An expert panel of gastroenterologists, dieticians, and psychologists, as well as focus panels of people with celiac disease, created an initial 80-item survey. They agreed on factors in five domains: symptoms, perceived adherence, reasons for adherence, self-efficacy, and disease-specific knowledge.

An initial cohort of 150 patients completed the survey and had IgA tissue transglutaminase titers measured. The survey was then pared down to 40 items and administered to a second cohort of 50 others with celiac disease to confirm its validity.

This process resulted in a seven-item survey that has 89% accuracy in predicting gluten-free diet adherence, Dr. Leffler reported.

The Celiac Dietary Adherence Test asks patients to respond to the following questions and statements, and uses a table to rate the responses and obtain a total score that reflects the likelihood of adherence to the gluten-free diet:

▸ Have you been bothered by low energy level during the past 4 weeks?

▸ Have you been bothered by headaches during the past 4 weeks?

▸ I am able to follow a gluten-free diet when dining outside my home.

▸ Before I do something I carefully consider the consequences.

▸ I do not consider myself a failure.

▸ How important to your health are accidental gluten exposures?

▸ Over the past 4 weeks how many times have you eaten foods containing gluten on purpose?

The score on the tool highly correlated with dietician evaluation at 3 months: 0.771 among the first cohort of patients and 0.764 among the second group (using a Pearson's correlation coefficient area under the curve calculation).

The IgA tissue transglutaminase assay, in contrast, correlated less with the dietician, at 0.647. Dr. Leffler commented that “serologic tests are generally good for diagnosis, but unfortunately, few lines of testing suggest they're as good for ongoing monitoring.”

ORLANDO — A short survey that assesses compliance with a gluten-free diet among adults with celiac disease has been validated.

Scores on the Celiac Dietary Adherence Test corresponded better with an independent dietician's assessment of adherence than does the standard serum test, the IgA tissue transglutaminase titer, according to the results of an analysis of data obtained from 200 people with biopsy-proven celiac disease.

The survey “is a clinically relevant, easily administered, seven-item point of care evaluation of gluten-free diet adherence. We hope it will be a useful tool in clinical and research settings,” said Dr. Daniel Leffler, director of clinical research at the Celiac Center, Beth Israel Deaconess Medical Center, Boston.

Celiac disease affects up to 1% of the general population worldwide (Nutr. Clin. Care. 2005;8:54–69). Its increasing prevalence is outpacing the number of adequately trained dieticians. The short survey may be especially useful in areas where access to a dietician is limited, said Dr. Leffer, who presented the results at the annual meeting of the American College of Gastroenterology on behalf of the study's lead investigator, Dr. Shailaja Jamma, and associates.

Adherence to diet is important because a gluten-free diet is the only effective strategy for managing celiac disease, Dr. Leffler said.

An expert panel of gastroenterologists, dieticians, and psychologists, as well as focus panels of people with celiac disease, created an initial 80-item survey. They agreed on factors in five domains: symptoms, perceived adherence, reasons for adherence, self-efficacy, and disease-specific knowledge.

An initial cohort of 150 patients completed the survey and had IgA tissue transglutaminase titers measured. The survey was then pared down to 40 items and administered to a second cohort of 50 others with celiac disease to confirm its validity.

This process resulted in a seven-item survey that has 89% accuracy in predicting gluten-free diet adherence, Dr. Leffler reported.

The Celiac Dietary Adherence Test asks patients to respond to the following questions and statements, and uses a table to rate the responses and obtain a total score that reflects the likelihood of adherence to the gluten-free diet:

▸ Have you been bothered by low energy level during the past 4 weeks?

▸ Have you been bothered by headaches during the past 4 weeks?

▸ I am able to follow a gluten-free diet when dining outside my home.

▸ Before I do something I carefully consider the consequences.

▸ I do not consider myself a failure.

▸ How important to your health are accidental gluten exposures?

▸ Over the past 4 weeks how many times have you eaten foods containing gluten on purpose?

The score on the tool highly correlated with dietician evaluation at 3 months: 0.771 among the first cohort of patients and 0.764 among the second group (using a Pearson's correlation coefficient area under the curve calculation).

The IgA tissue transglutaminase assay, in contrast, correlated less with the dietician, at 0.647. Dr. Leffler commented that “serologic tests are generally good for diagnosis, but unfortunately, few lines of testing suggest they're as good for ongoing monitoring.”

ORLANDO—Endoscopic improvement occurred in more than 60% of Crohn's disease patients after 10 weeks of treatment with a pegylated biologic agent, certolizumab pegol. The study was the first prospective, phase III, multicenter, open-label study of the drug in such patients.

The tumor necrosis factor (TNF) blocker also led to improved clinical scores and histologic response among patients with moderate to severe disease.

The investigators showed that Cimzia (certolizumab pegol) was associated with endoscopic improvement in 62% of patients at week 10.

They also assessed endoscopic remission, defined as a Crohn's Disease Endoscopic Index of Severity (CDEIS) score decrease of at least 7 points from baseline.

“We confirmed clinical efficacy, with 42% of patients in remission at week 10,” said Dr. Jean-Frederic Colombel, a hepatogastroenterologist at Centre Hospitalier Universitaire de Lille (France). He is a consultant and on the advisory board for UCB Pharma, which initiated and analyzed the study.

Cimzia was approved by the U.S. Food and Drug Administration in April 2008 for the reduction of signs and symptoms of Crohn's disease and the maintenance of clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

In the study, 51% of the initial 89 participants were on immunosuppressant therapy and 42% were taking corticosteroids. Participants started with a CDEIS score of 8 or greater, ulcerations in at least two segments, and a Crohn's Disease Activity Index (CDAI) score between 220 and 450. “This is one of the most severe populations studied,” Dr. Colombel said at the annual meeting of the American College of Gastroenterology.

The primary outcome, change in CDEIS scores, showed improvement from a mean of 15 at baseline to 8 at week 10. This was “highly significant,” Dr. Colombel said. He presented these first, 10-week results of the ongoing endoscopic Mucosal Improvement in Patients with Active Crohn's Disease (MUSIC) study, and said the 54-week results are pending.

Mean duration of Crohn's disease in study participants was 8 years, mean age was 30 years, and 30% were men. A total of 71 patients (80%) experienced an adverse event during the study in an intent-to-treat analysis, including 37 patients with a drug-related event. Nine participants discontinued treatment before 10 weeks—two citing lack of efficacy, and seven because of adverse events.

Participants received subcutaneous injections of certolizumab pegol 400 mg at weeks 0, 2, and 4 and then every 4 weeks. After week 10, depending on CDEIS response, some patients switched to injections every 2 weeks, Dr. Colombel said.

A meeting attendee asked about the rationale for increasing administration to every 2 weeks. “The induction regimen is the same used in clinical practice,” Dr. Colombel said. “For this short-term data, we did not escalate the dose. For the long-term data, there is evidence that you can go from every 4 to every 2 weeks. That is what we are doing with the 54-week data.”

At baseline, 92% of the patients had deep intestinal ulcerations; this percentage decreased to 42% at week 10. In addition, 5% had superficial lesions detected at study entry, and this increased to 31% at week 10, Dr. Colombel said.

Compared with baseline, histologic Crohn's disease scores decreased a mean of 2.7 points in the colon and 2.8 points in the ileum at 10 weeks. In addition, 46% of patients achieved clinical remission, defined as a decrease in CDAI baseline scores of 150 points or more by 10 weeks.

A meeting attendee asked if the single-arm study design is a limitation. “Good question,” Dr. Colombel said. “It's quite difficult to put patients in a placebo-controlled study because anti-TNF is available, and they need three endoscopies in 1 year.

“What we also plan to do is look at videotapes in a blinded way, and do the same thing with histology—which will significantly improve the value of the data,” he added.

ORLANDO—Endoscopic improvement occurred in more than 60% of Crohn's disease patients after 10 weeks of treatment with a pegylated biologic agent, certolizumab pegol. The study was the first prospective, phase III, multicenter, open-label study of the drug in such patients.

The tumor necrosis factor (TNF) blocker also led to improved clinical scores and histologic response among patients with moderate to severe disease.

The investigators showed that Cimzia (certolizumab pegol) was associated with endoscopic improvement in 62% of patients at week 10.

They also assessed endoscopic remission, defined as a Crohn's Disease Endoscopic Index of Severity (CDEIS) score decrease of at least 7 points from baseline.

“We confirmed clinical efficacy, with 42% of patients in remission at week 10,” said Dr. Jean-Frederic Colombel, a hepatogastroenterologist at Centre Hospitalier Universitaire de Lille (France). He is a consultant and on the advisory board for UCB Pharma, which initiated and analyzed the study.

Cimzia was approved by the U.S. Food and Drug Administration in April 2008 for the reduction of signs and symptoms of Crohn's disease and the maintenance of clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

In the study, 51% of the initial 89 participants were on immunosuppressant therapy and 42% were taking corticosteroids. Participants started with a CDEIS score of 8 or greater, ulcerations in at least two segments, and a Crohn's Disease Activity Index (CDAI) score between 220 and 450. “This is one of the most severe populations studied,” Dr. Colombel said at the annual meeting of the American College of Gastroenterology.

The primary outcome, change in CDEIS scores, showed improvement from a mean of 15 at baseline to 8 at week 10. This was “highly significant,” Dr. Colombel said. He presented these first, 10-week results of the ongoing endoscopic Mucosal Improvement in Patients with Active Crohn's Disease (MUSIC) study, and said the 54-week results are pending.

Mean duration of Crohn's disease in study participants was 8 years, mean age was 30 years, and 30% were men. A total of 71 patients (80%) experienced an adverse event during the study in an intent-to-treat analysis, including 37 patients with a drug-related event. Nine participants discontinued treatment before 10 weeks—two citing lack of efficacy, and seven because of adverse events.

Participants received subcutaneous injections of certolizumab pegol 400 mg at weeks 0, 2, and 4 and then every 4 weeks. After week 10, depending on CDEIS response, some patients switched to injections every 2 weeks, Dr. Colombel said.

A meeting attendee asked about the rationale for increasing administration to every 2 weeks. “The induction regimen is the same used in clinical practice,” Dr. Colombel said. “For this short-term data, we did not escalate the dose. For the long-term data, there is evidence that you can go from every 4 to every 2 weeks. That is what we are doing with the 54-week data.”

At baseline, 92% of the patients had deep intestinal ulcerations; this percentage decreased to 42% at week 10. In addition, 5% had superficial lesions detected at study entry, and this increased to 31% at week 10, Dr. Colombel said.

Compared with baseline, histologic Crohn's disease scores decreased a mean of 2.7 points in the colon and 2.8 points in the ileum at 10 weeks. In addition, 46% of patients achieved clinical remission, defined as a decrease in CDAI baseline scores of 150 points or more by 10 weeks.

A meeting attendee asked if the single-arm study design is a limitation. “Good question,” Dr. Colombel said. “It's quite difficult to put patients in a placebo-controlled study because anti-TNF is available, and they need three endoscopies in 1 year.

“What we also plan to do is look at videotapes in a blinded way, and do the same thing with histology—which will significantly improve the value of the data,” he added.

ORLANDO—Endoscopic improvement occurred in more than 60% of Crohn's disease patients after 10 weeks of treatment with a pegylated biologic agent, certolizumab pegol. The study was the first prospective, phase III, multicenter, open-label study of the drug in such patients.

The tumor necrosis factor (TNF) blocker also led to improved clinical scores and histologic response among patients with moderate to severe disease.

The investigators showed that Cimzia (certolizumab pegol) was associated with endoscopic improvement in 62% of patients at week 10.

They also assessed endoscopic remission, defined as a Crohn's Disease Endoscopic Index of Severity (CDEIS) score decrease of at least 7 points from baseline.

“We confirmed clinical efficacy, with 42% of patients in remission at week 10,” said Dr. Jean-Frederic Colombel, a hepatogastroenterologist at Centre Hospitalier Universitaire de Lille (France). He is a consultant and on the advisory board for UCB Pharma, which initiated and analyzed the study.

Cimzia was approved by the U.S. Food and Drug Administration in April 2008 for the reduction of signs and symptoms of Crohn's disease and the maintenance of clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

In the study, 51% of the initial 89 participants were on immunosuppressant therapy and 42% were taking corticosteroids. Participants started with a CDEIS score of 8 or greater, ulcerations in at least two segments, and a Crohn's Disease Activity Index (CDAI) score between 220 and 450. “This is one of the most severe populations studied,” Dr. Colombel said at the annual meeting of the American College of Gastroenterology.

The primary outcome, change in CDEIS scores, showed improvement from a mean of 15 at baseline to 8 at week 10. This was “highly significant,” Dr. Colombel said. He presented these first, 10-week results of the ongoing endoscopic Mucosal Improvement in Patients with Active Crohn's Disease (MUSIC) study, and said the 54-week results are pending.

Mean duration of Crohn's disease in study participants was 8 years, mean age was 30 years, and 30% were men. A total of 71 patients (80%) experienced an adverse event during the study in an intent-to-treat analysis, including 37 patients with a drug-related event. Nine participants discontinued treatment before 10 weeks—two citing lack of efficacy, and seven because of adverse events.

Participants received subcutaneous injections of certolizumab pegol 400 mg at weeks 0, 2, and 4 and then every 4 weeks. After week 10, depending on CDEIS response, some patients switched to injections every 2 weeks, Dr. Colombel said.

A meeting attendee asked about the rationale for increasing administration to every 2 weeks. “The induction regimen is the same used in clinical practice,” Dr. Colombel said. “For this short-term data, we did not escalate the dose. For the long-term data, there is evidence that you can go from every 4 to every 2 weeks. That is what we are doing with the 54-week data.”

At baseline, 92% of the patients had deep intestinal ulcerations; this percentage decreased to 42% at week 10. In addition, 5% had superficial lesions detected at study entry, and this increased to 31% at week 10, Dr. Colombel said.

Compared with baseline, histologic Crohn's disease scores decreased a mean of 2.7 points in the colon and 2.8 points in the ileum at 10 weeks. In addition, 46% of patients achieved clinical remission, defined as a decrease in CDAI baseline scores of 150 points or more by 10 weeks.

A meeting attendee asked if the single-arm study design is a limitation. “Good question,” Dr. Colombel said. “It's quite difficult to put patients in a placebo-controlled study because anti-TNF is available, and they need three endoscopies in 1 year.

“What we also plan to do is look at videotapes in a blinded way, and do the same thing with histology—which will significantly improve the value of the data,” he added.

White students attending more racially diverse medical schools consider themselves better prepared to care for patients of racial and ethnic minority groups than are students at less diverse medical schools, according to a study of more than 20,000 graduates.

Attitudes about providing equivalent access to health care for everyone also were stronger among students at more diverse schools. These students' responses were 50% more favorable toward equitable access to care, compared with their counterparts at the least diverse schools.

The associations were particularly strong at medical schools that foster positive interactions and sharing of opinions among students from different backgrounds, Dr. Somnath Saha and colleagues reported in a recent issue of JAMA (2008;300:1135-45).

The investigators also found a “threshold effect” regarding minority student enrollment. Specifically, diversity outcomes were positive among the 118 medical schools in the study if the proportion of underrepresented minority graduates (URMs) exceeded 10%, or the total nonwhite student population was more than 36%. The authors had no financial conflict-of-interest disclosures relevant to the study.

Policies and programs devised to achieve racial diversity in medical schools and to increase the numbers of underrepresented black, Hispanic, and Native American students “have come under increasing scrutiny as being unnecessary and discriminatory,” the authors wrote. Dr. Saha is an internist at the Portland VA Medical Center and Oregon Health and Science University.

Affirmative action and addressing prior injustices are the justifications for most programs to increase URM student diversity, However, Dr. Olveen Carrasquillo and Dr. Elizabeth T. Lee-Rey wrote in an editorial in the same issue of JAMA, “the well-documented history of widespread racism within organized medicine and the American Medical Association's apology is a reminder of how pervasive and tolerated such practices were only a few decades ago” (2008;300:1203-4).

In the current study, Dr. Saha and colleagues assessed results of the online graduation questionnaires administered by the Association of American Medical Colleges in 2003 and 2004. They assessed anonymous responses from 20,112 individuals, representing 64% of all graduates during those 2 years.

Race and ethnicity were self-reported. The 9% of URM respondents included black, American Indian, Alaska Native, Mexican American/Chicano, mainland Puerto Rican, and Native Hawaiian students.

Minorities not considered to be underrepresented in the physician workforce, primarily Asians and non-URM Hispanic or Latino students, comprised the 23% nonwhite/non-URM group. The remaining 68% were white students.

A total of 21% of the 13,764 graduates in 2003 and 22% of the 7,472 graduates in 2004 strongly agreed that “everyone is entitled to adequate care.” Also, 42% of the 2003 graduates and 44% of the 2004 graduates strongly agreed that “access to care is a major problem.”

A total of 59% of the 2003 cohort and 60% of the 2004 cohort indicated they felt prepared to serve diverse populations.

Interestingly, white students at more diverse medical schools did not indicate they were more likely to care for underserved populations. “This may reflect confounding by the urban versus rural location of schools,” the authors wrote. “Rural schools are likely to have both fewer nonwhite students and more students who plan to practice in rural, underserved locations.”

In contrast, a total of 49% of URMs planned to work with underserved patient populations, significantly more than both white (19%) and nonwhite/non-URM students (16%).

“The finding by Saha and colleagues in this issue of JAMA that… increased medical school diversity is associated with white students feeling better prepared to care for diverse patients is an important contribution to the medical literature,” Dr. Carrasquillo and Dr. Lee-Rey wrote.

“Findings from this methodologically rigorous study can inform efforts to elicit continued support by the Supreme Court for admissions policies favorable to URM diversity.” Dr. Carrasquillo is director of the Center for the Health of Urban Minorities at Columbia University Medical Center and Dr. Lee-Rey is codirector of the Hispanic Center for Excellence, Albert Einstein College of Medicine, both in New York.

“As with all cross-sectional studies, there are important limitations, the most important of which is the inability to address causality,” Dr. Carrasquillo and Dr. Lee-Rey wrote.

Dr. Saha and colleagues noted that they had no measures of student attitude, experience, or plans to practice medicine prior to entering medical school.

In addition, schools that actively recruit a diverse student body might be more committed to improving diversity-related outcomes, another possible confounder of the study.

“A diverse student body is likely to be necessary but not sufficient. Medical schools may need to actively foster positive interaction among individuals from different backgrounds to derive the benefits of diversity.

“Two overarching questions remain,” Dr. Carrasquillo and Dr. Lee-Rey wrote. “First, is more evidence needed to justify increased medical school diversity? No, but it might help. Second, why have medical schools not been able to tackle this important challenge? There may not be a genuine commitment by academic leaders toward increasing URM diversity, so that it may be more about having the will than finding the way.”

White students attending more racially diverse medical schools consider themselves better prepared to care for patients of racial and ethnic minority groups than are students at less diverse medical schools, according to a study of more than 20,000 graduates.

Attitudes about providing equivalent access to health care for everyone also were stronger among students at more diverse schools. These students' responses were 50% more favorable toward equitable access to care, compared with their counterparts at the least diverse schools.

The associations were particularly strong at medical schools that foster positive interactions and sharing of opinions among students from different backgrounds, Dr. Somnath Saha and colleagues reported in a recent issue of JAMA (2008;300:1135-45).

The investigators also found a “threshold effect” regarding minority student enrollment. Specifically, diversity outcomes were positive among the 118 medical schools in the study if the proportion of underrepresented minority graduates (URMs) exceeded 10%, or the total nonwhite student population was more than 36%. The authors had no financial conflict-of-interest disclosures relevant to the study.

Policies and programs devised to achieve racial diversity in medical schools and to increase the numbers of underrepresented black, Hispanic, and Native American students “have come under increasing scrutiny as being unnecessary and discriminatory,” the authors wrote. Dr. Saha is an internist at the Portland VA Medical Center and Oregon Health and Science University.

Affirmative action and addressing prior injustices are the justifications for most programs to increase URM student diversity, However, Dr. Olveen Carrasquillo and Dr. Elizabeth T. Lee-Rey wrote in an editorial in the same issue of JAMA, “the well-documented history of widespread racism within organized medicine and the American Medical Association's apology is a reminder of how pervasive and tolerated such practices were only a few decades ago” (2008;300:1203-4).

In the current study, Dr. Saha and colleagues assessed results of the online graduation questionnaires administered by the Association of American Medical Colleges in 2003 and 2004. They assessed anonymous responses from 20,112 individuals, representing 64% of all graduates during those 2 years.

Race and ethnicity were self-reported. The 9% of URM respondents included black, American Indian, Alaska Native, Mexican American/Chicano, mainland Puerto Rican, and Native Hawaiian students.

Minorities not considered to be underrepresented in the physician workforce, primarily Asians and non-URM Hispanic or Latino students, comprised the 23% nonwhite/non-URM group. The remaining 68% were white students.

A total of 21% of the 13,764 graduates in 2003 and 22% of the 7,472 graduates in 2004 strongly agreed that “everyone is entitled to adequate care.” Also, 42% of the 2003 graduates and 44% of the 2004 graduates strongly agreed that “access to care is a major problem.”

A total of 59% of the 2003 cohort and 60% of the 2004 cohort indicated they felt prepared to serve diverse populations.

Interestingly, white students at more diverse medical schools did not indicate they were more likely to care for underserved populations. “This may reflect confounding by the urban versus rural location of schools,” the authors wrote. “Rural schools are likely to have both fewer nonwhite students and more students who plan to practice in rural, underserved locations.”

In contrast, a total of 49% of URMs planned to work with underserved patient populations, significantly more than both white (19%) and nonwhite/non-URM students (16%).

“The finding by Saha and colleagues in this issue of JAMA that… increased medical school diversity is associated with white students feeling better prepared to care for diverse patients is an important contribution to the medical literature,” Dr. Carrasquillo and Dr. Lee-Rey wrote.

“Findings from this methodologically rigorous study can inform efforts to elicit continued support by the Supreme Court for admissions policies favorable to URM diversity.” Dr. Carrasquillo is director of the Center for the Health of Urban Minorities at Columbia University Medical Center and Dr. Lee-Rey is codirector of the Hispanic Center for Excellence, Albert Einstein College of Medicine, both in New York.

“As with all cross-sectional studies, there are important limitations, the most important of which is the inability to address causality,” Dr. Carrasquillo and Dr. Lee-Rey wrote.

Dr. Saha and colleagues noted that they had no measures of student attitude, experience, or plans to practice medicine prior to entering medical school.

In addition, schools that actively recruit a diverse student body might be more committed to improving diversity-related outcomes, another possible confounder of the study.

“A diverse student body is likely to be necessary but not sufficient. Medical schools may need to actively foster positive interaction among individuals from different backgrounds to derive the benefits of diversity.

“Two overarching questions remain,” Dr. Carrasquillo and Dr. Lee-Rey wrote. “First, is more evidence needed to justify increased medical school diversity? No, but it might help. Second, why have medical schools not been able to tackle this important challenge? There may not be a genuine commitment by academic leaders toward increasing URM diversity, so that it may be more about having the will than finding the way.”

White students attending more racially diverse medical schools consider themselves better prepared to care for patients of racial and ethnic minority groups than are students at less diverse medical schools, according to a study of more than 20,000 graduates.

Attitudes about providing equivalent access to health care for everyone also were stronger among students at more diverse schools. These students' responses were 50% more favorable toward equitable access to care, compared with their counterparts at the least diverse schools.

The associations were particularly strong at medical schools that foster positive interactions and sharing of opinions among students from different backgrounds, Dr. Somnath Saha and colleagues reported in a recent issue of JAMA (2008;300:1135-45).

The investigators also found a “threshold effect” regarding minority student enrollment. Specifically, diversity outcomes were positive among the 118 medical schools in the study if the proportion of underrepresented minority graduates (URMs) exceeded 10%, or the total nonwhite student population was more than 36%. The authors had no financial conflict-of-interest disclosures relevant to the study.

Policies and programs devised to achieve racial diversity in medical schools and to increase the numbers of underrepresented black, Hispanic, and Native American students “have come under increasing scrutiny as being unnecessary and discriminatory,” the authors wrote. Dr. Saha is an internist at the Portland VA Medical Center and Oregon Health and Science University.

Affirmative action and addressing prior injustices are the justifications for most programs to increase URM student diversity, However, Dr. Olveen Carrasquillo and Dr. Elizabeth T. Lee-Rey wrote in an editorial in the same issue of JAMA, “the well-documented history of widespread racism within organized medicine and the American Medical Association's apology is a reminder of how pervasive and tolerated such practices were only a few decades ago” (2008;300:1203-4).

In the current study, Dr. Saha and colleagues assessed results of the online graduation questionnaires administered by the Association of American Medical Colleges in 2003 and 2004. They assessed anonymous responses from 20,112 individuals, representing 64% of all graduates during those 2 years.

Race and ethnicity were self-reported. The 9% of URM respondents included black, American Indian, Alaska Native, Mexican American/Chicano, mainland Puerto Rican, and Native Hawaiian students.

Minorities not considered to be underrepresented in the physician workforce, primarily Asians and non-URM Hispanic or Latino students, comprised the 23% nonwhite/non-URM group. The remaining 68% were white students.

A total of 21% of the 13,764 graduates in 2003 and 22% of the 7,472 graduates in 2004 strongly agreed that “everyone is entitled to adequate care.” Also, 42% of the 2003 graduates and 44% of the 2004 graduates strongly agreed that “access to care is a major problem.”

A total of 59% of the 2003 cohort and 60% of the 2004 cohort indicated they felt prepared to serve diverse populations.

Interestingly, white students at more diverse medical schools did not indicate they were more likely to care for underserved populations. “This may reflect confounding by the urban versus rural location of schools,” the authors wrote. “Rural schools are likely to have both fewer nonwhite students and more students who plan to practice in rural, underserved locations.”

In contrast, a total of 49% of URMs planned to work with underserved patient populations, significantly more than both white (19%) and nonwhite/non-URM students (16%).

“The finding by Saha and colleagues in this issue of JAMA that… increased medical school diversity is associated with white students feeling better prepared to care for diverse patients is an important contribution to the medical literature,” Dr. Carrasquillo and Dr. Lee-Rey wrote.

“Findings from this methodologically rigorous study can inform efforts to elicit continued support by the Supreme Court for admissions policies favorable to URM diversity.” Dr. Carrasquillo is director of the Center for the Health of Urban Minorities at Columbia University Medical Center and Dr. Lee-Rey is codirector of the Hispanic Center for Excellence, Albert Einstein College of Medicine, both in New York.

“As with all cross-sectional studies, there are important limitations, the most important of which is the inability to address causality,” Dr. Carrasquillo and Dr. Lee-Rey wrote.

Dr. Saha and colleagues noted that they had no measures of student attitude, experience, or plans to practice medicine prior to entering medical school.

In addition, schools that actively recruit a diverse student body might be more committed to improving diversity-related outcomes, another possible confounder of the study.

“A diverse student body is likely to be necessary but not sufficient. Medical schools may need to actively foster positive interaction among individuals from different backgrounds to derive the benefits of diversity.

“Two overarching questions remain,” Dr. Carrasquillo and Dr. Lee-Rey wrote. “First, is more evidence needed to justify increased medical school diversity? No, but it might help. Second, why have medical schools not been able to tackle this important challenge? There may not be a genuine commitment by academic leaders toward increasing URM diversity, so that it may be more about having the will than finding the way.”

ORLANDO — A recommendation for antibiotic therapy to combat bacterial overgrowth, a stronger recommendation for antidepressants to ease symptoms, and serum testing for celiac disease are forthcoming updates to the American College of Gastroenterology's irritable bowel syndrome guidelines.

New recommendations on the diagnosis of irritable bowel syndrome (IBS) are also expected in the updated guidelines, which the college plans to publish in January 2009, with an earlier release online.

The guidelines also will recommend the addition of microscopic colitis to the differential diagnosis of IBS. This addition is based on the findings from a prospective, multicenter study that 4% of 454 people suspected of IBS actually had microscopic colitis.

“This is definitely new … and potentially a very, very important message from this document,” Dr. William D. Chey said during a media briefing at the annual meeting of the American College of Gastroenterology.

“If a patient has diarrhea-predominant IBS and undergoes colonoscopy, then it is reasonable to consider taking random biopsies to exclude microscopic colitis,” said Dr. Chey, professor of medicine at the University of Michigan, Ann Arbor.

The updated diagnosis recommendations will be reassuring for many health care providers Dr. Chey continued. “Doctors are uncomfortable with assigning a diagnosis of IBS. They are worried that they are missing something else” such as colon cancer, ulcerative colitis, or Crohn's disease.

“The reassuring bit of information that comes out of our analysis … is that the likelihood of a person who has IBS symptoms and no warning signs having some other organic diagnosis such as colon cancer, inflammatory bowel disease, or thyroid disease is no greater than in the general population,” he continued. “Although I understand why it's a concern, it is not an entirely rational concern.”

Doctors in clinical practice often characterize people with only abdominal pain as having IBS, he added.

However, “These recommendations, based on the best available evidence, apply to people with pain and altered bowel habits,” Dr. Chey said.

The link between pain and bowel disturbance is very close, Dr. Nicholas J. Talley said.

“They have pain, they pass stool and get relief—that is IBS. It's absolutely obvious to me.” Dr. Talley is chair of the department of internal medicine at the Mayo Clinic, Jacksonville, Fla.

Because of a greater risk of organic disease, patients who present with IBS symptoms plus other warning signs such as unexplained weight loss, GI bleeding, or a family history of colon cancer, inflammatory bowel disease, or celiac sprue require a more detailed evaluation, Dr. Chey said.

Another new recommendation is for use of a “nonabsorbable antibiotic” to relieve IBS symptoms.

The only approved antibiotic that remains in the gut to alter flora without systemic absorption is rifaximin (Xifaxan), now under investigation as a treatment for IBS. Rifaximin was found to be superior to placebo for improvement of IBS symptoms, especially bloating, in recent studies (Ann. Pharmacother. 2008;42:408-12; Adv. Med. Sci. 2007;52:139-42).

“What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur,” said Dr. Philip S. Schoenfeld, a gastroenterologist at the University of Michigan, who also spoke at the media briefing.

“There is evidence of benefit in the short term [with rifaximin]. It is critical that you know that,” Dr. Talley said. He predicted that this recommendation will be controversial because IBS is chronic and antibiotics are typically prescribed acutely.

Dr. Schoenfeld said that physicians may be concerned about increasing antibiotic resistance if the agents are given to thousands of IBS patients.

In addition, there is a greater focus on the use of antidepressants to treat IBS in the new guidelines.

For example, “there is a stronger recommendation that tricyclic antidepressants, used in low doses before people go to sleep at night, are an effective medicine for irritable bowel syndrome,” Dr. Schoenfeld said.

The agents can reduce bloating and discomfort by altering brain-gut signaling about motility and distention. He added that constipation, a side effect of tricyclic antidepressants, is actually beneficial in this population.

The authors of the guidelines also found enough evidence to support SSRIs for symptom improvement. “I want to emphasize that this does not appear to be related to depression,” Dr. Talley said. “This appears to be related to effects of these drugs either in the brain or the gut, but probably both places.”

Some treatment recommendations in the guidelines are not expected to change, including the use of loperamide (Imodium) or alosetron (Lotronex).

The new recommendation for serologic celiac disease testing is for a subset of IBS patients.

“We made a much stronger recommendation for testing for celiac disease in patients with diarrhea-predominant or mixed IBS,” Dr. Chey said. “We actually came out and said serologic screening for celiac disease should be pursued.”

Evidence of benefit from probiotics is also addressed. “Every one of my patients with IBS asked about probiotics,” Dr. Talley said.

“The guidelines will basically say that probiotics are efficacious, but the evidence supporting this is not as good as we would like,” he stated. The large number of probiotic products with varying degrees of efficacy precluded a stronger recommendation.

“Probiotics seem to be relatively safe as well, based on the data we have,” Dr. Talley said. “So I'm not uncomfortable with recommending a probiotic to my patients.”

He added, however, that some people are nonresponders.

In addition, recent evidence that indicates peppermint oil improves IBS symptoms will be in the update.

Dr. Schoenfeld disclosed that he is a consultant to, and is on the advisory committee for, Salix Pharmaceuticals Ltd., which markets Xifaxan.

Dr. Talley is also a consultant for Salix and a variety of other pharmaceutical companies, and receives financial support from several firms.

Dr. Chey reported no relevant financial disclosures for his presentation.

'What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur.' DR. SCHOENFELD

ORLANDO — A recommendation for antibiotic therapy to combat bacterial overgrowth, a stronger recommendation for antidepressants to ease symptoms, and serum testing for celiac disease are forthcoming updates to the American College of Gastroenterology's irritable bowel syndrome guidelines.

New recommendations on the diagnosis of irritable bowel syndrome (IBS) are also expected in the updated guidelines, which the college plans to publish in January 2009, with an earlier release online.

The guidelines also will recommend the addition of microscopic colitis to the differential diagnosis of IBS. This addition is based on the findings from a prospective, multicenter study that 4% of 454 people suspected of IBS actually had microscopic colitis.

“This is definitely new … and potentially a very, very important message from this document,” Dr. William D. Chey said during a media briefing at the annual meeting of the American College of Gastroenterology.

“If a patient has diarrhea-predominant IBS and undergoes colonoscopy, then it is reasonable to consider taking random biopsies to exclude microscopic colitis,” said Dr. Chey, professor of medicine at the University of Michigan, Ann Arbor.

The updated diagnosis recommendations will be reassuring for many health care providers Dr. Chey continued. “Doctors are uncomfortable with assigning a diagnosis of IBS. They are worried that they are missing something else” such as colon cancer, ulcerative colitis, or Crohn's disease.

“The reassuring bit of information that comes out of our analysis … is that the likelihood of a person who has IBS symptoms and no warning signs having some other organic diagnosis such as colon cancer, inflammatory bowel disease, or thyroid disease is no greater than in the general population,” he continued. “Although I understand why it's a concern, it is not an entirely rational concern.”

Doctors in clinical practice often characterize people with only abdominal pain as having IBS, he added.

However, “These recommendations, based on the best available evidence, apply to people with pain and altered bowel habits,” Dr. Chey said.

The link between pain and bowel disturbance is very close, Dr. Nicholas J. Talley said.

“They have pain, they pass stool and get relief—that is IBS. It's absolutely obvious to me.” Dr. Talley is chair of the department of internal medicine at the Mayo Clinic, Jacksonville, Fla.

Because of a greater risk of organic disease, patients who present with IBS symptoms plus other warning signs such as unexplained weight loss, GI bleeding, or a family history of colon cancer, inflammatory bowel disease, or celiac sprue require a more detailed evaluation, Dr. Chey said.

Another new recommendation is for use of a “nonabsorbable antibiotic” to relieve IBS symptoms.

The only approved antibiotic that remains in the gut to alter flora without systemic absorption is rifaximin (Xifaxan), now under investigation as a treatment for IBS. Rifaximin was found to be superior to placebo for improvement of IBS symptoms, especially bloating, in recent studies (Ann. Pharmacother. 2008;42:408-12; Adv. Med. Sci. 2007;52:139-42).

“What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur,” said Dr. Philip S. Schoenfeld, a gastroenterologist at the University of Michigan, who also spoke at the media briefing.

“There is evidence of benefit in the short term [with rifaximin]. It is critical that you know that,” Dr. Talley said. He predicted that this recommendation will be controversial because IBS is chronic and antibiotics are typically prescribed acutely.

Dr. Schoenfeld said that physicians may be concerned about increasing antibiotic resistance if the agents are given to thousands of IBS patients.

In addition, there is a greater focus on the use of antidepressants to treat IBS in the new guidelines.

For example, “there is a stronger recommendation that tricyclic antidepressants, used in low doses before people go to sleep at night, are an effective medicine for irritable bowel syndrome,” Dr. Schoenfeld said.

The agents can reduce bloating and discomfort by altering brain-gut signaling about motility and distention. He added that constipation, a side effect of tricyclic antidepressants, is actually beneficial in this population.

The authors of the guidelines also found enough evidence to support SSRIs for symptom improvement. “I want to emphasize that this does not appear to be related to depression,” Dr. Talley said. “This appears to be related to effects of these drugs either in the brain or the gut, but probably both places.”

Some treatment recommendations in the guidelines are not expected to change, including the use of loperamide (Imodium) or alosetron (Lotronex).

The new recommendation for serologic celiac disease testing is for a subset of IBS patients.

“We made a much stronger recommendation for testing for celiac disease in patients with diarrhea-predominant or mixed IBS,” Dr. Chey said. “We actually came out and said serologic screening for celiac disease should be pursued.”

Evidence of benefit from probiotics is also addressed. “Every one of my patients with IBS asked about probiotics,” Dr. Talley said.

“The guidelines will basically say that probiotics are efficacious, but the evidence supporting this is not as good as we would like,” he stated. The large number of probiotic products with varying degrees of efficacy precluded a stronger recommendation.

“Probiotics seem to be relatively safe as well, based on the data we have,” Dr. Talley said. “So I'm not uncomfortable with recommending a probiotic to my patients.”

He added, however, that some people are nonresponders.

In addition, recent evidence that indicates peppermint oil improves IBS symptoms will be in the update.

Dr. Schoenfeld disclosed that he is a consultant to, and is on the advisory committee for, Salix Pharmaceuticals Ltd., which markets Xifaxan.

Dr. Talley is also a consultant for Salix and a variety of other pharmaceutical companies, and receives financial support from several firms.

Dr. Chey reported no relevant financial disclosures for his presentation.

'What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur.' DR. SCHOENFELD

ORLANDO — A recommendation for antibiotic therapy to combat bacterial overgrowth, a stronger recommendation for antidepressants to ease symptoms, and serum testing for celiac disease are forthcoming updates to the American College of Gastroenterology's irritable bowel syndrome guidelines.

New recommendations on the diagnosis of irritable bowel syndrome (IBS) are also expected in the updated guidelines, which the college plans to publish in January 2009, with an earlier release online.

The guidelines also will recommend the addition of microscopic colitis to the differential diagnosis of IBS. This addition is based on the findings from a prospective, multicenter study that 4% of 454 people suspected of IBS actually had microscopic colitis.

“This is definitely new … and potentially a very, very important message from this document,” Dr. William D. Chey said during a media briefing at the annual meeting of the American College of Gastroenterology.

“If a patient has diarrhea-predominant IBS and undergoes colonoscopy, then it is reasonable to consider taking random biopsies to exclude microscopic colitis,” said Dr. Chey, professor of medicine at the University of Michigan, Ann Arbor.

The updated diagnosis recommendations will be reassuring for many health care providers Dr. Chey continued. “Doctors are uncomfortable with assigning a diagnosis of IBS. They are worried that they are missing something else” such as colon cancer, ulcerative colitis, or Crohn's disease.

“The reassuring bit of information that comes out of our analysis … is that the likelihood of a person who has IBS symptoms and no warning signs having some other organic diagnosis such as colon cancer, inflammatory bowel disease, or thyroid disease is no greater than in the general population,” he continued. “Although I understand why it's a concern, it is not an entirely rational concern.”

Doctors in clinical practice often characterize people with only abdominal pain as having IBS, he added.

However, “These recommendations, based on the best available evidence, apply to people with pain and altered bowel habits,” Dr. Chey said.

The link between pain and bowel disturbance is very close, Dr. Nicholas J. Talley said.

“They have pain, they pass stool and get relief—that is IBS. It's absolutely obvious to me.” Dr. Talley is chair of the department of internal medicine at the Mayo Clinic, Jacksonville, Fla.

Because of a greater risk of organic disease, patients who present with IBS symptoms plus other warning signs such as unexplained weight loss, GI bleeding, or a family history of colon cancer, inflammatory bowel disease, or celiac sprue require a more detailed evaluation, Dr. Chey said.

Another new recommendation is for use of a “nonabsorbable antibiotic” to relieve IBS symptoms.

The only approved antibiotic that remains in the gut to alter flora without systemic absorption is rifaximin (Xifaxan), now under investigation as a treatment for IBS. Rifaximin was found to be superior to placebo for improvement of IBS symptoms, especially bloating, in recent studies (Ann. Pharmacother. 2008;42:408-12; Adv. Med. Sci. 2007;52:139-42).

“What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur,” said Dr. Philip S. Schoenfeld, a gastroenterologist at the University of Michigan, who also spoke at the media briefing.

“There is evidence of benefit in the short term [with rifaximin]. It is critical that you know that,” Dr. Talley said. He predicted that this recommendation will be controversial because IBS is chronic and antibiotics are typically prescribed acutely.

Dr. Schoenfeld said that physicians may be concerned about increasing antibiotic resistance if the agents are given to thousands of IBS patients.

In addition, there is a greater focus on the use of antidepressants to treat IBS in the new guidelines.

For example, “there is a stronger recommendation that tricyclic antidepressants, used in low doses before people go to sleep at night, are an effective medicine for irritable bowel syndrome,” Dr. Schoenfeld said.

The agents can reduce bloating and discomfort by altering brain-gut signaling about motility and distention. He added that constipation, a side effect of tricyclic antidepressants, is actually beneficial in this population.

The authors of the guidelines also found enough evidence to support SSRIs for symptom improvement. “I want to emphasize that this does not appear to be related to depression,” Dr. Talley said. “This appears to be related to effects of these drugs either in the brain or the gut, but probably both places.”

Some treatment recommendations in the guidelines are not expected to change, including the use of loperamide (Imodium) or alosetron (Lotronex).

The new recommendation for serologic celiac disease testing is for a subset of IBS patients.

“We made a much stronger recommendation for testing for celiac disease in patients with diarrhea-predominant or mixed IBS,” Dr. Chey said. “We actually came out and said serologic screening for celiac disease should be pursued.”

Evidence of benefit from probiotics is also addressed. “Every one of my patients with IBS asked about probiotics,” Dr. Talley said.

“The guidelines will basically say that probiotics are efficacious, but the evidence supporting this is not as good as we would like,” he stated. The large number of probiotic products with varying degrees of efficacy precluded a stronger recommendation.

“Probiotics seem to be relatively safe as well, based on the data we have,” Dr. Talley said. “So I'm not uncomfortable with recommending a probiotic to my patients.”

He added, however, that some people are nonresponders.

In addition, recent evidence that indicates peppermint oil improves IBS symptoms will be in the update.

Dr. Schoenfeld disclosed that he is a consultant to, and is on the advisory committee for, Salix Pharmaceuticals Ltd., which markets Xifaxan.

Dr. Talley is also a consultant for Salix and a variety of other pharmaceutical companies, and receives financial support from several firms.

Dr. Chey reported no relevant financial disclosures for his presentation.

'What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur.' DR. SCHOENFELD

ORLANDO — A recommendation for antibiotic therapy to combat bacterial overgrowth, a stronger recommendation for antidepressants to ease symptoms, and serum testing for celiac disease are forthcoming updates to the American College of Gastroenterology's irritable bowel syndrome guidelines.

New recommendations on the diagnosis of irritable bowel syndrome (IBS) are also expected in the updated guidelines, which the college plans to publish in January 2009, with an earlier release online.

The guidelines also will recommend the addition of microscopic colitis to the differential diagnosis of IBS. This addition is based on a prospective, multicenter study that found 4% of 454 people suspected of IBS actually had microscopic colitis.

“This is definitely new … and potentially a very, very important message from this document,” Dr. William D. Chey said during a media briefing at the annual meeting of the American College of Gastroenterology.

“If a patient has diarrhea-predominant IBS and undergoes colonoscopy, it is reasonable to consider taking random biopsies to exclude microscopic colitis,” said Dr. Chey, who is professor of medicine at the University of Michigan, Ann Arbor.

Updated diagnosis recommendations will be reassuring for many clinicians, he said. “Doctors are uncomfortable with assigning a diagnosis of IBS. They are worried that they are missing something else” such as colon cancer, ulcerative colitis, or Crohn's disease.

“The reassuring bit of information that comes out of our analysis … is that the likelihood of a person who has IBS symptoms and no warning signs having some other organic diagnosis such as colon cancer, inflammatory bowel disease, or thyroid disease is no greater than in the general population,” he continued. “Although I understand why it's a concern, it is not an entirely rational concern.”

Doctors in clinical practice often characterize people with only abdominal pain as having IBS, he added. “These recommendations, based on the best available evidence, apply to people with pain and altered bowel habits.”

The link between pain and bowel disturbance is very close, Dr. Nicholas J. Talley said. “They have pain, they pass stool and get relief—that is IBS. It's absolutely obvious to me.” Dr. Talley is chair of the department of internal medicine at the Mayo Clinic, Jacksonville, Fla.

Because of a greater risk of organic disease, patients who present with IBS symptoms plus other warning signs such as unexplained weight loss, GI bleeding, or a family history of colon cancer, inflammatory bowel disease, or celiac sprue require a more detailed evaluation, Dr. Chey said.

Another new recommendation is for use of a “nonabsorbable antibiotic” to relieve IBS symptoms. The only approved antibiotic that remains in the gut to alter flora without systemic absorption is rifaximin (Xifaxan), now under investigation as a treatment for IBS. Rifaximin was found to be superior to placebo for improvement of IBS symptoms, especially bloating, in recent studies (Ann. Pharmacother. 2008;42:408–12; Adv. Med. Sci. 2007;52:139–42).

“What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur,” said Dr. Philip S. Schoenfeld, a gastroenterologist at the University of Michigan, who also spoke at the media briefing.

“There is evidence of benefit in the short term [with rifaximin]. It is critical that you know that,” Dr. Talley commented. He predicted this recommendation will be controversial because IBS is chronic and antibiotics are typically prescribed acutely.

Dr. Schoenfeld said that physicians may be concerned about increasing antibiotic resistance if the agents are given to thousands of IBS patients.

There is a greater focus on the use of antidepressants to treat IBS in the new guidelines.

“There is a stronger recommendation that tricyclic antidepressants, used in low doses before people go to sleep at night, are an effective medicine for irritable bowel syndrome,” Dr. Schoenfeld said. The agents can reduce bloating and discomfort by altering brain-gut signaling about motility and distention. He added that constipation, a side effect of tricyclic antidepressants, is actually beneficial in this population.

The authors of the guidelines also found enough evidence to support SSRIs for symptom improvement. “I want to emphasize that this does not appear to be related to depression,” Dr. Talley said. “This appears to be related to effects of these drugs either in the brain or the gut, but probably both places.”

Some treatment recommendations in the guidelines are not expected to change, such as those for treatment with loperamide (Imodium) or alosetron (Lotronex).

The new recommendation for serologic celiac disease testing is for a subset of IBS patients. “We made a much stronger recommendation for testing for celiac disease in patients with diarrhea-predominant or mixed IBS,” Dr. Chey said. “We actually came out and said serologic screening for celiac disease should be pursued.”

Evidence of benefit from probiotics is also addressed. “Every one of my patients with IBS asked about probiotics,” Dr. Talley said. “The guidelines will basically say that probiotics are efficacious, but the evidence supporting this is not as good as we would like.” The large number of probiotic products with varying degrees of efficacy precluded a stronger recommendation.

“Probiotics seem to be relatively safe as well, based on the data we have,” Dr. Talley said. “So I'm not uncomfortable with recommending a probiotic to my patients.” He added that some people are nonresponders.

In addition, recent evidence that indicates peppermint oil improves IBS symptoms will be in the update.

Dr. Schoenfeld is a consultant to, and is on the advisory committee for, Salix Pharmaceuticals Ltd., which markets Xifaxan. Dr. Talley is also a consultant for Salix and a variety of other pharmaceutical companies, and receives financial support from several firms. Dr. Chey reported no relevant financial disclosures for his presentation.

'Serologic screening for celiac disease should be pursued' in a subset of IBS patients. DR. CHEY

ORLANDO — A recommendation for antibiotic therapy to combat bacterial overgrowth, a stronger recommendation for antidepressants to ease symptoms, and serum testing for celiac disease are forthcoming updates to the American College of Gastroenterology's irritable bowel syndrome guidelines.

New recommendations on the diagnosis of irritable bowel syndrome (IBS) are also expected in the updated guidelines, which the college plans to publish in January 2009, with an earlier release online.

The guidelines also will recommend the addition of microscopic colitis to the differential diagnosis of IBS. This addition is based on a prospective, multicenter study that found 4% of 454 people suspected of IBS actually had microscopic colitis.

“This is definitely new … and potentially a very, very important message from this document,” Dr. William D. Chey said during a media briefing at the annual meeting of the American College of Gastroenterology.

“If a patient has diarrhea-predominant IBS and undergoes colonoscopy, it is reasonable to consider taking random biopsies to exclude microscopic colitis,” said Dr. Chey, who is professor of medicine at the University of Michigan, Ann Arbor.

Updated diagnosis recommendations will be reassuring for many clinicians, he said. “Doctors are uncomfortable with assigning a diagnosis of IBS. They are worried that they are missing something else” such as colon cancer, ulcerative colitis, or Crohn's disease.

“The reassuring bit of information that comes out of our analysis … is that the likelihood of a person who has IBS symptoms and no warning signs having some other organic diagnosis such as colon cancer, inflammatory bowel disease, or thyroid disease is no greater than in the general population,” he continued. “Although I understand why it's a concern, it is not an entirely rational concern.”

Doctors in clinical practice often characterize people with only abdominal pain as having IBS, he added. “These recommendations, based on the best available evidence, apply to people with pain and altered bowel habits.”

The link between pain and bowel disturbance is very close, Dr. Nicholas J. Talley said. “They have pain, they pass stool and get relief—that is IBS. It's absolutely obvious to me.” Dr. Talley is chair of the department of internal medicine at the Mayo Clinic, Jacksonville, Fla.

Because of a greater risk of organic disease, patients who present with IBS symptoms plus other warning signs such as unexplained weight loss, GI bleeding, or a family history of colon cancer, inflammatory bowel disease, or celiac sprue require a more detailed evaluation, Dr. Chey said.

Another new recommendation is for use of a “nonabsorbable antibiotic” to relieve IBS symptoms. The only approved antibiotic that remains in the gut to alter flora without systemic absorption is rifaximin (Xifaxan), now under investigation as a treatment for IBS. Rifaximin was found to be superior to placebo for improvement of IBS symptoms, especially bloating, in recent studies (Ann. Pharmacother. 2008;42:408–12; Adv. Med. Sci. 2007;52:139–42).

“What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur,” said Dr. Philip S. Schoenfeld, a gastroenterologist at the University of Michigan, who also spoke at the media briefing.

“There is evidence of benefit in the short term [with rifaximin]. It is critical that you know that,” Dr. Talley commented. He predicted this recommendation will be controversial because IBS is chronic and antibiotics are typically prescribed acutely.

Dr. Schoenfeld said that physicians may be concerned about increasing antibiotic resistance if the agents are given to thousands of IBS patients.

There is a greater focus on the use of antidepressants to treat IBS in the new guidelines.

“There is a stronger recommendation that tricyclic antidepressants, used in low doses before people go to sleep at night, are an effective medicine for irritable bowel syndrome,” Dr. Schoenfeld said. The agents can reduce bloating and discomfort by altering brain-gut signaling about motility and distention. He added that constipation, a side effect of tricyclic antidepressants, is actually beneficial in this population.

The authors of the guidelines also found enough evidence to support SSRIs for symptom improvement. “I want to emphasize that this does not appear to be related to depression,” Dr. Talley said. “This appears to be related to effects of these drugs either in the brain or the gut, but probably both places.”

Some treatment recommendations in the guidelines are not expected to change, such as those for treatment with loperamide (Imodium) or alosetron (Lotronex).

The new recommendation for serologic celiac disease testing is for a subset of IBS patients. “We made a much stronger recommendation for testing for celiac disease in patients with diarrhea-predominant or mixed IBS,” Dr. Chey said. “We actually came out and said serologic screening for celiac disease should be pursued.”

Evidence of benefit from probiotics is also addressed. “Every one of my patients with IBS asked about probiotics,” Dr. Talley said. “The guidelines will basically say that probiotics are efficacious, but the evidence supporting this is not as good as we would like.” The large number of probiotic products with varying degrees of efficacy precluded a stronger recommendation.

“Probiotics seem to be relatively safe as well, based on the data we have,” Dr. Talley said. “So I'm not uncomfortable with recommending a probiotic to my patients.” He added that some people are nonresponders.

In addition, recent evidence that indicates peppermint oil improves IBS symptoms will be in the update.

Dr. Schoenfeld is a consultant to, and is on the advisory committee for, Salix Pharmaceuticals Ltd., which markets Xifaxan. Dr. Talley is also a consultant for Salix and a variety of other pharmaceutical companies, and receives financial support from several firms. Dr. Chey reported no relevant financial disclosures for his presentation.

'Serologic screening for celiac disease should be pursued' in a subset of IBS patients. DR. CHEY

ORLANDO — A recommendation for antibiotic therapy to combat bacterial overgrowth, a stronger recommendation for antidepressants to ease symptoms, and serum testing for celiac disease are forthcoming updates to the American College of Gastroenterology's irritable bowel syndrome guidelines.

New recommendations on the diagnosis of irritable bowel syndrome (IBS) are also expected in the updated guidelines, which the college plans to publish in January 2009, with an earlier release online.

The guidelines also will recommend the addition of microscopic colitis to the differential diagnosis of IBS. This addition is based on a prospective, multicenter study that found 4% of 454 people suspected of IBS actually had microscopic colitis.

“This is definitely new … and potentially a very, very important message from this document,” Dr. William D. Chey said during a media briefing at the annual meeting of the American College of Gastroenterology.

“If a patient has diarrhea-predominant IBS and undergoes colonoscopy, it is reasonable to consider taking random biopsies to exclude microscopic colitis,” said Dr. Chey, who is professor of medicine at the University of Michigan, Ann Arbor.

Updated diagnosis recommendations will be reassuring for many clinicians, he said. “Doctors are uncomfortable with assigning a diagnosis of IBS. They are worried that they are missing something else” such as colon cancer, ulcerative colitis, or Crohn's disease.

“The reassuring bit of information that comes out of our analysis … is that the likelihood of a person who has IBS symptoms and no warning signs having some other organic diagnosis such as colon cancer, inflammatory bowel disease, or thyroid disease is no greater than in the general population,” he continued. “Although I understand why it's a concern, it is not an entirely rational concern.”

Doctors in clinical practice often characterize people with only abdominal pain as having IBS, he added. “These recommendations, based on the best available evidence, apply to people with pain and altered bowel habits.”

The link between pain and bowel disturbance is very close, Dr. Nicholas J. Talley said. “They have pain, they pass stool and get relief—that is IBS. It's absolutely obvious to me.” Dr. Talley is chair of the department of internal medicine at the Mayo Clinic, Jacksonville, Fla.

Because of a greater risk of organic disease, patients who present with IBS symptoms plus other warning signs such as unexplained weight loss, GI bleeding, or a family history of colon cancer, inflammatory bowel disease, or celiac sprue require a more detailed evaluation, Dr. Chey said.

Another new recommendation is for use of a “nonabsorbable antibiotic” to relieve IBS symptoms. The only approved antibiotic that remains in the gut to alter flora without systemic absorption is rifaximin (Xifaxan), now under investigation as a treatment for IBS. Rifaximin was found to be superior to placebo for improvement of IBS symptoms, especially bloating, in recent studies (Ann. Pharmacother. 2008;42:408–12; Adv. Med. Sci. 2007;52:139–42).

“What is uncertain is how long the symptom relief lasts and what you should do if the symptoms recur,” said Dr. Philip S. Schoenfeld, a gastroenterologist at the University of Michigan, who also spoke at the media briefing.

“There is evidence of benefit in the short term [with rifaximin]. It is critical that you know that,” Dr. Talley commented. He predicted this recommendation will be controversial because IBS is chronic and antibiotics are typically prescribed acutely.

Dr. Schoenfeld said that physicians may be concerned about increasing antibiotic resistance if the agents are given to thousands of IBS patients.

There is a greater focus on the use of antidepressants to treat IBS in the new guidelines.

“There is a stronger recommendation that tricyclic antidepressants, used in low doses before people go to sleep at night, are an effective medicine for irritable bowel syndrome,” Dr. Schoenfeld said. The agents can reduce bloating and discomfort by altering brain-gut signaling about motility and distention. He added that constipation, a side effect of tricyclic antidepressants, is actually beneficial in this population.

The authors of the guidelines also found enough evidence to support SSRIs for symptom improvement. “I want to emphasize that this does not appear to be related to depression,” Dr. Talley said. “This appears to be related to effects of these drugs either in the brain or the gut, but probably both places.”

Some treatment recommendations in the guidelines are not expected to change, such as those for treatment with loperamide (Imodium) or alosetron (Lotronex).

The new recommendation for serologic celiac disease testing is for a subset of IBS patients. “We made a much stronger recommendation for testing for celiac disease in patients with diarrhea-predominant or mixed IBS,” Dr. Chey said. “We actually came out and said serologic screening for celiac disease should be pursued.”

Evidence of benefit from probiotics is also addressed. “Every one of my patients with IBS asked about probiotics,” Dr. Talley said. “The guidelines will basically say that probiotics are efficacious, but the evidence supporting this is not as good as we would like.” The large number of probiotic products with varying degrees of efficacy precluded a stronger recommendation.

“Probiotics seem to be relatively safe as well, based on the data we have,” Dr. Talley said. “So I'm not uncomfortable with recommending a probiotic to my patients.” He added that some people are nonresponders.

In addition, recent evidence that indicates peppermint oil improves IBS symptoms will be in the update.

Dr. Schoenfeld is a consultant to, and is on the advisory committee for, Salix Pharmaceuticals Ltd., which markets Xifaxan. Dr. Talley is also a consultant for Salix and a variety of other pharmaceutical companies, and receives financial support from several firms. Dr. Chey reported no relevant financial disclosures for his presentation.

'Serologic screening for celiac disease should be pursued' in a subset of IBS patients. DR. CHEY

ORLANDO — Infliximab, alone or in combination with azathioprine, was superior to azathioprine monotherapy for inducing steroid-free remission and mucosal healing in a study of 508 patients with moderate to severe Crohn's disease.

Many physicians who treat Crohn's disease patients with the anti-tumor necrosis factor-? agent infliximab (Remicade) do not use it first line, Dr. William J. Sandborn said. However, based on the study findings, doctors might want to consider prescribing the agent sooner, forgoing the classic step-up therapy, he said.

“We have compelling evidence that anti-tumor necrosis factor therapy should be considered in patients [earlier],” Dr. Sandborn said at the annual meeting of the American College of Gastroenterology.

The multicenter, phase IIIb Study of Biologic and Immunomodulator-Naive Patients with Crohn's Disease (SONIC) included people who had previously failed 5-aminosalicylate therapy and/or who were steroid dependent. A total of 41% of participants were taking steroids at baseline; 52% were men, and the mean age was 34 years. The median baseline Crohn's Disease Activity Index was 275.

As the study name suggests, participants had no prior exposure to biologic or immunomodulator agents, including azathioprine (Imuran), 6-mercaptopurine, and methotrexate. A meeting attendee commented that many previous trials showed no significant benefit when azathioprine was added to infliximab. “All other trials were retrospective and looked at patients who failed azathioprine previously, whereas if you are naive to the drugs, you have a better chance of getting synergy,” Dr. Sandborn replied. Use of azathioprine in the United States is off label for Crohn's disease.

“As early as week 6, infliximab (either as monotherapy or in combination with azathioprine) was superior to azathioprine for corticosteroid remission, and in addition the combination was also superior to infliximab monotherapy after 10 weeks,” said Dr. Sandborn, professor of medicine and vice chair of the division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Participants were randomized into three groups. In all, 170 received azathioprine 2.5 mg/kg per day plus a placebo infusion; another 169 received a placebo capsule and infliximab 5 mg/kg infusions; and the 169 others in the combination group received azathioprine 2.5 mg/kg and infliximab 5 mg/kg infusions. The infusions were given at weeks 0, 2, and 6, and every 8 weeks thereafter through 30 weeks.

At 26 weeks, corticosteroid-free clinical remission was achieved by 31% of the azathioprine monotherapy group, 44% of the infliximab monotherapy patients, and 57% of the combination group.

Also at 26 weeks, a secondary end point of mucosal healing was achieved by 17% of the azathioprine monotherapy group, 30% of the infliximab monotherapy patients, and 44% of the combination group.

“Infliximab and azathioprine, when started together, are superior to azathioprine alone. Infliximab monotherapy was superior to azathioprine monotherapy,” said Dr. Sandborn, the principal investigator for the SONIC trial. Centocor Inc., manufacturer of infliximab, funded this research. Mayo Clinic receives consulting fees for work provided by Dr. Sandborn from Centocor, Abbott Laboratories, and UCB Pharma. Dr. Sandborn had no disclosures related to azathioprine.

A subgroup of 204 patients had both elevated C-reactive protein levels and lesions on baseline examination. In this subgroup, corticosteroid-free clinical remission was attained by 28% of the azathioprine monotherapy group, 57% of the infliximab monotherapy group, and 69% of the combination group. Dr. Sandborn said this was “a very significant finding.”

At week 30, a higher proportion of patients in the azathioprine monotherapy group, 24%, experienced at least one serious adverse event, compared with 16% of the infliximab monotherapy group and 14% of the combination therapy group.

The rate of serious infections was relatively low and was similar across treatment groups, Dr. Sandborn said. Specifically, eight serious infections were reported in the azathioprine monotherapy group, four occurred in the infliximab monotherapy group, and there were six in the combination therapy group.

'Anti-tumor necrosis factor therapy should be considered in patients [earlier].' DR. SANDBORN

ORLANDO — Infliximab, alone or in combination with azathioprine, was superior to azathioprine monotherapy for inducing steroid-free remission and mucosal healing in a study of 508 patients with moderate to severe Crohn's disease.

Many physicians who treat Crohn's disease patients with the anti-tumor necrosis factor-? agent infliximab (Remicade) do not use it first line, Dr. William J. Sandborn said. However, based on the study findings, doctors might want to consider prescribing the agent sooner, forgoing the classic step-up therapy, he said.

“We have compelling evidence that anti-tumor necrosis factor therapy should be considered in patients [earlier],” Dr. Sandborn said at the annual meeting of the American College of Gastroenterology.

The multicenter, phase IIIb Study of Biologic and Immunomodulator-Naive Patients with Crohn's Disease (SONIC) included people who had previously failed 5-aminosalicylate therapy and/or who were steroid dependent. A total of 41% of participants were taking steroids at baseline; 52% were men, and the mean age was 34 years. The median baseline Crohn's Disease Activity Index was 275.

As the study name suggests, participants had no prior exposure to biologic or immunomodulator agents, including azathioprine (Imuran), 6-mercaptopurine, and methotrexate. A meeting attendee commented that many previous trials showed no significant benefit when azathioprine was added to infliximab. “All other trials were retrospective and looked at patients who failed azathioprine previously, whereas if you are naive to the drugs, you have a better chance of getting synergy,” Dr. Sandborn replied. Use of azathioprine in the United States is off label for Crohn's disease.

“As early as week 6, infliximab (either as monotherapy or in combination with azathioprine) was superior to azathioprine for corticosteroid remission, and in addition the combination was also superior to infliximab monotherapy after 10 weeks,” said Dr. Sandborn, professor of medicine and vice chair of the division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Participants were randomized into three groups. In all, 170 received azathioprine 2.5 mg/kg per day plus a placebo infusion; another 169 received a placebo capsule and infliximab 5 mg/kg infusions; and the 169 others in the combination group received azathioprine 2.5 mg/kg and infliximab 5 mg/kg infusions. The infusions were given at weeks 0, 2, and 6, and every 8 weeks thereafter through 30 weeks.

At 26 weeks, corticosteroid-free clinical remission was achieved by 31% of the azathioprine monotherapy group, 44% of the infliximab monotherapy patients, and 57% of the combination group.

Also at 26 weeks, a secondary end point of mucosal healing was achieved by 17% of the azathioprine monotherapy group, 30% of the infliximab monotherapy patients, and 44% of the combination group.

“Infliximab and azathioprine, when started together, are superior to azathioprine alone. Infliximab monotherapy was superior to azathioprine monotherapy,” said Dr. Sandborn, the principal investigator for the SONIC trial. Centocor Inc., manufacturer of infliximab, funded this research. Mayo Clinic receives consulting fees for work provided by Dr. Sandborn from Centocor, Abbott Laboratories, and UCB Pharma. Dr. Sandborn had no disclosures related to azathioprine.

A subgroup of 204 patients had both elevated C-reactive protein levels and lesions on baseline examination. In this subgroup, corticosteroid-free clinical remission was attained by 28% of the azathioprine monotherapy group, 57% of the infliximab monotherapy group, and 69% of the combination group. Dr. Sandborn said this was “a very significant finding.”

At week 30, a higher proportion of patients in the azathioprine monotherapy group, 24%, experienced at least one serious adverse event, compared with 16% of the infliximab monotherapy group and 14% of the combination therapy group.

The rate of serious infections was relatively low and was similar across treatment groups, Dr. Sandborn said. Specifically, eight serious infections were reported in the azathioprine monotherapy group, four occurred in the infliximab monotherapy group, and there were six in the combination therapy group.

'Anti-tumor necrosis factor therapy should be considered in patients [earlier].' DR. SANDBORN

ORLANDO — Infliximab, alone or in combination with azathioprine, was superior to azathioprine monotherapy for inducing steroid-free remission and mucosal healing in a study of 508 patients with moderate to severe Crohn's disease.

Many physicians who treat Crohn's disease patients with the anti-tumor necrosis factor-? agent infliximab (Remicade) do not use it first line, Dr. William J. Sandborn said. However, based on the study findings, doctors might want to consider prescribing the agent sooner, forgoing the classic step-up therapy, he said.

“We have compelling evidence that anti-tumor necrosis factor therapy should be considered in patients [earlier],” Dr. Sandborn said at the annual meeting of the American College of Gastroenterology.

The multicenter, phase IIIb Study of Biologic and Immunomodulator-Naive Patients with Crohn's Disease (SONIC) included people who had previously failed 5-aminosalicylate therapy and/or who were steroid dependent. A total of 41% of participants were taking steroids at baseline; 52% were men, and the mean age was 34 years. The median baseline Crohn's Disease Activity Index was 275.

As the study name suggests, participants had no prior exposure to biologic or immunomodulator agents, including azathioprine (Imuran), 6-mercaptopurine, and methotrexate. A meeting attendee commented that many previous trials showed no significant benefit when azathioprine was added to infliximab. “All other trials were retrospective and looked at patients who failed azathioprine previously, whereas if you are naive to the drugs, you have a better chance of getting synergy,” Dr. Sandborn replied. Use of azathioprine in the United States is off label for Crohn's disease.

“As early as week 6, infliximab (either as monotherapy or in combination with azathioprine) was superior to azathioprine for corticosteroid remission, and in addition the combination was also superior to infliximab monotherapy after 10 weeks,” said Dr. Sandborn, professor of medicine and vice chair of the division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn.

Participants were randomized into three groups. In all, 170 received azathioprine 2.5 mg/kg per day plus a placebo infusion; another 169 received a placebo capsule and infliximab 5 mg/kg infusions; and the 169 others in the combination group received azathioprine 2.5 mg/kg and infliximab 5 mg/kg infusions. The infusions were given at weeks 0, 2, and 6, and every 8 weeks thereafter through 30 weeks.

At 26 weeks, corticosteroid-free clinical remission was achieved by 31% of the azathioprine monotherapy group, 44% of the infliximab monotherapy patients, and 57% of the combination group.

Also at 26 weeks, a secondary end point of mucosal healing was achieved by 17% of the azathioprine monotherapy group, 30% of the infliximab monotherapy patients, and 44% of the combination group.

“Infliximab and azathioprine, when started together, are superior to azathioprine alone. Infliximab monotherapy was superior to azathioprine monotherapy,” said Dr. Sandborn, the principal investigator for the SONIC trial. Centocor Inc., manufacturer of infliximab, funded this research. Mayo Clinic receives consulting fees for work provided by Dr. Sandborn from Centocor, Abbott Laboratories, and UCB Pharma. Dr. Sandborn had no disclosures related to azathioprine.

A subgroup of 204 patients had both elevated C-reactive protein levels and lesions on baseline examination. In this subgroup, corticosteroid-free clinical remission was attained by 28% of the azathioprine monotherapy group, 57% of the infliximab monotherapy group, and 69% of the combination group. Dr. Sandborn said this was “a very significant finding.”

At week 30, a higher proportion of patients in the azathioprine monotherapy group, 24%, experienced at least one serious adverse event, compared with 16% of the infliximab monotherapy group and 14% of the combination therapy group.

The rate of serious infections was relatively low and was similar across treatment groups, Dr. Sandborn said. Specifically, eight serious infections were reported in the azathioprine monotherapy group, four occurred in the infliximab monotherapy group, and there were six in the combination therapy group.

'Anti-tumor necrosis factor therapy should be considered in patients [earlier].' DR. SANDBORN

MONTREAL — The cutaneous features of dermatomyositis often hold the key to making its definitive diagnosis, without having to resort to a muscle biopsy.

So key are the cutaneous manifestations that dermatologists can be a useful resource for rheumatologists faced with a possibly affected patient. “We play a critical role in diagnosing dermatomyositis—we know the visual diagnosis,” Dr. Victoria P. Werth said. The incidence is increasing and the early presentation is often subtle. “We are seeing more of these patients, and they are confusing our rheumatology colleagues.”

Patients can present differently to the dermatology and rheumatology departments at the University of Pennsylvania, Philadelphia, according to a study by Dr. Werth and colleagues (J. Am. Acad. Dermatol. 2007;57:937–43). The degree of skin and/or muscle involvement was the primary distinction among 131 patients who consulted dermatology, 58 who saw rheumatologists, and 13 seen by both specialties.

A correct diagnosis is crucial because dermatomyositis can affect many organ systems beyond the skin, including lung, heart, and muscle. In addition, patients need to be monitored regularly over the long term for malignancies (Ann. Intern. Med. 2001;134:1087–95). Researchers found a relative risk of 2.4 for malignancy among dermatomyositis patients, compared with those who had polymyositis in this retrospective study of 537 patients with biopsy-proven myopathy.

“The adjusted relative risk for malignancy was higher in the first 3 years after diagnosis with dermatomyositis, including for lung, ovary, pancreatic, and other cancers,” Dr. Werth said at the annual conference of the Canadian Dermatology Association. “Risk remains high for years.” She recommended evaluation at least annually.

Cutaneous features include scale, pruritus, and Gottron's papules. A violaceous erythema in a photodistribution pattern or confluent erythema is possible. Also look for Gottron's sign, a symmetrical, macular erythema with or without edema located on the dorsal hand, interphalangeal joints, elbow, and/or medial ankle. Subepidermal vesicles or blisters, vasculopathy, and poikiloderma are among the secondary skin features.

A meeting attendee commented that many patients have extensive scalp pruritus. “Scalp dermatomyositis is very resistant [to treatment]. I have patients where everything else gets better,” Dr. Werth said. “Pruritus is a very big problem. And some patients with only scalp involvement early on get misdiagnosed as seborrheic dermatitis,” added Dr. Werth, who is on the dermatology and medicine faculties at the university.

Dermatomyositis patients often get nasolabial fold involvement, a distinction from systemic lupus erythematous patients. In addition, “nail fold findings are critical,” she said. “It is very important to look at the hands of all our dermatomyositis patients.” Periungual infarcts and telangiectasias are among the characteristic signs.

A definitive dermatomyositis diagnosis includes the typical skin rash and at least three of the following criteria: an abnormal muscle biopsy, abnormal electromyogram (EMG), elevated skeletal muscle-derived enzymes, or symmetric proximal weakness with or without dysphagia or respiratory muscle involvement.

Physicians often ask Dr. Werth if a muscle biopsy is required. “By and large, we can make our diagnosis with a skin biopsy,” she said. Skin findings and an abnormal creatine kinase, EMG, or MRI result are generally sufficient. Make sure to document the muscle disease if a patient is symptomatic, she added. Another attendee asked how to determine if muscle weakness is caused by the disease or by steroid treatment. “You sometimes have to do an MRI,” Dr. Werth replied. “You can also taper the steroid and see if they get better. EMGs can also be helpful. If the patient lets you do a [skin] biopsy, you at least know what you are dealing with,” Dr. Werth said. “We had one patient who we thought had psoriasis—but it was dermatomyositis that had targeted his hand joints.”

Systemic involvement can be quite extensive, Dr. Werth said. Interstitial lung disease, for example, is present in about a quarter of patients. “Cardiac involvement is less common, but still worth looking for,” said Dr. Werth, who is a consultant for Centocor Inc., Aegis Pharmaceutical Ltd., Celgene Corp., Kemia Inc., and Teva Pharmaceutical Industries Ltd.

Topical antipruritic agents and/or corticosteroids are often prescribed as first-line agents for localized skin dermatomyositis, whereas systemic therapy is typically reserved for more widespread disease, according to a review article by Dr. Werth and Rhonda D. Quain, who is now a resident at Mount Sinai School of Medicine, New York (Am. J. Clin. Dermatol. 2006;7:341–51). Antimalarial agents are often used to treat significant skin disease, as are other anti-inflammatory agents, systemic corticosteroids, corticosteroid-sparing immunosuppressants, and more recently, biologics and intravenous immunoglobulin (IVIG).

Dr. Werth cautioned about IVIG in dermatomyositis, however. She cited the case of a hyperviscous dermatomyositis patient who experienced a stroke while on IVIG therapy.

Cutaneous features such as violaceous erythema and Gottron's papules can hold the key to diagnosing dermatomyositis. Courtesy Dr. Victoria P. Werth

MONTREAL — The cutaneous features of dermatomyositis often hold the key to making its definitive diagnosis, without having to resort to a muscle biopsy.

So key are the cutaneous manifestations that dermatologists can be a useful resource for rheumatologists faced with a possibly affected patient. “We play a critical role in diagnosing dermatomyositis—we know the visual diagnosis,” Dr. Victoria P. Werth said. The incidence is increasing and the early presentation is often subtle. “We are seeing more of these patients, and they are confusing our rheumatology colleagues.”

Patients can present differently to the dermatology and rheumatology departments at the University of Pennsylvania, Philadelphia, according to a study by Dr. Werth and colleagues (J. Am. Acad. Dermatol. 2007;57:937–43). The degree of skin and/or muscle involvement was the primary distinction among 131 patients who consulted dermatology, 58 who saw rheumatologists, and 13 seen by both specialties.

A correct diagnosis is crucial because dermatomyositis can affect many organ systems beyond the skin, including lung, heart, and muscle. In addition, patients need to be monitored regularly over the long term for malignancies (Ann. Intern. Med. 2001;134:1087–95). Researchers found a relative risk of 2.4 for malignancy among dermatomyositis patients, compared with those who had polymyositis in this retrospective study of 537 patients with biopsy-proven myopathy.

“The adjusted relative risk for malignancy was higher in the first 3 years after diagnosis with dermatomyositis, including for lung, ovary, pancreatic, and other cancers,” Dr. Werth said at the annual conference of the Canadian Dermatology Association. “Risk remains high for years.” She recommended evaluation at least annually.

Cutaneous features include scale, pruritus, and Gottron's papules. A violaceous erythema in a photodistribution pattern or confluent erythema is possible. Also look for Gottron's sign, a symmetrical, macular erythema with or without edema located on the dorsal hand, interphalangeal joints, elbow, and/or medial ankle. Subepidermal vesicles or blisters, vasculopathy, and poikiloderma are among the secondary skin features.

A meeting attendee commented that many patients have extensive scalp pruritus. “Scalp dermatomyositis is very resistant [to treatment]. I have patients where everything else gets better,” Dr. Werth said. “Pruritus is a very big problem. And some patients with only scalp involvement early on get misdiagnosed as seborrheic dermatitis,” added Dr. Werth, who is on the dermatology and medicine faculties at the university.

Dermatomyositis patients often get nasolabial fold involvement, a distinction from systemic lupus erythematous patients. In addition, “nail fold findings are critical,” she said. “It is very important to look at the hands of all our dermatomyositis patients.” Periungual infarcts and telangiectasias are among the characteristic signs.

A definitive dermatomyositis diagnosis includes the typical skin rash and at least three of the following criteria: an abnormal muscle biopsy, abnormal electromyogram (EMG), elevated skeletal muscle-derived enzymes, or symmetric proximal weakness with or without dysphagia or respiratory muscle involvement.

Physicians often ask Dr. Werth if a muscle biopsy is required. “By and large, we can make our diagnosis with a skin biopsy,” she said. Skin findings and an abnormal creatine kinase, EMG, or MRI result are generally sufficient. Make sure to document the muscle disease if a patient is symptomatic, she added. Another attendee asked how to determine if muscle weakness is caused by the disease or by steroid treatment. “You sometimes have to do an MRI,” Dr. Werth replied. “You can also taper the steroid and see if they get better. EMGs can also be helpful. If the patient lets you do a [skin] biopsy, you at least know what you are dealing with,” Dr. Werth said. “We had one patient who we thought had psoriasis—but it was dermatomyositis that had targeted his hand joints.”

Systemic involvement can be quite extensive, Dr. Werth said. Interstitial lung disease, for example, is present in about a quarter of patients. “Cardiac involvement is less common, but still worth looking for,” said Dr. Werth, who is a consultant for Centocor Inc., Aegis Pharmaceutical Ltd., Celgene Corp., Kemia Inc., and Teva Pharmaceutical Industries Ltd.

Topical antipruritic agents and/or corticosteroids are often prescribed as first-line agents for localized skin dermatomyositis, whereas systemic therapy is typically reserved for more widespread disease, according to a review article by Dr. Werth and Rhonda D. Quain, who is now a resident at Mount Sinai School of Medicine, New York (Am. J. Clin. Dermatol. 2006;7:341–51). Antimalarial agents are often used to treat significant skin disease, as are other anti-inflammatory agents, systemic corticosteroids, corticosteroid-sparing immunosuppressants, and more recently, biologics and intravenous immunoglobulin (IVIG).

Dr. Werth cautioned about IVIG in dermatomyositis, however. She cited the case of a hyperviscous dermatomyositis patient who experienced a stroke while on IVIG therapy.

Cutaneous features such as violaceous erythema and Gottron's papules can hold the key to diagnosing dermatomyositis. Courtesy Dr. Victoria P. Werth

MONTREAL — The cutaneous features of dermatomyositis often hold the key to making its definitive diagnosis, without having to resort to a muscle biopsy.

So key are the cutaneous manifestations that dermatologists can be a useful resource for rheumatologists faced with a possibly affected patient. “We play a critical role in diagnosing dermatomyositis—we know the visual diagnosis,” Dr. Victoria P. Werth said. The incidence is increasing and the early presentation is often subtle. “We are seeing more of these patients, and they are confusing our rheumatology colleagues.”

Patients can present differently to the dermatology and rheumatology departments at the University of Pennsylvania, Philadelphia, according to a study by Dr. Werth and colleagues (J. Am. Acad. Dermatol. 2007;57:937–43). The degree of skin and/or muscle involvement was the primary distinction among 131 patients who consulted dermatology, 58 who saw rheumatologists, and 13 seen by both specialties.

A correct diagnosis is crucial because dermatomyositis can affect many organ systems beyond the skin, including lung, heart, and muscle. In addition, patients need to be monitored regularly over the long term for malignancies (Ann. Intern. Med. 2001;134:1087–95). Researchers found a relative risk of 2.4 for malignancy among dermatomyositis patients, compared with those who had polymyositis in this retrospective study of 537 patients with biopsy-proven myopathy.

“The adjusted relative risk for malignancy was higher in the first 3 years after diagnosis with dermatomyositis, including for lung, ovary, pancreatic, and other cancers,” Dr. Werth said at the annual conference of the Canadian Dermatology Association. “Risk remains high for years.” She recommended evaluation at least annually.

Cutaneous features include scale, pruritus, and Gottron's papules. A violaceous erythema in a photodistribution pattern or confluent erythema is possible. Also look for Gottron's sign, a symmetrical, macular erythema with or without edema located on the dorsal hand, interphalangeal joints, elbow, and/or medial ankle. Subepidermal vesicles or blisters, vasculopathy, and poikiloderma are among the secondary skin features.

A meeting attendee commented that many patients have extensive scalp pruritus. “Scalp dermatomyositis is very resistant [to treatment]. I have patients where everything else gets better,” Dr. Werth said. “Pruritus is a very big problem. And some patients with only scalp involvement early on get misdiagnosed as seborrheic dermatitis,” added Dr. Werth, who is on the dermatology and medicine faculties at the university.

Dermatomyositis patients often get nasolabial fold involvement, a distinction from systemic lupus erythematous patients. In addition, “nail fold findings are critical,” she said. “It is very important to look at the hands of all our dermatomyositis patients.” Periungual infarcts and telangiectasias are among the characteristic signs.

A definitive dermatomyositis diagnosis includes the typical skin rash and at least three of the following criteria: an abnormal muscle biopsy, abnormal electromyogram (EMG), elevated skeletal muscle-derived enzymes, or symmetric proximal weakness with or without dysphagia or respiratory muscle involvement.

Physicians often ask Dr. Werth if a muscle biopsy is required. “By and large, we can make our diagnosis with a skin biopsy,” she said. Skin findings and an abnormal creatine kinase, EMG, or MRI result are generally sufficient. Make sure to document the muscle disease if a patient is symptomatic, she added. Another attendee asked how to determine if muscle weakness is caused by the disease or by steroid treatment. “You sometimes have to do an MRI,” Dr. Werth replied. “You can also taper the steroid and see if they get better. EMGs can also be helpful. If the patient lets you do a [skin] biopsy, you at least know what you are dealing with,” Dr. Werth said. “We had one patient who we thought had psoriasis—but it was dermatomyositis that had targeted his hand joints.”

Systemic involvement can be quite extensive, Dr. Werth said. Interstitial lung disease, for example, is present in about a quarter of patients. “Cardiac involvement is less common, but still worth looking for,” said Dr. Werth, who is a consultant for Centocor Inc., Aegis Pharmaceutical Ltd., Celgene Corp., Kemia Inc., and Teva Pharmaceutical Industries Ltd.

Topical antipruritic agents and/or corticosteroids are often prescribed as first-line agents for localized skin dermatomyositis, whereas systemic therapy is typically reserved for more widespread disease, according to a review article by Dr. Werth and Rhonda D. Quain, who is now a resident at Mount Sinai School of Medicine, New York (Am. J. Clin. Dermatol. 2006;7:341–51). Antimalarial agents are often used to treat significant skin disease, as are other anti-inflammatory agents, systemic corticosteroids, corticosteroid-sparing immunosuppressants, and more recently, biologics and intravenous immunoglobulin (IVIG).

Dr. Werth cautioned about IVIG in dermatomyositis, however. She cited the case of a hyperviscous dermatomyositis patient who experienced a stroke while on IVIG therapy.

Cutaneous features such as violaceous erythema and Gottron's papules can hold the key to diagnosing dermatomyositis. Courtesy Dr. Victoria P. Werth

MIAMI — A “progressive discipline” system of warnings and suggestions for improvement before firing an underperforming employee maximizes chances of winning a wrongful termination lawsuit, according to a labor and employee attorney.

In addition, perform regular and honest performance evaluations and keep all employee documents under lock and key.

“I suggest to my clients that they do not fire someone until there is enough of a paper trail,” said Chad K. Lang, a labor and employee attorney practicing in Miami.

“Progressive discipline … is about fairness. The No. 1 reason employees file lawsuits is they believe they were not treated fairly, regardless of how many warnings you gave them. They truly believe they are right,” Mr. Lang said.

There is no legal requirement for progressive discipline, but it will look “very fair to a jury.” It will be perceived as, “We gave them benefit of the doubt, they chose not to listen, and we had to let them go.”

Avoid oral warnings about performance, Mr. Lang said. But if an initial warning is spoken, document it in writing afterward. Write, for example, I met with him on this date, we discussed this, and this is what I asked him to improve. E-mail is acceptable. For example, send an e-mail stating, “Thank you for meeting with me today. This is what we discussed.”

Subsequent warnings are more formal and always should be in writing, Mr. Lang said at a pediatric update sponsored by Miami Children's Hospital.

Have a witness in the room when presenting an employee with a written performance warning, Mr. Lang suggested. “A lot of people do these in a closed-door situation.” The presence of a manager or supervisor is recommended, preferably one of the same gender as the employee in question to avoid allegations of sexual harassment before termination.

Link the written warning to prior oral discussions and require the employee to sign and date it. “A lot of times, people remember the signature but forget to date it,” Mr. Lang said. “They might countersue and say they signed it at different time.”

If an employee refuses to sign the written warning, note this, sign and date it, and have witness do the same. “The witness does not need to say a word. They are observers, so if it comes down to it, it does not become a 'he said, she said' situation.”

Employees also should sign an employee handbook acknowledgment form, Mr. Lang said. “An employee will most likely lie and say [she] never received it.”

A written company policy should state that these progressive steps are a guideline and, in some instances, there will be immediate termination, Mr. Lang said. The employee handbook should include an “at-will” employee policy. This implies there is no contract for you to keep them.

Honest, written performance evaluations for all employees are another protection against a future lawsuit, Mr. Lang said. “A lukewarm evaluation will not help if you fire them for doing a poor job. If you are going to take the time to do these, tell the truth and be accurate.”

Many employers tie evaluation scores to salary and bonus pay. It will look inconsistent to a judge or jury, however, if an underperformer gets the same raise as another employee doing well. “If it goes to disposition, they will ask why you gave an underperformer a raise in the first place, and then why was it equal to someone you did not fire,” Mr. Lang said.

A final piece of advice is to have a specific document retention strategy in your office policies, Mr. Lang said.

“This is where lawsuits are won and lost nowadays.” It is advantageous, for example, to state that all e-mail messages are automatically deleted after 6 months or 1 year.

“Otherwise, a judge or jury can deem failure to preserve electronic records “willful spoliation.” “Adverse jury inference instructs the jury to assume the spoliation of documents presumes they were harmful to the defendant's case.”

MIAMI — A “progressive discipline” system of warnings and suggestions for improvement before firing an underperforming employee maximizes chances of winning a wrongful termination lawsuit, according to a labor and employee attorney.

In addition, perform regular and honest performance evaluations and keep all employee documents under lock and key.

“I suggest to my clients that they do not fire someone until there is enough of a paper trail,” said Chad K. Lang, a labor and employee attorney practicing in Miami.

“Progressive discipline … is about fairness. The No. 1 reason employees file lawsuits is they believe they were not treated fairly, regardless of how many warnings you gave them. They truly believe they are right,” Mr. Lang said.

There is no legal requirement for progressive discipline, but it will look “very fair to a jury.” It will be perceived as, “We gave them benefit of the doubt, they chose not to listen, and we had to let them go.”

Avoid oral warnings about performance, Mr. Lang said. But if an initial warning is spoken, document it in writing afterward. Write, for example, I met with him on this date, we discussed this, and this is what I asked him to improve. E-mail is acceptable. For example, send an e-mail stating, “Thank you for meeting with me today. This is what we discussed.”

Subsequent warnings are more formal and always should be in writing, Mr. Lang said at a pediatric update sponsored by Miami Children's Hospital.

Have a witness in the room when presenting an employee with a written performance warning, Mr. Lang suggested. “A lot of people do these in a closed-door situation.” The presence of a manager or supervisor is recommended, preferably one of the same gender as the employee in question to avoid allegations of sexual harassment before termination.

Link the written warning to prior oral discussions and require the employee to sign and date it. “A lot of times, people remember the signature but forget to date it,” Mr. Lang said. “They might countersue and say they signed it at different time.”

If an employee refuses to sign the written warning, note this, sign and date it, and have witness do the same. “The witness does not need to say a word. They are observers, so if it comes down to it, it does not become a 'he said, she said' situation.”

Employees also should sign an employee handbook acknowledgment form, Mr. Lang said. “An employee will most likely lie and say [she] never received it.”

A written company policy should state that these progressive steps are a guideline and, in some instances, there will be immediate termination, Mr. Lang said. The employee handbook should include an “at-will” employee policy. This implies there is no contract for you to keep them.

Honest, written performance evaluations for all employees are another protection against a future lawsuit, Mr. Lang said. “A lukewarm evaluation will not help if you fire them for doing a poor job. If you are going to take the time to do these, tell the truth and be accurate.”

Many employers tie evaluation scores to salary and bonus pay. It will look inconsistent to a judge or jury, however, if an underperformer gets the same raise as another employee doing well. “If it goes to disposition, they will ask why you gave an underperformer a raise in the first place, and then why was it equal to someone you did not fire,” Mr. Lang said.

A final piece of advice is to have a specific document retention strategy in your office policies, Mr. Lang said.

“This is where lawsuits are won and lost nowadays.” It is advantageous, for example, to state that all e-mail messages are automatically deleted after 6 months or 1 year.

“Otherwise, a judge or jury can deem failure to preserve electronic records “willful spoliation.” “Adverse jury inference instructs the jury to assume the spoliation of documents presumes they were harmful to the defendant's case.”

MIAMI — A “progressive discipline” system of warnings and suggestions for improvement before firing an underperforming employee maximizes chances of winning a wrongful termination lawsuit, according to a labor and employee attorney.

In addition, perform regular and honest performance evaluations and keep all employee documents under lock and key.

“I suggest to my clients that they do not fire someone until there is enough of a paper trail,” said Chad K. Lang, a labor and employee attorney practicing in Miami.

“Progressive discipline … is about fairness. The No. 1 reason employees file lawsuits is they believe they were not treated fairly, regardless of how many warnings you gave them. They truly believe they are right,” Mr. Lang said.

There is no legal requirement for progressive discipline, but it will look “very fair to a jury.” It will be perceived as, “We gave them benefit of the doubt, they chose not to listen, and we had to let them go.”

Avoid oral warnings about performance, Mr. Lang said. But if an initial warning is spoken, document it in writing afterward. Write, for example, I met with him on this date, we discussed this, and this is what I asked him to improve. E-mail is acceptable. For example, send an e-mail stating, “Thank you for meeting with me today. This is what we discussed.”

Subsequent warnings are more formal and always should be in writing, Mr. Lang said at a pediatric update sponsored by Miami Children's Hospital.

Have a witness in the room when presenting an employee with a written performance warning, Mr. Lang suggested. “A lot of people do these in a closed-door situation.” The presence of a manager or supervisor is recommended, preferably one of the same gender as the employee in question to avoid allegations of sexual harassment before termination.

Link the written warning to prior oral discussions and require the employee to sign and date it. “A lot of times, people remember the signature but forget to date it,” Mr. Lang said. “They might countersue and say they signed it at different time.”

If an employee refuses to sign the written warning, note this, sign and date it, and have witness do the same. “The witness does not need to say a word. They are observers, so if it comes down to it, it does not become a 'he said, she said' situation.”

Employees also should sign an employee handbook acknowledgment form, Mr. Lang said. “An employee will most likely lie and say [she] never received it.”

A written company policy should state that these progressive steps are a guideline and, in some instances, there will be immediate termination, Mr. Lang said. The employee handbook should include an “at-will” employee policy. This implies there is no contract for you to keep them.

Honest, written performance evaluations for all employees are another protection against a future lawsuit, Mr. Lang said. “A lukewarm evaluation will not help if you fire them for doing a poor job. If you are going to take the time to do these, tell the truth and be accurate.”

Many employers tie evaluation scores to salary and bonus pay. It will look inconsistent to a judge or jury, however, if an underperformer gets the same raise as another employee doing well. “If it goes to disposition, they will ask why you gave an underperformer a raise in the first place, and then why was it equal to someone you did not fire,” Mr. Lang said.

A final piece of advice is to have a specific document retention strategy in your office policies, Mr. Lang said.

“This is where lawsuits are won and lost nowadays.” It is advantageous, for example, to state that all e-mail messages are automatically deleted after 6 months or 1 year.

“Otherwise, a judge or jury can deem failure to preserve electronic records “willful spoliation.” “Adverse jury inference instructs the jury to assume the spoliation of documents presumes they were harmful to the defendant's case.”

ORLANDO — Strategies for screening and treatment approaches for Barrett's esophagus, which were addressed in clinical practice guidelines released by the American College of Gastroenterology earlier this year, continued to trigger discussion during the college's annual meeting.

Screening of the general population for Barrett's esophagus is not recommended, nor is there sufficient evidence to support selective screening of higher-risk populations, according to the updated recommendations on diagnosis, surveillance, and treatment of Barrett's esophagus (Am. J. Gastroenterol. 2008;103:788-97).

Previous guidelines, issued in 2002, said people with chronic gastroesophageal reflux disease (GERD) symptoms should undergo upper endoscopy because of their increased risk of Barrett's esophagus.

“You would end up having more serious adverse events from the very safe upper endoscopy—perforations, cardiac collapse, death—than the number of cancers detected if we were to screen everyone with chronic GERD symptoms,” Dr. Nicholas J. Shaheen of the departments of medicine and epidemiology at the University of North Carolina at Chapel Hill commented during the meeting. Current screening and surveillance practices in Barrett's esophagus are limited by poor risk stratification, he said.

The guideline committee noted that the highest screening yield for Barrett's esophagus would be among Caucasian men older than 50 years with longstanding heartburn, though even in this group, efficacy has not been proven and the screening yield has been low, said Dr. Shaheen, who is on the speakers bureau and is a consultant for AstraZeneca PLC and TAP Pharmaceutical Products Inc. He has received grant support from BÂRRX Medical Inc., CSA Medical Inc., and Procter & Gamble Co.

Another criticism came from Dr. Joel Richter, a gastroenterologist who is chairman of the department of medicine at Temple University, Philadelphia. “They did not distinguish long-segment versus short-segment Barrett's. There is a higher chance of cancer with increasing length,” he said during a media briefing.

The guidelines state that patients who undergo endoscopic mucosal resection require long-term surveillance for cancer recurrence “for life, at least once a year or more,” Dr. Richter noted.

The grade of dysplasia determines the recommended surveillance interval, according to the guidelines. Low-grade dysplasia, for example, warrants a follow-up endoscopy within 6 months to rule out development of high-grade dysplasia. If that procedure yields a negative finding, annual endoscopy is recommended until two consecutive assessments reveal no dysplasia.

The guidelines suggest that physicians prescribe proton pump inhibitors (PPIs) for patients on long-term surveillance. PPIs suppress acid and lower inflammation, thus permitting better visualization and pathologic interpretation of tissue, but other potential benefits are less clear. “There is no randomized, controlled trial that shows a person randomized to a PPI with Barrett's will live longer than someone without a PPI,” said Dr. Yvonne Romero of the department of medicine at the Mayo Clinic, Rochester, Minn.

Some experts have suggested that capsule endoscopy could be used to screen for Barrett's esophagus. One study found a sensitivity of 100% and specificity of 80%, Dr. Shaheen said (Aliment. Pharmacol. Ther. 2004;20:1083-9), though subsequent studies “were less compelling.” The guidelines state this technique cannot yet be recommended.

In regard to detection of Barrett's esophagus using biomarkers, the guidelines state that “no biomarkers or panel is currently ready for routine clinical use.” They also state that esophagectomy is no longer required for all people with high-grade dysplasia. “This is a paradigm shift—that we'll more selectively use surgery,” Dr. Richter said.

The guideline does not distinguish long-segment versus short-segment Barrett's. DR. RICHTER

ORLANDO — Strategies for screening and treatment approaches for Barrett's esophagus, which were addressed in clinical practice guidelines released by the American College of Gastroenterology earlier this year, continued to trigger discussion during the college's annual meeting.

Screening of the general population for Barrett's esophagus is not recommended, nor is there sufficient evidence to support selective screening of higher-risk populations, according to the updated recommendations on diagnosis, surveillance, and treatment of Barrett's esophagus (Am. J. Gastroenterol. 2008;103:788-97).

Previous guidelines, issued in 2002, said people with chronic gastroesophageal reflux disease (GERD) symptoms should undergo upper endoscopy because of their increased risk of Barrett's esophagus.

“You would end up having more serious adverse events from the very safe upper endoscopy—perforations, cardiac collapse, death—than the number of cancers detected if we were to screen everyone with chronic GERD symptoms,” Dr. Nicholas J. Shaheen of the departments of medicine and epidemiology at the University of North Carolina at Chapel Hill commented during the meeting. Current screening and surveillance practices in Barrett's esophagus are limited by poor risk stratification, he said.

The guideline committee noted that the highest screening yield for Barrett's esophagus would be among Caucasian men older than 50 years with longstanding heartburn, though even in this group, efficacy has not been proven and the screening yield has been low, said Dr. Shaheen, who is on the speakers bureau and is a consultant for AstraZeneca PLC and TAP Pharmaceutical Products Inc. He has received grant support from BÂRRX Medical Inc., CSA Medical Inc., and Procter & Gamble Co.

Another criticism came from Dr. Joel Richter, a gastroenterologist who is chairman of the department of medicine at Temple University, Philadelphia. “They did not distinguish long-segment versus short-segment Barrett's. There is a higher chance of cancer with increasing length,” he said during a media briefing.

The guidelines state that patients who undergo endoscopic mucosal resection require long-term surveillance for cancer recurrence “for life, at least once a year or more,” Dr. Richter noted.

The grade of dysplasia determines the recommended surveillance interval, according to the guidelines. Low-grade dysplasia, for example, warrants a follow-up endoscopy within 6 months to rule out development of high-grade dysplasia. If that procedure yields a negative finding, annual endoscopy is recommended until two consecutive assessments reveal no dysplasia.

The guidelines suggest that physicians prescribe proton pump inhibitors (PPIs) for patients on long-term surveillance. PPIs suppress acid and lower inflammation, thus permitting better visualization and pathologic interpretation of tissue, but other potential benefits are less clear. “There is no randomized, controlled trial that shows a person randomized to a PPI with Barrett's will live longer than someone without a PPI,” said Dr. Yvonne Romero of the department of medicine at the Mayo Clinic, Rochester, Minn.

Some experts have suggested that capsule endoscopy could be used to screen for Barrett's esophagus. One study found a sensitivity of 100% and specificity of 80%, Dr. Shaheen said (Aliment. Pharmacol. Ther. 2004;20:1083-9), though subsequent studies “were less compelling.” The guidelines state this technique cannot yet be recommended.

In regard to detection of Barrett's esophagus using biomarkers, the guidelines state that “no biomarkers or panel is currently ready for routine clinical use.” They also state that esophagectomy is no longer required for all people with high-grade dysplasia. “This is a paradigm shift—that we'll more selectively use surgery,” Dr. Richter said.

The guideline does not distinguish long-segment versus short-segment Barrett's. DR. RICHTER

ORLANDO — Strategies for screening and treatment approaches for Barrett's esophagus, which were addressed in clinical practice guidelines released by the American College of Gastroenterology earlier this year, continued to trigger discussion during the college's annual meeting.

Screening of the general population for Barrett's esophagus is not recommended, nor is there sufficient evidence to support selective screening of higher-risk populations, according to the updated recommendations on diagnosis, surveillance, and treatment of Barrett's esophagus (Am. J. Gastroenterol. 2008;103:788-97).

Previous guidelines, issued in 2002, said people with chronic gastroesophageal reflux disease (GERD) symptoms should undergo upper endoscopy because of their increased risk of Barrett's esophagus.

“You would end up having more serious adverse events from the very safe upper endoscopy—perforations, cardiac collapse, death—than the number of cancers detected if we were to screen everyone with chronic GERD symptoms,” Dr. Nicholas J. Shaheen of the departments of medicine and epidemiology at the University of North Carolina at Chapel Hill commented during the meeting. Current screening and surveillance practices in Barrett's esophagus are limited by poor risk stratification, he said.

The guideline committee noted that the highest screening yield for Barrett's esophagus would be among Caucasian men older than 50 years with longstanding heartburn, though even in this group, efficacy has not been proven and the screening yield has been low, said Dr. Shaheen, who is on the speakers bureau and is a consultant for AstraZeneca PLC and TAP Pharmaceutical Products Inc. He has received grant support from BÂRRX Medical Inc., CSA Medical Inc., and Procter & Gamble Co.

Another criticism came from Dr. Joel Richter, a gastroenterologist who is chairman of the department of medicine at Temple University, Philadelphia. “They did not distinguish long-segment versus short-segment Barrett's. There is a higher chance of cancer with increasing length,” he said during a media briefing.

The guidelines state that patients who undergo endoscopic mucosal resection require long-term surveillance for cancer recurrence “for life, at least once a year or more,” Dr. Richter noted.

The grade of dysplasia determines the recommended surveillance interval, according to the guidelines. Low-grade dysplasia, for example, warrants a follow-up endoscopy within 6 months to rule out development of high-grade dysplasia. If that procedure yields a negative finding, annual endoscopy is recommended until two consecutive assessments reveal no dysplasia.

The guidelines suggest that physicians prescribe proton pump inhibitors (PPIs) for patients on long-term surveillance. PPIs suppress acid and lower inflammation, thus permitting better visualization and pathologic interpretation of tissue, but other potential benefits are less clear. “There is no randomized, controlled trial that shows a person randomized to a PPI with Barrett's will live longer than someone without a PPI,” said Dr. Yvonne Romero of the department of medicine at the Mayo Clinic, Rochester, Minn.

Some experts have suggested that capsule endoscopy could be used to screen for Barrett's esophagus. One study found a sensitivity of 100% and specificity of 80%, Dr. Shaheen said (Aliment. Pharmacol. Ther. 2004;20:1083-9), though subsequent studies “were less compelling.” The guidelines state this technique cannot yet be recommended.

In regard to detection of Barrett's esophagus using biomarkers, the guidelines state that “no biomarkers or panel is currently ready for routine clinical use.” They also state that esophagectomy is no longer required for all people with high-grade dysplasia. “This is a paradigm shift—that we'll more selectively use surgery,” Dr. Richter said.

The guideline does not distinguish long-segment versus short-segment Barrett's. DR. RICHTER