Doug Brunk

Major Finding: In the first 3 months, the rate of bone loss among patients with early RA who were treated with intra-articular corticosteroid injections plus methotrexate vs. methotrexate alone was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Data Source: A study of 40 patients who were treated for 12 months.

Disclosures: The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding “supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone,” reported researchers led by Dr. Glenn Haugeberg.

Dr. Haugeberg, professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at Sørlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months. Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7). They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group. The rate of bone loss was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (−1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with −2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

“Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand,” the researchers wrote.

In discussing their findings, the investigators wrote that the “results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss.

From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body,” they wrote.

Major Finding: In the first 3 months, the rate of bone loss among patients with early RA who were treated with intra-articular corticosteroid injections plus methotrexate vs. methotrexate alone was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Data Source: A study of 40 patients who were treated for 12 months.

Disclosures: The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding “supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone,” reported researchers led by Dr. Glenn Haugeberg.

Dr. Haugeberg, professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at Sørlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months. Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7). They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group. The rate of bone loss was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (−1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with −2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

“Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand,” the researchers wrote.

In discussing their findings, the investigators wrote that the “results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss.

From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body,” they wrote.

Major Finding: In the first 3 months, the rate of bone loss among patients with early RA who were treated with intra-articular corticosteroid injections plus methotrexate vs. methotrexate alone was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Data Source: A study of 40 patients who were treated for 12 months.

Disclosures: The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding “supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone,” reported researchers led by Dr. Glenn Haugeberg.

Dr. Haugeberg, professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at Sørlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months. Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7). They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group. The rate of bone loss was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (−1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with −2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

“Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand,” the researchers wrote.

In discussing their findings, the investigators wrote that the “results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss.

From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body,” they wrote.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

“A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media,” Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). “The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk.”

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6–23 months with mild otalgia and a temperature of less than 39° C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained “substantial limitations,” according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include “the lack of stringent diagnostic criteria, the inclusion of very young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses. Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear,” they said.

Dr. Hoberman, who is also vice chair of clinical research at Children's Hospital of Pittsburgh, and his associates randomized 291 children aged 6–23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on one of three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6–23 months with AOM “affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria.”

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6–35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child's condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo. They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, “together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial.”

Dr. Klein noted in his editorial that since physicians “cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent.”

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

View on the News

Trials Are Well Designed

Prior clinical studies have compared the outcome of AOM treated with antibiotics to that with placebo and have in general reported a more rapid resolution of signs and/or symptoms of AOM in the antibiotic-treated cohort. What is new?

First, both studies employed stringent criteria for entry ensuring that most, if not all, had AOM. Second, the choice and dose of amoxicillin-clavulanate provided coverage based on pharmacokinetic-pharmacodynamic principles for the majority of pneumococcal and Haemophilus isolates in each community. Thirdly, the study protocol provided for a sufficient frequency of follow-up to address the primary outcome (time to resolution in Pittsburgh and time to treatment failure in Turku). The results, a high rate of treatment failure in the placebo groups in both studies, distinguish these trials from several recent clinical trials and detail the potential advantages of effective antimicrobial therapy on the resolution of signs and symptoms.

Will these results change our approach to young children with AOM? As most episodes are currently treated with antibiotics, presumably these results will reinforce that approach. But these results also should challenge clinicians to further develop their diagnostic approach to AOM with greater emphasis on physical exam and to emphasize close follow-up for children who are initially managed with symptomatic care only.

DR. STEPHEN I. PELTON is with the division of pediatric infectious diseases at Boston Medical Center. He said he had no relevant financial disclosures.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

“A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media,” Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). “The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk.”

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6–23 months with mild otalgia and a temperature of less than 39° C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained “substantial limitations,” according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include “the lack of stringent diagnostic criteria, the inclusion of very young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses. Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear,” they said.

Dr. Hoberman, who is also vice chair of clinical research at Children's Hospital of Pittsburgh, and his associates randomized 291 children aged 6–23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on one of three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6–23 months with AOM “affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria.”

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6–35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child's condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo. They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, “together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial.”

Dr. Klein noted in his editorial that since physicians “cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent.”

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

View on the News

Trials Are Well Designed

Prior clinical studies have compared the outcome of AOM treated with antibiotics to that with placebo and have in general reported a more rapid resolution of signs and/or symptoms of AOM in the antibiotic-treated cohort. What is new?

First, both studies employed stringent criteria for entry ensuring that most, if not all, had AOM. Second, the choice and dose of amoxicillin-clavulanate provided coverage based on pharmacokinetic-pharmacodynamic principles for the majority of pneumococcal and Haemophilus isolates in each community. Thirdly, the study protocol provided for a sufficient frequency of follow-up to address the primary outcome (time to resolution in Pittsburgh and time to treatment failure in Turku). The results, a high rate of treatment failure in the placebo groups in both studies, distinguish these trials from several recent clinical trials and detail the potential advantages of effective antimicrobial therapy on the resolution of signs and symptoms.

Will these results change our approach to young children with AOM? As most episodes are currently treated with antibiotics, presumably these results will reinforce that approach. But these results also should challenge clinicians to further develop their diagnostic approach to AOM with greater emphasis on physical exam and to emphasize close follow-up for children who are initially managed with symptomatic care only.

DR. STEPHEN I. PELTON is with the division of pediatric infectious diseases at Boston Medical Center. He said he had no relevant financial disclosures.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

“A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media,” Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9). “The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk.”

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6–23 months with mild otalgia and a temperature of less than 39° C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained “substantial limitations,” according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include “the lack of stringent diagnostic criteria, the inclusion of very young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses. Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear,” they said.

Dr. Hoberman, who is also vice chair of clinical research at Children's Hospital of Pittsburgh, and his associates randomized 291 children aged 6–23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days. To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on one of three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6–23 months with AOM “affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria.”

Researchers from Finland reported similar findings. With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6–35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child's condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo. They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, “together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial.”

Dr. Klein noted in his editorial that since physicians “cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent.”

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation. One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project. Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

View on the News

Trials Are Well Designed

Prior clinical studies have compared the outcome of AOM treated with antibiotics to that with placebo and have in general reported a more rapid resolution of signs and/or symptoms of AOM in the antibiotic-treated cohort. What is new?

First, both studies employed stringent criteria for entry ensuring that most, if not all, had AOM. Second, the choice and dose of amoxicillin-clavulanate provided coverage based on pharmacokinetic-pharmacodynamic principles for the majority of pneumococcal and Haemophilus isolates in each community. Thirdly, the study protocol provided for a sufficient frequency of follow-up to address the primary outcome (time to resolution in Pittsburgh and time to treatment failure in Turku). The results, a high rate of treatment failure in the placebo groups in both studies, distinguish these trials from several recent clinical trials and detail the potential advantages of effective antimicrobial therapy on the resolution of signs and symptoms.

Will these results change our approach to young children with AOM? As most episodes are currently treated with antibiotics, presumably these results will reinforce that approach. But these results also should challenge clinicians to further develop their diagnostic approach to AOM with greater emphasis on physical exam and to emphasize close follow-up for children who are initially managed with symptomatic care only.

DR. STEPHEN I. PELTON is with the division of pediatric infectious diseases at Boston Medical Center. He said he had no relevant financial disclosures.

Time and again, parents come to Dr. Michael Rich overwhelmed by the role that texting, Facebook, Twitter, and other social media are playing in the lives of their children and adolescents.

“Most parents are coming with no idea or fairly misinformed ideas about what these media are,” said Dr. Rich, director of the center on media and child health at Children's Hospital Boston. “They're either lumping texting, Facebook, and Twitter – all of which behave differently – into one, or they don't want to know about it because they're scared of it. Others say they're so far behind in technology they could never catch up.”

Some report that their daughter is losing sleep and failing in school because she stays up until 2 or 3 a.m. texting her friends.

Others tell him that their son has becoming increasingly violent and disrespectful since playing war games online with friends and perfect strangers.

Still others inform him that their child has been cyberbullied by a classmate and refuses to attend school.

Welcome to the world of social media, a place Dr. Donald Shifrin calls the world's largest cocktail party, where you'll encounter every kind of experience and personality imaginable. It's not inherently good or bad, but rather “a great uncontrolled experiment on our children,” said Dr. Shifrin, a Bellevue, Wash.–based pediatrician who served as the American Academy of Pediatrics' consultant to Microsoft when it developed a family safety setting for Windows XP.

“There's no question that social media can make you a better person because there are various ways for you to send out things and ask, 'What does everybody think about this' and consider those responses in your decision making if indeed you're cognitively able to make a conscious and rational decision. But that's not usually the purview of most tweens and teens, who are messaging and texting as fast as their fingers can fly,” he said.

According to a 2009 survey by the Kaiser Family Foundation, young people aged 8–18 years spend an average of 7 hours and 38 minutes each day with TV, video games, or computers, an increase of 1 hour and 17 minutes over the average in 2004. In addition, 66% of these youngsters own a cell phone (on which they text or talk for another 2 hours each day), 76% of them have an iPod or other media player, and 74% of kids in grades 7–12 say they have a profile on a social networking site such as Facebook.

What about the long-term effects of social media on the development and behavior of today's children and adolescents? Experts interviewed for this story say there is no way to tell for sure what kind of impact routine use of social media will have on current children and adolescents as they become adults.

But one thing's for sure, said Dr. Susan Greenfield, a neuroscientist who directs the Institute for the Future of the Mind at the Oxford Martin School, Oxford (England) University: “It's a given that it will affect the brain, because the human brain adapts to whatever environment it's placed in. If you're in an environment as different as the cyberworld is from the real world, I don't think there's any question that we'll adapt to it. The big question is, How will we adapt to it? Is it good or bad? What can we do about it?”

Social media have revolutionized the way children learn about the world and communicate with each other, said Dr. Gwenn Schurgin O'Keeffe, a pediatrician and author of “CyberSafe: Protecting and Empowering Digital Kids in the World of Texting, Gaming, and Social Media” (Elk Grove Village, Ill.: American Academy of Pediatrics, 2010). Even families who struggle to put food on the table “will get their kids a digital device because they want them to be a part of society,” she said.

She describes Facebook as their “neighborhood hangout,” which “they do well if they get online in an age-appropriate way. You don't want a 10-year-old hanging out on Facebook because they don't have the social skills, and there are too many older people on it. But if you help them get online in an age-appropriate way, they learn how to post well. They learn how to interact better online than some adults do. It can be powerful.

“I have a theory that cyberbullying and sexting is partly our fault as adults because we're still catching up to the digital world, and we've never really taught kids how to use it well. It's kind of like putting them in a car without teaching them how to drive. So it's no wonder mistakes have happened.”

Dr. Rich said that Facebook can be used in positive ways by kids who are trying to understand themselves, to understand that they're not alone in their challenges and struggles growing up, “whether it's confronting the fact that their parents aren't perfect, or that the world isn't the way they magically thought it should be, or whether they are confused and conflicted about their sexuality. Social media can be particularly empowering for kids who are marginalized or minority groups of any kind. It is a wonderful environment for connecting with 'people like me,' and feeling that you're not alone. And as a social equalizer, they create a fabulous place for kids to develop a sense of participatory democracy, a place where they have a voice. They start to see how their voice can make a difference in the world.”

Some experts suggest that social media are having a certain benefit on the smarts of youngsters. In his 2005 book “Everything Bad Is Good for You: How Today's Popular Culture Is Making Us Smarter” (New York: Riverhead Books, 2005), author Steven Johnson notes that IQ scores have improved in several different countries around the world in recent years, likely because youngsters are rehearsing the kind of skills required for IQ tests when they play computer games.

However, Dr. Shifrin pointed out that other research has shown that frequent exposure to videos and other screen-based media slows down language acquisition in toddlers.

Social media also have the potential to unite families in shared activities such as playing chess online, tennis on Nintendo's Wii console, football on the Madden NFL video series, or updating the family Facebook page.

For some families, though, social media eat into quality time together, said Dr. O'Keeffe, who has two teenaged daughters and who authors a syndicated blog called “Dr. Gwenn Is In.” 

A Different Way of Talking

Dr. Rich authors a blog called "Ask the Mediatrician."

Dr. Greenfield is concerned that children and adolescents who spend too much time on social media may be compromising the proper development of certain cognitive skills. “We know that people are getting good at processing information very quickly and efficiently – the kind of skills you have when you're driving,” she said. “What we're talking about is turning yourself into kind of a computer in a way: making efficient and fast responses as appropriate. This is very different from reading a book, which is very linear and slow. That's what the brain needs to understand something usually; you don't want to have it diluted and distracted, because the brain only has so much power. If it's being employed in attending to lots of different things, it's not going to be able to pursue a linear train of thought.”

The result, Dr. Greenfield offered, “could be an infantilizing of the brain, that we are going to create a generation of Peter Pans who live in a world that is a literal one, dominated by sensory content over cognitive significance, a world where what you see is what you get.”

Dr. O'Keeffe acknowledged the potential for an inattentive future generation, “but I think we can reel them in while they're still teenagers and younger kids. Each generation that passes is going to be more digital. So while we still remember what an offline world is, if we can instill in the current teenagers and elementary school kids what it's like to be unplugged, they'll instill it in their kids, and it should pay forward.”

Much of the onus is on parents, Dr. Rich said, to learn how social media work and to help their kids become good citizens of the digital world. “You can't afford to check out because you don't know the digital world. The default is that your children will be raised by whomever and whatever is in the digital domain. We know from 'Lord of the Flies' what happens when the kids are left in charge of society. We have a responsibility to parent in the digital domain, because our kids are spending most of their time there.” Dr. Michael Rich said, “Social media fundamentally alter how we interact with other people. When you see two kids who are sitting at a table together texting each other, it's a very different dynamic than if they were actually talking to each other.”

Time and again, parents come to Dr. Michael Rich overwhelmed by the role that texting, Facebook, Twitter, and other social media are playing in the lives of their children and adolescents.

“Most parents are coming with no idea or fairly misinformed ideas about what these media are,” said Dr. Rich, director of the center on media and child health at Children's Hospital Boston. “They're either lumping texting, Facebook, and Twitter – all of which behave differently – into one, or they don't want to know about it because they're scared of it. Others say they're so far behind in technology they could never catch up.”

Some report that their daughter is losing sleep and failing in school because she stays up until 2 or 3 a.m. texting her friends.

Others tell him that their son has becoming increasingly violent and disrespectful since playing war games online with friends and perfect strangers.

Still others inform him that their child has been cyberbullied by a classmate and refuses to attend school.

Welcome to the world of social media, a place Dr. Donald Shifrin calls the world's largest cocktail party, where you'll encounter every kind of experience and personality imaginable. It's not inherently good or bad, but rather “a great uncontrolled experiment on our children,” said Dr. Shifrin, a Bellevue, Wash.–based pediatrician who served as the American Academy of Pediatrics' consultant to Microsoft when it developed a family safety setting for Windows XP.

“There's no question that social media can make you a better person because there are various ways for you to send out things and ask, 'What does everybody think about this' and consider those responses in your decision making if indeed you're cognitively able to make a conscious and rational decision. But that's not usually the purview of most tweens and teens, who are messaging and texting as fast as their fingers can fly,” he said.

According to a 2009 survey by the Kaiser Family Foundation, young people aged 8–18 years spend an average of 7 hours and 38 minutes each day with TV, video games, or computers, an increase of 1 hour and 17 minutes over the average in 2004. In addition, 66% of these youngsters own a cell phone (on which they text or talk for another 2 hours each day), 76% of them have an iPod or other media player, and 74% of kids in grades 7–12 say they have a profile on a social networking site such as Facebook.

What about the long-term effects of social media on the development and behavior of today's children and adolescents? Experts interviewed for this story say there is no way to tell for sure what kind of impact routine use of social media will have on current children and adolescents as they become adults.

But one thing's for sure, said Dr. Susan Greenfield, a neuroscientist who directs the Institute for the Future of the Mind at the Oxford Martin School, Oxford (England) University: “It's a given that it will affect the brain, because the human brain adapts to whatever environment it's placed in. If you're in an environment as different as the cyberworld is from the real world, I don't think there's any question that we'll adapt to it. The big question is, How will we adapt to it? Is it good or bad? What can we do about it?”

Social media have revolutionized the way children learn about the world and communicate with each other, said Dr. Gwenn Schurgin O'Keeffe, a pediatrician and author of “CyberSafe: Protecting and Empowering Digital Kids in the World of Texting, Gaming, and Social Media” (Elk Grove Village, Ill.: American Academy of Pediatrics, 2010). Even families who struggle to put food on the table “will get their kids a digital device because they want them to be a part of society,” she said.

She describes Facebook as their “neighborhood hangout,” which “they do well if they get online in an age-appropriate way. You don't want a 10-year-old hanging out on Facebook because they don't have the social skills, and there are too many older people on it. But if you help them get online in an age-appropriate way, they learn how to post well. They learn how to interact better online than some adults do. It can be powerful.

“I have a theory that cyberbullying and sexting is partly our fault as adults because we're still catching up to the digital world, and we've never really taught kids how to use it well. It's kind of like putting them in a car without teaching them how to drive. So it's no wonder mistakes have happened.”

Dr. Rich said that Facebook can be used in positive ways by kids who are trying to understand themselves, to understand that they're not alone in their challenges and struggles growing up, “whether it's confronting the fact that their parents aren't perfect, or that the world isn't the way they magically thought it should be, or whether they are confused and conflicted about their sexuality. Social media can be particularly empowering for kids who are marginalized or minority groups of any kind. It is a wonderful environment for connecting with 'people like me,' and feeling that you're not alone. And as a social equalizer, they create a fabulous place for kids to develop a sense of participatory democracy, a place where they have a voice. They start to see how their voice can make a difference in the world.”

Some experts suggest that social media are having a certain benefit on the smarts of youngsters. In his 2005 book “Everything Bad Is Good for You: How Today's Popular Culture Is Making Us Smarter” (New York: Riverhead Books, 2005), author Steven Johnson notes that IQ scores have improved in several different countries around the world in recent years, likely because youngsters are rehearsing the kind of skills required for IQ tests when they play computer games.

However, Dr. Shifrin pointed out that other research has shown that frequent exposure to videos and other screen-based media slows down language acquisition in toddlers.

Social media also have the potential to unite families in shared activities such as playing chess online, tennis on Nintendo's Wii console, football on the Madden NFL video series, or updating the family Facebook page.

For some families, though, social media eat into quality time together, said Dr. O'Keeffe, who has two teenaged daughters and who authors a syndicated blog called “Dr. Gwenn Is In.” 

A Different Way of Talking

Dr. Rich authors a blog called "Ask the Mediatrician."

Dr. Greenfield is concerned that children and adolescents who spend too much time on social media may be compromising the proper development of certain cognitive skills. “We know that people are getting good at processing information very quickly and efficiently – the kind of skills you have when you're driving,” she said. “What we're talking about is turning yourself into kind of a computer in a way: making efficient and fast responses as appropriate. This is very different from reading a book, which is very linear and slow. That's what the brain needs to understand something usually; you don't want to have it diluted and distracted, because the brain only has so much power. If it's being employed in attending to lots of different things, it's not going to be able to pursue a linear train of thought.”

The result, Dr. Greenfield offered, “could be an infantilizing of the brain, that we are going to create a generation of Peter Pans who live in a world that is a literal one, dominated by sensory content over cognitive significance, a world where what you see is what you get.”

Dr. O'Keeffe acknowledged the potential for an inattentive future generation, “but I think we can reel them in while they're still teenagers and younger kids. Each generation that passes is going to be more digital. So while we still remember what an offline world is, if we can instill in the current teenagers and elementary school kids what it's like to be unplugged, they'll instill it in their kids, and it should pay forward.”

Much of the onus is on parents, Dr. Rich said, to learn how social media work and to help their kids become good citizens of the digital world. “You can't afford to check out because you don't know the digital world. The default is that your children will be raised by whomever and whatever is in the digital domain. We know from 'Lord of the Flies' what happens when the kids are left in charge of society. We have a responsibility to parent in the digital domain, because our kids are spending most of their time there.” Dr. Michael Rich said, “Social media fundamentally alter how we interact with other people. When you see two kids who are sitting at a table together texting each other, it's a very different dynamic than if they were actually talking to each other.”

Time and again, parents come to Dr. Michael Rich overwhelmed by the role that texting, Facebook, Twitter, and other social media are playing in the lives of their children and adolescents.

“Most parents are coming with no idea or fairly misinformed ideas about what these media are,” said Dr. Rich, director of the center on media and child health at Children's Hospital Boston. “They're either lumping texting, Facebook, and Twitter – all of which behave differently – into one, or they don't want to know about it because they're scared of it. Others say they're so far behind in technology they could never catch up.”

Some report that their daughter is losing sleep and failing in school because she stays up until 2 or 3 a.m. texting her friends.

Others tell him that their son has becoming increasingly violent and disrespectful since playing war games online with friends and perfect strangers.

Still others inform him that their child has been cyberbullied by a classmate and refuses to attend school.

Welcome to the world of social media, a place Dr. Donald Shifrin calls the world's largest cocktail party, where you'll encounter every kind of experience and personality imaginable. It's not inherently good or bad, but rather “a great uncontrolled experiment on our children,” said Dr. Shifrin, a Bellevue, Wash.–based pediatrician who served as the American Academy of Pediatrics' consultant to Microsoft when it developed a family safety setting for Windows XP.

“There's no question that social media can make you a better person because there are various ways for you to send out things and ask, 'What does everybody think about this' and consider those responses in your decision making if indeed you're cognitively able to make a conscious and rational decision. But that's not usually the purview of most tweens and teens, who are messaging and texting as fast as their fingers can fly,” he said.

According to a 2009 survey by the Kaiser Family Foundation, young people aged 8–18 years spend an average of 7 hours and 38 minutes each day with TV, video games, or computers, an increase of 1 hour and 17 minutes over the average in 2004. In addition, 66% of these youngsters own a cell phone (on which they text or talk for another 2 hours each day), 76% of them have an iPod or other media player, and 74% of kids in grades 7–12 say they have a profile on a social networking site such as Facebook.

What about the long-term effects of social media on the development and behavior of today's children and adolescents? Experts interviewed for this story say there is no way to tell for sure what kind of impact routine use of social media will have on current children and adolescents as they become adults.

But one thing's for sure, said Dr. Susan Greenfield, a neuroscientist who directs the Institute for the Future of the Mind at the Oxford Martin School, Oxford (England) University: “It's a given that it will affect the brain, because the human brain adapts to whatever environment it's placed in. If you're in an environment as different as the cyberworld is from the real world, I don't think there's any question that we'll adapt to it. The big question is, How will we adapt to it? Is it good or bad? What can we do about it?”

Social media have revolutionized the way children learn about the world and communicate with each other, said Dr. Gwenn Schurgin O'Keeffe, a pediatrician and author of “CyberSafe: Protecting and Empowering Digital Kids in the World of Texting, Gaming, and Social Media” (Elk Grove Village, Ill.: American Academy of Pediatrics, 2010). Even families who struggle to put food on the table “will get their kids a digital device because they want them to be a part of society,” she said.

She describes Facebook as their “neighborhood hangout,” which “they do well if they get online in an age-appropriate way. You don't want a 10-year-old hanging out on Facebook because they don't have the social skills, and there are too many older people on it. But if you help them get online in an age-appropriate way, they learn how to post well. They learn how to interact better online than some adults do. It can be powerful.

“I have a theory that cyberbullying and sexting is partly our fault as adults because we're still catching up to the digital world, and we've never really taught kids how to use it well. It's kind of like putting them in a car without teaching them how to drive. So it's no wonder mistakes have happened.”

Dr. Rich said that Facebook can be used in positive ways by kids who are trying to understand themselves, to understand that they're not alone in their challenges and struggles growing up, “whether it's confronting the fact that their parents aren't perfect, or that the world isn't the way they magically thought it should be, or whether they are confused and conflicted about their sexuality. Social media can be particularly empowering for kids who are marginalized or minority groups of any kind. It is a wonderful environment for connecting with 'people like me,' and feeling that you're not alone. And as a social equalizer, they create a fabulous place for kids to develop a sense of participatory democracy, a place where they have a voice. They start to see how their voice can make a difference in the world.”

Some experts suggest that social media are having a certain benefit on the smarts of youngsters. In his 2005 book “Everything Bad Is Good for You: How Today's Popular Culture Is Making Us Smarter” (New York: Riverhead Books, 2005), author Steven Johnson notes that IQ scores have improved in several different countries around the world in recent years, likely because youngsters are rehearsing the kind of skills required for IQ tests when they play computer games.

However, Dr. Shifrin pointed out that other research has shown that frequent exposure to videos and other screen-based media slows down language acquisition in toddlers.

Social media also have the potential to unite families in shared activities such as playing chess online, tennis on Nintendo's Wii console, football on the Madden NFL video series, or updating the family Facebook page.

For some families, though, social media eat into quality time together, said Dr. O'Keeffe, who has two teenaged daughters and who authors a syndicated blog called “Dr. Gwenn Is In.” 

A Different Way of Talking

Dr. Rich authors a blog called "Ask the Mediatrician."

Dr. Greenfield is concerned that children and adolescents who spend too much time on social media may be compromising the proper development of certain cognitive skills. “We know that people are getting good at processing information very quickly and efficiently – the kind of skills you have when you're driving,” she said. “What we're talking about is turning yourself into kind of a computer in a way: making efficient and fast responses as appropriate. This is very different from reading a book, which is very linear and slow. That's what the brain needs to understand something usually; you don't want to have it diluted and distracted, because the brain only has so much power. If it's being employed in attending to lots of different things, it's not going to be able to pursue a linear train of thought.”

The result, Dr. Greenfield offered, “could be an infantilizing of the brain, that we are going to create a generation of Peter Pans who live in a world that is a literal one, dominated by sensory content over cognitive significance, a world where what you see is what you get.”

Dr. O'Keeffe acknowledged the potential for an inattentive future generation, “but I think we can reel them in while they're still teenagers and younger kids. Each generation that passes is going to be more digital. So while we still remember what an offline world is, if we can instill in the current teenagers and elementary school kids what it's like to be unplugged, they'll instill it in their kids, and it should pay forward.”

Much of the onus is on parents, Dr. Rich said, to learn how social media work and to help their kids become good citizens of the digital world. “You can't afford to check out because you don't know the digital world. The default is that your children will be raised by whomever and whatever is in the digital domain. We know from 'Lord of the Flies' what happens when the kids are left in charge of society. We have a responsibility to parent in the digital domain, because our kids are spending most of their time there.” Dr. Michael Rich said, “Social media fundamentally alter how we interact with other people. When you see two kids who are sitting at a table together texting each other, it's a very different dynamic than if they were actually talking to each other.”

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

“A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media,” Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9).

“The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk,” Dr. Klein added.

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39° C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained “substantial limitations,” according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include “the lack of stringent diagnostic criteria, the inclusion of very young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses,” the researchers noted.

“Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear,” they said.

Dr. Hoberman, who is also vice chair of clinical research at Children's Hospital of Pittsburgh, and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days.

To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on one of three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM “affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria.”

Researchers from Finland reported similar findings.

With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child's condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, “together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial.”

Dr. Klein noted in his editorial that since physicians “cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent.”

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation.

One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project.

Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

“A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media,” Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9).

“The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk,” Dr. Klein added.

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39° C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained “substantial limitations,” according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include “the lack of stringent diagnostic criteria, the inclusion of very young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses,” the researchers noted.

“Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear,” they said.

Dr. Hoberman, who is also vice chair of clinical research at Children's Hospital of Pittsburgh, and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days.

To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on one of three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM “affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria.”

Researchers from Finland reported similar findings.

With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child's condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, “together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial.”

Dr. Klein noted in his editorial that since physicians “cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent.”

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation.

One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project.

Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

Children with a certain diagnosis of acute otitis media who were treated with amoxicillin-clavulanate recovered more quickly, compared with those who received placebo, results from two large, separate studies demonstrated.

The findings, conducted by researchers at the University of Pittsburgh and at the University of Turku, Finland, provide the strongest evidence to date supporting a regimen of antimicrobial therapy in children with a certain diagnosis of acute otitis media (AOM).

“A study with an appropriate design was needed to resolve the controversy regarding antimicrobial therapy versus observation in children with certain diagnoses of acute otitis media,” Dr. Jerome O. Klein of the department of pediatrics at Boston University, wrote in an editorial about the studies (N. Engl. J. Med. 2011;364:168-9).

“The investigators in both Pittsburgh and Turku have provided such a study. They performed randomized, blinded trials of the use of amoxicillin-clavulanate as compared with placebo in the age group at greatest risk,” Dr. Klein added.

In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians issued a clinical practice guideline that endorsed initial observation as an option in children aged 6-23 months with mild otalgia and a temperature of less than 39° C in the last 24 hours, and in whom the diagnosis of AOM is uncertain (Pediatrics 2004;113:1451-65).

However, those recommendations were based on previous clinical trials that contained “substantial limitations,” according to researchers from one of the studies, who were led by Dr. Alejandro Hoberman of the department of pediatrics at the University of Pittsburgh (N. Engl. J. Med. 2011;364:105-15).

These include “the lack of stringent diagnostic criteria, the inclusion of very young children, and the use of an antimicrobial drug that had limited efficacy or that was administered in suboptimal doses,” the researchers noted.

“Moreover, rates of spontaneous improvement similar to the rates seen in those studies among children receiving placebo have not been found uniformly. Therefore, for children with acute otitis media, the circumstances in which immediate antimicrobial treatment is the preferred strategy have remained unclear,” they said.

Dr. Hoberman, who is also vice chair of clinical research at Children's Hospital of Pittsburgh, and his associates randomized 291 children aged 6-23 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 10 days.

To meet eligibility for the trial, the children were required to have received at least two doses of pneumococcal conjugate vaccine and to have AOM that was diagnosed based on one of three criteria: onset of symptoms within 48 hours that parents rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM-SOS) scale; the presence of middle-ear effusion; and moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane.

A significantly higher proportion of children who received amoxicillin-clavulanate had initial clearance within 7 days, compared with their counterparts in the placebo group (35% vs. 28%, respectively by day 2; 61% vs. 54% by day 4; and 80% vs. 74% by day 7). A similar relationship was seen in terms of sustained resolution of symptoms (20% vs. 14% by day 2; 41% vs. 36% by day 4; and 67% vs. 53% by day 7).

The rate of clinical failure, which was defined as the persistence of signs of acute infection on otoscopic evaluation, was less likely in the children who received amoxicillin-clavulanate, compared with those who received placebo (4% vs. 23%, respectively, at or before the visit on day 4 or 5; and 16% vs. 51% at or before the visit on days 10-12).

Dr. Hoberman and his associates concluded that treatment with amoxicillin-clavulanate for 10 days in children aged 6-23 months with AOM “affords a measurable short-term benefit, irrespective of the apparent severity of the illness. The benefit must be weighed against concern not only about the side effects of the medication but also about the contribution of antimicrobial treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed with the use of stringent criteria.”

Researchers from Finland reported similar findings.

With equally strict eligibility criteria, Dr. Paula Tähtinen and her associates at Turku University Hospital randomized 319 children aged 6-35 months who were diagnosed with AOM to receive amoxicillin-clavulanate or placebo for 7 days (N. Engl. J. Med. 2011;364:116-26).

The main outcome of the study was time to treatment failure from the first dose until the end-of-treatment visit on day 8. Treatment failure was a composite outcome consisting of six components: no improvement in overall condition by the first scheduled visit (day 3); a worsening of the child's condition at any time; no improvement in otoscopic signs by day 8; perforation of the tympanic membrane at any time; severe infection that required systemic open-label antimicrobial treatment at any time; or any other reason for discontinuing the study drug.

Dr. Tähtinen and her associates reported that a significantly lower rate of treatment failures occurred in children who received amoxicillin-clavulanate, compared with those who received placebo group (18.6% vs. 44.9%, respectively). The difference in treatment failures was already apparent on day 3 in 13.7% of children who received amoxicillin-clavulanate, compared with 25.3% of those who received placebo.

They also reported that overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio 0.38) and the need for rescue treatment by 81% (HR 0.19).

In terms of side effects, the prevalence of diarrhea and eczema in the amoxicillin-clavulanate group was 47.8% and 8.7%, respectively, which was statistically higher than the rates in the placebo group (26.6% vs. 3.2%).

Going forward, they hypothesized, the identification of prognostic markers, “together with the use of stringent diagnostic criteria, could reduce the use of antimicrobial agents in the treatment of acute otitis media. Reduced use of antimicrobial agents may limit the development of resistant bacteria and increase the chances that the subsequent use of antimicrobial agents, when truly indicated, would be beneficial.”

Dr. Klein noted in his editorial that since physicians “cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made. Is acute otitis media a treatable disease? The investigators in Pittsburgh and Turku have provided the best data yet to answer the question, and the answer is yes; more young children with a certain diagnosis of acute otitis media recover more quickly with an appropriate antimicrobial agent.”

Dr. Hoberman disclosed that he has received honoraria and travel expense reimbursement from GlaxoSmithKline. One of the other study authors, Dr. Ellen R. Wald, disclosed that she has received grant support from Merck and GlaxoSmithKline. Dr. Jack Paradise disclosed that he received a consulting fee from University of Pittsburgh Medical Center. The study was supported by a grant from the National Institute of Allergy and Infectious Diseases.

The Turku study was supported by the Fellowship Award of the European Society for Pediatric Infectious Diseases. It also was supported by grants from the Foundation for Pediatric Research; Research Funds from Specified Government Transfers; the Jenny and Antti Wihuri Foundation; the Paulo Foundation; the Maud Kuistila Memorial Foundation; the Emil Aaltonen Foundation; the Finnish Cultural Foundation, Varsinais-Suomi Regional Fund; the Turku University Hospital Research Foundation; and the Finnish–Norwegian Medical Foundation.

One of the other study authors, Dr. Aino Ruohola, disclosed that he received support for the travel to meetings for the study or other purposes from the Finnish Society of Infectious Disease Specialists, and that Inverness Medical Point of Care Diagnostics, Binax Inc. donated Binax NOW Streptococcus pneumoniae test for the study project.

Dr. Olli Ruuskanen disclosed that he had been a consultant for Abbott and Novartis.

Dr. Klein disclosed that he received honoraria from Innovia Medical from 2005 to 2008.

Major Finding: In the first 3 months, the rate of bone loss among patients with early RA who were treated with intra-articular corticosteroid injections plus methotrexate vs. methotrexate alone was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Data Source: A study of 40 patients who were treated for 12 months.

Disclosures: The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding “supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone,” reported researchers led by Dr. Glenn Haugeberg.

Dr. Haugeberg, who is professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at Sørlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months.

Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7).

They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group.

The rate of bone loss was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (−1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with −2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

“Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand,” the researchers wrote.

“This may support the view that periarticular osteoporosis results from local production of proinflammatory cytokines which activate osteoclasts to break down bone locally and is not predominantly the result of circulating proinflammatory cytokines.”

In discussing their findings, the investigators wrote that the “results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss. From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body.”

They acknowledged certain limitations of the study, including the small sample size and the fact that “the precision of DXA for periarticular regions is poor compared with whole hand measurement. Furthermore, the method is not feasible for clinical use; it has therefore been recommended that assessment of the whole hand be used as a marker for periarticular bone loss.

Major Finding: In the first 3 months, the rate of bone loss among patients with early RA who were treated with intra-articular corticosteroid injections plus methotrexate vs. methotrexate alone was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Data Source: A study of 40 patients who were treated for 12 months.

Disclosures: The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding “supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone,” reported researchers led by Dr. Glenn Haugeberg.

Dr. Haugeberg, who is professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at Sørlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months.

Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7).

They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group.

The rate of bone loss was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (−1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with −2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

“Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand,” the researchers wrote.

“This may support the view that periarticular osteoporosis results from local production of proinflammatory cytokines which activate osteoclasts to break down bone locally and is not predominantly the result of circulating proinflammatory cytokines.”

In discussing their findings, the investigators wrote that the “results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss. From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body.”

They acknowledged certain limitations of the study, including the small sample size and the fact that “the precision of DXA for periarticular regions is poor compared with whole hand measurement. Furthermore, the method is not feasible for clinical use; it has therefore been recommended that assessment of the whole hand be used as a marker for periarticular bone loss.

Major Finding: In the first 3 months, the rate of bone loss among patients with early RA who were treated with intra-articular corticosteroid injections plus methotrexate vs. methotrexate alone was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Data Source: A study of 40 patients who were treated for 12 months.

Disclosures: The researchers stated that they had no relevant financial disclosures to make.

Patients with early rheumatoid arthritis who were on methotrexate and received intra-articular corticosteroid injections into inflamed metacarpophalangeal joints for 3 months lost less periarticular density than did those who received methotrexate alone, results from a small study demonstrated.

The finding “supports the concept that, in conditions where inflammation dominates such as early RA, treating inflammation is more important than the negative effect of corticosteroids on bone,” reported researchers led by Dr. Glenn Haugeberg.

Dr. Haugeberg, who is professor of neuroscience at the Norwegian University of Science and Technology, Trondheim, and a member of the department of rheumatology at Sørlandet Hospital in Kristiansand (Norway), and his associates at two clinical centers in the United Kingdom treated 19 early RA patients with methotrexate alone and 21 with methotrexate plus intra-articular corticosteroid injections for 3 months.

Over the next 9 months, all 40 patients received methotrexate plus intra-articular corticosteroid injections.

To assess the effect of treatment on bone loss, the researchers used MRI of the metacarpophalangeal joints of the dominant hand (that is, MCP joints 2-5) at baseline and 3 and 12 months, as well as DXA (dual-energy x-ray absorptiometry) images of both hands at baseline and 3, 6, and 12 months (Ann. Rheum. Dis. 2011;70:184-7).

They used linear regression analysis to determine the association between reduction in bone mineral density and demographic and disease variables, adjusting for treatment group.

The mean age of patients was 54 years, and 55% were women. In the first 3 months of the study, patients in the group who received methotrexate plus intra-articular-corticosteroid injections experienced significantly lower rates of bone loss in MCP joints 2-5 than did their counterparts in the methotrexate-only group.

The rate of bone loss was −0.45% vs. −2.69%, respectively, in digit 2; −0.34% vs. −3.32% in digit 3; −0.39% vs. −2.57% in digit 4, and −0.59% vs. −2.70% in digit 5.

Bone loss in the hand overall was less pronounced over the same time period (−1.53% among patients who received methotrexate plus intra-articular corticosteroid injections, compared with −2.42% among those in the methotrexate-only group).

In months 3-12, when all patients received intra-articular corticosteroid injections, only minor, nonsignificant differences in the rate of bone loss were observed between the two groups.

“Data from the current study suggest that bone loss may be arrested by intra-articular corticosteroid injections more effectively in periarticular regions than in the whole hand,” the researchers wrote.

“This may support the view that periarticular osteoporosis results from local production of proinflammatory cytokines which activate osteoclasts to break down bone locally and is not predominantly the result of circulating proinflammatory cytokines.”

In discussing their findings, the investigators wrote that the “results from the hand bone density studies also suggest that prednisolone is equivalent to [anti–tumor necrosis factor] treatment in reducing the rate of hand bone loss. From a practical point of view, local administration of corticosteroids may be better than systemic administration as the drug is administered at the target site of the inflammatory process and is not disseminated throughout the body.”

They acknowledged certain limitations of the study, including the small sample size and the fact that “the precision of DXA for periarticular regions is poor compared with whole hand measurement. Furthermore, the method is not feasible for clinical use; it has therefore been recommended that assessment of the whole hand be used as a marker for periarticular bone loss.

Revised gonorrhea treatment regimens and expanded STD prevention recommendations are key features in the updated Sexually Transmitted Diseases Treatment Guidelines released in December 2010 by the Centers for Disease Control and Prevention.

Dr. Kimberly A. Workowski of the division of STD prevention at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, chaired the effort and wrote the guidelines with her colleague, Dr. Stuart Berman, after consulting with numerous experts. The guidelines, last updated in 2006, are available online at www.cdc.gov/std/treatment/2010

Gonorrhea treatment regimens were revised in the wake of Neisseria gonorrhoeae's decreased susceptibility to cephalosporins and other antimicrobials. In 2007 the CDC recommended that fluoroquinolones not be used for gonorrhea treatment because of resistance to that class of antimicrobials (MMWR 2007;56:332-6).

“What we've been seeing over the past number of decades is change in the N. gonorrhoeae organism in different parts of the world,” Dr. Workowski said in an interview. “There have been increasing reports of isolates resistant to cephalosporins from Southeast Asia and from Norway.”

Because of these developments, patients who present with an uncomplicated urogenital gonorrheal infection should be treated with a single 250-mg intramuscular injection of ceftriaxone. If this is not an option, consider a single 400-mg tablet of cefixime, or a single-dose cephalosporin regimen. To prevent co-infection with Chlamydia trachomatis, treatment with azithromycin 1 mg orally in a single dose or doxycycline 100 mg twice a day for 7 days is recommended.

Expanded STD prevention recommendations include support for the pre-exposure human papillomavirus (HPV) vaccine, which the report calls “one of the most effective methods for preventing transmission of some STDs.” Two vaccines are currently available: the quadrivalent HPV vaccine (Gardasil; Merck), which also prevents genital warts, and the bivalent HPV vaccine (Cervarix; GlaxoSmithKline). Routine vaccination of females aged 11 or 12 years is recommended with either vaccine, as is catch-up vaccination for females aged 13-26 years. More information regarding HPV vaccination can be found at www.cdc.gov/std/hpv

Other changes that differ from the 2006 guidelines include:

▸ New treatment regimens for genital warts and bacterial vaginosis. The list of patient-applied options for treating external genital warts now includes sinecatechins 15% ointment, a green-tea extract. “We don't know exactly how it works from a scientific standpoint,” said Dr. Workowski, who is also an associate professor of medicine at Emory University, Atlanta. “But in published studies it has done well for genital warts, so it's another alternative.”

The guidelines recommend applying a 0.5-cm strand of ointment to each wart three times per day until complete clearance of warts. “This product should not be continued for longer than 16 weeks,” the recommendations state. “The medication should not be washed off after use. Sexual (i.e., genital, anal, or oral) contact should be avoided while the ointment is on the skin. The most common side effects of sinecatechins 15% are erythema, pruritus/burning, pain, ulceration, edema, induration, and vesicular rash.”

The list of alternative regimens for treating bacterial vaginosis now includes tinidazole 2 g orally once daily for 2 days or tinidazole 1 g orally once daily for 5 days.

▸ Increasing awareness of lymphogranuloma venereum proctocolitis. Lymphogranuloma venereum is a disease that causes enlarged lymph nodes in the inguinal-femoral area, and it can also cause an infection in the rectum, Dr. Workowski said. Lymphogranuloma venereum proctocolitis can present as rectal bleeding or rectal pain “and is being increasingly recognized in men who have sex with men, particularly in HIV-infected men who have sex with men,” she said. “It can also occur in women who engage in receptive rectal intercourse,” and should be part of the differential diagnosis in anyone who engages in receptive anal intercourse and presents with a bloody discharge or pain around the rectal area.

▸ The emergence of azithromycin-resistant Treponema pallidum. Penicillin remains the treatment of choice for syphilis. In those with allergy to penicillin, a 14-day course of doxycycline 100 mg orally twice daily or a 14-day course of tetracycline 500 mg four times daily is recommended. “Azithromycin as a single 2-g oral dose is effective for treating early syphilis,” according to the guidelines. “However, T. pallidum chromosomal mutations associated with azithromycin resistance and treatment failures have been documented in several areas in the United States. As such, azithromycin should be used with caution only when treatment with penicillin or doxycycline is not feasible.”

▸ Discussion of the role of Mycoplasma genitalium and trichomoniasis in the evaluation of urethritis and cervicitis and treatment-related implications. While N. gonorrhoeae and C. trachomatis are well established as clinically important infectious causes of urethritis, M. genitalium has also been associated with urethritis. “If clinic-based diagnostic tools (e.g., Gram-stain microscopy, first void urine with microscopy, and leukocyte esterase) are not available, patients should be treated with drug regimens effective against both gonorrhea and chlamydia,” the guidelines state. “Further testing to determine the specific etiology is recommended because both chlamydia and gonorrhea are reportable to health departments and a specific diagnosis might improve partner notification and treatment.”

The guidelines note that culture, nucleic acid hybridization tests, and nucleic acid amplification testing (NAAT) are available for the detection of both N. gonorrhoeae and C. trachomatis. “Culture and hybridization tests require urethral swab specimens, whereas NAATs can be performed on urine specimens. Because of their higher sensitivity, NAATs are preferred for the detection of C. trachomatis.”

▸ Revised guidance on the evaluation of neurosyphilis. Laboratory diagnosis of neurosyphilis usually depends on various combinations of reactive serologic test results, cerebrospinal fluid (CSF) cell count or protein, and a reactive CSF-Venereal Disease Research Lab [VDRL] test with or without clinical manifestations.

“Among persons with HIV infection, the CSF leukocyte count usually is elevated (greater than 5 white blood cell count/mm

Dr. Workowski and Dr. Berman emphasized that the guidelines “should be regarded as a source of clinical guidance and not prescriptive standards; health care providers should always consider the clinical circumstances of each person in the context of local disease prevalence. They are applicable to various patient-care settings, including family-planning clinics, private physicians' offices, managed care organizations, and other primary care facilities.”

Routine HPV vaccination of females aged 11 or 12 years is recommended, as is a catch-up vaccine.

Source DR. WORKOWSKI

Revised gonorrhea treatment regimens and expanded STD prevention recommendations are key features in the updated Sexually Transmitted Diseases Treatment Guidelines released in December 2010 by the Centers for Disease Control and Prevention.

Dr. Kimberly A. Workowski of the division of STD prevention at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, chaired the effort and wrote the guidelines with her colleague, Dr. Stuart Berman, after consulting with numerous experts. The guidelines, last updated in 2006, are available online at www.cdc.gov/std/treatment/2010

Gonorrhea treatment regimens were revised in the wake of Neisseria gonorrhoeae's decreased susceptibility to cephalosporins and other antimicrobials. In 2007 the CDC recommended that fluoroquinolones not be used for gonorrhea treatment because of resistance to that class of antimicrobials (MMWR 2007;56:332-6).

“What we've been seeing over the past number of decades is change in the N. gonorrhoeae organism in different parts of the world,” Dr. Workowski said in an interview. “There have been increasing reports of isolates resistant to cephalosporins from Southeast Asia and from Norway.”

Because of these developments, patients who present with an uncomplicated urogenital gonorrheal infection should be treated with a single 250-mg intramuscular injection of ceftriaxone. If this is not an option, consider a single 400-mg tablet of cefixime, or a single-dose cephalosporin regimen. To prevent co-infection with Chlamydia trachomatis, treatment with azithromycin 1 mg orally in a single dose or doxycycline 100 mg twice a day for 7 days is recommended.

Expanded STD prevention recommendations include support for the pre-exposure human papillomavirus (HPV) vaccine, which the report calls “one of the most effective methods for preventing transmission of some STDs.” Two vaccines are currently available: the quadrivalent HPV vaccine (Gardasil; Merck), which also prevents genital warts, and the bivalent HPV vaccine (Cervarix; GlaxoSmithKline). Routine vaccination of females aged 11 or 12 years is recommended with either vaccine, as is catch-up vaccination for females aged 13-26 years. More information regarding HPV vaccination can be found at www.cdc.gov/std/hpv

Other changes that differ from the 2006 guidelines include:

▸ New treatment regimens for genital warts and bacterial vaginosis. The list of patient-applied options for treating external genital warts now includes sinecatechins 15% ointment, a green-tea extract. “We don't know exactly how it works from a scientific standpoint,” said Dr. Workowski, who is also an associate professor of medicine at Emory University, Atlanta. “But in published studies it has done well for genital warts, so it's another alternative.”

The guidelines recommend applying a 0.5-cm strand of ointment to each wart three times per day until complete clearance of warts. “This product should not be continued for longer than 16 weeks,” the recommendations state. “The medication should not be washed off after use. Sexual (i.e., genital, anal, or oral) contact should be avoided while the ointment is on the skin. The most common side effects of sinecatechins 15% are erythema, pruritus/burning, pain, ulceration, edema, induration, and vesicular rash.”

The list of alternative regimens for treating bacterial vaginosis now includes tinidazole 2 g orally once daily for 2 days or tinidazole 1 g orally once daily for 5 days.

▸ Increasing awareness of lymphogranuloma venereum proctocolitis. Lymphogranuloma venereum is a disease that causes enlarged lymph nodes in the inguinal-femoral area, and it can also cause an infection in the rectum, Dr. Workowski said. Lymphogranuloma venereum proctocolitis can present as rectal bleeding or rectal pain “and is being increasingly recognized in men who have sex with men, particularly in HIV-infected men who have sex with men,” she said. “It can also occur in women who engage in receptive rectal intercourse,” and should be part of the differential diagnosis in anyone who engages in receptive anal intercourse and presents with a bloody discharge or pain around the rectal area.

▸ The emergence of azithromycin-resistant Treponema pallidum. Penicillin remains the treatment of choice for syphilis. In those with allergy to penicillin, a 14-day course of doxycycline 100 mg orally twice daily or a 14-day course of tetracycline 500 mg four times daily is recommended. “Azithromycin as a single 2-g oral dose is effective for treating early syphilis,” according to the guidelines. “However, T. pallidum chromosomal mutations associated with azithromycin resistance and treatment failures have been documented in several areas in the United States. As such, azithromycin should be used with caution only when treatment with penicillin or doxycycline is not feasible.”

▸ Discussion of the role of Mycoplasma genitalium and trichomoniasis in the evaluation of urethritis and cervicitis and treatment-related implications. While N. gonorrhoeae and C. trachomatis are well established as clinically important infectious causes of urethritis, M. genitalium has also been associated with urethritis. “If clinic-based diagnostic tools (e.g., Gram-stain microscopy, first void urine with microscopy, and leukocyte esterase) are not available, patients should be treated with drug regimens effective against both gonorrhea and chlamydia,” the guidelines state. “Further testing to determine the specific etiology is recommended because both chlamydia and gonorrhea are reportable to health departments and a specific diagnosis might improve partner notification and treatment.”

The guidelines note that culture, nucleic acid hybridization tests, and nucleic acid amplification testing (NAAT) are available for the detection of both N. gonorrhoeae and C. trachomatis. “Culture and hybridization tests require urethral swab specimens, whereas NAATs can be performed on urine specimens. Because of their higher sensitivity, NAATs are preferred for the detection of C. trachomatis.”

▸ Revised guidance on the evaluation of neurosyphilis. Laboratory diagnosis of neurosyphilis usually depends on various combinations of reactive serologic test results, cerebrospinal fluid (CSF) cell count or protein, and a reactive CSF-Venereal Disease Research Lab [VDRL] test with or without clinical manifestations.

“Among persons with HIV infection, the CSF leukocyte count usually is elevated (greater than 5 white blood cell count/mm

Dr. Workowski and Dr. Berman emphasized that the guidelines “should be regarded as a source of clinical guidance and not prescriptive standards; health care providers should always consider the clinical circumstances of each person in the context of local disease prevalence. They are applicable to various patient-care settings, including family-planning clinics, private physicians' offices, managed care organizations, and other primary care facilities.”

Routine HPV vaccination of females aged 11 or 12 years is recommended, as is a catch-up vaccine.

Source DR. WORKOWSKI

Revised gonorrhea treatment regimens and expanded STD prevention recommendations are key features in the updated Sexually Transmitted Diseases Treatment Guidelines released in December 2010 by the Centers for Disease Control and Prevention.

Dr. Kimberly A. Workowski of the division of STD prevention at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, chaired the effort and wrote the guidelines with her colleague, Dr. Stuart Berman, after consulting with numerous experts. The guidelines, last updated in 2006, are available online at www.cdc.gov/std/treatment/2010

Gonorrhea treatment regimens were revised in the wake of Neisseria gonorrhoeae's decreased susceptibility to cephalosporins and other antimicrobials. In 2007 the CDC recommended that fluoroquinolones not be used for gonorrhea treatment because of resistance to that class of antimicrobials (MMWR 2007;56:332-6).

“What we've been seeing over the past number of decades is change in the N. gonorrhoeae organism in different parts of the world,” Dr. Workowski said in an interview. “There have been increasing reports of isolates resistant to cephalosporins from Southeast Asia and from Norway.”

Because of these developments, patients who present with an uncomplicated urogenital gonorrheal infection should be treated with a single 250-mg intramuscular injection of ceftriaxone. If this is not an option, consider a single 400-mg tablet of cefixime, or a single-dose cephalosporin regimen. To prevent co-infection with Chlamydia trachomatis, treatment with azithromycin 1 mg orally in a single dose or doxycycline 100 mg twice a day for 7 days is recommended.

Expanded STD prevention recommendations include support for the pre-exposure human papillomavirus (HPV) vaccine, which the report calls “one of the most effective methods for preventing transmission of some STDs.” Two vaccines are currently available: the quadrivalent HPV vaccine (Gardasil; Merck), which also prevents genital warts, and the bivalent HPV vaccine (Cervarix; GlaxoSmithKline). Routine vaccination of females aged 11 or 12 years is recommended with either vaccine, as is catch-up vaccination for females aged 13-26 years. More information regarding HPV vaccination can be found at www.cdc.gov/std/hpv

Other changes that differ from the 2006 guidelines include:

▸ New treatment regimens for genital warts and bacterial vaginosis. The list of patient-applied options for treating external genital warts now includes sinecatechins 15% ointment, a green-tea extract. “We don't know exactly how it works from a scientific standpoint,” said Dr. Workowski, who is also an associate professor of medicine at Emory University, Atlanta. “But in published studies it has done well for genital warts, so it's another alternative.”

The guidelines recommend applying a 0.5-cm strand of ointment to each wart three times per day until complete clearance of warts. “This product should not be continued for longer than 16 weeks,” the recommendations state. “The medication should not be washed off after use. Sexual (i.e., genital, anal, or oral) contact should be avoided while the ointment is on the skin. The most common side effects of sinecatechins 15% are erythema, pruritus/burning, pain, ulceration, edema, induration, and vesicular rash.”

The list of alternative regimens for treating bacterial vaginosis now includes tinidazole 2 g orally once daily for 2 days or tinidazole 1 g orally once daily for 5 days.

▸ Increasing awareness of lymphogranuloma venereum proctocolitis. Lymphogranuloma venereum is a disease that causes enlarged lymph nodes in the inguinal-femoral area, and it can also cause an infection in the rectum, Dr. Workowski said. Lymphogranuloma venereum proctocolitis can present as rectal bleeding or rectal pain “and is being increasingly recognized in men who have sex with men, particularly in HIV-infected men who have sex with men,” she said. “It can also occur in women who engage in receptive rectal intercourse,” and should be part of the differential diagnosis in anyone who engages in receptive anal intercourse and presents with a bloody discharge or pain around the rectal area.

▸ The emergence of azithromycin-resistant Treponema pallidum. Penicillin remains the treatment of choice for syphilis. In those with allergy to penicillin, a 14-day course of doxycycline 100 mg orally twice daily or a 14-day course of tetracycline 500 mg four times daily is recommended. “Azithromycin as a single 2-g oral dose is effective for treating early syphilis,” according to the guidelines. “However, T. pallidum chromosomal mutations associated with azithromycin resistance and treatment failures have been documented in several areas in the United States. As such, azithromycin should be used with caution only when treatment with penicillin or doxycycline is not feasible.”

▸ Discussion of the role of Mycoplasma genitalium and trichomoniasis in the evaluation of urethritis and cervicitis and treatment-related implications. While N. gonorrhoeae and C. trachomatis are well established as clinically important infectious causes of urethritis, M. genitalium has also been associated with urethritis. “If clinic-based diagnostic tools (e.g., Gram-stain microscopy, first void urine with microscopy, and leukocyte esterase) are not available, patients should be treated with drug regimens effective against both gonorrhea and chlamydia,” the guidelines state. “Further testing to determine the specific etiology is recommended because both chlamydia and gonorrhea are reportable to health departments and a specific diagnosis might improve partner notification and treatment.”

The guidelines note that culture, nucleic acid hybridization tests, and nucleic acid amplification testing (NAAT) are available for the detection of both N. gonorrhoeae and C. trachomatis. “Culture and hybridization tests require urethral swab specimens, whereas NAATs can be performed on urine specimens. Because of their higher sensitivity, NAATs are preferred for the detection of C. trachomatis.”

▸ Revised guidance on the evaluation of neurosyphilis. Laboratory diagnosis of neurosyphilis usually depends on various combinations of reactive serologic test results, cerebrospinal fluid (CSF) cell count or protein, and a reactive CSF-Venereal Disease Research Lab [VDRL] test with or without clinical manifestations.

“Among persons with HIV infection, the CSF leukocyte count usually is elevated (greater than 5 white blood cell count/mm

Dr. Workowski and Dr. Berman emphasized that the guidelines “should be regarded as a source of clinical guidance and not prescriptive standards; health care providers should always consider the clinical circumstances of each person in the context of local disease prevalence. They are applicable to various patient-care settings, including family-planning clinics, private physicians' offices, managed care organizations, and other primary care facilities.”

Routine HPV vaccination of females aged 11 or 12 years is recommended, as is a catch-up vaccine.

Source DR. WORKOWSKI

SAN DIEGO – There is no apparent relationship between the neighborhood poverty rate, based on patient address, and mortality following critical care, results from a large, 10-year analysis showed.

"Our findings are in contrast to data in other arenas of health care that have established an inverse relationship between socioeconomic status and mortality," Sam Zager said at the annual congress of the Society of Critical Care Medicine. "The few studies that examine economic disparities and mortality in the critically ill are contradictory."

Using 1990 census and hospital administration data, Mr. Zager, a fourth-year student at Harvard Medical School, Boston, and his associates performed an observational study of 38,917 patients aged 18 years and older who received critical care at Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, in 1997-2007.

Neighborhood poverty rate was defined as the percentage of each neighborhood’s residents with incomes below the federal poverty line, categorized as 5%-10%, 10%-20%, 20%-40%, or greater than 40%. They used logistic regression to examine death by day 30, 90, and 365 post ICU, as well as in-hospital mortality, and adjusted the data for age, sex, race, admission year, patient type (medical vs. surgical), Charlson-Deyo index, sepsis, CABG, myocardial infarction, hematocrit, white blood cell count, creatinine, and blood urea nitrogen.

The researchers also performed a sensitivity analysis for 1-year postdischarge mortality among patients discharged to home, as well as mortality among patients who lived less than 50 miles from the hospital of care.

The mean age of patients was 62 years, 42% were women, and 78% were white. After multivariable adjustment of the data, Mr. Zager and his associates found no statistically significant relationship between neighborhood poverty rate and all-cause 30-day mortality. The odds ratio was 1.05 for those who resided in neighborhoods in which 5%-10% of residents lived below the federal poverty line (P = .2), 0.96 for those who resided in neighborhoods in which 10%-20% of residents lived below the federal poverty line (P = .5), 1.08 for those who resided in neighborhoods in which 20%-40% of residents lived below the federal poverty line (P = .2), and 1.20 for those who resided in neighborhoods in which more than 40% of residents lived below the federal poverty line (P = .2).

Similar nonsignificant associations were observed for 90-day and 365-day mortality post ICU admission and for in-hospital mortality. In addition, neighborhood poverty rate was not significantly associated with 1-year postdischarge mortality in patients who were discharged to home or in patients who resided less than 50 miles from the hospital of care.

Mr. Zager also reported that patients from neighborhoods in which 20% or more of residents lived below the federal poverty line were more likely to be black, Hispanic, or young; to have a hematocrit of less than 36%; and to live 5 miles or less from the hospital.

He acknowledged certain limitations of the study, including its observational design and the fact that the researchers were unable to fully exclude patients who received critical care only in the emergency department. Also, "our study focuses on neighborhood poverty at the time of critical care initiation, which may not fully reveal the contribution of socioeconomic status to mortality risk," he said.

The study was supported by the National Institutes of Health. The researchers said that they had no relevant financial conflicts to disclose.

SAN DIEGO – There is no apparent relationship between the neighborhood poverty rate, based on patient address, and mortality following critical care, results from a large, 10-year analysis showed.

"Our findings are in contrast to data in other arenas of health care that have established an inverse relationship between socioeconomic status and mortality," Sam Zager said at the annual congress of the Society of Critical Care Medicine. "The few studies that examine economic disparities and mortality in the critically ill are contradictory."

Using 1990 census and hospital administration data, Mr. Zager, a fourth-year student at Harvard Medical School, Boston, and his associates performed an observational study of 38,917 patients aged 18 years and older who received critical care at Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, in 1997-2007.

Neighborhood poverty rate was defined as the percentage of each neighborhood’s residents with incomes below the federal poverty line, categorized as 5%-10%, 10%-20%, 20%-40%, or greater than 40%. They used logistic regression to examine death by day 30, 90, and 365 post ICU, as well as in-hospital mortality, and adjusted the data for age, sex, race, admission year, patient type (medical vs. surgical), Charlson-Deyo index, sepsis, CABG, myocardial infarction, hematocrit, white blood cell count, creatinine, and blood urea nitrogen.

The researchers also performed a sensitivity analysis for 1-year postdischarge mortality among patients discharged to home, as well as mortality among patients who lived less than 50 miles from the hospital of care.

The mean age of patients was 62 years, 42% were women, and 78% were white. After multivariable adjustment of the data, Mr. Zager and his associates found no statistically significant relationship between neighborhood poverty rate and all-cause 30-day mortality. The odds ratio was 1.05 for those who resided in neighborhoods in which 5%-10% of residents lived below the federal poverty line (P = .2), 0.96 for those who resided in neighborhoods in which 10%-20% of residents lived below the federal poverty line (P = .5), 1.08 for those who resided in neighborhoods in which 20%-40% of residents lived below the federal poverty line (P = .2), and 1.20 for those who resided in neighborhoods in which more than 40% of residents lived below the federal poverty line (P = .2).

Similar nonsignificant associations were observed for 90-day and 365-day mortality post ICU admission and for in-hospital mortality. In addition, neighborhood poverty rate was not significantly associated with 1-year postdischarge mortality in patients who were discharged to home or in patients who resided less than 50 miles from the hospital of care.

Mr. Zager also reported that patients from neighborhoods in which 20% or more of residents lived below the federal poverty line were more likely to be black, Hispanic, or young; to have a hematocrit of less than 36%; and to live 5 miles or less from the hospital.

He acknowledged certain limitations of the study, including its observational design and the fact that the researchers were unable to fully exclude patients who received critical care only in the emergency department. Also, "our study focuses on neighborhood poverty at the time of critical care initiation, which may not fully reveal the contribution of socioeconomic status to mortality risk," he said.

The study was supported by the National Institutes of Health. The researchers said that they had no relevant financial conflicts to disclose.

SAN DIEGO – There is no apparent relationship between the neighborhood poverty rate, based on patient address, and mortality following critical care, results from a large, 10-year analysis showed.

"Our findings are in contrast to data in other arenas of health care that have established an inverse relationship between socioeconomic status and mortality," Sam Zager said at the annual congress of the Society of Critical Care Medicine. "The few studies that examine economic disparities and mortality in the critically ill are contradictory."

Using 1990 census and hospital administration data, Mr. Zager, a fourth-year student at Harvard Medical School, Boston, and his associates performed an observational study of 38,917 patients aged 18 years and older who received critical care at Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, in 1997-2007.

Neighborhood poverty rate was defined as the percentage of each neighborhood’s residents with incomes below the federal poverty line, categorized as 5%-10%, 10%-20%, 20%-40%, or greater than 40%. They used logistic regression to examine death by day 30, 90, and 365 post ICU, as well as in-hospital mortality, and adjusted the data for age, sex, race, admission year, patient type (medical vs. surgical), Charlson-Deyo index, sepsis, CABG, myocardial infarction, hematocrit, white blood cell count, creatinine, and blood urea nitrogen.

The researchers also performed a sensitivity analysis for 1-year postdischarge mortality among patients discharged to home, as well as mortality among patients who lived less than 50 miles from the hospital of care.

The mean age of patients was 62 years, 42% were women, and 78% were white. After multivariable adjustment of the data, Mr. Zager and his associates found no statistically significant relationship between neighborhood poverty rate and all-cause 30-day mortality. The odds ratio was 1.05 for those who resided in neighborhoods in which 5%-10% of residents lived below the federal poverty line (P = .2), 0.96 for those who resided in neighborhoods in which 10%-20% of residents lived below the federal poverty line (P = .5), 1.08 for those who resided in neighborhoods in which 20%-40% of residents lived below the federal poverty line (P = .2), and 1.20 for those who resided in neighborhoods in which more than 40% of residents lived below the federal poverty line (P = .2).

Similar nonsignificant associations were observed for 90-day and 365-day mortality post ICU admission and for in-hospital mortality. In addition, neighborhood poverty rate was not significantly associated with 1-year postdischarge mortality in patients who were discharged to home or in patients who resided less than 50 miles from the hospital of care.

Mr. Zager also reported that patients from neighborhoods in which 20% or more of residents lived below the federal poverty line were more likely to be black, Hispanic, or young; to have a hematocrit of less than 36%; and to live 5 miles or less from the hospital.

He acknowledged certain limitations of the study, including its observational design and the fact that the researchers were unable to fully exclude patients who received critical care only in the emergency department. Also, "our study focuses on neighborhood poverty at the time of critical care initiation, which may not fully reveal the contribution of socioeconomic status to mortality risk," he said.

The study was supported by the National Institutes of Health. The researchers said that they had no relevant financial conflicts to disclose.

SAN DIEGO – There is no apparent relationship between the neighborhood poverty rate, based on patient address, and mortality following critical care, results from a large, 10-year analysis showed.

"Our findings are in contrast to data in other arenas of health care that have established an inverse relationship between socioeconomic status and mortality," Sam Zager said at the annual congress of the Society of Critical Care Medicine. "The few studies that examine economic disparities and mortality in the critically ill are contradictory."

Using 1990 census and hospital administration data, Mr. Zager, a fourth-year student at Harvard Medical School, Boston, and his associates performed an observational study of 38,917 patients aged 18 years and older who received critical care at Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, in 1997-2007.

Neighborhood poverty rate was defined as the percentage of each neighborhood’s residents with incomes below the federal poverty line, categorized as 5%-10%, 10%-20%, 20%-40%, or greater than 40%. They used logistic regression to examine death by day 30, 90, and 365 post ICU, as well as in-hospital mortality, and adjusted the data for age, sex, race, admission year, patient type (medical vs. surgical), Charlson-Deyo index, sepsis, CABG, myocardial infarction, hematocrit, white blood cell count, creatinine, and blood urea nitrogen.

The researchers also performed a sensitivity analysis for 1-year postdischarge mortality among patients discharged to home, as well as mortality among patients who lived less than 50 miles from the hospital of care.

The mean age of patients was 62 years, 42% were women, and 78% were white. After multivariable adjustment of the data, Mr. Zager and his associates found no statistically significant relationship between neighborhood poverty rate and all-cause 30-day mortality. The odds ratio was 1.05 for those who resided in neighborhoods in which 5%-10% of residents lived below the federal poverty line (P = .2), 0.96 for those who resided in neighborhoods in which 10%-20% of residents lived below the federal poverty line (P = .5), 1.08 for those who resided in neighborhoods in which 20%-40% of residents lived below the federal poverty line (P = .2), and 1.20 for those who resided in neighborhoods in which more than 40% of residents lived below the federal poverty line (P = .2).

Similar nonsignificant associations were observed for 90-day and 365-day mortality post ICU admission and for in-hospital mortality. In addition, neighborhood poverty rate was not significantly associated with 1-year postdischarge mortality in patients who were discharged to home or in patients who resided less than 50 miles from the hospital of care.

Mr. Zager also reported that patients from neighborhoods in which 20% or more of residents lived below the federal poverty line were more likely to be black, Hispanic, or young; to have a hematocrit of less than 36%; and to live 5 miles or less from the hospital.

He acknowledged certain limitations of the study, including its observational design and the fact that the researchers were unable to fully exclude patients who received critical care only in the emergency department. Also, "our study focuses on neighborhood poverty at the time of critical care initiation, which may not fully reveal the contribution of socioeconomic status to mortality risk," he said.

The study was supported by the National Institutes of Health. The researchers said that they had no relevant financial conflicts to disclose.

SAN DIEGO – There is no apparent relationship between the neighborhood poverty rate, based on patient address, and mortality following critical care, results from a large, 10-year analysis showed.

"Our findings are in contrast to data in other arenas of health care that have established an inverse relationship between socioeconomic status and mortality," Sam Zager said at the annual congress of the Society of Critical Care Medicine. "The few studies that examine economic disparities and mortality in the critically ill are contradictory."

Using 1990 census and hospital administration data, Mr. Zager, a fourth-year student at Harvard Medical School, Boston, and his associates performed an observational study of 38,917 patients aged 18 years and older who received critical care at Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, in 1997-2007.

Neighborhood poverty rate was defined as the percentage of each neighborhood’s residents with incomes below the federal poverty line, categorized as 5%-10%, 10%-20%, 20%-40%, or greater than 40%. They used logistic regression to examine death by day 30, 90, and 365 post ICU, as well as in-hospital mortality, and adjusted the data for age, sex, race, admission year, patient type (medical vs. surgical), Charlson-Deyo index, sepsis, CABG, myocardial infarction, hematocrit, white blood cell count, creatinine, and blood urea nitrogen.

The researchers also performed a sensitivity analysis for 1-year postdischarge mortality among patients discharged to home, as well as mortality among patients who lived less than 50 miles from the hospital of care.

The mean age of patients was 62 years, 42% were women, and 78% were white. After multivariable adjustment of the data, Mr. Zager and his associates found no statistically significant relationship between neighborhood poverty rate and all-cause 30-day mortality. The odds ratio was 1.05 for those who resided in neighborhoods in which 5%-10% of residents lived below the federal poverty line (P = .2), 0.96 for those who resided in neighborhoods in which 10%-20% of residents lived below the federal poverty line (P = .5), 1.08 for those who resided in neighborhoods in which 20%-40% of residents lived below the federal poverty line (P = .2), and 1.20 for those who resided in neighborhoods in which more than 40% of residents lived below the federal poverty line (P = .2).

Similar nonsignificant associations were observed for 90-day and 365-day mortality post ICU admission and for in-hospital mortality. In addition, neighborhood poverty rate was not significantly associated with 1-year postdischarge mortality in patients who were discharged to home or in patients who resided less than 50 miles from the hospital of care.

Mr. Zager also reported that patients from neighborhoods in which 20% or more of residents lived below the federal poverty line were more likely to be black, Hispanic, or young; to have a hematocrit of less than 36%; and to live 5 miles or less from the hospital.

He acknowledged certain limitations of the study, including its observational design and the fact that the researchers were unable to fully exclude patients who received critical care only in the emergency department. Also, "our study focuses on neighborhood poverty at the time of critical care initiation, which may not fully reveal the contribution of socioeconomic status to mortality risk," he said.

The study was supported by the National Institutes of Health. The researchers said that they had no relevant financial conflicts to disclose.

SAN DIEGO – There is no apparent relationship between the neighborhood poverty rate, based on patient address, and mortality following critical care, results from a large, 10-year analysis showed.

"Our findings are in contrast to data in other arenas of health care that have established an inverse relationship between socioeconomic status and mortality," Sam Zager said at the annual congress of the Society of Critical Care Medicine. "The few studies that examine economic disparities and mortality in the critically ill are contradictory."

Using 1990 census and hospital administration data, Mr. Zager, a fourth-year student at Harvard Medical School, Boston, and his associates performed an observational study of 38,917 patients aged 18 years and older who received critical care at Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, in 1997-2007.

Neighborhood poverty rate was defined as the percentage of each neighborhood’s residents with incomes below the federal poverty line, categorized as 5%-10%, 10%-20%, 20%-40%, or greater than 40%. They used logistic regression to examine death by day 30, 90, and 365 post ICU, as well as in-hospital mortality, and adjusted the data for age, sex, race, admission year, patient type (medical vs. surgical), Charlson-Deyo index, sepsis, CABG, myocardial infarction, hematocrit, white blood cell count, creatinine, and blood urea nitrogen.

The researchers also performed a sensitivity analysis for 1-year postdischarge mortality among patients discharged to home, as well as mortality among patients who lived less than 50 miles from the hospital of care.

The mean age of patients was 62 years, 42% were women, and 78% were white. After multivariable adjustment of the data, Mr. Zager and his associates found no statistically significant relationship between neighborhood poverty rate and all-cause 30-day mortality. The odds ratio was 1.05 for those who resided in neighborhoods in which 5%-10% of residents lived below the federal poverty line (P = .2), 0.96 for those who resided in neighborhoods in which 10%-20% of residents lived below the federal poverty line (P = .5), 1.08 for those who resided in neighborhoods in which 20%-40% of residents lived below the federal poverty line (P = .2), and 1.20 for those who resided in neighborhoods in which more than 40% of residents lived below the federal poverty line (P = .2).

Similar nonsignificant associations were observed for 90-day and 365-day mortality post ICU admission and for in-hospital mortality. In addition, neighborhood poverty rate was not significantly associated with 1-year postdischarge mortality in patients who were discharged to home or in patients who resided less than 50 miles from the hospital of care.

Mr. Zager also reported that patients from neighborhoods in which 20% or more of residents lived below the federal poverty line were more likely to be black, Hispanic, or young; to have a hematocrit of less than 36%; and to live 5 miles or less from the hospital.

He acknowledged certain limitations of the study, including its observational design and the fact that the researchers were unable to fully exclude patients who received critical care only in the emergency department. Also, "our study focuses on neighborhood poverty at the time of critical care initiation, which may not fully reveal the contribution of socioeconomic status to mortality risk," he said.

The study was supported by the National Institutes of Health. The researchers said that they had no relevant financial conflicts to disclose.

SAN DIEGO – Nearly all veterans admitted to a surgical intensive care unit were vitamin D deficient, yet they were only mildly hypocalcemic, results from a single-center study showed.

"Research is still needed to determine if vitamin D deficiency contributes to complications in the ICU setting and if acute supplementation improves morbidity," researchers led by Mark Wong, Pharm.D., of the South Texas Veterans Health System, San Antonio, wrote in an abstract presented during a poster session at the annual congress of the Society of Critical Care Medicine. "Preemptive screening may become the standard of practice as more research becomes available."

To test the hypothesis that the frequency of vitamin D deficiency based on 25-hydroxyvitamin D levels was high in patients admitted to the surgical ICU, he and his associates evaluated 100 patients aged 18 years and older who were admitted to the surgical ICU between January of 2010 and August of 2010 and remained there for at least 2 days. Patients who were transferred out of the surgical ICU before labs were drawn were excluded from the analysis.

The researchers recorded 25(OH)D levels, calcium levels, as well as basic demographic information. The hospital’s reference ranges for 25(OH)D and calcium are greater than 32 ng/mL and 8.6-10 mg/dL, respectively. Vitamin D supplementation was begun based on the patient’s 25(OH)D level.

The mean age of patients was 66 years, 97% were male, and 50% had undergone cardiothoracic surgery. Other types of surgery were general (23%), neurology/ENT (14%), urology (7%), and orthopedic (6%).

Dr. Wong reported that 97% of patients met the criteria for vitamin D deficiency. Levels of 25(OH)D ranged from 5-46.4 ng/mL, for a mean of 17.5 ng/mL. The mean calcium level was 8.2 ng/mL.

No associations were seen between age, 25(OH)D, and calcium levels.

Dr. Wong said that he had no relevant financial conflicts of interest.

SAN DIEGO – Nearly all veterans admitted to a surgical intensive care unit were vitamin D deficient, yet they were only mildly hypocalcemic, results from a single-center study showed.

"Research is still needed to determine if vitamin D deficiency contributes to complications in the ICU setting and if acute supplementation improves morbidity," researchers led by Mark Wong, Pharm.D., of the South Texas Veterans Health System, San Antonio, wrote in an abstract presented during a poster session at the annual congress of the Society of Critical Care Medicine. "Preemptive screening may become the standard of practice as more research becomes available."

To test the hypothesis that the frequency of vitamin D deficiency based on 25-hydroxyvitamin D levels was high in patients admitted to the surgical ICU, he and his associates evaluated 100 patients aged 18 years and older who were admitted to the surgical ICU between January of 2010 and August of 2010 and remained there for at least 2 days. Patients who were transferred out of the surgical ICU before labs were drawn were excluded from the analysis.

The researchers recorded 25(OH)D levels, calcium levels, as well as basic demographic information. The hospital’s reference ranges for 25(OH)D and calcium are greater than 32 ng/mL and 8.6-10 mg/dL, respectively. Vitamin D supplementation was begun based on the patient’s 25(OH)D level.

The mean age of patients was 66 years, 97% were male, and 50% had undergone cardiothoracic surgery. Other types of surgery were general (23%), neurology/ENT (14%), urology (7%), and orthopedic (6%).

Dr. Wong reported that 97% of patients met the criteria for vitamin D deficiency. Levels of 25(OH)D ranged from 5-46.4 ng/mL, for a mean of 17.5 ng/mL. The mean calcium level was 8.2 ng/mL.

No associations were seen between age, 25(OH)D, and calcium levels.

Dr. Wong said that he had no relevant financial conflicts of interest.

SAN DIEGO – Nearly all veterans admitted to a surgical intensive care unit were vitamin D deficient, yet they were only mildly hypocalcemic, results from a single-center study showed.

"Research is still needed to determine if vitamin D deficiency contributes to complications in the ICU setting and if acute supplementation improves morbidity," researchers led by Mark Wong, Pharm.D., of the South Texas Veterans Health System, San Antonio, wrote in an abstract presented during a poster session at the annual congress of the Society of Critical Care Medicine. "Preemptive screening may become the standard of practice as more research becomes available."

To test the hypothesis that the frequency of vitamin D deficiency based on 25-hydroxyvitamin D levels was high in patients admitted to the surgical ICU, he and his associates evaluated 100 patients aged 18 years and older who were admitted to the surgical ICU between January of 2010 and August of 2010 and remained there for at least 2 days. Patients who were transferred out of the surgical ICU before labs were drawn were excluded from the analysis.

The researchers recorded 25(OH)D levels, calcium levels, as well as basic demographic information. The hospital’s reference ranges for 25(OH)D and calcium are greater than 32 ng/mL and 8.6-10 mg/dL, respectively. Vitamin D supplementation was begun based on the patient’s 25(OH)D level.

The mean age of patients was 66 years, 97% were male, and 50% had undergone cardiothoracic surgery. Other types of surgery were general (23%), neurology/ENT (14%), urology (7%), and orthopedic (6%).

Dr. Wong reported that 97% of patients met the criteria for vitamin D deficiency. Levels of 25(OH)D ranged from 5-46.4 ng/mL, for a mean of 17.5 ng/mL. The mean calcium level was 8.2 ng/mL.

No associations were seen between age, 25(OH)D, and calcium levels.

Dr. Wong said that he had no relevant financial conflicts of interest.

SAN DIEGO – Nearly all veterans admitted to a surgical intensive care unit were vitamin D deficient, yet they were only mildly hypocalcemic, results from a single-center study showed.

"Research is still needed to determine if vitamin D deficiency contributes to complications in the ICU setting and if acute supplementation improves morbidity," researchers led by Mark Wong, Pharm.D., of the South Texas Veterans Health System, San Antonio, wrote in an abstract presented during a poster session at the annual congress of the Society of Critical Care Medicine. "Preemptive screening may become the standard of practice as more research becomes available."

To test the hypothesis that the frequency of vitamin D deficiency based on 25-hydroxyvitamin D levels was high in patients admitted to the surgical ICU, he and his associates evaluated 100 patients aged 18 years and older who were admitted to the surgical ICU between January of 2010 and August of 2010 and remained there for at least 2 days. Patients who were transferred out of the surgical ICU before labs were drawn were excluded from the analysis.

The researchers recorded 25(OH)D levels, calcium levels, as well as basic demographic information. The hospital’s reference ranges for 25(OH)D and calcium are greater than 32 ng/mL and 8.6-10 mg/dL, respectively. Vitamin D supplementation was begun based on the patient’s 25(OH)D level.

The mean age of patients was 66 years, 97% were male, and 50% had undergone cardiothoracic surgery. Other types of surgery were general (23%), neurology/ENT (14%), urology (7%), and orthopedic (6%).

Dr. Wong reported that 97% of patients met the criteria for vitamin D deficiency. Levels of 25(OH)D ranged from 5-46.4 ng/mL, for a mean of 17.5 ng/mL. The mean calcium level was 8.2 ng/mL.

No associations were seen between age, 25(OH)D, and calcium levels.

Dr. Wong said that he had no relevant financial conflicts of interest.

SAN DIEGO – Nearly all veterans admitted to a surgical intensive care unit were vitamin D deficient, yet they were only mildly hypocalcemic, results from a single-center study showed.

"Research is still needed to determine if vitamin D deficiency contributes to complications in the ICU setting and if acute supplementation improves morbidity," researchers led by Mark Wong, Pharm.D., of the South Texas Veterans Health System, San Antonio, wrote in an abstract presented during a poster session at the annual congress of the Society of Critical Care Medicine. "Preemptive screening may become the standard of practice as more research becomes available."

To test the hypothesis that the frequency of vitamin D deficiency based on 25-hydroxyvitamin D levels was high in patients admitted to the surgical ICU, he and his associates evaluated 100 patients aged 18 years and older who were admitted to the surgical ICU between January of 2010 and August of 2010 and remained there for at least 2 days. Patients who were transferred out of the surgical ICU before labs were drawn were excluded from the analysis.

The researchers recorded 25(OH)D levels, calcium levels, as well as basic demographic information. The hospital’s reference ranges for 25(OH)D and calcium are greater than 32 ng/mL and 8.6-10 mg/dL, respectively. Vitamin D supplementation was begun based on the patient’s 25(OH)D level.

The mean age of patients was 66 years, 97% were male, and 50% had undergone cardiothoracic surgery. Other types of surgery were general (23%), neurology/ENT (14%), urology (7%), and orthopedic (6%).

Dr. Wong reported that 97% of patients met the criteria for vitamin D deficiency. Levels of 25(OH)D ranged from 5-46.4 ng/mL, for a mean of 17.5 ng/mL. The mean calcium level was 8.2 ng/mL.

No associations were seen between age, 25(OH)D, and calcium levels.

Dr. Wong said that he had no relevant financial conflicts of interest.

SAN DIEGO – Nearly all veterans admitted to a surgical intensive care unit were vitamin D deficient, yet they were only mildly hypocalcemic, results from a single-center study showed.

"Research is still needed to determine if vitamin D deficiency contributes to complications in the ICU setting and if acute supplementation improves morbidity," researchers led by Mark Wong, Pharm.D., of the South Texas Veterans Health System, San Antonio, wrote in an abstract presented during a poster session at the annual congress of the Society of Critical Care Medicine. "Preemptive screening may become the standard of practice as more research becomes available."

To test the hypothesis that the frequency of vitamin D deficiency based on 25-hydroxyvitamin D levels was high in patients admitted to the surgical ICU, he and his associates evaluated 100 patients aged 18 years and older who were admitted to the surgical ICU between January of 2010 and August of 2010 and remained there for at least 2 days. Patients who were transferred out of the surgical ICU before labs were drawn were excluded from the analysis.

The researchers recorded 25(OH)D levels, calcium levels, as well as basic demographic information. The hospital’s reference ranges for 25(OH)D and calcium are greater than 32 ng/mL and 8.6-10 mg/dL, respectively. Vitamin D supplementation was begun based on the patient’s 25(OH)D level.

The mean age of patients was 66 years, 97% were male, and 50% had undergone cardiothoracic surgery. Other types of surgery were general (23%), neurology/ENT (14%), urology (7%), and orthopedic (6%).

Dr. Wong reported that 97% of patients met the criteria for vitamin D deficiency. Levels of 25(OH)D ranged from 5-46.4 ng/mL, for a mean of 17.5 ng/mL. The mean calcium level was 8.2 ng/mL.

No associations were seen between age, 25(OH)D, and calcium levels.

Dr. Wong said that he had no relevant financial conflicts of interest.