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Nonpharmacologic AD therapy: Strongest evidence supports moisturizers
BOSTON – Moisturizers are “a cornerstone” of therapy for children with atopic dermatitis, according to Julie V. Schaffer, MD.
Moisturizers improve skin hydration, increase the time between flares, and reduce xerosis and pruritus, Dr. Schaffer of Hackensack (N.J.) University Medical Group said at the American Academy of Dermatology summer meeting.
In 2014, the AAD released guidelines that “very strongly” recommended moisturizers as an important nonpharmacologic intervention for patients with AD, stating that moisturizer use decreases disease severity and can reduce the need for pharmacologic intervention, she said.
In fact, the recommendation for moisturizer was based on “strength A, level 1 evidence,” she noted.
The role of bathing is a bit less clear; bathing is suggested as part of treatment and maintenance, but no standard exists with respect to frequency or duration for those with AD (evidence level: III, strength of recommendation: C). In general, the AAD recommends daily or less frequent bathing in warm water for 5-10 minutes, but surveys suggest that bathing recommendations vary widely among specialists and primary care providers, Dr. Schaffer said.
She noted that she sometimes sees children who have been told to bathe only once a week.
“They will come in just covered with disgusting gunk and it can’t be good for them,” she said. Bathing, especially if they have crusting and scaling, removes irritants and potential allergens, and provides hydration. It can also improve penetration of topical medications, as well as tolerance of those medications so that they burn less.
“So I give a thumbs up to daily bathing,” she said.
It is generally agreed that moisturizers should be applied soon after bathing (after applying medication) to improve skin hydration in patients with AD, Dr. Schaffer said.
The AAD says that moisturizers should be applied liberally and frequently, but the ideal frequency and type of moisturizer remains “a bit of an art form rather than a precise science,” she added.
The ideal moisturizer is one that is safe, effective, and free of fragrance, irritants, and potential sensitizers, she said, noting that “an individualized approach to moisturizer and vehicle selection can be very helpful.”
For young children, it is important that the product doesn’t sting; an ointment may be preferable in this population. Preteens and teenagers may dislike greasiness, so that is an important consideration, she said.
Dr. Schaffer pointed out that lotion formulations typically have water content that is too high to be helpful for patients with substantial xerosis. Creams or ointments may be a better bet, but take care to avoid contamination in large jars of such products, she advised.
“I’ve had a couple times when patients were getting recurrent infections, and we traced it down to a nasty jar that had a little too much bacteria in it,” she said, noting that using a clean scoop or pump can help prevent contamination.
As for cleansers, the “pretty clear winner” is a nonsoap cleanser, Dr. Schaffer said.
The AAD recommends limited use of hypoallergenic, fragrance-free, nonsoap cleansers with neutral to low pH, but the evidence is insufficient for recommending the addition of bath oils, emollients, oatmeal, and most other additives to bath water, as well as for the use of acidic spring water, she said (evidence level: III, strength of recommendation: C). An exception is bleach baths, as adding a small amount of bleach to bath water has been shown to improve symptoms, but the other products have not been shown to be beneficial.
The AAD notes that wet wrap therapy, either with or without a topical corticosteroid, can be recommended for patients with moderate to severe AD, as this can decrease disease severity and water loss during flares (evidence level: II, strength of recommendation: B).
Use moisturizer in newborns at risk for AD
Moisturizers don’t just help improve atopic dermatitis in children, they may also prevent the condition in at risk newborns.
Parents of a child with eczema who are concerned about the condition developing in their next child may find hope in the findings from two studies published in 2014, Dr. Schaffer said.
In a study of 124 newborns at high risk for AD who were randomized to daily emollient therapy or usual infant skin care started by age 3 weeks, the incidence of AD over 6 months was 43% in the control group, vs. 22% in the emollient group, a relative risk reduction of 50% (J Allergy Clin Immunol. 2014 Oct;134[4]:818-23). Parents in the emollient therapy group were allowed to choose between sunflower oil, Cetaphil cream, or Aquaphor Healing Ointment.
In a similar Japanese study of 118 high risk infants who were randomized to daily treatment with an emulsion-type emollient or usual skin care starting the first week of life, the AD/eczema rates at 32 weeks were 47% and 32% in the control and emollient groups, respectively (J Allergy Clin Immunol. 2014 Oct;134[4], 824-30). Both groups were allowed to use petroleum jelly.
“So that is something you can potentially make a recommendation for,” she said.
Dr. Schaffer reported having no conflicts of interest.
BOSTON – Moisturizers are “a cornerstone” of therapy for children with atopic dermatitis, according to Julie V. Schaffer, MD.
Moisturizers improve skin hydration, increase the time between flares, and reduce xerosis and pruritus, Dr. Schaffer of Hackensack (N.J.) University Medical Group said at the American Academy of Dermatology summer meeting.
In 2014, the AAD released guidelines that “very strongly” recommended moisturizers as an important nonpharmacologic intervention for patients with AD, stating that moisturizer use decreases disease severity and can reduce the need for pharmacologic intervention, she said.
In fact, the recommendation for moisturizer was based on “strength A, level 1 evidence,” she noted.
The role of bathing is a bit less clear; bathing is suggested as part of treatment and maintenance, but no standard exists with respect to frequency or duration for those with AD (evidence level: III, strength of recommendation: C). In general, the AAD recommends daily or less frequent bathing in warm water for 5-10 minutes, but surveys suggest that bathing recommendations vary widely among specialists and primary care providers, Dr. Schaffer said.
She noted that she sometimes sees children who have been told to bathe only once a week.
“They will come in just covered with disgusting gunk and it can’t be good for them,” she said. Bathing, especially if they have crusting and scaling, removes irritants and potential allergens, and provides hydration. It can also improve penetration of topical medications, as well as tolerance of those medications so that they burn less.
“So I give a thumbs up to daily bathing,” she said.
It is generally agreed that moisturizers should be applied soon after bathing (after applying medication) to improve skin hydration in patients with AD, Dr. Schaffer said.
The AAD says that moisturizers should be applied liberally and frequently, but the ideal frequency and type of moisturizer remains “a bit of an art form rather than a precise science,” she added.
The ideal moisturizer is one that is safe, effective, and free of fragrance, irritants, and potential sensitizers, she said, noting that “an individualized approach to moisturizer and vehicle selection can be very helpful.”
For young children, it is important that the product doesn’t sting; an ointment may be preferable in this population. Preteens and teenagers may dislike greasiness, so that is an important consideration, she said.
Dr. Schaffer pointed out that lotion formulations typically have water content that is too high to be helpful for patients with substantial xerosis. Creams or ointments may be a better bet, but take care to avoid contamination in large jars of such products, she advised.
“I’ve had a couple times when patients were getting recurrent infections, and we traced it down to a nasty jar that had a little too much bacteria in it,” she said, noting that using a clean scoop or pump can help prevent contamination.
As for cleansers, the “pretty clear winner” is a nonsoap cleanser, Dr. Schaffer said.
The AAD recommends limited use of hypoallergenic, fragrance-free, nonsoap cleansers with neutral to low pH, but the evidence is insufficient for recommending the addition of bath oils, emollients, oatmeal, and most other additives to bath water, as well as for the use of acidic spring water, she said (evidence level: III, strength of recommendation: C). An exception is bleach baths, as adding a small amount of bleach to bath water has been shown to improve symptoms, but the other products have not been shown to be beneficial.
The AAD notes that wet wrap therapy, either with or without a topical corticosteroid, can be recommended for patients with moderate to severe AD, as this can decrease disease severity and water loss during flares (evidence level: II, strength of recommendation: B).
Use moisturizer in newborns at risk for AD
Moisturizers don’t just help improve atopic dermatitis in children, they may also prevent the condition in at risk newborns.
Parents of a child with eczema who are concerned about the condition developing in their next child may find hope in the findings from two studies published in 2014, Dr. Schaffer said.
In a study of 124 newborns at high risk for AD who were randomized to daily emollient therapy or usual infant skin care started by age 3 weeks, the incidence of AD over 6 months was 43% in the control group, vs. 22% in the emollient group, a relative risk reduction of 50% (J Allergy Clin Immunol. 2014 Oct;134[4]:818-23). Parents in the emollient therapy group were allowed to choose between sunflower oil, Cetaphil cream, or Aquaphor Healing Ointment.
In a similar Japanese study of 118 high risk infants who were randomized to daily treatment with an emulsion-type emollient or usual skin care starting the first week of life, the AD/eczema rates at 32 weeks were 47% and 32% in the control and emollient groups, respectively (J Allergy Clin Immunol. 2014 Oct;134[4], 824-30). Both groups were allowed to use petroleum jelly.
“So that is something you can potentially make a recommendation for,” she said.
Dr. Schaffer reported having no conflicts of interest.
BOSTON – Moisturizers are “a cornerstone” of therapy for children with atopic dermatitis, according to Julie V. Schaffer, MD.
Moisturizers improve skin hydration, increase the time between flares, and reduce xerosis and pruritus, Dr. Schaffer of Hackensack (N.J.) University Medical Group said at the American Academy of Dermatology summer meeting.
In 2014, the AAD released guidelines that “very strongly” recommended moisturizers as an important nonpharmacologic intervention for patients with AD, stating that moisturizer use decreases disease severity and can reduce the need for pharmacologic intervention, she said.
In fact, the recommendation for moisturizer was based on “strength A, level 1 evidence,” she noted.
The role of bathing is a bit less clear; bathing is suggested as part of treatment and maintenance, but no standard exists with respect to frequency or duration for those with AD (evidence level: III, strength of recommendation: C). In general, the AAD recommends daily or less frequent bathing in warm water for 5-10 minutes, but surveys suggest that bathing recommendations vary widely among specialists and primary care providers, Dr. Schaffer said.
She noted that she sometimes sees children who have been told to bathe only once a week.
“They will come in just covered with disgusting gunk and it can’t be good for them,” she said. Bathing, especially if they have crusting and scaling, removes irritants and potential allergens, and provides hydration. It can also improve penetration of topical medications, as well as tolerance of those medications so that they burn less.
“So I give a thumbs up to daily bathing,” she said.
It is generally agreed that moisturizers should be applied soon after bathing (after applying medication) to improve skin hydration in patients with AD, Dr. Schaffer said.
The AAD says that moisturizers should be applied liberally and frequently, but the ideal frequency and type of moisturizer remains “a bit of an art form rather than a precise science,” she added.
The ideal moisturizer is one that is safe, effective, and free of fragrance, irritants, and potential sensitizers, she said, noting that “an individualized approach to moisturizer and vehicle selection can be very helpful.”
For young children, it is important that the product doesn’t sting; an ointment may be preferable in this population. Preteens and teenagers may dislike greasiness, so that is an important consideration, she said.
Dr. Schaffer pointed out that lotion formulations typically have water content that is too high to be helpful for patients with substantial xerosis. Creams or ointments may be a better bet, but take care to avoid contamination in large jars of such products, she advised.
“I’ve had a couple times when patients were getting recurrent infections, and we traced it down to a nasty jar that had a little too much bacteria in it,” she said, noting that using a clean scoop or pump can help prevent contamination.
As for cleansers, the “pretty clear winner” is a nonsoap cleanser, Dr. Schaffer said.
The AAD recommends limited use of hypoallergenic, fragrance-free, nonsoap cleansers with neutral to low pH, but the evidence is insufficient for recommending the addition of bath oils, emollients, oatmeal, and most other additives to bath water, as well as for the use of acidic spring water, she said (evidence level: III, strength of recommendation: C). An exception is bleach baths, as adding a small amount of bleach to bath water has been shown to improve symptoms, but the other products have not been shown to be beneficial.
The AAD notes that wet wrap therapy, either with or without a topical corticosteroid, can be recommended for patients with moderate to severe AD, as this can decrease disease severity and water loss during flares (evidence level: II, strength of recommendation: B).
Use moisturizer in newborns at risk for AD
Moisturizers don’t just help improve atopic dermatitis in children, they may also prevent the condition in at risk newborns.
Parents of a child with eczema who are concerned about the condition developing in their next child may find hope in the findings from two studies published in 2014, Dr. Schaffer said.
In a study of 124 newborns at high risk for AD who were randomized to daily emollient therapy or usual infant skin care started by age 3 weeks, the incidence of AD over 6 months was 43% in the control group, vs. 22% in the emollient group, a relative risk reduction of 50% (J Allergy Clin Immunol. 2014 Oct;134[4]:818-23). Parents in the emollient therapy group were allowed to choose between sunflower oil, Cetaphil cream, or Aquaphor Healing Ointment.
In a similar Japanese study of 118 high risk infants who were randomized to daily treatment with an emulsion-type emollient or usual skin care starting the first week of life, the AD/eczema rates at 32 weeks were 47% and 32% in the control and emollient groups, respectively (J Allergy Clin Immunol. 2014 Oct;134[4], 824-30). Both groups were allowed to use petroleum jelly.
“So that is something you can potentially make a recommendation for,” she said.
Dr. Schaffer reported having no conflicts of interest.
EXPERT ANALYSIS FROM THE AAD SUMMER ACADEMY 2016
Native Israelis have higher risk of Hodgkin lymphoma
Photo from Hebrew
University of Jerusalem
A study of 2.3 million Jewish subjects suggests that being born in Israel increases a person’s risk of developing Hodgkin lymphoma (HL).
Native Israelis had a higher risk of HL than subjects who immigrated to Israel from Europe, Asia, or North Africa.
Researchers said this finding, published in Leukemia & Lymphoma, suggests that exposure to as-yet-unidentified elements of Israel’s environment increases the risk of HL.
“While we still need further studies to identify the specific causes of the high rates of Hodgkin lymphoma among native Israelis, our findings direct us to search for possible environmental causes in Israel and the neighboring countries,” said study author Hagai Levine, MD, of Hebrew University of Jerusalem in Israel.
“These causes could be not only environmental exposures but also diet, climate, social environment, and stress that may be related to chronic regional conflict.”
Dr Levine and his colleagues noted that the incidence of HL in Israel is among the highest in the world. Based on GLOBOCAN estimates for 2012, Israeli females have the highest age-standardized incidence rate of HL worldwide, and Israeli males have the second highest. From 1960 through 2005, Israel experienced a sharp rise in HL incidence among Israeli-born individuals of both sexes.
Despite evidence for an environmental etiology, very few risk factors have been identified. Studying immigrant populations provides a means of investigating the relative importance of genetic factors as compared to environmental factors in disease development.
With all that in mind, Dr Levine and his colleagues conducted the current study. They included Jewish men and women, ages 16 to 19 at examination, with no history of a cancer diagnosis.
Nationwide data on 2,285,009 adolescents, collected from 1967 through 2011, were linked to Israel’s Cancer Registry to obtain the incidence of HL until 2012.
During 47 million person-years of follow-up, there were 2093 cases of HL detected.
Multivariate analysis suggested native Israelis had a significantly higher risk of developing HL than individuals who immigrated to the country (hazard ratio=1.29, P<0.001). This increased risk was driven largely by an elevated risk for the nodular sclerosis subtype of HL (hazard ratio=1.59, P<0.001).
The researchers noted that the elevated risk appeared within one generation. The low incidence of HL observed for immigrants from Western Asia was no longer evident among Israeli-born individuals of Asian origin. Among immigrants, there was no difference by age at migration.
Therefore, the researchers suggested that immigration from a low-risk to a high-risk location, mostly to locales with a modern lifestyle and environment, is associated with an increase in HL incidence (mainly the nodular sclerosis subtype) within short periods, making genetic drift unlikely as a causal explanation.
On the other hand, the Israeli lifestyle and environment, either independently or by gene-environment interaction, may pose exceptional risks for HL.
“There is increasing evidence for developmental origins of health and disease, with different possible mechanisms, including epigenetic changes or endocrine disruption,” Dr Levine said.
“There is also increasing evidence on the role of prenatal stress in offspring development, including cancer development, especially for hematological malignancies. These data suggest that risk of HL (the nodular sclerosis subtype) is possibly increased due to preconception, prenatal, or early life exposures to a changing lifestyle and environment and its interaction with susceptibility genes.”
Dr Levine and his colleagues also found a higher risk of HL for women, subjects born in more recent years, those with a higher body mass index, and subjects of taller stature.
Photo from Hebrew
University of Jerusalem
A study of 2.3 million Jewish subjects suggests that being born in Israel increases a person’s risk of developing Hodgkin lymphoma (HL).
Native Israelis had a higher risk of HL than subjects who immigrated to Israel from Europe, Asia, or North Africa.
Researchers said this finding, published in Leukemia & Lymphoma, suggests that exposure to as-yet-unidentified elements of Israel’s environment increases the risk of HL.
“While we still need further studies to identify the specific causes of the high rates of Hodgkin lymphoma among native Israelis, our findings direct us to search for possible environmental causes in Israel and the neighboring countries,” said study author Hagai Levine, MD, of Hebrew University of Jerusalem in Israel.
“These causes could be not only environmental exposures but also diet, climate, social environment, and stress that may be related to chronic regional conflict.”
Dr Levine and his colleagues noted that the incidence of HL in Israel is among the highest in the world. Based on GLOBOCAN estimates for 2012, Israeli females have the highest age-standardized incidence rate of HL worldwide, and Israeli males have the second highest. From 1960 through 2005, Israel experienced a sharp rise in HL incidence among Israeli-born individuals of both sexes.
Despite evidence for an environmental etiology, very few risk factors have been identified. Studying immigrant populations provides a means of investigating the relative importance of genetic factors as compared to environmental factors in disease development.
With all that in mind, Dr Levine and his colleagues conducted the current study. They included Jewish men and women, ages 16 to 19 at examination, with no history of a cancer diagnosis.
Nationwide data on 2,285,009 adolescents, collected from 1967 through 2011, were linked to Israel’s Cancer Registry to obtain the incidence of HL until 2012.
During 47 million person-years of follow-up, there were 2093 cases of HL detected.
Multivariate analysis suggested native Israelis had a significantly higher risk of developing HL than individuals who immigrated to the country (hazard ratio=1.29, P<0.001). This increased risk was driven largely by an elevated risk for the nodular sclerosis subtype of HL (hazard ratio=1.59, P<0.001).
The researchers noted that the elevated risk appeared within one generation. The low incidence of HL observed for immigrants from Western Asia was no longer evident among Israeli-born individuals of Asian origin. Among immigrants, there was no difference by age at migration.
Therefore, the researchers suggested that immigration from a low-risk to a high-risk location, mostly to locales with a modern lifestyle and environment, is associated with an increase in HL incidence (mainly the nodular sclerosis subtype) within short periods, making genetic drift unlikely as a causal explanation.
On the other hand, the Israeli lifestyle and environment, either independently or by gene-environment interaction, may pose exceptional risks for HL.
“There is increasing evidence for developmental origins of health and disease, with different possible mechanisms, including epigenetic changes or endocrine disruption,” Dr Levine said.
“There is also increasing evidence on the role of prenatal stress in offspring development, including cancer development, especially for hematological malignancies. These data suggest that risk of HL (the nodular sclerosis subtype) is possibly increased due to preconception, prenatal, or early life exposures to a changing lifestyle and environment and its interaction with susceptibility genes.”
Dr Levine and his colleagues also found a higher risk of HL for women, subjects born in more recent years, those with a higher body mass index, and subjects of taller stature.
Photo from Hebrew
University of Jerusalem
A study of 2.3 million Jewish subjects suggests that being born in Israel increases a person’s risk of developing Hodgkin lymphoma (HL).
Native Israelis had a higher risk of HL than subjects who immigrated to Israel from Europe, Asia, or North Africa.
Researchers said this finding, published in Leukemia & Lymphoma, suggests that exposure to as-yet-unidentified elements of Israel’s environment increases the risk of HL.
“While we still need further studies to identify the specific causes of the high rates of Hodgkin lymphoma among native Israelis, our findings direct us to search for possible environmental causes in Israel and the neighboring countries,” said study author Hagai Levine, MD, of Hebrew University of Jerusalem in Israel.
“These causes could be not only environmental exposures but also diet, climate, social environment, and stress that may be related to chronic regional conflict.”
Dr Levine and his colleagues noted that the incidence of HL in Israel is among the highest in the world. Based on GLOBOCAN estimates for 2012, Israeli females have the highest age-standardized incidence rate of HL worldwide, and Israeli males have the second highest. From 1960 through 2005, Israel experienced a sharp rise in HL incidence among Israeli-born individuals of both sexes.
Despite evidence for an environmental etiology, very few risk factors have been identified. Studying immigrant populations provides a means of investigating the relative importance of genetic factors as compared to environmental factors in disease development.
With all that in mind, Dr Levine and his colleagues conducted the current study. They included Jewish men and women, ages 16 to 19 at examination, with no history of a cancer diagnosis.
Nationwide data on 2,285,009 adolescents, collected from 1967 through 2011, were linked to Israel’s Cancer Registry to obtain the incidence of HL until 2012.
During 47 million person-years of follow-up, there were 2093 cases of HL detected.
Multivariate analysis suggested native Israelis had a significantly higher risk of developing HL than individuals who immigrated to the country (hazard ratio=1.29, P<0.001). This increased risk was driven largely by an elevated risk for the nodular sclerosis subtype of HL (hazard ratio=1.59, P<0.001).
The researchers noted that the elevated risk appeared within one generation. The low incidence of HL observed for immigrants from Western Asia was no longer evident among Israeli-born individuals of Asian origin. Among immigrants, there was no difference by age at migration.
Therefore, the researchers suggested that immigration from a low-risk to a high-risk location, mostly to locales with a modern lifestyle and environment, is associated with an increase in HL incidence (mainly the nodular sclerosis subtype) within short periods, making genetic drift unlikely as a causal explanation.
On the other hand, the Israeli lifestyle and environment, either independently or by gene-environment interaction, may pose exceptional risks for HL.
“There is increasing evidence for developmental origins of health and disease, with different possible mechanisms, including epigenetic changes or endocrine disruption,” Dr Levine said.
“There is also increasing evidence on the role of prenatal stress in offspring development, including cancer development, especially for hematological malignancies. These data suggest that risk of HL (the nodular sclerosis subtype) is possibly increased due to preconception, prenatal, or early life exposures to a changing lifestyle and environment and its interaction with susceptibility genes.”
Dr Levine and his colleagues also found a higher risk of HL for women, subjects born in more recent years, those with a higher body mass index, and subjects of taller stature.
Gastroesophageal cancers continue to make their mark globally
CHICAGO – Severe intestinal metaplasia can progress to adenocarcinoma in a small number of patients over 10 years, whether it’s in the esophagus or in the stomach.
Studies emerging from around the world find the same patterns and similar rates of progression in both diseases: 2% for esophageal and 3%-5% for gastric cancers over 10 years, no matter where the studies are conducted, Ernst Kuipers, MD, PhD, said at the meeting sponsored by the American Gastroenterological Association.
“It doesn’t matter if you’re in an area with a high rate or a low rate,” of gastroesophageal cancer, said Dr. Kuipers, professor of gastroenterology and hepatology at Erasmus University Medical Center, Rotterdam, the Netherlands. “The risk is about the same.”
On the flip side, global data also confirm that surveillance and treatment mitigate the risks. Following at-risk patients endoscopically means tumors are found earlier. And when a severely dysplastic lesion is removed, the risk of recurrence is very low – less than 1%.
These findings of a relatively constant rate of progression from gastroesophageal dysplasia to adenocarcinomas somewhat contradict the idea that the cancers are more of a concern in Asian countries, and fading away in Western countries. There has indeed been a dramatic decrease in stomach cancer in the last century – in the early 1900s, Dr. Kuipers said, up to 40% of cancers reported in Germany were gastric. The reasons for the decrease are many: improved diet, improved hygiene, and widespread use of antibiotics are factors. But the disease does still exist, especially among some ethnic/racial groups.
“The U.S. Surveillance, Epidemiology, and End Results (SEER) database shows that there is still a lot of it out there, and there’s huge disparity within groups, so we have to look at this from a broader perspective.”
Overall, the U.S. rates of esophageal and gastric cancer are about 8 and 10/100,000, respectively. In whites, those rates are about 8 and 9/100,000, but much higher in blacks, Asians, Native Americans, and Hispanics, with gastric cancer hovering around 14/100,000.
A 2010 meta-analysis found that Barrett’s metaplasia progressed to esophageal adenocarcinoma at a rate of 6.3/1,000 patients per year, but that number in particular came from analysis of tertiary care cohorts (Clin Gastroenterol Hepatol. 2010. doi: 10.1016/j.cgh.2009.10.010).
A 2015 analysis found lower rates of progression – about 2/1,000 patients per year in patients with short-segment Barrett’s, and about 3/1,000 patients per year in long-segment Barrett’s patients that have no dysplasia. “That means if you’re following 300 patients, one of these will convert to cancer every year,” Dr. Kuipers said (Gut. 2015. doi: 10.1136/gutjnl-2013-305506).
The risk appears much higher for patients with dysplastic Barrett’s, although the data vary widely. “Some report low progression rates, but some report these patients have a 50% or higher risk of progression within a few years. This variation depends on how selective one is in diagnosing low-grade dysplasia.”
A Dutch nationwide study of 42,200 patients with Barrett’s found that 4% progressed to adenocarcinoma over 10 years, for an annual progression rate of 0.4%. But among the small group of those with low-grade dysplasia, more than 10% had progressed by 10 years – a 1% annual progression rate (Gut. 2010. doi: 10.1136/gut.2009.176701).
An Irish national study found strikingly similar results. The annual progression risk in patients with metaplasia was 1.6/1,000 patients per year overall, but 2.7/1,000 per year in those with intestinal metaplasia (J Natl Cancer Inst. 2011. doi: 10.1093/jnci/djr203).
“So, if we have some idea of progression rate, is there evidence that we could identify and treat these cancers earlier if our patients are under surveillance?” Dr. Kuipers said. “Well the answer is ‘yes.’ ”
He cited a very recent study by his colleagues at Erasmus University (Gut. 2016. doi: 10.1136/gutjnl-2014-308802). Investigators determined that in Barrett’s patients who were followed endoscopically, esophageal cancers were identified at much earlier stages than among the general population; 66% of the neoplasias were identified at the high-grade dysplasia stage, 26% at stage 1. The remainder were stage 2; there were no stage 3 or 4 cancers. In the general population, numbers were reversed: 45% were stage 4 when identified, 25% stage 3, 18% stage 2, and only a few at stages 1 or high-grade dysplasia.
Gastric cancer shows the same consistency of incidence and relation to baseline premalignant severity. A Dutch study with 98,000 cases found the annual incidence of gastric cancer was 0.1% for patients with atrophic gastritis, 0.25% for intestinal metaplasia, 0.6% for mild to moderate dysplasia, and 6% for severe dysplasia within 5 years after diagnosis (Gastroenterology. 2008. doi: 10.1053/j.gastro.2008.01.071).
A Swedish study last year found a progression rate of 3% over 10 years for patients with extensive intestinal metaplasia. (BMJ. 2015. doi: 10.1136/bmj.h3867).
“And this year, from Los Angeles, we saw a study of 4,300 patients with extensive intestinal metaplasia and a very similar progression rate of close to 5% in 10 years (Am J Gastro. 2016. doi: 10.1038/ajg.2016.188). It’s the same findings, everywhere,” he said, adding that a team from Iran presented almost identical numbers for gastric cancer incidence at this year’s Digestive Disease Week.
Again, follow-up improves outcomes. A gastric cancer endoscopy screening program for high-risk people improved survival of gastric cancer significantly over community-identified patients (80% vs. 60% at 60 months after diagnosis) (J Gastro Hepatol. 2014. doi: 10.1111/jgh.12387).
These data contribute strongly to recent guidelines for managing patients with premalignant stomach conditions. The European Society for Gastroenterological Endoscopy recommends that those with extensive intestinal metaplasia undergo endoscopy every 3 years (Endoscopy. 2012. doi: 10.1055/s-0031-1291491). Last year, the Kyoto global consensus report on Helicobacter pylori gastritis (Gut. 2015. doi: 10.1136/gutjnl-2015-309252) recommended that patients with extensive gastric atrophy be offered endoscopic surveillance.
There is no place for general population screening, Dr. Kuipers said in an interview. “I would not advocate actual population screening – i.e., offer the general population or risk groups a first screening endoscopy. There is at present no indication [for] this. This is different, however, from surveillance of patients who happen to be diagnosed with advanced intestinal metaplasia of the stomach, or long-segment Barrett’s esophagus, because this allows us to early detect development of neoplasia (high-grade dysplasia and cancer), which then allows for less invasive treatment, and better outcomes.”
He had no financial disclosures.
CHICAGO – Severe intestinal metaplasia can progress to adenocarcinoma in a small number of patients over 10 years, whether it’s in the esophagus or in the stomach.
Studies emerging from around the world find the same patterns and similar rates of progression in both diseases: 2% for esophageal and 3%-5% for gastric cancers over 10 years, no matter where the studies are conducted, Ernst Kuipers, MD, PhD, said at the meeting sponsored by the American Gastroenterological Association.
“It doesn’t matter if you’re in an area with a high rate or a low rate,” of gastroesophageal cancer, said Dr. Kuipers, professor of gastroenterology and hepatology at Erasmus University Medical Center, Rotterdam, the Netherlands. “The risk is about the same.”
On the flip side, global data also confirm that surveillance and treatment mitigate the risks. Following at-risk patients endoscopically means tumors are found earlier. And when a severely dysplastic lesion is removed, the risk of recurrence is very low – less than 1%.
These findings of a relatively constant rate of progression from gastroesophageal dysplasia to adenocarcinomas somewhat contradict the idea that the cancers are more of a concern in Asian countries, and fading away in Western countries. There has indeed been a dramatic decrease in stomach cancer in the last century – in the early 1900s, Dr. Kuipers said, up to 40% of cancers reported in Germany were gastric. The reasons for the decrease are many: improved diet, improved hygiene, and widespread use of antibiotics are factors. But the disease does still exist, especially among some ethnic/racial groups.
“The U.S. Surveillance, Epidemiology, and End Results (SEER) database shows that there is still a lot of it out there, and there’s huge disparity within groups, so we have to look at this from a broader perspective.”
Overall, the U.S. rates of esophageal and gastric cancer are about 8 and 10/100,000, respectively. In whites, those rates are about 8 and 9/100,000, but much higher in blacks, Asians, Native Americans, and Hispanics, with gastric cancer hovering around 14/100,000.
A 2010 meta-analysis found that Barrett’s metaplasia progressed to esophageal adenocarcinoma at a rate of 6.3/1,000 patients per year, but that number in particular came from analysis of tertiary care cohorts (Clin Gastroenterol Hepatol. 2010. doi: 10.1016/j.cgh.2009.10.010).
A 2015 analysis found lower rates of progression – about 2/1,000 patients per year in patients with short-segment Barrett’s, and about 3/1,000 patients per year in long-segment Barrett’s patients that have no dysplasia. “That means if you’re following 300 patients, one of these will convert to cancer every year,” Dr. Kuipers said (Gut. 2015. doi: 10.1136/gutjnl-2013-305506).
The risk appears much higher for patients with dysplastic Barrett’s, although the data vary widely. “Some report low progression rates, but some report these patients have a 50% or higher risk of progression within a few years. This variation depends on how selective one is in diagnosing low-grade dysplasia.”
A Dutch nationwide study of 42,200 patients with Barrett’s found that 4% progressed to adenocarcinoma over 10 years, for an annual progression rate of 0.4%. But among the small group of those with low-grade dysplasia, more than 10% had progressed by 10 years – a 1% annual progression rate (Gut. 2010. doi: 10.1136/gut.2009.176701).
An Irish national study found strikingly similar results. The annual progression risk in patients with metaplasia was 1.6/1,000 patients per year overall, but 2.7/1,000 per year in those with intestinal metaplasia (J Natl Cancer Inst. 2011. doi: 10.1093/jnci/djr203).
“So, if we have some idea of progression rate, is there evidence that we could identify and treat these cancers earlier if our patients are under surveillance?” Dr. Kuipers said. “Well the answer is ‘yes.’ ”
He cited a very recent study by his colleagues at Erasmus University (Gut. 2016. doi: 10.1136/gutjnl-2014-308802). Investigators determined that in Barrett’s patients who were followed endoscopically, esophageal cancers were identified at much earlier stages than among the general population; 66% of the neoplasias were identified at the high-grade dysplasia stage, 26% at stage 1. The remainder were stage 2; there were no stage 3 or 4 cancers. In the general population, numbers were reversed: 45% were stage 4 when identified, 25% stage 3, 18% stage 2, and only a few at stages 1 or high-grade dysplasia.
Gastric cancer shows the same consistency of incidence and relation to baseline premalignant severity. A Dutch study with 98,000 cases found the annual incidence of gastric cancer was 0.1% for patients with atrophic gastritis, 0.25% for intestinal metaplasia, 0.6% for mild to moderate dysplasia, and 6% for severe dysplasia within 5 years after diagnosis (Gastroenterology. 2008. doi: 10.1053/j.gastro.2008.01.071).
A Swedish study last year found a progression rate of 3% over 10 years for patients with extensive intestinal metaplasia. (BMJ. 2015. doi: 10.1136/bmj.h3867).
“And this year, from Los Angeles, we saw a study of 4,300 patients with extensive intestinal metaplasia and a very similar progression rate of close to 5% in 10 years (Am J Gastro. 2016. doi: 10.1038/ajg.2016.188). It’s the same findings, everywhere,” he said, adding that a team from Iran presented almost identical numbers for gastric cancer incidence at this year’s Digestive Disease Week.
Again, follow-up improves outcomes. A gastric cancer endoscopy screening program for high-risk people improved survival of gastric cancer significantly over community-identified patients (80% vs. 60% at 60 months after diagnosis) (J Gastro Hepatol. 2014. doi: 10.1111/jgh.12387).
These data contribute strongly to recent guidelines for managing patients with premalignant stomach conditions. The European Society for Gastroenterological Endoscopy recommends that those with extensive intestinal metaplasia undergo endoscopy every 3 years (Endoscopy. 2012. doi: 10.1055/s-0031-1291491). Last year, the Kyoto global consensus report on Helicobacter pylori gastritis (Gut. 2015. doi: 10.1136/gutjnl-2015-309252) recommended that patients with extensive gastric atrophy be offered endoscopic surveillance.
There is no place for general population screening, Dr. Kuipers said in an interview. “I would not advocate actual population screening – i.e., offer the general population or risk groups a first screening endoscopy. There is at present no indication [for] this. This is different, however, from surveillance of patients who happen to be diagnosed with advanced intestinal metaplasia of the stomach, or long-segment Barrett’s esophagus, because this allows us to early detect development of neoplasia (high-grade dysplasia and cancer), which then allows for less invasive treatment, and better outcomes.”
He had no financial disclosures.
CHICAGO – Severe intestinal metaplasia can progress to adenocarcinoma in a small number of patients over 10 years, whether it’s in the esophagus or in the stomach.
Studies emerging from around the world find the same patterns and similar rates of progression in both diseases: 2% for esophageal and 3%-5% for gastric cancers over 10 years, no matter where the studies are conducted, Ernst Kuipers, MD, PhD, said at the meeting sponsored by the American Gastroenterological Association.
“It doesn’t matter if you’re in an area with a high rate or a low rate,” of gastroesophageal cancer, said Dr. Kuipers, professor of gastroenterology and hepatology at Erasmus University Medical Center, Rotterdam, the Netherlands. “The risk is about the same.”
On the flip side, global data also confirm that surveillance and treatment mitigate the risks. Following at-risk patients endoscopically means tumors are found earlier. And when a severely dysplastic lesion is removed, the risk of recurrence is very low – less than 1%.
These findings of a relatively constant rate of progression from gastroesophageal dysplasia to adenocarcinomas somewhat contradict the idea that the cancers are more of a concern in Asian countries, and fading away in Western countries. There has indeed been a dramatic decrease in stomach cancer in the last century – in the early 1900s, Dr. Kuipers said, up to 40% of cancers reported in Germany were gastric. The reasons for the decrease are many: improved diet, improved hygiene, and widespread use of antibiotics are factors. But the disease does still exist, especially among some ethnic/racial groups.
“The U.S. Surveillance, Epidemiology, and End Results (SEER) database shows that there is still a lot of it out there, and there’s huge disparity within groups, so we have to look at this from a broader perspective.”
Overall, the U.S. rates of esophageal and gastric cancer are about 8 and 10/100,000, respectively. In whites, those rates are about 8 and 9/100,000, but much higher in blacks, Asians, Native Americans, and Hispanics, with gastric cancer hovering around 14/100,000.
A 2010 meta-analysis found that Barrett’s metaplasia progressed to esophageal adenocarcinoma at a rate of 6.3/1,000 patients per year, but that number in particular came from analysis of tertiary care cohorts (Clin Gastroenterol Hepatol. 2010. doi: 10.1016/j.cgh.2009.10.010).
A 2015 analysis found lower rates of progression – about 2/1,000 patients per year in patients with short-segment Barrett’s, and about 3/1,000 patients per year in long-segment Barrett’s patients that have no dysplasia. “That means if you’re following 300 patients, one of these will convert to cancer every year,” Dr. Kuipers said (Gut. 2015. doi: 10.1136/gutjnl-2013-305506).
The risk appears much higher for patients with dysplastic Barrett’s, although the data vary widely. “Some report low progression rates, but some report these patients have a 50% or higher risk of progression within a few years. This variation depends on how selective one is in diagnosing low-grade dysplasia.”
A Dutch nationwide study of 42,200 patients with Barrett’s found that 4% progressed to adenocarcinoma over 10 years, for an annual progression rate of 0.4%. But among the small group of those with low-grade dysplasia, more than 10% had progressed by 10 years – a 1% annual progression rate (Gut. 2010. doi: 10.1136/gut.2009.176701).
An Irish national study found strikingly similar results. The annual progression risk in patients with metaplasia was 1.6/1,000 patients per year overall, but 2.7/1,000 per year in those with intestinal metaplasia (J Natl Cancer Inst. 2011. doi: 10.1093/jnci/djr203).
“So, if we have some idea of progression rate, is there evidence that we could identify and treat these cancers earlier if our patients are under surveillance?” Dr. Kuipers said. “Well the answer is ‘yes.’ ”
He cited a very recent study by his colleagues at Erasmus University (Gut. 2016. doi: 10.1136/gutjnl-2014-308802). Investigators determined that in Barrett’s patients who were followed endoscopically, esophageal cancers were identified at much earlier stages than among the general population; 66% of the neoplasias were identified at the high-grade dysplasia stage, 26% at stage 1. The remainder were stage 2; there were no stage 3 or 4 cancers. In the general population, numbers were reversed: 45% were stage 4 when identified, 25% stage 3, 18% stage 2, and only a few at stages 1 or high-grade dysplasia.
Gastric cancer shows the same consistency of incidence and relation to baseline premalignant severity. A Dutch study with 98,000 cases found the annual incidence of gastric cancer was 0.1% for patients with atrophic gastritis, 0.25% for intestinal metaplasia, 0.6% for mild to moderate dysplasia, and 6% for severe dysplasia within 5 years after diagnosis (Gastroenterology. 2008. doi: 10.1053/j.gastro.2008.01.071).
A Swedish study last year found a progression rate of 3% over 10 years for patients with extensive intestinal metaplasia. (BMJ. 2015. doi: 10.1136/bmj.h3867).
“And this year, from Los Angeles, we saw a study of 4,300 patients with extensive intestinal metaplasia and a very similar progression rate of close to 5% in 10 years (Am J Gastro. 2016. doi: 10.1038/ajg.2016.188). It’s the same findings, everywhere,” he said, adding that a team from Iran presented almost identical numbers for gastric cancer incidence at this year’s Digestive Disease Week.
Again, follow-up improves outcomes. A gastric cancer endoscopy screening program for high-risk people improved survival of gastric cancer significantly over community-identified patients (80% vs. 60% at 60 months after diagnosis) (J Gastro Hepatol. 2014. doi: 10.1111/jgh.12387).
These data contribute strongly to recent guidelines for managing patients with premalignant stomach conditions. The European Society for Gastroenterological Endoscopy recommends that those with extensive intestinal metaplasia undergo endoscopy every 3 years (Endoscopy. 2012. doi: 10.1055/s-0031-1291491). Last year, the Kyoto global consensus report on Helicobacter pylori gastritis (Gut. 2015. doi: 10.1136/gutjnl-2015-309252) recommended that patients with extensive gastric atrophy be offered endoscopic surveillance.
There is no place for general population screening, Dr. Kuipers said in an interview. “I would not advocate actual population screening – i.e., offer the general population or risk groups a first screening endoscopy. There is at present no indication [for] this. This is different, however, from surveillance of patients who happen to be diagnosed with advanced intestinal metaplasia of the stomach, or long-segment Barrett’s esophagus, because this allows us to early detect development of neoplasia (high-grade dysplasia and cancer), which then allows for less invasive treatment, and better outcomes.”
He had no financial disclosures.
AT THE 2016 JAMES W. FRESTON CONFERENCE
Ties to industry among NCCN guideline authors
A study published in JAMA Oncology has quantified financial ties to the pharmaceutical industry among authors of National Comprehensive Cancer Network (NCCN) guidelines.
In 2014, the authors studied received more money in research payments than “general” payments (for things like consulting, meals, and lodging)—$29 million vs $1.25 million.
But more of the authors received general payments than research payments—84% vs 47%.
Study investigators said this finding may mean that some of the guideline authors are receiving general payments unconnected to research. However, because the study only included 1 year of data, these results may not tell the full story.
“Understanding the extent to which guideline authors have financial relationships with the pharmaceutical industry—and the types of financial arrangements that they have—is useful for the NCCN and for the public,” said investigator Stacie Dusetzina, PhD, of the University of North Carolina at Chapel Hill.
“As we learn more about the role of industry payments in shaping prescribing and practice, it is best to proceed with caution and continue to encourage transparency.”
For this study, Dr Dusetzina and her colleagues analyzed financial conflicts of interest (FCOIs) for 125 panelists who worked on setting the NCCN guidelines for lung, breast, prostate, and colorectal cancer (the cancers with the highest incidence in the US).
Eighty-six percent (n=108) of the guideline authors reported at least 1 FCOI in 2014. The total value of FCOIs was $30,287,549, which included $29,036,127 in research payments and $1,251,422 in general payments.
Eighty-four percent of the authors (n=105) received general payments, and 47% (n=59) received research payments.
The authors received an average of $10,011 in general payments and an average of $236,066 in research payments.
The majority of the payments received were within the limits set by the NCCN, but 8 authors (6%) exceeded them. The NCCN says guideline authors cannot receive $20,000 or more from a single company or $50,000 or more in total.
Dr Dusetzina and her colleagues noted that this study was not designed to explore whether the payments influenced the guideline authors’ clinical practice or the recommendations they made in the guidelines.
However, finding a high prevalence of financial relationships with industry among guideline authors lays the foundation for future studies to investigate the impact of such relationships.
“It is not a given that industry funding leads to undue influence,” Dr Dusetzina said, “but it is important to analyze these relationships and the potential impact they have on care guidelines because they do influence patient care decisions and the cost of providing patient care.”
A study published in JAMA Oncology has quantified financial ties to the pharmaceutical industry among authors of National Comprehensive Cancer Network (NCCN) guidelines.
In 2014, the authors studied received more money in research payments than “general” payments (for things like consulting, meals, and lodging)—$29 million vs $1.25 million.
But more of the authors received general payments than research payments—84% vs 47%.
Study investigators said this finding may mean that some of the guideline authors are receiving general payments unconnected to research. However, because the study only included 1 year of data, these results may not tell the full story.
“Understanding the extent to which guideline authors have financial relationships with the pharmaceutical industry—and the types of financial arrangements that they have—is useful for the NCCN and for the public,” said investigator Stacie Dusetzina, PhD, of the University of North Carolina at Chapel Hill.
“As we learn more about the role of industry payments in shaping prescribing and practice, it is best to proceed with caution and continue to encourage transparency.”
For this study, Dr Dusetzina and her colleagues analyzed financial conflicts of interest (FCOIs) for 125 panelists who worked on setting the NCCN guidelines for lung, breast, prostate, and colorectal cancer (the cancers with the highest incidence in the US).
Eighty-six percent (n=108) of the guideline authors reported at least 1 FCOI in 2014. The total value of FCOIs was $30,287,549, which included $29,036,127 in research payments and $1,251,422 in general payments.
Eighty-four percent of the authors (n=105) received general payments, and 47% (n=59) received research payments.
The authors received an average of $10,011 in general payments and an average of $236,066 in research payments.
The majority of the payments received were within the limits set by the NCCN, but 8 authors (6%) exceeded them. The NCCN says guideline authors cannot receive $20,000 or more from a single company or $50,000 or more in total.
Dr Dusetzina and her colleagues noted that this study was not designed to explore whether the payments influenced the guideline authors’ clinical practice or the recommendations they made in the guidelines.
However, finding a high prevalence of financial relationships with industry among guideline authors lays the foundation for future studies to investigate the impact of such relationships.
“It is not a given that industry funding leads to undue influence,” Dr Dusetzina said, “but it is important to analyze these relationships and the potential impact they have on care guidelines because they do influence patient care decisions and the cost of providing patient care.”
A study published in JAMA Oncology has quantified financial ties to the pharmaceutical industry among authors of National Comprehensive Cancer Network (NCCN) guidelines.
In 2014, the authors studied received more money in research payments than “general” payments (for things like consulting, meals, and lodging)—$29 million vs $1.25 million.
But more of the authors received general payments than research payments—84% vs 47%.
Study investigators said this finding may mean that some of the guideline authors are receiving general payments unconnected to research. However, because the study only included 1 year of data, these results may not tell the full story.
“Understanding the extent to which guideline authors have financial relationships with the pharmaceutical industry—and the types of financial arrangements that they have—is useful for the NCCN and for the public,” said investigator Stacie Dusetzina, PhD, of the University of North Carolina at Chapel Hill.
“As we learn more about the role of industry payments in shaping prescribing and practice, it is best to proceed with caution and continue to encourage transparency.”
For this study, Dr Dusetzina and her colleagues analyzed financial conflicts of interest (FCOIs) for 125 panelists who worked on setting the NCCN guidelines for lung, breast, prostate, and colorectal cancer (the cancers with the highest incidence in the US).
Eighty-six percent (n=108) of the guideline authors reported at least 1 FCOI in 2014. The total value of FCOIs was $30,287,549, which included $29,036,127 in research payments and $1,251,422 in general payments.
Eighty-four percent of the authors (n=105) received general payments, and 47% (n=59) received research payments.
The authors received an average of $10,011 in general payments and an average of $236,066 in research payments.
The majority of the payments received were within the limits set by the NCCN, but 8 authors (6%) exceeded them. The NCCN says guideline authors cannot receive $20,000 or more from a single company or $50,000 or more in total.
Dr Dusetzina and her colleagues noted that this study was not designed to explore whether the payments influenced the guideline authors’ clinical practice or the recommendations they made in the guidelines.
However, finding a high prevalence of financial relationships with industry among guideline authors lays the foundation for future studies to investigate the impact of such relationships.
“It is not a given that industry funding leads to undue influence,” Dr Dusetzina said, “but it is important to analyze these relationships and the potential impact they have on care guidelines because they do influence patient care decisions and the cost of providing patient care.”
Hospital Mobility Program Maintains Older Patients’ Mobility after Discharge
Background: Older hospitalized patients experience decreased mobility while in the hospital and suffer from impaired function and mobility after they are discharged. The efficacy and safety of inpatient mobility programs are unknown.
Study design: Randomized, single-blinded controlled trial.
Setting: Birmingham Veterans Affairs Medical Center, Alabama.
Synopsis: The study included 100 patients age 65 years and older admitted to general medical wards. Researchers excluded cognitively impaired patients and patients with limited life expectancy. Intervention patients received a standardized hospital mobility protocol, with up to twice daily 15- to 20-minute visits by research personnel. Visits sought to progressively increase mobility from assisted sitting to ambulation. Physical activity was coupled with a behavioral intervention focused on goal setting and mobility barrier resolution. The comparison group received usual care. Outcomes included changes in activities of daily living (ADLs) and community mobility one month after hospital discharge.
One month after hospitalization, there were no differences in ADLs between intervention and control patients. Patients in the mobility protocol arm, however, maintained their prehospital community mobility, whereas usual-care patients had a statistically significant decrease in mobility as measured by the Life-Space Assessment. There was no difference in falls between groups.
Bottom line: A hospital mobility intervention was a safe and effective means of preserving community mobility. Future effectiveness studies are needed to demonstrate feasibility and outcomes in real-world settings.
Citation: Brown CJ, Foley KT, Lowman JD Jr, et al. Comparison of posthospitalization function and community mobility in hospital mobility program and usual care patients: a randomized clinical trial. JAMA Intern Med. 2016;176(7):921-927.
Short Take
Topical NSAIDs Effective for Back Pain
Using ketoprofen gel in addition to intravenous dexketoprofen improves pain relief in patients presenting to the emergency department with low back pain.
Citation: Serinken M, Eken C, Tunay K, Golcuk Y. Ketoprofen gel improves low back pain in addition to IV dexkeoprofen: a randomized placebo-controlled trial. Am J Emerg Med. 2016;34(8):1458-1461.
Background: Older hospitalized patients experience decreased mobility while in the hospital and suffer from impaired function and mobility after they are discharged. The efficacy and safety of inpatient mobility programs are unknown.
Study design: Randomized, single-blinded controlled trial.
Setting: Birmingham Veterans Affairs Medical Center, Alabama.
Synopsis: The study included 100 patients age 65 years and older admitted to general medical wards. Researchers excluded cognitively impaired patients and patients with limited life expectancy. Intervention patients received a standardized hospital mobility protocol, with up to twice daily 15- to 20-minute visits by research personnel. Visits sought to progressively increase mobility from assisted sitting to ambulation. Physical activity was coupled with a behavioral intervention focused on goal setting and mobility barrier resolution. The comparison group received usual care. Outcomes included changes in activities of daily living (ADLs) and community mobility one month after hospital discharge.
One month after hospitalization, there were no differences in ADLs between intervention and control patients. Patients in the mobility protocol arm, however, maintained their prehospital community mobility, whereas usual-care patients had a statistically significant decrease in mobility as measured by the Life-Space Assessment. There was no difference in falls between groups.
Bottom line: A hospital mobility intervention was a safe and effective means of preserving community mobility. Future effectiveness studies are needed to demonstrate feasibility and outcomes in real-world settings.
Citation: Brown CJ, Foley KT, Lowman JD Jr, et al. Comparison of posthospitalization function and community mobility in hospital mobility program and usual care patients: a randomized clinical trial. JAMA Intern Med. 2016;176(7):921-927.
Short Take
Topical NSAIDs Effective for Back Pain
Using ketoprofen gel in addition to intravenous dexketoprofen improves pain relief in patients presenting to the emergency department with low back pain.
Citation: Serinken M, Eken C, Tunay K, Golcuk Y. Ketoprofen gel improves low back pain in addition to IV dexkeoprofen: a randomized placebo-controlled trial. Am J Emerg Med. 2016;34(8):1458-1461.
Background: Older hospitalized patients experience decreased mobility while in the hospital and suffer from impaired function and mobility after they are discharged. The efficacy and safety of inpatient mobility programs are unknown.
Study design: Randomized, single-blinded controlled trial.
Setting: Birmingham Veterans Affairs Medical Center, Alabama.
Synopsis: The study included 100 patients age 65 years and older admitted to general medical wards. Researchers excluded cognitively impaired patients and patients with limited life expectancy. Intervention patients received a standardized hospital mobility protocol, with up to twice daily 15- to 20-minute visits by research personnel. Visits sought to progressively increase mobility from assisted sitting to ambulation. Physical activity was coupled with a behavioral intervention focused on goal setting and mobility barrier resolution. The comparison group received usual care. Outcomes included changes in activities of daily living (ADLs) and community mobility one month after hospital discharge.
One month after hospitalization, there were no differences in ADLs between intervention and control patients. Patients in the mobility protocol arm, however, maintained their prehospital community mobility, whereas usual-care patients had a statistically significant decrease in mobility as measured by the Life-Space Assessment. There was no difference in falls between groups.
Bottom line: A hospital mobility intervention was a safe and effective means of preserving community mobility. Future effectiveness studies are needed to demonstrate feasibility and outcomes in real-world settings.
Citation: Brown CJ, Foley KT, Lowman JD Jr, et al. Comparison of posthospitalization function and community mobility in hospital mobility program and usual care patients: a randomized clinical trial. JAMA Intern Med. 2016;176(7):921-927.
Short Take
Topical NSAIDs Effective for Back Pain
Using ketoprofen gel in addition to intravenous dexketoprofen improves pain relief in patients presenting to the emergency department with low back pain.
Citation: Serinken M, Eken C, Tunay K, Golcuk Y. Ketoprofen gel improves low back pain in addition to IV dexkeoprofen: a randomized placebo-controlled trial. Am J Emerg Med. 2016;34(8):1458-1461.
Daily Round Checklists in ICU Setting Don’t Reduce Mortality
Background: Checklists, goal assessment, and clinician prompting have shown promise in improving communication, care-process adherence, and clinical outcomes in ICUs and acute-care settings, but existing studies are limited by nonrandomized design and high-income settings.
Study design: Cluster randomized trial.
Setting: 118 academic and nonacademic ICUs in Brazil.
Synopsis: Researchers randomized 6,761 patients to a quality improvement (QI) intervention with daily round checklists, goal setting, and clinician prompting. Analyses were adjusted for patient’s severity of illness and the ICU’s adjusted mortality ratio. There was no significant difference in in-hospital mortality (odds ratio, 1.02; 95% CI, 0.82–1.26). The QI intervention had no effect on 10 secondary clinical outcomes (e.g., ventilator-associated pneumonia). The intervention improved adherence with four of seven care processes (e.g., use of low tidal volumes) and two of six factors of the safety climate. After adjusting for multiple comparisons, only urinary catheter use remained statistically significant.
Strengths of this study are the large number of ICUs involved and a high rate of QI adherence. Limitations include the setting in a resource-constrained nation, limited success with adopting changes in care processes, and relatively short intervention period of six months.
Bottom line: In a large Brazilian randomized control trial, implementation of daily round checklists, along with goal setting and clinician prompting, did not change in-hospital mortality. It is possible that a longer intervention period would have found improved outcomes.
Citation: Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet), Cavalcanti AB, Bozza FA, et al. Effect of a quality improvement intervention with daily round checklists, goal setting, and clinician prompting on mortality of critically ill patients: a randomized clinical trial. JAMA. 2016;315(14):1480-1490.
Short Take
More Restrictions on Fluoroquinolones
The U.S. Food and Drug Administration has recommended avoidance of fluoroquinolone drugs, which are often used for patients with acute bronchitis, acute sinusitis, and uncomplicated UTI, due to the potential of serious side effects. Exceptions should be made for cases with no other treatment options.
Citation: Fluoroquinolone antibacterial drugs: drug safety communication - FDA advises restricting use for certain uncomplicated infections. U.S. Food and Drug Administration website.
Background: Checklists, goal assessment, and clinician prompting have shown promise in improving communication, care-process adherence, and clinical outcomes in ICUs and acute-care settings, but existing studies are limited by nonrandomized design and high-income settings.
Study design: Cluster randomized trial.
Setting: 118 academic and nonacademic ICUs in Brazil.
Synopsis: Researchers randomized 6,761 patients to a quality improvement (QI) intervention with daily round checklists, goal setting, and clinician prompting. Analyses were adjusted for patient’s severity of illness and the ICU’s adjusted mortality ratio. There was no significant difference in in-hospital mortality (odds ratio, 1.02; 95% CI, 0.82–1.26). The QI intervention had no effect on 10 secondary clinical outcomes (e.g., ventilator-associated pneumonia). The intervention improved adherence with four of seven care processes (e.g., use of low tidal volumes) and two of six factors of the safety climate. After adjusting for multiple comparisons, only urinary catheter use remained statistically significant.
Strengths of this study are the large number of ICUs involved and a high rate of QI adherence. Limitations include the setting in a resource-constrained nation, limited success with adopting changes in care processes, and relatively short intervention period of six months.
Bottom line: In a large Brazilian randomized control trial, implementation of daily round checklists, along with goal setting and clinician prompting, did not change in-hospital mortality. It is possible that a longer intervention period would have found improved outcomes.
Citation: Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet), Cavalcanti AB, Bozza FA, et al. Effect of a quality improvement intervention with daily round checklists, goal setting, and clinician prompting on mortality of critically ill patients: a randomized clinical trial. JAMA. 2016;315(14):1480-1490.
Short Take
More Restrictions on Fluoroquinolones
The U.S. Food and Drug Administration has recommended avoidance of fluoroquinolone drugs, which are often used for patients with acute bronchitis, acute sinusitis, and uncomplicated UTI, due to the potential of serious side effects. Exceptions should be made for cases with no other treatment options.
Citation: Fluoroquinolone antibacterial drugs: drug safety communication - FDA advises restricting use for certain uncomplicated infections. U.S. Food and Drug Administration website.
Background: Checklists, goal assessment, and clinician prompting have shown promise in improving communication, care-process adherence, and clinical outcomes in ICUs and acute-care settings, but existing studies are limited by nonrandomized design and high-income settings.
Study design: Cluster randomized trial.
Setting: 118 academic and nonacademic ICUs in Brazil.
Synopsis: Researchers randomized 6,761 patients to a quality improvement (QI) intervention with daily round checklists, goal setting, and clinician prompting. Analyses were adjusted for patient’s severity of illness and the ICU’s adjusted mortality ratio. There was no significant difference in in-hospital mortality (odds ratio, 1.02; 95% CI, 0.82–1.26). The QI intervention had no effect on 10 secondary clinical outcomes (e.g., ventilator-associated pneumonia). The intervention improved adherence with four of seven care processes (e.g., use of low tidal volumes) and two of six factors of the safety climate. After adjusting for multiple comparisons, only urinary catheter use remained statistically significant.
Strengths of this study are the large number of ICUs involved and a high rate of QI adherence. Limitations include the setting in a resource-constrained nation, limited success with adopting changes in care processes, and relatively short intervention period of six months.
Bottom line: In a large Brazilian randomized control trial, implementation of daily round checklists, along with goal setting and clinician prompting, did not change in-hospital mortality. It is possible that a longer intervention period would have found improved outcomes.
Citation: Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet), Cavalcanti AB, Bozza FA, et al. Effect of a quality improvement intervention with daily round checklists, goal setting, and clinician prompting on mortality of critically ill patients: a randomized clinical trial. JAMA. 2016;315(14):1480-1490.
Short Take
More Restrictions on Fluoroquinolones
The U.S. Food and Drug Administration has recommended avoidance of fluoroquinolone drugs, which are often used for patients with acute bronchitis, acute sinusitis, and uncomplicated UTI, due to the potential of serious side effects. Exceptions should be made for cases with no other treatment options.
Citation: Fluoroquinolone antibacterial drugs: drug safety communication - FDA advises restricting use for certain uncomplicated infections. U.S. Food and Drug Administration website.
Long-Term Survival of a Patient With Late-Stage Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death in the world, with non-small cell lung cancer (NSCLC) a significant component of those deaths.1,2 Treatments for advanced-stage NSCLC, however, are limited. Erlotinib, a small-molecule tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR), has aided in advancing NSCLC therapy. Erlotinib has been shown to increase survival by 2 months compared with placebo in a phase 3, randomized controlled trial when used as second- or third-line therapy.3 The authors present a case of a man surviving almost 8 years with late-stage NSCLC on treatment with erlotinib at the VA West Los Angeles Medical Center (WLAMC).
Note: Page numbers differ between the print issue and digital edition.
Lung cancer is the leading cause of cancer death in the world, with non-small cell lung cancer (NSCLC) a significant component of those deaths.1,2 Treatments for advanced-stage NSCLC, however, are limited. Erlotinib, a small-molecule tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR), has aided in advancing NSCLC therapy. Erlotinib has been shown to increase survival by 2 months compared with placebo in a phase 3, randomized controlled trial when used as second- or third-line therapy.3 The authors present a case of a man surviving almost 8 years with late-stage NSCLC on treatment with erlotinib at the VA West Los Angeles Medical Center (WLAMC).
Lung cancer is the leading cause of cancer death in the world, with non-small cell lung cancer (NSCLC) a significant component of those deaths.1,2 Treatments for advanced-stage NSCLC, however, are limited. Erlotinib, a small-molecule tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR), has aided in advancing NSCLC therapy. Erlotinib has been shown to increase survival by 2 months compared with placebo in a phase 3, randomized controlled trial when used as second- or third-line therapy.3 The authors present a case of a man surviving almost 8 years with late-stage NSCLC on treatment with erlotinib at the VA West Los Angeles Medical Center (WLAMC).
Note: Page numbers differ between the print issue and digital edition.
Note: Page numbers differ between the print issue and digital edition.
Potential therapeutic target for leukemia, other cancers
Photo by Thomas Semkow
Preclinical research indicates that a member of the Mediator protein complex plays a key role in hematopoiesis.
Investigators found that MED12 was required for the survival of hematopoietic stem and progenitor cells (HSPCs).
The team said this finding, along with the fact that MED12 mutations have been linked to leukemia and solid tumor malignancies, suggests that targeting MED12 hyperactivity might be a useful strategy for treating cancers.
“Because MED12 appears to be so essential to hematopoiesis, our study points to it as a possible target for future anticancer therapies for both chronic and acute forms of leukemia,” said Iannis Aifantis, PhD, of NYU Langone Medical Center in New York.
“Our study also suggests that MED12 hyperactivation or loss of control is a possible explanation for what factors may trigger these cancers and other solid tumors.”
Dr Aifantis and his colleagues described their study in Cell Stem Cell.
The investigators first analyzed the effects of MED12 deletion in mice. Mice bred to lack MED12 died within 2 weeks of birth and showed evidence of aberrant hematopoiesis—namely, a “severe reduction of bone marrow and thymus cellularity.”
Adult mice that were engineered to lose expression of MED12 after the injection of an activating molecule experienced a “rapid” reduction in bone marrow cellularity, as well as reductions in spleen and thymus size. These mice also had low white blood cell and platelet counts and died within 3 weeks of MED12 deletion.
Subsequent analyses of the animals’ bone marrow showed that estimates of HSPCs in each mouse fell from nearly 150,000 to 15,000 within 4 days of injection. Within 10 days, there were no HSPCs left.
Deleting MED12 was also lethal for human HSPCs. Colonies of CD34+ cells dropped from an average of 25 per plate to 5 per plate within 10 days of MED12 deletion.
On the other hand, MED12 did not affect the survival of other cell types. For example, MED12 deletion did not impact mouse embryonic fibroblasts, embryonic stem cells, or hair follicle stem cells.
In addition, deleting members of the Mediator kinase module besides MED12—MED13, CDK8, or CYCLIN C—did not have a significant effect on HSPCs and did not kill mice. The investigators said this provides further evidence that MED12—by loss of its function alone—is essential for hematopoiesis.
The team found that MED12 deletion destabilizes P300 binding at lineage-specific enhancers, which results in H3K27Ac depletion, enhancer de-activation, and the consequent loss of hematopoietic stem cell gene expression signatures.
As a next step, the investigators plan to screen blood samples from cancer patients for signs of MED12 mutations and uncontrolled HSPC development.
The team also hopes to determine the biological mechanisms involved in MED12 hyperactivation and identify drug molecules that could block MED12 hyperactivity and serve as potential MED12 inhibitors.
Photo by Thomas Semkow
Preclinical research indicates that a member of the Mediator protein complex plays a key role in hematopoiesis.
Investigators found that MED12 was required for the survival of hematopoietic stem and progenitor cells (HSPCs).
The team said this finding, along with the fact that MED12 mutations have been linked to leukemia and solid tumor malignancies, suggests that targeting MED12 hyperactivity might be a useful strategy for treating cancers.
“Because MED12 appears to be so essential to hematopoiesis, our study points to it as a possible target for future anticancer therapies for both chronic and acute forms of leukemia,” said Iannis Aifantis, PhD, of NYU Langone Medical Center in New York.
“Our study also suggests that MED12 hyperactivation or loss of control is a possible explanation for what factors may trigger these cancers and other solid tumors.”
Dr Aifantis and his colleagues described their study in Cell Stem Cell.
The investigators first analyzed the effects of MED12 deletion in mice. Mice bred to lack MED12 died within 2 weeks of birth and showed evidence of aberrant hematopoiesis—namely, a “severe reduction of bone marrow and thymus cellularity.”
Adult mice that were engineered to lose expression of MED12 after the injection of an activating molecule experienced a “rapid” reduction in bone marrow cellularity, as well as reductions in spleen and thymus size. These mice also had low white blood cell and platelet counts and died within 3 weeks of MED12 deletion.
Subsequent analyses of the animals’ bone marrow showed that estimates of HSPCs in each mouse fell from nearly 150,000 to 15,000 within 4 days of injection. Within 10 days, there were no HSPCs left.
Deleting MED12 was also lethal for human HSPCs. Colonies of CD34+ cells dropped from an average of 25 per plate to 5 per plate within 10 days of MED12 deletion.
On the other hand, MED12 did not affect the survival of other cell types. For example, MED12 deletion did not impact mouse embryonic fibroblasts, embryonic stem cells, or hair follicle stem cells.
In addition, deleting members of the Mediator kinase module besides MED12—MED13, CDK8, or CYCLIN C—did not have a significant effect on HSPCs and did not kill mice. The investigators said this provides further evidence that MED12—by loss of its function alone—is essential for hematopoiesis.
The team found that MED12 deletion destabilizes P300 binding at lineage-specific enhancers, which results in H3K27Ac depletion, enhancer de-activation, and the consequent loss of hematopoietic stem cell gene expression signatures.
As a next step, the investigators plan to screen blood samples from cancer patients for signs of MED12 mutations and uncontrolled HSPC development.
The team also hopes to determine the biological mechanisms involved in MED12 hyperactivation and identify drug molecules that could block MED12 hyperactivity and serve as potential MED12 inhibitors.
Photo by Thomas Semkow
Preclinical research indicates that a member of the Mediator protein complex plays a key role in hematopoiesis.
Investigators found that MED12 was required for the survival of hematopoietic stem and progenitor cells (HSPCs).
The team said this finding, along with the fact that MED12 mutations have been linked to leukemia and solid tumor malignancies, suggests that targeting MED12 hyperactivity might be a useful strategy for treating cancers.
“Because MED12 appears to be so essential to hematopoiesis, our study points to it as a possible target for future anticancer therapies for both chronic and acute forms of leukemia,” said Iannis Aifantis, PhD, of NYU Langone Medical Center in New York.
“Our study also suggests that MED12 hyperactivation or loss of control is a possible explanation for what factors may trigger these cancers and other solid tumors.”
Dr Aifantis and his colleagues described their study in Cell Stem Cell.
The investigators first analyzed the effects of MED12 deletion in mice. Mice bred to lack MED12 died within 2 weeks of birth and showed evidence of aberrant hematopoiesis—namely, a “severe reduction of bone marrow and thymus cellularity.”
Adult mice that were engineered to lose expression of MED12 after the injection of an activating molecule experienced a “rapid” reduction in bone marrow cellularity, as well as reductions in spleen and thymus size. These mice also had low white blood cell and platelet counts and died within 3 weeks of MED12 deletion.
Subsequent analyses of the animals’ bone marrow showed that estimates of HSPCs in each mouse fell from nearly 150,000 to 15,000 within 4 days of injection. Within 10 days, there were no HSPCs left.
Deleting MED12 was also lethal for human HSPCs. Colonies of CD34+ cells dropped from an average of 25 per plate to 5 per plate within 10 days of MED12 deletion.
On the other hand, MED12 did not affect the survival of other cell types. For example, MED12 deletion did not impact mouse embryonic fibroblasts, embryonic stem cells, or hair follicle stem cells.
In addition, deleting members of the Mediator kinase module besides MED12—MED13, CDK8, or CYCLIN C—did not have a significant effect on HSPCs and did not kill mice. The investigators said this provides further evidence that MED12—by loss of its function alone—is essential for hematopoiesis.
The team found that MED12 deletion destabilizes P300 binding at lineage-specific enhancers, which results in H3K27Ac depletion, enhancer de-activation, and the consequent loss of hematopoietic stem cell gene expression signatures.
As a next step, the investigators plan to screen blood samples from cancer patients for signs of MED12 mutations and uncontrolled HSPC development.
The team also hopes to determine the biological mechanisms involved in MED12 hyperactivation and identify drug molecules that could block MED12 hyperactivity and serve as potential MED12 inhibitors.
NICE approves bosutinib for routine NHS use
The National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending that bosutinib (Bosulif), a tyrosine kinase inhibitor used to treat certain patients with chronic myeloid leukemia (CML), be made available through the National Health Service (NHS).
This means patients will no longer have to apply to the Cancer Drugs Fund (CDF) to obtain bosutinib.
The CDF is money the government sets aside to pay for cancer drugs that haven’t been approved by NICE and aren’t available within the NHS in England.
Following the decision to reform the CDF earlier this year, NICE began to reappraise all drugs currently in the CDF in April. Bosutinib is the first drug to be looked at through this reconsideration process.
NICE previously considered making bosutinib available through the NHS in 2013 but decided the drug was not cost-effective. So bosutinib was made available to patients via the CDF.
As part of the reappraisal process, Pfizer offered a discount for bosutinib. Taking this discount into consideration, as well as the limited treatment options for CML patients, NICE decided bosutinib is cost-effective.
Bosutinib has conditional approval from the European Commission to treat adults with Philadelphia-chromosome-positive CML in chronic phase, accelerated phase, or blast phase, but only if those patients have previously received one or more tyrosine kinase inhibitors and are not considered eligible for treatment with imatinib, nilotinib, or dasatinib.
The National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending that bosutinib (Bosulif), a tyrosine kinase inhibitor used to treat certain patients with chronic myeloid leukemia (CML), be made available through the National Health Service (NHS).
This means patients will no longer have to apply to the Cancer Drugs Fund (CDF) to obtain bosutinib.
The CDF is money the government sets aside to pay for cancer drugs that haven’t been approved by NICE and aren’t available within the NHS in England.
Following the decision to reform the CDF earlier this year, NICE began to reappraise all drugs currently in the CDF in April. Bosutinib is the first drug to be looked at through this reconsideration process.
NICE previously considered making bosutinib available through the NHS in 2013 but decided the drug was not cost-effective. So bosutinib was made available to patients via the CDF.
As part of the reappraisal process, Pfizer offered a discount for bosutinib. Taking this discount into consideration, as well as the limited treatment options for CML patients, NICE decided bosutinib is cost-effective.
Bosutinib has conditional approval from the European Commission to treat adults with Philadelphia-chromosome-positive CML in chronic phase, accelerated phase, or blast phase, but only if those patients have previously received one or more tyrosine kinase inhibitors and are not considered eligible for treatment with imatinib, nilotinib, or dasatinib.
The National Institute for Health and Care Excellence (NICE) has issued a final guidance recommending that bosutinib (Bosulif), a tyrosine kinase inhibitor used to treat certain patients with chronic myeloid leukemia (CML), be made available through the National Health Service (NHS).
This means patients will no longer have to apply to the Cancer Drugs Fund (CDF) to obtain bosutinib.
The CDF is money the government sets aside to pay for cancer drugs that haven’t been approved by NICE and aren’t available within the NHS in England.
Following the decision to reform the CDF earlier this year, NICE began to reappraise all drugs currently in the CDF in April. Bosutinib is the first drug to be looked at through this reconsideration process.
NICE previously considered making bosutinib available through the NHS in 2013 but decided the drug was not cost-effective. So bosutinib was made available to patients via the CDF.
As part of the reappraisal process, Pfizer offered a discount for bosutinib. Taking this discount into consideration, as well as the limited treatment options for CML patients, NICE decided bosutinib is cost-effective.
Bosutinib has conditional approval from the European Commission to treat adults with Philadelphia-chromosome-positive CML in chronic phase, accelerated phase, or blast phase, but only if those patients have previously received one or more tyrosine kinase inhibitors and are not considered eligible for treatment with imatinib, nilotinib, or dasatinib.
Patients with HBV inadequately monitored for disease activity
Chronic hepatitis B virus patients are insufficiently monitored for disease activity and hepatocellular carcinoma (HCC), according to Philip R. Spradling, MD, and his associates of the Centers for Disease Control and Prevention.
In a cohort study of 2,992 patients with CHB, 2,338 were used for assessment. Researchers used alanine aminotransferase (ALT) monitoring, HBV DNA monitoring, assessment for cirrhosis, and HBV antiviral therapy for examination. For ALT monitoring, 1,814 (78%) of patients had at least one ALT level obtained per year of follow-up. Only 876 patients (37%) had at least one HBV DNA level assessment per year of follow-up and 1,037 (44%) had less than annual testing, and 18% of patients never had an HBV DNA level assessed. Among patients with cirrhosis, 297 (54%) had HBV DNA testing done at least annually, 189 (35%) had testing done but less frequently than annually, and 61 (11%) never had an HBV DNA test done. And of the 547 patients with cirrhosis, 305 (56%) were prescribed HBV antiviral therapy.
It was noted that patients were monitored during 2006-2013. Only 68% of patients had not been prescribed treatment, and 72% had received liver-related specialty care.
“Our findings reiterate the need for clinicians who treat patients with [chronic HBV] to provide ongoing, continual assessment of disease activity based on HBV DNA and ALT levels, as well as liver imaging surveillance among patients at high risk for HCC,” researchers concluded. “As antiviral therapy for [chronic HBV] now includes potent and highly efficacious oral agents that have few contraindications and minimal side effects, as well as a high barrier to resistance, clinicians should be vigilant for opportunities to decrease the likelihood of poor clinical outcomes.”
Read the full study in Clinical Infectious Diseases here.
Chronic hepatitis B virus patients are insufficiently monitored for disease activity and hepatocellular carcinoma (HCC), according to Philip R. Spradling, MD, and his associates of the Centers for Disease Control and Prevention.
In a cohort study of 2,992 patients with CHB, 2,338 were used for assessment. Researchers used alanine aminotransferase (ALT) monitoring, HBV DNA monitoring, assessment for cirrhosis, and HBV antiviral therapy for examination. For ALT monitoring, 1,814 (78%) of patients had at least one ALT level obtained per year of follow-up. Only 876 patients (37%) had at least one HBV DNA level assessment per year of follow-up and 1,037 (44%) had less than annual testing, and 18% of patients never had an HBV DNA level assessed. Among patients with cirrhosis, 297 (54%) had HBV DNA testing done at least annually, 189 (35%) had testing done but less frequently than annually, and 61 (11%) never had an HBV DNA test done. And of the 547 patients with cirrhosis, 305 (56%) were prescribed HBV antiviral therapy.
It was noted that patients were monitored during 2006-2013. Only 68% of patients had not been prescribed treatment, and 72% had received liver-related specialty care.
“Our findings reiterate the need for clinicians who treat patients with [chronic HBV] to provide ongoing, continual assessment of disease activity based on HBV DNA and ALT levels, as well as liver imaging surveillance among patients at high risk for HCC,” researchers concluded. “As antiviral therapy for [chronic HBV] now includes potent and highly efficacious oral agents that have few contraindications and minimal side effects, as well as a high barrier to resistance, clinicians should be vigilant for opportunities to decrease the likelihood of poor clinical outcomes.”
Read the full study in Clinical Infectious Diseases here.
Chronic hepatitis B virus patients are insufficiently monitored for disease activity and hepatocellular carcinoma (HCC), according to Philip R. Spradling, MD, and his associates of the Centers for Disease Control and Prevention.
In a cohort study of 2,992 patients with CHB, 2,338 were used for assessment. Researchers used alanine aminotransferase (ALT) monitoring, HBV DNA monitoring, assessment for cirrhosis, and HBV antiviral therapy for examination. For ALT monitoring, 1,814 (78%) of patients had at least one ALT level obtained per year of follow-up. Only 876 patients (37%) had at least one HBV DNA level assessment per year of follow-up and 1,037 (44%) had less than annual testing, and 18% of patients never had an HBV DNA level assessed. Among patients with cirrhosis, 297 (54%) had HBV DNA testing done at least annually, 189 (35%) had testing done but less frequently than annually, and 61 (11%) never had an HBV DNA test done. And of the 547 patients with cirrhosis, 305 (56%) were prescribed HBV antiviral therapy.
It was noted that patients were monitored during 2006-2013. Only 68% of patients had not been prescribed treatment, and 72% had received liver-related specialty care.
“Our findings reiterate the need for clinicians who treat patients with [chronic HBV] to provide ongoing, continual assessment of disease activity based on HBV DNA and ALT levels, as well as liver imaging surveillance among patients at high risk for HCC,” researchers concluded. “As antiviral therapy for [chronic HBV] now includes potent and highly efficacious oral agents that have few contraindications and minimal side effects, as well as a high barrier to resistance, clinicians should be vigilant for opportunities to decrease the likelihood of poor clinical outcomes.”
Read the full study in Clinical Infectious Diseases here.
FROM CLINICAL INFECTIOUS DISEASES