News & Analysis
Nephrologists Question ACP’s Kidney Disease Guidelines Mike Mitka, MSJ
E
lements of new guidelines on screening, monitoring, and treatment of chronic kidney disease released October 22 by the American College of Physicians (ACP) are sparking criticisms by some members of the nephrology community, who say the guidance rejects some practices that benefit patients. The progressive loss of kidney function over time that characterizes chronic kidney disease affects about 26 million adults in the United States. Disease severity is divided into 5 stages based on glomerular filtration rate (GFR), estimated from serum creatinine as a measure of kidney function, and albuminuria, a marker of kidney damage from cause. People with stage 1 to 3 chronic kidney disease have normal to moderately reduced kidney function; individuals with stage 4 of the disease have severely reduced kidney function; and those with stage 5 have very severe disease, known as end-stage kidney failure. About 22 million US adults (11%) have stage 1 to 3 chronic kidney disease. The ACP’s guidelines are intended for clinicians encountering and treating these patients (Qaseem A et al. Ann Intern Med. doi: 10.7326/0003-4819-159-12-201312170 -00726 [published online October 22, 2013]). The guidance includes recommendations for managing hypertension with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and treating elevated lowdensity lipoprotein cholesterol with statin therapy. However, it is the screening recommendations in the guidelines that have garnered the most attention in the lay press and among physicians. The guidelines recommend against screening for chronic kidney disease in asymptomatic adults who do not have risk factors for the condition. Risk factors include diabetes; hypertension; cardiovascular disease; older age; obesity; family history; and African American, Native American, or Hispanic ethnicity. The guidelines further recommend against testing for proteinuria in adults with or without diabetes who are taking an ACE inhibitor or an ARB. The recommendation against screening in asymptomatic adults is based in large
part on a 2012 US Preventive Services Task Force (USPSTF) Recommendation Statement, which gave the recommendation to screen asymptomatic adults an “I” recommendation, meaning there is insufficient evidence to assess the balance of the benefits and harms of the practices. The USPSTF noted that there are no studies assessing the
New guidelines recommend against screening for chronic kidney disease in certain asymptomatic adults, but some nephrologists beg to differ.
sensitivity and specificity of screening for chronic kidney disease with tests for estimated GFR or urinary albuminuria; that the evidence that routine screening improves clinical outcomes for asymptomatic adults is inadequate; and that while evidence on harms of screening is inadequate, there is convincing evidence that medications used to treat early stages of the disease may have adverse effects (Fin HA et al. Ann Intern Med. 2012;156[8]:570-581). In that context, the ACP guidelines’ authors noted their recommendations regarding screening and testing for proteinuria are categorized as weak and based on low-quality evidence (their other 2 recommendations were categorized as strong). Molly Cooke, MD, ACP president, said her organization’s recommendations are intended to keep physicians focused on evidence-based medicine. “Doing simple screening across a large population means
jama.com
you are spending a fair amount of money on tests that may provide inaccurate results,” Cooke said. “I’m not going to do it in patients in whom, after a history and physical, I don’t find reason to be concerned about renal disease.” The National Kidney Foundation, an advocacy organization, agrees with the ACP that screening asymptomatic adults is not necessary and increases the number of falsepositive results, which, in turn, lead to unnecessary concerns, additional testing, and excess costs. Taking a different view is the American Society of Nephrology (ASN), which strongly recommends that all adults undergo routine screening for chronic kidney disease. “Early detection is the key to preventing patients from progressing to relying on dialysis to stay alive,” said Tod Ibrahim, the society’s executive director in a release. “ASN and its nearly 15 000 members—all of whom are experts in kidney disease—are disappointed by ACP’s irresponsible recommendation.” Andrew S. Levey, MD, chief, division of nephrology at Tufts Medical Center in Boston, said that although it seems as though the question of screening asymptomatic adults would affect a large number of individuals, in reality, the vast majority of the older public have a risk factor that calls for screening. Joseph Vassalotti, MD, the National Kidney Foundation’s chief medical officer, added that most decisions on whether to screen individual patients are made on a case-bycase basis by practicing physicians. “We do recommend screening at-risk groups like those with diabetes and hypertension, but really, screening gets done at the physician’s discretion.” Levey, who coauthored an editorial when the USPSTF recommendations came out (Uhlig K and Levey AS. Ann Intern Med. 2012;156[8]:599-601), said both the task force and the ACP, by relying on the need for rigorous evidence to justify clinical decision making, reject certain practices in nephrology that benefit patients. “The ACP didn’t really consider all the outcomes. For example, one outcome is JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Nanyang Technological University User on 05/20/2015
2387
News & Analysis
foundation and the only global developer of evidence-based clinical practice guidelines in kidney disease. “It’s unfortunate there wasn’t an attempt to harmonize these recommendations, because it’s not responsible for one body to put out recommendations after another did, without discussing any differences,” Levey said. “This leaves clinicians in the middle saying, ‘What am I supposed to believe?’”
Pregnancy After Bariatric Surgery Associated With Risks to Offspring Jill Jin, MD, MPH
W
ith the worldwide prevalence of obesity on the increase, more individuals are opting for bariatric surgery as a solution, including an increasing number of women of childbearing age. Given the known negative effects of obesity on both fertility and pregnancy outcomes, bariatric surgery in obese women hoping to have children has generally not been discouraged by physicians. Now, however, new research suggests that pregnancies in women with previous bariatric surgery may have worse perinatal outcomes than previously thought. In a new study, researchers at the Karolinska Institute in Sweden looked at outcomes of pregnancies among 2534 women who had undergone previous bariatric surgery (gastric bypass, gastric banding, or vertical banded gastroplasty) and more than 12 000 from women without a history of bariatric surgery, all of whom gave birth between 1992 and 2009 (Roos N et al. BMJ. 2013;347:f6460. doi:10.1136/bmj.f6460). To account for other factors that could influence pregnancy outcome, the women without a history of bariatric surgery were matched to the bariatric surgery group in a 5:1 ratio based on age, parity, body mass index (BMI) at first prenatal visit, smoking status, educational level, and year of delivery. The main outcome measures were preterm birth (less than 37 weeks’ gestation) and birth weight for gestational age. The researchers found that women who had undergone previous bariatric
2388
surgery had a statistically significant higher rate of preterm birth than those who had not: 9.7% vs 6.1%. They were also significantly more likely to deliver a small-for-gestational-age infant (a sign of fetal growth restriction) compared with those who did not have the surgery (5.2% vs 3.0%). These increased risks were seen with all 3 types of bariatric surgery, and the risks were still present more than 5 years after surgery. There was no difference in rates of stillbirth or neonatal death, although both of these outcomes were sufficiently rare that a difference may not have been detected based on the study size. Women who had undergone bariatric surgery were less likely than those in the control group to deliver an infant that was large for gestational age (4.2% vs 7.3%). Such infants are at increased risk of impaired glucose tolerance and childhood obesity. The researchers commented that poorer nutrient absorption in women who have had bariatric surgery may result in micronutrient deficiencies that negatively affect both fetal and placental growth but noted that their study did not investigate this possibility. They suggested that it may be beneficial for pregnant women with a history of bariatric surgery to be regarded as a high-risk group and to receive prenatal counseling on the increased risks of preterm birth and fetal growth restriction.
.
news@JAMA FROM JAMA’S DAILY NEWS SITE
Genes, Ethnicity, and Health Risks Researchers from 5 institutions will explore whether subtle variations in the genetic makeup of ethnically diverse populations account for their differences in various health risks. The National Institutes of Health is funding the work through the Population Architecture Using Genomics and Epidemiology program of the National Human Genome Research Institute. The investigators will use large epidemiological studies and data sets that include whites, blacks, Hispanics, Native Americans, Native Hawaiians, and Japanese Americans. Because population-related biological pathways often contribute to disease, examining many traits and diseases together gives a more thorough picture of the role of genetic variation. http://jama.md/17dYlu6 Children at Risk for Pertussis An increasing number of children aged 3 to 36 months are undervaccinated, putting them at increased risk of developing pertussis. In a recent study, researchers found 72 confirmed cases of pertussis among children born between 2004 and 2008 who received care through 1 of 8 managed care organizations. Children who were undervaccinated were much more likely than fully vaccinated children to become ill with pertussis. Children undervaccinated for 3 or 4 doses of vaccine were about 18 times and about 28 times more likely, respectively, to be diagnosed with pertussis than age-appropriately vaccinated children. http://jama.md/1ex8ZQk “Sausage Making” in Clinical Research Clinicaltrials.gov, the database created to increase transparency in clinical research, is shining an unflattering light on how data are compiled and published. No one anticipated the role of clinicaltrials.gov “as a window into the sausage factory,” said Deborah Zarin, MD, director of clinicaltrials.gov, which is run by the US National Library of Medicine. Reviews of the database have shown reporting errors, typos in journals, or intentional distortion of results to present more favorable findings in published studies. http://jama.md/17Wa4ds
For more on these stories and other medical news, visit http://newsatjama.jama.com.
JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Nanyang Technological University User on 05/20/2015
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avoiding drug toxicity, and you need to do the basic metabolic panel when a patient comes in sick so you know his or her kidney function to adjust a medication dose appropriately,” said Levey. Another issue for Levey is that the ACP guidelines conflict with the recently released guidelines on the treatment of hypertension in patients with chronic kidney disease from Kidney Disease: Improving Global Outcomes (KDIGO), a Belgian
Nephrologists Question ACP’s Kidney Disease Guidelines Mike Mitka, MSJ
E
lements of new guidelines on screening, monitoring, and treatment of chronic kidney disease released October 22 by the American College of Physicians (ACP) are sparking criticisms by some members of the nephrology community, who say the guidance rejects some practices that benefit patients. The progressive loss of kidney function over time that characterizes chronic kidney disease affects about 26 million adults in the United States. Disease severity is divided into 5 stages based on glomerular filtration rate (GFR), estimated from serum creatinine as a measure of kidney function, and albuminuria, a marker of kidney damage from cause. People with stage 1 to 3 chronic kidney disease have normal to moderately reduced kidney function; individuals with stage 4 of the disease have severely reduced kidney function; and those with stage 5 have very severe disease, known as end-stage kidney failure. About 22 million US adults (11%) have stage 1 to 3 chronic kidney disease. The ACP’s guidelines are intended for clinicians encountering and treating these patients (Qaseem A et al. Ann Intern Med. doi: 10.7326/0003-4819-159-12-201312170 -00726 [published online October 22, 2013]). The guidance includes recommendations for managing hypertension with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and treating elevated lowdensity lipoprotein cholesterol with statin therapy. However, it is the screening recommendations in the guidelines that have garnered the most attention in the lay press and among physicians. The guidelines recommend against screening for chronic kidney disease in asymptomatic adults who do not have risk factors for the condition. Risk factors include diabetes; hypertension; cardiovascular disease; older age; obesity; family history; and African American, Native American, or Hispanic ethnicity. The guidelines further recommend against testing for proteinuria in adults with or without diabetes who are taking an ACE inhibitor or an ARB. The recommendation against screening in asymptomatic adults is based in large
part on a 2012 US Preventive Services Task Force (USPSTF) Recommendation Statement, which gave the recommendation to screen asymptomatic adults an “I” recommendation, meaning there is insufficient evidence to assess the balance of the benefits and harms of the practices. The USPSTF noted that there are no studies assessing the
New guidelines recommend against screening for chronic kidney disease in certain asymptomatic adults, but some nephrologists beg to differ.
sensitivity and specificity of screening for chronic kidney disease with tests for estimated GFR or urinary albuminuria; that the evidence that routine screening improves clinical outcomes for asymptomatic adults is inadequate; and that while evidence on harms of screening is inadequate, there is convincing evidence that medications used to treat early stages of the disease may have adverse effects (Fin HA et al. Ann Intern Med. 2012;156[8]:570-581). In that context, the ACP guidelines’ authors noted their recommendations regarding screening and testing for proteinuria are categorized as weak and based on low-quality evidence (their other 2 recommendations were categorized as strong). Molly Cooke, MD, ACP president, said her organization’s recommendations are intended to keep physicians focused on evidence-based medicine. “Doing simple screening across a large population means
jama.com
you are spending a fair amount of money on tests that may provide inaccurate results,” Cooke said. “I’m not going to do it in patients in whom, after a history and physical, I don’t find reason to be concerned about renal disease.” The National Kidney Foundation, an advocacy organization, agrees with the ACP that screening asymptomatic adults is not necessary and increases the number of falsepositive results, which, in turn, lead to unnecessary concerns, additional testing, and excess costs. Taking a different view is the American Society of Nephrology (ASN), which strongly recommends that all adults undergo routine screening for chronic kidney disease. “Early detection is the key to preventing patients from progressing to relying on dialysis to stay alive,” said Tod Ibrahim, the society’s executive director in a release. “ASN and its nearly 15 000 members—all of whom are experts in kidney disease—are disappointed by ACP’s irresponsible recommendation.” Andrew S. Levey, MD, chief, division of nephrology at Tufts Medical Center in Boston, said that although it seems as though the question of screening asymptomatic adults would affect a large number of individuals, in reality, the vast majority of the older public have a risk factor that calls for screening. Joseph Vassalotti, MD, the National Kidney Foundation’s chief medical officer, added that most decisions on whether to screen individual patients are made on a case-bycase basis by practicing physicians. “We do recommend screening at-risk groups like those with diabetes and hypertension, but really, screening gets done at the physician’s discretion.” Levey, who coauthored an editorial when the USPSTF recommendations came out (Uhlig K and Levey AS. Ann Intern Med. 2012;156[8]:599-601), said both the task force and the ACP, by relying on the need for rigorous evidence to justify clinical decision making, reject certain practices in nephrology that benefit patients. “The ACP didn’t really consider all the outcomes. For example, one outcome is JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Nanyang Technological University User on 05/20/2015
2387
News & Analysis
foundation and the only global developer of evidence-based clinical practice guidelines in kidney disease. “It’s unfortunate there wasn’t an attempt to harmonize these recommendations, because it’s not responsible for one body to put out recommendations after another did, without discussing any differences,” Levey said. “This leaves clinicians in the middle saying, ‘What am I supposed to believe?’”
Pregnancy After Bariatric Surgery Associated With Risks to Offspring Jill Jin, MD, MPH
W
ith the worldwide prevalence of obesity on the increase, more individuals are opting for bariatric surgery as a solution, including an increasing number of women of childbearing age. Given the known negative effects of obesity on both fertility and pregnancy outcomes, bariatric surgery in obese women hoping to have children has generally not been discouraged by physicians. Now, however, new research suggests that pregnancies in women with previous bariatric surgery may have worse perinatal outcomes than previously thought. In a new study, researchers at the Karolinska Institute in Sweden looked at outcomes of pregnancies among 2534 women who had undergone previous bariatric surgery (gastric bypass, gastric banding, or vertical banded gastroplasty) and more than 12 000 from women without a history of bariatric surgery, all of whom gave birth between 1992 and 2009 (Roos N et al. BMJ. 2013;347:f6460. doi:10.1136/bmj.f6460). To account for other factors that could influence pregnancy outcome, the women without a history of bariatric surgery were matched to the bariatric surgery group in a 5:1 ratio based on age, parity, body mass index (BMI) at first prenatal visit, smoking status, educational level, and year of delivery. The main outcome measures were preterm birth (less than 37 weeks’ gestation) and birth weight for gestational age. The researchers found that women who had undergone previous bariatric
2388
surgery had a statistically significant higher rate of preterm birth than those who had not: 9.7% vs 6.1%. They were also significantly more likely to deliver a small-for-gestational-age infant (a sign of fetal growth restriction) compared with those who did not have the surgery (5.2% vs 3.0%). These increased risks were seen with all 3 types of bariatric surgery, and the risks were still present more than 5 years after surgery. There was no difference in rates of stillbirth or neonatal death, although both of these outcomes were sufficiently rare that a difference may not have been detected based on the study size. Women who had undergone bariatric surgery were less likely than those in the control group to deliver an infant that was large for gestational age (4.2% vs 7.3%). Such infants are at increased risk of impaired glucose tolerance and childhood obesity. The researchers commented that poorer nutrient absorption in women who have had bariatric surgery may result in micronutrient deficiencies that negatively affect both fetal and placental growth but noted that their study did not investigate this possibility. They suggested that it may be beneficial for pregnant women with a history of bariatric surgery to be regarded as a high-risk group and to receive prenatal counseling on the increased risks of preterm birth and fetal growth restriction.
.
news@JAMA FROM JAMA’S DAILY NEWS SITE
Genes, Ethnicity, and Health Risks Researchers from 5 institutions will explore whether subtle variations in the genetic makeup of ethnically diverse populations account for their differences in various health risks. The National Institutes of Health is funding the work through the Population Architecture Using Genomics and Epidemiology program of the National Human Genome Research Institute. The investigators will use large epidemiological studies and data sets that include whites, blacks, Hispanics, Native Americans, Native Hawaiians, and Japanese Americans. Because population-related biological pathways often contribute to disease, examining many traits and diseases together gives a more thorough picture of the role of genetic variation. http://jama.md/17dYlu6 Children at Risk for Pertussis An increasing number of children aged 3 to 36 months are undervaccinated, putting them at increased risk of developing pertussis. In a recent study, researchers found 72 confirmed cases of pertussis among children born between 2004 and 2008 who received care through 1 of 8 managed care organizations. Children who were undervaccinated were much more likely than fully vaccinated children to become ill with pertussis. Children undervaccinated for 3 or 4 doses of vaccine were about 18 times and about 28 times more likely, respectively, to be diagnosed with pertussis than age-appropriately vaccinated children. http://jama.md/1ex8ZQk “Sausage Making” in Clinical Research Clinicaltrials.gov, the database created to increase transparency in clinical research, is shining an unflattering light on how data are compiled and published. No one anticipated the role of clinicaltrials.gov “as a window into the sausage factory,” said Deborah Zarin, MD, director of clinicaltrials.gov, which is run by the US National Library of Medicine. Reviews of the database have shown reporting errors, typos in journals, or intentional distortion of results to present more favorable findings in published studies. http://jama.md/17Wa4ds
For more on these stories and other medical news, visit http://newsatjama.jama.com.
JAMA December 11, 2013 Volume 310, Number 22
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Nanyang Technological University User on 05/20/2015
jama.com
cosmin4000/iStock.com
avoiding drug toxicity, and you need to do the basic metabolic panel when a patient comes in sick so you know his or her kidney function to adjust a medication dose appropriately,” said Levey. Another issue for Levey is that the ACP guidelines conflict with the recently released guidelines on the treatment of hypertension in patients with chronic kidney disease from Kidney Disease: Improving Global Outcomes (KDIGO), a Belgian
