Q) I’ve heard a lot of references to “renal denervation” and its use for resistant hypertension. What is it? Does it work? Is it common in the US?

Renal denervation is a minimally invasive endovascular procedure that ablates (or disrupts) the renal nerves in and around the renal arteries with radiofrequency energy.⁵ Renal denervation has been approved in the US and other countries and is being used clinically in Europe, Canada, and Australia.⁶

It is thought that renal denervation interrupts the efferent and afferent signals that stimulate the renin-angiotensin-aldosterone system (RAAS) and regulate whole-body sympathetic nervous system activity.⁵ Similar to surgical sympathectomy, renal denervation should theoretically lower blood pressure. However, Ezzahti et al found that renin levels did not decrease in patients following renal denervation.⁷

Drug-resistant hypertension is defined as blood pressure that remains greater than 140/90 mm Hg despite treatment with three or more antihypertensive medications, including a diuretic.⁸ Patients with resistant hypertension have increased cardiovascular risk.⁹ Clinical trials of renal denervation have focused on treatment of resistant hypertension, in the hope of reducing the associated morbidity and mortality.

Results of the Symplicity HTN-3 trial, which assessed the safety and efficacy of renal denervation, were anxiously awaited, since prior trials yielded mixed results. Although the Symplicity HTN-1 and Symplicity HTN-2 studies demonstrated a possible benefit of renal denervation to lower office measured blood pressure, other studies did not show a decrease in BP in patients who had undergone renal denervation.^6,7 These early trials, however, were small and did not randomize patients to a sham procedure.¹⁰

The Symplicity HTN-3 trial included 535 patients at 88 centers in the US. Patients were randomly assigned to receive either renal denervation plus baseline antihypertensive medications or a sham procedure plus baseline antihypertensive medications.

The researchers found that the sham procedure was just as effective as the “true” renal denervation in decreasing systolic blood pressure in patients with resistant hypertension.¹⁰ In other words, renal denervation did not demonstrate efficacy for this purpose.

In response to the results of this well-designed trial, the FDA has halted approval to perform renal denervation in patients with resistant hypertension in the US. However, clinical investigation will continue among subgroups of hypertensive patients or separate populations.

Despite a lack of efficacy, renal denervation does appear to be well tolerated, as evidenced by safety data from Symplicity HTN-3. —JK

Jessica Knight, ACNP
University of New Mexico Hospital, Albuquerque

REFERENCES
5. Esler MD, Krum H, Schlaich M, et al. Renal sympathetic denervation for the treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012;126(25):2976-2982.
6. Thukkani AK, Bhatt LD. Renal denervation therapy for hypertension. Circulation. 2013;128:2251-2254.
7. Ezzahti M, Moelker A, Friesema E, et al. Blood pressure and neurohormonal responses to renal nerve ablation in treatment-resistant hypertension. J Hypertens. 2014;32(1):135-141.
8. Calhoun DA, Jones D, Textor S, et al. Resistant hypertension: Diagnosis, evaluation, and treatment: A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension. 2008;51(6):1403-1419.
9. Daugherty SL, Powers JD, Magid DJ, et al. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation. 2012;125(13):1635-1642.
10. Bhatt DL, Kandzari DE, O’Neill WW, et al; Symplicity HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-1401.

The author would like to thank Eric Judd, MD, of the University of Alabama at Birmingham, for his advice on the preparation of this response.

Q) I’ve heard a lot of references to “renal denervation” and its use for resistant hypertension. What is it? Does it work? Is it common in the US?

Renal denervation is a minimally invasive endovascular procedure that ablates (or disrupts) the renal nerves in and around the renal arteries with radiofrequency energy.⁵ Renal denervation has been approved in the US and other countries and is being used clinically in Europe, Canada, and Australia.⁶

It is thought that renal denervation interrupts the efferent and afferent signals that stimulate the renin-angiotensin-aldosterone system (RAAS) and regulate whole-body sympathetic nervous system activity.⁵ Similar to surgical sympathectomy, renal denervation should theoretically lower blood pressure. However, Ezzahti et al found that renin levels did not decrease in patients following renal denervation.⁷

Drug-resistant hypertension is defined as blood pressure that remains greater than 140/90 mm Hg despite treatment with three or more antihypertensive medications, including a diuretic.⁸ Patients with resistant hypertension have increased cardiovascular risk.⁹ Clinical trials of renal denervation have focused on treatment of resistant hypertension, in the hope of reducing the associated morbidity and mortality.

Results of the Symplicity HTN-3 trial, which assessed the safety and efficacy of renal denervation, were anxiously awaited, since prior trials yielded mixed results. Although the Symplicity HTN-1 and Symplicity HTN-2 studies demonstrated a possible benefit of renal denervation to lower office measured blood pressure, other studies did not show a decrease in BP in patients who had undergone renal denervation.^6,7 These early trials, however, were small and did not randomize patients to a sham procedure.¹⁰

The Symplicity HTN-3 trial included 535 patients at 88 centers in the US. Patients were randomly assigned to receive either renal denervation plus baseline antihypertensive medications or a sham procedure plus baseline antihypertensive medications.

The researchers found that the sham procedure was just as effective as the “true” renal denervation in decreasing systolic blood pressure in patients with resistant hypertension.¹⁰ In other words, renal denervation did not demonstrate efficacy for this purpose.

In response to the results of this well-designed trial, the FDA has halted approval to perform renal denervation in patients with resistant hypertension in the US. However, clinical investigation will continue among subgroups of hypertensive patients or separate populations.

Despite a lack of efficacy, renal denervation does appear to be well tolerated, as evidenced by safety data from Symplicity HTN-3. —JK

Jessica Knight, ACNP
University of New Mexico Hospital, Albuquerque

REFERENCES
5. Esler MD, Krum H, Schlaich M, et al. Renal sympathetic denervation for the treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012;126(25):2976-2982.
6. Thukkani AK, Bhatt LD. Renal denervation therapy for hypertension. Circulation. 2013;128:2251-2254.
7. Ezzahti M, Moelker A, Friesema E, et al. Blood pressure and neurohormonal responses to renal nerve ablation in treatment-resistant hypertension. J Hypertens. 2014;32(1):135-141.
8. Calhoun DA, Jones D, Textor S, et al. Resistant hypertension: Diagnosis, evaluation, and treatment: A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension. 2008;51(6):1403-1419.
9. Daugherty SL, Powers JD, Magid DJ, et al. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation. 2012;125(13):1635-1642.
10. Bhatt DL, Kandzari DE, O’Neill WW, et al; Symplicity HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-1401.

The author would like to thank Eric Judd, MD, of the University of Alabama at Birmingham, for his advice on the preparation of this response.

Q) I’ve heard a lot of references to “renal denervation” and its use for resistant hypertension. What is it? Does it work? Is it common in the US?

Renal denervation is a minimally invasive endovascular procedure that ablates (or disrupts) the renal nerves in and around the renal arteries with radiofrequency energy.⁵ Renal denervation has been approved in the US and other countries and is being used clinically in Europe, Canada, and Australia.⁶

It is thought that renal denervation interrupts the efferent and afferent signals that stimulate the renin-angiotensin-aldosterone system (RAAS) and regulate whole-body sympathetic nervous system activity.⁵ Similar to surgical sympathectomy, renal denervation should theoretically lower blood pressure. However, Ezzahti et al found that renin levels did not decrease in patients following renal denervation.⁷

Drug-resistant hypertension is defined as blood pressure that remains greater than 140/90 mm Hg despite treatment with three or more antihypertensive medications, including a diuretic.⁸ Patients with resistant hypertension have increased cardiovascular risk.⁹ Clinical trials of renal denervation have focused on treatment of resistant hypertension, in the hope of reducing the associated morbidity and mortality.

Results of the Symplicity HTN-3 trial, which assessed the safety and efficacy of renal denervation, were anxiously awaited, since prior trials yielded mixed results. Although the Symplicity HTN-1 and Symplicity HTN-2 studies demonstrated a possible benefit of renal denervation to lower office measured blood pressure, other studies did not show a decrease in BP in patients who had undergone renal denervation.^6,7 These early trials, however, were small and did not randomize patients to a sham procedure.¹⁰

The Symplicity HTN-3 trial included 535 patients at 88 centers in the US. Patients were randomly assigned to receive either renal denervation plus baseline antihypertensive medications or a sham procedure plus baseline antihypertensive medications.

The researchers found that the sham procedure was just as effective as the “true” renal denervation in decreasing systolic blood pressure in patients with resistant hypertension.¹⁰ In other words, renal denervation did not demonstrate efficacy for this purpose.

In response to the results of this well-designed trial, the FDA has halted approval to perform renal denervation in patients with resistant hypertension in the US. However, clinical investigation will continue among subgroups of hypertensive patients or separate populations.

Despite a lack of efficacy, renal denervation does appear to be well tolerated, as evidenced by safety data from Symplicity HTN-3. —JK

Jessica Knight, ACNP
University of New Mexico Hospital, Albuquerque

REFERENCES
5. Esler MD, Krum H, Schlaich M, et al. Renal sympathetic denervation for the treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012;126(25):2976-2982.
6. Thukkani AK, Bhatt LD. Renal denervation therapy for hypertension. Circulation. 2013;128:2251-2254.
7. Ezzahti M, Moelker A, Friesema E, et al. Blood pressure and neurohormonal responses to renal nerve ablation in treatment-resistant hypertension. J Hypertens. 2014;32(1):135-141.
8. Calhoun DA, Jones D, Textor S, et al. Resistant hypertension: Diagnosis, evaluation, and treatment: A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension. 2008;51(6):1403-1419.
9. Daugherty SL, Powers JD, Magid DJ, et al. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation. 2012;125(13):1635-1642.
10. Bhatt DL, Kandzari DE, O’Neill WW, et al; Symplicity HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-1401.

The author would like to thank Eric Judd, MD, of the University of Alabama at Birmingham, for his advice on the preparation of this response.

ANSWER
The radiograph shows a fracture of both the distal radius and distal ulna. The patient was placed in a splint and referred to orthopedics for outpatient follow-up.

ANSWER
The radiograph shows a fracture of both the distal radius and distal ulna. The patient was placed in a splint and referred to orthopedics for outpatient follow-up.

ANSWER
The radiograph shows a fracture of both the distal radius and distal ulna. The patient was placed in a splint and referred to orthopedics for outpatient follow-up.

In May 2015, the American Academy of Pediatrics convened an invitation-only symposium titled Growing Up Digital. Its goal was to reconsider the Academy’s advice on “screen time” and make sure that its policies were “science-driven, not based merely on the precautionary principle.” (“Beyond ‘turn it off’: How to advice families on media use,” Brown et al. AAP News, October 2015). Driven by the concern that the current AAP advice was becoming obsolete and as a result likely to be ignored by parents faced with the realities of our digital culture, the participants investigated the available data on “early learning, game-based learning, social/emotional and developmental concerns, and strategies to foster digital citizenship.”

Their findings have been distilled into a collection of “key messages” for parents published in the October, 2015 AAP News. It’s hard to argue with most of the common sense advice that includes “Role modeling is critical; playtime is important; co-engagement counts; set limits; and create tech-free zones.” A set of formal recommendations is in the works and will be published at a later date.

It is comforting to learn of the academy’s concern to keep its advice current and evidence-based. It is frustrating for those of us expected to deliver the party line when we suspect that parents are muttering to themselves, “Really?” I assume that most pediatricians at the parent/doctor interface will join me in welcoming much of the more nuanced advice in the final recommendations, particularly those for older children and adolescents.

However, if the new document is not carefully worded and promoted, I fear that the potent message of “no screen time under age 2” will be lost or diluted. While the symposium participants may have uncovered some evidence of benefit or at least no serious harm from some digital platforms, does this warrant softening the catchy and clear advice of “no screen time under 2?” I have to ask myself when would a child under the age of 2 being raised in a healthy environment have time for electronic distraction?

As Dr. Ari Brown, Dr. Donald L. Shifrin, and Dr. David L. Hill ask parents in their AAP News piece, “Does your child’s technology use help or hinder participation in other activities?” Just doing a little quick math: Wake up at 7 a.m., breakfast, playground time, maybe a midmorning nap, snack, lunch, afternoon nap, afternoon playground time, maybe another snack, dinner, bedtime story and lights out at 7 p.m. I don’t see a spot to shoehorn in some screen time without eliminating a developmentally and socially important activity. You could replace the hard cover book at bedtime with an electronic one on a tablet, but in my experience that runs the risk of replacing a soporific activity with one that is too visually stimulating.

One could argue that depriving a young child of screen time is going to put him behind his peers who have become masterful web navigators by the time they are 18 months. Rubbish. The learning curve for most electronic devices is so short that the “deprived” child will catch up in a couple of dozen clicks. However, screens require little more than a moving and tapping index finger. What about those other manipulative skills and the strength and coordination of the muscles sitting unused during screen time?

Unfortunately, the crafters of these new guidelines have repeated the same mistake the academy has made before when they observe, “The quality of the content is more important than the platform or time spent with media.” In my opinion, if the time spent on a screen is kept sufficiently short, children won’t squander it on bad stuff for very long nor will what they see be that harmful. Burdening parents with the task of determining quality is unrealistic. However, setting a time limit is far more workable and enforceable.

Finally, when it comes to parents enforcing no screen time under 2, everyone knows that Skyping with Grandma and Grandpa gets a free pass.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping With a Picky Eater.” Email him at [email protected].

In May 2015, the American Academy of Pediatrics convened an invitation-only symposium titled Growing Up Digital. Its goal was to reconsider the Academy’s advice on “screen time” and make sure that its policies were “science-driven, not based merely on the precautionary principle.” (“Beyond ‘turn it off’: How to advice families on media use,” Brown et al. AAP News, October 2015). Driven by the concern that the current AAP advice was becoming obsolete and as a result likely to be ignored by parents faced with the realities of our digital culture, the participants investigated the available data on “early learning, game-based learning, social/emotional and developmental concerns, and strategies to foster digital citizenship.”

Their findings have been distilled into a collection of “key messages” for parents published in the October, 2015 AAP News. It’s hard to argue with most of the common sense advice that includes “Role modeling is critical; playtime is important; co-engagement counts; set limits; and create tech-free zones.” A set of formal recommendations is in the works and will be published at a later date.

It is comforting to learn of the academy’s concern to keep its advice current and evidence-based. It is frustrating for those of us expected to deliver the party line when we suspect that parents are muttering to themselves, “Really?” I assume that most pediatricians at the parent/doctor interface will join me in welcoming much of the more nuanced advice in the final recommendations, particularly those for older children and adolescents.

However, if the new document is not carefully worded and promoted, I fear that the potent message of “no screen time under age 2” will be lost or diluted. While the symposium participants may have uncovered some evidence of benefit or at least no serious harm from some digital platforms, does this warrant softening the catchy and clear advice of “no screen time under 2?” I have to ask myself when would a child under the age of 2 being raised in a healthy environment have time for electronic distraction?

As Dr. Ari Brown, Dr. Donald L. Shifrin, and Dr. David L. Hill ask parents in their AAP News piece, “Does your child’s technology use help or hinder participation in other activities?” Just doing a little quick math: Wake up at 7 a.m., breakfast, playground time, maybe a midmorning nap, snack, lunch, afternoon nap, afternoon playground time, maybe another snack, dinner, bedtime story and lights out at 7 p.m. I don’t see a spot to shoehorn in some screen time without eliminating a developmentally and socially important activity. You could replace the hard cover book at bedtime with an electronic one on a tablet, but in my experience that runs the risk of replacing a soporific activity with one that is too visually stimulating.

One could argue that depriving a young child of screen time is going to put him behind his peers who have become masterful web navigators by the time they are 18 months. Rubbish. The learning curve for most electronic devices is so short that the “deprived” child will catch up in a couple of dozen clicks. However, screens require little more than a moving and tapping index finger. What about those other manipulative skills and the strength and coordination of the muscles sitting unused during screen time?

Unfortunately, the crafters of these new guidelines have repeated the same mistake the academy has made before when they observe, “The quality of the content is more important than the platform or time spent with media.” In my opinion, if the time spent on a screen is kept sufficiently short, children won’t squander it on bad stuff for very long nor will what they see be that harmful. Burdening parents with the task of determining quality is unrealistic. However, setting a time limit is far more workable and enforceable.

Finally, when it comes to parents enforcing no screen time under 2, everyone knows that Skyping with Grandma and Grandpa gets a free pass.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping With a Picky Eater.” Email him at [email protected].

In May 2015, the American Academy of Pediatrics convened an invitation-only symposium titled Growing Up Digital. Its goal was to reconsider the Academy’s advice on “screen time” and make sure that its policies were “science-driven, not based merely on the precautionary principle.” (“Beyond ‘turn it off’: How to advice families on media use,” Brown et al. AAP News, October 2015). Driven by the concern that the current AAP advice was becoming obsolete and as a result likely to be ignored by parents faced with the realities of our digital culture, the participants investigated the available data on “early learning, game-based learning, social/emotional and developmental concerns, and strategies to foster digital citizenship.”

Their findings have been distilled into a collection of “key messages” for parents published in the October, 2015 AAP News. It’s hard to argue with most of the common sense advice that includes “Role modeling is critical; playtime is important; co-engagement counts; set limits; and create tech-free zones.” A set of formal recommendations is in the works and will be published at a later date.

It is comforting to learn of the academy’s concern to keep its advice current and evidence-based. It is frustrating for those of us expected to deliver the party line when we suspect that parents are muttering to themselves, “Really?” I assume that most pediatricians at the parent/doctor interface will join me in welcoming much of the more nuanced advice in the final recommendations, particularly those for older children and adolescents.

However, if the new document is not carefully worded and promoted, I fear that the potent message of “no screen time under age 2” will be lost or diluted. While the symposium participants may have uncovered some evidence of benefit or at least no serious harm from some digital platforms, does this warrant softening the catchy and clear advice of “no screen time under 2?” I have to ask myself when would a child under the age of 2 being raised in a healthy environment have time for electronic distraction?

As Dr. Ari Brown, Dr. Donald L. Shifrin, and Dr. David L. Hill ask parents in their AAP News piece, “Does your child’s technology use help or hinder participation in other activities?” Just doing a little quick math: Wake up at 7 a.m., breakfast, playground time, maybe a midmorning nap, snack, lunch, afternoon nap, afternoon playground time, maybe another snack, dinner, bedtime story and lights out at 7 p.m. I don’t see a spot to shoehorn in some screen time without eliminating a developmentally and socially important activity. You could replace the hard cover book at bedtime with an electronic one on a tablet, but in my experience that runs the risk of replacing a soporific activity with one that is too visually stimulating.

One could argue that depriving a young child of screen time is going to put him behind his peers who have become masterful web navigators by the time they are 18 months. Rubbish. The learning curve for most electronic devices is so short that the “deprived” child will catch up in a couple of dozen clicks. However, screens require little more than a moving and tapping index finger. What about those other manipulative skills and the strength and coordination of the muscles sitting unused during screen time?

Unfortunately, the crafters of these new guidelines have repeated the same mistake the academy has made before when they observe, “The quality of the content is more important than the platform or time spent with media.” In my opinion, if the time spent on a screen is kept sufficiently short, children won’t squander it on bad stuff for very long nor will what they see be that harmful. Burdening parents with the task of determining quality is unrealistic. However, setting a time limit is far more workable and enforceable.

Finally, when it comes to parents enforcing no screen time under 2, everyone knows that Skyping with Grandma and Grandpa gets a free pass.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Coping With a Picky Eater.” Email him at [email protected].

LAKE BUENA VISTA, FLA. – Normalizing maternal thyroid function early in pregnancy may improve obstetric outcomes for women with subclinical hypothyroidism.

A high level of thyroid-stimulating hormone (TSH) was associated with increased stillbirth in women who didn’t receive prenatal levothyroxine, Peter N. Taylor, Ph.D., reported at the International Thyroid Congress.

And women who were untreated for low free thyroxine (T₄) were significantly more likely to need an early cesarean section than treated women, suggesting that levothyroxine could be reducing conditions leading to maternal-fetal distress.

“The good thing is that many physicians are already treating with levothyroxine anyway,” said Dr. Taylor of Cardiff (Wales) University. “There are no obvious adverse obstetric events associated with it. It seems relatively benign, and the accepted dose of 150 mcg per day seems adequate.”

He reported data from a subgroup analysis of the large Controlled Antenatal Thyroid Screening Study (N Eng J Med. 2012;366:493-501). That trial enrolled more than 21,000 mother-child pairs, and examined the effect of maternal levothyroxine treatment on the child’s IQ at 3 years. Among the children of women with hypothyroidism, the mean IQ scores were 99.2 and 100 in the treated and control groups – not significantly different. The proportions of children with an IQ of less than 85 were 12% in the treated group and 14% in the control group, also not significantly different.

Dr. Taylor’s cohort involved about 14,000 mother-child pairs from this study, all of whom were from Wales. Using national health care databases as well as study data, he was able to examine obstetric outcomes in women with low thyroid function (664) who received or did not receive levothyroxine early between 11 and 16 weeks’ gestation.

About half of the hypothyroid women (351) had TSH levels above 3.5 mU/L. The remainder had free T₄ levels below 10.9 pmol/L. Each of these groups was randomized to levothyroxine treatment or placebo. The rest of the cohort had normal thyroid status.

The study’s primary endpoint was the rate of stillbirth. Secondary endpoints were cesarean section rate (both overall and early); gestational age at birth; and macrosomia.

Among the euthyroid group, the rate of stillbirth was 0.34%, similar to the national background rate. There were no stillbirths among women with high TSH who were treated. Three (1.68%) occurred in the untreated group. The TSH levels in those women before treatment were 3.63 mU/L, 3.66 mU/L, and 4.58 mU/L – not dramatically high, Dr. Taylor noted. “But they could have risen later in pregnancy as stress on the thyroid increased.”

After adjusting for maternal age, weight, parity, birth year, and smoking, stillbirths were five times more likely among the untreated women than the treated women. However, Dr. Taylor cautioned, “This is a very small number of events. But it is quite seductive to think that stillbirths could be prevented by levothyroxine.”

There were no significant associations of high TSH with macrosomia or gestational age.

Untreated low free T₄ was not associated with stillbirth. However, Dr. Taylor said, it was very strongly associated with early C-section.

The overall C-section rate was similar between untreated and treated women (28%). But 5.6% of the untreated women had an early C-section, compared with none of the treated women. This hints strongly at a protective effect of levothyroxine, Dr. Taylor said. Early C-sections – between 26 and 32 weeks – are medically driven rather than driven by patient choice. This finding of fewer early interventions among treated women suggests that levothyroxine is exerting some protective effect, especially given the finding that infants of untreated mothers actually tended to be about 133 g lighter at birth.

“We would speculate this is probably due to a decrease in preeclampsia and gestational hypertension, which are more common among women with hypothyroidism.”

Infants of untreated mothers also were born slightly earlier – about half a week, he said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Dr. Taylor had no financial disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Normalizing maternal thyroid function early in pregnancy may improve obstetric outcomes for women with subclinical hypothyroidism.

A high level of thyroid-stimulating hormone (TSH) was associated with increased stillbirth in women who didn’t receive prenatal levothyroxine, Peter N. Taylor, Ph.D., reported at the International Thyroid Congress.

And women who were untreated for low free thyroxine (T₄) were significantly more likely to need an early cesarean section than treated women, suggesting that levothyroxine could be reducing conditions leading to maternal-fetal distress.

“The good thing is that many physicians are already treating with levothyroxine anyway,” said Dr. Taylor of Cardiff (Wales) University. “There are no obvious adverse obstetric events associated with it. It seems relatively benign, and the accepted dose of 150 mcg per day seems adequate.”

He reported data from a subgroup analysis of the large Controlled Antenatal Thyroid Screening Study (N Eng J Med. 2012;366:493-501). That trial enrolled more than 21,000 mother-child pairs, and examined the effect of maternal levothyroxine treatment on the child’s IQ at 3 years. Among the children of women with hypothyroidism, the mean IQ scores were 99.2 and 100 in the treated and control groups – not significantly different. The proportions of children with an IQ of less than 85 were 12% in the treated group and 14% in the control group, also not significantly different.

Dr. Taylor’s cohort involved about 14,000 mother-child pairs from this study, all of whom were from Wales. Using national health care databases as well as study data, he was able to examine obstetric outcomes in women with low thyroid function (664) who received or did not receive levothyroxine early between 11 and 16 weeks’ gestation.

About half of the hypothyroid women (351) had TSH levels above 3.5 mU/L. The remainder had free T₄ levels below 10.9 pmol/L. Each of these groups was randomized to levothyroxine treatment or placebo. The rest of the cohort had normal thyroid status.

The study’s primary endpoint was the rate of stillbirth. Secondary endpoints were cesarean section rate (both overall and early); gestational age at birth; and macrosomia.

Among the euthyroid group, the rate of stillbirth was 0.34%, similar to the national background rate. There were no stillbirths among women with high TSH who were treated. Three (1.68%) occurred in the untreated group. The TSH levels in those women before treatment were 3.63 mU/L, 3.66 mU/L, and 4.58 mU/L – not dramatically high, Dr. Taylor noted. “But they could have risen later in pregnancy as stress on the thyroid increased.”

After adjusting for maternal age, weight, parity, birth year, and smoking, stillbirths were five times more likely among the untreated women than the treated women. However, Dr. Taylor cautioned, “This is a very small number of events. But it is quite seductive to think that stillbirths could be prevented by levothyroxine.”

There were no significant associations of high TSH with macrosomia or gestational age.

Untreated low free T₄ was not associated with stillbirth. However, Dr. Taylor said, it was very strongly associated with early C-section.

The overall C-section rate was similar between untreated and treated women (28%). But 5.6% of the untreated women had an early C-section, compared with none of the treated women. This hints strongly at a protective effect of levothyroxine, Dr. Taylor said. Early C-sections – between 26 and 32 weeks – are medically driven rather than driven by patient choice. This finding of fewer early interventions among treated women suggests that levothyroxine is exerting some protective effect, especially given the finding that infants of untreated mothers actually tended to be about 133 g lighter at birth.

“We would speculate this is probably due to a decrease in preeclampsia and gestational hypertension, which are more common among women with hypothyroidism.”

Infants of untreated mothers also were born slightly earlier – about half a week, he said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Dr. Taylor had no financial disclosures.

[email protected]

LAKE BUENA VISTA, FLA. – Normalizing maternal thyroid function early in pregnancy may improve obstetric outcomes for women with subclinical hypothyroidism.

A high level of thyroid-stimulating hormone (TSH) was associated with increased stillbirth in women who didn’t receive prenatal levothyroxine, Peter N. Taylor, Ph.D., reported at the International Thyroid Congress.

And women who were untreated for low free thyroxine (T₄) were significantly more likely to need an early cesarean section than treated women, suggesting that levothyroxine could be reducing conditions leading to maternal-fetal distress.

“The good thing is that many physicians are already treating with levothyroxine anyway,” said Dr. Taylor of Cardiff (Wales) University. “There are no obvious adverse obstetric events associated with it. It seems relatively benign, and the accepted dose of 150 mcg per day seems adequate.”

He reported data from a subgroup analysis of the large Controlled Antenatal Thyroid Screening Study (N Eng J Med. 2012;366:493-501). That trial enrolled more than 21,000 mother-child pairs, and examined the effect of maternal levothyroxine treatment on the child’s IQ at 3 years. Among the children of women with hypothyroidism, the mean IQ scores were 99.2 and 100 in the treated and control groups – not significantly different. The proportions of children with an IQ of less than 85 were 12% in the treated group and 14% in the control group, also not significantly different.

Dr. Taylor’s cohort involved about 14,000 mother-child pairs from this study, all of whom were from Wales. Using national health care databases as well as study data, he was able to examine obstetric outcomes in women with low thyroid function (664) who received or did not receive levothyroxine early between 11 and 16 weeks’ gestation.

About half of the hypothyroid women (351) had TSH levels above 3.5 mU/L. The remainder had free T₄ levels below 10.9 pmol/L. Each of these groups was randomized to levothyroxine treatment or placebo. The rest of the cohort had normal thyroid status.

The study’s primary endpoint was the rate of stillbirth. Secondary endpoints were cesarean section rate (both overall and early); gestational age at birth; and macrosomia.

Among the euthyroid group, the rate of stillbirth was 0.34%, similar to the national background rate. There were no stillbirths among women with high TSH who were treated. Three (1.68%) occurred in the untreated group. The TSH levels in those women before treatment were 3.63 mU/L, 3.66 mU/L, and 4.58 mU/L – not dramatically high, Dr. Taylor noted. “But they could have risen later in pregnancy as stress on the thyroid increased.”

After adjusting for maternal age, weight, parity, birth year, and smoking, stillbirths were five times more likely among the untreated women than the treated women. However, Dr. Taylor cautioned, “This is a very small number of events. But it is quite seductive to think that stillbirths could be prevented by levothyroxine.”

There were no significant associations of high TSH with macrosomia or gestational age.

Untreated low free T₄ was not associated with stillbirth. However, Dr. Taylor said, it was very strongly associated with early C-section.

The overall C-section rate was similar between untreated and treated women (28%). But 5.6% of the untreated women had an early C-section, compared with none of the treated women. This hints strongly at a protective effect of levothyroxine, Dr. Taylor said. Early C-sections – between 26 and 32 weeks – are medically driven rather than driven by patient choice. This finding of fewer early interventions among treated women suggests that levothyroxine is exerting some protective effect, especially given the finding that infants of untreated mothers actually tended to be about 133 g lighter at birth.

“We would speculate this is probably due to a decrease in preeclampsia and gestational hypertension, which are more common among women with hypothyroidism.”

Infants of untreated mothers also were born slightly earlier – about half a week, he said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

Dr. Taylor had no financial disclosures.

[email protected]

Q) Quite a few of my teenage patients are overweight. I know they are at risk for diabetes, but does their weight also affect their kidneys? Isn’t diabetes the main cause of kidney failure?

The number one cause of chronic kidney disease (CKD) in the United States and worldwide is diabetes, but it is certainly not the only risk factor. Studies have shown a link between obesity and CKD; even in the absence of kidney disease, obesity may cause glomerular dysfunction and an increase in glomerular size.¹

Obesity during adolescence has been identified as a strong predictor of CKD in adulthood. Other diseases and conditions that, if present in adolescence, indicate future risk for kidney ­disease include diabetes, hypertension, inflammation, and proteinuria.

A recent Swedish study followed patients from adolescence to adulthood to identify markers that would predict later kidney disease. In this study, the most predictive factor of kidney failure in adulthood was proteinuria in adolescence (odds ratio, 7.72). These results may be limited by the homogeneity of the predominantly white, male study population, but the extensive follow-up period, which “highlights the long natural history” of kidney disease, is one strength of this study.²

Based on these and other findings, you know that if your teenage patients have proteinuria, they are much more likely to develop kidney failure as an adult. Yet, in the US, the American Academy of Pediatrics and the US Preventive Services Task Force do not recommend urine screening for asymptomatic children.³

Interestingly, however, a survey of pediatric practices revealed that 58% of pediatricians screen adolescents with urinalysis, even if they are asymptomatic.⁴ In other words, they ignore the guidelines. If they did not, we would likely miss what is possibly the most important predictive factor for kidney failure in adults. —TAH

Tia Austin Hayes, FNP-C
UMMC/JMM Outpatient Dialysis/Renal Clinic, Jackson, Mississippi

REFERENCES
1. Rocchini A. Childhood obesity and a diabetes epidemic. N Engl J Med. 2002;346(11):854-855.
2. Sundin PO, Udumyan R, Sjöström P, Montgomery S. Predictors in adolescence of ESRD in middle-aged men. Am J Kidney Dis. 2014;64(5):723-729.
3. Kaplan RE, Springate JE, Feld LG. Screening dipstick urinalysis: a time to change. Pediatrics. 1997;100(6):919-921.
4. Sox CM, Christakis DA. Pediatricians’ screening urinalysis practices. J Pediatr. 2005; 147(3):362-365.

The author would like to thank Eric Judd, MD, of the University of Alabama at Birmingham, for his advice on the preparation of this response.

Q) Quite a few of my teenage patients are overweight. I know they are at risk for diabetes, but does their weight also affect their kidneys? Isn’t diabetes the main cause of kidney failure?

The number one cause of chronic kidney disease (CKD) in the United States and worldwide is diabetes, but it is certainly not the only risk factor. Studies have shown a link between obesity and CKD; even in the absence of kidney disease, obesity may cause glomerular dysfunction and an increase in glomerular size.¹

Obesity during adolescence has been identified as a strong predictor of CKD in adulthood. Other diseases and conditions that, if present in adolescence, indicate future risk for kidney ­disease include diabetes, hypertension, inflammation, and proteinuria.

A recent Swedish study followed patients from adolescence to adulthood to identify markers that would predict later kidney disease. In this study, the most predictive factor of kidney failure in adulthood was proteinuria in adolescence (odds ratio, 7.72). These results may be limited by the homogeneity of the predominantly white, male study population, but the extensive follow-up period, which “highlights the long natural history” of kidney disease, is one strength of this study.²

Based on these and other findings, you know that if your teenage patients have proteinuria, they are much more likely to develop kidney failure as an adult. Yet, in the US, the American Academy of Pediatrics and the US Preventive Services Task Force do not recommend urine screening for asymptomatic children.³

Interestingly, however, a survey of pediatric practices revealed that 58% of pediatricians screen adolescents with urinalysis, even if they are asymptomatic.⁴ In other words, they ignore the guidelines. If they did not, we would likely miss what is possibly the most important predictive factor for kidney failure in adults. —TAH

Tia Austin Hayes, FNP-C
UMMC/JMM Outpatient Dialysis/Renal Clinic, Jackson, Mississippi

REFERENCES
1. Rocchini A. Childhood obesity and a diabetes epidemic. N Engl J Med. 2002;346(11):854-855.
2. Sundin PO, Udumyan R, Sjöström P, Montgomery S. Predictors in adolescence of ESRD in middle-aged men. Am J Kidney Dis. 2014;64(5):723-729.
3. Kaplan RE, Springate JE, Feld LG. Screening dipstick urinalysis: a time to change. Pediatrics. 1997;100(6):919-921.
4. Sox CM, Christakis DA. Pediatricians’ screening urinalysis practices. J Pediatr. 2005; 147(3):362-365.

The author would like to thank Eric Judd, MD, of the University of Alabama at Birmingham, for his advice on the preparation of this response.

Q) Quite a few of my teenage patients are overweight. I know they are at risk for diabetes, but does their weight also affect their kidneys? Isn’t diabetes the main cause of kidney failure?

The number one cause of chronic kidney disease (CKD) in the United States and worldwide is diabetes, but it is certainly not the only risk factor. Studies have shown a link between obesity and CKD; even in the absence of kidney disease, obesity may cause glomerular dysfunction and an increase in glomerular size.¹

Obesity during adolescence has been identified as a strong predictor of CKD in adulthood. Other diseases and conditions that, if present in adolescence, indicate future risk for kidney ­disease include diabetes, hypertension, inflammation, and proteinuria.

A recent Swedish study followed patients from adolescence to adulthood to identify markers that would predict later kidney disease. In this study, the most predictive factor of kidney failure in adulthood was proteinuria in adolescence (odds ratio, 7.72). These results may be limited by the homogeneity of the predominantly white, male study population, but the extensive follow-up period, which “highlights the long natural history” of kidney disease, is one strength of this study.²

Based on these and other findings, you know that if your teenage patients have proteinuria, they are much more likely to develop kidney failure as an adult. Yet, in the US, the American Academy of Pediatrics and the US Preventive Services Task Force do not recommend urine screening for asymptomatic children.³

Interestingly, however, a survey of pediatric practices revealed that 58% of pediatricians screen adolescents with urinalysis, even if they are asymptomatic.⁴ In other words, they ignore the guidelines. If they did not, we would likely miss what is possibly the most important predictive factor for kidney failure in adults. —TAH

Tia Austin Hayes, FNP-C
UMMC/JMM Outpatient Dialysis/Renal Clinic, Jackson, Mississippi

REFERENCES
1. Rocchini A. Childhood obesity and a diabetes epidemic. N Engl J Med. 2002;346(11):854-855.
2. Sundin PO, Udumyan R, Sjöström P, Montgomery S. Predictors in adolescence of ESRD in middle-aged men. Am J Kidney Dis. 2014;64(5):723-729.
3. Kaplan RE, Springate JE, Feld LG. Screening dipstick urinalysis: a time to change. Pediatrics. 1997;100(6):919-921.
4. Sox CM, Christakis DA. Pediatricians’ screening urinalysis practices. J Pediatr. 2005; 147(3):362-365.

The author would like to thank Eric Judd, MD, of the University of Alabama at Birmingham, for his advice on the preparation of this response.

ANSWER
The correct interpretation includes atrial fibrillation with a rapid ventricular response and aberrantly conducted complexes, left axis deviation, and a left bundle branch block.

Atrial fibrillation is evidenced by the irregularly irregular heart rhythm without a measurable PR interval, and the rapid ventricular response is indicated by a ventricular rate > 100 beats/min.

Aberrant conduction, caused by conduction delay down the His-Purkinje system, is evidenced by the wide QRS complexes with a normally conducted beat (see first beat in leads V₁-V₃). Criteria for left axis deviation include an R axis between –30° and –90°, and left bundle branch block criteria include a QRS duration > 120 ms, a dominant S wave in V₁, and broad monophasic R waves in leads I, aVL, and V₅-V₆.

ANSWER
The correct interpretation includes atrial fibrillation with a rapid ventricular response and aberrantly conducted complexes, left axis deviation, and a left bundle branch block.

Atrial fibrillation is evidenced by the irregularly irregular heart rhythm without a measurable PR interval, and the rapid ventricular response is indicated by a ventricular rate > 100 beats/min.

Aberrant conduction, caused by conduction delay down the His-Purkinje system, is evidenced by the wide QRS complexes with a normally conducted beat (see first beat in leads V₁-V₃). Criteria for left axis deviation include an R axis between –30° and –90°, and left bundle branch block criteria include a QRS duration > 120 ms, a dominant S wave in V₁, and broad monophasic R waves in leads I, aVL, and V₅-V₆.

ANSWER
The correct interpretation includes atrial fibrillation with a rapid ventricular response and aberrantly conducted complexes, left axis deviation, and a left bundle branch block.

Atrial fibrillation is evidenced by the irregularly irregular heart rhythm without a measurable PR interval, and the rapid ventricular response is indicated by a ventricular rate > 100 beats/min.

Aberrant conduction, caused by conduction delay down the His-Purkinje system, is evidenced by the wide QRS complexes with a normally conducted beat (see first beat in leads V₁-V₃). Criteria for left axis deviation include an R axis between –30° and –90°, and left bundle branch block criteria include a QRS duration > 120 ms, a dominant S wave in V₁, and broad monophasic R waves in leads I, aVL, and V₅-V₆.

Illustrative case

A 50-year-old man comes to your office to have a mole removed from his arm. You decide to excise the lesion in your office today. Do you need to use sterile gloves for this procedure, or can you use gloves from the clean non-sterile box in the exam room?

Non-sterile gloves are readily available during a typical office visit and cost up to a dollar less per pair than sterile gloves.^1-3 Studies conducted in settings other than primary care offices have shown that non-sterile gloves do not increase the risk of infection during several types of minor skin procedures.

A partially blinded, randomized controlled trial (RCT) in an emergency department found no significant difference in infection rates between the use of sterile (6.1%) vs non-sterile (4.4%) gloves during laceration repairs.² Similarly, a small RCT in an outpatient dermatology clinic and a larger prospective trial by a Mohs dermatologist showed that infection rates were not increased after Mohs surgery using non-sterile (0.49%) vs sterile (0.50%) gloves.^3,4

Guidelines on the use of sterile vs non-sterile gloves for minor skin excisions in outpatient primary care are difficult to come by. Current guidelines from the Centers for Disease Control and Prevention (CDC) and other agencies regarding surgical site infections are broad and focus on the operating room environment.^5-7

The American Academy of Dermatology is working on a guideline for treatment of non-melanoma skin cancer that’s due out this winter, and this may provide additional guidance.⁸ A 2003 review instructed primary care physicians to use sterile gloves for excisional skin biopsies that require sutures.⁹

The 2015 study by Heal et al¹ appears to be the first RCT to address the question of sterile vs non-sterile glove use for minor skin excisions in a primary care outpatient practice.

STUDY SUMMARY: Non-sterile gloves are not inferior to sterile gloves

Heal et al¹ conducted a prospective, randomized, controlled, noninferiority trial to compare the incidence of infection after minor skin surgery performed by 6 physicians from a single general practice in Australia using sterile vs non-sterile clean gloves. They evaluated 576 consecutive patients who presented for skin excision between June 2012 and March 2013. Eighty-three patients were excluded because they had a latex allergy, were using oral antibiotics or immunosuppressive drugs, or required a skin flap procedure or excision of a sebaceous cyst. The physicians followed a standard process for performing the procedures and did not use topical antibiotics or antiseptic cleansing after the procedure.

The primary outcome was surgical site infection within 30 days of the excision, defined as purulent discharge, pain or tenderness, localized swelling or redness or heat at the site, or a diagnosis of skin or soft tissue infection by a general practitioner. The clinicians who assessed for infection were blinded to the patient’s assignment to the sterile or non-sterile glove group, and a stitch abscess was not counted as an infection.

Tradition and training die hard. A single study in the primary care office setting may not be enough to sway family physicians from ingrained habits.

The patients’ mean age was 65 years and 59% were men. At baseline, there were no large differences between patients in the sterile and non-sterile glove groups in terms of smoking status, anticoagulant or steroid use, diabetes, excision site, size of excision, and median days until removal of sutures. The lesions were identified histologically as nevus or seborrheic keratosis, skin cancer and precursor, or other.

The incidence of infection in the non-sterile gloves group was 21/241 (8.7%; 95% confidence interval [CI], 4.9%-12.6%) vs 22/237 in the control group (9.3%; 95% CI, 7.4%-11.1%). The CI (95%) for the difference in infection rate (-0.6%) was -4.0% to 2.9%. This was significantly below the predetermined noninferiority margin of 7%. In a sensitivity analysis of patients lost to follow-up (15 patients, 3%) that assumed all of these patients were without infection, or with infection, the CI was still below the noninferiority margin of 7%. The per-protocol analysis showed similar results.

WHAT'S NEW: New evidence questions the need for sterile gloves for in-office excisions

Heal et al¹ demonstrated that in a primary care setting, non-sterile gloves are not inferior to sterile gloves for performing excisional procedures that require sutures. While standard practice has many family physicians using sterile gloves for these procedures, this study promotes changing this behavior.

CAVEATS: A high infection rate, other factors might limit generalizability 

The overall rate of infection in this study (9%) was higher than that found in the studies from emergency medicine and dermatology literature cited earlier.^2-4 A similarly high infection rate has been found in other studies of minor surgery by Heal et al, including a 2006 study that showed a wound infection rate of 8.6%.¹⁰ The significance of the higher infection rate is unknown, but there is no clear reason why non-sterile gloves might be less effective in preventing infection in environments with lower infection rates.

This was not a double-blinded study, and physicians might change their behavior during a procedure depending on the type of gloves they are wearing. The sterile gloves used in this study contained powder, while the non-sterile gloves were powderless, but this variable is not known to affect infection rates. A study of Mohs surgery avoided this variable by only using powderless gloves, and had similar outcomes in terms of the difference in infection rate between sterile and non-sterile gloves.⁴

CHALLENGES TO IMPLEMENTATION:  Ingrained habits can be hard to change

Tradition and training die hard. While multiple studies in several settings have found non-sterile gloves are non-inferior to sterile gloves in preventing surgical site infection after minor skin surgeries, this single study in the primary care office setting may not be enough to sway family physicians from ingrained habits.

ACKNOWLEDGEMENT 
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Illustrative case

A 50-year-old man comes to your office to have a mole removed from his arm. You decide to excise the lesion in your office today. Do you need to use sterile gloves for this procedure, or can you use gloves from the clean non-sterile box in the exam room?

Non-sterile gloves are readily available during a typical office visit and cost up to a dollar less per pair than sterile gloves.^1-3 Studies conducted in settings other than primary care offices have shown that non-sterile gloves do not increase the risk of infection during several types of minor skin procedures.

A partially blinded, randomized controlled trial (RCT) in an emergency department found no significant difference in infection rates between the use of sterile (6.1%) vs non-sterile (4.4%) gloves during laceration repairs.² Similarly, a small RCT in an outpatient dermatology clinic and a larger prospective trial by a Mohs dermatologist showed that infection rates were not increased after Mohs surgery using non-sterile (0.49%) vs sterile (0.50%) gloves.^3,4

Guidelines on the use of sterile vs non-sterile gloves for minor skin excisions in outpatient primary care are difficult to come by. Current guidelines from the Centers for Disease Control and Prevention (CDC) and other agencies regarding surgical site infections are broad and focus on the operating room environment.^5-7

The American Academy of Dermatology is working on a guideline for treatment of non-melanoma skin cancer that’s due out this winter, and this may provide additional guidance.⁸ A 2003 review instructed primary care physicians to use sterile gloves for excisional skin biopsies that require sutures.⁹

The 2015 study by Heal et al¹ appears to be the first RCT to address the question of sterile vs non-sterile glove use for minor skin excisions in a primary care outpatient practice.

STUDY SUMMARY: Non-sterile gloves are not inferior to sterile gloves

Heal et al¹ conducted a prospective, randomized, controlled, noninferiority trial to compare the incidence of infection after minor skin surgery performed by 6 physicians from a single general practice in Australia using sterile vs non-sterile clean gloves. They evaluated 576 consecutive patients who presented for skin excision between June 2012 and March 2013. Eighty-three patients were excluded because they had a latex allergy, were using oral antibiotics or immunosuppressive drugs, or required a skin flap procedure or excision of a sebaceous cyst. The physicians followed a standard process for performing the procedures and did not use topical antibiotics or antiseptic cleansing after the procedure.

The primary outcome was surgical site infection within 30 days of the excision, defined as purulent discharge, pain or tenderness, localized swelling or redness or heat at the site, or a diagnosis of skin or soft tissue infection by a general practitioner. The clinicians who assessed for infection were blinded to the patient’s assignment to the sterile or non-sterile glove group, and a stitch abscess was not counted as an infection.

Tradition and training die hard. A single study in the primary care office setting may not be enough to sway family physicians from ingrained habits.

The patients’ mean age was 65 years and 59% were men. At baseline, there were no large differences between patients in the sterile and non-sterile glove groups in terms of smoking status, anticoagulant or steroid use, diabetes, excision site, size of excision, and median days until removal of sutures. The lesions were identified histologically as nevus or seborrheic keratosis, skin cancer and precursor, or other.

The incidence of infection in the non-sterile gloves group was 21/241 (8.7%; 95% confidence interval [CI], 4.9%-12.6%) vs 22/237 in the control group (9.3%; 95% CI, 7.4%-11.1%). The CI (95%) for the difference in infection rate (-0.6%) was -4.0% to 2.9%. This was significantly below the predetermined noninferiority margin of 7%. In a sensitivity analysis of patients lost to follow-up (15 patients, 3%) that assumed all of these patients were without infection, or with infection, the CI was still below the noninferiority margin of 7%. The per-protocol analysis showed similar results.

WHAT'S NEW: New evidence questions the need for sterile gloves for in-office excisions

Heal et al¹ demonstrated that in a primary care setting, non-sterile gloves are not inferior to sterile gloves for performing excisional procedures that require sutures. While standard practice has many family physicians using sterile gloves for these procedures, this study promotes changing this behavior.

CAVEATS: A high infection rate, other factors might limit generalizability 

The overall rate of infection in this study (9%) was higher than that found in the studies from emergency medicine and dermatology literature cited earlier.^2-4 A similarly high infection rate has been found in other studies of minor surgery by Heal et al, including a 2006 study that showed a wound infection rate of 8.6%.¹⁰ The significance of the higher infection rate is unknown, but there is no clear reason why non-sterile gloves might be less effective in preventing infection in environments with lower infection rates.

This was not a double-blinded study, and physicians might change their behavior during a procedure depending on the type of gloves they are wearing. The sterile gloves used in this study contained powder, while the non-sterile gloves were powderless, but this variable is not known to affect infection rates. A study of Mohs surgery avoided this variable by only using powderless gloves, and had similar outcomes in terms of the difference in infection rate between sterile and non-sterile gloves.⁴

CHALLENGES TO IMPLEMENTATION:  Ingrained habits can be hard to change

Tradition and training die hard. While multiple studies in several settings have found non-sterile gloves are non-inferior to sterile gloves in preventing surgical site infection after minor skin surgeries, this single study in the primary care office setting may not be enough to sway family physicians from ingrained habits.

ACKNOWLEDGEMENT 
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Illustrative case

A 50-year-old man comes to your office to have a mole removed from his arm. You decide to excise the lesion in your office today. Do you need to use sterile gloves for this procedure, or can you use gloves from the clean non-sterile box in the exam room?

Non-sterile gloves are readily available during a typical office visit and cost up to a dollar less per pair than sterile gloves.^1-3 Studies conducted in settings other than primary care offices have shown that non-sterile gloves do not increase the risk of infection during several types of minor skin procedures.

A partially blinded, randomized controlled trial (RCT) in an emergency department found no significant difference in infection rates between the use of sterile (6.1%) vs non-sterile (4.4%) gloves during laceration repairs.² Similarly, a small RCT in an outpatient dermatology clinic and a larger prospective trial by a Mohs dermatologist showed that infection rates were not increased after Mohs surgery using non-sterile (0.49%) vs sterile (0.50%) gloves.^3,4

Guidelines on the use of sterile vs non-sterile gloves for minor skin excisions in outpatient primary care are difficult to come by. Current guidelines from the Centers for Disease Control and Prevention (CDC) and other agencies regarding surgical site infections are broad and focus on the operating room environment.^5-7

The American Academy of Dermatology is working on a guideline for treatment of non-melanoma skin cancer that’s due out this winter, and this may provide additional guidance.⁸ A 2003 review instructed primary care physicians to use sterile gloves for excisional skin biopsies that require sutures.⁹

The 2015 study by Heal et al¹ appears to be the first RCT to address the question of sterile vs non-sterile glove use for minor skin excisions in a primary care outpatient practice.

STUDY SUMMARY: Non-sterile gloves are not inferior to sterile gloves

Heal et al¹ conducted a prospective, randomized, controlled, noninferiority trial to compare the incidence of infection after minor skin surgery performed by 6 physicians from a single general practice in Australia using sterile vs non-sterile clean gloves. They evaluated 576 consecutive patients who presented for skin excision between June 2012 and March 2013. Eighty-three patients were excluded because they had a latex allergy, were using oral antibiotics or immunosuppressive drugs, or required a skin flap procedure or excision of a sebaceous cyst. The physicians followed a standard process for performing the procedures and did not use topical antibiotics or antiseptic cleansing after the procedure.

The primary outcome was surgical site infection within 30 days of the excision, defined as purulent discharge, pain or tenderness, localized swelling or redness or heat at the site, or a diagnosis of skin or soft tissue infection by a general practitioner. The clinicians who assessed for infection were blinded to the patient’s assignment to the sterile or non-sterile glove group, and a stitch abscess was not counted as an infection.

Tradition and training die hard. A single study in the primary care office setting may not be enough to sway family physicians from ingrained habits.

The patients’ mean age was 65 years and 59% were men. At baseline, there were no large differences between patients in the sterile and non-sterile glove groups in terms of smoking status, anticoagulant or steroid use, diabetes, excision site, size of excision, and median days until removal of sutures. The lesions were identified histologically as nevus or seborrheic keratosis, skin cancer and precursor, or other.

The incidence of infection in the non-sterile gloves group was 21/241 (8.7%; 95% confidence interval [CI], 4.9%-12.6%) vs 22/237 in the control group (9.3%; 95% CI, 7.4%-11.1%). The CI (95%) for the difference in infection rate (-0.6%) was -4.0% to 2.9%. This was significantly below the predetermined noninferiority margin of 7%. In a sensitivity analysis of patients lost to follow-up (15 patients, 3%) that assumed all of these patients were without infection, or with infection, the CI was still below the noninferiority margin of 7%. The per-protocol analysis showed similar results.

WHAT'S NEW: New evidence questions the need for sterile gloves for in-office excisions

Heal et al¹ demonstrated that in a primary care setting, non-sterile gloves are not inferior to sterile gloves for performing excisional procedures that require sutures. While standard practice has many family physicians using sterile gloves for these procedures, this study promotes changing this behavior.

CAVEATS: A high infection rate, other factors might limit generalizability 

The overall rate of infection in this study (9%) was higher than that found in the studies from emergency medicine and dermatology literature cited earlier.^2-4 A similarly high infection rate has been found in other studies of minor surgery by Heal et al, including a 2006 study that showed a wound infection rate of 8.6%.¹⁰ The significance of the higher infection rate is unknown, but there is no clear reason why non-sterile gloves might be less effective in preventing infection in environments with lower infection rates.

This was not a double-blinded study, and physicians might change their behavior during a procedure depending on the type of gloves they are wearing. The sterile gloves used in this study contained powder, while the non-sterile gloves were powderless, but this variable is not known to affect infection rates. A study of Mohs surgery avoided this variable by only using powderless gloves, and had similar outcomes in terms of the difference in infection rate between sterile and non-sterile gloves.⁴

CHALLENGES TO IMPLEMENTATION:  Ingrained habits can be hard to change

Tradition and training die hard. While multiple studies in several settings have found non-sterile gloves are non-inferior to sterile gloves in preventing surgical site infection after minor skin surgeries, this single study in the primary care office setting may not be enough to sway family physicians from ingrained habits.

ACKNOWLEDGEMENT 
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Dr. Unger’s guest editorial, “Med students: Look up from your EMRs” (J Fam Pract. 2015;64:517-518), vividly describes what those who have been paying attention see quite clearly: Not only has the widespread implementation of electronic medical records (EMRs) failed to deliver all it has promised, but it has made patient care worse. Many students and members of the health care team spend as little time as possible talking and listening to patients. Instead, the goal is to complete every box in our EMRs to qualify for meaningful use payments and whatever “quality” incentives are available in our local environment.

That said, I believe EMRs are very good at doing the things computers do well, and I hope I never again have to rifle through a paper chart the size of a phone book to find a critical piece of information. The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story, and the resulting diversion of the entire health care team away from caring for the patients we are supposedly here to serve.

I am tired of complaining to my patients, partners, family, friends, and anyone else who will listen. It is time for family medicine to reclaim its role as “counterculture” and lead the charge for comprehensive, continuous, compassionate care—whose centerpiece is actually talking to, listening to, and examining patients.

David A. Silverstein, MD
Buffalo, NY

The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story.

While I agree with Dr. Unger about EMRs, I respectfully disagree with his approach when he suspected he had appendicitis. When he initially ordered his own computed tomography scan, rather than seeing his own doctor or going to the emergency department, he (inadvertently) “assigned” himself as his own doctor. He then should have at least offered his history in the hospital, rather than making it a test for the student and the hospital. It sounds like an adversarial situation developed, which did not help matters. Good that he’s doing OK!

Michael Kelly, MD
Minneapolis, Minn

Dr. Unger’s guest editorial, “Med students: Look up from your EMRs” (J Fam Pract. 2015;64:517-518), vividly describes what those who have been paying attention see quite clearly: Not only has the widespread implementation of electronic medical records (EMRs) failed to deliver all it has promised, but it has made patient care worse. Many students and members of the health care team spend as little time as possible talking and listening to patients. Instead, the goal is to complete every box in our EMRs to qualify for meaningful use payments and whatever “quality” incentives are available in our local environment.

That said, I believe EMRs are very good at doing the things computers do well, and I hope I never again have to rifle through a paper chart the size of a phone book to find a critical piece of information. The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story, and the resulting diversion of the entire health care team away from caring for the patients we are supposedly here to serve.

I am tired of complaining to my patients, partners, family, friends, and anyone else who will listen. It is time for family medicine to reclaim its role as “counterculture” and lead the charge for comprehensive, continuous, compassionate care—whose centerpiece is actually talking to, listening to, and examining patients.

David A. Silverstein, MD
Buffalo, NY

The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story.

While I agree with Dr. Unger about EMRs, I respectfully disagree with his approach when he suspected he had appendicitis. When he initially ordered his own computed tomography scan, rather than seeing his own doctor or going to the emergency department, he (inadvertently) “assigned” himself as his own doctor. He then should have at least offered his history in the hospital, rather than making it a test for the student and the hospital. It sounds like an adversarial situation developed, which did not help matters. Good that he’s doing OK!

Michael Kelly, MD
Minneapolis, Minn

Dr. Unger’s guest editorial, “Med students: Look up from your EMRs” (J Fam Pract. 2015;64:517-518), vividly describes what those who have been paying attention see quite clearly: Not only has the widespread implementation of electronic medical records (EMRs) failed to deliver all it has promised, but it has made patient care worse. Many students and members of the health care team spend as little time as possible talking and listening to patients. Instead, the goal is to complete every box in our EMRs to qualify for meaningful use payments and whatever “quality” incentives are available in our local environment.

That said, I believe EMRs are very good at doing the things computers do well, and I hope I never again have to rifle through a paper chart the size of a phone book to find a critical piece of information. The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story, and the resulting diversion of the entire health care team away from caring for the patients we are supposedly here to serve.

I am tired of complaining to my patients, partners, family, friends, and anyone else who will listen. It is time for family medicine to reclaim its role as “counterculture” and lead the charge for comprehensive, continuous, compassionate care—whose centerpiece is actually talking to, listening to, and examining patients.

David A. Silverstein, MD
Buffalo, NY

The problem lies in the myriad inappropriate ways the EMR is used in place of accurately telling the patient’s story.

While I agree with Dr. Unger about EMRs, I respectfully disagree with his approach when he suspected he had appendicitis. When he initially ordered his own computed tomography scan, rather than seeing his own doctor or going to the emergency department, he (inadvertently) “assigned” himself as his own doctor. He then should have at least offered his history in the hospital, rather than making it a test for the student and the hospital. It sounds like an adversarial situation developed, which did not help matters. Good that he’s doing OK!

Michael Kelly, MD
Minneapolis, Minn

Colorectal cancer (CRC) screening has been shown to save lives. Screening can prevent CRC by detecting and removing precancerous adenomatous polyps, which are the precursors of most cancers.¹ Screening also can detect cancer at an early, asymptomatic stage while it is still localized and amenable to treatment; 5-year survival rates are 80% to 90% for patients with localized, early stage I/II CRC.²

Colorectal cancer (CRC) screening has been shown to save lives. Screening can prevent CRC by detecting and removing precancerous adenomatous polyps, which are the precursors of most cancers.¹ Screening also can detect cancer at an early, asymptomatic stage while it is still localized and amenable to treatment; 5-year survival rates are 80% to 90% for patients with localized, early stage I/II CRC.²

Colorectal cancer (CRC) screening has been shown to save lives. Screening can prevent CRC by detecting and removing precancerous adenomatous polyps, which are the precursors of most cancers.¹ Screening also can detect cancer at an early, asymptomatic stage while it is still localized and amenable to treatment; 5-year survival rates are 80% to 90% for patients with localized, early stage I/II CRC.²

It seems like every time I ask a family physician how things are going, the electronic medical record (EMR) inevitably rears its ugly face. At the annual Illinois Academy of Family Physicians business meeting last month, one of the physicians lamented the evenings he spends finishing his charting. A family physician I consider a master user of EMRs e-mailed me recently, saying he is fed up with documentation expectations for coding, billing, meaningful use, and quality measures. He wrote, “We are challenged by good intentions but crushingly poor execution … and it is taking its toll.”

At the 2015 American Academy of Family Physicians Family Medicine Expo, keynote speaker, general internist, and bestselling author Abraham Verghese, MD, talked about the “iPatient.” He said, “The patient in the bed has become a mere icon for the ‘real patient’ who is in the computer. The iPatient is getting wonderful care all across America. The real patient is wondering where the heck is everyone and when are they going to tell me what is going on.”

He had received this comment from a patient: “When I go to my doctor’s office, I have to remind him that I am hard of hearing and need him to look at me when I talk. But it only lasts about 30 seconds until he needs to shift back to the competing screen.”

Patients want to engage in a face-to-face conversation, not face-to-back or face-to-side-of-head.

Patients don’t like us attending to the screen instead of to them. The observational study of 126 primary care encounters by Farber et al in this issue supports this assertion. Although Farber et al found that patients’ satisfaction with their primary care physician or nurse practitioner was high overall, patients were even more satisfied with their office visit when the clinician spent more time looking at them. Patients want to engage in a face-to-face conversation, not face-to-back or face-to-side-of-head.

Until clever innovators figure out a much better way to document patient visits, there are ways to overcome this patient-physician-computer screen triangle. Take my optometrist, for example. He opens my EMR at the beginning of the visit to take a quick look, but doesn’t return to the computer until the end of the visit. When he does the charting, he excuses himself and says, “I need to enter some information in the computer. It will take me a few minutes.” I pull out my cell phone to check e-mails while he types.

I follow his example, and patients regularly thank me for truly listening to them.

It seems like every time I ask a family physician how things are going, the electronic medical record (EMR) inevitably rears its ugly face. At the annual Illinois Academy of Family Physicians business meeting last month, one of the physicians lamented the evenings he spends finishing his charting. A family physician I consider a master user of EMRs e-mailed me recently, saying he is fed up with documentation expectations for coding, billing, meaningful use, and quality measures. He wrote, “We are challenged by good intentions but crushingly poor execution … and it is taking its toll.”

At the 2015 American Academy of Family Physicians Family Medicine Expo, keynote speaker, general internist, and bestselling author Abraham Verghese, MD, talked about the “iPatient.” He said, “The patient in the bed has become a mere icon for the ‘real patient’ who is in the computer. The iPatient is getting wonderful care all across America. The real patient is wondering where the heck is everyone and when are they going to tell me what is going on.”

He had received this comment from a patient: “When I go to my doctor’s office, I have to remind him that I am hard of hearing and need him to look at me when I talk. But it only lasts about 30 seconds until he needs to shift back to the competing screen.”

Patients want to engage in a face-to-face conversation, not face-to-back or face-to-side-of-head.

Patients don’t like us attending to the screen instead of to them. The observational study of 126 primary care encounters by Farber et al in this issue supports this assertion. Although Farber et al found that patients’ satisfaction with their primary care physician or nurse practitioner was high overall, patients were even more satisfied with their office visit when the clinician spent more time looking at them. Patients want to engage in a face-to-face conversation, not face-to-back or face-to-side-of-head.

Until clever innovators figure out a much better way to document patient visits, there are ways to overcome this patient-physician-computer screen triangle. Take my optometrist, for example. He opens my EMR at the beginning of the visit to take a quick look, but doesn’t return to the computer until the end of the visit. When he does the charting, he excuses himself and says, “I need to enter some information in the computer. It will take me a few minutes.” I pull out my cell phone to check e-mails while he types.

I follow his example, and patients regularly thank me for truly listening to them.

It seems like every time I ask a family physician how things are going, the electronic medical record (EMR) inevitably rears its ugly face. At the annual Illinois Academy of Family Physicians business meeting last month, one of the physicians lamented the evenings he spends finishing his charting. A family physician I consider a master user of EMRs e-mailed me recently, saying he is fed up with documentation expectations for coding, billing, meaningful use, and quality measures. He wrote, “We are challenged by good intentions but crushingly poor execution … and it is taking its toll.”

At the 2015 American Academy of Family Physicians Family Medicine Expo, keynote speaker, general internist, and bestselling author Abraham Verghese, MD, talked about the “iPatient.” He said, “The patient in the bed has become a mere icon for the ‘real patient’ who is in the computer. The iPatient is getting wonderful care all across America. The real patient is wondering where the heck is everyone and when are they going to tell me what is going on.”

He had received this comment from a patient: “When I go to my doctor’s office, I have to remind him that I am hard of hearing and need him to look at me when I talk. But it only lasts about 30 seconds until he needs to shift back to the competing screen.”

Patients want to engage in a face-to-face conversation, not face-to-back or face-to-side-of-head.

Patients don’t like us attending to the screen instead of to them. The observational study of 126 primary care encounters by Farber et al in this issue supports this assertion. Although Farber et al found that patients’ satisfaction with their primary care physician or nurse practitioner was high overall, patients were even more satisfied with their office visit when the clinician spent more time looking at them. Patients want to engage in a face-to-face conversation, not face-to-back or face-to-side-of-head.

Until clever innovators figure out a much better way to document patient visits, there are ways to overcome this patient-physician-computer screen triangle. Take my optometrist, for example. He opens my EMR at the beginning of the visit to take a quick look, but doesn’t return to the computer until the end of the visit. When he does the charting, he excuses himself and says, “I need to enter some information in the computer. It will take me a few minutes.” I pull out my cell phone to check e-mails while he types.

I follow his example, and patients regularly thank me for truly listening to them.