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Weight loss and dietary management for PCOS
“TREATING POLYCYSTIC OVARY SYNDROME: START USING DUAL MEDICAL THERAPY”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2017)
Weight loss and dietary management for PCOS
I enjoyed Dr. Barbieri’s editorial on polycystic ovary syndrome (PCOS), but I feel that first-line management for PCOS should be weight loss and diet modifications that include instructions on decreasing carbohydrates and i
Luis Linan, MD
El Paso, Texas
Metformin and progesterone for PCOS-related infertility
I have been using Beyaz and Yaz for several years in my PCOS patients for the lower androgenic activity of the drospirenone based on the same assumption and its similarity to spironolactone. I have gotten great results with metformin 1,500 mg daily and, for those who desire fertility, cycling once a month for 10 days with progesterone. My own daughter was able to conceive in just 3 months of therapy. PCOS is extremely common in our region, probably due to the high obesity rate. I saw many more cases here than I ever thought I would when I was training.
Lisa Gowan, CNM, WHNP-BC
Albany, Georgia
Check insulin levels in PCOS patients
Thank you for the very nice article regarding PCOS treatment. Does Dr. Barbieri routinely check insulin levels on patients before treating with metformin and does he require abnormal insulin levels to be present before initiating treatment? The article suggested that using the listed risk factors is sufficient. Additionally, does he perform glucose-insulin testing? If so, what is the protocol used? I have used fasting levels and 2-hour post 75-g glucose-drink testing as well. What is the best approach?
Scott A. Beckman, MD
Jasper, Indiana
Contraception and spironolactone
As usual, Dr. Barbieri has provided a thorough, concise, and practical overview on the medical management of PCOS. I would add just one small point. Another reason for using an oral estrogen-progestin pill concomitantly with spironolactone is due to the potential teratogenicity of this medication.
Bryan R. Hecht, MD
Cleveland, Ohio
Low-carb diet helps mitigate metformin side effects
Thank you for the article on PCOS. I have been treating PCOS this way for about 15 years and have been following lipids and seen dramatic improvements with that as well. I wish we as a medical community would focus on the low carbohydrate diet to help avert metformin side effects as well as treat the metabolic issues. You can get many people back on metformin by just adjusting their diet. I hope you can spread this word.
Steven Foley, MD
Lamar, Colorado
Appreciates Dr. Barbieri’s editorials
G’Day from Australia. I am a big fan of your editorials and opinions and enjoy reading
Kanapathippillai Sivanesan, MD
Brisbane, Australia
Dr. Barbieri responds
I thank Dr. Linan, Dr. Foley, and Ms. Gowan for sharing their important insights with our readers. I agree with Dr. Linan that I should have highlighted the important guidance that women with PCOS and a body mass index (BMI) above the normal range should be encouraged to reduce their weight by 5% to 10% with diet and exercise. Dr. Foley offers a clinical pearl that a low carbohydrate diet will reduce the gastrointestinal symptoms that may occur with metformin therapy. Ms. Gowan notes that the combination of metformin plus cyclic progesterone may help to initiate more frequent ovulatory cycles in women with PCOS, thereby improving fertility. Dr. Hecht reminds us that spironolactone is a teratogen and using effective contraception can help reduce the risk of exposing a pregnancy to the medication.
Dr. Beckman raises the important clinical issue of whether it is helpful to measure insulin concentration. Measuring insulin and glucose is especially helpful in understanding the causes of hypoglycemia. An elevated insulin level at the time of an abnormally low glucose level is very worrisome. However, for women with PCOS, in whom insulin resistance is common, measuring insulin is of minimal clinical value. A normal or elevated insulin level is consistent with the diagnosis of PCOS. Assessing BMI, waist circumference, HDL-cholesterol, fasting triglyceride level, and blood pressure— components of the metabolic syndrome—are much more useful clinically. The dermatologic skin lesion acanthosis nigricans is also a sign consistent with insulin resistance. I do not measure insulin levels in my patients with PCOS. Metformin is a useful agent in the treatment of PCOS whether or not insulin resistance is present. Metformin may have direct actions on the ovary to reduce androgen production, in addition to its beneficial effects in the liver.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“TREATING POLYCYSTIC OVARY SYNDROME: START USING DUAL MEDICAL THERAPY”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2017)
Weight loss and dietary management for PCOS
I enjoyed Dr. Barbieri’s editorial on polycystic ovary syndrome (PCOS), but I feel that first-line management for PCOS should be weight loss and diet modifications that include instructions on decreasing carbohydrates and i
Luis Linan, MD
El Paso, Texas
Metformin and progesterone for PCOS-related infertility
I have been using Beyaz and Yaz for several years in my PCOS patients for the lower androgenic activity of the drospirenone based on the same assumption and its similarity to spironolactone. I have gotten great results with metformin 1,500 mg daily and, for those who desire fertility, cycling once a month for 10 days with progesterone. My own daughter was able to conceive in just 3 months of therapy. PCOS is extremely common in our region, probably due to the high obesity rate. I saw many more cases here than I ever thought I would when I was training.
Lisa Gowan, CNM, WHNP-BC
Albany, Georgia
Check insulin levels in PCOS patients
Thank you for the very nice article regarding PCOS treatment. Does Dr. Barbieri routinely check insulin levels on patients before treating with metformin and does he require abnormal insulin levels to be present before initiating treatment? The article suggested that using the listed risk factors is sufficient. Additionally, does he perform glucose-insulin testing? If so, what is the protocol used? I have used fasting levels and 2-hour post 75-g glucose-drink testing as well. What is the best approach?
Scott A. Beckman, MD
Jasper, Indiana
Contraception and spironolactone
As usual, Dr. Barbieri has provided a thorough, concise, and practical overview on the medical management of PCOS. I would add just one small point. Another reason for using an oral estrogen-progestin pill concomitantly with spironolactone is due to the potential teratogenicity of this medication.
Bryan R. Hecht, MD
Cleveland, Ohio
Low-carb diet helps mitigate metformin side effects
Thank you for the article on PCOS. I have been treating PCOS this way for about 15 years and have been following lipids and seen dramatic improvements with that as well. I wish we as a medical community would focus on the low carbohydrate diet to help avert metformin side effects as well as treat the metabolic issues. You can get many people back on metformin by just adjusting their diet. I hope you can spread this word.
Steven Foley, MD
Lamar, Colorado
Appreciates Dr. Barbieri’s editorials
G’Day from Australia. I am a big fan of your editorials and opinions and enjoy reading
Kanapathippillai Sivanesan, MD
Brisbane, Australia
Dr. Barbieri responds
I thank Dr. Linan, Dr. Foley, and Ms. Gowan for sharing their important insights with our readers. I agree with Dr. Linan that I should have highlighted the important guidance that women with PCOS and a body mass index (BMI) above the normal range should be encouraged to reduce their weight by 5% to 10% with diet and exercise. Dr. Foley offers a clinical pearl that a low carbohydrate diet will reduce the gastrointestinal symptoms that may occur with metformin therapy. Ms. Gowan notes that the combination of metformin plus cyclic progesterone may help to initiate more frequent ovulatory cycles in women with PCOS, thereby improving fertility. Dr. Hecht reminds us that spironolactone is a teratogen and using effective contraception can help reduce the risk of exposing a pregnancy to the medication.
Dr. Beckman raises the important clinical issue of whether it is helpful to measure insulin concentration. Measuring insulin and glucose is especially helpful in understanding the causes of hypoglycemia. An elevated insulin level at the time of an abnormally low glucose level is very worrisome. However, for women with PCOS, in whom insulin resistance is common, measuring insulin is of minimal clinical value. A normal or elevated insulin level is consistent with the diagnosis of PCOS. Assessing BMI, waist circumference, HDL-cholesterol, fasting triglyceride level, and blood pressure— components of the metabolic syndrome—are much more useful clinically. The dermatologic skin lesion acanthosis nigricans is also a sign consistent with insulin resistance. I do not measure insulin levels in my patients with PCOS. Metformin is a useful agent in the treatment of PCOS whether or not insulin resistance is present. Metformin may have direct actions on the ovary to reduce androgen production, in addition to its beneficial effects in the liver.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
“TREATING POLYCYSTIC OVARY SYNDROME: START USING DUAL MEDICAL THERAPY”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2017)
Weight loss and dietary management for PCOS
I enjoyed Dr. Barbieri’s editorial on polycystic ovary syndrome (PCOS), but I feel that first-line management for PCOS should be weight loss and diet modifications that include instructions on decreasing carbohydrates and i
Luis Linan, MD
El Paso, Texas
Metformin and progesterone for PCOS-related infertility
I have been using Beyaz and Yaz for several years in my PCOS patients for the lower androgenic activity of the drospirenone based on the same assumption and its similarity to spironolactone. I have gotten great results with metformin 1,500 mg daily and, for those who desire fertility, cycling once a month for 10 days with progesterone. My own daughter was able to conceive in just 3 months of therapy. PCOS is extremely common in our region, probably due to the high obesity rate. I saw many more cases here than I ever thought I would when I was training.
Lisa Gowan, CNM, WHNP-BC
Albany, Georgia
Check insulin levels in PCOS patients
Thank you for the very nice article regarding PCOS treatment. Does Dr. Barbieri routinely check insulin levels on patients before treating with metformin and does he require abnormal insulin levels to be present before initiating treatment? The article suggested that using the listed risk factors is sufficient. Additionally, does he perform glucose-insulin testing? If so, what is the protocol used? I have used fasting levels and 2-hour post 75-g glucose-drink testing as well. What is the best approach?
Scott A. Beckman, MD
Jasper, Indiana
Contraception and spironolactone
As usual, Dr. Barbieri has provided a thorough, concise, and practical overview on the medical management of PCOS. I would add just one small point. Another reason for using an oral estrogen-progestin pill concomitantly with spironolactone is due to the potential teratogenicity of this medication.
Bryan R. Hecht, MD
Cleveland, Ohio
Low-carb diet helps mitigate metformin side effects
Thank you for the article on PCOS. I have been treating PCOS this way for about 15 years and have been following lipids and seen dramatic improvements with that as well. I wish we as a medical community would focus on the low carbohydrate diet to help avert metformin side effects as well as treat the metabolic issues. You can get many people back on metformin by just adjusting their diet. I hope you can spread this word.
Steven Foley, MD
Lamar, Colorado
Appreciates Dr. Barbieri’s editorials
G’Day from Australia. I am a big fan of your editorials and opinions and enjoy reading
Kanapathippillai Sivanesan, MD
Brisbane, Australia
Dr. Barbieri responds
I thank Dr. Linan, Dr. Foley, and Ms. Gowan for sharing their important insights with our readers. I agree with Dr. Linan that I should have highlighted the important guidance that women with PCOS and a body mass index (BMI) above the normal range should be encouraged to reduce their weight by 5% to 10% with diet and exercise. Dr. Foley offers a clinical pearl that a low carbohydrate diet will reduce the gastrointestinal symptoms that may occur with metformin therapy. Ms. Gowan notes that the combination of metformin plus cyclic progesterone may help to initiate more frequent ovulatory cycles in women with PCOS, thereby improving fertility. Dr. Hecht reminds us that spironolactone is a teratogen and using effective contraception can help reduce the risk of exposing a pregnancy to the medication.
Dr. Beckman raises the important clinical issue of whether it is helpful to measure insulin concentration. Measuring insulin and glucose is especially helpful in understanding the causes of hypoglycemia. An elevated insulin level at the time of an abnormally low glucose level is very worrisome. However, for women with PCOS, in whom insulin resistance is common, measuring insulin is of minimal clinical value. A normal or elevated insulin level is consistent with the diagnosis of PCOS. Assessing BMI, waist circumference, HDL-cholesterol, fasting triglyceride level, and blood pressure— components of the metabolic syndrome—are much more useful clinically. The dermatologic skin lesion acanthosis nigricans is also a sign consistent with insulin resistance. I do not measure insulin levels in my patients with PCOS. Metformin is a useful agent in the treatment of PCOS whether or not insulin resistance is present. Metformin may have direct actions on the ovary to reduce androgen production, in addition to its beneficial effects in the liver.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Universal cervical length screening–saving babies lives
Transvaginal ultrasound (TVU) cervical length (CL) screening for prediction and prevention of spontaneous preterm birth (SPTB) is among the most transformative clinical changes in obstetrics in the last decades. TVU CL screening should now be offered to all pregnant women: hence the appellative ‘universal CL screening.’
TVU CL screening is an excellent screening test for several reasons. It screens for SPTB, which is a clinically important, well-defined disease whose prevalence and natural history is known, and has an early recognizable asymptomatic phase in CL shortening detected by TVU. TVU CL screening is a well-described technique, safe and acceptable, with a reasonable cutoff (25 mm) now identified for all populations, and results are reproducible and accurate. There are hundreds of studies proving these facts. In the last 10 years, TVU measurement of CL as a screening test has been accepted1,2: it identifies women at risk for SPTB, and an early intervention (progesterone or cerclage depending on the clinical situation) is effective in preventing SPTB. Screening and treatment of short cervix is cost-effective and readily available as an early intervention (progesterone or cerclage depending on the clinical situation), is effective in preventing the outcome (SPTB), treating abnormal results is cost-effective, and facilities for screening are available and treatments are readily available.3–5 It is also important to emphasize that CL screening for prevention of SPTB should be done by TVU, and not by transabdominal ultrasound.6It is best to review TVU CL screening by populations: singletons without prior SPTB, singletons with prior SPTB, and twins (Table).
Related Article:
Can transabdominal ultrasound exclude short cervix?
Singletons without prior SPTB
Women with no previous SPTB who are carrying a singleton pregnancy is the population in which TVU CL could have the greatest impact on decreasing SPTB, for several reasons:
- Up to 60% to 90% of SPTB occur in this population.
- More than 90% of these women have risk factors for SPTB.7,8
- Vaginal progesterone has been associated with a significant 39% decrease in PTB at <33 weeks of gestation and a significant 38% decrease in perinatal morbidity and mortality in a meta-analysis of randomized controlled trials (RCTs) including 606 women without prior PTB.9,10
- Cost-effectiveness studies have shown that TVU CL screening in this specific population prevents thousands of preterm births, saves or improves from death or major morbidity 350 babies’ lives annually, and saves approximately $320,000 per year in the US alone.3 These numbers may be even higher now as the TVU CL cutoff for offering vaginal progesterone has moved in many centers from ≤20 mm to ≤25 mm, including more women (from about 0.8% to about 2% to 3%, respectively11) who benefit from screening.
- Real-world implementation studies have indeed shown significant decreases in SPTB when a policy of universal TVU CL screening in this specific population is implemented.12,13
Universal TVU CL screening recently called into question
In a recent article published in the Journal of the American Medical Association,14 TVU CL screening in this population, in particular for nulliparous women, has come under interrogation. The authors found only an 8% sensitivity of TVU CL screening for SPTB using a cutoff of ≤25 mm at 16 0/7 to 22 6/7 weeks of gestation in 9,410 nulliparous women. This result is different compared with other previous cohort studies in this area, however, and is likely related to a number of issues in the methodology.
First, TVU CL screening was done in many women at too early a gestational age. The earlier the CL screening, the lower the sensitivity of the procedure. Data at 16 and 17 weeks of gestation should have been excluded, as almost all RCTs and other studies on universal TVU CL screening in this population recommended doing screening at about 18 0/7 to 23 6/7 weeks.
Second, women with TVU CL <15 mm received vaginal progesterone. This would decrease the incidence of PTB and, therefore, sensitivity.
Third, outcomes data were not available for 469 women and, compared with women analyzed, these women were at higher risk for SPTB as they were more likely to be aged 21 years or younger, black, with less than a high school education, and single, all significant risk factors for SPTB. (Not all risk factors for SPTB were reported in this study.)
Fourth, pregnancy losses before 20 weeks were excluded, and these could have been early SPTB; therefore, the sensitivity could have been decreased if women with this outcome were excluded.
Fifth, prior studies have shown that TVU CL screening in singletons without prior SPTB has a sensitivity of about 30% to 40%.15,16 In nulliparas, the sensitivity of TVU CL ≤20 mm had been reported previously to be 20%.16 Additional data from 2012–2014 at our institution demonstrate that the incidence of CL ≤25 mm is about 2.8% in nulliparous women, with a sensitivity of 19.5% for SPTB <37 weeks. These numbers show again that 8% sensitivity was low in the JAMA study14 due the shortcomings we just highlighted. Furthermore, the reported sensitivity of TVU CL ≤25 mm for PTB <32 weeks was 24% in Esplin and colleagues’ study,14 while 60% in our data. Given that early preterm births are the most significant source of neonatal morbidity and mortality, women with a singleton gestation and no prior SPTB but with a short TVU CL are perhaps the most important subgroup to identify.
Sixth, a low sensitivity in and of itself is not reflective of a poor screening test. We have known for a long time that SPTB has many etiologies. No one screening test, and no one intervention, would independently prevent all SPTBs. In a population that accounts for more than half of PTBs and for whom no other screening test has been found to be effective, much less cost effective, it is important not to cast aside the dramatic potential clinical benefit to TVU CL screening.
Related Article:
A stepwise approach to cervical cerclage
Singletons with a prior SPTB
This is the first population in which TVU CL screening was first proven beneficial for prevention of SPTB. These women all should receive progesterone starting at 16 weeks because of the prior SPTB. In these women, TVU CL screening should be initiated at 16 weeks, and repeated every 2 weeks (weekly if TVU CL is found to be 25 mm to 29 mm) until 23 6/7 weeks. If the TVU CL is identified to be <25 mm before 24 weeks, cerclage should be recommended.1,2,17
Twins
Twins are the most recent population in which an intervention based on TVU CL screening has been shown to be beneficial. Vaginal progesterone has been associated with a significant decrease in SPTB as well as in some neonatal outcomes in twin gestations found to have a TVU CL <25 mm in the midtrimester in a meta-analysis of RCTs.18 Based on these results, we at our institution recently have started offering TVU CL screening at the time of the anatomy scan (about 20 weeks) to twin gestations.
Related Article:
Which perioperative strategies for transvaginal cervical cerclage are backed by data?
Bottom line
In summary, universal second trimester TVU CL screening of both singletons and twin gestations should be considered seriously by obstetric practitioners to successfully decrease the grave burden of SPTB.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Berghella V. Progesterone and preterm birth prevention: Translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376-386.
- Committee on Practice Bulletins--Obstetrics, The American College of Obstetricians and Gynecologists. Practice Bulletin No. 130: Prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964-973.
- Werner EF, Hamel MS, Orzechowski K, Berghella V, Thung SF. Cost-effectiveness of transvaginal ultrasound cervical length screening in singletons without a prior preterm birth: an update. Am J Obstet Gynecol. 2015;213(4):554.e1-e6.
- Einerson BD, Grobman WA, Miller ES. Cost-effectiveness of risk-based screening for cervical length to prevent preterm birth. Am J Obstet Gynecol. 2016;215(1):100.e1-e7.
- McIntosh J, Feltovich H, Berghella V, Manuck T; Society for Maternal-Fetal medicine. The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. Am J Obstet Gynecol. 2016;215(3):B2-B7.
- Khalifeh A, Quist-Nelson J. Current implementation of universal cervical length screening for preterm birth prevention in the United States. Obstet Gynecol. 2016;127(suppl 1):7S.
- Mella MT, Mackeen AD, Gache D, Baxter JK, Berghella V. The utility of screening for historical risk factors for preterm birth in women with known second trimester cervical length. J Matern Fetal Neonatal Med. 2013;26(7):710-715.
- Saccone G, Perriera L, Berghella V. Prior uterine evacuation of pregnancy as independent risk factor for preterm birth: a systematic review and metaanalysis. Am J Obstet Gynecol. 2016;214(5):572-591.
- Romero R, Nicolaides K, Conde-Agudelo A, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: A systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012;206(2):124.e1-e19.
- Romero R, Nicolaides KH, Conde-Agudelo A, et al. Vaginal progesterone decreases preterm birth ≤34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study. Ultrasound Obstet Gynecol. 2016;48(3):308-317.
- Orzechoski KM, Boelig RC, Baxter JK, Berghella V. A universal transvaginal cervical length screening program for preterm birth prevention. Obstet Gynecol. 2014;124(3):520-525.
- Son M, Grobman WA, Ayala NK, Miller ES. A universal mid-trimester transvaginal cervical length screening program and its associated reduced preterm birth rate. Am J Obstet Gynecol. 2016;214(3):365.e1-e5.
- Temming LA, Durst JK, Tuuli MG, et al. Universal cervical length screening: implementation and outcomes. Am J Obstet Gynecol. 2016;214(4):523.e1-e8.
- Esplin MS, Elovitz MA, Iams JD, et al; njMoM2b Network. Predictive accuracy of serial ttransvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women. JAMA. 2017;317(10):1047-1056.
- Iams JD, Goldenberg RL, Meis PJ, et al. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996;334(9):567-572.
- Orzechowski KM, Boelig R, Nicholas SS, Baxter J, Berghella V. Is universal cervical length screening indicated in women with prior term birth? Am J Obstet Gynecol. 2015;212(2):234.e1-e5.
- Preterm labour and birth. National Institute for Health and Care Excellence website. https://www.nice.org.uk/guidance/ng25?unlid=9291036072016213201257. Published November 2015. Accessed May 18, 2017.
- Romero R, Conde-Agudelo A, El-Refaie W, et al. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017;49(3):303-314.
Vincenzo Berghella, MD
Dr. Berghella is Director, Division of Maternal-Fetal Medicine, and Professor, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania
Rupsa C. Boelig, MD
Dr. Boelig is Fellow, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University
Vincenzo Berghella, MD
Dr. Berghella is Director, Division of Maternal-Fetal Medicine, and Professor, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania
Rupsa C. Boelig, MD
Dr. Boelig is Fellow, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University
Vincenzo Berghella, MD
Dr. Berghella is Director, Division of Maternal-Fetal Medicine, and Professor, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania
Rupsa C. Boelig, MD
Dr. Boelig is Fellow, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University
Transvaginal ultrasound (TVU) cervical length (CL) screening for prediction and prevention of spontaneous preterm birth (SPTB) is among the most transformative clinical changes in obstetrics in the last decades. TVU CL screening should now be offered to all pregnant women: hence the appellative ‘universal CL screening.’
TVU CL screening is an excellent screening test for several reasons. It screens for SPTB, which is a clinically important, well-defined disease whose prevalence and natural history is known, and has an early recognizable asymptomatic phase in CL shortening detected by TVU. TVU CL screening is a well-described technique, safe and acceptable, with a reasonable cutoff (25 mm) now identified for all populations, and results are reproducible and accurate. There are hundreds of studies proving these facts. In the last 10 years, TVU measurement of CL as a screening test has been accepted1,2: it identifies women at risk for SPTB, and an early intervention (progesterone or cerclage depending on the clinical situation) is effective in preventing SPTB. Screening and treatment of short cervix is cost-effective and readily available as an early intervention (progesterone or cerclage depending on the clinical situation), is effective in preventing the outcome (SPTB), treating abnormal results is cost-effective, and facilities for screening are available and treatments are readily available.3–5 It is also important to emphasize that CL screening for prevention of SPTB should be done by TVU, and not by transabdominal ultrasound.6It is best to review TVU CL screening by populations: singletons without prior SPTB, singletons with prior SPTB, and twins (Table).
Related Article:
Can transabdominal ultrasound exclude short cervix?
Singletons without prior SPTB
Women with no previous SPTB who are carrying a singleton pregnancy is the population in which TVU CL could have the greatest impact on decreasing SPTB, for several reasons:
- Up to 60% to 90% of SPTB occur in this population.
- More than 90% of these women have risk factors for SPTB.7,8
- Vaginal progesterone has been associated with a significant 39% decrease in PTB at <33 weeks of gestation and a significant 38% decrease in perinatal morbidity and mortality in a meta-analysis of randomized controlled trials (RCTs) including 606 women without prior PTB.9,10
- Cost-effectiveness studies have shown that TVU CL screening in this specific population prevents thousands of preterm births, saves or improves from death or major morbidity 350 babies’ lives annually, and saves approximately $320,000 per year in the US alone.3 These numbers may be even higher now as the TVU CL cutoff for offering vaginal progesterone has moved in many centers from ≤20 mm to ≤25 mm, including more women (from about 0.8% to about 2% to 3%, respectively11) who benefit from screening.
- Real-world implementation studies have indeed shown significant decreases in SPTB when a policy of universal TVU CL screening in this specific population is implemented.12,13
Universal TVU CL screening recently called into question
In a recent article published in the Journal of the American Medical Association,14 TVU CL screening in this population, in particular for nulliparous women, has come under interrogation. The authors found only an 8% sensitivity of TVU CL screening for SPTB using a cutoff of ≤25 mm at 16 0/7 to 22 6/7 weeks of gestation in 9,410 nulliparous women. This result is different compared with other previous cohort studies in this area, however, and is likely related to a number of issues in the methodology.
First, TVU CL screening was done in many women at too early a gestational age. The earlier the CL screening, the lower the sensitivity of the procedure. Data at 16 and 17 weeks of gestation should have been excluded, as almost all RCTs and other studies on universal TVU CL screening in this population recommended doing screening at about 18 0/7 to 23 6/7 weeks.
Second, women with TVU CL <15 mm received vaginal progesterone. This would decrease the incidence of PTB and, therefore, sensitivity.
Third, outcomes data were not available for 469 women and, compared with women analyzed, these women were at higher risk for SPTB as they were more likely to be aged 21 years or younger, black, with less than a high school education, and single, all significant risk factors for SPTB. (Not all risk factors for SPTB were reported in this study.)
Fourth, pregnancy losses before 20 weeks were excluded, and these could have been early SPTB; therefore, the sensitivity could have been decreased if women with this outcome were excluded.
Fifth, prior studies have shown that TVU CL screening in singletons without prior SPTB has a sensitivity of about 30% to 40%.15,16 In nulliparas, the sensitivity of TVU CL ≤20 mm had been reported previously to be 20%.16 Additional data from 2012–2014 at our institution demonstrate that the incidence of CL ≤25 mm is about 2.8% in nulliparous women, with a sensitivity of 19.5% for SPTB <37 weeks. These numbers show again that 8% sensitivity was low in the JAMA study14 due the shortcomings we just highlighted. Furthermore, the reported sensitivity of TVU CL ≤25 mm for PTB <32 weeks was 24% in Esplin and colleagues’ study,14 while 60% in our data. Given that early preterm births are the most significant source of neonatal morbidity and mortality, women with a singleton gestation and no prior SPTB but with a short TVU CL are perhaps the most important subgroup to identify.
Sixth, a low sensitivity in and of itself is not reflective of a poor screening test. We have known for a long time that SPTB has many etiologies. No one screening test, and no one intervention, would independently prevent all SPTBs. In a population that accounts for more than half of PTBs and for whom no other screening test has been found to be effective, much less cost effective, it is important not to cast aside the dramatic potential clinical benefit to TVU CL screening.
Related Article:
A stepwise approach to cervical cerclage
Singletons with a prior SPTB
This is the first population in which TVU CL screening was first proven beneficial for prevention of SPTB. These women all should receive progesterone starting at 16 weeks because of the prior SPTB. In these women, TVU CL screening should be initiated at 16 weeks, and repeated every 2 weeks (weekly if TVU CL is found to be 25 mm to 29 mm) until 23 6/7 weeks. If the TVU CL is identified to be <25 mm before 24 weeks, cerclage should be recommended.1,2,17
Twins
Twins are the most recent population in which an intervention based on TVU CL screening has been shown to be beneficial. Vaginal progesterone has been associated with a significant decrease in SPTB as well as in some neonatal outcomes in twin gestations found to have a TVU CL <25 mm in the midtrimester in a meta-analysis of RCTs.18 Based on these results, we at our institution recently have started offering TVU CL screening at the time of the anatomy scan (about 20 weeks) to twin gestations.
Related Article:
Which perioperative strategies for transvaginal cervical cerclage are backed by data?
Bottom line
In summary, universal second trimester TVU CL screening of both singletons and twin gestations should be considered seriously by obstetric practitioners to successfully decrease the grave burden of SPTB.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Transvaginal ultrasound (TVU) cervical length (CL) screening for prediction and prevention of spontaneous preterm birth (SPTB) is among the most transformative clinical changes in obstetrics in the last decades. TVU CL screening should now be offered to all pregnant women: hence the appellative ‘universal CL screening.’
TVU CL screening is an excellent screening test for several reasons. It screens for SPTB, which is a clinically important, well-defined disease whose prevalence and natural history is known, and has an early recognizable asymptomatic phase in CL shortening detected by TVU. TVU CL screening is a well-described technique, safe and acceptable, with a reasonable cutoff (25 mm) now identified for all populations, and results are reproducible and accurate. There are hundreds of studies proving these facts. In the last 10 years, TVU measurement of CL as a screening test has been accepted1,2: it identifies women at risk for SPTB, and an early intervention (progesterone or cerclage depending on the clinical situation) is effective in preventing SPTB. Screening and treatment of short cervix is cost-effective and readily available as an early intervention (progesterone or cerclage depending on the clinical situation), is effective in preventing the outcome (SPTB), treating abnormal results is cost-effective, and facilities for screening are available and treatments are readily available.3–5 It is also important to emphasize that CL screening for prevention of SPTB should be done by TVU, and not by transabdominal ultrasound.6It is best to review TVU CL screening by populations: singletons without prior SPTB, singletons with prior SPTB, and twins (Table).
Related Article:
Can transabdominal ultrasound exclude short cervix?
Singletons without prior SPTB
Women with no previous SPTB who are carrying a singleton pregnancy is the population in which TVU CL could have the greatest impact on decreasing SPTB, for several reasons:
- Up to 60% to 90% of SPTB occur in this population.
- More than 90% of these women have risk factors for SPTB.7,8
- Vaginal progesterone has been associated with a significant 39% decrease in PTB at <33 weeks of gestation and a significant 38% decrease in perinatal morbidity and mortality in a meta-analysis of randomized controlled trials (RCTs) including 606 women without prior PTB.9,10
- Cost-effectiveness studies have shown that TVU CL screening in this specific population prevents thousands of preterm births, saves or improves from death or major morbidity 350 babies’ lives annually, and saves approximately $320,000 per year in the US alone.3 These numbers may be even higher now as the TVU CL cutoff for offering vaginal progesterone has moved in many centers from ≤20 mm to ≤25 mm, including more women (from about 0.8% to about 2% to 3%, respectively11) who benefit from screening.
- Real-world implementation studies have indeed shown significant decreases in SPTB when a policy of universal TVU CL screening in this specific population is implemented.12,13
Universal TVU CL screening recently called into question
In a recent article published in the Journal of the American Medical Association,14 TVU CL screening in this population, in particular for nulliparous women, has come under interrogation. The authors found only an 8% sensitivity of TVU CL screening for SPTB using a cutoff of ≤25 mm at 16 0/7 to 22 6/7 weeks of gestation in 9,410 nulliparous women. This result is different compared with other previous cohort studies in this area, however, and is likely related to a number of issues in the methodology.
First, TVU CL screening was done in many women at too early a gestational age. The earlier the CL screening, the lower the sensitivity of the procedure. Data at 16 and 17 weeks of gestation should have been excluded, as almost all RCTs and other studies on universal TVU CL screening in this population recommended doing screening at about 18 0/7 to 23 6/7 weeks.
Second, women with TVU CL <15 mm received vaginal progesterone. This would decrease the incidence of PTB and, therefore, sensitivity.
Third, outcomes data were not available for 469 women and, compared with women analyzed, these women were at higher risk for SPTB as they were more likely to be aged 21 years or younger, black, with less than a high school education, and single, all significant risk factors for SPTB. (Not all risk factors for SPTB were reported in this study.)
Fourth, pregnancy losses before 20 weeks were excluded, and these could have been early SPTB; therefore, the sensitivity could have been decreased if women with this outcome were excluded.
Fifth, prior studies have shown that TVU CL screening in singletons without prior SPTB has a sensitivity of about 30% to 40%.15,16 In nulliparas, the sensitivity of TVU CL ≤20 mm had been reported previously to be 20%.16 Additional data from 2012–2014 at our institution demonstrate that the incidence of CL ≤25 mm is about 2.8% in nulliparous women, with a sensitivity of 19.5% for SPTB <37 weeks. These numbers show again that 8% sensitivity was low in the JAMA study14 due the shortcomings we just highlighted. Furthermore, the reported sensitivity of TVU CL ≤25 mm for PTB <32 weeks was 24% in Esplin and colleagues’ study,14 while 60% in our data. Given that early preterm births are the most significant source of neonatal morbidity and mortality, women with a singleton gestation and no prior SPTB but with a short TVU CL are perhaps the most important subgroup to identify.
Sixth, a low sensitivity in and of itself is not reflective of a poor screening test. We have known for a long time that SPTB has many etiologies. No one screening test, and no one intervention, would independently prevent all SPTBs. In a population that accounts for more than half of PTBs and for whom no other screening test has been found to be effective, much less cost effective, it is important not to cast aside the dramatic potential clinical benefit to TVU CL screening.
Related Article:
A stepwise approach to cervical cerclage
Singletons with a prior SPTB
This is the first population in which TVU CL screening was first proven beneficial for prevention of SPTB. These women all should receive progesterone starting at 16 weeks because of the prior SPTB. In these women, TVU CL screening should be initiated at 16 weeks, and repeated every 2 weeks (weekly if TVU CL is found to be 25 mm to 29 mm) until 23 6/7 weeks. If the TVU CL is identified to be <25 mm before 24 weeks, cerclage should be recommended.1,2,17
Twins
Twins are the most recent population in which an intervention based on TVU CL screening has been shown to be beneficial. Vaginal progesterone has been associated with a significant decrease in SPTB as well as in some neonatal outcomes in twin gestations found to have a TVU CL <25 mm in the midtrimester in a meta-analysis of RCTs.18 Based on these results, we at our institution recently have started offering TVU CL screening at the time of the anatomy scan (about 20 weeks) to twin gestations.
Related Article:
Which perioperative strategies for transvaginal cervical cerclage are backed by data?
Bottom line
In summary, universal second trimester TVU CL screening of both singletons and twin gestations should be considered seriously by obstetric practitioners to successfully decrease the grave burden of SPTB.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Berghella V. Progesterone and preterm birth prevention: Translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376-386.
- Committee on Practice Bulletins--Obstetrics, The American College of Obstetricians and Gynecologists. Practice Bulletin No. 130: Prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964-973.
- Werner EF, Hamel MS, Orzechowski K, Berghella V, Thung SF. Cost-effectiveness of transvaginal ultrasound cervical length screening in singletons without a prior preterm birth: an update. Am J Obstet Gynecol. 2015;213(4):554.e1-e6.
- Einerson BD, Grobman WA, Miller ES. Cost-effectiveness of risk-based screening for cervical length to prevent preterm birth. Am J Obstet Gynecol. 2016;215(1):100.e1-e7.
- McIntosh J, Feltovich H, Berghella V, Manuck T; Society for Maternal-Fetal medicine. The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. Am J Obstet Gynecol. 2016;215(3):B2-B7.
- Khalifeh A, Quist-Nelson J. Current implementation of universal cervical length screening for preterm birth prevention in the United States. Obstet Gynecol. 2016;127(suppl 1):7S.
- Mella MT, Mackeen AD, Gache D, Baxter JK, Berghella V. The utility of screening for historical risk factors for preterm birth in women with known second trimester cervical length. J Matern Fetal Neonatal Med. 2013;26(7):710-715.
- Saccone G, Perriera L, Berghella V. Prior uterine evacuation of pregnancy as independent risk factor for preterm birth: a systematic review and metaanalysis. Am J Obstet Gynecol. 2016;214(5):572-591.
- Romero R, Nicolaides K, Conde-Agudelo A, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: A systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012;206(2):124.e1-e19.
- Romero R, Nicolaides KH, Conde-Agudelo A, et al. Vaginal progesterone decreases preterm birth ≤34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study. Ultrasound Obstet Gynecol. 2016;48(3):308-317.
- Orzechoski KM, Boelig RC, Baxter JK, Berghella V. A universal transvaginal cervical length screening program for preterm birth prevention. Obstet Gynecol. 2014;124(3):520-525.
- Son M, Grobman WA, Ayala NK, Miller ES. A universal mid-trimester transvaginal cervical length screening program and its associated reduced preterm birth rate. Am J Obstet Gynecol. 2016;214(3):365.e1-e5.
- Temming LA, Durst JK, Tuuli MG, et al. Universal cervical length screening: implementation and outcomes. Am J Obstet Gynecol. 2016;214(4):523.e1-e8.
- Esplin MS, Elovitz MA, Iams JD, et al; njMoM2b Network. Predictive accuracy of serial ttransvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women. JAMA. 2017;317(10):1047-1056.
- Iams JD, Goldenberg RL, Meis PJ, et al. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996;334(9):567-572.
- Orzechowski KM, Boelig R, Nicholas SS, Baxter J, Berghella V. Is universal cervical length screening indicated in women with prior term birth? Am J Obstet Gynecol. 2015;212(2):234.e1-e5.
- Preterm labour and birth. National Institute for Health and Care Excellence website. https://www.nice.org.uk/guidance/ng25?unlid=9291036072016213201257. Published November 2015. Accessed May 18, 2017.
- Romero R, Conde-Agudelo A, El-Refaie W, et al. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017;49(3):303-314.
- Berghella V. Progesterone and preterm birth prevention: Translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376-386.
- Committee on Practice Bulletins--Obstetrics, The American College of Obstetricians and Gynecologists. Practice Bulletin No. 130: Prediction and prevention of preterm birth. Obstet Gynecol. 2012;120(4):964-973.
- Werner EF, Hamel MS, Orzechowski K, Berghella V, Thung SF. Cost-effectiveness of transvaginal ultrasound cervical length screening in singletons without a prior preterm birth: an update. Am J Obstet Gynecol. 2015;213(4):554.e1-e6.
- Einerson BD, Grobman WA, Miller ES. Cost-effectiveness of risk-based screening for cervical length to prevent preterm birth. Am J Obstet Gynecol. 2016;215(1):100.e1-e7.
- McIntosh J, Feltovich H, Berghella V, Manuck T; Society for Maternal-Fetal medicine. The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. Am J Obstet Gynecol. 2016;215(3):B2-B7.
- Khalifeh A, Quist-Nelson J. Current implementation of universal cervical length screening for preterm birth prevention in the United States. Obstet Gynecol. 2016;127(suppl 1):7S.
- Mella MT, Mackeen AD, Gache D, Baxter JK, Berghella V. The utility of screening for historical risk factors for preterm birth in women with known second trimester cervical length. J Matern Fetal Neonatal Med. 2013;26(7):710-715.
- Saccone G, Perriera L, Berghella V. Prior uterine evacuation of pregnancy as independent risk factor for preterm birth: a systematic review and metaanalysis. Am J Obstet Gynecol. 2016;214(5):572-591.
- Romero R, Nicolaides K, Conde-Agudelo A, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: A systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012;206(2):124.e1-e19.
- Romero R, Nicolaides KH, Conde-Agudelo A, et al. Vaginal progesterone decreases preterm birth ≤34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study. Ultrasound Obstet Gynecol. 2016;48(3):308-317.
- Orzechoski KM, Boelig RC, Baxter JK, Berghella V. A universal transvaginal cervical length screening program for preterm birth prevention. Obstet Gynecol. 2014;124(3):520-525.
- Son M, Grobman WA, Ayala NK, Miller ES. A universal mid-trimester transvaginal cervical length screening program and its associated reduced preterm birth rate. Am J Obstet Gynecol. 2016;214(3):365.e1-e5.
- Temming LA, Durst JK, Tuuli MG, et al. Universal cervical length screening: implementation and outcomes. Am J Obstet Gynecol. 2016;214(4):523.e1-e8.
- Esplin MS, Elovitz MA, Iams JD, et al; njMoM2b Network. Predictive accuracy of serial ttransvaginal cervical lengths and quantitative vaginal fetal fibronectin levels for spontaneous preterm birth among nulliparous women. JAMA. 2017;317(10):1047-1056.
- Iams JD, Goldenberg RL, Meis PJ, et al. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996;334(9):567-572.
- Orzechowski KM, Boelig R, Nicholas SS, Baxter J, Berghella V. Is universal cervical length screening indicated in women with prior term birth? Am J Obstet Gynecol. 2015;212(2):234.e1-e5.
- Preterm labour and birth. National Institute for Health and Care Excellence website. https://www.nice.org.uk/guidance/ng25?unlid=9291036072016213201257. Published November 2015. Accessed May 18, 2017.
- Romero R, Conde-Agudelo A, El-Refaie W, et al. Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data. Ultrasound Obstet Gynecol. 2017;49(3):303-314.
LARCs are underutilized, even where Zika risk is high
SAN DIEGO – Los Angeles County officials report that few women surveyed are using the most effective contraceptive measures, a fact that concerns public health officials in an area at potential risk for local Zika virus infection.
With close to half of the births in Los Angeles County being unplanned and more than 59% of women reporting use of less effective contraceptive measures, educating providers on the why and the how of placing the most effective contraceptive measures could make a big difference, said Diana Ramos, MD, of the Los Angeles County Department of Public Health.
Los Angeles-area health care providers and public health officials are bracing themselves for a summer mosquito population explosion brought on by the West Coast’s very wet winter and spring of 2016-2017, Dr. Ramos said during a press briefing at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
This sets up the very real possibility of local transmission in the Los Angeles area in the summer of 2017, Dr. Ramos said, adding that the county has both Aedes aegypti and Aedes albopictus mosquitoes, two species capable of transmitting Zika virus.
Dr. Ramos and her colleagues drew from the Los Angeles Mommy and Baby (LAMB) project, a population-based survey of women who have recently given birth. As part of ongoing surveillance to assess whether the county is meeting the CDC’s Healthy People 2020 goals, the 2012 LAMB survey asked about preconception and perinatal experiences, including family planning methods used. From the 2012 survey, the investigators could then identify women who had not had a subsequent pregnancy. They excluded women who did not complete the family planning portion of the 2012 survey. A total of 3,175 women were queried in 2014 about their current family planning practices.
Overall, 28% of women said that they were using not using any form of birth control. The remaining women (n = 2,400) used a variety of methods, with condoms being the most common, used by 38.1%. Oral contraceptives were used by 15.6% of respondents, but nearly as many (14.8%) reported using the withdrawal method, and 6.1% said they used the rhythm method. An additional 15% reported that either they or their partner had undergone a permanent sterilization procedure. Vaginal rings were used by 1.7%.
Of the remaining women who were using birth control, 14.5% were using intrauterine devices, and 6.1% were using depot medroxyprogesterone acetate. These two methods of long-acting reversible contraception (LARC) represent some of the most effective methods to prevent conception, Dr. Ramos said. The fact that only one in five women is using these methods leaves room for provider and public education, she said.
Though some women used a combination of methods, the researchers estimated that about 59% of the women using any birth control were using methods proven to be less effective in real-world studies, including condoms, withdrawal, and the rhythm method.
Accordingly, she said her department is working with providers to expand awareness of the high efficacy rates and good safety profiles of LARCs, and also to educate the public that “the most effective contraceptive methods can decrease neonatal Zika complications by preventing unplanned pregnancies.” The hope, Dr. Ramos said, is to decrease the number of neonatal Zika cases.
Dr. Ramos and her coauthors reported no external sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Los Angeles County officials report that few women surveyed are using the most effective contraceptive measures, a fact that concerns public health officials in an area at potential risk for local Zika virus infection.
With close to half of the births in Los Angeles County being unplanned and more than 59% of women reporting use of less effective contraceptive measures, educating providers on the why and the how of placing the most effective contraceptive measures could make a big difference, said Diana Ramos, MD, of the Los Angeles County Department of Public Health.
Los Angeles-area health care providers and public health officials are bracing themselves for a summer mosquito population explosion brought on by the West Coast’s very wet winter and spring of 2016-2017, Dr. Ramos said during a press briefing at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
This sets up the very real possibility of local transmission in the Los Angeles area in the summer of 2017, Dr. Ramos said, adding that the county has both Aedes aegypti and Aedes albopictus mosquitoes, two species capable of transmitting Zika virus.
Dr. Ramos and her colleagues drew from the Los Angeles Mommy and Baby (LAMB) project, a population-based survey of women who have recently given birth. As part of ongoing surveillance to assess whether the county is meeting the CDC’s Healthy People 2020 goals, the 2012 LAMB survey asked about preconception and perinatal experiences, including family planning methods used. From the 2012 survey, the investigators could then identify women who had not had a subsequent pregnancy. They excluded women who did not complete the family planning portion of the 2012 survey. A total of 3,175 women were queried in 2014 about their current family planning practices.
Overall, 28% of women said that they were using not using any form of birth control. The remaining women (n = 2,400) used a variety of methods, with condoms being the most common, used by 38.1%. Oral contraceptives were used by 15.6% of respondents, but nearly as many (14.8%) reported using the withdrawal method, and 6.1% said they used the rhythm method. An additional 15% reported that either they or their partner had undergone a permanent sterilization procedure. Vaginal rings were used by 1.7%.
Of the remaining women who were using birth control, 14.5% were using intrauterine devices, and 6.1% were using depot medroxyprogesterone acetate. These two methods of long-acting reversible contraception (LARC) represent some of the most effective methods to prevent conception, Dr. Ramos said. The fact that only one in five women is using these methods leaves room for provider and public education, she said.
Though some women used a combination of methods, the researchers estimated that about 59% of the women using any birth control were using methods proven to be less effective in real-world studies, including condoms, withdrawal, and the rhythm method.
Accordingly, she said her department is working with providers to expand awareness of the high efficacy rates and good safety profiles of LARCs, and also to educate the public that “the most effective contraceptive methods can decrease neonatal Zika complications by preventing unplanned pregnancies.” The hope, Dr. Ramos said, is to decrease the number of neonatal Zika cases.
Dr. Ramos and her coauthors reported no external sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
SAN DIEGO – Los Angeles County officials report that few women surveyed are using the most effective contraceptive measures, a fact that concerns public health officials in an area at potential risk for local Zika virus infection.
With close to half of the births in Los Angeles County being unplanned and more than 59% of women reporting use of less effective contraceptive measures, educating providers on the why and the how of placing the most effective contraceptive measures could make a big difference, said Diana Ramos, MD, of the Los Angeles County Department of Public Health.
Los Angeles-area health care providers and public health officials are bracing themselves for a summer mosquito population explosion brought on by the West Coast’s very wet winter and spring of 2016-2017, Dr. Ramos said during a press briefing at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
This sets up the very real possibility of local transmission in the Los Angeles area in the summer of 2017, Dr. Ramos said, adding that the county has both Aedes aegypti and Aedes albopictus mosquitoes, two species capable of transmitting Zika virus.
Dr. Ramos and her colleagues drew from the Los Angeles Mommy and Baby (LAMB) project, a population-based survey of women who have recently given birth. As part of ongoing surveillance to assess whether the county is meeting the CDC’s Healthy People 2020 goals, the 2012 LAMB survey asked about preconception and perinatal experiences, including family planning methods used. From the 2012 survey, the investigators could then identify women who had not had a subsequent pregnancy. They excluded women who did not complete the family planning portion of the 2012 survey. A total of 3,175 women were queried in 2014 about their current family planning practices.
Overall, 28% of women said that they were using not using any form of birth control. The remaining women (n = 2,400) used a variety of methods, with condoms being the most common, used by 38.1%. Oral contraceptives were used by 15.6% of respondents, but nearly as many (14.8%) reported using the withdrawal method, and 6.1% said they used the rhythm method. An additional 15% reported that either they or their partner had undergone a permanent sterilization procedure. Vaginal rings were used by 1.7%.
Of the remaining women who were using birth control, 14.5% were using intrauterine devices, and 6.1% were using depot medroxyprogesterone acetate. These two methods of long-acting reversible contraception (LARC) represent some of the most effective methods to prevent conception, Dr. Ramos said. The fact that only one in five women is using these methods leaves room for provider and public education, she said.
Though some women used a combination of methods, the researchers estimated that about 59% of the women using any birth control were using methods proven to be less effective in real-world studies, including condoms, withdrawal, and the rhythm method.
Accordingly, she said her department is working with providers to expand awareness of the high efficacy rates and good safety profiles of LARCs, and also to educate the public that “the most effective contraceptive methods can decrease neonatal Zika complications by preventing unplanned pregnancies.” The hope, Dr. Ramos said, is to decrease the number of neonatal Zika cases.
Dr. Ramos and her coauthors reported no external sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT ACOG 2017
Key clinical point:
Major finding: Of women surveyed who were using contraception, 20.6% were using a highly effective long-acting reversible contraceptive.
Data source: A population-based survey of 3,175 women in Los Angeles County who had previously given birth.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
Gastric bands hit with high reoperation rates, rising costs
About one in five laparoscopic gastric band surgeries result in device-related reoperations and reoperations account for almost half of all Medicare expenditures for gastric band surgery, a large retrospective study has found.
The laparoscopic adjustable gastric band for treatment of morbid obesity, approved in 2001 by the Food and Drug Administration, was once a common choice for bariatric patients. Although its use has declined from in recent years, the American Society for Metabolic and Bariatric Surgery estimated that 11,000 bands were placed in 2015 and many others remain in place (ASMBS, Estimate of bariatric surgery numbers, 2011-2015, https://goo.gl/f8iByl). Many of these gastric bands will need to be removed, replaced, or revised in a series of procedures over the coming years.
Of the 24,042 gastric band patients in this study group, 4,636 (18.5%) underwent reoperation, defined as band removal, band replacement, or revision to a different bariatric procedure, but not including band size adjustment. Patients who had reoperations were more likely to be women, to be white, and to have slightly lower rates of hypertension and diabetes. But they were also more likely to have received a psychiatric, anemia, or electrolyte disorder diagnosis at the time of their index operations.
Among the 4,636 patients who had reoperations, 17,539 such procedures were performed, an average of 3.8 procedures per patient, in addition to the index operation, over an average follow-up of 4.5 years. The most common reoperation was for band removal (41.8%). Other reasons included conversion to laparoscopic Roux-en-Y gastric bypass (13.1%) or laparoscopic sleeve gastrectomy (5.3%).
The study also looked at the regional differences, reflecting the comparative success of some programs in managing laparoscopic gastric band placement. Reoperation rates across the referral hospitals ranged from 5% to 95.5%, The study found a nearly a threefold variation in reoperation rates across geographic regions. The bottom quartile of hospital referral regions had an average reoperation rate of 13.3% (0.3 standard deviation) and the top quartile had an average reoperation rate of 39.1% (0.21 SD). Top-quartile regions were concentrated in the West, but were otherwise distributed throughout the country.
Most reoperations were elective admissions (79.9%), while 10% were classified as urgent and another 10.1% as emergency. So although previous studies have documented complications such as band slippage and gastric erosion, the preponderance of elective admissions suggests patient and clinician preferences, or weight loss failure, rather than emergency situations, may be the driving force in the reoperation trend.
The investigators concluded that patients should be fully informed about the likelihood of reoperation with the gastric band. In addition, the wide range of reoperation rates across regions and institutions suggests that more training or better patient selection may be needed to improve outcomes. However, they suggested that “taken together, these findings indicate that the gastric band is associated with high reoperation rates and considerable costs to the payers, which raises concerns about its safety, effectiveness, and value.” They added that “payers should reconsider their coverage of the gastric band device.”
Coauthor Justin B. Dimick, MD, disclosed a financial interest in ArborMetrix. The other coauthors reported having no financial disclosures. The Robert Wood Johnson Foundation, U.S. Department of Veterans Affairs, National Institute on Aging, and National Institute of Diabetes and Digestive and Kidney Diseases provided funding.
Dr. Ibrahim and his colleagues have suggested that payers reconsider covering the adjustable laparoscopic gastric band. I disagree and feel that this device still has a role, albeit limited in the modern bariatric surgical program. Many patients do well for a long period. A committed surgeon and program, and the ideal patient with a similar level of commitment, are needed to achieve these best outcomes. Now that patients and surgeons are better informed of the drawbacks to the device, use has decreased without external regulations or policies to drive this change. No single bariatric procedure is appropriate for all patients. Patients need options, and we need better data to help guide their decisions. Do not throw the baby out with the bathwater.
Jon C. Gould, MD, FACS, is with the Medical College of Wisconsin, Milwaukee. Dr. Gould made these comments in an editorial (JAMA Surg. 2017 May 17; doi: 10.1001/jamasurg.2017.1082) that accompanied the study. He has no disclosures.
Dr. Ibrahim and his colleagues have suggested that payers reconsider covering the adjustable laparoscopic gastric band. I disagree and feel that this device still has a role, albeit limited in the modern bariatric surgical program. Many patients do well for a long period. A committed surgeon and program, and the ideal patient with a similar level of commitment, are needed to achieve these best outcomes. Now that patients and surgeons are better informed of the drawbacks to the device, use has decreased without external regulations or policies to drive this change. No single bariatric procedure is appropriate for all patients. Patients need options, and we need better data to help guide their decisions. Do not throw the baby out with the bathwater.
Jon C. Gould, MD, FACS, is with the Medical College of Wisconsin, Milwaukee. Dr. Gould made these comments in an editorial (JAMA Surg. 2017 May 17; doi: 10.1001/jamasurg.2017.1082) that accompanied the study. He has no disclosures.
Dr. Ibrahim and his colleagues have suggested that payers reconsider covering the adjustable laparoscopic gastric band. I disagree and feel that this device still has a role, albeit limited in the modern bariatric surgical program. Many patients do well for a long period. A committed surgeon and program, and the ideal patient with a similar level of commitment, are needed to achieve these best outcomes. Now that patients and surgeons are better informed of the drawbacks to the device, use has decreased without external regulations or policies to drive this change. No single bariatric procedure is appropriate for all patients. Patients need options, and we need better data to help guide their decisions. Do not throw the baby out with the bathwater.
Jon C. Gould, MD, FACS, is with the Medical College of Wisconsin, Milwaukee. Dr. Gould made these comments in an editorial (JAMA Surg. 2017 May 17; doi: 10.1001/jamasurg.2017.1082) that accompanied the study. He has no disclosures.
About one in five laparoscopic gastric band surgeries result in device-related reoperations and reoperations account for almost half of all Medicare expenditures for gastric band surgery, a large retrospective study has found.
The laparoscopic adjustable gastric band for treatment of morbid obesity, approved in 2001 by the Food and Drug Administration, was once a common choice for bariatric patients. Although its use has declined from in recent years, the American Society for Metabolic and Bariatric Surgery estimated that 11,000 bands were placed in 2015 and many others remain in place (ASMBS, Estimate of bariatric surgery numbers, 2011-2015, https://goo.gl/f8iByl). Many of these gastric bands will need to be removed, replaced, or revised in a series of procedures over the coming years.
Of the 24,042 gastric band patients in this study group, 4,636 (18.5%) underwent reoperation, defined as band removal, band replacement, or revision to a different bariatric procedure, but not including band size adjustment. Patients who had reoperations were more likely to be women, to be white, and to have slightly lower rates of hypertension and diabetes. But they were also more likely to have received a psychiatric, anemia, or electrolyte disorder diagnosis at the time of their index operations.
Among the 4,636 patients who had reoperations, 17,539 such procedures were performed, an average of 3.8 procedures per patient, in addition to the index operation, over an average follow-up of 4.5 years. The most common reoperation was for band removal (41.8%). Other reasons included conversion to laparoscopic Roux-en-Y gastric bypass (13.1%) or laparoscopic sleeve gastrectomy (5.3%).
The study also looked at the regional differences, reflecting the comparative success of some programs in managing laparoscopic gastric band placement. Reoperation rates across the referral hospitals ranged from 5% to 95.5%, The study found a nearly a threefold variation in reoperation rates across geographic regions. The bottom quartile of hospital referral regions had an average reoperation rate of 13.3% (0.3 standard deviation) and the top quartile had an average reoperation rate of 39.1% (0.21 SD). Top-quartile regions were concentrated in the West, but were otherwise distributed throughout the country.
Most reoperations were elective admissions (79.9%), while 10% were classified as urgent and another 10.1% as emergency. So although previous studies have documented complications such as band slippage and gastric erosion, the preponderance of elective admissions suggests patient and clinician preferences, or weight loss failure, rather than emergency situations, may be the driving force in the reoperation trend.
The investigators concluded that patients should be fully informed about the likelihood of reoperation with the gastric band. In addition, the wide range of reoperation rates across regions and institutions suggests that more training or better patient selection may be needed to improve outcomes. However, they suggested that “taken together, these findings indicate that the gastric band is associated with high reoperation rates and considerable costs to the payers, which raises concerns about its safety, effectiveness, and value.” They added that “payers should reconsider their coverage of the gastric band device.”
Coauthor Justin B. Dimick, MD, disclosed a financial interest in ArborMetrix. The other coauthors reported having no financial disclosures. The Robert Wood Johnson Foundation, U.S. Department of Veterans Affairs, National Institute on Aging, and National Institute of Diabetes and Digestive and Kidney Diseases provided funding.
About one in five laparoscopic gastric band surgeries result in device-related reoperations and reoperations account for almost half of all Medicare expenditures for gastric band surgery, a large retrospective study has found.
The laparoscopic adjustable gastric band for treatment of morbid obesity, approved in 2001 by the Food and Drug Administration, was once a common choice for bariatric patients. Although its use has declined from in recent years, the American Society for Metabolic and Bariatric Surgery estimated that 11,000 bands were placed in 2015 and many others remain in place (ASMBS, Estimate of bariatric surgery numbers, 2011-2015, https://goo.gl/f8iByl). Many of these gastric bands will need to be removed, replaced, or revised in a series of procedures over the coming years.
Of the 24,042 gastric band patients in this study group, 4,636 (18.5%) underwent reoperation, defined as band removal, band replacement, or revision to a different bariatric procedure, but not including band size adjustment. Patients who had reoperations were more likely to be women, to be white, and to have slightly lower rates of hypertension and diabetes. But they were also more likely to have received a psychiatric, anemia, or electrolyte disorder diagnosis at the time of their index operations.
Among the 4,636 patients who had reoperations, 17,539 such procedures were performed, an average of 3.8 procedures per patient, in addition to the index operation, over an average follow-up of 4.5 years. The most common reoperation was for band removal (41.8%). Other reasons included conversion to laparoscopic Roux-en-Y gastric bypass (13.1%) or laparoscopic sleeve gastrectomy (5.3%).
The study also looked at the regional differences, reflecting the comparative success of some programs in managing laparoscopic gastric band placement. Reoperation rates across the referral hospitals ranged from 5% to 95.5%, The study found a nearly a threefold variation in reoperation rates across geographic regions. The bottom quartile of hospital referral regions had an average reoperation rate of 13.3% (0.3 standard deviation) and the top quartile had an average reoperation rate of 39.1% (0.21 SD). Top-quartile regions were concentrated in the West, but were otherwise distributed throughout the country.
Most reoperations were elective admissions (79.9%), while 10% were classified as urgent and another 10.1% as emergency. So although previous studies have documented complications such as band slippage and gastric erosion, the preponderance of elective admissions suggests patient and clinician preferences, or weight loss failure, rather than emergency situations, may be the driving force in the reoperation trend.
The investigators concluded that patients should be fully informed about the likelihood of reoperation with the gastric band. In addition, the wide range of reoperation rates across regions and institutions suggests that more training or better patient selection may be needed to improve outcomes. However, they suggested that “taken together, these findings indicate that the gastric band is associated with high reoperation rates and considerable costs to the payers, which raises concerns about its safety, effectiveness, and value.” They added that “payers should reconsider their coverage of the gastric band device.”
Coauthor Justin B. Dimick, MD, disclosed a financial interest in ArborMetrix. The other coauthors reported having no financial disclosures. The Robert Wood Johnson Foundation, U.S. Department of Veterans Affairs, National Institute on Aging, and National Institute of Diabetes and Digestive and Kidney Diseases provided funding.
FROM JAMA SURGERY
Key clinical point: Reoperations after gastric band placement are common and raise concerns about the safety, effectiveness, and value of the device.
Major finding: During the study period, reoperations accounted for 47.6% of Medicare payments for laparoscopic gastric band procedures.
Data source: Medicare Provider Analysis and Review file of 25,042 beneficiaries who had gastric band procedures between 2006 and 2013.
Disclosures: Coauthor Justin B. Dimick, MD, disclosed a financial interest in ArborMetrix. The other coauthors reported having no financial disclosures. The Robert Wood Johnson Foundation, U.S. Department of Veterans Affairs, National Institute on Aging, and National Institute of Diabetes and Digestive and Kidney Diseases provided funding.
iFCG achieves high MRD-negative remission in untreated CLL
NEW YORK – Three courses of treatment with the novel combination of ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (iFCG) was well tolerated and associated with a high rate of minimal residual disease (MRD)–negative remission in the bone marrow of favorable-risk, treatment-naive patients with chronic lymphocytic leukemia, based on early results from an ongoing investigator-initiated phase II trial.
Of 29 patients, 24 had completed treatment and been followed for a median of 8.3 months. All 24 had an overall response rate (42% complete response/complete remission with incomplete blood count recovery and 58% partial response), and 83% of patients achieved MRD negativity (100% with complete response and 71% with partial response), Nitin Jain, MD, reported at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.
All nine patients who reached the 12-month time point are off therapy and are being monitored, he said.
Patients with IGHV mutations generally have favorable long-term outcomes with 10-year progression-free survival rates greater than 60% after receiving standard first-line therapy with fludarabine, cyclophosphamide, and rituximab (FCR). However, ibrutinib is approved for patients with CLL, and obinutuzumab, a glycoengineered type II CD20 monoclonal antibody, was superior to rituximab in the CLL11 trial, Dr. Jain said.
Further, data from the HELIOS trial indicated that combining targeted therapies with chemoimmunotherapy is safe and effective.
iFCG was developed with the intent to limit fludarabine and cyclophosphamide to three courses, potentially reducing short- and long-term toxicity, while maintaining efficacy through the addition of ibrutinib and obinutuzumab, he explained.
Of note, higher pretreatment levels of beta-2 microglobulin were associated with a lower MRD-negativity rate after 3 cycles of iFCG, he said.
In six patients with beta-2 microglobulin of 4 mg/dL or greater, the rate was 50%, compared with 94% in 18 patients with beta-2 microglobulin less than 4 mg/dL.
The patients in the current analysis had a median age of 60 years and adequate organ function. All had IGHV mutation and did not have del(17p) or TP53 mutation. They received three courses of iFCG, including ibrutinib at 420 mg once daily continuously starting at day 1 of course 1 (C1D1); obinutuzumab at 100 mg C1D1, 900 mg C1D2, 1000 mg C1D8, 1000 mg C1D15, 1000 mg C2D1, and 1000 mg C3D1; fludarabine at 25 mg/m2 daily for 3 days each course; and cyclophosphamide at 250mg/m2 daily for 3 days each course.
Per study protocol, all patients receive ibrutinib with obinutuzumab for courses 4-6. Patients meeting the primary endpoint of complete response/complete remission with incomplete blood count recovery and bone marrow MRD negativity received ibrutinib monotherapy for courses 7-12. Those who did not achieve the primary endpoint received six more courses of ibrutinib and obinutuzumab. All patients who are MRD negative at 1 year stop all therapy, including ibrutinib, while those who are MRD positive at 1 year may continue ibrutinib monotherapy until disease progression.
The target bone marrow MRD-negative rate after 3 cycles of iFCG is 45%. The historic C3 bone marrow MRD-negative rate with standard FCR therapy in patients with IGHV mutation is 26%, Dr. Jain said, noting that the rate in the current analysis compared favorably with both.
The treatment thus far has been generally well tolerated. Toxicities included neutropenia (grade 3 and 4 occurring in 9 and 12 patients, respectively), thrombocytopenia (grade 3 and 4 occurring in 12 and 1 patients, respectively), ALT/AST (grade 3 and 4 occurring in 3 and 1 patients respectively), atrial fibrillation (grade 3 occurring in 1 patient), arthralgia (grade 3 occurring in 1 patient), and infusion-related reaction (grade 2 and 3 occurring in 9 patients and 1 patient, respectively).
Infections included herpes zoster, acute cholecystitis, pulmonary mycobacterium avium complex infection, and pneumocystis pneumonia, which occurred in 1 patient each, and neutropenic fever, which occurred in 4 patients.
“Notably, no patient has progressed or died in the study so far,” Dr. Jain said.
The trial continues to enroll patients, with plans for enrolling a total of 45.
Dr. Jain has received research support from and/or served on an advisory board for Pharmacyclics, Genentech, Abbvie, Prizer, Incyte, BMS, Infinity, ADC Therapeutics, Seattle Genetics, Celgene, Servier, Novartis Novimmune, and Adaptive Biotechnologies.
NEW YORK – Three courses of treatment with the novel combination of ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (iFCG) was well tolerated and associated with a high rate of minimal residual disease (MRD)–negative remission in the bone marrow of favorable-risk, treatment-naive patients with chronic lymphocytic leukemia, based on early results from an ongoing investigator-initiated phase II trial.
Of 29 patients, 24 had completed treatment and been followed for a median of 8.3 months. All 24 had an overall response rate (42% complete response/complete remission with incomplete blood count recovery and 58% partial response), and 83% of patients achieved MRD negativity (100% with complete response and 71% with partial response), Nitin Jain, MD, reported at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.
All nine patients who reached the 12-month time point are off therapy and are being monitored, he said.
Patients with IGHV mutations generally have favorable long-term outcomes with 10-year progression-free survival rates greater than 60% after receiving standard first-line therapy with fludarabine, cyclophosphamide, and rituximab (FCR). However, ibrutinib is approved for patients with CLL, and obinutuzumab, a glycoengineered type II CD20 monoclonal antibody, was superior to rituximab in the CLL11 trial, Dr. Jain said.
Further, data from the HELIOS trial indicated that combining targeted therapies with chemoimmunotherapy is safe and effective.
iFCG was developed with the intent to limit fludarabine and cyclophosphamide to three courses, potentially reducing short- and long-term toxicity, while maintaining efficacy through the addition of ibrutinib and obinutuzumab, he explained.
Of note, higher pretreatment levels of beta-2 microglobulin were associated with a lower MRD-negativity rate after 3 cycles of iFCG, he said.
In six patients with beta-2 microglobulin of 4 mg/dL or greater, the rate was 50%, compared with 94% in 18 patients with beta-2 microglobulin less than 4 mg/dL.
The patients in the current analysis had a median age of 60 years and adequate organ function. All had IGHV mutation and did not have del(17p) or TP53 mutation. They received three courses of iFCG, including ibrutinib at 420 mg once daily continuously starting at day 1 of course 1 (C1D1); obinutuzumab at 100 mg C1D1, 900 mg C1D2, 1000 mg C1D8, 1000 mg C1D15, 1000 mg C2D1, and 1000 mg C3D1; fludarabine at 25 mg/m2 daily for 3 days each course; and cyclophosphamide at 250mg/m2 daily for 3 days each course.
Per study protocol, all patients receive ibrutinib with obinutuzumab for courses 4-6. Patients meeting the primary endpoint of complete response/complete remission with incomplete blood count recovery and bone marrow MRD negativity received ibrutinib monotherapy for courses 7-12. Those who did not achieve the primary endpoint received six more courses of ibrutinib and obinutuzumab. All patients who are MRD negative at 1 year stop all therapy, including ibrutinib, while those who are MRD positive at 1 year may continue ibrutinib monotherapy until disease progression.
The target bone marrow MRD-negative rate after 3 cycles of iFCG is 45%. The historic C3 bone marrow MRD-negative rate with standard FCR therapy in patients with IGHV mutation is 26%, Dr. Jain said, noting that the rate in the current analysis compared favorably with both.
The treatment thus far has been generally well tolerated. Toxicities included neutropenia (grade 3 and 4 occurring in 9 and 12 patients, respectively), thrombocytopenia (grade 3 and 4 occurring in 12 and 1 patients, respectively), ALT/AST (grade 3 and 4 occurring in 3 and 1 patients respectively), atrial fibrillation (grade 3 occurring in 1 patient), arthralgia (grade 3 occurring in 1 patient), and infusion-related reaction (grade 2 and 3 occurring in 9 patients and 1 patient, respectively).
Infections included herpes zoster, acute cholecystitis, pulmonary mycobacterium avium complex infection, and pneumocystis pneumonia, which occurred in 1 patient each, and neutropenic fever, which occurred in 4 patients.
“Notably, no patient has progressed or died in the study so far,” Dr. Jain said.
The trial continues to enroll patients, with plans for enrolling a total of 45.
Dr. Jain has received research support from and/or served on an advisory board for Pharmacyclics, Genentech, Abbvie, Prizer, Incyte, BMS, Infinity, ADC Therapeutics, Seattle Genetics, Celgene, Servier, Novartis Novimmune, and Adaptive Biotechnologies.
NEW YORK – Three courses of treatment with the novel combination of ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (iFCG) was well tolerated and associated with a high rate of minimal residual disease (MRD)–negative remission in the bone marrow of favorable-risk, treatment-naive patients with chronic lymphocytic leukemia, based on early results from an ongoing investigator-initiated phase II trial.
Of 29 patients, 24 had completed treatment and been followed for a median of 8.3 months. All 24 had an overall response rate (42% complete response/complete remission with incomplete blood count recovery and 58% partial response), and 83% of patients achieved MRD negativity (100% with complete response and 71% with partial response), Nitin Jain, MD, reported at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.
All nine patients who reached the 12-month time point are off therapy and are being monitored, he said.
Patients with IGHV mutations generally have favorable long-term outcomes with 10-year progression-free survival rates greater than 60% after receiving standard first-line therapy with fludarabine, cyclophosphamide, and rituximab (FCR). However, ibrutinib is approved for patients with CLL, and obinutuzumab, a glycoengineered type II CD20 monoclonal antibody, was superior to rituximab in the CLL11 trial, Dr. Jain said.
Further, data from the HELIOS trial indicated that combining targeted therapies with chemoimmunotherapy is safe and effective.
iFCG was developed with the intent to limit fludarabine and cyclophosphamide to three courses, potentially reducing short- and long-term toxicity, while maintaining efficacy through the addition of ibrutinib and obinutuzumab, he explained.
Of note, higher pretreatment levels of beta-2 microglobulin were associated with a lower MRD-negativity rate after 3 cycles of iFCG, he said.
In six patients with beta-2 microglobulin of 4 mg/dL or greater, the rate was 50%, compared with 94% in 18 patients with beta-2 microglobulin less than 4 mg/dL.
The patients in the current analysis had a median age of 60 years and adequate organ function. All had IGHV mutation and did not have del(17p) or TP53 mutation. They received three courses of iFCG, including ibrutinib at 420 mg once daily continuously starting at day 1 of course 1 (C1D1); obinutuzumab at 100 mg C1D1, 900 mg C1D2, 1000 mg C1D8, 1000 mg C1D15, 1000 mg C2D1, and 1000 mg C3D1; fludarabine at 25 mg/m2 daily for 3 days each course; and cyclophosphamide at 250mg/m2 daily for 3 days each course.
Per study protocol, all patients receive ibrutinib with obinutuzumab for courses 4-6. Patients meeting the primary endpoint of complete response/complete remission with incomplete blood count recovery and bone marrow MRD negativity received ibrutinib monotherapy for courses 7-12. Those who did not achieve the primary endpoint received six more courses of ibrutinib and obinutuzumab. All patients who are MRD negative at 1 year stop all therapy, including ibrutinib, while those who are MRD positive at 1 year may continue ibrutinib monotherapy until disease progression.
The target bone marrow MRD-negative rate after 3 cycles of iFCG is 45%. The historic C3 bone marrow MRD-negative rate with standard FCR therapy in patients with IGHV mutation is 26%, Dr. Jain said, noting that the rate in the current analysis compared favorably with both.
The treatment thus far has been generally well tolerated. Toxicities included neutropenia (grade 3 and 4 occurring in 9 and 12 patients, respectively), thrombocytopenia (grade 3 and 4 occurring in 12 and 1 patients, respectively), ALT/AST (grade 3 and 4 occurring in 3 and 1 patients respectively), atrial fibrillation (grade 3 occurring in 1 patient), arthralgia (grade 3 occurring in 1 patient), and infusion-related reaction (grade 2 and 3 occurring in 9 patients and 1 patient, respectively).
Infections included herpes zoster, acute cholecystitis, pulmonary mycobacterium avium complex infection, and pneumocystis pneumonia, which occurred in 1 patient each, and neutropenic fever, which occurred in 4 patients.
“Notably, no patient has progressed or died in the study so far,” Dr. Jain said.
The trial continues to enroll patients, with plans for enrolling a total of 45.
Dr. Jain has received research support from and/or served on an advisory board for Pharmacyclics, Genentech, Abbvie, Prizer, Incyte, BMS, Infinity, ADC Therapeutics, Seattle Genetics, Celgene, Servier, Novartis Novimmune, and Adaptive Biotechnologies.
AT THE IWCLL MEETING
Key clinical point:
Major finding: The overall response rate was 100%, and 83% of patients achieved MRD-negativity after three courses.
Data source: 29 patients from an investigator-initiated phase II trial.
Disclosures: Dr. Jain has received research support from and/or served on an advisory board for Pharmacyclics, Genentech, Abbvie, Prizer, Incyte, BMS, Infinity, ADC Therapeutics, Seattle Genetics, Celgene, Servier, Novartis, Novimmune, and Adaptive Biotechnologies.
The ‘monster note’ in EHR systems rarely helps
Recently, the hospital I take call at switched to Epic as its electronic health record system.
Overall, I don’t have too many complaints about it. It does some things better and some things worse than other systems I’ve used. That’s to be expected.
But with Epic has come an alarming new trend: the monster note.
Rarely does it ever give you a hint into the thought process or what’s going on that (at least to me) is so critical to medicine.
In a recent example of the insanity, one of my office patients was in the hospital overnight for a transient ischemic attack. When I went to get the discharge summary, it was 97 pages long! (Really, it was.) All of it was auto-filled in with test results, vital signs, MRI screening forms, medication administration records, and nurse, therapy, and respiratory notes. Most of it was far from the stuff that discharge summaries are supposed to contain. What part of “summary” are people not understanding anymore?
Of course, this isn’t Epic’s fault. It’s just a tool. It’s how humans use it that becomes the problem. This misuse of the system has made routine notes, as Shakespeare’s Macbeth said, “a tale told by an idiot, full of sound and fury, signifying nothing.”
For better or worse, I deliberately don’t do this. I let Epic put in the patient’s name, birthday, and most recent vital signs ... and nothing else. I’ll fill in the test results when needed, in a concise form that I can grasp. (It’s my note, after all.) To me, writing (or typing) the note is part of the thought process. As I enter results, I turn over what they mean, in a way that just seeing five paragraphs auto-pasted in doesn’t do. It also allows me to boil them down to one or two sentences.
After all, brevity is the soul of wit. And while I’m not trying to be witty in my notes, I am trying solve the problem in front of me. Taking the time write it out in my own words is essential to my thought process and letting others understand how I came to my plan. And, as a result, it is what’s best for the patient.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Recently, the hospital I take call at switched to Epic as its electronic health record system.
Overall, I don’t have too many complaints about it. It does some things better and some things worse than other systems I’ve used. That’s to be expected.
But with Epic has come an alarming new trend: the monster note.
Rarely does it ever give you a hint into the thought process or what’s going on that (at least to me) is so critical to medicine.
In a recent example of the insanity, one of my office patients was in the hospital overnight for a transient ischemic attack. When I went to get the discharge summary, it was 97 pages long! (Really, it was.) All of it was auto-filled in with test results, vital signs, MRI screening forms, medication administration records, and nurse, therapy, and respiratory notes. Most of it was far from the stuff that discharge summaries are supposed to contain. What part of “summary” are people not understanding anymore?
Of course, this isn’t Epic’s fault. It’s just a tool. It’s how humans use it that becomes the problem. This misuse of the system has made routine notes, as Shakespeare’s Macbeth said, “a tale told by an idiot, full of sound and fury, signifying nothing.”
For better or worse, I deliberately don’t do this. I let Epic put in the patient’s name, birthday, and most recent vital signs ... and nothing else. I’ll fill in the test results when needed, in a concise form that I can grasp. (It’s my note, after all.) To me, writing (or typing) the note is part of the thought process. As I enter results, I turn over what they mean, in a way that just seeing five paragraphs auto-pasted in doesn’t do. It also allows me to boil them down to one or two sentences.
After all, brevity is the soul of wit. And while I’m not trying to be witty in my notes, I am trying solve the problem in front of me. Taking the time write it out in my own words is essential to my thought process and letting others understand how I came to my plan. And, as a result, it is what’s best for the patient.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Recently, the hospital I take call at switched to Epic as its electronic health record system.
Overall, I don’t have too many complaints about it. It does some things better and some things worse than other systems I’ve used. That’s to be expected.
But with Epic has come an alarming new trend: the monster note.
Rarely does it ever give you a hint into the thought process or what’s going on that (at least to me) is so critical to medicine.
In a recent example of the insanity, one of my office patients was in the hospital overnight for a transient ischemic attack. When I went to get the discharge summary, it was 97 pages long! (Really, it was.) All of it was auto-filled in with test results, vital signs, MRI screening forms, medication administration records, and nurse, therapy, and respiratory notes. Most of it was far from the stuff that discharge summaries are supposed to contain. What part of “summary” are people not understanding anymore?
Of course, this isn’t Epic’s fault. It’s just a tool. It’s how humans use it that becomes the problem. This misuse of the system has made routine notes, as Shakespeare’s Macbeth said, “a tale told by an idiot, full of sound and fury, signifying nothing.”
For better or worse, I deliberately don’t do this. I let Epic put in the patient’s name, birthday, and most recent vital signs ... and nothing else. I’ll fill in the test results when needed, in a concise form that I can grasp. (It’s my note, after all.) To me, writing (or typing) the note is part of the thought process. As I enter results, I turn over what they mean, in a way that just seeing five paragraphs auto-pasted in doesn’t do. It also allows me to boil them down to one or two sentences.
After all, brevity is the soul of wit. And while I’m not trying to be witty in my notes, I am trying solve the problem in front of me. Taking the time write it out in my own words is essential to my thought process and letting others understand how I came to my plan. And, as a result, it is what’s best for the patient.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Experts endorse routine screening for pediatric psoriasis comorbidities
Pediatric psoriasis patients should be screened regularly to identify risk factors for comorbidities including depression, gastrointestinal problems, diabetes, and dyslipidemia, according to the debut guidelines issued by an expert panel.
The National Psoriasis Foundation and the Pediatric Dermatology Research Alliance joined forces to assess the literature and develop recommendations for screening comorbidities for children with psoriasis. The National Psoriasis Foundation has guidelines for comorbidity screening in adults with psoriasis, but no guidelines previously existed for children, wrote Emily Osier, MD, of Eastern Virginia Medical School, Norfolk, and her colleagues (JAMA Dermatol 2017 May 17. doi: 10.1001/jamadermatol.2017.0499).
The panelists reviewed the literature on psoriasis and comorbidities published between 1999 and 2015 and identified 153 studies, 26 of which involved children.
“The screening recommendations derived are largely consistent with those endorsed by the AAP for the general pediatric patient,” the researchers noted.
Although many young children are screened for a range of comorbid conditions at annual checkups, preteens and teenagers may be less likely to receive preventive services in primary care, they said. “Thus, all health care providers caring for patients with pediatric psoriasis should help assess and ensure that appropriate screening has been performed,” they emphasized.
Some notable recommendations include the following:
• Screen children with psoriasis for overweight and obesity annually using body mass index percentiles.
• Screen for diabetes every 3 years starting at age 10 years.
• Perform universal lipid screening at ages 9-11 years and 17-21 years.
• Screen for nonalcoholic fatty liver disease every 2-3 years starting at age 9-11 years.
• Screen for hypertension annually starting at age 3 years.
• Screen for arthritis at the time of psoriasis diagnosis and periodically.
• Screen yearly for depression and anxiety at all ages, with yearly screening for substance abuse starting at age 11 years.
Uveitis screening is recommended only for children with psoriatic arthritis, the researchers said.
In addition, clinicians “should recognize the profound psychosocial ramifications of psoriasis and the potential significant impact on quality of life of patients and caregivers,” the researchers wrote. Clinicians may consider a formal quality of life measurement, such as the Children’s Dermatology Life Quality Index, or at least asking questions about the impact of psoriasis on the child’s life at home, at school, and during other activities.
Awareness of comorbidities also impacts potential psoriasis treatment, the researchers said. “Direct baseline screening and monitoring tests should be performed as indicated by each individual’s therapeutic plan,” they said.
The consensus statement is a starting point for screening that will be refined over time, and may include stratifying patients by age, disease subtype, or disease severity, the researchers noted.
“Communication and collaboration between dermatologists, primary care providers, and other pediatric specialists will be critical to accomplish the recommended screenings and to limit the sequelae of this disorder,” they wrote.
The National Psoriasis Foundation and the University of California, San Diego, Eczema and Inflammatory Skin Disease Center supported the study. Dr. Osier was supported in part by a Medical Dermatology Research Fellowship grant from the National Psoriasis Foundation in 2014-2016, but she had no financial conflicts to disclose.
Pediatric psoriasis patients should be screened regularly to identify risk factors for comorbidities including depression, gastrointestinal problems, diabetes, and dyslipidemia, according to the debut guidelines issued by an expert panel.
The National Psoriasis Foundation and the Pediatric Dermatology Research Alliance joined forces to assess the literature and develop recommendations for screening comorbidities for children with psoriasis. The National Psoriasis Foundation has guidelines for comorbidity screening in adults with psoriasis, but no guidelines previously existed for children, wrote Emily Osier, MD, of Eastern Virginia Medical School, Norfolk, and her colleagues (JAMA Dermatol 2017 May 17. doi: 10.1001/jamadermatol.2017.0499).
The panelists reviewed the literature on psoriasis and comorbidities published between 1999 and 2015 and identified 153 studies, 26 of which involved children.
“The screening recommendations derived are largely consistent with those endorsed by the AAP for the general pediatric patient,” the researchers noted.
Although many young children are screened for a range of comorbid conditions at annual checkups, preteens and teenagers may be less likely to receive preventive services in primary care, they said. “Thus, all health care providers caring for patients with pediatric psoriasis should help assess and ensure that appropriate screening has been performed,” they emphasized.
Some notable recommendations include the following:
• Screen children with psoriasis for overweight and obesity annually using body mass index percentiles.
• Screen for diabetes every 3 years starting at age 10 years.
• Perform universal lipid screening at ages 9-11 years and 17-21 years.
• Screen for nonalcoholic fatty liver disease every 2-3 years starting at age 9-11 years.
• Screen for hypertension annually starting at age 3 years.
• Screen for arthritis at the time of psoriasis diagnosis and periodically.
• Screen yearly for depression and anxiety at all ages, with yearly screening for substance abuse starting at age 11 years.
Uveitis screening is recommended only for children with psoriatic arthritis, the researchers said.
In addition, clinicians “should recognize the profound psychosocial ramifications of psoriasis and the potential significant impact on quality of life of patients and caregivers,” the researchers wrote. Clinicians may consider a formal quality of life measurement, such as the Children’s Dermatology Life Quality Index, or at least asking questions about the impact of psoriasis on the child’s life at home, at school, and during other activities.
Awareness of comorbidities also impacts potential psoriasis treatment, the researchers said. “Direct baseline screening and monitoring tests should be performed as indicated by each individual’s therapeutic plan,” they said.
The consensus statement is a starting point for screening that will be refined over time, and may include stratifying patients by age, disease subtype, or disease severity, the researchers noted.
“Communication and collaboration between dermatologists, primary care providers, and other pediatric specialists will be critical to accomplish the recommended screenings and to limit the sequelae of this disorder,” they wrote.
The National Psoriasis Foundation and the University of California, San Diego, Eczema and Inflammatory Skin Disease Center supported the study. Dr. Osier was supported in part by a Medical Dermatology Research Fellowship grant from the National Psoriasis Foundation in 2014-2016, but she had no financial conflicts to disclose.
Pediatric psoriasis patients should be screened regularly to identify risk factors for comorbidities including depression, gastrointestinal problems, diabetes, and dyslipidemia, according to the debut guidelines issued by an expert panel.
The National Psoriasis Foundation and the Pediatric Dermatology Research Alliance joined forces to assess the literature and develop recommendations for screening comorbidities for children with psoriasis. The National Psoriasis Foundation has guidelines for comorbidity screening in adults with psoriasis, but no guidelines previously existed for children, wrote Emily Osier, MD, of Eastern Virginia Medical School, Norfolk, and her colleagues (JAMA Dermatol 2017 May 17. doi: 10.1001/jamadermatol.2017.0499).
The panelists reviewed the literature on psoriasis and comorbidities published between 1999 and 2015 and identified 153 studies, 26 of which involved children.
“The screening recommendations derived are largely consistent with those endorsed by the AAP for the general pediatric patient,” the researchers noted.
Although many young children are screened for a range of comorbid conditions at annual checkups, preteens and teenagers may be less likely to receive preventive services in primary care, they said. “Thus, all health care providers caring for patients with pediatric psoriasis should help assess and ensure that appropriate screening has been performed,” they emphasized.
Some notable recommendations include the following:
• Screen children with psoriasis for overweight and obesity annually using body mass index percentiles.
• Screen for diabetes every 3 years starting at age 10 years.
• Perform universal lipid screening at ages 9-11 years and 17-21 years.
• Screen for nonalcoholic fatty liver disease every 2-3 years starting at age 9-11 years.
• Screen for hypertension annually starting at age 3 years.
• Screen for arthritis at the time of psoriasis diagnosis and periodically.
• Screen yearly for depression and anxiety at all ages, with yearly screening for substance abuse starting at age 11 years.
Uveitis screening is recommended only for children with psoriatic arthritis, the researchers said.
In addition, clinicians “should recognize the profound psychosocial ramifications of psoriasis and the potential significant impact on quality of life of patients and caregivers,” the researchers wrote. Clinicians may consider a formal quality of life measurement, such as the Children’s Dermatology Life Quality Index, or at least asking questions about the impact of psoriasis on the child’s life at home, at school, and during other activities.
Awareness of comorbidities also impacts potential psoriasis treatment, the researchers said. “Direct baseline screening and monitoring tests should be performed as indicated by each individual’s therapeutic plan,” they said.
The consensus statement is a starting point for screening that will be refined over time, and may include stratifying patients by age, disease subtype, or disease severity, the researchers noted.
“Communication and collaboration between dermatologists, primary care providers, and other pediatric specialists will be critical to accomplish the recommended screenings and to limit the sequelae of this disorder,” they wrote.
The National Psoriasis Foundation and the University of California, San Diego, Eczema and Inflammatory Skin Disease Center supported the study. Dr. Osier was supported in part by a Medical Dermatology Research Fellowship grant from the National Psoriasis Foundation in 2014-2016, but she had no financial conflicts to disclose.
FROM JAMA DERMATOLOGY
Osteoarthritis contributes more to difficulty walking than do diabetes, CVD
Hip and knee osteoarthritis on their own predict difficulty walking in adults aged 55 years and older to a greater extent than do diabetes or cardiovascular disease individually, according to findings from a Canadian population-based study.
The ability of hip and knee osteoarthritis (OA) to predict difficulty walking also increased with the number of joints affected and acted additively with either diabetes or cardiovascular disease (CVD) or both to raise the odds for walking problems, reported Lauren K. King, MBBS, of the University of Toronto, and colleagues.
To determine the impact of hip and knee OA on difficulty walking, the researchers reviewed data from 18,490 adults recruited between 1996 and 1998. The average age of the participants was 68 years, 60% were women, and 25% reported difficulty with walking during the past 3 months (Arthritis Care Res. 2017 May 17 doi: 10.1002/acr.23250). They completed questionnaires about their health conditions, and the researchers developed a clinical nomogram using their final multivariate logistic model.
The researchers calculated that the predicted probability of difficulty walking for a 60-year-old, middle-income, normal-weight woman with no health conditions was 5%-10%. However, the probability of walking problems was 10%-20% for the same woman with diabetes and CVD; 40% with osteoarthritis in two hips/knees; 60%-70% with diabetes, CVD, and osteoarthritis in two hips/knees; and 80% with diabetes, CVD, and osteoarthritis in all hips/knees.
Overall, 10% of the participants met criteria for hip OA and 15% met criteria for knee OA. The most common chronic conditions were hypertension (43%), diabetes (11%), and CVD (11%).
In a multivariate analysis, individuals with knee or hip OA had the highest odds of reporting walking difficulty, and the odds increased with the number of joints affected.
The results were limited by the cross-sectional nature of the study and the use of self-reports, the researchers noted.
However, “Given the high prevalence of OA and the substantial physical, social, and psychological consequences of walking difficulty, we believe our findings have high clinical relevance to primary care physicians and internal medicine specialists beyond rheumatology,” they said.
“Further research is warranted to understand the mechanisms by which chronic conditions affect mobility, physical activity, and sedentary behavior, and to elucidate safe and effective management approaches to reduce OA-related walking difficulty,” they added.
None of the investigators had relevant financial disclosures to report.
Hip and knee osteoarthritis on their own predict difficulty walking in adults aged 55 years and older to a greater extent than do diabetes or cardiovascular disease individually, according to findings from a Canadian population-based study.
The ability of hip and knee osteoarthritis (OA) to predict difficulty walking also increased with the number of joints affected and acted additively with either diabetes or cardiovascular disease (CVD) or both to raise the odds for walking problems, reported Lauren K. King, MBBS, of the University of Toronto, and colleagues.
To determine the impact of hip and knee OA on difficulty walking, the researchers reviewed data from 18,490 adults recruited between 1996 and 1998. The average age of the participants was 68 years, 60% were women, and 25% reported difficulty with walking during the past 3 months (Arthritis Care Res. 2017 May 17 doi: 10.1002/acr.23250). They completed questionnaires about their health conditions, and the researchers developed a clinical nomogram using their final multivariate logistic model.
The researchers calculated that the predicted probability of difficulty walking for a 60-year-old, middle-income, normal-weight woman with no health conditions was 5%-10%. However, the probability of walking problems was 10%-20% for the same woman with diabetes and CVD; 40% with osteoarthritis in two hips/knees; 60%-70% with diabetes, CVD, and osteoarthritis in two hips/knees; and 80% with diabetes, CVD, and osteoarthritis in all hips/knees.
Overall, 10% of the participants met criteria for hip OA and 15% met criteria for knee OA. The most common chronic conditions were hypertension (43%), diabetes (11%), and CVD (11%).
In a multivariate analysis, individuals with knee or hip OA had the highest odds of reporting walking difficulty, and the odds increased with the number of joints affected.
The results were limited by the cross-sectional nature of the study and the use of self-reports, the researchers noted.
However, “Given the high prevalence of OA and the substantial physical, social, and psychological consequences of walking difficulty, we believe our findings have high clinical relevance to primary care physicians and internal medicine specialists beyond rheumatology,” they said.
“Further research is warranted to understand the mechanisms by which chronic conditions affect mobility, physical activity, and sedentary behavior, and to elucidate safe and effective management approaches to reduce OA-related walking difficulty,” they added.
None of the investigators had relevant financial disclosures to report.
Hip and knee osteoarthritis on their own predict difficulty walking in adults aged 55 years and older to a greater extent than do diabetes or cardiovascular disease individually, according to findings from a Canadian population-based study.
The ability of hip and knee osteoarthritis (OA) to predict difficulty walking also increased with the number of joints affected and acted additively with either diabetes or cardiovascular disease (CVD) or both to raise the odds for walking problems, reported Lauren K. King, MBBS, of the University of Toronto, and colleagues.
To determine the impact of hip and knee OA on difficulty walking, the researchers reviewed data from 18,490 adults recruited between 1996 and 1998. The average age of the participants was 68 years, 60% were women, and 25% reported difficulty with walking during the past 3 months (Arthritis Care Res. 2017 May 17 doi: 10.1002/acr.23250). They completed questionnaires about their health conditions, and the researchers developed a clinical nomogram using their final multivariate logistic model.
The researchers calculated that the predicted probability of difficulty walking for a 60-year-old, middle-income, normal-weight woman with no health conditions was 5%-10%. However, the probability of walking problems was 10%-20% for the same woman with diabetes and CVD; 40% with osteoarthritis in two hips/knees; 60%-70% with diabetes, CVD, and osteoarthritis in two hips/knees; and 80% with diabetes, CVD, and osteoarthritis in all hips/knees.
Overall, 10% of the participants met criteria for hip OA and 15% met criteria for knee OA. The most common chronic conditions were hypertension (43%), diabetes (11%), and CVD (11%).
In a multivariate analysis, individuals with knee or hip OA had the highest odds of reporting walking difficulty, and the odds increased with the number of joints affected.
The results were limited by the cross-sectional nature of the study and the use of self-reports, the researchers noted.
However, “Given the high prevalence of OA and the substantial physical, social, and psychological consequences of walking difficulty, we believe our findings have high clinical relevance to primary care physicians and internal medicine specialists beyond rheumatology,” they said.
“Further research is warranted to understand the mechanisms by which chronic conditions affect mobility, physical activity, and sedentary behavior, and to elucidate safe and effective management approaches to reduce OA-related walking difficulty,” they added.
None of the investigators had relevant financial disclosures to report.
FROM ARTHRITIS CARE & RESEARCH
Key clinical point:
Major finding: The probability of difficulty walking was 40% for a 60-year-old, middle-income, normal-weight woman with OA in two hips or knees vs. 5% in the same woman with no health conditions.
Data source: A population-based cohort study of 18,490 adults aged 55 years and older.
Disclosures: None of the investigators had relevant financial disclosures to report.
HM17 session summary: CT to PET scans – What every hospitalist needs to know
Presenter
Timothy Kasprzak, MD, MBA
Session summary
“What imaging study should I order for this patient?” is a question that comes up frequently in the hospital. Dr. Kasprzak, the director of abdominopelvic and oncologic imaging at Case Western MetroHealth, Cleveland, offered some practical advice for inpatient clinicians during a rapid-fire session at HM17.
The session also touched on the risks and benefits of contrast media for CT scans and MRIs. As with other tests and treatments in medicine, the use of contrast is always a “risk-benefit.” The main benefit of both forms of contrast is to improve the “conspicuity” of findings on imaging studies – many diagnoses that are visible with contrast (such as vascular lesions, solid organ lesions, or extravasations) are invisible without it.
The risks of both CT and MRI contrast have been re-evaluated over the past several years. More recent evidence is suggesting the prevalence of contrast-induced nephropathy is lower than previously thought, especially with newer non-ionic contrast. Conversely, there is some recent evidence that CT contrast might accentuate radiation-related DNA damage. Regarding MRIs, gadolinium has been associated with nephrogenic systemic fibrosis, particularly in patients with end-stage renal disease. This appears to be less prevalent with newer gadolinium agents. There are, however, recent reports of gadolinium deposition in the basal ganglia of patients. The clinical significance of this imaging finding is still unknown.
Lastly, Dr. Kasprzak offered advice on the use of PET scans on inpatients. While there are a few indications that would warrant inpatient use (such as evaluation in fever of unknown origin), most PET scans are done for oncologic reasons that do not warrant urgent inpatient use. In addition, some insurance companies don’t reimburse for inpatient PET studies.
Key takeaways for HM
• Utilize appropriate use criteria (such as offered by the ACR) for choosing the most worthwhile imaging study.
• Give relevant clinical history in your order to help the radiologist narrow the differential (and to help prevent the “clinically correlate” phrase as much as possible).
• Consider the risk/benefit of contrast use for all patients getting CT or MRI studies.
• Avoid the use of inpatient PET scans, except for very specific indications (such as obscure infections).
Dr. Sehgal is a hospitalist at the South Texas Veterans Health Care System in San Antonio, an associate professor of medicine at University of Texas Health-San Antonio, and a an editorial board member of The Hospitalist.
Presenter
Timothy Kasprzak, MD, MBA
Session summary
“What imaging study should I order for this patient?” is a question that comes up frequently in the hospital. Dr. Kasprzak, the director of abdominopelvic and oncologic imaging at Case Western MetroHealth, Cleveland, offered some practical advice for inpatient clinicians during a rapid-fire session at HM17.
The session also touched on the risks and benefits of contrast media for CT scans and MRIs. As with other tests and treatments in medicine, the use of contrast is always a “risk-benefit.” The main benefit of both forms of contrast is to improve the “conspicuity” of findings on imaging studies – many diagnoses that are visible with contrast (such as vascular lesions, solid organ lesions, or extravasations) are invisible without it.
The risks of both CT and MRI contrast have been re-evaluated over the past several years. More recent evidence is suggesting the prevalence of contrast-induced nephropathy is lower than previously thought, especially with newer non-ionic contrast. Conversely, there is some recent evidence that CT contrast might accentuate radiation-related DNA damage. Regarding MRIs, gadolinium has been associated with nephrogenic systemic fibrosis, particularly in patients with end-stage renal disease. This appears to be less prevalent with newer gadolinium agents. There are, however, recent reports of gadolinium deposition in the basal ganglia of patients. The clinical significance of this imaging finding is still unknown.
Lastly, Dr. Kasprzak offered advice on the use of PET scans on inpatients. While there are a few indications that would warrant inpatient use (such as evaluation in fever of unknown origin), most PET scans are done for oncologic reasons that do not warrant urgent inpatient use. In addition, some insurance companies don’t reimburse for inpatient PET studies.
Key takeaways for HM
• Utilize appropriate use criteria (such as offered by the ACR) for choosing the most worthwhile imaging study.
• Give relevant clinical history in your order to help the radiologist narrow the differential (and to help prevent the “clinically correlate” phrase as much as possible).
• Consider the risk/benefit of contrast use for all patients getting CT or MRI studies.
• Avoid the use of inpatient PET scans, except for very specific indications (such as obscure infections).
Dr. Sehgal is a hospitalist at the South Texas Veterans Health Care System in San Antonio, an associate professor of medicine at University of Texas Health-San Antonio, and a an editorial board member of The Hospitalist.
Presenter
Timothy Kasprzak, MD, MBA
Session summary
“What imaging study should I order for this patient?” is a question that comes up frequently in the hospital. Dr. Kasprzak, the director of abdominopelvic and oncologic imaging at Case Western MetroHealth, Cleveland, offered some practical advice for inpatient clinicians during a rapid-fire session at HM17.
The session also touched on the risks and benefits of contrast media for CT scans and MRIs. As with other tests and treatments in medicine, the use of contrast is always a “risk-benefit.” The main benefit of both forms of contrast is to improve the “conspicuity” of findings on imaging studies – many diagnoses that are visible with contrast (such as vascular lesions, solid organ lesions, or extravasations) are invisible without it.
The risks of both CT and MRI contrast have been re-evaluated over the past several years. More recent evidence is suggesting the prevalence of contrast-induced nephropathy is lower than previously thought, especially with newer non-ionic contrast. Conversely, there is some recent evidence that CT contrast might accentuate radiation-related DNA damage. Regarding MRIs, gadolinium has been associated with nephrogenic systemic fibrosis, particularly in patients with end-stage renal disease. This appears to be less prevalent with newer gadolinium agents. There are, however, recent reports of gadolinium deposition in the basal ganglia of patients. The clinical significance of this imaging finding is still unknown.
Lastly, Dr. Kasprzak offered advice on the use of PET scans on inpatients. While there are a few indications that would warrant inpatient use (such as evaluation in fever of unknown origin), most PET scans are done for oncologic reasons that do not warrant urgent inpatient use. In addition, some insurance companies don’t reimburse for inpatient PET studies.
Key takeaways for HM
• Utilize appropriate use criteria (such as offered by the ACR) for choosing the most worthwhile imaging study.
• Give relevant clinical history in your order to help the radiologist narrow the differential (and to help prevent the “clinically correlate” phrase as much as possible).
• Consider the risk/benefit of contrast use for all patients getting CT or MRI studies.
• Avoid the use of inpatient PET scans, except for very specific indications (such as obscure infections).
Dr. Sehgal is a hospitalist at the South Texas Veterans Health Care System in San Antonio, an associate professor of medicine at University of Texas Health-San Antonio, and a an editorial board member of The Hospitalist.
SHM group membership strengthens teams, builds leaders at iNDIGO
When it comes to developing, maintaining, and growing an effective hospital medicine team, James W. Levy, PA-C, SFHM, certified physician assistant and managing partner of iNDIGO Health Partners, credits much of the company’s success to a decision to purchase a group SHM membership for its hospital medicine team. Recognizing the value that membership brings, it was an easy decision to extend a group membership to iNDIGO’s hospital medicine team.
“As a company, we are strong supporters of SHM and its mission,” Mr. Levy said. “This seemed like the best way we could support SHM and allow all our providers access to all the personal and professional benefits of SHM membership.”
“We’re strong believers in aggressively fostering the deployment of PAs and NPs in hospital medicine, and, as a PA, I value SHM’s efforts to be a ‘big tent’ organization,” Levy said. “SHM, among professional societies, has been a model of inclusiveness, of encouraging all providers, and [for] providing a forum for like-minded people to collaborate.”
Even prior to the group membership, Dr. Burgess was an active SHM member, citing SHM as a key driver in his development of iNDIGO’s pediatric hospitalist team. He describes how The Pediatric Hospital Medicine Core Competencies, a publication outlining the key clinical skills and objectives for a pediatric hospital medicine team, continues to be critical in onboarding new colleagues and strengthening teams in community hospitals.
“In a community hospital, we’re somewhat removed from the cutting-edge research and programs being implemented at larger academic institutions,” Dr. Burgess said. “SHM provides that information to us and allows us to see trends and connect with colleagues in larger programs.”
Through SHM’s implementation toolkits and online forums, such as the Hospital Medicine Exchange (HMX), iNDIGO hospitalists have access to resources from leaders in the field that are not typically available in a community hospital. Over the last 2 years, Dr. Burgess’ team has implemented the Pediatric Early Warning System (PEWS), a scoring system presented at Hospital Medicine 2013 to aid in the identification of hospitalized patients at risk for clinical deterioration.
It is not only SHM’s resources that enhance iNDIGO’s hospital medicine practice. “As a former member of SHM’s Public Policy Committee, I especially respect the advocacy that SHM does so effectively in Washington to ensure that federal policy being developed positively affects hospitalists and the patients they serve,” Levy said. SHM’s recent advocacy efforts include work on observation status as well as physician payment and the Medicare Access and CHIP Reauthorization Act (MACRA).
iNDIGO continues to seek out partnerships with SHM at a local and national level, bringing best practices and innovative ideas – like a flexible scheduling system not reflective of the typical 7-on/7-off hospitalist schedule – to SHM and its members throughout the country.
From quality improvement and leadership training to advocacy and education, SHM helps hospital medicine professionals to build successful teams. “One of our goals is to develop great teams rather than just staffing programs,” Levy said. “Great teams need great leaders, and SHM’s resources promote and strengthen our on-the-ground leaders.”
To learn more about the membership opportunities available to you and your hospital medicine team, visit joinshm.org.
Brett Radler is SHM’s communications specialist.
When it comes to developing, maintaining, and growing an effective hospital medicine team, James W. Levy, PA-C, SFHM, certified physician assistant and managing partner of iNDIGO Health Partners, credits much of the company’s success to a decision to purchase a group SHM membership for its hospital medicine team. Recognizing the value that membership brings, it was an easy decision to extend a group membership to iNDIGO’s hospital medicine team.
“As a company, we are strong supporters of SHM and its mission,” Mr. Levy said. “This seemed like the best way we could support SHM and allow all our providers access to all the personal and professional benefits of SHM membership.”
“We’re strong believers in aggressively fostering the deployment of PAs and NPs in hospital medicine, and, as a PA, I value SHM’s efforts to be a ‘big tent’ organization,” Levy said. “SHM, among professional societies, has been a model of inclusiveness, of encouraging all providers, and [for] providing a forum for like-minded people to collaborate.”
Even prior to the group membership, Dr. Burgess was an active SHM member, citing SHM as a key driver in his development of iNDIGO’s pediatric hospitalist team. He describes how The Pediatric Hospital Medicine Core Competencies, a publication outlining the key clinical skills and objectives for a pediatric hospital medicine team, continues to be critical in onboarding new colleagues and strengthening teams in community hospitals.
“In a community hospital, we’re somewhat removed from the cutting-edge research and programs being implemented at larger academic institutions,” Dr. Burgess said. “SHM provides that information to us and allows us to see trends and connect with colleagues in larger programs.”
Through SHM’s implementation toolkits and online forums, such as the Hospital Medicine Exchange (HMX), iNDIGO hospitalists have access to resources from leaders in the field that are not typically available in a community hospital. Over the last 2 years, Dr. Burgess’ team has implemented the Pediatric Early Warning System (PEWS), a scoring system presented at Hospital Medicine 2013 to aid in the identification of hospitalized patients at risk for clinical deterioration.
It is not only SHM’s resources that enhance iNDIGO’s hospital medicine practice. “As a former member of SHM’s Public Policy Committee, I especially respect the advocacy that SHM does so effectively in Washington to ensure that federal policy being developed positively affects hospitalists and the patients they serve,” Levy said. SHM’s recent advocacy efforts include work on observation status as well as physician payment and the Medicare Access and CHIP Reauthorization Act (MACRA).
iNDIGO continues to seek out partnerships with SHM at a local and national level, bringing best practices and innovative ideas – like a flexible scheduling system not reflective of the typical 7-on/7-off hospitalist schedule – to SHM and its members throughout the country.
From quality improvement and leadership training to advocacy and education, SHM helps hospital medicine professionals to build successful teams. “One of our goals is to develop great teams rather than just staffing programs,” Levy said. “Great teams need great leaders, and SHM’s resources promote and strengthen our on-the-ground leaders.”
To learn more about the membership opportunities available to you and your hospital medicine team, visit joinshm.org.
Brett Radler is SHM’s communications specialist.
When it comes to developing, maintaining, and growing an effective hospital medicine team, James W. Levy, PA-C, SFHM, certified physician assistant and managing partner of iNDIGO Health Partners, credits much of the company’s success to a decision to purchase a group SHM membership for its hospital medicine team. Recognizing the value that membership brings, it was an easy decision to extend a group membership to iNDIGO’s hospital medicine team.
“As a company, we are strong supporters of SHM and its mission,” Mr. Levy said. “This seemed like the best way we could support SHM and allow all our providers access to all the personal and professional benefits of SHM membership.”
“We’re strong believers in aggressively fostering the deployment of PAs and NPs in hospital medicine, and, as a PA, I value SHM’s efforts to be a ‘big tent’ organization,” Levy said. “SHM, among professional societies, has been a model of inclusiveness, of encouraging all providers, and [for] providing a forum for like-minded people to collaborate.”
Even prior to the group membership, Dr. Burgess was an active SHM member, citing SHM as a key driver in his development of iNDIGO’s pediatric hospitalist team. He describes how The Pediatric Hospital Medicine Core Competencies, a publication outlining the key clinical skills and objectives for a pediatric hospital medicine team, continues to be critical in onboarding new colleagues and strengthening teams in community hospitals.
“In a community hospital, we’re somewhat removed from the cutting-edge research and programs being implemented at larger academic institutions,” Dr. Burgess said. “SHM provides that information to us and allows us to see trends and connect with colleagues in larger programs.”
Through SHM’s implementation toolkits and online forums, such as the Hospital Medicine Exchange (HMX), iNDIGO hospitalists have access to resources from leaders in the field that are not typically available in a community hospital. Over the last 2 years, Dr. Burgess’ team has implemented the Pediatric Early Warning System (PEWS), a scoring system presented at Hospital Medicine 2013 to aid in the identification of hospitalized patients at risk for clinical deterioration.
It is not only SHM’s resources that enhance iNDIGO’s hospital medicine practice. “As a former member of SHM’s Public Policy Committee, I especially respect the advocacy that SHM does so effectively in Washington to ensure that federal policy being developed positively affects hospitalists and the patients they serve,” Levy said. SHM’s recent advocacy efforts include work on observation status as well as physician payment and the Medicare Access and CHIP Reauthorization Act (MACRA).
iNDIGO continues to seek out partnerships with SHM at a local and national level, bringing best practices and innovative ideas – like a flexible scheduling system not reflective of the typical 7-on/7-off hospitalist schedule – to SHM and its members throughout the country.
From quality improvement and leadership training to advocacy and education, SHM helps hospital medicine professionals to build successful teams. “One of our goals is to develop great teams rather than just staffing programs,” Levy said. “Great teams need great leaders, and SHM’s resources promote and strengthen our on-the-ground leaders.”
To learn more about the membership opportunities available to you and your hospital medicine team, visit joinshm.org.
Brett Radler is SHM’s communications specialist.