LAS VEGAS─In recent years there has been an explosion in barefoot running, as well as the purchase and use of “minimalist” running shoes that more closely resemble barefoot running by encouraging the balls of the feet, between the arch and toes, to hit the pavement first. A new study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that a significant number of experienced runners, age 30 years and older (40% of men and 20% of women), maintained a heel-first running pattern—which naturally occurs when wearing a shoe with an elevated heel—when running without shoes. Maintaining a heel-toe pattern while running barefoot or in a minimalist shoe may lead to more frequent injuries.

“Previous studies have demonstrated that an adolescent runner’s foot strike is heavily influenced by their running shoe,” said orthopedic surgeon Scott Mullen, MD, the lead author of the study. “Young runners quickly adapt to a forefoot strike pattern when running barefoot, whereas a heel strike is normally associated with wearing large-heeled training shoes.”

In this study, a team of researchers from the University of Kansas Department of Orthopedics and Sports Medicine measured the heel-to-toe drop of 26 runners, all age 30 years or older with at least 10 years of running experience, when each ran in a traditional running shoe, and again when barefoot. The heel and forefoot thickness was measured at running speeds of 6, 7, and 8 miles per hour (mph) for women, and 7, 8, and 9 mph for men. A motion capture system was utilized to analyze foot strikes by a single blinded examiner skilled in the use of the camera system and running mechanics.

Heel-to-toe thickness of the running shoe did not significantly correlate with a change in heel strike, nor did alterations in speed. Running barefoot resulted in a significant drop in percent heel strike at all speeds; however, 40% of the men and 20% of the women persisted with consistent strike patterns across all speeds with and without shoes.

“Our study indicates that older runners (age 30 years and older) are not able to adapt as quickly to running barefoot,” said Dr. Mullen. “The inability to adapt the foot strike to the change in shoe type may put these runners at increased risk of injury. Older runners should be cautious when transitioning to a more minimalist type of shoe.”

LAS VEGAS─In recent years there has been an explosion in barefoot running, as well as the purchase and use of “minimalist” running shoes that more closely resemble barefoot running by encouraging the balls of the feet, between the arch and toes, to hit the pavement first. A new study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that a significant number of experienced runners, age 30 years and older (40% of men and 20% of women), maintained a heel-first running pattern—which naturally occurs when wearing a shoe with an elevated heel—when running without shoes. Maintaining a heel-toe pattern while running barefoot or in a minimalist shoe may lead to more frequent injuries.

“Previous studies have demonstrated that an adolescent runner’s foot strike is heavily influenced by their running shoe,” said orthopedic surgeon Scott Mullen, MD, the lead author of the study. “Young runners quickly adapt to a forefoot strike pattern when running barefoot, whereas a heel strike is normally associated with wearing large-heeled training shoes.”

In this study, a team of researchers from the University of Kansas Department of Orthopedics and Sports Medicine measured the heel-to-toe drop of 26 runners, all age 30 years or older with at least 10 years of running experience, when each ran in a traditional running shoe, and again when barefoot. The heel and forefoot thickness was measured at running speeds of 6, 7, and 8 miles per hour (mph) for women, and 7, 8, and 9 mph for men. A motion capture system was utilized to analyze foot strikes by a single blinded examiner skilled in the use of the camera system and running mechanics.

Heel-to-toe thickness of the running shoe did not significantly correlate with a change in heel strike, nor did alterations in speed. Running barefoot resulted in a significant drop in percent heel strike at all speeds; however, 40% of the men and 20% of the women persisted with consistent strike patterns across all speeds with and without shoes.

“Our study indicates that older runners (age 30 years and older) are not able to adapt as quickly to running barefoot,” said Dr. Mullen. “The inability to adapt the foot strike to the change in shoe type may put these runners at increased risk of injury. Older runners should be cautious when transitioning to a more minimalist type of shoe.”

LAS VEGAS─In recent years there has been an explosion in barefoot running, as well as the purchase and use of “minimalist” running shoes that more closely resemble barefoot running by encouraging the balls of the feet, between the arch and toes, to hit the pavement first. A new study presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that a significant number of experienced runners, age 30 years and older (40% of men and 20% of women), maintained a heel-first running pattern—which naturally occurs when wearing a shoe with an elevated heel—when running without shoes. Maintaining a heel-toe pattern while running barefoot or in a minimalist shoe may lead to more frequent injuries.

“Previous studies have demonstrated that an adolescent runner’s foot strike is heavily influenced by their running shoe,” said orthopedic surgeon Scott Mullen, MD, the lead author of the study. “Young runners quickly adapt to a forefoot strike pattern when running barefoot, whereas a heel strike is normally associated with wearing large-heeled training shoes.”

In this study, a team of researchers from the University of Kansas Department of Orthopedics and Sports Medicine measured the heel-to-toe drop of 26 runners, all age 30 years or older with at least 10 years of running experience, when each ran in a traditional running shoe, and again when barefoot. The heel and forefoot thickness was measured at running speeds of 6, 7, and 8 miles per hour (mph) for women, and 7, 8, and 9 mph for men. A motion capture system was utilized to analyze foot strikes by a single blinded examiner skilled in the use of the camera system and running mechanics.

Heel-to-toe thickness of the running shoe did not significantly correlate with a change in heel strike, nor did alterations in speed. Running barefoot resulted in a significant drop in percent heel strike at all speeds; however, 40% of the men and 20% of the women persisted with consistent strike patterns across all speeds with and without shoes.

“Our study indicates that older runners (age 30 years and older) are not able to adapt as quickly to running barefoot,” said Dr. Mullen. “The inability to adapt the foot strike to the change in shoe type may put these runners at increased risk of injury. Older runners should be cautious when transitioning to a more minimalist type of shoe.”

LAS VEGAS—Improved surgical, pain management, and rehabilitation procedures can allow patients who undergo a total hip replacement (THR) to safely drive as early as 2 weeks following surgery, according to new research presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

Each year, more than 322,000 patients undergo hip replacement surgery in the United States. Previous studies, conducted more than a decade ago, recommended between 6 and 8 weeks of recovery before driving; however, recent advances in surgical treatment and care may have shortened this time frame. A shorter driving ban would allow patients to more quickly resume daily activities and return to work.

In this study, which appeared online November 2014 in the Journal of Arthroplasty, researchers evaluated 38 patients who underwent right THR between 2013 and 2014. Driving performance was evaluated using the Brake Reaction Test (BRT), which measures brake time reaction after a stimulus. All patients underwent preoperative assessment to establish a baseline reaction time, and then agreed to be retested at 2, 4, and 6 weeks after surgery. Patients were allowed to drive when their postoperative reaction time was equal to or less than their preoperative baseline reaction time. At each testing session patients were asked if they felt ready to drive again.

Of the 38 patients, 33 (87%) reached their baseline time within 2 weeks. The remaining patients (13%) reached their baseline at 4 weeks. Among the other findings of the study:

• There were no differences with respect to age, gender, or the use of assistance devices in terms of driving readiness.

• Of the 33 patients who tested ready to drive at 2 weeks, 24 (73%) stated that they felt ready to drive while 5 (15%) were not sure. Four patients (12%) reported that they did not feel ready to drive.

• Of the 5 patients who returned to driving at 4 weeks, 3 agreed that they were not able to drive at the 2-week mark, and the other 2 thought they were able to drive by 2 weeks.

“We found that brake reaction time returned to baseline or better in the vast majority of patients undergoing contemporary THR by 2 weeks following surgery, and all patients achieved a safe brake reaction time according to nationally recognized guidelines,” said lead study author and orthopedic surgeon Victor Hugo Hernandez, MD.

Dr. Hernandez said the “findings have allowed us to encourage patients to re-evaluate their driving ability as soon as 2 weeks after THR,” but warned that the study results “are based on our particular population, and caution should be taken in translating these results to the regular population.” In addition, patients should never drive if they are still taking narcotic pain medication.

LAS VEGAS—Improved surgical, pain management, and rehabilitation procedures can allow patients who undergo a total hip replacement (THR) to safely drive as early as 2 weeks following surgery, according to new research presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

Each year, more than 322,000 patients undergo hip replacement surgery in the United States. Previous studies, conducted more than a decade ago, recommended between 6 and 8 weeks of recovery before driving; however, recent advances in surgical treatment and care may have shortened this time frame. A shorter driving ban would allow patients to more quickly resume daily activities and return to work.

In this study, which appeared online November 2014 in the Journal of Arthroplasty, researchers evaluated 38 patients who underwent right THR between 2013 and 2014. Driving performance was evaluated using the Brake Reaction Test (BRT), which measures brake time reaction after a stimulus. All patients underwent preoperative assessment to establish a baseline reaction time, and then agreed to be retested at 2, 4, and 6 weeks after surgery. Patients were allowed to drive when their postoperative reaction time was equal to or less than their preoperative baseline reaction time. At each testing session patients were asked if they felt ready to drive again.

Of the 38 patients, 33 (87%) reached their baseline time within 2 weeks. The remaining patients (13%) reached their baseline at 4 weeks. Among the other findings of the study:

• There were no differences with respect to age, gender, or the use of assistance devices in terms of driving readiness.

• Of the 33 patients who tested ready to drive at 2 weeks, 24 (73%) stated that they felt ready to drive while 5 (15%) were not sure. Four patients (12%) reported that they did not feel ready to drive.

• Of the 5 patients who returned to driving at 4 weeks, 3 agreed that they were not able to drive at the 2-week mark, and the other 2 thought they were able to drive by 2 weeks.

“We found that brake reaction time returned to baseline or better in the vast majority of patients undergoing contemporary THR by 2 weeks following surgery, and all patients achieved a safe brake reaction time according to nationally recognized guidelines,” said lead study author and orthopedic surgeon Victor Hugo Hernandez, MD.

Dr. Hernandez said the “findings have allowed us to encourage patients to re-evaluate their driving ability as soon as 2 weeks after THR,” but warned that the study results “are based on our particular population, and caution should be taken in translating these results to the regular population.” In addition, patients should never drive if they are still taking narcotic pain medication.

LAS VEGAS—Improved surgical, pain management, and rehabilitation procedures can allow patients who undergo a total hip replacement (THR) to safely drive as early as 2 weeks following surgery, according to new research presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

Each year, more than 322,000 patients undergo hip replacement surgery in the United States. Previous studies, conducted more than a decade ago, recommended between 6 and 8 weeks of recovery before driving; however, recent advances in surgical treatment and care may have shortened this time frame. A shorter driving ban would allow patients to more quickly resume daily activities and return to work.

In this study, which appeared online November 2014 in the Journal of Arthroplasty, researchers evaluated 38 patients who underwent right THR between 2013 and 2014. Driving performance was evaluated using the Brake Reaction Test (BRT), which measures brake time reaction after a stimulus. All patients underwent preoperative assessment to establish a baseline reaction time, and then agreed to be retested at 2, 4, and 6 weeks after surgery. Patients were allowed to drive when their postoperative reaction time was equal to or less than their preoperative baseline reaction time. At each testing session patients were asked if they felt ready to drive again.

Of the 38 patients, 33 (87%) reached their baseline time within 2 weeks. The remaining patients (13%) reached their baseline at 4 weeks. Among the other findings of the study:

• There were no differences with respect to age, gender, or the use of assistance devices in terms of driving readiness.

• Of the 33 patients who tested ready to drive at 2 weeks, 24 (73%) stated that they felt ready to drive while 5 (15%) were not sure. Four patients (12%) reported that they did not feel ready to drive.

• Of the 5 patients who returned to driving at 4 weeks, 3 agreed that they were not able to drive at the 2-week mark, and the other 2 thought they were able to drive by 2 weeks.

“We found that brake reaction time returned to baseline or better in the vast majority of patients undergoing contemporary THR by 2 weeks following surgery, and all patients achieved a safe brake reaction time according to nationally recognized guidelines,” said lead study author and orthopedic surgeon Victor Hugo Hernandez, MD.

Dr. Hernandez said the “findings have allowed us to encourage patients to re-evaluate their driving ability as soon as 2 weeks after THR,” but warned that the study results “are based on our particular population, and caution should be taken in translating these results to the regular population.” In addition, patients should never drive if they are still taking narcotic pain medication.

LAS VEGAS—Chronic low back pain can limit everyday activities, including sex. New research presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that 70% of patients consider sexual activity “relevant” to their quality of life, and patients who receive surgical treatment for spinal degenerative spondylolisthesis (DS) and spinal stenosis (SS) were twice as likely to report no pain during sex.

“Our current research sheds light on the effect that spinal surgery has on a patient’s sex life and begins to describe the impact spinal disease has on this very important aspect of life,” said senior study author Shane Burch, MD, an orthopedic surgeon at the University of California, San Francisco.

Researchers reviewed data from the Spine Patients Outcomes Research Trial (SPORT) of 1,235 patients diagnosed with DS or SS. Patient responses to the question, “In the past week, how has pain affected your sex life?” were used to determine sex-life relevance. Patients selecting the options, “unable to answer” or “does not apply to me,” were placed in the sex-life non-relevant (NR) group. Patients selecting other options were placed into the sex-life relevant (SLR) group. The mean age of patients in the NR and SLR groups were 68 years and 63 years, respectively. Seventy percent of patients were in the SLR group.

There was a higher association of being in the NR group for patients who were female or unmarried, or had a coexisting joint problem or hypertension. At baseline, 40% of SLR patients reported having some level of pain related to sex.

The study included 825 patients, 449 with SS and 376 with DS. A total of 294 patients received nonoperative treatment, and 531 received surgical treatment. The nonoperative patients were more likely to report pain related to sex at all follow-up time frames (from 41% compared to 20%). The percentages remained constant during annual visits at 1 year, 2 years, 3 years, and 4 years after surgery. Prior studies found that 41% of physicians routinely question patients with lumbar disc herniation about sexual problems.

“Our current research has two important findings,” said Dr. Horst. “The first is that sexual activity and sexual function is an important consideration for patients with degenerative spine conditions. The study also shows that sexual function is a more relevant consideration for patients who are married, younger, and male. The second important finding of our study is that patients with degenerative conditions of the spine treated with surgery reported less pain with their sex life compared to patients treated without surgery. This finding lasted throughout the four years of follow-up.”

LAS VEGAS—Chronic low back pain can limit everyday activities, including sex. New research presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that 70% of patients consider sexual activity “relevant” to their quality of life, and patients who receive surgical treatment for spinal degenerative spondylolisthesis (DS) and spinal stenosis (SS) were twice as likely to report no pain during sex.

“Our current research sheds light on the effect that spinal surgery has on a patient’s sex life and begins to describe the impact spinal disease has on this very important aspect of life,” said senior study author Shane Burch, MD, an orthopedic surgeon at the University of California, San Francisco.

Researchers reviewed data from the Spine Patients Outcomes Research Trial (SPORT) of 1,235 patients diagnosed with DS or SS. Patient responses to the question, “In the past week, how has pain affected your sex life?” were used to determine sex-life relevance. Patients selecting the options, “unable to answer” or “does not apply to me,” were placed in the sex-life non-relevant (NR) group. Patients selecting other options were placed into the sex-life relevant (SLR) group. The mean age of patients in the NR and SLR groups were 68 years and 63 years, respectively. Seventy percent of patients were in the SLR group.

There was a higher association of being in the NR group for patients who were female or unmarried, or had a coexisting joint problem or hypertension. At baseline, 40% of SLR patients reported having some level of pain related to sex.

The study included 825 patients, 449 with SS and 376 with DS. A total of 294 patients received nonoperative treatment, and 531 received surgical treatment. The nonoperative patients were more likely to report pain related to sex at all follow-up time frames (from 41% compared to 20%). The percentages remained constant during annual visits at 1 year, 2 years, 3 years, and 4 years after surgery. Prior studies found that 41% of physicians routinely question patients with lumbar disc herniation about sexual problems.

“Our current research has two important findings,” said Dr. Horst. “The first is that sexual activity and sexual function is an important consideration for patients with degenerative spine conditions. The study also shows that sexual function is a more relevant consideration for patients who are married, younger, and male. The second important finding of our study is that patients with degenerative conditions of the spine treated with surgery reported less pain with their sex life compared to patients treated without surgery. This finding lasted throughout the four years of follow-up.”

LAS VEGAS—Chronic low back pain can limit everyday activities, including sex. New research presented at the 2015 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) found that 70% of patients consider sexual activity “relevant” to their quality of life, and patients who receive surgical treatment for spinal degenerative spondylolisthesis (DS) and spinal stenosis (SS) were twice as likely to report no pain during sex.

“Our current research sheds light on the effect that spinal surgery has on a patient’s sex life and begins to describe the impact spinal disease has on this very important aspect of life,” said senior study author Shane Burch, MD, an orthopedic surgeon at the University of California, San Francisco.

Researchers reviewed data from the Spine Patients Outcomes Research Trial (SPORT) of 1,235 patients diagnosed with DS or SS. Patient responses to the question, “In the past week, how has pain affected your sex life?” were used to determine sex-life relevance. Patients selecting the options, “unable to answer” or “does not apply to me,” were placed in the sex-life non-relevant (NR) group. Patients selecting other options were placed into the sex-life relevant (SLR) group. The mean age of patients in the NR and SLR groups were 68 years and 63 years, respectively. Seventy percent of patients were in the SLR group.

There was a higher association of being in the NR group for patients who were female or unmarried, or had a coexisting joint problem or hypertension. At baseline, 40% of SLR patients reported having some level of pain related to sex.

The study included 825 patients, 449 with SS and 376 with DS. A total of 294 patients received nonoperative treatment, and 531 received surgical treatment. The nonoperative patients were more likely to report pain related to sex at all follow-up time frames (from 41% compared to 20%). The percentages remained constant during annual visits at 1 year, 2 years, 3 years, and 4 years after surgery. Prior studies found that 41% of physicians routinely question patients with lumbar disc herniation about sexual problems.

“Our current research has two important findings,” said Dr. Horst. “The first is that sexual activity and sexual function is an important consideration for patients with degenerative spine conditions. The study also shows that sexual function is a more relevant consideration for patients who are married, younger, and male. The second important finding of our study is that patients with degenerative conditions of the spine treated with surgery reported less pain with their sex life compared to patients treated without surgery. This finding lasted throughout the four years of follow-up.”

Management of thyroid disease during pregnancy presents unique challenges due to physiologic changes that occur. These include
• Serum levels of thyroxine-binding globulin (TBG) increase along with estrogen; in turn, total thyroxine (T4) and triiodothyronine (T3) levels increase.
• Human chorionic gonadotropin (hCG) stimulates the thyroid stimulating hormone (TSH) receptors.¹

Since hCG and TSH share similar glycoprotein subunits, a transient suppression of TSH—especially around weeks 10 to 12, when hCG concentrations peak—is considered a physiologic finding. Interpretation of thyroid function testing should be made in relation to the hCG-mediated decrease in serum TSH levels.²

The following four cases will help guide your clinical management of thyroid disease in both preconception and pregnancy. Inadequately controlled thyroid dysfunction can lead to poor pregnancy outcomes for both mother and child, which will be further discussed.

Continue for Case 1: Stable Hypothyroidism >>

 

CASE 1: STABLE ­HYPOTHYROIDISM
A 29-year-old woman with stable primary hypothyroidism calls your office to report that she is pregnant. She has taken levothyroxine (100 mg) for the past three years, and her TSH level was 1.21 mIU/L at last measurement. She denies any symptoms of hyperthyroidism or hypothyroidism. What is your next step in her management?

Recommendation
The American Thyroid Association recommends monitoring serum TSH every four weeks during the first half of pregnancy and at least once per trimester thereafter, with frequency depending on symptoms and TSH levels.³ Most women will require higher doses of levothyroxine supplementation to maintain therapeutic TSH levels.

Prior to 18 weeks’ gestation, the fetus is dependent on maternal thyroid hormone. When pregnancy is confirmed, there is support in the literature for having the patient take two additional doses of levothyroxine per week until TSH can be tested.⁴ However, many endocrinology practices opt to check TSH and total T4 as soon as pregnancy is confirmed.

Since free T4 results may be unreliable during pregnancy (due to the effect of TBG), free thyroxine index (FTI) or total T4 should be monitored instead. FTI mathematically corrects free T4 for TBG levels, making it a useful marker. If total T4 is measured, it is important to remember that results will be approximately 1.5x the nonpregnancy value; thus, the reference range must be multiplied by 1.5 to calculate appropriate high and low parameters for pregnant patients.

Ideally, all women of childbearing age should be encouraged to plan pregnancy, to ensure TSH is at target prior to conception. Maintaining a euthyroid state throughout pregnancy (starting at conception) is important to decrease risk for such adverse outcomes as spontaneous abortion, placental abruption, and gestational hypertension.² Low birth weight and respiratory distress are potential complications for newborns whose mothers have inadequately controlled hypothyroidism.

Patients should be counseled against simultaneous dosing of prenatal vitamins and levothyroxine. Prenatal vitamins contain iron, which reduces absorption of levothyroxine; therefore, it is recommended that the levothyroxine be taken four hours or more apart from prenatal vitamins.

The Endocrine Society recommends a TSH no higher than 2.5 mIU/L for hypothyroidism diagnosed prior to pregnancy.^2,3 After delivery, levothyroxine doses should be reduced to prepregnancy levels, with close monitoring of TSH.²

Next page: Case 2 >>

 

CASE 2: HISTORY OF SPONTANEOUS ABORTION
A 36-year-old G3P0 woman visits your office for a work-up after her third spontaneous abortion at 16 weeks. The patient denies history of thyroid disease but notes her maternal grandmother has Hashimoto disease. She denies symptoms of hyperthyroidism or hypothyroidism. 

Recommendation
Both hyperthyroidism and hypothyroidism are associated with an increase in spontaneous abortion, premature labor, and low birth weight. Negro et al observed an increased risk for fetal loss, small-for-gestational-age fetus, premature delivery, and premature mortality in women who were TPO-antibody-positive, even if they were euthyroid. Improved fetal outcomes occurred when TPO-antibody-positive mothers received supplemental levothyroxine.⁵

However, the American Thyroid Association and the Endocrine Society state there is currently insufficient evidence to recommend universal screening of thyroid antibodies during pregnancy.^2,3 Obtaining thyroid function studies and TPO-antibody tests could be considered as part of a work-up for women who experience multiple spontaneous abortions or have a personal or family history of autoimmune diseases.

Continue for Case 3: Cardiovascular Symptoms >>

 

CASE 3: CARDIOVASCULAR SYMPTOMS
A 24-year-old primigravida woman presents with complaints of palpitations and increased anxiety. She is currently 28 weeks pregnant. Her TSH level is undetectable (< 0.01 mIU/L), and her free T4 is 2.1 mg/dL (reference range, 0.5-1.6 mg/dL). An ECG performed at your office shows sinus tachycardia with a rate of 127 beats/min. 

Recommendation
Maternal hyperthyroidism increases risk for maternal congestive heart failure, uncontrolled hypertension, atrial fibrillation, and thyroid storm. Additionally, fetal hyperthyroidism can occur, especially if the mother has Graves disease. Since thyroid-stimulating immunoglobulins (TSI) can permeate the placental barrier, poor fetal growth, cardiac failure, and fetal thyrotoxicosis are severe adverse effects of in-utero TSI exposure.

To prevent further complications, antithyroid medications should be started in this case. Methimazole (MMI) carries a risk for a rare birth defect, aplasia cutis, in the first trimester and is best avoided during this time. Propylthiouracil (PTU) should be given in the first trimester and then switched to MMI in the second trimester to decrease the risk for hepatotoxicity associated with PTU. Breastfeeding mothers should be assured that low-dose MMI is generally considered safe for breastfed infants but should be taken after feeding in divided doses if possible.¹

For symptom relief, b-blockers can be used, although they do come with some risks. As pregnancy Category C drugs, b-blockers are associated with neonatal growth retardation, hypoglycemia, hypoxia, lower Apgar scores, and neonatal respiratory distress.⁶ Consider giving the lowest dose possible for the duration of the patient’s symptoms. 

Radioactive iodine (I-131) should not be given to patients who plan to become pregnant or who are pregnant.^2,3 The Endocrine Society recommends that if a woman inadvertently becomes pregnant, she should be counseled on the risks of radiation to the fetus, which include thyroid destruction if treatment occurs/continues after the 12th week of pregnancy.² Furthermore, pregnancy should be avoided for the first six months after thyroid ablation to allow sufficient time to obtain the target maternal serum TSH level of 0.3 to 2.5 mIU/L.

Next page: Case 4 >>

 

CASE 4: PRECONCEPTION SCREENING
A 39-year-old G0P0 woman presents for preconception counseling. She denies family or personal history of thyroid disease and symptoms of thyroid disease. Should she be screened?

Recommendation
There is no consensus or guideline regarding preconception laboratory screening for thyroid disease. Current guidelines by the American Thyroid Association, the American College of Obstetricians and Gynecologists, and The Endocrine Society recommend targeted, not universal, screening.^2,3,7

The American Thyroid Association and the Endocrine Society recommend screening TSH in women who are pregnant or intend to become pregnant and
• Have a personal or family history of thyroid disease
• Are older than 30
• Demonstrate symptoms of thyroid dysfunction
• Have goiter
• Are TPO-antibody positive
• Have type 1 diabetes or other autoimmune disorders
• Have a history of miscarriage or preterm delivery
• Have a history of head or neck radiation or thyroid surgery
• Are morbidly obese (BMI > 40)
• Use amiodarone or lithium or were exposed to iodinated radiologic contrast
• Are infertile
• Live in an area with moderate to severe iodine insufficiency.^2,3

Rationale for targeted screening of asymptomatic women: Large-scale research has not demonstrated significantly better outcomes in those with subclinical hypothyroidism who receive treatment.⁷ Small studies² have demonstrated improved fetal outcomes when subclinical hypothyroidism is treated, but for large bodies  (eg, the US Preventive Services Task Force) to recommend screening, a clear improvement in health outcomes must be established via controlled studies. Future research should evaluate the effect of treating subclinical hypothyroidism during pregnancy.

REFERENCES
1. Ballabio, M, Poshychinda M, Ekins RP. Pregnancy-induced changes in thyroid function: role of human chorionic gonadotropin as putative regulator of maternal thyroid. J Clin Endocrinol Metab. 1991;73(4):824.
2. The Endocrine Society. Management of thyroid disease in pregnancy and postpartum. J Clin Endocrinol Metab. 2012;97:2543–2565.
3. Stagnaro-Green A, Abalovich M, Alexander E, et al. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2011;21(10):1081-1125.
4. Alexander EK, Marqusee E, Lawrence J, et al. Timing and magnitude of increases in levothyroxine requirements during pregnancy in women with hypothyroidism. N Engl J Med. 2004;351:241-249.
5. Negro R, Formoso G, Mangieri T, et al. Levothyroxine treatment in euthyroid pregnant women with autoimmune thyroid disease: effects on obstetrical complications. Clin Endocrinol Metab. 2006;91(7):2587-2591.
6. Cooper DH. Antithyroid drugs. N Engl J Med. 2005;352:905-917.
7. American College of Obstetricians and Gynecologists. Routine thyroid screening not recommended for pregnant women. J Obstet Gynecol. 2007;110:959-960.

Management of thyroid disease during pregnancy presents unique challenges due to physiologic changes that occur. These include
• Serum levels of thyroxine-binding globulin (TBG) increase along with estrogen; in turn, total thyroxine (T4) and triiodothyronine (T3) levels increase.
• Human chorionic gonadotropin (hCG) stimulates the thyroid stimulating hormone (TSH) receptors.¹

Since hCG and TSH share similar glycoprotein subunits, a transient suppression of TSH—especially around weeks 10 to 12, when hCG concentrations peak—is considered a physiologic finding. Interpretation of thyroid function testing should be made in relation to the hCG-mediated decrease in serum TSH levels.²

The following four cases will help guide your clinical management of thyroid disease in both preconception and pregnancy. Inadequately controlled thyroid dysfunction can lead to poor pregnancy outcomes for both mother and child, which will be further discussed.

Continue for Case 1: Stable Hypothyroidism >>

 

CASE 1: STABLE ­HYPOTHYROIDISM
A 29-year-old woman with stable primary hypothyroidism calls your office to report that she is pregnant. She has taken levothyroxine (100 mg) for the past three years, and her TSH level was 1.21 mIU/L at last measurement. She denies any symptoms of hyperthyroidism or hypothyroidism. What is your next step in her management?

Recommendation
The American Thyroid Association recommends monitoring serum TSH every four weeks during the first half of pregnancy and at least once per trimester thereafter, with frequency depending on symptoms and TSH levels.³ Most women will require higher doses of levothyroxine supplementation to maintain therapeutic TSH levels.

Prior to 18 weeks’ gestation, the fetus is dependent on maternal thyroid hormone. When pregnancy is confirmed, there is support in the literature for having the patient take two additional doses of levothyroxine per week until TSH can be tested.⁴ However, many endocrinology practices opt to check TSH and total T4 as soon as pregnancy is confirmed.

Since free T4 results may be unreliable during pregnancy (due to the effect of TBG), free thyroxine index (FTI) or total T4 should be monitored instead. FTI mathematically corrects free T4 for TBG levels, making it a useful marker. If total T4 is measured, it is important to remember that results will be approximately 1.5x the nonpregnancy value; thus, the reference range must be multiplied by 1.5 to calculate appropriate high and low parameters for pregnant patients.

Ideally, all women of childbearing age should be encouraged to plan pregnancy, to ensure TSH is at target prior to conception. Maintaining a euthyroid state throughout pregnancy (starting at conception) is important to decrease risk for such adverse outcomes as spontaneous abortion, placental abruption, and gestational hypertension.² Low birth weight and respiratory distress are potential complications for newborns whose mothers have inadequately controlled hypothyroidism.

Patients should be counseled against simultaneous dosing of prenatal vitamins and levothyroxine. Prenatal vitamins contain iron, which reduces absorption of levothyroxine; therefore, it is recommended that the levothyroxine be taken four hours or more apart from prenatal vitamins.

The Endocrine Society recommends a TSH no higher than 2.5 mIU/L for hypothyroidism diagnosed prior to pregnancy.^2,3 After delivery, levothyroxine doses should be reduced to prepregnancy levels, with close monitoring of TSH.²

Next page: Case 2 >>

 

CASE 2: HISTORY OF SPONTANEOUS ABORTION
A 36-year-old G3P0 woman visits your office for a work-up after her third spontaneous abortion at 16 weeks. The patient denies history of thyroid disease but notes her maternal grandmother has Hashimoto disease. She denies symptoms of hyperthyroidism or hypothyroidism. 

Recommendation
Both hyperthyroidism and hypothyroidism are associated with an increase in spontaneous abortion, premature labor, and low birth weight. Negro et al observed an increased risk for fetal loss, small-for-gestational-age fetus, premature delivery, and premature mortality in women who were TPO-antibody-positive, even if they were euthyroid. Improved fetal outcomes occurred when TPO-antibody-positive mothers received supplemental levothyroxine.⁵

However, the American Thyroid Association and the Endocrine Society state there is currently insufficient evidence to recommend universal screening of thyroid antibodies during pregnancy.^2,3 Obtaining thyroid function studies and TPO-antibody tests could be considered as part of a work-up for women who experience multiple spontaneous abortions or have a personal or family history of autoimmune diseases.

Continue for Case 3: Cardiovascular Symptoms >>

 

CASE 3: CARDIOVASCULAR SYMPTOMS
A 24-year-old primigravida woman presents with complaints of palpitations and increased anxiety. She is currently 28 weeks pregnant. Her TSH level is undetectable (< 0.01 mIU/L), and her free T4 is 2.1 mg/dL (reference range, 0.5-1.6 mg/dL). An ECG performed at your office shows sinus tachycardia with a rate of 127 beats/min. 

Recommendation
Maternal hyperthyroidism increases risk for maternal congestive heart failure, uncontrolled hypertension, atrial fibrillation, and thyroid storm. Additionally, fetal hyperthyroidism can occur, especially if the mother has Graves disease. Since thyroid-stimulating immunoglobulins (TSI) can permeate the placental barrier, poor fetal growth, cardiac failure, and fetal thyrotoxicosis are severe adverse effects of in-utero TSI exposure.

To prevent further complications, antithyroid medications should be started in this case. Methimazole (MMI) carries a risk for a rare birth defect, aplasia cutis, in the first trimester and is best avoided during this time. Propylthiouracil (PTU) should be given in the first trimester and then switched to MMI in the second trimester to decrease the risk for hepatotoxicity associated with PTU. Breastfeeding mothers should be assured that low-dose MMI is generally considered safe for breastfed infants but should be taken after feeding in divided doses if possible.¹

For symptom relief, b-blockers can be used, although they do come with some risks. As pregnancy Category C drugs, b-blockers are associated with neonatal growth retardation, hypoglycemia, hypoxia, lower Apgar scores, and neonatal respiratory distress.⁶ Consider giving the lowest dose possible for the duration of the patient’s symptoms. 

Radioactive iodine (I-131) should not be given to patients who plan to become pregnant or who are pregnant.^2,3 The Endocrine Society recommends that if a woman inadvertently becomes pregnant, she should be counseled on the risks of radiation to the fetus, which include thyroid destruction if treatment occurs/continues after the 12th week of pregnancy.² Furthermore, pregnancy should be avoided for the first six months after thyroid ablation to allow sufficient time to obtain the target maternal serum TSH level of 0.3 to 2.5 mIU/L.

Next page: Case 4 >>

 

CASE 4: PRECONCEPTION SCREENING
A 39-year-old G0P0 woman presents for preconception counseling. She denies family or personal history of thyroid disease and symptoms of thyroid disease. Should she be screened?

Recommendation
There is no consensus or guideline regarding preconception laboratory screening for thyroid disease. Current guidelines by the American Thyroid Association, the American College of Obstetricians and Gynecologists, and The Endocrine Society recommend targeted, not universal, screening.^2,3,7

The American Thyroid Association and the Endocrine Society recommend screening TSH in women who are pregnant or intend to become pregnant and
• Have a personal or family history of thyroid disease
• Are older than 30
• Demonstrate symptoms of thyroid dysfunction
• Have goiter
• Are TPO-antibody positive
• Have type 1 diabetes or other autoimmune disorders
• Have a history of miscarriage or preterm delivery
• Have a history of head or neck radiation or thyroid surgery
• Are morbidly obese (BMI > 40)
• Use amiodarone or lithium or were exposed to iodinated radiologic contrast
• Are infertile
• Live in an area with moderate to severe iodine insufficiency.^2,3

Rationale for targeted screening of asymptomatic women: Large-scale research has not demonstrated significantly better outcomes in those with subclinical hypothyroidism who receive treatment.⁷ Small studies² have demonstrated improved fetal outcomes when subclinical hypothyroidism is treated, but for large bodies  (eg, the US Preventive Services Task Force) to recommend screening, a clear improvement in health outcomes must be established via controlled studies. Future research should evaluate the effect of treating subclinical hypothyroidism during pregnancy.

REFERENCES
1. Ballabio, M, Poshychinda M, Ekins RP. Pregnancy-induced changes in thyroid function: role of human chorionic gonadotropin as putative regulator of maternal thyroid. J Clin Endocrinol Metab. 1991;73(4):824.
2. The Endocrine Society. Management of thyroid disease in pregnancy and postpartum. J Clin Endocrinol Metab. 2012;97:2543–2565.
3. Stagnaro-Green A, Abalovich M, Alexander E, et al. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2011;21(10):1081-1125.
4. Alexander EK, Marqusee E, Lawrence J, et al. Timing and magnitude of increases in levothyroxine requirements during pregnancy in women with hypothyroidism. N Engl J Med. 2004;351:241-249.
5. Negro R, Formoso G, Mangieri T, et al. Levothyroxine treatment in euthyroid pregnant women with autoimmune thyroid disease: effects on obstetrical complications. Clin Endocrinol Metab. 2006;91(7):2587-2591.
6. Cooper DH. Antithyroid drugs. N Engl J Med. 2005;352:905-917.
7. American College of Obstetricians and Gynecologists. Routine thyroid screening not recommended for pregnant women. J Obstet Gynecol. 2007;110:959-960.

Management of thyroid disease during pregnancy presents unique challenges due to physiologic changes that occur. These include
• Serum levels of thyroxine-binding globulin (TBG) increase along with estrogen; in turn, total thyroxine (T4) and triiodothyronine (T3) levels increase.
• Human chorionic gonadotropin (hCG) stimulates the thyroid stimulating hormone (TSH) receptors.¹

Since hCG and TSH share similar glycoprotein subunits, a transient suppression of TSH—especially around weeks 10 to 12, when hCG concentrations peak—is considered a physiologic finding. Interpretation of thyroid function testing should be made in relation to the hCG-mediated decrease in serum TSH levels.²

The following four cases will help guide your clinical management of thyroid disease in both preconception and pregnancy. Inadequately controlled thyroid dysfunction can lead to poor pregnancy outcomes for both mother and child, which will be further discussed.

Continue for Case 1: Stable Hypothyroidism >>

 

CASE 1: STABLE ­HYPOTHYROIDISM
A 29-year-old woman with stable primary hypothyroidism calls your office to report that she is pregnant. She has taken levothyroxine (100 mg) for the past three years, and her TSH level was 1.21 mIU/L at last measurement. She denies any symptoms of hyperthyroidism or hypothyroidism. What is your next step in her management?

Recommendation
The American Thyroid Association recommends monitoring serum TSH every four weeks during the first half of pregnancy and at least once per trimester thereafter, with frequency depending on symptoms and TSH levels.³ Most women will require higher doses of levothyroxine supplementation to maintain therapeutic TSH levels.

Prior to 18 weeks’ gestation, the fetus is dependent on maternal thyroid hormone. When pregnancy is confirmed, there is support in the literature for having the patient take two additional doses of levothyroxine per week until TSH can be tested.⁴ However, many endocrinology practices opt to check TSH and total T4 as soon as pregnancy is confirmed.

Since free T4 results may be unreliable during pregnancy (due to the effect of TBG), free thyroxine index (FTI) or total T4 should be monitored instead. FTI mathematically corrects free T4 for TBG levels, making it a useful marker. If total T4 is measured, it is important to remember that results will be approximately 1.5x the nonpregnancy value; thus, the reference range must be multiplied by 1.5 to calculate appropriate high and low parameters for pregnant patients.

Ideally, all women of childbearing age should be encouraged to plan pregnancy, to ensure TSH is at target prior to conception. Maintaining a euthyroid state throughout pregnancy (starting at conception) is important to decrease risk for such adverse outcomes as spontaneous abortion, placental abruption, and gestational hypertension.² Low birth weight and respiratory distress are potential complications for newborns whose mothers have inadequately controlled hypothyroidism.

Patients should be counseled against simultaneous dosing of prenatal vitamins and levothyroxine. Prenatal vitamins contain iron, which reduces absorption of levothyroxine; therefore, it is recommended that the levothyroxine be taken four hours or more apart from prenatal vitamins.

The Endocrine Society recommends a TSH no higher than 2.5 mIU/L for hypothyroidism diagnosed prior to pregnancy.^2,3 After delivery, levothyroxine doses should be reduced to prepregnancy levels, with close monitoring of TSH.²

Next page: Case 2 >>

 

CASE 2: HISTORY OF SPONTANEOUS ABORTION
A 36-year-old G3P0 woman visits your office for a work-up after her third spontaneous abortion at 16 weeks. The patient denies history of thyroid disease but notes her maternal grandmother has Hashimoto disease. She denies symptoms of hyperthyroidism or hypothyroidism. 

Recommendation
Both hyperthyroidism and hypothyroidism are associated with an increase in spontaneous abortion, premature labor, and low birth weight. Negro et al observed an increased risk for fetal loss, small-for-gestational-age fetus, premature delivery, and premature mortality in women who were TPO-antibody-positive, even if they were euthyroid. Improved fetal outcomes occurred when TPO-antibody-positive mothers received supplemental levothyroxine.⁵

However, the American Thyroid Association and the Endocrine Society state there is currently insufficient evidence to recommend universal screening of thyroid antibodies during pregnancy.^2,3 Obtaining thyroid function studies and TPO-antibody tests could be considered as part of a work-up for women who experience multiple spontaneous abortions or have a personal or family history of autoimmune diseases.

Continue for Case 3: Cardiovascular Symptoms >>

 

CASE 3: CARDIOVASCULAR SYMPTOMS
A 24-year-old primigravida woman presents with complaints of palpitations and increased anxiety. She is currently 28 weeks pregnant. Her TSH level is undetectable (< 0.01 mIU/L), and her free T4 is 2.1 mg/dL (reference range, 0.5-1.6 mg/dL). An ECG performed at your office shows sinus tachycardia with a rate of 127 beats/min. 

Recommendation
Maternal hyperthyroidism increases risk for maternal congestive heart failure, uncontrolled hypertension, atrial fibrillation, and thyroid storm. Additionally, fetal hyperthyroidism can occur, especially if the mother has Graves disease. Since thyroid-stimulating immunoglobulins (TSI) can permeate the placental barrier, poor fetal growth, cardiac failure, and fetal thyrotoxicosis are severe adverse effects of in-utero TSI exposure.

To prevent further complications, antithyroid medications should be started in this case. Methimazole (MMI) carries a risk for a rare birth defect, aplasia cutis, in the first trimester and is best avoided during this time. Propylthiouracil (PTU) should be given in the first trimester and then switched to MMI in the second trimester to decrease the risk for hepatotoxicity associated with PTU. Breastfeeding mothers should be assured that low-dose MMI is generally considered safe for breastfed infants but should be taken after feeding in divided doses if possible.¹

For symptom relief, b-blockers can be used, although they do come with some risks. As pregnancy Category C drugs, b-blockers are associated with neonatal growth retardation, hypoglycemia, hypoxia, lower Apgar scores, and neonatal respiratory distress.⁶ Consider giving the lowest dose possible for the duration of the patient’s symptoms. 

Radioactive iodine (I-131) should not be given to patients who plan to become pregnant or who are pregnant.^2,3 The Endocrine Society recommends that if a woman inadvertently becomes pregnant, she should be counseled on the risks of radiation to the fetus, which include thyroid destruction if treatment occurs/continues after the 12th week of pregnancy.² Furthermore, pregnancy should be avoided for the first six months after thyroid ablation to allow sufficient time to obtain the target maternal serum TSH level of 0.3 to 2.5 mIU/L.

Next page: Case 4 >>

 

CASE 4: PRECONCEPTION SCREENING
A 39-year-old G0P0 woman presents for preconception counseling. She denies family or personal history of thyroid disease and symptoms of thyroid disease. Should she be screened?

Recommendation
There is no consensus or guideline regarding preconception laboratory screening for thyroid disease. Current guidelines by the American Thyroid Association, the American College of Obstetricians and Gynecologists, and The Endocrine Society recommend targeted, not universal, screening.^2,3,7

The American Thyroid Association and the Endocrine Society recommend screening TSH in women who are pregnant or intend to become pregnant and
• Have a personal or family history of thyroid disease
• Are older than 30
• Demonstrate symptoms of thyroid dysfunction
• Have goiter
• Are TPO-antibody positive
• Have type 1 diabetes or other autoimmune disorders
• Have a history of miscarriage or preterm delivery
• Have a history of head or neck radiation or thyroid surgery
• Are morbidly obese (BMI > 40)
• Use amiodarone or lithium or were exposed to iodinated radiologic contrast
• Are infertile
• Live in an area with moderate to severe iodine insufficiency.^2,3

Rationale for targeted screening of asymptomatic women: Large-scale research has not demonstrated significantly better outcomes in those with subclinical hypothyroidism who receive treatment.⁷ Small studies² have demonstrated improved fetal outcomes when subclinical hypothyroidism is treated, but for large bodies  (eg, the US Preventive Services Task Force) to recommend screening, a clear improvement in health outcomes must be established via controlled studies. Future research should evaluate the effect of treating subclinical hypothyroidism during pregnancy.

REFERENCES
1. Ballabio, M, Poshychinda M, Ekins RP. Pregnancy-induced changes in thyroid function: role of human chorionic gonadotropin as putative regulator of maternal thyroid. J Clin Endocrinol Metab. 1991;73(4):824.
2. The Endocrine Society. Management of thyroid disease in pregnancy and postpartum. J Clin Endocrinol Metab. 2012;97:2543–2565.
3. Stagnaro-Green A, Abalovich M, Alexander E, et al. Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2011;21(10):1081-1125.
4. Alexander EK, Marqusee E, Lawrence J, et al. Timing and magnitude of increases in levothyroxine requirements during pregnancy in women with hypothyroidism. N Engl J Med. 2004;351:241-249.
5. Negro R, Formoso G, Mangieri T, et al. Levothyroxine treatment in euthyroid pregnant women with autoimmune thyroid disease: effects on obstetrical complications. Clin Endocrinol Metab. 2006;91(7):2587-2591.
6. Cooper DH. Antithyroid drugs. N Engl J Med. 2005;352:905-917.
7. American College of Obstetricians and Gynecologists. Routine thyroid screening not recommended for pregnant women. J Obstet Gynecol. 2007;110:959-960.

In January 2009, an Alabama woman with multiple sclerosis visited Dr T., the defendant ob-gyn, for severe pelvic pain. Dr T. made a diagnosis of a fibroid uterus and ovarian cysts. The patient underwent a transvaginal hysterectomy, but her pain persisted after the surgery.

After being discharged, she discovered a long strip of packing protruding from her vagina, which Dr T. instructed her to extract herself. After doing so, however, the patient continued to have pain, bleeding, and a foul–smelling vaginal discharge. Dr T. diagnosed urinary tract infection and bacterial vaginosis. Antibiotics and pain medication were prescribed, but the patient’s pelvic pain persisted.

In April 2009, Dr T. ordered CT to rule out an abscess or a foreign body. A gauze surgical sponge, left at the conclusion of the patient’s hysterectomy, was detected. Surgery was performed to remove the sponge.

The plaintiff alleged negligence in the sponge’s retention, maintaining that not only was a second surgery required, but that her multiple sclerosis was exacerbated as a result of the entire situation.

The defendant claimed that tests had been performed to investigate the possibility of a foreign body, and that as soon as the surgical sponge was detected, it was removed.

What was the outcome? >>

 

OUTCOME
According to a published report, a defense verdict was returned.

COMMENT
The defense verdict here is surprising. In most cases in which surgical instruments are left in patients, plaintiffs prevail by using a legal doctrine known as res ipsa loquitur—a Latin legal term of art meaning “the thing speaks for itself.” This is generally requested as a jury charge, wherein the plaintiff asks the judge to explain to the jury that they may find negligence from a certain unusual fact that cannot have occurred without negligence (eg, a sponge left in a patient after surgery).

The history of res ipsa loquitur dates back to 1863 in the case of Byrne v Boadle, in which a barrel of flour rolled from a second-story window and struck a pedestrian below, causing serious injury. The defendants’ claim was that the plaintiff (who had no recollection of the event) was unable to show evidence of negligence. The court created the doctrine, holding that the fact of the accident itself provided ample evidence of negligence, excusing the plaintiff from the burden of proving that negligent acts (eg, inadequate harnessing of the barrels) led to the accident.

Why is this important? The concept of res ipsa loquitur is commonly invoked in medical malpractice actions. It generally requires three elements: the plaintiff suffers an unusual injury, the plaintiff was under the exclusive control of the medical defendants, and the plaintiff did not contribute to the injury.

In a leading malpractice case, Ybarra v Spangard (1944), a plaintiff awoke after undergoing an appendectomy with difficulty moving his arm as a result of reflex sympathetic dystrophy. The plaintiff alleged negligence stemming from the intraoperative positioning of his body, but he could not show the specifics of positioning during surgery. The court held that the patient’s body was under the exclusive control of the team of medical professionals, and that negligence could be inferred because loss of an arm’s function following an appendectomy is unusual and cannot occur without some negligent action involved.

When successfully used in malpractice cases, res ipsa loquitur relieves the plaintiff of the need to prove by a preponderance of the evidence the actions that led to the breach of the standard of care. In order to prevail, she must show the injury, the defendants’ exclusive control, and no contribution on her part. Practically, this permits the case to withstand defense motions for summary judgment and to be brought before a jury with scant to no evidence on the purported negligent act itself—merely the unusual injury and the defendants’ exclusive control.

Traditional application of the doctrine was limited to cases in which negligence was obvious to a layperson: for example, instruments left in patients or amputation of the wrong leg—the thing that “speaks for itself.” Newer evolution of the doctrine is problematic when extended to cases in which expert testimony should be required to demonstrate the standard of care and the defendant’s breach of it. When courts are willing to extend the doctrine, the plaintiff is awarded the presumption of negligence, which the defendant(s) must now come forward to rebut. For example, in a 2010 case in Illinois, a jury returned a $3.6 million verdict following the death of a 2-year-old who had had a seizure. The child’s seizure was reportedly controlled, but he was allegedly hypoventilated while undergoing CT and unfortunately died. The plaintiff was permitted to invoke the doctrine of res ipsa loquitur and was allowed the presumption that medical negligence was responsible for the outcome.

Unlike the surgical sponge left in a patient, matters of central nervous system status, monitoring during CT, airway and ventilation status, hypoxemia, and postictal states are not within the experience of the typical juror. The negligent “thing” is not a sponge that “speaks for itself,” but a course of actions that requires expert testimony precisely because it does not “speak for itself.” In cases in which an injury is ­beyond the average juror’s realm of experience, courts should require the plaintiff to prove her case. The doctrine should not “evolve” to excuse a plaintiff from the burden of producing evidence and persuading a jury. This forms the foundation of our civil law system. —DML

In January 2009, an Alabama woman with multiple sclerosis visited Dr T., the defendant ob-gyn, for severe pelvic pain. Dr T. made a diagnosis of a fibroid uterus and ovarian cysts. The patient underwent a transvaginal hysterectomy, but her pain persisted after the surgery.

After being discharged, she discovered a long strip of packing protruding from her vagina, which Dr T. instructed her to extract herself. After doing so, however, the patient continued to have pain, bleeding, and a foul–smelling vaginal discharge. Dr T. diagnosed urinary tract infection and bacterial vaginosis. Antibiotics and pain medication were prescribed, but the patient’s pelvic pain persisted.

In April 2009, Dr T. ordered CT to rule out an abscess or a foreign body. A gauze surgical sponge, left at the conclusion of the patient’s hysterectomy, was detected. Surgery was performed to remove the sponge.

The plaintiff alleged negligence in the sponge’s retention, maintaining that not only was a second surgery required, but that her multiple sclerosis was exacerbated as a result of the entire situation.

The defendant claimed that tests had been performed to investigate the possibility of a foreign body, and that as soon as the surgical sponge was detected, it was removed.

What was the outcome? >>

 

OUTCOME
According to a published report, a defense verdict was returned.

COMMENT
The defense verdict here is surprising. In most cases in which surgical instruments are left in patients, plaintiffs prevail by using a legal doctrine known as res ipsa loquitur—a Latin legal term of art meaning “the thing speaks for itself.” This is generally requested as a jury charge, wherein the plaintiff asks the judge to explain to the jury that they may find negligence from a certain unusual fact that cannot have occurred without negligence (eg, a sponge left in a patient after surgery).

The history of res ipsa loquitur dates back to 1863 in the case of Byrne v Boadle, in which a barrel of flour rolled from a second-story window and struck a pedestrian below, causing serious injury. The defendants’ claim was that the plaintiff (who had no recollection of the event) was unable to show evidence of negligence. The court created the doctrine, holding that the fact of the accident itself provided ample evidence of negligence, excusing the plaintiff from the burden of proving that negligent acts (eg, inadequate harnessing of the barrels) led to the accident.

Why is this important? The concept of res ipsa loquitur is commonly invoked in medical malpractice actions. It generally requires three elements: the plaintiff suffers an unusual injury, the plaintiff was under the exclusive control of the medical defendants, and the plaintiff did not contribute to the injury.

In a leading malpractice case, Ybarra v Spangard (1944), a plaintiff awoke after undergoing an appendectomy with difficulty moving his arm as a result of reflex sympathetic dystrophy. The plaintiff alleged negligence stemming from the intraoperative positioning of his body, but he could not show the specifics of positioning during surgery. The court held that the patient’s body was under the exclusive control of the team of medical professionals, and that negligence could be inferred because loss of an arm’s function following an appendectomy is unusual and cannot occur without some negligent action involved.

When successfully used in malpractice cases, res ipsa loquitur relieves the plaintiff of the need to prove by a preponderance of the evidence the actions that led to the breach of the standard of care. In order to prevail, she must show the injury, the defendants’ exclusive control, and no contribution on her part. Practically, this permits the case to withstand defense motions for summary judgment and to be brought before a jury with scant to no evidence on the purported negligent act itself—merely the unusual injury and the defendants’ exclusive control.

Traditional application of the doctrine was limited to cases in which negligence was obvious to a layperson: for example, instruments left in patients or amputation of the wrong leg—the thing that “speaks for itself.” Newer evolution of the doctrine is problematic when extended to cases in which expert testimony should be required to demonstrate the standard of care and the defendant’s breach of it. When courts are willing to extend the doctrine, the plaintiff is awarded the presumption of negligence, which the defendant(s) must now come forward to rebut. For example, in a 2010 case in Illinois, a jury returned a $3.6 million verdict following the death of a 2-year-old who had had a seizure. The child’s seizure was reportedly controlled, but he was allegedly hypoventilated while undergoing CT and unfortunately died. The plaintiff was permitted to invoke the doctrine of res ipsa loquitur and was allowed the presumption that medical negligence was responsible for the outcome.

Unlike the surgical sponge left in a patient, matters of central nervous system status, monitoring during CT, airway and ventilation status, hypoxemia, and postictal states are not within the experience of the typical juror. The negligent “thing” is not a sponge that “speaks for itself,” but a course of actions that requires expert testimony precisely because it does not “speak for itself.” In cases in which an injury is ­beyond the average juror’s realm of experience, courts should require the plaintiff to prove her case. The doctrine should not “evolve” to excuse a plaintiff from the burden of producing evidence and persuading a jury. This forms the foundation of our civil law system. —DML

In January 2009, an Alabama woman with multiple sclerosis visited Dr T., the defendant ob-gyn, for severe pelvic pain. Dr T. made a diagnosis of a fibroid uterus and ovarian cysts. The patient underwent a transvaginal hysterectomy, but her pain persisted after the surgery.

After being discharged, she discovered a long strip of packing protruding from her vagina, which Dr T. instructed her to extract herself. After doing so, however, the patient continued to have pain, bleeding, and a foul–smelling vaginal discharge. Dr T. diagnosed urinary tract infection and bacterial vaginosis. Antibiotics and pain medication were prescribed, but the patient’s pelvic pain persisted.

In April 2009, Dr T. ordered CT to rule out an abscess or a foreign body. A gauze surgical sponge, left at the conclusion of the patient’s hysterectomy, was detected. Surgery was performed to remove the sponge.

The plaintiff alleged negligence in the sponge’s retention, maintaining that not only was a second surgery required, but that her multiple sclerosis was exacerbated as a result of the entire situation.

The defendant claimed that tests had been performed to investigate the possibility of a foreign body, and that as soon as the surgical sponge was detected, it was removed.

What was the outcome? >>

 

OUTCOME
According to a published report, a defense verdict was returned.

COMMENT
The defense verdict here is surprising. In most cases in which surgical instruments are left in patients, plaintiffs prevail by using a legal doctrine known as res ipsa loquitur—a Latin legal term of art meaning “the thing speaks for itself.” This is generally requested as a jury charge, wherein the plaintiff asks the judge to explain to the jury that they may find negligence from a certain unusual fact that cannot have occurred without negligence (eg, a sponge left in a patient after surgery).

The history of res ipsa loquitur dates back to 1863 in the case of Byrne v Boadle, in which a barrel of flour rolled from a second-story window and struck a pedestrian below, causing serious injury. The defendants’ claim was that the plaintiff (who had no recollection of the event) was unable to show evidence of negligence. The court created the doctrine, holding that the fact of the accident itself provided ample evidence of negligence, excusing the plaintiff from the burden of proving that negligent acts (eg, inadequate harnessing of the barrels) led to the accident.

Why is this important? The concept of res ipsa loquitur is commonly invoked in medical malpractice actions. It generally requires three elements: the plaintiff suffers an unusual injury, the plaintiff was under the exclusive control of the medical defendants, and the plaintiff did not contribute to the injury.

In a leading malpractice case, Ybarra v Spangard (1944), a plaintiff awoke after undergoing an appendectomy with difficulty moving his arm as a result of reflex sympathetic dystrophy. The plaintiff alleged negligence stemming from the intraoperative positioning of his body, but he could not show the specifics of positioning during surgery. The court held that the patient’s body was under the exclusive control of the team of medical professionals, and that negligence could be inferred because loss of an arm’s function following an appendectomy is unusual and cannot occur without some negligent action involved.

When successfully used in malpractice cases, res ipsa loquitur relieves the plaintiff of the need to prove by a preponderance of the evidence the actions that led to the breach of the standard of care. In order to prevail, she must show the injury, the defendants’ exclusive control, and no contribution on her part. Practically, this permits the case to withstand defense motions for summary judgment and to be brought before a jury with scant to no evidence on the purported negligent act itself—merely the unusual injury and the defendants’ exclusive control.

Traditional application of the doctrine was limited to cases in which negligence was obvious to a layperson: for example, instruments left in patients or amputation of the wrong leg—the thing that “speaks for itself.” Newer evolution of the doctrine is problematic when extended to cases in which expert testimony should be required to demonstrate the standard of care and the defendant’s breach of it. When courts are willing to extend the doctrine, the plaintiff is awarded the presumption of negligence, which the defendant(s) must now come forward to rebut. For example, in a 2010 case in Illinois, a jury returned a $3.6 million verdict following the death of a 2-year-old who had had a seizure. The child’s seizure was reportedly controlled, but he was allegedly hypoventilated while undergoing CT and unfortunately died. The plaintiff was permitted to invoke the doctrine of res ipsa loquitur and was allowed the presumption that medical negligence was responsible for the outcome.

Unlike the surgical sponge left in a patient, matters of central nervous system status, monitoring during CT, airway and ventilation status, hypoxemia, and postictal states are not within the experience of the typical juror. The negligent “thing” is not a sponge that “speaks for itself,” but a course of actions that requires expert testimony precisely because it does not “speak for itself.” In cases in which an injury is ­beyond the average juror’s realm of experience, courts should require the plaintiff to prove her case. The doctrine should not “evolve” to excuse a plaintiff from the burden of producing evidence and persuading a jury. This forms the foundation of our civil law system. —DML

New research suggests that heritable mutations in the gene ETV6 can predispose people to acute lymphoblastic leukemia (ALL).

Somatic mutations in ETV6 have previously been implicated in the development of ALL and other hematologic malignancies.

The new study, published in Nature Genetics, has shown that germline mutations in ETV6 are associated with thrombocytopenia, red blood cell (RBC) macrocytosis, and predisposition to ALL.

The research began with a family (family 1) that had autosomal dominant thrombocytopenia  (67,000-132,000 platelets/μL), high RBC mean corpuscular volume (MCV,  92.5-101.5 fl), and 2 cases of B-cell-precursor ALL.

“All of them had big red blood cells, low platelet counts, and propensity to bleed,” said study author Christopher Porter, MD, of the University of Colorado Denver.

This familial link to abnormal blood dynamics and predisposition to ALL implied a common genetic denominator. To find it, the researchers performed whole-exome sequencing and found a heterozygous single-nucleotide change in ETV6, c.641C>T, encoding a p.Pro214Leu substitution in the central domain.

The researchers then screened 23 other families with similar phenotypes as the first and identified 2 families with ETV6 mutations.

One family (family 2) had members with platelet counts ranging from 44,000 to 115,000 platelets/μL, RBC MCVs ranging from 88 to 97 fl, and a member with ALL. All affected family members had a c.641C>T mutation identical to the one identified in family 1.

Another family (family 3) had members with platelet counts ranging from 99,000 to 101,000 platelets/μL and RBC MCVs ranging from 93 to 98 fl but no malignancies. Members of this family had a c.1252A>G transition producing a p.Arg418Gly substitution in the DNA-binding domain, with alternative splicing and exon skipping.

The researchers said these mutations partially disrupt ETV6 transcriptional repression in vitro and cause aberrant cytoplasmic localization of both mutant and endogenous ETV6, suggesting a dominant-negative effect. The mutations also impair megakaryocyte development and proplatelet formation in culture.

Dr Porter and his colleagues noted that another team of researchers recently discovered germline missense mutations in ETV6 in 3 unrelated families. Dr Porter’s group hopes future work will show the prevalence of germline mutations in ETV6.

“It’s not common in a general population, but we think it might be much more common in people who develop ALL,” Dr Porter said. “[Our] paper highlights this gene in the development of leukemia. By studying this mutation, we should be able to gather a better understanding of how leukemia develops.”

New research suggests that heritable mutations in the gene ETV6 can predispose people to acute lymphoblastic leukemia (ALL).

Somatic mutations in ETV6 have previously been implicated in the development of ALL and other hematologic malignancies.

The new study, published in Nature Genetics, has shown that germline mutations in ETV6 are associated with thrombocytopenia, red blood cell (RBC) macrocytosis, and predisposition to ALL.

The research began with a family (family 1) that had autosomal dominant thrombocytopenia  (67,000-132,000 platelets/μL), high RBC mean corpuscular volume (MCV,  92.5-101.5 fl), and 2 cases of B-cell-precursor ALL.

“All of them had big red blood cells, low platelet counts, and propensity to bleed,” said study author Christopher Porter, MD, of the University of Colorado Denver.

This familial link to abnormal blood dynamics and predisposition to ALL implied a common genetic denominator. To find it, the researchers performed whole-exome sequencing and found a heterozygous single-nucleotide change in ETV6, c.641C>T, encoding a p.Pro214Leu substitution in the central domain.

The researchers then screened 23 other families with similar phenotypes as the first and identified 2 families with ETV6 mutations.

One family (family 2) had members with platelet counts ranging from 44,000 to 115,000 platelets/μL, RBC MCVs ranging from 88 to 97 fl, and a member with ALL. All affected family members had a c.641C>T mutation identical to the one identified in family 1.

Another family (family 3) had members with platelet counts ranging from 99,000 to 101,000 platelets/μL and RBC MCVs ranging from 93 to 98 fl but no malignancies. Members of this family had a c.1252A>G transition producing a p.Arg418Gly substitution in the DNA-binding domain, with alternative splicing and exon skipping.

The researchers said these mutations partially disrupt ETV6 transcriptional repression in vitro and cause aberrant cytoplasmic localization of both mutant and endogenous ETV6, suggesting a dominant-negative effect. The mutations also impair megakaryocyte development and proplatelet formation in culture.

Dr Porter and his colleagues noted that another team of researchers recently discovered germline missense mutations in ETV6 in 3 unrelated families. Dr Porter’s group hopes future work will show the prevalence of germline mutations in ETV6.

“It’s not common in a general population, but we think it might be much more common in people who develop ALL,” Dr Porter said. “[Our] paper highlights this gene in the development of leukemia. By studying this mutation, we should be able to gather a better understanding of how leukemia develops.”

New research suggests that heritable mutations in the gene ETV6 can predispose people to acute lymphoblastic leukemia (ALL).

Somatic mutations in ETV6 have previously been implicated in the development of ALL and other hematologic malignancies.

The new study, published in Nature Genetics, has shown that germline mutations in ETV6 are associated with thrombocytopenia, red blood cell (RBC) macrocytosis, and predisposition to ALL.

The research began with a family (family 1) that had autosomal dominant thrombocytopenia  (67,000-132,000 platelets/μL), high RBC mean corpuscular volume (MCV,  92.5-101.5 fl), and 2 cases of B-cell-precursor ALL.

“All of them had big red blood cells, low platelet counts, and propensity to bleed,” said study author Christopher Porter, MD, of the University of Colorado Denver.

This familial link to abnormal blood dynamics and predisposition to ALL implied a common genetic denominator. To find it, the researchers performed whole-exome sequencing and found a heterozygous single-nucleotide change in ETV6, c.641C>T, encoding a p.Pro214Leu substitution in the central domain.

The researchers then screened 23 other families with similar phenotypes as the first and identified 2 families with ETV6 mutations.

One family (family 2) had members with platelet counts ranging from 44,000 to 115,000 platelets/μL, RBC MCVs ranging from 88 to 97 fl, and a member with ALL. All affected family members had a c.641C>T mutation identical to the one identified in family 1.

Another family (family 3) had members with platelet counts ranging from 99,000 to 101,000 platelets/μL and RBC MCVs ranging from 93 to 98 fl but no malignancies. Members of this family had a c.1252A>G transition producing a p.Arg418Gly substitution in the DNA-binding domain, with alternative splicing and exon skipping.

The researchers said these mutations partially disrupt ETV6 transcriptional repression in vitro and cause aberrant cytoplasmic localization of both mutant and endogenous ETV6, suggesting a dominant-negative effect. The mutations also impair megakaryocyte development and proplatelet formation in culture.

Dr Porter and his colleagues noted that another team of researchers recently discovered germline missense mutations in ETV6 in 3 unrelated families. Dr Porter’s group hopes future work will show the prevalence of germline mutations in ETV6.

“It’s not common in a general population, but we think it might be much more common in people who develop ALL,” Dr Porter said. “[Our] paper highlights this gene in the development of leukemia. By studying this mutation, we should be able to gather a better understanding of how leukemia develops.”

A new study has improved researchers’ understanding of a genetic defect associated with myelodysplastic syndromes (MDS), and the team hopes this will ultimately help us correct the defect in patients.

The researchers used induced pluripotent stem cells (iPSCs) to study del(7q), a chromosomal abnormality found in patients with MDS.

This provided the team with new insight into how the deletion contributes to MDS development.

Steven D. Nimer, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami in Florida, and his colleagues described this work in Nature Biotechnology.

To determine how del(7q) contributes to MDS development, the researchers isolated hematopoietic cells from a patient with del(7q) and reprogrammed them into iPSCs. These iPSCs recapitulated MDS-associated phenotypes, including impaired hematopoietic differentiation.

The researchers also showed that, by engineering heterozygous chromosome 7q loss, they could recapitulate in normal iPSCs the characteristics they observed in the del(7q) iPSCs.

So the team was not surprised to find that disease phenotypes were rescued when del(7q) iPSC lines acquired a duplicate copy of chromosome 7q material.

The researchers also found that hemizygosity of chromosome 7q reduced the expression of many genes in the chromosome7q-deleted region. But gene expression was restored upon chromosome 7q dosage correction.

“[W]e were able to pinpoint a region on chromosome 7 that is critical and were able to identify candidate genes residing there that may cause this disease,” said study author Eirini Papapetrou, MD, PhD, of the Icahn School of Medicine at Mount Sinai in New York, New York.

Focusing on hits residing in this region, 7q32.3–7q36.1, the researchers found 10 genes that were enriched (by >1.5-fold) recurrently.

Further investigation confirmed that 4 of these genes—HIPK2, ATP6V0E2, LUC7L2, and EZH2—could partially rescue the emergence of CD45⁺ hematopoietic progenitors when overexpressed in del(7q) iPSCs.

The researchers conducted additional experiments focusing on EZH2 alone and found that haploinsufficiency of EZH2 decreases cells’ hematopoietic potential.

But it seems the hematopoietic defects caused by chromosome 7q hemizygosity are mediated through the haploinsufficiency of EZH2 in combination with 1 or more additional genes, which might include LUC7L2, HIPK2, ATP6V0E2, and/or other genes.

A new study has improved researchers’ understanding of a genetic defect associated with myelodysplastic syndromes (MDS), and the team hopes this will ultimately help us correct the defect in patients.

The researchers used induced pluripotent stem cells (iPSCs) to study del(7q), a chromosomal abnormality found in patients with MDS.

This provided the team with new insight into how the deletion contributes to MDS development.

Steven D. Nimer, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami in Florida, and his colleagues described this work in Nature Biotechnology.

To determine how del(7q) contributes to MDS development, the researchers isolated hematopoietic cells from a patient with del(7q) and reprogrammed them into iPSCs. These iPSCs recapitulated MDS-associated phenotypes, including impaired hematopoietic differentiation.

The researchers also showed that, by engineering heterozygous chromosome 7q loss, they could recapitulate in normal iPSCs the characteristics they observed in the del(7q) iPSCs.

So the team was not surprised to find that disease phenotypes were rescued when del(7q) iPSC lines acquired a duplicate copy of chromosome 7q material.

The researchers also found that hemizygosity of chromosome 7q reduced the expression of many genes in the chromosome7q-deleted region. But gene expression was restored upon chromosome 7q dosage correction.

“[W]e were able to pinpoint a region on chromosome 7 that is critical and were able to identify candidate genes residing there that may cause this disease,” said study author Eirini Papapetrou, MD, PhD, of the Icahn School of Medicine at Mount Sinai in New York, New York.

Focusing on hits residing in this region, 7q32.3–7q36.1, the researchers found 10 genes that were enriched (by >1.5-fold) recurrently.

Further investigation confirmed that 4 of these genes—HIPK2, ATP6V0E2, LUC7L2, and EZH2—could partially rescue the emergence of CD45⁺ hematopoietic progenitors when overexpressed in del(7q) iPSCs.

The researchers conducted additional experiments focusing on EZH2 alone and found that haploinsufficiency of EZH2 decreases cells’ hematopoietic potential.

But it seems the hematopoietic defects caused by chromosome 7q hemizygosity are mediated through the haploinsufficiency of EZH2 in combination with 1 or more additional genes, which might include LUC7L2, HIPK2, ATP6V0E2, and/or other genes.

A new study has improved researchers’ understanding of a genetic defect associated with myelodysplastic syndromes (MDS), and the team hopes this will ultimately help us correct the defect in patients.

The researchers used induced pluripotent stem cells (iPSCs) to study del(7q), a chromosomal abnormality found in patients with MDS.

This provided the team with new insight into how the deletion contributes to MDS development.

Steven D. Nimer, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami in Florida, and his colleagues described this work in Nature Biotechnology.

To determine how del(7q) contributes to MDS development, the researchers isolated hematopoietic cells from a patient with del(7q) and reprogrammed them into iPSCs. These iPSCs recapitulated MDS-associated phenotypes, including impaired hematopoietic differentiation.

The researchers also showed that, by engineering heterozygous chromosome 7q loss, they could recapitulate in normal iPSCs the characteristics they observed in the del(7q) iPSCs.

So the team was not surprised to find that disease phenotypes were rescued when del(7q) iPSC lines acquired a duplicate copy of chromosome 7q material.

The researchers also found that hemizygosity of chromosome 7q reduced the expression of many genes in the chromosome7q-deleted region. But gene expression was restored upon chromosome 7q dosage correction.

“[W]e were able to pinpoint a region on chromosome 7 that is critical and were able to identify candidate genes residing there that may cause this disease,” said study author Eirini Papapetrou, MD, PhD, of the Icahn School of Medicine at Mount Sinai in New York, New York.

Focusing on hits residing in this region, 7q32.3–7q36.1, the researchers found 10 genes that were enriched (by >1.5-fold) recurrently.

Further investigation confirmed that 4 of these genes—HIPK2, ATP6V0E2, LUC7L2, and EZH2—could partially rescue the emergence of CD45⁺ hematopoietic progenitors when overexpressed in del(7q) iPSCs.

The researchers conducted additional experiments focusing on EZH2 alone and found that haploinsufficiency of EZH2 decreases cells’ hematopoietic potential.

But it seems the hematopoietic defects caused by chromosome 7q hemizygosity are mediated through the haploinsufficiency of EZH2 in combination with 1 or more additional genes, which might include LUC7L2, HIPK2, ATP6V0E2, and/or other genes.

Patients want more information about medical imaging tests that use radiation, according to research published in Radiology.

Most of the 30 subjects involved in this study said their healthcare providers did not initiate a discussion about the risks and benefits of imaging tests.

So a majority of participants obtained information from the Internet. Researchers said these findings highlight a need for better communication between patients and providers.

“This may not be what we in the medical field want to hear, but I think it’s important that we hear it,” said study author Jennifer Hay, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York.

“Patients want this information, and they prefer to receive it from doctors they know and trust.”

Dr Hay and her colleagues analyzed over 9 hours of transcribed conversations with 30 people who had undergone medical imaging exams or consented for their children to undergo such exams.

The goal was to determine the subjects’ understanding of the benefits and risks associated with various medical imaging procedures and their expectations regarding communication of those benefits and risks.

The study group was divided into 6 focus groups, including 5 groups of cancer patients (or parents of young cancer patients) and 1 group of participants in a lung cancer screening program.

Quantifying subjects’ knowledge

The researchers found that participants perceived clear benefits from imaging tests like X-rays, computed tomography (CT) scans, and nuclear medicine examinations.

And most subjects were highly aware of the risks associated with ionizing radiation exposure, including the potential risk of future cancer. But their knowledge regarding which imaging tests use ionizing radiation varied.

In general, participants were more likely to understand that X-rays, CTs, and positron emission tomography (PET) scans deliver ionizing radiation and less likely to know about mammography, bone scanning, or stress tests. Many subjects did not know if magnetic resonance imaging (MRI) involved ionizing radiation.

Some participants did not know how tests differed, and some believed there was a “best” imaging test. Occasionally, subjects confused ionizing radiation from diagnostic medical imaging with radiation therapy.

Desire for information

Participants considered the availability of basic benefit-risk information to be a fundamental component of care. And they expressed a desire for a wide range of information about medical imaging tests.

Most subjects wanted basic education about which imaging tests use ionizing radiation and how doses compare among them. Nearly all subjects wanted to understand how tests differ, what governs selection of one over another, and why multiple tests are sometimes ordered.

A majority of participants met their needs for more information through self-directed Internet searches.

Concern about risks

Most subjects agreed that learning about possible future risks was important, but having this information would probably not alter their decision to proceed with a recommended test.

The desire for information about risks was strongest among cancer patients who had made the transition from treatment to survivorship.

These patients wanted to know how risk accumulates from multiple exams over time, whether additional ionizing radiation exposure could be avoided by substituting MRI for CT, and if longer intervals between follow-up examinations could be negotiated.

“Interest in having more information and participating in decision-making about medical imaging clearly increased as patients transitioned from active cancer treatment to survivorship,” said study author Raymond H. Thornton, MD, of Memorial Sloan Kettering Cancer Center.

“Cancer survivors typically focus on healthful living and risk-factor reduction, so they were particularly eager to participate in discussions about potential long-term risks of radiation.”

 

The different levels of desire for information among the study subjects lend support to a tiered approach for patient-centered communication, according to Dr Hay.

“A tiered approach would provide all patients with information and offer additional options to those who want to dig deeper and find out more,” she said.

Presenting information

Subjects expressed interest in 2 different modes of information exchange. Many participants said the ideal situation would be a face-to-face discussion with their personal physician, a medical physicist, or radiologist.

Others expressed an interest in written resources, especially hospital-endorsed Internet sites and printed materials.

Patients want more information about medical imaging tests that use radiation, according to research published in Radiology.

Most of the 30 subjects involved in this study said their healthcare providers did not initiate a discussion about the risks and benefits of imaging tests.

So a majority of participants obtained information from the Internet. Researchers said these findings highlight a need for better communication between patients and providers.

“This may not be what we in the medical field want to hear, but I think it’s important that we hear it,” said study author Jennifer Hay, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York.

“Patients want this information, and they prefer to receive it from doctors they know and trust.”

Dr Hay and her colleagues analyzed over 9 hours of transcribed conversations with 30 people who had undergone medical imaging exams or consented for their children to undergo such exams.

The goal was to determine the subjects’ understanding of the benefits and risks associated with various medical imaging procedures and their expectations regarding communication of those benefits and risks.

The study group was divided into 6 focus groups, including 5 groups of cancer patients (or parents of young cancer patients) and 1 group of participants in a lung cancer screening program.

Quantifying subjects’ knowledge

The researchers found that participants perceived clear benefits from imaging tests like X-rays, computed tomography (CT) scans, and nuclear medicine examinations.

And most subjects were highly aware of the risks associated with ionizing radiation exposure, including the potential risk of future cancer. But their knowledge regarding which imaging tests use ionizing radiation varied.

In general, participants were more likely to understand that X-rays, CTs, and positron emission tomography (PET) scans deliver ionizing radiation and less likely to know about mammography, bone scanning, or stress tests. Many subjects did not know if magnetic resonance imaging (MRI) involved ionizing radiation.

Some participants did not know how tests differed, and some believed there was a “best” imaging test. Occasionally, subjects confused ionizing radiation from diagnostic medical imaging with radiation therapy.

Desire for information

Participants considered the availability of basic benefit-risk information to be a fundamental component of care. And they expressed a desire for a wide range of information about medical imaging tests.

Most subjects wanted basic education about which imaging tests use ionizing radiation and how doses compare among them. Nearly all subjects wanted to understand how tests differ, what governs selection of one over another, and why multiple tests are sometimes ordered.

A majority of participants met their needs for more information through self-directed Internet searches.

Concern about risks

Most subjects agreed that learning about possible future risks was important, but having this information would probably not alter their decision to proceed with a recommended test.

The desire for information about risks was strongest among cancer patients who had made the transition from treatment to survivorship.

These patients wanted to know how risk accumulates from multiple exams over time, whether additional ionizing radiation exposure could be avoided by substituting MRI for CT, and if longer intervals between follow-up examinations could be negotiated.

“Interest in having more information and participating in decision-making about medical imaging clearly increased as patients transitioned from active cancer treatment to survivorship,” said study author Raymond H. Thornton, MD, of Memorial Sloan Kettering Cancer Center.

“Cancer survivors typically focus on healthful living and risk-factor reduction, so they were particularly eager to participate in discussions about potential long-term risks of radiation.”

 

The different levels of desire for information among the study subjects lend support to a tiered approach for patient-centered communication, according to Dr Hay.

“A tiered approach would provide all patients with information and offer additional options to those who want to dig deeper and find out more,” she said.

Presenting information

Subjects expressed interest in 2 different modes of information exchange. Many participants said the ideal situation would be a face-to-face discussion with their personal physician, a medical physicist, or radiologist.

Others expressed an interest in written resources, especially hospital-endorsed Internet sites and printed materials.

Patients want more information about medical imaging tests that use radiation, according to research published in Radiology.

Most of the 30 subjects involved in this study said their healthcare providers did not initiate a discussion about the risks and benefits of imaging tests.

So a majority of participants obtained information from the Internet. Researchers said these findings highlight a need for better communication between patients and providers.

“This may not be what we in the medical field want to hear, but I think it’s important that we hear it,” said study author Jennifer Hay, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York.

“Patients want this information, and they prefer to receive it from doctors they know and trust.”

Dr Hay and her colleagues analyzed over 9 hours of transcribed conversations with 30 people who had undergone medical imaging exams or consented for their children to undergo such exams.

The goal was to determine the subjects’ understanding of the benefits and risks associated with various medical imaging procedures and their expectations regarding communication of those benefits and risks.

The study group was divided into 6 focus groups, including 5 groups of cancer patients (or parents of young cancer patients) and 1 group of participants in a lung cancer screening program.

Quantifying subjects’ knowledge

The researchers found that participants perceived clear benefits from imaging tests like X-rays, computed tomography (CT) scans, and nuclear medicine examinations.

And most subjects were highly aware of the risks associated with ionizing radiation exposure, including the potential risk of future cancer. But their knowledge regarding which imaging tests use ionizing radiation varied.

In general, participants were more likely to understand that X-rays, CTs, and positron emission tomography (PET) scans deliver ionizing radiation and less likely to know about mammography, bone scanning, or stress tests. Many subjects did not know if magnetic resonance imaging (MRI) involved ionizing radiation.

Some participants did not know how tests differed, and some believed there was a “best” imaging test. Occasionally, subjects confused ionizing radiation from diagnostic medical imaging with radiation therapy.

Desire for information

Participants considered the availability of basic benefit-risk information to be a fundamental component of care. And they expressed a desire for a wide range of information about medical imaging tests.

Most subjects wanted basic education about which imaging tests use ionizing radiation and how doses compare among them. Nearly all subjects wanted to understand how tests differ, what governs selection of one over another, and why multiple tests are sometimes ordered.

A majority of participants met their needs for more information through self-directed Internet searches.

Concern about risks

Most subjects agreed that learning about possible future risks was important, but having this information would probably not alter their decision to proceed with a recommended test.

The desire for information about risks was strongest among cancer patients who had made the transition from treatment to survivorship.

These patients wanted to know how risk accumulates from multiple exams over time, whether additional ionizing radiation exposure could be avoided by substituting MRI for CT, and if longer intervals between follow-up examinations could be negotiated.

“Interest in having more information and participating in decision-making about medical imaging clearly increased as patients transitioned from active cancer treatment to survivorship,” said study author Raymond H. Thornton, MD, of Memorial Sloan Kettering Cancer Center.

“Cancer survivors typically focus on healthful living and risk-factor reduction, so they were particularly eager to participate in discussions about potential long-term risks of radiation.”

 

The different levels of desire for information among the study subjects lend support to a tiered approach for patient-centered communication, according to Dr Hay.

“A tiered approach would provide all patients with information and offer additional options to those who want to dig deeper and find out more,” she said.

Presenting information

Subjects expressed interest in 2 different modes of information exchange. Many participants said the ideal situation would be a face-to-face discussion with their personal physician, a medical physicist, or radiologist.

Others expressed an interest in written resources, especially hospital-endorsed Internet sites and printed materials.

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance documents for rivaroxaban (Xarelto) and pomalidomide (Imnovid).

The agency is recommending rivaroxaban (in combination) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).

But NICE said it cannot recommend pomalidomide (in combination) for the treatment of relapsed/refractory multiple myeloma (MM).

Rivaroxaban

Rivaroxaban is licensed in the European Union to prevent atherothrombotic events in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood. The drug is given with aspirin and clopidogrel or aspirin alone.

Based on results of the ATLAS-ACS 2-TIMI 51 trial, an appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.

The committee also found rivaroxaban to be a cost-effective use of National Health Service (NHS) resources. They noted, however, that the drug can increase the risk of bleeding.

“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the guidance recommends that, before starting treatment, doctors should carry out a careful assessment of a person’s bleeding risk,” said Carole Longson, NICE Health Technology Evaluation Centre Director.

“The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”

Pomalidomide

NICE’s final guidance on pomalidomide said the agency cannot recommend the drug as a treatment option for MM.

Pomalidomide is approved in the European Union for use in combination with dexamethasone to treat adults with relapsed and refractory MM who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.

“Unfortunately, we cannot recommend pomalidomide, as the analyses from Celgene, the company that markets the drug, showed that it does not offer enough benefit to justify its high price,” said Sir Andrew Dillon, NICE chief executive.

NICE said the appraisal committee could not judge with any confidence how effective pomalidomide is compared to current treatment options based on the available evidence provided before and after consultation.

Bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high-dose dexamethasone in the phase 3 MM-003 trial and all data presented to the committee for comparators, the committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care.

However, considering the incremental cost-effectiveness ratios, the committee concluded that, even with the end-of-life criteria met, the weighting that would have to be placed on the quality-adjusted life-years gained would be too high to consider pomalidomide a cost-effective use of NHS resources.

The committee also said the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on quality-adjusted life-years gained.

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance documents for rivaroxaban (Xarelto) and pomalidomide (Imnovid).

The agency is recommending rivaroxaban (in combination) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).

But NICE said it cannot recommend pomalidomide (in combination) for the treatment of relapsed/refractory multiple myeloma (MM).

Rivaroxaban

Rivaroxaban is licensed in the European Union to prevent atherothrombotic events in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood. The drug is given with aspirin and clopidogrel or aspirin alone.

Based on results of the ATLAS-ACS 2-TIMI 51 trial, an appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.

The committee also found rivaroxaban to be a cost-effective use of National Health Service (NHS) resources. They noted, however, that the drug can increase the risk of bleeding.

“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the guidance recommends that, before starting treatment, doctors should carry out a careful assessment of a person’s bleeding risk,” said Carole Longson, NICE Health Technology Evaluation Centre Director.

“The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”

Pomalidomide

NICE’s final guidance on pomalidomide said the agency cannot recommend the drug as a treatment option for MM.

Pomalidomide is approved in the European Union for use in combination with dexamethasone to treat adults with relapsed and refractory MM who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.

“Unfortunately, we cannot recommend pomalidomide, as the analyses from Celgene, the company that markets the drug, showed that it does not offer enough benefit to justify its high price,” said Sir Andrew Dillon, NICE chief executive.

NICE said the appraisal committee could not judge with any confidence how effective pomalidomide is compared to current treatment options based on the available evidence provided before and after consultation.

Bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high-dose dexamethasone in the phase 3 MM-003 trial and all data presented to the committee for comparators, the committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care.

However, considering the incremental cost-effectiveness ratios, the committee concluded that, even with the end-of-life criteria met, the weighting that would have to be placed on the quality-adjusted life-years gained would be too high to consider pomalidomide a cost-effective use of NHS resources.

The committee also said the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on quality-adjusted life-years gained.

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance documents for rivaroxaban (Xarelto) and pomalidomide (Imnovid).

The agency is recommending rivaroxaban (in combination) as an option for preventing atherothrombotic events in patients with acute coronary syndrome (ACS).

But NICE said it cannot recommend pomalidomide (in combination) for the treatment of relapsed/refractory multiple myeloma (MM).

Rivaroxaban

Rivaroxaban is licensed in the European Union to prevent atherothrombotic events in adults who have an ACS severe enough to result in the release of cardiac biomarkers into the blood. The drug is given with aspirin and clopidogrel or aspirin alone.

Based on results of the ATLAS-ACS 2-TIMI 51 trial, an appraisal committee advising NICE concluded that rivaroxaban given at 2.5 mg twice daily in combination with aspirin plus clopidogrel or with aspirin alone was more effective than aspirin plus clopidogrel or aspirin alone for preventing further cardiovascular deaths and myocardial infarction in patients with ACS and raised cardiac biomarkers.

The committee also found rivaroxaban to be a cost-effective use of National Health Service (NHS) resources. They noted, however, that the drug can increase the risk of bleeding.

“Because rivaroxaban is associated with a higher risk of causing bleeding than clopidogrel in combination with aspirin or aspirin alone, the guidance recommends that, before starting treatment, doctors should carry out a careful assessment of a person’s bleeding risk,” said Carole Longson, NICE Health Technology Evaluation Centre Director.

“The decision to start treatment should be made after an informed discussion between the doctor and patient about the benefits and risks of rivaroxaban. Also, because there is limited experience of treatment with rivaroxaban up to 24 months, the guidance recommends careful consideration should be given to whether treatment is continued beyond 12 months.”

Pomalidomide

NICE’s final guidance on pomalidomide said the agency cannot recommend the drug as a treatment option for MM.

Pomalidomide is approved in the European Union for use in combination with dexamethasone to treat adults with relapsed and refractory MM who have had at least 2 prior treatments, including lenalidomide and bortezomib, and whose disease has progressed on the last therapy.

“Unfortunately, we cannot recommend pomalidomide, as the analyses from Celgene, the company that markets the drug, showed that it does not offer enough benefit to justify its high price,” said Sir Andrew Dillon, NICE chief executive.

NICE said the appraisal committee could not judge with any confidence how effective pomalidomide is compared to current treatment options based on the available evidence provided before and after consultation.

Bearing in mind the magnitude of the differences in the overall survival estimates between pomalidomide and high-dose dexamethasone in the phase 3 MM-003 trial and all data presented to the committee for comparators, the committee was persuaded that pomalidomide extends life for at least 3 months on average when compared with standard NHS care.

However, considering the incremental cost-effectiveness ratios, the committee concluded that, even with the end-of-life criteria met, the weighting that would have to be placed on the quality-adjusted life-years gained would be too high to consider pomalidomide a cost-effective use of NHS resources.

The committee also said the uncertainty in the relative effectiveness of pomalidomide compared with established NHS practice would affect any weighting that could be placed on quality-adjusted life-years gained.

Anticoagulation may be an effective option for patients with superficial venous thrombosis and are at high risk of venous thromboembolism (VTE), according to an evidence-based review by Dr. Joseph Raffetto and Dr. Robert Eberhardt.

In particular, they reviewed the results of three clinical trials with a total of nearly 1400 patients: STENOX, STEFLUX, and CALISTO.

Based on their assessment, Dr. Raffetto and Dr. Eberhardt, summarized that surgery and anticoagulants were both acceptable treatments for SVT patients at high risk of VTE, who had severe symptoms, who presented with close proximity to the saphenofemoral junction, or who had recurrence. Anticoagulants seemed to have fewer complications and a lower VTE rate than did surgery. However, treating all SVT patients with anticoagulants is not recommended because of cost concerns.

While anticoagulants do appear to be an effective treatment for SVT, “it is not known if SVT is causative of or an epiphenomenon for VTE. The optimal treatment of SVT is unknown with respect to selection of patient and vein, preferred therapy, and timing and duration of therapy,” the authors cautioned.

Find the full report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (doi: 10.1016/j.jvsv.2014.11.005).

Anticoagulation may be an effective option for patients with superficial venous thrombosis and are at high risk of venous thromboembolism (VTE), according to an evidence-based review by Dr. Joseph Raffetto and Dr. Robert Eberhardt.

In particular, they reviewed the results of three clinical trials with a total of nearly 1400 patients: STENOX, STEFLUX, and CALISTO.

Based on their assessment, Dr. Raffetto and Dr. Eberhardt, summarized that surgery and anticoagulants were both acceptable treatments for SVT patients at high risk of VTE, who had severe symptoms, who presented with close proximity to the saphenofemoral junction, or who had recurrence. Anticoagulants seemed to have fewer complications and a lower VTE rate than did surgery. However, treating all SVT patients with anticoagulants is not recommended because of cost concerns.

While anticoagulants do appear to be an effective treatment for SVT, “it is not known if SVT is causative of or an epiphenomenon for VTE. The optimal treatment of SVT is unknown with respect to selection of patient and vein, preferred therapy, and timing and duration of therapy,” the authors cautioned.

Find the full report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (doi: 10.1016/j.jvsv.2014.11.005).

Anticoagulation may be an effective option for patients with superficial venous thrombosis and are at high risk of venous thromboembolism (VTE), according to an evidence-based review by Dr. Joseph Raffetto and Dr. Robert Eberhardt.

In particular, they reviewed the results of three clinical trials with a total of nearly 1400 patients: STENOX, STEFLUX, and CALISTO.

Based on their assessment, Dr. Raffetto and Dr. Eberhardt, summarized that surgery and anticoagulants were both acceptable treatments for SVT patients at high risk of VTE, who had severe symptoms, who presented with close proximity to the saphenofemoral junction, or who had recurrence. Anticoagulants seemed to have fewer complications and a lower VTE rate than did surgery. However, treating all SVT patients with anticoagulants is not recommended because of cost concerns.

While anticoagulants do appear to be an effective treatment for SVT, “it is not known if SVT is causative of or an epiphenomenon for VTE. The optimal treatment of SVT is unknown with respect to selection of patient and vein, preferred therapy, and timing and duration of therapy,” the authors cautioned.

Find the full report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (doi: 10.1016/j.jvsv.2014.11.005).