The Centers for Disease Control and Prevention recently released data regarding the use of long-acting reversible contraception (LARC), specifically intrauterine devices (IUDs), in adolescents, and suggested ways to increase their use. The American Congress of Obstetricians and Gynecologists then reiterated its recommendation promoting the use of LARC in adolescents (Obstet Gynecol. 2012;120:983-8). Historically, the use of IUDs in nulliparous females was concerning because of the risk of pelvic inflammatory disease (which could lead to infertility), pain at insertion, and the cost. But more recent research has dispelled many of those concerns, and new legislation has made access and affordability a reality; hence, the use of IUDs in teens was recommended. Despite these advances, physicians still are not making teens aware of this method of contraception.

In 2013, two important things occurred. First, emergency contraception was made available over the counter without age restriction. Second, the Affordable Care Act required most private insurance plans to cover at least one type of all 18 Food and Drug Administration–approved contraceptive methods for women as prescribed without cost sharing; this reduced the barrier of cost for IUDs. For patients covered by Medicaid, details vary, but in many cases some type of IUD is covered. In considering the best method of contraception in teens, we can all agree contraception is only as good as its proper use. If we remove the concern of infertility secondary to pelvic inflammatory disease and the barrier of cost, we can make the argument that LARC is an ideal choice for young women.

Birth rates for teenagers fell 9% from 2013 to 2014, to 24.2 births per 1,000 females aged 15-19 years – a record low according to CDC data. The rate has declined 42% since 2007 and 61% since 1991. Considering that the percent of teens who engage in sexual activity has not changed, the cause of the decline has to be related to increased contraception use and education. Although rates have declined significantly, there is much work to be done to protect our teens from unintended pregnancies.

The Contraceptive Choice Project was designed to give teens the option of birth control with the barrier of cost removed. Sixty-nine percent of 10,000 girls aged 14-17 years chose the IUD (Am J Obstet Gynecol. 2010;203[2]:115.e1-e7). The Contraceptive Choice Project also stated that the teens in this study were 20 times more likely to become pregnant using oral contraceptives, the patch, or a vaginal ring, compared with LARC or an injectable contraceptive. That is a significant statistic given that the choice of birth control used is heavily dependent on the options available. As primary care physicians, we are likely the first line of intervention, so it is important that we do not exclude the options most likely to prevent unintended pregnancies.

The rate of adolescents using IUDs increased from 0.2 to 2.5 in the 2002 and 2006-2010 National Surveys of Family Growth (J Adolesc Health. 2013;53:401-6).

There are choices when it comes to IUDs. ParaGard and Mirena are most well known. ParaGard contains copper and is hormone free; it can be used as emergency contraception and can remain in place for 12 years. Mirena releases levonorgestrel, and can be left in place for 5 years; there now is a generic form. There has been hesitation in using this product in teens because of a marketing decision made when Mirena was brought to the U.S. market. The company sought FDA approval only for women who already had children to avoid concerns about fertility. But research shows IUDS are safe and effective in women of all ages.

Unlike birth control pills, Mirena and Paragard do not reduce acne. But Mirena does reduce bloating and cramping associated with periods. Paragard has unpredictable bleeding and, therefore, is a less favorable choice in women who are not restricted to hormone-free contraception.

Newer brands on the market are Skyla and Liletta. Both are comparable to Mirena but have lower amounts of hormone, so these IUDs will be less effective in controlling the cramping and bloating. Skyla, unlike Mirena, is marketed to teens.

Implementing birth control options in your practice is imperative in caring for adolescents. Bedsider.org is a wonderful website that reviews all forms of birth control, and the pros and cons associated with each; it also compares the different types to help young women make the best choice. Another useful website is thenationalcampaign.org; this website is dedicated to educating physicians, parents, and adolescents in birth control choices to reduce unplanned pregnancies.

Dr. Pearce is a pediatrician in Frankfort, Ill.

The Centers for Disease Control and Prevention recently released data regarding the use of long-acting reversible contraception (LARC), specifically intrauterine devices (IUDs), in adolescents, and suggested ways to increase their use. The American Congress of Obstetricians and Gynecologists then reiterated its recommendation promoting the use of LARC in adolescents (Obstet Gynecol. 2012;120:983-8). Historically, the use of IUDs in nulliparous females was concerning because of the risk of pelvic inflammatory disease (which could lead to infertility), pain at insertion, and the cost. But more recent research has dispelled many of those concerns, and new legislation has made access and affordability a reality; hence, the use of IUDs in teens was recommended. Despite these advances, physicians still are not making teens aware of this method of contraception.

In 2013, two important things occurred. First, emergency contraception was made available over the counter without age restriction. Second, the Affordable Care Act required most private insurance plans to cover at least one type of all 18 Food and Drug Administration–approved contraceptive methods for women as prescribed without cost sharing; this reduced the barrier of cost for IUDs. For patients covered by Medicaid, details vary, but in many cases some type of IUD is covered. In considering the best method of contraception in teens, we can all agree contraception is only as good as its proper use. If we remove the concern of infertility secondary to pelvic inflammatory disease and the barrier of cost, we can make the argument that LARC is an ideal choice for young women.

Birth rates for teenagers fell 9% from 2013 to 2014, to 24.2 births per 1,000 females aged 15-19 years – a record low according to CDC data. The rate has declined 42% since 2007 and 61% since 1991. Considering that the percent of teens who engage in sexual activity has not changed, the cause of the decline has to be related to increased contraception use and education. Although rates have declined significantly, there is much work to be done to protect our teens from unintended pregnancies.

The Contraceptive Choice Project was designed to give teens the option of birth control with the barrier of cost removed. Sixty-nine percent of 10,000 girls aged 14-17 years chose the IUD (Am J Obstet Gynecol. 2010;203[2]:115.e1-e7). The Contraceptive Choice Project also stated that the teens in this study were 20 times more likely to become pregnant using oral contraceptives, the patch, or a vaginal ring, compared with LARC or an injectable contraceptive. That is a significant statistic given that the choice of birth control used is heavily dependent on the options available. As primary care physicians, we are likely the first line of intervention, so it is important that we do not exclude the options most likely to prevent unintended pregnancies.

The rate of adolescents using IUDs increased from 0.2 to 2.5 in the 2002 and 2006-2010 National Surveys of Family Growth (J Adolesc Health. 2013;53:401-6).

There are choices when it comes to IUDs. ParaGard and Mirena are most well known. ParaGard contains copper and is hormone free; it can be used as emergency contraception and can remain in place for 12 years. Mirena releases levonorgestrel, and can be left in place for 5 years; there now is a generic form. There has been hesitation in using this product in teens because of a marketing decision made when Mirena was brought to the U.S. market. The company sought FDA approval only for women who already had children to avoid concerns about fertility. But research shows IUDS are safe and effective in women of all ages.

Unlike birth control pills, Mirena and Paragard do not reduce acne. But Mirena does reduce bloating and cramping associated with periods. Paragard has unpredictable bleeding and, therefore, is a less favorable choice in women who are not restricted to hormone-free contraception.

Newer brands on the market are Skyla and Liletta. Both are comparable to Mirena but have lower amounts of hormone, so these IUDs will be less effective in controlling the cramping and bloating. Skyla, unlike Mirena, is marketed to teens.

Implementing birth control options in your practice is imperative in caring for adolescents. Bedsider.org is a wonderful website that reviews all forms of birth control, and the pros and cons associated with each; it also compares the different types to help young women make the best choice. Another useful website is thenationalcampaign.org; this website is dedicated to educating physicians, parents, and adolescents in birth control choices to reduce unplanned pregnancies.

Dr. Pearce is a pediatrician in Frankfort, Ill.

The Centers for Disease Control and Prevention recently released data regarding the use of long-acting reversible contraception (LARC), specifically intrauterine devices (IUDs), in adolescents, and suggested ways to increase their use. The American Congress of Obstetricians and Gynecologists then reiterated its recommendation promoting the use of LARC in adolescents (Obstet Gynecol. 2012;120:983-8). Historically, the use of IUDs in nulliparous females was concerning because of the risk of pelvic inflammatory disease (which could lead to infertility), pain at insertion, and the cost. But more recent research has dispelled many of those concerns, and new legislation has made access and affordability a reality; hence, the use of IUDs in teens was recommended. Despite these advances, physicians still are not making teens aware of this method of contraception.

In 2013, two important things occurred. First, emergency contraception was made available over the counter without age restriction. Second, the Affordable Care Act required most private insurance plans to cover at least one type of all 18 Food and Drug Administration–approved contraceptive methods for women as prescribed without cost sharing; this reduced the barrier of cost for IUDs. For patients covered by Medicaid, details vary, but in many cases some type of IUD is covered. In considering the best method of contraception in teens, we can all agree contraception is only as good as its proper use. If we remove the concern of infertility secondary to pelvic inflammatory disease and the barrier of cost, we can make the argument that LARC is an ideal choice for young women.

Birth rates for teenagers fell 9% from 2013 to 2014, to 24.2 births per 1,000 females aged 15-19 years – a record low according to CDC data. The rate has declined 42% since 2007 and 61% since 1991. Considering that the percent of teens who engage in sexual activity has not changed, the cause of the decline has to be related to increased contraception use and education. Although rates have declined significantly, there is much work to be done to protect our teens from unintended pregnancies.

The Contraceptive Choice Project was designed to give teens the option of birth control with the barrier of cost removed. Sixty-nine percent of 10,000 girls aged 14-17 years chose the IUD (Am J Obstet Gynecol. 2010;203[2]:115.e1-e7). The Contraceptive Choice Project also stated that the teens in this study were 20 times more likely to become pregnant using oral contraceptives, the patch, or a vaginal ring, compared with LARC or an injectable contraceptive. That is a significant statistic given that the choice of birth control used is heavily dependent on the options available. As primary care physicians, we are likely the first line of intervention, so it is important that we do not exclude the options most likely to prevent unintended pregnancies.

The rate of adolescents using IUDs increased from 0.2 to 2.5 in the 2002 and 2006-2010 National Surveys of Family Growth (J Adolesc Health. 2013;53:401-6).

There are choices when it comes to IUDs. ParaGard and Mirena are most well known. ParaGard contains copper and is hormone free; it can be used as emergency contraception and can remain in place for 12 years. Mirena releases levonorgestrel, and can be left in place for 5 years; there now is a generic form. There has been hesitation in using this product in teens because of a marketing decision made when Mirena was brought to the U.S. market. The company sought FDA approval only for women who already had children to avoid concerns about fertility. But research shows IUDS are safe and effective in women of all ages.

Unlike birth control pills, Mirena and Paragard do not reduce acne. But Mirena does reduce bloating and cramping associated with periods. Paragard has unpredictable bleeding and, therefore, is a less favorable choice in women who are not restricted to hormone-free contraception.

Newer brands on the market are Skyla and Liletta. Both are comparable to Mirena but have lower amounts of hormone, so these IUDs will be less effective in controlling the cramping and bloating. Skyla, unlike Mirena, is marketed to teens.

Implementing birth control options in your practice is imperative in caring for adolescents. Bedsider.org is a wonderful website that reviews all forms of birth control, and the pros and cons associated with each; it also compares the different types to help young women make the best choice. Another useful website is thenationalcampaign.org; this website is dedicated to educating physicians, parents, and adolescents in birth control choices to reduce unplanned pregnancies.

Dr. Pearce is a pediatrician in Frankfort, Ill.

Micrograph of HL
Copyright 2010 Nephron

Results of a small trial suggest the radiolabeled anti-CD25 antibody ⁹⁰Y-daclizumab can treat certain patients with relapsed/refractory Hodgkin lymphoma (HL).

⁹⁰Y-daclizumab produced responses in 50% of patients studied, and most of these were complete responses.

Several patients developed myelodysplastic syndrome (MDS) after receiving ⁹⁰Y-daclizumab, but researchers found they could prevent this side effect with pretreatment screening.

John Janik, MD, of the National Cancer Institute in Bethesda, Maryland, and his colleagues described this research in PNAS.

The researchers conducted this study to determine if CD25 is a favorable target for systemic radioimmunotherapy in HL. The team noted that although most normal cells don’t express CD25, it is expressed by a minority of Reed–Sternberg cells and by most polyclonal T cells rosetting around Reed–Sternberg cells.

So the researchers tested the anti-CD25 antibody ⁹⁰Y-daclizumab in 46 patients with relapsed and refractory HL. Patients received ⁹⁰Y-daclizumab at 10 mCi to 15 mCi every 6 to 10 weeks for up to 7 doses.

The overall response rate was 50%. There were 14 complete responses and 9 partial responses. Fourteen patients had stable disease, and 9 progressed.

The researchers noted that responses occurred in patients whose Reed–Sternberg cells expressed CD25 and in those whose neoplastic cells were CD25-negative, as long as associated rosetting T cells expressed CD25.

Grade 3 or higher toxicities observed in this study included lymphopenia (n=10), neutropenia (n=7), MDS (n=6), thrombocytopenia (n=5), anemia (n=5), and pneumonia (n=2).

At a median follow-up of 9 years, MDS had occurred in 6 patients. They had received a mean of 3.2 doses of ⁹⁰Y-daclizumab. Prior to ⁹⁰Y-daclizumab, they had received a mean of 6.2 courses of chemotherapy.

The median time from the initiation of ⁹⁰Y-daclizumab to MDS diagnosis was 37 months. A retrospective review of 1 patient with MDS revealed that the patient had cytogenetic aberrations on chromosomes 5 and 7 after receiving chemotherapy but before starting ⁹⁰Y-daclizumab.

So the researchers changed the trial’s entry criteria to require a bone marrow karyotype analysis, and patients who had aberrations were excluded. None of the 16 patients who entered the trial after this change developed MDS.

The researchers said this study is too small to draw meaningful conclusions about the relative roles of chemotherapy and ⁹⁰Y-daclizumab in the pathogenesis of MDS.

However, this complication is a serious concern, and any subsequent trial should require cytogenetic studies of bone marrow specimens before patients receive systemic radioimmunotherapy.

Micrograph of HL
Copyright 2010 Nephron

Results of a small trial suggest the radiolabeled anti-CD25 antibody ⁹⁰Y-daclizumab can treat certain patients with relapsed/refractory Hodgkin lymphoma (HL).

⁹⁰Y-daclizumab produced responses in 50% of patients studied, and most of these were complete responses.

Several patients developed myelodysplastic syndrome (MDS) after receiving ⁹⁰Y-daclizumab, but researchers found they could prevent this side effect with pretreatment screening.

John Janik, MD, of the National Cancer Institute in Bethesda, Maryland, and his colleagues described this research in PNAS.

The researchers conducted this study to determine if CD25 is a favorable target for systemic radioimmunotherapy in HL. The team noted that although most normal cells don’t express CD25, it is expressed by a minority of Reed–Sternberg cells and by most polyclonal T cells rosetting around Reed–Sternberg cells.

So the researchers tested the anti-CD25 antibody ⁹⁰Y-daclizumab in 46 patients with relapsed and refractory HL. Patients received ⁹⁰Y-daclizumab at 10 mCi to 15 mCi every 6 to 10 weeks for up to 7 doses.

The overall response rate was 50%. There were 14 complete responses and 9 partial responses. Fourteen patients had stable disease, and 9 progressed.

The researchers noted that responses occurred in patients whose Reed–Sternberg cells expressed CD25 and in those whose neoplastic cells were CD25-negative, as long as associated rosetting T cells expressed CD25.

Grade 3 or higher toxicities observed in this study included lymphopenia (n=10), neutropenia (n=7), MDS (n=6), thrombocytopenia (n=5), anemia (n=5), and pneumonia (n=2).

At a median follow-up of 9 years, MDS had occurred in 6 patients. They had received a mean of 3.2 doses of ⁹⁰Y-daclizumab. Prior to ⁹⁰Y-daclizumab, they had received a mean of 6.2 courses of chemotherapy.

The median time from the initiation of ⁹⁰Y-daclizumab to MDS diagnosis was 37 months. A retrospective review of 1 patient with MDS revealed that the patient had cytogenetic aberrations on chromosomes 5 and 7 after receiving chemotherapy but before starting ⁹⁰Y-daclizumab.

So the researchers changed the trial’s entry criteria to require a bone marrow karyotype analysis, and patients who had aberrations were excluded. None of the 16 patients who entered the trial after this change developed MDS.

The researchers said this study is too small to draw meaningful conclusions about the relative roles of chemotherapy and ⁹⁰Y-daclizumab in the pathogenesis of MDS.

However, this complication is a serious concern, and any subsequent trial should require cytogenetic studies of bone marrow specimens before patients receive systemic radioimmunotherapy.

Micrograph of HL
Copyright 2010 Nephron

Results of a small trial suggest the radiolabeled anti-CD25 antibody ⁹⁰Y-daclizumab can treat certain patients with relapsed/refractory Hodgkin lymphoma (HL).

⁹⁰Y-daclizumab produced responses in 50% of patients studied, and most of these were complete responses.

Several patients developed myelodysplastic syndrome (MDS) after receiving ⁹⁰Y-daclizumab, but researchers found they could prevent this side effect with pretreatment screening.

John Janik, MD, of the National Cancer Institute in Bethesda, Maryland, and his colleagues described this research in PNAS.

The researchers conducted this study to determine if CD25 is a favorable target for systemic radioimmunotherapy in HL. The team noted that although most normal cells don’t express CD25, it is expressed by a minority of Reed–Sternberg cells and by most polyclonal T cells rosetting around Reed–Sternberg cells.

So the researchers tested the anti-CD25 antibody ⁹⁰Y-daclizumab in 46 patients with relapsed and refractory HL. Patients received ⁹⁰Y-daclizumab at 10 mCi to 15 mCi every 6 to 10 weeks for up to 7 doses.

The overall response rate was 50%. There were 14 complete responses and 9 partial responses. Fourteen patients had stable disease, and 9 progressed.

The researchers noted that responses occurred in patients whose Reed–Sternberg cells expressed CD25 and in those whose neoplastic cells were CD25-negative, as long as associated rosetting T cells expressed CD25.

Grade 3 or higher toxicities observed in this study included lymphopenia (n=10), neutropenia (n=7), MDS (n=6), thrombocytopenia (n=5), anemia (n=5), and pneumonia (n=2).

At a median follow-up of 9 years, MDS had occurred in 6 patients. They had received a mean of 3.2 doses of ⁹⁰Y-daclizumab. Prior to ⁹⁰Y-daclizumab, they had received a mean of 6.2 courses of chemotherapy.

The median time from the initiation of ⁹⁰Y-daclizumab to MDS diagnosis was 37 months. A retrospective review of 1 patient with MDS revealed that the patient had cytogenetic aberrations on chromosomes 5 and 7 after receiving chemotherapy but before starting ⁹⁰Y-daclizumab.

So the researchers changed the trial’s entry criteria to require a bone marrow karyotype analysis, and patients who had aberrations were excluded. None of the 16 patients who entered the trial after this change developed MDS.

The researchers said this study is too small to draw meaningful conclusions about the relative roles of chemotherapy and ⁹⁰Y-daclizumab in the pathogenesis of MDS.

However, this complication is a serious concern, and any subsequent trial should require cytogenetic studies of bone marrow specimens before patients receive systemic radioimmunotherapy.

Lab mice

Photo by Aaron Logan

A study of animal-based research published over the last 70 years suggests that scientists could have done more to reduce the risk of bias.

A group of researchers examined a few thousand published studies conducted in animals and found that, most of the time, scientists did not employ 4 measures believed to reduce the risk of bias: randomization, blinded assessment of outcome, a conflict of interest statement, and sample size calculation.

“I don’t believe for a moment that scientists set out to do anything other than excellent research, but what this work shows is that there is considerable room for improvement,” said Malcolm Macleod, PhD, of the University of Edinburgh in the UK.

Dr Macleod and his colleagues conducted this research and reported their findings in PLOS Biology.

The team first looked at a random sample of 146 in vivo studies published between 1941 and 2012. Randomization was reported in 20% of the publications in which it would have been appropriate.

Three percent of the publications reported blinding, 10% reported a conflict of interest statement, and none reported a sample size calculation.

Next, the researchers looked at 2671 studies published between 1992 and 2012 that reported drug efficacy in 8 disease models. Randomization was reported in 25% of publications, blinding in 30%, sample size calculation in 0.7%, and a statement of potential conflict of interest in 12%.

However, there were significant increases in 3 of these measures over time. The use of randomization increased from 14% in 1992 to 42% in 2011 (P<0.001), blinding increased from 16% to 39% (P<0.001), and a statement of possible conflict of interest increased from 2% to 35% (P<0.001).

The reporting of a sample size calculation did not change significantly and actually decreased from 2% to 1%.

Dr Macleod and his colleagues also used this dataset to determine whether a journal’s impact factor (a commonly used but disputed measure of journal “quality”)

played a role in the use of the 4 risk-of-bias measures.

The median journal impact factor was significantly higher (P<0.001) for studies reporting a potential conflict of interest, but it was significantly lower in studies reporting randomization (P=0.001). There was no significant difference for the other 2 measures.

Finally, the researchers examined bias in animal studies from the UK’s top 5 universities (according to the

2008 Research Assessment Exercise).

Of 1028 studies published in 2009 and 2010, 14% reported randomization, 17% reported blinding, 10% reported inclusion or exclusion criteria or both, and 1% reported a sample size calculation. Only 1 publication reported using all 4 of these measures.

Dr Macleod and his colleagues concluded that, although this study had its limitations, the results suggest room for improvement in in vivo research.

Lab mice

Photo by Aaron Logan

A study of animal-based research published over the last 70 years suggests that scientists could have done more to reduce the risk of bias.

A group of researchers examined a few thousand published studies conducted in animals and found that, most of the time, scientists did not employ 4 measures believed to reduce the risk of bias: randomization, blinded assessment of outcome, a conflict of interest statement, and sample size calculation.

“I don’t believe for a moment that scientists set out to do anything other than excellent research, but what this work shows is that there is considerable room for improvement,” said Malcolm Macleod, PhD, of the University of Edinburgh in the UK.

Dr Macleod and his colleagues conducted this research and reported their findings in PLOS Biology.

The team first looked at a random sample of 146 in vivo studies published between 1941 and 2012. Randomization was reported in 20% of the publications in which it would have been appropriate.

Three percent of the publications reported blinding, 10% reported a conflict of interest statement, and none reported a sample size calculation.

Next, the researchers looked at 2671 studies published between 1992 and 2012 that reported drug efficacy in 8 disease models. Randomization was reported in 25% of publications, blinding in 30%, sample size calculation in 0.7%, and a statement of potential conflict of interest in 12%.

However, there were significant increases in 3 of these measures over time. The use of randomization increased from 14% in 1992 to 42% in 2011 (P<0.001), blinding increased from 16% to 39% (P<0.001), and a statement of possible conflict of interest increased from 2% to 35% (P<0.001).

The reporting of a sample size calculation did not change significantly and actually decreased from 2% to 1%.

Dr Macleod and his colleagues also used this dataset to determine whether a journal’s impact factor (a commonly used but disputed measure of journal “quality”)

played a role in the use of the 4 risk-of-bias measures.

The median journal impact factor was significantly higher (P<0.001) for studies reporting a potential conflict of interest, but it was significantly lower in studies reporting randomization (P=0.001). There was no significant difference for the other 2 measures.

Finally, the researchers examined bias in animal studies from the UK’s top 5 universities (according to the

2008 Research Assessment Exercise).

Of 1028 studies published in 2009 and 2010, 14% reported randomization, 17% reported blinding, 10% reported inclusion or exclusion criteria or both, and 1% reported a sample size calculation. Only 1 publication reported using all 4 of these measures.

Dr Macleod and his colleagues concluded that, although this study had its limitations, the results suggest room for improvement in in vivo research.

Lab mice

Photo by Aaron Logan

A study of animal-based research published over the last 70 years suggests that scientists could have done more to reduce the risk of bias.

A group of researchers examined a few thousand published studies conducted in animals and found that, most of the time, scientists did not employ 4 measures believed to reduce the risk of bias: randomization, blinded assessment of outcome, a conflict of interest statement, and sample size calculation.

“I don’t believe for a moment that scientists set out to do anything other than excellent research, but what this work shows is that there is considerable room for improvement,” said Malcolm Macleod, PhD, of the University of Edinburgh in the UK.

Dr Macleod and his colleagues conducted this research and reported their findings in PLOS Biology.

The team first looked at a random sample of 146 in vivo studies published between 1941 and 2012. Randomization was reported in 20% of the publications in which it would have been appropriate.

Three percent of the publications reported blinding, 10% reported a conflict of interest statement, and none reported a sample size calculation.

Next, the researchers looked at 2671 studies published between 1992 and 2012 that reported drug efficacy in 8 disease models. Randomization was reported in 25% of publications, blinding in 30%, sample size calculation in 0.7%, and a statement of potential conflict of interest in 12%.

However, there were significant increases in 3 of these measures over time. The use of randomization increased from 14% in 1992 to 42% in 2011 (P<0.001), blinding increased from 16% to 39% (P<0.001), and a statement of possible conflict of interest increased from 2% to 35% (P<0.001).

The reporting of a sample size calculation did not change significantly and actually decreased from 2% to 1%.

Dr Macleod and his colleagues also used this dataset to determine whether a journal’s impact factor (a commonly used but disputed measure of journal “quality”)

played a role in the use of the 4 risk-of-bias measures.

The median journal impact factor was significantly higher (P<0.001) for studies reporting a potential conflict of interest, but it was significantly lower in studies reporting randomization (P=0.001). There was no significant difference for the other 2 measures.

Finally, the researchers examined bias in animal studies from the UK’s top 5 universities (according to the

2008 Research Assessment Exercise).

Of 1028 studies published in 2009 and 2010, 14% reported randomization, 17% reported blinding, 10% reported inclusion or exclusion criteria or both, and 1% reported a sample size calculation. Only 1 publication reported using all 4 of these measures.

Dr Macleod and his colleagues concluded that, although this study had its limitations, the results suggest room for improvement in in vivo research.

Mouse embryo

Image by Matthias Zepper

Murine research has provided new insight into the functionality of hematopoietic stem cells (HSCs).

Investigators found that a full complement of mini-chromosome maintenance (MCM) proteins is required to preserve HSC functionality and the proper differentiation and maturation of erythrocytes.

Downregulation of the gene MCM3 during embryonic development caused replication stress in hematopoietic progenitors and led to fetal anemia.

In adult mice, downregulation of MCM3 reduced life expectancy and promoted lymphomagenesis.

The investigators therefore believe that therapies designed to modulate replication stress could fight aging, anemia, and hematopoietic malignancies.

This research was published in Nature Communications.

A previous study revealed that replication stress drives the functional decline of HSCs that occurs with age. With the new study, investigators have managed to replicate this phenomenon in mouse embryos.

The team did this by reducing levels of MCM3, one of the components of the MCM complex that is responsible for separating the strands of the DNA double helix during replication. Cells need to maintain high levels of MCM during DNA replication or they experience replication stress.

“When we reduce the levels of the MCM3 gene in the entire organism, we observe that replication stress especially affects the stem cells that give rise to the other blood cells and, in particular, the red blood cell precursors,” explained study author Juan Méndez, PhD, of Centro Nacional de Investigaciones Oncologicas (CNIO) in Madrid, Spain.

“In adult organisms, the production and maturation of red blood cells takes place in the bone marrow, but, during embryonic development, it occurs mainly in the fetal liver. In animals with MCM3 deficiency, the stem cells of the fetal liver are deteriorated, and the embryos develop a severe form of anemia that prevents them from being born.”

“We could say that replication stress turns fetal stem cells, which should be in perfect working order, into very old cells. We have verified this finding in transplantation experiments, where fetal cells with replication stress were unable to adequately reconstitute the blood system in the recipient animals.”

However, the investigators managed to prevent embryonic lethality and reduce anemia by increasing the levels of another gene, CHK1.

“CHK1 is one of the genes responsible for protecting cells from replication stress,” Dr Méndez noted. “It supervises DNA replication. When something goes wrong, CHK1 slows down or halts cell division until the problem has been resolved.”

Embryos that were subjected to replication stress (due to loss of MCM3) but had higher levels of CHK1 showed less pronounced anemia. Four of every 10 embryos developed normally and completed their gestation.

The investigators said an interesting implication of this work is that the type of anemia caused by replication stress is very similar to the aplastic anemia that arises in patients receiving chemotherapy or radiation therapy.

Therefore, the team believes these results could aid the development of novel therapies for aplastic anemia.

Mouse embryo

Image by Matthias Zepper

Murine research has provided new insight into the functionality of hematopoietic stem cells (HSCs).

Investigators found that a full complement of mini-chromosome maintenance (MCM) proteins is required to preserve HSC functionality and the proper differentiation and maturation of erythrocytes.

Downregulation of the gene MCM3 during embryonic development caused replication stress in hematopoietic progenitors and led to fetal anemia.

In adult mice, downregulation of MCM3 reduced life expectancy and promoted lymphomagenesis.

The investigators therefore believe that therapies designed to modulate replication stress could fight aging, anemia, and hematopoietic malignancies.

This research was published in Nature Communications.

A previous study revealed that replication stress drives the functional decline of HSCs that occurs with age. With the new study, investigators have managed to replicate this phenomenon in mouse embryos.

The team did this by reducing levels of MCM3, one of the components of the MCM complex that is responsible for separating the strands of the DNA double helix during replication. Cells need to maintain high levels of MCM during DNA replication or they experience replication stress.

“When we reduce the levels of the MCM3 gene in the entire organism, we observe that replication stress especially affects the stem cells that give rise to the other blood cells and, in particular, the red blood cell precursors,” explained study author Juan Méndez, PhD, of Centro Nacional de Investigaciones Oncologicas (CNIO) in Madrid, Spain.

“In adult organisms, the production and maturation of red blood cells takes place in the bone marrow, but, during embryonic development, it occurs mainly in the fetal liver. In animals with MCM3 deficiency, the stem cells of the fetal liver are deteriorated, and the embryos develop a severe form of anemia that prevents them from being born.”

“We could say that replication stress turns fetal stem cells, which should be in perfect working order, into very old cells. We have verified this finding in transplantation experiments, where fetal cells with replication stress were unable to adequately reconstitute the blood system in the recipient animals.”

However, the investigators managed to prevent embryonic lethality and reduce anemia by increasing the levels of another gene, CHK1.

“CHK1 is one of the genes responsible for protecting cells from replication stress,” Dr Méndez noted. “It supervises DNA replication. When something goes wrong, CHK1 slows down or halts cell division until the problem has been resolved.”

Embryos that were subjected to replication stress (due to loss of MCM3) but had higher levels of CHK1 showed less pronounced anemia. Four of every 10 embryos developed normally and completed their gestation.

The investigators said an interesting implication of this work is that the type of anemia caused by replication stress is very similar to the aplastic anemia that arises in patients receiving chemotherapy or radiation therapy.

Therefore, the team believes these results could aid the development of novel therapies for aplastic anemia.

Mouse embryo

Image by Matthias Zepper

Murine research has provided new insight into the functionality of hematopoietic stem cells (HSCs).

Investigators found that a full complement of mini-chromosome maintenance (MCM) proteins is required to preserve HSC functionality and the proper differentiation and maturation of erythrocytes.

Downregulation of the gene MCM3 during embryonic development caused replication stress in hematopoietic progenitors and led to fetal anemia.

In adult mice, downregulation of MCM3 reduced life expectancy and promoted lymphomagenesis.

The investigators therefore believe that therapies designed to modulate replication stress could fight aging, anemia, and hematopoietic malignancies.

This research was published in Nature Communications.

A previous study revealed that replication stress drives the functional decline of HSCs that occurs with age. With the new study, investigators have managed to replicate this phenomenon in mouse embryos.

The team did this by reducing levels of MCM3, one of the components of the MCM complex that is responsible for separating the strands of the DNA double helix during replication. Cells need to maintain high levels of MCM during DNA replication or they experience replication stress.

“When we reduce the levels of the MCM3 gene in the entire organism, we observe that replication stress especially affects the stem cells that give rise to the other blood cells and, in particular, the red blood cell precursors,” explained study author Juan Méndez, PhD, of Centro Nacional de Investigaciones Oncologicas (CNIO) in Madrid, Spain.

“In adult organisms, the production and maturation of red blood cells takes place in the bone marrow, but, during embryonic development, it occurs mainly in the fetal liver. In animals with MCM3 deficiency, the stem cells of the fetal liver are deteriorated, and the embryos develop a severe form of anemia that prevents them from being born.”

“We could say that replication stress turns fetal stem cells, which should be in perfect working order, into very old cells. We have verified this finding in transplantation experiments, where fetal cells with replication stress were unable to adequately reconstitute the blood system in the recipient animals.”

However, the investigators managed to prevent embryonic lethality and reduce anemia by increasing the levels of another gene, CHK1.

“CHK1 is one of the genes responsible for protecting cells from replication stress,” Dr Méndez noted. “It supervises DNA replication. When something goes wrong, CHK1 slows down or halts cell division until the problem has been resolved.”

Embryos that were subjected to replication stress (due to loss of MCM3) but had higher levels of CHK1 showed less pronounced anemia. Four of every 10 embryos developed normally and completed their gestation.

The investigators said an interesting implication of this work is that the type of anemia caused by replication stress is very similar to the aplastic anemia that arises in patients receiving chemotherapy or radiation therapy.

Therefore, the team believes these results could aid the development of novel therapies for aplastic anemia.

Vials and a syringe

The US Food and Drug Administration (FDA) has approved a factor X product derived from human plasma (Coagadex) to treat patients with hereditary factor X deficiency who are 12 years of age and older.

Coagadex is approved for on-demand treatment and control of bleeding episodes in these patients as well as for perioperative management of bleeding in patients with mild hereditary factor X deficiency.

Prior to this approval, there was no specific coagulation factor replacement therapy available for patients with hereditary factor X deficiency in the US. The FDA previously granted Coagadex orphan product designation, fast track designation, and priority review.

The FDA based its approval of Coagadex on results from 2 phase 3 trials of patients age 12 and older.

The first trial included 16 patients who received Coagadex for pharmacokinetic evaluation, on-demand treatment and control of bleeding episodes, and/or perioperative management of minor surgical or dental procedures.

Coagadex was used to treat 208 bleeding episodes, and 187 of these episodes (in 15 patients) were evaluated for efficacy. Ninety-eight episodes were major bleeds, 88 were minor bleeds, and 1 was not assessed.

One hundred and fifty-five bleeds (83%) were treated with a single infusion of Coagadex, 28 (15%) were treated with 2 infusions, 3 bleeds (2%) required 3 infusions, and 1 bleed (0.5%) required 4 infusions. Four bleeding episodes in 2 patients were considered treatment failures.

The mean dose of Coagadex per infusion was 25.4 IU/kg, and the mean total dose was 30.4 IU/kg. The recommended dose of 25 IU/kg to treat a bleed was maintained for 14 of the 16 patients. The other 2 patients used doses of up to 30 IU/kg and 33 IU/kg.

There were 176 adverse events in this trial, but only 6 events in 2 patients were considered possibly related to Coagadex. This included 2 reports of infusion site erythema in 1 patient, 2 reports of fatigue in 1 patient, 1 report of back pain, and 1 report of infusion site pain.

The second trial included patients who received Coagadex for perioperative management. Five patients received Coagadex for 7 surgical procedures.

For major surgeries, a median of 13 infusions (range, 2-15) and a median cumulative dose of 181 IU/kg (range, 45-210 IU/kg) were required to maintain hemostasis. For minor surgeries, a median of 2.5 infusions (range, 1-4) and a median cumulative dose of 89 IU/kg (range, 51-127 IU/kg) were required to maintain hemostasis.

There were no adverse events related to Coagadex in this trial.

For more details on these trials, see the Coagadex package insert. Coagadex is manufactured by Bio Products Laboratory Limited in Elstree, Hertfordshire, UK.

Vials and a syringe

The US Food and Drug Administration (FDA) has approved a factor X product derived from human plasma (Coagadex) to treat patients with hereditary factor X deficiency who are 12 years of age and older.

Coagadex is approved for on-demand treatment and control of bleeding episodes in these patients as well as for perioperative management of bleeding in patients with mild hereditary factor X deficiency.

Prior to this approval, there was no specific coagulation factor replacement therapy available for patients with hereditary factor X deficiency in the US. The FDA previously granted Coagadex orphan product designation, fast track designation, and priority review.

The FDA based its approval of Coagadex on results from 2 phase 3 trials of patients age 12 and older.

The first trial included 16 patients who received Coagadex for pharmacokinetic evaluation, on-demand treatment and control of bleeding episodes, and/or perioperative management of minor surgical or dental procedures.

Coagadex was used to treat 208 bleeding episodes, and 187 of these episodes (in 15 patients) were evaluated for efficacy. Ninety-eight episodes were major bleeds, 88 were minor bleeds, and 1 was not assessed.

One hundred and fifty-five bleeds (83%) were treated with a single infusion of Coagadex, 28 (15%) were treated with 2 infusions, 3 bleeds (2%) required 3 infusions, and 1 bleed (0.5%) required 4 infusions. Four bleeding episodes in 2 patients were considered treatment failures.

The mean dose of Coagadex per infusion was 25.4 IU/kg, and the mean total dose was 30.4 IU/kg. The recommended dose of 25 IU/kg to treat a bleed was maintained for 14 of the 16 patients. The other 2 patients used doses of up to 30 IU/kg and 33 IU/kg.

There were 176 adverse events in this trial, but only 6 events in 2 patients were considered possibly related to Coagadex. This included 2 reports of infusion site erythema in 1 patient, 2 reports of fatigue in 1 patient, 1 report of back pain, and 1 report of infusion site pain.

The second trial included patients who received Coagadex for perioperative management. Five patients received Coagadex for 7 surgical procedures.

For major surgeries, a median of 13 infusions (range, 2-15) and a median cumulative dose of 181 IU/kg (range, 45-210 IU/kg) were required to maintain hemostasis. For minor surgeries, a median of 2.5 infusions (range, 1-4) and a median cumulative dose of 89 IU/kg (range, 51-127 IU/kg) were required to maintain hemostasis.

There were no adverse events related to Coagadex in this trial.

For more details on these trials, see the Coagadex package insert. Coagadex is manufactured by Bio Products Laboratory Limited in Elstree, Hertfordshire, UK.

Vials and a syringe

The US Food and Drug Administration (FDA) has approved a factor X product derived from human plasma (Coagadex) to treat patients with hereditary factor X deficiency who are 12 years of age and older.

Coagadex is approved for on-demand treatment and control of bleeding episodes in these patients as well as for perioperative management of bleeding in patients with mild hereditary factor X deficiency.

Prior to this approval, there was no specific coagulation factor replacement therapy available for patients with hereditary factor X deficiency in the US. The FDA previously granted Coagadex orphan product designation, fast track designation, and priority review.

The FDA based its approval of Coagadex on results from 2 phase 3 trials of patients age 12 and older.

The first trial included 16 patients who received Coagadex for pharmacokinetic evaluation, on-demand treatment and control of bleeding episodes, and/or perioperative management of minor surgical or dental procedures.

Coagadex was used to treat 208 bleeding episodes, and 187 of these episodes (in 15 patients) were evaluated for efficacy. Ninety-eight episodes were major bleeds, 88 were minor bleeds, and 1 was not assessed.

One hundred and fifty-five bleeds (83%) were treated with a single infusion of Coagadex, 28 (15%) were treated with 2 infusions, 3 bleeds (2%) required 3 infusions, and 1 bleed (0.5%) required 4 infusions. Four bleeding episodes in 2 patients were considered treatment failures.

The mean dose of Coagadex per infusion was 25.4 IU/kg, and the mean total dose was 30.4 IU/kg. The recommended dose of 25 IU/kg to treat a bleed was maintained for 14 of the 16 patients. The other 2 patients used doses of up to 30 IU/kg and 33 IU/kg.

There were 176 adverse events in this trial, but only 6 events in 2 patients were considered possibly related to Coagadex. This included 2 reports of infusion site erythema in 1 patient, 2 reports of fatigue in 1 patient, 1 report of back pain, and 1 report of infusion site pain.

The second trial included patients who received Coagadex for perioperative management. Five patients received Coagadex for 7 surgical procedures.

For major surgeries, a median of 13 infusions (range, 2-15) and a median cumulative dose of 181 IU/kg (range, 45-210 IU/kg) were required to maintain hemostasis. For minor surgeries, a median of 2.5 infusions (range, 1-4) and a median cumulative dose of 89 IU/kg (range, 51-127 IU/kg) were required to maintain hemostasis.

There were no adverse events related to Coagadex in this trial.

For more details on these trials, see the Coagadex package insert. Coagadex is manufactured by Bio Products Laboratory Limited in Elstree, Hertfordshire, UK.

Chronic cough is defined by the American College of Chest Physicians as a cough lasting longer than 8 weeks. Chronic cough is a troubling disorder, mostly for the patients, who frequently make several outpatient visits to seek help for their symptoms, and whose quality of life can be severely impaired.

An algorithmic approach should be used in the diagnosis of chronic cough. Once we have ruled out the “bad actors” and have run through our nasal sprays, proton pump inhibitors, and antihistamines, it is time to get creative. Don’t neglect to provide lung cancer screening for your smokers – which, in the case of chronic cough, is actually case finding.

Dr. Peter G. Gibson of the University of Newcastle, Australia, and his colleagues published an article presenting some new concepts for chronic cough, an assessment tool, and a literature review on the use of gabapentin for this troubling disorder (Pulm Pharmacol Ther. 2015 Jul 2. pii:S1094-5539[15]00072-3).

The new concepts include laryngeal hypersensitivity, central reflex hypersensitivity, and cough hypersensitivity syndrome. The authors posit that these concepts reformulate into chronic cough as a neuropathic disorder, which may be amenable to treatment with neuromodulatory agents such as gabapentin.

I have several patients in my panel who might benefit from this therapy. But there are a couple of things to remember. First, gabapentin can be taken with food, but antacids decrease the bioavailability by 20% when taken together or up to 2 hours after gabapentin ingestion. Also, gabapentin has a wide therapeutic window, which will make it easier to find an individualized dose for our patients.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow him on Twitter @jonebbert.

Chronic cough is defined by the American College of Chest Physicians as a cough lasting longer than 8 weeks. Chronic cough is a troubling disorder, mostly for the patients, who frequently make several outpatient visits to seek help for their symptoms, and whose quality of life can be severely impaired.

An algorithmic approach should be used in the diagnosis of chronic cough. Once we have ruled out the “bad actors” and have run through our nasal sprays, proton pump inhibitors, and antihistamines, it is time to get creative. Don’t neglect to provide lung cancer screening for your smokers – which, in the case of chronic cough, is actually case finding.

Dr. Peter G. Gibson of the University of Newcastle, Australia, and his colleagues published an article presenting some new concepts for chronic cough, an assessment tool, and a literature review on the use of gabapentin for this troubling disorder (Pulm Pharmacol Ther. 2015 Jul 2. pii:S1094-5539[15]00072-3).

The new concepts include laryngeal hypersensitivity, central reflex hypersensitivity, and cough hypersensitivity syndrome. The authors posit that these concepts reformulate into chronic cough as a neuropathic disorder, which may be amenable to treatment with neuromodulatory agents such as gabapentin.

I have several patients in my panel who might benefit from this therapy. But there are a couple of things to remember. First, gabapentin can be taken with food, but antacids decrease the bioavailability by 20% when taken together or up to 2 hours after gabapentin ingestion. Also, gabapentin has a wide therapeutic window, which will make it easier to find an individualized dose for our patients.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow him on Twitter @jonebbert.

Chronic cough is defined by the American College of Chest Physicians as a cough lasting longer than 8 weeks. Chronic cough is a troubling disorder, mostly for the patients, who frequently make several outpatient visits to seek help for their symptoms, and whose quality of life can be severely impaired.

An algorithmic approach should be used in the diagnosis of chronic cough. Once we have ruled out the “bad actors” and have run through our nasal sprays, proton pump inhibitors, and antihistamines, it is time to get creative. Don’t neglect to provide lung cancer screening for your smokers – which, in the case of chronic cough, is actually case finding.

Dr. Peter G. Gibson of the University of Newcastle, Australia, and his colleagues published an article presenting some new concepts for chronic cough, an assessment tool, and a literature review on the use of gabapentin for this troubling disorder (Pulm Pharmacol Ther. 2015 Jul 2. pii:S1094-5539[15]00072-3).

The new concepts include laryngeal hypersensitivity, central reflex hypersensitivity, and cough hypersensitivity syndrome. The authors posit that these concepts reformulate into chronic cough as a neuropathic disorder, which may be amenable to treatment with neuromodulatory agents such as gabapentin.

I have several patients in my panel who might benefit from this therapy. But there are a couple of things to remember. First, gabapentin can be taken with food, but antacids decrease the bioavailability by 20% when taken together or up to 2 hours after gabapentin ingestion. Also, gabapentin has a wide therapeutic window, which will make it easier to find an individualized dose for our patients.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow him on Twitter @jonebbert.

Total knee replacement was superior to nonsurgical treatment in relieving pain, restoring function, and improving quality of life for patients with moderate to severe knee osteoarthritis, according to a report published online Oct. 22 in the New England Journal of Medicine.

Even though the number of total knee replacements performed each year is large and steadily increasing – with more than 670,000 done in 2012 in the United States alone – no high-quality randomized, controlled trials have ever compared the effectiveness of the procedure against nonsurgical treatment, said Søren T. Skou, Ph.D., of the Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, and his associates.

Dr. Skou and his colleagues remedied that situation by randomly assigning 100 adults (mean age, 66 years) who were eligible for unilateral total knee replacement to either undergo the procedure and then receive a comprehensive nonsurgical intervention (50 patients) or receive the comprehensive nonsurgical intervention alone (50 patients) at two specialized university clinics in Denmark. The 12-week nonsurgical intervention comprised a twice-weekly group exercise program to restore neutral, functional realignment of the legs; two 1-hour education sessions regarding osteoarthritis characteristics, treatments, and self-help strategies; a dietary (weight-loss) program; provision of individually fitted insoles with medial arch support and a lateral wedge if patients had knee-lateral-to-foot positioning; and as-needed pain medication for pain – acetaminophen and ibuprofen – and pantoprazole, a proton-pump inhibitor.

The primary outcome measure in the trial was the between-group difference at 1 year in improvement on four subscales of the Knee Injury and Osteoarthritis Outcome Scores (KOOS) for pain, symptoms, activities of daily living, and quality of life. The surgical group showed a significantly greater improvement (32.5 out of a possible 100 points) than the nonsurgical group (16.0 points) in this outcome. The surgical group also showed significantly greater improvements in all five individual subscales and in a timed chair-rising test, a timed 20-meter walk test, and on a quality-of-life index, the investigators said (N Engl J Med. 2015 373;17:1597-606).

However, it is important to note that patients who had only the nonsurgical intervention showed clinically relevant improvements, and only 26% of them chose to have the surgery after the conclusion of the study. As expected, the surgical group had more serious adverse events than did the nonsurgical group (24 vs. 6), including three cases of deep venous thrombosis and three cases of knee stiffness requiring brisement forcé while the patient was anesthetized, Dr. Skou and his associates said.

This study was supported by the Obel Family Foundation, the Danish Rheumatism Association, the Health Science Foundation of the North Denmark Region, Foot Science International, Spar Nord Foundation, the Bevica Foundation, the Association of Danish Physiotherapists Research Fund, the Medical Specialist Heinrich Kopp’s Grant, and the Danish Medical Association Research Fund. Dr. Skou and his associates reported having no relevant financial disclosures.

Total knee replacement was superior to nonsurgical treatment in relieving pain, restoring function, and improving quality of life for patients with moderate to severe knee osteoarthritis, according to a report published online Oct. 22 in the New England Journal of Medicine.

Even though the number of total knee replacements performed each year is large and steadily increasing – with more than 670,000 done in 2012 in the United States alone – no high-quality randomized, controlled trials have ever compared the effectiveness of the procedure against nonsurgical treatment, said Søren T. Skou, Ph.D., of the Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, and his associates.

Dr. Skou and his colleagues remedied that situation by randomly assigning 100 adults (mean age, 66 years) who were eligible for unilateral total knee replacement to either undergo the procedure and then receive a comprehensive nonsurgical intervention (50 patients) or receive the comprehensive nonsurgical intervention alone (50 patients) at two specialized university clinics in Denmark. The 12-week nonsurgical intervention comprised a twice-weekly group exercise program to restore neutral, functional realignment of the legs; two 1-hour education sessions regarding osteoarthritis characteristics, treatments, and self-help strategies; a dietary (weight-loss) program; provision of individually fitted insoles with medial arch support and a lateral wedge if patients had knee-lateral-to-foot positioning; and as-needed pain medication for pain – acetaminophen and ibuprofen – and pantoprazole, a proton-pump inhibitor.

The primary outcome measure in the trial was the between-group difference at 1 year in improvement on four subscales of the Knee Injury and Osteoarthritis Outcome Scores (KOOS) for pain, symptoms, activities of daily living, and quality of life. The surgical group showed a significantly greater improvement (32.5 out of a possible 100 points) than the nonsurgical group (16.0 points) in this outcome. The surgical group also showed significantly greater improvements in all five individual subscales and in a timed chair-rising test, a timed 20-meter walk test, and on a quality-of-life index, the investigators said (N Engl J Med. 2015 373;17:1597-606).

However, it is important to note that patients who had only the nonsurgical intervention showed clinically relevant improvements, and only 26% of them chose to have the surgery after the conclusion of the study. As expected, the surgical group had more serious adverse events than did the nonsurgical group (24 vs. 6), including three cases of deep venous thrombosis and three cases of knee stiffness requiring brisement forcé while the patient was anesthetized, Dr. Skou and his associates said.

This study was supported by the Obel Family Foundation, the Danish Rheumatism Association, the Health Science Foundation of the North Denmark Region, Foot Science International, Spar Nord Foundation, the Bevica Foundation, the Association of Danish Physiotherapists Research Fund, the Medical Specialist Heinrich Kopp’s Grant, and the Danish Medical Association Research Fund. Dr. Skou and his associates reported having no relevant financial disclosures.

Total knee replacement was superior to nonsurgical treatment in relieving pain, restoring function, and improving quality of life for patients with moderate to severe knee osteoarthritis, according to a report published online Oct. 22 in the New England Journal of Medicine.

Even though the number of total knee replacements performed each year is large and steadily increasing – with more than 670,000 done in 2012 in the United States alone – no high-quality randomized, controlled trials have ever compared the effectiveness of the procedure against nonsurgical treatment, said Søren T. Skou, Ph.D., of the Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, and his associates.

Dr. Skou and his colleagues remedied that situation by randomly assigning 100 adults (mean age, 66 years) who were eligible for unilateral total knee replacement to either undergo the procedure and then receive a comprehensive nonsurgical intervention (50 patients) or receive the comprehensive nonsurgical intervention alone (50 patients) at two specialized university clinics in Denmark. The 12-week nonsurgical intervention comprised a twice-weekly group exercise program to restore neutral, functional realignment of the legs; two 1-hour education sessions regarding osteoarthritis characteristics, treatments, and self-help strategies; a dietary (weight-loss) program; provision of individually fitted insoles with medial arch support and a lateral wedge if patients had knee-lateral-to-foot positioning; and as-needed pain medication for pain – acetaminophen and ibuprofen – and pantoprazole, a proton-pump inhibitor.

The primary outcome measure in the trial was the between-group difference at 1 year in improvement on four subscales of the Knee Injury and Osteoarthritis Outcome Scores (KOOS) for pain, symptoms, activities of daily living, and quality of life. The surgical group showed a significantly greater improvement (32.5 out of a possible 100 points) than the nonsurgical group (16.0 points) in this outcome. The surgical group also showed significantly greater improvements in all five individual subscales and in a timed chair-rising test, a timed 20-meter walk test, and on a quality-of-life index, the investigators said (N Engl J Med. 2015 373;17:1597-606).

However, it is important to note that patients who had only the nonsurgical intervention showed clinically relevant improvements, and only 26% of them chose to have the surgery after the conclusion of the study. As expected, the surgical group had more serious adverse events than did the nonsurgical group (24 vs. 6), including three cases of deep venous thrombosis and three cases of knee stiffness requiring brisement forcé while the patient was anesthetized, Dr. Skou and his associates said.

This study was supported by the Obel Family Foundation, the Danish Rheumatism Association, the Health Science Foundation of the North Denmark Region, Foot Science International, Spar Nord Foundation, the Bevica Foundation, the Association of Danish Physiotherapists Research Fund, the Medical Specialist Heinrich Kopp’s Grant, and the Danish Medical Association Research Fund. Dr. Skou and his associates reported having no relevant financial disclosures.

LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.

The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.

Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.

For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.

An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.

Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.

In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).

“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.

sworcester@frontlinemedcom.com

LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.

The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.

Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.

For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.

An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.

Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.

In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).

“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.

sworcester@frontlinemedcom.com

LAKE BUENA VISTA, FLA. – Outcomes in patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib did not differ based on metastatic site, according to a subanalysis of data from the phase 3, randomized, double-blind SELECT trial.

The overall response rate in 257 patients from that trial (the Study of Lenvatinib in Differentiated Cancer of the Thyroid) who had one or more metastatic sites of radioiodine-refractory differentiated thyroid cancer (RR-DTC) was more than 50% (vs. 1.6% or less in 131 treated with placebo) regardless of the number of metastatic sites at baseline and regardless of the site, Dr. Mouhammed Amir Habra reported in a poster at the International Thyroid Congress.

Further, the overall response rate did not differ significantly between those with zero to one vs. two or more metastatic sites, said Dr. Habra of the University of Texas MD Anderson Cancer Center, Houston.

For common sites of metastasis, including bone, liver, lungs, and lymph nodes, median progression-free survival (PFS) was significantly prolonged with lenvatinib vs. placebo. The median was not estimable for those with one or no metastatic sites who were treated with lenvatinib and was 3.7 months for those who received placebo. The corresponding values for those with two or more metastatic sites were 15.9 vs. 3.6 months.

An exception was in those with brain metastasis, who had PFS of 8.8 vs. 3.7 months with lenvatinib vs. placebo, respectively, but this subgroup included only 16 patients, Dr. Habra noted.

Time to first objective response was also similar between metastatic groups (1.9, 3.6, 3.5, and 2 months in those with brain, bone, liver, and lung metastases at baseline, respectively). The median duration of objective response was 6.9 months in those with brain metastases and 9.2 months in those with liver metastases at baseline. The duration of objective response was not reached in those with bone and lung metastases at baseline.

In the pivotal SELECT trial, the oral multikinase inhibitor lenvatinib significantly prolonged PFS in patients with RR-DTC vs. placebo (median PFS of 18.3 vs. 3.6 months).

“These [current] findings suggest a treatment benefit vs. placebo with lenvatinib regardless of number and type of metastatic sites at baseline,” Dr. Habra concluded at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.

The study was funded by Eisai, and additional support was provided by Oxford PharmaGenesis.

sworcester@frontlinemedcom.com

After, test your knowledge by answering the 5 practice questions.

Practice Questions

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 
2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

After, test your knowledge by answering the 5 practice questions.

Practice Questions

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 
2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

After, test your knowledge by answering the 5 practice questions.

Practice Questions

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

1. A 5-year-old girl presented to your clinic with an itchy rash in the vulvar and anal regions. The patient’s mother reported erythema and erosion of the anal area. Her pediatrician prescribed an oral antibiotic that showed good results but the condition recurred 2 weeks after she finished the medication. The most likely diagnosis is:

a. Behçet disease

b. pemphigus vulgaris

c. perianal streptococcal dermatitis

d. plasma cell vulvitis

e. vulvodynia

 
2. A 34-year-old woman presented with pain and a burning sensation on the vulva. She reported a history of migraines. On physical examination, mild erythema was noted on the labia majora and minora and the patient reported pain to the touch of a cotton-tipped applicator in the vestibule. The most likely diagnosis is:

a. Crohn disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

3. A 25-year-old woman with a history of oral ulcers presented to your clinic with pain in the genital area. On physical examination, multiple ulcers were noted on the labia majora with no discharge. The most likely diagnosis is:

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

4. A 56-year-old woman presented to your clinic with vulvar pruritus and a burning sensation of 6 months’ duration. She had used a topical antibiotic and hydrocortisone cream 1% without relief. On physical examination, a red, irregular plaque is noted on the vestibule. The most likely diagnosis is:

a. Behçet disease

b. extramammary Paget disease

c. pemphigus vulgaris

d. plasma cell vulvitis

e. vulvodynia

5. A 44-year-old woman presented to your clinic with pain and edema of the vulva. At physical examination, erythema and fissures were noted around the anus with fistulas involving the perianal skin. What is the most likely diagnosis?

a. Behçet disease

b. Crohn disease

c. extramammary Paget disease

d. pemphigus vulgaris

e. plasma cell vulvitis

Patients with bipolar disorder who perceive their overall physical health as poor experience worse disease outcomes, according to Emily E. Bernstein of Harvard University, Cambridge, Mass., and her associates.

Data were collected from the Systematic Treatment Enhancement Program for Bipolar Disorder and were analyzed via the Short Form Health Survey (SF-36). An increased sense of role limitation increased the risk of depressive symptoms, while increased physical pain raised the risk of mania/hypomania. “Reports of specific or concrete physical limitations in daily life showed no associations with psychiatric symptoms at concurrent assessments, but did predict worse course of illness” 1 year later, the researchers wrote.

“Though further research is warranted, changes in subjective physical health–related quality of life, even independent of objective health changes, may offer important insight into global well-being and be targets of psychotherapy treatment,” they concluded.

Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.052).

lfranki@frontlinemedcom.com

Patients with bipolar disorder who perceive their overall physical health as poor experience worse disease outcomes, according to Emily E. Bernstein of Harvard University, Cambridge, Mass., and her associates.

Data were collected from the Systematic Treatment Enhancement Program for Bipolar Disorder and were analyzed via the Short Form Health Survey (SF-36). An increased sense of role limitation increased the risk of depressive symptoms, while increased physical pain raised the risk of mania/hypomania. “Reports of specific or concrete physical limitations in daily life showed no associations with psychiatric symptoms at concurrent assessments, but did predict worse course of illness” 1 year later, the researchers wrote.

“Though further research is warranted, changes in subjective physical health–related quality of life, even independent of objective health changes, may offer important insight into global well-being and be targets of psychotherapy treatment,” they concluded.

Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.052).

lfranki@frontlinemedcom.com

Patients with bipolar disorder who perceive their overall physical health as poor experience worse disease outcomes, according to Emily E. Bernstein of Harvard University, Cambridge, Mass., and her associates.

Data were collected from the Systematic Treatment Enhancement Program for Bipolar Disorder and were analyzed via the Short Form Health Survey (SF-36). An increased sense of role limitation increased the risk of depressive symptoms, while increased physical pain raised the risk of mania/hypomania. “Reports of specific or concrete physical limitations in daily life showed no associations with psychiatric symptoms at concurrent assessments, but did predict worse course of illness” 1 year later, the researchers wrote.

“Though further research is warranted, changes in subjective physical health–related quality of life, even independent of objective health changes, may offer important insight into global well-being and be targets of psychotherapy treatment,” they concluded.

Find the study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.052).

lfranki@frontlinemedcom.com