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Dendritic cells promote Myc-driven lymphoma
Studies have shown that dendritic cells (DCs) can contribute to tumor growth and help shield the tumor from the immune system in colon, stomach, breast, and prostate cancer.
Now, researchers have found evidence suggesting this phenomenon also occurs in Myc-driven lymphomas.
The team has also identified the molecular mechanism that induces the immune cells to promote tumor growth.
They reported these findings in Nature Communications.
Uta Höpken, PhD, of the Max Delbrück Center for Molecular Medicine in Berlin, Germany, and her colleagues investigated how DCs drive tumor in mouse models of Eµ-Myc lymphoma.
The team began by depleting DCs in these mice and found that tumor growth was delayed—the first clue that DCs are indeed associated with lymphoma growth.
Next, the researchers found that, after contact with lymphoma cells, the DCs increasingly secrete immunomodulatory cytokines and growth factors. The cytokine secretion takes place in the spleen and lymph nodes.
Dr Höpken and her colleagues previously demonstrated that various forms of lymphoma cells settle in the lymph nodes and in the spleen, where they create their own survival niche. This process is regulated by selective cytokines and growth factors the researchers identified a few years ago.
“In these niches, almost everything is already there that the lymphoma cells as malignant B cells need to survive, including blood vessels and connective tissue cells [stromal cells],” Dr Höpken said. “The survival substances secreted by the DCs optimize the niche so that the tumors can grow better.”
This also means the DCs prevent the T lymphocytes from exercising their defensive function. Normally, healthy B or T cells settle in the respective B- or T-cell niches of the spleen and the lymph nodes to be made fit for immune defense.
“What is paradoxical is that the mouse lymphoma cells we studied—malignant B cells—found their survival niche in the T-cell zones of the lymph nodes and the spleen and not in the B-cell zones,” Dr Höpken said.
After making contact with the lymphoma cells, the DCs increasingly upregulate C/EBPβ, a transcription factor that promotes the production of cytokines that mediate inflammation.
The researchers found that C/EBPβ regulates DCs. Without it, the cells could not secrete inflammatory cytokines. C/EBPβ also indirectly blocks apoptosis in the lymphoma cells, allowing the cancer cells to grow unchecked.
The team pointed out that, even if their model of Eµ-Myc lymphoma is not entirely comparable to B-cell lymphomas in humans, it shows that lymphoma cells and DCs interact—a previously unknown molecular mechanism.
Furthermore, these findings may have clinical applications. The researchers noted that the immunomodulatory agent lenalidomide induces downregulation of C/EBPβ, which is secreted by cancer cells.
So Dr Höpken and her colleagues believe it might be appropriate to approve the use of lenalidomide for patients with Myc B-cell lymphoma, as an addition to their existing treatment, to strengthen their immune defense. 
Studies have shown that dendritic cells (DCs) can contribute to tumor growth and help shield the tumor from the immune system in colon, stomach, breast, and prostate cancer.
Now, researchers have found evidence suggesting this phenomenon also occurs in Myc-driven lymphomas.
The team has also identified the molecular mechanism that induces the immune cells to promote tumor growth.
They reported these findings in Nature Communications.
Uta Höpken, PhD, of the Max Delbrück Center for Molecular Medicine in Berlin, Germany, and her colleagues investigated how DCs drive tumor in mouse models of Eµ-Myc lymphoma.
The team began by depleting DCs in these mice and found that tumor growth was delayed—the first clue that DCs are indeed associated with lymphoma growth.
Next, the researchers found that, after contact with lymphoma cells, the DCs increasingly secrete immunomodulatory cytokines and growth factors. The cytokine secretion takes place in the spleen and lymph nodes.
Dr Höpken and her colleagues previously demonstrated that various forms of lymphoma cells settle in the lymph nodes and in the spleen, where they create their own survival niche. This process is regulated by selective cytokines and growth factors the researchers identified a few years ago.
“In these niches, almost everything is already there that the lymphoma cells as malignant B cells need to survive, including blood vessels and connective tissue cells [stromal cells],” Dr Höpken said. “The survival substances secreted by the DCs optimize the niche so that the tumors can grow better.”
This also means the DCs prevent the T lymphocytes from exercising their defensive function. Normally, healthy B or T cells settle in the respective B- or T-cell niches of the spleen and the lymph nodes to be made fit for immune defense.
“What is paradoxical is that the mouse lymphoma cells we studied—malignant B cells—found their survival niche in the T-cell zones of the lymph nodes and the spleen and not in the B-cell zones,” Dr Höpken said.
After making contact with the lymphoma cells, the DCs increasingly upregulate C/EBPβ, a transcription factor that promotes the production of cytokines that mediate inflammation.
The researchers found that C/EBPβ regulates DCs. Without it, the cells could not secrete inflammatory cytokines. C/EBPβ also indirectly blocks apoptosis in the lymphoma cells, allowing the cancer cells to grow unchecked.
The team pointed out that, even if their model of Eµ-Myc lymphoma is not entirely comparable to B-cell lymphomas in humans, it shows that lymphoma cells and DCs interact—a previously unknown molecular mechanism.
Furthermore, these findings may have clinical applications. The researchers noted that the immunomodulatory agent lenalidomide induces downregulation of C/EBPβ, which is secreted by cancer cells.
So Dr Höpken and her colleagues believe it might be appropriate to approve the use of lenalidomide for patients with Myc B-cell lymphoma, as an addition to their existing treatment, to strengthen their immune defense.
Studies have shown that dendritic cells (DCs) can contribute to tumor growth and help shield the tumor from the immune system in colon, stomach, breast, and prostate cancer.
Now, researchers have found evidence suggesting this phenomenon also occurs in Myc-driven lymphomas.
The team has also identified the molecular mechanism that induces the immune cells to promote tumor growth.
They reported these findings in Nature Communications.
Uta Höpken, PhD, of the Max Delbrück Center for Molecular Medicine in Berlin, Germany, and her colleagues investigated how DCs drive tumor in mouse models of Eµ-Myc lymphoma.
The team began by depleting DCs in these mice and found that tumor growth was delayed—the first clue that DCs are indeed associated with lymphoma growth.
Next, the researchers found that, after contact with lymphoma cells, the DCs increasingly secrete immunomodulatory cytokines and growth factors. The cytokine secretion takes place in the spleen and lymph nodes.
Dr Höpken and her colleagues previously demonstrated that various forms of lymphoma cells settle in the lymph nodes and in the spleen, where they create their own survival niche. This process is regulated by selective cytokines and growth factors the researchers identified a few years ago.
“In these niches, almost everything is already there that the lymphoma cells as malignant B cells need to survive, including blood vessels and connective tissue cells [stromal cells],” Dr Höpken said. “The survival substances secreted by the DCs optimize the niche so that the tumors can grow better.”
This also means the DCs prevent the T lymphocytes from exercising their defensive function. Normally, healthy B or T cells settle in the respective B- or T-cell niches of the spleen and the lymph nodes to be made fit for immune defense.
“What is paradoxical is that the mouse lymphoma cells we studied—malignant B cells—found their survival niche in the T-cell zones of the lymph nodes and the spleen and not in the B-cell zones,” Dr Höpken said.
After making contact with the lymphoma cells, the DCs increasingly upregulate C/EBPβ, a transcription factor that promotes the production of cytokines that mediate inflammation.
The researchers found that C/EBPβ regulates DCs. Without it, the cells could not secrete inflammatory cytokines. C/EBPβ also indirectly blocks apoptosis in the lymphoma cells, allowing the cancer cells to grow unchecked.
The team pointed out that, even if their model of Eµ-Myc lymphoma is not entirely comparable to B-cell lymphomas in humans, it shows that lymphoma cells and DCs interact—a previously unknown molecular mechanism.
Furthermore, these findings may have clinical applications. The researchers noted that the immunomodulatory agent lenalidomide induces downregulation of C/EBPβ, which is secreted by cancer cells.
So Dr Höpken and her colleagues believe it might be appropriate to approve the use of lenalidomide for patients with Myc B-cell lymphoma, as an addition to their existing treatment, to strengthen their immune defense.
Product appears safe, effective in rel/ref ALL
Credit: Bill Branson
Eryaspase, a product consisting of L-asparaginase encapsulated in red blood cells, may be safer and more effective than native E coli L-asparaginase, results of a phase 2/3 study suggest.
In patients with relapsed or refractory acute lymphoblastic leukemia (ALL), eryaspase given in combination with chemotherapy produced a higher complete response rate and fewer allergic reactions than native E coli L-asparaginase in combination with chemotherapy.
Eryaspase was also well-tolerated in patients who had previously experienced allergic reactions to L-asparaginase.
ERYTECH Pharma, the company developing eryaspase, recently announced these results from the GRASPIVOTALL trial.
The study included 80 children and adults with relapsed or refractory ALL, who were randomized to 1 of 3 treatment arms.
In the first 2 arms, researchers compared eryaspase to native E coli L-asparaginase, both in combination with standard chemotherapy (COOPRALL), in patients without prior allergies to L-asparaginase. In the third arm, the team evaluated eryaspase for patients who have experienced allergic reactions related to asparaginase in their first-line treatment.
The primary endpoint of the study consisted of 2 objectives: (a) superior safety, expressed as a significant reduction of the incidence of allergic reactions with eryaspase compared to native L-asparaginase, and (b) noninferior duration of asparaginase activity above the threshold of 100 IU/L during the induction phase in the nonallergic patients. Both endpoints needed to be met for the study to be considered positive.
The main secondary efficacy endpoints included complete response, minimal residual disease, event-free survival, and overall survival.
At 1 year of follow-up, both primary endpoints were met. There was a significant reduction of allergic reactions in the eryaspase arm compared to the native L-asparaginase arm—0% (0/26) and 42.9% (12/28), respectively (P<0.001).
And there was a significant increase in the duration of circulating asparaginase activity in the eryaspase arm compared to the native L-asparaginase arm. Asparaginase levels were maintained above 100 IU/L for an average of 20.5 days with up to 2 injections during the first month of treatment with eryaspase, compared to 9.2 days in the native L-asparaginase arm, with up to 8 injections of L-asparaginase (P<0.001).
In addition, the complete response rate was higher with eryaspase. At the end of the induction phase, 71.4% of patients (n=15) in the eryaspase arm had a complete response, compared to 42.3% of patients (n=11) in the native L-asparaginase arm.
Finally, the study showed that eryaspase is well-tolerated by patients with previous allergies to L-asparaginase. Two of the 26 patients with prior allergies to L-asparaginase experienced mild allergic reactions to eryaspase.
“The results of this study are an important step forward for the treatment of ALL patients that are at risk to receive L-asparaginase, which remains an important unmet medical need,” said Yves Betrand, MD, of the Institute for Pediatric Hematology and Oncology in Lyon, France.
“The virtual absence of allergic reactions, also in patients with prior allergies to L-asparaginase, is very encouraging.”
The analysis of additional secondary and exploratory endpoints for this study is ongoing. ERYTECH said results will be available later this year and are set to be presented at an upcoming scientific conference.
Based on the results of this and earlier studies of eryaspase, ERYTECH intends to submit its application for European Marketing Authorization in the first half of 2015.
The company also plans to accelerate the product’s development in ALL in the US and to launch phase 2 clinical trials in additional oncology indications with high unmet medical need. A phase 2b study of eryaspase in acute myeloid leukemia is already underway, with more than half of the patients enrolled. 
Credit: Bill Branson
Eryaspase, a product consisting of L-asparaginase encapsulated in red blood cells, may be safer and more effective than native E coli L-asparaginase, results of a phase 2/3 study suggest.
In patients with relapsed or refractory acute lymphoblastic leukemia (ALL), eryaspase given in combination with chemotherapy produced a higher complete response rate and fewer allergic reactions than native E coli L-asparaginase in combination with chemotherapy.
Eryaspase was also well-tolerated in patients who had previously experienced allergic reactions to L-asparaginase.
ERYTECH Pharma, the company developing eryaspase, recently announced these results from the GRASPIVOTALL trial.
The study included 80 children and adults with relapsed or refractory ALL, who were randomized to 1 of 3 treatment arms.
In the first 2 arms, researchers compared eryaspase to native E coli L-asparaginase, both in combination with standard chemotherapy (COOPRALL), in patients without prior allergies to L-asparaginase. In the third arm, the team evaluated eryaspase for patients who have experienced allergic reactions related to asparaginase in their first-line treatment.
The primary endpoint of the study consisted of 2 objectives: (a) superior safety, expressed as a significant reduction of the incidence of allergic reactions with eryaspase compared to native L-asparaginase, and (b) noninferior duration of asparaginase activity above the threshold of 100 IU/L during the induction phase in the nonallergic patients. Both endpoints needed to be met for the study to be considered positive.
The main secondary efficacy endpoints included complete response, minimal residual disease, event-free survival, and overall survival.
At 1 year of follow-up, both primary endpoints were met. There was a significant reduction of allergic reactions in the eryaspase arm compared to the native L-asparaginase arm—0% (0/26) and 42.9% (12/28), respectively (P<0.001).
And there was a significant increase in the duration of circulating asparaginase activity in the eryaspase arm compared to the native L-asparaginase arm. Asparaginase levels were maintained above 100 IU/L for an average of 20.5 days with up to 2 injections during the first month of treatment with eryaspase, compared to 9.2 days in the native L-asparaginase arm, with up to 8 injections of L-asparaginase (P<0.001).
In addition, the complete response rate was higher with eryaspase. At the end of the induction phase, 71.4% of patients (n=15) in the eryaspase arm had a complete response, compared to 42.3% of patients (n=11) in the native L-asparaginase arm.
Finally, the study showed that eryaspase is well-tolerated by patients with previous allergies to L-asparaginase. Two of the 26 patients with prior allergies to L-asparaginase experienced mild allergic reactions to eryaspase.
“The results of this study are an important step forward for the treatment of ALL patients that are at risk to receive L-asparaginase, which remains an important unmet medical need,” said Yves Betrand, MD, of the Institute for Pediatric Hematology and Oncology in Lyon, France.
“The virtual absence of allergic reactions, also in patients with prior allergies to L-asparaginase, is very encouraging.”
The analysis of additional secondary and exploratory endpoints for this study is ongoing. ERYTECH said results will be available later this year and are set to be presented at an upcoming scientific conference.
Based on the results of this and earlier studies of eryaspase, ERYTECH intends to submit its application for European Marketing Authorization in the first half of 2015.
The company also plans to accelerate the product’s development in ALL in the US and to launch phase 2 clinical trials in additional oncology indications with high unmet medical need. A phase 2b study of eryaspase in acute myeloid leukemia is already underway, with more than half of the patients enrolled.
Credit: Bill Branson
Eryaspase, a product consisting of L-asparaginase encapsulated in red blood cells, may be safer and more effective than native E coli L-asparaginase, results of a phase 2/3 study suggest.
In patients with relapsed or refractory acute lymphoblastic leukemia (ALL), eryaspase given in combination with chemotherapy produced a higher complete response rate and fewer allergic reactions than native E coli L-asparaginase in combination with chemotherapy.
Eryaspase was also well-tolerated in patients who had previously experienced allergic reactions to L-asparaginase.
ERYTECH Pharma, the company developing eryaspase, recently announced these results from the GRASPIVOTALL trial.
The study included 80 children and adults with relapsed or refractory ALL, who were randomized to 1 of 3 treatment arms.
In the first 2 arms, researchers compared eryaspase to native E coli L-asparaginase, both in combination with standard chemotherapy (COOPRALL), in patients without prior allergies to L-asparaginase. In the third arm, the team evaluated eryaspase for patients who have experienced allergic reactions related to asparaginase in their first-line treatment.
The primary endpoint of the study consisted of 2 objectives: (a) superior safety, expressed as a significant reduction of the incidence of allergic reactions with eryaspase compared to native L-asparaginase, and (b) noninferior duration of asparaginase activity above the threshold of 100 IU/L during the induction phase in the nonallergic patients. Both endpoints needed to be met for the study to be considered positive.
The main secondary efficacy endpoints included complete response, minimal residual disease, event-free survival, and overall survival.
At 1 year of follow-up, both primary endpoints were met. There was a significant reduction of allergic reactions in the eryaspase arm compared to the native L-asparaginase arm—0% (0/26) and 42.9% (12/28), respectively (P<0.001).
And there was a significant increase in the duration of circulating asparaginase activity in the eryaspase arm compared to the native L-asparaginase arm. Asparaginase levels were maintained above 100 IU/L for an average of 20.5 days with up to 2 injections during the first month of treatment with eryaspase, compared to 9.2 days in the native L-asparaginase arm, with up to 8 injections of L-asparaginase (P<0.001).
In addition, the complete response rate was higher with eryaspase. At the end of the induction phase, 71.4% of patients (n=15) in the eryaspase arm had a complete response, compared to 42.3% of patients (n=11) in the native L-asparaginase arm.
Finally, the study showed that eryaspase is well-tolerated by patients with previous allergies to L-asparaginase. Two of the 26 patients with prior allergies to L-asparaginase experienced mild allergic reactions to eryaspase.
“The results of this study are an important step forward for the treatment of ALL patients that are at risk to receive L-asparaginase, which remains an important unmet medical need,” said Yves Betrand, MD, of the Institute for Pediatric Hematology and Oncology in Lyon, France.
“The virtual absence of allergic reactions, also in patients with prior allergies to L-asparaginase, is very encouraging.”
The analysis of additional secondary and exploratory endpoints for this study is ongoing. ERYTECH said results will be available later this year and are set to be presented at an upcoming scientific conference.
Based on the results of this and earlier studies of eryaspase, ERYTECH intends to submit its application for European Marketing Authorization in the first half of 2015.
The company also plans to accelerate the product’s development in ALL in the US and to launch phase 2 clinical trials in additional oncology indications with high unmet medical need. A phase 2b study of eryaspase in acute myeloid leukemia is already underway, with more than half of the patients enrolled.
Cancer treatment during pregnancy can be safe
MADRID—Two new studies suggest that children exposed to chemotherapy or radiotherapy in the womb can be spared negative long-term effects.
At a median age of 6, most of the children exposed to radiation in utero had neuropsychological, behavioral, and general health outcomes that were within normal ranges.
And children who were exposed to chemotherapy in the womb had normal mental and cardiac health at a median age of 2.
“When chemotherapy is administered after the first trimester of pregnancy, we cannot discern any problems in the children,” said Frederic Amant, MD, PhD, of University Hospitals Leuven in Belgium.
“Fear about the risks of chemotherapy administration should not be a reason to terminate a pregnancy, delay cancer treatment for the mother, or to deliver a baby prematurely.”
Dr Amant and his colleagues presented these findings (abstract 267PD_PR) and their findings on radiation (abstract 49LBA_PR) at the ESMO 2014 Congress.
Outcomes with chemotherapy
In the first study, the researchers recruited 38 children from the International Network for Cancer, Infertility and Pregnancy registry who were prenatally exposed to chemotherapy.
Most of the mothers had breast (61%) or hematologic (22%) cancers. Most were treated with anthracyclines (61%) and had received an average of 4 cycles (range, 1-7) of treatment.
The researchers assessed mental development and cardiac health in the children of these subjects, comparing them to 38 control children who were not exposed to chemotherapy.
At a median age of almost 2 years, mental development was in the normal range for both groups of children, and development was not significantly different between the groups. The mean Mental Development Index score was 99.13 for exposed children and 101.47 for controls.
Cardiac dimensions and functions were within normal ranges for both groups as well. Mean fractional shortening was 36% (range, 32-42) for exposed children and 39% (range, 32-51) for controls. Although the difference was signficant (P=0.004), the researchers said it was not clinically relevant.
“This paper points to the very important issue of long-term safety of prenatal exposure to chemotherapy and reinforces the notion that chemotherapy during gestation does not endanger the fetus and her or his subsequent development,” said Fedro Alessandro Peccatori, MD, PhD, of the European Institute of Oncology in Milan, Italy, who was not involved in this study.
“To further ameliorate neonatal outcome, a special effort should be made to prolong pregnancy duration, and stringent long-term follow-up should be pursued to confirm these findings. Meanwhile, specific measures to support prematurely delivered babies and their families should be implemented.”
Dr Amant said future studies will explore the effects of specific chemotherapy types in detail and include longer-term follow-up.
Outcomes with radiation
In a second study, Dr Amant and his colleagues explored the impact of radiotherapy on the children of women with cancer.
The study included 16 children, with a median age of 6 years, who had been exposed to radiotherapy in utero. The median maternal irradiation was 48 Gy (range, 12-70), and the median estimated fetal irradiation was 91 mGy (range, 0-1690).
Neuropsychological, behavioral, and general health outcomes were within normal ranges for most of the children. And the researchers found no linear relationship between the fetal dose of radiation and cognitive outcome.
However, there was a negative linear relationship between the gestational age at radiotherapy exposure and verbal intelligence, based on results in 8 children. Two of these children were exposed to radiotherapy in the third trimester and had verbal intelligence scores outside the normal range.
One of the 2 children had low scores on all variables of cognitive development, but other pregnancy-related complications are confounding factors. The child’s mother suffered from an aggressive non-Hodgkin tumor of the brain that impacted her general state, and she had a preterm delivery.
Dr Amant noted that this is based on a very small number of children, so the results should be interpreted with caution.
“We cannot exclude that there might be an impact of prenatal radiotherapy exposure,” he said, “but larger series are needed to further investigate this relationship.”
MADRID—Two new studies suggest that children exposed to chemotherapy or radiotherapy in the womb can be spared negative long-term effects.
At a median age of 6, most of the children exposed to radiation in utero had neuropsychological, behavioral, and general health outcomes that were within normal ranges.
And children who were exposed to chemotherapy in the womb had normal mental and cardiac health at a median age of 2.
“When chemotherapy is administered after the first trimester of pregnancy, we cannot discern any problems in the children,” said Frederic Amant, MD, PhD, of University Hospitals Leuven in Belgium.
“Fear about the risks of chemotherapy administration should not be a reason to terminate a pregnancy, delay cancer treatment for the mother, or to deliver a baby prematurely.”
Dr Amant and his colleagues presented these findings (abstract 267PD_PR) and their findings on radiation (abstract 49LBA_PR) at the ESMO 2014 Congress.
Outcomes with chemotherapy
In the first study, the researchers recruited 38 children from the International Network for Cancer, Infertility and Pregnancy registry who were prenatally exposed to chemotherapy.
Most of the mothers had breast (61%) or hematologic (22%) cancers. Most were treated with anthracyclines (61%) and had received an average of 4 cycles (range, 1-7) of treatment.
The researchers assessed mental development and cardiac health in the children of these subjects, comparing them to 38 control children who were not exposed to chemotherapy.
At a median age of almost 2 years, mental development was in the normal range for both groups of children, and development was not significantly different between the groups. The mean Mental Development Index score was 99.13 for exposed children and 101.47 for controls.
Cardiac dimensions and functions were within normal ranges for both groups as well. Mean fractional shortening was 36% (range, 32-42) for exposed children and 39% (range, 32-51) for controls. Although the difference was signficant (P=0.004), the researchers said it was not clinically relevant.
“This paper points to the very important issue of long-term safety of prenatal exposure to chemotherapy and reinforces the notion that chemotherapy during gestation does not endanger the fetus and her or his subsequent development,” said Fedro Alessandro Peccatori, MD, PhD, of the European Institute of Oncology in Milan, Italy, who was not involved in this study.
“To further ameliorate neonatal outcome, a special effort should be made to prolong pregnancy duration, and stringent long-term follow-up should be pursued to confirm these findings. Meanwhile, specific measures to support prematurely delivered babies and their families should be implemented.”
Dr Amant said future studies will explore the effects of specific chemotherapy types in detail and include longer-term follow-up.
Outcomes with radiation
In a second study, Dr Amant and his colleagues explored the impact of radiotherapy on the children of women with cancer.
The study included 16 children, with a median age of 6 years, who had been exposed to radiotherapy in utero. The median maternal irradiation was 48 Gy (range, 12-70), and the median estimated fetal irradiation was 91 mGy (range, 0-1690).
Neuropsychological, behavioral, and general health outcomes were within normal ranges for most of the children. And the researchers found no linear relationship between the fetal dose of radiation and cognitive outcome.
However, there was a negative linear relationship between the gestational age at radiotherapy exposure and verbal intelligence, based on results in 8 children. Two of these children were exposed to radiotherapy in the third trimester and had verbal intelligence scores outside the normal range.
One of the 2 children had low scores on all variables of cognitive development, but other pregnancy-related complications are confounding factors. The child’s mother suffered from an aggressive non-Hodgkin tumor of the brain that impacted her general state, and she had a preterm delivery.
Dr Amant noted that this is based on a very small number of children, so the results should be interpreted with caution.
“We cannot exclude that there might be an impact of prenatal radiotherapy exposure,” he said, “but larger series are needed to further investigate this relationship.”
MADRID—Two new studies suggest that children exposed to chemotherapy or radiotherapy in the womb can be spared negative long-term effects.
At a median age of 6, most of the children exposed to radiation in utero had neuropsychological, behavioral, and general health outcomes that were within normal ranges.
And children who were exposed to chemotherapy in the womb had normal mental and cardiac health at a median age of 2.
“When chemotherapy is administered after the first trimester of pregnancy, we cannot discern any problems in the children,” said Frederic Amant, MD, PhD, of University Hospitals Leuven in Belgium.
“Fear about the risks of chemotherapy administration should not be a reason to terminate a pregnancy, delay cancer treatment for the mother, or to deliver a baby prematurely.”
Dr Amant and his colleagues presented these findings (abstract 267PD_PR) and their findings on radiation (abstract 49LBA_PR) at the ESMO 2014 Congress.
Outcomes with chemotherapy
In the first study, the researchers recruited 38 children from the International Network for Cancer, Infertility and Pregnancy registry who were prenatally exposed to chemotherapy.
Most of the mothers had breast (61%) or hematologic (22%) cancers. Most were treated with anthracyclines (61%) and had received an average of 4 cycles (range, 1-7) of treatment.
The researchers assessed mental development and cardiac health in the children of these subjects, comparing them to 38 control children who were not exposed to chemotherapy.
At a median age of almost 2 years, mental development was in the normal range for both groups of children, and development was not significantly different between the groups. The mean Mental Development Index score was 99.13 for exposed children and 101.47 for controls.
Cardiac dimensions and functions were within normal ranges for both groups as well. Mean fractional shortening was 36% (range, 32-42) for exposed children and 39% (range, 32-51) for controls. Although the difference was signficant (P=0.004), the researchers said it was not clinically relevant.
“This paper points to the very important issue of long-term safety of prenatal exposure to chemotherapy and reinforces the notion that chemotherapy during gestation does not endanger the fetus and her or his subsequent development,” said Fedro Alessandro Peccatori, MD, PhD, of the European Institute of Oncology in Milan, Italy, who was not involved in this study.
“To further ameliorate neonatal outcome, a special effort should be made to prolong pregnancy duration, and stringent long-term follow-up should be pursued to confirm these findings. Meanwhile, specific measures to support prematurely delivered babies and their families should be implemented.”
Dr Amant said future studies will explore the effects of specific chemotherapy types in detail and include longer-term follow-up.
Outcomes with radiation
In a second study, Dr Amant and his colleagues explored the impact of radiotherapy on the children of women with cancer.
The study included 16 children, with a median age of 6 years, who had been exposed to radiotherapy in utero. The median maternal irradiation was 48 Gy (range, 12-70), and the median estimated fetal irradiation was 91 mGy (range, 0-1690).
Neuropsychological, behavioral, and general health outcomes were within normal ranges for most of the children. And the researchers found no linear relationship between the fetal dose of radiation and cognitive outcome.
However, there was a negative linear relationship between the gestational age at radiotherapy exposure and verbal intelligence, based on results in 8 children. Two of these children were exposed to radiotherapy in the third trimester and had verbal intelligence scores outside the normal range.
One of the 2 children had low scores on all variables of cognitive development, but other pregnancy-related complications are confounding factors. The child’s mother suffered from an aggressive non-Hodgkin tumor of the brain that impacted her general state, and she had a preterm delivery.
Dr Amant noted that this is based on a very small number of children, so the results should be interpreted with caution.
“We cannot exclude that there might be an impact of prenatal radiotherapy exposure,” he said, “but larger series are needed to further investigate this relationship.”
Consolidation can improve PFS in HL
Consolidation therapy with brentuximab vedotin can improve progression-free survival (PFS) for Hodgkin lymphoma (HL) patients who have undergone a transplant, according to a phase 3 study.
The trial, known as AETHERA, is a comparison of single-agent brentuximab vedotin to placebo in patients with HL who were at risk of relapse following autologous stem cell transplant (ASCT).
Brentuximab vedotin conferred a 75% improvement in PFS over placebo.
However, there was no significant difference in overall survival between the 2 treatment arms.
These results were recently announced by Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited, the companies developing brentuximab vedotin (Adcetris).
The companies said more complete results from AETHERA will be presented at the 2014 ASH Annual Meeting in December.
AETHERA is a randomized, double-blind, placebo-controlled study designed to evaluate the potential of brentuximab vedotin to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival, safety, and tolerability.
Patients were eligible if they had risk factors for residual HL, defined as a history of refractory HL, those who relapse or progress within a year of receiving frontline chemotherapy, and/or those who have disease outside of the lymph nodes at the time of pre-ASCT relapse.
The study included 329 patients who received brentuximab vedotin or placebo every 3 weeks for up to a year.
The researchers assessed PFS a minimum of 2 years after the initiation of treatment for all patients. There was a significant improvement in PFS with brentuximab vedotin compared to placebo (hazard ratio=0.57; P=0.001).
However, a prespecified interim analysis of overall survival showed no significant difference between the treatment arms.
Patients in both arms who experienced progression received a variety of subsequent therapies. Most patients on the placebo arm received brentuximab vedotin after progression.
A further analysis of overall survival is planned in 2016. The safety profile of brentuximab vedotin in the AETHERA trial was generally consistent with the existing prescribing information.
“We anticipate reporting more complete AETHERA data at the ASH Annual Meeting in December and intend to submit a supplemental Biologics License Application to the FDA in 2015 for approval in this setting,” said Clay B. Siegall, PhD, President and Chief Executive Officer of Seattle Genetics.
The FDA has already granted brentuximab vedotin accelerated approval to treat HL patients after ASCT failure or after the failure of at least 2 prior multiagent chemotherapy regimens in patients who are not ASCT candidates. The FDA also granted the drug accelerated approval to treat systemic anaplastic large cell lymphoma after the failure of at least 1 prior multiagent chemotherapy regimen.
The European Commission granted brentuximab vedotin conditional marketing authorization for the same indications. In both cases, the drug can gain full, traditional approval once studies have shown it confers a clinical benefit.
Brentuximab vedotin has a boxed warning detailing the risk of progressive multifocal leukoencephalopathy associated with use of the drug. The drug has also been shown to pose a risk of pulmonary toxicity when combined with bleomycin.
Consolidation therapy with brentuximab vedotin can improve progression-free survival (PFS) for Hodgkin lymphoma (HL) patients who have undergone a transplant, according to a phase 3 study.
The trial, known as AETHERA, is a comparison of single-agent brentuximab vedotin to placebo in patients with HL who were at risk of relapse following autologous stem cell transplant (ASCT).
Brentuximab vedotin conferred a 75% improvement in PFS over placebo.
However, there was no significant difference in overall survival between the 2 treatment arms.
These results were recently announced by Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited, the companies developing brentuximab vedotin (Adcetris).
The companies said more complete results from AETHERA will be presented at the 2014 ASH Annual Meeting in December.
AETHERA is a randomized, double-blind, placebo-controlled study designed to evaluate the potential of brentuximab vedotin to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival, safety, and tolerability.
Patients were eligible if they had risk factors for residual HL, defined as a history of refractory HL, those who relapse or progress within a year of receiving frontline chemotherapy, and/or those who have disease outside of the lymph nodes at the time of pre-ASCT relapse.
The study included 329 patients who received brentuximab vedotin or placebo every 3 weeks for up to a year.
The researchers assessed PFS a minimum of 2 years after the initiation of treatment for all patients. There was a significant improvement in PFS with brentuximab vedotin compared to placebo (hazard ratio=0.57; P=0.001).
However, a prespecified interim analysis of overall survival showed no significant difference between the treatment arms.
Patients in both arms who experienced progression received a variety of subsequent therapies. Most patients on the placebo arm received brentuximab vedotin after progression.
A further analysis of overall survival is planned in 2016. The safety profile of brentuximab vedotin in the AETHERA trial was generally consistent with the existing prescribing information.
“We anticipate reporting more complete AETHERA data at the ASH Annual Meeting in December and intend to submit a supplemental Biologics License Application to the FDA in 2015 for approval in this setting,” said Clay B. Siegall, PhD, President and Chief Executive Officer of Seattle Genetics.
The FDA has already granted brentuximab vedotin accelerated approval to treat HL patients after ASCT failure or after the failure of at least 2 prior multiagent chemotherapy regimens in patients who are not ASCT candidates. The FDA also granted the drug accelerated approval to treat systemic anaplastic large cell lymphoma after the failure of at least 1 prior multiagent chemotherapy regimen.
The European Commission granted brentuximab vedotin conditional marketing authorization for the same indications. In both cases, the drug can gain full, traditional approval once studies have shown it confers a clinical benefit.
Brentuximab vedotin has a boxed warning detailing the risk of progressive multifocal leukoencephalopathy associated with use of the drug. The drug has also been shown to pose a risk of pulmonary toxicity when combined with bleomycin.
Consolidation therapy with brentuximab vedotin can improve progression-free survival (PFS) for Hodgkin lymphoma (HL) patients who have undergone a transplant, according to a phase 3 study.
The trial, known as AETHERA, is a comparison of single-agent brentuximab vedotin to placebo in patients with HL who were at risk of relapse following autologous stem cell transplant (ASCT).
Brentuximab vedotin conferred a 75% improvement in PFS over placebo.
However, there was no significant difference in overall survival between the 2 treatment arms.
These results were recently announced by Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited, the companies developing brentuximab vedotin (Adcetris).
The companies said more complete results from AETHERA will be presented at the 2014 ASH Annual Meeting in December.
AETHERA is a randomized, double-blind, placebo-controlled study designed to evaluate the potential of brentuximab vedotin to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival, safety, and tolerability.
Patients were eligible if they had risk factors for residual HL, defined as a history of refractory HL, those who relapse or progress within a year of receiving frontline chemotherapy, and/or those who have disease outside of the lymph nodes at the time of pre-ASCT relapse.
The study included 329 patients who received brentuximab vedotin or placebo every 3 weeks for up to a year.
The researchers assessed PFS a minimum of 2 years after the initiation of treatment for all patients. There was a significant improvement in PFS with brentuximab vedotin compared to placebo (hazard ratio=0.57; P=0.001).
However, a prespecified interim analysis of overall survival showed no significant difference between the treatment arms.
Patients in both arms who experienced progression received a variety of subsequent therapies. Most patients on the placebo arm received brentuximab vedotin after progression.
A further analysis of overall survival is planned in 2016. The safety profile of brentuximab vedotin in the AETHERA trial was generally consistent with the existing prescribing information.
“We anticipate reporting more complete AETHERA data at the ASH Annual Meeting in December and intend to submit a supplemental Biologics License Application to the FDA in 2015 for approval in this setting,” said Clay B. Siegall, PhD, President and Chief Executive Officer of Seattle Genetics.
The FDA has already granted brentuximab vedotin accelerated approval to treat HL patients after ASCT failure or after the failure of at least 2 prior multiagent chemotherapy regimens in patients who are not ASCT candidates. The FDA also granted the drug accelerated approval to treat systemic anaplastic large cell lymphoma after the failure of at least 1 prior multiagent chemotherapy regimen.
The European Commission granted brentuximab vedotin conditional marketing authorization for the same indications. In both cases, the drug can gain full, traditional approval once studies have shown it confers a clinical benefit.
Brentuximab vedotin has a boxed warning detailing the risk of progressive multifocal leukoencephalopathy associated with use of the drug. The drug has also been shown to pose a risk of pulmonary toxicity when combined with bleomycin.
The five “I’s” of electronic health records
It is clear at this point that physicians are not friends of electronic health records (EHRs). The predominant sentiment is that EHRs are costly (1/3 of providers are buying their second EHR system) and are poorly functional. Much has been said about the failures of EHRs. The shortcomings discussed have ranged from lack of cost benefits to interoperability with medical devices and security of interoperability with medical devices. Decreasing provider productivity and direct patient interaction time are also of concern. These opinions were raised in a ‘Medical Economics’ survey as well as a study by Rand Corporation. Interestingly, physicians do not desire to return to paper records. I will discuss what I call “The Five Important ‘I’s” of EHRs.
1. EHRs are not INTUITIVE. Navigating an EHR is akin to guessing what is behind Door Number 2 of “Let’s Make a Deal.” Documentation does not follow a provider’s thought process or the interaction workflow. It is built to meet regulatory and billing requirements. Many physicians are required to learn and be facile with different EHRs if they go to different hospitals. The AMA has called for a design overhaul of EHRs.
2. EHRs are IMPOSING. Providers are spending an inordinate amount of time with the EHR and less with patients. Most providers do not receive adequate training time, which is inversely related to privacy and security breaches. EHRs are inflexible and progressive practices with ambitious patient quality initiatives cannot implement them because of IT issues.
3. EHRs have limited INTEROPERABILITY. At a recent session of the Office of the National Coordinator at the annual conference of the American Health Information Management Association, Chief Science Officer Doug Fridsma laid out an ambitious vision of what he calls the “Learning Healthcare System” which comprises the building blocks of health IT systems. This will result in improved interoperability by way of the system adapting to change with encounters.
4. EHRs need INSIGHTFUL analytics. Data without good analytics is almost useless. Clinical decision support tools make EHRs pertinent insomuch as they can incorporate accepted practice guidelines as well as customized “best practice” decision support. These follow provider workflows and make the tool more intuitive. Add to this proscribing analytics that actually recommend (not prescribe) tests or treatment plans, and one ends up with a physician’s friend.
5. EHRs must INCLUDE robust portals. Robust patient portals will be critical in creating a true patient-centric health care system. Most portals used today are proprietary to the customer’s EHR vendor because of its low cost. There are some excellent third-party portals that have the ability to corral data from different providers who might have different EHR vendors. In addition, they are places to communicate multimedia content including video consultations.
While this list is not inclusive of all issues regarding EHRs, it serves as a focal point for discussion by clinicians about them. A 6th ‘I’ might be ‘IMMOBILE.’ A physician running back and forth to computer stations from patient beds creates self-evident inefficiencies. Presently available (not offered by most all vendors) mobile versions of EHRs have their own drawbacks. The small screen on a smartphone is a severe limitation, though many physicians do use tablets. That being said, in a 2013 cited survey by Black Book, only 8% of physician responders used the mobile EHR for purposes of ePrescribing, accessing records, ordering tests, or viewing results. As a champion of digital health technologies, I can only be frustrated about the vision I and many others have for their use. However, as with most technologies (and few have been as disruptive as EHRs) adoption in health care is slow. I look forward to leaders like Doug Fridsma and organizations like HIMSS, which has excellent representation by clinicians to help bring about necessary changes.
It is clear at this point that physicians are not friends of electronic health records (EHRs). The predominant sentiment is that EHRs are costly (1/3 of providers are buying their second EHR system) and are poorly functional. Much has been said about the failures of EHRs. The shortcomings discussed have ranged from lack of cost benefits to interoperability with medical devices and security of interoperability with medical devices. Decreasing provider productivity and direct patient interaction time are also of concern. These opinions were raised in a ‘Medical Economics’ survey as well as a study by Rand Corporation. Interestingly, physicians do not desire to return to paper records. I will discuss what I call “The Five Important ‘I’s” of EHRs.
1. EHRs are not INTUITIVE. Navigating an EHR is akin to guessing what is behind Door Number 2 of “Let’s Make a Deal.” Documentation does not follow a provider’s thought process or the interaction workflow. It is built to meet regulatory and billing requirements. Many physicians are required to learn and be facile with different EHRs if they go to different hospitals. The AMA has called for a design overhaul of EHRs.
2. EHRs are IMPOSING. Providers are spending an inordinate amount of time with the EHR and less with patients. Most providers do not receive adequate training time, which is inversely related to privacy and security breaches. EHRs are inflexible and progressive practices with ambitious patient quality initiatives cannot implement them because of IT issues.
3. EHRs have limited INTEROPERABILITY. At a recent session of the Office of the National Coordinator at the annual conference of the American Health Information Management Association, Chief Science Officer Doug Fridsma laid out an ambitious vision of what he calls the “Learning Healthcare System” which comprises the building blocks of health IT systems. This will result in improved interoperability by way of the system adapting to change with encounters.
4. EHRs need INSIGHTFUL analytics. Data without good analytics is almost useless. Clinical decision support tools make EHRs pertinent insomuch as they can incorporate accepted practice guidelines as well as customized “best practice” decision support. These follow provider workflows and make the tool more intuitive. Add to this proscribing analytics that actually recommend (not prescribe) tests or treatment plans, and one ends up with a physician’s friend.
5. EHRs must INCLUDE robust portals. Robust patient portals will be critical in creating a true patient-centric health care system. Most portals used today are proprietary to the customer’s EHR vendor because of its low cost. There are some excellent third-party portals that have the ability to corral data from different providers who might have different EHR vendors. In addition, they are places to communicate multimedia content including video consultations.
While this list is not inclusive of all issues regarding EHRs, it serves as a focal point for discussion by clinicians about them. A 6th ‘I’ might be ‘IMMOBILE.’ A physician running back and forth to computer stations from patient beds creates self-evident inefficiencies. Presently available (not offered by most all vendors) mobile versions of EHRs have their own drawbacks. The small screen on a smartphone is a severe limitation, though many physicians do use tablets. That being said, in a 2013 cited survey by Black Book, only 8% of physician responders used the mobile EHR for purposes of ePrescribing, accessing records, ordering tests, or viewing results. As a champion of digital health technologies, I can only be frustrated about the vision I and many others have for their use. However, as with most technologies (and few have been as disruptive as EHRs) adoption in health care is slow. I look forward to leaders like Doug Fridsma and organizations like HIMSS, which has excellent representation by clinicians to help bring about necessary changes.
It is clear at this point that physicians are not friends of electronic health records (EHRs). The predominant sentiment is that EHRs are costly (1/3 of providers are buying their second EHR system) and are poorly functional. Much has been said about the failures of EHRs. The shortcomings discussed have ranged from lack of cost benefits to interoperability with medical devices and security of interoperability with medical devices. Decreasing provider productivity and direct patient interaction time are also of concern. These opinions were raised in a ‘Medical Economics’ survey as well as a study by Rand Corporation. Interestingly, physicians do not desire to return to paper records. I will discuss what I call “The Five Important ‘I’s” of EHRs.
1. EHRs are not INTUITIVE. Navigating an EHR is akin to guessing what is behind Door Number 2 of “Let’s Make a Deal.” Documentation does not follow a provider’s thought process or the interaction workflow. It is built to meet regulatory and billing requirements. Many physicians are required to learn and be facile with different EHRs if they go to different hospitals. The AMA has called for a design overhaul of EHRs.
2. EHRs are IMPOSING. Providers are spending an inordinate amount of time with the EHR and less with patients. Most providers do not receive adequate training time, which is inversely related to privacy and security breaches. EHRs are inflexible and progressive practices with ambitious patient quality initiatives cannot implement them because of IT issues.
3. EHRs have limited INTEROPERABILITY. At a recent session of the Office of the National Coordinator at the annual conference of the American Health Information Management Association, Chief Science Officer Doug Fridsma laid out an ambitious vision of what he calls the “Learning Healthcare System” which comprises the building blocks of health IT systems. This will result in improved interoperability by way of the system adapting to change with encounters.
4. EHRs need INSIGHTFUL analytics. Data without good analytics is almost useless. Clinical decision support tools make EHRs pertinent insomuch as they can incorporate accepted practice guidelines as well as customized “best practice” decision support. These follow provider workflows and make the tool more intuitive. Add to this proscribing analytics that actually recommend (not prescribe) tests or treatment plans, and one ends up with a physician’s friend.
5. EHRs must INCLUDE robust portals. Robust patient portals will be critical in creating a true patient-centric health care system. Most portals used today are proprietary to the customer’s EHR vendor because of its low cost. There are some excellent third-party portals that have the ability to corral data from different providers who might have different EHR vendors. In addition, they are places to communicate multimedia content including video consultations.
While this list is not inclusive of all issues regarding EHRs, it serves as a focal point for discussion by clinicians about them. A 6th ‘I’ might be ‘IMMOBILE.’ A physician running back and forth to computer stations from patient beds creates self-evident inefficiencies. Presently available (not offered by most all vendors) mobile versions of EHRs have their own drawbacks. The small screen on a smartphone is a severe limitation, though many physicians do use tablets. That being said, in a 2013 cited survey by Black Book, only 8% of physician responders used the mobile EHR for purposes of ePrescribing, accessing records, ordering tests, or viewing results. As a champion of digital health technologies, I can only be frustrated about the vision I and many others have for their use. However, as with most technologies (and few have been as disruptive as EHRs) adoption in health care is slow. I look forward to leaders like Doug Fridsma and organizations like HIMSS, which has excellent representation by clinicians to help bring about necessary changes.
What are cancer survivors’ needs and how well are they being met?
ABSTRACT
Purpose This study sought to identify the needs and unmet needs of the growing number of adult cancer survivors.
Methods Vermont survivor advocates partnered with academic researchers to create a survivor registry and conduct a cross-sectional survey of cancer-related needs and unmet needs of adult survivors. The mailed survey addressed 53 specific needs in 5 domains based on prior research, contributions from the research partners, and pilot testing. Results were summarized by computing proportions who reported having needs met or unmet.
Results Survey participants included 1668 of 2005 individuals invited from the survivor registry (83%); 65.7% were ages 60 or older and 61.9% were women. These participants had received their diagnosis 2 to 16 years earlier; 77.5% had been diagnosed ≥5 years previously; 30.2% had at least one unmet need in the emotional, social, and spiritual (e) domain; just 14.4% had at least one unmet need in the economic and legal domain. The most commonly identified individual unmet needs were in the e and the information (i) domains and included “help reducing stress” (14.8% of all respondents) and “information about possible after effects of treatment” (14.4%).
Conclusions Most needs of these longer-term survivors were met, but substantial proportions of survivors identified unmet needs. Unmet needs such as information about late and long-term adverse effects of treatment could be met within clinical care with a cancer survivor care plan, but some survivors may require referral to services focused on stress and coping.
Following a successful course of treatment for cancer, many patients return to or remain in the care of their primary care physician (PCP). What often goes unrecognized, however, are these cancer survivors’ unique needs—physical, psychological, social, spiritual, economic, and legal—and the informational and professional services available to address them.1,2
Increased cancer survival creates new needs. There are already >12 million cancer survivors in the United States and >30 million worldwide.3 As baby boomers age, the number of cancers diagnosed over the next 45 years will double4 and improved diagnosis and treatments are already prolonging survivors’ lives. With the greater number of cancer survivors and longer survival time, a cancer survivorship advocacy community has developed to help identify and address the concerns, needs, and benefits of having lived with, through, and beyond a cancer diagnosis.
The purpose of our study. Some of these areas of need have been studied extensively with childhood survivors, breast cancer survivors, and, more recently, prostate cancer survivors. However, few studies have examined adult survivors from all cancer types5-9 or have had cohorts large enough to yield meaningful information.5,7-9 The aim of this study was to describe the needs of adult survivors of all cancer types in a general population from Vermont and to determine whether these needs were met. The results of this study can help identify the services needed by cancer survivors.
METHODS
Population and sample
In November 2009, we invited all survivors listed in a cancer survivor registry to complete a 12-page survey. The registry10 was created as part of the Cancer Survivor Community Study, a community-based participatory research project funded by the National Cancer Institute. The study’s Steering Committee was comprised of cancer survivors, cancer registrars, and researchers. We identified and invited cancer survivors from 4 hospital registries in northwest and central Vermont to participate. Registry participants who indicated willingness to enroll in research studies received an invitation letter and informed consent form, the 12-page survey, and an addressed and stamped return envelope. We obtained Institutional Review Board (IRB) approval for these procedures at the University of Vermont and at local hospital IRBs.
Instrument development
A working group from the Steering Committee reviewed a range of available instruments to assess cancer survivors’ needs.9,11-15 We determined that the survey most relevant to our objectives was the Cancer Survivors’ Unmet Needs (CaSun) instrument.13 Because CaSun was developed in Australia, we carefully examined each question for appropriateness to our target audience. We eliminated several questions that we thought less important, added questions from other instruments, and simplified the survey format. Survivors from the Steering Committee pilot tested the draft questionnaire to identify awkward wording or concepts.
We piloted the revised draft using a standardized feedback form with cancer survivors who were not connected to our project and not enrolled in the survivor registry, and with residents at a senior center. Students and a teacher from an Adult Basic Education program helped to ensure easy readability. Our final instrument had 53 questions about needs in 5 domains. Questions within each domain completed the lead-in, “Since your cancer diagnosis, did you need....” We asked participants to check only 1 of the 3 boxes to the right of each question to indicate that there was no need in that area, that there was a need and it was met, or that there was a need and it was not met. We obtained self-reported demographic data during enrollment in the registry.
Data analysis
We summarized data by computing the percent of survivors who reported having each need (either met or unmet) and the percent for whom the need was unmet. The latter was computed both as a percent of all survivors and as a percent of those who had the need. We also calculated the percentage of survivors that had at least one need and at least one unmet need in each domain, as well as the average number of needs per survivor in each domain. We used SPSS for Unix, Release 6.1 (AIX 3.2)(IBM, Armonk, New York).
RESULTS
Of the 2005 cancer survivors invited into the study, 1668 responded, yielding a participation rate of 83%. TABLE 1 describes the self-reported demographic and cancer characteristics of participants in this study. Most respondents were female, ≥60 years old, urban dwellers, married or with a partner, well educated, and had household incomes of ≥$50,000. There were more breast cancer survivors than survivors of other cancers, and 14.6% of all survivors reported being diagnosed with more than one cancer. Cancer was diagnosed at stages 1 or 2 for 78.3% of the participants; 61.9% reported having undergone ≥2 treatment regimens.
The survey addressed needs in 5 domains: access to care and services (A); information (I); emotional, social, and spiritual (E); physical (P); and economic and legal (L). More than 80% of respondents reported having at least one need in the A, I, and E domains. The E domain had the most survivors with at least one unmet need (N=503), followed by the I (N=410) and P (N=375) domains.
Identifying unmet needs. TABLE 2 shows results for the specific questions within the domains in the order they were asked. Most participants who had a need also had it met. However, some needs that were not commonly reported were deemed unmet by a large proportion of those who expressed the need. For example, the A need for “A case manager to whom you could go to find out about services whenever they were needed” (A5) was reported by only 29.1% of survivors. But 32.1% of those reporting the need said it was unmet, which corresponds to 9.4% of all study participants having the need unmet. Similarly, the need for “More information about complementary and alternative medicine” (I3) was reported by about a quarter of the study population, 41.4% of whom (9.8% of all participants) reported it as unmet. In the P domain, the need for “Help to address problems with your sex life” (P4) was reported by only 26.5% of the respondents; yet 40.7% of those reporting the need had it unmet. Similarly, in the L domain, “Help with life insurance concerns as a result of your cancer” (L3) was only reported by 10.9% of the participants but was unmet for 46.4% of those who reported the need, or 5% of all study participants.
Most commonly expressed needs. TABLE 2 also identifies 12 needs reported by ≥50% of participants. Three of these needs were in the A domain, 6 in the I domain, and 3 in the E domain. The 2 most common needs related to A: the need “To feel like you were managing your health together with the medical team” (A3) was reported by 68.6% and was viewed as unmet by 5.2% of all respondents; the need for “Access to screening for recurrence or other cancers” (A7) was reported by 63.8% of the survivors but was deemed unmet by only 3.1% of all the respondents. “More information about possible after effects of your treatment” (I5) was a need for 63.2% that went unmet in 22.9% (14.4% of all participants). “Help managing your concerns about the cancer coming back” (E13) was reported as a need by 54.1% and as unmet by 11.8% of all participants.
The rank order of 7 unmet needs reported by ≥10% of the participants is shown in TABLE 3. Four of the 7 unmet needs were in the E domain. The most common unmet need in this domain was “Help reducing stress in your life” (E19).
Only 3 needs were both commonly reported and also unmet for at least 10% of the participants: “More information about possible after effects of your treatment” (I5), “More information about possible side effects of your treatment” (I4), and “Help managing your concerns about the cancer coming back” (E13).
DISCUSSION
The survey instrument we used to assess the needs of cancer survivors in a large community-based registry included a detailed list of potential needs generated, in part, by representatives of the survivor community. Most cancer survivor needs mentioned in this survey were met. However, some needs were not met for substantial proportions of respondents and should be examined carefully to determine whether services could be improved to better address them. This study was planned and implemented by researchers and cancer survivors using community-based participatory principles to learn about local needs. The results of this study may be generalizable to similar populations of survivors and will inform the survivorship goals for the Vermont State Cancer Plan and future Vermont Cancer Survivor Network activities.
Acting on patients’ expressed needs. Over 80% of participants had needs in the A, I, and E domains. The most commonly reported need was in the A domain, “To feel like you were managing your health together with the medical team” (A3). It was also a top need in other studies that asked this question.16,17 A cancer diagnosis may cause patients to feel out of control. Participation in the management of their health may help them gain a greater sense of control. PCP accommodation of expressed patient preferences may be an important part of a cancer survivor’s long-term adaptation to the disease.
Six of the 12 most frequently reported needs and 2 frequently reported unmet needs were in the I domain. Communication of information increases patients’ involvement in decision-making and enables them to cope better during diagnosis, treatment, and follow-up.18 “More information about possible after effects of your treatment” and “More information about possible side effects of your treatment” were reported by a high proportion of participants, and many also reported these needs as unmet. In another study about health-related information needs of survivors, 52% wanted more information about “What late and long-term side effects of cancer treatment are expected”19; and in a 2005 review of information needs, 12% of survivors reported similar needs.20 Two recent articles also noted such needs in adolescent and young adult cancer survivors.21,22 Based on current evidence, it would be advisable to discuss anticipated effects of treatment with patients not only at the outset but also at the end of treatment, and to write it in a cancer survivor care plan.
Individual needs that were not met for at least 10% of respondents, regardless of how common the need (TABLE 3), provided additional insights. Among these 7 needs, 3 also were reported as a need by more than 50% of respondents (TABLE 2), and 4 by <50%, indicating that some less common needs are not being met adequately. Among these 7 prominent unmet needs, 4 were E Issues (TABLE 3) and 2 were I Issues.
Unmet needs are an opportunity to improve care. In our study and in others, E needs were most likely to be unmet.17,23-26 Among the 4 common unmet E needs, 2 (E19 and E11) focused on generalized stress and worry, and one (E15) focused on concern about illness impact on family members or partners. Although these issues may be challenging to address successfully in a typical clinical environment, others have confirmed the importance of these needs and proposed ways to meet them.27 The fourth most common unmet E need focused on concern about cancer recurrence, also a prominent need found in other studies.15-17 These needs might be addressed more adequately in the course of usual clinical care by PCPs or specialists. In fact, the American College of Surgeons’ Commission on Cancer 2012 standards now require psychosocial distress screening and the provision of referral for psychosocial services.24 Our results are consistent in many respects with prior studies of needs reported by cancer survivors in other countries. The CaSUN survey developed by Hodgkinson et al13 has been applied to several survivor populations in Australia. In a diverse survivor sample, specific E, I, and A issues were frequently reported as unmet needs.13 The most prominent unmet needs in a gynecologic cancer sample using CaSUN focused on emotional and social issues such as worry, stress, coping, and relationships with, and expectations of, others.25
Barg et al23 conducted a survey of unmet needs in the United States using a detailed list based on prior survivor research and targeting individuals in a cancer registry. The most prominent area of need expressed was “emotional,” similar to the high rank of E needs in our study. In contrast to our study, however, physical and financial issues also were prominent. The latter variances might be explained by differences in access to care, or perhaps the study’s low response rate (23.8%). A similar survey reported by Campbell et al12 identified needs in the emotional domain as the most cited unmet survivor needs based on psychometrically developed subscales of a 152-item survey (29% response rate).
These results from several studies, including ours, call for more detailed exploration of the E needs of long-term cancer survivors. A useful framework developed by Stein et al28 accounts for factors contributing to cancer stress and burden as well as resources available to survivors (intrapersonal, social, informational, and tangible services), with the interactions between these 2 domains determining how well a survivor will be able to cope. There clearly is a role for development of more effective communication channels and focused services to meet survivor needs.
The list of most common unmet needs in TABLE 3 also includes a focus on “problems with your sex life” (P4). This is an area that may be difficult to address in a cancer care setting because of the focus on disease management. Primary care providers might be better prepared to address this issue because they likely encounter similar issues among the wide range of patients they serve. However, a recent study reported that only 46% of internists were somewhat or likely to initiate a discussion about sexuality with cancer survivors.29 Some additional preparation for physicians to address this need might be warranted.
The proportion in this sample reporting needs for access to, or information about, complementary and alternative medicine services fell below the thresholds chosen to designate common needs in this study. Although reported use is relatively common among cancer survivor in several studies,30-32 it appears that in our survivor sample, those who were interested in these approaches encountered only moderate barriers.
Study limitations. We invited participants from a registry unlikely to include cancer survivors with lower educational attainment or from rural locations9—that is, our participants were less likely to have challenges in obtaining appropriate services and information. This sample limitation therefore likely underestimates the overall level of needs among cancer survivors.
This was a cross-sectional assessment of perceived needs among a diverse group of survivors, which may have overlooked needs that were met but only after considerable effort on the part of survivors. Longitudinal studies would provide more complete accounts of how readily needs are met and the changes in needs at different times in the continuum of care.
The Vermont population is less diverse racially and ethnically, but not with respect to household income or educational attainment, than the overall US population. Access to health care also is relatively high in Vermont compared with many other states. According to a 2009 Vermont Household Health Insurance Survey, only 7.6% of Vermonters are uninsured.33
CORRESPONDENCE
Berta Geller, EdD, University of Vermont, Health Promotion Research/Family Medicine, 1 South Prospect Street, Burlington, VT 05401-3444; [email protected]
ACKNOWLEDGEMENTS
We would like to thank Anne Dorwaldt, Kathy Howe, Mark Bowman and John Mace at the University of Vermont, and the Cancer Survivor Community Study Steering Committee for their contributions to the successful completion of this study. We also thank the cancer survivors who participated in the pilot testing and the overall survey.
1. Potosky A, Han PK, Rowland J, et al. Differences between primary care physicians’ and oncologists’ knowledge, attitudes and practices regarding the care of cancer survivors. J Gen Intern Med. 2011;26:1403-1410.
2. Rowland J. Survivorship research: past, present, and future. In: Chang AE, Ganz PA, Hayes DF, et al, eds. Oncology: An Evidence-Based Approach. New York, NY: Springer; 2005:1753-1767.
3. Jemal A, Center MM, DeSantis C, et al. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010;19:1893-1907.
4. Hewitt ME, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: National Academies Press; 2005.
5. Hawkins NA, Smith T, Zhao L, et al. Health-related behavior change after cancer: results of the American Cancer Society’s studies of cancer survivors (SCS). J Cancer Surviv. 2010;4:20-32.
6. Katz ML, Reiter PL, Corbin S, et al. Are rural Ohio Appalachia cancer survivors needs different than urban cancer survivors? J Cancer Surviv. 2010;4:140-148.
7. Yabroff KR, Lawrence WF, Clauser S, et al. Burden of illness in cancer survivors: findings from a population-based national sample. J Natl Cancer Inst. 2004;96:1322-1330.
8. Sanson-Fisher R, Girgis A, Boyes A, et al; Supportive Care Review Group. The unmet supportive care needs of patients with cancer. Cancer. 2000;88:226-237.
9. Smith T, Stein KD, Mehta CC, et al. The rationale, design, and implementation of the American Cancer Society’s studies of cancer survivors. Cancer. 2007;109:1-12.
10. Geller BM, Mace J, Vacek P, et al. Are cancer survivors willing to participate in research? J Community Health. 2011;36: 772-778.
11. Crespi CM, Ganz PA, Petersen L, et al. Refinement and psychometric evaluation of the impact of cancer scale. J Natl Cancer Inst. 2008;100:1530-1541.
12. Campbell HS, Sanson-Fisher R, Turner D, et al. Psychometric properties of cancer survivors’ unmet needs survey. Support Care Cancer. 2010;19:221-230.
13. Hodgkinson K, Butow P, Hunt GE, et al. The development and evaluation of a measure to assess cancer survivors’ unmet supportive care needs: the CaSUN (Cancer Survivors’ Unmet Needs measure). Psychooncology. 2007;16:796-804.
14. Zebrack BJ, Ganz PA, Bernaards CA, et al. Assessing the impact of cancer: development of a new instrument for long-term survivors. Psychooncology. 2006;15:407-421.
15. Arora NK, Hesse BW, Rimer BK, et al. Frustrated and confused: the American public rates its cancer-related information-seeking experiences. J Gen Intern Med. 2008;23:223-228.
16. Hodgkinson K, Butow P, Hunt GE, et al. Breast cancer survivors’ supportive care needs 2-10 years after diagnosis. Support Care Cancer. 2007;15:515-523.
17. Harrison SE, Watson EK, Ward AM, et al. Primary health and supportive care needs of long-term cancer survivors: a questionnaire study. J Clin Oncol. 2011;29:2091-2098.
18. Rutten LJ, Squiers L, Treiman K. Requests for information by family and friends of cancer patients calling the National Cancer Institute’s Cancer Information Service. Psychooncology. 2006;15:664-672.
19. Beckjord EB, Arora NK, McLaughlin W, et al. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008;2:179-189.
20. Rutten LJ, Arora NK, Bakos AD, et al. Information needs and sources of information among cancer patients: a systematic review of research (1980-2003). Patient Educ Couns. 2005;57:250-261.
21. Zebrack BJ, Block R, Hayes-Lattin B, et al. Psychosocial service use and unmet need among recently diagnosed adolescent and youg adult patients. Cancer. 2013;119:201-214.
22. Keegan TH, Lichtensztajn DY, Kato I, et al. Unmet adolescent and young adult cancer survivors information and service needs: a population-based cancer registry study. J Cancer Surviv. 2012;6:239-250.
23. Barg KF, Cronholm PF, Straton JB, et al. Unmet psychosocial needs of Pennsylvanians with cancer: 1996-2005. Cancer. 2007;110:631-639.
24. American College of Surgeons. Cancer Program Standards 2012: Ensuring Patient-Centered Care. Chicago, IL: American College of Surgeons; 2011.
25. Hodgkinson K, Butow P, Fuchs A, et al. Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. Gynecol Oncol. 2007;104:381-389.
26. Houts PS, Yasko JM, Kahn SB, et al. Unmet psychological, social, and economic needs of persons with cancer in Pennsylvania. Cancer. 1986;58:2355-2361.
27. Holland JC, Reznik I. Pathways for psychosocial care of cancer survivors. Cancer. 2005;104(11 suppl):2624-2637.
28. Stein KD, Syrjala KL, Andrykowski MA. Physical and psychological long-term and late effects of cancer. Cancer. 2008;112(11 suppl):2577-2592.
29. Park ER, Bober SL, Campbell EG, et al. General: Internist communication about sexual function with cancer survivors. J Gen Intern Med. 2009;24(suppl 2):S407-S411.
30. Girgis A, Adams J, Sibbritt D. The use of complementary and alternative therapies by patients with cancer. Oncol Res. 2005;15:281-289.
31. Gansler T, Kaw C, Crammer C, et al. A population-based study of prevalence of complementary methods use by cancer survivors: a report from the American Cancer Society’s studies of cancer survivors. Cancer. 2008;113:1048-1057.
32. Fouladbakhsh JM, Stommel M. Gender, symptom experience, and use of complementary and alternative medicine practices among cancer survivors in the U.S. cancer population. Oncol Nurs Forum. 2010;37:E7-E15.
33. Vermont Department of Financial Regulation. Vermont Household Health Insurance Survey (VHHIS). Vermont Department of Financial Regulation Web site. Available at: http://www.dfr.vermont.gov/insurance/health-insurance/vermont-household-health-insurance-survey-vhhis. Accessed July 15, 2014.
ABSTRACT
Purpose This study sought to identify the needs and unmet needs of the growing number of adult cancer survivors.
Methods Vermont survivor advocates partnered with academic researchers to create a survivor registry and conduct a cross-sectional survey of cancer-related needs and unmet needs of adult survivors. The mailed survey addressed 53 specific needs in 5 domains based on prior research, contributions from the research partners, and pilot testing. Results were summarized by computing proportions who reported having needs met or unmet.
Results Survey participants included 1668 of 2005 individuals invited from the survivor registry (83%); 65.7% were ages 60 or older and 61.9% were women. These participants had received their diagnosis 2 to 16 years earlier; 77.5% had been diagnosed ≥5 years previously; 30.2% had at least one unmet need in the emotional, social, and spiritual (e) domain; just 14.4% had at least one unmet need in the economic and legal domain. The most commonly identified individual unmet needs were in the e and the information (i) domains and included “help reducing stress” (14.8% of all respondents) and “information about possible after effects of treatment” (14.4%).
Conclusions Most needs of these longer-term survivors were met, but substantial proportions of survivors identified unmet needs. Unmet needs such as information about late and long-term adverse effects of treatment could be met within clinical care with a cancer survivor care plan, but some survivors may require referral to services focused on stress and coping.
Following a successful course of treatment for cancer, many patients return to or remain in the care of their primary care physician (PCP). What often goes unrecognized, however, are these cancer survivors’ unique needs—physical, psychological, social, spiritual, economic, and legal—and the informational and professional services available to address them.1,2
Increased cancer survival creates new needs. There are already >12 million cancer survivors in the United States and >30 million worldwide.3 As baby boomers age, the number of cancers diagnosed over the next 45 years will double4 and improved diagnosis and treatments are already prolonging survivors’ lives. With the greater number of cancer survivors and longer survival time, a cancer survivorship advocacy community has developed to help identify and address the concerns, needs, and benefits of having lived with, through, and beyond a cancer diagnosis.
The purpose of our study. Some of these areas of need have been studied extensively with childhood survivors, breast cancer survivors, and, more recently, prostate cancer survivors. However, few studies have examined adult survivors from all cancer types5-9 or have had cohorts large enough to yield meaningful information.5,7-9 The aim of this study was to describe the needs of adult survivors of all cancer types in a general population from Vermont and to determine whether these needs were met. The results of this study can help identify the services needed by cancer survivors.
METHODS
Population and sample
In November 2009, we invited all survivors listed in a cancer survivor registry to complete a 12-page survey. The registry10 was created as part of the Cancer Survivor Community Study, a community-based participatory research project funded by the National Cancer Institute. The study’s Steering Committee was comprised of cancer survivors, cancer registrars, and researchers. We identified and invited cancer survivors from 4 hospital registries in northwest and central Vermont to participate. Registry participants who indicated willingness to enroll in research studies received an invitation letter and informed consent form, the 12-page survey, and an addressed and stamped return envelope. We obtained Institutional Review Board (IRB) approval for these procedures at the University of Vermont and at local hospital IRBs.
Instrument development
A working group from the Steering Committee reviewed a range of available instruments to assess cancer survivors’ needs.9,11-15 We determined that the survey most relevant to our objectives was the Cancer Survivors’ Unmet Needs (CaSun) instrument.13 Because CaSun was developed in Australia, we carefully examined each question for appropriateness to our target audience. We eliminated several questions that we thought less important, added questions from other instruments, and simplified the survey format. Survivors from the Steering Committee pilot tested the draft questionnaire to identify awkward wording or concepts.
We piloted the revised draft using a standardized feedback form with cancer survivors who were not connected to our project and not enrolled in the survivor registry, and with residents at a senior center. Students and a teacher from an Adult Basic Education program helped to ensure easy readability. Our final instrument had 53 questions about needs in 5 domains. Questions within each domain completed the lead-in, “Since your cancer diagnosis, did you need....” We asked participants to check only 1 of the 3 boxes to the right of each question to indicate that there was no need in that area, that there was a need and it was met, or that there was a need and it was not met. We obtained self-reported demographic data during enrollment in the registry.
Data analysis
We summarized data by computing the percent of survivors who reported having each need (either met or unmet) and the percent for whom the need was unmet. The latter was computed both as a percent of all survivors and as a percent of those who had the need. We also calculated the percentage of survivors that had at least one need and at least one unmet need in each domain, as well as the average number of needs per survivor in each domain. We used SPSS for Unix, Release 6.1 (AIX 3.2)(IBM, Armonk, New York).
RESULTS
Of the 2005 cancer survivors invited into the study, 1668 responded, yielding a participation rate of 83%. TABLE 1 describes the self-reported demographic and cancer characteristics of participants in this study. Most respondents were female, ≥60 years old, urban dwellers, married or with a partner, well educated, and had household incomes of ≥$50,000. There were more breast cancer survivors than survivors of other cancers, and 14.6% of all survivors reported being diagnosed with more than one cancer. Cancer was diagnosed at stages 1 or 2 for 78.3% of the participants; 61.9% reported having undergone ≥2 treatment regimens.
The survey addressed needs in 5 domains: access to care and services (A); information (I); emotional, social, and spiritual (E); physical (P); and economic and legal (L). More than 80% of respondents reported having at least one need in the A, I, and E domains. The E domain had the most survivors with at least one unmet need (N=503), followed by the I (N=410) and P (N=375) domains.
Identifying unmet needs. TABLE 2 shows results for the specific questions within the domains in the order they were asked. Most participants who had a need also had it met. However, some needs that were not commonly reported were deemed unmet by a large proportion of those who expressed the need. For example, the A need for “A case manager to whom you could go to find out about services whenever they were needed” (A5) was reported by only 29.1% of survivors. But 32.1% of those reporting the need said it was unmet, which corresponds to 9.4% of all study participants having the need unmet. Similarly, the need for “More information about complementary and alternative medicine” (I3) was reported by about a quarter of the study population, 41.4% of whom (9.8% of all participants) reported it as unmet. In the P domain, the need for “Help to address problems with your sex life” (P4) was reported by only 26.5% of the respondents; yet 40.7% of those reporting the need had it unmet. Similarly, in the L domain, “Help with life insurance concerns as a result of your cancer” (L3) was only reported by 10.9% of the participants but was unmet for 46.4% of those who reported the need, or 5% of all study participants.
Most commonly expressed needs. TABLE 2 also identifies 12 needs reported by ≥50% of participants. Three of these needs were in the A domain, 6 in the I domain, and 3 in the E domain. The 2 most common needs related to A: the need “To feel like you were managing your health together with the medical team” (A3) was reported by 68.6% and was viewed as unmet by 5.2% of all respondents; the need for “Access to screening for recurrence or other cancers” (A7) was reported by 63.8% of the survivors but was deemed unmet by only 3.1% of all the respondents. “More information about possible after effects of your treatment” (I5) was a need for 63.2% that went unmet in 22.9% (14.4% of all participants). “Help managing your concerns about the cancer coming back” (E13) was reported as a need by 54.1% and as unmet by 11.8% of all participants.
The rank order of 7 unmet needs reported by ≥10% of the participants is shown in TABLE 3. Four of the 7 unmet needs were in the E domain. The most common unmet need in this domain was “Help reducing stress in your life” (E19).
Only 3 needs were both commonly reported and also unmet for at least 10% of the participants: “More information about possible after effects of your treatment” (I5), “More information about possible side effects of your treatment” (I4), and “Help managing your concerns about the cancer coming back” (E13).
DISCUSSION
The survey instrument we used to assess the needs of cancer survivors in a large community-based registry included a detailed list of potential needs generated, in part, by representatives of the survivor community. Most cancer survivor needs mentioned in this survey were met. However, some needs were not met for substantial proportions of respondents and should be examined carefully to determine whether services could be improved to better address them. This study was planned and implemented by researchers and cancer survivors using community-based participatory principles to learn about local needs. The results of this study may be generalizable to similar populations of survivors and will inform the survivorship goals for the Vermont State Cancer Plan and future Vermont Cancer Survivor Network activities.
Acting on patients’ expressed needs. Over 80% of participants had needs in the A, I, and E domains. The most commonly reported need was in the A domain, “To feel like you were managing your health together with the medical team” (A3). It was also a top need in other studies that asked this question.16,17 A cancer diagnosis may cause patients to feel out of control. Participation in the management of their health may help them gain a greater sense of control. PCP accommodation of expressed patient preferences may be an important part of a cancer survivor’s long-term adaptation to the disease.
Six of the 12 most frequently reported needs and 2 frequently reported unmet needs were in the I domain. Communication of information increases patients’ involvement in decision-making and enables them to cope better during diagnosis, treatment, and follow-up.18 “More information about possible after effects of your treatment” and “More information about possible side effects of your treatment” were reported by a high proportion of participants, and many also reported these needs as unmet. In another study about health-related information needs of survivors, 52% wanted more information about “What late and long-term side effects of cancer treatment are expected”19; and in a 2005 review of information needs, 12% of survivors reported similar needs.20 Two recent articles also noted such needs in adolescent and young adult cancer survivors.21,22 Based on current evidence, it would be advisable to discuss anticipated effects of treatment with patients not only at the outset but also at the end of treatment, and to write it in a cancer survivor care plan.
Individual needs that were not met for at least 10% of respondents, regardless of how common the need (TABLE 3), provided additional insights. Among these 7 needs, 3 also were reported as a need by more than 50% of respondents (TABLE 2), and 4 by <50%, indicating that some less common needs are not being met adequately. Among these 7 prominent unmet needs, 4 were E Issues (TABLE 3) and 2 were I Issues.
Unmet needs are an opportunity to improve care. In our study and in others, E needs were most likely to be unmet.17,23-26 Among the 4 common unmet E needs, 2 (E19 and E11) focused on generalized stress and worry, and one (E15) focused on concern about illness impact on family members or partners. Although these issues may be challenging to address successfully in a typical clinical environment, others have confirmed the importance of these needs and proposed ways to meet them.27 The fourth most common unmet E need focused on concern about cancer recurrence, also a prominent need found in other studies.15-17 These needs might be addressed more adequately in the course of usual clinical care by PCPs or specialists. In fact, the American College of Surgeons’ Commission on Cancer 2012 standards now require psychosocial distress screening and the provision of referral for psychosocial services.24 Our results are consistent in many respects with prior studies of needs reported by cancer survivors in other countries. The CaSUN survey developed by Hodgkinson et al13 has been applied to several survivor populations in Australia. In a diverse survivor sample, specific E, I, and A issues were frequently reported as unmet needs.13 The most prominent unmet needs in a gynecologic cancer sample using CaSUN focused on emotional and social issues such as worry, stress, coping, and relationships with, and expectations of, others.25
Barg et al23 conducted a survey of unmet needs in the United States using a detailed list based on prior survivor research and targeting individuals in a cancer registry. The most prominent area of need expressed was “emotional,” similar to the high rank of E needs in our study. In contrast to our study, however, physical and financial issues also were prominent. The latter variances might be explained by differences in access to care, or perhaps the study’s low response rate (23.8%). A similar survey reported by Campbell et al12 identified needs in the emotional domain as the most cited unmet survivor needs based on psychometrically developed subscales of a 152-item survey (29% response rate).
These results from several studies, including ours, call for more detailed exploration of the E needs of long-term cancer survivors. A useful framework developed by Stein et al28 accounts for factors contributing to cancer stress and burden as well as resources available to survivors (intrapersonal, social, informational, and tangible services), with the interactions between these 2 domains determining how well a survivor will be able to cope. There clearly is a role for development of more effective communication channels and focused services to meet survivor needs.
The list of most common unmet needs in TABLE 3 also includes a focus on “problems with your sex life” (P4). This is an area that may be difficult to address in a cancer care setting because of the focus on disease management. Primary care providers might be better prepared to address this issue because they likely encounter similar issues among the wide range of patients they serve. However, a recent study reported that only 46% of internists were somewhat or likely to initiate a discussion about sexuality with cancer survivors.29 Some additional preparation for physicians to address this need might be warranted.
The proportion in this sample reporting needs for access to, or information about, complementary and alternative medicine services fell below the thresholds chosen to designate common needs in this study. Although reported use is relatively common among cancer survivor in several studies,30-32 it appears that in our survivor sample, those who were interested in these approaches encountered only moderate barriers.
Study limitations. We invited participants from a registry unlikely to include cancer survivors with lower educational attainment or from rural locations9—that is, our participants were less likely to have challenges in obtaining appropriate services and information. This sample limitation therefore likely underestimates the overall level of needs among cancer survivors.
This was a cross-sectional assessment of perceived needs among a diverse group of survivors, which may have overlooked needs that were met but only after considerable effort on the part of survivors. Longitudinal studies would provide more complete accounts of how readily needs are met and the changes in needs at different times in the continuum of care.
The Vermont population is less diverse racially and ethnically, but not with respect to household income or educational attainment, than the overall US population. Access to health care also is relatively high in Vermont compared with many other states. According to a 2009 Vermont Household Health Insurance Survey, only 7.6% of Vermonters are uninsured.33
CORRESPONDENCE
Berta Geller, EdD, University of Vermont, Health Promotion Research/Family Medicine, 1 South Prospect Street, Burlington, VT 05401-3444; [email protected]
ACKNOWLEDGEMENTS
We would like to thank Anne Dorwaldt, Kathy Howe, Mark Bowman and John Mace at the University of Vermont, and the Cancer Survivor Community Study Steering Committee for their contributions to the successful completion of this study. We also thank the cancer survivors who participated in the pilot testing and the overall survey.
ABSTRACT
Purpose This study sought to identify the needs and unmet needs of the growing number of adult cancer survivors.
Methods Vermont survivor advocates partnered with academic researchers to create a survivor registry and conduct a cross-sectional survey of cancer-related needs and unmet needs of adult survivors. The mailed survey addressed 53 specific needs in 5 domains based on prior research, contributions from the research partners, and pilot testing. Results were summarized by computing proportions who reported having needs met or unmet.
Results Survey participants included 1668 of 2005 individuals invited from the survivor registry (83%); 65.7% were ages 60 or older and 61.9% were women. These participants had received their diagnosis 2 to 16 years earlier; 77.5% had been diagnosed ≥5 years previously; 30.2% had at least one unmet need in the emotional, social, and spiritual (e) domain; just 14.4% had at least one unmet need in the economic and legal domain. The most commonly identified individual unmet needs were in the e and the information (i) domains and included “help reducing stress” (14.8% of all respondents) and “information about possible after effects of treatment” (14.4%).
Conclusions Most needs of these longer-term survivors were met, but substantial proportions of survivors identified unmet needs. Unmet needs such as information about late and long-term adverse effects of treatment could be met within clinical care with a cancer survivor care plan, but some survivors may require referral to services focused on stress and coping.
Following a successful course of treatment for cancer, many patients return to or remain in the care of their primary care physician (PCP). What often goes unrecognized, however, are these cancer survivors’ unique needs—physical, psychological, social, spiritual, economic, and legal—and the informational and professional services available to address them.1,2
Increased cancer survival creates new needs. There are already >12 million cancer survivors in the United States and >30 million worldwide.3 As baby boomers age, the number of cancers diagnosed over the next 45 years will double4 and improved diagnosis and treatments are already prolonging survivors’ lives. With the greater number of cancer survivors and longer survival time, a cancer survivorship advocacy community has developed to help identify and address the concerns, needs, and benefits of having lived with, through, and beyond a cancer diagnosis.
The purpose of our study. Some of these areas of need have been studied extensively with childhood survivors, breast cancer survivors, and, more recently, prostate cancer survivors. However, few studies have examined adult survivors from all cancer types5-9 or have had cohorts large enough to yield meaningful information.5,7-9 The aim of this study was to describe the needs of adult survivors of all cancer types in a general population from Vermont and to determine whether these needs were met. The results of this study can help identify the services needed by cancer survivors.
METHODS
Population and sample
In November 2009, we invited all survivors listed in a cancer survivor registry to complete a 12-page survey. The registry10 was created as part of the Cancer Survivor Community Study, a community-based participatory research project funded by the National Cancer Institute. The study’s Steering Committee was comprised of cancer survivors, cancer registrars, and researchers. We identified and invited cancer survivors from 4 hospital registries in northwest and central Vermont to participate. Registry participants who indicated willingness to enroll in research studies received an invitation letter and informed consent form, the 12-page survey, and an addressed and stamped return envelope. We obtained Institutional Review Board (IRB) approval for these procedures at the University of Vermont and at local hospital IRBs.
Instrument development
A working group from the Steering Committee reviewed a range of available instruments to assess cancer survivors’ needs.9,11-15 We determined that the survey most relevant to our objectives was the Cancer Survivors’ Unmet Needs (CaSun) instrument.13 Because CaSun was developed in Australia, we carefully examined each question for appropriateness to our target audience. We eliminated several questions that we thought less important, added questions from other instruments, and simplified the survey format. Survivors from the Steering Committee pilot tested the draft questionnaire to identify awkward wording or concepts.
We piloted the revised draft using a standardized feedback form with cancer survivors who were not connected to our project and not enrolled in the survivor registry, and with residents at a senior center. Students and a teacher from an Adult Basic Education program helped to ensure easy readability. Our final instrument had 53 questions about needs in 5 domains. Questions within each domain completed the lead-in, “Since your cancer diagnosis, did you need....” We asked participants to check only 1 of the 3 boxes to the right of each question to indicate that there was no need in that area, that there was a need and it was met, or that there was a need and it was not met. We obtained self-reported demographic data during enrollment in the registry.
Data analysis
We summarized data by computing the percent of survivors who reported having each need (either met or unmet) and the percent for whom the need was unmet. The latter was computed both as a percent of all survivors and as a percent of those who had the need. We also calculated the percentage of survivors that had at least one need and at least one unmet need in each domain, as well as the average number of needs per survivor in each domain. We used SPSS for Unix, Release 6.1 (AIX 3.2)(IBM, Armonk, New York).
RESULTS
Of the 2005 cancer survivors invited into the study, 1668 responded, yielding a participation rate of 83%. TABLE 1 describes the self-reported demographic and cancer characteristics of participants in this study. Most respondents were female, ≥60 years old, urban dwellers, married or with a partner, well educated, and had household incomes of ≥$50,000. There were more breast cancer survivors than survivors of other cancers, and 14.6% of all survivors reported being diagnosed with more than one cancer. Cancer was diagnosed at stages 1 or 2 for 78.3% of the participants; 61.9% reported having undergone ≥2 treatment regimens.
The survey addressed needs in 5 domains: access to care and services (A); information (I); emotional, social, and spiritual (E); physical (P); and economic and legal (L). More than 80% of respondents reported having at least one need in the A, I, and E domains. The E domain had the most survivors with at least one unmet need (N=503), followed by the I (N=410) and P (N=375) domains.
Identifying unmet needs. TABLE 2 shows results for the specific questions within the domains in the order they were asked. Most participants who had a need also had it met. However, some needs that were not commonly reported were deemed unmet by a large proportion of those who expressed the need. For example, the A need for “A case manager to whom you could go to find out about services whenever they were needed” (A5) was reported by only 29.1% of survivors. But 32.1% of those reporting the need said it was unmet, which corresponds to 9.4% of all study participants having the need unmet. Similarly, the need for “More information about complementary and alternative medicine” (I3) was reported by about a quarter of the study population, 41.4% of whom (9.8% of all participants) reported it as unmet. In the P domain, the need for “Help to address problems with your sex life” (P4) was reported by only 26.5% of the respondents; yet 40.7% of those reporting the need had it unmet. Similarly, in the L domain, “Help with life insurance concerns as a result of your cancer” (L3) was only reported by 10.9% of the participants but was unmet for 46.4% of those who reported the need, or 5% of all study participants.
Most commonly expressed needs. TABLE 2 also identifies 12 needs reported by ≥50% of participants. Three of these needs were in the A domain, 6 in the I domain, and 3 in the E domain. The 2 most common needs related to A: the need “To feel like you were managing your health together with the medical team” (A3) was reported by 68.6% and was viewed as unmet by 5.2% of all respondents; the need for “Access to screening for recurrence or other cancers” (A7) was reported by 63.8% of the survivors but was deemed unmet by only 3.1% of all the respondents. “More information about possible after effects of your treatment” (I5) was a need for 63.2% that went unmet in 22.9% (14.4% of all participants). “Help managing your concerns about the cancer coming back” (E13) was reported as a need by 54.1% and as unmet by 11.8% of all participants.
The rank order of 7 unmet needs reported by ≥10% of the participants is shown in TABLE 3. Four of the 7 unmet needs were in the E domain. The most common unmet need in this domain was “Help reducing stress in your life” (E19).
Only 3 needs were both commonly reported and also unmet for at least 10% of the participants: “More information about possible after effects of your treatment” (I5), “More information about possible side effects of your treatment” (I4), and “Help managing your concerns about the cancer coming back” (E13).
DISCUSSION
The survey instrument we used to assess the needs of cancer survivors in a large community-based registry included a detailed list of potential needs generated, in part, by representatives of the survivor community. Most cancer survivor needs mentioned in this survey were met. However, some needs were not met for substantial proportions of respondents and should be examined carefully to determine whether services could be improved to better address them. This study was planned and implemented by researchers and cancer survivors using community-based participatory principles to learn about local needs. The results of this study may be generalizable to similar populations of survivors and will inform the survivorship goals for the Vermont State Cancer Plan and future Vermont Cancer Survivor Network activities.
Acting on patients’ expressed needs. Over 80% of participants had needs in the A, I, and E domains. The most commonly reported need was in the A domain, “To feel like you were managing your health together with the medical team” (A3). It was also a top need in other studies that asked this question.16,17 A cancer diagnosis may cause patients to feel out of control. Participation in the management of their health may help them gain a greater sense of control. PCP accommodation of expressed patient preferences may be an important part of a cancer survivor’s long-term adaptation to the disease.
Six of the 12 most frequently reported needs and 2 frequently reported unmet needs were in the I domain. Communication of information increases patients’ involvement in decision-making and enables them to cope better during diagnosis, treatment, and follow-up.18 “More information about possible after effects of your treatment” and “More information about possible side effects of your treatment” were reported by a high proportion of participants, and many also reported these needs as unmet. In another study about health-related information needs of survivors, 52% wanted more information about “What late and long-term side effects of cancer treatment are expected”19; and in a 2005 review of information needs, 12% of survivors reported similar needs.20 Two recent articles also noted such needs in adolescent and young adult cancer survivors.21,22 Based on current evidence, it would be advisable to discuss anticipated effects of treatment with patients not only at the outset but also at the end of treatment, and to write it in a cancer survivor care plan.
Individual needs that were not met for at least 10% of respondents, regardless of how common the need (TABLE 3), provided additional insights. Among these 7 needs, 3 also were reported as a need by more than 50% of respondents (TABLE 2), and 4 by <50%, indicating that some less common needs are not being met adequately. Among these 7 prominent unmet needs, 4 were E Issues (TABLE 3) and 2 were I Issues.
Unmet needs are an opportunity to improve care. In our study and in others, E needs were most likely to be unmet.17,23-26 Among the 4 common unmet E needs, 2 (E19 and E11) focused on generalized stress and worry, and one (E15) focused on concern about illness impact on family members or partners. Although these issues may be challenging to address successfully in a typical clinical environment, others have confirmed the importance of these needs and proposed ways to meet them.27 The fourth most common unmet E need focused on concern about cancer recurrence, also a prominent need found in other studies.15-17 These needs might be addressed more adequately in the course of usual clinical care by PCPs or specialists. In fact, the American College of Surgeons’ Commission on Cancer 2012 standards now require psychosocial distress screening and the provision of referral for psychosocial services.24 Our results are consistent in many respects with prior studies of needs reported by cancer survivors in other countries. The CaSUN survey developed by Hodgkinson et al13 has been applied to several survivor populations in Australia. In a diverse survivor sample, specific E, I, and A issues were frequently reported as unmet needs.13 The most prominent unmet needs in a gynecologic cancer sample using CaSUN focused on emotional and social issues such as worry, stress, coping, and relationships with, and expectations of, others.25
Barg et al23 conducted a survey of unmet needs in the United States using a detailed list based on prior survivor research and targeting individuals in a cancer registry. The most prominent area of need expressed was “emotional,” similar to the high rank of E needs in our study. In contrast to our study, however, physical and financial issues also were prominent. The latter variances might be explained by differences in access to care, or perhaps the study’s low response rate (23.8%). A similar survey reported by Campbell et al12 identified needs in the emotional domain as the most cited unmet survivor needs based on psychometrically developed subscales of a 152-item survey (29% response rate).
These results from several studies, including ours, call for more detailed exploration of the E needs of long-term cancer survivors. A useful framework developed by Stein et al28 accounts for factors contributing to cancer stress and burden as well as resources available to survivors (intrapersonal, social, informational, and tangible services), with the interactions between these 2 domains determining how well a survivor will be able to cope. There clearly is a role for development of more effective communication channels and focused services to meet survivor needs.
The list of most common unmet needs in TABLE 3 also includes a focus on “problems with your sex life” (P4). This is an area that may be difficult to address in a cancer care setting because of the focus on disease management. Primary care providers might be better prepared to address this issue because they likely encounter similar issues among the wide range of patients they serve. However, a recent study reported that only 46% of internists were somewhat or likely to initiate a discussion about sexuality with cancer survivors.29 Some additional preparation for physicians to address this need might be warranted.
The proportion in this sample reporting needs for access to, or information about, complementary and alternative medicine services fell below the thresholds chosen to designate common needs in this study. Although reported use is relatively common among cancer survivor in several studies,30-32 it appears that in our survivor sample, those who were interested in these approaches encountered only moderate barriers.
Study limitations. We invited participants from a registry unlikely to include cancer survivors with lower educational attainment or from rural locations9—that is, our participants were less likely to have challenges in obtaining appropriate services and information. This sample limitation therefore likely underestimates the overall level of needs among cancer survivors.
This was a cross-sectional assessment of perceived needs among a diverse group of survivors, which may have overlooked needs that were met but only after considerable effort on the part of survivors. Longitudinal studies would provide more complete accounts of how readily needs are met and the changes in needs at different times in the continuum of care.
The Vermont population is less diverse racially and ethnically, but not with respect to household income or educational attainment, than the overall US population. Access to health care also is relatively high in Vermont compared with many other states. According to a 2009 Vermont Household Health Insurance Survey, only 7.6% of Vermonters are uninsured.33
CORRESPONDENCE
Berta Geller, EdD, University of Vermont, Health Promotion Research/Family Medicine, 1 South Prospect Street, Burlington, VT 05401-3444; [email protected]
ACKNOWLEDGEMENTS
We would like to thank Anne Dorwaldt, Kathy Howe, Mark Bowman and John Mace at the University of Vermont, and the Cancer Survivor Community Study Steering Committee for their contributions to the successful completion of this study. We also thank the cancer survivors who participated in the pilot testing and the overall survey.
1. Potosky A, Han PK, Rowland J, et al. Differences between primary care physicians’ and oncologists’ knowledge, attitudes and practices regarding the care of cancer survivors. J Gen Intern Med. 2011;26:1403-1410.
2. Rowland J. Survivorship research: past, present, and future. In: Chang AE, Ganz PA, Hayes DF, et al, eds. Oncology: An Evidence-Based Approach. New York, NY: Springer; 2005:1753-1767.
3. Jemal A, Center MM, DeSantis C, et al. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010;19:1893-1907.
4. Hewitt ME, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: National Academies Press; 2005.
5. Hawkins NA, Smith T, Zhao L, et al. Health-related behavior change after cancer: results of the American Cancer Society’s studies of cancer survivors (SCS). J Cancer Surviv. 2010;4:20-32.
6. Katz ML, Reiter PL, Corbin S, et al. Are rural Ohio Appalachia cancer survivors needs different than urban cancer survivors? J Cancer Surviv. 2010;4:140-148.
7. Yabroff KR, Lawrence WF, Clauser S, et al. Burden of illness in cancer survivors: findings from a population-based national sample. J Natl Cancer Inst. 2004;96:1322-1330.
8. Sanson-Fisher R, Girgis A, Boyes A, et al; Supportive Care Review Group. The unmet supportive care needs of patients with cancer. Cancer. 2000;88:226-237.
9. Smith T, Stein KD, Mehta CC, et al. The rationale, design, and implementation of the American Cancer Society’s studies of cancer survivors. Cancer. 2007;109:1-12.
10. Geller BM, Mace J, Vacek P, et al. Are cancer survivors willing to participate in research? J Community Health. 2011;36: 772-778.
11. Crespi CM, Ganz PA, Petersen L, et al. Refinement and psychometric evaluation of the impact of cancer scale. J Natl Cancer Inst. 2008;100:1530-1541.
12. Campbell HS, Sanson-Fisher R, Turner D, et al. Psychometric properties of cancer survivors’ unmet needs survey. Support Care Cancer. 2010;19:221-230.
13. Hodgkinson K, Butow P, Hunt GE, et al. The development and evaluation of a measure to assess cancer survivors’ unmet supportive care needs: the CaSUN (Cancer Survivors’ Unmet Needs measure). Psychooncology. 2007;16:796-804.
14. Zebrack BJ, Ganz PA, Bernaards CA, et al. Assessing the impact of cancer: development of a new instrument for long-term survivors. Psychooncology. 2006;15:407-421.
15. Arora NK, Hesse BW, Rimer BK, et al. Frustrated and confused: the American public rates its cancer-related information-seeking experiences. J Gen Intern Med. 2008;23:223-228.
16. Hodgkinson K, Butow P, Hunt GE, et al. Breast cancer survivors’ supportive care needs 2-10 years after diagnosis. Support Care Cancer. 2007;15:515-523.
17. Harrison SE, Watson EK, Ward AM, et al. Primary health and supportive care needs of long-term cancer survivors: a questionnaire study. J Clin Oncol. 2011;29:2091-2098.
18. Rutten LJ, Squiers L, Treiman K. Requests for information by family and friends of cancer patients calling the National Cancer Institute’s Cancer Information Service. Psychooncology. 2006;15:664-672.
19. Beckjord EB, Arora NK, McLaughlin W, et al. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008;2:179-189.
20. Rutten LJ, Arora NK, Bakos AD, et al. Information needs and sources of information among cancer patients: a systematic review of research (1980-2003). Patient Educ Couns. 2005;57:250-261.
21. Zebrack BJ, Block R, Hayes-Lattin B, et al. Psychosocial service use and unmet need among recently diagnosed adolescent and youg adult patients. Cancer. 2013;119:201-214.
22. Keegan TH, Lichtensztajn DY, Kato I, et al. Unmet adolescent and young adult cancer survivors information and service needs: a population-based cancer registry study. J Cancer Surviv. 2012;6:239-250.
23. Barg KF, Cronholm PF, Straton JB, et al. Unmet psychosocial needs of Pennsylvanians with cancer: 1996-2005. Cancer. 2007;110:631-639.
24. American College of Surgeons. Cancer Program Standards 2012: Ensuring Patient-Centered Care. Chicago, IL: American College of Surgeons; 2011.
25. Hodgkinson K, Butow P, Fuchs A, et al. Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. Gynecol Oncol. 2007;104:381-389.
26. Houts PS, Yasko JM, Kahn SB, et al. Unmet psychological, social, and economic needs of persons with cancer in Pennsylvania. Cancer. 1986;58:2355-2361.
27. Holland JC, Reznik I. Pathways for psychosocial care of cancer survivors. Cancer. 2005;104(11 suppl):2624-2637.
28. Stein KD, Syrjala KL, Andrykowski MA. Physical and psychological long-term and late effects of cancer. Cancer. 2008;112(11 suppl):2577-2592.
29. Park ER, Bober SL, Campbell EG, et al. General: Internist communication about sexual function with cancer survivors. J Gen Intern Med. 2009;24(suppl 2):S407-S411.
30. Girgis A, Adams J, Sibbritt D. The use of complementary and alternative therapies by patients with cancer. Oncol Res. 2005;15:281-289.
31. Gansler T, Kaw C, Crammer C, et al. A population-based study of prevalence of complementary methods use by cancer survivors: a report from the American Cancer Society’s studies of cancer survivors. Cancer. 2008;113:1048-1057.
32. Fouladbakhsh JM, Stommel M. Gender, symptom experience, and use of complementary and alternative medicine practices among cancer survivors in the U.S. cancer population. Oncol Nurs Forum. 2010;37:E7-E15.
33. Vermont Department of Financial Regulation. Vermont Household Health Insurance Survey (VHHIS). Vermont Department of Financial Regulation Web site. Available at: http://www.dfr.vermont.gov/insurance/health-insurance/vermont-household-health-insurance-survey-vhhis. Accessed July 15, 2014.
1. Potosky A, Han PK, Rowland J, et al. Differences between primary care physicians’ and oncologists’ knowledge, attitudes and practices regarding the care of cancer survivors. J Gen Intern Med. 2011;26:1403-1410.
2. Rowland J. Survivorship research: past, present, and future. In: Chang AE, Ganz PA, Hayes DF, et al, eds. Oncology: An Evidence-Based Approach. New York, NY: Springer; 2005:1753-1767.
3. Jemal A, Center MM, DeSantis C, et al. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010;19:1893-1907.
4. Hewitt ME, Greenfield S, Stovall E, eds. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, DC: National Academies Press; 2005.
5. Hawkins NA, Smith T, Zhao L, et al. Health-related behavior change after cancer: results of the American Cancer Society’s studies of cancer survivors (SCS). J Cancer Surviv. 2010;4:20-32.
6. Katz ML, Reiter PL, Corbin S, et al. Are rural Ohio Appalachia cancer survivors needs different than urban cancer survivors? J Cancer Surviv. 2010;4:140-148.
7. Yabroff KR, Lawrence WF, Clauser S, et al. Burden of illness in cancer survivors: findings from a population-based national sample. J Natl Cancer Inst. 2004;96:1322-1330.
8. Sanson-Fisher R, Girgis A, Boyes A, et al; Supportive Care Review Group. The unmet supportive care needs of patients with cancer. Cancer. 2000;88:226-237.
9. Smith T, Stein KD, Mehta CC, et al. The rationale, design, and implementation of the American Cancer Society’s studies of cancer survivors. Cancer. 2007;109:1-12.
10. Geller BM, Mace J, Vacek P, et al. Are cancer survivors willing to participate in research? J Community Health. 2011;36: 772-778.
11. Crespi CM, Ganz PA, Petersen L, et al. Refinement and psychometric evaluation of the impact of cancer scale. J Natl Cancer Inst. 2008;100:1530-1541.
12. Campbell HS, Sanson-Fisher R, Turner D, et al. Psychometric properties of cancer survivors’ unmet needs survey. Support Care Cancer. 2010;19:221-230.
13. Hodgkinson K, Butow P, Hunt GE, et al. The development and evaluation of a measure to assess cancer survivors’ unmet supportive care needs: the CaSUN (Cancer Survivors’ Unmet Needs measure). Psychooncology. 2007;16:796-804.
14. Zebrack BJ, Ganz PA, Bernaards CA, et al. Assessing the impact of cancer: development of a new instrument for long-term survivors. Psychooncology. 2006;15:407-421.
15. Arora NK, Hesse BW, Rimer BK, et al. Frustrated and confused: the American public rates its cancer-related information-seeking experiences. J Gen Intern Med. 2008;23:223-228.
16. Hodgkinson K, Butow P, Hunt GE, et al. Breast cancer survivors’ supportive care needs 2-10 years after diagnosis. Support Care Cancer. 2007;15:515-523.
17. Harrison SE, Watson EK, Ward AM, et al. Primary health and supportive care needs of long-term cancer survivors: a questionnaire study. J Clin Oncol. 2011;29:2091-2098.
18. Rutten LJ, Squiers L, Treiman K. Requests for information by family and friends of cancer patients calling the National Cancer Institute’s Cancer Information Service. Psychooncology. 2006;15:664-672.
19. Beckjord EB, Arora NK, McLaughlin W, et al. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008;2:179-189.
20. Rutten LJ, Arora NK, Bakos AD, et al. Information needs and sources of information among cancer patients: a systematic review of research (1980-2003). Patient Educ Couns. 2005;57:250-261.
21. Zebrack BJ, Block R, Hayes-Lattin B, et al. Psychosocial service use and unmet need among recently diagnosed adolescent and youg adult patients. Cancer. 2013;119:201-214.
22. Keegan TH, Lichtensztajn DY, Kato I, et al. Unmet adolescent and young adult cancer survivors information and service needs: a population-based cancer registry study. J Cancer Surviv. 2012;6:239-250.
23. Barg KF, Cronholm PF, Straton JB, et al. Unmet psychosocial needs of Pennsylvanians with cancer: 1996-2005. Cancer. 2007;110:631-639.
24. American College of Surgeons. Cancer Program Standards 2012: Ensuring Patient-Centered Care. Chicago, IL: American College of Surgeons; 2011.
25. Hodgkinson K, Butow P, Fuchs A, et al. Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. Gynecol Oncol. 2007;104:381-389.
26. Houts PS, Yasko JM, Kahn SB, et al. Unmet psychological, social, and economic needs of persons with cancer in Pennsylvania. Cancer. 1986;58:2355-2361.
27. Holland JC, Reznik I. Pathways for psychosocial care of cancer survivors. Cancer. 2005;104(11 suppl):2624-2637.
28. Stein KD, Syrjala KL, Andrykowski MA. Physical and psychological long-term and late effects of cancer. Cancer. 2008;112(11 suppl):2577-2592.
29. Park ER, Bober SL, Campbell EG, et al. General: Internist communication about sexual function with cancer survivors. J Gen Intern Med. 2009;24(suppl 2):S407-S411.
30. Girgis A, Adams J, Sibbritt D. The use of complementary and alternative therapies by patients with cancer. Oncol Res. 2005;15:281-289.
31. Gansler T, Kaw C, Crammer C, et al. A population-based study of prevalence of complementary methods use by cancer survivors: a report from the American Cancer Society’s studies of cancer survivors. Cancer. 2008;113:1048-1057.
32. Fouladbakhsh JM, Stommel M. Gender, symptom experience, and use of complementary and alternative medicine practices among cancer survivors in the U.S. cancer population. Oncol Nurs Forum. 2010;37:E7-E15.
33. Vermont Department of Financial Regulation. Vermont Household Health Insurance Survey (VHHIS). Vermont Department of Financial Regulation Web site. Available at: http://www.dfr.vermont.gov/insurance/health-insurance/vermont-household-health-insurance-survey-vhhis. Accessed July 15, 2014.
Failure to properly manage a patient’s hypertension
Failure to properly manage a patient’s hypertension
A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.
PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.
THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.
VERDICT $136,000 New Jersey verdict.
COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.
Did the patient’s age discourage proper evaluation?
THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.
PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.
THE DEFENSE No information about the defense is available.
VERDICT $2.5 million Maryland verdict.
COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”
23-year-old dies when myocarditis is mistaken for bronchitis
A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.
PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.
THE DEFENSE The patient was evaluated properly. An EKG was not necessary.
VERDICT $2.9 million Massachusetts verdict.
COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.
Failure to properly manage a patient’s hypertension
A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.
PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.
THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.
VERDICT $136,000 New Jersey verdict.
COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.
Did the patient’s age discourage proper evaluation?
THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.
PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.
THE DEFENSE No information about the defense is available.
VERDICT $2.5 million Maryland verdict.
COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”
23-year-old dies when myocarditis is mistaken for bronchitis
A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.
PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.
THE DEFENSE The patient was evaluated properly. An EKG was not necessary.
VERDICT $2.9 million Massachusetts verdict.
COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.
Failure to properly manage a patient’s hypertension
A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.
PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.
THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.
VERDICT $136,000 New Jersey verdict.
COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.
Did the patient’s age discourage proper evaluation?
THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.
PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.
THE DEFENSE No information about the defense is available.
VERDICT $2.5 million Maryland verdict.
COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”
23-year-old dies when myocarditis is mistaken for bronchitis
A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.
PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.
THE DEFENSE The patient was evaluated properly. An EKG was not necessary.
VERDICT $2.9 million Massachusetts verdict.
COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.
Probiotics for colic? A PURL update
In “Colicky baby? Here’s a surprising remedy” (J Fam Pract. 2011;60:34-36), we summarized a 2010 double-blind randomized controlled trial (RCT) that found the probiotic Lactobacillus reuteri DSM 17938 reduced daily crying time in colicky, exclusively breastfed infants.1
A recently published RCT of the same probiotic by Sung et al2 adds to the body of evidence and suggests that the jury may still be out as to the value of probiotics for colicky babies.
The newer study (which also measured colic using modified Wessel’s criteria) included babies who were formula-fed as well as those who were breastfed. When researchers looked at all babies as a single group, those who received probiotics fussed significantly more than those who received placebo at nearly all of the postintervention time points. However, when they delved deeper, the researchers noted that an increase in fussing occurred only among infants on formula. On the other hand, the time that breastfed infants spent crying or fussing did not vary significantly between those who received probiotics and those who received placebo.
Both the 2010 and 2014 studies used valid RCT methods with low risk for bias, so we’re not clear why the results (especially for breastfed infants) differed. The 2010 study was done in Italy and required breastfeeding moms to avoid cow’s milk, while the 2014 Sung et al2 study was conducted in Australia and did not have this requirement, so environmental factors may have played a role. The reporting method in the Sung et al2 study—a well-validated, detailed diary of infant behaviors—may have led to less parent recall error than the diary used in the 2010 study. All in all, we can only conclude that it is unclear whether probiotics work to reduce crying in colicky infants.
A safe bet may be to avoid recommending probiotics for colicky formula-fed infants, since no study of this population has shown probiotics are effective, and in the Sung et al2 study, they appeared to worsen symptoms. For breastfed babies, there is no evidence of harm, and mixed evidence on whether probiotics help.
1. Savino F, Cordisco L, Tarasco V, et al. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010;126:e526-e533.
2. Sung V, Hiscock H, Tang ML, et al. Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ. 2014;348:g2107.
In “Colicky baby? Here’s a surprising remedy” (J Fam Pract. 2011;60:34-36), we summarized a 2010 double-blind randomized controlled trial (RCT) that found the probiotic Lactobacillus reuteri DSM 17938 reduced daily crying time in colicky, exclusively breastfed infants.1
A recently published RCT of the same probiotic by Sung et al2 adds to the body of evidence and suggests that the jury may still be out as to the value of probiotics for colicky babies.
The newer study (which also measured colic using modified Wessel’s criteria) included babies who were formula-fed as well as those who were breastfed. When researchers looked at all babies as a single group, those who received probiotics fussed significantly more than those who received placebo at nearly all of the postintervention time points. However, when they delved deeper, the researchers noted that an increase in fussing occurred only among infants on formula. On the other hand, the time that breastfed infants spent crying or fussing did not vary significantly between those who received probiotics and those who received placebo.
Both the 2010 and 2014 studies used valid RCT methods with low risk for bias, so we’re not clear why the results (especially for breastfed infants) differed. The 2010 study was done in Italy and required breastfeeding moms to avoid cow’s milk, while the 2014 Sung et al2 study was conducted in Australia and did not have this requirement, so environmental factors may have played a role. The reporting method in the Sung et al2 study—a well-validated, detailed diary of infant behaviors—may have led to less parent recall error than the diary used in the 2010 study. All in all, we can only conclude that it is unclear whether probiotics work to reduce crying in colicky infants.
A safe bet may be to avoid recommending probiotics for colicky formula-fed infants, since no study of this population has shown probiotics are effective, and in the Sung et al2 study, they appeared to worsen symptoms. For breastfed babies, there is no evidence of harm, and mixed evidence on whether probiotics help.
In “Colicky baby? Here’s a surprising remedy” (J Fam Pract. 2011;60:34-36), we summarized a 2010 double-blind randomized controlled trial (RCT) that found the probiotic Lactobacillus reuteri DSM 17938 reduced daily crying time in colicky, exclusively breastfed infants.1
A recently published RCT of the same probiotic by Sung et al2 adds to the body of evidence and suggests that the jury may still be out as to the value of probiotics for colicky babies.
The newer study (which also measured colic using modified Wessel’s criteria) included babies who were formula-fed as well as those who were breastfed. When researchers looked at all babies as a single group, those who received probiotics fussed significantly more than those who received placebo at nearly all of the postintervention time points. However, when they delved deeper, the researchers noted that an increase in fussing occurred only among infants on formula. On the other hand, the time that breastfed infants spent crying or fussing did not vary significantly between those who received probiotics and those who received placebo.
Both the 2010 and 2014 studies used valid RCT methods with low risk for bias, so we’re not clear why the results (especially for breastfed infants) differed. The 2010 study was done in Italy and required breastfeeding moms to avoid cow’s milk, while the 2014 Sung et al2 study was conducted in Australia and did not have this requirement, so environmental factors may have played a role. The reporting method in the Sung et al2 study—a well-validated, detailed diary of infant behaviors—may have led to less parent recall error than the diary used in the 2010 study. All in all, we can only conclude that it is unclear whether probiotics work to reduce crying in colicky infants.
A safe bet may be to avoid recommending probiotics for colicky formula-fed infants, since no study of this population has shown probiotics are effective, and in the Sung et al2 study, they appeared to worsen symptoms. For breastfed babies, there is no evidence of harm, and mixed evidence on whether probiotics help.
1. Savino F, Cordisco L, Tarasco V, et al. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010;126:e526-e533.
2. Sung V, Hiscock H, Tang ML, et al. Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ. 2014;348:g2107.
1. Savino F, Cordisco L, Tarasco V, et al. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010;126:e526-e533.
2. Sung V, Hiscock H, Tang ML, et al. Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ. 2014;348:g2107.
Copyright © 2014 Family Physicians Inquiries Network. All rights reserved.
Dutch study clarifies risk of attempted vaginal birth of breech fetus
Should a baby that presents breech at term be delivered vaginally or by cesarean delivery? In October 2000, results of the Term Breech Trial (TBT), the largest randomized controlled trial to investigate the effect of delivery mode for term breech deliveries on neonatal and maternal outcomes, essentially answered this question, showing that planned cesarean delivery was safer than planned vaginal delivery (with combined perinatal morbidity and mortality scores of 5% vs 16%, respectively).1 These study results affected national guidelines for choosing delivery mode in the Netherlands as well as other countries around the world.
What has been the impact on mode of delivery and neonatal outcome in the Netherlands since the TBT’s publication? Furthermore, are there antepartum parameters that can distinguish which women are at high risk versus low risk for adverse neonatal outcomes when presenting breech at delivery? Vlemmix and colleagues sought to answer these questions, using retrospective data from the Netherlands Perinatal Registry (PRN) from 1999 through 2007.1
Perinatal death decreased over time—but only for women electing cesarean
During the study period, approximately 4% of all births were breech. The researchers studied 58,320 women with term breech delivery, using the PRN. They noted an increase in the elective cesarean delivery (ECD) rate for these women, from 24% before October 2000 to 60% after December 2000, and as a consequence, found that overall perinatal mortality decreased from 1.3% to 0.7% (odds ratio [OR] 0.51; 95% confidence interval [CI] 0.28–0.93).1
However, among the women who underwent planned vaginal delivery, the overall perinatal mortality remained stable (1.7% vs 1.6%; OR, 0.96; 95% CI, 0.52–1.76). “Despite the lower percentage of women opting for or offered a vaginal delivery, and despite a higher emergency cesarean rate during vaginal breech birth, neonatal outcome within the planned vaginal birth group did not improve,” state the authors.1
Putting the results in absolute numbers
The investigators say that the 40% of Dutch women with breech presentation at term who still attempt vaginal birth do so without improved neonatal outcome; these deliveries generate a 10-fold higher fetal mortality rate compared with ECD. Further, no subgroup of women, when evaluating parity, onset of labor, type of breech presentation, and birthweight, could be identified with a low risk of poor neonatal outcome during planned vaginal delivery compared with ECD.1
Since the TBT, 1,692 more combined elective and emergency cesarean deliveries were performed annually, leading to five less neonatal deaths per year (number needed to treat, 338). If all women who still undergo planned vaginal birth receive ECD, 6,490 more ECDs would be performed, with 10 less neonatal deaths, 116 less neonates with low Apgar score, and 20 less neonates with birth trauma per year, according to the researchers.1
They suggest that clinicians use the results of this study when counseling women with a term breech presentation on mode of delivery. “To properly inform patients, a combination of risk presentation (absolute risks, relative risks and figures) is necessary to enable individual informed decision making.”1
Share your thoughts on this news! Send your Letter to the Editor to [email protected]. Please include your name, and the city and state in which you practice.
Reference
- Vlemmix F, Bergenhenegouwen L, Schaaf JM, et al. Term breech deliveries in the Netherlands: did the increased cesarean rate affect neonatal outcome? A population-based cohort study. Acta Obstet Gynecol Scand. 2014;93:888–896.
Should a baby that presents breech at term be delivered vaginally or by cesarean delivery? In October 2000, results of the Term Breech Trial (TBT), the largest randomized controlled trial to investigate the effect of delivery mode for term breech deliveries on neonatal and maternal outcomes, essentially answered this question, showing that planned cesarean delivery was safer than planned vaginal delivery (with combined perinatal morbidity and mortality scores of 5% vs 16%, respectively).1 These study results affected national guidelines for choosing delivery mode in the Netherlands as well as other countries around the world.
What has been the impact on mode of delivery and neonatal outcome in the Netherlands since the TBT’s publication? Furthermore, are there antepartum parameters that can distinguish which women are at high risk versus low risk for adverse neonatal outcomes when presenting breech at delivery? Vlemmix and colleagues sought to answer these questions, using retrospective data from the Netherlands Perinatal Registry (PRN) from 1999 through 2007.1
Perinatal death decreased over time—but only for women electing cesarean
During the study period, approximately 4% of all births were breech. The researchers studied 58,320 women with term breech delivery, using the PRN. They noted an increase in the elective cesarean delivery (ECD) rate for these women, from 24% before October 2000 to 60% after December 2000, and as a consequence, found that overall perinatal mortality decreased from 1.3% to 0.7% (odds ratio [OR] 0.51; 95% confidence interval [CI] 0.28–0.93).1
However, among the women who underwent planned vaginal delivery, the overall perinatal mortality remained stable (1.7% vs 1.6%; OR, 0.96; 95% CI, 0.52–1.76). “Despite the lower percentage of women opting for or offered a vaginal delivery, and despite a higher emergency cesarean rate during vaginal breech birth, neonatal outcome within the planned vaginal birth group did not improve,” state the authors.1
Putting the results in absolute numbers
The investigators say that the 40% of Dutch women with breech presentation at term who still attempt vaginal birth do so without improved neonatal outcome; these deliveries generate a 10-fold higher fetal mortality rate compared with ECD. Further, no subgroup of women, when evaluating parity, onset of labor, type of breech presentation, and birthweight, could be identified with a low risk of poor neonatal outcome during planned vaginal delivery compared with ECD.1
Since the TBT, 1,692 more combined elective and emergency cesarean deliveries were performed annually, leading to five less neonatal deaths per year (number needed to treat, 338). If all women who still undergo planned vaginal birth receive ECD, 6,490 more ECDs would be performed, with 10 less neonatal deaths, 116 less neonates with low Apgar score, and 20 less neonates with birth trauma per year, according to the researchers.1
They suggest that clinicians use the results of this study when counseling women with a term breech presentation on mode of delivery. “To properly inform patients, a combination of risk presentation (absolute risks, relative risks and figures) is necessary to enable individual informed decision making.”1
Share your thoughts on this news! Send your Letter to the Editor to [email protected]. Please include your name, and the city and state in which you practice.
Should a baby that presents breech at term be delivered vaginally or by cesarean delivery? In October 2000, results of the Term Breech Trial (TBT), the largest randomized controlled trial to investigate the effect of delivery mode for term breech deliveries on neonatal and maternal outcomes, essentially answered this question, showing that planned cesarean delivery was safer than planned vaginal delivery (with combined perinatal morbidity and mortality scores of 5% vs 16%, respectively).1 These study results affected national guidelines for choosing delivery mode in the Netherlands as well as other countries around the world.
What has been the impact on mode of delivery and neonatal outcome in the Netherlands since the TBT’s publication? Furthermore, are there antepartum parameters that can distinguish which women are at high risk versus low risk for adverse neonatal outcomes when presenting breech at delivery? Vlemmix and colleagues sought to answer these questions, using retrospective data from the Netherlands Perinatal Registry (PRN) from 1999 through 2007.1
Perinatal death decreased over time—but only for women electing cesarean
During the study period, approximately 4% of all births were breech. The researchers studied 58,320 women with term breech delivery, using the PRN. They noted an increase in the elective cesarean delivery (ECD) rate for these women, from 24% before October 2000 to 60% after December 2000, and as a consequence, found that overall perinatal mortality decreased from 1.3% to 0.7% (odds ratio [OR] 0.51; 95% confidence interval [CI] 0.28–0.93).1
However, among the women who underwent planned vaginal delivery, the overall perinatal mortality remained stable (1.7% vs 1.6%; OR, 0.96; 95% CI, 0.52–1.76). “Despite the lower percentage of women opting for or offered a vaginal delivery, and despite a higher emergency cesarean rate during vaginal breech birth, neonatal outcome within the planned vaginal birth group did not improve,” state the authors.1
Putting the results in absolute numbers
The investigators say that the 40% of Dutch women with breech presentation at term who still attempt vaginal birth do so without improved neonatal outcome; these deliveries generate a 10-fold higher fetal mortality rate compared with ECD. Further, no subgroup of women, when evaluating parity, onset of labor, type of breech presentation, and birthweight, could be identified with a low risk of poor neonatal outcome during planned vaginal delivery compared with ECD.1
Since the TBT, 1,692 more combined elective and emergency cesarean deliveries were performed annually, leading to five less neonatal deaths per year (number needed to treat, 338). If all women who still undergo planned vaginal birth receive ECD, 6,490 more ECDs would be performed, with 10 less neonatal deaths, 116 less neonates with low Apgar score, and 20 less neonates with birth trauma per year, according to the researchers.1
They suggest that clinicians use the results of this study when counseling women with a term breech presentation on mode of delivery. “To properly inform patients, a combination of risk presentation (absolute risks, relative risks and figures) is necessary to enable individual informed decision making.”1
Share your thoughts on this news! Send your Letter to the Editor to [email protected]. Please include your name, and the city and state in which you practice.
Reference
- Vlemmix F, Bergenhenegouwen L, Schaaf JM, et al. Term breech deliveries in the Netherlands: did the increased cesarean rate affect neonatal outcome? A population-based cohort study. Acta Obstet Gynecol Scand. 2014;93:888–896.
Reference
- Vlemmix F, Bergenhenegouwen L, Schaaf JM, et al. Term breech deliveries in the Netherlands: did the increased cesarean rate affect neonatal outcome? A population-based cohort study. Acta Obstet Gynecol Scand. 2014;93:888–896.
Total abdominal hysterectomy the Mayo Clinic way
The abdominal approach to hysterectomy remains the most common route to hysterectomy in the United States. Its greatest advantage: It allows the uterus to be removed intact.1–3
The recent US Food and Drug Administration (FDA) warning against the use of power morcellation in women with known or suspected uterine malignancy has left many gynecologic surgeons wondering what might be the optimal approach to the removal of a large uterus.4
Although most hysterectomies are performed for benign conditions—namely, uterine fibroids—malignancy should be considered in the differential diagnosis. When hysterectomy is performed laparoscopically, a large uterus must be morcellated intraperitoneally. Since the FDA safety communication was issued, some hospitals have imposed a moratorium on the use of power morcellators for removal of uterine tissue until more definitive evidence is put forth regarding safety and best practices. This chain of events allows us an opportunity to review the basics of abdominal hysterectomy.
For the sake of this discussion, I will assume that the hysterectomy is being performed for a benign indication as I highlight the Mayo Clinic approach to total abdominal hysterectomy (TAH).5
Preoperative considerations
The patient should be medically able to undergo operative intervention. If she has preexisting medical conditions, preoperative clearance should be obtained from her primary care provider, and her medical conditions should be optimized prior to surgical intervention.
Baseline laboratory studies include a complete blood count, electrolyte panel, glucose assessment, and an electrocardiogram (EKG). Bowel prep typically is not required. Provisions should be made to prevent deep venous thrombosis (DVT), usually by utilizing sequential compression devices, based on the individual patient’s risk factors.6,7
A prophylactic antibiotic to prevent surgical site infection (often a first-generation cephalosporin) should be given as a single intravenous (IV) dose prior to the incision.8 If bacterial vaginosis is present, treatment prior to surgery can reduce the frequency of vaginal cuff infection.9
Again, for the sake of this discussion, I will assume that malignancy has been ruled out.
Positioning and preparation
After induction of anesthesia, position the patient either in a dorsal supine (traditional) or lithotomy (yellow-fin stirrups) position and reexamine her to confirm the findings of the pelvic exam. If the patient is positioned in the supine position, use ankle straps to prevent her from moving as the Trendelenburg position advances during the procedure.
Prep the abdominal skin with a bactericidal agent (most often a povidone-iodine solution). Also prep the vagina with a povidone-iodine solution because the vaginal cuff will be opened during the TAH. Place a transurethral catheter to drain urine throughout the case. Use of a three-way catheter allows the bladder to be easily backfilled during the procedure for identification of its borders or assessment of its integrity.
Last, incorporate a surgical pause prior to the incision to confirm that you have the right patient, know the procedure and incision planned, and are aware of any allergies. Also confirm that antibiotics have been given.
Operative technique
Intraoperative principles
A planned approach avoids wasteful time and motion, and an adequate incision allows for sufficient exposure, which is critical but often underappreciated by the novice surgeon. We prefer a midline incision because it allows the most flexibility to adapt to intraoperative findings, but a Pfannenstiel incision also is an option.
Fixed retraction is paramount to “set up” exposure for the remainder of the case. We prefer a Balfour fixed retractor but, with smaller uteri, a self-retaining Alexis retractor (Applied Medical, Rancho Santa Margarita, California) affords decent exposure and may cause less postoperative abdominal wall discomfort; it also avoids the possibility of retractor-related neuropathy.
Moistened abdominal packing allows the bowel to be packed into the upper abdomen for the remainder of the case, which facilitates consistent exposure of the operative field. Adequate lighting is essential, as is one or more knowledgeable assistants.
Use sharp dissection throughout the procedure. Clean, sharp dissection averts injury to adjacent structures, such as the ureter, bladder, and rectum, and promotes recognition of any injuries, permitting immediate repair.
The application of proper traction and counter-traction on tissues allows accurate definition of the correct tissue planes and facilitates identification of important anatomic structures. Vital structures should be identified and, if necessary, mobilized before any clamps are placed or pedicles transected. Adhesions should be sharply lysed to facilitate exposure.
Freeing the bladder anteriorly and the rectum posteriorly prevents their inadvertent inclusion in closure of the vagina and minimizes the risk of fistula formation. The bladder and rectum should be sharply mobilized at least 1 cm beyond the site of planned vaginal transection.
Last, excellent support of the vaginal wall can be provided by securing the uterosacral-cardinal ligaments to the corners of the vaginal vault.
 |
| FIGURE 1: Place straight Kocher clamps to facilitate traction during the operation. |
 |
| FIGURE 2: Clamp and divide the right round ligament, opening the broad ligament. |
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| FIGURE 3: Identify the right ureter along the medial leaf of the broad ligament. |
Identifying the ureter
Once good exposure and adequate Trendelenburg position are achieved, place Kocher clamps across the cornual portion of the uterus (incorporating the round ligament, tube, and utero-ovarian pedicle) (FIGURE 1). This facilitates continuous traction and prevents back bleeding throughout the case.
With traction applied to the left, identify the right round ligament, clamp it with a Kocher clamp, and transect it. Incise the peritoneum parallel to the uterus and gonadal vessels (FIGURE 2). This opens the broad ligament and allows identification of the critical underlying structures (ureter, external and internal iliac vessels). Following the medial leaf of the broad ligament downward, identify the ureter by both visualization and palpation (FIGURE 3).
Although I do not discuss salpingo-oophorectomy in this article, be aware that the ureter is at risk when clamping the gonadal vessels near the pelvic brim.
Once the ureter is identified, create a window in the broad ligament above the ureter. In a medial to lateral fashion, place your index finger through that peritoneal window, making certain the ureter is below and out of the way. Place a Kocher clamp across the tube and utero-ovarian pedicle, and transect and suture-ligate the pedicle (preserving the tube and ovary). Repeat this procedure on the patient’s left side, using traction and counter-traction to facilitate exposure (FIGURE 4).
Mobilizing the bladder
With the assistant providing upward traction on the uterus, use Russian forceps to elevate the peritoneum overlying the bladder. Undermine and incise the peritoneum from the patient’s left to the right (FIGURE 5). Begin sharp dissection of the loose areolar tissue. By gently spreading the tissue using the tips of the scissors, and snipping the tissue in the midline, you allow the dissection to proceed down the lower uterine segment (FIGURE 6).
Any bleeding usually means you are too close to the bladder or have ventured too far laterally. If the patient has had a previous cesarean delivery, this area may be densely scarred. Often, it is easiest to dissect laterally around the scar on each side, where there is less dense scarring, and mobilize the tissue until the denser central scarring can be dissected. Note that the bladder attachment curves upward on each side and lateral to the cervix, over the lateral vagina and the uterine vessels.
It is absolutely critical to dissect and expose 1 or 2 cm of the entire anterior vaginal wall below the level of the cervix to be certain that the bladder has been fully mobilized and to prevent later incorporation into the vaginal cuff closure. The exact location of the cervix is best detected by placing a finger behind the uterus and using the thumb to compress the area of the anterior portion of the cervix under the bladder.
Fibroids can cause distortion of the anatomic planes we utilize. Be aware of the distortion and adjust your dissection accordingly. The structures of the urinary tract are most often affected; sharp dissection is necessary to mobilize the ureter and bladder in these cases. (See the case discussions)
 |  |
FIGURE 5: Upward traction on the peritoneum overlying the bladder facilitates development of the bladder flap off of the lower uterus. | FIGURE 6: Dissect the bladder off the lower uterus |
Large intramural or pedunculated myomas can be difficult surgical challenges. Broad-ligament myomas, however, are unique. Significant anatomic distortion can occur. Always consider the possibility of some degree of ureteral obstruction and be on the lookout for unrecognized bladder injury.
Case 1
This very large myoma essentially filled the pelvis but seems to arise from the left side of the uterus, distorting the anatomy. Note the attenuation of the round ligaments and the normal appearance of the tubes and ovaries (the left tube has a distal paratubal cyst.) Note also the bladder, particularly how sharp dissection will be required to mobilize it off the underlying mass.
To manage removal, at case outset, we placed bilateral external ureteral stents and used a lucite vaginal dilator to aid in respective ureter and vaginal apex identification. The bladder was attenuated over this large mass and was rather easily dissected, given the defined mass around it. The ureters were well lateral and inferior and readily identified with stent palpation. The cervix was certainly elongated and, after the uterine vessels were removed, the hysterectomy was completed without incident.
Surgical pearl: To extract very large masses during total abdominal hysterectomy, sometimes you have more “room” if the fixed retractor is removed. You can then use a series of handheld retractors (Deavor, Harrington, etc) on the side you are operating until the mass has been mobilized enough to place a fixed retractor.
CASE 2
 |  |
 |  |
This large cervical myoma is creating urinary urgency, frequency, and moderate obstruction of the right ureter. Sharp dissection is critical to mobilize the bladder well free of the myoma. We placed bilateral ureteral stents to start the case to aid in identification of the ureter.
The first illustration at right (top left) shows the operative appearance before the bladder flap was taken down. The second photo (top right) reveals the extent of this large myoma after the bladder has been sharply dissected free of the mass. The third photo (bottom left) displays the specimen sent to pathology (be sure to minimize the amount of vaginal tissue taken with the specimen). Note the distortion of the endocervical canal and cervix. The last photo (bottom right) reveals the sectioned specimen.
Surgical pearl: Use a three-way catheter and backfill the bladder for identification during the procedure and at the conclusion of the case to rule out bladder injury. A few drops of methylene blue added to the solution makes recognition easier.
Ligation of the uterine arteries
Apply cephalad traction to the uterus and place a Harrington retractor anteriorly to retract the bladder away from the cervix on the upper portion of the vagina. With the uterus pulled first to the left, palpate the right ureter between the thumb and index finger at the level of the uterine artery (FIGURE 7). Once you have determined the course of the ureter, place a Kocher clamp well down on the right side of the lower cervix at about a 45° angle, sliding off the side of the cervix (FIGURE 8). The clamp should now include the superior portion of the cardinal ligament with the uterine vessels and paracolpium immediately above the lateral vaginal fornix.
Transect the cardinal pedicle. Repeat the procedure on the left side after adjusting the Harrington retractor slightly to the left and identifying the course of the ureter where the Kocher clamp will be placed. Thus, a single Kocher clamp is placed on each side to control the blood supply.
It is paramount that you know the location of the ureter prior to placement and transection of the uterine vessels to prevent inadvertent injury or obstruction of the ureters.
Divide the uterine vessel–cardinal ligament complex close to the cervix (medial to the Kocher clamp), slightly undercutting the tip (FIGURE 9). This creates a fascial window, the anterior edge of which is the pubocervical fascia. This is subsequently developed and managed as a separate layer during the vaginal vault closure.
Repeat this procedure on the left side.
 |  |  |
| FIGURE 7: After mobilizing the bladder, palpate the right ureter prior to placement of a Kocher clamp on the cardinal vascular pedicle. | FIGURE 8: Place a single Kocher clamp on the right uterine vessels. See the right ureter well lateral of the clamp. | FIGURE 9: The right uterine vessels have been clamped and transected. The clamp is slightly undercut to allow access to the vaginal fornix. |
Preparing and opening the vaginal cuff
Develop the anterior pubocervical fascia by cutting with a scissors horizontally across the anterior vaginal wall at the level of the cervix (FIGURE 10). This layer of tissue will be utilized to close the vaginal cuff in a secondary layer later on. This technique will serve to close the pubocervical fascial ring at the vaginal vault and, with support of the uterosacral ligaments, provide support to the vaginal apex. At this point, the vagina has not yet been entered. The remaining tissue beneath the mobilized layer and the anterior cervix is the anterior vaginal wall.
Pull the uterus up and anterior toward the pubic symphysis to make the uterosacral ligaments prominent. Then transect the uterosacral ligaments close to the uterus (FIGURE 11). You may encounter minor bleeding, but there is no need to ligate the stumps at this point. Cut the tissue between the ligaments horizontally, similarly to the anterior dissection. With gentle finger dissection, as necessary, this should free the rectosigmoid colon from the posterior vaginal wall.
If this is a new technique for you, it may serve you well to place a stitch in each uterosacral ligament, below the spot where you will transect it, prior to cutting. When you have the uterus on tension, the ligaments are most recognizable, and these sutures can then be incorporated into the vaginal angles.
At this point there should be a circular area just beneath the cervix that is the vaginal wall at the apex of the vagina. Retract the uterus anteriorly and to the left, and enter the vagina posteriorly and laterally, just above the stump of the right uterosacral ligament (FIGURE 12). The uterus now can be removed by circumcising the vagina as close to the cervix as possible to avoid vaginal shortening. As the uterus is being removed, place four vulsellum tenacula successively at the 3, 12, 9, and 6 o’clock positions of the vaginal cuff as it is developed (FIGURE 13). Then swab povidone-iodine on the vaginal cuff and canal.
 |  |
| FIGURE 10: After mobilizing the bladder and securing the vascular pedicles, develop the anterior endopelvic fascia. It will be used as a second layer to close the vaginal cuff. | FIGURE 11: A. Transect the uterosacral ligaments. B. Mobilize the rectum posteriorly. |
 |  |
| FIGURE 12: Enter the right vaginal fornix and grasp it with a vulsellum tenaculum. | FIGURE 13: A. After entering the right vaginal fornix, extend the incision in a counter-clockwise fashion, preserving vaginal length. B. Placement of the tenaculum as the incision proceeds. |
Cuff closure
Place a lap salt sponge over the Kocher clamps to prevent suture entanglement. Use a 36-inch continuous 0-polyglactin suture to close the vaginal vault and achieve hemostasis. Begin suturing with a right vaginal angle stitch, placed so that the small vessels are ligated and the lateral supporting tissues from the base of the cardinal ligament are attached to the right vaginal angle. This closes the “window” that was created with slight undercutting of the cardinal ligament earlier. Continue suturing toward the left, with each bite placed submucosally so that the epithelial edges are approximated and inverted into the vagina. The suture does not enter the vagina (FIGURE 14). As you reach the left vaginal angle, obtain a healthy purchase of the left uterosacral ligament and then pass the needle laterally to the vaginal fornix angle, through the lateral supporting tissues at the base of the cardinal ligament, as was done on the right vaginal angle. Then lock the suture and return across the vaginal vault. This will plicate together the anterior and posterior pubocervical fascia layers developed earlier, creating a second layer, before closing the fascial ring at the vaginal apex. Incorporate the right uterosacral ligament into the right vaginal angle and tie the suture (FIGURES 15 AND 16).
Close the cuff and verify hemostasis. Use the lap salt sponge covering the Kocher clamps on the cardinal ligament pedicles to wipe the surgical field clean. Then use light cautery along the cuff and the base and back of the bladder. If there is some bleeding at the very corners of the vagina, it can usually be managed during suturing of the cardinal ligament pedicles into the corners of the vault.
Elevate the Kocher clamp containing the cardinal ligament and uterine vessels toward the midline. Then palpate the ureter between your index finger and thumb as it courses through the cardinal ligament toward the bladder. This step provides a second check on the location of the ureter (the first was when the clamp was originally placed) before the cardinal ligament is tied to the corner of the vault (FIGURE 17). The needle should enter the peritoneum, right uterosacral ligament, and full thickness of the right angle of the vagina just lateral to the suture used to close the vaginal apex. Bring the pedicle over the corner of the vagina and tie it close to the lateral aspect of the Kocher clamp, leaving an adequate stump. Then free-tie the stump of the cardinal ligament to add a double ligation of this vascular pedicle. Repeat this procedure on the opposite side (FIGURE 18). Then verify hemostasis throughout the operative field.
Take the patient out of Trendelenburg position and place her flat, and copiously irrigate the pelvis. Once needle and sponge counts are completed, close the abdomen in a layered fashion. Place a wound dressing and a Foley catheter, leaving the latter in place overnight.
 |  |
| FIGURE 14: A. Begin in the right vaginal corner, closing the area that was “undercut” (see FIGURE 10). B. Close the first layer in in a subcuticular manner. | FIGURE 15: The second layer of cuff closure utilizes the anterior and posterior endopelvic fascia and imbricates the first layer. |
 | |
FIGURE 16: Two-layer closure of the vaginal cuff. | |
 |  |
| FIGURE 17: Prior to suture ligation of the right uterine vessels, palpate the ureter again to identify its location. | FIGURE 18: Suture-ligate the uterine pedicles into the corners of the vaginal cuff. |
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Wu JM, Wechter ME, Geller EJ, et al. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110(5):1091–1095.
2. Falcone T, Walters MD. Hysterectomy for benign disease. Obstet Gynecol. 2008;111(3):753–767.
3. Unger JB, Paul R, Caldito G. Hysterectomy for the massive leiomyomatous uterus. Obstet Gynecol. 2002;100(6):1271–1275.
4. US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Published April 17, 2014. Accessed September 15, 2014.
5. Webb MJ. Mayo Clinic Manual of Pelvic Surgery. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:55–72.
6. Committee on Practice Bulletins–Gynecology, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 84. Prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007;110(2 pt 1):429–440.
7. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e227S–e277S.
8. Committee on Practice Bulletins, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 74. Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2006;108(1):225–234.
9. Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133–140.
John B. Gebhart, MD, MS
Dr. Gebhart is Associate Professor of Obstetrics and Gynecology at the Mayo Clinic in Rochester, Minnesota.
The author reports no financial relationships relevant to this article.
John B. Gebhart, MD, MS
Dr. Gebhart is Associate Professor of Obstetrics and Gynecology at the Mayo Clinic in Rochester, Minnesota.
The author reports no financial relationships relevant to this article.
John B. Gebhart, MD, MS
Dr. Gebhart is Associate Professor of Obstetrics and Gynecology at the Mayo Clinic in Rochester, Minnesota.
The author reports no financial relationships relevant to this article.
The abdominal approach to hysterectomy remains the most common route to hysterectomy in the United States. Its greatest advantage: It allows the uterus to be removed intact.1–3
The recent US Food and Drug Administration (FDA) warning against the use of power morcellation in women with known or suspected uterine malignancy has left many gynecologic surgeons wondering what might be the optimal approach to the removal of a large uterus.4
Although most hysterectomies are performed for benign conditions—namely, uterine fibroids—malignancy should be considered in the differential diagnosis. When hysterectomy is performed laparoscopically, a large uterus must be morcellated intraperitoneally. Since the FDA safety communication was issued, some hospitals have imposed a moratorium on the use of power morcellators for removal of uterine tissue until more definitive evidence is put forth regarding safety and best practices. This chain of events allows us an opportunity to review the basics of abdominal hysterectomy.
For the sake of this discussion, I will assume that the hysterectomy is being performed for a benign indication as I highlight the Mayo Clinic approach to total abdominal hysterectomy (TAH).5
Preoperative considerations
The patient should be medically able to undergo operative intervention. If she has preexisting medical conditions, preoperative clearance should be obtained from her primary care provider, and her medical conditions should be optimized prior to surgical intervention.
Baseline laboratory studies include a complete blood count, electrolyte panel, glucose assessment, and an electrocardiogram (EKG). Bowel prep typically is not required. Provisions should be made to prevent deep venous thrombosis (DVT), usually by utilizing sequential compression devices, based on the individual patient’s risk factors.6,7
A prophylactic antibiotic to prevent surgical site infection (often a first-generation cephalosporin) should be given as a single intravenous (IV) dose prior to the incision.8 If bacterial vaginosis is present, treatment prior to surgery can reduce the frequency of vaginal cuff infection.9
Again, for the sake of this discussion, I will assume that malignancy has been ruled out.
Positioning and preparation
After induction of anesthesia, position the patient either in a dorsal supine (traditional) or lithotomy (yellow-fin stirrups) position and reexamine her to confirm the findings of the pelvic exam. If the patient is positioned in the supine position, use ankle straps to prevent her from moving as the Trendelenburg position advances during the procedure.
Prep the abdominal skin with a bactericidal agent (most often a povidone-iodine solution). Also prep the vagina with a povidone-iodine solution because the vaginal cuff will be opened during the TAH. Place a transurethral catheter to drain urine throughout the case. Use of a three-way catheter allows the bladder to be easily backfilled during the procedure for identification of its borders or assessment of its integrity.
Last, incorporate a surgical pause prior to the incision to confirm that you have the right patient, know the procedure and incision planned, and are aware of any allergies. Also confirm that antibiotics have been given.
Operative technique
Intraoperative principles
A planned approach avoids wasteful time and motion, and an adequate incision allows for sufficient exposure, which is critical but often underappreciated by the novice surgeon. We prefer a midline incision because it allows the most flexibility to adapt to intraoperative findings, but a Pfannenstiel incision also is an option.
Fixed retraction is paramount to “set up” exposure for the remainder of the case. We prefer a Balfour fixed retractor but, with smaller uteri, a self-retaining Alexis retractor (Applied Medical, Rancho Santa Margarita, California) affords decent exposure and may cause less postoperative abdominal wall discomfort; it also avoids the possibility of retractor-related neuropathy.
Moistened abdominal packing allows the bowel to be packed into the upper abdomen for the remainder of the case, which facilitates consistent exposure of the operative field. Adequate lighting is essential, as is one or more knowledgeable assistants.
Use sharp dissection throughout the procedure. Clean, sharp dissection averts injury to adjacent structures, such as the ureter, bladder, and rectum, and promotes recognition of any injuries, permitting immediate repair.
The application of proper traction and counter-traction on tissues allows accurate definition of the correct tissue planes and facilitates identification of important anatomic structures. Vital structures should be identified and, if necessary, mobilized before any clamps are placed or pedicles transected. Adhesions should be sharply lysed to facilitate exposure.
Freeing the bladder anteriorly and the rectum posteriorly prevents their inadvertent inclusion in closure of the vagina and minimizes the risk of fistula formation. The bladder and rectum should be sharply mobilized at least 1 cm beyond the site of planned vaginal transection.
Last, excellent support of the vaginal wall can be provided by securing the uterosacral-cardinal ligaments to the corners of the vaginal vault.
|
| FIGURE 1: Place straight Kocher clamps to facilitate traction during the operation. |
|
| FIGURE 2: Clamp and divide the right round ligament, opening the broad ligament. |
|
| FIGURE 3: Identify the right ureter along the medial leaf of the broad ligament. |
Identifying the ureter
Once good exposure and adequate Trendelenburg position are achieved, place Kocher clamps across the cornual portion of the uterus (incorporating the round ligament, tube, and utero-ovarian pedicle) (FIGURE 1). This facilitates continuous traction and prevents back bleeding throughout the case.
With traction applied to the left, identify the right round ligament, clamp it with a Kocher clamp, and transect it. Incise the peritoneum parallel to the uterus and gonadal vessels (FIGURE 2). This opens the broad ligament and allows identification of the critical underlying structures (ureter, external and internal iliac vessels). Following the medial leaf of the broad ligament downward, identify the ureter by both visualization and palpation (FIGURE 3).
Although I do not discuss salpingo-oophorectomy in this article, be aware that the ureter is at risk when clamping the gonadal vessels near the pelvic brim.
Once the ureter is identified, create a window in the broad ligament above the ureter. In a medial to lateral fashion, place your index finger through that peritoneal window, making certain the ureter is below and out of the way. Place a Kocher clamp across the tube and utero-ovarian pedicle, and transect and suture-ligate the pedicle (preserving the tube and ovary). Repeat this procedure on the patient’s left side, using traction and counter-traction to facilitate exposure (FIGURE 4).
Mobilizing the bladder
With the assistant providing upward traction on the uterus, use Russian forceps to elevate the peritoneum overlying the bladder. Undermine and incise the peritoneum from the patient’s left to the right (FIGURE 5). Begin sharp dissection of the loose areolar tissue. By gently spreading the tissue using the tips of the scissors, and snipping the tissue in the midline, you allow the dissection to proceed down the lower uterine segment (FIGURE 6).
Any bleeding usually means you are too close to the bladder or have ventured too far laterally. If the patient has had a previous cesarean delivery, this area may be densely scarred. Often, it is easiest to dissect laterally around the scar on each side, where there is less dense scarring, and mobilize the tissue until the denser central scarring can be dissected. Note that the bladder attachment curves upward on each side and lateral to the cervix, over the lateral vagina and the uterine vessels.
It is absolutely critical to dissect and expose 1 or 2 cm of the entire anterior vaginal wall below the level of the cervix to be certain that the bladder has been fully mobilized and to prevent later incorporation into the vaginal cuff closure. The exact location of the cervix is best detected by placing a finger behind the uterus and using the thumb to compress the area of the anterior portion of the cervix under the bladder.
Fibroids can cause distortion of the anatomic planes we utilize. Be aware of the distortion and adjust your dissection accordingly. The structures of the urinary tract are most often affected; sharp dissection is necessary to mobilize the ureter and bladder in these cases. (See the case discussions)
| |
FIGURE 5: Upward traction on the peritoneum overlying the bladder facilitates development of the bladder flap off of the lower uterus. | FIGURE 6: Dissect the bladder off the lower uterus |
Large intramural or pedunculated myomas can be difficult surgical challenges. Broad-ligament myomas, however, are unique. Significant anatomic distortion can occur. Always consider the possibility of some degree of ureteral obstruction and be on the lookout for unrecognized bladder injury.
Case 1
This very large myoma essentially filled the pelvis but seems to arise from the left side of the uterus, distorting the anatomy. Note the attenuation of the round ligaments and the normal appearance of the tubes and ovaries (the left tube has a distal paratubal cyst.) Note also the bladder, particularly how sharp dissection will be required to mobilize it off the underlying mass.
To manage removal, at case outset, we placed bilateral external ureteral stents and used a lucite vaginal dilator to aid in respective ureter and vaginal apex identification. The bladder was attenuated over this large mass and was rather easily dissected, given the defined mass around it. The ureters were well lateral and inferior and readily identified with stent palpation. The cervix was certainly elongated and, after the uterine vessels were removed, the hysterectomy was completed without incident.
Surgical pearl: To extract very large masses during total abdominal hysterectomy, sometimes you have more “room” if the fixed retractor is removed. You can then use a series of handheld retractors (Deavor, Harrington, etc) on the side you are operating until the mass has been mobilized enough to place a fixed retractor.
CASE 2
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| |
This large cervical myoma is creating urinary urgency, frequency, and moderate obstruction of the right ureter. Sharp dissection is critical to mobilize the bladder well free of the myoma. We placed bilateral ureteral stents to start the case to aid in identification of the ureter.
The first illustration at right (top left) shows the operative appearance before the bladder flap was taken down. The second photo (top right) reveals the extent of this large myoma after the bladder has been sharply dissected free of the mass. The third photo (bottom left) displays the specimen sent to pathology (be sure to minimize the amount of vaginal tissue taken with the specimen). Note the distortion of the endocervical canal and cervix. The last photo (bottom right) reveals the sectioned specimen.
Surgical pearl: Use a three-way catheter and backfill the bladder for identification during the procedure and at the conclusion of the case to rule out bladder injury. A few drops of methylene blue added to the solution makes recognition easier.
Ligation of the uterine arteries
Apply cephalad traction to the uterus and place a Harrington retractor anteriorly to retract the bladder away from the cervix on the upper portion of the vagina. With the uterus pulled first to the left, palpate the right ureter between the thumb and index finger at the level of the uterine artery (FIGURE 7). Once you have determined the course of the ureter, place a Kocher clamp well down on the right side of the lower cervix at about a 45° angle, sliding off the side of the cervix (FIGURE 8). The clamp should now include the superior portion of the cardinal ligament with the uterine vessels and paracolpium immediately above the lateral vaginal fornix.
Transect the cardinal pedicle. Repeat the procedure on the left side after adjusting the Harrington retractor slightly to the left and identifying the course of the ureter where the Kocher clamp will be placed. Thus, a single Kocher clamp is placed on each side to control the blood supply.
It is paramount that you know the location of the ureter prior to placement and transection of the uterine vessels to prevent inadvertent injury or obstruction of the ureters.
Divide the uterine vessel–cardinal ligament complex close to the cervix (medial to the Kocher clamp), slightly undercutting the tip (FIGURE 9). This creates a fascial window, the anterior edge of which is the pubocervical fascia. This is subsequently developed and managed as a separate layer during the vaginal vault closure.
Repeat this procedure on the left side.
| | |
| FIGURE 7: After mobilizing the bladder, palpate the right ureter prior to placement of a Kocher clamp on the cardinal vascular pedicle. | FIGURE 8: Place a single Kocher clamp on the right uterine vessels. See the right ureter well lateral of the clamp. | FIGURE 9: The right uterine vessels have been clamped and transected. The clamp is slightly undercut to allow access to the vaginal fornix. |
Preparing and opening the vaginal cuff
Develop the anterior pubocervical fascia by cutting with a scissors horizontally across the anterior vaginal wall at the level of the cervix (FIGURE 10). This layer of tissue will be utilized to close the vaginal cuff in a secondary layer later on. This technique will serve to close the pubocervical fascial ring at the vaginal vault and, with support of the uterosacral ligaments, provide support to the vaginal apex. At this point, the vagina has not yet been entered. The remaining tissue beneath the mobilized layer and the anterior cervix is the anterior vaginal wall.
Pull the uterus up and anterior toward the pubic symphysis to make the uterosacral ligaments prominent. Then transect the uterosacral ligaments close to the uterus (FIGURE 11). You may encounter minor bleeding, but there is no need to ligate the stumps at this point. Cut the tissue between the ligaments horizontally, similarly to the anterior dissection. With gentle finger dissection, as necessary, this should free the rectosigmoid colon from the posterior vaginal wall.
If this is a new technique for you, it may serve you well to place a stitch in each uterosacral ligament, below the spot where you will transect it, prior to cutting. When you have the uterus on tension, the ligaments are most recognizable, and these sutures can then be incorporated into the vaginal angles.
At this point there should be a circular area just beneath the cervix that is the vaginal wall at the apex of the vagina. Retract the uterus anteriorly and to the left, and enter the vagina posteriorly and laterally, just above the stump of the right uterosacral ligament (FIGURE 12). The uterus now can be removed by circumcising the vagina as close to the cervix as possible to avoid vaginal shortening. As the uterus is being removed, place four vulsellum tenacula successively at the 3, 12, 9, and 6 o’clock positions of the vaginal cuff as it is developed (FIGURE 13). Then swab povidone-iodine on the vaginal cuff and canal.
| |
| FIGURE 10: After mobilizing the bladder and securing the vascular pedicles, develop the anterior endopelvic fascia. It will be used as a second layer to close the vaginal cuff. | FIGURE 11: A. Transect the uterosacral ligaments. B. Mobilize the rectum posteriorly. |
| |
| FIGURE 12: Enter the right vaginal fornix and grasp it with a vulsellum tenaculum. | FIGURE 13: A. After entering the right vaginal fornix, extend the incision in a counter-clockwise fashion, preserving vaginal length. B. Placement of the tenaculum as the incision proceeds. |
Cuff closure
Place a lap salt sponge over the Kocher clamps to prevent suture entanglement. Use a 36-inch continuous 0-polyglactin suture to close the vaginal vault and achieve hemostasis. Begin suturing with a right vaginal angle stitch, placed so that the small vessels are ligated and the lateral supporting tissues from the base of the cardinal ligament are attached to the right vaginal angle. This closes the “window” that was created with slight undercutting of the cardinal ligament earlier. Continue suturing toward the left, with each bite placed submucosally so that the epithelial edges are approximated and inverted into the vagina. The suture does not enter the vagina (FIGURE 14). As you reach the left vaginal angle, obtain a healthy purchase of the left uterosacral ligament and then pass the needle laterally to the vaginal fornix angle, through the lateral supporting tissues at the base of the cardinal ligament, as was done on the right vaginal angle. Then lock the suture and return across the vaginal vault. This will plicate together the anterior and posterior pubocervical fascia layers developed earlier, creating a second layer, before closing the fascial ring at the vaginal apex. Incorporate the right uterosacral ligament into the right vaginal angle and tie the suture (FIGURES 15 AND 16).
Close the cuff and verify hemostasis. Use the lap salt sponge covering the Kocher clamps on the cardinal ligament pedicles to wipe the surgical field clean. Then use light cautery along the cuff and the base and back of the bladder. If there is some bleeding at the very corners of the vagina, it can usually be managed during suturing of the cardinal ligament pedicles into the corners of the vault.
Elevate the Kocher clamp containing the cardinal ligament and uterine vessels toward the midline. Then palpate the ureter between your index finger and thumb as it courses through the cardinal ligament toward the bladder. This step provides a second check on the location of the ureter (the first was when the clamp was originally placed) before the cardinal ligament is tied to the corner of the vault (FIGURE 17). The needle should enter the peritoneum, right uterosacral ligament, and full thickness of the right angle of the vagina just lateral to the suture used to close the vaginal apex. Bring the pedicle over the corner of the vagina and tie it close to the lateral aspect of the Kocher clamp, leaving an adequate stump. Then free-tie the stump of the cardinal ligament to add a double ligation of this vascular pedicle. Repeat this procedure on the opposite side (FIGURE 18). Then verify hemostasis throughout the operative field.
Take the patient out of Trendelenburg position and place her flat, and copiously irrigate the pelvis. Once needle and sponge counts are completed, close the abdomen in a layered fashion. Place a wound dressing and a Foley catheter, leaving the latter in place overnight.
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| FIGURE 14: A. Begin in the right vaginal corner, closing the area that was “undercut” (see FIGURE 10). B. Close the first layer in in a subcuticular manner. | FIGURE 15: The second layer of cuff closure utilizes the anterior and posterior endopelvic fascia and imbricates the first layer. |
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FIGURE 16: Two-layer closure of the vaginal cuff. | |
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| FIGURE 17: Prior to suture ligation of the right uterine vessels, palpate the ureter again to identify its location. | FIGURE 18: Suture-ligate the uterine pedicles into the corners of the vaginal cuff. |
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The abdominal approach to hysterectomy remains the most common route to hysterectomy in the United States. Its greatest advantage: It allows the uterus to be removed intact.1–3
The recent US Food and Drug Administration (FDA) warning against the use of power morcellation in women with known or suspected uterine malignancy has left many gynecologic surgeons wondering what might be the optimal approach to the removal of a large uterus.4
Although most hysterectomies are performed for benign conditions—namely, uterine fibroids—malignancy should be considered in the differential diagnosis. When hysterectomy is performed laparoscopically, a large uterus must be morcellated intraperitoneally. Since the FDA safety communication was issued, some hospitals have imposed a moratorium on the use of power morcellators for removal of uterine tissue until more definitive evidence is put forth regarding safety and best practices. This chain of events allows us an opportunity to review the basics of abdominal hysterectomy.
For the sake of this discussion, I will assume that the hysterectomy is being performed for a benign indication as I highlight the Mayo Clinic approach to total abdominal hysterectomy (TAH).5
Preoperative considerations
The patient should be medically able to undergo operative intervention. If she has preexisting medical conditions, preoperative clearance should be obtained from her primary care provider, and her medical conditions should be optimized prior to surgical intervention.
Baseline laboratory studies include a complete blood count, electrolyte panel, glucose assessment, and an electrocardiogram (EKG). Bowel prep typically is not required. Provisions should be made to prevent deep venous thrombosis (DVT), usually by utilizing sequential compression devices, based on the individual patient’s risk factors.6,7
A prophylactic antibiotic to prevent surgical site infection (often a first-generation cephalosporin) should be given as a single intravenous (IV) dose prior to the incision.8 If bacterial vaginosis is present, treatment prior to surgery can reduce the frequency of vaginal cuff infection.9
Again, for the sake of this discussion, I will assume that malignancy has been ruled out.
Positioning and preparation
After induction of anesthesia, position the patient either in a dorsal supine (traditional) or lithotomy (yellow-fin stirrups) position and reexamine her to confirm the findings of the pelvic exam. If the patient is positioned in the supine position, use ankle straps to prevent her from moving as the Trendelenburg position advances during the procedure.
Prep the abdominal skin with a bactericidal agent (most often a povidone-iodine solution). Also prep the vagina with a povidone-iodine solution because the vaginal cuff will be opened during the TAH. Place a transurethral catheter to drain urine throughout the case. Use of a three-way catheter allows the bladder to be easily backfilled during the procedure for identification of its borders or assessment of its integrity.
Last, incorporate a surgical pause prior to the incision to confirm that you have the right patient, know the procedure and incision planned, and are aware of any allergies. Also confirm that antibiotics have been given.
Operative technique
Intraoperative principles
A planned approach avoids wasteful time and motion, and an adequate incision allows for sufficient exposure, which is critical but often underappreciated by the novice surgeon. We prefer a midline incision because it allows the most flexibility to adapt to intraoperative findings, but a Pfannenstiel incision also is an option.
Fixed retraction is paramount to “set up” exposure for the remainder of the case. We prefer a Balfour fixed retractor but, with smaller uteri, a self-retaining Alexis retractor (Applied Medical, Rancho Santa Margarita, California) affords decent exposure and may cause less postoperative abdominal wall discomfort; it also avoids the possibility of retractor-related neuropathy.
Moistened abdominal packing allows the bowel to be packed into the upper abdomen for the remainder of the case, which facilitates consistent exposure of the operative field. Adequate lighting is essential, as is one or more knowledgeable assistants.
Use sharp dissection throughout the procedure. Clean, sharp dissection averts injury to adjacent structures, such as the ureter, bladder, and rectum, and promotes recognition of any injuries, permitting immediate repair.
The application of proper traction and counter-traction on tissues allows accurate definition of the correct tissue planes and facilitates identification of important anatomic structures. Vital structures should be identified and, if necessary, mobilized before any clamps are placed or pedicles transected. Adhesions should be sharply lysed to facilitate exposure.
Freeing the bladder anteriorly and the rectum posteriorly prevents their inadvertent inclusion in closure of the vagina and minimizes the risk of fistula formation. The bladder and rectum should be sharply mobilized at least 1 cm beyond the site of planned vaginal transection.
Last, excellent support of the vaginal wall can be provided by securing the uterosacral-cardinal ligaments to the corners of the vaginal vault.
|
| FIGURE 1: Place straight Kocher clamps to facilitate traction during the operation. |
|
| FIGURE 2: Clamp and divide the right round ligament, opening the broad ligament. |
|
| FIGURE 3: Identify the right ureter along the medial leaf of the broad ligament. |
Identifying the ureter
Once good exposure and adequate Trendelenburg position are achieved, place Kocher clamps across the cornual portion of the uterus (incorporating the round ligament, tube, and utero-ovarian pedicle) (FIGURE 1). This facilitates continuous traction and prevents back bleeding throughout the case.
With traction applied to the left, identify the right round ligament, clamp it with a Kocher clamp, and transect it. Incise the peritoneum parallel to the uterus and gonadal vessels (FIGURE 2). This opens the broad ligament and allows identification of the critical underlying structures (ureter, external and internal iliac vessels). Following the medial leaf of the broad ligament downward, identify the ureter by both visualization and palpation (FIGURE 3).
Although I do not discuss salpingo-oophorectomy in this article, be aware that the ureter is at risk when clamping the gonadal vessels near the pelvic brim.
Once the ureter is identified, create a window in the broad ligament above the ureter. In a medial to lateral fashion, place your index finger through that peritoneal window, making certain the ureter is below and out of the way. Place a Kocher clamp across the tube and utero-ovarian pedicle, and transect and suture-ligate the pedicle (preserving the tube and ovary). Repeat this procedure on the patient’s left side, using traction and counter-traction to facilitate exposure (FIGURE 4).
Mobilizing the bladder
With the assistant providing upward traction on the uterus, use Russian forceps to elevate the peritoneum overlying the bladder. Undermine and incise the peritoneum from the patient’s left to the right (FIGURE 5). Begin sharp dissection of the loose areolar tissue. By gently spreading the tissue using the tips of the scissors, and snipping the tissue in the midline, you allow the dissection to proceed down the lower uterine segment (FIGURE 6).
Any bleeding usually means you are too close to the bladder or have ventured too far laterally. If the patient has had a previous cesarean delivery, this area may be densely scarred. Often, it is easiest to dissect laterally around the scar on each side, where there is less dense scarring, and mobilize the tissue until the denser central scarring can be dissected. Note that the bladder attachment curves upward on each side and lateral to the cervix, over the lateral vagina and the uterine vessels.
It is absolutely critical to dissect and expose 1 or 2 cm of the entire anterior vaginal wall below the level of the cervix to be certain that the bladder has been fully mobilized and to prevent later incorporation into the vaginal cuff closure. The exact location of the cervix is best detected by placing a finger behind the uterus and using the thumb to compress the area of the anterior portion of the cervix under the bladder.
Fibroids can cause distortion of the anatomic planes we utilize. Be aware of the distortion and adjust your dissection accordingly. The structures of the urinary tract are most often affected; sharp dissection is necessary to mobilize the ureter and bladder in these cases. (See the case discussions)
| |
FIGURE 5: Upward traction on the peritoneum overlying the bladder facilitates development of the bladder flap off of the lower uterus. | FIGURE 6: Dissect the bladder off the lower uterus |
Large intramural or pedunculated myomas can be difficult surgical challenges. Broad-ligament myomas, however, are unique. Significant anatomic distortion can occur. Always consider the possibility of some degree of ureteral obstruction and be on the lookout for unrecognized bladder injury.
Case 1
This very large myoma essentially filled the pelvis but seems to arise from the left side of the uterus, distorting the anatomy. Note the attenuation of the round ligaments and the normal appearance of the tubes and ovaries (the left tube has a distal paratubal cyst.) Note also the bladder, particularly how sharp dissection will be required to mobilize it off the underlying mass.
To manage removal, at case outset, we placed bilateral external ureteral stents and used a lucite vaginal dilator to aid in respective ureter and vaginal apex identification. The bladder was attenuated over this large mass and was rather easily dissected, given the defined mass around it. The ureters were well lateral and inferior and readily identified with stent palpation. The cervix was certainly elongated and, after the uterine vessels were removed, the hysterectomy was completed without incident.
Surgical pearl: To extract very large masses during total abdominal hysterectomy, sometimes you have more “room” if the fixed retractor is removed. You can then use a series of handheld retractors (Deavor, Harrington, etc) on the side you are operating until the mass has been mobilized enough to place a fixed retractor.
CASE 2
| |
| |
This large cervical myoma is creating urinary urgency, frequency, and moderate obstruction of the right ureter. Sharp dissection is critical to mobilize the bladder well free of the myoma. We placed bilateral ureteral stents to start the case to aid in identification of the ureter.
The first illustration at right (top left) shows the operative appearance before the bladder flap was taken down. The second photo (top right) reveals the extent of this large myoma after the bladder has been sharply dissected free of the mass. The third photo (bottom left) displays the specimen sent to pathology (be sure to minimize the amount of vaginal tissue taken with the specimen). Note the distortion of the endocervical canal and cervix. The last photo (bottom right) reveals the sectioned specimen.
Surgical pearl: Use a three-way catheter and backfill the bladder for identification during the procedure and at the conclusion of the case to rule out bladder injury. A few drops of methylene blue added to the solution makes recognition easier.
Ligation of the uterine arteries
Apply cephalad traction to the uterus and place a Harrington retractor anteriorly to retract the bladder away from the cervix on the upper portion of the vagina. With the uterus pulled first to the left, palpate the right ureter between the thumb and index finger at the level of the uterine artery (FIGURE 7). Once you have determined the course of the ureter, place a Kocher clamp well down on the right side of the lower cervix at about a 45° angle, sliding off the side of the cervix (FIGURE 8). The clamp should now include the superior portion of the cardinal ligament with the uterine vessels and paracolpium immediately above the lateral vaginal fornix.
Transect the cardinal pedicle. Repeat the procedure on the left side after adjusting the Harrington retractor slightly to the left and identifying the course of the ureter where the Kocher clamp will be placed. Thus, a single Kocher clamp is placed on each side to control the blood supply.
It is paramount that you know the location of the ureter prior to placement and transection of the uterine vessels to prevent inadvertent injury or obstruction of the ureters.
Divide the uterine vessel–cardinal ligament complex close to the cervix (medial to the Kocher clamp), slightly undercutting the tip (FIGURE 9). This creates a fascial window, the anterior edge of which is the pubocervical fascia. This is subsequently developed and managed as a separate layer during the vaginal vault closure.
Repeat this procedure on the left side.
| | |
| FIGURE 7: After mobilizing the bladder, palpate the right ureter prior to placement of a Kocher clamp on the cardinal vascular pedicle. | FIGURE 8: Place a single Kocher clamp on the right uterine vessels. See the right ureter well lateral of the clamp. | FIGURE 9: The right uterine vessels have been clamped and transected. The clamp is slightly undercut to allow access to the vaginal fornix. |
Preparing and opening the vaginal cuff
Develop the anterior pubocervical fascia by cutting with a scissors horizontally across the anterior vaginal wall at the level of the cervix (FIGURE 10). This layer of tissue will be utilized to close the vaginal cuff in a secondary layer later on. This technique will serve to close the pubocervical fascial ring at the vaginal vault and, with support of the uterosacral ligaments, provide support to the vaginal apex. At this point, the vagina has not yet been entered. The remaining tissue beneath the mobilized layer and the anterior cervix is the anterior vaginal wall.
Pull the uterus up and anterior toward the pubic symphysis to make the uterosacral ligaments prominent. Then transect the uterosacral ligaments close to the uterus (FIGURE 11). You may encounter minor bleeding, but there is no need to ligate the stumps at this point. Cut the tissue between the ligaments horizontally, similarly to the anterior dissection. With gentle finger dissection, as necessary, this should free the rectosigmoid colon from the posterior vaginal wall.
If this is a new technique for you, it may serve you well to place a stitch in each uterosacral ligament, below the spot where you will transect it, prior to cutting. When you have the uterus on tension, the ligaments are most recognizable, and these sutures can then be incorporated into the vaginal angles.
At this point there should be a circular area just beneath the cervix that is the vaginal wall at the apex of the vagina. Retract the uterus anteriorly and to the left, and enter the vagina posteriorly and laterally, just above the stump of the right uterosacral ligament (FIGURE 12). The uterus now can be removed by circumcising the vagina as close to the cervix as possible to avoid vaginal shortening. As the uterus is being removed, place four vulsellum tenacula successively at the 3, 12, 9, and 6 o’clock positions of the vaginal cuff as it is developed (FIGURE 13). Then swab povidone-iodine on the vaginal cuff and canal.
| |
| FIGURE 10: After mobilizing the bladder and securing the vascular pedicles, develop the anterior endopelvic fascia. It will be used as a second layer to close the vaginal cuff. | FIGURE 11: A. Transect the uterosacral ligaments. B. Mobilize the rectum posteriorly. |
| |
| FIGURE 12: Enter the right vaginal fornix and grasp it with a vulsellum tenaculum. | FIGURE 13: A. After entering the right vaginal fornix, extend the incision in a counter-clockwise fashion, preserving vaginal length. B. Placement of the tenaculum as the incision proceeds. |
Cuff closure
Place a lap salt sponge over the Kocher clamps to prevent suture entanglement. Use a 36-inch continuous 0-polyglactin suture to close the vaginal vault and achieve hemostasis. Begin suturing with a right vaginal angle stitch, placed so that the small vessels are ligated and the lateral supporting tissues from the base of the cardinal ligament are attached to the right vaginal angle. This closes the “window” that was created with slight undercutting of the cardinal ligament earlier. Continue suturing toward the left, with each bite placed submucosally so that the epithelial edges are approximated and inverted into the vagina. The suture does not enter the vagina (FIGURE 14). As you reach the left vaginal angle, obtain a healthy purchase of the left uterosacral ligament and then pass the needle laterally to the vaginal fornix angle, through the lateral supporting tissues at the base of the cardinal ligament, as was done on the right vaginal angle. Then lock the suture and return across the vaginal vault. This will plicate together the anterior and posterior pubocervical fascia layers developed earlier, creating a second layer, before closing the fascial ring at the vaginal apex. Incorporate the right uterosacral ligament into the right vaginal angle and tie the suture (FIGURES 15 AND 16).
Close the cuff and verify hemostasis. Use the lap salt sponge covering the Kocher clamps on the cardinal ligament pedicles to wipe the surgical field clean. Then use light cautery along the cuff and the base and back of the bladder. If there is some bleeding at the very corners of the vagina, it can usually be managed during suturing of the cardinal ligament pedicles into the corners of the vault.
Elevate the Kocher clamp containing the cardinal ligament and uterine vessels toward the midline. Then palpate the ureter between your index finger and thumb as it courses through the cardinal ligament toward the bladder. This step provides a second check on the location of the ureter (the first was when the clamp was originally placed) before the cardinal ligament is tied to the corner of the vault (FIGURE 17). The needle should enter the peritoneum, right uterosacral ligament, and full thickness of the right angle of the vagina just lateral to the suture used to close the vaginal apex. Bring the pedicle over the corner of the vagina and tie it close to the lateral aspect of the Kocher clamp, leaving an adequate stump. Then free-tie the stump of the cardinal ligament to add a double ligation of this vascular pedicle. Repeat this procedure on the opposite side (FIGURE 18). Then verify hemostasis throughout the operative field.
Take the patient out of Trendelenburg position and place her flat, and copiously irrigate the pelvis. Once needle and sponge counts are completed, close the abdomen in a layered fashion. Place a wound dressing and a Foley catheter, leaving the latter in place overnight.
| |
| FIGURE 14: A. Begin in the right vaginal corner, closing the area that was “undercut” (see FIGURE 10). B. Close the first layer in in a subcuticular manner. | FIGURE 15: The second layer of cuff closure utilizes the anterior and posterior endopelvic fascia and imbricates the first layer. |
| |
FIGURE 16: Two-layer closure of the vaginal cuff. | |
| |
| FIGURE 17: Prior to suture ligation of the right uterine vessels, palpate the ureter again to identify its location. | FIGURE 18: Suture-ligate the uterine pedicles into the corners of the vaginal cuff. |
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
1. Wu JM, Wechter ME, Geller EJ, et al. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110(5):1091–1095.
2. Falcone T, Walters MD. Hysterectomy for benign disease. Obstet Gynecol. 2008;111(3):753–767.
3. Unger JB, Paul R, Caldito G. Hysterectomy for the massive leiomyomatous uterus. Obstet Gynecol. 2002;100(6):1271–1275.
4. US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Published April 17, 2014. Accessed September 15, 2014.
5. Webb MJ. Mayo Clinic Manual of Pelvic Surgery. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:55–72.
6. Committee on Practice Bulletins–Gynecology, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 84. Prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007;110(2 pt 1):429–440.
7. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e227S–e277S.
8. Committee on Practice Bulletins, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 74. Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2006;108(1):225–234.
9. Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133–140.
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5. Webb MJ. Mayo Clinic Manual of Pelvic Surgery. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:55–72.
6. Committee on Practice Bulletins–Gynecology, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 84. Prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol. 2007;110(2 pt 1):429–440.
7. Gould MK, Garcia DA, Wren SM, et al. Prevention of VTE in nonorthopedic surgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e227S–e277S.
8. Committee on Practice Bulletins, American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 74. Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2006;108(1):225–234.
9. Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133–140.
