Surgeries for cervical intraepithelial neoplasia (CIN) have been linked to preterm birth, low birth weight, and pregnancy loss, among other adverse effects. But the mechanisms have not been entirely explained. Are the outcomes due to the surgery, the immunologic factors, or the risk factors associated with CIN?

Related: PAP Test/HPV Co-test: Quality Improvement Initiative to Identify Approaches for Integrative Clinical Care Management

The greater risk of pregnancy problems derives primarily from the treatment not from characteristics of human papillomavirus or CIN, say researchers from Kaiser Permanente Northwest, Duke University, and GlaxoSmithKline. They compared 322 women who had undergone excisional and ablative cervical surgery with 4,307 women who had not and with 847 women who had undergone only diagnostic procedures.

Of the treated women, 163 had a live birth within 1 year of treatment. Women who had undergone thick excisional cervical surgical procedures ( ≥ 1.0 cm) had approximately double the risk of preterm birth and low-birth-weight infants compared with that of the other 2 groups. The risk was higher if the baby was born within 1 year of surgery.  The risk of cesarean delivery rose 20% with excisional surgery. The treated women did not have a substantially higher risk of dysfunctional labor.

Related: More Evidence of HPV’s Role in Cancer

Among the women who had cervical surgery, 21% lost the pregnancy (25% of those with ablative and 19% of those with excisional surgery). By contrast, 18% of the unexposed women and 20% of the diagnostic-only group experienced pregnancy loss. The researchers say the positive association between pregnancy loss and ablative surgical treatment has not been previously reported. “These findings suggest that efforts to minimize excision thickness in cervical surgeries are prudent,” the researchers advise.

Source:
Weinmann S, Naleway A, Swamy G, et al. PLoS One. 2017;12(1):e0165276.
doi:  10.1371/journal.pone.0165276.

Surgeries for cervical intraepithelial neoplasia (CIN) have been linked to preterm birth, low birth weight, and pregnancy loss, among other adverse effects. But the mechanisms have not been entirely explained. Are the outcomes due to the surgery, the immunologic factors, or the risk factors associated with CIN?

Related: PAP Test/HPV Co-test: Quality Improvement Initiative to Identify Approaches for Integrative Clinical Care Management

The greater risk of pregnancy problems derives primarily from the treatment not from characteristics of human papillomavirus or CIN, say researchers from Kaiser Permanente Northwest, Duke University, and GlaxoSmithKline. They compared 322 women who had undergone excisional and ablative cervical surgery with 4,307 women who had not and with 847 women who had undergone only diagnostic procedures.

Of the treated women, 163 had a live birth within 1 year of treatment. Women who had undergone thick excisional cervical surgical procedures ( ≥ 1.0 cm) had approximately double the risk of preterm birth and low-birth-weight infants compared with that of the other 2 groups. The risk was higher if the baby was born within 1 year of surgery.  The risk of cesarean delivery rose 20% with excisional surgery. The treated women did not have a substantially higher risk of dysfunctional labor.

Related: More Evidence of HPV’s Role in Cancer

Among the women who had cervical surgery, 21% lost the pregnancy (25% of those with ablative and 19% of those with excisional surgery). By contrast, 18% of the unexposed women and 20% of the diagnostic-only group experienced pregnancy loss. The researchers say the positive association between pregnancy loss and ablative surgical treatment has not been previously reported. “These findings suggest that efforts to minimize excision thickness in cervical surgeries are prudent,” the researchers advise.

Source:
Weinmann S, Naleway A, Swamy G, et al. PLoS One. 2017;12(1):e0165276.
doi:  10.1371/journal.pone.0165276.

Surgeries for cervical intraepithelial neoplasia (CIN) have been linked to preterm birth, low birth weight, and pregnancy loss, among other adverse effects. But the mechanisms have not been entirely explained. Are the outcomes due to the surgery, the immunologic factors, or the risk factors associated with CIN?

Related: PAP Test/HPV Co-test: Quality Improvement Initiative to Identify Approaches for Integrative Clinical Care Management

The greater risk of pregnancy problems derives primarily from the treatment not from characteristics of human papillomavirus or CIN, say researchers from Kaiser Permanente Northwest, Duke University, and GlaxoSmithKline. They compared 322 women who had undergone excisional and ablative cervical surgery with 4,307 women who had not and with 847 women who had undergone only diagnostic procedures.

Of the treated women, 163 had a live birth within 1 year of treatment. Women who had undergone thick excisional cervical surgical procedures ( ≥ 1.0 cm) had approximately double the risk of preterm birth and low-birth-weight infants compared with that of the other 2 groups. The risk was higher if the baby was born within 1 year of surgery.  The risk of cesarean delivery rose 20% with excisional surgery. The treated women did not have a substantially higher risk of dysfunctional labor.

Related: More Evidence of HPV’s Role in Cancer

Among the women who had cervical surgery, 21% lost the pregnancy (25% of those with ablative and 19% of those with excisional surgery). By contrast, 18% of the unexposed women and 20% of the diagnostic-only group experienced pregnancy loss. The researchers say the positive association between pregnancy loss and ablative surgical treatment has not been previously reported. “These findings suggest that efforts to minimize excision thickness in cervical surgeries are prudent,” the researchers advise.

Source:
Weinmann S, Naleway A, Swamy G, et al. PLoS One. 2017;12(1):e0165276.
doi:  10.1371/journal.pone.0165276.

High-dose immunosuppressive therapy and autologous hematopoietic cell transplant (HDIT/HCT) has had “highly promising” results for patients with relapsing-remitting multiple sclerosis (MS), according to researchers from the HALT-MS trial. In the 5-year study, 69% of 24 participants survived without progression of disability, relapse, or new brain lesions, despite not taking MS medications.

Findings published at the 3-year mark were encouraging. The event-free survival rate was 78%. The extended findings suggest that “onetime treatment with HDIT/HCT may be substantially more effective than long-term treatment with the best available medications” for these patients, said NIAID Director Anthony Fauci, MD.

The treatment “resets” the immune system, the researchers say. First, doctors collect the patient’s blood-forming stem cells, then give the patient chemotherapy to deplete the immune system. Finally, the doctors return the patient’s stem cells to rebuild the immune system.

Adverse events were consistent with those routinely observed after HDIT/HCT. Adverse effects recorded at 4 and 5 years were not related to the transplant and were not considered severe. Three patients died, but their deaths were not related to the study treatments.

Five years later, most trial participants remained in remission and stabilized, and some showed improvements, such as recovering mobility.

High-dose immunosuppressive therapy and autologous hematopoietic cell transplant (HDIT/HCT) has had “highly promising” results for patients with relapsing-remitting multiple sclerosis (MS), according to researchers from the HALT-MS trial. In the 5-year study, 69% of 24 participants survived without progression of disability, relapse, or new brain lesions, despite not taking MS medications.

Findings published at the 3-year mark were encouraging. The event-free survival rate was 78%. The extended findings suggest that “onetime treatment with HDIT/HCT may be substantially more effective than long-term treatment with the best available medications” for these patients, said NIAID Director Anthony Fauci, MD.

The treatment “resets” the immune system, the researchers say. First, doctors collect the patient’s blood-forming stem cells, then give the patient chemotherapy to deplete the immune system. Finally, the doctors return the patient’s stem cells to rebuild the immune system.

Adverse events were consistent with those routinely observed after HDIT/HCT. Adverse effects recorded at 4 and 5 years were not related to the transplant and were not considered severe. Three patients died, but their deaths were not related to the study treatments.

Five years later, most trial participants remained in remission and stabilized, and some showed improvements, such as recovering mobility.

High-dose immunosuppressive therapy and autologous hematopoietic cell transplant (HDIT/HCT) has had “highly promising” results for patients with relapsing-remitting multiple sclerosis (MS), according to researchers from the HALT-MS trial. In the 5-year study, 69% of 24 participants survived without progression of disability, relapse, or new brain lesions, despite not taking MS medications.

Findings published at the 3-year mark were encouraging. The event-free survival rate was 78%. The extended findings suggest that “onetime treatment with HDIT/HCT may be substantially more effective than long-term treatment with the best available medications” for these patients, said NIAID Director Anthony Fauci, MD.

The treatment “resets” the immune system, the researchers say. First, doctors collect the patient’s blood-forming stem cells, then give the patient chemotherapy to deplete the immune system. Finally, the doctors return the patient’s stem cells to rebuild the immune system.

Adverse events were consistent with those routinely observed after HDIT/HCT. Adverse effects recorded at 4 and 5 years were not related to the transplant and were not considered severe. Three patients died, but their deaths were not related to the study treatments.

Five years later, most trial participants remained in remission and stabilized, and some showed improvements, such as recovering mobility.

Lab mouse

The lungs may play a previously unrecognized role in blood production, according to preclinical research published in Nature.

Researchers discovered large numbers of megakaryocytes in the lungs of mice and found these cells produced roughly half of the animals’ platelets.

The team also identified a pool of hematopoietic progenitors in the extravascular spaces of mouse lungs that were capable of multi-lineage bone marrow reconstitution.

“This finding definitely suggests a more sophisticated view of the lungs—that they’re not just for respiration but also a key partner in formation of crucial aspects of the blood,” said study author Mark R. Looney, MD, of the University of California - San Francisco.

“What we’ve observed here in mice strongly suggests the lung may play a key role in blood formation in humans as well.”

The researchers believe these findings could have major implications for understanding diseases in which patients suffer from thrombocytopenia.

Imaging reveals surprise

This research was made possible by a refinement of a technique known as 2-photon intravital imaging. This approach allowed the researchers to visualize the behavior of individual cells within the blood vessels of a living mouse lung.

Dr Looney and his colleagues used the technique to examine interactions between the immune system and circulating platelets in the lungs in a mouse strain engineered so that platelets emit bright green fluorescence (GFP+).

In this way, the team noticed a large population of megakaryocytes in the lung vasculature. Though megakaryocytes had been observed in the lung before, they were generally thought to live and produce platelets primarily in the bone marrow.

“When we discovered this massive population of megakaryocytes that appeared to be living in the lung, we realized we had to follow this up,” said study author Emma Lefrançais, PhD, a postdoctoral researcher in Dr Looney’s lab.

More detailed imaging sessions revealed megakaryocytes in the act of producing more than 10 million platelets per hour within the lung vasculature. This suggests that roughly half of a mouse’s total platelet production occurs in the lung, not the bone marrow, as researchers had long presumed.

Subsequent experiments also revealed a variety of previously overlooked hematopoietic progenitors outside the lung vasculature.

Transplants provide more insight

The discovery of megakaryocytes and hematopoietic progenitors in the lung raised questions about how these cells move back and forth between the lung and bone marrow. To address these questions, the researchers conducted a set of lung transplant studies.

The team transplanted lungs from wild-type mice into mice with GFP+ megakaryocytes and vice-versa. The researchers said they observed proplatelet formation from GFP+ megakaryocytes in the lung vasculature of the GFP+ mice but not in the wild-type mice.

This suggests the megakaryocytes releasing platelets in the lung circulation originate from outside the lungs, the researchers said. And subsequent experiments suggested the megakaryocytes originate in the bone marrow.

“It’s fascinating that megakaryocytes travel all the way from the bone marrow to the lungs to produce platelets,” said Guadalupe Ortiz-Muñoz, PhD, a postdoctoral researcher in Dr Looney’s lab.

“It’s possible that the lung is an ideal bioreactor for platelet production because of the mechanical force of the blood, or perhaps because of some molecular signaling we don’t yet know about.”

In another experiment, the researchers transplanted lungs with GFP+ megakaryocyte progenitors into mutant mice with low platelet counts.

The transplants successfully restored platelet levels to normal, an effect that persisted over a few months of observation—much longer than the lifespan of individual megakaryocytes or platelets.

To the researchers, this indicated that resident megakaryocyte progenitors in the transplanted lungs had become activated by the recipient mouse’s low platelet counts and had produced healthy megakaryocytes to restore proper platelet production.

Finally, the researchers tested whether lung hematopoietic progenitors were capable of multi-lineage bone marrow reconstitution.

They found that cells originating from transplanted lungs traveled to damaged bone marrow and contributed to the production of platelets and other blood cells, including neutrophils, B cells, and T cells.

The researchers said these experiments suggest the lungs play host to a variety of hematopoietic progenitors capable of reconstituting damaged bone marrow and restoring the production of many components of the blood.

“To our knowledge, this is the first description of blood progenitors resident in the lung, and it raises a lot of questions with clinical relevance for the millions of people who suffer from thrombocytopenia,” Dr Looney said.

In particular, the study suggests that researchers who have proposed treating platelet diseases with platelets produced from engineered megakaryocytes should look to the lungs as a resource for platelet production, Dr Looney noted.

The study also presents new avenues of research for stem cell biologists to explore how the bone marrow and lung collaborate to produce a healthy blood system through the mutual exchange of stem cells.

“These observations alter existing paradigms regarding blood cell formation, lung biology and disease, and transplantation,” said pulmonologist Guy A. Zimmerman, MD, who is associate chair of the Department of Internal Medicine at the University of Utah School of Medicine and was an independent reviewer of this study for Nature.

“The findings have direct clinical relevance and provide a rich group of questions for future studies of platelet genesis and megakaryocyte function in lung inflammation and other inflammatory conditions, bleeding and thrombotic disorders, and transplantation.”

Lab mouse

The lungs may play a previously unrecognized role in blood production, according to preclinical research published in Nature.

Researchers discovered large numbers of megakaryocytes in the lungs of mice and found these cells produced roughly half of the animals’ platelets.

The team also identified a pool of hematopoietic progenitors in the extravascular spaces of mouse lungs that were capable of multi-lineage bone marrow reconstitution.

“This finding definitely suggests a more sophisticated view of the lungs—that they’re not just for respiration but also a key partner in formation of crucial aspects of the blood,” said study author Mark R. Looney, MD, of the University of California - San Francisco.

“What we’ve observed here in mice strongly suggests the lung may play a key role in blood formation in humans as well.”

The researchers believe these findings could have major implications for understanding diseases in which patients suffer from thrombocytopenia.

Imaging reveals surprise

This research was made possible by a refinement of a technique known as 2-photon intravital imaging. This approach allowed the researchers to visualize the behavior of individual cells within the blood vessels of a living mouse lung.

Dr Looney and his colleagues used the technique to examine interactions between the immune system and circulating platelets in the lungs in a mouse strain engineered so that platelets emit bright green fluorescence (GFP+).

In this way, the team noticed a large population of megakaryocytes in the lung vasculature. Though megakaryocytes had been observed in the lung before, they were generally thought to live and produce platelets primarily in the bone marrow.

“When we discovered this massive population of megakaryocytes that appeared to be living in the lung, we realized we had to follow this up,” said study author Emma Lefrançais, PhD, a postdoctoral researcher in Dr Looney’s lab.

More detailed imaging sessions revealed megakaryocytes in the act of producing more than 10 million platelets per hour within the lung vasculature. This suggests that roughly half of a mouse’s total platelet production occurs in the lung, not the bone marrow, as researchers had long presumed.

Subsequent experiments also revealed a variety of previously overlooked hematopoietic progenitors outside the lung vasculature.

Transplants provide more insight

The discovery of megakaryocytes and hematopoietic progenitors in the lung raised questions about how these cells move back and forth between the lung and bone marrow. To address these questions, the researchers conducted a set of lung transplant studies.

The team transplanted lungs from wild-type mice into mice with GFP+ megakaryocytes and vice-versa. The researchers said they observed proplatelet formation from GFP+ megakaryocytes in the lung vasculature of the GFP+ mice but not in the wild-type mice.

This suggests the megakaryocytes releasing platelets in the lung circulation originate from outside the lungs, the researchers said. And subsequent experiments suggested the megakaryocytes originate in the bone marrow.

“It’s fascinating that megakaryocytes travel all the way from the bone marrow to the lungs to produce platelets,” said Guadalupe Ortiz-Muñoz, PhD, a postdoctoral researcher in Dr Looney’s lab.

“It’s possible that the lung is an ideal bioreactor for platelet production because of the mechanical force of the blood, or perhaps because of some molecular signaling we don’t yet know about.”

In another experiment, the researchers transplanted lungs with GFP+ megakaryocyte progenitors into mutant mice with low platelet counts.

The transplants successfully restored platelet levels to normal, an effect that persisted over a few months of observation—much longer than the lifespan of individual megakaryocytes or platelets.

To the researchers, this indicated that resident megakaryocyte progenitors in the transplanted lungs had become activated by the recipient mouse’s low platelet counts and had produced healthy megakaryocytes to restore proper platelet production.

Finally, the researchers tested whether lung hematopoietic progenitors were capable of multi-lineage bone marrow reconstitution.

They found that cells originating from transplanted lungs traveled to damaged bone marrow and contributed to the production of platelets and other blood cells, including neutrophils, B cells, and T cells.

The researchers said these experiments suggest the lungs play host to a variety of hematopoietic progenitors capable of reconstituting damaged bone marrow and restoring the production of many components of the blood.

“To our knowledge, this is the first description of blood progenitors resident in the lung, and it raises a lot of questions with clinical relevance for the millions of people who suffer from thrombocytopenia,” Dr Looney said.

In particular, the study suggests that researchers who have proposed treating platelet diseases with platelets produced from engineered megakaryocytes should look to the lungs as a resource for platelet production, Dr Looney noted.

The study also presents new avenues of research for stem cell biologists to explore how the bone marrow and lung collaborate to produce a healthy blood system through the mutual exchange of stem cells.

“These observations alter existing paradigms regarding blood cell formation, lung biology and disease, and transplantation,” said pulmonologist Guy A. Zimmerman, MD, who is associate chair of the Department of Internal Medicine at the University of Utah School of Medicine and was an independent reviewer of this study for Nature.

“The findings have direct clinical relevance and provide a rich group of questions for future studies of platelet genesis and megakaryocyte function in lung inflammation and other inflammatory conditions, bleeding and thrombotic disorders, and transplantation.”

Lab mouse

The lungs may play a previously unrecognized role in blood production, according to preclinical research published in Nature.

Researchers discovered large numbers of megakaryocytes in the lungs of mice and found these cells produced roughly half of the animals’ platelets.

The team also identified a pool of hematopoietic progenitors in the extravascular spaces of mouse lungs that were capable of multi-lineage bone marrow reconstitution.

“This finding definitely suggests a more sophisticated view of the lungs—that they’re not just for respiration but also a key partner in formation of crucial aspects of the blood,” said study author Mark R. Looney, MD, of the University of California - San Francisco.

“What we’ve observed here in mice strongly suggests the lung may play a key role in blood formation in humans as well.”

The researchers believe these findings could have major implications for understanding diseases in which patients suffer from thrombocytopenia.

Imaging reveals surprise

This research was made possible by a refinement of a technique known as 2-photon intravital imaging. This approach allowed the researchers to visualize the behavior of individual cells within the blood vessels of a living mouse lung.

Dr Looney and his colleagues used the technique to examine interactions between the immune system and circulating platelets in the lungs in a mouse strain engineered so that platelets emit bright green fluorescence (GFP+).

In this way, the team noticed a large population of megakaryocytes in the lung vasculature. Though megakaryocytes had been observed in the lung before, they were generally thought to live and produce platelets primarily in the bone marrow.

“When we discovered this massive population of megakaryocytes that appeared to be living in the lung, we realized we had to follow this up,” said study author Emma Lefrançais, PhD, a postdoctoral researcher in Dr Looney’s lab.

More detailed imaging sessions revealed megakaryocytes in the act of producing more than 10 million platelets per hour within the lung vasculature. This suggests that roughly half of a mouse’s total platelet production occurs in the lung, not the bone marrow, as researchers had long presumed.

Subsequent experiments also revealed a variety of previously overlooked hematopoietic progenitors outside the lung vasculature.

Transplants provide more insight

The discovery of megakaryocytes and hematopoietic progenitors in the lung raised questions about how these cells move back and forth between the lung and bone marrow. To address these questions, the researchers conducted a set of lung transplant studies.

The team transplanted lungs from wild-type mice into mice with GFP+ megakaryocytes and vice-versa. The researchers said they observed proplatelet formation from GFP+ megakaryocytes in the lung vasculature of the GFP+ mice but not in the wild-type mice.

This suggests the megakaryocytes releasing platelets in the lung circulation originate from outside the lungs, the researchers said. And subsequent experiments suggested the megakaryocytes originate in the bone marrow.

“It’s fascinating that megakaryocytes travel all the way from the bone marrow to the lungs to produce platelets,” said Guadalupe Ortiz-Muñoz, PhD, a postdoctoral researcher in Dr Looney’s lab.

“It’s possible that the lung is an ideal bioreactor for platelet production because of the mechanical force of the blood, or perhaps because of some molecular signaling we don’t yet know about.”

In another experiment, the researchers transplanted lungs with GFP+ megakaryocyte progenitors into mutant mice with low platelet counts.

The transplants successfully restored platelet levels to normal, an effect that persisted over a few months of observation—much longer than the lifespan of individual megakaryocytes or platelets.

To the researchers, this indicated that resident megakaryocyte progenitors in the transplanted lungs had become activated by the recipient mouse’s low platelet counts and had produced healthy megakaryocytes to restore proper platelet production.

Finally, the researchers tested whether lung hematopoietic progenitors were capable of multi-lineage bone marrow reconstitution.

They found that cells originating from transplanted lungs traveled to damaged bone marrow and contributed to the production of platelets and other blood cells, including neutrophils, B cells, and T cells.

The researchers said these experiments suggest the lungs play host to a variety of hematopoietic progenitors capable of reconstituting damaged bone marrow and restoring the production of many components of the blood.

“To our knowledge, this is the first description of blood progenitors resident in the lung, and it raises a lot of questions with clinical relevance for the millions of people who suffer from thrombocytopenia,” Dr Looney said.

In particular, the study suggests that researchers who have proposed treating platelet diseases with platelets produced from engineered megakaryocytes should look to the lungs as a resource for platelet production, Dr Looney noted.

The study also presents new avenues of research for stem cell biologists to explore how the bone marrow and lung collaborate to produce a healthy blood system through the mutual exchange of stem cells.

“These observations alter existing paradigms regarding blood cell formation, lung biology and disease, and transplantation,” said pulmonologist Guy A. Zimmerman, MD, who is associate chair of the Department of Internal Medicine at the University of Utah School of Medicine and was an independent reviewer of this study for Nature.

“The findings have direct clinical relevance and provide a rich group of questions for future studies of platelet genesis and megakaryocyte function in lung inflammation and other inflammatory conditions, bleeding and thrombotic disorders, and transplantation.”

Image by Andre E.X. Brown

New research has revealed sex-based differences in utilization and outcomes of catheter-directed thrombolysis (CDT) in patients with deep vein thrombosis (DVT).

The study showed that CDT use was more common in men than women, although use of the procedure increased over time for both sexes.

There were significant between-sex differences in the rates of some bleeding complications and certain in-hospital outcomes, but in-hospital mortality rates were similar between the sexes.

Riyaz Bashir, MD, of Temple University in Philadelphia, Pennsylvania, and his colleagues reported these findings in Vascular Medicine.

“The data provided some interesting findings,” Dr Bashir said. “In addition to differences in utilization, we were able to find variations in the incidence of a number of complications, including bleeding that requires blood transfusion, intracranial hemorrhage, gastrointestinal bleeding, and acute kidney injury, as well as the incidence of angioplasty, stenting, and adjunctive IVC filter placement.”

For this study, Dr Bashir and his colleagues analyzed data from the Nationwide Inpatient Sample database.

The team identified 108,243 patients age 18 or older with a primary discharge diagnosis of proximal lower extremity or caval DVT between January 2005 and December 2011. Of those patients, 4826 (4.5%) were treated with CDT.

The researchers found that women underwent CDT less often than men—4.1% and 4.9%, respectively (P<0.01).

But the rates of CDT use increased between 2005 and 2011 for both sexes—from 2.1% to 5.9% in women (P<0.01) and from 2.5% to 7.5% (P<0.01) in men.

The rate of in-hospital mortality was similar between women (1.2%) and men (1.3%, P=0.76).

Likewise, there was no significant between-sex difference in length of hospital stay or total hospital charges. The average length of stay was 7.0 ± 5.7 days for men and 7.1 ± 5.5 days for women (P=0.55).

Average total hospital charges were $88,837 ± 68,284 for men and $91,487 ± 77,129 for women (P=0.28).

Women were more likely than men to:

• Require blood transfusions—11.7% and 8.8%, respectively, (P<0.01)
• Undergo angioplasty—64.1% and 54.3%, respectively (P<0.01)
• Undergo stenting—32.2% and 19.9%, respectively (P<0.01)
• Receive an inferior vena cava filter—37.0% and 32.1%, respectively (P<0.01).

Men were more likely than women to:

• Experience acute kidney injury—9.9% and 6.5%, respectively (P<0.01)
• Have an intracranial hemorrhage (ICH)—1.2% and 0.5%, respectively (P=0.03)
• Experience gastrointestinal bleeding—2.2% and 0.9%, respectively (P<0.01).

The researchers noted that the higher rate of ICH among men overall was due to a higher incidence of ICH among men over the age of 75.

There was no significant difference between men and women when it came to procedure-related hemorrhage—1.4% and 1.2%, respectively (P=0.45).

“Future research should focus on uncovering why these sex-based differences exist,” Dr Bashir said. “The answers to those questions could help shape future treatment guidelines for patients who are suitable candidates for CDT.”

Image by Andre E.X. Brown

New research has revealed sex-based differences in utilization and outcomes of catheter-directed thrombolysis (CDT) in patients with deep vein thrombosis (DVT).

The study showed that CDT use was more common in men than women, although use of the procedure increased over time for both sexes.

There were significant between-sex differences in the rates of some bleeding complications and certain in-hospital outcomes, but in-hospital mortality rates were similar between the sexes.

Riyaz Bashir, MD, of Temple University in Philadelphia, Pennsylvania, and his colleagues reported these findings in Vascular Medicine.

“The data provided some interesting findings,” Dr Bashir said. “In addition to differences in utilization, we were able to find variations in the incidence of a number of complications, including bleeding that requires blood transfusion, intracranial hemorrhage, gastrointestinal bleeding, and acute kidney injury, as well as the incidence of angioplasty, stenting, and adjunctive IVC filter placement.”

For this study, Dr Bashir and his colleagues analyzed data from the Nationwide Inpatient Sample database.

The team identified 108,243 patients age 18 or older with a primary discharge diagnosis of proximal lower extremity or caval DVT between January 2005 and December 2011. Of those patients, 4826 (4.5%) were treated with CDT.

The researchers found that women underwent CDT less often than men—4.1% and 4.9%, respectively (P<0.01).

But the rates of CDT use increased between 2005 and 2011 for both sexes—from 2.1% to 5.9% in women (P<0.01) and from 2.5% to 7.5% (P<0.01) in men.

The rate of in-hospital mortality was similar between women (1.2%) and men (1.3%, P=0.76).

Likewise, there was no significant between-sex difference in length of hospital stay or total hospital charges. The average length of stay was 7.0 ± 5.7 days for men and 7.1 ± 5.5 days for women (P=0.55).

Average total hospital charges were $88,837 ± 68,284 for men and $91,487 ± 77,129 for women (P=0.28).

Women were more likely than men to:

• Require blood transfusions—11.7% and 8.8%, respectively, (P<0.01)
• Undergo angioplasty—64.1% and 54.3%, respectively (P<0.01)
• Undergo stenting—32.2% and 19.9%, respectively (P<0.01)
• Receive an inferior vena cava filter—37.0% and 32.1%, respectively (P<0.01).

Men were more likely than women to:

• Experience acute kidney injury—9.9% and 6.5%, respectively (P<0.01)
• Have an intracranial hemorrhage (ICH)—1.2% and 0.5%, respectively (P=0.03)
• Experience gastrointestinal bleeding—2.2% and 0.9%, respectively (P<0.01).

The researchers noted that the higher rate of ICH among men overall was due to a higher incidence of ICH among men over the age of 75.

There was no significant difference between men and women when it came to procedure-related hemorrhage—1.4% and 1.2%, respectively (P=0.45).

“Future research should focus on uncovering why these sex-based differences exist,” Dr Bashir said. “The answers to those questions could help shape future treatment guidelines for patients who are suitable candidates for CDT.”

Image by Andre E.X. Brown

New research has revealed sex-based differences in utilization and outcomes of catheter-directed thrombolysis (CDT) in patients with deep vein thrombosis (DVT).

The study showed that CDT use was more common in men than women, although use of the procedure increased over time for both sexes.

There were significant between-sex differences in the rates of some bleeding complications and certain in-hospital outcomes, but in-hospital mortality rates were similar between the sexes.

Riyaz Bashir, MD, of Temple University in Philadelphia, Pennsylvania, and his colleagues reported these findings in Vascular Medicine.

“The data provided some interesting findings,” Dr Bashir said. “In addition to differences in utilization, we were able to find variations in the incidence of a number of complications, including bleeding that requires blood transfusion, intracranial hemorrhage, gastrointestinal bleeding, and acute kidney injury, as well as the incidence of angioplasty, stenting, and adjunctive IVC filter placement.”

For this study, Dr Bashir and his colleagues analyzed data from the Nationwide Inpatient Sample database.

The team identified 108,243 patients age 18 or older with a primary discharge diagnosis of proximal lower extremity or caval DVT between January 2005 and December 2011. Of those patients, 4826 (4.5%) were treated with CDT.

The researchers found that women underwent CDT less often than men—4.1% and 4.9%, respectively (P<0.01).

But the rates of CDT use increased between 2005 and 2011 for both sexes—from 2.1% to 5.9% in women (P<0.01) and from 2.5% to 7.5% (P<0.01) in men.

The rate of in-hospital mortality was similar between women (1.2%) and men (1.3%, P=0.76).

Likewise, there was no significant between-sex difference in length of hospital stay or total hospital charges. The average length of stay was 7.0 ± 5.7 days for men and 7.1 ± 5.5 days for women (P=0.55).

Average total hospital charges were $88,837 ± 68,284 for men and $91,487 ± 77,129 for women (P=0.28).

Women were more likely than men to:

• Require blood transfusions—11.7% and 8.8%, respectively, (P<0.01)
• Undergo angioplasty—64.1% and 54.3%, respectively (P<0.01)
• Undergo stenting—32.2% and 19.9%, respectively (P<0.01)
• Receive an inferior vena cava filter—37.0% and 32.1%, respectively (P<0.01).

Men were more likely than women to:

• Experience acute kidney injury—9.9% and 6.5%, respectively (P<0.01)
• Have an intracranial hemorrhage (ICH)—1.2% and 0.5%, respectively (P=0.03)
• Experience gastrointestinal bleeding—2.2% and 0.9%, respectively (P<0.01).

The researchers noted that the higher rate of ICH among men overall was due to a higher incidence of ICH among men over the age of 75.

There was no significant difference between men and women when it came to procedure-related hemorrhage—1.4% and 1.2%, respectively (P=0.45).

“Future research should focus on uncovering why these sex-based differences exist,” Dr Bashir said. “The answers to those questions could help shape future treatment guidelines for patients who are suitable candidates for CDT.”

Photo by Rhoda Baer

The Hematology/Oncology Pharmacy Association (HOPA) has announced the release of a toolkit intended to help prevent chemotherapy-induced nausea and vomiting (CINV) in cancer patients.

The Time to Talk CINV™ toolkit was designed to facilitate dialogue between patients and their healthcare teams to ensure no patient is needlessly suffering from CINV.

The tools in the kit, which are targeted to both patients and healthcare providers, were created with guidance from patients, caregivers, pharmacists, and nurses.

The entire toolkit is available for free download at TimeToTalkCINV.com.

The toolkit is part of the Time to Talk CINV™ campaign, which is a collaboration between HOPA, Eisai Inc., and Helsinn Therapeutics (US), Inc. (funded by Eisai and Helsinn Therapeutics).

The campaign began in response to results from a survey of cancer patients.

“Our research revealed a vast majority of patients on chemotherapy who experience nausea and vomiting expect to have this side effect, and 95% of these patients said, at some point, chemo-induced nausea and vomiting had an impact on their daily lives,” said Sarah Peters, PharmD, president of HOPA.

“In response to these findings, as well as the finding that healthcare team members are looking for better communication tools, the Time to Talk CINV toolkit was created to facilitate efficient and effective conversations about nausea and vomiting from chemotherapy to ensure that each patient is receiving the right information and effective management approaches.”

The Time to Talk CINV toolkit includes the following resources:

• A list of myths and truths about CINV intended to eliminate common misperceptions
• A checklist of questions patients can ask healthcare providers to better understand CINV
• A chemotherapy side effect tracker, which enables patients to track their experience and report back to their healthcare team
• A communication checklist for the healthcare team outlining best practices for communicating with patients to prevent CINV.

Each tool can be printed or filled out digitally.

Additional information about CINV, including videos and infographics, can be found on the Time to Talk CINV website.

Photo by Rhoda Baer

The Hematology/Oncology Pharmacy Association (HOPA) has announced the release of a toolkit intended to help prevent chemotherapy-induced nausea and vomiting (CINV) in cancer patients.

The Time to Talk CINV™ toolkit was designed to facilitate dialogue between patients and their healthcare teams to ensure no patient is needlessly suffering from CINV.

The tools in the kit, which are targeted to both patients and healthcare providers, were created with guidance from patients, caregivers, pharmacists, and nurses.

The entire toolkit is available for free download at TimeToTalkCINV.com.

The toolkit is part of the Time to Talk CINV™ campaign, which is a collaboration between HOPA, Eisai Inc., and Helsinn Therapeutics (US), Inc. (funded by Eisai and Helsinn Therapeutics).

The campaign began in response to results from a survey of cancer patients.

“Our research revealed a vast majority of patients on chemotherapy who experience nausea and vomiting expect to have this side effect, and 95% of these patients said, at some point, chemo-induced nausea and vomiting had an impact on their daily lives,” said Sarah Peters, PharmD, president of HOPA.

“In response to these findings, as well as the finding that healthcare team members are looking for better communication tools, the Time to Talk CINV toolkit was created to facilitate efficient and effective conversations about nausea and vomiting from chemotherapy to ensure that each patient is receiving the right information and effective management approaches.”

The Time to Talk CINV toolkit includes the following resources:

• A list of myths and truths about CINV intended to eliminate common misperceptions
• A checklist of questions patients can ask healthcare providers to better understand CINV
• A chemotherapy side effect tracker, which enables patients to track their experience and report back to their healthcare team
• A communication checklist for the healthcare team outlining best practices for communicating with patients to prevent CINV.

Each tool can be printed or filled out digitally.

Additional information about CINV, including videos and infographics, can be found on the Time to Talk CINV website.

Photo by Rhoda Baer

The Hematology/Oncology Pharmacy Association (HOPA) has announced the release of a toolkit intended to help prevent chemotherapy-induced nausea and vomiting (CINV) in cancer patients.

The Time to Talk CINV™ toolkit was designed to facilitate dialogue between patients and their healthcare teams to ensure no patient is needlessly suffering from CINV.

The tools in the kit, which are targeted to both patients and healthcare providers, were created with guidance from patients, caregivers, pharmacists, and nurses.

The entire toolkit is available for free download at TimeToTalkCINV.com.

The toolkit is part of the Time to Talk CINV™ campaign, which is a collaboration between HOPA, Eisai Inc., and Helsinn Therapeutics (US), Inc. (funded by Eisai and Helsinn Therapeutics).

The campaign began in response to results from a survey of cancer patients.

“Our research revealed a vast majority of patients on chemotherapy who experience nausea and vomiting expect to have this side effect, and 95% of these patients said, at some point, chemo-induced nausea and vomiting had an impact on their daily lives,” said Sarah Peters, PharmD, president of HOPA.

“In response to these findings, as well as the finding that healthcare team members are looking for better communication tools, the Time to Talk CINV toolkit was created to facilitate efficient and effective conversations about nausea and vomiting from chemotherapy to ensure that each patient is receiving the right information and effective management approaches.”

The Time to Talk CINV toolkit includes the following resources:

• A list of myths and truths about CINV intended to eliminate common misperceptions
• A checklist of questions patients can ask healthcare providers to better understand CINV
• A chemotherapy side effect tracker, which enables patients to track their experience and report back to their healthcare team
• A communication checklist for the healthcare team outlining best practices for communicating with patients to prevent CINV.

Each tool can be printed or filled out digitally.

Additional information about CINV, including videos and infographics, can be found on the Time to Talk CINV website.

The family physician (FP) asked some more questions about the antibiotic ointment and discovered that it was a triple antibiotic ointment (which typically contains neomycin, bacitracin, and polymyxin). The patient acknowledged that after applying the ointment to the bug bite, she’d used a bandage that was rectangular in shape—just like the patch of erythematous skin with papules.

The FP deduced that this was a case of contact dermatitis and the patient was reacting to at least one of the topical antibiotics in the triple antibiotic preparation. The most likely offending topical antibiotic was neomycin, as it’s a common contact allergen. However, bacitracin is also a common contact allergen.

The FP told the patient to stop using the triple antibiotic ointment and to avoid using any preparations that contain neomycin, bacitracin—or both—in the future. The FP explained that most minor skin injuries, including bug bites and minor scrapes, do not require topical antibiotics.

The FP prescribed 0.1% triamcinolone cream to be applied twice daily to treat the erythema and itching caused by the contact dermatitis. At a follow-up visit one month later, the only skin problem that persisted was some postinflammatory hyperpigmentation. The FP explained that this would likely fade over time.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R. Contact dermatitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:591-596.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The family physician (FP) asked some more questions about the antibiotic ointment and discovered that it was a triple antibiotic ointment (which typically contains neomycin, bacitracin, and polymyxin). The patient acknowledged that after applying the ointment to the bug bite, she’d used a bandage that was rectangular in shape—just like the patch of erythematous skin with papules.

The FP deduced that this was a case of contact dermatitis and the patient was reacting to at least one of the topical antibiotics in the triple antibiotic preparation. The most likely offending topical antibiotic was neomycin, as it’s a common contact allergen. However, bacitracin is also a common contact allergen.

The FP told the patient to stop using the triple antibiotic ointment and to avoid using any preparations that contain neomycin, bacitracin—or both—in the future. The FP explained that most minor skin injuries, including bug bites and minor scrapes, do not require topical antibiotics.

The FP prescribed 0.1% triamcinolone cream to be applied twice daily to treat the erythema and itching caused by the contact dermatitis. At a follow-up visit one month later, the only skin problem that persisted was some postinflammatory hyperpigmentation. The FP explained that this would likely fade over time.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R. Contact dermatitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:591-596.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The family physician (FP) asked some more questions about the antibiotic ointment and discovered that it was a triple antibiotic ointment (which typically contains neomycin, bacitracin, and polymyxin). The patient acknowledged that after applying the ointment to the bug bite, she’d used a bandage that was rectangular in shape—just like the patch of erythematous skin with papules.

The FP deduced that this was a case of contact dermatitis and the patient was reacting to at least one of the topical antibiotics in the triple antibiotic preparation. The most likely offending topical antibiotic was neomycin, as it’s a common contact allergen. However, bacitracin is also a common contact allergen.

The FP told the patient to stop using the triple antibiotic ointment and to avoid using any preparations that contain neomycin, bacitracin—or both—in the future. The FP explained that most minor skin injuries, including bug bites and minor scrapes, do not require topical antibiotics.

The FP prescribed 0.1% triamcinolone cream to be applied twice daily to treat the erythema and itching caused by the contact dermatitis. At a follow-up visit one month later, the only skin problem that persisted was some postinflammatory hyperpigmentation. The FP explained that this would likely fade over time.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R. Contact dermatitis. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:591-596.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

Clinical Question: What are the benefits and harms of perioperative pharmacological thromboprophylaxis in cancer patients undergoing surgery?

Background: Both cancer and surgery increase the risk of venous thromboembolism (VTE). In postsurgical patients with cancer, the benefits and harms of anticoagulation remain unknown.

Dr. Patil is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.

Clinical Question: What are the benefits and harms of perioperative pharmacological thromboprophylaxis in cancer patients undergoing surgery?

Background: Both cancer and surgery increase the risk of venous thromboembolism (VTE). In postsurgical patients with cancer, the benefits and harms of anticoagulation remain unknown.

Dr. Patil is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.

Clinical Question: What are the benefits and harms of perioperative pharmacological thromboprophylaxis in cancer patients undergoing surgery?

Background: Both cancer and surgery increase the risk of venous thromboembolism (VTE). In postsurgical patients with cancer, the benefits and harms of anticoagulation remain unknown.

Dr. Patil is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.

Clinical Question: Did hospitals receiving the highest penalties for readmissions have accelerated improvement in this metric after passage of Medicare Hospital Readmissions Reduction Program (HRRP)?

Background: Medicare passed the HRRP to incentivize reductions in readmission rates. The impact of penalties on relative hospital improvement rates remains unknown.

Dr. Patil is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.

Clinical Question: Did hospitals receiving the highest penalties for readmissions have accelerated improvement in this metric after passage of Medicare Hospital Readmissions Reduction Program (HRRP)?

Background: Medicare passed the HRRP to incentivize reductions in readmission rates. The impact of penalties on relative hospital improvement rates remains unknown.

Dr. Patil is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.

Clinical Question: Did hospitals receiving the highest penalties for readmissions have accelerated improvement in this metric after passage of Medicare Hospital Readmissions Reduction Program (HRRP)?

Background: Medicare passed the HRRP to incentivize reductions in readmission rates. The impact of penalties on relative hospital improvement rates remains unknown.

Dr. Patil is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.

As of 2016, Florida ranks second among all states in the United States in estimated new cases of prostate cancer and second in estimated deaths from prostate cancer.¹ Disparities in diagnosis, mortality rates, and access to cancer care also continue to be a major problem in Florida, especially for black men. For example, black men were the only racial/ethnic group that did not meet the Healthy People (HP) 2010 objective to reduce the prostate cancer death rate to 28.2 per 100,000 men and that has not met the HP 2020 objective to reduce the prostate cancer death rate to 21.2 per 100,000 men (Table 1). Based on the 2013 prostate cancer mortality rates for Florida,² the death rate for black men is almost twice the HP 2020 goal (37.49 per 100,000).

According to the American Cancer Society, about 30,000 black men were diagnosed with prostate cancer in 2016.⁷ It is important to understand these men’s needs and help them cope effectively as they navigate the survivorship continuum. In line with our research program’s goal of ensuring quality cancer care for black men, the primary objective of this study was to explore the experiences and needs of black men at the point of prostate cancer diagnosis (PPCD). Specifically, we developed an interpretative framework for black men’s experiences at the PPCD, focusing on United States or native-born black men (NBBM) and Caribbean-born black men (CBBM). African-born black men were not included in this study because of the low sample size for that ethnicity. This study is part of a large-scale study that focuses on developing a model of prostate cancer care and survivorship (CaPCaS model) using grounded theory to study black, ethnically diverse prostate cancer survivors.

Methods

The study aims to close the prostate health disparity gap for black men in Florida through community engaged research in partnership with survivors of prostate cancer and their advocates. The current study was a prospective, grounded theory study that involved one-on-one, in-depth interviews with 31 prostate cancer patients about their care and survivorship experiences. Specifically, 17 NBBM and 14 CBBM were enrolled in the project. Appropriate human subjects review and approval were obtained from the University of Florida, the Florida Department of Health, and the Department of Defense.

Research design

This is a qualitative research study. Based on the principles of community engaged research and using a rigorous qualitative research methodology, we recruited NBBM and CBBM with a personal history of prostate cancer. Guided by open-ended questions developed by the team, one-on-one in-depth interviews were conducted with each participant in their home or at a convenient location in the community. Our primary focus was on the participants’ care and survivorship experiences, with primary focus on their prostate cancer diagnosis. Qualitative research was our methodology of choice because little is known about the PPCD experiences of black men.⁸ With qualitative research, we were able to get our participants to “relive” their experiences in the presence of a culturally competent, well-trained interviewer and elicit the information about their care and survivorship experiences based on their interpretation. In addition, we were able to capture the dynamic processes associated with their experiences, documenting sequential patterns and change through both verbal and nonverbal communications, because the participants were interviewed twice.

Research population and recruitment

The study setting was Florida. The inclusion criteria were: black men, personal history of prostate cancer, ability to complete two separate interviews with each one expected to last 2-3 hours, and flexibility to meet interviewers at a convenient community site for the interviews. Participants were identified through the Florida Cancer Data System (FCDS)⁹ database. At the time of the study, the most recent FCDS database was for 2010. The FCDS has collected the number of new cancer cancers diagnosed in the state of Florida annually since 1981. It is a comprehensive incidence-only registry and does not extract data on patients with a death certificate. All investigators are bounded by the confidential pledge required for the use of the FCDS data.

We used the Florida Department of Health’s (DoH’s) Bureau of Epidemiology standard procedure for the FCDS⁹ to recruit participants. Our recruitment strategies included: initial patient contact by written correspondence; second mailing that included a telephone opt-out card after 3 weeks for nonrespondents (the telephone opt-out card explained to the patient that if no response was received, the study investigator would attempt a telephone call to introduce the study); and a telephone call by a study staff to introduce the study for nonrespondents. As per the Florida DoH standard procedure, we did not disclose on the cover of the study mailings that the patient was being contacted for a study specific to cancer. Efforts to recruit a patient stopped immediately if a patient indicated that he did not wish to participate. All of the study staff making participant contact were extensively trained to provide a clear and accurate description of cancer registration in Florida. In addition, to assist the study staff in providing clear and accurate responses, responses to frequently asked questions were made available to the study staff. During the participant recruitment phase, anyone who seemed to be upset when contacted was reported immediately (within 24 hours) to the DoH cancer epidemiologist. In addition, the name of anyone who stated that he did not wish to be contacted again was given to the DoH so that the person would not be re-contacted.

Prescreening of participants for eligibility

All eligible participants who agreed to participate in the study comprised the pool of potential study participants. For those who agreed to participate, the following information was obtained by telephone interview using REDCap software:¹⁰ name and contact information, country of birth, age, marital status, and education level. The demographic information facilitated a purposeful systematic selection of black men of diverse age groups (younger than 50 years or older than 50 years), marital status (single, including divorced or separated, or married/in a relationship), and educational level (college degree or not college educated). An incentive of a $5 gift card was provided to all the men who participated in the screening phase. Using systematic sampling to ensure demographically diverse participants, 40 participants (20 NBBM, 20 CBBM) were selected from the initial pool of participants to participate in the study.

Data collection

The data collection was conducted by a trained Community Health Worker (CHW) using semi-structured interview process. The interview guide was constructed by the research team and the study community advisory board members to ensure language appropriateness, understanding and cultural sensitivity. For this study, the interview questions focused on participants’ background information and diagnosis history, including: participants’ personal story of diagnosis, feelings, emotions, reactions, regrets and level of personal/family/physician involvement in diagnosis. For the CBBM, we also obtained information on the age at which they immigrated to the United States. The CHW interviewer was trained to question participants and encourage them to elaborate on areas of importance to their experience.

A total time of about 5-6 hours was scheduled for the data collection per participant, which is sufficient for gathering in-depth perspectives. We scheduled two interviews lasting not more than 3 hours at a time so as not to create burden for study participants. Participants had the choice to have the interviews completed in a single session or spread out over 2 days. The interviews were audio-recorded to provide ease of transcription and back-up of data. At the end of the interviews, participants were compensated for participating in the study.

Data management and analyses

The study dataset included interview transcripts and field notes of the CHW interviewer describing his insights about the interviews. The data analyses included preparing and verifying the narrative data, coding data, and developing an interpretative framework for black men’s experiences at the PPCD. Interviews were transcribed verbatim by a professional transcription service that has policies in place for protected health information. Each transcript was then verified for accuracy by the CHW interviewer. The interview transcripts were imported directly into NVivo 11, a computer-assisted data analysis software that allows coding and modeling of complex narrative data. The data coding was conducted by our interdisciplinary team of clinicians, behavioral scientists, and social scientists. It is important to note that the NVivo 11 software was not used to analyze the data per se. However, it provided a sophisticated and systematic way to manage the following tasks for the analyses: organizing large quantities of narrative data, coding text, retrieving text by codes, querying the data, comparing sets of data interpretation between NBBM and CBBM; and developing analytic models. The study team members coded the data in weekly team meetings. The coding consisted of reading the data and identifying major themes, then assigning labels to and defining emerging categories.

Two levels of coding were used. The first, open coding, refers to an approach to data with no preconceived ideas about what will be found; and the second, focused or axial coding, refers to reviewing data for the purpose of more richly coding on a particular theme.¹¹ We used dimensional analysis to ensure that each emerging concept was carefully defined. The study team went back and forth between the data and the emerging analytic framework, using constant comparison of new data with already coded data and new categories with previously analyzed text.¹²

To ensure trustworthiness and credibility,¹³ the study team maintained an audit trail that documented how and when analytic decisions were made. In addition, peer debriefing was conducted to ensure credibility, including the presentation of findings to the study community advisory board members as part of the community engaged research approach.

Results

Description of participants

The FCDS provided a database of 1,813 participants identified as black men diagnosed with prostate cancer in 2010. Because the FCDS does not extract data on patients with a death certificate, we found out during the pre-screening phase that a few of the men were deceased. In addition, there were a significant number of incorrect addresses. We obtained a total of 212 completed responses by phone during the prescreening phase. The majority of the participants were aged 60-69 years (48.2%), had a high school diploma only (26.1%), and were currently married (65.3%). Relative to ethnicity, 67% of participants classified themselves NBBM, 24% as CBBM, 3.5% as black men born in Africa, and 5.5% as Other/Don’t know/Refused. For the CBBM, the most common countries of birth were Jamaica, Haiti, and Guyana, respectively.

In all, 40 participants (20 NBBM and 20 CBBM) were selected from the 212 participants to participate in the study. Selection was conducted systematically to ensure representation in terms of age, marital status, education, and geographical location. Data saturation was achieved with 17 NBBM and 14 CBBM, after which we ended data collection (Table 2). Data saturation is the standard for deciding that we are not finding anything different from the interviews first coded and last coded. Although we were specifically looking for differences between the two groups (NBBM and CBBM), no between-group differences emerged. Each man’s experience was unique to him with some common themes emerging described hereinafter (Figure).

Moderating factors and experiences at PPCD

Some of the moderating factors that the study participants identified as affecting their reactions to the PPCD included health literacy, insurance status, spirituality, mistrust, prior experience with cancer, perceived susceptibility to cancer, and delay in diagnosis (Table 3). Health literacy, defined as personal, cognitive, and social skills that determine the ability of individuals to gain access to, understand, and use information to promote and maintain good health, was one of the moderating factors found in this study.¹³ Some of the black men came to the PPCD with a low level of health literacy, which had an impact on their understanding of the treatment options. For example, in the interview, participant 798 (NBBM) was confused about what tests had been done and was not able to accurately describe the treatments offered to him. Participant 1263 (CBBM) struggled to express the purpose and procedures associated with diagnostic biopsy. However, there were participants with a high level of health literacy (eg, participant 449 [NBBM]), who decided to research the disease.

Another factor to consider is the insurance status of participants at the PPCD. The majority of the participants had good insurance coverage, but some were affected by poor insurance coverage. Participant 1881(NBBM) made his treatment decision primarily on the basis of the pending lapse of his insurance coverage rather than the best clinical option for him. Participant 1979 (CBBM) described both his confusion on the screening tests and the impact of not having insurance coverage. Upon obtaining insurance coverage, he sought treatment for his prostate cancer with an urgency that he did not experience when he was first diagnosed when uninsured.

The spirituality of black men was another moderating factor at the PPCD. Participant 827 (NBBM) noted that he was unaffected when he received his diagnosis because he was a true believer. Some of the black men also came to the PPCD with lack of trust in the physician and/or the health care system and perceived a sense of contempt from the physician. Participant 1594 (NBBM) described mistrust based on the history of medical exploitation of black men as well as a perception of current discriminatory practices.

Another important PPCD status to note for black men is prior experience with cancer, including prior personal cancer history and/or prior cancer history of a family member. Participant 2024 (CBBM) described the meaning of cancer to him, while participant 798 (NBBM) echoed the despair of the cancer diagnosis based on experience with other cancers in the family. Sometimes there were multiple cancers in the family or even among the significant others of the participant, as was the case with Participant 1936 (CBBM).

Of greatest concern were men who delayed their diagnosis or treatment, perhaps resulting in their cancer being at a more advanced stage when they eventually did return for care. Finally, some of the men came to the PPCD appointment with a low expectation of receiving a diagnosis of prostate cancer, whereas others came to the PPCD fearful of the results of their testing.

In describing their experiences, participants expressed both positive and negative experiences: on the positive side, they found the information provided by the physician to be helpful; but on the negative side, the sterile or medically focused encounter was perceived as a lack empathy on the part of the physician.

Cognitive, emotional, and behavioral coping experiences

As expected, there were ranges of emotions, including shock, disbelief and denial (Table 4). Some of the men questioned why this (the cancer) was happening to them when they had done “nothing” to deserve it. Doing nothing in this case meant that they had lived a healthy lifestyle with no obvious apparent cause to have the cancer. Fear and cancer fatalism were experienced by a significant number of the men, with their thoughts immediately turning to death and dying. This was especially the case for men who had lost a loved one to cancer. Conversely, some of the men wanted immediate resolution, focusing instead on ways to beat the cancer and with a strong will to live.

Reliance on faith was a big part of coping at the PPCD. Some of the men drew strength from their faith to get them through their cancer journey. Others found a way to accept the diagnosis – one participant accepted the diagnosis and the fact that this could mean dying (after living a good life), whereas another participant accepted the diagnosis with the hope that he would find a cure. Hope was more realistic with the knowledge that other men had survived prostate cancer.

Reflecting back on their experiences, the men also identified clear needs at the PPCD. One of the needs they identified was having a physician they were comfortable with to discuss their diagnosis. Another need was for a second opinion. Participant 1594 (NBBM) advised that it was important for black men to take control by requesting a second opinion. Participant 2039 (NBBM) described a feeling of navigating blindly and trying to find answers that would be helpful to him in his cancer journey. However, his experience with a second opinion was not helpful because the second physician was at the same clinic as his primary physician. His recommendation was to get a second opinion at a different clinic or center. Another important need was emotional support at the PPCD. Participant 2024 (CBBM) made a strong case for emotional support, especially for men who are not accompanied during diagnosis. In addition, Participant 2024’s (CBBM) reflections underscore the fact that the PPCD may not be an ideal place or time to discuss treatment options. With the range of emotions that the men go through at the PPCD, it is difficult to comprehend any follow-up discussions after hearing the words “you have prostate cancer.” Participant 2024 (CBBM) also strongly expressed that men need time to deal with the diagnosis at the PPCD.

Discussion

The primary goal of this study was to develop an interpretative framework of black men’s experiences at the PPCD. The Figure provides a pictorial summary of the framework. Study results indicated that black men come to the PPCD with different emotions and different experiences. Although the majority of the men were NBBM, there is a significantly increasing number of foreign-born black men receiving a diagnosis of prostate cancer in the United States. Given that black men carry a disproportionate burden of the disease, with a significantly higher incidence compared with any other racial group, it is important that tailored services are provided to black men at the PPCD.

We also found that black men came to the PPCD diverse in terms of their ethnicity, health literacy, spirituality, trust in health care system/physician, prior experience with cancer, perceived susceptibility to cancer, delayed time for diagnosis, and fear of diagnosis. Of importance for physicians is that the black race is not homogeneous. There is a significant number of foreign-born blacks at the PPCD, and they often have different cultural beliefs and values compared with NBBM. In addition, some of the foreign-born black men may not have English proficiency and may need a medical interpreter during the PPCD consultation. In addition, a patient’s pre-existing lack of trust in the health care system may have a negative impact on the PPCD consultation. It is thus important that the physician takes the time to instill trust and make the men comfortable during the PPCD consultation.

For some of the men who had fear of a prostate cancer diagnosis and/or prior experience with cancer, cancer fatalism was experienced at the PPCD. Cancer fatalism, defined as an individual’s belief that death is bound to happen when diagnosed with cancer, has been documented as a major barrier to cancer detection and control.¹⁵ For example, fatalistic perspectives have been reported to affect cervical cancer,¹⁶ breast cancer,^17,18 colorectal cancer,¹⁹ and prostate cancer^20,21 among blacks. It is thus important to effectively address fatalistic beliefs when a man is diagnosed with prostate cancer.

Other emotions at the PPCD that may affect effective treatment decision making also need to be addressed immediately. For example, the emotions of fear, denial, and feeling overwhelmed are potential barriers to timely treatment decision making. Psycho-oncology interventions to appropriately deal with these emotions at PPCD or right after the diagnosis may be crucial for the men. In particular, a group-based psychosocial intervention focusing on: provision of education about treatment options for prostate cancer and their acute and late effects; negotiating treatment and treatment side effects; enhancing communication with treatment providers; managing distress; and engaging positive family- and community-based social support to optimize emotional, behavioral, social, and physical outcomes in black men with prostate cancer.

In addition to having physicians make them comfortable at PPCD, the PPCD needs expressed by participants included having time to come to terms with the diagnosis and receiving psycho-oncology/emotional support. Anyone who has just received a diagnosis of cancer cannot be expected to immediately continue to function as he did before the PPCD. This is especially difficult for men who are alone at the PPCD. Nevertheless, it is expected that they will listen attentively and understand subsequent consultation by the physician, then leave the consultation room almost immediately, and be able drive home or back to work right after the diagnosis. There seems to be a support gap that needs to be closed at the PPCD. Providing the men with immediate support to cope with the diagnosis may make a significant difference in effective treatment choices and eliminating treatment decisional regrets.

Methodological rigor was established through purposeful sampling, extended time with participants, standardized procedures for data collection, management and analysis, multidisciplinary interpretation, and validation of results with the community advisory board. Because the research participants were purposefully selected from a statewide database of black men diagnosed with CaP, generalizability of findings to the two target groups of NBBM and CBBM can be assumed, with the caveat that men with different experiences may have chosen not to respond to recruitment efforts or refused participation. Black men who were not sufficiently fluent in English to be interviewed were also excluded and are not represented in these findings. Black men of other nativity (including African-born black men) and residing outside of Florida were also not represented.

In conclusion, the PPCD interpretative framework developed in this study, describes the status of black men at the PPCD, their experiences during the PPCD, and their needs at the PPCD. The framework provides information that can be used by physicians to prepare for their PPCD consultation with black men as well as develop a support system for black men at the PPCD.

Acknowledgments
The authors thank the men who participated in the CaPCaS study. They also thank the CaPCaS project community advisory board chairs (Mr Jim West, Dr Angela Adams, and Prince Oladapo Odedina) and all the CaPCaS project community advisory board members for their effort throughout the project. Finally, they rxecognize the effort of additional CaPCaS scientific team, especially the primary interviewer, Mr Kenneth Stokes. Weekly meeting support for this study was provided by the University of Florida MiCaRT Center, which is funded by the NIH-National Cancer Institute Award # 1P20CA192990-02. REDCaP software was supported by the UF Clinical and Translational Science Institute, which is funded in part by the NIH Clinical and Translational Science Award program (grants UL1TR001427, KL2TR001429 and TL1TR001428).

As of 2016, Florida ranks second among all states in the United States in estimated new cases of prostate cancer and second in estimated deaths from prostate cancer.¹ Disparities in diagnosis, mortality rates, and access to cancer care also continue to be a major problem in Florida, especially for black men. For example, black men were the only racial/ethnic group that did not meet the Healthy People (HP) 2010 objective to reduce the prostate cancer death rate to 28.2 per 100,000 men and that has not met the HP 2020 objective to reduce the prostate cancer death rate to 21.2 per 100,000 men (Table 1). Based on the 2013 prostate cancer mortality rates for Florida,² the death rate for black men is almost twice the HP 2020 goal (37.49 per 100,000).

According to the American Cancer Society, about 30,000 black men were diagnosed with prostate cancer in 2016.⁷ It is important to understand these men’s needs and help them cope effectively as they navigate the survivorship continuum. In line with our research program’s goal of ensuring quality cancer care for black men, the primary objective of this study was to explore the experiences and needs of black men at the point of prostate cancer diagnosis (PPCD). Specifically, we developed an interpretative framework for black men’s experiences at the PPCD, focusing on United States or native-born black men (NBBM) and Caribbean-born black men (CBBM). African-born black men were not included in this study because of the low sample size for that ethnicity. This study is part of a large-scale study that focuses on developing a model of prostate cancer care and survivorship (CaPCaS model) using grounded theory to study black, ethnically diverse prostate cancer survivors.

Methods

The study aims to close the prostate health disparity gap for black men in Florida through community engaged research in partnership with survivors of prostate cancer and their advocates. The current study was a prospective, grounded theory study that involved one-on-one, in-depth interviews with 31 prostate cancer patients about their care and survivorship experiences. Specifically, 17 NBBM and 14 CBBM were enrolled in the project. Appropriate human subjects review and approval were obtained from the University of Florida, the Florida Department of Health, and the Department of Defense.

Research design

This is a qualitative research study. Based on the principles of community engaged research and using a rigorous qualitative research methodology, we recruited NBBM and CBBM with a personal history of prostate cancer. Guided by open-ended questions developed by the team, one-on-one in-depth interviews were conducted with each participant in their home or at a convenient location in the community. Our primary focus was on the participants’ care and survivorship experiences, with primary focus on their prostate cancer diagnosis. Qualitative research was our methodology of choice because little is known about the PPCD experiences of black men.⁸ With qualitative research, we were able to get our participants to “relive” their experiences in the presence of a culturally competent, well-trained interviewer and elicit the information about their care and survivorship experiences based on their interpretation. In addition, we were able to capture the dynamic processes associated with their experiences, documenting sequential patterns and change through both verbal and nonverbal communications, because the participants were interviewed twice.

Research population and recruitment

The study setting was Florida. The inclusion criteria were: black men, personal history of prostate cancer, ability to complete two separate interviews with each one expected to last 2-3 hours, and flexibility to meet interviewers at a convenient community site for the interviews. Participants were identified through the Florida Cancer Data System (FCDS)⁹ database. At the time of the study, the most recent FCDS database was for 2010. The FCDS has collected the number of new cancer cancers diagnosed in the state of Florida annually since 1981. It is a comprehensive incidence-only registry and does not extract data on patients with a death certificate. All investigators are bounded by the confidential pledge required for the use of the FCDS data.

We used the Florida Department of Health’s (DoH’s) Bureau of Epidemiology standard procedure for the FCDS⁹ to recruit participants. Our recruitment strategies included: initial patient contact by written correspondence; second mailing that included a telephone opt-out card after 3 weeks for nonrespondents (the telephone opt-out card explained to the patient that if no response was received, the study investigator would attempt a telephone call to introduce the study); and a telephone call by a study staff to introduce the study for nonrespondents. As per the Florida DoH standard procedure, we did not disclose on the cover of the study mailings that the patient was being contacted for a study specific to cancer. Efforts to recruit a patient stopped immediately if a patient indicated that he did not wish to participate. All of the study staff making participant contact were extensively trained to provide a clear and accurate description of cancer registration in Florida. In addition, to assist the study staff in providing clear and accurate responses, responses to frequently asked questions were made available to the study staff. During the participant recruitment phase, anyone who seemed to be upset when contacted was reported immediately (within 24 hours) to the DoH cancer epidemiologist. In addition, the name of anyone who stated that he did not wish to be contacted again was given to the DoH so that the person would not be re-contacted.

Prescreening of participants for eligibility

All eligible participants who agreed to participate in the study comprised the pool of potential study participants. For those who agreed to participate, the following information was obtained by telephone interview using REDCap software:¹⁰ name and contact information, country of birth, age, marital status, and education level. The demographic information facilitated a purposeful systematic selection of black men of diverse age groups (younger than 50 years or older than 50 years), marital status (single, including divorced or separated, or married/in a relationship), and educational level (college degree or not college educated). An incentive of a $5 gift card was provided to all the men who participated in the screening phase. Using systematic sampling to ensure demographically diverse participants, 40 participants (20 NBBM, 20 CBBM) were selected from the initial pool of participants to participate in the study.

Data collection

The data collection was conducted by a trained Community Health Worker (CHW) using semi-structured interview process. The interview guide was constructed by the research team and the study community advisory board members to ensure language appropriateness, understanding and cultural sensitivity. For this study, the interview questions focused on participants’ background information and diagnosis history, including: participants’ personal story of diagnosis, feelings, emotions, reactions, regrets and level of personal/family/physician involvement in diagnosis. For the CBBM, we also obtained information on the age at which they immigrated to the United States. The CHW interviewer was trained to question participants and encourage them to elaborate on areas of importance to their experience.

A total time of about 5-6 hours was scheduled for the data collection per participant, which is sufficient for gathering in-depth perspectives. We scheduled two interviews lasting not more than 3 hours at a time so as not to create burden for study participants. Participants had the choice to have the interviews completed in a single session or spread out over 2 days. The interviews were audio-recorded to provide ease of transcription and back-up of data. At the end of the interviews, participants were compensated for participating in the study.

Data management and analyses

The study dataset included interview transcripts and field notes of the CHW interviewer describing his insights about the interviews. The data analyses included preparing and verifying the narrative data, coding data, and developing an interpretative framework for black men’s experiences at the PPCD. Interviews were transcribed verbatim by a professional transcription service that has policies in place for protected health information. Each transcript was then verified for accuracy by the CHW interviewer. The interview transcripts were imported directly into NVivo 11, a computer-assisted data analysis software that allows coding and modeling of complex narrative data. The data coding was conducted by our interdisciplinary team of clinicians, behavioral scientists, and social scientists. It is important to note that the NVivo 11 software was not used to analyze the data per se. However, it provided a sophisticated and systematic way to manage the following tasks for the analyses: organizing large quantities of narrative data, coding text, retrieving text by codes, querying the data, comparing sets of data interpretation between NBBM and CBBM; and developing analytic models. The study team members coded the data in weekly team meetings. The coding consisted of reading the data and identifying major themes, then assigning labels to and defining emerging categories.

Two levels of coding were used. The first, open coding, refers to an approach to data with no preconceived ideas about what will be found; and the second, focused or axial coding, refers to reviewing data for the purpose of more richly coding on a particular theme.¹¹ We used dimensional analysis to ensure that each emerging concept was carefully defined. The study team went back and forth between the data and the emerging analytic framework, using constant comparison of new data with already coded data and new categories with previously analyzed text.¹²

To ensure trustworthiness and credibility,¹³ the study team maintained an audit trail that documented how and when analytic decisions were made. In addition, peer debriefing was conducted to ensure credibility, including the presentation of findings to the study community advisory board members as part of the community engaged research approach.

Results

Description of participants

The FCDS provided a database of 1,813 participants identified as black men diagnosed with prostate cancer in 2010. Because the FCDS does not extract data on patients with a death certificate, we found out during the pre-screening phase that a few of the men were deceased. In addition, there were a significant number of incorrect addresses. We obtained a total of 212 completed responses by phone during the prescreening phase. The majority of the participants were aged 60-69 years (48.2%), had a high school diploma only (26.1%), and were currently married (65.3%). Relative to ethnicity, 67% of participants classified themselves NBBM, 24% as CBBM, 3.5% as black men born in Africa, and 5.5% as Other/Don’t know/Refused. For the CBBM, the most common countries of birth were Jamaica, Haiti, and Guyana, respectively.

In all, 40 participants (20 NBBM and 20 CBBM) were selected from the 212 participants to participate in the study. Selection was conducted systematically to ensure representation in terms of age, marital status, education, and geographical location. Data saturation was achieved with 17 NBBM and 14 CBBM, after which we ended data collection (Table 2). Data saturation is the standard for deciding that we are not finding anything different from the interviews first coded and last coded. Although we were specifically looking for differences between the two groups (NBBM and CBBM), no between-group differences emerged. Each man’s experience was unique to him with some common themes emerging described hereinafter (Figure).

Moderating factors and experiences at PPCD

Some of the moderating factors that the study participants identified as affecting their reactions to the PPCD included health literacy, insurance status, spirituality, mistrust, prior experience with cancer, perceived susceptibility to cancer, and delay in diagnosis (Table 3). Health literacy, defined as personal, cognitive, and social skills that determine the ability of individuals to gain access to, understand, and use information to promote and maintain good health, was one of the moderating factors found in this study.¹³ Some of the black men came to the PPCD with a low level of health literacy, which had an impact on their understanding of the treatment options. For example, in the interview, participant 798 (NBBM) was confused about what tests had been done and was not able to accurately describe the treatments offered to him. Participant 1263 (CBBM) struggled to express the purpose and procedures associated with diagnostic biopsy. However, there were participants with a high level of health literacy (eg, participant 449 [NBBM]), who decided to research the disease.

Another factor to consider is the insurance status of participants at the PPCD. The majority of the participants had good insurance coverage, but some were affected by poor insurance coverage. Participant 1881(NBBM) made his treatment decision primarily on the basis of the pending lapse of his insurance coverage rather than the best clinical option for him. Participant 1979 (CBBM) described both his confusion on the screening tests and the impact of not having insurance coverage. Upon obtaining insurance coverage, he sought treatment for his prostate cancer with an urgency that he did not experience when he was first diagnosed when uninsured.

The spirituality of black men was another moderating factor at the PPCD. Participant 827 (NBBM) noted that he was unaffected when he received his diagnosis because he was a true believer. Some of the black men also came to the PPCD with lack of trust in the physician and/or the health care system and perceived a sense of contempt from the physician. Participant 1594 (NBBM) described mistrust based on the history of medical exploitation of black men as well as a perception of current discriminatory practices.

Another important PPCD status to note for black men is prior experience with cancer, including prior personal cancer history and/or prior cancer history of a family member. Participant 2024 (CBBM) described the meaning of cancer to him, while participant 798 (NBBM) echoed the despair of the cancer diagnosis based on experience with other cancers in the family. Sometimes there were multiple cancers in the family or even among the significant others of the participant, as was the case with Participant 1936 (CBBM).

Of greatest concern were men who delayed their diagnosis or treatment, perhaps resulting in their cancer being at a more advanced stage when they eventually did return for care. Finally, some of the men came to the PPCD appointment with a low expectation of receiving a diagnosis of prostate cancer, whereas others came to the PPCD fearful of the results of their testing.

In describing their experiences, participants expressed both positive and negative experiences: on the positive side, they found the information provided by the physician to be helpful; but on the negative side, the sterile or medically focused encounter was perceived as a lack empathy on the part of the physician.

Cognitive, emotional, and behavioral coping experiences

As expected, there were ranges of emotions, including shock, disbelief and denial (Table 4). Some of the men questioned why this (the cancer) was happening to them when they had done “nothing” to deserve it. Doing nothing in this case meant that they had lived a healthy lifestyle with no obvious apparent cause to have the cancer. Fear and cancer fatalism were experienced by a significant number of the men, with their thoughts immediately turning to death and dying. This was especially the case for men who had lost a loved one to cancer. Conversely, some of the men wanted immediate resolution, focusing instead on ways to beat the cancer and with a strong will to live.

Reliance on faith was a big part of coping at the PPCD. Some of the men drew strength from their faith to get them through their cancer journey. Others found a way to accept the diagnosis – one participant accepted the diagnosis and the fact that this could mean dying (after living a good life), whereas another participant accepted the diagnosis with the hope that he would find a cure. Hope was more realistic with the knowledge that other men had survived prostate cancer.

Reflecting back on their experiences, the men also identified clear needs at the PPCD. One of the needs they identified was having a physician they were comfortable with to discuss their diagnosis. Another need was for a second opinion. Participant 1594 (NBBM) advised that it was important for black men to take control by requesting a second opinion. Participant 2039 (NBBM) described a feeling of navigating blindly and trying to find answers that would be helpful to him in his cancer journey. However, his experience with a second opinion was not helpful because the second physician was at the same clinic as his primary physician. His recommendation was to get a second opinion at a different clinic or center. Another important need was emotional support at the PPCD. Participant 2024 (CBBM) made a strong case for emotional support, especially for men who are not accompanied during diagnosis. In addition, Participant 2024’s (CBBM) reflections underscore the fact that the PPCD may not be an ideal place or time to discuss treatment options. With the range of emotions that the men go through at the PPCD, it is difficult to comprehend any follow-up discussions after hearing the words “you have prostate cancer.” Participant 2024 (CBBM) also strongly expressed that men need time to deal with the diagnosis at the PPCD.

Discussion

The primary goal of this study was to develop an interpretative framework of black men’s experiences at the PPCD. The Figure provides a pictorial summary of the framework. Study results indicated that black men come to the PPCD with different emotions and different experiences. Although the majority of the men were NBBM, there is a significantly increasing number of foreign-born black men receiving a diagnosis of prostate cancer in the United States. Given that black men carry a disproportionate burden of the disease, with a significantly higher incidence compared with any other racial group, it is important that tailored services are provided to black men at the PPCD.

We also found that black men came to the PPCD diverse in terms of their ethnicity, health literacy, spirituality, trust in health care system/physician, prior experience with cancer, perceived susceptibility to cancer, delayed time for diagnosis, and fear of diagnosis. Of importance for physicians is that the black race is not homogeneous. There is a significant number of foreign-born blacks at the PPCD, and they often have different cultural beliefs and values compared with NBBM. In addition, some of the foreign-born black men may not have English proficiency and may need a medical interpreter during the PPCD consultation. In addition, a patient’s pre-existing lack of trust in the health care system may have a negative impact on the PPCD consultation. It is thus important that the physician takes the time to instill trust and make the men comfortable during the PPCD consultation.

For some of the men who had fear of a prostate cancer diagnosis and/or prior experience with cancer, cancer fatalism was experienced at the PPCD. Cancer fatalism, defined as an individual’s belief that death is bound to happen when diagnosed with cancer, has been documented as a major barrier to cancer detection and control.¹⁵ For example, fatalistic perspectives have been reported to affect cervical cancer,¹⁶ breast cancer,^17,18 colorectal cancer,¹⁹ and prostate cancer^20,21 among blacks. It is thus important to effectively address fatalistic beliefs when a man is diagnosed with prostate cancer.

Other emotions at the PPCD that may affect effective treatment decision making also need to be addressed immediately. For example, the emotions of fear, denial, and feeling overwhelmed are potential barriers to timely treatment decision making. Psycho-oncology interventions to appropriately deal with these emotions at PPCD or right after the diagnosis may be crucial for the men. In particular, a group-based psychosocial intervention focusing on: provision of education about treatment options for prostate cancer and their acute and late effects; negotiating treatment and treatment side effects; enhancing communication with treatment providers; managing distress; and engaging positive family- and community-based social support to optimize emotional, behavioral, social, and physical outcomes in black men with prostate cancer.

In addition to having physicians make them comfortable at PPCD, the PPCD needs expressed by participants included having time to come to terms with the diagnosis and receiving psycho-oncology/emotional support. Anyone who has just received a diagnosis of cancer cannot be expected to immediately continue to function as he did before the PPCD. This is especially difficult for men who are alone at the PPCD. Nevertheless, it is expected that they will listen attentively and understand subsequent consultation by the physician, then leave the consultation room almost immediately, and be able drive home or back to work right after the diagnosis. There seems to be a support gap that needs to be closed at the PPCD. Providing the men with immediate support to cope with the diagnosis may make a significant difference in effective treatment choices and eliminating treatment decisional regrets.

Methodological rigor was established through purposeful sampling, extended time with participants, standardized procedures for data collection, management and analysis, multidisciplinary interpretation, and validation of results with the community advisory board. Because the research participants were purposefully selected from a statewide database of black men diagnosed with CaP, generalizability of findings to the two target groups of NBBM and CBBM can be assumed, with the caveat that men with different experiences may have chosen not to respond to recruitment efforts or refused participation. Black men who were not sufficiently fluent in English to be interviewed were also excluded and are not represented in these findings. Black men of other nativity (including African-born black men) and residing outside of Florida were also not represented.

In conclusion, the PPCD interpretative framework developed in this study, describes the status of black men at the PPCD, their experiences during the PPCD, and their needs at the PPCD. The framework provides information that can be used by physicians to prepare for their PPCD consultation with black men as well as develop a support system for black men at the PPCD.

Acknowledgments
The authors thank the men who participated in the CaPCaS study. They also thank the CaPCaS project community advisory board chairs (Mr Jim West, Dr Angela Adams, and Prince Oladapo Odedina) and all the CaPCaS project community advisory board members for their effort throughout the project. Finally, they rxecognize the effort of additional CaPCaS scientific team, especially the primary interviewer, Mr Kenneth Stokes. Weekly meeting support for this study was provided by the University of Florida MiCaRT Center, which is funded by the NIH-National Cancer Institute Award # 1P20CA192990-02. REDCaP software was supported by the UF Clinical and Translational Science Institute, which is funded in part by the NIH Clinical and Translational Science Award program (grants UL1TR001427, KL2TR001429 and TL1TR001428).

As of 2016, Florida ranks second among all states in the United States in estimated new cases of prostate cancer and second in estimated deaths from prostate cancer.¹ Disparities in diagnosis, mortality rates, and access to cancer care also continue to be a major problem in Florida, especially for black men. For example, black men were the only racial/ethnic group that did not meet the Healthy People (HP) 2010 objective to reduce the prostate cancer death rate to 28.2 per 100,000 men and that has not met the HP 2020 objective to reduce the prostate cancer death rate to 21.2 per 100,000 men (Table 1). Based on the 2013 prostate cancer mortality rates for Florida,² the death rate for black men is almost twice the HP 2020 goal (37.49 per 100,000).

According to the American Cancer Society, about 30,000 black men were diagnosed with prostate cancer in 2016.⁷ It is important to understand these men’s needs and help them cope effectively as they navigate the survivorship continuum. In line with our research program’s goal of ensuring quality cancer care for black men, the primary objective of this study was to explore the experiences and needs of black men at the point of prostate cancer diagnosis (PPCD). Specifically, we developed an interpretative framework for black men’s experiences at the PPCD, focusing on United States or native-born black men (NBBM) and Caribbean-born black men (CBBM). African-born black men were not included in this study because of the low sample size for that ethnicity. This study is part of a large-scale study that focuses on developing a model of prostate cancer care and survivorship (CaPCaS model) using grounded theory to study black, ethnically diverse prostate cancer survivors.

Methods

The study aims to close the prostate health disparity gap for black men in Florida through community engaged research in partnership with survivors of prostate cancer and their advocates. The current study was a prospective, grounded theory study that involved one-on-one, in-depth interviews with 31 prostate cancer patients about their care and survivorship experiences. Specifically, 17 NBBM and 14 CBBM were enrolled in the project. Appropriate human subjects review and approval were obtained from the University of Florida, the Florida Department of Health, and the Department of Defense.

Research design

This is a qualitative research study. Based on the principles of community engaged research and using a rigorous qualitative research methodology, we recruited NBBM and CBBM with a personal history of prostate cancer. Guided by open-ended questions developed by the team, one-on-one in-depth interviews were conducted with each participant in their home or at a convenient location in the community. Our primary focus was on the participants’ care and survivorship experiences, with primary focus on their prostate cancer diagnosis. Qualitative research was our methodology of choice because little is known about the PPCD experiences of black men.⁸ With qualitative research, we were able to get our participants to “relive” their experiences in the presence of a culturally competent, well-trained interviewer and elicit the information about their care and survivorship experiences based on their interpretation. In addition, we were able to capture the dynamic processes associated with their experiences, documenting sequential patterns and change through both verbal and nonverbal communications, because the participants were interviewed twice.

Research population and recruitment

The study setting was Florida. The inclusion criteria were: black men, personal history of prostate cancer, ability to complete two separate interviews with each one expected to last 2-3 hours, and flexibility to meet interviewers at a convenient community site for the interviews. Participants were identified through the Florida Cancer Data System (FCDS)⁹ database. At the time of the study, the most recent FCDS database was for 2010. The FCDS has collected the number of new cancer cancers diagnosed in the state of Florida annually since 1981. It is a comprehensive incidence-only registry and does not extract data on patients with a death certificate. All investigators are bounded by the confidential pledge required for the use of the FCDS data.

We used the Florida Department of Health’s (DoH’s) Bureau of Epidemiology standard procedure for the FCDS⁹ to recruit participants. Our recruitment strategies included: initial patient contact by written correspondence; second mailing that included a telephone opt-out card after 3 weeks for nonrespondents (the telephone opt-out card explained to the patient that if no response was received, the study investigator would attempt a telephone call to introduce the study); and a telephone call by a study staff to introduce the study for nonrespondents. As per the Florida DoH standard procedure, we did not disclose on the cover of the study mailings that the patient was being contacted for a study specific to cancer. Efforts to recruit a patient stopped immediately if a patient indicated that he did not wish to participate. All of the study staff making participant contact were extensively trained to provide a clear and accurate description of cancer registration in Florida. In addition, to assist the study staff in providing clear and accurate responses, responses to frequently asked questions were made available to the study staff. During the participant recruitment phase, anyone who seemed to be upset when contacted was reported immediately (within 24 hours) to the DoH cancer epidemiologist. In addition, the name of anyone who stated that he did not wish to be contacted again was given to the DoH so that the person would not be re-contacted.

Prescreening of participants for eligibility

All eligible participants who agreed to participate in the study comprised the pool of potential study participants. For those who agreed to participate, the following information was obtained by telephone interview using REDCap software:¹⁰ name and contact information, country of birth, age, marital status, and education level. The demographic information facilitated a purposeful systematic selection of black men of diverse age groups (younger than 50 years or older than 50 years), marital status (single, including divorced or separated, or married/in a relationship), and educational level (college degree or not college educated). An incentive of a $5 gift card was provided to all the men who participated in the screening phase. Using systematic sampling to ensure demographically diverse participants, 40 participants (20 NBBM, 20 CBBM) were selected from the initial pool of participants to participate in the study.

Data collection

The data collection was conducted by a trained Community Health Worker (CHW) using semi-structured interview process. The interview guide was constructed by the research team and the study community advisory board members to ensure language appropriateness, understanding and cultural sensitivity. For this study, the interview questions focused on participants’ background information and diagnosis history, including: participants’ personal story of diagnosis, feelings, emotions, reactions, regrets and level of personal/family/physician involvement in diagnosis. For the CBBM, we also obtained information on the age at which they immigrated to the United States. The CHW interviewer was trained to question participants and encourage them to elaborate on areas of importance to their experience.

A total time of about 5-6 hours was scheduled for the data collection per participant, which is sufficient for gathering in-depth perspectives. We scheduled two interviews lasting not more than 3 hours at a time so as not to create burden for study participants. Participants had the choice to have the interviews completed in a single session or spread out over 2 days. The interviews were audio-recorded to provide ease of transcription and back-up of data. At the end of the interviews, participants were compensated for participating in the study.

Data management and analyses

The study dataset included interview transcripts and field notes of the CHW interviewer describing his insights about the interviews. The data analyses included preparing and verifying the narrative data, coding data, and developing an interpretative framework for black men’s experiences at the PPCD. Interviews were transcribed verbatim by a professional transcription service that has policies in place for protected health information. Each transcript was then verified for accuracy by the CHW interviewer. The interview transcripts were imported directly into NVivo 11, a computer-assisted data analysis software that allows coding and modeling of complex narrative data. The data coding was conducted by our interdisciplinary team of clinicians, behavioral scientists, and social scientists. It is important to note that the NVivo 11 software was not used to analyze the data per se. However, it provided a sophisticated and systematic way to manage the following tasks for the analyses: organizing large quantities of narrative data, coding text, retrieving text by codes, querying the data, comparing sets of data interpretation between NBBM and CBBM; and developing analytic models. The study team members coded the data in weekly team meetings. The coding consisted of reading the data and identifying major themes, then assigning labels to and defining emerging categories.

Two levels of coding were used. The first, open coding, refers to an approach to data with no preconceived ideas about what will be found; and the second, focused or axial coding, refers to reviewing data for the purpose of more richly coding on a particular theme.¹¹ We used dimensional analysis to ensure that each emerging concept was carefully defined. The study team went back and forth between the data and the emerging analytic framework, using constant comparison of new data with already coded data and new categories with previously analyzed text.¹²

To ensure trustworthiness and credibility,¹³ the study team maintained an audit trail that documented how and when analytic decisions were made. In addition, peer debriefing was conducted to ensure credibility, including the presentation of findings to the study community advisory board members as part of the community engaged research approach.

Results

Description of participants

The FCDS provided a database of 1,813 participants identified as black men diagnosed with prostate cancer in 2010. Because the FCDS does not extract data on patients with a death certificate, we found out during the pre-screening phase that a few of the men were deceased. In addition, there were a significant number of incorrect addresses. We obtained a total of 212 completed responses by phone during the prescreening phase. The majority of the participants were aged 60-69 years (48.2%), had a high school diploma only (26.1%), and were currently married (65.3%). Relative to ethnicity, 67% of participants classified themselves NBBM, 24% as CBBM, 3.5% as black men born in Africa, and 5.5% as Other/Don’t know/Refused. For the CBBM, the most common countries of birth were Jamaica, Haiti, and Guyana, respectively.

In all, 40 participants (20 NBBM and 20 CBBM) were selected from the 212 participants to participate in the study. Selection was conducted systematically to ensure representation in terms of age, marital status, education, and geographical location. Data saturation was achieved with 17 NBBM and 14 CBBM, after which we ended data collection (Table 2). Data saturation is the standard for deciding that we are not finding anything different from the interviews first coded and last coded. Although we were specifically looking for differences between the two groups (NBBM and CBBM), no between-group differences emerged. Each man’s experience was unique to him with some common themes emerging described hereinafter (Figure).

Moderating factors and experiences at PPCD

Some of the moderating factors that the study participants identified as affecting their reactions to the PPCD included health literacy, insurance status, spirituality, mistrust, prior experience with cancer, perceived susceptibility to cancer, and delay in diagnosis (Table 3). Health literacy, defined as personal, cognitive, and social skills that determine the ability of individuals to gain access to, understand, and use information to promote and maintain good health, was one of the moderating factors found in this study.¹³ Some of the black men came to the PPCD with a low level of health literacy, which had an impact on their understanding of the treatment options. For example, in the interview, participant 798 (NBBM) was confused about what tests had been done and was not able to accurately describe the treatments offered to him. Participant 1263 (CBBM) struggled to express the purpose and procedures associated with diagnostic biopsy. However, there were participants with a high level of health literacy (eg, participant 449 [NBBM]), who decided to research the disease.

Another factor to consider is the insurance status of participants at the PPCD. The majority of the participants had good insurance coverage, but some were affected by poor insurance coverage. Participant 1881(NBBM) made his treatment decision primarily on the basis of the pending lapse of his insurance coverage rather than the best clinical option for him. Participant 1979 (CBBM) described both his confusion on the screening tests and the impact of not having insurance coverage. Upon obtaining insurance coverage, he sought treatment for his prostate cancer with an urgency that he did not experience when he was first diagnosed when uninsured.

The spirituality of black men was another moderating factor at the PPCD. Participant 827 (NBBM) noted that he was unaffected when he received his diagnosis because he was a true believer. Some of the black men also came to the PPCD with lack of trust in the physician and/or the health care system and perceived a sense of contempt from the physician. Participant 1594 (NBBM) described mistrust based on the history of medical exploitation of black men as well as a perception of current discriminatory practices.

Another important PPCD status to note for black men is prior experience with cancer, including prior personal cancer history and/or prior cancer history of a family member. Participant 2024 (CBBM) described the meaning of cancer to him, while participant 798 (NBBM) echoed the despair of the cancer diagnosis based on experience with other cancers in the family. Sometimes there were multiple cancers in the family or even among the significant others of the participant, as was the case with Participant 1936 (CBBM).

Of greatest concern were men who delayed their diagnosis or treatment, perhaps resulting in their cancer being at a more advanced stage when they eventually did return for care. Finally, some of the men came to the PPCD appointment with a low expectation of receiving a diagnosis of prostate cancer, whereas others came to the PPCD fearful of the results of their testing.

In describing their experiences, participants expressed both positive and negative experiences: on the positive side, they found the information provided by the physician to be helpful; but on the negative side, the sterile or medically focused encounter was perceived as a lack empathy on the part of the physician.

Cognitive, emotional, and behavioral coping experiences

As expected, there were ranges of emotions, including shock, disbelief and denial (Table 4). Some of the men questioned why this (the cancer) was happening to them when they had done “nothing” to deserve it. Doing nothing in this case meant that they had lived a healthy lifestyle with no obvious apparent cause to have the cancer. Fear and cancer fatalism were experienced by a significant number of the men, with their thoughts immediately turning to death and dying. This was especially the case for men who had lost a loved one to cancer. Conversely, some of the men wanted immediate resolution, focusing instead on ways to beat the cancer and with a strong will to live.

Reliance on faith was a big part of coping at the PPCD. Some of the men drew strength from their faith to get them through their cancer journey. Others found a way to accept the diagnosis – one participant accepted the diagnosis and the fact that this could mean dying (after living a good life), whereas another participant accepted the diagnosis with the hope that he would find a cure. Hope was more realistic with the knowledge that other men had survived prostate cancer.

Reflecting back on their experiences, the men also identified clear needs at the PPCD. One of the needs they identified was having a physician they were comfortable with to discuss their diagnosis. Another need was for a second opinion. Participant 1594 (NBBM) advised that it was important for black men to take control by requesting a second opinion. Participant 2039 (NBBM) described a feeling of navigating blindly and trying to find answers that would be helpful to him in his cancer journey. However, his experience with a second opinion was not helpful because the second physician was at the same clinic as his primary physician. His recommendation was to get a second opinion at a different clinic or center. Another important need was emotional support at the PPCD. Participant 2024 (CBBM) made a strong case for emotional support, especially for men who are not accompanied during diagnosis. In addition, Participant 2024’s (CBBM) reflections underscore the fact that the PPCD may not be an ideal place or time to discuss treatment options. With the range of emotions that the men go through at the PPCD, it is difficult to comprehend any follow-up discussions after hearing the words “you have prostate cancer.” Participant 2024 (CBBM) also strongly expressed that men need time to deal with the diagnosis at the PPCD.

Discussion

The primary goal of this study was to develop an interpretative framework of black men’s experiences at the PPCD. The Figure provides a pictorial summary of the framework. Study results indicated that black men come to the PPCD with different emotions and different experiences. Although the majority of the men were NBBM, there is a significantly increasing number of foreign-born black men receiving a diagnosis of prostate cancer in the United States. Given that black men carry a disproportionate burden of the disease, with a significantly higher incidence compared with any other racial group, it is important that tailored services are provided to black men at the PPCD.

We also found that black men came to the PPCD diverse in terms of their ethnicity, health literacy, spirituality, trust in health care system/physician, prior experience with cancer, perceived susceptibility to cancer, delayed time for diagnosis, and fear of diagnosis. Of importance for physicians is that the black race is not homogeneous. There is a significant number of foreign-born blacks at the PPCD, and they often have different cultural beliefs and values compared with NBBM. In addition, some of the foreign-born black men may not have English proficiency and may need a medical interpreter during the PPCD consultation. In addition, a patient’s pre-existing lack of trust in the health care system may have a negative impact on the PPCD consultation. It is thus important that the physician takes the time to instill trust and make the men comfortable during the PPCD consultation.

For some of the men who had fear of a prostate cancer diagnosis and/or prior experience with cancer, cancer fatalism was experienced at the PPCD. Cancer fatalism, defined as an individual’s belief that death is bound to happen when diagnosed with cancer, has been documented as a major barrier to cancer detection and control.¹⁵ For example, fatalistic perspectives have been reported to affect cervical cancer,¹⁶ breast cancer,^17,18 colorectal cancer,¹⁹ and prostate cancer^20,21 among blacks. It is thus important to effectively address fatalistic beliefs when a man is diagnosed with prostate cancer.

Other emotions at the PPCD that may affect effective treatment decision making also need to be addressed immediately. For example, the emotions of fear, denial, and feeling overwhelmed are potential barriers to timely treatment decision making. Psycho-oncology interventions to appropriately deal with these emotions at PPCD or right after the diagnosis may be crucial for the men. In particular, a group-based psychosocial intervention focusing on: provision of education about treatment options for prostate cancer and their acute and late effects; negotiating treatment and treatment side effects; enhancing communication with treatment providers; managing distress; and engaging positive family- and community-based social support to optimize emotional, behavioral, social, and physical outcomes in black men with prostate cancer.

In addition to having physicians make them comfortable at PPCD, the PPCD needs expressed by participants included having time to come to terms with the diagnosis and receiving psycho-oncology/emotional support. Anyone who has just received a diagnosis of cancer cannot be expected to immediately continue to function as he did before the PPCD. This is especially difficult for men who are alone at the PPCD. Nevertheless, it is expected that they will listen attentively and understand subsequent consultation by the physician, then leave the consultation room almost immediately, and be able drive home or back to work right after the diagnosis. There seems to be a support gap that needs to be closed at the PPCD. Providing the men with immediate support to cope with the diagnosis may make a significant difference in effective treatment choices and eliminating treatment decisional regrets.

Methodological rigor was established through purposeful sampling, extended time with participants, standardized procedures for data collection, management and analysis, multidisciplinary interpretation, and validation of results with the community advisory board. Because the research participants were purposefully selected from a statewide database of black men diagnosed with CaP, generalizability of findings to the two target groups of NBBM and CBBM can be assumed, with the caveat that men with different experiences may have chosen not to respond to recruitment efforts or refused participation. Black men who were not sufficiently fluent in English to be interviewed were also excluded and are not represented in these findings. Black men of other nativity (including African-born black men) and residing outside of Florida were also not represented.

In conclusion, the PPCD interpretative framework developed in this study, describes the status of black men at the PPCD, their experiences during the PPCD, and their needs at the PPCD. The framework provides information that can be used by physicians to prepare for their PPCD consultation with black men as well as develop a support system for black men at the PPCD.

Acknowledgments
The authors thank the men who participated in the CaPCaS study. They also thank the CaPCaS project community advisory board chairs (Mr Jim West, Dr Angela Adams, and Prince Oladapo Odedina) and all the CaPCaS project community advisory board members for their effort throughout the project. Finally, they rxecognize the effort of additional CaPCaS scientific team, especially the primary interviewer, Mr Kenneth Stokes. Weekly meeting support for this study was provided by the University of Florida MiCaRT Center, which is funded by the NIH-National Cancer Institute Award # 1P20CA192990-02. REDCaP software was supported by the UF Clinical and Translational Science Institute, which is funded in part by the NIH Clinical and Translational Science Award program (grants UL1TR001427, KL2TR001429 and TL1TR001428).

Engaging caregivers in the management and treatment of early childhood developmental challenges is a critical component of effective intervention.¹ Family-centered care helps to promote positive outcomes with early intervention (across developmental domains), and there’s increasing evidence that parent-training programs can be effective in promoting skill generalization and targeting core impairments in toddlers with autism.²

Furthermore, a 2014 randomized controlled trial revealed that individual Early Social Interaction (ESI) with home coaching using the SCERTS (Social Communication, Emotional Regulation, and Transactional Support) curriculum was associated with improvement of a range of child outcomes, compared with group ESI. The authors commented on the importance of individualized parent coaching in natural environments as a way to improve social components of communication and receptive language for toddlers with autism.³

For many parents and at-home caregivers, however, engaging in home-based and parent-delivered interventions can be overwhelming and anxiety-provoking, as well as complicated by other barriers (competing responsibilities, cultural beliefs, and so on). Additionally, these interventions can themselves be a source of stress for some families.

Case

Jake is a 3-year-old boy with a history of global developmental delays, who presents with particular struggles: relating his expressive communication, ability to engage peers in an age-appropriate manner, and capacity to self-regulate when frustrated. He and his family participated in an comprehensive autism diagnostic assessment. In reviewing the history and presentation, considerable challenges in the two core symptom domains that characterize an autism spectrum disorder were noted. A diagnosis of autism was provided, and treatment recommendations were discussed. “What can I do at home to help Jake learn?” his mother asked, noting that, with one-on-one attention, he does seem to demonstrate increased responsiveness, less use of echolalic language, and improved eye contact.

Discussion

To complement the autism services that Jake would likely qualify for through an Early Education program, in-home interaction and play to ensure skill development was discussed at length with his mother, who readily acknowledged her own care-giving struggles that, in part, are informed by her own mental health troubles.

We openly explored Jake’s mother’s perceived challenges in engaging with her son at home and developed initial recommendations for interaction that didn’t risk overwhelming her. We impressed upon Jake’s mother that, regardless of a child’s developmental profile, toddlers use play to learn and she can be Jake’s “favorite toy.” After all, “play is really the work of childhood,” as Fred Rogers said.

With all children, back-and-forth interactions serve as the foundation for future development. Using scaffolding techniques, parent support is a primary driver of “how children develop cognitive, language, social-emotional, and higher-level thinking skills.”⁴ In particular, the quality of parental interaction can influence language development, and, when considering children with autism, there are several recommendations for what parents can do to help build social, play, and communication skills.⁵ The Hanen Program is a great resource for providers and parents to learn more about parent engagement in early learning, the power of building communication through everyday experiences and attention to responsiveness, and the use of a child’s strengths to help make family interactions more meaningful and enjoyable. Additionally, the 2012 book “An Early Start for Your Child with Autism: Using Everyday Activities to Help Kids Connect, Communicate, and Learn” by Sally Rogers, PhD, et al. is an easy-to-read text for parents and caregivers for learning effective and practical strategies for engaging their child with autism.

With Jake and his mother, our team offered the following in-home recommendations:

• Try to keep interaction fun. Be enthusiastic when encouraging Jake’s attempts to communicate.
• Teach Jake song-gesture games. Encourage him to produce routine, predictable gestures to keep the song going (in imitation of mom). Using songs with vowel emphasis is encouraged (for example: Farmer in the Dell with “E I E I OOOOO”).
• Encourage Jake to produce responsive gestures in play and daily routines not involving songs, such as open arms to receive a ball, reaching to mom when about to be tickled, or having his arms up to have his shirt taken off.
• Capitalize on Jake’s natural desires and personal preferences. Activate a wind-up toy, let it deactivate, and then hand it to Jake.
• Initiate a familiar social game with Jake until he expresses pleasure. Then stop the game and wait for him to initiate continuance.
• Adapt the environment so that Jake will need to frequently request objects of assistance to make choices (place favorite toys in clear containers which may be difficult to open so that he must request help).

Clinical pearl

The United States Department of Education recognizes the importance of family engagement in a child’s early years. Their 2015 policy statement notes that “families are their children’s first and most important teachers, advocates, and nurturers. As such, strong family engagement is central – not supplemental – to the success of early childhood systems and programs that promote children’s healthy development, learning, and wellness.”

By recognizing this principle, primary care providers are in a position to talk with parents about how much youth learn through play and regular interaction. This especially holds true for children with autism. Developing in-home strategies to facilitate active engagement, even strategies that may not be a formal component of a home-based intervention program, are instrumental in fostering positive family- and child-based outcomes and wellness.
 

Dr. Dickerson, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington, where he is director of the autism diagnostic clinic. Email him at [email protected].

References

1. Annu Rev Clin Psychol. 2010;6:447-68.

2. J Autism Dev Disord. 2010 Sep;40(9):1045-56.

3. Pediatrics. 2014 Dec;134(6):1084-93.

4. JAMA Pediatr. 2016 Feb;170(2):112-3.

5. Child Dev. 2012 Sep-Oct;83(5):1762-74.

Engaging caregivers in the management and treatment of early childhood developmental challenges is a critical component of effective intervention.¹ Family-centered care helps to promote positive outcomes with early intervention (across developmental domains), and there’s increasing evidence that parent-training programs can be effective in promoting skill generalization and targeting core impairments in toddlers with autism.²

Furthermore, a 2014 randomized controlled trial revealed that individual Early Social Interaction (ESI) with home coaching using the SCERTS (Social Communication, Emotional Regulation, and Transactional Support) curriculum was associated with improvement of a range of child outcomes, compared with group ESI. The authors commented on the importance of individualized parent coaching in natural environments as a way to improve social components of communication and receptive language for toddlers with autism.³

For many parents and at-home caregivers, however, engaging in home-based and parent-delivered interventions can be overwhelming and anxiety-provoking, as well as complicated by other barriers (competing responsibilities, cultural beliefs, and so on). Additionally, these interventions can themselves be a source of stress for some families.

Case

Jake is a 3-year-old boy with a history of global developmental delays, who presents with particular struggles: relating his expressive communication, ability to engage peers in an age-appropriate manner, and capacity to self-regulate when frustrated. He and his family participated in an comprehensive autism diagnostic assessment. In reviewing the history and presentation, considerable challenges in the two core symptom domains that characterize an autism spectrum disorder were noted. A diagnosis of autism was provided, and treatment recommendations were discussed. “What can I do at home to help Jake learn?” his mother asked, noting that, with one-on-one attention, he does seem to demonstrate increased responsiveness, less use of echolalic language, and improved eye contact.

Discussion

To complement the autism services that Jake would likely qualify for through an Early Education program, in-home interaction and play to ensure skill development was discussed at length with his mother, who readily acknowledged her own care-giving struggles that, in part, are informed by her own mental health troubles.

We openly explored Jake’s mother’s perceived challenges in engaging with her son at home and developed initial recommendations for interaction that didn’t risk overwhelming her. We impressed upon Jake’s mother that, regardless of a child’s developmental profile, toddlers use play to learn and she can be Jake’s “favorite toy.” After all, “play is really the work of childhood,” as Fred Rogers said.

With all children, back-and-forth interactions serve as the foundation for future development. Using scaffolding techniques, parent support is a primary driver of “how children develop cognitive, language, social-emotional, and higher-level thinking skills.”⁴ In particular, the quality of parental interaction can influence language development, and, when considering children with autism, there are several recommendations for what parents can do to help build social, play, and communication skills.⁵ The Hanen Program is a great resource for providers and parents to learn more about parent engagement in early learning, the power of building communication through everyday experiences and attention to responsiveness, and the use of a child’s strengths to help make family interactions more meaningful and enjoyable. Additionally, the 2012 book “An Early Start for Your Child with Autism: Using Everyday Activities to Help Kids Connect, Communicate, and Learn” by Sally Rogers, PhD, et al. is an easy-to-read text for parents and caregivers for learning effective and practical strategies for engaging their child with autism.

With Jake and his mother, our team offered the following in-home recommendations:

• Try to keep interaction fun. Be enthusiastic when encouraging Jake’s attempts to communicate.
• Teach Jake song-gesture games. Encourage him to produce routine, predictable gestures to keep the song going (in imitation of mom). Using songs with vowel emphasis is encouraged (for example: Farmer in the Dell with “E I E I OOOOO”).
• Encourage Jake to produce responsive gestures in play and daily routines not involving songs, such as open arms to receive a ball, reaching to mom when about to be tickled, or having his arms up to have his shirt taken off.
• Capitalize on Jake’s natural desires and personal preferences. Activate a wind-up toy, let it deactivate, and then hand it to Jake.
• Initiate a familiar social game with Jake until he expresses pleasure. Then stop the game and wait for him to initiate continuance.
• Adapt the environment so that Jake will need to frequently request objects of assistance to make choices (place favorite toys in clear containers which may be difficult to open so that he must request help).

Clinical pearl

The United States Department of Education recognizes the importance of family engagement in a child’s early years. Their 2015 policy statement notes that “families are their children’s first and most important teachers, advocates, and nurturers. As such, strong family engagement is central – not supplemental – to the success of early childhood systems and programs that promote children’s healthy development, learning, and wellness.”

By recognizing this principle, primary care providers are in a position to talk with parents about how much youth learn through play and regular interaction. This especially holds true for children with autism. Developing in-home strategies to facilitate active engagement, even strategies that may not be a formal component of a home-based intervention program, are instrumental in fostering positive family- and child-based outcomes and wellness.
 

Dr. Dickerson, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington, where he is director of the autism diagnostic clinic. Email him at [email protected].

References

1. Annu Rev Clin Psychol. 2010;6:447-68.

2. J Autism Dev Disord. 2010 Sep;40(9):1045-56.

3. Pediatrics. 2014 Dec;134(6):1084-93.

4. JAMA Pediatr. 2016 Feb;170(2):112-3.

5. Child Dev. 2012 Sep-Oct;83(5):1762-74.

Engaging caregivers in the management and treatment of early childhood developmental challenges is a critical component of effective intervention.¹ Family-centered care helps to promote positive outcomes with early intervention (across developmental domains), and there’s increasing evidence that parent-training programs can be effective in promoting skill generalization and targeting core impairments in toddlers with autism.²

Furthermore, a 2014 randomized controlled trial revealed that individual Early Social Interaction (ESI) with home coaching using the SCERTS (Social Communication, Emotional Regulation, and Transactional Support) curriculum was associated with improvement of a range of child outcomes, compared with group ESI. The authors commented on the importance of individualized parent coaching in natural environments as a way to improve social components of communication and receptive language for toddlers with autism.³

For many parents and at-home caregivers, however, engaging in home-based and parent-delivered interventions can be overwhelming and anxiety-provoking, as well as complicated by other barriers (competing responsibilities, cultural beliefs, and so on). Additionally, these interventions can themselves be a source of stress for some families.

Case

Jake is a 3-year-old boy with a history of global developmental delays, who presents with particular struggles: relating his expressive communication, ability to engage peers in an age-appropriate manner, and capacity to self-regulate when frustrated. He and his family participated in an comprehensive autism diagnostic assessment. In reviewing the history and presentation, considerable challenges in the two core symptom domains that characterize an autism spectrum disorder were noted. A diagnosis of autism was provided, and treatment recommendations were discussed. “What can I do at home to help Jake learn?” his mother asked, noting that, with one-on-one attention, he does seem to demonstrate increased responsiveness, less use of echolalic language, and improved eye contact.

Discussion

To complement the autism services that Jake would likely qualify for through an Early Education program, in-home interaction and play to ensure skill development was discussed at length with his mother, who readily acknowledged her own care-giving struggles that, in part, are informed by her own mental health troubles.

We openly explored Jake’s mother’s perceived challenges in engaging with her son at home and developed initial recommendations for interaction that didn’t risk overwhelming her. We impressed upon Jake’s mother that, regardless of a child’s developmental profile, toddlers use play to learn and she can be Jake’s “favorite toy.” After all, “play is really the work of childhood,” as Fred Rogers said.

With all children, back-and-forth interactions serve as the foundation for future development. Using scaffolding techniques, parent support is a primary driver of “how children develop cognitive, language, social-emotional, and higher-level thinking skills.”⁴ In particular, the quality of parental interaction can influence language development, and, when considering children with autism, there are several recommendations for what parents can do to help build social, play, and communication skills.⁵ The Hanen Program is a great resource for providers and parents to learn more about parent engagement in early learning, the power of building communication through everyday experiences and attention to responsiveness, and the use of a child’s strengths to help make family interactions more meaningful and enjoyable. Additionally, the 2012 book “An Early Start for Your Child with Autism: Using Everyday Activities to Help Kids Connect, Communicate, and Learn” by Sally Rogers, PhD, et al. is an easy-to-read text for parents and caregivers for learning effective and practical strategies for engaging their child with autism.

With Jake and his mother, our team offered the following in-home recommendations:

• Try to keep interaction fun. Be enthusiastic when encouraging Jake’s attempts to communicate.
• Teach Jake song-gesture games. Encourage him to produce routine, predictable gestures to keep the song going (in imitation of mom). Using songs with vowel emphasis is encouraged (for example: Farmer in the Dell with “E I E I OOOOO”).
• Encourage Jake to produce responsive gestures in play and daily routines not involving songs, such as open arms to receive a ball, reaching to mom when about to be tickled, or having his arms up to have his shirt taken off.
• Capitalize on Jake’s natural desires and personal preferences. Activate a wind-up toy, let it deactivate, and then hand it to Jake.
• Initiate a familiar social game with Jake until he expresses pleasure. Then stop the game and wait for him to initiate continuance.
• Adapt the environment so that Jake will need to frequently request objects of assistance to make choices (place favorite toys in clear containers which may be difficult to open so that he must request help).

Clinical pearl

The United States Department of Education recognizes the importance of family engagement in a child’s early years. Their 2015 policy statement notes that “families are their children’s first and most important teachers, advocates, and nurturers. As such, strong family engagement is central – not supplemental – to the success of early childhood systems and programs that promote children’s healthy development, learning, and wellness.”

By recognizing this principle, primary care providers are in a position to talk with parents about how much youth learn through play and regular interaction. This especially holds true for children with autism. Developing in-home strategies to facilitate active engagement, even strategies that may not be a formal component of a home-based intervention program, are instrumental in fostering positive family- and child-based outcomes and wellness.
 

Dr. Dickerson, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington, where he is director of the autism diagnostic clinic. Email him at [email protected].

References

1. Annu Rev Clin Psychol. 2010;6:447-68.

2. J Autism Dev Disord. 2010 Sep;40(9):1045-56.

3. Pediatrics. 2014 Dec;134(6):1084-93.

4. JAMA Pediatr. 2016 Feb;170(2):112-3.

5. Child Dev. 2012 Sep-Oct;83(5):1762-74.