“HIV” has become a more common internet search term than “AIDS.” That change reflects the fact that more people now are living with HIV than with AIDS. What’s more, the number of annual HIV infections fell 18% between 2008 - 2014. In honor of the progress made in changing AIDS from an almost universally fatal disease to a manageable condition, AIDS.gov has changed its name to HIV.gov.

The name change comes 36 years after the CDC’s first report of the initial cases of what became known as acquired immune deficiency syndrome. “Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives—an outcome that once seemed unattainable.”

Organizations from the HIV/AIDS community are pleased with the name change. National Minority AIDS Council Executive Director Paul Kawata applauds it, saying it “honors the past while recognizing the power of words and acknowledging that their meanings change over time.”

“HIV” has become a more common internet search term than “AIDS.” That change reflects the fact that more people now are living with HIV than with AIDS. What’s more, the number of annual HIV infections fell 18% between 2008 - 2014. In honor of the progress made in changing AIDS from an almost universally fatal disease to a manageable condition, AIDS.gov has changed its name to HIV.gov.

The name change comes 36 years after the CDC’s first report of the initial cases of what became known as acquired immune deficiency syndrome. “Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives—an outcome that once seemed unattainable.”

Organizations from the HIV/AIDS community are pleased with the name change. National Minority AIDS Council Executive Director Paul Kawata applauds it, saying it “honors the past while recognizing the power of words and acknowledging that their meanings change over time.”

“HIV” has become a more common internet search term than “AIDS.” That change reflects the fact that more people now are living with HIV than with AIDS. What’s more, the number of annual HIV infections fell 18% between 2008 - 2014. In honor of the progress made in changing AIDS from an almost universally fatal disease to a manageable condition, AIDS.gov has changed its name to HIV.gov.

The name change comes 36 years after the CDC’s first report of the initial cases of what became known as acquired immune deficiency syndrome. “Much progress has been made in HIV/AIDS research since the disease was first recognized in 1981,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “Today, lifesaving antiretroviral therapies allow those living with HIV to enjoy longer, healthier lives—an outcome that once seemed unattainable.”

Organizations from the HIV/AIDS community are pleased with the name change. National Minority AIDS Council Executive Director Paul Kawata applauds it, saying it “honors the past while recognizing the power of words and acknowledging that their meanings change over time.”

Photo by Sage Ross

BARCELONA—Three-year follow-up of the NIPPON study showed no significant difference in net clinical benefit with short-term or long-term dual antiplatelet therapy (DAPT).

Overall, there was no significant difference in safety or efficacy outcomes between patients who received 6 months of DAPT or 18 months of DAPT after placement of a drug-eluting stent (DES).

However, the data did suggest certain patients may benefit from long-term DAPT.

Details of this study were presented at ESC Congress 2017 (abstract 3831).

“These findings support and strengthen the evidence for short-term DAPT after DES deployment and may help confirm that clinical benefits of extended DAPT are reduced in patients with newer-generation DES,” said study investigator Masato Nakamura MD, PhD, of Toho University Ohashi Medical Center in Tokyo, Japan.

“The findings are important because shorter duration of therapy is less expensive and could theoretically reduce the risk of side effects.”

NIPPON enrolled 3775 patients with coronary artery disease or acute myocardial infarction who had undergone percutaneous coronary intervention and DES placement at 130 Japanese institutions.

All patients had received the Nobori bioabsorbable abluminal-coated stent. They then received DAPT—consisting of aspirin (81–162 mg/day) and clopidogrel (75 mg/day) or ticlopidine (200 mg/day)—for 6 months or 18 months.

Initial results from this trial were presented last year at ESC Congress.

The 3-year follow-up included 3307 patients—1887 who received long-term DAPT and 1886 who received short-term DAPT.

Dr Nakamura first reported the net adverse clinical and cerebrovascular events (NACCEs)—which included all-cause mortality, myocardial infarction, stroke, and major bleeding—in each arm.

Three years from the start of the study, the cumulative incidence of NACCE was 7.03% in the short-term DAPT arm and 4.85% in the long-term DAPT arm (hazard ratio [HR]=1.20, P=0.27).

In the landmark analysis, which only included data from 6 months to 3 years, the incidence of NACCE was 5.60% in the short-term DAPT arm and 3.48% in the long-term DAPT arm (HR=1.49, P=0.06).

The investigators also looked at efficacy and safety endpoints separately.

The efficacy endpoint included cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis. The safety endpoint included BARC 2, 3, or 5 bleeding.

In the landmark analysis, the incidence of the efficacy endpoint was 2.58% in the short-term DAPT arm and 1.70% in the long-term DAPT arm (HR=1.53, P=0.17). The incidence of the safety endpoint was 2.22% and 2.01%, respectively (HR=1.02, P=0.94).

Although there were no significant differences between the arms in the overall cohort, the investigators did identify patients with a high risk of ischemic events who might benefit from long-term DAPT.

In patients older than 70 who had a SYNTAX score above 23.3, the rate of efficacy events was 0% in those on long-term DAPT and 18.8% in those on short-term DAPT (HR=13.24, P=0.01).

In patients age 70 to 76 who had diabetes, the rate of efficacy events was 2.0% in those on long-term DAPT and 6.0% in those on short-term DAPT (HR=2.89, P=0.04)

“In real-world practice, it is not easy to find the balance between risks and benefits of DAPT duration, and consensus criteria for individualization therapy have not been established,” Dr Nakamura said.

“The present findings may provide some assistance, although it is essential to obtain confirmation by further investigation.”

This study was sponsored by the Association for Establishment of Evidence in Interventions. Dr Nakamura disclosed research expert witness payment from Terumo Corporation, grant support from Daiichi Sankyo and Sanofi, and honoraria from Terumo Corporation, Daiichi Sankyo, and Sanofi.

Photo by Sage Ross

BARCELONA—Three-year follow-up of the NIPPON study showed no significant difference in net clinical benefit with short-term or long-term dual antiplatelet therapy (DAPT).

Overall, there was no significant difference in safety or efficacy outcomes between patients who received 6 months of DAPT or 18 months of DAPT after placement of a drug-eluting stent (DES).

However, the data did suggest certain patients may benefit from long-term DAPT.

Details of this study were presented at ESC Congress 2017 (abstract 3831).

“These findings support and strengthen the evidence for short-term DAPT after DES deployment and may help confirm that clinical benefits of extended DAPT are reduced in patients with newer-generation DES,” said study investigator Masato Nakamura MD, PhD, of Toho University Ohashi Medical Center in Tokyo, Japan.

“The findings are important because shorter duration of therapy is less expensive and could theoretically reduce the risk of side effects.”

NIPPON enrolled 3775 patients with coronary artery disease or acute myocardial infarction who had undergone percutaneous coronary intervention and DES placement at 130 Japanese institutions.

All patients had received the Nobori bioabsorbable abluminal-coated stent. They then received DAPT—consisting of aspirin (81–162 mg/day) and clopidogrel (75 mg/day) or ticlopidine (200 mg/day)—for 6 months or 18 months.

Initial results from this trial were presented last year at ESC Congress.

The 3-year follow-up included 3307 patients—1887 who received long-term DAPT and 1886 who received short-term DAPT.

Dr Nakamura first reported the net adverse clinical and cerebrovascular events (NACCEs)—which included all-cause mortality, myocardial infarction, stroke, and major bleeding—in each arm.

Three years from the start of the study, the cumulative incidence of NACCE was 7.03% in the short-term DAPT arm and 4.85% in the long-term DAPT arm (hazard ratio [HR]=1.20, P=0.27).

In the landmark analysis, which only included data from 6 months to 3 years, the incidence of NACCE was 5.60% in the short-term DAPT arm and 3.48% in the long-term DAPT arm (HR=1.49, P=0.06).

The investigators also looked at efficacy and safety endpoints separately.

The efficacy endpoint included cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis. The safety endpoint included BARC 2, 3, or 5 bleeding.

In the landmark analysis, the incidence of the efficacy endpoint was 2.58% in the short-term DAPT arm and 1.70% in the long-term DAPT arm (HR=1.53, P=0.17). The incidence of the safety endpoint was 2.22% and 2.01%, respectively (HR=1.02, P=0.94).

Although there were no significant differences between the arms in the overall cohort, the investigators did identify patients with a high risk of ischemic events who might benefit from long-term DAPT.

In patients older than 70 who had a SYNTAX score above 23.3, the rate of efficacy events was 0% in those on long-term DAPT and 18.8% in those on short-term DAPT (HR=13.24, P=0.01).

In patients age 70 to 76 who had diabetes, the rate of efficacy events was 2.0% in those on long-term DAPT and 6.0% in those on short-term DAPT (HR=2.89, P=0.04)

“In real-world practice, it is not easy to find the balance between risks and benefits of DAPT duration, and consensus criteria for individualization therapy have not been established,” Dr Nakamura said.

“The present findings may provide some assistance, although it is essential to obtain confirmation by further investigation.”

This study was sponsored by the Association for Establishment of Evidence in Interventions. Dr Nakamura disclosed research expert witness payment from Terumo Corporation, grant support from Daiichi Sankyo and Sanofi, and honoraria from Terumo Corporation, Daiichi Sankyo, and Sanofi.

Photo by Sage Ross

BARCELONA—Three-year follow-up of the NIPPON study showed no significant difference in net clinical benefit with short-term or long-term dual antiplatelet therapy (DAPT).

Overall, there was no significant difference in safety or efficacy outcomes between patients who received 6 months of DAPT or 18 months of DAPT after placement of a drug-eluting stent (DES).

However, the data did suggest certain patients may benefit from long-term DAPT.

Details of this study were presented at ESC Congress 2017 (abstract 3831).

“These findings support and strengthen the evidence for short-term DAPT after DES deployment and may help confirm that clinical benefits of extended DAPT are reduced in patients with newer-generation DES,” said study investigator Masato Nakamura MD, PhD, of Toho University Ohashi Medical Center in Tokyo, Japan.

“The findings are important because shorter duration of therapy is less expensive and could theoretically reduce the risk of side effects.”

NIPPON enrolled 3775 patients with coronary artery disease or acute myocardial infarction who had undergone percutaneous coronary intervention and DES placement at 130 Japanese institutions.

All patients had received the Nobori bioabsorbable abluminal-coated stent. They then received DAPT—consisting of aspirin (81–162 mg/day) and clopidogrel (75 mg/day) or ticlopidine (200 mg/day)—for 6 months or 18 months.

Initial results from this trial were presented last year at ESC Congress.

The 3-year follow-up included 3307 patients—1887 who received long-term DAPT and 1886 who received short-term DAPT.

Dr Nakamura first reported the net adverse clinical and cerebrovascular events (NACCEs)—which included all-cause mortality, myocardial infarction, stroke, and major bleeding—in each arm.

Three years from the start of the study, the cumulative incidence of NACCE was 7.03% in the short-term DAPT arm and 4.85% in the long-term DAPT arm (hazard ratio [HR]=1.20, P=0.27).

In the landmark analysis, which only included data from 6 months to 3 years, the incidence of NACCE was 5.60% in the short-term DAPT arm and 3.48% in the long-term DAPT arm (HR=1.49, P=0.06).

The investigators also looked at efficacy and safety endpoints separately.

The efficacy endpoint included cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis. The safety endpoint included BARC 2, 3, or 5 bleeding.

In the landmark analysis, the incidence of the efficacy endpoint was 2.58% in the short-term DAPT arm and 1.70% in the long-term DAPT arm (HR=1.53, P=0.17). The incidence of the safety endpoint was 2.22% and 2.01%, respectively (HR=1.02, P=0.94).

Although there were no significant differences between the arms in the overall cohort, the investigators did identify patients with a high risk of ischemic events who might benefit from long-term DAPT.

In patients older than 70 who had a SYNTAX score above 23.3, the rate of efficacy events was 0% in those on long-term DAPT and 18.8% in those on short-term DAPT (HR=13.24, P=0.01).

In patients age 70 to 76 who had diabetes, the rate of efficacy events was 2.0% in those on long-term DAPT and 6.0% in those on short-term DAPT (HR=2.89, P=0.04)

“In real-world practice, it is not easy to find the balance between risks and benefits of DAPT duration, and consensus criteria for individualization therapy have not been established,” Dr Nakamura said.

“The present findings may provide some assistance, although it is essential to obtain confirmation by further investigation.”

This study was sponsored by the Association for Establishment of Evidence in Interventions. Dr Nakamura disclosed research expert witness payment from Terumo Corporation, grant support from Daiichi Sankyo and Sanofi, and honoraria from Terumo Corporation, Daiichi Sankyo, and Sanofi.

Follicular lymphoma

The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva®).

With this sBLA, Genentech is seeking approval for obinutuzumab to be used, first in combination with chemotherapy and then alone as maintenance, in patients with previously untreated follicular lymphoma (FL).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

The FDA plans to make a decision on the sBLA for obinutuzumab by December 23, 2017.

The sBLA is supported by results of the GALLIUM study, which were presented at the 2016 ASH Annual Meeting.

About obinutuzumab

Obinutuzumab is a glycoengineered, humanized, monoclonal antibody that selectively binds to the extracellular domain of the CD20 antigen on B cells.

The drug is FDA-approved for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia.

Obinutuzumab is also approved to treat FL patients who relapse after, or are refractory to, a rituximab-containing regimen. In these patients, obinutuzumab is given first in combination with bendamustine and then alone as maintenance.

The full prescribing information for obinutuzumab is available at http://www.Gazyva.com.

About the GALLIUM study

GALLIUM enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

Follicular lymphoma

The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva®).

With this sBLA, Genentech is seeking approval for obinutuzumab to be used, first in combination with chemotherapy and then alone as maintenance, in patients with previously untreated follicular lymphoma (FL).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

The FDA plans to make a decision on the sBLA for obinutuzumab by December 23, 2017.

The sBLA is supported by results of the GALLIUM study, which were presented at the 2016 ASH Annual Meeting.

About obinutuzumab

Obinutuzumab is a glycoengineered, humanized, monoclonal antibody that selectively binds to the extracellular domain of the CD20 antigen on B cells.

The drug is FDA-approved for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia.

Obinutuzumab is also approved to treat FL patients who relapse after, or are refractory to, a rituximab-containing regimen. In these patients, obinutuzumab is given first in combination with bendamustine and then alone as maintenance.

The full prescribing information for obinutuzumab is available at http://www.Gazyva.com.

About the GALLIUM study

GALLIUM enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

Follicular lymphoma

The US Food and Drug Administration (FDA) has granted priority review to a supplemental biologics license application (sBLA) for obinutuzumab (Gazyva®).

With this sBLA, Genentech is seeking approval for obinutuzumab to be used, first in combination with chemotherapy and then alone as maintenance, in patients with previously untreated follicular lymphoma (FL).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

The FDA plans to make a decision on the sBLA for obinutuzumab by December 23, 2017.

The sBLA is supported by results of the GALLIUM study, which were presented at the 2016 ASH Annual Meeting.

About obinutuzumab

Obinutuzumab is a glycoengineered, humanized, monoclonal antibody that selectively binds to the extracellular domain of the CD20 antigen on B cells.

The drug is FDA-approved for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia.

Obinutuzumab is also approved to treat FL patients who relapse after, or are refractory to, a rituximab-containing regimen. In these patients, obinutuzumab is given first in combination with bendamustine and then alone as maintenance.

The full prescribing information for obinutuzumab is available at http://www.Gazyva.com.

About the GALLIUM study

GALLIUM enrolled 1401 patients with previously untreated, indolent non-Hodgkin lymphoma, including 1202 with FL.

Half of the FL patients (n=601) were randomized to receive obinutuzumab plus chemotherapy (followed by obinutuzumab maintenance for up to 2 years), and half were randomized to rituximab plus chemotherapy (followed by rituximab maintenance for up to 2 years).

The different chemotherapies used were CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone), CVP (cyclophosphamide, vincristine, and prednisolone), and bendamustine.

Patients who received obinutuzumab had significantly better progression-free survival than patients who received rituximab. The 3-year progression-free survival rate was 73.3% in the rituximab arm and 80% in the obinutuzumab arm (hazard ratio [HR]=0.66, P=0.0012).

There was no significant difference between the treatment arms with regard to overall survival. The 3-year overall survival was 92.1% in the rituximab arm and 94% in the obinutuzumab arm (HR=0.75, P=0.21).

The overall incidence of adverse events (AEs) was 98.3% in the rituximab arm and 99.5% in the obinutuzumab arm. The incidence of serious AEs was 39.9% and 46.1%, respectively.

The incidence of grade 3 or higher AEs was higher among patients who received obinutuzumab.

Grade 3 or higher AEs occurring in at least 5% of patients in either arm (rituximab and obinutuzumab, respectively) included neutropenia (67.8% and 74.6%), leukopenia (37.9% and 43.9%), febrile neutropenia (4.9% and 6.9%), infections and infestations (3.7% and 6.7%), and thrombocytopenia (2.7% and 6.1%).

Red and white blood cells

New research suggests that bacterial infection activates hematopoietic stem cells (HSCs) and significantly reduces their ability to produce blood by forcibly inducing proliferation.

These findings indicate that bacterial infections might cause dysregulated hematopoiesis like that which occurs in patients with anemias and leukemias.

Hitoshi Takizawa, PhD, of Kumamoto University’s International Research Center for Medical Sciences in Kumamoto, Japan, and his colleagues reported these findings in Cell Stem Cell.

The researchers gave lipopolysaccharide to mice to generate a bacterial infection model and analyzed the role of Toll-like receptors (TLRs) in HSCs.

The team found that lipopolysaccharides spread throughout the body, with some eventually reaching the bone marrow. This stimulated TLR4 and induced HSCs to proliferate.

However, the stimulus also induced stress on the HSCs.

So although HSCs proliferate temporarily upon TLR4 stimulation, their ability to successfully self-replicate decreases, resulting in diminished blood production.

The researchers observed similar results after infecting mice with Salmonella Typhimurium.

“Fortunately, we were able to confirm that this molecular reaction can be inhibited by drugs,” Dr Takizawa said.

Specifically, the researchers found that activation of reactive oxygen species and p38 through TLR4 ligation is key to HSC dysfunction.

And small-molecule inhibitors of reactive oxygen species and p38 were able to prevent HSC dysfunction.

“The medication maintains the production of blood and immune cells without weakening the immune reaction against pathogenic bacteria,” Dr Takizawa said. “It might be possible to simultaneously prevent blood diseases and many bacterial infections in the future.” 

Red and white blood cells

New research suggests that bacterial infection activates hematopoietic stem cells (HSCs) and significantly reduces their ability to produce blood by forcibly inducing proliferation.

These findings indicate that bacterial infections might cause dysregulated hematopoiesis like that which occurs in patients with anemias and leukemias.

Hitoshi Takizawa, PhD, of Kumamoto University’s International Research Center for Medical Sciences in Kumamoto, Japan, and his colleagues reported these findings in Cell Stem Cell.

The researchers gave lipopolysaccharide to mice to generate a bacterial infection model and analyzed the role of Toll-like receptors (TLRs) in HSCs.

The team found that lipopolysaccharides spread throughout the body, with some eventually reaching the bone marrow. This stimulated TLR4 and induced HSCs to proliferate.

However, the stimulus also induced stress on the HSCs.

So although HSCs proliferate temporarily upon TLR4 stimulation, their ability to successfully self-replicate decreases, resulting in diminished blood production.

The researchers observed similar results after infecting mice with Salmonella Typhimurium.

“Fortunately, we were able to confirm that this molecular reaction can be inhibited by drugs,” Dr Takizawa said.

Specifically, the researchers found that activation of reactive oxygen species and p38 through TLR4 ligation is key to HSC dysfunction.

And small-molecule inhibitors of reactive oxygen species and p38 were able to prevent HSC dysfunction.

“The medication maintains the production of blood and immune cells without weakening the immune reaction against pathogenic bacteria,” Dr Takizawa said. “It might be possible to simultaneously prevent blood diseases and many bacterial infections in the future.” 

Red and white blood cells

New research suggests that bacterial infection activates hematopoietic stem cells (HSCs) and significantly reduces their ability to produce blood by forcibly inducing proliferation.

These findings indicate that bacterial infections might cause dysregulated hematopoiesis like that which occurs in patients with anemias and leukemias.

Hitoshi Takizawa, PhD, of Kumamoto University’s International Research Center for Medical Sciences in Kumamoto, Japan, and his colleagues reported these findings in Cell Stem Cell.

The researchers gave lipopolysaccharide to mice to generate a bacterial infection model and analyzed the role of Toll-like receptors (TLRs) in HSCs.

The team found that lipopolysaccharides spread throughout the body, with some eventually reaching the bone marrow. This stimulated TLR4 and induced HSCs to proliferate.

However, the stimulus also induced stress on the HSCs.

So although HSCs proliferate temporarily upon TLR4 stimulation, their ability to successfully self-replicate decreases, resulting in diminished blood production.

The researchers observed similar results after infecting mice with Salmonella Typhimurium.

“Fortunately, we were able to confirm that this molecular reaction can be inhibited by drugs,” Dr Takizawa said.

Specifically, the researchers found that activation of reactive oxygen species and p38 through TLR4 ligation is key to HSC dysfunction.

And small-molecule inhibitors of reactive oxygen species and p38 were able to prevent HSC dysfunction.

“The medication maintains the production of blood and immune cells without weakening the immune reaction against pathogenic bacteria,” Dr Takizawa said. “It might be possible to simultaneously prevent blood diseases and many bacterial infections in the future.” 

Clinical Question: Will a simplified HOSPITAL score accurately predict 30-day readmissions?

Background: Hospital readmissions stress patients and health care systems. Interventions to prevent avoidable readmissions are complex and expensive. The HOSPITAL score predicts 30-day readmissions which may help direct resources toward high risk patients.

Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.

Clinical Question: Will a simplified HOSPITAL score accurately predict 30-day readmissions?

Background: Hospital readmissions stress patients and health care systems. Interventions to prevent avoidable readmissions are complex and expensive. The HOSPITAL score predicts 30-day readmissions which may help direct resources toward high risk patients.

Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.

Clinical Question: Will a simplified HOSPITAL score accurately predict 30-day readmissions?

Background: Hospital readmissions stress patients and health care systems. Interventions to prevent avoidable readmissions are complex and expensive. The HOSPITAL score predicts 30-day readmissions which may help direct resources toward high risk patients.

Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.

Take-Home Points

• Pain relief and return of strength are important satisfaction variables for patients undergoing ARCR.
• Pain relief and strength return are equally desirable in the majority (50%) of the patients before and after ARCR.
• Overall, patient preference for strength return dominates pain relief in long-term.
• Increasing age is associated with a stronger preference for pain relief.

• Improved understanding of patient expectations after ARCR will promote meaningful changes in patient satisfaction.

A rotator cuff tear (RCT) can cause significant pain, weakness, stiffness, and loss of function in the shoulder. In most patients, arthroscopic rotator cuff repair (ARCR) provides significant and reproducible pain relief and variable return of shoulder strength and function.^1-4 ARCR outcomes are well described and well represented by validated outcome measures.^5-9 However, these outcomes do not always correlate with patient satisfaction. For example, after ARCR, 2 patients with similar outcome scores may have different satisfaction levels.

Patient satisfaction involves multiple factors and varies with the patient’s preoperative expectations and the degree to which the surgery matches the patient’s desired outcomes.^10-15 In clinical studies, Tashjian and colleagues,¹⁰ Henn and colleagues,¹¹ and O’Holleran and colleagues¹² found patient satisfaction correlated most highly with postoperative shoulder pain, shoulder function, general health status, and outcome scores. However, our understanding of patients’ desired outcomes and expectations of ARCR is limited, particularly regarding the importance of pain relief and strength return relative to each other. We believe patients’ preoperative expectations are influenced by their self-assessments of symptom severity and by their understanding of the outcomes of surgical procedures and of the information they receive from their surgeons during preoperative evaluation.

We conducted an observational study to determine patients’ preoperative preferences and the importance of post-ARCR pain relief and strength return relative to each other. After surgery, preferences and ratings of pain relief and strength return were reevaluated to determine if they were altered by outcomes. We also studied the influence of multiple factors, including severity of preoperative symptoms (pain, weakness), age, sex, occupation, and active sports involvement, on patients’ preoperative ratings of the importance of post-ARCR improvements in pain relief and strength return. We hypothesized that patients would vary in how they preoperatively value and desire post-ARCR pain relief and strength return.

Materials and Methods

The simple shoulder questionnaire (Figure) designed for this study had 12 items. Patients subjectively assessed the severity of their symptoms (pain level, shoulder weakness) and rated the importance of both pain relief and strength return to their occupational and personal life.

Before patients underwent surgery for symptomatic suspected RCTs, they were approached to participate in this prospective study. Sixty-five patients provided informed consent on forms approved by an Institutional Review Board. Inclusion criteria were suspected unilateral rotator cuff pathology and willingness to participate. Of the 65 patients, 60 underwent ARCR without another procedure, such as shoulder instability repair, SLAP (superior labrum anterior-to-posterior) repair, or distal clavicle excision; the other 5 patients elected nonoperative treatment and were excluded from review. At a mean (SD) follow-up of 5.2 (0.2) years, the 60 patients who had surgery completed the questionnaire again and rated the importance of pain relief and strength return relative to each other.

Patients with RCTs were divided according to age, sex, shoulder dominance, occupation type, and active sports involvement. Standard definitions for occupation types were used: blue-collar, manual labor jobs; white-collar, salaried/educated positions; and retired.

Matched-pairs t tests were used to compare preoperative and postoperative continuous variables (strength return preference, pain relief preference, SPD). One-way analysis of variance (ANOVA) was used to compare categorical variables (sex, shoulder dominance, active sports involvement) with continuous variables (SPD), and bivariate regression was used to compare groups with continuous data (age, SPD). In cases involving more than 2 groups (occupation types), the Tukey honestly significant difference (HSD) test was used to evaluate intergroup differences. P < .05 was used for statistical significance.

Results

ARCR Outcomes

After ARCR, there was significant improvement in patient-reported pain and subjective strength scores. Mean (SD) pain score improved from 5.9 (2.3) to 1.3 (2.3) after ARCR (P < .001), and mean (SD) strength improved from 46% (22%) of normal to 84% (17%) of normal (P < .001).

Importance of Post-ARCR Pain Relief and Strength Return

Analysis of preoperative questionnaire responses

revealed that, of 60 patients, 29 (48.3%) considered pain relief and strength return equally important, 20 (33.3%) valued postoperative strength return was more important, and 11 patients (18.3%) rated pain relief was more important than strength return. After a mean (SD) follow-up of 5.2 (0.2) years, 33 patients (55 %) valued pain relief and strength return as equally important, 17 patients (28.3%) preferred a strength recovery, and 10 patients (16.7%) preferred pain relief.

Overall patient ratings were significantly higher for strength return compared to pain relief before surgery, mean (SD), 9.2 (2.1) and 8.6 (2.3) (P = .02), and afterward, 8.9 (1.9) and 8.2 (3.1) (P = .03) (Table 1).

Subgroup Analyses

Sex and Age. Of the 60 patients, 43 were male and 17 female. Mean (SD) preoperative SPD was 1.0 (2.7) for males and 0.7 (2.3) females; the difference was not significant (P = .61). After surgery, females emphasized strength return over pain relief more than males did: Mean (SD) SPD was significantly higher (P = .04) for females, 1.7 (3.0), than for males, 0.4 (2.5). There were no preoperative–postoperative differences (P = .33) for males or females (Table 2).

Hand Dominance. RCT was found in the dominant shoulder of 31 patients (52%). Shoulder dominance did not affect SPD: Mean (SD) preoperative SPD was 1.3 (2.3) for dominant shoulders and 0.5 (2.7) for nondominant shoulders (P = .21), and postoperative SPD was 0.7 (2.6) for dominant and 0.9 (2.8) for nondominant (P = .79). SPD did not change from before surgery to after surgery for dominant (P = .14) or nondominant (P = .28) shoulders (Table 2).

Active Sports Participation. Thirty-two patients (53%) reported preoperative involvement in sports; 35 (58%) reported postoperative involvement (P = .37). Mean (SD) preoperative SPD was 1.4 (3.0) for involved patients and 0.3 (1.7) for uninvolved patients (P = .09), and postoperative SPD was 0.6 (2.8) for involved patients and 1.0 (2.6) for uninvolved patients (P = .53). SPD did not change from before surgery to after surgery for involved (P = .17) or uninvolved (P = .26) patients (Table 2).

Occupation Type. There were 9 blue-collar workers (15%), 32 white-collar workers (53%), and 19 retirees (32%). Mean (SD) preoperative SPD was 2.8 (4.2) for blue-collar workers, 1.2 (2.1) for white-collar workers, and –0.4 (0.4) for retirees. There were no significant differences in preoperative SPD between blue-collar and white-collar workers (P = .19) or between white-collar workers and retirees (P = .06), but there was a significant difference between blue-collar workers and retirees (P = .004). Mean (SD) postoperative SPD was 1.3 (2.7) for blue-collar workers, 1.2 (3.1) for white-collar workers, and –0.3 (1.6) for retirees. There were no significant differences between blue-collar and white-collar workers (P = .99), white-collar workers and retirees (P = .13), or blue-collar workers and retirees (P = .3).

Discussion

In this study, we wanted to determine patients’ pre- and postoperative preferences for pain relief and strength return after ARCR. Preoperative and postoperative preference analysis of the 60 patients who underwent ARCR revealed that the majority valued pain relief and strength return equally. However, overall, there was higher ratings for strength return in long term after ARCR, irrespective of age, sex, preoperative levels of shoulder pain and weakness, and preoperative and postoperative sports involvement.

Patients’ preoperative expectations are a function of their assessment of their symptoms, their perceptions of expected surgical outcomes, and their understanding of preoperative discussion with their surgeons. In this study, patients self-assessed their shoulder symptoms and their effect on their occupational and personal life. They also rated the importance of post-ARCR pain relief and strength return relative to each other. To assess whether surgical outcomes affected perceptions of pain relief and strength return, patients completed the questionnaire before and after surgery. Overall, patients rated postoperative strength return over pain relief on long-term (5 years).

Subgroup analysis revealed a weak positive correlation between patient-reported preoperative pain scores and ratings of the importance of pain relief after surgery, but there was no correlation between postoperative pain scores and ratings of the importance of pain relief after surgery. This finding was surprising because we thought pain relief would be more important than strength return for patients with higher pain scores.^1-3,16-21 We would like to clarify a point about this study: That patients preferred strength return over pain relief does not mean they did not care about pain relief. A substantial subset of patients (~50%) valued pain relief and strength return equally. In rotator cuff pathology, pain and weakness are to an extent interrelated. Shoulder pain that limits a patient’s ability to perform a strenuous task can be perceived as shoulder weakness, which may explain why, despite having higher pain scores, patients preferred strength return over pain relief. Increasing age showed a positive correlation with preference for pain relief, which explains the finding that retirees preferred pain relief over strength return. We used SPD to express the preference for strength return over pain relief before and after ARCR. Unfortunately, SPD may not be used to quantitatively define the preference for strength return over pain relief.

Patient satisfaction after RCR involves multiple factors and has been well studied. In a retrospective analysis of 112 patients, Tashjian and colleagues¹⁰ found that patient satisfaction was affected by preoperative expectations, marital status, disability status, preoperative pain function, and general health status after RCR. They also found a positive but weak correlation between patient satisfaction and functional outcome scores, including visual analog scale (VAS), Simple Shoulder Test (SST), and Disabilities of the Arm, Shoulder, and Hand (DASH) scores. Henn and colleagues¹¹ evaluated 125 patients who underwent primary RCR for a chronic RCT. Higher preoperative expectations correlated with better postoperative VAS, SST, DASH, and Short Form 36 performance, irrespective of worker compensation status, symptom duration, number of patient comorbidities, tear size, repair technique, and number of previous operations. In a prospective cohort analysis of 311 RCR patients, O’Holleran and colleagues¹² found that decreased patient satisfaction was associated with postoperative pain and dysfunction. Furthermore, willingness to recommend surgery to another person was significantly related to patient satisfaction. In the present study, we did not correlate preoperative expectations with postoperative outcome scores or evaluate the effect of other known factors on RCR outcomes. Our main goal was to understand ARCR patients’ preoperative and postoperative evaluations of the importance of pain relief and strength return relative to each other. Improved understanding of patients’ expectations will allow us to identify disparities between expectations and outcomes.

Our study had several limitations. First, our questionnaire was not validated. However, we used it only as an assessment tool, to collect data, and do not propose using it to assess ARCR outcomes. Second, objective strength measurements were not performed, before or after surgery, and therefore patients’ perceptions of weakness were not tested. Third, we did not correlate preoperative or postoperative shoulder outcome scores with patients’ expectations. Our intention was to understand how ARCR patients rate the importance of pain relief and strength return relative to each other. Fourth, we did not correlate patients’ expectations of strength return and pain relief with preoperative tear size or postoperative retear status.

Our observational study results showed that, before undergoing ARCR, most patients valued postoperative pain relief and strength return equally. However, there was an overall preference for strength return over pain relief. Furthermore, this preference held up irrespective of age, sex, sports involvement, or preoperative symptom severity. These findings add to our understanding of patients’ preoperative expectations of ARCR.

Am J Orthop. 2017;46(4):E244-E250. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Pain relief and return of strength are important satisfaction variables for patients undergoing ARCR.
• Pain relief and strength return are equally desirable in the majority (50%) of the patients before and after ARCR.
• Overall, patient preference for strength return dominates pain relief in long-term.
• Increasing age is associated with a stronger preference for pain relief.

• Improved understanding of patient expectations after ARCR will promote meaningful changes in patient satisfaction.

A rotator cuff tear (RCT) can cause significant pain, weakness, stiffness, and loss of function in the shoulder. In most patients, arthroscopic rotator cuff repair (ARCR) provides significant and reproducible pain relief and variable return of shoulder strength and function.^1-4 ARCR outcomes are well described and well represented by validated outcome measures.^5-9 However, these outcomes do not always correlate with patient satisfaction. For example, after ARCR, 2 patients with similar outcome scores may have different satisfaction levels.

Patient satisfaction involves multiple factors and varies with the patient’s preoperative expectations and the degree to which the surgery matches the patient’s desired outcomes.^10-15 In clinical studies, Tashjian and colleagues,¹⁰ Henn and colleagues,¹¹ and O’Holleran and colleagues¹² found patient satisfaction correlated most highly with postoperative shoulder pain, shoulder function, general health status, and outcome scores. However, our understanding of patients’ desired outcomes and expectations of ARCR is limited, particularly regarding the importance of pain relief and strength return relative to each other. We believe patients’ preoperative expectations are influenced by their self-assessments of symptom severity and by their understanding of the outcomes of surgical procedures and of the information they receive from their surgeons during preoperative evaluation.

We conducted an observational study to determine patients’ preoperative preferences and the importance of post-ARCR pain relief and strength return relative to each other. After surgery, preferences and ratings of pain relief and strength return were reevaluated to determine if they were altered by outcomes. We also studied the influence of multiple factors, including severity of preoperative symptoms (pain, weakness), age, sex, occupation, and active sports involvement, on patients’ preoperative ratings of the importance of post-ARCR improvements in pain relief and strength return. We hypothesized that patients would vary in how they preoperatively value and desire post-ARCR pain relief and strength return.

Materials and Methods

The simple shoulder questionnaire (Figure) designed for this study had 12 items. Patients subjectively assessed the severity of their symptoms (pain level, shoulder weakness) and rated the importance of both pain relief and strength return to their occupational and personal life.

Before patients underwent surgery for symptomatic suspected RCTs, they were approached to participate in this prospective study. Sixty-five patients provided informed consent on forms approved by an Institutional Review Board. Inclusion criteria were suspected unilateral rotator cuff pathology and willingness to participate. Of the 65 patients, 60 underwent ARCR without another procedure, such as shoulder instability repair, SLAP (superior labrum anterior-to-posterior) repair, or distal clavicle excision; the other 5 patients elected nonoperative treatment and were excluded from review. At a mean (SD) follow-up of 5.2 (0.2) years, the 60 patients who had surgery completed the questionnaire again and rated the importance of pain relief and strength return relative to each other.

Patients with RCTs were divided according to age, sex, shoulder dominance, occupation type, and active sports involvement. Standard definitions for occupation types were used: blue-collar, manual labor jobs; white-collar, salaried/educated positions; and retired.

Matched-pairs t tests were used to compare preoperative and postoperative continuous variables (strength return preference, pain relief preference, SPD). One-way analysis of variance (ANOVA) was used to compare categorical variables (sex, shoulder dominance, active sports involvement) with continuous variables (SPD), and bivariate regression was used to compare groups with continuous data (age, SPD). In cases involving more than 2 groups (occupation types), the Tukey honestly significant difference (HSD) test was used to evaluate intergroup differences. P < .05 was used for statistical significance.

Results

ARCR Outcomes

After ARCR, there was significant improvement in patient-reported pain and subjective strength scores. Mean (SD) pain score improved from 5.9 (2.3) to 1.3 (2.3) after ARCR (P < .001), and mean (SD) strength improved from 46% (22%) of normal to 84% (17%) of normal (P < .001).

Importance of Post-ARCR Pain Relief and Strength Return

Analysis of preoperative questionnaire responses

revealed that, of 60 patients, 29 (48.3%) considered pain relief and strength return equally important, 20 (33.3%) valued postoperative strength return was more important, and 11 patients (18.3%) rated pain relief was more important than strength return. After a mean (SD) follow-up of 5.2 (0.2) years, 33 patients (55 %) valued pain relief and strength return as equally important, 17 patients (28.3%) preferred a strength recovery, and 10 patients (16.7%) preferred pain relief.

Overall patient ratings were significantly higher for strength return compared to pain relief before surgery, mean (SD), 9.2 (2.1) and 8.6 (2.3) (P = .02), and afterward, 8.9 (1.9) and 8.2 (3.1) (P = .03) (Table 1).

Subgroup Analyses

Sex and Age. Of the 60 patients, 43 were male and 17 female. Mean (SD) preoperative SPD was 1.0 (2.7) for males and 0.7 (2.3) females; the difference was not significant (P = .61). After surgery, females emphasized strength return over pain relief more than males did: Mean (SD) SPD was significantly higher (P = .04) for females, 1.7 (3.0), than for males, 0.4 (2.5). There were no preoperative–postoperative differences (P = .33) for males or females (Table 2).

Hand Dominance. RCT was found in the dominant shoulder of 31 patients (52%). Shoulder dominance did not affect SPD: Mean (SD) preoperative SPD was 1.3 (2.3) for dominant shoulders and 0.5 (2.7) for nondominant shoulders (P = .21), and postoperative SPD was 0.7 (2.6) for dominant and 0.9 (2.8) for nondominant (P = .79). SPD did not change from before surgery to after surgery for dominant (P = .14) or nondominant (P = .28) shoulders (Table 2).

Active Sports Participation. Thirty-two patients (53%) reported preoperative involvement in sports; 35 (58%) reported postoperative involvement (P = .37). Mean (SD) preoperative SPD was 1.4 (3.0) for involved patients and 0.3 (1.7) for uninvolved patients (P = .09), and postoperative SPD was 0.6 (2.8) for involved patients and 1.0 (2.6) for uninvolved patients (P = .53). SPD did not change from before surgery to after surgery for involved (P = .17) or uninvolved (P = .26) patients (Table 2).

Occupation Type. There were 9 blue-collar workers (15%), 32 white-collar workers (53%), and 19 retirees (32%). Mean (SD) preoperative SPD was 2.8 (4.2) for blue-collar workers, 1.2 (2.1) for white-collar workers, and –0.4 (0.4) for retirees. There were no significant differences in preoperative SPD between blue-collar and white-collar workers (P = .19) or between white-collar workers and retirees (P = .06), but there was a significant difference between blue-collar workers and retirees (P = .004). Mean (SD) postoperative SPD was 1.3 (2.7) for blue-collar workers, 1.2 (3.1) for white-collar workers, and –0.3 (1.6) for retirees. There were no significant differences between blue-collar and white-collar workers (P = .99), white-collar workers and retirees (P = .13), or blue-collar workers and retirees (P = .3).

Discussion

In this study, we wanted to determine patients’ pre- and postoperative preferences for pain relief and strength return after ARCR. Preoperative and postoperative preference analysis of the 60 patients who underwent ARCR revealed that the majority valued pain relief and strength return equally. However, overall, there was higher ratings for strength return in long term after ARCR, irrespective of age, sex, preoperative levels of shoulder pain and weakness, and preoperative and postoperative sports involvement.

Patients’ preoperative expectations are a function of their assessment of their symptoms, their perceptions of expected surgical outcomes, and their understanding of preoperative discussion with their surgeons. In this study, patients self-assessed their shoulder symptoms and their effect on their occupational and personal life. They also rated the importance of post-ARCR pain relief and strength return relative to each other. To assess whether surgical outcomes affected perceptions of pain relief and strength return, patients completed the questionnaire before and after surgery. Overall, patients rated postoperative strength return over pain relief on long-term (5 years).

Subgroup analysis revealed a weak positive correlation between patient-reported preoperative pain scores and ratings of the importance of pain relief after surgery, but there was no correlation between postoperative pain scores and ratings of the importance of pain relief after surgery. This finding was surprising because we thought pain relief would be more important than strength return for patients with higher pain scores.^1-3,16-21 We would like to clarify a point about this study: That patients preferred strength return over pain relief does not mean they did not care about pain relief. A substantial subset of patients (~50%) valued pain relief and strength return equally. In rotator cuff pathology, pain and weakness are to an extent interrelated. Shoulder pain that limits a patient’s ability to perform a strenuous task can be perceived as shoulder weakness, which may explain why, despite having higher pain scores, patients preferred strength return over pain relief. Increasing age showed a positive correlation with preference for pain relief, which explains the finding that retirees preferred pain relief over strength return. We used SPD to express the preference for strength return over pain relief before and after ARCR. Unfortunately, SPD may not be used to quantitatively define the preference for strength return over pain relief.

Patient satisfaction after RCR involves multiple factors and has been well studied. In a retrospective analysis of 112 patients, Tashjian and colleagues¹⁰ found that patient satisfaction was affected by preoperative expectations, marital status, disability status, preoperative pain function, and general health status after RCR. They also found a positive but weak correlation between patient satisfaction and functional outcome scores, including visual analog scale (VAS), Simple Shoulder Test (SST), and Disabilities of the Arm, Shoulder, and Hand (DASH) scores. Henn and colleagues¹¹ evaluated 125 patients who underwent primary RCR for a chronic RCT. Higher preoperative expectations correlated with better postoperative VAS, SST, DASH, and Short Form 36 performance, irrespective of worker compensation status, symptom duration, number of patient comorbidities, tear size, repair technique, and number of previous operations. In a prospective cohort analysis of 311 RCR patients, O’Holleran and colleagues¹² found that decreased patient satisfaction was associated with postoperative pain and dysfunction. Furthermore, willingness to recommend surgery to another person was significantly related to patient satisfaction. In the present study, we did not correlate preoperative expectations with postoperative outcome scores or evaluate the effect of other known factors on RCR outcomes. Our main goal was to understand ARCR patients’ preoperative and postoperative evaluations of the importance of pain relief and strength return relative to each other. Improved understanding of patients’ expectations will allow us to identify disparities between expectations and outcomes.

Our study had several limitations. First, our questionnaire was not validated. However, we used it only as an assessment tool, to collect data, and do not propose using it to assess ARCR outcomes. Second, objective strength measurements were not performed, before or after surgery, and therefore patients’ perceptions of weakness were not tested. Third, we did not correlate preoperative or postoperative shoulder outcome scores with patients’ expectations. Our intention was to understand how ARCR patients rate the importance of pain relief and strength return relative to each other. Fourth, we did not correlate patients’ expectations of strength return and pain relief with preoperative tear size or postoperative retear status.

Our observational study results showed that, before undergoing ARCR, most patients valued postoperative pain relief and strength return equally. However, there was an overall preference for strength return over pain relief. Furthermore, this preference held up irrespective of age, sex, sports involvement, or preoperative symptom severity. These findings add to our understanding of patients’ preoperative expectations of ARCR.

Am J Orthop. 2017;46(4):E244-E250. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

• Pain relief and return of strength are important satisfaction variables for patients undergoing ARCR.
• Pain relief and strength return are equally desirable in the majority (50%) of the patients before and after ARCR.
• Overall, patient preference for strength return dominates pain relief in long-term.
• Increasing age is associated with a stronger preference for pain relief.

• Improved understanding of patient expectations after ARCR will promote meaningful changes in patient satisfaction.

A rotator cuff tear (RCT) can cause significant pain, weakness, stiffness, and loss of function in the shoulder. In most patients, arthroscopic rotator cuff repair (ARCR) provides significant and reproducible pain relief and variable return of shoulder strength and function.^1-4 ARCR outcomes are well described and well represented by validated outcome measures.^5-9 However, these outcomes do not always correlate with patient satisfaction. For example, after ARCR, 2 patients with similar outcome scores may have different satisfaction levels.

Patient satisfaction involves multiple factors and varies with the patient’s preoperative expectations and the degree to which the surgery matches the patient’s desired outcomes.^10-15 In clinical studies, Tashjian and colleagues,¹⁰ Henn and colleagues,¹¹ and O’Holleran and colleagues¹² found patient satisfaction correlated most highly with postoperative shoulder pain, shoulder function, general health status, and outcome scores. However, our understanding of patients’ desired outcomes and expectations of ARCR is limited, particularly regarding the importance of pain relief and strength return relative to each other. We believe patients’ preoperative expectations are influenced by their self-assessments of symptom severity and by their understanding of the outcomes of surgical procedures and of the information they receive from their surgeons during preoperative evaluation.

We conducted an observational study to determine patients’ preoperative preferences and the importance of post-ARCR pain relief and strength return relative to each other. After surgery, preferences and ratings of pain relief and strength return were reevaluated to determine if they were altered by outcomes. We also studied the influence of multiple factors, including severity of preoperative symptoms (pain, weakness), age, sex, occupation, and active sports involvement, on patients’ preoperative ratings of the importance of post-ARCR improvements in pain relief and strength return. We hypothesized that patients would vary in how they preoperatively value and desire post-ARCR pain relief and strength return.

Materials and Methods

The simple shoulder questionnaire (Figure) designed for this study had 12 items. Patients subjectively assessed the severity of their symptoms (pain level, shoulder weakness) and rated the importance of both pain relief and strength return to their occupational and personal life.

Before patients underwent surgery for symptomatic suspected RCTs, they were approached to participate in this prospective study. Sixty-five patients provided informed consent on forms approved by an Institutional Review Board. Inclusion criteria were suspected unilateral rotator cuff pathology and willingness to participate. Of the 65 patients, 60 underwent ARCR without another procedure, such as shoulder instability repair, SLAP (superior labrum anterior-to-posterior) repair, or distal clavicle excision; the other 5 patients elected nonoperative treatment and were excluded from review. At a mean (SD) follow-up of 5.2 (0.2) years, the 60 patients who had surgery completed the questionnaire again and rated the importance of pain relief and strength return relative to each other.

Patients with RCTs were divided according to age, sex, shoulder dominance, occupation type, and active sports involvement. Standard definitions for occupation types were used: blue-collar, manual labor jobs; white-collar, salaried/educated positions; and retired.

Matched-pairs t tests were used to compare preoperative and postoperative continuous variables (strength return preference, pain relief preference, SPD). One-way analysis of variance (ANOVA) was used to compare categorical variables (sex, shoulder dominance, active sports involvement) with continuous variables (SPD), and bivariate regression was used to compare groups with continuous data (age, SPD). In cases involving more than 2 groups (occupation types), the Tukey honestly significant difference (HSD) test was used to evaluate intergroup differences. P < .05 was used for statistical significance.

Results

ARCR Outcomes

After ARCR, there was significant improvement in patient-reported pain and subjective strength scores. Mean (SD) pain score improved from 5.9 (2.3) to 1.3 (2.3) after ARCR (P < .001), and mean (SD) strength improved from 46% (22%) of normal to 84% (17%) of normal (P < .001).

Importance of Post-ARCR Pain Relief and Strength Return

Analysis of preoperative questionnaire responses

revealed that, of 60 patients, 29 (48.3%) considered pain relief and strength return equally important, 20 (33.3%) valued postoperative strength return was more important, and 11 patients (18.3%) rated pain relief was more important than strength return. After a mean (SD) follow-up of 5.2 (0.2) years, 33 patients (55 %) valued pain relief and strength return as equally important, 17 patients (28.3%) preferred a strength recovery, and 10 patients (16.7%) preferred pain relief.

Overall patient ratings were significantly higher for strength return compared to pain relief before surgery, mean (SD), 9.2 (2.1) and 8.6 (2.3) (P = .02), and afterward, 8.9 (1.9) and 8.2 (3.1) (P = .03) (Table 1).

Subgroup Analyses

Sex and Age. Of the 60 patients, 43 were male and 17 female. Mean (SD) preoperative SPD was 1.0 (2.7) for males and 0.7 (2.3) females; the difference was not significant (P = .61). After surgery, females emphasized strength return over pain relief more than males did: Mean (SD) SPD was significantly higher (P = .04) for females, 1.7 (3.0), than for males, 0.4 (2.5). There were no preoperative–postoperative differences (P = .33) for males or females (Table 2).

Hand Dominance. RCT was found in the dominant shoulder of 31 patients (52%). Shoulder dominance did not affect SPD: Mean (SD) preoperative SPD was 1.3 (2.3) for dominant shoulders and 0.5 (2.7) for nondominant shoulders (P = .21), and postoperative SPD was 0.7 (2.6) for dominant and 0.9 (2.8) for nondominant (P = .79). SPD did not change from before surgery to after surgery for dominant (P = .14) or nondominant (P = .28) shoulders (Table 2).

Active Sports Participation. Thirty-two patients (53%) reported preoperative involvement in sports; 35 (58%) reported postoperative involvement (P = .37). Mean (SD) preoperative SPD was 1.4 (3.0) for involved patients and 0.3 (1.7) for uninvolved patients (P = .09), and postoperative SPD was 0.6 (2.8) for involved patients and 1.0 (2.6) for uninvolved patients (P = .53). SPD did not change from before surgery to after surgery for involved (P = .17) or uninvolved (P = .26) patients (Table 2).

Occupation Type. There were 9 blue-collar workers (15%), 32 white-collar workers (53%), and 19 retirees (32%). Mean (SD) preoperative SPD was 2.8 (4.2) for blue-collar workers, 1.2 (2.1) for white-collar workers, and –0.4 (0.4) for retirees. There were no significant differences in preoperative SPD between blue-collar and white-collar workers (P = .19) or between white-collar workers and retirees (P = .06), but there was a significant difference between blue-collar workers and retirees (P = .004). Mean (SD) postoperative SPD was 1.3 (2.7) for blue-collar workers, 1.2 (3.1) for white-collar workers, and –0.3 (1.6) for retirees. There were no significant differences between blue-collar and white-collar workers (P = .99), white-collar workers and retirees (P = .13), or blue-collar workers and retirees (P = .3).

Discussion

In this study, we wanted to determine patients’ pre- and postoperative preferences for pain relief and strength return after ARCR. Preoperative and postoperative preference analysis of the 60 patients who underwent ARCR revealed that the majority valued pain relief and strength return equally. However, overall, there was higher ratings for strength return in long term after ARCR, irrespective of age, sex, preoperative levels of shoulder pain and weakness, and preoperative and postoperative sports involvement.

Patients’ preoperative expectations are a function of their assessment of their symptoms, their perceptions of expected surgical outcomes, and their understanding of preoperative discussion with their surgeons. In this study, patients self-assessed their shoulder symptoms and their effect on their occupational and personal life. They also rated the importance of post-ARCR pain relief and strength return relative to each other. To assess whether surgical outcomes affected perceptions of pain relief and strength return, patients completed the questionnaire before and after surgery. Overall, patients rated postoperative strength return over pain relief on long-term (5 years).

Subgroup analysis revealed a weak positive correlation between patient-reported preoperative pain scores and ratings of the importance of pain relief after surgery, but there was no correlation between postoperative pain scores and ratings of the importance of pain relief after surgery. This finding was surprising because we thought pain relief would be more important than strength return for patients with higher pain scores.^1-3,16-21 We would like to clarify a point about this study: That patients preferred strength return over pain relief does not mean they did not care about pain relief. A substantial subset of patients (~50%) valued pain relief and strength return equally. In rotator cuff pathology, pain and weakness are to an extent interrelated. Shoulder pain that limits a patient’s ability to perform a strenuous task can be perceived as shoulder weakness, which may explain why, despite having higher pain scores, patients preferred strength return over pain relief. Increasing age showed a positive correlation with preference for pain relief, which explains the finding that retirees preferred pain relief over strength return. We used SPD to express the preference for strength return over pain relief before and after ARCR. Unfortunately, SPD may not be used to quantitatively define the preference for strength return over pain relief.

Patient satisfaction after RCR involves multiple factors and has been well studied. In a retrospective analysis of 112 patients, Tashjian and colleagues¹⁰ found that patient satisfaction was affected by preoperative expectations, marital status, disability status, preoperative pain function, and general health status after RCR. They also found a positive but weak correlation between patient satisfaction and functional outcome scores, including visual analog scale (VAS), Simple Shoulder Test (SST), and Disabilities of the Arm, Shoulder, and Hand (DASH) scores. Henn and colleagues¹¹ evaluated 125 patients who underwent primary RCR for a chronic RCT. Higher preoperative expectations correlated with better postoperative VAS, SST, DASH, and Short Form 36 performance, irrespective of worker compensation status, symptom duration, number of patient comorbidities, tear size, repair technique, and number of previous operations. In a prospective cohort analysis of 311 RCR patients, O’Holleran and colleagues¹² found that decreased patient satisfaction was associated with postoperative pain and dysfunction. Furthermore, willingness to recommend surgery to another person was significantly related to patient satisfaction. In the present study, we did not correlate preoperative expectations with postoperative outcome scores or evaluate the effect of other known factors on RCR outcomes. Our main goal was to understand ARCR patients’ preoperative and postoperative evaluations of the importance of pain relief and strength return relative to each other. Improved understanding of patients’ expectations will allow us to identify disparities between expectations and outcomes.

Our study had several limitations. First, our questionnaire was not validated. However, we used it only as an assessment tool, to collect data, and do not propose using it to assess ARCR outcomes. Second, objective strength measurements were not performed, before or after surgery, and therefore patients’ perceptions of weakness were not tested. Third, we did not correlate preoperative or postoperative shoulder outcome scores with patients’ expectations. Our intention was to understand how ARCR patients rate the importance of pain relief and strength return relative to each other. Fourth, we did not correlate patients’ expectations of strength return and pain relief with preoperative tear size or postoperative retear status.

Our observational study results showed that, before undergoing ARCR, most patients valued postoperative pain relief and strength return equally. However, there was an overall preference for strength return over pain relief. Furthermore, this preference held up irrespective of age, sex, sports involvement, or preoperative symptom severity. These findings add to our understanding of patients’ preoperative expectations of ARCR.

Am J Orthop. 2017;46(4):E244-E250. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Titers of postdose three G1 serum-neutralizing antibody (PD3 G1 SNA) appear to be the best correlate of protection for pentavalent rotavirus vaccine (RV5), reported G. Frank Liu, PhD, and his associates at Merck in Kenilworth, N.J.

The researchers discovered this by analyzing data from five clinical trials of RV5 at both the individual and aggregated population level. Also, by looking at immunogenicity measures and case status of individuals from phase 2 and 3 trials of RV5, they found that “higher PD3 G1 SNA titers are associated with lower odds of contracting any [rotavirus gastroenteritis].”

CDC/Dr. Erskine Palmer

Titers of postdose three G1 serum-neutralizing antibody (PD3 G1 SNA) appear to be the best correlate of protection for pentavalent rotavirus vaccine (RV5), reported G. Frank Liu, PhD, and his associates at Merck in Kenilworth, N.J.

The researchers discovered this by analyzing data from five clinical trials of RV5 at both the individual and aggregated population level. Also, by looking at immunogenicity measures and case status of individuals from phase 2 and 3 trials of RV5, they found that “higher PD3 G1 SNA titers are associated with lower odds of contracting any [rotavirus gastroenteritis].”

CDC/Dr. Erskine Palmer

Titers of postdose three G1 serum-neutralizing antibody (PD3 G1 SNA) appear to be the best correlate of protection for pentavalent rotavirus vaccine (RV5), reported G. Frank Liu, PhD, and his associates at Merck in Kenilworth, N.J.

The researchers discovered this by analyzing data from five clinical trials of RV5 at both the individual and aggregated population level. Also, by looking at immunogenicity measures and case status of individuals from phase 2 and 3 trials of RV5, they found that “higher PD3 G1 SNA titers are associated with lower odds of contracting any [rotavirus gastroenteritis].”

CDC/Dr. Erskine Palmer

A) Globular enlarged uterus INCORRECT
A homogeneously enlarged uterus in the absence of fibroids is characteristic of adenomyosis.¹

A) Globular enlarged uterus INCORRECT
A homogeneously enlarged uterus in the absence of fibroids is characteristic of adenomyosis.¹

A) Globular enlarged uterus INCORRECT
A homogeneously enlarged uterus in the absence of fibroids is characteristic of adenomyosis.¹

Reported rates of side effects of a bivalent serogroup B meningococcal vaccine given to college students were lower or similar to those in clinical trials, said Theresa M. Fiorito, MD, of Brown University, Providence, R.I., and her associates.

In February 2015, two unlinked, culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island, and a bivalent MenB vaccine subsequently was administered. After the first-dose vaccination clinic, a 94% coverage rate was achieved, and there were no other cases of MenB disease. Injection site pain occurred in 78% of 1,736 students after dose one, in 64% of 1,395 after dose two, and in 71% of 609 students after dose three.

Micah Young/istockphoto

[email protected]

Reported rates of side effects of a bivalent serogroup B meningococcal vaccine given to college students were lower or similar to those in clinical trials, said Theresa M. Fiorito, MD, of Brown University, Providence, R.I., and her associates.

In February 2015, two unlinked, culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island, and a bivalent MenB vaccine subsequently was administered. After the first-dose vaccination clinic, a 94% coverage rate was achieved, and there were no other cases of MenB disease. Injection site pain occurred in 78% of 1,736 students after dose one, in 64% of 1,395 after dose two, and in 71% of 609 students after dose three.

Micah Young/istockphoto

[email protected]

Reported rates of side effects of a bivalent serogroup B meningococcal vaccine given to college students were lower or similar to those in clinical trials, said Theresa M. Fiorito, MD, of Brown University, Providence, R.I., and her associates.

In February 2015, two unlinked, culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island, and a bivalent MenB vaccine subsequently was administered. After the first-dose vaccination clinic, a 94% coverage rate was achieved, and there were no other cases of MenB disease. Injection site pain occurred in 78% of 1,736 students after dose one, in 64% of 1,395 after dose two, and in 71% of 609 students after dose three.

Micah Young/istockphoto

[email protected]