SHM Fellows designation is a prestigious way to differentiate yourself in the rapidly growing profession of hospital medicine. There are currently 2,000 hospitalists who have earned the FHM/SFHM designation by demonstrating core values of leadership, teamwork, and quality improvement.

The application process is now open. Apply by Sept. 15 to receive an early decision on or before Oct. 28. The regular decision application will remain open through Nov. 30, with a decision notification on or before Dec. 31. Apply now and learn how you can join other hospitalists who have earned this exclusive designation and recognition at www.hospitalmedicine.org/fellows.

SHM Fellows designation is a prestigious way to differentiate yourself in the rapidly growing profession of hospital medicine. There are currently 2,000 hospitalists who have earned the FHM/SFHM designation by demonstrating core values of leadership, teamwork, and quality improvement.

The application process is now open. Apply by Sept. 15 to receive an early decision on or before Oct. 28. The regular decision application will remain open through Nov. 30, with a decision notification on or before Dec. 31. Apply now and learn how you can join other hospitalists who have earned this exclusive designation and recognition at www.hospitalmedicine.org/fellows.

SHM Fellows designation is a prestigious way to differentiate yourself in the rapidly growing profession of hospital medicine. There are currently 2,000 hospitalists who have earned the FHM/SFHM designation by demonstrating core values of leadership, teamwork, and quality improvement.

The application process is now open. Apply by Sept. 15 to receive an early decision on or before Oct. 28. The regular decision application will remain open through Nov. 30, with a decision notification on or before Dec. 31. Apply now and learn how you can join other hospitalists who have earned this exclusive designation and recognition at www.hospitalmedicine.org/fellows.

The eighth annual Academic Hospitalist Academy (AHA) will be held Sept. 12–15 at the Lakeway Resort and Spa in Austin, Texas. This is a can’t-miss event for academic hospitalists. At AHA, you will:

• Gain valuable tools for career development
• Establish a national network
• Take advantage of an effective learning environment with a 1:10

  faculty-to-student ratio

• Develop scholarly work and increase scholarly output
• Earn CME credit

Seats are limited. Reserve your spot now at www.academichospitalist.org.

The eighth annual Academic Hospitalist Academy (AHA) will be held Sept. 12–15 at the Lakeway Resort and Spa in Austin, Texas. This is a can’t-miss event for academic hospitalists. At AHA, you will:

• Gain valuable tools for career development
• Establish a national network
• Take advantage of an effective learning environment with a 1:10

  faculty-to-student ratio

• Develop scholarly work and increase scholarly output
• Earn CME credit

Seats are limited. Reserve your spot now at www.academichospitalist.org.

The eighth annual Academic Hospitalist Academy (AHA) will be held Sept. 12–15 at the Lakeway Resort and Spa in Austin, Texas. This is a can’t-miss event for academic hospitalists. At AHA, you will:

• Gain valuable tools for career development
• Establish a national network
• Take advantage of an effective learning environment with a 1:10

  faculty-to-student ratio

• Develop scholarly work and increase scholarly output
• Earn CME credit

Seats are limited. Reserve your spot now at www.academichospitalist.org.

Brentuximab vedotin

Photo from Business Wire

The European Commission (EC) has extended the current conditional marketing authorization of brentuximab vedotin (Adcetris) to include the treatment of adults with CD30+ Hodgkin lymphoma (HL) who are at an increased risk of relapse or progression following autologous stem cell transplant (ASCT).

Conditional marketing authorizations are valid for 1 year and are reviewed annually.

The company developing the drug is required to provide comprehensive data confirming the drug’s benefit-risk balance is positive. Once these data are available, the marketing authorization may be converted into a standard marketing authorization.

Drugs are eligible for conditional marketing authorization if they are designated as orphan medicines, intended for use in emergency situations, or designed to treat, prevent, or diagnose seriously debilitating or life-threatening diseases.

The EC previously granted brentuximab vedotin conditional marketing authorization for 2 indications:

• To treat adults with relapsed or refractory CD30+ HL after ASCT or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option
• To treat adults with relapsed or refractory systemic anaplastic large-cell lymphoma (sALCL).

In January 2016, the EC approved a Type II variation to include data on the retreatment of adult patients with HL or sALCL who previously responded to brentuximab vedotin and later relapsed.

Brentuximab vedotin is under joint development by Seattle Genetics and Takeda Pharmaceutical Company Limited.

AETHERA trial

The EC’s decision to extend the conditional marketing authorization of brentuximab vedotin is based on results from the phase 3 AETHERA trial.

The trial was designed to compare brentuximab vedotin to placebo, both administered for up to 16 cycles (approximately 1 year) every 3 weeks following ASCT. Results from the trial were published in The Lancet in March 2015 and presented at the 2014 ASH Annual Meeting.

The study enrolled 329 HL patients at risk of relapse or progression, including 165 on the brentuximab vedotin arm and 164 on the placebo arm.

Patients were eligible for enrollment if they had a history of primary refractory HL, relapsed within a year of receiving frontline chemotherapy, and/or had disease outside of the lymph nodes at the time of pre-ASCT relapse.

Brentuximab vedotin conferred a significant increase in progression-free survival over placebo, with a hazard ratio of 0.57 (P=0.001). The median progression-free survival was 43 months for patients who received brentuximab vedotin and 24 months for those who received placebo.

The most common adverse events (≥20%), of any grade and regardless of causality, in the brentuximab vedotin arm were neutropenia (78%), peripheral sensory neuropathy (56%), thrombocytopenia (41%), anemia (27%), upper respiratory tract infection (26%), fatigue (24%), peripheral motor neuropathy (23%), nausea (22%), cough (21%), and diarrhea (20%).

The most common adverse events (≥20%), of any grade and regardless of causality, in the placebo arm were neutropenia (34%), upper respiratory tract infection (23%), and thrombocytopenia (20%).

In all, 67% of patients on the brentuximab vedotin arm experienced peripheral neuropathy. Of those patients, 85% had resolution (59%) or partial improvement (26%) in symptoms at the time of their last evaluation, with a median time to improvement of 23 weeks (range, 0.1-138).

Brentuximab vedotin

Photo from Business Wire

The European Commission (EC) has extended the current conditional marketing authorization of brentuximab vedotin (Adcetris) to include the treatment of adults with CD30+ Hodgkin lymphoma (HL) who are at an increased risk of relapse or progression following autologous stem cell transplant (ASCT).

Conditional marketing authorizations are valid for 1 year and are reviewed annually.

The company developing the drug is required to provide comprehensive data confirming the drug’s benefit-risk balance is positive. Once these data are available, the marketing authorization may be converted into a standard marketing authorization.

Drugs are eligible for conditional marketing authorization if they are designated as orphan medicines, intended for use in emergency situations, or designed to treat, prevent, or diagnose seriously debilitating or life-threatening diseases.

The EC previously granted brentuximab vedotin conditional marketing authorization for 2 indications:

• To treat adults with relapsed or refractory CD30+ HL after ASCT or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option
• To treat adults with relapsed or refractory systemic anaplastic large-cell lymphoma (sALCL).

In January 2016, the EC approved a Type II variation to include data on the retreatment of adult patients with HL or sALCL who previously responded to brentuximab vedotin and later relapsed.

Brentuximab vedotin is under joint development by Seattle Genetics and Takeda Pharmaceutical Company Limited.

AETHERA trial

The EC’s decision to extend the conditional marketing authorization of brentuximab vedotin is based on results from the phase 3 AETHERA trial.

The trial was designed to compare brentuximab vedotin to placebo, both administered for up to 16 cycles (approximately 1 year) every 3 weeks following ASCT. Results from the trial were published in The Lancet in March 2015 and presented at the 2014 ASH Annual Meeting.

The study enrolled 329 HL patients at risk of relapse or progression, including 165 on the brentuximab vedotin arm and 164 on the placebo arm.

Patients were eligible for enrollment if they had a history of primary refractory HL, relapsed within a year of receiving frontline chemotherapy, and/or had disease outside of the lymph nodes at the time of pre-ASCT relapse.

Brentuximab vedotin conferred a significant increase in progression-free survival over placebo, with a hazard ratio of 0.57 (P=0.001). The median progression-free survival was 43 months for patients who received brentuximab vedotin and 24 months for those who received placebo.

The most common adverse events (≥20%), of any grade and regardless of causality, in the brentuximab vedotin arm were neutropenia (78%), peripheral sensory neuropathy (56%), thrombocytopenia (41%), anemia (27%), upper respiratory tract infection (26%), fatigue (24%), peripheral motor neuropathy (23%), nausea (22%), cough (21%), and diarrhea (20%).

The most common adverse events (≥20%), of any grade and regardless of causality, in the placebo arm were neutropenia (34%), upper respiratory tract infection (23%), and thrombocytopenia (20%).

In all, 67% of patients on the brentuximab vedotin arm experienced peripheral neuropathy. Of those patients, 85% had resolution (59%) or partial improvement (26%) in symptoms at the time of their last evaluation, with a median time to improvement of 23 weeks (range, 0.1-138).

Brentuximab vedotin

Photo from Business Wire

The European Commission (EC) has extended the current conditional marketing authorization of brentuximab vedotin (Adcetris) to include the treatment of adults with CD30+ Hodgkin lymphoma (HL) who are at an increased risk of relapse or progression following autologous stem cell transplant (ASCT).

Conditional marketing authorizations are valid for 1 year and are reviewed annually.

The company developing the drug is required to provide comprehensive data confirming the drug’s benefit-risk balance is positive. Once these data are available, the marketing authorization may be converted into a standard marketing authorization.

Drugs are eligible for conditional marketing authorization if they are designated as orphan medicines, intended for use in emergency situations, or designed to treat, prevent, or diagnose seriously debilitating or life-threatening diseases.

The EC previously granted brentuximab vedotin conditional marketing authorization for 2 indications:

• To treat adults with relapsed or refractory CD30+ HL after ASCT or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option
• To treat adults with relapsed or refractory systemic anaplastic large-cell lymphoma (sALCL).

In January 2016, the EC approved a Type II variation to include data on the retreatment of adult patients with HL or sALCL who previously responded to brentuximab vedotin and later relapsed.

Brentuximab vedotin is under joint development by Seattle Genetics and Takeda Pharmaceutical Company Limited.

AETHERA trial

The EC’s decision to extend the conditional marketing authorization of brentuximab vedotin is based on results from the phase 3 AETHERA trial.

The trial was designed to compare brentuximab vedotin to placebo, both administered for up to 16 cycles (approximately 1 year) every 3 weeks following ASCT. Results from the trial were published in The Lancet in March 2015 and presented at the 2014 ASH Annual Meeting.

The study enrolled 329 HL patients at risk of relapse or progression, including 165 on the brentuximab vedotin arm and 164 on the placebo arm.

Patients were eligible for enrollment if they had a history of primary refractory HL, relapsed within a year of receiving frontline chemotherapy, and/or had disease outside of the lymph nodes at the time of pre-ASCT relapse.

Brentuximab vedotin conferred a significant increase in progression-free survival over placebo, with a hazard ratio of 0.57 (P=0.001). The median progression-free survival was 43 months for patients who received brentuximab vedotin and 24 months for those who received placebo.

The most common adverse events (≥20%), of any grade and regardless of causality, in the brentuximab vedotin arm were neutropenia (78%), peripheral sensory neuropathy (56%), thrombocytopenia (41%), anemia (27%), upper respiratory tract infection (26%), fatigue (24%), peripheral motor neuropathy (23%), nausea (22%), cough (21%), and diarrhea (20%).

The most common adverse events (≥20%), of any grade and regardless of causality, in the placebo arm were neutropenia (34%), upper respiratory tract infection (23%), and thrombocytopenia (20%).

In all, 67% of patients on the brentuximab vedotin arm experienced peripheral neuropathy. Of those patients, 85% had resolution (59%) or partial improvement (26%) in symptoms at the time of their last evaluation, with a median time to improvement of 23 weeks (range, 0.1-138).

Doctor and patient

Photo courtesy of NIH

Compared to patients with other common cancers, patients with non-Hodgkin lymphoma (NHL) have a higher risk of developing a second, unrelated malignancy, according to a new study.

Researchers looked at data on more than 2.1 million patients with 10 of the most common cancers and found that patients with NHL or bladder cancer had the highest risk of developing a second malignancy.

The researchers reported these findings in Cancer.

For this study, Karim Chamie, MD, of the University of California, Los Angeles, and his colleagues looked at data from Surveillance, Epidemiology, and End Results database.

The team identified patients age 18 and older who were diagnosed with one of the 10 most common cancers—NHL, melanoma, and prostate, breast, lung, colon, rectal, bladder, uterine, and kidney cancers—between 1992 and 2008.

Of the 2,116,163 patients identified, 170,865 (8.1%) developed a second primary malignancy.

In multivariable analysis, patients with NHL or bladder cancer had the highest risk of developing a second malignancy.

The hazard ratios for patients with NHL were 2.70 for men and 2.88 for women. The hazard ratios for bladder cancer were 1.88 for men and 1.66 for women.

Lung cancer was a common second malignancy for both NHL and bladder cancer patients. NHL patients also tended to develop prostate and breast cancer.

Among patients with 2 incident cancers, 13% died of their initial cancer, and 55% died of their second primary malignancy. Lung cancer was the cause of death in 12% of the patients.

“As clinicians, we can become so focused on surveilling our patients to see if a primary cancer recurs that we sometimes may not be aware that patients can be at risk of developing a second, unrelated cancer,” Dr Chamie said.

He and his colleagues believe this study makes a case for monitoring cancer patients for second malignancies.

Doctor and patient

Photo courtesy of NIH

Compared to patients with other common cancers, patients with non-Hodgkin lymphoma (NHL) have a higher risk of developing a second, unrelated malignancy, according to a new study.

Researchers looked at data on more than 2.1 million patients with 10 of the most common cancers and found that patients with NHL or bladder cancer had the highest risk of developing a second malignancy.

The researchers reported these findings in Cancer.

For this study, Karim Chamie, MD, of the University of California, Los Angeles, and his colleagues looked at data from Surveillance, Epidemiology, and End Results database.

The team identified patients age 18 and older who were diagnosed with one of the 10 most common cancers—NHL, melanoma, and prostate, breast, lung, colon, rectal, bladder, uterine, and kidney cancers—between 1992 and 2008.

Of the 2,116,163 patients identified, 170,865 (8.1%) developed a second primary malignancy.

In multivariable analysis, patients with NHL or bladder cancer had the highest risk of developing a second malignancy.

The hazard ratios for patients with NHL were 2.70 for men and 2.88 for women. The hazard ratios for bladder cancer were 1.88 for men and 1.66 for women.

Lung cancer was a common second malignancy for both NHL and bladder cancer patients. NHL patients also tended to develop prostate and breast cancer.

Among patients with 2 incident cancers, 13% died of their initial cancer, and 55% died of their second primary malignancy. Lung cancer was the cause of death in 12% of the patients.

“As clinicians, we can become so focused on surveilling our patients to see if a primary cancer recurs that we sometimes may not be aware that patients can be at risk of developing a second, unrelated cancer,” Dr Chamie said.

He and his colleagues believe this study makes a case for monitoring cancer patients for second malignancies.

Doctor and patient

Photo courtesy of NIH

Compared to patients with other common cancers, patients with non-Hodgkin lymphoma (NHL) have a higher risk of developing a second, unrelated malignancy, according to a new study.

Researchers looked at data on more than 2.1 million patients with 10 of the most common cancers and found that patients with NHL or bladder cancer had the highest risk of developing a second malignancy.

The researchers reported these findings in Cancer.

For this study, Karim Chamie, MD, of the University of California, Los Angeles, and his colleagues looked at data from Surveillance, Epidemiology, and End Results database.

The team identified patients age 18 and older who were diagnosed with one of the 10 most common cancers—NHL, melanoma, and prostate, breast, lung, colon, rectal, bladder, uterine, and kidney cancers—between 1992 and 2008.

Of the 2,116,163 patients identified, 170,865 (8.1%) developed a second primary malignancy.

In multivariable analysis, patients with NHL or bladder cancer had the highest risk of developing a second malignancy.

The hazard ratios for patients with NHL were 2.70 for men and 2.88 for women. The hazard ratios for bladder cancer were 1.88 for men and 1.66 for women.

Lung cancer was a common second malignancy for both NHL and bladder cancer patients. NHL patients also tended to develop prostate and breast cancer.

Among patients with 2 incident cancers, 13% died of their initial cancer, and 55% died of their second primary malignancy. Lung cancer was the cause of death in 12% of the patients.

“As clinicians, we can become so focused on surveilling our patients to see if a primary cancer recurs that we sometimes may not be aware that patients can be at risk of developing a second, unrelated cancer,” Dr Chamie said.

He and his colleagues believe this study makes a case for monitoring cancer patients for second malignancies.

Red blood cell stages of P vivax

from patients in Thailand

Image by Wanlapa Roobsoong

Researchers say they have uncovered the global, evolving, and historic make-up of the malaria parasite Plasmodium vivax.

The group’s study revealed 4 genetically distinct populations of P vivax that provide insight into the movement of the parasite over time and

show how it is still adapting to regional variations in the mosquitoes that transmit P vivax, the humans infected with the parasite, and the drugs used to fight it.

“Our findings show it is evolving in response to antimalarial drugs and adapting to regional differences, indicating a wide range of approaches will likely be necessary to eliminate it globally,” said Jane Carlton, PhD, of New York University in New York, New York.

Dr Carlton and her colleagues reported these findings in Nature Genetics.

The researchers sequenced 182 DNA samples of P vivax collected from patients in 11 countries. The team said this provided new insights into the nature of P vivax as it exists today and also served as a “genetic history book” of the studied regions.

“The DNA data show that P vivax has clearly had a different history of association with global human populations than other malaria parasites, indicating that unique aspects of its biology may have influenced the ways in which it spread around the world,” said Daniel Neafsey, PhD, of the Broad Institute in Cambridge, Massachusetts.

Specifically, the researchers found that Central and South American P vivax populations are genetically diverse and distinct from all other contemporary P vivax populations. The team said this suggests that New World parasites may have been introduced by colonial seafarers and represent a now-eliminated European parasite population.

The researchers also found that contemporary African and South Asian P vivax populations are genetically similar. They said this suggests that South Asian P vivax populations may have genetically mingled with European lineages during the colonial era, or it may reflect ancient connections between human populations in the Eastern Mediterranean, Middle East, and Indian subcontinent.

Another finding was the relatively homogeneous genetic makeup of P vivax in Mexico, which reflects a steady decline of the disease in this country over the last decade.

By contrast, the Papua New Guinea population of P vivax was shown to be very diverse relative to other P vivax populations.

A similar study, which also illustrated the global variations of P vivax, was recently published in Nature Genetics in as well.

Red blood cell stages of P vivax

from patients in Thailand

Image by Wanlapa Roobsoong

Researchers say they have uncovered the global, evolving, and historic make-up of the malaria parasite Plasmodium vivax.

The group’s study revealed 4 genetically distinct populations of P vivax that provide insight into the movement of the parasite over time and

show how it is still adapting to regional variations in the mosquitoes that transmit P vivax, the humans infected with the parasite, and the drugs used to fight it.

“Our findings show it is evolving in response to antimalarial drugs and adapting to regional differences, indicating a wide range of approaches will likely be necessary to eliminate it globally,” said Jane Carlton, PhD, of New York University in New York, New York.

Dr Carlton and her colleagues reported these findings in Nature Genetics.

The researchers sequenced 182 DNA samples of P vivax collected from patients in 11 countries. The team said this provided new insights into the nature of P vivax as it exists today and also served as a “genetic history book” of the studied regions.

“The DNA data show that P vivax has clearly had a different history of association with global human populations than other malaria parasites, indicating that unique aspects of its biology may have influenced the ways in which it spread around the world,” said Daniel Neafsey, PhD, of the Broad Institute in Cambridge, Massachusetts.

Specifically, the researchers found that Central and South American P vivax populations are genetically diverse and distinct from all other contemporary P vivax populations. The team said this suggests that New World parasites may have been introduced by colonial seafarers and represent a now-eliminated European parasite population.

The researchers also found that contemporary African and South Asian P vivax populations are genetically similar. They said this suggests that South Asian P vivax populations may have genetically mingled with European lineages during the colonial era, or it may reflect ancient connections between human populations in the Eastern Mediterranean, Middle East, and Indian subcontinent.

Another finding was the relatively homogeneous genetic makeup of P vivax in Mexico, which reflects a steady decline of the disease in this country over the last decade.

By contrast, the Papua New Guinea population of P vivax was shown to be very diverse relative to other P vivax populations.

A similar study, which also illustrated the global variations of P vivax, was recently published in Nature Genetics in as well.

Red blood cell stages of P vivax

from patients in Thailand

Image by Wanlapa Roobsoong

Researchers say they have uncovered the global, evolving, and historic make-up of the malaria parasite Plasmodium vivax.

The group’s study revealed 4 genetically distinct populations of P vivax that provide insight into the movement of the parasite over time and

show how it is still adapting to regional variations in the mosquitoes that transmit P vivax, the humans infected with the parasite, and the drugs used to fight it.

“Our findings show it is evolving in response to antimalarial drugs and adapting to regional differences, indicating a wide range of approaches will likely be necessary to eliminate it globally,” said Jane Carlton, PhD, of New York University in New York, New York.

Dr Carlton and her colleagues reported these findings in Nature Genetics.

The researchers sequenced 182 DNA samples of P vivax collected from patients in 11 countries. The team said this provided new insights into the nature of P vivax as it exists today and also served as a “genetic history book” of the studied regions.

“The DNA data show that P vivax has clearly had a different history of association with global human populations than other malaria parasites, indicating that unique aspects of its biology may have influenced the ways in which it spread around the world,” said Daniel Neafsey, PhD, of the Broad Institute in Cambridge, Massachusetts.

Specifically, the researchers found that Central and South American P vivax populations are genetically diverse and distinct from all other contemporary P vivax populations. The team said this suggests that New World parasites may have been introduced by colonial seafarers and represent a now-eliminated European parasite population.

The researchers also found that contemporary African and South Asian P vivax populations are genetically similar. They said this suggests that South Asian P vivax populations may have genetically mingled with European lineages during the colonial era, or it may reflect ancient connections between human populations in the Eastern Mediterranean, Middle East, and Indian subcontinent.

Another finding was the relatively homogeneous genetic makeup of P vivax in Mexico, which reflects a steady decline of the disease in this country over the last decade.

By contrast, the Papua New Guinea population of P vivax was shown to be very diverse relative to other P vivax populations.

A similar study, which also illustrated the global variations of P vivax, was recently published in Nature Genetics in as well.

Warfarin tablets

Results of a systematic review support self-monitoring and self-management for patients on long-term oral anticoagulation therapy.

Researchers found that both self-monitoring and self-management were associated with a reduction in thromboembolic events when compared to standard monitoring.

Self-management, but not self-monitoring, was associated with a reduction in all-cause mortality.

And neither practice appeared to have an effect on major bleeding.

These results were published in the Cochrane Database of Systematic Reviews.

Point-of-care testing has made it possible for patients on long-term oral anticoagulation therapy to monitor their own international normalized ratio (INR).

Patients can either adjust their own medication according to a pre-determined dose-INR schedule, which is known as self-management, or they can call into a clinic to be told the appropriate dose adjustment, which is known as self-monitoring.

For the current review, Carl Heneghan, BM BCh, DPhil, of the University of Oxford in the UK, and his colleagues evaluated data from 28 randomized trials including 8950 patients. The trials compared self-monitoring and self-management with standard monitoring.

The researchers said pooled estimates showed a reduction in thromboembolic events with both self-management and self-monitoring, compared to standard monitoring.

Eleven studies including 3497 patients showed the relative risk (RR) of thromboembolic events was 0.47 (95% CI 0.31 to 0.70) for self-management compared to standard monitoring.

Seven studies including 4097 patients showed the RR of thromboembolic events was 0.69 (95% CI 0.49 to 0.97) for self-monitoring compared to standard monitoring.

Eight studies including 3058 patients suggested that self-management caused a reduction in all-cause mortality (RR=0.55, 95% CI 0.36 to 0.84) when compared to standard monitoring.

But 3 studies of 3300 patients indicated that self-monitoring did not reduce all-cause mortality (RR=0.94, 95% CI 0.78 to 1.15).

In 20 trials of 8018 patients, neither self-monitoring nor self-management reduced major hemorrhage (RR=0.95, 95% CI, 0.80 to 1.12) when compared to standard monitoring.

For all of these analyses, the quality of evidence was moderate.

“Our review of the latest research finds that self-monitoring alone does indeed result in a statistically significant reduction in thromboembolic events, whereas our previous review did not find this effect,” Dr Heneghan said.

“Suitable patients still need to be identified and educated for self-monitoring as it is not feasible for everyone, but the evidence clearly demonstrates that self-monitoring can improve the quality of oral anticoagulation therapy and adds weight to the argument that more patients should be given the opportunity to benefit from this treatment approach.”

The current review is an update on a previous review carried out by the same researchers in 2010. It includes 10 new studies of 4227 participants.

Warfarin tablets

Results of a systematic review support self-monitoring and self-management for patients on long-term oral anticoagulation therapy.

Researchers found that both self-monitoring and self-management were associated with a reduction in thromboembolic events when compared to standard monitoring.

Self-management, but not self-monitoring, was associated with a reduction in all-cause mortality.

And neither practice appeared to have an effect on major bleeding.

These results were published in the Cochrane Database of Systematic Reviews.

Point-of-care testing has made it possible for patients on long-term oral anticoagulation therapy to monitor their own international normalized ratio (INR).

Patients can either adjust their own medication according to a pre-determined dose-INR schedule, which is known as self-management, or they can call into a clinic to be told the appropriate dose adjustment, which is known as self-monitoring.

For the current review, Carl Heneghan, BM BCh, DPhil, of the University of Oxford in the UK, and his colleagues evaluated data from 28 randomized trials including 8950 patients. The trials compared self-monitoring and self-management with standard monitoring.

The researchers said pooled estimates showed a reduction in thromboembolic events with both self-management and self-monitoring, compared to standard monitoring.

Eleven studies including 3497 patients showed the relative risk (RR) of thromboembolic events was 0.47 (95% CI 0.31 to 0.70) for self-management compared to standard monitoring.

Seven studies including 4097 patients showed the RR of thromboembolic events was 0.69 (95% CI 0.49 to 0.97) for self-monitoring compared to standard monitoring.

Eight studies including 3058 patients suggested that self-management caused a reduction in all-cause mortality (RR=0.55, 95% CI 0.36 to 0.84) when compared to standard monitoring.

But 3 studies of 3300 patients indicated that self-monitoring did not reduce all-cause mortality (RR=0.94, 95% CI 0.78 to 1.15).

In 20 trials of 8018 patients, neither self-monitoring nor self-management reduced major hemorrhage (RR=0.95, 95% CI, 0.80 to 1.12) when compared to standard monitoring.

For all of these analyses, the quality of evidence was moderate.

“Our review of the latest research finds that self-monitoring alone does indeed result in a statistically significant reduction in thromboembolic events, whereas our previous review did not find this effect,” Dr Heneghan said.

“Suitable patients still need to be identified and educated for self-monitoring as it is not feasible for everyone, but the evidence clearly demonstrates that self-monitoring can improve the quality of oral anticoagulation therapy and adds weight to the argument that more patients should be given the opportunity to benefit from this treatment approach.”

The current review is an update on a previous review carried out by the same researchers in 2010. It includes 10 new studies of 4227 participants.

Warfarin tablets

Results of a systematic review support self-monitoring and self-management for patients on long-term oral anticoagulation therapy.

Researchers found that both self-monitoring and self-management were associated with a reduction in thromboembolic events when compared to standard monitoring.

Self-management, but not self-monitoring, was associated with a reduction in all-cause mortality.

And neither practice appeared to have an effect on major bleeding.

These results were published in the Cochrane Database of Systematic Reviews.

Point-of-care testing has made it possible for patients on long-term oral anticoagulation therapy to monitor their own international normalized ratio (INR).

Patients can either adjust their own medication according to a pre-determined dose-INR schedule, which is known as self-management, or they can call into a clinic to be told the appropriate dose adjustment, which is known as self-monitoring.

For the current review, Carl Heneghan, BM BCh, DPhil, of the University of Oxford in the UK, and his colleagues evaluated data from 28 randomized trials including 8950 patients. The trials compared self-monitoring and self-management with standard monitoring.

The researchers said pooled estimates showed a reduction in thromboembolic events with both self-management and self-monitoring, compared to standard monitoring.

Eleven studies including 3497 patients showed the relative risk (RR) of thromboembolic events was 0.47 (95% CI 0.31 to 0.70) for self-management compared to standard monitoring.

Seven studies including 4097 patients showed the RR of thromboembolic events was 0.69 (95% CI 0.49 to 0.97) for self-monitoring compared to standard monitoring.

Eight studies including 3058 patients suggested that self-management caused a reduction in all-cause mortality (RR=0.55, 95% CI 0.36 to 0.84) when compared to standard monitoring.

But 3 studies of 3300 patients indicated that self-monitoring did not reduce all-cause mortality (RR=0.94, 95% CI 0.78 to 1.15).

In 20 trials of 8018 patients, neither self-monitoring nor self-management reduced major hemorrhage (RR=0.95, 95% CI, 0.80 to 1.12) when compared to standard monitoring.

For all of these analyses, the quality of evidence was moderate.

“Our review of the latest research finds that self-monitoring alone does indeed result in a statistically significant reduction in thromboembolic events, whereas our previous review did not find this effect,” Dr Heneghan said.

“Suitable patients still need to be identified and educated for self-monitoring as it is not feasible for everyone, but the evidence clearly demonstrates that self-monitoring can improve the quality of oral anticoagulation therapy and adds weight to the argument that more patients should be given the opportunity to benefit from this treatment approach.”

The current review is an update on a previous review carried out by the same researchers in 2010. It includes 10 new studies of 4227 participants.

Study Overview

Objective. To determine whether weight loss and cardiometabolic risk factors are improved when mindfulness training is added to a diet-exercise program.

Design. 2-arm randomized controlled trial.

Setting and participants. Study participants were recruited through fliers, newspaper advertisements, online postings, and referrals at University of California, San Francisco clinics, and were enrolled from July 2009 to February 2012. Inclusion criteria were body mass index (BMI) between 30 and 45.9, abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women), and age 18 or older. Exclusion criteria were current involvement with diet program or diet mediation, diabetes mellitus, fasting glucose ≥ 126 mg/dL, or hemoglobin A1c (HbA1C) between 6.0% and 6.5% with abnormal oral glucose tolerance test. Participants were randomized in a 1:1 ratio to one of 2 weight loss program arms using a computer-generated randomization sequence.

Intervention. In both arms, participants received general diet and exercise guidelines prescribing healthy eating and frequent exercise delivered in 16 sessions lasting 2 to 2½ hours and one all-day session over 5.5 months. Participants in the mindfulness intervention additionally received mindfulness training for eating, physical activity, and stress management from mindfulness mediation instructors and a registered dietician. They also followed guidelines at home, which included practicing meditation for up to 30 minutes 6 days a week, mini-meditations, and eating mindfully. To control for the activities and attention inherent in the mindfulness arm (eg, social support, expectation of benefit, snacks provided during mindful eating exercises, at home practice), the control arm was an “active control” and  included additional nutritional and physical activity information, snacks, strength training, home activities, conversations about society and weight loss, and low-dose progressive muscle relaxation and cognitive-behavioral training. Active control materials were delivered by one of 3 registered dieticians.

Main outcomes measures. The primary outcome was 18-month weight change. Participants’ weight, height, blood pressure, and weight circumference were measured at baseline and 3, 6, 12, and 18 months between 8 am and 10 am. Measurements were taken under fasting conditions and by arm-blinded staff. Blood samples were taken to assess secondary outcome changes in glucose, lipid, HbA1C, insulin, and C-reactive protein. Researchers also collected anonymous qualitative feedback from participants and supervisors to do a secondary analysis assessing differences in effectiveness and helpfulness of mindfulness teachings among instructors.

Main results. Of the potential participants that contacted the study team in response to recruitment efforts (n = 1485), 216 were fully eligible based on criteria and a screening visit. Participants that consented to participate (n = 194) were randomized. Participants across both groups were predominantly female, of European ethnic origin, and similar in age: mindfulness group, 47.2 years (13.0) and active control group, 47.8 years (12.4). At baseline, the mindfulness and active control arms had average BMIs of 35.4 (3.5) and 35.6 (3.8), respectively. Baseline characteristics, session attendance, and 18-month retention were similar for both arms. Participants in the mindfulness arm reported completing 70% (2.1 hours per week, SD = 1.2) of the recommended meditation time and eating 57% (SD = 29) of meals mindfully.

Weight loss outcomes between groups favored the mindfulness arms, but results were not significant. The largest difference of –1.9 kg (95% CI –4.5 to 0.8; P = 0.17) was at 12 months. The difference persisted at 18 months with –1.7 kg (95% CI –4.7 to 1.2 kg; P = 0.24). The mindfulness arm lost 4.2 kg (95% CI –6.2 to 2.2 kg) while the active control arm lost 2.4 kg (95% CI –4.5 to –0.3 kg).

Cardiometabolic outcomes at 12 months showed group differences in fasting glucose that favored the mindfulness arm, –3.1 mg/dL (95% CI 26.3 to 0.1; P = 0.06), while there was a significant group difference at 18 months, –4.1 mg/dL (95% CI –7.3 to –0.9; P  = 0.01). Data at 18-months showed that normal glucose changed minimally in the mindfulness arm, –0.31 mg/dL (95% CI –2.5 to 1.9), but increased in the active control arm 3.8 mg/dL (95% CI 1.5 to 6.1). Other cardiometabolic outcomes (ie,  triglyceride/HDL ratio and triglycerides) showed significance at 12 months, favoring the mindfulness arm, but not at 18 months. Although not all were statistically significant, 9 of 11 outcomes favored the mindfulness arm at 18 months.

Significant interactions (P < 0.05) were found between arm and enrollment rounds categorized by mindfulness instructor on weight, BMI, fasting glucose, homeostatic homeostasis model assessment of insulin resistance (defined as [glucose x insulin/{40 × 33.25}]), and HbA1c, with a marginally significant effect for waist circumference (P = 0.08). Qualitative feedback on mindfulness instructors showed that in the group with a lowly rated instructor, participants lost less weight at 18 months (–2.0 kg [95% CI –4.7 to 0.7]), compared to participants in groups with highly rated instructors (–6.3 kg [95% CI –9.1 to –3.6]; P = 0.02). Similar trends followed for reductions in BMI and waist circumference.

Conclusions. With regard to weight loss outcomes, a mindfulness-enhanced diet-exercise program and an active control arm did not show substantial differences. Some evidence, however, suggests modest benefit of added mindfulness components, which may lead to long-term maintenance of fasting glucose levels and improved atherogenic lipid profiles.

Commentary

Mindfulness, or nonjudgmental focus on the present moment, has been utilized by many interventions targeted at self-regulated behavior [1]. Mindfulness interventions aim to promote healthy behavior changes by encouraging careful monitoring of behavior reactivity. Weight loss and weight loss maintenance have been of particular interest with this approach because mindfulness-based interventions may promote long-term maintenance of weight loss [2]. This maintenance is achieved through a focus on modifying health behaviors, rather than a focus on weight loss alone [3]. Mindfulness has been incorporated into weight loss interventions through yoga practices [4] and mindfulness meditation [5].

Several studies have explored the relationship between mindfulness and weight loss in various populations, highlighting mindfulness’s role in weight loss and behavior change. Most notably, mindfulness interventions have shown improvements in fasting glucose levels [6], psychological distress [7], self-efficacy, weight loss, eating behaviors, and physical activity [8–10]. Despite being well designed, this study by Daubenmier et al did not find significant changes in weight loss. However, secondary outcomes related to weight, metabolic, syndrome, and cardiovascular risk showed modest improvements with mindfulness. These results may correlate to previous findings showing that lifestyle changes many not result in weight loss but can reverse or reduce disorders related to obesity [11].

The study was strengthened by randomization, intention-to-treat analysis, objective measures by arm-blinded staff, standardized measuring conditions, balanced participant allocation to each arm, 1-year follow-up, and qualitative feedback on instructors to assess whether weight loss may be instructor-dependent. In addition, the authors made an effort to mask their intention to test the effects of a mindfulness-enhanced intervention. They designed a rigorous active control intervention arm by controlling for attention, social support, expectations of benefit, diet-exercise guidelines, and elements of a mindfulness approach to stress management. An additional strength included a cost-analysis of adding mindfulness components. The generalizability of the results may be limited as the study population were predominantly white females and most had a bachelor’s degree. The study sample was also disproportionately menopausal women, a group that especially struggles with weight loss. This demographic factor may be responsible for the lack of significant weight loss. Other limitations of this study include participant dropout and variability between instructor styles, although the latter was explored in a secondary analysis of weight loss differences between instructors.

The researchers discussed how the active control intervention arm may have contributed to the lack of significant weight loss difference between groups. The researchers also highlighted that participants randomized to the mindfulness arm that were not interested in mindfulness practices may have benefitted less than those who were interested.  This combined with the modest diet and exercise components of the intervention may also explain the lack of significance in results. It may also explain why some outcomes were significant at earlier months but attenuated by 18 months. Future studies should assess incorporating more intense exercise and diet approaches, as well as continuous contact throughout the 18-month time period.

Applications for Clinical Practice

This study demonstrated that mindfulness components added to a diet-exercise program can be helpful in promoting metabolic changes but not necessarily weight loss. Since metabolic changes can be protective against morbidities (eg, type 2 diabetes), mindfulness can be a powerful and cost-effective approach within clinical practice. Mindfulness practices can also be easily implemented in various settings and with diverse populations. Future studies should explore adding mindfulness components to more intensive weight loss interventions. Providers and health care settings should consider incorporating mindfulness practices into weight management counseling and programs.

—Michelle J. Williamson and Katrina F. Mateo, MPH

Study Overview

Objective. To determine whether weight loss and cardiometabolic risk factors are improved when mindfulness training is added to a diet-exercise program.

Design. 2-arm randomized controlled trial.

Setting and participants. Study participants were recruited through fliers, newspaper advertisements, online postings, and referrals at University of California, San Francisco clinics, and were enrolled from July 2009 to February 2012. Inclusion criteria were body mass index (BMI) between 30 and 45.9, abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women), and age 18 or older. Exclusion criteria were current involvement with diet program or diet mediation, diabetes mellitus, fasting glucose ≥ 126 mg/dL, or hemoglobin A1c (HbA1C) between 6.0% and 6.5% with abnormal oral glucose tolerance test. Participants were randomized in a 1:1 ratio to one of 2 weight loss program arms using a computer-generated randomization sequence.

Intervention. In both arms, participants received general diet and exercise guidelines prescribing healthy eating and frequent exercise delivered in 16 sessions lasting 2 to 2½ hours and one all-day session over 5.5 months. Participants in the mindfulness intervention additionally received mindfulness training for eating, physical activity, and stress management from mindfulness mediation instructors and a registered dietician. They also followed guidelines at home, which included practicing meditation for up to 30 minutes 6 days a week, mini-meditations, and eating mindfully. To control for the activities and attention inherent in the mindfulness arm (eg, social support, expectation of benefit, snacks provided during mindful eating exercises, at home practice), the control arm was an “active control” and  included additional nutritional and physical activity information, snacks, strength training, home activities, conversations about society and weight loss, and low-dose progressive muscle relaxation and cognitive-behavioral training. Active control materials were delivered by one of 3 registered dieticians.

Main outcomes measures. The primary outcome was 18-month weight change. Participants’ weight, height, blood pressure, and weight circumference were measured at baseline and 3, 6, 12, and 18 months between 8 am and 10 am. Measurements were taken under fasting conditions and by arm-blinded staff. Blood samples were taken to assess secondary outcome changes in glucose, lipid, HbA1C, insulin, and C-reactive protein. Researchers also collected anonymous qualitative feedback from participants and supervisors to do a secondary analysis assessing differences in effectiveness and helpfulness of mindfulness teachings among instructors.

Main results. Of the potential participants that contacted the study team in response to recruitment efforts (n = 1485), 216 were fully eligible based on criteria and a screening visit. Participants that consented to participate (n = 194) were randomized. Participants across both groups were predominantly female, of European ethnic origin, and similar in age: mindfulness group, 47.2 years (13.0) and active control group, 47.8 years (12.4). At baseline, the mindfulness and active control arms had average BMIs of 35.4 (3.5) and 35.6 (3.8), respectively. Baseline characteristics, session attendance, and 18-month retention were similar for both arms. Participants in the mindfulness arm reported completing 70% (2.1 hours per week, SD = 1.2) of the recommended meditation time and eating 57% (SD = 29) of meals mindfully.

Weight loss outcomes between groups favored the mindfulness arms, but results were not significant. The largest difference of –1.9 kg (95% CI –4.5 to 0.8; P = 0.17) was at 12 months. The difference persisted at 18 months with –1.7 kg (95% CI –4.7 to 1.2 kg; P = 0.24). The mindfulness arm lost 4.2 kg (95% CI –6.2 to 2.2 kg) while the active control arm lost 2.4 kg (95% CI –4.5 to –0.3 kg).

Cardiometabolic outcomes at 12 months showed group differences in fasting glucose that favored the mindfulness arm, –3.1 mg/dL (95% CI 26.3 to 0.1; P = 0.06), while there was a significant group difference at 18 months, –4.1 mg/dL (95% CI –7.3 to –0.9; P  = 0.01). Data at 18-months showed that normal glucose changed minimally in the mindfulness arm, –0.31 mg/dL (95% CI –2.5 to 1.9), but increased in the active control arm 3.8 mg/dL (95% CI 1.5 to 6.1). Other cardiometabolic outcomes (ie,  triglyceride/HDL ratio and triglycerides) showed significance at 12 months, favoring the mindfulness arm, but not at 18 months. Although not all were statistically significant, 9 of 11 outcomes favored the mindfulness arm at 18 months.

Significant interactions (P < 0.05) were found between arm and enrollment rounds categorized by mindfulness instructor on weight, BMI, fasting glucose, homeostatic homeostasis model assessment of insulin resistance (defined as [glucose x insulin/{40 × 33.25}]), and HbA1c, with a marginally significant effect for waist circumference (P = 0.08). Qualitative feedback on mindfulness instructors showed that in the group with a lowly rated instructor, participants lost less weight at 18 months (–2.0 kg [95% CI –4.7 to 0.7]), compared to participants in groups with highly rated instructors (–6.3 kg [95% CI –9.1 to –3.6]; P = 0.02). Similar trends followed for reductions in BMI and waist circumference.

Conclusions. With regard to weight loss outcomes, a mindfulness-enhanced diet-exercise program and an active control arm did not show substantial differences. Some evidence, however, suggests modest benefit of added mindfulness components, which may lead to long-term maintenance of fasting glucose levels and improved atherogenic lipid profiles.

Commentary

Mindfulness, or nonjudgmental focus on the present moment, has been utilized by many interventions targeted at self-regulated behavior [1]. Mindfulness interventions aim to promote healthy behavior changes by encouraging careful monitoring of behavior reactivity. Weight loss and weight loss maintenance have been of particular interest with this approach because mindfulness-based interventions may promote long-term maintenance of weight loss [2]. This maintenance is achieved through a focus on modifying health behaviors, rather than a focus on weight loss alone [3]. Mindfulness has been incorporated into weight loss interventions through yoga practices [4] and mindfulness meditation [5].

Several studies have explored the relationship between mindfulness and weight loss in various populations, highlighting mindfulness’s role in weight loss and behavior change. Most notably, mindfulness interventions have shown improvements in fasting glucose levels [6], psychological distress [7], self-efficacy, weight loss, eating behaviors, and physical activity [8–10]. Despite being well designed, this study by Daubenmier et al did not find significant changes in weight loss. However, secondary outcomes related to weight, metabolic, syndrome, and cardiovascular risk showed modest improvements with mindfulness. These results may correlate to previous findings showing that lifestyle changes many not result in weight loss but can reverse or reduce disorders related to obesity [11].

The study was strengthened by randomization, intention-to-treat analysis, objective measures by arm-blinded staff, standardized measuring conditions, balanced participant allocation to each arm, 1-year follow-up, and qualitative feedback on instructors to assess whether weight loss may be instructor-dependent. In addition, the authors made an effort to mask their intention to test the effects of a mindfulness-enhanced intervention. They designed a rigorous active control intervention arm by controlling for attention, social support, expectations of benefit, diet-exercise guidelines, and elements of a mindfulness approach to stress management. An additional strength included a cost-analysis of adding mindfulness components. The generalizability of the results may be limited as the study population were predominantly white females and most had a bachelor’s degree. The study sample was also disproportionately menopausal women, a group that especially struggles with weight loss. This demographic factor may be responsible for the lack of significant weight loss. Other limitations of this study include participant dropout and variability between instructor styles, although the latter was explored in a secondary analysis of weight loss differences between instructors.

The researchers discussed how the active control intervention arm may have contributed to the lack of significant weight loss difference between groups. The researchers also highlighted that participants randomized to the mindfulness arm that were not interested in mindfulness practices may have benefitted less than those who were interested.  This combined with the modest diet and exercise components of the intervention may also explain the lack of significance in results. It may also explain why some outcomes were significant at earlier months but attenuated by 18 months. Future studies should assess incorporating more intense exercise and diet approaches, as well as continuous contact throughout the 18-month time period.

Applications for Clinical Practice

This study demonstrated that mindfulness components added to a diet-exercise program can be helpful in promoting metabolic changes but not necessarily weight loss. Since metabolic changes can be protective against morbidities (eg, type 2 diabetes), mindfulness can be a powerful and cost-effective approach within clinical practice. Mindfulness practices can also be easily implemented in various settings and with diverse populations. Future studies should explore adding mindfulness components to more intensive weight loss interventions. Providers and health care settings should consider incorporating mindfulness practices into weight management counseling and programs.

—Michelle J. Williamson and Katrina F. Mateo, MPH

Study Overview

Objective. To determine whether weight loss and cardiometabolic risk factors are improved when mindfulness training is added to a diet-exercise program.

Design. 2-arm randomized controlled trial.

Setting and participants. Study participants were recruited through fliers, newspaper advertisements, online postings, and referrals at University of California, San Francisco clinics, and were enrolled from July 2009 to February 2012. Inclusion criteria were body mass index (BMI) between 30 and 45.9, abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women), and age 18 or older. Exclusion criteria were current involvement with diet program or diet mediation, diabetes mellitus, fasting glucose ≥ 126 mg/dL, or hemoglobin A1c (HbA1C) between 6.0% and 6.5% with abnormal oral glucose tolerance test. Participants were randomized in a 1:1 ratio to one of 2 weight loss program arms using a computer-generated randomization sequence.

Intervention. In both arms, participants received general diet and exercise guidelines prescribing healthy eating and frequent exercise delivered in 16 sessions lasting 2 to 2½ hours and one all-day session over 5.5 months. Participants in the mindfulness intervention additionally received mindfulness training for eating, physical activity, and stress management from mindfulness mediation instructors and a registered dietician. They also followed guidelines at home, which included practicing meditation for up to 30 minutes 6 days a week, mini-meditations, and eating mindfully. To control for the activities and attention inherent in the mindfulness arm (eg, social support, expectation of benefit, snacks provided during mindful eating exercises, at home practice), the control arm was an “active control” and  included additional nutritional and physical activity information, snacks, strength training, home activities, conversations about society and weight loss, and low-dose progressive muscle relaxation and cognitive-behavioral training. Active control materials were delivered by one of 3 registered dieticians.

Main outcomes measures. The primary outcome was 18-month weight change. Participants’ weight, height, blood pressure, and weight circumference were measured at baseline and 3, 6, 12, and 18 months between 8 am and 10 am. Measurements were taken under fasting conditions and by arm-blinded staff. Blood samples were taken to assess secondary outcome changes in glucose, lipid, HbA1C, insulin, and C-reactive protein. Researchers also collected anonymous qualitative feedback from participants and supervisors to do a secondary analysis assessing differences in effectiveness and helpfulness of mindfulness teachings among instructors.

Main results. Of the potential participants that contacted the study team in response to recruitment efforts (n = 1485), 216 were fully eligible based on criteria and a screening visit. Participants that consented to participate (n = 194) were randomized. Participants across both groups were predominantly female, of European ethnic origin, and similar in age: mindfulness group, 47.2 years (13.0) and active control group, 47.8 years (12.4). At baseline, the mindfulness and active control arms had average BMIs of 35.4 (3.5) and 35.6 (3.8), respectively. Baseline characteristics, session attendance, and 18-month retention were similar for both arms. Participants in the mindfulness arm reported completing 70% (2.1 hours per week, SD = 1.2) of the recommended meditation time and eating 57% (SD = 29) of meals mindfully.

Weight loss outcomes between groups favored the mindfulness arms, but results were not significant. The largest difference of –1.9 kg (95% CI –4.5 to 0.8; P = 0.17) was at 12 months. The difference persisted at 18 months with –1.7 kg (95% CI –4.7 to 1.2 kg; P = 0.24). The mindfulness arm lost 4.2 kg (95% CI –6.2 to 2.2 kg) while the active control arm lost 2.4 kg (95% CI –4.5 to –0.3 kg).

Cardiometabolic outcomes at 12 months showed group differences in fasting glucose that favored the mindfulness arm, –3.1 mg/dL (95% CI 26.3 to 0.1; P = 0.06), while there was a significant group difference at 18 months, –4.1 mg/dL (95% CI –7.3 to –0.9; P  = 0.01). Data at 18-months showed that normal glucose changed minimally in the mindfulness arm, –0.31 mg/dL (95% CI –2.5 to 1.9), but increased in the active control arm 3.8 mg/dL (95% CI 1.5 to 6.1). Other cardiometabolic outcomes (ie,  triglyceride/HDL ratio and triglycerides) showed significance at 12 months, favoring the mindfulness arm, but not at 18 months. Although not all were statistically significant, 9 of 11 outcomes favored the mindfulness arm at 18 months.

Significant interactions (P < 0.05) were found between arm and enrollment rounds categorized by mindfulness instructor on weight, BMI, fasting glucose, homeostatic homeostasis model assessment of insulin resistance (defined as [glucose x insulin/{40 × 33.25}]), and HbA1c, with a marginally significant effect for waist circumference (P = 0.08). Qualitative feedback on mindfulness instructors showed that in the group with a lowly rated instructor, participants lost less weight at 18 months (–2.0 kg [95% CI –4.7 to 0.7]), compared to participants in groups with highly rated instructors (–6.3 kg [95% CI –9.1 to –3.6]; P = 0.02). Similar trends followed for reductions in BMI and waist circumference.

Conclusions. With regard to weight loss outcomes, a mindfulness-enhanced diet-exercise program and an active control arm did not show substantial differences. Some evidence, however, suggests modest benefit of added mindfulness components, which may lead to long-term maintenance of fasting glucose levels and improved atherogenic lipid profiles.

Commentary

Mindfulness, or nonjudgmental focus on the present moment, has been utilized by many interventions targeted at self-regulated behavior [1]. Mindfulness interventions aim to promote healthy behavior changes by encouraging careful monitoring of behavior reactivity. Weight loss and weight loss maintenance have been of particular interest with this approach because mindfulness-based interventions may promote long-term maintenance of weight loss [2]. This maintenance is achieved through a focus on modifying health behaviors, rather than a focus on weight loss alone [3]. Mindfulness has been incorporated into weight loss interventions through yoga practices [4] and mindfulness meditation [5].

Several studies have explored the relationship between mindfulness and weight loss in various populations, highlighting mindfulness’s role in weight loss and behavior change. Most notably, mindfulness interventions have shown improvements in fasting glucose levels [6], psychological distress [7], self-efficacy, weight loss, eating behaviors, and physical activity [8–10]. Despite being well designed, this study by Daubenmier et al did not find significant changes in weight loss. However, secondary outcomes related to weight, metabolic, syndrome, and cardiovascular risk showed modest improvements with mindfulness. These results may correlate to previous findings showing that lifestyle changes many not result in weight loss but can reverse or reduce disorders related to obesity [11].

The study was strengthened by randomization, intention-to-treat analysis, objective measures by arm-blinded staff, standardized measuring conditions, balanced participant allocation to each arm, 1-year follow-up, and qualitative feedback on instructors to assess whether weight loss may be instructor-dependent. In addition, the authors made an effort to mask their intention to test the effects of a mindfulness-enhanced intervention. They designed a rigorous active control intervention arm by controlling for attention, social support, expectations of benefit, diet-exercise guidelines, and elements of a mindfulness approach to stress management. An additional strength included a cost-analysis of adding mindfulness components. The generalizability of the results may be limited as the study population were predominantly white females and most had a bachelor’s degree. The study sample was also disproportionately menopausal women, a group that especially struggles with weight loss. This demographic factor may be responsible for the lack of significant weight loss. Other limitations of this study include participant dropout and variability between instructor styles, although the latter was explored in a secondary analysis of weight loss differences between instructors.

The researchers discussed how the active control intervention arm may have contributed to the lack of significant weight loss difference between groups. The researchers also highlighted that participants randomized to the mindfulness arm that were not interested in mindfulness practices may have benefitted less than those who were interested.  This combined with the modest diet and exercise components of the intervention may also explain the lack of significance in results. It may also explain why some outcomes were significant at earlier months but attenuated by 18 months. Future studies should assess incorporating more intense exercise and diet approaches, as well as continuous contact throughout the 18-month time period.

Applications for Clinical Practice

This study demonstrated that mindfulness components added to a diet-exercise program can be helpful in promoting metabolic changes but not necessarily weight loss. Since metabolic changes can be protective against morbidities (eg, type 2 diabetes), mindfulness can be a powerful and cost-effective approach within clinical practice. Mindfulness practices can also be easily implemented in various settings and with diverse populations. Future studies should explore adding mindfulness components to more intensive weight loss interventions. Providers and health care settings should consider incorporating mindfulness practices into weight management counseling and programs.

—Michelle J. Williamson and Katrina F. Mateo, MPH

Study Overview

Objective. To examine the feasibility, acceptability and benefits of mindfulness meditation training in men with low-grade prostate cancer on active surveillance.

Design. Randomized controlled pilot trial.

Setting and participants. Participants were men with low-risk localized prostate cancer who were on an IRB-approved active surveillance protocol within a medium-sized community hospital system in suburban Chicago. Enrolled patients were randomized to the active intervention or a control condition where participants received a book on mindfulness but no specific instructions to read it.

Intervention. Patients in the intervention arm attended an 8-week mindfulness-based stress reduction intervention, consisting of weekly sessions lasting 2½ hours held at their local primary hospital. Sessions were conducted by a trained and experienced mindfulness instructor. The intervention also included a half day retreat near the end of the intervention period to practice the skills that were taught.

Main outcome measures. Main outcome measures were prostate cancer anxiety (measured using the 18-item Memorial Anxiety Scale for Prostate Cancer), uncertainty tolerance (measured using the 12-item Intolerance of Uncertainty Short Form), mindfulness (measured via the 15-item Mindful Attention Awareness Scale), and health-related quality of life (measured using 10-item PROMIS Global Health-10). Researchers also measured “posttraumatic growth” using the Posttraumatic Growth Inventory, a 21-item self-report scale used to assess growth or benefits after a specific traumatic life event, such as a diagnosis of cancer. Participants completed instruments at baseline, 8 weeks, 6 months, and 12 months. At 12 months they also complete a brief feasibility and acceptance survey.

Main results. Over a 3-year period, 115 men were approached to participate and 54 enrolled. 11 withdrew prior to randomization citing lack of time as the primary reason. Ultimately, 24 men were randomized to the mindfulness arm and 19 to control. Average age was 70 years and 95% were white. Over 90% had never previously meditated or had never meditated on a regular basis. There were no significant differences between enrollees and decliners on baseline clinical or sociodemographic variables, and there were no significant differences between mindfulness and control patients on sociodemographic or clinical variables or outcome measures.

Participants in the intervention group reported decreased prostate cancer anxiety at 6 months (P = 0.02, effect size ([ES] 0.30) and uncertainty intolerance at 12 months (P = 0.02, ES 0.32) and increased quality of life at 8 weeks (P = 0.05, ES 0.17), mindfulness at 8 weeks (P < 0.04, ES 0.35) and 12 months (P < 0.01, ES 0.17), and posttraumatic growth (P < 0.05 for all follow-up measurements). When measuring changes between the groups, the only outcome that was significant was posttraumatic growth (P = 0.01, ES 0.73). Written responses to the open-ended survey questions regarding participants’ experience with the course cited increased emotional regulation and self-awareness and positive health behavior change.

Conclusion. An 8-week mindfulness training is feasible and acceptable to men with prostate cancer on active surveillance and may help men cope more effectively with stress and anxiety related to their cancer experience.

Commentary

Prostate cancer is the most common nonskin malignancy in men. More than 180,000 men are diagnosed per year, with over 26,000 prostate cancer deaths annually [1]. The optimal approach to treating newly diagnosed prostate cancer can be variable, but for most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy [2]. Despite the favorable prognosis of low-risk prostate cancer, men who choose active surveillance may experience anxiety and uncertainty, which can cause many to request definitive therapy even when there is no tumor progression [3].

Mindfulness-based meditation is a practice that is increasingly being investigated for a wide array of health conditions. Mindfulness has been defined as being intentionally aware of internal and external experiences that occur at the present moment, without judgment. Behavioral interventions such as mindfulness training may lessen anxiety related to uncertainty intolerance and help maintain patient engagement in active surveillance [4].

This small pilot study by Victorson et al evaluated an 8-week mindfulness meditation intervention intended to help men in active surveillance manage cancer-related uncertainty intolerance. They found the meditation training to be generally feasible and acceptable among participants. Men in the active intervention demonstrated statistically significant within-group changes that included decreased prostate cancer anxiety and increased mental well-being and posttraumatic growth, but there were no differences between groups except for posttraumatic growth. Interestingly, the control group also reported a moderate increase in mindfulness at 12 months, which was found (in an exploratory follow-up analysis) to be unrelated to reading the mindfulness book they were given (eg, those who did not open the book had higher average mindfulness scores than those who read the book from cover to cover).

Limitations of the study include the small sample size and lack of diversity among the participants, who were 95% white and well educated. In addition, the response rate prior to randomization was low: out of 115 men approached, 43 were ultimately randomized. Retention rates at 12 months were similar: 71% for intervention and 74% for control.

Applications for Clinical Practice

A growing body of research demonstrates that mindfulness practice may aid in improving psychological well-being. Further research is necessary before a clinical recommendation can be offered regarding use of mindfulness instruction to alleviate anxiety in men with low-grade prostate cancer being managed with active surveillance.

Study Overview

Objective. To examine the feasibility, acceptability and benefits of mindfulness meditation training in men with low-grade prostate cancer on active surveillance.

Design. Randomized controlled pilot trial.

Setting and participants. Participants were men with low-risk localized prostate cancer who were on an IRB-approved active surveillance protocol within a medium-sized community hospital system in suburban Chicago. Enrolled patients were randomized to the active intervention or a control condition where participants received a book on mindfulness but no specific instructions to read it.

Intervention. Patients in the intervention arm attended an 8-week mindfulness-based stress reduction intervention, consisting of weekly sessions lasting 2½ hours held at their local primary hospital. Sessions were conducted by a trained and experienced mindfulness instructor. The intervention also included a half day retreat near the end of the intervention period to practice the skills that were taught.

Main outcome measures. Main outcome measures were prostate cancer anxiety (measured using the 18-item Memorial Anxiety Scale for Prostate Cancer), uncertainty tolerance (measured using the 12-item Intolerance of Uncertainty Short Form), mindfulness (measured via the 15-item Mindful Attention Awareness Scale), and health-related quality of life (measured using 10-item PROMIS Global Health-10). Researchers also measured “posttraumatic growth” using the Posttraumatic Growth Inventory, a 21-item self-report scale used to assess growth or benefits after a specific traumatic life event, such as a diagnosis of cancer. Participants completed instruments at baseline, 8 weeks, 6 months, and 12 months. At 12 months they also complete a brief feasibility and acceptance survey.

Main results. Over a 3-year period, 115 men were approached to participate and 54 enrolled. 11 withdrew prior to randomization citing lack of time as the primary reason. Ultimately, 24 men were randomized to the mindfulness arm and 19 to control. Average age was 70 years and 95% were white. Over 90% had never previously meditated or had never meditated on a regular basis. There were no significant differences between enrollees and decliners on baseline clinical or sociodemographic variables, and there were no significant differences between mindfulness and control patients on sociodemographic or clinical variables or outcome measures.

Participants in the intervention group reported decreased prostate cancer anxiety at 6 months (P = 0.02, effect size ([ES] 0.30) and uncertainty intolerance at 12 months (P = 0.02, ES 0.32) and increased quality of life at 8 weeks (P = 0.05, ES 0.17), mindfulness at 8 weeks (P < 0.04, ES 0.35) and 12 months (P < 0.01, ES 0.17), and posttraumatic growth (P < 0.05 for all follow-up measurements). When measuring changes between the groups, the only outcome that was significant was posttraumatic growth (P = 0.01, ES 0.73). Written responses to the open-ended survey questions regarding participants’ experience with the course cited increased emotional regulation and self-awareness and positive health behavior change.

Conclusion. An 8-week mindfulness training is feasible and acceptable to men with prostate cancer on active surveillance and may help men cope more effectively with stress and anxiety related to their cancer experience.

Commentary

Prostate cancer is the most common nonskin malignancy in men. More than 180,000 men are diagnosed per year, with over 26,000 prostate cancer deaths annually [1]. The optimal approach to treating newly diagnosed prostate cancer can be variable, but for most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy [2]. Despite the favorable prognosis of low-risk prostate cancer, men who choose active surveillance may experience anxiety and uncertainty, which can cause many to request definitive therapy even when there is no tumor progression [3].

Mindfulness-based meditation is a practice that is increasingly being investigated for a wide array of health conditions. Mindfulness has been defined as being intentionally aware of internal and external experiences that occur at the present moment, without judgment. Behavioral interventions such as mindfulness training may lessen anxiety related to uncertainty intolerance and help maintain patient engagement in active surveillance [4].

This small pilot study by Victorson et al evaluated an 8-week mindfulness meditation intervention intended to help men in active surveillance manage cancer-related uncertainty intolerance. They found the meditation training to be generally feasible and acceptable among participants. Men in the active intervention demonstrated statistically significant within-group changes that included decreased prostate cancer anxiety and increased mental well-being and posttraumatic growth, but there were no differences between groups except for posttraumatic growth. Interestingly, the control group also reported a moderate increase in mindfulness at 12 months, which was found (in an exploratory follow-up analysis) to be unrelated to reading the mindfulness book they were given (eg, those who did not open the book had higher average mindfulness scores than those who read the book from cover to cover).

Limitations of the study include the small sample size and lack of diversity among the participants, who were 95% white and well educated. In addition, the response rate prior to randomization was low: out of 115 men approached, 43 were ultimately randomized. Retention rates at 12 months were similar: 71% for intervention and 74% for control.

Applications for Clinical Practice

A growing body of research demonstrates that mindfulness practice may aid in improving psychological well-being. Further research is necessary before a clinical recommendation can be offered regarding use of mindfulness instruction to alleviate anxiety in men with low-grade prostate cancer being managed with active surveillance.

Study Overview

Objective. To examine the feasibility, acceptability and benefits of mindfulness meditation training in men with low-grade prostate cancer on active surveillance.

Design. Randomized controlled pilot trial.

Setting and participants. Participants were men with low-risk localized prostate cancer who were on an IRB-approved active surveillance protocol within a medium-sized community hospital system in suburban Chicago. Enrolled patients were randomized to the active intervention or a control condition where participants received a book on mindfulness but no specific instructions to read it.

Intervention. Patients in the intervention arm attended an 8-week mindfulness-based stress reduction intervention, consisting of weekly sessions lasting 2½ hours held at their local primary hospital. Sessions were conducted by a trained and experienced mindfulness instructor. The intervention also included a half day retreat near the end of the intervention period to practice the skills that were taught.

Main outcome measures. Main outcome measures were prostate cancer anxiety (measured using the 18-item Memorial Anxiety Scale for Prostate Cancer), uncertainty tolerance (measured using the 12-item Intolerance of Uncertainty Short Form), mindfulness (measured via the 15-item Mindful Attention Awareness Scale), and health-related quality of life (measured using 10-item PROMIS Global Health-10). Researchers also measured “posttraumatic growth” using the Posttraumatic Growth Inventory, a 21-item self-report scale used to assess growth or benefits after a specific traumatic life event, such as a diagnosis of cancer. Participants completed instruments at baseline, 8 weeks, 6 months, and 12 months. At 12 months they also complete a brief feasibility and acceptance survey.

Main results. Over a 3-year period, 115 men were approached to participate and 54 enrolled. 11 withdrew prior to randomization citing lack of time as the primary reason. Ultimately, 24 men were randomized to the mindfulness arm and 19 to control. Average age was 70 years and 95% were white. Over 90% had never previously meditated or had never meditated on a regular basis. There were no significant differences between enrollees and decliners on baseline clinical or sociodemographic variables, and there were no significant differences between mindfulness and control patients on sociodemographic or clinical variables or outcome measures.

Participants in the intervention group reported decreased prostate cancer anxiety at 6 months (P = 0.02, effect size ([ES] 0.30) and uncertainty intolerance at 12 months (P = 0.02, ES 0.32) and increased quality of life at 8 weeks (P = 0.05, ES 0.17), mindfulness at 8 weeks (P < 0.04, ES 0.35) and 12 months (P < 0.01, ES 0.17), and posttraumatic growth (P < 0.05 for all follow-up measurements). When measuring changes between the groups, the only outcome that was significant was posttraumatic growth (P = 0.01, ES 0.73). Written responses to the open-ended survey questions regarding participants’ experience with the course cited increased emotional regulation and self-awareness and positive health behavior change.

Conclusion. An 8-week mindfulness training is feasible and acceptable to men with prostate cancer on active surveillance and may help men cope more effectively with stress and anxiety related to their cancer experience.

Commentary

Prostate cancer is the most common nonskin malignancy in men. More than 180,000 men are diagnosed per year, with over 26,000 prostate cancer deaths annually [1]. The optimal approach to treating newly diagnosed prostate cancer can be variable, but for most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy [2]. Despite the favorable prognosis of low-risk prostate cancer, men who choose active surveillance may experience anxiety and uncertainty, which can cause many to request definitive therapy even when there is no tumor progression [3].

Mindfulness-based meditation is a practice that is increasingly being investigated for a wide array of health conditions. Mindfulness has been defined as being intentionally aware of internal and external experiences that occur at the present moment, without judgment. Behavioral interventions such as mindfulness training may lessen anxiety related to uncertainty intolerance and help maintain patient engagement in active surveillance [4].

This small pilot study by Victorson et al evaluated an 8-week mindfulness meditation intervention intended to help men in active surveillance manage cancer-related uncertainty intolerance. They found the meditation training to be generally feasible and acceptable among participants. Men in the active intervention demonstrated statistically significant within-group changes that included decreased prostate cancer anxiety and increased mental well-being and posttraumatic growth, but there were no differences between groups except for posttraumatic growth. Interestingly, the control group also reported a moderate increase in mindfulness at 12 months, which was found (in an exploratory follow-up analysis) to be unrelated to reading the mindfulness book they were given (eg, those who did not open the book had higher average mindfulness scores than those who read the book from cover to cover).

Limitations of the study include the small sample size and lack of diversity among the participants, who were 95% white and well educated. In addition, the response rate prior to randomization was low: out of 115 men approached, 43 were ultimately randomized. Retention rates at 12 months were similar: 71% for intervention and 74% for control.

Applications for Clinical Practice

A growing body of research demonstrates that mindfulness practice may aid in improving psychological well-being. Further research is necessary before a clinical recommendation can be offered regarding use of mindfulness instruction to alleviate anxiety in men with low-grade prostate cancer being managed with active surveillance.

From the Mayo Clinic Center for Innovation (Dr. Romero-Brufau) Department of Medicine (Drs. Manning, Borrud, Keller, Kashiwagi, Huddleston, and Croghan) Department of Health Sciences Research (Mr. Cha), Mayo Clinic, Rochester, MN.

Abstract

• Objective: To determine whether a score of 8 or greater on the I-MOVE, a bedside instrument that evaluates the need for assistance in turning, sitting, standing, transferring from bed to a chair, and ambulating, predicts lower risk for 30-day readmission or mortality.
• Design: Retrospective cohort study of patients discharged from 2003 to 2011 from a referral hospital in Southeastern Minnesota. We used a convenience sample of 426 inpatients who had at least one documented calculation of the I-MOVE score performed as part of the clinical process during the study.
• Results: Overall 30-day mortality rate, readmission rate, and rate of the combined death/readmission outcome were 6.1% (26 patients), 15% (64 patients) and 19.7% (84 patients), respectively. After controlling for confounding variables, an I-MOVE score ≥ 8 was a significant predictive factor for 30-day mortality (OR = 0.136, P < 0.01) but not 30-day readmission (OR = 1.143, P = 0.62) or the combined outcome death/readmission (OR = 0.682, P = 0.13).
• Conclusion: The clinical information provided by a patient's I-MOVE score before discharge does not provide information about readmission risk but may offer incremental information about 30-day mortality risk.

Risk factors for hospital 30-day readmission have been studied by Hasan et al [1], van Walraven et al [2], Allaudeen et al [3], and more recently, Donze et al [4]. Risk factors found to be associated with readmission include race, length of stay, and number of hospitalizations in the last 12 months. Additionally, patients identified “feeling unprepared for discharge” and “difficulty performing activities of daily living” as top issues contributing to readmission. The Affordable Care Act established the Value-Based Purchasing (VBP) model for defined hospital illnesses such as acute myocardial infarction, heart failure, and community acquired pneumonia. This has focused more attention on post-discharge 30-day mortality and readmissions as publicly reported metrics that in part determine the Centers for Medicare and Medicaid Services care reimbursement rates [5].

In our hospital, over 400 inpatients have been evaluated since 2004 using the I-MOVE scoring system in the course of their usual care. I-MOVE was most commonly employed by geriatricians in the division of hospital internal medicine, who collectively endorsed the tool in their practice meetings, especially for elderly patients returning to home alone whose mobility independence was uncertain.

Although it was initially designed to help clinicians understand the mobility independence of a patient before discharge, it may provide incremental value discerning risk of 30-day readmission and/or death. We therefore hypothesized that an I-MOVE score of less than 8 (not being able to transfer from a bed to a chair without assistance) would be a significant predictor of 30-day readmission and/or death.

Methods

Study Design

We performed a retrospective cohort study using a convenience sample including the patients in which the I-MOVE score had been calculated as part of the clinical process of care.

Setting and Participants

Participants were any inpatients discharged from the general medicine unit at Mayo Clinic Rochester from January 2003 to May 2011 who had at least one documented calculation of the I-MOVE score performed as part of the clinical process. Patients in the general medicine unit are adults not requiring subspecialty cardiovascular or neurology, coronary care unit, surgical, psychiatry, or rehabilitation. Patients were excluded if there was missing key outcome information or if they died during the hospitalization. For patients with more than one I-MOVE assessment, only the one closest to discharge was used. Data were abstracted from the electronic medical records between July and August 2011.

Variables

Outcome variables were 30-day readmission, 30-day mortality, and the combined outcome of mortality or readmission. We used the last I-MOVE score as a dichotomous variable with a cut-off of 8, which corresponds to the ability to transfer from bed to a chair unaided, for predicting the 2 outcomes. Only readmissions to the study hospital were captured. Deaths were identified from the electronic medical record. Mayo Clinic patient records are updated monthly with external reports of confirmed, actuarial records of deaths reported from public databases.

To control for possible confounding variables, we included the following covariates: age, gender, race/ethnicity, dates of admission and discharge, insurance (Medicare, Medicaid, self-pay, or private), marital status (currently married/not currently married), length of hospital stay, emergent admission, number of hospital admissions in the last 12 months, number of visits to the emergency department in the last 6 months and Charlson Index. All variables were abstracted from the electronic medical record.

Sample

A search was performed in the electronic medical record to find clinical documents (admission notes, progress notes, and hospital summaries) that mentioned the term “I-MOVE.” Manual review of the records was performed to confirm inclusion criteria.

Statistical Analysis

Separate analyses were performed for the 2 outcomes considered. First, a univariate analysis was performed with all covariates for variable selection. Variables that were significantly predictive with P < 0.1 were included in the multivariate model. Variables included in the first run of the multivariate model were excluded from the final multivariate model if they were not independently significant with P < 0.05. The I-MOVE variable was then added to that model to check its predictive power beyond that of the included covariates.

Results

Patient Characteristics

For the final dataset of 426 patients, 30-day mortality rate, readmission rate, and rate of the combined death/readmission outcome were 6.1% (26 patients), 15% (64 patients) and 19.7% (84 patients), respectively. A total of 6 patients were readmitted and died within 30 days after the initial discharge. The number of patients that had an I-MOVE score greater than or equal to 8 was 232 (54.4%). Table 2 presents the mean, standard deviation, and median I-MOVE score by patient discharge destination. Patients discharged home had an average I-MOVE score of 11.98, versus 7.24 for patients discharge to a skilled nursing facility (P = 0.2).

Analysis

Table 3 presents the odds ratios and coefficient estimate of the models. In the univariate analysis, an I-MOVE score greater than or equal to 8 was significantly correlated with 30-day mortality (P < 0.001), and the combined outcome (P = 0.044) but not with 30-day readmission (P = 0.76). After controlling for confounding variables, I-MOVE greater than or equal to 8 was a significant predictor of 30-day mortality (P < 0.01) but not 30-day readmission (P = 0.75) 

Discussion

An I-MOVE score of less than 8 (inability to transfer from bed to a chair unassisted) is a statistically significant predictor of 30-day post-discharge mortality but not readmission or the combined outcome of death/readmission.

A recent review that evaluated published models that attempted to predict readmissions concluded that most current readmission risk prediction models designed for either comparative or clinical purposes perform poorly and that efforts are needed to improve their performance as use becomes more widespread [8]. Health care providers’ ability to predict which patients would be readmitted within 30 days was also shown by a recent study to be very poor, with C-statistics around 0.60 [9]. This inability of both experts and statistical methods to accurately predict readmissions may reflect some inherent randomness or unpredictability of readmissions, or the fact that a paradigm shift is still needed in the identification of the most important risk factors for readmissions. Along the same line, a recent evaluation of interventions aimed at reducing readmissions found that none of those identified in the literature managed to consistently reduce readmission rates long-term [10]. In addition, hospitals with greater adherence to recommended care processes did not achieve meaningfully better 30-day hospital readmission rates compared to those with lower levels of performance.

Conceptually, readmissions are an example of what is called “complexity science,” where many agents or factors (including the patient’s underlying illness, quality of care delivered, continuity and coordination of care, and resources available in the patient’s environment) and their interactions all play a role in the outcome [11,12]. Since I-MOVE primarily evaluates the physical capacity of the patient, and not any of the other variables that strongly affect readmission, it is perhaps not surprising that it did not predict readmission. It can be argued, on the other hand, that short term (30-day) mortality is more dependent on the patient’s physical and functional status [13] and so more likely to correlate with a measure such as I-MOVE. Inouye et al [13] found that pre-hospital, self-reported need for assistance in 7 basic “activities of daily living” (among which are transfers and ambulation) correlated with 90-day, and 2-year, post-hospital mortality.

The study has the advantage of a relatively large sample size, and the fact that the I-MOVE score was assessed before discharge eliminates the possibility of assessor bias. However, it has some limitations. We used a convenience sample, which may have introduced selection bias. Although we have no data on how providers selected patients for I-MOVE assessment, it would be reasonable to assume that patients were selected from among those whose activity level was, in terms of independence, doubtful or uncertain. That is, those who were not clearly vigorous (up and walking easily), nor clearly debilitated (in need of great assistance) may have been more likely to be assessed using I-MOVE. A more systematic selection of subjects might increase or decrease the predictive performance of the I-MOVE assessment. In addition, although we attempted to control for potential confounders, it is possible that additional confounders were left out of our analysis.

In summary, although the predictive performance of I-MOVE still needs to be confirmed by prospective studies with a comprehensive selection of subjects, the I-MOVE score at discharge appears to be associated with 30-day post-discharge mortality.

Acknowledgments: We thank the Department of Medicine’s clinical research office for their help in study design, data acquisition, and statistical analysis. 

Corresponding author: Santiago Romero-Brufau, MD, Mayo Clinic Center for Innovation,  200 First St. SW, Rochester, MN 55905,  [email protected].

Funding/support: This publication was supported by grant number UL1 TR000135 from the National Center for Advancing Translational Sciences (NCATS). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.  

From the Mayo Clinic Center for Innovation (Dr. Romero-Brufau) Department of Medicine (Drs. Manning, Borrud, Keller, Kashiwagi, Huddleston, and Croghan) Department of Health Sciences Research (Mr. Cha), Mayo Clinic, Rochester, MN.

Abstract

• Objective: To determine whether a score of 8 or greater on the I-MOVE, a bedside instrument that evaluates the need for assistance in turning, sitting, standing, transferring from bed to a chair, and ambulating, predicts lower risk for 30-day readmission or mortality.
• Design: Retrospective cohort study of patients discharged from 2003 to 2011 from a referral hospital in Southeastern Minnesota. We used a convenience sample of 426 inpatients who had at least one documented calculation of the I-MOVE score performed as part of the clinical process during the study.
• Results: Overall 30-day mortality rate, readmission rate, and rate of the combined death/readmission outcome were 6.1% (26 patients), 15% (64 patients) and 19.7% (84 patients), respectively. After controlling for confounding variables, an I-MOVE score ≥ 8 was a significant predictive factor for 30-day mortality (OR = 0.136, P < 0.01) but not 30-day readmission (OR = 1.143, P = 0.62) or the combined outcome death/readmission (OR = 0.682, P = 0.13).
• Conclusion: The clinical information provided by a patient's I-MOVE score before discharge does not provide information about readmission risk but may offer incremental information about 30-day mortality risk.

Risk factors for hospital 30-day readmission have been studied by Hasan et al [1], van Walraven et al [2], Allaudeen et al [3], and more recently, Donze et al [4]. Risk factors found to be associated with readmission include race, length of stay, and number of hospitalizations in the last 12 months. Additionally, patients identified “feeling unprepared for discharge” and “difficulty performing activities of daily living” as top issues contributing to readmission. The Affordable Care Act established the Value-Based Purchasing (VBP) model for defined hospital illnesses such as acute myocardial infarction, heart failure, and community acquired pneumonia. This has focused more attention on post-discharge 30-day mortality and readmissions as publicly reported metrics that in part determine the Centers for Medicare and Medicaid Services care reimbursement rates [5].

In our hospital, over 400 inpatients have been evaluated since 2004 using the I-MOVE scoring system in the course of their usual care. I-MOVE was most commonly employed by geriatricians in the division of hospital internal medicine, who collectively endorsed the tool in their practice meetings, especially for elderly patients returning to home alone whose mobility independence was uncertain.

Although it was initially designed to help clinicians understand the mobility independence of a patient before discharge, it may provide incremental value discerning risk of 30-day readmission and/or death. We therefore hypothesized that an I-MOVE score of less than 8 (not being able to transfer from a bed to a chair without assistance) would be a significant predictor of 30-day readmission and/or death.

Methods

Study Design

We performed a retrospective cohort study using a convenience sample including the patients in which the I-MOVE score had been calculated as part of the clinical process of care.

Setting and Participants

Participants were any inpatients discharged from the general medicine unit at Mayo Clinic Rochester from January 2003 to May 2011 who had at least one documented calculation of the I-MOVE score performed as part of the clinical process. Patients in the general medicine unit are adults not requiring subspecialty cardiovascular or neurology, coronary care unit, surgical, psychiatry, or rehabilitation. Patients were excluded if there was missing key outcome information or if they died during the hospitalization. For patients with more than one I-MOVE assessment, only the one closest to discharge was used. Data were abstracted from the electronic medical records between July and August 2011.

Variables

Outcome variables were 30-day readmission, 30-day mortality, and the combined outcome of mortality or readmission. We used the last I-MOVE score as a dichotomous variable with a cut-off of 8, which corresponds to the ability to transfer from bed to a chair unaided, for predicting the 2 outcomes. Only readmissions to the study hospital were captured. Deaths were identified from the electronic medical record. Mayo Clinic patient records are updated monthly with external reports of confirmed, actuarial records of deaths reported from public databases.

To control for possible confounding variables, we included the following covariates: age, gender, race/ethnicity, dates of admission and discharge, insurance (Medicare, Medicaid, self-pay, or private), marital status (currently married/not currently married), length of hospital stay, emergent admission, number of hospital admissions in the last 12 months, number of visits to the emergency department in the last 6 months and Charlson Index. All variables were abstracted from the electronic medical record.

Sample

A search was performed in the electronic medical record to find clinical documents (admission notes, progress notes, and hospital summaries) that mentioned the term “I-MOVE.” Manual review of the records was performed to confirm inclusion criteria.

Statistical Analysis

Separate analyses were performed for the 2 outcomes considered. First, a univariate analysis was performed with all covariates for variable selection. Variables that were significantly predictive with P < 0.1 were included in the multivariate model. Variables included in the first run of the multivariate model were excluded from the final multivariate model if they were not independently significant with P < 0.05. The I-MOVE variable was then added to that model to check its predictive power beyond that of the included covariates.

Results

Patient Characteristics

For the final dataset of 426 patients, 30-day mortality rate, readmission rate, and rate of the combined death/readmission outcome were 6.1% (26 patients), 15% (64 patients) and 19.7% (84 patients), respectively. A total of 6 patients were readmitted and died within 30 days after the initial discharge. The number of patients that had an I-MOVE score greater than or equal to 8 was 232 (54.4%). Table 2 presents the mean, standard deviation, and median I-MOVE score by patient discharge destination. Patients discharged home had an average I-MOVE score of 11.98, versus 7.24 for patients discharge to a skilled nursing facility (P = 0.2).

Analysis

Table 3 presents the odds ratios and coefficient estimate of the models. In the univariate analysis, an I-MOVE score greater than or equal to 8 was significantly correlated with 30-day mortality (P < 0.001), and the combined outcome (P = 0.044) but not with 30-day readmission (P = 0.76). After controlling for confounding variables, I-MOVE greater than or equal to 8 was a significant predictor of 30-day mortality (P < 0.01) but not 30-day readmission (P = 0.75) 

Discussion

An I-MOVE score of less than 8 (inability to transfer from bed to a chair unassisted) is a statistically significant predictor of 30-day post-discharge mortality but not readmission or the combined outcome of death/readmission.

A recent review that evaluated published models that attempted to predict readmissions concluded that most current readmission risk prediction models designed for either comparative or clinical purposes perform poorly and that efforts are needed to improve their performance as use becomes more widespread [8]. Health care providers’ ability to predict which patients would be readmitted within 30 days was also shown by a recent study to be very poor, with C-statistics around 0.60 [9]. This inability of both experts and statistical methods to accurately predict readmissions may reflect some inherent randomness or unpredictability of readmissions, or the fact that a paradigm shift is still needed in the identification of the most important risk factors for readmissions. Along the same line, a recent evaluation of interventions aimed at reducing readmissions found that none of those identified in the literature managed to consistently reduce readmission rates long-term [10]. In addition, hospitals with greater adherence to recommended care processes did not achieve meaningfully better 30-day hospital readmission rates compared to those with lower levels of performance.

Conceptually, readmissions are an example of what is called “complexity science,” where many agents or factors (including the patient’s underlying illness, quality of care delivered, continuity and coordination of care, and resources available in the patient’s environment) and their interactions all play a role in the outcome [11,12]. Since I-MOVE primarily evaluates the physical capacity of the patient, and not any of the other variables that strongly affect readmission, it is perhaps not surprising that it did not predict readmission. It can be argued, on the other hand, that short term (30-day) mortality is more dependent on the patient’s physical and functional status [13] and so more likely to correlate with a measure such as I-MOVE. Inouye et al [13] found that pre-hospital, self-reported need for assistance in 7 basic “activities of daily living” (among which are transfers and ambulation) correlated with 90-day, and 2-year, post-hospital mortality.

The study has the advantage of a relatively large sample size, and the fact that the I-MOVE score was assessed before discharge eliminates the possibility of assessor bias. However, it has some limitations. We used a convenience sample, which may have introduced selection bias. Although we have no data on how providers selected patients for I-MOVE assessment, it would be reasonable to assume that patients were selected from among those whose activity level was, in terms of independence, doubtful or uncertain. That is, those who were not clearly vigorous (up and walking easily), nor clearly debilitated (in need of great assistance) may have been more likely to be assessed using I-MOVE. A more systematic selection of subjects might increase or decrease the predictive performance of the I-MOVE assessment. In addition, although we attempted to control for potential confounders, it is possible that additional confounders were left out of our analysis.

In summary, although the predictive performance of I-MOVE still needs to be confirmed by prospective studies with a comprehensive selection of subjects, the I-MOVE score at discharge appears to be associated with 30-day post-discharge mortality.

Acknowledgments: We thank the Department of Medicine’s clinical research office for their help in study design, data acquisition, and statistical analysis. 

Corresponding author: Santiago Romero-Brufau, MD, Mayo Clinic Center for Innovation,  200 First St. SW, Rochester, MN 55905,  [email protected].

Funding/support: This publication was supported by grant number UL1 TR000135 from the National Center for Advancing Translational Sciences (NCATS). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.  

From the Mayo Clinic Center for Innovation (Dr. Romero-Brufau) Department of Medicine (Drs. Manning, Borrud, Keller, Kashiwagi, Huddleston, and Croghan) Department of Health Sciences Research (Mr. Cha), Mayo Clinic, Rochester, MN.

Abstract

• Objective: To determine whether a score of 8 or greater on the I-MOVE, a bedside instrument that evaluates the need for assistance in turning, sitting, standing, transferring from bed to a chair, and ambulating, predicts lower risk for 30-day readmission or mortality.
• Design: Retrospective cohort study of patients discharged from 2003 to 2011 from a referral hospital in Southeastern Minnesota. We used a convenience sample of 426 inpatients who had at least one documented calculation of the I-MOVE score performed as part of the clinical process during the study.
• Results: Overall 30-day mortality rate, readmission rate, and rate of the combined death/readmission outcome were 6.1% (26 patients), 15% (64 patients) and 19.7% (84 patients), respectively. After controlling for confounding variables, an I-MOVE score ≥ 8 was a significant predictive factor for 30-day mortality (OR = 0.136, P < 0.01) but not 30-day readmission (OR = 1.143, P = 0.62) or the combined outcome death/readmission (OR = 0.682, P = 0.13).
• Conclusion: The clinical information provided by a patient's I-MOVE score before discharge does not provide information about readmission risk but may offer incremental information about 30-day mortality risk.

Risk factors for hospital 30-day readmission have been studied by Hasan et al [1], van Walraven et al [2], Allaudeen et al [3], and more recently, Donze et al [4]. Risk factors found to be associated with readmission include race, length of stay, and number of hospitalizations in the last 12 months. Additionally, patients identified “feeling unprepared for discharge” and “difficulty performing activities of daily living” as top issues contributing to readmission. The Affordable Care Act established the Value-Based Purchasing (VBP) model for defined hospital illnesses such as acute myocardial infarction, heart failure, and community acquired pneumonia. This has focused more attention on post-discharge 30-day mortality and readmissions as publicly reported metrics that in part determine the Centers for Medicare and Medicaid Services care reimbursement rates [5].

In our hospital, over 400 inpatients have been evaluated since 2004 using the I-MOVE scoring system in the course of their usual care. I-MOVE was most commonly employed by geriatricians in the division of hospital internal medicine, who collectively endorsed the tool in their practice meetings, especially for elderly patients returning to home alone whose mobility independence was uncertain.

Although it was initially designed to help clinicians understand the mobility independence of a patient before discharge, it may provide incremental value discerning risk of 30-day readmission and/or death. We therefore hypothesized that an I-MOVE score of less than 8 (not being able to transfer from a bed to a chair without assistance) would be a significant predictor of 30-day readmission and/or death.

Methods

Study Design

We performed a retrospective cohort study using a convenience sample including the patients in which the I-MOVE score had been calculated as part of the clinical process of care.

Setting and Participants

Participants were any inpatients discharged from the general medicine unit at Mayo Clinic Rochester from January 2003 to May 2011 who had at least one documented calculation of the I-MOVE score performed as part of the clinical process. Patients in the general medicine unit are adults not requiring subspecialty cardiovascular or neurology, coronary care unit, surgical, psychiatry, or rehabilitation. Patients were excluded if there was missing key outcome information or if they died during the hospitalization. For patients with more than one I-MOVE assessment, only the one closest to discharge was used. Data were abstracted from the electronic medical records between July and August 2011.

Variables

Outcome variables were 30-day readmission, 30-day mortality, and the combined outcome of mortality or readmission. We used the last I-MOVE score as a dichotomous variable with a cut-off of 8, which corresponds to the ability to transfer from bed to a chair unaided, for predicting the 2 outcomes. Only readmissions to the study hospital were captured. Deaths were identified from the electronic medical record. Mayo Clinic patient records are updated monthly with external reports of confirmed, actuarial records of deaths reported from public databases.

To control for possible confounding variables, we included the following covariates: age, gender, race/ethnicity, dates of admission and discharge, insurance (Medicare, Medicaid, self-pay, or private), marital status (currently married/not currently married), length of hospital stay, emergent admission, number of hospital admissions in the last 12 months, number of visits to the emergency department in the last 6 months and Charlson Index. All variables were abstracted from the electronic medical record.

Sample

A search was performed in the electronic medical record to find clinical documents (admission notes, progress notes, and hospital summaries) that mentioned the term “I-MOVE.” Manual review of the records was performed to confirm inclusion criteria.

Statistical Analysis

Separate analyses were performed for the 2 outcomes considered. First, a univariate analysis was performed with all covariates for variable selection. Variables that were significantly predictive with P < 0.1 were included in the multivariate model. Variables included in the first run of the multivariate model were excluded from the final multivariate model if they were not independently significant with P < 0.05. The I-MOVE variable was then added to that model to check its predictive power beyond that of the included covariates.

Results

Patient Characteristics

For the final dataset of 426 patients, 30-day mortality rate, readmission rate, and rate of the combined death/readmission outcome were 6.1% (26 patients), 15% (64 patients) and 19.7% (84 patients), respectively. A total of 6 patients were readmitted and died within 30 days after the initial discharge. The number of patients that had an I-MOVE score greater than or equal to 8 was 232 (54.4%). Table 2 presents the mean, standard deviation, and median I-MOVE score by patient discharge destination. Patients discharged home had an average I-MOVE score of 11.98, versus 7.24 for patients discharge to a skilled nursing facility (P = 0.2).

Analysis

Table 3 presents the odds ratios and coefficient estimate of the models. In the univariate analysis, an I-MOVE score greater than or equal to 8 was significantly correlated with 30-day mortality (P < 0.001), and the combined outcome (P = 0.044) but not with 30-day readmission (P = 0.76). After controlling for confounding variables, I-MOVE greater than or equal to 8 was a significant predictor of 30-day mortality (P < 0.01) but not 30-day readmission (P = 0.75) 

Discussion

An I-MOVE score of less than 8 (inability to transfer from bed to a chair unassisted) is a statistically significant predictor of 30-day post-discharge mortality but not readmission or the combined outcome of death/readmission.

A recent review that evaluated published models that attempted to predict readmissions concluded that most current readmission risk prediction models designed for either comparative or clinical purposes perform poorly and that efforts are needed to improve their performance as use becomes more widespread [8]. Health care providers’ ability to predict which patients would be readmitted within 30 days was also shown by a recent study to be very poor, with C-statistics around 0.60 [9]. This inability of both experts and statistical methods to accurately predict readmissions may reflect some inherent randomness or unpredictability of readmissions, or the fact that a paradigm shift is still needed in the identification of the most important risk factors for readmissions. Along the same line, a recent evaluation of interventions aimed at reducing readmissions found that none of those identified in the literature managed to consistently reduce readmission rates long-term [10]. In addition, hospitals with greater adherence to recommended care processes did not achieve meaningfully better 30-day hospital readmission rates compared to those with lower levels of performance.

Conceptually, readmissions are an example of what is called “complexity science,” where many agents or factors (including the patient’s underlying illness, quality of care delivered, continuity and coordination of care, and resources available in the patient’s environment) and their interactions all play a role in the outcome [11,12]. Since I-MOVE primarily evaluates the physical capacity of the patient, and not any of the other variables that strongly affect readmission, it is perhaps not surprising that it did not predict readmission. It can be argued, on the other hand, that short term (30-day) mortality is more dependent on the patient’s physical and functional status [13] and so more likely to correlate with a measure such as I-MOVE. Inouye et al [13] found that pre-hospital, self-reported need for assistance in 7 basic “activities of daily living” (among which are transfers and ambulation) correlated with 90-day, and 2-year, post-hospital mortality.

The study has the advantage of a relatively large sample size, and the fact that the I-MOVE score was assessed before discharge eliminates the possibility of assessor bias. However, it has some limitations. We used a convenience sample, which may have introduced selection bias. Although we have no data on how providers selected patients for I-MOVE assessment, it would be reasonable to assume that patients were selected from among those whose activity level was, in terms of independence, doubtful or uncertain. That is, those who were not clearly vigorous (up and walking easily), nor clearly debilitated (in need of great assistance) may have been more likely to be assessed using I-MOVE. A more systematic selection of subjects might increase or decrease the predictive performance of the I-MOVE assessment. In addition, although we attempted to control for potential confounders, it is possible that additional confounders were left out of our analysis.

In summary, although the predictive performance of I-MOVE still needs to be confirmed by prospective studies with a comprehensive selection of subjects, the I-MOVE score at discharge appears to be associated with 30-day post-discharge mortality.

Acknowledgments: We thank the Department of Medicine’s clinical research office for their help in study design, data acquisition, and statistical analysis. 

Corresponding author: Santiago Romero-Brufau, MD, Mayo Clinic Center for Innovation,  200 First St. SW, Rochester, MN 55905,  [email protected].

Funding/support: This publication was supported by grant number UL1 TR000135 from the National Center for Advancing Translational Sciences (NCATS). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.  

SCOTTSDALE, ARIZ. – Psoriasis of all severities was linked to a 3.5-fold increase in risk of cutaneous T-cell lymphoma, and severe psoriasis upped the associated risk of Hodgkin lymphoma by about 2.5 times, in a large, longitudinal, population-based cohort study.

Psoriasis also was tied to a smaller but statistically significant increase in the risk of non-Hodgkin lymphoma, said Zelma Chiesa Fuxench, MD, of the department of dermatology, the University of Pennsylvania, Philadelphia. Overall, lymphoma risk was highest in people with severe psoriasis, independent of traditional risk factors and exposure to immunosuppressive medications, Dr. Fuxench said at the annual meeting of the Society for Investigative Dermatology.

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis affects more than 125 million people worldwide, and severe cases are a major cause of cancer-related mortality. “Prior studies have suggested an increased risk of lymphoma in psoriasis patients, but it is unclear if this due to chronic inflammation, exposure to immunosuppressive therapies, or a combination of both factors,” Dr. Fuxench said.

To further explore these links, she and her associates analyzed electronic medical records from THIN (The Health Information Network), which includes about 12 million patients across the United Kingdom. Adults with psoriasis were matched to up to five nonpsoriatic controls based on date and clinic location. Patients who needed systemic medications or phototherapy were categorized as having severe psoriasis. The final dataset included more than 12,000 such patients, as well as 184,000 patients with mild psoriasis and more than 965,000 patients without psoriasis.

Psoriasis patients were younger and more likely to be overweight, male, and smoke and drink alcohol than patients without psoriasis, Dr. Fuxench said. Almost 80% of patients with severe disease had received systemic therapies, most often methotrexate (70% of systemic treatments) or cyclosporine (10%), while only 1% had received biologics.

Patients with severe psoriasis were more likely to be diagnosed with Hodgkin disease, non-Hodgkin lymphoma, and cutaneous T-cell lymphoma than were patients with mild psoriasis or controls. Over a median follow-up of 5.3 years, 34 patients with severe psoriasis were diagnosed with any type of lymphoma, for an incidence of 5.2 cases per 10,000 person-years (95% confidence interval, 3.7-7.3). In contrast, incidence rates for patients with mild psoriasis and controls were 3.3 and 3.2 cases per 10,000 person-years, respectively, Dr. Fuxench said.

In the multivariable analysis, patients with psoriasis were about 18% more likely to develop any type of lymphoma than were controls, an association that reached statistical significance (adjusted hazard ratio, 1.18; 95% CI, 1.06-1.31). Mild psoriasis increased lymphoma risk by 14%, and severe psoriasis upped it by about 83%, and both associations were statistically significant.

The increase in risk of non-Hodgkin lymphoma was 13% greater with mild psoriasis and 56% greater with severe disease, compared with controls, and these associations also reached statistical significance. Mild psoriasis was not linked to Hodgkin lymphoma, but patients with severe psoriasis were about 250% more likely to develop it than controls, with a trend toward statistical significance (aHR, 2.54; 95% CI, 0.94-6.87).

Finally, severe psoriasis was linked to a more than ninefold increase in risk of cutaneous T-cell lymphoma (aHR, 9.3; 95% CI, 4.1-21.4), while mild psoriasis was linked to about a threefold increase in risk.

“These results were robust in multiple sensitivity analyses, including analyses that excluded patients with rheumatoid arthritis, psoriatic arthritis, or a history of exposure to methotrexate, cyclosporine, or biologics,” Dr. Fuxench said. Future studies should explore the effect of treatment timing and selection on cancer risk, she added. “For those of us who care for these patients, we are increasingly using systemic agents that selectively target the immune system, and these questions will arise in clinics.”

The study’s design made it possible to pinpoint dates of diagnosis more effectively than investigators could estimate disease duration or confirm whether patients initially diagnosed with psoriasis actually had cutaneous T-cell lymphoma, Dr. Fuxench noted. “Ideally, we could have another cohort study of incident psoriasis with prospective follow-up, but lymphoma is so rare that there is currently not enough power [in the THIN database] to determine associations.”

The study was funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Fuxench disclosed unrestricted research funding from Pfizer outside the submitted work.

SCOTTSDALE, ARIZ. – Psoriasis of all severities was linked to a 3.5-fold increase in risk of cutaneous T-cell lymphoma, and severe psoriasis upped the associated risk of Hodgkin lymphoma by about 2.5 times, in a large, longitudinal, population-based cohort study.

Psoriasis also was tied to a smaller but statistically significant increase in the risk of non-Hodgkin lymphoma, said Zelma Chiesa Fuxench, MD, of the department of dermatology, the University of Pennsylvania, Philadelphia. Overall, lymphoma risk was highest in people with severe psoriasis, independent of traditional risk factors and exposure to immunosuppressive medications, Dr. Fuxench said at the annual meeting of the Society for Investigative Dermatology.

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis affects more than 125 million people worldwide, and severe cases are a major cause of cancer-related mortality. “Prior studies have suggested an increased risk of lymphoma in psoriasis patients, but it is unclear if this due to chronic inflammation, exposure to immunosuppressive therapies, or a combination of both factors,” Dr. Fuxench said.

To further explore these links, she and her associates analyzed electronic medical records from THIN (The Health Information Network), which includes about 12 million patients across the United Kingdom. Adults with psoriasis were matched to up to five nonpsoriatic controls based on date and clinic location. Patients who needed systemic medications or phototherapy were categorized as having severe psoriasis. The final dataset included more than 12,000 such patients, as well as 184,000 patients with mild psoriasis and more than 965,000 patients without psoriasis.

Psoriasis patients were younger and more likely to be overweight, male, and smoke and drink alcohol than patients without psoriasis, Dr. Fuxench said. Almost 80% of patients with severe disease had received systemic therapies, most often methotrexate (70% of systemic treatments) or cyclosporine (10%), while only 1% had received biologics.

Patients with severe psoriasis were more likely to be diagnosed with Hodgkin disease, non-Hodgkin lymphoma, and cutaneous T-cell lymphoma than were patients with mild psoriasis or controls. Over a median follow-up of 5.3 years, 34 patients with severe psoriasis were diagnosed with any type of lymphoma, for an incidence of 5.2 cases per 10,000 person-years (95% confidence interval, 3.7-7.3). In contrast, incidence rates for patients with mild psoriasis and controls were 3.3 and 3.2 cases per 10,000 person-years, respectively, Dr. Fuxench said.

In the multivariable analysis, patients with psoriasis were about 18% more likely to develop any type of lymphoma than were controls, an association that reached statistical significance (adjusted hazard ratio, 1.18; 95% CI, 1.06-1.31). Mild psoriasis increased lymphoma risk by 14%, and severe psoriasis upped it by about 83%, and both associations were statistically significant.

The increase in risk of non-Hodgkin lymphoma was 13% greater with mild psoriasis and 56% greater with severe disease, compared with controls, and these associations also reached statistical significance. Mild psoriasis was not linked to Hodgkin lymphoma, but patients with severe psoriasis were about 250% more likely to develop it than controls, with a trend toward statistical significance (aHR, 2.54; 95% CI, 0.94-6.87).

Finally, severe psoriasis was linked to a more than ninefold increase in risk of cutaneous T-cell lymphoma (aHR, 9.3; 95% CI, 4.1-21.4), while mild psoriasis was linked to about a threefold increase in risk.

“These results were robust in multiple sensitivity analyses, including analyses that excluded patients with rheumatoid arthritis, psoriatic arthritis, or a history of exposure to methotrexate, cyclosporine, or biologics,” Dr. Fuxench said. Future studies should explore the effect of treatment timing and selection on cancer risk, she added. “For those of us who care for these patients, we are increasingly using systemic agents that selectively target the immune system, and these questions will arise in clinics.”

The study’s design made it possible to pinpoint dates of diagnosis more effectively than investigators could estimate disease duration or confirm whether patients initially diagnosed with psoriasis actually had cutaneous T-cell lymphoma, Dr. Fuxench noted. “Ideally, we could have another cohort study of incident psoriasis with prospective follow-up, but lymphoma is so rare that there is currently not enough power [in the THIN database] to determine associations.”

The study was funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Fuxench disclosed unrestricted research funding from Pfizer outside the submitted work.

SCOTTSDALE, ARIZ. – Psoriasis of all severities was linked to a 3.5-fold increase in risk of cutaneous T-cell lymphoma, and severe psoriasis upped the associated risk of Hodgkin lymphoma by about 2.5 times, in a large, longitudinal, population-based cohort study.

Psoriasis also was tied to a smaller but statistically significant increase in the risk of non-Hodgkin lymphoma, said Zelma Chiesa Fuxench, MD, of the department of dermatology, the University of Pennsylvania, Philadelphia. Overall, lymphoma risk was highest in people with severe psoriasis, independent of traditional risk factors and exposure to immunosuppressive medications, Dr. Fuxench said at the annual meeting of the Society for Investigative Dermatology.

Courtesy of the Centers for Disease Control and Prevention (CDC)

Psoriasis affects more than 125 million people worldwide, and severe cases are a major cause of cancer-related mortality. “Prior studies have suggested an increased risk of lymphoma in psoriasis patients, but it is unclear if this due to chronic inflammation, exposure to immunosuppressive therapies, or a combination of both factors,” Dr. Fuxench said.

To further explore these links, she and her associates analyzed electronic medical records from THIN (The Health Information Network), which includes about 12 million patients across the United Kingdom. Adults with psoriasis were matched to up to five nonpsoriatic controls based on date and clinic location. Patients who needed systemic medications or phototherapy were categorized as having severe psoriasis. The final dataset included more than 12,000 such patients, as well as 184,000 patients with mild psoriasis and more than 965,000 patients without psoriasis.

Psoriasis patients were younger and more likely to be overweight, male, and smoke and drink alcohol than patients without psoriasis, Dr. Fuxench said. Almost 80% of patients with severe disease had received systemic therapies, most often methotrexate (70% of systemic treatments) or cyclosporine (10%), while only 1% had received biologics.

Patients with severe psoriasis were more likely to be diagnosed with Hodgkin disease, non-Hodgkin lymphoma, and cutaneous T-cell lymphoma than were patients with mild psoriasis or controls. Over a median follow-up of 5.3 years, 34 patients with severe psoriasis were diagnosed with any type of lymphoma, for an incidence of 5.2 cases per 10,000 person-years (95% confidence interval, 3.7-7.3). In contrast, incidence rates for patients with mild psoriasis and controls were 3.3 and 3.2 cases per 10,000 person-years, respectively, Dr. Fuxench said.

In the multivariable analysis, patients with psoriasis were about 18% more likely to develop any type of lymphoma than were controls, an association that reached statistical significance (adjusted hazard ratio, 1.18; 95% CI, 1.06-1.31). Mild psoriasis increased lymphoma risk by 14%, and severe psoriasis upped it by about 83%, and both associations were statistically significant.

The increase in risk of non-Hodgkin lymphoma was 13% greater with mild psoriasis and 56% greater with severe disease, compared with controls, and these associations also reached statistical significance. Mild psoriasis was not linked to Hodgkin lymphoma, but patients with severe psoriasis were about 250% more likely to develop it than controls, with a trend toward statistical significance (aHR, 2.54; 95% CI, 0.94-6.87).

Finally, severe psoriasis was linked to a more than ninefold increase in risk of cutaneous T-cell lymphoma (aHR, 9.3; 95% CI, 4.1-21.4), while mild psoriasis was linked to about a threefold increase in risk.

“These results were robust in multiple sensitivity analyses, including analyses that excluded patients with rheumatoid arthritis, psoriatic arthritis, or a history of exposure to methotrexate, cyclosporine, or biologics,” Dr. Fuxench said. Future studies should explore the effect of treatment timing and selection on cancer risk, she added. “For those of us who care for these patients, we are increasingly using systemic agents that selectively target the immune system, and these questions will arise in clinics.”

The study’s design made it possible to pinpoint dates of diagnosis more effectively than investigators could estimate disease duration or confirm whether patients initially diagnosed with psoriasis actually had cutaneous T-cell lymphoma, Dr. Fuxench noted. “Ideally, we could have another cohort study of incident psoriasis with prospective follow-up, but lymphoma is so rare that there is currently not enough power [in the THIN database] to determine associations.”

The study was funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Fuxench disclosed unrestricted research funding from Pfizer outside the submitted work.