Treatment with opioids is not cost effective in osteoarthritis patients without comorbidities, according to Savannah R. Smith and her associates.

When a 10% reduction in total knee arthroplasty (TKA) effectiveness from opioid-based therapies was assumed, tramadol therapy delayed TKA by 7 years and tramadol plus oxycodone therapy delayed TKA by 9 years. Opioid-based therapy reduced primary TKA utilization by 4% for tramadol and by 10% for tramadol plus oxycodone, and reduced revision TKA use by 23% and 39%, respectively.

©decade3d/Thinkstock

While both opioid-based therapies reduced dependence on TKA, treatment was more expensive and it reduced quality of life, compared with an opioid-sparing therapy. For a 60-year-old OA patient for whom TKA was not an option, the incremental cost-effectiveness ratio for tramadol was $39,600 per quality-adjusted life-year, compared with a therapy without opioids, and the incremental cost-effectiveness ratio for tramadol plus oxycodone was $116,800 per quality-adjusted life-year.

“Given the risk of diversion and its associated cost for potent opioids, policy makers may consider limiting the use of potent opioids in knee OA patients. From a cost-effectiveness standpoint, both opioid-based strategies led to higher costs without providing additional benefits, unless patients were unwilling or unable to undergo TKA later,” the investigators noted.

Find the full study in Arthritis Care and Research (doi: 10.1002/acr.22916).

[email protected]

Treatment with opioids is not cost effective in osteoarthritis patients without comorbidities, according to Savannah R. Smith and her associates.

When a 10% reduction in total knee arthroplasty (TKA) effectiveness from opioid-based therapies was assumed, tramadol therapy delayed TKA by 7 years and tramadol plus oxycodone therapy delayed TKA by 9 years. Opioid-based therapy reduced primary TKA utilization by 4% for tramadol and by 10% for tramadol plus oxycodone, and reduced revision TKA use by 23% and 39%, respectively.

©decade3d/Thinkstock

While both opioid-based therapies reduced dependence on TKA, treatment was more expensive and it reduced quality of life, compared with an opioid-sparing therapy. For a 60-year-old OA patient for whom TKA was not an option, the incremental cost-effectiveness ratio for tramadol was $39,600 per quality-adjusted life-year, compared with a therapy without opioids, and the incremental cost-effectiveness ratio for tramadol plus oxycodone was $116,800 per quality-adjusted life-year.

“Given the risk of diversion and its associated cost for potent opioids, policy makers may consider limiting the use of potent opioids in knee OA patients. From a cost-effectiveness standpoint, both opioid-based strategies led to higher costs without providing additional benefits, unless patients were unwilling or unable to undergo TKA later,” the investigators noted.

Find the full study in Arthritis Care and Research (doi: 10.1002/acr.22916).

[email protected]

Treatment with opioids is not cost effective in osteoarthritis patients without comorbidities, according to Savannah R. Smith and her associates.

When a 10% reduction in total knee arthroplasty (TKA) effectiveness from opioid-based therapies was assumed, tramadol therapy delayed TKA by 7 years and tramadol plus oxycodone therapy delayed TKA by 9 years. Opioid-based therapy reduced primary TKA utilization by 4% for tramadol and by 10% for tramadol plus oxycodone, and reduced revision TKA use by 23% and 39%, respectively.

©decade3d/Thinkstock

While both opioid-based therapies reduced dependence on TKA, treatment was more expensive and it reduced quality of life, compared with an opioid-sparing therapy. For a 60-year-old OA patient for whom TKA was not an option, the incremental cost-effectiveness ratio for tramadol was $39,600 per quality-adjusted life-year, compared with a therapy without opioids, and the incremental cost-effectiveness ratio for tramadol plus oxycodone was $116,800 per quality-adjusted life-year.

“Given the risk of diversion and its associated cost for potent opioids, policy makers may consider limiting the use of potent opioids in knee OA patients. From a cost-effectiveness standpoint, both opioid-based strategies led to higher costs without providing additional benefits, unless patients were unwilling or unable to undergo TKA later,” the investigators noted.

Find the full study in Arthritis Care and Research (doi: 10.1002/acr.22916).

[email protected]

Lab mouse

Researchers say they have developed an animal model that allows them to better understand the mechanisms leading to multiple myeloma (MM) and other plasma cell neoplasms.

The group described this model in Scientific Reports.

“So far, there have not been animal models of malignant plasma cell diseases that allow us to study their stepwise progression and fully understand the complex cellular mechanisms,” said study author Stephen D. Nimer, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami in Florida.

“Now that we have a proper model of the disease, we’ll be able to more effectively study multiple myeloma as well as potential treatments.”

To create this model, the researchers crossed 2 genetically modified mice: mice lacking the Mef gene and mice with a Rad50 gene mutation (Rad50s).

Mef, also called Elf4, is a transcription factor known to both promote and suppress cancer formation. Rad50 is a component of a sensor of DNA damage induced by various stresses, and it regulates the DNA damage response pathways in cells.

The researchers found that Mef^−/−Rad50^s/s mice initially had abnormal plasma cell proliferation and monoclonal protein production.

Then, they developed anemia and a decreased bone mineral density. And 70% of these mice died from MM or other plasma cell neoplasms.

“We also found that the phenotype of these mice is not linked to activation of a specific oncogene or inactivation of a specific tumor suppressor, other than Mef,” said study author Takashi Asai, MD, PhD, also of the Sylvester Comprehensive Cancer Center.

Considering their findings together, the researchers said this model recapitulates the systemic manifestations of human MM and other plasma cell neoplasms. And their work suggests the Rad50s and Mef/Elf4 pathways cooperate to initiate myelomagenic mutations that promote plasma cell transformation.

“Although outcomes for multiple myeloma patients have greatly improved, it remains an incurable disease, despite the availability of newer treatments,” Dr Nimer noted.

“Several animal models of multiple myeloma have been reported, including models of human myeloma cells. However, these models imperfectly mimic the human disease. Developing more reliable and accurate animal models that help us better understand myeloma and test new treatments will take us to the next level on the long and challenging road to a cure.”

Lab mouse

Researchers say they have developed an animal model that allows them to better understand the mechanisms leading to multiple myeloma (MM) and other plasma cell neoplasms.

The group described this model in Scientific Reports.

“So far, there have not been animal models of malignant plasma cell diseases that allow us to study their stepwise progression and fully understand the complex cellular mechanisms,” said study author Stephen D. Nimer, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami in Florida.

“Now that we have a proper model of the disease, we’ll be able to more effectively study multiple myeloma as well as potential treatments.”

To create this model, the researchers crossed 2 genetically modified mice: mice lacking the Mef gene and mice with a Rad50 gene mutation (Rad50s).

Mef, also called Elf4, is a transcription factor known to both promote and suppress cancer formation. Rad50 is a component of a sensor of DNA damage induced by various stresses, and it regulates the DNA damage response pathways in cells.

The researchers found that Mef^−/−Rad50^s/s mice initially had abnormal plasma cell proliferation and monoclonal protein production.

Then, they developed anemia and a decreased bone mineral density. And 70% of these mice died from MM or other plasma cell neoplasms.

“We also found that the phenotype of these mice is not linked to activation of a specific oncogene or inactivation of a specific tumor suppressor, other than Mef,” said study author Takashi Asai, MD, PhD, also of the Sylvester Comprehensive Cancer Center.

Considering their findings together, the researchers said this model recapitulates the systemic manifestations of human MM and other plasma cell neoplasms. And their work suggests the Rad50s and Mef/Elf4 pathways cooperate to initiate myelomagenic mutations that promote plasma cell transformation.

“Although outcomes for multiple myeloma patients have greatly improved, it remains an incurable disease, despite the availability of newer treatments,” Dr Nimer noted.

“Several animal models of multiple myeloma have been reported, including models of human myeloma cells. However, these models imperfectly mimic the human disease. Developing more reliable and accurate animal models that help us better understand myeloma and test new treatments will take us to the next level on the long and challenging road to a cure.”

Lab mouse

Researchers say they have developed an animal model that allows them to better understand the mechanisms leading to multiple myeloma (MM) and other plasma cell neoplasms.

The group described this model in Scientific Reports.

“So far, there have not been animal models of malignant plasma cell diseases that allow us to study their stepwise progression and fully understand the complex cellular mechanisms,” said study author Stephen D. Nimer, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami in Florida.

“Now that we have a proper model of the disease, we’ll be able to more effectively study multiple myeloma as well as potential treatments.”

To create this model, the researchers crossed 2 genetically modified mice: mice lacking the Mef gene and mice with a Rad50 gene mutation (Rad50s).

Mef, also called Elf4, is a transcription factor known to both promote and suppress cancer formation. Rad50 is a component of a sensor of DNA damage induced by various stresses, and it regulates the DNA damage response pathways in cells.

The researchers found that Mef^−/−Rad50^s/s mice initially had abnormal plasma cell proliferation and monoclonal protein production.

Then, they developed anemia and a decreased bone mineral density. And 70% of these mice died from MM or other plasma cell neoplasms.

“We also found that the phenotype of these mice is not linked to activation of a specific oncogene or inactivation of a specific tumor suppressor, other than Mef,” said study author Takashi Asai, MD, PhD, also of the Sylvester Comprehensive Cancer Center.

Considering their findings together, the researchers said this model recapitulates the systemic manifestations of human MM and other plasma cell neoplasms. And their work suggests the Rad50s and Mef/Elf4 pathways cooperate to initiate myelomagenic mutations that promote plasma cell transformation.

“Although outcomes for multiple myeloma patients have greatly improved, it remains an incurable disease, despite the availability of newer treatments,” Dr Nimer noted.

“Several animal models of multiple myeloma have been reported, including models of human myeloma cells. However, these models imperfectly mimic the human disease. Developing more reliable and accurate animal models that help us better understand myeloma and test new treatments will take us to the next level on the long and challenging road to a cure.”

Clinical question: What is the relationship between crowding in the ED and the number of interventions adopted by the ED to address this?

Background: ED crowding results in long waits, prolonged lengths of stay, and delays in providing treatments, which can result in adverse events. Numerous interventions, including bedside registration, ED observation units, fast track, bed czar, surgical schedule smoothing, and pooled nursing, have been implemented to reduce crowding.

Study design: Retrospective, cross-sectional analysis.

Setting: U.S. hospitals in the National Hospital Ambulatory Medical Care Survey (NHAMCS).

Synopsis: From 2007 to 2010, an average of 341 hospitals per year were analyzed from the NHAMCS, representing 139,502 patient encounters. This study evaluated the adoption of nine crowding interventions at the emergency department level (bedside registration, electronic dashboard, RFID tracking, etc.) and eight crowding interventions at the hospital level (bed czar, pooled nursing, full-capacity protocol, board patients in inpatient hallways, etc.).

Bedside registration, electronic dashboard, RFID tracking, bed census, pooled nursing, full-capacity protocol, and boarding patients in the hallway had the highest statistically significant increases in adoption over the study period.

The average number of interventions adopted increased to 6.6 from 5.2, and more-crowded EDs adopted a greater number of interventions than less-crowded EDs. However, in the most-crowded quartile of EDs, 19% did not use bedside registration, and 94% did not use surgical schedule smoothing.

Given that this study is a retrospective, cross-sectional study, it is difficult to determine causality.

Bottom line: More interventions are being adopted by EDs and hospitals to decrease ED crowding, but several of the busiest EDs and hospitals have room for improvement.

Citation: Warner LS, Pines JM, Chambers JG, Schuur JD. The most crowded US hospital emergency departments did not adopt effective interventions to improve flow, 2007–10. Health Aff. 2015;34(12):2151-2159.

Clinical question: What is the relationship between crowding in the ED and the number of interventions adopted by the ED to address this?

Background: ED crowding results in long waits, prolonged lengths of stay, and delays in providing treatments, which can result in adverse events. Numerous interventions, including bedside registration, ED observation units, fast track, bed czar, surgical schedule smoothing, and pooled nursing, have been implemented to reduce crowding.

Study design: Retrospective, cross-sectional analysis.

Setting: U.S. hospitals in the National Hospital Ambulatory Medical Care Survey (NHAMCS).

Synopsis: From 2007 to 2010, an average of 341 hospitals per year were analyzed from the NHAMCS, representing 139,502 patient encounters. This study evaluated the adoption of nine crowding interventions at the emergency department level (bedside registration, electronic dashboard, RFID tracking, etc.) and eight crowding interventions at the hospital level (bed czar, pooled nursing, full-capacity protocol, board patients in inpatient hallways, etc.).

Bedside registration, electronic dashboard, RFID tracking, bed census, pooled nursing, full-capacity protocol, and boarding patients in the hallway had the highest statistically significant increases in adoption over the study period.

The average number of interventions adopted increased to 6.6 from 5.2, and more-crowded EDs adopted a greater number of interventions than less-crowded EDs. However, in the most-crowded quartile of EDs, 19% did not use bedside registration, and 94% did not use surgical schedule smoothing.

Given that this study is a retrospective, cross-sectional study, it is difficult to determine causality.

Bottom line: More interventions are being adopted by EDs and hospitals to decrease ED crowding, but several of the busiest EDs and hospitals have room for improvement.

Citation: Warner LS, Pines JM, Chambers JG, Schuur JD. The most crowded US hospital emergency departments did not adopt effective interventions to improve flow, 2007–10. Health Aff. 2015;34(12):2151-2159.

Clinical question: What is the relationship between crowding in the ED and the number of interventions adopted by the ED to address this?

Background: ED crowding results in long waits, prolonged lengths of stay, and delays in providing treatments, which can result in adverse events. Numerous interventions, including bedside registration, ED observation units, fast track, bed czar, surgical schedule smoothing, and pooled nursing, have been implemented to reduce crowding.

Study design: Retrospective, cross-sectional analysis.

Setting: U.S. hospitals in the National Hospital Ambulatory Medical Care Survey (NHAMCS).

Synopsis: From 2007 to 2010, an average of 341 hospitals per year were analyzed from the NHAMCS, representing 139,502 patient encounters. This study evaluated the adoption of nine crowding interventions at the emergency department level (bedside registration, electronic dashboard, RFID tracking, etc.) and eight crowding interventions at the hospital level (bed czar, pooled nursing, full-capacity protocol, board patients in inpatient hallways, etc.).

Bedside registration, electronic dashboard, RFID tracking, bed census, pooled nursing, full-capacity protocol, and boarding patients in the hallway had the highest statistically significant increases in adoption over the study period.

The average number of interventions adopted increased to 6.6 from 5.2, and more-crowded EDs adopted a greater number of interventions than less-crowded EDs. However, in the most-crowded quartile of EDs, 19% did not use bedside registration, and 94% did not use surgical schedule smoothing.

Given that this study is a retrospective, cross-sectional study, it is difficult to determine causality.

Bottom line: More interventions are being adopted by EDs and hospitals to decrease ED crowding, but several of the busiest EDs and hospitals have room for improvement.

Citation: Warner LS, Pines JM, Chambers JG, Schuur JD. The most crowded US hospital emergency departments did not adopt effective interventions to improve flow, 2007–10. Health Aff. 2015;34(12):2151-2159.

Clinical question: What is the appropriate frequency of INR monitoring in the hospital and its relationship to the risk of over-anticoagulation and warfarin-related adverse events?

Background: Warfarin use is a common cause of adverse drug events in hospitalized patients due to narrow therapeutic windows, drug interactions, and variability of metabolism. Current guidelines, including those by the American College of Chest Physicians, do not provide recommendations on how often to monitor INR or adjust warfarin dosing in the hospital.

Study design: Retrospective cohort.

Setting: Hospitalized patients included in the Medicare Patient Safety Monitoring System.

Synopsis: The study included 14,217 adult patients ≥18 years of age from the Medicare Patient Safety Monitoring System admitted from 2009 to 2013 with pneumonia, acute cardiac disease (myocardial infarction or congestive heart failure), or surgery and taking warfarin. Of those, 1,055 (7.4%) developed a warfarin-associated adverse event (bleeding, drop in hematocrit ≥3, hematoma, death, intracranial bleeding, or cardiac arrest). Patients admitted for acute cardiac disease (acute myocardial infarction or heart failure) or surgery on warfarin for ≥3 days but not monitored for ≥2 days had more warfarin-associated adverse events (OR 1.48; 95% CI, 1.02–2.17), but this association was not true in pneumonia patients. Cardiac and pneumonia patients with ≥1 day without INR being measured had higher rates of INR ≥6.0 (OR 1.61; 95% CI, 1.07–2.41, and OR 1.92, 95% CI, 1.36–2.71, respectively). A single-day rise in INR ≥0.9 had a likelihood ratio of 4.2 in predicting subsequent INR ≥6.0.

Bottom line: Frequent monitoring of INR may decrease warfarin-associated adverse events in hospitalized patients.

Citation: Metersky ML, Eldridge N, Wang Y, et al. Predictors of warfarin-associated adverse events in hospitalized patients: opportunities to prevent harm. J Hosp Med. 2016;11(4):276-282.

Short Take

CDC Guidelines on Prescribing Opioids

New CDC guidelines for chronic pain management stress the importance of non-pharmacologic (physical therapy, etc.) and non-opioid therapy (NSAIDs, etc.), using opioid therapy only if the expected benefits outweigh the risks.

Citation: CDC. CDC guideline for prescribing opioids for chronic pain. Available at: http://www.cdc.gov/drugoverdose/prescribing/guideline.html. Published March 16, 2016. Accessed April 8, 2016.

Clinical question: What is the appropriate frequency of INR monitoring in the hospital and its relationship to the risk of over-anticoagulation and warfarin-related adverse events?

Background: Warfarin use is a common cause of adverse drug events in hospitalized patients due to narrow therapeutic windows, drug interactions, and variability of metabolism. Current guidelines, including those by the American College of Chest Physicians, do not provide recommendations on how often to monitor INR or adjust warfarin dosing in the hospital.

Study design: Retrospective cohort.

Setting: Hospitalized patients included in the Medicare Patient Safety Monitoring System.

Synopsis: The study included 14,217 adult patients ≥18 years of age from the Medicare Patient Safety Monitoring System admitted from 2009 to 2013 with pneumonia, acute cardiac disease (myocardial infarction or congestive heart failure), or surgery and taking warfarin. Of those, 1,055 (7.4%) developed a warfarin-associated adverse event (bleeding, drop in hematocrit ≥3, hematoma, death, intracranial bleeding, or cardiac arrest). Patients admitted for acute cardiac disease (acute myocardial infarction or heart failure) or surgery on warfarin for ≥3 days but not monitored for ≥2 days had more warfarin-associated adverse events (OR 1.48; 95% CI, 1.02–2.17), but this association was not true in pneumonia patients. Cardiac and pneumonia patients with ≥1 day without INR being measured had higher rates of INR ≥6.0 (OR 1.61; 95% CI, 1.07–2.41, and OR 1.92, 95% CI, 1.36–2.71, respectively). A single-day rise in INR ≥0.9 had a likelihood ratio of 4.2 in predicting subsequent INR ≥6.0.

Bottom line: Frequent monitoring of INR may decrease warfarin-associated adverse events in hospitalized patients.

Citation: Metersky ML, Eldridge N, Wang Y, et al. Predictors of warfarin-associated adverse events in hospitalized patients: opportunities to prevent harm. J Hosp Med. 2016;11(4):276-282.

Short Take

CDC Guidelines on Prescribing Opioids

New CDC guidelines for chronic pain management stress the importance of non-pharmacologic (physical therapy, etc.) and non-opioid therapy (NSAIDs, etc.), using opioid therapy only if the expected benefits outweigh the risks.

Citation: CDC. CDC guideline for prescribing opioids for chronic pain. Available at: http://www.cdc.gov/drugoverdose/prescribing/guideline.html. Published March 16, 2016. Accessed April 8, 2016.

Clinical question: What is the appropriate frequency of INR monitoring in the hospital and its relationship to the risk of over-anticoagulation and warfarin-related adverse events?

Background: Warfarin use is a common cause of adverse drug events in hospitalized patients due to narrow therapeutic windows, drug interactions, and variability of metabolism. Current guidelines, including those by the American College of Chest Physicians, do not provide recommendations on how often to monitor INR or adjust warfarin dosing in the hospital.

Study design: Retrospective cohort.

Setting: Hospitalized patients included in the Medicare Patient Safety Monitoring System.

Synopsis: The study included 14,217 adult patients ≥18 years of age from the Medicare Patient Safety Monitoring System admitted from 2009 to 2013 with pneumonia, acute cardiac disease (myocardial infarction or congestive heart failure), or surgery and taking warfarin. Of those, 1,055 (7.4%) developed a warfarin-associated adverse event (bleeding, drop in hematocrit ≥3, hematoma, death, intracranial bleeding, or cardiac arrest). Patients admitted for acute cardiac disease (acute myocardial infarction or heart failure) or surgery on warfarin for ≥3 days but not monitored for ≥2 days had more warfarin-associated adverse events (OR 1.48; 95% CI, 1.02–2.17), but this association was not true in pneumonia patients. Cardiac and pneumonia patients with ≥1 day without INR being measured had higher rates of INR ≥6.0 (OR 1.61; 95% CI, 1.07–2.41, and OR 1.92, 95% CI, 1.36–2.71, respectively). A single-day rise in INR ≥0.9 had a likelihood ratio of 4.2 in predicting subsequent INR ≥6.0.

Bottom line: Frequent monitoring of INR may decrease warfarin-associated adverse events in hospitalized patients.

Citation: Metersky ML, Eldridge N, Wang Y, et al. Predictors of warfarin-associated adverse events in hospitalized patients: opportunities to prevent harm. J Hosp Med. 2016;11(4):276-282.

Short Take

CDC Guidelines on Prescribing Opioids

New CDC guidelines for chronic pain management stress the importance of non-pharmacologic (physical therapy, etc.) and non-opioid therapy (NSAIDs, etc.), using opioid therapy only if the expected benefits outweigh the risks.

Citation: CDC. CDC guideline for prescribing opioids for chronic pain. Available at: http://www.cdc.gov/drugoverdose/prescribing/guideline.html. Published March 16, 2016. Accessed April 8, 2016.

NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.

"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.

To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.

Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.

A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean

followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.

A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.

In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.

The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.

The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.

Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.

Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."

He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."

Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.

She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."

Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."

With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."

The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.

NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.

"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.

To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.

Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.

A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean

followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.

A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.

In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.

The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.

The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.

Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.

Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."

He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."

Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.

She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."

Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."

With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."

The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.

NEW YORK (Reuters Health) - Certain metal-on-metal (MoM) hip replacement devices implanted after 2006 have an "unacceptably high" revision rate, due mainly to manufacturing problems, according to a new study.

"Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain," Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and colleagues wrote in an article online April 29 in BMJ Open.

To determine risk factors for revision in patients implanted with the commonly used DePuy Pinnacle MoM hip prostheses, the researchers identified all patients at the Stockton-based hospital who were implanted with a 36 mm MoM Pinnacle hip in conjunction with an S-ROM or Corail uncemented stem. They then identified only patients with components that had been implanted by either of the two senior authors of the study, Dr. Raj Logishetty or Dr. Antoni Viral Francis Nargol.

Implantations were performed from 2003-2009 and patients were monitored yearly. From 2007-2011, as awareness of the risk of adverse reactions to metal debris (ARMD) from MoMs increased, the hospital offered patients who developed symptoms blood metal ion testing and as-needed ultrasound scanning. From 2011 onward, given the widespread problems reported with MoMs, the hospital recalled all Pinnacle MoM patients for examination.

A total of 489 MoM Pinnacle hips had been implanted into 243 women and 191 men. Of these, 352 patients attended the MoM recall clinics and 64 died during the study period (mean

followup, about 7.5 years). For the purposes of survival analyses, those who did not attend the recall clinics were assumed to have well-functioning prostheses.

A total of 71 hips were revised -- an "unacceptably high" rate, according to the authors. All but one were carried out for ARMD, with one revision for a loose cup. Prosthetic survival rate for the cohort as a whole was 83.6% at nine years.

In 53 revisions (75%), "copious amounts" of fluid were found, and in 32 (45%), it was noted to be under pressure or had fistulated through the capsule. No abnormal fluid was identified at revision in only one case.

The researchers noted obvious damage to the abductor musculature in 38 cases. They documented a moderate-to-severe aseptic lymphocyte-dominated vasculitis-associated lesion on examination of retrieved tissues in 36 cases (51%). In 13 cases (19%), they found metallosis with no identified lymphocytic infiltration.

The majority of explanted devices showed signs of taper junction failure. A significant number of devices were found to be manufactured out of their specifications -- a finding that was confirmed by an analysis of a wider data set from the Northern Retrieval Registry.

Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 or later. Women were found to be at greater risk of early device failure. However, shell sizes and bearing diameters confounded the analyses, and liner size and/or earlier year of liner manufacture were determined to be greater threats to prosthetic survival than gender. The authors suggest that this analysis be repeated with input from an additional registry.

Dr. Langton, who is involved in litigation related to the Pinnacle device, told Reuters Health by email, "We have essentially shown that one of the major health care/orthopedic product manufacturers sold a product to surgeons and health care systems on the basis (that it was a) technologically advanced precision-engineered device, and it wasn't precision-engineered."

He added, "the product was produced in the same factories as (DePuy's) other failed product, the ASR, which was . . . marketed on the same premise."

Mindy Tinsley, senior director, Communications and Public Affairs at DePuy Synthes Franchise, refuted the study findings. "We stand behind the strong record of safety and effectiveness of the (Pinnacle) ULTAMET Metal-on-Metal," she told Reuters Health by email.

She added that "there are no manufacturing problems" with the device and noted that DePuy "questions the validity of the . . . paper given significant flaws in how it was conducted." According to Tinsley, "measurements taken following an accepted international standard at the DePuy UK manufacturing facility" showed the device liners "were manufactured within specification."

Dr. Mark W. Hungerford, director of Joint Replacement and Reconstruction at Mercy Medical Center in Baltimore, told Reuters Health by phone, "One study does not make or break anything in science. There have been issues in the field about MoM and early failure rates or not. That's a serious issue being looked at by a lot of people. This is one more study showing a problem, but it's not a definitive one."

With respect to patients, "the obligation is no different than for any orthopedic device," said Dr. Hungerford, who has not used the Pinnacle device. "All can fail, all need to be monitored for failure on a regular basis, and if problems arise, they need to be dealt with."

The authors reported no funding. Dr. Langton, Dr. Nargol, and coauthors Dr. Thomas Joyce and Dr. Nick Cooke are retained experts for plaintiffs in ongoing MoM litigation. Dr. Langton and Dr. Nargol have worked with the U.S. Department of Justice in litigation involving DePuy.

Warfarin tablets

SAN FRANCISCO—Patients with atrial fibrillation (AF) who are taking warfarin have a higher risk of kidney problems if their anticoagulation levels are not properly managed, according to a new study.

Researchers found that patients who had low times in therapeutic range were significantly more likely to develop renal dysfunction and experience renal failure.

Furthermore, all patients were at risk of developing renal dysfunction, whether they began the study with healthy kidney function or moderate to severe kidney disease.

T. Jared Bunch, MD, of Intermountain Medical Center Heart Institute in Salt Lake City, Utah, and his colleagues presented these findings during the Heart Rhythm Society’s 37th Annual Scientific Sessions (abstract PO02-210).

The researchers studied 2753 AF patients who were anticoagulated with warfarin and managed by Intermountain Healthcare Clinical Pharmacist Anticoagulation Services.

The patients’ mean age was 74.7±10.7, and 50.3% were male. The patients had a baseline creatinine level of less than 2.0 mg/dL or a glomerular filtration rate greater than 30 and serial renal function studies.

Dr Bunch and his colleagues stratified patients into 4 categories based on the amount of time their international normalized ratio levels were determined to be in the therapeutic range (TTR): >75%, 51% to 75%, 26% to 50%, and <25%.

The researchers then performed multivariate, adjusted analyses to calculate odds ratios (ORs) for renal dysfunction and hazard ratios (HRs) for renal failure based on TTR group. The >75% group was the reference.

Among patients with baseline creatinine ≤2.0 mg/dL, the OR for a 25% increase in creatinine was:

• 1.35 for the 51%-75% TTR group (P=0.06)
• 1.80 for the 26-50% TTR group (P=0.003)
• 2.34 for the ≤25% TTR group (P=0.003).

Among patients with baseline creatinine ≤2.0 mg/dL, the HR for renal failure was:

• 1.72 for the 51%-75% TTR group (P=0.001)
• 2.36 for the 26-50% TTR group (P<0.0001)
• 2.38 for the ≤25% TTR group (P<0.0001).

Among patients with baseline glomerular filtration rate >30, the OR for a 25% decrease in glomerular filtration rate was:

• 1.45 for the 51%-75% TTR group (P=0.03)
• 1.46 for the 26-50% TTR group (P=0.08)
• 1.52 for the ≤25% TTR group (P=0.20).

Among patients with a baseline glomerular filtration rate >30, the HR for renal failure was:

• 1.88 for the 51%-75% TTR group (P<0.0001)
• 2.40 for the 26-50% TTR group (P<0.0001)
• 2.60 for the ≤25% TTR group (P<0.0001).

The researchers said these results suggest the quality of anticoagulation management is associated with renal dysfunction and failure, so improving anticoagulation control might improve the long-term risk of end-organ injury in AF patients.

“Patients who use warfarin as part of their anticoagulation treatment for atrial fibrillation should have their anticoagulation levels closely monitored to ensure proper levels,” Dr Bunch said.

“Those who have erratic levels of warfarin despite close monitoring and care should consider other approaches such as newer anticoagulants that have more predictable blood effects, even if they have moderate kidney disease, and non drug-based methods to lower clot risk with atrial fibrillation.”

Warfarin tablets

SAN FRANCISCO—Patients with atrial fibrillation (AF) who are taking warfarin have a higher risk of kidney problems if their anticoagulation levels are not properly managed, according to a new study.

Researchers found that patients who had low times in therapeutic range were significantly more likely to develop renal dysfunction and experience renal failure.

Furthermore, all patients were at risk of developing renal dysfunction, whether they began the study with healthy kidney function or moderate to severe kidney disease.

T. Jared Bunch, MD, of Intermountain Medical Center Heart Institute in Salt Lake City, Utah, and his colleagues presented these findings during the Heart Rhythm Society’s 37th Annual Scientific Sessions (abstract PO02-210).

The researchers studied 2753 AF patients who were anticoagulated with warfarin and managed by Intermountain Healthcare Clinical Pharmacist Anticoagulation Services.

The patients’ mean age was 74.7±10.7, and 50.3% were male. The patients had a baseline creatinine level of less than 2.0 mg/dL or a glomerular filtration rate greater than 30 and serial renal function studies.

Dr Bunch and his colleagues stratified patients into 4 categories based on the amount of time their international normalized ratio levels were determined to be in the therapeutic range (TTR): >75%, 51% to 75%, 26% to 50%, and <25%.

The researchers then performed multivariate, adjusted analyses to calculate odds ratios (ORs) for renal dysfunction and hazard ratios (HRs) for renal failure based on TTR group. The >75% group was the reference.

Among patients with baseline creatinine ≤2.0 mg/dL, the OR for a 25% increase in creatinine was:

• 1.35 for the 51%-75% TTR group (P=0.06)
• 1.80 for the 26-50% TTR group (P=0.003)
• 2.34 for the ≤25% TTR group (P=0.003).

Among patients with baseline creatinine ≤2.0 mg/dL, the HR for renal failure was:

• 1.72 for the 51%-75% TTR group (P=0.001)
• 2.36 for the 26-50% TTR group (P<0.0001)
• 2.38 for the ≤25% TTR group (P<0.0001).

Among patients with baseline glomerular filtration rate >30, the OR for a 25% decrease in glomerular filtration rate was:

• 1.45 for the 51%-75% TTR group (P=0.03)
• 1.46 for the 26-50% TTR group (P=0.08)
• 1.52 for the ≤25% TTR group (P=0.20).

Among patients with a baseline glomerular filtration rate >30, the HR for renal failure was:

• 1.88 for the 51%-75% TTR group (P<0.0001)
• 2.40 for the 26-50% TTR group (P<0.0001)
• 2.60 for the ≤25% TTR group (P<0.0001).

The researchers said these results suggest the quality of anticoagulation management is associated with renal dysfunction and failure, so improving anticoagulation control might improve the long-term risk of end-organ injury in AF patients.

“Patients who use warfarin as part of their anticoagulation treatment for atrial fibrillation should have their anticoagulation levels closely monitored to ensure proper levels,” Dr Bunch said.

“Those who have erratic levels of warfarin despite close monitoring and care should consider other approaches such as newer anticoagulants that have more predictable blood effects, even if they have moderate kidney disease, and non drug-based methods to lower clot risk with atrial fibrillation.”

Warfarin tablets

SAN FRANCISCO—Patients with atrial fibrillation (AF) who are taking warfarin have a higher risk of kidney problems if their anticoagulation levels are not properly managed, according to a new study.

Researchers found that patients who had low times in therapeutic range were significantly more likely to develop renal dysfunction and experience renal failure.

Furthermore, all patients were at risk of developing renal dysfunction, whether they began the study with healthy kidney function or moderate to severe kidney disease.

T. Jared Bunch, MD, of Intermountain Medical Center Heart Institute in Salt Lake City, Utah, and his colleagues presented these findings during the Heart Rhythm Society’s 37th Annual Scientific Sessions (abstract PO02-210).

The researchers studied 2753 AF patients who were anticoagulated with warfarin and managed by Intermountain Healthcare Clinical Pharmacist Anticoagulation Services.

The patients’ mean age was 74.7±10.7, and 50.3% were male. The patients had a baseline creatinine level of less than 2.0 mg/dL or a glomerular filtration rate greater than 30 and serial renal function studies.

Dr Bunch and his colleagues stratified patients into 4 categories based on the amount of time their international normalized ratio levels were determined to be in the therapeutic range (TTR): >75%, 51% to 75%, 26% to 50%, and <25%.

The researchers then performed multivariate, adjusted analyses to calculate odds ratios (ORs) for renal dysfunction and hazard ratios (HRs) for renal failure based on TTR group. The >75% group was the reference.

Among patients with baseline creatinine ≤2.0 mg/dL, the OR for a 25% increase in creatinine was:

• 1.35 for the 51%-75% TTR group (P=0.06)
• 1.80 for the 26-50% TTR group (P=0.003)
• 2.34 for the ≤25% TTR group (P=0.003).

Among patients with baseline creatinine ≤2.0 mg/dL, the HR for renal failure was:

• 1.72 for the 51%-75% TTR group (P=0.001)
• 2.36 for the 26-50% TTR group (P<0.0001)
• 2.38 for the ≤25% TTR group (P<0.0001).

Among patients with baseline glomerular filtration rate >30, the OR for a 25% decrease in glomerular filtration rate was:

• 1.45 for the 51%-75% TTR group (P=0.03)
• 1.46 for the 26-50% TTR group (P=0.08)
• 1.52 for the ≤25% TTR group (P=0.20).

Among patients with a baseline glomerular filtration rate >30, the HR for renal failure was:

• 1.88 for the 51%-75% TTR group (P<0.0001)
• 2.40 for the 26-50% TTR group (P<0.0001)
• 2.60 for the ≤25% TTR group (P<0.0001).

The researchers said these results suggest the quality of anticoagulation management is associated with renal dysfunction and failure, so improving anticoagulation control might improve the long-term risk of end-organ injury in AF patients.

“Patients who use warfarin as part of their anticoagulation treatment for atrial fibrillation should have their anticoagulation levels closely monitored to ensure proper levels,” Dr Bunch said.

“Those who have erratic levels of warfarin despite close monitoring and care should consider other approaches such as newer anticoagulants that have more predictable blood effects, even if they have moderate kidney disease, and non drug-based methods to lower clot risk with atrial fibrillation.”

Thrombus

Image by Andre E.X. Brown

Results of a meta-analysis suggest elastic compression stockings do not significantly reduce the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT).

Investigators analyzed more than 600 past reports and studies involving elastic compression stockings, including the SOX trial.

And the results showed no significant difference in PTS incidence between patients who wore these stockings and those who did not.

Riyaz Bashir, MD, of Temple University Hospital in Philadelphia, Pennsylvania, and his colleagues performed the analysis and reported the results in The Lancet Haematology.

The investigators analyzed 674 reports, which included 6 randomized trials and a total of 1462 patients. The patients’ mean age was 59.5, and 56% were men.

All of the studies used stockings with a pressure range of 20 mm Hg to 40 mm Hg. Patient compliance varied from 55.6% to 91.6% and often decreased during follow-up. In most of the studies, the control group did not wear stockings, but, in 2 studies, the control group wore placebo stockings.

The data showed that use of elastic compression stockings was not associated with PTS prevention. The incidence of PTS was 36% (269/739) among patients who wore the stockings and 45% (322/723) among controls. The odds ratio (OR) was 0.56 (P=0.12).

The investigators observed similar results in subgroup analyses, when they tried to account for patient heterogeneity (27% vs 37%, OR=0.63, P=0.23) or diagnosis by Villalta scoring (43% vs 45%, OR=0.81, P=0.62) and when they looked at patients randomized within 1 month of DVT diagnosis (41% vs 49%, OR=0.57, P=0.24).

Furthermore, there was no significant difference between the treatment groups with regard to mortality or DVT recurrence.

The mortality incidence was 10% in both groups (OR 0.98, P=0.92), while the incidence of DVT recurrence was 6.4% in the compression stocking group and 6.8% in controls (OR=0.93, P=0.69).

“Many questions remain, such as whether certain groups of patients—like females or elderly patients—benefit from [compression stockings] or whether the timing of the intervention would make a difference,” Dr Bashir said.

“Based on the results of our study, we believe it’s too early to recommend that physicians stop using compression stockings and therefore should not give up on this modality of treatment yet. This study also highlights that there is a real need for new and more effective therapies for the treatment and prevention of post-thrombotic syndrome.”

Thrombus

Image by Andre E.X. Brown

Results of a meta-analysis suggest elastic compression stockings do not significantly reduce the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT).

Investigators analyzed more than 600 past reports and studies involving elastic compression stockings, including the SOX trial.

And the results showed no significant difference in PTS incidence between patients who wore these stockings and those who did not.

Riyaz Bashir, MD, of Temple University Hospital in Philadelphia, Pennsylvania, and his colleagues performed the analysis and reported the results in The Lancet Haematology.

The investigators analyzed 674 reports, which included 6 randomized trials and a total of 1462 patients. The patients’ mean age was 59.5, and 56% were men.

All of the studies used stockings with a pressure range of 20 mm Hg to 40 mm Hg. Patient compliance varied from 55.6% to 91.6% and often decreased during follow-up. In most of the studies, the control group did not wear stockings, but, in 2 studies, the control group wore placebo stockings.

The data showed that use of elastic compression stockings was not associated with PTS prevention. The incidence of PTS was 36% (269/739) among patients who wore the stockings and 45% (322/723) among controls. The odds ratio (OR) was 0.56 (P=0.12).

The investigators observed similar results in subgroup analyses, when they tried to account for patient heterogeneity (27% vs 37%, OR=0.63, P=0.23) or diagnosis by Villalta scoring (43% vs 45%, OR=0.81, P=0.62) and when they looked at patients randomized within 1 month of DVT diagnosis (41% vs 49%, OR=0.57, P=0.24).

Furthermore, there was no significant difference between the treatment groups with regard to mortality or DVT recurrence.

The mortality incidence was 10% in both groups (OR 0.98, P=0.92), while the incidence of DVT recurrence was 6.4% in the compression stocking group and 6.8% in controls (OR=0.93, P=0.69).

“Many questions remain, such as whether certain groups of patients—like females or elderly patients—benefit from [compression stockings] or whether the timing of the intervention would make a difference,” Dr Bashir said.

“Based on the results of our study, we believe it’s too early to recommend that physicians stop using compression stockings and therefore should not give up on this modality of treatment yet. This study also highlights that there is a real need for new and more effective therapies for the treatment and prevention of post-thrombotic syndrome.”

Thrombus

Image by Andre E.X. Brown

Results of a meta-analysis suggest elastic compression stockings do not significantly reduce the risk of post-thrombotic syndrome (PTS) after deep vein thrombosis (DVT).

Investigators analyzed more than 600 past reports and studies involving elastic compression stockings, including the SOX trial.

And the results showed no significant difference in PTS incidence between patients who wore these stockings and those who did not.

Riyaz Bashir, MD, of Temple University Hospital in Philadelphia, Pennsylvania, and his colleagues performed the analysis and reported the results in The Lancet Haematology.

The investigators analyzed 674 reports, which included 6 randomized trials and a total of 1462 patients. The patients’ mean age was 59.5, and 56% were men.

All of the studies used stockings with a pressure range of 20 mm Hg to 40 mm Hg. Patient compliance varied from 55.6% to 91.6% and often decreased during follow-up. In most of the studies, the control group did not wear stockings, but, in 2 studies, the control group wore placebo stockings.

The data showed that use of elastic compression stockings was not associated with PTS prevention. The incidence of PTS was 36% (269/739) among patients who wore the stockings and 45% (322/723) among controls. The odds ratio (OR) was 0.56 (P=0.12).

The investigators observed similar results in subgroup analyses, when they tried to account for patient heterogeneity (27% vs 37%, OR=0.63, P=0.23) or diagnosis by Villalta scoring (43% vs 45%, OR=0.81, P=0.62) and when they looked at patients randomized within 1 month of DVT diagnosis (41% vs 49%, OR=0.57, P=0.24).

Furthermore, there was no significant difference between the treatment groups with regard to mortality or DVT recurrence.

The mortality incidence was 10% in both groups (OR 0.98, P=0.92), while the incidence of DVT recurrence was 6.4% in the compression stocking group and 6.8% in controls (OR=0.93, P=0.69).

“Many questions remain, such as whether certain groups of patients—like females or elderly patients—benefit from [compression stockings] or whether the timing of the intervention would make a difference,” Dr Bashir said.

“Based on the results of our study, we believe it’s too early to recommend that physicians stop using compression stockings and therefore should not give up on this modality of treatment yet. This study also highlights that there is a real need for new and more effective therapies for the treatment and prevention of post-thrombotic syndrome.”

Doctor evaluating patient

Photo courtesy of the CDC

WASHINGTON, DC—The American Society of Hematology (ASH) has created a toolkit to help hematologists aid patients who are transitioning from pediatric to adult practices.

The toolkit contains general resources for all hematologic conditions, as well as specific resources for patients with hemophilia and sickle cell disease.

It includes 2 types of forms—a transition-readiness assessment and a clinical summary.

The toolkit was presented at the American College of Physicians (ACP) Internal Medicine Meeting 2016.

“Transitioning from pediatric to adult healthcare practices is often a challenge for patients with chronic medical issues because it can be difficult to adhere to a treatment regimen or attend regular appointments without the assistance of a parent or guardian,” said ASH President Charles S. Abrams, MD, of the University of Pennsylvania in Philadelphia.

“ASH recognizes that understanding a patient’s preparedness to take control of his or her medical condition in adulthood can make a huge difference in quality of care, which is why we are pleased to join the American College of Physicians and partner societies in this important initiative.”

ASH joined more than 2 dozen groups to participate in the ACP’s Pediatric to Adult Care Transition Initiative. The goal of this initiative was to develop guidance and tools that both primary care internal medicine and subspecialty practices can use for patients who are transitioning from pediatric/adolescent practices to adult care.

An ASH Transitions Work Group, made up of society members from pediatric and adult practices, developed 3 segments of the hematology-specific toolkit:

• generic forms for patients with any hematologic condition, with an addendum that includes links to additional condition-specific guidelines and resources
• specific forms for hemophilia
• specific forms for sickle cell disease.

For each segment, there are 2 types of forms— a transition-readiness assessment and a clinical summary.

The transition-readiness assessment should be completed by the patient. It assesses the patient’s readiness for the transition to adult care by evaluating the patient’s understanding of his or her condition and ability to manage medications, appointments, insurance, and medical privacy issues.

This assessment should be used by the adult care team to assess any remaining gaps in the patient’s self-care knowledge or additional issues that should be addressed to ensure optimal care.

The clinical summary is a medical record summary to be completed by the referring provider and the patient. The summary contains essential clinical information regarding the patient’s condition that is to be included in the patient’s medical record upon transfer to the adult practice.

More information on the ACP Pediatric to Adult Care Transitions Initiative is available on the ACP website. The forms for the ASH transitions toolkit are available in the “Hematology” section of the Condition-Specific Tools page.

Doctor evaluating patient

Photo courtesy of the CDC

WASHINGTON, DC—The American Society of Hematology (ASH) has created a toolkit to help hematologists aid patients who are transitioning from pediatric to adult practices.

The toolkit contains general resources for all hematologic conditions, as well as specific resources for patients with hemophilia and sickle cell disease.

It includes 2 types of forms—a transition-readiness assessment and a clinical summary.

The toolkit was presented at the American College of Physicians (ACP) Internal Medicine Meeting 2016.

“Transitioning from pediatric to adult healthcare practices is often a challenge for patients with chronic medical issues because it can be difficult to adhere to a treatment regimen or attend regular appointments without the assistance of a parent or guardian,” said ASH President Charles S. Abrams, MD, of the University of Pennsylvania in Philadelphia.

“ASH recognizes that understanding a patient’s preparedness to take control of his or her medical condition in adulthood can make a huge difference in quality of care, which is why we are pleased to join the American College of Physicians and partner societies in this important initiative.”

ASH joined more than 2 dozen groups to participate in the ACP’s Pediatric to Adult Care Transition Initiative. The goal of this initiative was to develop guidance and tools that both primary care internal medicine and subspecialty practices can use for patients who are transitioning from pediatric/adolescent practices to adult care.

An ASH Transitions Work Group, made up of society members from pediatric and adult practices, developed 3 segments of the hematology-specific toolkit:

• generic forms for patients with any hematologic condition, with an addendum that includes links to additional condition-specific guidelines and resources
• specific forms for hemophilia
• specific forms for sickle cell disease.

For each segment, there are 2 types of forms— a transition-readiness assessment and a clinical summary.

The transition-readiness assessment should be completed by the patient. It assesses the patient’s readiness for the transition to adult care by evaluating the patient’s understanding of his or her condition and ability to manage medications, appointments, insurance, and medical privacy issues.

This assessment should be used by the adult care team to assess any remaining gaps in the patient’s self-care knowledge or additional issues that should be addressed to ensure optimal care.

The clinical summary is a medical record summary to be completed by the referring provider and the patient. The summary contains essential clinical information regarding the patient’s condition that is to be included in the patient’s medical record upon transfer to the adult practice.

More information on the ACP Pediatric to Adult Care Transitions Initiative is available on the ACP website. The forms for the ASH transitions toolkit are available in the “Hematology” section of the Condition-Specific Tools page.

Doctor evaluating patient

Photo courtesy of the CDC

WASHINGTON, DC—The American Society of Hematology (ASH) has created a toolkit to help hematologists aid patients who are transitioning from pediatric to adult practices.

The toolkit contains general resources for all hematologic conditions, as well as specific resources for patients with hemophilia and sickle cell disease.

It includes 2 types of forms—a transition-readiness assessment and a clinical summary.

The toolkit was presented at the American College of Physicians (ACP) Internal Medicine Meeting 2016.

“Transitioning from pediatric to adult healthcare practices is often a challenge for patients with chronic medical issues because it can be difficult to adhere to a treatment regimen or attend regular appointments without the assistance of a parent or guardian,” said ASH President Charles S. Abrams, MD, of the University of Pennsylvania in Philadelphia.

“ASH recognizes that understanding a patient’s preparedness to take control of his or her medical condition in adulthood can make a huge difference in quality of care, which is why we are pleased to join the American College of Physicians and partner societies in this important initiative.”

ASH joined more than 2 dozen groups to participate in the ACP’s Pediatric to Adult Care Transition Initiative. The goal of this initiative was to develop guidance and tools that both primary care internal medicine and subspecialty practices can use for patients who are transitioning from pediatric/adolescent practices to adult care.

An ASH Transitions Work Group, made up of society members from pediatric and adult practices, developed 3 segments of the hematology-specific toolkit:

• generic forms for patients with any hematologic condition, with an addendum that includes links to additional condition-specific guidelines and resources
• specific forms for hemophilia
• specific forms for sickle cell disease.

For each segment, there are 2 types of forms— a transition-readiness assessment and a clinical summary.

The transition-readiness assessment should be completed by the patient. It assesses the patient’s readiness for the transition to adult care by evaluating the patient’s understanding of his or her condition and ability to manage medications, appointments, insurance, and medical privacy issues.

This assessment should be used by the adult care team to assess any remaining gaps in the patient’s self-care knowledge or additional issues that should be addressed to ensure optimal care.

The clinical summary is a medical record summary to be completed by the referring provider and the patient. The summary contains essential clinical information regarding the patient’s condition that is to be included in the patient’s medical record upon transfer to the adult practice.

More information on the ACP Pediatric to Adult Care Transitions Initiative is available on the ACP website. The forms for the ASH transitions toolkit are available in the “Hematology” section of the Condition-Specific Tools page.

AMSTERDAM – Neither cycling through a regular schedule of antibiotics on a unit-wide basis, nor randomly mixing them on a patient-level basis reduced the prevalence of antibiotic resistance in eight European intensive care units, a randomized study has determined.

Lead investigator Dr. Pleun Joppe van Duijn of University Medical Center Utrecht (the Netherlands), said he and his colleagues did, however, discover a few common sense findings that seemed to positively affect antibiotic resistance, including compliance with hand hygiene, shorter lengths of stay, staff ratio, and unit occupancy rate. He reported the results of his research at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Edwin Verin/©Thinkstock

Many ICUs in Europe have one preferred empirical treatment strategy which, Dr. van Duijn said, may create selective pressure for a single resistance type. “An alternative to this is a program of antibiotic rotation,” he noted. “By constantly changing the preferred first-line treatment, selective pressure is constantly changing, which may reduce selection of antibiotic resistance.”

Dr. van Duijn and his colleagues examined this idea in a randomized crossover trial that compared antibiotic cycling and mixing. The protocols employed three antibiotic classes: third- and fourth-generation cephalosporins, piperacillin/tazobactam, and carbapenems. The trial was conducted in eight ICUs in Belgium, Germany, France, Slovenia, and Portugal.

The sites were randomized to two 9-month interventions of cycling or mixing antibiotics, with a 1-month washout period between the two interventions. In cycling protocol, the preferred empiric antibiotic was changed every 6 weeks. In the mixing protocol, every consecutive patient received a different antibiotic. However, treating physicians were allowed to deviate from any protocol for patient safety or to optimize treatment.

The primary endpoint was the monthly prevalence of perineal and/or respiratory carriage of two classes of bacteria:

• Enterobacteriaceae species that were piperacillin/tazobactam–resistant or that showed extended spectrum beta-lactamase production.

• Pseudomonas aeruginosa and Acinetobacter species that were either piperacillin/tazobactam– or carbapenem-resistant.

In all, 8,945 patients were involved, with 4,238 exposed to cycling and 4,707 to mixing. Patients were a mean of 62 years old, with a mean 7-day length of stay. About 4.5% were already colonized with resistant bacteria upon admission. A quarter were on contact isolation; 2% were on both droplet and respiratory isolation.

The overall mortality rate was 11% and did not differ between the cycling and mixing groups (10.9% vs. 11.6%). Antibiotic resistance developed in 22.6% of the cycling group and 21.5% of the mixing group – not a significant difference. Neither protocol significantly reduced over time the amount of antibiotic resistance that was observed in the baseline period.

A multivariate analysis did, however, find a few things associated with resistance prevalence. Women were about 58% less likely to develop a resistant bacterial strain than men. Patients who stayed less than 48 hours had a 38% decreased risk of developing a resistant strain. Good staff compliance with hand hygiene reduced the risk by 12%, and having one-on-one nursing reduced it by 53%.

The study was funded by the European Community’s Seventh Framework Programme. Dr. van Duijn had no financial declarations.

[email protected]

AMSTERDAM – Neither cycling through a regular schedule of antibiotics on a unit-wide basis, nor randomly mixing them on a patient-level basis reduced the prevalence of antibiotic resistance in eight European intensive care units, a randomized study has determined.

Lead investigator Dr. Pleun Joppe van Duijn of University Medical Center Utrecht (the Netherlands), said he and his colleagues did, however, discover a few common sense findings that seemed to positively affect antibiotic resistance, including compliance with hand hygiene, shorter lengths of stay, staff ratio, and unit occupancy rate. He reported the results of his research at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Edwin Verin/©Thinkstock

Many ICUs in Europe have one preferred empirical treatment strategy which, Dr. van Duijn said, may create selective pressure for a single resistance type. “An alternative to this is a program of antibiotic rotation,” he noted. “By constantly changing the preferred first-line treatment, selective pressure is constantly changing, which may reduce selection of antibiotic resistance.”

Dr. van Duijn and his colleagues examined this idea in a randomized crossover trial that compared antibiotic cycling and mixing. The protocols employed three antibiotic classes: third- and fourth-generation cephalosporins, piperacillin/tazobactam, and carbapenems. The trial was conducted in eight ICUs in Belgium, Germany, France, Slovenia, and Portugal.

The sites were randomized to two 9-month interventions of cycling or mixing antibiotics, with a 1-month washout period between the two interventions. In cycling protocol, the preferred empiric antibiotic was changed every 6 weeks. In the mixing protocol, every consecutive patient received a different antibiotic. However, treating physicians were allowed to deviate from any protocol for patient safety or to optimize treatment.

The primary endpoint was the monthly prevalence of perineal and/or respiratory carriage of two classes of bacteria:

• Enterobacteriaceae species that were piperacillin/tazobactam–resistant or that showed extended spectrum beta-lactamase production.

• Pseudomonas aeruginosa and Acinetobacter species that were either piperacillin/tazobactam– or carbapenem-resistant.

In all, 8,945 patients were involved, with 4,238 exposed to cycling and 4,707 to mixing. Patients were a mean of 62 years old, with a mean 7-day length of stay. About 4.5% were already colonized with resistant bacteria upon admission. A quarter were on contact isolation; 2% were on both droplet and respiratory isolation.

The overall mortality rate was 11% and did not differ between the cycling and mixing groups (10.9% vs. 11.6%). Antibiotic resistance developed in 22.6% of the cycling group and 21.5% of the mixing group – not a significant difference. Neither protocol significantly reduced over time the amount of antibiotic resistance that was observed in the baseline period.

A multivariate analysis did, however, find a few things associated with resistance prevalence. Women were about 58% less likely to develop a resistant bacterial strain than men. Patients who stayed less than 48 hours had a 38% decreased risk of developing a resistant strain. Good staff compliance with hand hygiene reduced the risk by 12%, and having one-on-one nursing reduced it by 53%.

The study was funded by the European Community’s Seventh Framework Programme. Dr. van Duijn had no financial declarations.

[email protected]

AMSTERDAM – Neither cycling through a regular schedule of antibiotics on a unit-wide basis, nor randomly mixing them on a patient-level basis reduced the prevalence of antibiotic resistance in eight European intensive care units, a randomized study has determined.

Lead investigator Dr. Pleun Joppe van Duijn of University Medical Center Utrecht (the Netherlands), said he and his colleagues did, however, discover a few common sense findings that seemed to positively affect antibiotic resistance, including compliance with hand hygiene, shorter lengths of stay, staff ratio, and unit occupancy rate. He reported the results of his research at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Edwin Verin/©Thinkstock

Many ICUs in Europe have one preferred empirical treatment strategy which, Dr. van Duijn said, may create selective pressure for a single resistance type. “An alternative to this is a program of antibiotic rotation,” he noted. “By constantly changing the preferred first-line treatment, selective pressure is constantly changing, which may reduce selection of antibiotic resistance.”

Dr. van Duijn and his colleagues examined this idea in a randomized crossover trial that compared antibiotic cycling and mixing. The protocols employed three antibiotic classes: third- and fourth-generation cephalosporins, piperacillin/tazobactam, and carbapenems. The trial was conducted in eight ICUs in Belgium, Germany, France, Slovenia, and Portugal.

The sites were randomized to two 9-month interventions of cycling or mixing antibiotics, with a 1-month washout period between the two interventions. In cycling protocol, the preferred empiric antibiotic was changed every 6 weeks. In the mixing protocol, every consecutive patient received a different antibiotic. However, treating physicians were allowed to deviate from any protocol for patient safety or to optimize treatment.

The primary endpoint was the monthly prevalence of perineal and/or respiratory carriage of two classes of bacteria:

• Enterobacteriaceae species that were piperacillin/tazobactam–resistant or that showed extended spectrum beta-lactamase production.

• Pseudomonas aeruginosa and Acinetobacter species that were either piperacillin/tazobactam– or carbapenem-resistant.

In all, 8,945 patients were involved, with 4,238 exposed to cycling and 4,707 to mixing. Patients were a mean of 62 years old, with a mean 7-day length of stay. About 4.5% were already colonized with resistant bacteria upon admission. A quarter were on contact isolation; 2% were on both droplet and respiratory isolation.

The overall mortality rate was 11% and did not differ between the cycling and mixing groups (10.9% vs. 11.6%). Antibiotic resistance developed in 22.6% of the cycling group and 21.5% of the mixing group – not a significant difference. Neither protocol significantly reduced over time the amount of antibiotic resistance that was observed in the baseline period.

A multivariate analysis did, however, find a few things associated with resistance prevalence. Women were about 58% less likely to develop a resistant bacterial strain than men. Patients who stayed less than 48 hours had a 38% decreased risk of developing a resistant strain. Good staff compliance with hand hygiene reduced the risk by 12%, and having one-on-one nursing reduced it by 53%.

The study was funded by the European Community’s Seventh Framework Programme. Dr. van Duijn had no financial declarations.

[email protected]

VANCOUVER—At a rate of 2.5 per 1,000 person-years, epilepsy incidence in adults age 65 and older is common, according to a retrospective analysis of clinical and administrative data. "To put these study results in context, this incidence rate is 1.5 times higher than that of Parkinson's disease," said Hyunmi Choi, MD, MS, of Columbia University, New York City. Most important, she said, is the finding that black older adults have double the incidence rate of their white counterparts, independent of stroke. "These findings underscore the need for further studies that directly examine the mechanisms by which race affects epilepsy risk," said Dr. Choi at the 68th Annual Meeting of the American Academy of Neurology.

Geographic and Cultural Diversity

Dr. Choi and colleagues from Columbia University and the University of Washington in Seattle, examined data from the Cardiovascular Health Study (CHS), a prospective cohort study of coronary heart disease and stroke. CHS began in 1989 and enrolled 5,201 adults age 65 and older from multiple regions of the country: Sacramento county, California; Washington county, Maryland; Forsyth county, North Carolina; and Pittsburgh, Pennsylvania. A second cohort of 687 predominantly African American participants was enrolled in 1992. In-person evaluations were conducted at baseline, followed by annual in-person evaluations interspersed with phone calls every six months. "Recently, CHS merged its data with those of the Centers for Medicare and Medicaid Services (CMS)," Dr. Choi said.

The researchers used multiple data sources to identify potential epilepsy cases, including self report, information on antiepileptic medication, hospitalization discharge claims data, and outpatient CMS claims data using International Classification of Diseases, ninth edition codes. "Two independent reviewers applied the specific criteria to classify the cases, then we assessed the agreement between them. All discordant cases were discussed, and we arrived at a final consensus diagnosis." The study end points were prevalent epilepsy (ie, those who had epilepsy at baseline) and incident epilepsy (ie, those who developed epilepsy during follow-up).

Incidence and Prevalence Data

Dr. Choi and colleagues found the inter-rater reliability to be high and, in the final analysis, identified 335 participants from the CHS cohort with probable epilepsy at baseline. "This is the group that we used to define an overall epilepsy prevalence of 5.7% out of 5,888 participants," Dr. Choi said. Black participants with a prior history of transient ischemic attack were more likely to have prevalent epilepsy.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up, for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 for per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

Adjustment for Stroke Risk

Epilepsy incidence was highest among participants age 75 to 79; however, the incidence rate dropped among those who were older. Using a model that examined participants with a history of cardiovascular risk factors at CHS baseline, Choi and colleagues found that black race, age 75 to 79, and history of stroke were independent risk factors for incident epilepsy. In a second model, which looked at patients who did not have cardiovascular risk factors prior to CHS enrollment but developed these conditions before the onset of epilepsy, black race and incident stroke were independent risk factors for incident epilepsy.

Dr. Choi acknowledged that survival bias may have occurred, whereby healthy participants were retained in the analysis and the sicker patients, possibly with seizures, died earlier. Also, while the analysis adjusted for stroke risk and stroke incidence (which is disproportionately higher in black older adults), other covariates may be more likely to occur in elderly black patients that may have confounded the relationship and increased epilepsy risk.

—Adriene Marshall

VANCOUVER—At a rate of 2.5 per 1,000 person-years, epilepsy incidence in adults age 65 and older is common, according to a retrospective analysis of clinical and administrative data. "To put these study results in context, this incidence rate is 1.5 times higher than that of Parkinson's disease," said Hyunmi Choi, MD, MS, of Columbia University, New York City. Most important, she said, is the finding that black older adults have double the incidence rate of their white counterparts, independent of stroke. "These findings underscore the need for further studies that directly examine the mechanisms by which race affects epilepsy risk," said Dr. Choi at the 68th Annual Meeting of the American Academy of Neurology.

Geographic and Cultural Diversity

Dr. Choi and colleagues from Columbia University and the University of Washington in Seattle, examined data from the Cardiovascular Health Study (CHS), a prospective cohort study of coronary heart disease and stroke. CHS began in 1989 and enrolled 5,201 adults age 65 and older from multiple regions of the country: Sacramento county, California; Washington county, Maryland; Forsyth county, North Carolina; and Pittsburgh, Pennsylvania. A second cohort of 687 predominantly African American participants was enrolled in 1992. In-person evaluations were conducted at baseline, followed by annual in-person evaluations interspersed with phone calls every six months. "Recently, CHS merged its data with those of the Centers for Medicare and Medicaid Services (CMS)," Dr. Choi said.

The researchers used multiple data sources to identify potential epilepsy cases, including self report, information on antiepileptic medication, hospitalization discharge claims data, and outpatient CMS claims data using International Classification of Diseases, ninth edition codes. "Two independent reviewers applied the specific criteria to classify the cases, then we assessed the agreement between them. All discordant cases were discussed, and we arrived at a final consensus diagnosis." The study end points were prevalent epilepsy (ie, those who had epilepsy at baseline) and incident epilepsy (ie, those who developed epilepsy during follow-up).

Incidence and Prevalence Data

Dr. Choi and colleagues found the inter-rater reliability to be high and, in the final analysis, identified 335 participants from the CHS cohort with probable epilepsy at baseline. "This is the group that we used to define an overall epilepsy prevalence of 5.7% out of 5,888 participants," Dr. Choi said. Black participants with a prior history of transient ischemic attack were more likely to have prevalent epilepsy.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up, for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 for per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

Adjustment for Stroke Risk

Epilepsy incidence was highest among participants age 75 to 79; however, the incidence rate dropped among those who were older. Using a model that examined participants with a history of cardiovascular risk factors at CHS baseline, Choi and colleagues found that black race, age 75 to 79, and history of stroke were independent risk factors for incident epilepsy. In a second model, which looked at patients who did not have cardiovascular risk factors prior to CHS enrollment but developed these conditions before the onset of epilepsy, black race and incident stroke were independent risk factors for incident epilepsy.

Dr. Choi acknowledged that survival bias may have occurred, whereby healthy participants were retained in the analysis and the sicker patients, possibly with seizures, died earlier. Also, while the analysis adjusted for stroke risk and stroke incidence (which is disproportionately higher in black older adults), other covariates may be more likely to occur in elderly black patients that may have confounded the relationship and increased epilepsy risk.

—Adriene Marshall

VANCOUVER—At a rate of 2.5 per 1,000 person-years, epilepsy incidence in adults age 65 and older is common, according to a retrospective analysis of clinical and administrative data. "To put these study results in context, this incidence rate is 1.5 times higher than that of Parkinson's disease," said Hyunmi Choi, MD, MS, of Columbia University, New York City. Most important, she said, is the finding that black older adults have double the incidence rate of their white counterparts, independent of stroke. "These findings underscore the need for further studies that directly examine the mechanisms by which race affects epilepsy risk," said Dr. Choi at the 68th Annual Meeting of the American Academy of Neurology.

Geographic and Cultural Diversity

Dr. Choi and colleagues from Columbia University and the University of Washington in Seattle, examined data from the Cardiovascular Health Study (CHS), a prospective cohort study of coronary heart disease and stroke. CHS began in 1989 and enrolled 5,201 adults age 65 and older from multiple regions of the country: Sacramento county, California; Washington county, Maryland; Forsyth county, North Carolina; and Pittsburgh, Pennsylvania. A second cohort of 687 predominantly African American participants was enrolled in 1992. In-person evaluations were conducted at baseline, followed by annual in-person evaluations interspersed with phone calls every six months. "Recently, CHS merged its data with those of the Centers for Medicare and Medicaid Services (CMS)," Dr. Choi said.

The researchers used multiple data sources to identify potential epilepsy cases, including self report, information on antiepileptic medication, hospitalization discharge claims data, and outpatient CMS claims data using International Classification of Diseases, ninth edition codes. "Two independent reviewers applied the specific criteria to classify the cases, then we assessed the agreement between them. All discordant cases were discussed, and we arrived at a final consensus diagnosis." The study end points were prevalent epilepsy (ie, those who had epilepsy at baseline) and incident epilepsy (ie, those who developed epilepsy during follow-up).

Incidence and Prevalence Data

Dr. Choi and colleagues found the inter-rater reliability to be high and, in the final analysis, identified 335 participants from the CHS cohort with probable epilepsy at baseline. "This is the group that we used to define an overall epilepsy prevalence of 5.7% out of 5,888 participants," Dr. Choi said. Black participants with a prior history of transient ischemic attack were more likely to have prevalent epilepsy.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up, for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

In addition, Dr. Choi and colleagues identified 120 participants who developed epilepsy during follow-up for an overall incidence rate of 2.5 per 1,000 person-years, which is similar to that of prior research by Faught and colleagues, she pointed out. In the current study, the incidence rate was elevated in black participants at 4.2 for per 1,000 person-years versus 2.1 per 1,000 person-years for white participants.

Adjustment for Stroke Risk

Epilepsy incidence was highest among participants age 75 to 79; however, the incidence rate dropped among those who were older. Using a model that examined participants with a history of cardiovascular risk factors at CHS baseline, Choi and colleagues found that black race, age 75 to 79, and history of stroke were independent risk factors for incident epilepsy. In a second model, which looked at patients who did not have cardiovascular risk factors prior to CHS enrollment but developed these conditions before the onset of epilepsy, black race and incident stroke were independent risk factors for incident epilepsy.

Dr. Choi acknowledged that survival bias may have occurred, whereby healthy participants were retained in the analysis and the sicker patients, possibly with seizures, died earlier. Also, while the analysis adjusted for stroke risk and stroke incidence (which is disproportionately higher in black older adults), other covariates may be more likely to occur in elderly black patients that may have confounded the relationship and increased epilepsy risk.

—Adriene Marshall