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New PAD guidelines expected to boost awareness and treatment
NEW ORLEANS – The latest revision of U.S. guidelines for diagnosing and managing lower-extremity peripheral artery disease is seen by several experts as primarily a renewed call to action by American physicians to more diligently identify at-risk people in their practices, diagnose the disease with ankle-brachial index measurement, and appropriately treat patients who have the disease.
The new lower-extremity peripheral artery disease (PAD) guidelines “give us a platform to get something done,” said Heather L. Gornik, MD, vice chair of the guidelines panel and medical director of the noninvasive vascular lab at the Cleveland Clinic. Improved PAD identification and care “starts with the fundamentals of recognizing who is at risk for PAD and then doing some clinical investigation to find it, because it’s there. You just need to ask patients if they have leg symptoms, have them take off their socks and examine their feet,” Dr. Gornik said in an interview following a program devoted to the revised guidelines at the American Heart Association scientific sessions.
The new guidelines are “a clarion call to action,” commented Alan T. Hirsch, MD, professor of medicine, epidemiology, and community health and director of the vascular medicine program at the University of Minnesota in Minneapolis. PAD “is the single most morbid and fatal of all cardiovascular diseases, so why in 2016 are we challenged to have every cardiologist trained in basic PAD competency?” asked Dr. Hirsch, who chaired the 2005 guidelines panel.
The AHA wants to “elevate awareness of PAD among the public and health professionals, and we want to better understand how we can be a catalyst for change,” said Terri Wiggins, the organization’s vice president for vascular health programs. AHA publications now stress that clinicians need to have patients “take off their socks and look at the patient’s feet,” she said.
The problem with the way many U.S. physicians handle PAD goes beyond a failure to properly screen and diagnose the disease. Analysis of data collected by the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey during 2006-2013 showed that, among an average of 3.9 million patients seen each year with PAD, just 38% received treatment with an antiplatelet drug, 35% received a statin, and among those patients who smoked, 36% received counseling for smoking cessation, Jeffrey S. Berger, MD, reported in a separate talk at the meeting. These rates were roughly constant throughout the 8-year period he examined.
“These data are eye-opening. They highlight a clear opportunity to improve the care of patients with PAD with guideline-directed therapy. PAD is problematic because only 10%-15% of patients have typical symptoms, so many physicians have a false perception that these patients are not at high risk,” Dr. Berger said in an interview. “What the AHA is doing is great” for raising awareness, he added.
The revised 2016 PAD guidelines made several changes, compared with what had been on the books from the 2005 guidelines and 2011 update, including classifying vorapaxar (Zontivity) treatment a class IIb recommendation with “uncertain” incremental benefit when used as an add-on agent on top of standard antiplatelet therapy, endorsement of annual influenza vaccination as something every PAD patient should receive and a class I recommendation, and acknowledgment that selected patients with critical limb ischemia are candidates for an “endovascular first” approach to revascularization,
Perhaps just as important was inclusion for the first time in the new guidelines of three advocacy priorities for initiatives by various professional societies with an interest in PAD: easy availability of ankle-brachial index measurement as the initial test to establish a diagnosis of PAD in patients with physical examination findings suggestive of the disease; access to supervised exercise programs for patients diagnosed with PAD; and incorporation of patient-centered outcomes into the regulatory approval process of new medical therapies and revascularization technologies for treating PAD.
The new guidelines “ form the basis for the AHA establishing a Get With The Guidelines program for PAD so that clinicians can be held accountable for delivering these treatments,” said Naomi M. Hamburg, MD, chief of vascular biology at Boston University and a member of the guidelines panel.
Dr. Gornik has an ownership interest in Summit Doppler Systems and Zin Medical and has received research support from AstraZeneca and Theravasc. Dr. Hamburg has been a consultant to Acceleron and has received research support from Everest Genomics, Hershey’s, Unex, and Welch’s. Dr. Hirsch, Ms. Wiggins, and Dr. Berger had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – The latest revision of U.S. guidelines for diagnosing and managing lower-extremity peripheral artery disease is seen by several experts as primarily a renewed call to action by American physicians to more diligently identify at-risk people in their practices, diagnose the disease with ankle-brachial index measurement, and appropriately treat patients who have the disease.
The new lower-extremity peripheral artery disease (PAD) guidelines “give us a platform to get something done,” said Heather L. Gornik, MD, vice chair of the guidelines panel and medical director of the noninvasive vascular lab at the Cleveland Clinic. Improved PAD identification and care “starts with the fundamentals of recognizing who is at risk for PAD and then doing some clinical investigation to find it, because it’s there. You just need to ask patients if they have leg symptoms, have them take off their socks and examine their feet,” Dr. Gornik said in an interview following a program devoted to the revised guidelines at the American Heart Association scientific sessions.
The new guidelines are “a clarion call to action,” commented Alan T. Hirsch, MD, professor of medicine, epidemiology, and community health and director of the vascular medicine program at the University of Minnesota in Minneapolis. PAD “is the single most morbid and fatal of all cardiovascular diseases, so why in 2016 are we challenged to have every cardiologist trained in basic PAD competency?” asked Dr. Hirsch, who chaired the 2005 guidelines panel.
The AHA wants to “elevate awareness of PAD among the public and health professionals, and we want to better understand how we can be a catalyst for change,” said Terri Wiggins, the organization’s vice president for vascular health programs. AHA publications now stress that clinicians need to have patients “take off their socks and look at the patient’s feet,” she said.
The problem with the way many U.S. physicians handle PAD goes beyond a failure to properly screen and diagnose the disease. Analysis of data collected by the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey during 2006-2013 showed that, among an average of 3.9 million patients seen each year with PAD, just 38% received treatment with an antiplatelet drug, 35% received a statin, and among those patients who smoked, 36% received counseling for smoking cessation, Jeffrey S. Berger, MD, reported in a separate talk at the meeting. These rates were roughly constant throughout the 8-year period he examined.
“These data are eye-opening. They highlight a clear opportunity to improve the care of patients with PAD with guideline-directed therapy. PAD is problematic because only 10%-15% of patients have typical symptoms, so many physicians have a false perception that these patients are not at high risk,” Dr. Berger said in an interview. “What the AHA is doing is great” for raising awareness, he added.
The revised 2016 PAD guidelines made several changes, compared with what had been on the books from the 2005 guidelines and 2011 update, including classifying vorapaxar (Zontivity) treatment a class IIb recommendation with “uncertain” incremental benefit when used as an add-on agent on top of standard antiplatelet therapy, endorsement of annual influenza vaccination as something every PAD patient should receive and a class I recommendation, and acknowledgment that selected patients with critical limb ischemia are candidates for an “endovascular first” approach to revascularization,
Perhaps just as important was inclusion for the first time in the new guidelines of three advocacy priorities for initiatives by various professional societies with an interest in PAD: easy availability of ankle-brachial index measurement as the initial test to establish a diagnosis of PAD in patients with physical examination findings suggestive of the disease; access to supervised exercise programs for patients diagnosed with PAD; and incorporation of patient-centered outcomes into the regulatory approval process of new medical therapies and revascularization technologies for treating PAD.
The new guidelines “ form the basis for the AHA establishing a Get With The Guidelines program for PAD so that clinicians can be held accountable for delivering these treatments,” said Naomi M. Hamburg, MD, chief of vascular biology at Boston University and a member of the guidelines panel.
Dr. Gornik has an ownership interest in Summit Doppler Systems and Zin Medical and has received research support from AstraZeneca and Theravasc. Dr. Hamburg has been a consultant to Acceleron and has received research support from Everest Genomics, Hershey’s, Unex, and Welch’s. Dr. Hirsch, Ms. Wiggins, and Dr. Berger had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – The latest revision of U.S. guidelines for diagnosing and managing lower-extremity peripheral artery disease is seen by several experts as primarily a renewed call to action by American physicians to more diligently identify at-risk people in their practices, diagnose the disease with ankle-brachial index measurement, and appropriately treat patients who have the disease.
The new lower-extremity peripheral artery disease (PAD) guidelines “give us a platform to get something done,” said Heather L. Gornik, MD, vice chair of the guidelines panel and medical director of the noninvasive vascular lab at the Cleveland Clinic. Improved PAD identification and care “starts with the fundamentals of recognizing who is at risk for PAD and then doing some clinical investigation to find it, because it’s there. You just need to ask patients if they have leg symptoms, have them take off their socks and examine their feet,” Dr. Gornik said in an interview following a program devoted to the revised guidelines at the American Heart Association scientific sessions.
The new guidelines are “a clarion call to action,” commented Alan T. Hirsch, MD, professor of medicine, epidemiology, and community health and director of the vascular medicine program at the University of Minnesota in Minneapolis. PAD “is the single most morbid and fatal of all cardiovascular diseases, so why in 2016 are we challenged to have every cardiologist trained in basic PAD competency?” asked Dr. Hirsch, who chaired the 2005 guidelines panel.
The AHA wants to “elevate awareness of PAD among the public and health professionals, and we want to better understand how we can be a catalyst for change,” said Terri Wiggins, the organization’s vice president for vascular health programs. AHA publications now stress that clinicians need to have patients “take off their socks and look at the patient’s feet,” she said.
The problem with the way many U.S. physicians handle PAD goes beyond a failure to properly screen and diagnose the disease. Analysis of data collected by the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey during 2006-2013 showed that, among an average of 3.9 million patients seen each year with PAD, just 38% received treatment with an antiplatelet drug, 35% received a statin, and among those patients who smoked, 36% received counseling for smoking cessation, Jeffrey S. Berger, MD, reported in a separate talk at the meeting. These rates were roughly constant throughout the 8-year period he examined.
“These data are eye-opening. They highlight a clear opportunity to improve the care of patients with PAD with guideline-directed therapy. PAD is problematic because only 10%-15% of patients have typical symptoms, so many physicians have a false perception that these patients are not at high risk,” Dr. Berger said in an interview. “What the AHA is doing is great” for raising awareness, he added.
The revised 2016 PAD guidelines made several changes, compared with what had been on the books from the 2005 guidelines and 2011 update, including classifying vorapaxar (Zontivity) treatment a class IIb recommendation with “uncertain” incremental benefit when used as an add-on agent on top of standard antiplatelet therapy, endorsement of annual influenza vaccination as something every PAD patient should receive and a class I recommendation, and acknowledgment that selected patients with critical limb ischemia are candidates for an “endovascular first” approach to revascularization,
Perhaps just as important was inclusion for the first time in the new guidelines of three advocacy priorities for initiatives by various professional societies with an interest in PAD: easy availability of ankle-brachial index measurement as the initial test to establish a diagnosis of PAD in patients with physical examination findings suggestive of the disease; access to supervised exercise programs for patients diagnosed with PAD; and incorporation of patient-centered outcomes into the regulatory approval process of new medical therapies and revascularization technologies for treating PAD.
The new guidelines “ form the basis for the AHA establishing a Get With The Guidelines program for PAD so that clinicians can be held accountable for delivering these treatments,” said Naomi M. Hamburg, MD, chief of vascular biology at Boston University and a member of the guidelines panel.
Dr. Gornik has an ownership interest in Summit Doppler Systems and Zin Medical and has received research support from AstraZeneca and Theravasc. Dr. Hamburg has been a consultant to Acceleron and has received research support from Everest Genomics, Hershey’s, Unex, and Welch’s. Dr. Hirsch, Ms. Wiggins, and Dr. Berger had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE AHA SCIENTIFIC SESSIONS
Age correlated with occult cancer in VTE patients
A newly devised risk score may help identify which patients with acute venous thromboembolism (VTE) are most likely to have occult cancer and where they are likely to have it, according to a report published online in CHEST.
Although VTE is known to occur before an occult cancer becomes symptomatic in a minority of patients, clinicians don’t agree on which patients with VTE should be screened for occult cancer or on how extensive that screening should be. Some favor a basic screening with only a clinical history, physical exam, simple lab tests, and a chest X-ray, while others advocate a more thorough work-up to improve the patient’s chance for a cure. “The potential benefits and harms of such screening are controversial, partly because there is little evidence” concerning which patients are at highest risk and which cancer types/sites should be assessed, said Luis Jara-Palomares, MD, PhD, of the medical surgical unit of respiratory diseases, Virgen del Rocio Hospital, Seville, Spain, and his associates.
Dr. Jara-Palomares and his associates devised a prognostic score by assigning points to the variables they found to be most significantly associated with occult cancer. For example, male sex was accorded 1 point, chronic lung disease or a high platelet count was accorded 1 point, age over 70 years or anemia was accorded 2 points, and postoperative or prior VTE was accorded negative 2 points. The incidence of occult cancer was significantly lower among patients whose total score was 2 points or less (5.8%) than among those whose total score was 3 points or higher (12%).
The mean age of these study participants was 63 years, and approximately half were women. A total of 444 (7.6%) were diagnosed as having cancer at 1-24 months after presenting with VTE. Most of these cancers were discovered within 6 months of the VTE.
Patients who had occult cancer were significantly more likely than those who did not to be male and older than 70 years of age; to have chronic lung disease, an elevated platelet count, and/or anemia; and to have a history of recent surgery and/or prior VTE.
The percentage of VTE patients who had occult cancer increased with advancing age, from 2%-3% in the youngest age group (younger than 50 years) to 8%-12% in the oldest age group (older than 70 years). Among men with occult cancer, the most frequently affected sites were the lung (26%), prostate (17%), and colon/rectum (10%). Among women, the most frequent types of cancer were colorectal (19%), breast (12%), uterine (9.1%), hematologic (8.6%), pancreatic (7.6%), and stomach (6.6%).
Overall, more than half of the men who had occult cancer had cancer affecting the lung, prostate, or colon/rectum, while two-thirds of the women who had occult cancer had cancer affecting the colon/rectum, breast, or abdomen. “This is important because [cancer] screening is not necessary in all VTE patients, but any information suggesting [which] patients are at increased risk and [which] sites are more common may be of help to decide the most appropriate work-up for each patient,” the investigators noted.
To determine which patients are most likely to have occult cancer and which cancer types are most likely to develop, the investigators analyzed data from RIETE (the Computerized Registry of Patients With Venous Thromboembolism), an international registry of more than 50,000 consecutive patients with confirmed acute VTE. They focused on 5,863 patients who presented with pulmonary embolism (34%), deep vein thrombosis (48%), or both disorders (18%) and were followed for at least 2 years for the development of cancer.
The accuracy of this risk scoring system must be tested further in a large validation cohort before it can be widely adopted. If it proves to be accurate, then patients with low total risk scores could forgo the expense, discomfort, and psychological stress of extensive cancer screening, Dr. Jara-Palomares and his associates said.
Men whose total score is 3 points or more could benefit from a rectal exam and fecal occult blood test to rule out colorectal cancer, a rectal exam and prostate-specific antigen test to rule out prostate cancer, and a chest CT to rule out lung cancer. Women whose total score is 3 points or higher could benefit from a fecal occult blood test to rule out colorectal cancer, a mammogram to rule out breast cancer, and abdominopelvic CT to rule out uterine, pancreatic, and stomach cancer, they noted.
The RIETE Registry is supported by an unrestricted educational grant from Sanofi Spain and by Bayer Pharma AG. Dr. Jara-Palomares reported having no relevant financial disclosures; his associates reported ties to Sanofi, Bayer, and LEO Pharma.
A newly devised risk score may help identify which patients with acute venous thromboembolism (VTE) are most likely to have occult cancer and where they are likely to have it, according to a report published online in CHEST.
Although VTE is known to occur before an occult cancer becomes symptomatic in a minority of patients, clinicians don’t agree on which patients with VTE should be screened for occult cancer or on how extensive that screening should be. Some favor a basic screening with only a clinical history, physical exam, simple lab tests, and a chest X-ray, while others advocate a more thorough work-up to improve the patient’s chance for a cure. “The potential benefits and harms of such screening are controversial, partly because there is little evidence” concerning which patients are at highest risk and which cancer types/sites should be assessed, said Luis Jara-Palomares, MD, PhD, of the medical surgical unit of respiratory diseases, Virgen del Rocio Hospital, Seville, Spain, and his associates.
Dr. Jara-Palomares and his associates devised a prognostic score by assigning points to the variables they found to be most significantly associated with occult cancer. For example, male sex was accorded 1 point, chronic lung disease or a high platelet count was accorded 1 point, age over 70 years or anemia was accorded 2 points, and postoperative or prior VTE was accorded negative 2 points. The incidence of occult cancer was significantly lower among patients whose total score was 2 points or less (5.8%) than among those whose total score was 3 points or higher (12%).
The mean age of these study participants was 63 years, and approximately half were women. A total of 444 (7.6%) were diagnosed as having cancer at 1-24 months after presenting with VTE. Most of these cancers were discovered within 6 months of the VTE.
Patients who had occult cancer were significantly more likely than those who did not to be male and older than 70 years of age; to have chronic lung disease, an elevated platelet count, and/or anemia; and to have a history of recent surgery and/or prior VTE.
The percentage of VTE patients who had occult cancer increased with advancing age, from 2%-3% in the youngest age group (younger than 50 years) to 8%-12% in the oldest age group (older than 70 years). Among men with occult cancer, the most frequently affected sites were the lung (26%), prostate (17%), and colon/rectum (10%). Among women, the most frequent types of cancer were colorectal (19%), breast (12%), uterine (9.1%), hematologic (8.6%), pancreatic (7.6%), and stomach (6.6%).
Overall, more than half of the men who had occult cancer had cancer affecting the lung, prostate, or colon/rectum, while two-thirds of the women who had occult cancer had cancer affecting the colon/rectum, breast, or abdomen. “This is important because [cancer] screening is not necessary in all VTE patients, but any information suggesting [which] patients are at increased risk and [which] sites are more common may be of help to decide the most appropriate work-up for each patient,” the investigators noted.
To determine which patients are most likely to have occult cancer and which cancer types are most likely to develop, the investigators analyzed data from RIETE (the Computerized Registry of Patients With Venous Thromboembolism), an international registry of more than 50,000 consecutive patients with confirmed acute VTE. They focused on 5,863 patients who presented with pulmonary embolism (34%), deep vein thrombosis (48%), or both disorders (18%) and were followed for at least 2 years for the development of cancer.
The accuracy of this risk scoring system must be tested further in a large validation cohort before it can be widely adopted. If it proves to be accurate, then patients with low total risk scores could forgo the expense, discomfort, and psychological stress of extensive cancer screening, Dr. Jara-Palomares and his associates said.
Men whose total score is 3 points or more could benefit from a rectal exam and fecal occult blood test to rule out colorectal cancer, a rectal exam and prostate-specific antigen test to rule out prostate cancer, and a chest CT to rule out lung cancer. Women whose total score is 3 points or higher could benefit from a fecal occult blood test to rule out colorectal cancer, a mammogram to rule out breast cancer, and abdominopelvic CT to rule out uterine, pancreatic, and stomach cancer, they noted.
The RIETE Registry is supported by an unrestricted educational grant from Sanofi Spain and by Bayer Pharma AG. Dr. Jara-Palomares reported having no relevant financial disclosures; his associates reported ties to Sanofi, Bayer, and LEO Pharma.
A newly devised risk score may help identify which patients with acute venous thromboembolism (VTE) are most likely to have occult cancer and where they are likely to have it, according to a report published online in CHEST.
Although VTE is known to occur before an occult cancer becomes symptomatic in a minority of patients, clinicians don’t agree on which patients with VTE should be screened for occult cancer or on how extensive that screening should be. Some favor a basic screening with only a clinical history, physical exam, simple lab tests, and a chest X-ray, while others advocate a more thorough work-up to improve the patient’s chance for a cure. “The potential benefits and harms of such screening are controversial, partly because there is little evidence” concerning which patients are at highest risk and which cancer types/sites should be assessed, said Luis Jara-Palomares, MD, PhD, of the medical surgical unit of respiratory diseases, Virgen del Rocio Hospital, Seville, Spain, and his associates.
Dr. Jara-Palomares and his associates devised a prognostic score by assigning points to the variables they found to be most significantly associated with occult cancer. For example, male sex was accorded 1 point, chronic lung disease or a high platelet count was accorded 1 point, age over 70 years or anemia was accorded 2 points, and postoperative or prior VTE was accorded negative 2 points. The incidence of occult cancer was significantly lower among patients whose total score was 2 points or less (5.8%) than among those whose total score was 3 points or higher (12%).
The mean age of these study participants was 63 years, and approximately half were women. A total of 444 (7.6%) were diagnosed as having cancer at 1-24 months after presenting with VTE. Most of these cancers were discovered within 6 months of the VTE.
Patients who had occult cancer were significantly more likely than those who did not to be male and older than 70 years of age; to have chronic lung disease, an elevated platelet count, and/or anemia; and to have a history of recent surgery and/or prior VTE.
The percentage of VTE patients who had occult cancer increased with advancing age, from 2%-3% in the youngest age group (younger than 50 years) to 8%-12% in the oldest age group (older than 70 years). Among men with occult cancer, the most frequently affected sites were the lung (26%), prostate (17%), and colon/rectum (10%). Among women, the most frequent types of cancer were colorectal (19%), breast (12%), uterine (9.1%), hematologic (8.6%), pancreatic (7.6%), and stomach (6.6%).
Overall, more than half of the men who had occult cancer had cancer affecting the lung, prostate, or colon/rectum, while two-thirds of the women who had occult cancer had cancer affecting the colon/rectum, breast, or abdomen. “This is important because [cancer] screening is not necessary in all VTE patients, but any information suggesting [which] patients are at increased risk and [which] sites are more common may be of help to decide the most appropriate work-up for each patient,” the investigators noted.
To determine which patients are most likely to have occult cancer and which cancer types are most likely to develop, the investigators analyzed data from RIETE (the Computerized Registry of Patients With Venous Thromboembolism), an international registry of more than 50,000 consecutive patients with confirmed acute VTE. They focused on 5,863 patients who presented with pulmonary embolism (34%), deep vein thrombosis (48%), or both disorders (18%) and were followed for at least 2 years for the development of cancer.
The accuracy of this risk scoring system must be tested further in a large validation cohort before it can be widely adopted. If it proves to be accurate, then patients with low total risk scores could forgo the expense, discomfort, and psychological stress of extensive cancer screening, Dr. Jara-Palomares and his associates said.
Men whose total score is 3 points or more could benefit from a rectal exam and fecal occult blood test to rule out colorectal cancer, a rectal exam and prostate-specific antigen test to rule out prostate cancer, and a chest CT to rule out lung cancer. Women whose total score is 3 points or higher could benefit from a fecal occult blood test to rule out colorectal cancer, a mammogram to rule out breast cancer, and abdominopelvic CT to rule out uterine, pancreatic, and stomach cancer, they noted.
The RIETE Registry is supported by an unrestricted educational grant from Sanofi Spain and by Bayer Pharma AG. Dr. Jara-Palomares reported having no relevant financial disclosures; his associates reported ties to Sanofi, Bayer, and LEO Pharma.
FROM CHEST
Key clinical point:
Major finding: The incidence of occult cancer was significantly lower among patients whose total score was 2 points or less (5.8%) than among those whose total score was 3 points or higher (12%).
Data source: A retrospective cohort study involving 5,863 consecutive VTE patients in an international observational registry.
Disclosures: The RIETE Registry is supported by an unrestricted educational grant from Sanofi Spain and by Bayer Pharma AG. Dr. Jara-Palomares reported having no relevant financial disclosures; his associates reported ties to Sanofi, Bayer, and LEO Pharma.
Biosimilar trastuzumab shows similar efficacy
A trastuzumab biosimilar drug has shown an equivalent response, compared with trastuzumab, in the treatment of ERBB2 (HER2)-positive metastatic breast cancer, according to the results of a randomized double-blind controlled trial.
The anti-ERBB2 humanized monoclonal antibody trastuzumab in combination with chemotherapy has been found in numerous trials to significantly improve progression-free survival and overall survival in women with ERBB2-positive metastatic breast, compared with chemotherapy alone.
“With impending patent expiration of some biological agents, development of biosimilars has become a high priority for drug developers and health authorities throughout the world to provide access to high-quality alternatives,” the authors wrote. “A biosimilar drug is a biological product that is highly similar to a licensed biological product, with no clinically meaningful differences in terms of safety, purity, or potency.”
In a phase III multicenter trial, 500 women with ERBB2 (HER2)-positive metastatic breast cancer, recruited from 95 sites in Europe, Africa, South America, and Asia, were randomized 1:1 to intravenous infusions of trastuzumab or a biosimilar labeled MYL-1401O, with both arms also receiving taxane therapy.
At 24 weeks, the overall response rate (ORR) was not significantly different between the biosimilar and trastuzumab groups (69.6% vs. 64.0%; ORR ratio, 1.09; 90% confidence interval, 0.974-1.211) and within the predefined equivalence boundaries, the investigators report (JAMA. 2016 Dec 1. doi: 10.1001/jama.2016.18305).
By week 48, both groups also showed no significant differences in time to tumor progression, progression-free survival (44.3% vs. 44.7%), or overall survival (89.1% vs. 85.1%).
Pharmacokinetic analysis showed the mean concentrations of trastuzumab were similar for the two treatments, and minimum drug concentrations were also comparable at week 16 of treatment.
“This confirmatory efficacy and safety study was the last step in the multistep process to demonstrate similarity of a trastuzumab biosimilar and was adequately powered to demonstrate equivalence with trastuzumab,” the authors wrote. “The results of this study are consistent with the physicochemical and functional similarity shown in vitro and in vivo and with the similar pharmacokinetics shown in healthy participants between the candidate biosimilar and trastuzumab.”
This consistency also extended to adverse events. Almost all participants in both the biosimilar and the trastuzumab groups reported at least one adverse event, which included neutropenia (57.5% vs. 53.3%), peripheral neuropathy (23.1% vs. 24.8%), and diarrhea (20.6% vs. 20.7%).
“A biosimilar treatment option may increase global access to biological cancer therapies, provided, among other issues, that the price of the biosimilar is sufficiently inexpensive to enable women in non–high-income countries to access this therapy,” the authors wrote.
However, they pointed out that the stepwise development program for biosimilar drugs tended to use shorter end-points – 24 weeks for the primary endpoint and 48 weeks for secondary endpoints in this particular study. By 48 weeks, more than 50% of patients had not shown progression, suggesting that the medians for efficacy parameters may have been longer with a longer data cut-off.
“The choice of the 24-week evaluation period for part 1 of this study was related to the ability to analyze the ORR as a short-term measure of clinical activity and safety directly related to the combination of taxanes with trastuzumab and the proposed biosimilar as first-line treatment.”
The study was funded and sponsored by Mylan, which manufactured the biosimilar drug, and Biocon Research Limited. Four authors declared stock in Mylan, two declared consulting fees from Mylan and one also declared stock in Biocon Research Limited. One author declared research and travel support from other pharmaceutical companies.
The availability of a biosimilar agent that achieves equivalent clinical outcomes at lower cost could enable many patients with breast cancer to have access to a therapy that may improve survival. Moreover, given the large number of patients with breast cancer, widespread use of this trastuzumab biosimilar evaluated by Rugo et al. (if approved for use by the U.S. FDA, the European Medicines Agency, and other regulatory agencies) also could have financial implications for the manufacturer of this product.
In announcing their FDA submission for the proposed trastuzumab biosimilar, the sponsors of the trial by Rugo et al. have expressed their “shared commitment to increasing access to these critical medicines worldwide” and indicated that “this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools.” Ultimately, to fulfill these pledges, the manufacturers must ensure that the pricing of this biosimilar product is responsible and fair and provides access to this important therapy at an affordable price.
Howard Bauchner, MD, is editor in chief of JAMA, Phil B. Fontanarosa, MD, MBA, is executive editor of JAMA, and Robert M. Golub, MD, is deputy editor of JAMA. These comments are taken from an accompanying editorial (JAMA. 2016 Dec 1. doi: 10.1001/jama.2016.18743). No conflicts of interest were declared.
The availability of a biosimilar agent that achieves equivalent clinical outcomes at lower cost could enable many patients with breast cancer to have access to a therapy that may improve survival. Moreover, given the large number of patients with breast cancer, widespread use of this trastuzumab biosimilar evaluated by Rugo et al. (if approved for use by the U.S. FDA, the European Medicines Agency, and other regulatory agencies) also could have financial implications for the manufacturer of this product.
In announcing their FDA submission for the proposed trastuzumab biosimilar, the sponsors of the trial by Rugo et al. have expressed their “shared commitment to increasing access to these critical medicines worldwide” and indicated that “this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools.” Ultimately, to fulfill these pledges, the manufacturers must ensure that the pricing of this biosimilar product is responsible and fair and provides access to this important therapy at an affordable price.
Howard Bauchner, MD, is editor in chief of JAMA, Phil B. Fontanarosa, MD, MBA, is executive editor of JAMA, and Robert M. Golub, MD, is deputy editor of JAMA. These comments are taken from an accompanying editorial (JAMA. 2016 Dec 1. doi: 10.1001/jama.2016.18743). No conflicts of interest were declared.
The availability of a biosimilar agent that achieves equivalent clinical outcomes at lower cost could enable many patients with breast cancer to have access to a therapy that may improve survival. Moreover, given the large number of patients with breast cancer, widespread use of this trastuzumab biosimilar evaluated by Rugo et al. (if approved for use by the U.S. FDA, the European Medicines Agency, and other regulatory agencies) also could have financial implications for the manufacturer of this product.
In announcing their FDA submission for the proposed trastuzumab biosimilar, the sponsors of the trial by Rugo et al. have expressed their “shared commitment to increasing access to these critical medicines worldwide” and indicated that “this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools.” Ultimately, to fulfill these pledges, the manufacturers must ensure that the pricing of this biosimilar product is responsible and fair and provides access to this important therapy at an affordable price.
Howard Bauchner, MD, is editor in chief of JAMA, Phil B. Fontanarosa, MD, MBA, is executive editor of JAMA, and Robert M. Golub, MD, is deputy editor of JAMA. These comments are taken from an accompanying editorial (JAMA. 2016 Dec 1. doi: 10.1001/jama.2016.18743). No conflicts of interest were declared.
A trastuzumab biosimilar drug has shown an equivalent response, compared with trastuzumab, in the treatment of ERBB2 (HER2)-positive metastatic breast cancer, according to the results of a randomized double-blind controlled trial.
The anti-ERBB2 humanized monoclonal antibody trastuzumab in combination with chemotherapy has been found in numerous trials to significantly improve progression-free survival and overall survival in women with ERBB2-positive metastatic breast, compared with chemotherapy alone.
“With impending patent expiration of some biological agents, development of biosimilars has become a high priority for drug developers and health authorities throughout the world to provide access to high-quality alternatives,” the authors wrote. “A biosimilar drug is a biological product that is highly similar to a licensed biological product, with no clinically meaningful differences in terms of safety, purity, or potency.”
In a phase III multicenter trial, 500 women with ERBB2 (HER2)-positive metastatic breast cancer, recruited from 95 sites in Europe, Africa, South America, and Asia, were randomized 1:1 to intravenous infusions of trastuzumab or a biosimilar labeled MYL-1401O, with both arms also receiving taxane therapy.
At 24 weeks, the overall response rate (ORR) was not significantly different between the biosimilar and trastuzumab groups (69.6% vs. 64.0%; ORR ratio, 1.09; 90% confidence interval, 0.974-1.211) and within the predefined equivalence boundaries, the investigators report (JAMA. 2016 Dec 1. doi: 10.1001/jama.2016.18305).
By week 48, both groups also showed no significant differences in time to tumor progression, progression-free survival (44.3% vs. 44.7%), or overall survival (89.1% vs. 85.1%).
Pharmacokinetic analysis showed the mean concentrations of trastuzumab were similar for the two treatments, and minimum drug concentrations were also comparable at week 16 of treatment.
“This confirmatory efficacy and safety study was the last step in the multistep process to demonstrate similarity of a trastuzumab biosimilar and was adequately powered to demonstrate equivalence with trastuzumab,” the authors wrote. “The results of this study are consistent with the physicochemical and functional similarity shown in vitro and in vivo and with the similar pharmacokinetics shown in healthy participants between the candidate biosimilar and trastuzumab.”
This consistency also extended to adverse events. Almost all participants in both the biosimilar and the trastuzumab groups reported at least one adverse event, which included neutropenia (57.5% vs. 53.3%), peripheral neuropathy (23.1% vs. 24.8%), and diarrhea (20.6% vs. 20.7%).
“A biosimilar treatment option may increase global access to biological cancer therapies, provided, among other issues, that the price of the biosimilar is sufficiently inexpensive to enable women in non–high-income countries to access this therapy,” the authors wrote.
However, they pointed out that the stepwise development program for biosimilar drugs tended to use shorter end-points – 24 weeks for the primary endpoint and 48 weeks for secondary endpoints in this particular study. By 48 weeks, more than 50% of patients had not shown progression, suggesting that the medians for efficacy parameters may have been longer with a longer data cut-off.
“The choice of the 24-week evaluation period for part 1 of this study was related to the ability to analyze the ORR as a short-term measure of clinical activity and safety directly related to the combination of taxanes with trastuzumab and the proposed biosimilar as first-line treatment.”
The study was funded and sponsored by Mylan, which manufactured the biosimilar drug, and Biocon Research Limited. Four authors declared stock in Mylan, two declared consulting fees from Mylan and one also declared stock in Biocon Research Limited. One author declared research and travel support from other pharmaceutical companies.
A trastuzumab biosimilar drug has shown an equivalent response, compared with trastuzumab, in the treatment of ERBB2 (HER2)-positive metastatic breast cancer, according to the results of a randomized double-blind controlled trial.
The anti-ERBB2 humanized monoclonal antibody trastuzumab in combination with chemotherapy has been found in numerous trials to significantly improve progression-free survival and overall survival in women with ERBB2-positive metastatic breast, compared with chemotherapy alone.
“With impending patent expiration of some biological agents, development of biosimilars has become a high priority for drug developers and health authorities throughout the world to provide access to high-quality alternatives,” the authors wrote. “A biosimilar drug is a biological product that is highly similar to a licensed biological product, with no clinically meaningful differences in terms of safety, purity, or potency.”
In a phase III multicenter trial, 500 women with ERBB2 (HER2)-positive metastatic breast cancer, recruited from 95 sites in Europe, Africa, South America, and Asia, were randomized 1:1 to intravenous infusions of trastuzumab or a biosimilar labeled MYL-1401O, with both arms also receiving taxane therapy.
At 24 weeks, the overall response rate (ORR) was not significantly different between the biosimilar and trastuzumab groups (69.6% vs. 64.0%; ORR ratio, 1.09; 90% confidence interval, 0.974-1.211) and within the predefined equivalence boundaries, the investigators report (JAMA. 2016 Dec 1. doi: 10.1001/jama.2016.18305).
By week 48, both groups also showed no significant differences in time to tumor progression, progression-free survival (44.3% vs. 44.7%), or overall survival (89.1% vs. 85.1%).
Pharmacokinetic analysis showed the mean concentrations of trastuzumab were similar for the two treatments, and minimum drug concentrations were also comparable at week 16 of treatment.
“This confirmatory efficacy and safety study was the last step in the multistep process to demonstrate similarity of a trastuzumab biosimilar and was adequately powered to demonstrate equivalence with trastuzumab,” the authors wrote. “The results of this study are consistent with the physicochemical and functional similarity shown in vitro and in vivo and with the similar pharmacokinetics shown in healthy participants between the candidate biosimilar and trastuzumab.”
This consistency also extended to adverse events. Almost all participants in both the biosimilar and the trastuzumab groups reported at least one adverse event, which included neutropenia (57.5% vs. 53.3%), peripheral neuropathy (23.1% vs. 24.8%), and diarrhea (20.6% vs. 20.7%).
“A biosimilar treatment option may increase global access to biological cancer therapies, provided, among other issues, that the price of the biosimilar is sufficiently inexpensive to enable women in non–high-income countries to access this therapy,” the authors wrote.
However, they pointed out that the stepwise development program for biosimilar drugs tended to use shorter end-points – 24 weeks for the primary endpoint and 48 weeks for secondary endpoints in this particular study. By 48 weeks, more than 50% of patients had not shown progression, suggesting that the medians for efficacy parameters may have been longer with a longer data cut-off.
“The choice of the 24-week evaluation period for part 1 of this study was related to the ability to analyze the ORR as a short-term measure of clinical activity and safety directly related to the combination of taxanes with trastuzumab and the proposed biosimilar as first-line treatment.”
The study was funded and sponsored by Mylan, which manufactured the biosimilar drug, and Biocon Research Limited. Four authors declared stock in Mylan, two declared consulting fees from Mylan and one also declared stock in Biocon Research Limited. One author declared research and travel support from other pharmaceutical companies.
FROM JAMA
Key clinical point: A trastuzumab biosimilar drug has shown an equivalent response, compared with trastuzumab, in the treatment of ERBB2 (HER2)-positive metastatic breast cancer.
Major finding: Patients treated with biosimilar trastuzumab showed no significant differences in response rate, progression, and survival, compared with those treated with trastuzumab.
Data source: Randomized, double-blind phase III controlled trial in 500 women with ERBB2 (HER2)-positive metastatic breast cancer.
Disclosures: The study was funded and sponsored by Mylan, which manufactured the biosimilar drug, and Biocon Research Limited. Four authors declared stock in Mylan, two declared consulting fees from Mylan, and one also declared stock in Biocon Research Limited. One author declared research and travel support from other pharmaceutical companies.
Ferric citrate effective for anemia in non–dialysis-dependent CKD
CHICAGO – Ferric citrate was safe and effective for treatment of iron-deficiency anemia in patients who had non–dialysis-dependent chronic kidney disease (NDD-CKD), based on data from a phase III, randomized, double-blind study.
The responses were durable, and none of the patients received erythropoiesis-stimulating agents (ESAs), presenter Pablo Pergola, MD, PhD, of Renal Associates, San Antonio, said in an interview at a meeting sponsored by the American Society of Nephrology.
The trial involved 234 anemic adults who had NDD-CKD and had not responded to oral iron supplements. The subjects were randomized to receive oral ferric citrate (n = 117) or placebo (n = 115) with meals (one patient did not receive placebo and laboratory data were lacking for one patient). The mean dose in the treatment arm was 5 pills per day.
The primary endpoint was the proportion of patients with hemoglobin (Hgb) greater than or equal to 1.0 g/dL anytime from baseline through week 16. Secondary endpoints included mean changes from baseline in Hgb, transferrin saturation, ferritin, and serum phosphate and evidence of sustained treatment effect based on target changes in Hgb with time.
Both arms were comparable at baseline for demographic and clinical characteristics, including phosphorus and hemoglobin levels and estimated glomerular filtration rate.
The primary endpoint was met by 51.2% of patients receiving ferric citrate and 19.1% of patients receiving placebo (P less than .001). All secondary efficacy endpoints were met, with statistically significant differences between the treatment and placebo arms, Dr. Pergola reported.
Serum phosphate level was significantly reduced from baseline at week 16 (–0.21 mg/dL; 95% confidence interval, –0.39 to –0.03 mg/dL; P equal to .02) in the active treatment group, and the levels remained in the normal range, he said.
During the 16-week treatment period and subsequent 8-week, open-label safety extension period, ferric citrate was well tolerated. Treatment-emergent adverse events (AEs), most commonly diarrhea, occurred in 93 (79.5%) and 75 (64.7%) patients in the treatment and placebo arms, respectively. Serious AEs developed in 14 (12.0%) and 13 (11.2%) of patients in the same respective order. Two deaths occurred, both in the treatment group. The deaths and serious AEs were not considered drug related.
Ferric citrate binds with dietary phosphate in the gastrointestinal tract. The resulting ferric phosphate is insoluble and is excreted. The remaining unbound ferric citrate increases serum iron parameters, including ferritin and transferrin saturation.
The findings potentially extend the therapeutic reach of the drug beyond its Food and Drug Administration–approved use for control of phosphorus levels in CKD patients on dialysis, Dr. Pergola said. The trial data will be used to seek approval for the oral iron medication as a treatment for iron-deficiency anemia in adults with NDD-CKD.
The study was sponsored by Keryx Biopharmaceuticals. Dr. Pergola is supported by honoraria and lecture fees from Akebia Therapeutics, Keryx, Relypsa, Vifor/Fresenius Pharma, and ZS Pharma.
CHICAGO – Ferric citrate was safe and effective for treatment of iron-deficiency anemia in patients who had non–dialysis-dependent chronic kidney disease (NDD-CKD), based on data from a phase III, randomized, double-blind study.
The responses were durable, and none of the patients received erythropoiesis-stimulating agents (ESAs), presenter Pablo Pergola, MD, PhD, of Renal Associates, San Antonio, said in an interview at a meeting sponsored by the American Society of Nephrology.
The trial involved 234 anemic adults who had NDD-CKD and had not responded to oral iron supplements. The subjects were randomized to receive oral ferric citrate (n = 117) or placebo (n = 115) with meals (one patient did not receive placebo and laboratory data were lacking for one patient). The mean dose in the treatment arm was 5 pills per day.
The primary endpoint was the proportion of patients with hemoglobin (Hgb) greater than or equal to 1.0 g/dL anytime from baseline through week 16. Secondary endpoints included mean changes from baseline in Hgb, transferrin saturation, ferritin, and serum phosphate and evidence of sustained treatment effect based on target changes in Hgb with time.
Both arms were comparable at baseline for demographic and clinical characteristics, including phosphorus and hemoglobin levels and estimated glomerular filtration rate.
The primary endpoint was met by 51.2% of patients receiving ferric citrate and 19.1% of patients receiving placebo (P less than .001). All secondary efficacy endpoints were met, with statistically significant differences between the treatment and placebo arms, Dr. Pergola reported.
Serum phosphate level was significantly reduced from baseline at week 16 (–0.21 mg/dL; 95% confidence interval, –0.39 to –0.03 mg/dL; P equal to .02) in the active treatment group, and the levels remained in the normal range, he said.
During the 16-week treatment period and subsequent 8-week, open-label safety extension period, ferric citrate was well tolerated. Treatment-emergent adverse events (AEs), most commonly diarrhea, occurred in 93 (79.5%) and 75 (64.7%) patients in the treatment and placebo arms, respectively. Serious AEs developed in 14 (12.0%) and 13 (11.2%) of patients in the same respective order. Two deaths occurred, both in the treatment group. The deaths and serious AEs were not considered drug related.
Ferric citrate binds with dietary phosphate in the gastrointestinal tract. The resulting ferric phosphate is insoluble and is excreted. The remaining unbound ferric citrate increases serum iron parameters, including ferritin and transferrin saturation.
The findings potentially extend the therapeutic reach of the drug beyond its Food and Drug Administration–approved use for control of phosphorus levels in CKD patients on dialysis, Dr. Pergola said. The trial data will be used to seek approval for the oral iron medication as a treatment for iron-deficiency anemia in adults with NDD-CKD.
The study was sponsored by Keryx Biopharmaceuticals. Dr. Pergola is supported by honoraria and lecture fees from Akebia Therapeutics, Keryx, Relypsa, Vifor/Fresenius Pharma, and ZS Pharma.
CHICAGO – Ferric citrate was safe and effective for treatment of iron-deficiency anemia in patients who had non–dialysis-dependent chronic kidney disease (NDD-CKD), based on data from a phase III, randomized, double-blind study.
The responses were durable, and none of the patients received erythropoiesis-stimulating agents (ESAs), presenter Pablo Pergola, MD, PhD, of Renal Associates, San Antonio, said in an interview at a meeting sponsored by the American Society of Nephrology.
The trial involved 234 anemic adults who had NDD-CKD and had not responded to oral iron supplements. The subjects were randomized to receive oral ferric citrate (n = 117) or placebo (n = 115) with meals (one patient did not receive placebo and laboratory data were lacking for one patient). The mean dose in the treatment arm was 5 pills per day.
The primary endpoint was the proportion of patients with hemoglobin (Hgb) greater than or equal to 1.0 g/dL anytime from baseline through week 16. Secondary endpoints included mean changes from baseline in Hgb, transferrin saturation, ferritin, and serum phosphate and evidence of sustained treatment effect based on target changes in Hgb with time.
Both arms were comparable at baseline for demographic and clinical characteristics, including phosphorus and hemoglobin levels and estimated glomerular filtration rate.
The primary endpoint was met by 51.2% of patients receiving ferric citrate and 19.1% of patients receiving placebo (P less than .001). All secondary efficacy endpoints were met, with statistically significant differences between the treatment and placebo arms, Dr. Pergola reported.
Serum phosphate level was significantly reduced from baseline at week 16 (–0.21 mg/dL; 95% confidence interval, –0.39 to –0.03 mg/dL; P equal to .02) in the active treatment group, and the levels remained in the normal range, he said.
During the 16-week treatment period and subsequent 8-week, open-label safety extension period, ferric citrate was well tolerated. Treatment-emergent adverse events (AEs), most commonly diarrhea, occurred in 93 (79.5%) and 75 (64.7%) patients in the treatment and placebo arms, respectively. Serious AEs developed in 14 (12.0%) and 13 (11.2%) of patients in the same respective order. Two deaths occurred, both in the treatment group. The deaths and serious AEs were not considered drug related.
Ferric citrate binds with dietary phosphate in the gastrointestinal tract. The resulting ferric phosphate is insoluble and is excreted. The remaining unbound ferric citrate increases serum iron parameters, including ferritin and transferrin saturation.
The findings potentially extend the therapeutic reach of the drug beyond its Food and Drug Administration–approved use for control of phosphorus levels in CKD patients on dialysis, Dr. Pergola said. The trial data will be used to seek approval for the oral iron medication as a treatment for iron-deficiency anemia in adults with NDD-CKD.
The study was sponsored by Keryx Biopharmaceuticals. Dr. Pergola is supported by honoraria and lecture fees from Akebia Therapeutics, Keryx, Relypsa, Vifor/Fresenius Pharma, and ZS Pharma.
AT KIDNEY WEEK 2016
Key clinical point: Ferric citrate appears to be safe and effective for treating anemia in non–dialysis-dependent CKD patients.
Major finding: Prevalence of increased hemoglobin was 52.1% in patients receiving the active drug and 19.1% in those given placebo.
Data source: Randomized, double-blind, placebo-controlled, phase III trial with 234 patients.
Disclosures: The study was sponsored by Keryx Biopharmaceuticals. Dr. Pergola is supported by honoraria and lecture fees from Akebia Therapeutics, Keryx, Relypsa, Vifor/Fresenius Pharma, and ZS Pharma.
Flesh-Colored Papular Eruption
Papular Mucinosis/Scleromyxedema
Papular mucinosis/scleromyxedema, also known as generalized lichen myxedematosus, is a rare dermal mucinosis characterized by a papular eruption that can have an associated IgG λ paraproteinemia. The clinical presentation is gradual with the development of firm, flesh-colored, 2- to 3-mm papules often involving the hands, face, and neck that can progress to plaques that cover the entire body. Skin stiffening also can be seen.1 Extracutaneous symptoms are common and include dysphagia, arthralgia, myopathy, and cardiac dysfunction.2 Occasionally, central nervous system involvement can lead to the often fatal dermato-neuro syndrome.3,4
Histologically, papular mucinosis/scleromyxedema demonstrates increased, irregularly arranged fibroblasts in the reticular dermis with increased dermal mucin deposition (quiz image and Figure 1). The epidermis is normal or slightly thinned due to pressure from dermal changes. There may be a mild superficial perivascular lymphocytic infiltrate and atrophy of hair follicles.5 In this case, the clinical and histologic findings best supported a diagnosis of papular mucinosis/scleromyxedema.
Infundibulofolliculitis is a pruritic follicular papular eruption typically involving the neck, trunk, and proximal upper arms and shoulders. It is most common in black men who reside in hot and humid climates. Although infundibulofolliculitis would be included in the clinical differential diagnosis for the current patient, the histopathologic findings were quite distinct for the correct diagnosis of papular mucinosis/scleromyxedema. Infundibulofolliculitis shows widening of the upper part of the hair follicle (infundibulum) and infundibular inflammatory infiltrate with follicular spongiosis (Figure 2). Neither mucin deposition nor fibroblast proliferation is appreciated in infundibulofolliculitis.6,7
Granuloma annulare (GA) often can be distinguished clinically from papular mucinosis/scleromyxedema due to the annular appearance of papules and plaques in GA and the lack of stiffness of underlying skin. Interstitial granuloma annulare is a histologic variant of GA that can be included in the histologic differential diagnosis of papular mucinosis/scleromyxedema. Histologically, there is an interstitial infiltrate of cytologically bland histiocytes dissecting between collagen bundles in interstitial GA (Figure 3). Necrobiosis and collections of mucin often are inconspicuous. Occasionally, the presence of eosinophils can be a helpful clue.8 A fibroblast proliferation is not a feature of GA.
Reticular erythematous mucinosis also is a type of cutaneous mucinosis but with a classic clinical appearance of a reticulated erythematous plaque on the chest or back, making it clinically distinct from papular mucinosis/scleromyxedema and the presentation described in the current patient. Reticular erythematous mucinosis can be histologically distinguished from papular mucinosis/scleromyxedema by the presence of a superficial and deep perivascular lymphocytic infiltrate with increased dermal mucin deposition (Figure 4). It often shows a positive IgM deposition on the basement membrane on direct immunofluorescence.9
Similar to papular mucinosis/scleromyxedema, scleredema shows thickening of the skin with decreased movement of involved areas. Scleredema often involves the upper back, shoulders, and neck where affected areas often have a peau d'orange appearance. Scleredema is classified into 3 clinical forms based on clinical associations. Type 1 often is preceded by an infection, classically Streptococcus pyogenes. Type 2 is associated with a hematologic dyscrasia such as multiple myeloma, or it can have an associated paraproteinemia that is typically of the IgA κ type, which is distinct from papular mucinosis/scleromyxedema where IgG λ paraproteinemia typically is seen. Type 3 is associated with diabetes mellitus. Histologically, scleredema also is distinct from papular mucinosis/scleromyxedema. Although increased mucin is seen in the dermis, the mucin is classically more prominent in the deep reticular dermis as compared with papular mucinosis/scleromyxedema (Figure 5). Additionally, collagen bundles are thickened with clear separation between them. Hyperplasia of fibroblasts in the dermis that is a characteristic feature of papular mucinosis/scleromyxedema is not observed in scleredema.10
- Georgakis CD, Falasca G, Georgakis A, et al. Scleromyxedema. Clin Dermatol. 2006;24:493-497.
- Rongioletti F, Merlo G, Cinotti E, et al. Scleromyxedema: a multicenter study of characteristics, comorbidities, course, and therapy in 30 patients. J Am Acad Dermatol. 2013;69:66-72.
- Fleming KE, Virmani D, Sutton E, et al. Scleromyxedema and the dermato-neuro syndrome: case report and review of the literature. J Cutan Pathol. 2012;39:508-517.
- Hummers LK. Scleromyxedema. Curr Opin Rheumatol. 2014;26:658-662.
- Rongioleti F, Rebora A. Updated classification of papular mucinosis, lichen myxedematosus, and scleromyxedema. J Am Acad Dermatol. 2001;44:273-281.
- Owen WR, Wood C. Disseminate and recurrent infundibulofolliculitis. Arch Dermatol. 1979;5:174-175.
- Soyinka F. Recurrent disseminated infundibulofolliculitis. Int J Dermatol. 1973;12:314-317.
- Keimig EL. Granuloma annulare. Dermatol Clin. 2015;33:315-329.
- Thareja S, Paghdal K, Lein MH, et al. Reticular erythematous mucinosis--a review. Int J Dermatol. 2012;51:903-909.
- Beers WH, Ince AI, Moore TL. Scleredema adultorum of Buschke: a case report and review of the literature. Semin Arthritis Rheum. 2006;35:355-359.
Papular Mucinosis/Scleromyxedema
Papular mucinosis/scleromyxedema, also known as generalized lichen myxedematosus, is a rare dermal mucinosis characterized by a papular eruption that can have an associated IgG λ paraproteinemia. The clinical presentation is gradual with the development of firm, flesh-colored, 2- to 3-mm papules often involving the hands, face, and neck that can progress to plaques that cover the entire body. Skin stiffening also can be seen.1 Extracutaneous symptoms are common and include dysphagia, arthralgia, myopathy, and cardiac dysfunction.2 Occasionally, central nervous system involvement can lead to the often fatal dermato-neuro syndrome.3,4
Histologically, papular mucinosis/scleromyxedema demonstrates increased, irregularly arranged fibroblasts in the reticular dermis with increased dermal mucin deposition (quiz image and Figure 1). The epidermis is normal or slightly thinned due to pressure from dermal changes. There may be a mild superficial perivascular lymphocytic infiltrate and atrophy of hair follicles.5 In this case, the clinical and histologic findings best supported a diagnosis of papular mucinosis/scleromyxedema.
Infundibulofolliculitis is a pruritic follicular papular eruption typically involving the neck, trunk, and proximal upper arms and shoulders. It is most common in black men who reside in hot and humid climates. Although infundibulofolliculitis would be included in the clinical differential diagnosis for the current patient, the histopathologic findings were quite distinct for the correct diagnosis of papular mucinosis/scleromyxedema. Infundibulofolliculitis shows widening of the upper part of the hair follicle (infundibulum) and infundibular inflammatory infiltrate with follicular spongiosis (Figure 2). Neither mucin deposition nor fibroblast proliferation is appreciated in infundibulofolliculitis.6,7
Granuloma annulare (GA) often can be distinguished clinically from papular mucinosis/scleromyxedema due to the annular appearance of papules and plaques in GA and the lack of stiffness of underlying skin. Interstitial granuloma annulare is a histologic variant of GA that can be included in the histologic differential diagnosis of papular mucinosis/scleromyxedema. Histologically, there is an interstitial infiltrate of cytologically bland histiocytes dissecting between collagen bundles in interstitial GA (Figure 3). Necrobiosis and collections of mucin often are inconspicuous. Occasionally, the presence of eosinophils can be a helpful clue.8 A fibroblast proliferation is not a feature of GA.
Reticular erythematous mucinosis also is a type of cutaneous mucinosis but with a classic clinical appearance of a reticulated erythematous plaque on the chest or back, making it clinically distinct from papular mucinosis/scleromyxedema and the presentation described in the current patient. Reticular erythematous mucinosis can be histologically distinguished from papular mucinosis/scleromyxedema by the presence of a superficial and deep perivascular lymphocytic infiltrate with increased dermal mucin deposition (Figure 4). It often shows a positive IgM deposition on the basement membrane on direct immunofluorescence.9
Similar to papular mucinosis/scleromyxedema, scleredema shows thickening of the skin with decreased movement of involved areas. Scleredema often involves the upper back, shoulders, and neck where affected areas often have a peau d'orange appearance. Scleredema is classified into 3 clinical forms based on clinical associations. Type 1 often is preceded by an infection, classically Streptococcus pyogenes. Type 2 is associated with a hematologic dyscrasia such as multiple myeloma, or it can have an associated paraproteinemia that is typically of the IgA κ type, which is distinct from papular mucinosis/scleromyxedema where IgG λ paraproteinemia typically is seen. Type 3 is associated with diabetes mellitus. Histologically, scleredema also is distinct from papular mucinosis/scleromyxedema. Although increased mucin is seen in the dermis, the mucin is classically more prominent in the deep reticular dermis as compared with papular mucinosis/scleromyxedema (Figure 5). Additionally, collagen bundles are thickened with clear separation between them. Hyperplasia of fibroblasts in the dermis that is a characteristic feature of papular mucinosis/scleromyxedema is not observed in scleredema.10
Papular Mucinosis/Scleromyxedema
Papular mucinosis/scleromyxedema, also known as generalized lichen myxedematosus, is a rare dermal mucinosis characterized by a papular eruption that can have an associated IgG λ paraproteinemia. The clinical presentation is gradual with the development of firm, flesh-colored, 2- to 3-mm papules often involving the hands, face, and neck that can progress to plaques that cover the entire body. Skin stiffening also can be seen.1 Extracutaneous symptoms are common and include dysphagia, arthralgia, myopathy, and cardiac dysfunction.2 Occasionally, central nervous system involvement can lead to the often fatal dermato-neuro syndrome.3,4
Histologically, papular mucinosis/scleromyxedema demonstrates increased, irregularly arranged fibroblasts in the reticular dermis with increased dermal mucin deposition (quiz image and Figure 1). The epidermis is normal or slightly thinned due to pressure from dermal changes. There may be a mild superficial perivascular lymphocytic infiltrate and atrophy of hair follicles.5 In this case, the clinical and histologic findings best supported a diagnosis of papular mucinosis/scleromyxedema.
Infundibulofolliculitis is a pruritic follicular papular eruption typically involving the neck, trunk, and proximal upper arms and shoulders. It is most common in black men who reside in hot and humid climates. Although infundibulofolliculitis would be included in the clinical differential diagnosis for the current patient, the histopathologic findings were quite distinct for the correct diagnosis of papular mucinosis/scleromyxedema. Infundibulofolliculitis shows widening of the upper part of the hair follicle (infundibulum) and infundibular inflammatory infiltrate with follicular spongiosis (Figure 2). Neither mucin deposition nor fibroblast proliferation is appreciated in infundibulofolliculitis.6,7
Granuloma annulare (GA) often can be distinguished clinically from papular mucinosis/scleromyxedema due to the annular appearance of papules and plaques in GA and the lack of stiffness of underlying skin. Interstitial granuloma annulare is a histologic variant of GA that can be included in the histologic differential diagnosis of papular mucinosis/scleromyxedema. Histologically, there is an interstitial infiltrate of cytologically bland histiocytes dissecting between collagen bundles in interstitial GA (Figure 3). Necrobiosis and collections of mucin often are inconspicuous. Occasionally, the presence of eosinophils can be a helpful clue.8 A fibroblast proliferation is not a feature of GA.
Reticular erythematous mucinosis also is a type of cutaneous mucinosis but with a classic clinical appearance of a reticulated erythematous plaque on the chest or back, making it clinically distinct from papular mucinosis/scleromyxedema and the presentation described in the current patient. Reticular erythematous mucinosis can be histologically distinguished from papular mucinosis/scleromyxedema by the presence of a superficial and deep perivascular lymphocytic infiltrate with increased dermal mucin deposition (Figure 4). It often shows a positive IgM deposition on the basement membrane on direct immunofluorescence.9
Similar to papular mucinosis/scleromyxedema, scleredema shows thickening of the skin with decreased movement of involved areas. Scleredema often involves the upper back, shoulders, and neck where affected areas often have a peau d'orange appearance. Scleredema is classified into 3 clinical forms based on clinical associations. Type 1 often is preceded by an infection, classically Streptococcus pyogenes. Type 2 is associated with a hematologic dyscrasia such as multiple myeloma, or it can have an associated paraproteinemia that is typically of the IgA κ type, which is distinct from papular mucinosis/scleromyxedema where IgG λ paraproteinemia typically is seen. Type 3 is associated with diabetes mellitus. Histologically, scleredema also is distinct from papular mucinosis/scleromyxedema. Although increased mucin is seen in the dermis, the mucin is classically more prominent in the deep reticular dermis as compared with papular mucinosis/scleromyxedema (Figure 5). Additionally, collagen bundles are thickened with clear separation between them. Hyperplasia of fibroblasts in the dermis that is a characteristic feature of papular mucinosis/scleromyxedema is not observed in scleredema.10
- Georgakis CD, Falasca G, Georgakis A, et al. Scleromyxedema. Clin Dermatol. 2006;24:493-497.
- Rongioletti F, Merlo G, Cinotti E, et al. Scleromyxedema: a multicenter study of characteristics, comorbidities, course, and therapy in 30 patients. J Am Acad Dermatol. 2013;69:66-72.
- Fleming KE, Virmani D, Sutton E, et al. Scleromyxedema and the dermato-neuro syndrome: case report and review of the literature. J Cutan Pathol. 2012;39:508-517.
- Hummers LK. Scleromyxedema. Curr Opin Rheumatol. 2014;26:658-662.
- Rongioleti F, Rebora A. Updated classification of papular mucinosis, lichen myxedematosus, and scleromyxedema. J Am Acad Dermatol. 2001;44:273-281.
- Owen WR, Wood C. Disseminate and recurrent infundibulofolliculitis. Arch Dermatol. 1979;5:174-175.
- Soyinka F. Recurrent disseminated infundibulofolliculitis. Int J Dermatol. 1973;12:314-317.
- Keimig EL. Granuloma annulare. Dermatol Clin. 2015;33:315-329.
- Thareja S, Paghdal K, Lein MH, et al. Reticular erythematous mucinosis--a review. Int J Dermatol. 2012;51:903-909.
- Beers WH, Ince AI, Moore TL. Scleredema adultorum of Buschke: a case report and review of the literature. Semin Arthritis Rheum. 2006;35:355-359.
- Georgakis CD, Falasca G, Georgakis A, et al. Scleromyxedema. Clin Dermatol. 2006;24:493-497.
- Rongioletti F, Merlo G, Cinotti E, et al. Scleromyxedema: a multicenter study of characteristics, comorbidities, course, and therapy in 30 patients. J Am Acad Dermatol. 2013;69:66-72.
- Fleming KE, Virmani D, Sutton E, et al. Scleromyxedema and the dermato-neuro syndrome: case report and review of the literature. J Cutan Pathol. 2012;39:508-517.
- Hummers LK. Scleromyxedema. Curr Opin Rheumatol. 2014;26:658-662.
- Rongioleti F, Rebora A. Updated classification of papular mucinosis, lichen myxedematosus, and scleromyxedema. J Am Acad Dermatol. 2001;44:273-281.
- Owen WR, Wood C. Disseminate and recurrent infundibulofolliculitis. Arch Dermatol. 1979;5:174-175.
- Soyinka F. Recurrent disseminated infundibulofolliculitis. Int J Dermatol. 1973;12:314-317.
- Keimig EL. Granuloma annulare. Dermatol Clin. 2015;33:315-329.
- Thareja S, Paghdal K, Lein MH, et al. Reticular erythematous mucinosis--a review. Int J Dermatol. 2012;51:903-909.
- Beers WH, Ince AI, Moore TL. Scleredema adultorum of Buschke: a case report and review of the literature. Semin Arthritis Rheum. 2006;35:355-359.
A 48-year-old black man presented with a rash of 7 months' duration that started on the face and spread to the body. He had extreme pruritus, increased stiffness in the hands and joints, and paresthesia. Physical examination revealed an eruption of 2- to 4-mm, flesh-colored papules with follicular accentuation on the face, neck, bilateral upper extremities, back, and thighs.
Parental online sharing involves balancing risks, benefits
SAN FRANCISCO – More than two-thirds of parents worry about their children’s privacy online and/or that photos of their children might be reshared on the wider Web, according to a survey conducted by C.S. Mott Children’s Hospital.
Those fears are not baseless, and they need to be considered more often by parents themselves in posting about their children online, presenters agreed at a symposium on the media at the annual meeting of the American Academy of Pediatrics.
“The first children of social media are just now entering adulthood, entering the job market,” said Stacey Steinberg, JD, a legal skills professor at the University of Florida Levin College of Law, Gainesville. She is also with the law school’s center on children and families.
She and Bahareh Keith, DO, a pediatrician at the University of Florida, discussed the challenges and risks of “sharenting” – parents’ sharing information and photos of their children online – and pediatricians’ role in advising parents and looking out for children’s best interests.
“The dearth of discussion on this topic leaves even the most well-intentioned parents without enough information to thoroughly analyze this,” Ms. Steinberg said. “We’re not sitting here saying we know what the answers are. But we’re saying this is an important issue that affects families, and these children require a voice in this discussion.”
The way social media and blogging have changed the landscape for children coming of age today means that they often have a digital footprint shaped by their parents long before they create their own first account. This reality means it’s necessary to consider how to balance children’s right to privacy with parents’ right to free speech and expression.
The 2015 C.S. Mott survey asked 569 parents of children aged 4 years and younger about how they use social media as parents, and reported that more than half of mothers (56%) and a third of fathers (34%) discuss parenting and child health topics on Facebook, Twitter, blogs, online forums, and other online platforms.
The risks of this sharenting can range from embarrassment of the child to significantly more sinister repercussions. Just over half of the parents (52%) in the Mott survey reported that they are concerned their child might feel embarrassed when they grow older and discover what their parents shared online. But that embarrassment also can lead to bullying or determent of psychosocial development, Ms. Steinberg and Dr. Keith explained.
More serious, if less common, risks include the possibility that data brokers could access and use information about the children or that online child pornographers could repurpose the photos inappropriately. One worst case scenario of the former is digital kidnapping, a disturbing practice in which a stranger uses baby photos and information that is not their own to pass off the child as their own or to invite others to “invent” identities for the child. The Children’s Online Privacy Protection Rule of the Federal Trade Commission addresses only online use by those under age 13 years, not others’ use of those images.
Regarding the latter, Ms. Steinberg and Dr. Keith showed an example of a bare-bottomed baby standing in front of a bathtub that had been reshared hundreds of times, but other images that have been shared on child pornography sites depict children in everyday situations such as playing on a playground, running at the beach, or doing gymnastics.
“These are images that many of us would think are innocent, but pornographers would categorize these into folders,” Dr. Keith said. “It’s not even naked or half-naked pictures.”
A study conducted by an e-safety commission in Australia, for example, found that half of the thousands of photos shared on a sample of child pornography sites had originated from parental sharing.
But Ms. Steinberg and Dr. Keith pointed out that benefits of parents’ online sharing exist as well, as the Mott survey found. In that survey, 72% of parents who discuss parenting and/or their children on social media reported that doing so helps them feel less alone. Similarly, 70% said they learn what not to do through those experiences, 67% said they receive advice from more experienced parents, and 62% said they consequently worry less. Common topics they discussed included sleep, nutrition, discipline, day care, and behavior management.
Other benefits, Ms. Steinberg pointed out, are that families geographically spread apart can stay connected, and communities can grow stronger with shared communal experiences of parents meeting others online.
“For some parents, it gives them an opportunity for advocacy work and raises awareness for important social issues,” Ms. Steinberg said, although she added, “If you’re going to share your children’s behavioral problems, consider sharing anonymously.”
Neither Ms. Steinberg and Dr. Keith said they had simple solutions to these challenges. Rather, they recommended using the public health model of raising awareness and encouraging open dialogue among pediatricians, parents, and their children to look for ways to balance competing interests.
“Social media offers many positive benefits, and we don’t want to silence the many voices of parents who take part in online sharing,” Ms. Steinberg explained. But she and Ms. Keith said it’s also worth considering children’s potential interest in controlling what their digital footprint is as they become adults.
For example, one study they cited found that, among 249 pairs of parents and their children, three times more children than parents wanted the parents to have and follow rules regarding what they could share on social media about their children.
Although guidance for parents on monitoring children’s social media use is a part of the AAP policy statement on media, only one recommendation obliquely addresses how parents should or shouldn’t use social media by advising them to model appropriate use for their children.
“It’s just like any medical decision: What is the benefit, and what is the risk, and does the benefit outweigh the risk?” said Wendy Sue Swanson, MD, executive director of digital health at Seattle Children’s Hospital. She recommended that parents ask their child for permission before posting a story or photo if their kids are aged 6 or older.
Ms. Steinberg and Dr. Keith recommended that pediatricians broach this subject with parents to help them think about risks they simply might not have considered before.
“When we looked at what sorts of best practices could be encouraged or doctors could talk to parents about – the tangible harms, such as whether data brokers or people interested in child pornography could access the information – we didn’t want to create any unnecessary panic,” Ms. Steinberg said. “But we did find some concerns that were troublesome, and we thought that parents or at least physicians [should] be aware of those potential risks.”
Ms. Steinberg and Dr. Keith reported that they had no relevant financial disclosures.
SAN FRANCISCO – More than two-thirds of parents worry about their children’s privacy online and/or that photos of their children might be reshared on the wider Web, according to a survey conducted by C.S. Mott Children’s Hospital.
Those fears are not baseless, and they need to be considered more often by parents themselves in posting about their children online, presenters agreed at a symposium on the media at the annual meeting of the American Academy of Pediatrics.
“The first children of social media are just now entering adulthood, entering the job market,” said Stacey Steinberg, JD, a legal skills professor at the University of Florida Levin College of Law, Gainesville. She is also with the law school’s center on children and families.
She and Bahareh Keith, DO, a pediatrician at the University of Florida, discussed the challenges and risks of “sharenting” – parents’ sharing information and photos of their children online – and pediatricians’ role in advising parents and looking out for children’s best interests.
“The dearth of discussion on this topic leaves even the most well-intentioned parents without enough information to thoroughly analyze this,” Ms. Steinberg said. “We’re not sitting here saying we know what the answers are. But we’re saying this is an important issue that affects families, and these children require a voice in this discussion.”
The way social media and blogging have changed the landscape for children coming of age today means that they often have a digital footprint shaped by their parents long before they create their own first account. This reality means it’s necessary to consider how to balance children’s right to privacy with parents’ right to free speech and expression.
The 2015 C.S. Mott survey asked 569 parents of children aged 4 years and younger about how they use social media as parents, and reported that more than half of mothers (56%) and a third of fathers (34%) discuss parenting and child health topics on Facebook, Twitter, blogs, online forums, and other online platforms.
The risks of this sharenting can range from embarrassment of the child to significantly more sinister repercussions. Just over half of the parents (52%) in the Mott survey reported that they are concerned their child might feel embarrassed when they grow older and discover what their parents shared online. But that embarrassment also can lead to bullying or determent of psychosocial development, Ms. Steinberg and Dr. Keith explained.
More serious, if less common, risks include the possibility that data brokers could access and use information about the children or that online child pornographers could repurpose the photos inappropriately. One worst case scenario of the former is digital kidnapping, a disturbing practice in which a stranger uses baby photos and information that is not their own to pass off the child as their own or to invite others to “invent” identities for the child. The Children’s Online Privacy Protection Rule of the Federal Trade Commission addresses only online use by those under age 13 years, not others’ use of those images.
Regarding the latter, Ms. Steinberg and Dr. Keith showed an example of a bare-bottomed baby standing in front of a bathtub that had been reshared hundreds of times, but other images that have been shared on child pornography sites depict children in everyday situations such as playing on a playground, running at the beach, or doing gymnastics.
“These are images that many of us would think are innocent, but pornographers would categorize these into folders,” Dr. Keith said. “It’s not even naked or half-naked pictures.”
A study conducted by an e-safety commission in Australia, for example, found that half of the thousands of photos shared on a sample of child pornography sites had originated from parental sharing.
But Ms. Steinberg and Dr. Keith pointed out that benefits of parents’ online sharing exist as well, as the Mott survey found. In that survey, 72% of parents who discuss parenting and/or their children on social media reported that doing so helps them feel less alone. Similarly, 70% said they learn what not to do through those experiences, 67% said they receive advice from more experienced parents, and 62% said they consequently worry less. Common topics they discussed included sleep, nutrition, discipline, day care, and behavior management.
Other benefits, Ms. Steinberg pointed out, are that families geographically spread apart can stay connected, and communities can grow stronger with shared communal experiences of parents meeting others online.
“For some parents, it gives them an opportunity for advocacy work and raises awareness for important social issues,” Ms. Steinberg said, although she added, “If you’re going to share your children’s behavioral problems, consider sharing anonymously.”
Neither Ms. Steinberg and Dr. Keith said they had simple solutions to these challenges. Rather, they recommended using the public health model of raising awareness and encouraging open dialogue among pediatricians, parents, and their children to look for ways to balance competing interests.
“Social media offers many positive benefits, and we don’t want to silence the many voices of parents who take part in online sharing,” Ms. Steinberg explained. But she and Ms. Keith said it’s also worth considering children’s potential interest in controlling what their digital footprint is as they become adults.
For example, one study they cited found that, among 249 pairs of parents and their children, three times more children than parents wanted the parents to have and follow rules regarding what they could share on social media about their children.
Although guidance for parents on monitoring children’s social media use is a part of the AAP policy statement on media, only one recommendation obliquely addresses how parents should or shouldn’t use social media by advising them to model appropriate use for their children.
“It’s just like any medical decision: What is the benefit, and what is the risk, and does the benefit outweigh the risk?” said Wendy Sue Swanson, MD, executive director of digital health at Seattle Children’s Hospital. She recommended that parents ask their child for permission before posting a story or photo if their kids are aged 6 or older.
Ms. Steinberg and Dr. Keith recommended that pediatricians broach this subject with parents to help them think about risks they simply might not have considered before.
“When we looked at what sorts of best practices could be encouraged or doctors could talk to parents about – the tangible harms, such as whether data brokers or people interested in child pornography could access the information – we didn’t want to create any unnecessary panic,” Ms. Steinberg said. “But we did find some concerns that were troublesome, and we thought that parents or at least physicians [should] be aware of those potential risks.”
Ms. Steinberg and Dr. Keith reported that they had no relevant financial disclosures.
SAN FRANCISCO – More than two-thirds of parents worry about their children’s privacy online and/or that photos of their children might be reshared on the wider Web, according to a survey conducted by C.S. Mott Children’s Hospital.
Those fears are not baseless, and they need to be considered more often by parents themselves in posting about their children online, presenters agreed at a symposium on the media at the annual meeting of the American Academy of Pediatrics.
“The first children of social media are just now entering adulthood, entering the job market,” said Stacey Steinberg, JD, a legal skills professor at the University of Florida Levin College of Law, Gainesville. She is also with the law school’s center on children and families.
She and Bahareh Keith, DO, a pediatrician at the University of Florida, discussed the challenges and risks of “sharenting” – parents’ sharing information and photos of their children online – and pediatricians’ role in advising parents and looking out for children’s best interests.
“The dearth of discussion on this topic leaves even the most well-intentioned parents without enough information to thoroughly analyze this,” Ms. Steinberg said. “We’re not sitting here saying we know what the answers are. But we’re saying this is an important issue that affects families, and these children require a voice in this discussion.”
The way social media and blogging have changed the landscape for children coming of age today means that they often have a digital footprint shaped by their parents long before they create their own first account. This reality means it’s necessary to consider how to balance children’s right to privacy with parents’ right to free speech and expression.
The 2015 C.S. Mott survey asked 569 parents of children aged 4 years and younger about how they use social media as parents, and reported that more than half of mothers (56%) and a third of fathers (34%) discuss parenting and child health topics on Facebook, Twitter, blogs, online forums, and other online platforms.
The risks of this sharenting can range from embarrassment of the child to significantly more sinister repercussions. Just over half of the parents (52%) in the Mott survey reported that they are concerned their child might feel embarrassed when they grow older and discover what their parents shared online. But that embarrassment also can lead to bullying or determent of psychosocial development, Ms. Steinberg and Dr. Keith explained.
More serious, if less common, risks include the possibility that data brokers could access and use information about the children or that online child pornographers could repurpose the photos inappropriately. One worst case scenario of the former is digital kidnapping, a disturbing practice in which a stranger uses baby photos and information that is not their own to pass off the child as their own or to invite others to “invent” identities for the child. The Children’s Online Privacy Protection Rule of the Federal Trade Commission addresses only online use by those under age 13 years, not others’ use of those images.
Regarding the latter, Ms. Steinberg and Dr. Keith showed an example of a bare-bottomed baby standing in front of a bathtub that had been reshared hundreds of times, but other images that have been shared on child pornography sites depict children in everyday situations such as playing on a playground, running at the beach, or doing gymnastics.
“These are images that many of us would think are innocent, but pornographers would categorize these into folders,” Dr. Keith said. “It’s not even naked or half-naked pictures.”
A study conducted by an e-safety commission in Australia, for example, found that half of the thousands of photos shared on a sample of child pornography sites had originated from parental sharing.
But Ms. Steinberg and Dr. Keith pointed out that benefits of parents’ online sharing exist as well, as the Mott survey found. In that survey, 72% of parents who discuss parenting and/or their children on social media reported that doing so helps them feel less alone. Similarly, 70% said they learn what not to do through those experiences, 67% said they receive advice from more experienced parents, and 62% said they consequently worry less. Common topics they discussed included sleep, nutrition, discipline, day care, and behavior management.
Other benefits, Ms. Steinberg pointed out, are that families geographically spread apart can stay connected, and communities can grow stronger with shared communal experiences of parents meeting others online.
“For some parents, it gives them an opportunity for advocacy work and raises awareness for important social issues,” Ms. Steinberg said, although she added, “If you’re going to share your children’s behavioral problems, consider sharing anonymously.”
Neither Ms. Steinberg and Dr. Keith said they had simple solutions to these challenges. Rather, they recommended using the public health model of raising awareness and encouraging open dialogue among pediatricians, parents, and their children to look for ways to balance competing interests.
“Social media offers many positive benefits, and we don’t want to silence the many voices of parents who take part in online sharing,” Ms. Steinberg explained. But she and Ms. Keith said it’s also worth considering children’s potential interest in controlling what their digital footprint is as they become adults.
For example, one study they cited found that, among 249 pairs of parents and their children, three times more children than parents wanted the parents to have and follow rules regarding what they could share on social media about their children.
Although guidance for parents on monitoring children’s social media use is a part of the AAP policy statement on media, only one recommendation obliquely addresses how parents should or shouldn’t use social media by advising them to model appropriate use for their children.
“It’s just like any medical decision: What is the benefit, and what is the risk, and does the benefit outweigh the risk?” said Wendy Sue Swanson, MD, executive director of digital health at Seattle Children’s Hospital. She recommended that parents ask their child for permission before posting a story or photo if their kids are aged 6 or older.
Ms. Steinberg and Dr. Keith recommended that pediatricians broach this subject with parents to help them think about risks they simply might not have considered before.
“When we looked at what sorts of best practices could be encouraged or doctors could talk to parents about – the tangible harms, such as whether data brokers or people interested in child pornography could access the information – we didn’t want to create any unnecessary panic,” Ms. Steinberg said. “But we did find some concerns that were troublesome, and we thought that parents or at least physicians [should] be aware of those potential risks.”
Ms. Steinberg and Dr. Keith reported that they had no relevant financial disclosures.
AT AAP 2016
SABCS 2016: Top picks from Dr. Hope S. Rugo and Dr. William J. Gradishar
Oncology Practice associate editors Dr. Hope S. Rugo and Dr. William J. Gradishar reveal several anticipated studies from the 39th annual San Antonio Breast Cancer Symposium, set to begin on Wednesday, Dec. 7:
• S1-02. PrECOG 0102. A randomized, double-blind, phase II trial of fulvestrant plus everolimus or placebo in postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer resistant to aromatase inhibitor therapy
• S1-03. First results from the multicenter phase III DATA study comparing 3 vs. 6 years of anastrozole after 2-3 years of tamoxifen in postmenopausal women with HR–positive early breast cancer.
• S1-04. Optimal duration of extended letrozole treatment after 5 years of adjuvant endocrine therapy; results of the randomized phase III IDEAL trial (BOOG 2006-05).
• S1-05. A randomized, double-blind, placebo-controlled clinical trial to evaluate extended adjuvant endocrine therapy (5 years of letrozole) in postmenopausal women with HR–positive breast cancer who have completed previous adjuvant endocrine therapy: initial results of NRG oncology/NSABP B-42.
• S1-08. Prognostic associations of tumor-infiltrating lymphocytes in metastatic HER2-positive breast cancer treated with trastuzumab and pertuzumab: a secondary analysis of the CLEOPATRA study.
• S2-03. Does BRCA status affect outcome in young breast cancer patients? Results from the Prospective Study of Outcomes in Sporadic versus Hereditary Breast Cancer (POSH).
• S2-05. Efficacy and tolerability of veliparib (ABT-888) in combination with carboplatin (C) and paclitaxel (P) vs. placebo (Plc)+C/P in patients with BRCA1 or BRCA2 mutations and metastatic breast cancer: a randomized, phase II study.
• S2-06. DNA repair deficiency biomarkers and MammaPrint High1/(ultra)High2 risk as predictors of veliparib/carboplatin response: results from the neoadjuvant I-SPY 2 trial for high-risk breast cancer.
• S3-02. Plasma microRNA levels for predicting therapeutic response to neoadjuvant treatment in HER2-positive breast cancer: results from Neo-ALTTO.
• S3-04. Primary analysis of PERTAIN: a randomized, two-arm, open-label, multicenter phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first-line patients with HER2-positive and HR–positive metastatic or locally advanced breast cancer.
• S4-06. Biologic effects of abemaciclib in a phase II neoadjuvant study for postmenopausal patients with HR–positive, HER2-negative breast cancer.
• S4-07. BELLE-3: a phase III study of buparlisib + fulvestrant in postmenopausal women with HR-positive, HER2-negative, aromatase inhibitor–treated locally advanced or metastatic breast cancer, who progressed on or after mTOR inhibitor–based treatment.
• S5-02. Scalp Cooling Alopecia Prevention (SCALP) trial for patients with early-stage breast cancer.
Dr. Rugo is professor of medicine, University of California, San Francisco, and director, breast oncology and clinical trials education, UCSF Helen Diller Family Comprehensive Cancer Center. Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology, professor of medicine, and deputy chief in the division of hematology/oncology, Feinberg School of Medicine, Chicago; and deputy director for the Clinical Network and director of the Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center Network of Northwestern University, Chicago.
Oncology Practice associate editors Dr. Hope S. Rugo and Dr. William J. Gradishar reveal several anticipated studies from the 39th annual San Antonio Breast Cancer Symposium, set to begin on Wednesday, Dec. 7:
• S1-02. PrECOG 0102. A randomized, double-blind, phase II trial of fulvestrant plus everolimus or placebo in postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer resistant to aromatase inhibitor therapy
• S1-03. First results from the multicenter phase III DATA study comparing 3 vs. 6 years of anastrozole after 2-3 years of tamoxifen in postmenopausal women with HR–positive early breast cancer.
• S1-04. Optimal duration of extended letrozole treatment after 5 years of adjuvant endocrine therapy; results of the randomized phase III IDEAL trial (BOOG 2006-05).
• S1-05. A randomized, double-blind, placebo-controlled clinical trial to evaluate extended adjuvant endocrine therapy (5 years of letrozole) in postmenopausal women with HR–positive breast cancer who have completed previous adjuvant endocrine therapy: initial results of NRG oncology/NSABP B-42.
• S1-08. Prognostic associations of tumor-infiltrating lymphocytes in metastatic HER2-positive breast cancer treated with trastuzumab and pertuzumab: a secondary analysis of the CLEOPATRA study.
• S2-03. Does BRCA status affect outcome in young breast cancer patients? Results from the Prospective Study of Outcomes in Sporadic versus Hereditary Breast Cancer (POSH).
• S2-05. Efficacy and tolerability of veliparib (ABT-888) in combination with carboplatin (C) and paclitaxel (P) vs. placebo (Plc)+C/P in patients with BRCA1 or BRCA2 mutations and metastatic breast cancer: a randomized, phase II study.
• S2-06. DNA repair deficiency biomarkers and MammaPrint High1/(ultra)High2 risk as predictors of veliparib/carboplatin response: results from the neoadjuvant I-SPY 2 trial for high-risk breast cancer.
• S3-02. Plasma microRNA levels for predicting therapeutic response to neoadjuvant treatment in HER2-positive breast cancer: results from Neo-ALTTO.
• S3-04. Primary analysis of PERTAIN: a randomized, two-arm, open-label, multicenter phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first-line patients with HER2-positive and HR–positive metastatic or locally advanced breast cancer.
• S4-06. Biologic effects of abemaciclib in a phase II neoadjuvant study for postmenopausal patients with HR–positive, HER2-negative breast cancer.
• S4-07. BELLE-3: a phase III study of buparlisib + fulvestrant in postmenopausal women with HR-positive, HER2-negative, aromatase inhibitor–treated locally advanced or metastatic breast cancer, who progressed on or after mTOR inhibitor–based treatment.
• S5-02. Scalp Cooling Alopecia Prevention (SCALP) trial for patients with early-stage breast cancer.
Dr. Rugo is professor of medicine, University of California, San Francisco, and director, breast oncology and clinical trials education, UCSF Helen Diller Family Comprehensive Cancer Center. Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology, professor of medicine, and deputy chief in the division of hematology/oncology, Feinberg School of Medicine, Chicago; and deputy director for the Clinical Network and director of the Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center Network of Northwestern University, Chicago.
Oncology Practice associate editors Dr. Hope S. Rugo and Dr. William J. Gradishar reveal several anticipated studies from the 39th annual San Antonio Breast Cancer Symposium, set to begin on Wednesday, Dec. 7:
• S1-02. PrECOG 0102. A randomized, double-blind, phase II trial of fulvestrant plus everolimus or placebo in postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer resistant to aromatase inhibitor therapy
• S1-03. First results from the multicenter phase III DATA study comparing 3 vs. 6 years of anastrozole after 2-3 years of tamoxifen in postmenopausal women with HR–positive early breast cancer.
• S1-04. Optimal duration of extended letrozole treatment after 5 years of adjuvant endocrine therapy; results of the randomized phase III IDEAL trial (BOOG 2006-05).
• S1-05. A randomized, double-blind, placebo-controlled clinical trial to evaluate extended adjuvant endocrine therapy (5 years of letrozole) in postmenopausal women with HR–positive breast cancer who have completed previous adjuvant endocrine therapy: initial results of NRG oncology/NSABP B-42.
• S1-08. Prognostic associations of tumor-infiltrating lymphocytes in metastatic HER2-positive breast cancer treated with trastuzumab and pertuzumab: a secondary analysis of the CLEOPATRA study.
• S2-03. Does BRCA status affect outcome in young breast cancer patients? Results from the Prospective Study of Outcomes in Sporadic versus Hereditary Breast Cancer (POSH).
• S2-05. Efficacy and tolerability of veliparib (ABT-888) in combination with carboplatin (C) and paclitaxel (P) vs. placebo (Plc)+C/P in patients with BRCA1 or BRCA2 mutations and metastatic breast cancer: a randomized, phase II study.
• S2-06. DNA repair deficiency biomarkers and MammaPrint High1/(ultra)High2 risk as predictors of veliparib/carboplatin response: results from the neoadjuvant I-SPY 2 trial for high-risk breast cancer.
• S3-02. Plasma microRNA levels for predicting therapeutic response to neoadjuvant treatment in HER2-positive breast cancer: results from Neo-ALTTO.
• S3-04. Primary analysis of PERTAIN: a randomized, two-arm, open-label, multicenter phase II trial assessing the efficacy and safety of pertuzumab given in combination with trastuzumab plus an aromatase inhibitor in first-line patients with HER2-positive and HR–positive metastatic or locally advanced breast cancer.
• S4-06. Biologic effects of abemaciclib in a phase II neoadjuvant study for postmenopausal patients with HR–positive, HER2-negative breast cancer.
• S4-07. BELLE-3: a phase III study of buparlisib + fulvestrant in postmenopausal women with HR-positive, HER2-negative, aromatase inhibitor–treated locally advanced or metastatic breast cancer, who progressed on or after mTOR inhibitor–based treatment.
• S5-02. Scalp Cooling Alopecia Prevention (SCALP) trial for patients with early-stage breast cancer.
Dr. Rugo is professor of medicine, University of California, San Francisco, and director, breast oncology and clinical trials education, UCSF Helen Diller Family Comprehensive Cancer Center. Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology, professor of medicine, and deputy chief in the division of hematology/oncology, Feinberg School of Medicine, Chicago; and deputy director for the Clinical Network and director of the Maggie Daley Center for Women’s Cancer Care, Robert H. Lurie Comprehensive Cancer Center Network of Northwestern University, Chicago.
FROM SABCS 2016
Clinical Challenges - December 2016
What is the most plausible diagnosis and what would be the next step?
The diagnosis
To clarify the diagnosis, endoscopic resection of the smaller lesion was performed and deeper biopsies of the other lesions were taken. Histology revealed lymphoid, centroblast, and centrocyte-like cell proliferation with follicular pattern (Figure D). Immunohistochemically, the follicles stained for bcl-6, CD20, and bcl-2 (Figure E), but not CD3, CD5, CD10, or cyclin D1.
Malignant lymphomas of the colon represent about 0.2% of all colonic neoplasms and most frequently are diffuse large B-cell, mucosa-associated lymphoid tissue, and mantle cell lymphomas.2 This phenotypic presentation, as multiple lymphomatous polyposis, has been reported in colon follicular lymphomas but is more typical of mantle cell lymphoma.3 Treatment usually consists of chemotherapy containing rituximab (anti-CD20) and should be decided on a case-by-case basis owing to possible relapse and the often indolent course.1
References
1. Damaj, G., Verkarre, V., Delmer, A. et al. Primary follicular lymphoma of the gastrointestinal tract: A study of 25 cases and a literature review. Ann Oncol. 2003;14:623-9.
2. Muller-Hermelink, H.K., Chott, A., Gascoyne, R.D. et al. B-cell lymphoma of the colon and rectum. In: S.R. Hamilton, L.A. Asltonen, eds. WHO Classification of Tumours. Lyon, France: IARC Press;2001:139-41.
3. Hiraide, T., Shoji, T., Higashi, Y. et al. Extranodal multiple polypoid follicular lymphoma of the sigmoid colon. Gastrointest Endosc. 2011;73(1):182-4.
The diagnosis
To clarify the diagnosis, endoscopic resection of the smaller lesion was performed and deeper biopsies of the other lesions were taken. Histology revealed lymphoid, centroblast, and centrocyte-like cell proliferation with follicular pattern (Figure D). Immunohistochemically, the follicles stained for bcl-6, CD20, and bcl-2 (Figure E), but not CD3, CD5, CD10, or cyclin D1.
Malignant lymphomas of the colon represent about 0.2% of all colonic neoplasms and most frequently are diffuse large B-cell, mucosa-associated lymphoid tissue, and mantle cell lymphomas.2 This phenotypic presentation, as multiple lymphomatous polyposis, has been reported in colon follicular lymphomas but is more typical of mantle cell lymphoma.3 Treatment usually consists of chemotherapy containing rituximab (anti-CD20) and should be decided on a case-by-case basis owing to possible relapse and the often indolent course.1
References
1. Damaj, G., Verkarre, V., Delmer, A. et al. Primary follicular lymphoma of the gastrointestinal tract: A study of 25 cases and a literature review. Ann Oncol. 2003;14:623-9.
2. Muller-Hermelink, H.K., Chott, A., Gascoyne, R.D. et al. B-cell lymphoma of the colon and rectum. In: S.R. Hamilton, L.A. Asltonen, eds. WHO Classification of Tumours. Lyon, France: IARC Press;2001:139-41.
3. Hiraide, T., Shoji, T., Higashi, Y. et al. Extranodal multiple polypoid follicular lymphoma of the sigmoid colon. Gastrointest Endosc. 2011;73(1):182-4.
The diagnosis
To clarify the diagnosis, endoscopic resection of the smaller lesion was performed and deeper biopsies of the other lesions were taken. Histology revealed lymphoid, centroblast, and centrocyte-like cell proliferation with follicular pattern (Figure D). Immunohistochemically, the follicles stained for bcl-6, CD20, and bcl-2 (Figure E), but not CD3, CD5, CD10, or cyclin D1.
Malignant lymphomas of the colon represent about 0.2% of all colonic neoplasms and most frequently are diffuse large B-cell, mucosa-associated lymphoid tissue, and mantle cell lymphomas.2 This phenotypic presentation, as multiple lymphomatous polyposis, has been reported in colon follicular lymphomas but is more typical of mantle cell lymphoma.3 Treatment usually consists of chemotherapy containing rituximab (anti-CD20) and should be decided on a case-by-case basis owing to possible relapse and the often indolent course.1
References
1. Damaj, G., Verkarre, V., Delmer, A. et al. Primary follicular lymphoma of the gastrointestinal tract: A study of 25 cases and a literature review. Ann Oncol. 2003;14:623-9.
2. Muller-Hermelink, H.K., Chott, A., Gascoyne, R.D. et al. B-cell lymphoma of the colon and rectum. In: S.R. Hamilton, L.A. Asltonen, eds. WHO Classification of Tumours. Lyon, France: IARC Press;2001:139-41.
3. Hiraide, T., Shoji, T., Higashi, Y. et al. Extranodal multiple polypoid follicular lymphoma of the sigmoid colon. Gastrointest Endosc. 2011;73(1):182-4.
What is the most plausible diagnosis and what would be the next step?
What is the most plausible diagnosis and what would be the next step?
What’s your diagnosis?
By Aníbal Ferreira, MD, PhD , Raquel Gonçalves, MD, and Carla Rolanda, MD. Published previously in Gastroenterology (2012 Dec;143[6]:1440, 1693-4).
An asymptomatic, 74-year-old woman with type 2 diabetes was referred for endoscopic colorectal cancer screening. Colonoscopy revealed a 30-mm, polypoid, firm lesion in the transverse colon (Figure A), a 20-mm similar lesion in the cecum (Figure B),
Can a Total Knee Arthroplasty Perioperative Surgical Home Close the Gap Between Primary and Revision TKA Outcomes?
Total knee arthroplasty (TKA) is an efficacious procedure for end-stage knee arthritis. Although TKA is cost-effective and has a high rate of success,1-6 TKAs fail and may require revision surgery. Failure mechanisms include periprosthetic fracture, aseptic loosening, wear, osteolysis, instability, and infection.7-9 In these cases, revision arthroplasty may be needed in order to restore function.
There has been a steady increase in the number of primary and revision TKAs performed in the United States.8,10,11 Revision rates are 4% at 5 years after index TKA and 8.9% at 9 years.12 However, surgical techniques and improved implants have led to improved outcomes after primary TKA, as evidenced by the reduction in revisions performed for polyethylene wear and osteolysis.13 Given the continuing need for revision TKAs (despite technical improvements13), evidence-based standard protocols that improve outcomes after revision TKA are necessary.
The Total Joint Replacement Perioperative Surgical Home (TJR-PSH) implemented and used by surgeons and anesthesiologists at our institution has shown that an evidence-based perioperative protocol can provide consistent and improved outcomes in primary TKA.14-16
Garson and colleagues14 and Chaurasia and colleagues15 found that patients who underwent primary TKA in a TJA-PSH had a predicted short length of stay (LOS): <3 days. About half were discharged to a location other than home, and 1.1% were readmitted within the first 30 days after surgery. There were no major complications and no mortalities. Conversely, as shown in different nationwide database analysis,17,18 mean LOS after primary unilateral TKA was 5.3 days, 8.2% of patients had procedure-related complications, 30-day readmission rate was 4.2%, and the in-hospital mortality rate was 0.3%. As with TJA-PSH, about half the patients were discharged to a place other than home.
We conducted a study to test the effect of the TJA-PSH clinical pathway on revision TKA patients. Early perioperative outcomes, such as LOS, readmission rate, and reoperation rate, are invaluable tools in measuring TKA outcomes and correlate with the dedicated orthopedic complication grading system proposed by the Knee Society.14,15,17,19 We hypothesized that the TJR-PSH clinical pathway would close the perioperative morbidity gap between primary and revision TKAs and yield equivalent perioperative outcomes.
Materials and Methods
In this study, which received Institutional Review Board approval, we performed a prospective cross-sectional analysis comparing the perioperative outcomes of patients who underwent primary TKA with those of patients who underwent revision TKA. Medical records and our institution’s data registry were queried for LOS, discharge disposition, readmission rates, and reoperation rates.
The study included all primary and revision TKAs performed at our institution since the inception of TJA-PSH. Unicompartmental knee arthroplasties and exchanges of a single component (patella, tibia, or femur) were excluded. We identified a total of 285 consecutive primary or revision TKAs, all performed by a single surgeon. Three cases lacked complete data and were excluded, leaving 282 cases: 235 primary and 50 revision TKAs (no simultaneous bilateral TKAs). The demographic data we collected included age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, calculated Charlson Comorbidity Index (CCI), LOS, and discharge disposition.
The same established perioperative surgical home clinical pathway was used to care for all patients, whether they underwent primary or revision TKA. The primary outcomes studied were LOS, discharge disposition (subacute nursing facility or home), 30-day orthopedic readmission, and return to operating room. All reoperations on the same knee were analyzed.
Statistical Analysis
Primary and revision TKAs were compared on LOS (with an independent-sample t test) and discharge disposition, 30-day readmissions, and reoperations (χ2 Fisher exact test). Multivariate regression analysis was performed with each primary outcome, using age, sex, BMI, ASA score, and CCI as covariates. Statistical significance was set at P ≤ .05. All analyses were performed with SPSS Version 16.0 (SPSS Inc.) and Microsoft Excel 2011 (Microsoft).
Results
Mean (SD) age was 66 (13.2) years for primary TKA patients and 62 (12.8) years for revision TKA patients. The cohort had more women (62.5%) than men (37.5%). There was no statistical difference in patient demographics with respect to age (P = .169) or BMI (P = .701) between the 2 groups. There was an even age distribution within each group and between the groups (Table).
There was no statistically significant difference in LOS between the groups. Mean (SD) LOS was 2.55 (1.25) days for primary TKA and 2.92 (1.24) days for revision TKA (P = .061; 95% confidence interval [CI], 0.017-0.749). Regression analysis showed a correlation between ASA score and LOS for primary TKAs but not revision TKAs. For every unit increase in ASA score, there was a 0.39-day increase in LOS for primary TKA (P = .46; 95% CI, 0.006-0.781). There was no correlation between ASA score and LOS for revision TKA when controlling for covariates (P = .124). Eighty (34%) of the 235 primary TKA patients and 21 (41%) of the 50 revision TKA patients were discharged to a subacute nursing facility; the difference was not significant (P = .123). No patient was discharged to an acute inpatient rehabilitation unit. In addition, there was no significant difference in 30-day readmission rates between primary and revision TKA (P = .081). One primary TKA patient (0.4%) and 2 revision TKA patients (4%) were readmitted within 30 days after surgery (P = .081). The primary TKA readmission was for severe spasticity and a history of cerebral palsy leading to a quadriceps avulsion fracture from the superior pole of the patella. One revision TKA readmission was for acute periprosthetic joint infection, and the other for periprosthetic fracture around a press-fit distal femoral replacement stem. There was no significant difference in number of 30-day reoperations between the groups (P = .993). None of the primary TKAs and 2 (4%) of the revision TKAs underwent reoperation. Of the revision TKA patients who returned to the operating room within 30 days after surgery, one was treated for an acute periprosthetic joint infection, the other for a femoral periprosthetic fracture.
Discussion
Advances in multidisciplinary co-management of TKA patients and their clinical effects are highlighted in the TJR-PSH.14 TJR-PSH allows the health team and the patient to prepare for surgery with an understanding of probable outcomes and to optimize the patient’s medical and educational standing to better meet expectations and increase satisfaction.
Previous studies have focused on the etiologies of revision TKA7,8 and on understanding the factors that may predict increased risk for a poor outcome after primary TKA and indicate a possible need for revision.8,12 The present study focused on practical clinical processes that could potentially constitute a standardized perioperative protocol for revision TKA. An organized TJR-PSH may allow the health team to educate patients that LOS, rehabilitation and acute recovery, risk of acute (30-day) complications, and risk of readmission and return to the operating room within the first 30 days after surgery are similar for revision and primary TKAs, as long as proper preoperative optimization and education occur within the TJR-PSH.
Studies have found correlations between revision TKA and significantly increased LOS and postoperative complications.20,21 In contrast, we found no significant difference in LOS between our primary and revision TKA groups. LOS was 2.6 days for primary TKA and 2.9 days for revision TKA—a significant improvement in care and cost for revision TKA patients. That the reduced mean LOS for revision TKA is similar to the mean LOS for primary TKA also implies a reduction in the higher cost of care in revision TKA.20 In addition to obtaining similar LOS for primary and revision TKA, TJR-PSH achieved an overall reduction in LOS.17,22Our results also showed no difference in discharge disposition between primary and revision TKA in our protocol. Discharge disposition also did not correlate with age, sex, BMI, ASA score, or CCI. In TJR-PSH, discharge planning starts before admission and is patient-oriented for optimal recovery. About 66% of primary TKA patients and 58% of revision TKA patients in our cohort were discharged home—implying we are able to send a majority of our postoperative patients home after a shorter hospital stay, while obtaining the same good outcomes. Discharging fewer revision TKA patients to extended-care facilities also indicates a possible reduction in the cost of postoperative care, bringing it in line with the cost in primary TKA. Early individualized discharge planning in TJA-PSH accounts for the similar outcomes in primary and revision TKAs.
There was no significant difference in 30-day readmission rates between our primary and revision TKA patients. An important component of the TJR-PSH pathway is the individualized postdischarge recovery plan, which helps with optimal recovery and reduces readmission rates. Our cohort’s 30-day readmission rate was 0.4% for primary TKA and 4% for revision TKA (P = .081). Thirty-day readmission is a good indicator of postoperative complications and recovery from surgery. We have previously reported on primary TKA outcomes.14,15,,18,22,23 In a study using an NSQIP (National Surgical Quality Improvement Program) database, 11,814 primary TKAs had a 30-day readmission rate of 4.2%.18 In an outcomes study of 17,994 patients who underwent primary TKA in a single fiscal year, the 30-day readmission rate was 5.9%.9 In addition, in a single-institution cohort study of 1032 primary TKA patients, Schairer and colleagues23 found a 30-day unplanned readmission rate of 3.4%. Compared with primary TKA, revision TKA traditionally has had a higher postoperative complication rate.20,21 There is also concern that shorter hospital stays may indicate that significant complications of revision TKAs are being missed. In this study, however, we established that the equal outcomes obtained in the perioperative period carry over to the 30-day postoperative period in our revision TKA group. Good postoperative follow-up and planning are important factors in readmission reduction. Readmissions also have significant overall cost implications.24There was no statistical difference in 30-day reoperation rates between our primary and revision TKA patients. The primary TKA patients had no 30-day reoperations. Previous studies have found reoperation rates ranging from 1.8% to 4.7%.25,26 Revision TKA patients are up to 6 times more likely than primary TKA patients to require reoperation.20 Our study found no significant difference in outcomes between primary and revision TKAs.
Comparison of the outcomes of primary TKA and revision TKA in TJR-PSH showed no difference in acute recovery from surgery. LOS and discharge disposition, 30-day readmission rate, and 30-day return to the operating room were the same for primary and revision TKAs. The morbidity gap between primary and revision TKA patients has been closed in our research cohort. This outcome is important, as indications for primary TKA continue to expand and more primary TKAs are performed in younger patients.18,23 The implication is that, in the future, more knees will need to be revised as patients outlive their prostheses.
Our study had some limitations. First, it involved a small sample of patients, operated on by a single surgeon in a well-organized TJR-PSH at a large academic center. This population might not represent the US patient population, but that should not have adversely affected data analysis, because patients were compared with a similar population. Second, the data might be incomplete because some patients with complications might have sought care at other medical facilities, and we might not have been aware of these cases. Third, we focused on objective clinical outcomes in order to measure the success of TKAs. We did not include any subjective, patient-reported data, such as rehabilitation advances and functioning levels. Fourth, multiple parameters can be used to address complication outcomes, but we used LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate because current payers and institutions often consider these variables when assessing quality of care. These parameters can be influenced by factors such as inpatient physical therapy goals, facility discharge practices, individual social support structure, and hospital pay-for-performance model. The implication is that different facilities have different outcomes in terms of LOS, discharge disposition, readmissions, and reoperations. However, we expect proportionate similarities in these parameters as patient perioperative outcomes become more complicated. Nevertheless, a multicenter study would be able to answer questions raised by this limitation. Fifth, our statistical analysis might have been affected by decreased power of some of the outcome variables.
TJR-PSH has succeeded in closing the perioperative morbidity and outcomes gap between primary and revision TKAs. Outcome parameters used to measure the success of TJR-PSH are standard measures of the immediate postoperative recovery and short-term outcomes of TKA patients. These measures are linked to complication rates and overall outcomes in many TKA studies.14,15,17,19 Also important is that hospital costs can be drastically cut by reducing LOS, readmissions, and reoperations. Presence of any complication of primary or revision TKA raises the cost up to 34%. This increase can go as high as 64% in the 90 days after surgery.27
Conclusion
The major challenge of the changing medical landscape is to integrate quality care and a continually improving healthcare system with the goal of cost-effective delivery of healthcare. Surgical care costs can be significantly increased by evitable hospital stays, complications that lead to readmissions, and unplanned returns to the operating room after index surgery. The new perioperative surgical home created for TJA has helped drastically reduce LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate in revision TKA. This study demonstrates similar outcomes in our revision TKA patients relative to their primary TKA counterparts.
Am J Orthop. 2016;45(7):E458-E464. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.
1. Berger RA, Rosenberg AG, Barden RM, Sheinkop MB, Jacobs JJ, Galante JO. Long-term followup of the Miller-Galante total knee replacement. Clin Orthop Relat Res. 2001;(388):58-67.
2. Rissanen P, Aro S, Slatis P, Sintonen H, Paavolainen P. Health and quality of life before and after hip or knee arthroplasty. J Arthroplasty. 1995;10(2):169-175.
3. March LM, Cross MJ, Lapsley H, et al. Outcomes after hip or knee replacement surgery for osteoarthritis. A prospective cohort study comparing patients’ quality of life before and after surgery with age-related population norms. Med J Aust. 1999;171(5):235-238.
4. Quintana JM, Arostegui I, Escobar A, Azkarate J, Goenaga JI, Lafuente I. Prevalence of knee and hip osteoarthritis and the appropriateness of joint replacement in an older population. Arch Intern Med. 2008;168(14):1576-1584.
5. Jones CA, Voaklander DC, Johnston DW, Suarez-Almazor ME. Health related quality of life outcomes after total hip and knee arthroplasties in a community based population. J Rheumatol. 2000;27(7):1745-1752.
6. Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004;86(5):963-974.
7. Mulhall KJ, Ghomrawi HM, Scully S, Callaghan JJ, Saleh KJ. Current etiologies and modes of failure in total knee arthroplasty revision. Clin Orthop Relat Res. 2006;(446):45-50.
8. Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;(404):7-13.
9. Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005;87(7):1487-1497.
10. Kurtz SM, Ong KL, Schmier J, Zhao K, Mowat F, Lau E. Primary and revision arthroplasty surgery caseloads in the United States from 1990 to 2004. J Arthroplasty. 2009;24(2):195-203.
11 Maloney WJ. National joint replacement registries: has the time come? J Bone Joint Surg Am. 2001;83(10):1582-1585.
12. Dy CJ, Marx RG, Bozic KJ, Pan TJ, Padgett DE, Lyman S. Risk factors for revision within 10 years of total knee arthroplasty. Clin Orthop Relat Res. 2014;472(4):1198-1207.
13. Dalury DF, Pomeroy DL, Gorab RS, Adams MJ. Why are total knee arthroplasties being revised? J Arthroplasty. 2013;28(8 suppl):120-121.
14. Garson L, Schwarzkopf R, Vakharia S, et al. Implementation of a total joint replacement-focused perioperative surgical home: a management case report. Anesth Analg. 2014;118(5):1081-1089.
15. Chaurasia A, Garson L, Kain ZL, Schwarzkopf R. Outcomes of a joint replacement surgical home model clinical pathway. Biomed Res Int. 2014;2014:296302.
16. Kain ZN, Vakharia S, Garson L, et al. The perioperative surgical home as a future perioperative practice model. Anesth Analg. 2014;118(5):1126-1130.
17. Memtsoudis SG, González Della Valle A, Besculides MC, Gaber L, Sculco TP. In-hospital complications and mortality of unilateral, bilateral, and revision TKA: based on an estimate of 4,159,661 discharges. Clin Orthop Relat Res. 2008;466(11):2617-2627.
18. Pugely AJ, Callaghan JJ, Martin CT, Cram P, Gao Y. Incidence of and risk factors for 30-day readmission following elective primary total joint arthroplasty: analysis from the ACS-NSQIP. J Arthroplasty. 2013;28(9):1499-1504.
19. Harris DY, McAngus JK, Kuo YF, Lindsey RW. Correlations between a dedicated orthopaedic complications grading system and early adverse outcomes in joint arthroplasty. Clin Orthop Relat Res. 2015;473(4):1524-1531.
20. Ong KL, Lau E, Suggs J, Kurtz SM, Manley MT. Risk of subsequent revision after primary and revision total joint arthroplasty. Clin Orthop Relat Res. 2010;468(11):3070-3076.
21. Bozic KJ, Katz P, Cisternas M, Ono L, Ries MD, Showstack J. Hospital resource utilization for primary and revision total hip arthroplasty. J Bone Joint Surg Am. 2005;87(3):570-576.
22. Singh JA, Kwoh CK, Richardson D, Chen W, Ibrahim SA. Sex and surgical outcomes and mortality after primary total knee arthroplasty: a risk-adjusted analysis. Arthritis Care Res. 2013;65(7):1095-1102.
23. Schairer WW, Vail TP, Bozic KJ. What are the rates and causes of hospital readmission after total knee arthroplasty? Clin Orthop Relat Res. 2014;472(1):181-187.
24. Bosco JA 3rd, Karkenny AJ, Hutzler LH, Slover JD, Iorio R Cost burden of 30-day readmissions following Medicare total hip and knee arthroplasty. J Arthroplasty. 2014;29(5):903-905.
25. Zmistowski B, Restrepo C, Kahl LK, Parvizi J, Sharkey PF. Incidence and reasons for nonrevision reoperation after total knee arthroplasty. Clin Orthop Relat Res 2011;469(1):138-145.26. Bottle A, Aylin P, Loeffler M. Return to theatre for elective hip and knee replacements: what is the relative importance of patient factors, surgeon and hospital? Bone Joint J Br. 2014;96(12):1663-1668.
27. Maradit Kremers H, Visscher SL, Moriarty JP, et al. Determinants of direct medical costs in primary and revision total knee arthroplasty. Clin Orthop Relat Res. 2013;471(1):206-214.
Total knee arthroplasty (TKA) is an efficacious procedure for end-stage knee arthritis. Although TKA is cost-effective and has a high rate of success,1-6 TKAs fail and may require revision surgery. Failure mechanisms include periprosthetic fracture, aseptic loosening, wear, osteolysis, instability, and infection.7-9 In these cases, revision arthroplasty may be needed in order to restore function.
There has been a steady increase in the number of primary and revision TKAs performed in the United States.8,10,11 Revision rates are 4% at 5 years after index TKA and 8.9% at 9 years.12 However, surgical techniques and improved implants have led to improved outcomes after primary TKA, as evidenced by the reduction in revisions performed for polyethylene wear and osteolysis.13 Given the continuing need for revision TKAs (despite technical improvements13), evidence-based standard protocols that improve outcomes after revision TKA are necessary.
The Total Joint Replacement Perioperative Surgical Home (TJR-PSH) implemented and used by surgeons and anesthesiologists at our institution has shown that an evidence-based perioperative protocol can provide consistent and improved outcomes in primary TKA.14-16
Garson and colleagues14 and Chaurasia and colleagues15 found that patients who underwent primary TKA in a TJA-PSH had a predicted short length of stay (LOS): <3 days. About half were discharged to a location other than home, and 1.1% were readmitted within the first 30 days after surgery. There were no major complications and no mortalities. Conversely, as shown in different nationwide database analysis,17,18 mean LOS after primary unilateral TKA was 5.3 days, 8.2% of patients had procedure-related complications, 30-day readmission rate was 4.2%, and the in-hospital mortality rate was 0.3%. As with TJA-PSH, about half the patients were discharged to a place other than home.
We conducted a study to test the effect of the TJA-PSH clinical pathway on revision TKA patients. Early perioperative outcomes, such as LOS, readmission rate, and reoperation rate, are invaluable tools in measuring TKA outcomes and correlate with the dedicated orthopedic complication grading system proposed by the Knee Society.14,15,17,19 We hypothesized that the TJR-PSH clinical pathway would close the perioperative morbidity gap between primary and revision TKAs and yield equivalent perioperative outcomes.
Materials and Methods
In this study, which received Institutional Review Board approval, we performed a prospective cross-sectional analysis comparing the perioperative outcomes of patients who underwent primary TKA with those of patients who underwent revision TKA. Medical records and our institution’s data registry were queried for LOS, discharge disposition, readmission rates, and reoperation rates.
The study included all primary and revision TKAs performed at our institution since the inception of TJA-PSH. Unicompartmental knee arthroplasties and exchanges of a single component (patella, tibia, or femur) were excluded. We identified a total of 285 consecutive primary or revision TKAs, all performed by a single surgeon. Three cases lacked complete data and were excluded, leaving 282 cases: 235 primary and 50 revision TKAs (no simultaneous bilateral TKAs). The demographic data we collected included age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, calculated Charlson Comorbidity Index (CCI), LOS, and discharge disposition.
The same established perioperative surgical home clinical pathway was used to care for all patients, whether they underwent primary or revision TKA. The primary outcomes studied were LOS, discharge disposition (subacute nursing facility or home), 30-day orthopedic readmission, and return to operating room. All reoperations on the same knee were analyzed.
Statistical Analysis
Primary and revision TKAs were compared on LOS (with an independent-sample t test) and discharge disposition, 30-day readmissions, and reoperations (χ2 Fisher exact test). Multivariate regression analysis was performed with each primary outcome, using age, sex, BMI, ASA score, and CCI as covariates. Statistical significance was set at P ≤ .05. All analyses were performed with SPSS Version 16.0 (SPSS Inc.) and Microsoft Excel 2011 (Microsoft).
Results
Mean (SD) age was 66 (13.2) years for primary TKA patients and 62 (12.8) years for revision TKA patients. The cohort had more women (62.5%) than men (37.5%). There was no statistical difference in patient demographics with respect to age (P = .169) or BMI (P = .701) between the 2 groups. There was an even age distribution within each group and between the groups (Table).
There was no statistically significant difference in LOS between the groups. Mean (SD) LOS was 2.55 (1.25) days for primary TKA and 2.92 (1.24) days for revision TKA (P = .061; 95% confidence interval [CI], 0.017-0.749). Regression analysis showed a correlation between ASA score and LOS for primary TKAs but not revision TKAs. For every unit increase in ASA score, there was a 0.39-day increase in LOS for primary TKA (P = .46; 95% CI, 0.006-0.781). There was no correlation between ASA score and LOS for revision TKA when controlling for covariates (P = .124). Eighty (34%) of the 235 primary TKA patients and 21 (41%) of the 50 revision TKA patients were discharged to a subacute nursing facility; the difference was not significant (P = .123). No patient was discharged to an acute inpatient rehabilitation unit. In addition, there was no significant difference in 30-day readmission rates between primary and revision TKA (P = .081). One primary TKA patient (0.4%) and 2 revision TKA patients (4%) were readmitted within 30 days after surgery (P = .081). The primary TKA readmission was for severe spasticity and a history of cerebral palsy leading to a quadriceps avulsion fracture from the superior pole of the patella. One revision TKA readmission was for acute periprosthetic joint infection, and the other for periprosthetic fracture around a press-fit distal femoral replacement stem. There was no significant difference in number of 30-day reoperations between the groups (P = .993). None of the primary TKAs and 2 (4%) of the revision TKAs underwent reoperation. Of the revision TKA patients who returned to the operating room within 30 days after surgery, one was treated for an acute periprosthetic joint infection, the other for a femoral periprosthetic fracture.
Discussion
Advances in multidisciplinary co-management of TKA patients and their clinical effects are highlighted in the TJR-PSH.14 TJR-PSH allows the health team and the patient to prepare for surgery with an understanding of probable outcomes and to optimize the patient’s medical and educational standing to better meet expectations and increase satisfaction.
Previous studies have focused on the etiologies of revision TKA7,8 and on understanding the factors that may predict increased risk for a poor outcome after primary TKA and indicate a possible need for revision.8,12 The present study focused on practical clinical processes that could potentially constitute a standardized perioperative protocol for revision TKA. An organized TJR-PSH may allow the health team to educate patients that LOS, rehabilitation and acute recovery, risk of acute (30-day) complications, and risk of readmission and return to the operating room within the first 30 days after surgery are similar for revision and primary TKAs, as long as proper preoperative optimization and education occur within the TJR-PSH.
Studies have found correlations between revision TKA and significantly increased LOS and postoperative complications.20,21 In contrast, we found no significant difference in LOS between our primary and revision TKA groups. LOS was 2.6 days for primary TKA and 2.9 days for revision TKA—a significant improvement in care and cost for revision TKA patients. That the reduced mean LOS for revision TKA is similar to the mean LOS for primary TKA also implies a reduction in the higher cost of care in revision TKA.20 In addition to obtaining similar LOS for primary and revision TKA, TJR-PSH achieved an overall reduction in LOS.17,22Our results also showed no difference in discharge disposition between primary and revision TKA in our protocol. Discharge disposition also did not correlate with age, sex, BMI, ASA score, or CCI. In TJR-PSH, discharge planning starts before admission and is patient-oriented for optimal recovery. About 66% of primary TKA patients and 58% of revision TKA patients in our cohort were discharged home—implying we are able to send a majority of our postoperative patients home after a shorter hospital stay, while obtaining the same good outcomes. Discharging fewer revision TKA patients to extended-care facilities also indicates a possible reduction in the cost of postoperative care, bringing it in line with the cost in primary TKA. Early individualized discharge planning in TJA-PSH accounts for the similar outcomes in primary and revision TKAs.
There was no significant difference in 30-day readmission rates between our primary and revision TKA patients. An important component of the TJR-PSH pathway is the individualized postdischarge recovery plan, which helps with optimal recovery and reduces readmission rates. Our cohort’s 30-day readmission rate was 0.4% for primary TKA and 4% for revision TKA (P = .081). Thirty-day readmission is a good indicator of postoperative complications and recovery from surgery. We have previously reported on primary TKA outcomes.14,15,,18,22,23 In a study using an NSQIP (National Surgical Quality Improvement Program) database, 11,814 primary TKAs had a 30-day readmission rate of 4.2%.18 In an outcomes study of 17,994 patients who underwent primary TKA in a single fiscal year, the 30-day readmission rate was 5.9%.9 In addition, in a single-institution cohort study of 1032 primary TKA patients, Schairer and colleagues23 found a 30-day unplanned readmission rate of 3.4%. Compared with primary TKA, revision TKA traditionally has had a higher postoperative complication rate.20,21 There is also concern that shorter hospital stays may indicate that significant complications of revision TKAs are being missed. In this study, however, we established that the equal outcomes obtained in the perioperative period carry over to the 30-day postoperative period in our revision TKA group. Good postoperative follow-up and planning are important factors in readmission reduction. Readmissions also have significant overall cost implications.24There was no statistical difference in 30-day reoperation rates between our primary and revision TKA patients. The primary TKA patients had no 30-day reoperations. Previous studies have found reoperation rates ranging from 1.8% to 4.7%.25,26 Revision TKA patients are up to 6 times more likely than primary TKA patients to require reoperation.20 Our study found no significant difference in outcomes between primary and revision TKAs.
Comparison of the outcomes of primary TKA and revision TKA in TJR-PSH showed no difference in acute recovery from surgery. LOS and discharge disposition, 30-day readmission rate, and 30-day return to the operating room were the same for primary and revision TKAs. The morbidity gap between primary and revision TKA patients has been closed in our research cohort. This outcome is important, as indications for primary TKA continue to expand and more primary TKAs are performed in younger patients.18,23 The implication is that, in the future, more knees will need to be revised as patients outlive their prostheses.
Our study had some limitations. First, it involved a small sample of patients, operated on by a single surgeon in a well-organized TJR-PSH at a large academic center. This population might not represent the US patient population, but that should not have adversely affected data analysis, because patients were compared with a similar population. Second, the data might be incomplete because some patients with complications might have sought care at other medical facilities, and we might not have been aware of these cases. Third, we focused on objective clinical outcomes in order to measure the success of TKAs. We did not include any subjective, patient-reported data, such as rehabilitation advances and functioning levels. Fourth, multiple parameters can be used to address complication outcomes, but we used LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate because current payers and institutions often consider these variables when assessing quality of care. These parameters can be influenced by factors such as inpatient physical therapy goals, facility discharge practices, individual social support structure, and hospital pay-for-performance model. The implication is that different facilities have different outcomes in terms of LOS, discharge disposition, readmissions, and reoperations. However, we expect proportionate similarities in these parameters as patient perioperative outcomes become more complicated. Nevertheless, a multicenter study would be able to answer questions raised by this limitation. Fifth, our statistical analysis might have been affected by decreased power of some of the outcome variables.
TJR-PSH has succeeded in closing the perioperative morbidity and outcomes gap between primary and revision TKAs. Outcome parameters used to measure the success of TJR-PSH are standard measures of the immediate postoperative recovery and short-term outcomes of TKA patients. These measures are linked to complication rates and overall outcomes in many TKA studies.14,15,17,19 Also important is that hospital costs can be drastically cut by reducing LOS, readmissions, and reoperations. Presence of any complication of primary or revision TKA raises the cost up to 34%. This increase can go as high as 64% in the 90 days after surgery.27
Conclusion
The major challenge of the changing medical landscape is to integrate quality care and a continually improving healthcare system with the goal of cost-effective delivery of healthcare. Surgical care costs can be significantly increased by evitable hospital stays, complications that lead to readmissions, and unplanned returns to the operating room after index surgery. The new perioperative surgical home created for TJA has helped drastically reduce LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate in revision TKA. This study demonstrates similar outcomes in our revision TKA patients relative to their primary TKA counterparts.
Am J Orthop. 2016;45(7):E458-E464. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.
Total knee arthroplasty (TKA) is an efficacious procedure for end-stage knee arthritis. Although TKA is cost-effective and has a high rate of success,1-6 TKAs fail and may require revision surgery. Failure mechanisms include periprosthetic fracture, aseptic loosening, wear, osteolysis, instability, and infection.7-9 In these cases, revision arthroplasty may be needed in order to restore function.
There has been a steady increase in the number of primary and revision TKAs performed in the United States.8,10,11 Revision rates are 4% at 5 years after index TKA and 8.9% at 9 years.12 However, surgical techniques and improved implants have led to improved outcomes after primary TKA, as evidenced by the reduction in revisions performed for polyethylene wear and osteolysis.13 Given the continuing need for revision TKAs (despite technical improvements13), evidence-based standard protocols that improve outcomes after revision TKA are necessary.
The Total Joint Replacement Perioperative Surgical Home (TJR-PSH) implemented and used by surgeons and anesthesiologists at our institution has shown that an evidence-based perioperative protocol can provide consistent and improved outcomes in primary TKA.14-16
Garson and colleagues14 and Chaurasia and colleagues15 found that patients who underwent primary TKA in a TJA-PSH had a predicted short length of stay (LOS): <3 days. About half were discharged to a location other than home, and 1.1% were readmitted within the first 30 days after surgery. There were no major complications and no mortalities. Conversely, as shown in different nationwide database analysis,17,18 mean LOS after primary unilateral TKA was 5.3 days, 8.2% of patients had procedure-related complications, 30-day readmission rate was 4.2%, and the in-hospital mortality rate was 0.3%. As with TJA-PSH, about half the patients were discharged to a place other than home.
We conducted a study to test the effect of the TJA-PSH clinical pathway on revision TKA patients. Early perioperative outcomes, such as LOS, readmission rate, and reoperation rate, are invaluable tools in measuring TKA outcomes and correlate with the dedicated orthopedic complication grading system proposed by the Knee Society.14,15,17,19 We hypothesized that the TJR-PSH clinical pathway would close the perioperative morbidity gap between primary and revision TKAs and yield equivalent perioperative outcomes.
Materials and Methods
In this study, which received Institutional Review Board approval, we performed a prospective cross-sectional analysis comparing the perioperative outcomes of patients who underwent primary TKA with those of patients who underwent revision TKA. Medical records and our institution’s data registry were queried for LOS, discharge disposition, readmission rates, and reoperation rates.
The study included all primary and revision TKAs performed at our institution since the inception of TJA-PSH. Unicompartmental knee arthroplasties and exchanges of a single component (patella, tibia, or femur) were excluded. We identified a total of 285 consecutive primary or revision TKAs, all performed by a single surgeon. Three cases lacked complete data and were excluded, leaving 282 cases: 235 primary and 50 revision TKAs (no simultaneous bilateral TKAs). The demographic data we collected included age, sex, body mass index (BMI), American Society of Anesthesiologists (ASA) score, calculated Charlson Comorbidity Index (CCI), LOS, and discharge disposition.
The same established perioperative surgical home clinical pathway was used to care for all patients, whether they underwent primary or revision TKA. The primary outcomes studied were LOS, discharge disposition (subacute nursing facility or home), 30-day orthopedic readmission, and return to operating room. All reoperations on the same knee were analyzed.
Statistical Analysis
Primary and revision TKAs were compared on LOS (with an independent-sample t test) and discharge disposition, 30-day readmissions, and reoperations (χ2 Fisher exact test). Multivariate regression analysis was performed with each primary outcome, using age, sex, BMI, ASA score, and CCI as covariates. Statistical significance was set at P ≤ .05. All analyses were performed with SPSS Version 16.0 (SPSS Inc.) and Microsoft Excel 2011 (Microsoft).
Results
Mean (SD) age was 66 (13.2) years for primary TKA patients and 62 (12.8) years for revision TKA patients. The cohort had more women (62.5%) than men (37.5%). There was no statistical difference in patient demographics with respect to age (P = .169) or BMI (P = .701) between the 2 groups. There was an even age distribution within each group and between the groups (Table).
There was no statistically significant difference in LOS between the groups. Mean (SD) LOS was 2.55 (1.25) days for primary TKA and 2.92 (1.24) days for revision TKA (P = .061; 95% confidence interval [CI], 0.017-0.749). Regression analysis showed a correlation between ASA score and LOS for primary TKAs but not revision TKAs. For every unit increase in ASA score, there was a 0.39-day increase in LOS for primary TKA (P = .46; 95% CI, 0.006-0.781). There was no correlation between ASA score and LOS for revision TKA when controlling for covariates (P = .124). Eighty (34%) of the 235 primary TKA patients and 21 (41%) of the 50 revision TKA patients were discharged to a subacute nursing facility; the difference was not significant (P = .123). No patient was discharged to an acute inpatient rehabilitation unit. In addition, there was no significant difference in 30-day readmission rates between primary and revision TKA (P = .081). One primary TKA patient (0.4%) and 2 revision TKA patients (4%) were readmitted within 30 days after surgery (P = .081). The primary TKA readmission was for severe spasticity and a history of cerebral palsy leading to a quadriceps avulsion fracture from the superior pole of the patella. One revision TKA readmission was for acute periprosthetic joint infection, and the other for periprosthetic fracture around a press-fit distal femoral replacement stem. There was no significant difference in number of 30-day reoperations between the groups (P = .993). None of the primary TKAs and 2 (4%) of the revision TKAs underwent reoperation. Of the revision TKA patients who returned to the operating room within 30 days after surgery, one was treated for an acute periprosthetic joint infection, the other for a femoral periprosthetic fracture.
Discussion
Advances in multidisciplinary co-management of TKA patients and their clinical effects are highlighted in the TJR-PSH.14 TJR-PSH allows the health team and the patient to prepare for surgery with an understanding of probable outcomes and to optimize the patient’s medical and educational standing to better meet expectations and increase satisfaction.
Previous studies have focused on the etiologies of revision TKA7,8 and on understanding the factors that may predict increased risk for a poor outcome after primary TKA and indicate a possible need for revision.8,12 The present study focused on practical clinical processes that could potentially constitute a standardized perioperative protocol for revision TKA. An organized TJR-PSH may allow the health team to educate patients that LOS, rehabilitation and acute recovery, risk of acute (30-day) complications, and risk of readmission and return to the operating room within the first 30 days after surgery are similar for revision and primary TKAs, as long as proper preoperative optimization and education occur within the TJR-PSH.
Studies have found correlations between revision TKA and significantly increased LOS and postoperative complications.20,21 In contrast, we found no significant difference in LOS between our primary and revision TKA groups. LOS was 2.6 days for primary TKA and 2.9 days for revision TKA—a significant improvement in care and cost for revision TKA patients. That the reduced mean LOS for revision TKA is similar to the mean LOS for primary TKA also implies a reduction in the higher cost of care in revision TKA.20 In addition to obtaining similar LOS for primary and revision TKA, TJR-PSH achieved an overall reduction in LOS.17,22Our results also showed no difference in discharge disposition between primary and revision TKA in our protocol. Discharge disposition also did not correlate with age, sex, BMI, ASA score, or CCI. In TJR-PSH, discharge planning starts before admission and is patient-oriented for optimal recovery. About 66% of primary TKA patients and 58% of revision TKA patients in our cohort were discharged home—implying we are able to send a majority of our postoperative patients home after a shorter hospital stay, while obtaining the same good outcomes. Discharging fewer revision TKA patients to extended-care facilities also indicates a possible reduction in the cost of postoperative care, bringing it in line with the cost in primary TKA. Early individualized discharge planning in TJA-PSH accounts for the similar outcomes in primary and revision TKAs.
There was no significant difference in 30-day readmission rates between our primary and revision TKA patients. An important component of the TJR-PSH pathway is the individualized postdischarge recovery plan, which helps with optimal recovery and reduces readmission rates. Our cohort’s 30-day readmission rate was 0.4% for primary TKA and 4% for revision TKA (P = .081). Thirty-day readmission is a good indicator of postoperative complications and recovery from surgery. We have previously reported on primary TKA outcomes.14,15,,18,22,23 In a study using an NSQIP (National Surgical Quality Improvement Program) database, 11,814 primary TKAs had a 30-day readmission rate of 4.2%.18 In an outcomes study of 17,994 patients who underwent primary TKA in a single fiscal year, the 30-day readmission rate was 5.9%.9 In addition, in a single-institution cohort study of 1032 primary TKA patients, Schairer and colleagues23 found a 30-day unplanned readmission rate of 3.4%. Compared with primary TKA, revision TKA traditionally has had a higher postoperative complication rate.20,21 There is also concern that shorter hospital stays may indicate that significant complications of revision TKAs are being missed. In this study, however, we established that the equal outcomes obtained in the perioperative period carry over to the 30-day postoperative period in our revision TKA group. Good postoperative follow-up and planning are important factors in readmission reduction. Readmissions also have significant overall cost implications.24There was no statistical difference in 30-day reoperation rates between our primary and revision TKA patients. The primary TKA patients had no 30-day reoperations. Previous studies have found reoperation rates ranging from 1.8% to 4.7%.25,26 Revision TKA patients are up to 6 times more likely than primary TKA patients to require reoperation.20 Our study found no significant difference in outcomes between primary and revision TKAs.
Comparison of the outcomes of primary TKA and revision TKA in TJR-PSH showed no difference in acute recovery from surgery. LOS and discharge disposition, 30-day readmission rate, and 30-day return to the operating room were the same for primary and revision TKAs. The morbidity gap between primary and revision TKA patients has been closed in our research cohort. This outcome is important, as indications for primary TKA continue to expand and more primary TKAs are performed in younger patients.18,23 The implication is that, in the future, more knees will need to be revised as patients outlive their prostheses.
Our study had some limitations. First, it involved a small sample of patients, operated on by a single surgeon in a well-organized TJR-PSH at a large academic center. This population might not represent the US patient population, but that should not have adversely affected data analysis, because patients were compared with a similar population. Second, the data might be incomplete because some patients with complications might have sought care at other medical facilities, and we might not have been aware of these cases. Third, we focused on objective clinical outcomes in order to measure the success of TKAs. We did not include any subjective, patient-reported data, such as rehabilitation advances and functioning levels. Fourth, multiple parameters can be used to address complication outcomes, but we used LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate because current payers and institutions often consider these variables when assessing quality of care. These parameters can be influenced by factors such as inpatient physical therapy goals, facility discharge practices, individual social support structure, and hospital pay-for-performance model. The implication is that different facilities have different outcomes in terms of LOS, discharge disposition, readmissions, and reoperations. However, we expect proportionate similarities in these parameters as patient perioperative outcomes become more complicated. Nevertheless, a multicenter study would be able to answer questions raised by this limitation. Fifth, our statistical analysis might have been affected by decreased power of some of the outcome variables.
TJR-PSH has succeeded in closing the perioperative morbidity and outcomes gap between primary and revision TKAs. Outcome parameters used to measure the success of TJR-PSH are standard measures of the immediate postoperative recovery and short-term outcomes of TKA patients. These measures are linked to complication rates and overall outcomes in many TKA studies.14,15,17,19 Also important is that hospital costs can be drastically cut by reducing LOS, readmissions, and reoperations. Presence of any complication of primary or revision TKA raises the cost up to 34%. This increase can go as high as 64% in the 90 days after surgery.27
Conclusion
The major challenge of the changing medical landscape is to integrate quality care and a continually improving healthcare system with the goal of cost-effective delivery of healthcare. Surgical care costs can be significantly increased by evitable hospital stays, complications that lead to readmissions, and unplanned returns to the operating room after index surgery. The new perioperative surgical home created for TJA has helped drastically reduce LOS, discharge disposition, 30-day readmission rate, and 30-day reoperation rate in revision TKA. This study demonstrates similar outcomes in our revision TKA patients relative to their primary TKA counterparts.
Am J Orthop. 2016;45(7):E458-E464. Copyright Frontline Medical Communications Inc. 2016. All rights reserved.
1. Berger RA, Rosenberg AG, Barden RM, Sheinkop MB, Jacobs JJ, Galante JO. Long-term followup of the Miller-Galante total knee replacement. Clin Orthop Relat Res. 2001;(388):58-67.
2. Rissanen P, Aro S, Slatis P, Sintonen H, Paavolainen P. Health and quality of life before and after hip or knee arthroplasty. J Arthroplasty. 1995;10(2):169-175.
3. March LM, Cross MJ, Lapsley H, et al. Outcomes after hip or knee replacement surgery for osteoarthritis. A prospective cohort study comparing patients’ quality of life before and after surgery with age-related population norms. Med J Aust. 1999;171(5):235-238.
4. Quintana JM, Arostegui I, Escobar A, Azkarate J, Goenaga JI, Lafuente I. Prevalence of knee and hip osteoarthritis and the appropriateness of joint replacement in an older population. Arch Intern Med. 2008;168(14):1576-1584.
5. Jones CA, Voaklander DC, Johnston DW, Suarez-Almazor ME. Health related quality of life outcomes after total hip and knee arthroplasties in a community based population. J Rheumatol. 2000;27(7):1745-1752.
6. Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004;86(5):963-974.
7. Mulhall KJ, Ghomrawi HM, Scully S, Callaghan JJ, Saleh KJ. Current etiologies and modes of failure in total knee arthroplasty revision. Clin Orthop Relat Res. 2006;(446):45-50.
8. Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;(404):7-13.
9. Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005;87(7):1487-1497.
10. Kurtz SM, Ong KL, Schmier J, Zhao K, Mowat F, Lau E. Primary and revision arthroplasty surgery caseloads in the United States from 1990 to 2004. J Arthroplasty. 2009;24(2):195-203.
11 Maloney WJ. National joint replacement registries: has the time come? J Bone Joint Surg Am. 2001;83(10):1582-1585.
12. Dy CJ, Marx RG, Bozic KJ, Pan TJ, Padgett DE, Lyman S. Risk factors for revision within 10 years of total knee arthroplasty. Clin Orthop Relat Res. 2014;472(4):1198-1207.
13. Dalury DF, Pomeroy DL, Gorab RS, Adams MJ. Why are total knee arthroplasties being revised? J Arthroplasty. 2013;28(8 suppl):120-121.
14. Garson L, Schwarzkopf R, Vakharia S, et al. Implementation of a total joint replacement-focused perioperative surgical home: a management case report. Anesth Analg. 2014;118(5):1081-1089.
15. Chaurasia A, Garson L, Kain ZL, Schwarzkopf R. Outcomes of a joint replacement surgical home model clinical pathway. Biomed Res Int. 2014;2014:296302.
16. Kain ZN, Vakharia S, Garson L, et al. The perioperative surgical home as a future perioperative practice model. Anesth Analg. 2014;118(5):1126-1130.
17. Memtsoudis SG, González Della Valle A, Besculides MC, Gaber L, Sculco TP. In-hospital complications and mortality of unilateral, bilateral, and revision TKA: based on an estimate of 4,159,661 discharges. Clin Orthop Relat Res. 2008;466(11):2617-2627.
18. Pugely AJ, Callaghan JJ, Martin CT, Cram P, Gao Y. Incidence of and risk factors for 30-day readmission following elective primary total joint arthroplasty: analysis from the ACS-NSQIP. J Arthroplasty. 2013;28(9):1499-1504.
19. Harris DY, McAngus JK, Kuo YF, Lindsey RW. Correlations between a dedicated orthopaedic complications grading system and early adverse outcomes in joint arthroplasty. Clin Orthop Relat Res. 2015;473(4):1524-1531.
20. Ong KL, Lau E, Suggs J, Kurtz SM, Manley MT. Risk of subsequent revision after primary and revision total joint arthroplasty. Clin Orthop Relat Res. 2010;468(11):3070-3076.
21. Bozic KJ, Katz P, Cisternas M, Ono L, Ries MD, Showstack J. Hospital resource utilization for primary and revision total hip arthroplasty. J Bone Joint Surg Am. 2005;87(3):570-576.
22. Singh JA, Kwoh CK, Richardson D, Chen W, Ibrahim SA. Sex and surgical outcomes and mortality after primary total knee arthroplasty: a risk-adjusted analysis. Arthritis Care Res. 2013;65(7):1095-1102.
23. Schairer WW, Vail TP, Bozic KJ. What are the rates and causes of hospital readmission after total knee arthroplasty? Clin Orthop Relat Res. 2014;472(1):181-187.
24. Bosco JA 3rd, Karkenny AJ, Hutzler LH, Slover JD, Iorio R Cost burden of 30-day readmissions following Medicare total hip and knee arthroplasty. J Arthroplasty. 2014;29(5):903-905.
25. Zmistowski B, Restrepo C, Kahl LK, Parvizi J, Sharkey PF. Incidence and reasons for nonrevision reoperation after total knee arthroplasty. Clin Orthop Relat Res 2011;469(1):138-145.26. Bottle A, Aylin P, Loeffler M. Return to theatre for elective hip and knee replacements: what is the relative importance of patient factors, surgeon and hospital? Bone Joint J Br. 2014;96(12):1663-1668.
27. Maradit Kremers H, Visscher SL, Moriarty JP, et al. Determinants of direct medical costs in primary and revision total knee arthroplasty. Clin Orthop Relat Res. 2013;471(1):206-214.
1. Berger RA, Rosenberg AG, Barden RM, Sheinkop MB, Jacobs JJ, Galante JO. Long-term followup of the Miller-Galante total knee replacement. Clin Orthop Relat Res. 2001;(388):58-67.
2. Rissanen P, Aro S, Slatis P, Sintonen H, Paavolainen P. Health and quality of life before and after hip or knee arthroplasty. J Arthroplasty. 1995;10(2):169-175.
3. March LM, Cross MJ, Lapsley H, et al. Outcomes after hip or knee replacement surgery for osteoarthritis. A prospective cohort study comparing patients’ quality of life before and after surgery with age-related population norms. Med J Aust. 1999;171(5):235-238.
4. Quintana JM, Arostegui I, Escobar A, Azkarate J, Goenaga JI, Lafuente I. Prevalence of knee and hip osteoarthritis and the appropriateness of joint replacement in an older population. Arch Intern Med. 2008;168(14):1576-1584.
5. Jones CA, Voaklander DC, Johnston DW, Suarez-Almazor ME. Health related quality of life outcomes after total hip and knee arthroplasties in a community based population. J Rheumatol. 2000;27(7):1745-1752.
6. Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004;86(5):963-974.
7. Mulhall KJ, Ghomrawi HM, Scully S, Callaghan JJ, Saleh KJ. Current etiologies and modes of failure in total knee arthroplasty revision. Clin Orthop Relat Res. 2006;(446):45-50.
8. Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;(404):7-13.
9. Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005;87(7):1487-1497.
10. Kurtz SM, Ong KL, Schmier J, Zhao K, Mowat F, Lau E. Primary and revision arthroplasty surgery caseloads in the United States from 1990 to 2004. J Arthroplasty. 2009;24(2):195-203.
11 Maloney WJ. National joint replacement registries: has the time come? J Bone Joint Surg Am. 2001;83(10):1582-1585.
12. Dy CJ, Marx RG, Bozic KJ, Pan TJ, Padgett DE, Lyman S. Risk factors for revision within 10 years of total knee arthroplasty. Clin Orthop Relat Res. 2014;472(4):1198-1207.
13. Dalury DF, Pomeroy DL, Gorab RS, Adams MJ. Why are total knee arthroplasties being revised? J Arthroplasty. 2013;28(8 suppl):120-121.
14. Garson L, Schwarzkopf R, Vakharia S, et al. Implementation of a total joint replacement-focused perioperative surgical home: a management case report. Anesth Analg. 2014;118(5):1081-1089.
15. Chaurasia A, Garson L, Kain ZL, Schwarzkopf R. Outcomes of a joint replacement surgical home model clinical pathway. Biomed Res Int. 2014;2014:296302.
16. Kain ZN, Vakharia S, Garson L, et al. The perioperative surgical home as a future perioperative practice model. Anesth Analg. 2014;118(5):1126-1130.
17. Memtsoudis SG, González Della Valle A, Besculides MC, Gaber L, Sculco TP. In-hospital complications and mortality of unilateral, bilateral, and revision TKA: based on an estimate of 4,159,661 discharges. Clin Orthop Relat Res. 2008;466(11):2617-2627.
18. Pugely AJ, Callaghan JJ, Martin CT, Cram P, Gao Y. Incidence of and risk factors for 30-day readmission following elective primary total joint arthroplasty: analysis from the ACS-NSQIP. J Arthroplasty. 2013;28(9):1499-1504.
19. Harris DY, McAngus JK, Kuo YF, Lindsey RW. Correlations between a dedicated orthopaedic complications grading system and early adverse outcomes in joint arthroplasty. Clin Orthop Relat Res. 2015;473(4):1524-1531.
20. Ong KL, Lau E, Suggs J, Kurtz SM, Manley MT. Risk of subsequent revision after primary and revision total joint arthroplasty. Clin Orthop Relat Res. 2010;468(11):3070-3076.
21. Bozic KJ, Katz P, Cisternas M, Ono L, Ries MD, Showstack J. Hospital resource utilization for primary and revision total hip arthroplasty. J Bone Joint Surg Am. 2005;87(3):570-576.
22. Singh JA, Kwoh CK, Richardson D, Chen W, Ibrahim SA. Sex and surgical outcomes and mortality after primary total knee arthroplasty: a risk-adjusted analysis. Arthritis Care Res. 2013;65(7):1095-1102.
23. Schairer WW, Vail TP, Bozic KJ. What are the rates and causes of hospital readmission after total knee arthroplasty? Clin Orthop Relat Res. 2014;472(1):181-187.
24. Bosco JA 3rd, Karkenny AJ, Hutzler LH, Slover JD, Iorio R Cost burden of 30-day readmissions following Medicare total hip and knee arthroplasty. J Arthroplasty. 2014;29(5):903-905.
25. Zmistowski B, Restrepo C, Kahl LK, Parvizi J, Sharkey PF. Incidence and reasons for nonrevision reoperation after total knee arthroplasty. Clin Orthop Relat Res 2011;469(1):138-145.26. Bottle A, Aylin P, Loeffler M. Return to theatre for elective hip and knee replacements: what is the relative importance of patient factors, surgeon and hospital? Bone Joint J Br. 2014;96(12):1663-1668.
27. Maradit Kremers H, Visscher SL, Moriarty JP, et al. Determinants of direct medical costs in primary and revision total knee arthroplasty. Clin Orthop Relat Res. 2013;471(1):206-214.
Internet-based CBT may be effective treatment for chronic insomnia
Internet-delivered cognitive-behavioral therapy is effective at overcoming chronic insomnia, a randomized controlled trial of 303 adults showed.
In the trial, patients who were randomized to receive cognitive-behavioral therapy for insomnia (CBT-I) used a Web-based program called Sleep Healthy Using the Internet (SHUTi), which “incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention,” wrote Lee M. Ritterband, PhD, and his associates. Meanwhile, patients in the control group received online, nonspecific patient education.
After a 9-week study period, the investigators found that sleep-onset latency, wake after sleep onset, and ratings on the Insomnia Severity Index all were significantly reduced in the SHUTi group, compared with the control group. The effect remained after the 6-month and 1-year follow-ups, reported Dr. Ritterband of the Center for Behavioral Health and Technology at the University of Virginia, Charlottesville, and his associates.
No significant difference was found in total sleep time between the SHUTi group and the control group, but sleep efficiency and sleep quality did improve. In addition, the number of awakenings dropped in the SHUTi group. Both groups reported a decrease in the use of sleep aids, such as medication. After completing the post assessment and 6-month follow-up, participants received online gift certificates of $50 each, and after completing the assessment at the 1-year follow-up, they received $100 gift certificates.
“Internet-delivered CBT-I provides a less expensive, scalable treatment option that could reach previously unimaginable numbers of people,” the investigators said. “Future studies are necessary to determine who may be best served by this type of intervention and how the next steps of dissemination should occur. Ensuring that these interventions work with different patient populations, whether tailored or not for those groups, should also be examined,” they noted.
Find the full study in JAMA Psychiatry (2016 Nov 30. doi: 10.1001/jamapsychiatry.2016.3249)
Internet-delivered cognitive-behavioral therapy is effective at overcoming chronic insomnia, a randomized controlled trial of 303 adults showed.
In the trial, patients who were randomized to receive cognitive-behavioral therapy for insomnia (CBT-I) used a Web-based program called Sleep Healthy Using the Internet (SHUTi), which “incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention,” wrote Lee M. Ritterband, PhD, and his associates. Meanwhile, patients in the control group received online, nonspecific patient education.
After a 9-week study period, the investigators found that sleep-onset latency, wake after sleep onset, and ratings on the Insomnia Severity Index all were significantly reduced in the SHUTi group, compared with the control group. The effect remained after the 6-month and 1-year follow-ups, reported Dr. Ritterband of the Center for Behavioral Health and Technology at the University of Virginia, Charlottesville, and his associates.
No significant difference was found in total sleep time between the SHUTi group and the control group, but sleep efficiency and sleep quality did improve. In addition, the number of awakenings dropped in the SHUTi group. Both groups reported a decrease in the use of sleep aids, such as medication. After completing the post assessment and 6-month follow-up, participants received online gift certificates of $50 each, and after completing the assessment at the 1-year follow-up, they received $100 gift certificates.
“Internet-delivered CBT-I provides a less expensive, scalable treatment option that could reach previously unimaginable numbers of people,” the investigators said. “Future studies are necessary to determine who may be best served by this type of intervention and how the next steps of dissemination should occur. Ensuring that these interventions work with different patient populations, whether tailored or not for those groups, should also be examined,” they noted.
Find the full study in JAMA Psychiatry (2016 Nov 30. doi: 10.1001/jamapsychiatry.2016.3249)
Internet-delivered cognitive-behavioral therapy is effective at overcoming chronic insomnia, a randomized controlled trial of 303 adults showed.
In the trial, patients who were randomized to receive cognitive-behavioral therapy for insomnia (CBT-I) used a Web-based program called Sleep Healthy Using the Internet (SHUTi), which “incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention,” wrote Lee M. Ritterband, PhD, and his associates. Meanwhile, patients in the control group received online, nonspecific patient education.
After a 9-week study period, the investigators found that sleep-onset latency, wake after sleep onset, and ratings on the Insomnia Severity Index all were significantly reduced in the SHUTi group, compared with the control group. The effect remained after the 6-month and 1-year follow-ups, reported Dr. Ritterband of the Center for Behavioral Health and Technology at the University of Virginia, Charlottesville, and his associates.
No significant difference was found in total sleep time between the SHUTi group and the control group, but sleep efficiency and sleep quality did improve. In addition, the number of awakenings dropped in the SHUTi group. Both groups reported a decrease in the use of sleep aids, such as medication. After completing the post assessment and 6-month follow-up, participants received online gift certificates of $50 each, and after completing the assessment at the 1-year follow-up, they received $100 gift certificates.
“Internet-delivered CBT-I provides a less expensive, scalable treatment option that could reach previously unimaginable numbers of people,” the investigators said. “Future studies are necessary to determine who may be best served by this type of intervention and how the next steps of dissemination should occur. Ensuring that these interventions work with different patient populations, whether tailored or not for those groups, should also be examined,” they noted.
Find the full study in JAMA Psychiatry (2016 Nov 30. doi: 10.1001/jamapsychiatry.2016.3249)
FROM JAMA PSYCHIATRY