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IUDs May Protect Against Cervical Cancer
Intrauterine devices appeared to protect against cervical cancer in a pooled analysis of data from 26 epidemiologic studies, published online Sept. 12 in the Lancet Oncology.
In a combined study population of 19,691 women around the world, there was a strong and consistent inverse association between IUD use and cervical cancer risk. Women who had used an IUD were at approximately half the risk of nonusers for cervical cancer in the first year of use, and that level of protection was maintained through 10 years of use, wrote Dr. Xavier Castellsagué of the Institut Català d’Oncologia, Bellvitge Biomedical Research Institute, L’Hospitalet de Llobregat, Catalonia, Spain, and his associates.
IUDs did not protect against human papillomavirus infection. Rather, they appeared to reduce the likelihood that HPV would progress to cervical cancer, the researchers noted.
IUDs are known to protect against endometrial cancer, but studies of a possible effect on cervical cancer or cervical HPV infection have yielded inconsistent results. "To our knowledge, this is the first large epidemiological study . . . to explore such potential associations taking into account cervical HPV status and Pap screening history," they said.
Dr. Castellsagué and his colleagues examined data from 16 HPV prevalence surveys and 10 case-control studies performed during the past 20 years.
The population-based prevalence surveys were conducted by the International Agency for Research on Cancer and included 13,179 HPV-negative women and 2,093 HPV-positive women in Vietnam, Thailand, South Korea, China, Mexico, Argentina, Colombia, Chile, Nigeria, Spain, and Poland. The case-control studies involved 2,205 women with cervical cancer and 2,214 matched control subjects without cervical cancer in Algeria, Brazil, Colombia, India, Mali, Morocco, Paraguay, Peru, the Philippines, Thailand, and Spain.
Robust inverse associations were consistently found between use of an IUD and all cervical cancers combined (odds ratio, 0.55). In addition, strong associations were consistently found between use of an IUD and two major histologic groups: squamous-cell carcinoma (OR, 0.56) and adenocarcinoma plus adenosquamous carcinomas (OR, 0.46).
"To address further the potential effect of residual confounding, we did a stratified analysis to assess the association between IUD use and cervical cancer risk within subcategories of selected covariates known to be potential confounders or cofactors in cervical carcinogenesis. These stratified analyses showed a consistent inverse association between cervical cancer and IUD use within each category of age, education, marital status, number of screening Paps, number of sexual partners, [and] parity," the investigators said (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-6]).
In contrast, there was no association in any of these analyses between IUD use and HPV infection, as assessed by tests for HPV DNA in cervical scrapings. "Overall, the associations found in our study strongly suggest that IUD use does not modify the likelihood of prevalent HPV infection, but might affect the likelihood of HPV progression to cervical cancer," they wrote.
The researchers proposed that IUDs may exert their anticarcinogenic effect "through the introduction of a reactive, chronic, low-grade, sterile inflammatory response in the endometrium, endocervical canal, and cervix that could modify, via changes in the local mucosal immune status, the course of HPV infections. Microscopic observation of typical cellular changes in the cervices of IUD users support this theory," noted Dr. Castellsagué and his associates.
It is also possible that trauma to the cervical tissue from the insertion of the device "induces local small foci of chronic inflammation and a long-lasting immune response similar to that noted in patients after colposcopically guided punch biopsies. This alternative hypothesis would explain better the immediate protective effect found for short-term users, and the observation that there was no difference in the protective effect by years of IUD use," they said.
A third possibility would be that insertion of the IUD scrapes away preinvasive lesions on the cervix, which also would explain why duration of IUD use doesn’t influence the protective effect.
"These possible mechanisms are speculative and provocative, but emphasize our limited knowledge and the need for other study designs to explore the underlying mechanisms by which IUDs might exert a protective effect on cervical cancer risk," they added.
Dr. Castellsagué and his colleagues concluded that, "in view of the wide use of IUDs worldwide, women, gynecologists, and reproductive-health professionals can be reassured that IUDs do not seem to increase the risk of cervical HPV infection; and our study contributes solid evidence that IUD use might even reduce the risk of developing cervical cancer."
In an editorial comment accompanying the report, Dr. Karl Ulrich Petry wrote that "the superficial trauma associated with loop insertion might occasionally result in complete destruction of tiny [cervical intraepithelial neoplastic] lesions located in the external ostium of the cervical canal, but as a colposcopist, I doubt that this mechanical effect can explain the observed significant reduction in cancer risk" (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-8]).
"Instead, I postulate that the tissue trauma associated with loop insertion induces a cellular immune response that might finally clear persistent HPV infections and preinvasive lesions. Small cohort studies have already shown that taking cervical biopsies increases the spontaneous regression rates of CIN, and that the residual dysplastic tissue remaining after surgical treatment is cleared in many cases," noted Dr. Petry of the Klinikum Wolfsburg in Germany.
Funding for the study was provided by Agencia de Gestio d’Ajuts Universitaris i Recerca; Bill & Melinda Gates Foundation; Conselho Nacional de Desenvolvimiento Cientifico e Tecnologico, Brazil; European Community; Department of Reproductive Health & Research, WHO Fondo de Investigaciones Sanitarias, Spain; Instituto de Salud Carlos III; International Agency for Research on Cancer; Marato TV3 Foundation; Preventiefonds, Netherlands; and Programa Interministerial de Investigacion y Desarrollo, Spain. No conflicts of interest were reported.
Dr. Petry reported no financial conflicts of interest.
"The superficial trauma associated with loop insertion might occasionally result in complete destruction of tiny [cervical intraepithelial neoplastic] lesions located in the external ostium of the cervical canal, but as a colposcopist, I doubt that this mechanical effect can explain the observed significant reduction in cancer risk," said Dr. Karl Ulrich Petry.
"Instead, I postulate that the tissue trauma associated with loop insertion induces a cellular immune response that might finally clear persistent HPV infections and preinvasive lesions. Small cohort studies have already shown that taking cervical biopsies increases the spontaneous regression rates of CIN, and that the residual dysplastic tissue remaining after surgical treatment is cleared in many cases," he noted.
Dr. Petry is at the Klinikum Wolfsburg in Germany. He reported no financial conflicts of interest. These remarks were taken from his editorial comment accompanying the report by Dr. Castellsagué and coauthors (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-8]).
"The superficial trauma associated with loop insertion might occasionally result in complete destruction of tiny [cervical intraepithelial neoplastic] lesions located in the external ostium of the cervical canal, but as a colposcopist, I doubt that this mechanical effect can explain the observed significant reduction in cancer risk," said Dr. Karl Ulrich Petry.
"Instead, I postulate that the tissue trauma associated with loop insertion induces a cellular immune response that might finally clear persistent HPV infections and preinvasive lesions. Small cohort studies have already shown that taking cervical biopsies increases the spontaneous regression rates of CIN, and that the residual dysplastic tissue remaining after surgical treatment is cleared in many cases," he noted.
Dr. Petry is at the Klinikum Wolfsburg in Germany. He reported no financial conflicts of interest. These remarks were taken from his editorial comment accompanying the report by Dr. Castellsagué and coauthors (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-8]).
"The superficial trauma associated with loop insertion might occasionally result in complete destruction of tiny [cervical intraepithelial neoplastic] lesions located in the external ostium of the cervical canal, but as a colposcopist, I doubt that this mechanical effect can explain the observed significant reduction in cancer risk," said Dr. Karl Ulrich Petry.
"Instead, I postulate that the tissue trauma associated with loop insertion induces a cellular immune response that might finally clear persistent HPV infections and preinvasive lesions. Small cohort studies have already shown that taking cervical biopsies increases the spontaneous regression rates of CIN, and that the residual dysplastic tissue remaining after surgical treatment is cleared in many cases," he noted.
Dr. Petry is at the Klinikum Wolfsburg in Germany. He reported no financial conflicts of interest. These remarks were taken from his editorial comment accompanying the report by Dr. Castellsagué and coauthors (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-8]).
Intrauterine devices appeared to protect against cervical cancer in a pooled analysis of data from 26 epidemiologic studies, published online Sept. 12 in the Lancet Oncology.
In a combined study population of 19,691 women around the world, there was a strong and consistent inverse association between IUD use and cervical cancer risk. Women who had used an IUD were at approximately half the risk of nonusers for cervical cancer in the first year of use, and that level of protection was maintained through 10 years of use, wrote Dr. Xavier Castellsagué of the Institut Català d’Oncologia, Bellvitge Biomedical Research Institute, L’Hospitalet de Llobregat, Catalonia, Spain, and his associates.
IUDs did not protect against human papillomavirus infection. Rather, they appeared to reduce the likelihood that HPV would progress to cervical cancer, the researchers noted.
IUDs are known to protect against endometrial cancer, but studies of a possible effect on cervical cancer or cervical HPV infection have yielded inconsistent results. "To our knowledge, this is the first large epidemiological study . . . to explore such potential associations taking into account cervical HPV status and Pap screening history," they said.
Dr. Castellsagué and his colleagues examined data from 16 HPV prevalence surveys and 10 case-control studies performed during the past 20 years.
The population-based prevalence surveys were conducted by the International Agency for Research on Cancer and included 13,179 HPV-negative women and 2,093 HPV-positive women in Vietnam, Thailand, South Korea, China, Mexico, Argentina, Colombia, Chile, Nigeria, Spain, and Poland. The case-control studies involved 2,205 women with cervical cancer and 2,214 matched control subjects without cervical cancer in Algeria, Brazil, Colombia, India, Mali, Morocco, Paraguay, Peru, the Philippines, Thailand, and Spain.
Robust inverse associations were consistently found between use of an IUD and all cervical cancers combined (odds ratio, 0.55). In addition, strong associations were consistently found between use of an IUD and two major histologic groups: squamous-cell carcinoma (OR, 0.56) and adenocarcinoma plus adenosquamous carcinomas (OR, 0.46).
"To address further the potential effect of residual confounding, we did a stratified analysis to assess the association between IUD use and cervical cancer risk within subcategories of selected covariates known to be potential confounders or cofactors in cervical carcinogenesis. These stratified analyses showed a consistent inverse association between cervical cancer and IUD use within each category of age, education, marital status, number of screening Paps, number of sexual partners, [and] parity," the investigators said (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-6]).
In contrast, there was no association in any of these analyses between IUD use and HPV infection, as assessed by tests for HPV DNA in cervical scrapings. "Overall, the associations found in our study strongly suggest that IUD use does not modify the likelihood of prevalent HPV infection, but might affect the likelihood of HPV progression to cervical cancer," they wrote.
The researchers proposed that IUDs may exert their anticarcinogenic effect "through the introduction of a reactive, chronic, low-grade, sterile inflammatory response in the endometrium, endocervical canal, and cervix that could modify, via changes in the local mucosal immune status, the course of HPV infections. Microscopic observation of typical cellular changes in the cervices of IUD users support this theory," noted Dr. Castellsagué and his associates.
It is also possible that trauma to the cervical tissue from the insertion of the device "induces local small foci of chronic inflammation and a long-lasting immune response similar to that noted in patients after colposcopically guided punch biopsies. This alternative hypothesis would explain better the immediate protective effect found for short-term users, and the observation that there was no difference in the protective effect by years of IUD use," they said.
A third possibility would be that insertion of the IUD scrapes away preinvasive lesions on the cervix, which also would explain why duration of IUD use doesn’t influence the protective effect.
"These possible mechanisms are speculative and provocative, but emphasize our limited knowledge and the need for other study designs to explore the underlying mechanisms by which IUDs might exert a protective effect on cervical cancer risk," they added.
Dr. Castellsagué and his colleagues concluded that, "in view of the wide use of IUDs worldwide, women, gynecologists, and reproductive-health professionals can be reassured that IUDs do not seem to increase the risk of cervical HPV infection; and our study contributes solid evidence that IUD use might even reduce the risk of developing cervical cancer."
In an editorial comment accompanying the report, Dr. Karl Ulrich Petry wrote that "the superficial trauma associated with loop insertion might occasionally result in complete destruction of tiny [cervical intraepithelial neoplastic] lesions located in the external ostium of the cervical canal, but as a colposcopist, I doubt that this mechanical effect can explain the observed significant reduction in cancer risk" (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-8]).
"Instead, I postulate that the tissue trauma associated with loop insertion induces a cellular immune response that might finally clear persistent HPV infections and preinvasive lesions. Small cohort studies have already shown that taking cervical biopsies increases the spontaneous regression rates of CIN, and that the residual dysplastic tissue remaining after surgical treatment is cleared in many cases," noted Dr. Petry of the Klinikum Wolfsburg in Germany.
Funding for the study was provided by Agencia de Gestio d’Ajuts Universitaris i Recerca; Bill & Melinda Gates Foundation; Conselho Nacional de Desenvolvimiento Cientifico e Tecnologico, Brazil; European Community; Department of Reproductive Health & Research, WHO Fondo de Investigaciones Sanitarias, Spain; Instituto de Salud Carlos III; International Agency for Research on Cancer; Marato TV3 Foundation; Preventiefonds, Netherlands; and Programa Interministerial de Investigacion y Desarrollo, Spain. No conflicts of interest were reported.
Dr. Petry reported no financial conflicts of interest.
Intrauterine devices appeared to protect against cervical cancer in a pooled analysis of data from 26 epidemiologic studies, published online Sept. 12 in the Lancet Oncology.
In a combined study population of 19,691 women around the world, there was a strong and consistent inverse association between IUD use and cervical cancer risk. Women who had used an IUD were at approximately half the risk of nonusers for cervical cancer in the first year of use, and that level of protection was maintained through 10 years of use, wrote Dr. Xavier Castellsagué of the Institut Català d’Oncologia, Bellvitge Biomedical Research Institute, L’Hospitalet de Llobregat, Catalonia, Spain, and his associates.
IUDs did not protect against human papillomavirus infection. Rather, they appeared to reduce the likelihood that HPV would progress to cervical cancer, the researchers noted.
IUDs are known to protect against endometrial cancer, but studies of a possible effect on cervical cancer or cervical HPV infection have yielded inconsistent results. "To our knowledge, this is the first large epidemiological study . . . to explore such potential associations taking into account cervical HPV status and Pap screening history," they said.
Dr. Castellsagué and his colleagues examined data from 16 HPV prevalence surveys and 10 case-control studies performed during the past 20 years.
The population-based prevalence surveys were conducted by the International Agency for Research on Cancer and included 13,179 HPV-negative women and 2,093 HPV-positive women in Vietnam, Thailand, South Korea, China, Mexico, Argentina, Colombia, Chile, Nigeria, Spain, and Poland. The case-control studies involved 2,205 women with cervical cancer and 2,214 matched control subjects without cervical cancer in Algeria, Brazil, Colombia, India, Mali, Morocco, Paraguay, Peru, the Philippines, Thailand, and Spain.
Robust inverse associations were consistently found between use of an IUD and all cervical cancers combined (odds ratio, 0.55). In addition, strong associations were consistently found between use of an IUD and two major histologic groups: squamous-cell carcinoma (OR, 0.56) and adenocarcinoma plus adenosquamous carcinomas (OR, 0.46).
"To address further the potential effect of residual confounding, we did a stratified analysis to assess the association between IUD use and cervical cancer risk within subcategories of selected covariates known to be potential confounders or cofactors in cervical carcinogenesis. These stratified analyses showed a consistent inverse association between cervical cancer and IUD use within each category of age, education, marital status, number of screening Paps, number of sexual partners, [and] parity," the investigators said (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-6]).
In contrast, there was no association in any of these analyses between IUD use and HPV infection, as assessed by tests for HPV DNA in cervical scrapings. "Overall, the associations found in our study strongly suggest that IUD use does not modify the likelihood of prevalent HPV infection, but might affect the likelihood of HPV progression to cervical cancer," they wrote.
The researchers proposed that IUDs may exert their anticarcinogenic effect "through the introduction of a reactive, chronic, low-grade, sterile inflammatory response in the endometrium, endocervical canal, and cervix that could modify, via changes in the local mucosal immune status, the course of HPV infections. Microscopic observation of typical cellular changes in the cervices of IUD users support this theory," noted Dr. Castellsagué and his associates.
It is also possible that trauma to the cervical tissue from the insertion of the device "induces local small foci of chronic inflammation and a long-lasting immune response similar to that noted in patients after colposcopically guided punch biopsies. This alternative hypothesis would explain better the immediate protective effect found for short-term users, and the observation that there was no difference in the protective effect by years of IUD use," they said.
A third possibility would be that insertion of the IUD scrapes away preinvasive lesions on the cervix, which also would explain why duration of IUD use doesn’t influence the protective effect.
"These possible mechanisms are speculative and provocative, but emphasize our limited knowledge and the need for other study designs to explore the underlying mechanisms by which IUDs might exert a protective effect on cervical cancer risk," they added.
Dr. Castellsagué and his colleagues concluded that, "in view of the wide use of IUDs worldwide, women, gynecologists, and reproductive-health professionals can be reassured that IUDs do not seem to increase the risk of cervical HPV infection; and our study contributes solid evidence that IUD use might even reduce the risk of developing cervical cancer."
In an editorial comment accompanying the report, Dr. Karl Ulrich Petry wrote that "the superficial trauma associated with loop insertion might occasionally result in complete destruction of tiny [cervical intraepithelial neoplastic] lesions located in the external ostium of the cervical canal, but as a colposcopist, I doubt that this mechanical effect can explain the observed significant reduction in cancer risk" (Lancet Oncol. 2011 Sept. 13 [doi:10.1016/S1470-2045(11)70223-8]).
"Instead, I postulate that the tissue trauma associated with loop insertion induces a cellular immune response that might finally clear persistent HPV infections and preinvasive lesions. Small cohort studies have already shown that taking cervical biopsies increases the spontaneous regression rates of CIN, and that the residual dysplastic tissue remaining after surgical treatment is cleared in many cases," noted Dr. Petry of the Klinikum Wolfsburg in Germany.
Funding for the study was provided by Agencia de Gestio d’Ajuts Universitaris i Recerca; Bill & Melinda Gates Foundation; Conselho Nacional de Desenvolvimiento Cientifico e Tecnologico, Brazil; European Community; Department of Reproductive Health & Research, WHO Fondo de Investigaciones Sanitarias, Spain; Instituto de Salud Carlos III; International Agency for Research on Cancer; Marato TV3 Foundation; Preventiefonds, Netherlands; and Programa Interministerial de Investigacion y Desarrollo, Spain. No conflicts of interest were reported.
Dr. Petry reported no financial conflicts of interest.
FROM THE LANCET ONCOLOGY
Major Finding: Robust inverse associations were consistently found between use of an IUD and all cervical cancers combined (odds ratio, 0.55), as well as with squamous-cell carcinomas (OR, 0.56) and with the combined category of adenocarcinoma plus adenosquamous carcinomas (OR 0.46).
Data Source: A pooled analysis of data from 16 surveys of HPV prevalence and 10 case-control studies involving a total of 19,691 women worldwide.
Disclosures: Funding for this study was provided by Agencia de Gestio d’Ajuts Universitaris i Recerca; Bill & Melinda Gates Foundation; Conselho Nacional de Desenvolvimiento Cientifico e Tecnologico, Brazil; European Community; Department of Reproductive Health & Research, WHO Fondo de Investigaciones Sanitarias, Spain; Instituto de Salud Carlos III; International Agency for Research on Cancer; Marato TV3 Foundation; Preventiefonds, Netherlands; and Programa Interministerial de Investigacion y Desarrollo, Spain. No conflicts of interest were reported.
Temporary Stents Reduced Risk of Post-ERCP Pancreatitis
Temporary pancreatic duct stents reduce the rate of pancreatitis due to endoscopic retrograde cholangiopancreatography in patients at high risk for the disorder, Dr. Atsushi Sofuni and colleagues reported in the October issue of Clinical Gastroenterology and Hepatology.
Although post-ERCP pancreatitis usually is mild and resolves with conservative treatment, some patients can develop substantial complications, "and on occasion they are fatal," said Dr. Sofuni of Tokyo Medical University, and associates (Clin. Gastroenterol. Hepatol. 2011 [doi:10.1016/j.cgh.2011.06.033]).
Post-ERCP pancreatitis is thought to arise primarily from impaired drainage from the pancreatic duct, which is thought to result from papillary edema and/or sphincter spasm brought on by the physical manipulation during the ERCP procedure.
The investigators performed a randomized clinical trial to assess whether placement of a temporary pancreatic duct stent during the ERCP would prevent pancreatitis from developing. The stent was designed to keep the duct open for a brief interval after the procedure to allow adequate drainage, and then to dislodge spontaneously within 3 days.
The trial involved 426 consecutive patients undergoing ERCP and related procedures at 37 endoscopic specialty centers in Japan. Half the patients were assigned to receive pancreatic stents and half were not.
The 3-cm-long polyethylene stent was unflanged on the pancreatic duct side but had two flanges on the duodenal side. Abdominal x-rays were performed every morning after the ERCP to track dislodgement. Stents that did not dislodge by the third day were to be removed by duodenoscopy on the fourth day.
After randomization, 12 cases that were found not to meet inclusion criteria and 7 cases with incomplete data were included in the intention-to-treat analysis but were not available for the as-treated analysis, which now comprised 203 patients in the stent group and 204 in the no-stent group.
The distinction between these two analyses became important because the results were different. In the as-treated analysis, the rate of post-ERCP pancreatitis was significantly lower (P = .02) with the stent (7.9%) than without the stent (15.2%), the investigators said.
In contrast, in the intention-to-treat analysis, the rate of post-ERCP pancreatitis was lower, but not significantly so, with the stent (9.4%) than without the stent (14.6%). The overall rate of post-ERCP pancreatitis in this study was approximately 11%, which "agrees in general with previous reports."
There was no significant difference in the rise in serum amylase levels between the stent and no-stent groups.
Stent placement failed in 25 patients (12%) in whom it was attempted. In three of these cases, anatomic deformities of the pancreatic duct were the cause. In another 15 cases, the duct could not be cannulated, and in the remaining 7 cases, the guidewire could not be passed deeply enough.
Six factors were found to put patients at risk for developing post-ERCP pancreatitis: undergoing pancreatography first, not achieving placement of the pancreatic stent, a procedure time of 30 minutes or longer, sampling of the pancreatic tissue by any method, undergoing intraductal ultrasonography, and difficulty in achieving cannulation (defined as taking 15 minutes or longer to do so).
"This indicates that post-ERCP pancreatitis might be affected by other factors as well as papillary edema, such as the direct burden placed on the pancreatic duct" by instrumentation used in tissue sampling and intraductal ultrasonography rubbing against it, the researchers noted.
In cases in which it was difficult to cannulate the bile duct, endoscopists sometimes placed a pancreatic guidewire to facilitate biliary cannulation. Such guidewires were used in approximately 35% of patients who developed post-ERCP pancreatitis, compared with only 8% of patients who did not develop post-ERCP pancreatitis.
"This suggests the possibility of direct damage to the pancreatic duct by the guidewire," they said. Use of a softer, more delicate guidewire might be beneficial when guidewire use cannot be avoided, they added.
This study had no financial support, and the authors stated that they had no conflicts of interest.
Temporary pancreatic duct stents reduce the rate of pancreatitis due to endoscopic retrograde cholangiopancreatography in patients at high risk for the disorder, Dr. Atsushi Sofuni and colleagues reported in the October issue of Clinical Gastroenterology and Hepatology.
Although post-ERCP pancreatitis usually is mild and resolves with conservative treatment, some patients can develop substantial complications, "and on occasion they are fatal," said Dr. Sofuni of Tokyo Medical University, and associates (Clin. Gastroenterol. Hepatol. 2011 [doi:10.1016/j.cgh.2011.06.033]).
Post-ERCP pancreatitis is thought to arise primarily from impaired drainage from the pancreatic duct, which is thought to result from papillary edema and/or sphincter spasm brought on by the physical manipulation during the ERCP procedure.
The investigators performed a randomized clinical trial to assess whether placement of a temporary pancreatic duct stent during the ERCP would prevent pancreatitis from developing. The stent was designed to keep the duct open for a brief interval after the procedure to allow adequate drainage, and then to dislodge spontaneously within 3 days.
The trial involved 426 consecutive patients undergoing ERCP and related procedures at 37 endoscopic specialty centers in Japan. Half the patients were assigned to receive pancreatic stents and half were not.
The 3-cm-long polyethylene stent was unflanged on the pancreatic duct side but had two flanges on the duodenal side. Abdominal x-rays were performed every morning after the ERCP to track dislodgement. Stents that did not dislodge by the third day were to be removed by duodenoscopy on the fourth day.
After randomization, 12 cases that were found not to meet inclusion criteria and 7 cases with incomplete data were included in the intention-to-treat analysis but were not available for the as-treated analysis, which now comprised 203 patients in the stent group and 204 in the no-stent group.
The distinction between these two analyses became important because the results were different. In the as-treated analysis, the rate of post-ERCP pancreatitis was significantly lower (P = .02) with the stent (7.9%) than without the stent (15.2%), the investigators said.
In contrast, in the intention-to-treat analysis, the rate of post-ERCP pancreatitis was lower, but not significantly so, with the stent (9.4%) than without the stent (14.6%). The overall rate of post-ERCP pancreatitis in this study was approximately 11%, which "agrees in general with previous reports."
There was no significant difference in the rise in serum amylase levels between the stent and no-stent groups.
Stent placement failed in 25 patients (12%) in whom it was attempted. In three of these cases, anatomic deformities of the pancreatic duct were the cause. In another 15 cases, the duct could not be cannulated, and in the remaining 7 cases, the guidewire could not be passed deeply enough.
Six factors were found to put patients at risk for developing post-ERCP pancreatitis: undergoing pancreatography first, not achieving placement of the pancreatic stent, a procedure time of 30 minutes or longer, sampling of the pancreatic tissue by any method, undergoing intraductal ultrasonography, and difficulty in achieving cannulation (defined as taking 15 minutes or longer to do so).
"This indicates that post-ERCP pancreatitis might be affected by other factors as well as papillary edema, such as the direct burden placed on the pancreatic duct" by instrumentation used in tissue sampling and intraductal ultrasonography rubbing against it, the researchers noted.
In cases in which it was difficult to cannulate the bile duct, endoscopists sometimes placed a pancreatic guidewire to facilitate biliary cannulation. Such guidewires were used in approximately 35% of patients who developed post-ERCP pancreatitis, compared with only 8% of patients who did not develop post-ERCP pancreatitis.
"This suggests the possibility of direct damage to the pancreatic duct by the guidewire," they said. Use of a softer, more delicate guidewire might be beneficial when guidewire use cannot be avoided, they added.
This study had no financial support, and the authors stated that they had no conflicts of interest.
Temporary pancreatic duct stents reduce the rate of pancreatitis due to endoscopic retrograde cholangiopancreatography in patients at high risk for the disorder, Dr. Atsushi Sofuni and colleagues reported in the October issue of Clinical Gastroenterology and Hepatology.
Although post-ERCP pancreatitis usually is mild and resolves with conservative treatment, some patients can develop substantial complications, "and on occasion they are fatal," said Dr. Sofuni of Tokyo Medical University, and associates (Clin. Gastroenterol. Hepatol. 2011 [doi:10.1016/j.cgh.2011.06.033]).
Post-ERCP pancreatitis is thought to arise primarily from impaired drainage from the pancreatic duct, which is thought to result from papillary edema and/or sphincter spasm brought on by the physical manipulation during the ERCP procedure.
The investigators performed a randomized clinical trial to assess whether placement of a temporary pancreatic duct stent during the ERCP would prevent pancreatitis from developing. The stent was designed to keep the duct open for a brief interval after the procedure to allow adequate drainage, and then to dislodge spontaneously within 3 days.
The trial involved 426 consecutive patients undergoing ERCP and related procedures at 37 endoscopic specialty centers in Japan. Half the patients were assigned to receive pancreatic stents and half were not.
The 3-cm-long polyethylene stent was unflanged on the pancreatic duct side but had two flanges on the duodenal side. Abdominal x-rays were performed every morning after the ERCP to track dislodgement. Stents that did not dislodge by the third day were to be removed by duodenoscopy on the fourth day.
After randomization, 12 cases that were found not to meet inclusion criteria and 7 cases with incomplete data were included in the intention-to-treat analysis but were not available for the as-treated analysis, which now comprised 203 patients in the stent group and 204 in the no-stent group.
The distinction between these two analyses became important because the results were different. In the as-treated analysis, the rate of post-ERCP pancreatitis was significantly lower (P = .02) with the stent (7.9%) than without the stent (15.2%), the investigators said.
In contrast, in the intention-to-treat analysis, the rate of post-ERCP pancreatitis was lower, but not significantly so, with the stent (9.4%) than without the stent (14.6%). The overall rate of post-ERCP pancreatitis in this study was approximately 11%, which "agrees in general with previous reports."
There was no significant difference in the rise in serum amylase levels between the stent and no-stent groups.
Stent placement failed in 25 patients (12%) in whom it was attempted. In three of these cases, anatomic deformities of the pancreatic duct were the cause. In another 15 cases, the duct could not be cannulated, and in the remaining 7 cases, the guidewire could not be passed deeply enough.
Six factors were found to put patients at risk for developing post-ERCP pancreatitis: undergoing pancreatography first, not achieving placement of the pancreatic stent, a procedure time of 30 minutes or longer, sampling of the pancreatic tissue by any method, undergoing intraductal ultrasonography, and difficulty in achieving cannulation (defined as taking 15 minutes or longer to do so).
"This indicates that post-ERCP pancreatitis might be affected by other factors as well as papillary edema, such as the direct burden placed on the pancreatic duct" by instrumentation used in tissue sampling and intraductal ultrasonography rubbing against it, the researchers noted.
In cases in which it was difficult to cannulate the bile duct, endoscopists sometimes placed a pancreatic guidewire to facilitate biliary cannulation. Such guidewires were used in approximately 35% of patients who developed post-ERCP pancreatitis, compared with only 8% of patients who did not develop post-ERCP pancreatitis.
"This suggests the possibility of direct damage to the pancreatic duct by the guidewire," they said. Use of a softer, more delicate guidewire might be beneficial when guidewire use cannot be avoided, they added.
This study had no financial support, and the authors stated that they had no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Overweight, Obesity Linked to Higher Mortality Risk in Black Women
Among black women, the risk of death from any cause is increased for all categories of overweight and obesity, as it is in whites, according to a report in the Sept. 8 issue of the New England Journal of Medicine.
The hazard ratios also are similar in magnitude for black women as for white women and men, said Deborah A. Boggs, Sc.D., of the Slone Epidemiology Center at Boston University, and her associates (N. Engl. J. Med. 2011;365:901-8).
Previous studies of the link between overweight and mortality have included only a limited number of black subjects or have failed to report results on black subjects separately from those on whites, so it was uncertain whether the association was present in black women. Yet the prevalence of obesity and abdominal obesity both have risen fastest in black women, with projections that by 2020, 70% of black women will be obese and 90% will have abdominal obesity, the investigators noted.
Dr. Boggs and her colleagues used data on a subgroup of 51,695 subjects enrolled in the Black Women’s Health Study (BWHS) to examine the relationship between risk of death and both overall and abdominal obesity. They focused their analysis on the 33,916 subjects who had never smoked because this association can be confounded by the effects of smoking.
The BWHS is an ongoing prospective follow-up study of black women across the United States who were aged 21-69 years at enrollment in 1995 and who have been followed every 2 years since then.
The researchers found that the association between body mass index (BMI) and risk of death from any cause was curvilinear: lowest among women with a BMI of 20-25 kg/m2 and rising as BMI approached both the lower and the higher extremes. Mortality risk was increased for every category of BMI in the overweight and obesity range.
Among women with a BMI of 20 or higher, every 5-unit increase in BMI correlated with an 18% rise in the risk of death. "Previous studies involving black women have shown weaker associations of BMI with risk of death," but those studies were small or otherwise flawed, the investigators said.
The higher mortality seen among women with the lowest BMI may have been associated with illness-related weight loss, they added.
Larger waist circumference was not significantly associated with increased risk of death except among nonobese black women. In contrast, previous studies in white women and men found larger waist circumference to predict higher mortality risk, independently of BMI.
The positive association between BMI and risk of death was particularly strong for cardiovascular causes of death. For other causes of death, only a very high BMI was associated with increased risk. And there were no associations between BMI and risk of death from cancer in this study.
The link between BMI and risk of death from all causes was stronger among women with higher levels of education, but not significantly so. Such an association may be more evident among less-educated persons because they have higher absolute risks of death and because of other factors related to low socioeconomic status, such as psychosocial stress and limited access to care, Dr. Boggs and her associates said.
"Previous studies of BMI and risk of death involving blacks have included a greater proportion of less-educated participants. This difference may account in part for the stronger relationship in the present study than that previously reported among blacks," they added.
It is unknown whether the study results can be generalized to black men, the investigators said.
This study was supported by the National Cancer Institute. Dr. Boggs and her associates reported no relevant financial disclosures.
Among black women, the risk of death from any cause is increased for all categories of overweight and obesity, as it is in whites, according to a report in the Sept. 8 issue of the New England Journal of Medicine.
The hazard ratios also are similar in magnitude for black women as for white women and men, said Deborah A. Boggs, Sc.D., of the Slone Epidemiology Center at Boston University, and her associates (N. Engl. J. Med. 2011;365:901-8).
Previous studies of the link between overweight and mortality have included only a limited number of black subjects or have failed to report results on black subjects separately from those on whites, so it was uncertain whether the association was present in black women. Yet the prevalence of obesity and abdominal obesity both have risen fastest in black women, with projections that by 2020, 70% of black women will be obese and 90% will have abdominal obesity, the investigators noted.
Dr. Boggs and her colleagues used data on a subgroup of 51,695 subjects enrolled in the Black Women’s Health Study (BWHS) to examine the relationship between risk of death and both overall and abdominal obesity. They focused their analysis on the 33,916 subjects who had never smoked because this association can be confounded by the effects of smoking.
The BWHS is an ongoing prospective follow-up study of black women across the United States who were aged 21-69 years at enrollment in 1995 and who have been followed every 2 years since then.
The researchers found that the association between body mass index (BMI) and risk of death from any cause was curvilinear: lowest among women with a BMI of 20-25 kg/m2 and rising as BMI approached both the lower and the higher extremes. Mortality risk was increased for every category of BMI in the overweight and obesity range.
Among women with a BMI of 20 or higher, every 5-unit increase in BMI correlated with an 18% rise in the risk of death. "Previous studies involving black women have shown weaker associations of BMI with risk of death," but those studies were small or otherwise flawed, the investigators said.
The higher mortality seen among women with the lowest BMI may have been associated with illness-related weight loss, they added.
Larger waist circumference was not significantly associated with increased risk of death except among nonobese black women. In contrast, previous studies in white women and men found larger waist circumference to predict higher mortality risk, independently of BMI.
The positive association between BMI and risk of death was particularly strong for cardiovascular causes of death. For other causes of death, only a very high BMI was associated with increased risk. And there were no associations between BMI and risk of death from cancer in this study.
The link between BMI and risk of death from all causes was stronger among women with higher levels of education, but not significantly so. Such an association may be more evident among less-educated persons because they have higher absolute risks of death and because of other factors related to low socioeconomic status, such as psychosocial stress and limited access to care, Dr. Boggs and her associates said.
"Previous studies of BMI and risk of death involving blacks have included a greater proportion of less-educated participants. This difference may account in part for the stronger relationship in the present study than that previously reported among blacks," they added.
It is unknown whether the study results can be generalized to black men, the investigators said.
This study was supported by the National Cancer Institute. Dr. Boggs and her associates reported no relevant financial disclosures.
Among black women, the risk of death from any cause is increased for all categories of overweight and obesity, as it is in whites, according to a report in the Sept. 8 issue of the New England Journal of Medicine.
The hazard ratios also are similar in magnitude for black women as for white women and men, said Deborah A. Boggs, Sc.D., of the Slone Epidemiology Center at Boston University, and her associates (N. Engl. J. Med. 2011;365:901-8).
Previous studies of the link between overweight and mortality have included only a limited number of black subjects or have failed to report results on black subjects separately from those on whites, so it was uncertain whether the association was present in black women. Yet the prevalence of obesity and abdominal obesity both have risen fastest in black women, with projections that by 2020, 70% of black women will be obese and 90% will have abdominal obesity, the investigators noted.
Dr. Boggs and her colleagues used data on a subgroup of 51,695 subjects enrolled in the Black Women’s Health Study (BWHS) to examine the relationship between risk of death and both overall and abdominal obesity. They focused their analysis on the 33,916 subjects who had never smoked because this association can be confounded by the effects of smoking.
The BWHS is an ongoing prospective follow-up study of black women across the United States who were aged 21-69 years at enrollment in 1995 and who have been followed every 2 years since then.
The researchers found that the association between body mass index (BMI) and risk of death from any cause was curvilinear: lowest among women with a BMI of 20-25 kg/m2 and rising as BMI approached both the lower and the higher extremes. Mortality risk was increased for every category of BMI in the overweight and obesity range.
Among women with a BMI of 20 or higher, every 5-unit increase in BMI correlated with an 18% rise in the risk of death. "Previous studies involving black women have shown weaker associations of BMI with risk of death," but those studies were small or otherwise flawed, the investigators said.
The higher mortality seen among women with the lowest BMI may have been associated with illness-related weight loss, they added.
Larger waist circumference was not significantly associated with increased risk of death except among nonobese black women. In contrast, previous studies in white women and men found larger waist circumference to predict higher mortality risk, independently of BMI.
The positive association between BMI and risk of death was particularly strong for cardiovascular causes of death. For other causes of death, only a very high BMI was associated with increased risk. And there were no associations between BMI and risk of death from cancer in this study.
The link between BMI and risk of death from all causes was stronger among women with higher levels of education, but not significantly so. Such an association may be more evident among less-educated persons because they have higher absolute risks of death and because of other factors related to low socioeconomic status, such as psychosocial stress and limited access to care, Dr. Boggs and her associates said.
"Previous studies of BMI and risk of death involving blacks have included a greater proportion of less-educated participants. This difference may account in part for the stronger relationship in the present study than that previously reported among blacks," they added.
It is unknown whether the study results can be generalized to black men, the investigators said.
This study was supported by the National Cancer Institute. Dr. Boggs and her associates reported no relevant financial disclosures.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major Finding: Black women’s risk of death from any cause was increased in all categories of overweight and obesity, so that at a body mass index of 20 kg/m2 or higher, every 5-unit increase in BMI correlated with an 18% rise in mortality risk.
Data Source: The ongoing, prospective follow-up Black Women’s Health Study of 51,695 subjects in the United States who were aged 21-69 years at enrollment in 1995.
Disclosures: This study was supported by the National Cancer Institute. Dr. Boggs and her associates reported no relevant financial disclosures.
Medical Therapy Beats Intracranial Stenting for Stroke
Correction: An earlier version of this story reported incorrect rates for the secondary end point of any stroke and any major hemorrhage for patients treated with percutaneuous transluminal angioplasty compared with medical management. This version has been corrected.
Aggressive medical management was superior to intracranial stenting for preventing recurrent stroke in patients with intracranial artery stenosis in the first randomized clinical trial to compare the two approaches.
The main drawback with percutaneous transluminal angioplasty and stenting (PTAS) was the relatively high rate of the combined primary end point of stroke or death within 30 days of enrollment or after revascularization of the target artery at any time during follow-up, or an ischemic stroke in the territory of the target artery at any time during follow-up. The trial was halted early when an interim analysis revealed that in the PTAS group, this rate was more than double what was observed in the medical therapy group (14.7% vs. 5.8%), Dr. Marc I. Chimowitz of the stroke program at the Medical University of South Carolina, Charleston, and his associates reported online Sept. 7 in the New England Journal of Medicine.
This trial, called the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study, involved the self-expanding Wingspan stent system (marketed by Stryker Neurovascular, formerly Boston Scientific Neurovascular), the only device approved by the Food and Drug Administration for use in treating atherosclerotic intracranial arterial stenosis. However, other similar devices are widely used "off label" in clinical practice. "Over the past decade, intracranial PTAS has increasingly been used in the United States and other countries," the investigators noted.
"The SAMMPRIS study results have immediate implications for clinical practice. Stroke patients with recent symptoms and intracranial arterial blockage of 70% or greater should be treated with aggressive medical therapy alone that follows the regimen used in this trial as closely as possible," Dr. Chimowitz said in a statement from the National Institute of Neurological Disorders and Stroke, which funded the trial.
The study enrolled 451 patients at 50 medical centers who had had a transient ischemic attack or a nondisabling stroke within the preceding 30 days, which was found on angiography to be due to 70%-99% stenosis of the diameter of a major intracranial artery. In all, 227 subjects were randomly assigned to receive aggressive medical management alone and 224 to receive identical medical therapy plus PTAS (N. Engl. J. Med. 2011 Sept. 7 [doi:10.1056/NEJMoa1105335]).
The medical management comprised daily aspirin (325 mg), daily clopidogrel (75 mg) for 90 days after enrollment, management of primary risk factors such as hypertension and hypercholesterolemia, and management of secondary risk factors such as diabetes, smoking, excess body weight, and insufficient exercise using a lifestyle modification program.
The probability of the combined primary end point at the end of 1 year of follow-up also differed significantly between the two groups (20% with PTAS and 12% with medical management).
There were five stroke-related deaths in the PTAS group (2.2%), compared with one death unrelated to stroke in the medical management group (0.4%).
Among the 33 strokes that occurred in the PTAS group within 1 month of enrollment, 25 happened within a day of the procedure and the remaining 8 took place within a week.
PTAS also led to a significantly higher rate of the secondary end point of any stroke and any major hemorrhage (23.2%), compared with medical management (16.3%).
"Contrary to what we hypothesized, the results of this trial showed that aggressive medical therapy was superior to PTAS with the use of the Wingspan system in high-risk patients with intracranial stenosis, because the rate of periprocedural stroke after PTAS was higher than expected and the rate of stroke in the medical management group was lower than estimated," Dr. Chimowitz and his colleagues wrote.
With regard to the success of medical therapy, "we were surprised at the extent and rapidity of the reduction" in recurrent stroke, they noted.
"One possible explanation for the higher rate of periprocedural stroke in this trial as compared with the [device] registries is that all the patients in this study had stenosis of 70% to 99% and recent symptoms, whereas the registries included patients with stenosis of 50% to 90% and symptoms that had occurred more than 30 days before enrollment. Recent symptoms may be a marker for unstable plaque, which could increase the risk of distal embolism during stenting," the researchers wrote.
The study findings warrant an immediate change in clinical practice. "Although not all the components of the aggressive medical regimen used in this trial may be easy to duplicate in clinical practice, essential elements can readily be adopted, including adding clopidogrel to aspirin for the first 90 days and following the trial’s protocol with respect to lowering blood pressure and LDL cholesterol," they wrote.
Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided stents and supplemental funding for the trial. AstraZeneca provided rosuvastatin, and Walgreens Pharmacies provided other study medications at a discount. Nationwide Better Health-INTERVENT provided a lifestyle modification program at a discount. Dr. Chimowitz’s colleagues disclosed potential conflicts of interest with numerous companies that manufacture neurovascular devices.
One surprising finding was that symptomatic intracranial hemorrhage, which is a relatively rare complication after revascularization of extracranial artery stenosis, accounted for almost one-third of the perioperative strokes in SAMMPRIS, according to Dr. Joseph P. Broderick.
"The intracranial hemorrhages were thought to be due to reperfusion hemorrhage or subarachnoid hemorrhage from wire manipulations during the procedure," he wrote.
"It is hoped that future analysis of data from the SAMMPRIS trial will clarify whether the recurrent strokes were due to embolism, stent thrombosis, or low perfusion pressure related to a critical stenosis."
Dr. Broderick is chair of the department of neurology at the University of Cincinnati. He reported being a consultant for Genentech. These remarks were taken from his editorial that accompanied the SAMMPRIS report (N. Engl. J. Med. 2011 Sept. 7 [doi:10.1056/NEJMe1108394]).
One surprising finding was that symptomatic intracranial hemorrhage, which is a relatively rare complication after revascularization of extracranial artery stenosis, accounted for almost one-third of the perioperative strokes in SAMMPRIS, according to Dr. Joseph P. Broderick.
"The intracranial hemorrhages were thought to be due to reperfusion hemorrhage or subarachnoid hemorrhage from wire manipulations during the procedure," he wrote.
"It is hoped that future analysis of data from the SAMMPRIS trial will clarify whether the recurrent strokes were due to embolism, stent thrombosis, or low perfusion pressure related to a critical stenosis."
Dr. Broderick is chair of the department of neurology at the University of Cincinnati. He reported being a consultant for Genentech. These remarks were taken from his editorial that accompanied the SAMMPRIS report (N. Engl. J. Med. 2011 Sept. 7 [doi:10.1056/NEJMe1108394]).
One surprising finding was that symptomatic intracranial hemorrhage, which is a relatively rare complication after revascularization of extracranial artery stenosis, accounted for almost one-third of the perioperative strokes in SAMMPRIS, according to Dr. Joseph P. Broderick.
"The intracranial hemorrhages were thought to be due to reperfusion hemorrhage or subarachnoid hemorrhage from wire manipulations during the procedure," he wrote.
"It is hoped that future analysis of data from the SAMMPRIS trial will clarify whether the recurrent strokes were due to embolism, stent thrombosis, or low perfusion pressure related to a critical stenosis."
Dr. Broderick is chair of the department of neurology at the University of Cincinnati. He reported being a consultant for Genentech. These remarks were taken from his editorial that accompanied the SAMMPRIS report (N. Engl. J. Med. 2011 Sept. 7 [doi:10.1056/NEJMe1108394]).
Correction: An earlier version of this story reported incorrect rates for the secondary end point of any stroke and any major hemorrhage for patients treated with percutaneuous transluminal angioplasty compared with medical management. This version has been corrected.
Aggressive medical management was superior to intracranial stenting for preventing recurrent stroke in patients with intracranial artery stenosis in the first randomized clinical trial to compare the two approaches.
The main drawback with percutaneous transluminal angioplasty and stenting (PTAS) was the relatively high rate of the combined primary end point of stroke or death within 30 days of enrollment or after revascularization of the target artery at any time during follow-up, or an ischemic stroke in the territory of the target artery at any time during follow-up. The trial was halted early when an interim analysis revealed that in the PTAS group, this rate was more than double what was observed in the medical therapy group (14.7% vs. 5.8%), Dr. Marc I. Chimowitz of the stroke program at the Medical University of South Carolina, Charleston, and his associates reported online Sept. 7 in the New England Journal of Medicine.
This trial, called the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study, involved the self-expanding Wingspan stent system (marketed by Stryker Neurovascular, formerly Boston Scientific Neurovascular), the only device approved by the Food and Drug Administration for use in treating atherosclerotic intracranial arterial stenosis. However, other similar devices are widely used "off label" in clinical practice. "Over the past decade, intracranial PTAS has increasingly been used in the United States and other countries," the investigators noted.
"The SAMMPRIS study results have immediate implications for clinical practice. Stroke patients with recent symptoms and intracranial arterial blockage of 70% or greater should be treated with aggressive medical therapy alone that follows the regimen used in this trial as closely as possible," Dr. Chimowitz said in a statement from the National Institute of Neurological Disorders and Stroke, which funded the trial.
The study enrolled 451 patients at 50 medical centers who had had a transient ischemic attack or a nondisabling stroke within the preceding 30 days, which was found on angiography to be due to 70%-99% stenosis of the diameter of a major intracranial artery. In all, 227 subjects were randomly assigned to receive aggressive medical management alone and 224 to receive identical medical therapy plus PTAS (N. Engl. J. Med. 2011 Sept. 7 [doi:10.1056/NEJMoa1105335]).
The medical management comprised daily aspirin (325 mg), daily clopidogrel (75 mg) for 90 days after enrollment, management of primary risk factors such as hypertension and hypercholesterolemia, and management of secondary risk factors such as diabetes, smoking, excess body weight, and insufficient exercise using a lifestyle modification program.
The probability of the combined primary end point at the end of 1 year of follow-up also differed significantly between the two groups (20% with PTAS and 12% with medical management).
There were five stroke-related deaths in the PTAS group (2.2%), compared with one death unrelated to stroke in the medical management group (0.4%).
Among the 33 strokes that occurred in the PTAS group within 1 month of enrollment, 25 happened within a day of the procedure and the remaining 8 took place within a week.
PTAS also led to a significantly higher rate of the secondary end point of any stroke and any major hemorrhage (23.2%), compared with medical management (16.3%).
"Contrary to what we hypothesized, the results of this trial showed that aggressive medical therapy was superior to PTAS with the use of the Wingspan system in high-risk patients with intracranial stenosis, because the rate of periprocedural stroke after PTAS was higher than expected and the rate of stroke in the medical management group was lower than estimated," Dr. Chimowitz and his colleagues wrote.
With regard to the success of medical therapy, "we were surprised at the extent and rapidity of the reduction" in recurrent stroke, they noted.
"One possible explanation for the higher rate of periprocedural stroke in this trial as compared with the [device] registries is that all the patients in this study had stenosis of 70% to 99% and recent symptoms, whereas the registries included patients with stenosis of 50% to 90% and symptoms that had occurred more than 30 days before enrollment. Recent symptoms may be a marker for unstable plaque, which could increase the risk of distal embolism during stenting," the researchers wrote.
The study findings warrant an immediate change in clinical practice. "Although not all the components of the aggressive medical regimen used in this trial may be easy to duplicate in clinical practice, essential elements can readily be adopted, including adding clopidogrel to aspirin for the first 90 days and following the trial’s protocol with respect to lowering blood pressure and LDL cholesterol," they wrote.
Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided stents and supplemental funding for the trial. AstraZeneca provided rosuvastatin, and Walgreens Pharmacies provided other study medications at a discount. Nationwide Better Health-INTERVENT provided a lifestyle modification program at a discount. Dr. Chimowitz’s colleagues disclosed potential conflicts of interest with numerous companies that manufacture neurovascular devices.
Correction: An earlier version of this story reported incorrect rates for the secondary end point of any stroke and any major hemorrhage for patients treated with percutaneuous transluminal angioplasty compared with medical management. This version has been corrected.
Aggressive medical management was superior to intracranial stenting for preventing recurrent stroke in patients with intracranial artery stenosis in the first randomized clinical trial to compare the two approaches.
The main drawback with percutaneous transluminal angioplasty and stenting (PTAS) was the relatively high rate of the combined primary end point of stroke or death within 30 days of enrollment or after revascularization of the target artery at any time during follow-up, or an ischemic stroke in the territory of the target artery at any time during follow-up. The trial was halted early when an interim analysis revealed that in the PTAS group, this rate was more than double what was observed in the medical therapy group (14.7% vs. 5.8%), Dr. Marc I. Chimowitz of the stroke program at the Medical University of South Carolina, Charleston, and his associates reported online Sept. 7 in the New England Journal of Medicine.
This trial, called the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study, involved the self-expanding Wingspan stent system (marketed by Stryker Neurovascular, formerly Boston Scientific Neurovascular), the only device approved by the Food and Drug Administration for use in treating atherosclerotic intracranial arterial stenosis. However, other similar devices are widely used "off label" in clinical practice. "Over the past decade, intracranial PTAS has increasingly been used in the United States and other countries," the investigators noted.
"The SAMMPRIS study results have immediate implications for clinical practice. Stroke patients with recent symptoms and intracranial arterial blockage of 70% or greater should be treated with aggressive medical therapy alone that follows the regimen used in this trial as closely as possible," Dr. Chimowitz said in a statement from the National Institute of Neurological Disorders and Stroke, which funded the trial.
The study enrolled 451 patients at 50 medical centers who had had a transient ischemic attack or a nondisabling stroke within the preceding 30 days, which was found on angiography to be due to 70%-99% stenosis of the diameter of a major intracranial artery. In all, 227 subjects were randomly assigned to receive aggressive medical management alone and 224 to receive identical medical therapy plus PTAS (N. Engl. J. Med. 2011 Sept. 7 [doi:10.1056/NEJMoa1105335]).
The medical management comprised daily aspirin (325 mg), daily clopidogrel (75 mg) for 90 days after enrollment, management of primary risk factors such as hypertension and hypercholesterolemia, and management of secondary risk factors such as diabetes, smoking, excess body weight, and insufficient exercise using a lifestyle modification program.
The probability of the combined primary end point at the end of 1 year of follow-up also differed significantly between the two groups (20% with PTAS and 12% with medical management).
There were five stroke-related deaths in the PTAS group (2.2%), compared with one death unrelated to stroke in the medical management group (0.4%).
Among the 33 strokes that occurred in the PTAS group within 1 month of enrollment, 25 happened within a day of the procedure and the remaining 8 took place within a week.
PTAS also led to a significantly higher rate of the secondary end point of any stroke and any major hemorrhage (23.2%), compared with medical management (16.3%).
"Contrary to what we hypothesized, the results of this trial showed that aggressive medical therapy was superior to PTAS with the use of the Wingspan system in high-risk patients with intracranial stenosis, because the rate of periprocedural stroke after PTAS was higher than expected and the rate of stroke in the medical management group was lower than estimated," Dr. Chimowitz and his colleagues wrote.
With regard to the success of medical therapy, "we were surprised at the extent and rapidity of the reduction" in recurrent stroke, they noted.
"One possible explanation for the higher rate of periprocedural stroke in this trial as compared with the [device] registries is that all the patients in this study had stenosis of 70% to 99% and recent symptoms, whereas the registries included patients with stenosis of 50% to 90% and symptoms that had occurred more than 30 days before enrollment. Recent symptoms may be a marker for unstable plaque, which could increase the risk of distal embolism during stenting," the researchers wrote.
The study findings warrant an immediate change in clinical practice. "Although not all the components of the aggressive medical regimen used in this trial may be easy to duplicate in clinical practice, essential elements can readily be adopted, including adding clopidogrel to aspirin for the first 90 days and following the trial’s protocol with respect to lowering blood pressure and LDL cholesterol," they wrote.
Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided stents and supplemental funding for the trial. AstraZeneca provided rosuvastatin, and Walgreens Pharmacies provided other study medications at a discount. Nationwide Better Health-INTERVENT provided a lifestyle modification program at a discount. Dr. Chimowitz’s colleagues disclosed potential conflicts of interest with numerous companies that manufacture neurovascular devices.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major Finding: The probability of the combined end point of recurrent stroke or death within 30 days was 14.7% with stenting, compared with only 5.8% with aggressive medical management.
Data Source: The SAMMPRIS study, a randomized clinical trial involving 451 patients who were treated at 50 U.S. medical centers for intracranial artery stenosis following a TIA or stroke.
Disclosures: The study was funded by the National Institute of Neurological Disorders and Stroke. Stryker Neurovascular (formerly Boston Scientific Neurovascular) provided stents and supplemental funding. AstraZeneca provided rosuvastatin, and Walgreens Pharmacies provided other study medications at a discount. Nationwide Better Health-INTERVENT provided a lifestyle modification program at a discount. Dr. Chimowitz’s colleagues disclosed potential conflicts of interest with numerous companies that manufacture neurovascular devices.
Medical Students' Biases Don't Affect Clinical Decisions
First-year medical students show an unconscious preference toward the white race and the upper class on two tests that measure automatic responses to racial and social visual cues, according to a report in the Sept. 7 issue of JAMA.
But surprisingly, these preferences did not influence the students’ clinical assessments or decision making in a series of hypothetical medical vignettes, said the researchers, led by Dr. Adil H. Haider, codirector of the Center for Surgical Trials and Outcomes Research at the Johns Hopkins University, Baltimore.
Previous studies among older physicians have shown that such unconscious biases influence their clinical decisions, the researchers noted. For example, physicians typically prescribe fewer analgesics for black or Hispanic patients than they do for white patients, despite identical self-reported assessments of pain. In turn, these implicit preferences could be the source of some of the race- and class-based disparities in American health care, the team said.
"Unconscious biases are normal and rooted in stereotyping, a cognitive process in which individuals use a social category to acquire, process, and recall information about people," Dr. Haider and his colleagues explained.
To assess unconscious race and class biases, the team did a Web-based survey of two cohorts of 202 first-year medical students at a single institution. The study subjects responded to eight written clinical vignettes that involved assessing pain, obtaining consent for a procedure, judging the reliability of a patient or family, and assessing the trustworthiness of hypothetical patients representing two races (black and white) and two social classes (upper and lower class).
The students also took the validated, race-focused Implicit Association Test (IAT), which assesses unconscious attitudes toward racial groups by measuring reaction times to visual and language cues, and a similar but not yet validated social class–focused IAT. The study subjects also answered direct questions about their explicit racial and class biases and provided demographic information, including their own ethnicity.
As in the general population, most of the medical students reported that they had no conscious racial preferences. Only 39% said they explicitly preferred white people and 7% said they explicitly preferred black people. The subjects appeared less guarded in their self-reports of class bias, with 51% saying they explicitly preferred upper-class individuals and 12% saying they explicitly preferred lower-class individuals.
However, the IATs revealed that these conscious preferences did not correlate well with subjects’ implicit (unconscious) preferences. The IAT results showed that unconsciously, 69% of medical students preferred white people and 86% preferred upper-class individuals, which are numbers similar to those in studies of the general population.
Yet, the medical students’ responses to the medical vignettes did not reflect either their unconscious or conscious preferences. There was no association between the hypothetical patients’ race or class and the students’ responses to the clinical situations. Similarly, there was no association between the hypothetical patients’ race or class and the students’ IAT scores, the investigators said (JAMA 2011;306:942-51).
In further analyses, the researchers continued to find no impact of the students’ biases on clinical decision making. These analyses included categorizing the students’ clinical responses according to their races and self-reported social classes. Even in the subgroup of students who admitted to having explicit racial (93 students) and class (125 students) biases, no clinical–decision making effect appeared.
The findings among medical students stand in stark contrast to results among practicing physicians, where "implicit race and social class biases ... are increasingly recognized as potential factors contributing to disparities in health care," Dr. Haider and his colleagues said.
They deemed the reasons for this discrepancy between students and physicians unknown. Possibly, because the students are younger, they "have been more exposed to educational curricula focused on cultural competency, translating to improved awareness and management of implicit bias," the team said.
It also is possible that students who "have not yet been exposed to the rigors of medical training" might not yet be influenced by implicit biases, the researchers suggested.
They called for further study of whether experiences during medical training influence social or racial bias in clinical decision making. If so, "medical training could be an effective intervention point to decrease implicit biases and possibly mitigate physician-driven health care disparities," they added.
The study was supported by the National Institute of General Medical Sciences, the National Institutes of Health, the American College of Surgeons, and the National Heart, Lung, and Blood Institute. The authors reported no financial conflict of interest.
The reason that medical students didn’t demonstrate their mostly unconscious racial and class biases in this study may be that they were able to focus their attention fully on the hypothetical vignettes and were motivated to get the "right" answer. In contrast, physicians in practice make clinical decisions in an atmosphere characterized by stress, multiple demands on working memory, distractions, a heavy workload, and time pressure, said Michelle van Ryn, Ph.D., and Dr. Somnath Saha.
Decision making is less likely to be affected by unconscious bias "when people are engaging in deliberate, thought-out decisions and have the cognitive resources, motivation, and opportunity to consider the pros and cons of different actions." In contrast, bias may take precedence when cognitive processing capacity is taxed and "people are less able to override automatic categorizing and stereotyping," they noted.
"When clinicians have sufficient cognitive resources, time, information, and motivation to be unbiased, their intent to provide equitable care is not undermined by biased implicit attitudes," Dr. van Ryn and Dr. Saha said.
Dr. van Ryn is in the department of family medicine and community health at the University of Minnesota, Minneapolis. Dr. Saha is in internal medicine at Portland Veterans Affairs Medical Center and Oregon Health & Science University, Portland. They reported no financial conflict of interest. These remarks were taken from their editorial (JAMA 2011;306:995-6) that accompanied the report by Dr. Haider and his colleagues.
The reason that medical students didn’t demonstrate their mostly unconscious racial and class biases in this study may be that they were able to focus their attention fully on the hypothetical vignettes and were motivated to get the "right" answer. In contrast, physicians in practice make clinical decisions in an atmosphere characterized by stress, multiple demands on working memory, distractions, a heavy workload, and time pressure, said Michelle van Ryn, Ph.D., and Dr. Somnath Saha.
Decision making is less likely to be affected by unconscious bias "when people are engaging in deliberate, thought-out decisions and have the cognitive resources, motivation, and opportunity to consider the pros and cons of different actions." In contrast, bias may take precedence when cognitive processing capacity is taxed and "people are less able to override automatic categorizing and stereotyping," they noted.
"When clinicians have sufficient cognitive resources, time, information, and motivation to be unbiased, their intent to provide equitable care is not undermined by biased implicit attitudes," Dr. van Ryn and Dr. Saha said.
Dr. van Ryn is in the department of family medicine and community health at the University of Minnesota, Minneapolis. Dr. Saha is in internal medicine at Portland Veterans Affairs Medical Center and Oregon Health & Science University, Portland. They reported no financial conflict of interest. These remarks were taken from their editorial (JAMA 2011;306:995-6) that accompanied the report by Dr. Haider and his colleagues.
The reason that medical students didn’t demonstrate their mostly unconscious racial and class biases in this study may be that they were able to focus their attention fully on the hypothetical vignettes and were motivated to get the "right" answer. In contrast, physicians in practice make clinical decisions in an atmosphere characterized by stress, multiple demands on working memory, distractions, a heavy workload, and time pressure, said Michelle van Ryn, Ph.D., and Dr. Somnath Saha.
Decision making is less likely to be affected by unconscious bias "when people are engaging in deliberate, thought-out decisions and have the cognitive resources, motivation, and opportunity to consider the pros and cons of different actions." In contrast, bias may take precedence when cognitive processing capacity is taxed and "people are less able to override automatic categorizing and stereotyping," they noted.
"When clinicians have sufficient cognitive resources, time, information, and motivation to be unbiased, their intent to provide equitable care is not undermined by biased implicit attitudes," Dr. van Ryn and Dr. Saha said.
Dr. van Ryn is in the department of family medicine and community health at the University of Minnesota, Minneapolis. Dr. Saha is in internal medicine at Portland Veterans Affairs Medical Center and Oregon Health & Science University, Portland. They reported no financial conflict of interest. These remarks were taken from their editorial (JAMA 2011;306:995-6) that accompanied the report by Dr. Haider and his colleagues.
First-year medical students show an unconscious preference toward the white race and the upper class on two tests that measure automatic responses to racial and social visual cues, according to a report in the Sept. 7 issue of JAMA.
But surprisingly, these preferences did not influence the students’ clinical assessments or decision making in a series of hypothetical medical vignettes, said the researchers, led by Dr. Adil H. Haider, codirector of the Center for Surgical Trials and Outcomes Research at the Johns Hopkins University, Baltimore.
Previous studies among older physicians have shown that such unconscious biases influence their clinical decisions, the researchers noted. For example, physicians typically prescribe fewer analgesics for black or Hispanic patients than they do for white patients, despite identical self-reported assessments of pain. In turn, these implicit preferences could be the source of some of the race- and class-based disparities in American health care, the team said.
"Unconscious biases are normal and rooted in stereotyping, a cognitive process in which individuals use a social category to acquire, process, and recall information about people," Dr. Haider and his colleagues explained.
To assess unconscious race and class biases, the team did a Web-based survey of two cohorts of 202 first-year medical students at a single institution. The study subjects responded to eight written clinical vignettes that involved assessing pain, obtaining consent for a procedure, judging the reliability of a patient or family, and assessing the trustworthiness of hypothetical patients representing two races (black and white) and two social classes (upper and lower class).
The students also took the validated, race-focused Implicit Association Test (IAT), which assesses unconscious attitudes toward racial groups by measuring reaction times to visual and language cues, and a similar but not yet validated social class–focused IAT. The study subjects also answered direct questions about their explicit racial and class biases and provided demographic information, including their own ethnicity.
As in the general population, most of the medical students reported that they had no conscious racial preferences. Only 39% said they explicitly preferred white people and 7% said they explicitly preferred black people. The subjects appeared less guarded in their self-reports of class bias, with 51% saying they explicitly preferred upper-class individuals and 12% saying they explicitly preferred lower-class individuals.
However, the IATs revealed that these conscious preferences did not correlate well with subjects’ implicit (unconscious) preferences. The IAT results showed that unconsciously, 69% of medical students preferred white people and 86% preferred upper-class individuals, which are numbers similar to those in studies of the general population.
Yet, the medical students’ responses to the medical vignettes did not reflect either their unconscious or conscious preferences. There was no association between the hypothetical patients’ race or class and the students’ responses to the clinical situations. Similarly, there was no association between the hypothetical patients’ race or class and the students’ IAT scores, the investigators said (JAMA 2011;306:942-51).
In further analyses, the researchers continued to find no impact of the students’ biases on clinical decision making. These analyses included categorizing the students’ clinical responses according to their races and self-reported social classes. Even in the subgroup of students who admitted to having explicit racial (93 students) and class (125 students) biases, no clinical–decision making effect appeared.
The findings among medical students stand in stark contrast to results among practicing physicians, where "implicit race and social class biases ... are increasingly recognized as potential factors contributing to disparities in health care," Dr. Haider and his colleagues said.
They deemed the reasons for this discrepancy between students and physicians unknown. Possibly, because the students are younger, they "have been more exposed to educational curricula focused on cultural competency, translating to improved awareness and management of implicit bias," the team said.
It also is possible that students who "have not yet been exposed to the rigors of medical training" might not yet be influenced by implicit biases, the researchers suggested.
They called for further study of whether experiences during medical training influence social or racial bias in clinical decision making. If so, "medical training could be an effective intervention point to decrease implicit biases and possibly mitigate physician-driven health care disparities," they added.
The study was supported by the National Institute of General Medical Sciences, the National Institutes of Health, the American College of Surgeons, and the National Heart, Lung, and Blood Institute. The authors reported no financial conflict of interest.
First-year medical students show an unconscious preference toward the white race and the upper class on two tests that measure automatic responses to racial and social visual cues, according to a report in the Sept. 7 issue of JAMA.
But surprisingly, these preferences did not influence the students’ clinical assessments or decision making in a series of hypothetical medical vignettes, said the researchers, led by Dr. Adil H. Haider, codirector of the Center for Surgical Trials and Outcomes Research at the Johns Hopkins University, Baltimore.
Previous studies among older physicians have shown that such unconscious biases influence their clinical decisions, the researchers noted. For example, physicians typically prescribe fewer analgesics for black or Hispanic patients than they do for white patients, despite identical self-reported assessments of pain. In turn, these implicit preferences could be the source of some of the race- and class-based disparities in American health care, the team said.
"Unconscious biases are normal and rooted in stereotyping, a cognitive process in which individuals use a social category to acquire, process, and recall information about people," Dr. Haider and his colleagues explained.
To assess unconscious race and class biases, the team did a Web-based survey of two cohorts of 202 first-year medical students at a single institution. The study subjects responded to eight written clinical vignettes that involved assessing pain, obtaining consent for a procedure, judging the reliability of a patient or family, and assessing the trustworthiness of hypothetical patients representing two races (black and white) and two social classes (upper and lower class).
The students also took the validated, race-focused Implicit Association Test (IAT), which assesses unconscious attitudes toward racial groups by measuring reaction times to visual and language cues, and a similar but not yet validated social class–focused IAT. The study subjects also answered direct questions about their explicit racial and class biases and provided demographic information, including their own ethnicity.
As in the general population, most of the medical students reported that they had no conscious racial preferences. Only 39% said they explicitly preferred white people and 7% said they explicitly preferred black people. The subjects appeared less guarded in their self-reports of class bias, with 51% saying they explicitly preferred upper-class individuals and 12% saying they explicitly preferred lower-class individuals.
However, the IATs revealed that these conscious preferences did not correlate well with subjects’ implicit (unconscious) preferences. The IAT results showed that unconsciously, 69% of medical students preferred white people and 86% preferred upper-class individuals, which are numbers similar to those in studies of the general population.
Yet, the medical students’ responses to the medical vignettes did not reflect either their unconscious or conscious preferences. There was no association between the hypothetical patients’ race or class and the students’ responses to the clinical situations. Similarly, there was no association between the hypothetical patients’ race or class and the students’ IAT scores, the investigators said (JAMA 2011;306:942-51).
In further analyses, the researchers continued to find no impact of the students’ biases on clinical decision making. These analyses included categorizing the students’ clinical responses according to their races and self-reported social classes. Even in the subgroup of students who admitted to having explicit racial (93 students) and class (125 students) biases, no clinical–decision making effect appeared.
The findings among medical students stand in stark contrast to results among practicing physicians, where "implicit race and social class biases ... are increasingly recognized as potential factors contributing to disparities in health care," Dr. Haider and his colleagues said.
They deemed the reasons for this discrepancy between students and physicians unknown. Possibly, because the students are younger, they "have been more exposed to educational curricula focused on cultural competency, translating to improved awareness and management of implicit bias," the team said.
It also is possible that students who "have not yet been exposed to the rigors of medical training" might not yet be influenced by implicit biases, the researchers suggested.
They called for further study of whether experiences during medical training influence social or racial bias in clinical decision making. If so, "medical training could be an effective intervention point to decrease implicit biases and possibly mitigate physician-driven health care disparities," they added.
The study was supported by the National Institute of General Medical Sciences, the National Institutes of Health, the American College of Surgeons, and the National Heart, Lung, and Blood Institute. The authors reported no financial conflict of interest.
FROM JAMA
Major Finding: Implicit Association Tests showed that 69% of first-year medical students’ unconsciously preferred white people and 86% preferred upper-class individuals, but neither of those implicit biases nor less-pronounced conscious biases influenced the students’ clinical decision making in a series of medical vignettes involving hypothetical patients of various races and social classes.
Data Source: A cross-sectional study in two cohorts of first-year medical students, assessing unconscious and conscious racial and class biases and comparing these with the students’ clinical assessments in hypothetical medical vignettes.
Disclosures: This study was supported by the National Institute of General Medical Sciences, the National Institutes of Health, the American College of Surgeons, and the National Heart, Lung, and Blood Institute. The authors reported having no financial conflicts of interest.
Certain Factors Peg Why Some Docs Get Board Certified
Age at graduation, gender, race, and test scores were found to predict whether a physician would attain board certification in any of eight specialty categories, according a study published in the Sept. 7 issue of JAMA.
"ABMS [American Board of Medical Specialties] member board certification is currently among the criteria used by HMOs, hospitals, and health insurance plans in evaluating physicians who wish to obtain privileges or join provider organizations, by medical school promotion committees in evaluating physician faculty members for promotion and tenure, and by the Accreditation Council for Graduate Medical Education as criteria for selection of physicians to serve as GME program directors and residency review committee members," according to Donna B. Jeffe, Ph.D., and Dr. Dorothy A. Andriole of Washington University, St. Louis.
"Thus, ABMS member board certification is emerging as a de facto requirement for the full participation of physicians in the U.S. health care system, and non–board-certified physicians compose an increasingly marginalized group," they noted.
To identify factors associated with achieving specialty certification, Dr. Jeffe and Dr. Andriole constructed a database with "deidentified" records for all medical students who graduated 1997-2000 and followed them for at least 8 years; a total of 42,440 graduates were included. These data were linked to testing records from the National Board of Medical Examiners, as well as data from the Association of American Medical Colleges and the American Medical Association Physician Masterfile, to track specialty certification.
The specialty categories included internal medicine, family medicine, pediatrics, emergency medicine, radiology, surgery (including several surgical subspecialties), ob.gyn., and a composite category comprised of allergy/immunology, anesthesiology, dermatology, neurology, genetics, nuclear medicine, ophthalmology, pathology, and psychiatry.
Overall, 87.3% of the sample were board certified, the investigators said (JAMA 2011;306:961-70).
Physicians who were 28 years or older at medical school graduation were less likely to become certified, which is perhaps related to the fact that older graduates also were more likely to have failed an initial attempt at certification.
"Our findings suggest that older graduates may experience greater difficulties, regardless of specialty choice, in timely advancement along the GME continuum toward board certification," Dr. Jeffe and Dr. Andriole said.
Women physicians were less likely than men to be board certified in three specialty categories, notably in obstetrics/gynecology, which is currently the category with the largest proportion of women physicians (79%).
Members of minority groups were less likely than white physicians to be board certified in every specialty except family medicine, "raising concerns about ongoing efforts by U.S. medical schools to increase the racial/ethnic diversity of the physician workforce," they noted.
In addition, physicians who had higher scores on Step 1 and Step 2 Clinical Knowledge tests on the U.S. Medical Licensing Examination were more likely than those with lower scores to become board certified. This finding "provides support for program directors’ use of first-attempt licensing examination results among criteria for evaluating applicants in a range of specialties," the researchers said.
This study was supported by the National Institute of General Medical Sciences, one of the National Institutes of Health. No financial conflicts of interest were reported.
Age at graduation, gender, race, and test scores were found to predict whether a physician would attain board certification in any of eight specialty categories, according a study published in the Sept. 7 issue of JAMA.
"ABMS [American Board of Medical Specialties] member board certification is currently among the criteria used by HMOs, hospitals, and health insurance plans in evaluating physicians who wish to obtain privileges or join provider organizations, by medical school promotion committees in evaluating physician faculty members for promotion and tenure, and by the Accreditation Council for Graduate Medical Education as criteria for selection of physicians to serve as GME program directors and residency review committee members," according to Donna B. Jeffe, Ph.D., and Dr. Dorothy A. Andriole of Washington University, St. Louis.
"Thus, ABMS member board certification is emerging as a de facto requirement for the full participation of physicians in the U.S. health care system, and non–board-certified physicians compose an increasingly marginalized group," they noted.
To identify factors associated with achieving specialty certification, Dr. Jeffe and Dr. Andriole constructed a database with "deidentified" records for all medical students who graduated 1997-2000 and followed them for at least 8 years; a total of 42,440 graduates were included. These data were linked to testing records from the National Board of Medical Examiners, as well as data from the Association of American Medical Colleges and the American Medical Association Physician Masterfile, to track specialty certification.
The specialty categories included internal medicine, family medicine, pediatrics, emergency medicine, radiology, surgery (including several surgical subspecialties), ob.gyn., and a composite category comprised of allergy/immunology, anesthesiology, dermatology, neurology, genetics, nuclear medicine, ophthalmology, pathology, and psychiatry.
Overall, 87.3% of the sample were board certified, the investigators said (JAMA 2011;306:961-70).
Physicians who were 28 years or older at medical school graduation were less likely to become certified, which is perhaps related to the fact that older graduates also were more likely to have failed an initial attempt at certification.
"Our findings suggest that older graduates may experience greater difficulties, regardless of specialty choice, in timely advancement along the GME continuum toward board certification," Dr. Jeffe and Dr. Andriole said.
Women physicians were less likely than men to be board certified in three specialty categories, notably in obstetrics/gynecology, which is currently the category with the largest proportion of women physicians (79%).
Members of minority groups were less likely than white physicians to be board certified in every specialty except family medicine, "raising concerns about ongoing efforts by U.S. medical schools to increase the racial/ethnic diversity of the physician workforce," they noted.
In addition, physicians who had higher scores on Step 1 and Step 2 Clinical Knowledge tests on the U.S. Medical Licensing Examination were more likely than those with lower scores to become board certified. This finding "provides support for program directors’ use of first-attempt licensing examination results among criteria for evaluating applicants in a range of specialties," the researchers said.
This study was supported by the National Institute of General Medical Sciences, one of the National Institutes of Health. No financial conflicts of interest were reported.
Age at graduation, gender, race, and test scores were found to predict whether a physician would attain board certification in any of eight specialty categories, according a study published in the Sept. 7 issue of JAMA.
"ABMS [American Board of Medical Specialties] member board certification is currently among the criteria used by HMOs, hospitals, and health insurance plans in evaluating physicians who wish to obtain privileges or join provider organizations, by medical school promotion committees in evaluating physician faculty members for promotion and tenure, and by the Accreditation Council for Graduate Medical Education as criteria for selection of physicians to serve as GME program directors and residency review committee members," according to Donna B. Jeffe, Ph.D., and Dr. Dorothy A. Andriole of Washington University, St. Louis.
"Thus, ABMS member board certification is emerging as a de facto requirement for the full participation of physicians in the U.S. health care system, and non–board-certified physicians compose an increasingly marginalized group," they noted.
To identify factors associated with achieving specialty certification, Dr. Jeffe and Dr. Andriole constructed a database with "deidentified" records for all medical students who graduated 1997-2000 and followed them for at least 8 years; a total of 42,440 graduates were included. These data were linked to testing records from the National Board of Medical Examiners, as well as data from the Association of American Medical Colleges and the American Medical Association Physician Masterfile, to track specialty certification.
The specialty categories included internal medicine, family medicine, pediatrics, emergency medicine, radiology, surgery (including several surgical subspecialties), ob.gyn., and a composite category comprised of allergy/immunology, anesthesiology, dermatology, neurology, genetics, nuclear medicine, ophthalmology, pathology, and psychiatry.
Overall, 87.3% of the sample were board certified, the investigators said (JAMA 2011;306:961-70).
Physicians who were 28 years or older at medical school graduation were less likely to become certified, which is perhaps related to the fact that older graduates also were more likely to have failed an initial attempt at certification.
"Our findings suggest that older graduates may experience greater difficulties, regardless of specialty choice, in timely advancement along the GME continuum toward board certification," Dr. Jeffe and Dr. Andriole said.
Women physicians were less likely than men to be board certified in three specialty categories, notably in obstetrics/gynecology, which is currently the category with the largest proportion of women physicians (79%).
Members of minority groups were less likely than white physicians to be board certified in every specialty except family medicine, "raising concerns about ongoing efforts by U.S. medical schools to increase the racial/ethnic diversity of the physician workforce," they noted.
In addition, physicians who had higher scores on Step 1 and Step 2 Clinical Knowledge tests on the U.S. Medical Licensing Examination were more likely than those with lower scores to become board certified. This finding "provides support for program directors’ use of first-attempt licensing examination results among criteria for evaluating applicants in a range of specialties," the researchers said.
This study was supported by the National Institute of General Medical Sciences, one of the National Institutes of Health. No financial conflicts of interest were reported.
FROM JAMA
Major Finding: Just over 87% of medical school graduates have attained specialty board certification, and factors such as their age, gender, race/ethnicity, debt, and test scores were predictors of certification.
Data Source: A retrospective cohort study of ABMS certification in 42,440 physicians who graduated from U.S. medical schools in 1997-2000 and were followed through 2009.
Disclosures: This study was supported by the National Institute of General Medical Sciences, one of the National Institutes of Health. No financial conflicts of interest were reported.
Long-Term Meds Get 'Lost' in Hospital Shuffle
Major Finding: Rates of unintentional discontinuation of long-term medications for chronic diseases were significantly higher in hospitalized than in nonhospitalized patients, at 19.4% for antiplatelet/anticoagulants, 13.6% for statins, 12.9% for gastric acid suppressors, 12.3% for levothyroxine, and 4.5% respiratory inhalers.
Data Source: A population-based cohort study of 369,036 elderly patients in Ontario, including 160,568 who were hospitalized and 16,474 admitted to an ICU between 1997 and 2009.
Disclosures: Some researchers reported ties to Merck Frosst Canada, AstraZeneca, Sanofi-Aventis, Johnson & Johnson, and the Centre for Medical Technology Policy.
Hospitalization raises the risk that patients' long-term medications for chronic diseases will be discontinued unintentionally, a study has shown.
That risk is further heightened with ICU care, which suggests that the more patients are transitioned from site to site and from clinician to clinician, the greater the chance that their long-term medications (statins, antiplatelet or anticoagulant agents, levothyroxine, respiratory inhalers, and gastric acid-suppressing drugs) will get lost in the shuffle.
Discontinuing these necessary medications appears to raise patients' risk of death, further hospitalization, and ED visits for up to 1 year after discharge, said Dr. Chaim M. Bell of St. Michael's Hospital, Toronto, and his associates.
“These findings emphasize the importance of a systematic approach to transitions in health care to ensure medication continuity,” they noted.
The investigators conducted a population-based cohort study of all hospitalizations of patients aged 66 years and older in Ontario between 1997 and 2009 to examine medication continuity. They reviewed the records of 396,036 patients who had been taking any of the five types of medications for chronic disease listed above for at least 1 year.
In all, 160,568 of these study subjects were hospitalized during the study period, including 16,474 who were admitted to the ICU; the remaining 208,468 who were not hospitalized served as control subjects. The rate of patients who failed to refill prescriptions of the five categories of medication within 90 days of discharge was calculated.
The investigators excluded cases in which patients developed complications or contraindications to their medications, or otherwise had a clear reason for discontinuing a drug. They also controlled for confounding factors that could influence stopping a medication, such as comorbid disease burden and the number of physician contacts during the year preceding hospitalization.
Drugs in all five medication categories were significantly more likely to be discontinued after hospitalization than in the controls. Rates of unintentional discontinuation were highest for antiplatelet/anticoagulants (19.4%), followed by statins (13.6%), gastric acid suppressors (12.9%), levothyroxine (12.3%), and respiratory inhalers (4.5%). The rates for control subjects were 11.8%, 10.7%, 9.4%, 11%, and 3%, respectively.
Rates of unintentional discontinuation were even higher among ICU patients in four of the five medication categories (22.8% for antiplatelet/anticoagulants, 15.4% for gastric acid suppressors, 15% for levothyroxine, and 14.6% for statins).
In a secondary analysis, the unintentional discontinuation of antiplatelet/anticoagulants and of statins was associated with higher risk of the combined outcome of death, further hospitalization, or emergency admission for up to 1 year after hospital discharge. “This underscores the widespread prevalence of potential errors of omission and the risk for long-term harm following hospitalization,” Dr. Bell and his colleagues said (JAMA 2011;306:840-7).
Studies suggest that miscommunication during transitions of care is not the only contributor to unintentional dropping of medications, they said. Some medications are purposely discontinued during a critical illness, but restarting them is overlooked after the acute event resolves.
Dr. Bell and colleagues said the findings of their study “are likely generalizable to the general population.”
The study was funded by the Canadian Institutes of Health Research, the Institute for Clinical and Evaluative Sciences, and the Ontario Ministry of Health and Long-Term Care.
View on the News
Scope and Scale of Problem Is Concerning
The major limitation of this study is that it cannot measure whether discontinuation of long-term medications was really unintentional, said Dr. Jeremy M. Kahn and Dr. Derek C. Angus.
Dr. Bell and his colleagues minimized this problem by excluding patients who developed known contraindications or complications, and by adjusting for legitimate reasons to discontinue the drugs. They studied patients who had been taking the medications for at least 1 year, to rule out the chance that physicians were simply rethinking the use of the drug or that patients were choosing to stop because of side effects.
“Given the high incidence of medication discontinuation in this study, even if some of [it] was intentional, the remaining unintentional discontinuation is of concerning scope and scale,” they noted.
DR. KAHN and DR. ANGUS are at the clinical research, investigation, and systems modeling of acute illness center in the department of critical care medicine, and in the department of health policy management, at the University of Pittsburgh. Dr. Angus is a contributing editor for JAMA. They reported no financial conflicts of interest. Dr. Kahn is supported by a career development award from the National Institutes of Health. These remarks were adapted from their editorial accompanying Dr. Bell's report (JAMA 2011;306:878-9).
Major Finding: Rates of unintentional discontinuation of long-term medications for chronic diseases were significantly higher in hospitalized than in nonhospitalized patients, at 19.4% for antiplatelet/anticoagulants, 13.6% for statins, 12.9% for gastric acid suppressors, 12.3% for levothyroxine, and 4.5% respiratory inhalers.
Data Source: A population-based cohort study of 369,036 elderly patients in Ontario, including 160,568 who were hospitalized and 16,474 admitted to an ICU between 1997 and 2009.
Disclosures: Some researchers reported ties to Merck Frosst Canada, AstraZeneca, Sanofi-Aventis, Johnson & Johnson, and the Centre for Medical Technology Policy.
Hospitalization raises the risk that patients' long-term medications for chronic diseases will be discontinued unintentionally, a study has shown.
That risk is further heightened with ICU care, which suggests that the more patients are transitioned from site to site and from clinician to clinician, the greater the chance that their long-term medications (statins, antiplatelet or anticoagulant agents, levothyroxine, respiratory inhalers, and gastric acid-suppressing drugs) will get lost in the shuffle.
Discontinuing these necessary medications appears to raise patients' risk of death, further hospitalization, and ED visits for up to 1 year after discharge, said Dr. Chaim M. Bell of St. Michael's Hospital, Toronto, and his associates.
“These findings emphasize the importance of a systematic approach to transitions in health care to ensure medication continuity,” they noted.
The investigators conducted a population-based cohort study of all hospitalizations of patients aged 66 years and older in Ontario between 1997 and 2009 to examine medication continuity. They reviewed the records of 396,036 patients who had been taking any of the five types of medications for chronic disease listed above for at least 1 year.
In all, 160,568 of these study subjects were hospitalized during the study period, including 16,474 who were admitted to the ICU; the remaining 208,468 who were not hospitalized served as control subjects. The rate of patients who failed to refill prescriptions of the five categories of medication within 90 days of discharge was calculated.
The investigators excluded cases in which patients developed complications or contraindications to their medications, or otherwise had a clear reason for discontinuing a drug. They also controlled for confounding factors that could influence stopping a medication, such as comorbid disease burden and the number of physician contacts during the year preceding hospitalization.
Drugs in all five medication categories were significantly more likely to be discontinued after hospitalization than in the controls. Rates of unintentional discontinuation were highest for antiplatelet/anticoagulants (19.4%), followed by statins (13.6%), gastric acid suppressors (12.9%), levothyroxine (12.3%), and respiratory inhalers (4.5%). The rates for control subjects were 11.8%, 10.7%, 9.4%, 11%, and 3%, respectively.
Rates of unintentional discontinuation were even higher among ICU patients in four of the five medication categories (22.8% for antiplatelet/anticoagulants, 15.4% for gastric acid suppressors, 15% for levothyroxine, and 14.6% for statins).
In a secondary analysis, the unintentional discontinuation of antiplatelet/anticoagulants and of statins was associated with higher risk of the combined outcome of death, further hospitalization, or emergency admission for up to 1 year after hospital discharge. “This underscores the widespread prevalence of potential errors of omission and the risk for long-term harm following hospitalization,” Dr. Bell and his colleagues said (JAMA 2011;306:840-7).
Studies suggest that miscommunication during transitions of care is not the only contributor to unintentional dropping of medications, they said. Some medications are purposely discontinued during a critical illness, but restarting them is overlooked after the acute event resolves.
Dr. Bell and colleagues said the findings of their study “are likely generalizable to the general population.”
The study was funded by the Canadian Institutes of Health Research, the Institute for Clinical and Evaluative Sciences, and the Ontario Ministry of Health and Long-Term Care.
View on the News
Scope and Scale of Problem Is Concerning
The major limitation of this study is that it cannot measure whether discontinuation of long-term medications was really unintentional, said Dr. Jeremy M. Kahn and Dr. Derek C. Angus.
Dr. Bell and his colleagues minimized this problem by excluding patients who developed known contraindications or complications, and by adjusting for legitimate reasons to discontinue the drugs. They studied patients who had been taking the medications for at least 1 year, to rule out the chance that physicians were simply rethinking the use of the drug or that patients were choosing to stop because of side effects.
“Given the high incidence of medication discontinuation in this study, even if some of [it] was intentional, the remaining unintentional discontinuation is of concerning scope and scale,” they noted.
DR. KAHN and DR. ANGUS are at the clinical research, investigation, and systems modeling of acute illness center in the department of critical care medicine, and in the department of health policy management, at the University of Pittsburgh. Dr. Angus is a contributing editor for JAMA. They reported no financial conflicts of interest. Dr. Kahn is supported by a career development award from the National Institutes of Health. These remarks were adapted from their editorial accompanying Dr. Bell's report (JAMA 2011;306:878-9).
Major Finding: Rates of unintentional discontinuation of long-term medications for chronic diseases were significantly higher in hospitalized than in nonhospitalized patients, at 19.4% for antiplatelet/anticoagulants, 13.6% for statins, 12.9% for gastric acid suppressors, 12.3% for levothyroxine, and 4.5% respiratory inhalers.
Data Source: A population-based cohort study of 369,036 elderly patients in Ontario, including 160,568 who were hospitalized and 16,474 admitted to an ICU between 1997 and 2009.
Disclosures: Some researchers reported ties to Merck Frosst Canada, AstraZeneca, Sanofi-Aventis, Johnson & Johnson, and the Centre for Medical Technology Policy.
Hospitalization raises the risk that patients' long-term medications for chronic diseases will be discontinued unintentionally, a study has shown.
That risk is further heightened with ICU care, which suggests that the more patients are transitioned from site to site and from clinician to clinician, the greater the chance that their long-term medications (statins, antiplatelet or anticoagulant agents, levothyroxine, respiratory inhalers, and gastric acid-suppressing drugs) will get lost in the shuffle.
Discontinuing these necessary medications appears to raise patients' risk of death, further hospitalization, and ED visits for up to 1 year after discharge, said Dr. Chaim M. Bell of St. Michael's Hospital, Toronto, and his associates.
“These findings emphasize the importance of a systematic approach to transitions in health care to ensure medication continuity,” they noted.
The investigators conducted a population-based cohort study of all hospitalizations of patients aged 66 years and older in Ontario between 1997 and 2009 to examine medication continuity. They reviewed the records of 396,036 patients who had been taking any of the five types of medications for chronic disease listed above for at least 1 year.
In all, 160,568 of these study subjects were hospitalized during the study period, including 16,474 who were admitted to the ICU; the remaining 208,468 who were not hospitalized served as control subjects. The rate of patients who failed to refill prescriptions of the five categories of medication within 90 days of discharge was calculated.
The investigators excluded cases in which patients developed complications or contraindications to their medications, or otherwise had a clear reason for discontinuing a drug. They also controlled for confounding factors that could influence stopping a medication, such as comorbid disease burden and the number of physician contacts during the year preceding hospitalization.
Drugs in all five medication categories were significantly more likely to be discontinued after hospitalization than in the controls. Rates of unintentional discontinuation were highest for antiplatelet/anticoagulants (19.4%), followed by statins (13.6%), gastric acid suppressors (12.9%), levothyroxine (12.3%), and respiratory inhalers (4.5%). The rates for control subjects were 11.8%, 10.7%, 9.4%, 11%, and 3%, respectively.
Rates of unintentional discontinuation were even higher among ICU patients in four of the five medication categories (22.8% for antiplatelet/anticoagulants, 15.4% for gastric acid suppressors, 15% for levothyroxine, and 14.6% for statins).
In a secondary analysis, the unintentional discontinuation of antiplatelet/anticoagulants and of statins was associated with higher risk of the combined outcome of death, further hospitalization, or emergency admission for up to 1 year after hospital discharge. “This underscores the widespread prevalence of potential errors of omission and the risk for long-term harm following hospitalization,” Dr. Bell and his colleagues said (JAMA 2011;306:840-7).
Studies suggest that miscommunication during transitions of care is not the only contributor to unintentional dropping of medications, they said. Some medications are purposely discontinued during a critical illness, but restarting them is overlooked after the acute event resolves.
Dr. Bell and colleagues said the findings of their study “are likely generalizable to the general population.”
The study was funded by the Canadian Institutes of Health Research, the Institute for Clinical and Evaluative Sciences, and the Ontario Ministry of Health and Long-Term Care.
View on the News
Scope and Scale of Problem Is Concerning
The major limitation of this study is that it cannot measure whether discontinuation of long-term medications was really unintentional, said Dr. Jeremy M. Kahn and Dr. Derek C. Angus.
Dr. Bell and his colleagues minimized this problem by excluding patients who developed known contraindications or complications, and by adjusting for legitimate reasons to discontinue the drugs. They studied patients who had been taking the medications for at least 1 year, to rule out the chance that physicians were simply rethinking the use of the drug or that patients were choosing to stop because of side effects.
“Given the high incidence of medication discontinuation in this study, even if some of [it] was intentional, the remaining unintentional discontinuation is of concerning scope and scale,” they noted.
DR. KAHN and DR. ANGUS are at the clinical research, investigation, and systems modeling of acute illness center in the department of critical care medicine, and in the department of health policy management, at the University of Pittsburgh. Dr. Angus is a contributing editor for JAMA. They reported no financial conflicts of interest. Dr. Kahn is supported by a career development award from the National Institutes of Health. These remarks were adapted from their editorial accompanying Dr. Bell's report (JAMA 2011;306:878-9).
Interventions Slashed Hospital Readmissions
Major Finding: One intervention to facilitate the transition from hospitalization to home care cut the 30-day readmission rate by 48%; the other cut the rate by 36%.
Data Source: A prospective pilot study of readmission in 56 heart failure patients participating in a 3-month intervention, and a prospective cohort study of readmission in 257 patients with a variety of disorders who participated in a different, 1-month intervention.
Disclosures: Dr. Stauffer's study was supported by the Baylor Health Care System, Dallas. Ms. Voss's study was funded by the Centers for Medicare & Medicaid Services. Both research groups reported no financial conflicts of interest.
Two interventions to improve the transition from hospital discharge to home care, and to thereby reduce readmissions, were effective in the first attempts to implement them in real-world settings.
Both interventions had been effective in the comparatively controlled conditions of several randomized controlled trials, but until now it wasn't known whether that success would translate into real-world practice.
The first report was a pilot study at a single medical center involving patients with heart failure. The 3-month intervention was a traditional care program in which advanced practice nurses educated patients and families about symptoms and self-management strategies, improved communication patterns with care providers, and marshaled caregiver and community resources to facilitate adherence to treatment and improve quality of life. It included at least eight home visits, beginning within 72 hours of hospital admission, as well as 24-hour phone availability.
A total of 140 Medicare fee-for-service patients with heart failure were eligible, and 56 enrolled in the study.
The 30-day readmission rate was 48% lower after the intervention was implemented than it had been before. No such reduction in readmissions was noted at other medical centers in the same area during the study period, said Dr. Brett D. Stauffer of the Institute for Health Care Research and Improvement, Baylor Health Care System, Dallas, and his associates.
Total direct costs were lower for patients who participated in the intervention than for those who did not; however, the cost of the intervention itself was not recovered by the hospital.
In the second report, a Medicare demonstration project following the Care Transitions Intervention (CTI) model was assessed in 257 adults in the Medicare fee-for-service program who were hospitalized for a variety of diagnoses at six Rhode Island medical centers during an 18-month period. The facilities included community hospitals, teaching hospitals, and a tertiary care center, and their size ranged from 129 to 719 beds, said Rachel Voss of Quality Partners of Rhode Island, the Medicare Quality Improvement Organization for Rhode Island, and her associates.
The CTI is a 1-month program designed to help patients on the verge of discharge and their families to manage their health more actively and to communicate more effectively with their providers. Nurses or social workers act as “coaches” who conduct a hospital visit, a home visit within 3 days of discharge, a phone visit within 7-10 days, and a final phone visit within 30 days.
At these visits, the coaches review a booklet in which patients record their health problems, medications, and questions for providers; troubleshoot problems with outpatient care; ensure patients understand the signs and symptoms of any worsening of their condition; and help patients locate other sources of continued support.
Before implementation of the CTI program, the average 30-day readmission rate at the six participating hospitals was 21%. In comparison, the rate was only 12.8% in patients who participated in the intervention.
The primary outcome measure was the difference between the readmission rate among the study participants (12.8%) and a control group of similar patients who did not participate (20%). This represents a 36% reduction in readmissions with intervention, a significant decrease, Ms. Voss and her colleagues said (Arch. Intern. Med. 2011;171:1232-7).
Only 55% of eligible patients who were approached agreed to participate in the intervention, and the attrition rate among those who initially agreed to a home visit was 75%.
View on the News
It is comforting to read about “two successful real-world translations of interventions shown to be effective in reducing hospitalizations in randomized controlled trials.” But other aspects of these real-world successes are sobering, said Dr. Mitchell H. Katz.
Both studies had low participation rates. And in the study by Voss et al, only 14% of the patients who were approached would agree to a home visit. With such a small proportion of patients willing to try such interventions, these programs cannot have a major impact on readmission rates, he noted.
Moreover, they can only reduce health care costs if the savings from the decreased readmissions outweighs the cost of the intervention program. Under the current system that reimburses hospitals 100% for every readmission, this cannot happen.
DR. KATZ is in the Los Angeles County Department of Health Services. He reported no financial conflicts of interest. These remarks were taken from his editorial accompanying the two reports (Arch. Intern. Med. 2011;171:1230).
Major Finding: One intervention to facilitate the transition from hospitalization to home care cut the 30-day readmission rate by 48%; the other cut the rate by 36%.
Data Source: A prospective pilot study of readmission in 56 heart failure patients participating in a 3-month intervention, and a prospective cohort study of readmission in 257 patients with a variety of disorders who participated in a different, 1-month intervention.
Disclosures: Dr. Stauffer's study was supported by the Baylor Health Care System, Dallas. Ms. Voss's study was funded by the Centers for Medicare & Medicaid Services. Both research groups reported no financial conflicts of interest.
Two interventions to improve the transition from hospital discharge to home care, and to thereby reduce readmissions, were effective in the first attempts to implement them in real-world settings.
Both interventions had been effective in the comparatively controlled conditions of several randomized controlled trials, but until now it wasn't known whether that success would translate into real-world practice.
The first report was a pilot study at a single medical center involving patients with heart failure. The 3-month intervention was a traditional care program in which advanced practice nurses educated patients and families about symptoms and self-management strategies, improved communication patterns with care providers, and marshaled caregiver and community resources to facilitate adherence to treatment and improve quality of life. It included at least eight home visits, beginning within 72 hours of hospital admission, as well as 24-hour phone availability.
A total of 140 Medicare fee-for-service patients with heart failure were eligible, and 56 enrolled in the study.
The 30-day readmission rate was 48% lower after the intervention was implemented than it had been before. No such reduction in readmissions was noted at other medical centers in the same area during the study period, said Dr. Brett D. Stauffer of the Institute for Health Care Research and Improvement, Baylor Health Care System, Dallas, and his associates.
Total direct costs were lower for patients who participated in the intervention than for those who did not; however, the cost of the intervention itself was not recovered by the hospital.
In the second report, a Medicare demonstration project following the Care Transitions Intervention (CTI) model was assessed in 257 adults in the Medicare fee-for-service program who were hospitalized for a variety of diagnoses at six Rhode Island medical centers during an 18-month period. The facilities included community hospitals, teaching hospitals, and a tertiary care center, and their size ranged from 129 to 719 beds, said Rachel Voss of Quality Partners of Rhode Island, the Medicare Quality Improvement Organization for Rhode Island, and her associates.
The CTI is a 1-month program designed to help patients on the verge of discharge and their families to manage their health more actively and to communicate more effectively with their providers. Nurses or social workers act as “coaches” who conduct a hospital visit, a home visit within 3 days of discharge, a phone visit within 7-10 days, and a final phone visit within 30 days.
At these visits, the coaches review a booklet in which patients record their health problems, medications, and questions for providers; troubleshoot problems with outpatient care; ensure patients understand the signs and symptoms of any worsening of their condition; and help patients locate other sources of continued support.
Before implementation of the CTI program, the average 30-day readmission rate at the six participating hospitals was 21%. In comparison, the rate was only 12.8% in patients who participated in the intervention.
The primary outcome measure was the difference between the readmission rate among the study participants (12.8%) and a control group of similar patients who did not participate (20%). This represents a 36% reduction in readmissions with intervention, a significant decrease, Ms. Voss and her colleagues said (Arch. Intern. Med. 2011;171:1232-7).
Only 55% of eligible patients who were approached agreed to participate in the intervention, and the attrition rate among those who initially agreed to a home visit was 75%.
View on the News
It is comforting to read about “two successful real-world translations of interventions shown to be effective in reducing hospitalizations in randomized controlled trials.” But other aspects of these real-world successes are sobering, said Dr. Mitchell H. Katz.
Both studies had low participation rates. And in the study by Voss et al, only 14% of the patients who were approached would agree to a home visit. With such a small proportion of patients willing to try such interventions, these programs cannot have a major impact on readmission rates, he noted.
Moreover, they can only reduce health care costs if the savings from the decreased readmissions outweighs the cost of the intervention program. Under the current system that reimburses hospitals 100% for every readmission, this cannot happen.
DR. KATZ is in the Los Angeles County Department of Health Services. He reported no financial conflicts of interest. These remarks were taken from his editorial accompanying the two reports (Arch. Intern. Med. 2011;171:1230).
Major Finding: One intervention to facilitate the transition from hospitalization to home care cut the 30-day readmission rate by 48%; the other cut the rate by 36%.
Data Source: A prospective pilot study of readmission in 56 heart failure patients participating in a 3-month intervention, and a prospective cohort study of readmission in 257 patients with a variety of disorders who participated in a different, 1-month intervention.
Disclosures: Dr. Stauffer's study was supported by the Baylor Health Care System, Dallas. Ms. Voss's study was funded by the Centers for Medicare & Medicaid Services. Both research groups reported no financial conflicts of interest.
Two interventions to improve the transition from hospital discharge to home care, and to thereby reduce readmissions, were effective in the first attempts to implement them in real-world settings.
Both interventions had been effective in the comparatively controlled conditions of several randomized controlled trials, but until now it wasn't known whether that success would translate into real-world practice.
The first report was a pilot study at a single medical center involving patients with heart failure. The 3-month intervention was a traditional care program in which advanced practice nurses educated patients and families about symptoms and self-management strategies, improved communication patterns with care providers, and marshaled caregiver and community resources to facilitate adherence to treatment and improve quality of life. It included at least eight home visits, beginning within 72 hours of hospital admission, as well as 24-hour phone availability.
A total of 140 Medicare fee-for-service patients with heart failure were eligible, and 56 enrolled in the study.
The 30-day readmission rate was 48% lower after the intervention was implemented than it had been before. No such reduction in readmissions was noted at other medical centers in the same area during the study period, said Dr. Brett D. Stauffer of the Institute for Health Care Research and Improvement, Baylor Health Care System, Dallas, and his associates.
Total direct costs were lower for patients who participated in the intervention than for those who did not; however, the cost of the intervention itself was not recovered by the hospital.
In the second report, a Medicare demonstration project following the Care Transitions Intervention (CTI) model was assessed in 257 adults in the Medicare fee-for-service program who were hospitalized for a variety of diagnoses at six Rhode Island medical centers during an 18-month period. The facilities included community hospitals, teaching hospitals, and a tertiary care center, and their size ranged from 129 to 719 beds, said Rachel Voss of Quality Partners of Rhode Island, the Medicare Quality Improvement Organization for Rhode Island, and her associates.
The CTI is a 1-month program designed to help patients on the verge of discharge and their families to manage their health more actively and to communicate more effectively with their providers. Nurses or social workers act as “coaches” who conduct a hospital visit, a home visit within 3 days of discharge, a phone visit within 7-10 days, and a final phone visit within 30 days.
At these visits, the coaches review a booklet in which patients record their health problems, medications, and questions for providers; troubleshoot problems with outpatient care; ensure patients understand the signs and symptoms of any worsening of their condition; and help patients locate other sources of continued support.
Before implementation of the CTI program, the average 30-day readmission rate at the six participating hospitals was 21%. In comparison, the rate was only 12.8% in patients who participated in the intervention.
The primary outcome measure was the difference between the readmission rate among the study participants (12.8%) and a control group of similar patients who did not participate (20%). This represents a 36% reduction in readmissions with intervention, a significant decrease, Ms. Voss and her colleagues said (Arch. Intern. Med. 2011;171:1232-7).
Only 55% of eligible patients who were approached agreed to participate in the intervention, and the attrition rate among those who initially agreed to a home visit was 75%.
View on the News
It is comforting to read about “two successful real-world translations of interventions shown to be effective in reducing hospitalizations in randomized controlled trials.” But other aspects of these real-world successes are sobering, said Dr. Mitchell H. Katz.
Both studies had low participation rates. And in the study by Voss et al, only 14% of the patients who were approached would agree to a home visit. With such a small proportion of patients willing to try such interventions, these programs cannot have a major impact on readmission rates, he noted.
Moreover, they can only reduce health care costs if the savings from the decreased readmissions outweighs the cost of the intervention program. Under the current system that reimburses hospitals 100% for every readmission, this cannot happen.
DR. KATZ is in the Los Angeles County Department of Health Services. He reported no financial conflicts of interest. These remarks were taken from his editorial accompanying the two reports (Arch. Intern. Med. 2011;171:1230).
Blood Loss After Phlebotomy Linked to Anemia
Major Finding: Of patients with acute MI, 20% acquired anemia during hospitalization, and those who did so lost approximately 174 mL of blood to draws for laboratory testing, compared with only 84 mL for patients who did not develop anemia. Every 50 mL of blood drawn was associated with an 18% rise in risk for anemia.
Data Source: A retrospective, observational study of blood draws for laboratory testing and hemoglobin values in 17,676 patients hospitalized at 57 U.S. medical centers for acute MI during an 8-year period.
Disclosures: Dr. Salisbury and two associates were funded in part by an award from the American Heart Association Pharmaceutical Round Table. The investigators reported ties to numerous drug companies.
Blood loss from diagnostic blood testing during hospitalization is substantial and has been linked to anemia in patients with acute myocardial infarction, in a study of 17,676 subjects.
One in five patients developed moderate to severe hospital-acquired anemia, and they had a mean estimated phlebotomy volume of 173.8 mL – the equivalent of half a unit of whole blood. Twelve percent of the study subjects lost more than 300 mL to blood draws during the course of their hospitalization, said Dr. Adam C. Salisbury of Saint Luke's Mid America Heart and Vascular Institute, Kansas City, Mo., and his associates.
“Our findings are likely generalizable to other populations of seriously ill medical patients,” they noted.
If further research establishes that minimizing blood loss from phlebotomy prevents anemia and improves patient outcomes, there would be broad implications for all hospitalized patients. Strategies to minimize blood loss, such as using pediatric instead of adult blood tubes or filling standard 4-mL adult tubes with only 1-2 mL of blood, would be widely adopted, Dr. Salisbury and his colleagues added.
They explored the relationship between diagnostic blood testing and the risk of hospital-acquired anemia in MI patients because blood draws have been associated with increased need for transfusions in this patient population. The researchers used an electronic medical record database that detailed the frequency and type of laboratory testing as well as patients' hemoglobin levels throughout hospitalization for acute MI. The database covered 57 hospitals during a recent 8-year period.
The study cohort comprised all patients with acute MI, excluding those who already had anemia at admission and those who underwent coronary artery bypass grafting, because both the etiology and outcomes of anemia differ from those of non-CABG patients.
The data did not include exact amounts of blood drawn for every test. The investigators estimated these amounts from the types of tests that were run, assuming that only the minimal blood volume needed to run the required tests was drawn and that no blood was wasted at the blood draws.
Twenty percent of the study cohort (3,551 patients) developed moderate to severe anemia during hospitalization. Mean hemoglobin values declined in all patients, but they declined to a greater degree in those who developed anemia (−3.9 g/dL), compared with patients who didn't develop anemia (−1.6 g/dL).
“The estimated mean blood loss from phlebotomy was nearly 100 mL higher over the course of hospitalization among patients who developed moderate to severe anemia, compared with those who did not (173.8 mL vs. 83.5 mL),” the researchers said (Arch. Intern Med. 2011 Aug. 8 [doi:10.1001/archinternmed.2011.361]).
The average amount of blood drawn for laboratory testing varied significantly across hospitals, from a low of 53 mL to a high of 109.6 mL. The amount of blood typically drawn at a hospital significantly correlated with the incidence of anemia in its patients.
In a preliminary analysis, every 50 mL of blood drawn was associated with an 18% increase in the risk of hospital-acquired anemia. That risk persisted and remained robust after the data were adjusted to account for potential confounders. When the data were broken down by day of hospitalization, the risk of developing anemia was highest on the first hospital day (10.5%), then remained relatively constant at 2.8%-4.5% through 10 days of hospitalization.
“Since most diagnostic evaluation and therapeutic interventions occur early during acute MI hospitalization, it is likely that much of the blood taken later during hospitalization represents routine, scheduled laboratory draws that could lead to ongoing blood loss.” Indeed, blood loss was particularly high among patients who had longer hospital stays.
Factors that contribute to the development of hospital-acquired anemia – such as patient age and sex, chronic kidney disease, and acute inflammation – are not modifiable. But clearly, providers can minimize phlebotomy, Dr. Salisbury and his associates said.
This study was retrospective and observational and so could not establish causality. Prospective randomized trials are needed to establish that the blood draws caused the anemia, and to determine whether limiting the number of blood draws and the volume of blood removed for diagnostic testing can prevent hospital-acquired anemia, they noted.
Major Finding: Of patients with acute MI, 20% acquired anemia during hospitalization, and those who did so lost approximately 174 mL of blood to draws for laboratory testing, compared with only 84 mL for patients who did not develop anemia. Every 50 mL of blood drawn was associated with an 18% rise in risk for anemia.
Data Source: A retrospective, observational study of blood draws for laboratory testing and hemoglobin values in 17,676 patients hospitalized at 57 U.S. medical centers for acute MI during an 8-year period.
Disclosures: Dr. Salisbury and two associates were funded in part by an award from the American Heart Association Pharmaceutical Round Table. The investigators reported ties to numerous drug companies.
Blood loss from diagnostic blood testing during hospitalization is substantial and has been linked to anemia in patients with acute myocardial infarction, in a study of 17,676 subjects.
One in five patients developed moderate to severe hospital-acquired anemia, and they had a mean estimated phlebotomy volume of 173.8 mL – the equivalent of half a unit of whole blood. Twelve percent of the study subjects lost more than 300 mL to blood draws during the course of their hospitalization, said Dr. Adam C. Salisbury of Saint Luke's Mid America Heart and Vascular Institute, Kansas City, Mo., and his associates.
“Our findings are likely generalizable to other populations of seriously ill medical patients,” they noted.
If further research establishes that minimizing blood loss from phlebotomy prevents anemia and improves patient outcomes, there would be broad implications for all hospitalized patients. Strategies to minimize blood loss, such as using pediatric instead of adult blood tubes or filling standard 4-mL adult tubes with only 1-2 mL of blood, would be widely adopted, Dr. Salisbury and his colleagues added.
They explored the relationship between diagnostic blood testing and the risk of hospital-acquired anemia in MI patients because blood draws have been associated with increased need for transfusions in this patient population. The researchers used an electronic medical record database that detailed the frequency and type of laboratory testing as well as patients' hemoglobin levels throughout hospitalization for acute MI. The database covered 57 hospitals during a recent 8-year period.
The study cohort comprised all patients with acute MI, excluding those who already had anemia at admission and those who underwent coronary artery bypass grafting, because both the etiology and outcomes of anemia differ from those of non-CABG patients.
The data did not include exact amounts of blood drawn for every test. The investigators estimated these amounts from the types of tests that were run, assuming that only the minimal blood volume needed to run the required tests was drawn and that no blood was wasted at the blood draws.
Twenty percent of the study cohort (3,551 patients) developed moderate to severe anemia during hospitalization. Mean hemoglobin values declined in all patients, but they declined to a greater degree in those who developed anemia (−3.9 g/dL), compared with patients who didn't develop anemia (−1.6 g/dL).
“The estimated mean blood loss from phlebotomy was nearly 100 mL higher over the course of hospitalization among patients who developed moderate to severe anemia, compared with those who did not (173.8 mL vs. 83.5 mL),” the researchers said (Arch. Intern Med. 2011 Aug. 8 [doi:10.1001/archinternmed.2011.361]).
The average amount of blood drawn for laboratory testing varied significantly across hospitals, from a low of 53 mL to a high of 109.6 mL. The amount of blood typically drawn at a hospital significantly correlated with the incidence of anemia in its patients.
In a preliminary analysis, every 50 mL of blood drawn was associated with an 18% increase in the risk of hospital-acquired anemia. That risk persisted and remained robust after the data were adjusted to account for potential confounders. When the data were broken down by day of hospitalization, the risk of developing anemia was highest on the first hospital day (10.5%), then remained relatively constant at 2.8%-4.5% through 10 days of hospitalization.
“Since most diagnostic evaluation and therapeutic interventions occur early during acute MI hospitalization, it is likely that much of the blood taken later during hospitalization represents routine, scheduled laboratory draws that could lead to ongoing blood loss.” Indeed, blood loss was particularly high among patients who had longer hospital stays.
Factors that contribute to the development of hospital-acquired anemia – such as patient age and sex, chronic kidney disease, and acute inflammation – are not modifiable. But clearly, providers can minimize phlebotomy, Dr. Salisbury and his associates said.
This study was retrospective and observational and so could not establish causality. Prospective randomized trials are needed to establish that the blood draws caused the anemia, and to determine whether limiting the number of blood draws and the volume of blood removed for diagnostic testing can prevent hospital-acquired anemia, they noted.
Major Finding: Of patients with acute MI, 20% acquired anemia during hospitalization, and those who did so lost approximately 174 mL of blood to draws for laboratory testing, compared with only 84 mL for patients who did not develop anemia. Every 50 mL of blood drawn was associated with an 18% rise in risk for anemia.
Data Source: A retrospective, observational study of blood draws for laboratory testing and hemoglobin values in 17,676 patients hospitalized at 57 U.S. medical centers for acute MI during an 8-year period.
Disclosures: Dr. Salisbury and two associates were funded in part by an award from the American Heart Association Pharmaceutical Round Table. The investigators reported ties to numerous drug companies.
Blood loss from diagnostic blood testing during hospitalization is substantial and has been linked to anemia in patients with acute myocardial infarction, in a study of 17,676 subjects.
One in five patients developed moderate to severe hospital-acquired anemia, and they had a mean estimated phlebotomy volume of 173.8 mL – the equivalent of half a unit of whole blood. Twelve percent of the study subjects lost more than 300 mL to blood draws during the course of their hospitalization, said Dr. Adam C. Salisbury of Saint Luke's Mid America Heart and Vascular Institute, Kansas City, Mo., and his associates.
“Our findings are likely generalizable to other populations of seriously ill medical patients,” they noted.
If further research establishes that minimizing blood loss from phlebotomy prevents anemia and improves patient outcomes, there would be broad implications for all hospitalized patients. Strategies to minimize blood loss, such as using pediatric instead of adult blood tubes or filling standard 4-mL adult tubes with only 1-2 mL of blood, would be widely adopted, Dr. Salisbury and his colleagues added.
They explored the relationship between diagnostic blood testing and the risk of hospital-acquired anemia in MI patients because blood draws have been associated with increased need for transfusions in this patient population. The researchers used an electronic medical record database that detailed the frequency and type of laboratory testing as well as patients' hemoglobin levels throughout hospitalization for acute MI. The database covered 57 hospitals during a recent 8-year period.
The study cohort comprised all patients with acute MI, excluding those who already had anemia at admission and those who underwent coronary artery bypass grafting, because both the etiology and outcomes of anemia differ from those of non-CABG patients.
The data did not include exact amounts of blood drawn for every test. The investigators estimated these amounts from the types of tests that were run, assuming that only the minimal blood volume needed to run the required tests was drawn and that no blood was wasted at the blood draws.
Twenty percent of the study cohort (3,551 patients) developed moderate to severe anemia during hospitalization. Mean hemoglobin values declined in all patients, but they declined to a greater degree in those who developed anemia (−3.9 g/dL), compared with patients who didn't develop anemia (−1.6 g/dL).
“The estimated mean blood loss from phlebotomy was nearly 100 mL higher over the course of hospitalization among patients who developed moderate to severe anemia, compared with those who did not (173.8 mL vs. 83.5 mL),” the researchers said (Arch. Intern Med. 2011 Aug. 8 [doi:10.1001/archinternmed.2011.361]).
The average amount of blood drawn for laboratory testing varied significantly across hospitals, from a low of 53 mL to a high of 109.6 mL. The amount of blood typically drawn at a hospital significantly correlated with the incidence of anemia in its patients.
In a preliminary analysis, every 50 mL of blood drawn was associated with an 18% increase in the risk of hospital-acquired anemia. That risk persisted and remained robust after the data were adjusted to account for potential confounders. When the data were broken down by day of hospitalization, the risk of developing anemia was highest on the first hospital day (10.5%), then remained relatively constant at 2.8%-4.5% through 10 days of hospitalization.
“Since most diagnostic evaluation and therapeutic interventions occur early during acute MI hospitalization, it is likely that much of the blood taken later during hospitalization represents routine, scheduled laboratory draws that could lead to ongoing blood loss.” Indeed, blood loss was particularly high among patients who had longer hospital stays.
Factors that contribute to the development of hospital-acquired anemia – such as patient age and sex, chronic kidney disease, and acute inflammation – are not modifiable. But clearly, providers can minimize phlebotomy, Dr. Salisbury and his associates said.
This study was retrospective and observational and so could not establish causality. Prospective randomized trials are needed to establish that the blood draws caused the anemia, and to determine whether limiting the number of blood draws and the volume of blood removed for diagnostic testing can prevent hospital-acquired anemia, they noted.
Two CPR Strategies Fail to Improve Outcomes After Cardiac Arrest
Two CPR strategies intended to improve patient survival after out-of-hospital cardiac arrest were found to have no significant effect in two related randomized clinical trials published in the Sept. 1 issue of the New England Journal of Medicine.
In the first study by the Resuscitation Outcomes Consortium (ROC), a "priming the pump" approach entailing a 3-minute period of chest compressions before the first analysis of cardiac rhythm and defibrillation produced the same rate of survival as did a briefer (30- to 60-second) period of manual chest compressions before cardiac rhythm analysis. Thus, extending CPR before defibrillation in the hope of increasing myocardial perfusion failed to improve patient outcomes.
In the second study, also by the ROC researchers, use of an impedance threshold device (ITD) to enhance venous return and cardiac output during CPR also produced the same rate of survival with satisfactory functional status, as did standard CPR without an ITD. Thus, use of the device also failed to improve patient outcomes.
These findings are particularly discouraging because the survival rate in the United States and Canada after out-of-hospital cardiac arrest "has been stagnant at 7.6% for more than 30 years," said Dr. Arthur B. Sanders of the department of emergency medicine at the University of Arizona’s Sarver Heart Center, Tucson.
The first ROC study was undertaken because despite several small studies of the issue, it was still unclear whether the traditional CPR approach of delivering defibrillatory shocks as soon as possible was inferior to the newer recommendation that EMS personnel should administer at least 2 minutes of CPR before delivering the shocks. In theory, "a few minutes of chest compression may increase myocardial perfusion, thus improving the metabolic state of the cardiac myocytes and enhancing the likelihood of successful defibrillation," said Dr. Ian G. Stiell of the department of emergency medicine and the Ottawa Hospital Research Institute, University of Ottawa, and his associates in the ROC.
They compared the two strategies by randomly assigning 9,933 adults treated by 150 EMS agencies in the United States and Canada to undergo either early (5,290 subjects) or delayed (4,643 subjects) defibrillation after nontraumatic cardiac arrest. The primary outcome measure was survival to hospital discharge with satisfactory functional status.
An identical 5.9% of subjects in each of the study groups survived to discharge with satisfactory status. There also were no differences between the two groups in several subgroup analyses, including survival to hospital admission, survival to hospital discharge regardless of functional status, and return of spontaneous circulation by arrival at the emergency department.
"Overall our data suggest that the administration of 2 minutes of CPR by EMS personnel before the first analysis of [cardiac] rhythm, which was suggested in the 2005 guidelines of the AHA-ILCOR [American Heart Association–International Liaison Committee on Resuscitation], is unlikely to provide a greater benefit than CPR of shorter duration," Dr. Stiell and his colleagues said (N. Engl. J. Med. 2011;365:787-97).
"The 2010 guidelines of the AHA-ILCOR give little direction as to the preferred period of CPR before analysis of cardiac rhythm. Each EMS system should consider its operational situation when deciding on its strategy for initial EMS-administered CPR," they added.
The second study was performed because no large randomized trial had yet addressed whether use of an ITD improved outcomes when compared with standard CPR, said Dr. Tom P. Aufderheide of the department of emergency medicine, Medical College of Wisconsin, Milwaukee.
The device is designed to increase the degree of negative intrathoracic pressure during CPR by preventing the passive inflow of air into the chest during chest recoil between compressions, without impeding active ventilation.
Animal studies showed that use of an ITD improved hemodynamics, perfusion of vital organs, and neurologically intact survival, and small, short-term clinical studies suggested that it increased systolic blood pressure during CPR and improved short-term survival. "The 2005 American Heart Association guidelines gave a class IIa recommendation for the use of the ITD to improve hemodynamic variables and the return of spontaneous circulation," Dr. Aufderheide and his colleagues in the ROC said.
They randomly assigned 8,718 adults with nontraumatic out-of-hospital cardiac arrest to undergo CPR with an ITD (4,373 subjects) or CPR with a sham ITD (4,345 subjects). As with the first ROC study, the primary outcome measure of this study was survival to hospital discharge with satisfactory functional status.
The rates of this outcome were 5.8% with the active ITD and 6.0% with the sham ITD, a nonsignificant difference, the researchers said (N. Engl. J. Med. 2011;365:798-806).
There also were no significant differences between the two study groups in secondary outcomes such as the return of spontaneous circulation by arrival at the emergency department, survival to hospital admission, or survival to hospital discharge regardless of functional status, they added.
These studies were funded by the U.S. National Heart, Lung, and Blood Institute; the U.S. National Institute of Neurological Disorders and Stroke; the Canadian Institutes of Health Research; and the Heart and Stroke Foundation of Canada. The authors and their associates reported ties to Medtronic, Philips Health Care, Amgen, Johnson & Johnson, Roche, Laerdal, Lifebridge, Zoll Medical, Imricor Medical Systems, Jolife, and the American Medical Association. Dr. Sanders reported no financial conflicts of interest.
The findings of these "extremely well-performed," high-level scientific inquiries show that it may be more useful to consider out-of-hospital cardiac arrest as a public health problem rather than as a disease process, Dr. Arthur B. Sanders said.
And "randomized, controlled trials may not be the best strategy for making progress in the management of public health problems." After all, the efficacy of closed-chest compression, mouth-to-mouth rescue breathing, layperson-administered CPR, and prehospital defibrillation by EMS "were all major clinical advances ... that were not subjected to randomized clinical trials," he noted.
An alternative strategy of making systemic changes in standard CPR protocols nearly tripled the survival rate after cardiac arrest in Arizona, and the same model achieved similar survival benefits when used in rural Wisconsin, Dr. Sanders said.
Dr. Sanders, M.D., is in the department of emergency medicine at the University of Arizona’s Sarver Heart Center, Tucson. He reported no financial conflicts of interest. These remarks were taken from his editorial accompanying the reports by Dr. Stiell and Dr. Aufderheide (N. Engl. J. Med. 2011;365:850-1).
The findings of these "extremely well-performed," high-level scientific inquiries show that it may be more useful to consider out-of-hospital cardiac arrest as a public health problem rather than as a disease process, Dr. Arthur B. Sanders said.
And "randomized, controlled trials may not be the best strategy for making progress in the management of public health problems." After all, the efficacy of closed-chest compression, mouth-to-mouth rescue breathing, layperson-administered CPR, and prehospital defibrillation by EMS "were all major clinical advances ... that were not subjected to randomized clinical trials," he noted.
An alternative strategy of making systemic changes in standard CPR protocols nearly tripled the survival rate after cardiac arrest in Arizona, and the same model achieved similar survival benefits when used in rural Wisconsin, Dr. Sanders said.
Dr. Sanders, M.D., is in the department of emergency medicine at the University of Arizona’s Sarver Heart Center, Tucson. He reported no financial conflicts of interest. These remarks were taken from his editorial accompanying the reports by Dr. Stiell and Dr. Aufderheide (N. Engl. J. Med. 2011;365:850-1).
The findings of these "extremely well-performed," high-level scientific inquiries show that it may be more useful to consider out-of-hospital cardiac arrest as a public health problem rather than as a disease process, Dr. Arthur B. Sanders said.
And "randomized, controlled trials may not be the best strategy for making progress in the management of public health problems." After all, the efficacy of closed-chest compression, mouth-to-mouth rescue breathing, layperson-administered CPR, and prehospital defibrillation by EMS "were all major clinical advances ... that were not subjected to randomized clinical trials," he noted.
An alternative strategy of making systemic changes in standard CPR protocols nearly tripled the survival rate after cardiac arrest in Arizona, and the same model achieved similar survival benefits when used in rural Wisconsin, Dr. Sanders said.
Dr. Sanders, M.D., is in the department of emergency medicine at the University of Arizona’s Sarver Heart Center, Tucson. He reported no financial conflicts of interest. These remarks were taken from his editorial accompanying the reports by Dr. Stiell and Dr. Aufderheide (N. Engl. J. Med. 2011;365:850-1).
Two CPR strategies intended to improve patient survival after out-of-hospital cardiac arrest were found to have no significant effect in two related randomized clinical trials published in the Sept. 1 issue of the New England Journal of Medicine.
In the first study by the Resuscitation Outcomes Consortium (ROC), a "priming the pump" approach entailing a 3-minute period of chest compressions before the first analysis of cardiac rhythm and defibrillation produced the same rate of survival as did a briefer (30- to 60-second) period of manual chest compressions before cardiac rhythm analysis. Thus, extending CPR before defibrillation in the hope of increasing myocardial perfusion failed to improve patient outcomes.
In the second study, also by the ROC researchers, use of an impedance threshold device (ITD) to enhance venous return and cardiac output during CPR also produced the same rate of survival with satisfactory functional status, as did standard CPR without an ITD. Thus, use of the device also failed to improve patient outcomes.
These findings are particularly discouraging because the survival rate in the United States and Canada after out-of-hospital cardiac arrest "has been stagnant at 7.6% for more than 30 years," said Dr. Arthur B. Sanders of the department of emergency medicine at the University of Arizona’s Sarver Heart Center, Tucson.
The first ROC study was undertaken because despite several small studies of the issue, it was still unclear whether the traditional CPR approach of delivering defibrillatory shocks as soon as possible was inferior to the newer recommendation that EMS personnel should administer at least 2 minutes of CPR before delivering the shocks. In theory, "a few minutes of chest compression may increase myocardial perfusion, thus improving the metabolic state of the cardiac myocytes and enhancing the likelihood of successful defibrillation," said Dr. Ian G. Stiell of the department of emergency medicine and the Ottawa Hospital Research Institute, University of Ottawa, and his associates in the ROC.
They compared the two strategies by randomly assigning 9,933 adults treated by 150 EMS agencies in the United States and Canada to undergo either early (5,290 subjects) or delayed (4,643 subjects) defibrillation after nontraumatic cardiac arrest. The primary outcome measure was survival to hospital discharge with satisfactory functional status.
An identical 5.9% of subjects in each of the study groups survived to discharge with satisfactory status. There also were no differences between the two groups in several subgroup analyses, including survival to hospital admission, survival to hospital discharge regardless of functional status, and return of spontaneous circulation by arrival at the emergency department.
"Overall our data suggest that the administration of 2 minutes of CPR by EMS personnel before the first analysis of [cardiac] rhythm, which was suggested in the 2005 guidelines of the AHA-ILCOR [American Heart Association–International Liaison Committee on Resuscitation], is unlikely to provide a greater benefit than CPR of shorter duration," Dr. Stiell and his colleagues said (N. Engl. J. Med. 2011;365:787-97).
"The 2010 guidelines of the AHA-ILCOR give little direction as to the preferred period of CPR before analysis of cardiac rhythm. Each EMS system should consider its operational situation when deciding on its strategy for initial EMS-administered CPR," they added.
The second study was performed because no large randomized trial had yet addressed whether use of an ITD improved outcomes when compared with standard CPR, said Dr. Tom P. Aufderheide of the department of emergency medicine, Medical College of Wisconsin, Milwaukee.
The device is designed to increase the degree of negative intrathoracic pressure during CPR by preventing the passive inflow of air into the chest during chest recoil between compressions, without impeding active ventilation.
Animal studies showed that use of an ITD improved hemodynamics, perfusion of vital organs, and neurologically intact survival, and small, short-term clinical studies suggested that it increased systolic blood pressure during CPR and improved short-term survival. "The 2005 American Heart Association guidelines gave a class IIa recommendation for the use of the ITD to improve hemodynamic variables and the return of spontaneous circulation," Dr. Aufderheide and his colleagues in the ROC said.
They randomly assigned 8,718 adults with nontraumatic out-of-hospital cardiac arrest to undergo CPR with an ITD (4,373 subjects) or CPR with a sham ITD (4,345 subjects). As with the first ROC study, the primary outcome measure of this study was survival to hospital discharge with satisfactory functional status.
The rates of this outcome were 5.8% with the active ITD and 6.0% with the sham ITD, a nonsignificant difference, the researchers said (N. Engl. J. Med. 2011;365:798-806).
There also were no significant differences between the two study groups in secondary outcomes such as the return of spontaneous circulation by arrival at the emergency department, survival to hospital admission, or survival to hospital discharge regardless of functional status, they added.
These studies were funded by the U.S. National Heart, Lung, and Blood Institute; the U.S. National Institute of Neurological Disorders and Stroke; the Canadian Institutes of Health Research; and the Heart and Stroke Foundation of Canada. The authors and their associates reported ties to Medtronic, Philips Health Care, Amgen, Johnson & Johnson, Roche, Laerdal, Lifebridge, Zoll Medical, Imricor Medical Systems, Jolife, and the American Medical Association. Dr. Sanders reported no financial conflicts of interest.
Two CPR strategies intended to improve patient survival after out-of-hospital cardiac arrest were found to have no significant effect in two related randomized clinical trials published in the Sept. 1 issue of the New England Journal of Medicine.
In the first study by the Resuscitation Outcomes Consortium (ROC), a "priming the pump" approach entailing a 3-minute period of chest compressions before the first analysis of cardiac rhythm and defibrillation produced the same rate of survival as did a briefer (30- to 60-second) period of manual chest compressions before cardiac rhythm analysis. Thus, extending CPR before defibrillation in the hope of increasing myocardial perfusion failed to improve patient outcomes.
In the second study, also by the ROC researchers, use of an impedance threshold device (ITD) to enhance venous return and cardiac output during CPR also produced the same rate of survival with satisfactory functional status, as did standard CPR without an ITD. Thus, use of the device also failed to improve patient outcomes.
These findings are particularly discouraging because the survival rate in the United States and Canada after out-of-hospital cardiac arrest "has been stagnant at 7.6% for more than 30 years," said Dr. Arthur B. Sanders of the department of emergency medicine at the University of Arizona’s Sarver Heart Center, Tucson.
The first ROC study was undertaken because despite several small studies of the issue, it was still unclear whether the traditional CPR approach of delivering defibrillatory shocks as soon as possible was inferior to the newer recommendation that EMS personnel should administer at least 2 minutes of CPR before delivering the shocks. In theory, "a few minutes of chest compression may increase myocardial perfusion, thus improving the metabolic state of the cardiac myocytes and enhancing the likelihood of successful defibrillation," said Dr. Ian G. Stiell of the department of emergency medicine and the Ottawa Hospital Research Institute, University of Ottawa, and his associates in the ROC.
They compared the two strategies by randomly assigning 9,933 adults treated by 150 EMS agencies in the United States and Canada to undergo either early (5,290 subjects) or delayed (4,643 subjects) defibrillation after nontraumatic cardiac arrest. The primary outcome measure was survival to hospital discharge with satisfactory functional status.
An identical 5.9% of subjects in each of the study groups survived to discharge with satisfactory status. There also were no differences between the two groups in several subgroup analyses, including survival to hospital admission, survival to hospital discharge regardless of functional status, and return of spontaneous circulation by arrival at the emergency department.
"Overall our data suggest that the administration of 2 minutes of CPR by EMS personnel before the first analysis of [cardiac] rhythm, which was suggested in the 2005 guidelines of the AHA-ILCOR [American Heart Association–International Liaison Committee on Resuscitation], is unlikely to provide a greater benefit than CPR of shorter duration," Dr. Stiell and his colleagues said (N. Engl. J. Med. 2011;365:787-97).
"The 2010 guidelines of the AHA-ILCOR give little direction as to the preferred period of CPR before analysis of cardiac rhythm. Each EMS system should consider its operational situation when deciding on its strategy for initial EMS-administered CPR," they added.
The second study was performed because no large randomized trial had yet addressed whether use of an ITD improved outcomes when compared with standard CPR, said Dr. Tom P. Aufderheide of the department of emergency medicine, Medical College of Wisconsin, Milwaukee.
The device is designed to increase the degree of negative intrathoracic pressure during CPR by preventing the passive inflow of air into the chest during chest recoil between compressions, without impeding active ventilation.
Animal studies showed that use of an ITD improved hemodynamics, perfusion of vital organs, and neurologically intact survival, and small, short-term clinical studies suggested that it increased systolic blood pressure during CPR and improved short-term survival. "The 2005 American Heart Association guidelines gave a class IIa recommendation for the use of the ITD to improve hemodynamic variables and the return of spontaneous circulation," Dr. Aufderheide and his colleagues in the ROC said.
They randomly assigned 8,718 adults with nontraumatic out-of-hospital cardiac arrest to undergo CPR with an ITD (4,373 subjects) or CPR with a sham ITD (4,345 subjects). As with the first ROC study, the primary outcome measure of this study was survival to hospital discharge with satisfactory functional status.
The rates of this outcome were 5.8% with the active ITD and 6.0% with the sham ITD, a nonsignificant difference, the researchers said (N. Engl. J. Med. 2011;365:798-806).
There also were no significant differences between the two study groups in secondary outcomes such as the return of spontaneous circulation by arrival at the emergency department, survival to hospital admission, or survival to hospital discharge regardless of functional status, they added.
These studies were funded by the U.S. National Heart, Lung, and Blood Institute; the U.S. National Institute of Neurological Disorders and Stroke; the Canadian Institutes of Health Research; and the Heart and Stroke Foundation of Canada. The authors and their associates reported ties to Medtronic, Philips Health Care, Amgen, Johnson & Johnson, Roche, Laerdal, Lifebridge, Zoll Medical, Imricor Medical Systems, Jolife, and the American Medical Association. Dr. Sanders reported no financial conflicts of interest.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major Finding: For approximately 9,000 patients with nontraumatic out-of-hospital cardiac arrest, rates of survival with satisfactory function were not improved by the use of prolonged CPR before defibrillation (5.9%) or of an impedance threshold device (5.8%), compared with "as soon as possible" defibrillation (5.9%) or a sham ITD (6.0%).
Data Source: Two large concurrent randomized clinical trials assessing two CPR strategies aimed at improving survival after cardiac arrest, conducted at 150 EMS agencies throughout the United States and Canada.
Disclosures: These studies were funded by the U.S. National Heart, Lung, and Blood Institute; the U.S. National Institute of Neurological Disorders and Stroke; the Canadian Institutes of Health Research; and the Heart and Stroke Foundation of Canada. The authors and their associates reported ties to Medtronic, Philips Health Care, Amgen, Johnson & Johnson, Roche, Laerdal, Lifebridge, Zoll Medical, Imricor Medical Systems, Jolife, and the American Medical Association.