With World Stroke Day scheduled for Saturday, a frequent speaker for the National Stroke Association (NSA) wants to remind hospitalists to push their patients to know their risk factors.

"They have an excellent opportunity to be an educator, particularly because of that captive audience," says David Willis, MD, a primary-care physician in Ocala, Fla., who frequently holds educational events for the NSA.

Dr. Willis cites data from a 2010 survey (PDF) compiled by NSA and Boehringer Ingelheim Pharmaceuticals that shows while more than 75% of healthcare providers reported talking to patients about atrial fibrillation (AF) and stroke, nearly half don't recall the conversation. And just 40% of patients initiate the discussion.

Dr. Willis, who served on the steering committee that interpreted the survey results, says that hospitalists dealing with AF patients can "quarterback" care plans and help improve communication with post-discharge physicians, be they primary care or specialists.

"We may not be getting that thought across as well as we think we are," he says.

Improved communication and transitions will become more important as unnecessary readmissions related to AF or stroke financially impact physicians because the government may reduce reimbursements for repeated hospital visits. Dr. Willis suggests that hospitalists take the reins of integrating their patient education efforts into checklists, health information technology, or some formalized process.

"My experience is, if you create protocols, they usually work better than educating people at a provider level," he says.

With World Stroke Day scheduled for Saturday, a frequent speaker for the National Stroke Association (NSA) wants to remind hospitalists to push their patients to know their risk factors.

"They have an excellent opportunity to be an educator, particularly because of that captive audience," says David Willis, MD, a primary-care physician in Ocala, Fla., who frequently holds educational events for the NSA.

Dr. Willis cites data from a 2010 survey (PDF) compiled by NSA and Boehringer Ingelheim Pharmaceuticals that shows while more than 75% of healthcare providers reported talking to patients about atrial fibrillation (AF) and stroke, nearly half don't recall the conversation. And just 40% of patients initiate the discussion.

Dr. Willis, who served on the steering committee that interpreted the survey results, says that hospitalists dealing with AF patients can "quarterback" care plans and help improve communication with post-discharge physicians, be they primary care or specialists.

"We may not be getting that thought across as well as we think we are," he says.

Improved communication and transitions will become more important as unnecessary readmissions related to AF or stroke financially impact physicians because the government may reduce reimbursements for repeated hospital visits. Dr. Willis suggests that hospitalists take the reins of integrating their patient education efforts into checklists, health information technology, or some formalized process.

"My experience is, if you create protocols, they usually work better than educating people at a provider level," he says.

With World Stroke Day scheduled for Saturday, a frequent speaker for the National Stroke Association (NSA) wants to remind hospitalists to push their patients to know their risk factors.

"They have an excellent opportunity to be an educator, particularly because of that captive audience," says David Willis, MD, a primary-care physician in Ocala, Fla., who frequently holds educational events for the NSA.

Dr. Willis cites data from a 2010 survey (PDF) compiled by NSA and Boehringer Ingelheim Pharmaceuticals that shows while more than 75% of healthcare providers reported talking to patients about atrial fibrillation (AF) and stroke, nearly half don't recall the conversation. And just 40% of patients initiate the discussion.

Dr. Willis, who served on the steering committee that interpreted the survey results, says that hospitalists dealing with AF patients can "quarterback" care plans and help improve communication with post-discharge physicians, be they primary care or specialists.

"We may not be getting that thought across as well as we think we are," he says.

Improved communication and transitions will become more important as unnecessary readmissions related to AF or stroke financially impact physicians because the government may reduce reimbursements for repeated hospital visits. Dr. Willis suggests that hospitalists take the reins of integrating their patient education efforts into checklists, health information technology, or some formalized process.

"My experience is, if you create protocols, they usually work better than educating people at a provider level," he says.

Medical professionals from across the country will attend the first national meeting on the topic of specialty hospitalists Nov. 4 at the Mandalay Bay Resort and Casino in Las Vegas. Sponsored by SHM, the American Hospital Association, the Neurohospitalist Society, and OBGynHospitalist.com, the gathering is for anyone interested in adopting a hospital-focused model of practice, including physician and nonphysician clinicians, as well as those in medical support industries, such as insurance carriers, policymakers, and healthcare media.

According to organizers, the one-day meeting will be structured to encourage networking and exchange of ideas among attendees, and will include presentations, panel discussions, and Q&A sessions.

"This is less 'Come hear from people who have this all figured out' … it's 'Come hear from people who are thinking about this a lot.' But the attendees are a big part of the knowledge base," says John Nelson, MD, MHM, hospitalist medical director at Overlake Hospital in Bellevue, Wash.

Dr. Nelson, cofounder and past president of SHM as well as the Nov. 4 meeting director, says he hopes to bring together healthcare leaders from diverse backgrounds to share their experiences and insights. Since this movement is growing organically rather than descending from a central agency, organizers expect to centralize the sharing of ideas and best practices.

Nearly 60 interested parties have pre-registered for the meeting, according to SHM. Attendees will take what they have learned back to their own hospitals or businesses, Dr. Nelson says, and continue the conversation with their colleagues.

The cost to attend the meeting is $350 and seats remain available; register by phone, 800-843-3360, or via the SHM website.

Medical professionals from across the country will attend the first national meeting on the topic of specialty hospitalists Nov. 4 at the Mandalay Bay Resort and Casino in Las Vegas. Sponsored by SHM, the American Hospital Association, the Neurohospitalist Society, and OBGynHospitalist.com, the gathering is for anyone interested in adopting a hospital-focused model of practice, including physician and nonphysician clinicians, as well as those in medical support industries, such as insurance carriers, policymakers, and healthcare media.

According to organizers, the one-day meeting will be structured to encourage networking and exchange of ideas among attendees, and will include presentations, panel discussions, and Q&A sessions.

"This is less 'Come hear from people who have this all figured out' … it's 'Come hear from people who are thinking about this a lot.' But the attendees are a big part of the knowledge base," says John Nelson, MD, MHM, hospitalist medical director at Overlake Hospital in Bellevue, Wash.

Dr. Nelson, cofounder and past president of SHM as well as the Nov. 4 meeting director, says he hopes to bring together healthcare leaders from diverse backgrounds to share their experiences and insights. Since this movement is growing organically rather than descending from a central agency, organizers expect to centralize the sharing of ideas and best practices.

Nearly 60 interested parties have pre-registered for the meeting, according to SHM. Attendees will take what they have learned back to their own hospitals or businesses, Dr. Nelson says, and continue the conversation with their colleagues.

The cost to attend the meeting is $350 and seats remain available; register by phone, 800-843-3360, or via the SHM website.

Medical professionals from across the country will attend the first national meeting on the topic of specialty hospitalists Nov. 4 at the Mandalay Bay Resort and Casino in Las Vegas. Sponsored by SHM, the American Hospital Association, the Neurohospitalist Society, and OBGynHospitalist.com, the gathering is for anyone interested in adopting a hospital-focused model of practice, including physician and nonphysician clinicians, as well as those in medical support industries, such as insurance carriers, policymakers, and healthcare media.

According to organizers, the one-day meeting will be structured to encourage networking and exchange of ideas among attendees, and will include presentations, panel discussions, and Q&A sessions.

"This is less 'Come hear from people who have this all figured out' … it's 'Come hear from people who are thinking about this a lot.' But the attendees are a big part of the knowledge base," says John Nelson, MD, MHM, hospitalist medical director at Overlake Hospital in Bellevue, Wash.

Dr. Nelson, cofounder and past president of SHM as well as the Nov. 4 meeting director, says he hopes to bring together healthcare leaders from diverse backgrounds to share their experiences and insights. Since this movement is growing organically rather than descending from a central agency, organizers expect to centralize the sharing of ideas and best practices.

Nearly 60 interested parties have pre-registered for the meeting, according to SHM. Attendees will take what they have learned back to their own hospitals or businesses, Dr. Nelson says, and continue the conversation with their colleagues.

The cost to attend the meeting is $350 and seats remain available; register by phone, 800-843-3360, or via the SHM website.

SAN FRANCISCO – Risk stratification is becoming progressively more refined in adults with acute leukemia, helping to identify patients most likely to benefit from transplantation, according to Dr. Robert S. Negrin.

"What has become clear is that there is important prognostic information that one can gain from the patient at the time of diagnosis that can really help guide therapy," Dr. Negrin, a professor of medicine and chief of the division of blood and marrow transplantation at Stanford (Calif.) University, said at the annual Oncology Congress.

"Clearly, one can identify patients who are at higher risk for [poor outcome]. They can be split, cytogenetics being the first pass and then molecular markers being the second pass," he told attendees.

AML Status Predicts Outcome

Typically, three groups of adults with acute myeloid leukemia (AML) are offered transplantation, he said: those having a failure of induction chemotherapy, those in a first complete remission but having an intermediate or high risk for relapse, and those beyond first complete remission.

"The No. 1 predictor of outcome is the status of the disease at the time of transplant consideration, by far and away," noted Dr. Negrin. With transplantation, the 10-year overall survival rate is only 17% for the patients with induction failure or relapsed disease, in the Stanford experience. But patients in first complete remission fare better, at 57%.

Outcomes among patients in first complete remission are varied, however, with cytogenetics identifying distinct subgroups: better risk (10%-15% of these patients), poor risk (20%-30%), and intermediate risk (all the rest).

The better-risk subgroup does fairly well with chemotherapy alone, according to Dr. Negrin. "Those are patients that we generally would recommend not to consider transplant in first complete remission. One would only consider transplant at time of relapse or second remission." At the other extreme, the poor-risk subgroup "should clearly be considered for transplant up front."

Then there is the large subgroup having intermediate risk, many of whom have normal cytogenetics. Molecular markers have shown these cytogenetically normal AMLs to be highly heterogeneous (Blood 2010;115:453-74) – information that is now being used to guide transplant decisions.

For example, patients with mutation of the nucleophosmin (NPM1) gene have a favorable prognosis and are generally managed with chemotherapy alone. In contrast, their counterparts with a mutation of the FMS-like tyrosine kinase 3 (FLT3) gene have an unfavorable prognosis with chemotherapy and may fare better with transplantation.

"So this [molecular analysis] is very helpful because it helps split those patients with cytogenetically normal AML into favorable and unfavorable groups of patients," he commented. And he predicted that such molecular risk stratification will likely be even further refined in the future.

Research is also showing that molecular prognostic information may modify cytogenetic prognostic information. For instance, in the better-risk subgroup in first remission, among patients having the favorable inversion 16 cytogenetic profile, those with a KIT mutation have poorer survival with chemotherapy than do their counterparts with wild-type KIT (J. Clin. Oncol. 2006;24:3904-11).

"By and large, unfortunately, negative markers overcome the positive ones. That’s obviously a gross generalization, but unfortunately, it is reasonably accurate," Dr. Negrin commented. "So just finding a favorable cytogenetic abnormality does not tell the whole story. One needs to do the molecular studies as well."

And doing them early is key.

"Cytogenetic and molecular studies should be done on all leukemic patients," he stressed. "When we see patients in referral, a lot of patients still are not having these molecular studies done on a routine basis, and that’s unfortunate because it’s very important that we do the best we can to try to [evaluate] patients with the most advanced technologies we have. ... It’s very important that we identify these patients up front to treat them as appropriately as we can."

Know bcr-abl Status in ALL

Risk stratification is also improving among adults with acute lymphoblastic leukemia (ALL). In these cases as well, three groups are typically offered transplantation: those having a failure of induction chemotherapy, those in first complete remission having high-risk disease, and those in either a second complete remission or first relapse.

"Clearly, one can identify patients who are at higher risk for [poor outcome]. They can be split."

Disease status at the time of transplantation is also the best predictor of outcome in ALL. In the Stanford experience, the 10-year rate of overall survival is 62% for patients who undergo transplantation in first complete remission, compared with 43% for patients having relapsed or refractory disease at transplantation.

In terms of cytogenetics, the bcr-abl translocation (Philadelphia chromosome) is "a very ominous" finding among patients with B cell–lineage ALL, according to Dr. Negrin. These patients are not cured by intensive chemotherapy and derive only short-term benefit from tyrosine kinase inhibitors. Transplantation can achieve cure, however, although less often than in other ALL subtypes.

At Stanford, the 10-year rate of overall survival for patients having this cytogenetic abnormality is about 55% among those in first complete remission at transplantation, and 20% among those beyond first complete remission.

"Clearly, patients with Philadelphia chromosome–positive ALL are at extraordinary risk and are those who do benefit from transplant," he said.

Dr. Negrin reported that he sits on the data safety monitoring boards for Abbott Pharmaceuticals and Ziopharm, and is a consultant to Genzyme and Baxter. The Oncology Congress is presented by Reed Medical Education. Reed Medical Education and this news organization are owned by Reed Elsevier Inc.

SAN FRANCISCO – Risk stratification is becoming progressively more refined in adults with acute leukemia, helping to identify patients most likely to benefit from transplantation, according to Dr. Robert S. Negrin.

"What has become clear is that there is important prognostic information that one can gain from the patient at the time of diagnosis that can really help guide therapy," Dr. Negrin, a professor of medicine and chief of the division of blood and marrow transplantation at Stanford (Calif.) University, said at the annual Oncology Congress.

"Clearly, one can identify patients who are at higher risk for [poor outcome]. They can be split, cytogenetics being the first pass and then molecular markers being the second pass," he told attendees.

AML Status Predicts Outcome

Typically, three groups of adults with acute myeloid leukemia (AML) are offered transplantation, he said: those having a failure of induction chemotherapy, those in a first complete remission but having an intermediate or high risk for relapse, and those beyond first complete remission.

"The No. 1 predictor of outcome is the status of the disease at the time of transplant consideration, by far and away," noted Dr. Negrin. With transplantation, the 10-year overall survival rate is only 17% for the patients with induction failure or relapsed disease, in the Stanford experience. But patients in first complete remission fare better, at 57%.

Outcomes among patients in first complete remission are varied, however, with cytogenetics identifying distinct subgroups: better risk (10%-15% of these patients), poor risk (20%-30%), and intermediate risk (all the rest).

The better-risk subgroup does fairly well with chemotherapy alone, according to Dr. Negrin. "Those are patients that we generally would recommend not to consider transplant in first complete remission. One would only consider transplant at time of relapse or second remission." At the other extreme, the poor-risk subgroup "should clearly be considered for transplant up front."

Then there is the large subgroup having intermediate risk, many of whom have normal cytogenetics. Molecular markers have shown these cytogenetically normal AMLs to be highly heterogeneous (Blood 2010;115:453-74) – information that is now being used to guide transplant decisions.

For example, patients with mutation of the nucleophosmin (NPM1) gene have a favorable prognosis and are generally managed with chemotherapy alone. In contrast, their counterparts with a mutation of the FMS-like tyrosine kinase 3 (FLT3) gene have an unfavorable prognosis with chemotherapy and may fare better with transplantation.

"So this [molecular analysis] is very helpful because it helps split those patients with cytogenetically normal AML into favorable and unfavorable groups of patients," he commented. And he predicted that such molecular risk stratification will likely be even further refined in the future.

Research is also showing that molecular prognostic information may modify cytogenetic prognostic information. For instance, in the better-risk subgroup in first remission, among patients having the favorable inversion 16 cytogenetic profile, those with a KIT mutation have poorer survival with chemotherapy than do their counterparts with wild-type KIT (J. Clin. Oncol. 2006;24:3904-11).

"By and large, unfortunately, negative markers overcome the positive ones. That’s obviously a gross generalization, but unfortunately, it is reasonably accurate," Dr. Negrin commented. "So just finding a favorable cytogenetic abnormality does not tell the whole story. One needs to do the molecular studies as well."

And doing them early is key.

"Cytogenetic and molecular studies should be done on all leukemic patients," he stressed. "When we see patients in referral, a lot of patients still are not having these molecular studies done on a routine basis, and that’s unfortunate because it’s very important that we do the best we can to try to [evaluate] patients with the most advanced technologies we have. ... It’s very important that we identify these patients up front to treat them as appropriately as we can."

Know bcr-abl Status in ALL

Risk stratification is also improving among adults with acute lymphoblastic leukemia (ALL). In these cases as well, three groups are typically offered transplantation: those having a failure of induction chemotherapy, those in first complete remission having high-risk disease, and those in either a second complete remission or first relapse.

"Clearly, one can identify patients who are at higher risk for [poor outcome]. They can be split."

Disease status at the time of transplantation is also the best predictor of outcome in ALL. In the Stanford experience, the 10-year rate of overall survival is 62% for patients who undergo transplantation in first complete remission, compared with 43% for patients having relapsed or refractory disease at transplantation.

In terms of cytogenetics, the bcr-abl translocation (Philadelphia chromosome) is "a very ominous" finding among patients with B cell–lineage ALL, according to Dr. Negrin. These patients are not cured by intensive chemotherapy and derive only short-term benefit from tyrosine kinase inhibitors. Transplantation can achieve cure, however, although less often than in other ALL subtypes.

At Stanford, the 10-year rate of overall survival for patients having this cytogenetic abnormality is about 55% among those in first complete remission at transplantation, and 20% among those beyond first complete remission.

"Clearly, patients with Philadelphia chromosome–positive ALL are at extraordinary risk and are those who do benefit from transplant," he said.

Dr. Negrin reported that he sits on the data safety monitoring boards for Abbott Pharmaceuticals and Ziopharm, and is a consultant to Genzyme and Baxter. The Oncology Congress is presented by Reed Medical Education. Reed Medical Education and this news organization are owned by Reed Elsevier Inc.

SAN FRANCISCO – Risk stratification is becoming progressively more refined in adults with acute leukemia, helping to identify patients most likely to benefit from transplantation, according to Dr. Robert S. Negrin.

"What has become clear is that there is important prognostic information that one can gain from the patient at the time of diagnosis that can really help guide therapy," Dr. Negrin, a professor of medicine and chief of the division of blood and marrow transplantation at Stanford (Calif.) University, said at the annual Oncology Congress.

"Clearly, one can identify patients who are at higher risk for [poor outcome]. They can be split, cytogenetics being the first pass and then molecular markers being the second pass," he told attendees.

AML Status Predicts Outcome

Typically, three groups of adults with acute myeloid leukemia (AML) are offered transplantation, he said: those having a failure of induction chemotherapy, those in a first complete remission but having an intermediate or high risk for relapse, and those beyond first complete remission.

"The No. 1 predictor of outcome is the status of the disease at the time of transplant consideration, by far and away," noted Dr. Negrin. With transplantation, the 10-year overall survival rate is only 17% for the patients with induction failure or relapsed disease, in the Stanford experience. But patients in first complete remission fare better, at 57%.

Outcomes among patients in first complete remission are varied, however, with cytogenetics identifying distinct subgroups: better risk (10%-15% of these patients), poor risk (20%-30%), and intermediate risk (all the rest).

The better-risk subgroup does fairly well with chemotherapy alone, according to Dr. Negrin. "Those are patients that we generally would recommend not to consider transplant in first complete remission. One would only consider transplant at time of relapse or second remission." At the other extreme, the poor-risk subgroup "should clearly be considered for transplant up front."

Then there is the large subgroup having intermediate risk, many of whom have normal cytogenetics. Molecular markers have shown these cytogenetically normal AMLs to be highly heterogeneous (Blood 2010;115:453-74) – information that is now being used to guide transplant decisions.

For example, patients with mutation of the nucleophosmin (NPM1) gene have a favorable prognosis and are generally managed with chemotherapy alone. In contrast, their counterparts with a mutation of the FMS-like tyrosine kinase 3 (FLT3) gene have an unfavorable prognosis with chemotherapy and may fare better with transplantation.

"So this [molecular analysis] is very helpful because it helps split those patients with cytogenetically normal AML into favorable and unfavorable groups of patients," he commented. And he predicted that such molecular risk stratification will likely be even further refined in the future.

Research is also showing that molecular prognostic information may modify cytogenetic prognostic information. For instance, in the better-risk subgroup in first remission, among patients having the favorable inversion 16 cytogenetic profile, those with a KIT mutation have poorer survival with chemotherapy than do their counterparts with wild-type KIT (J. Clin. Oncol. 2006;24:3904-11).

"By and large, unfortunately, negative markers overcome the positive ones. That’s obviously a gross generalization, but unfortunately, it is reasonably accurate," Dr. Negrin commented. "So just finding a favorable cytogenetic abnormality does not tell the whole story. One needs to do the molecular studies as well."

And doing them early is key.

"Cytogenetic and molecular studies should be done on all leukemic patients," he stressed. "When we see patients in referral, a lot of patients still are not having these molecular studies done on a routine basis, and that’s unfortunate because it’s very important that we do the best we can to try to [evaluate] patients with the most advanced technologies we have. ... It’s very important that we identify these patients up front to treat them as appropriately as we can."

Know bcr-abl Status in ALL

Risk stratification is also improving among adults with acute lymphoblastic leukemia (ALL). In these cases as well, three groups are typically offered transplantation: those having a failure of induction chemotherapy, those in first complete remission having high-risk disease, and those in either a second complete remission or first relapse.

"Clearly, one can identify patients who are at higher risk for [poor outcome]. They can be split."

Disease status at the time of transplantation is also the best predictor of outcome in ALL. In the Stanford experience, the 10-year rate of overall survival is 62% for patients who undergo transplantation in first complete remission, compared with 43% for patients having relapsed or refractory disease at transplantation.

In terms of cytogenetics, the bcr-abl translocation (Philadelphia chromosome) is "a very ominous" finding among patients with B cell–lineage ALL, according to Dr. Negrin. These patients are not cured by intensive chemotherapy and derive only short-term benefit from tyrosine kinase inhibitors. Transplantation can achieve cure, however, although less often than in other ALL subtypes.

At Stanford, the 10-year rate of overall survival for patients having this cytogenetic abnormality is about 55% among those in first complete remission at transplantation, and 20% among those beyond first complete remission.

"Clearly, patients with Philadelphia chromosome–positive ALL are at extraordinary risk and are those who do benefit from transplant," he said.

Dr. Negrin reported that he sits on the data safety monitoring boards for Abbott Pharmaceuticals and Ziopharm, and is a consultant to Genzyme and Baxter. The Oncology Congress is presented by Reed Medical Education. Reed Medical Education and this news organization are owned by Reed Elsevier Inc.

The measurement of quality of care has been the mantra of health policy care for the past decade, and has become as American as apple pie and Chevrolet. Yet there have been few data showing that the institution of quality of care guidelines has had any impact on mortality or morbidity.

Despite this lack of data, hospitals are being financially rewarded or penalized based on their ability to meet guidelines established by the Center for Medicare and Medicaid Services in conjunction with the American College of Cardiology and the American Heart Association. Two recent reports provide insight on the progress we have achieved with guidelines in heart failure and in instituting the shortening of the door-to-balloon time (D2B) for percutaneous coronary artery intervention (PCI) in ST-segment elevation MI.

Decreasing heart failure readmission within 30 days, which occurs in approximately one-third of hospitalized patients, has become a target for the quality improvement process. Using the "Get With the Guidelines Heart Failure" registry, a recent analysis indicates that there is a very poor correlation between the achievement or those standards and the 30 day mortality and readmission rate (Circulation 2011;124:712-9).

The guidelines include measurement of cardiac function, application of the usual heart failure medications, and discharge instructions. Data were collected in almost 20,000 patients in 153 hospitals during 2005. Adherence to these guidelines was quite good and was achieved in more than 75% of the hospitals, yet it was unrelated to the 30 day mortality or hospital readmission.

The authors emphasized that the factors that affect survival and readmission are very heterogeneous. Basing pay-for-performance standards on a single measure (such as readmission rates) may penalize institutions that face impediments that are unrelated to performance measurements. Penalizing hospitals that have high readmission rates as a result of a large populations of vulnerable patients may penalize institutions that actually could benefit from more resources in order to achieve better outcomes.

The effectiveness of PCI, when it is performed in less than 90 minutes in STEMI patients, has been supported by clinical data from selected cardiac centers. The application to the larger patient population of the guideline to shorten D2B time to less than 90 minutes has been championed by the ACC, which launched the D2B Alliance in 2006 and by the AHA in 2007 with its Mission: Lifeline program.

The success of these efforts was reported in August (Circulation 2011;124:1038-45) and indicates that in a selected group of CMS-reporting hospitals, D2B time decreased from 96 minutes in 2005 to 64 minutes in 2010. In addition, the percentage of patients with a D2B time of less than 90 minutes increased from 44% to 91%, and that of patients with D2B of less than 75 minutes rose from 27% to 70%. The success of this effort is to be applauded, but the report is striking for its absence of any information regarding outcomes of the shortened D2B time. Unfortunately, there is little outcome information available, with the exception of data from Michigan on all Medicare providers in that state, which indicates that although D2B time decreased by 90 minutes, there was no significant benefit.

Measurement of quality remains elusive, in spite of the good intentions of physicians and health planners to use a variety of seemingly beneficial criteria for its definition.

As consumers, we know that quality is not easy to measure. Most of us can compare the quality of American automobiles vs. their foreign competitors by "kicking the tires," that is, by doing a little research. But even with this knowledge, we are not always sure that the particular car we buy will be better or last longer. Health care faces the same problem. Establishing quality care measurements will require a great deal of further research before we can reward or penalize hospitals and physicians for their performance.

It is possible that in our zeal to measure what we can, we are confusing process with content. How to put a number on the performance that leads to quality remains uncertain using our current methodology.-

Dr. Sidney Goldstein is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The measurement of quality of care has been the mantra of health policy care for the past decade, and has become as American as apple pie and Chevrolet. Yet there have been few data showing that the institution of quality of care guidelines has had any impact on mortality or morbidity.

Despite this lack of data, hospitals are being financially rewarded or penalized based on their ability to meet guidelines established by the Center for Medicare and Medicaid Services in conjunction with the American College of Cardiology and the American Heart Association. Two recent reports provide insight on the progress we have achieved with guidelines in heart failure and in instituting the shortening of the door-to-balloon time (D2B) for percutaneous coronary artery intervention (PCI) in ST-segment elevation MI.

Decreasing heart failure readmission within 30 days, which occurs in approximately one-third of hospitalized patients, has become a target for the quality improvement process. Using the "Get With the Guidelines Heart Failure" registry, a recent analysis indicates that there is a very poor correlation between the achievement or those standards and the 30 day mortality and readmission rate (Circulation 2011;124:712-9).

The guidelines include measurement of cardiac function, application of the usual heart failure medications, and discharge instructions. Data were collected in almost 20,000 patients in 153 hospitals during 2005. Adherence to these guidelines was quite good and was achieved in more than 75% of the hospitals, yet it was unrelated to the 30 day mortality or hospital readmission.

The authors emphasized that the factors that affect survival and readmission are very heterogeneous. Basing pay-for-performance standards on a single measure (such as readmission rates) may penalize institutions that face impediments that are unrelated to performance measurements. Penalizing hospitals that have high readmission rates as a result of a large populations of vulnerable patients may penalize institutions that actually could benefit from more resources in order to achieve better outcomes.

The effectiveness of PCI, when it is performed in less than 90 minutes in STEMI patients, has been supported by clinical data from selected cardiac centers. The application to the larger patient population of the guideline to shorten D2B time to less than 90 minutes has been championed by the ACC, which launched the D2B Alliance in 2006 and by the AHA in 2007 with its Mission: Lifeline program.

The success of these efforts was reported in August (Circulation 2011;124:1038-45) and indicates that in a selected group of CMS-reporting hospitals, D2B time decreased from 96 minutes in 2005 to 64 minutes in 2010. In addition, the percentage of patients with a D2B time of less than 90 minutes increased from 44% to 91%, and that of patients with D2B of less than 75 minutes rose from 27% to 70%. The success of this effort is to be applauded, but the report is striking for its absence of any information regarding outcomes of the shortened D2B time. Unfortunately, there is little outcome information available, with the exception of data from Michigan on all Medicare providers in that state, which indicates that although D2B time decreased by 90 minutes, there was no significant benefit.

Measurement of quality remains elusive, in spite of the good intentions of physicians and health planners to use a variety of seemingly beneficial criteria for its definition.

As consumers, we know that quality is not easy to measure. Most of us can compare the quality of American automobiles vs. their foreign competitors by "kicking the tires," that is, by doing a little research. But even with this knowledge, we are not always sure that the particular car we buy will be better or last longer. Health care faces the same problem. Establishing quality care measurements will require a great deal of further research before we can reward or penalize hospitals and physicians for their performance.

It is possible that in our zeal to measure what we can, we are confusing process with content. How to put a number on the performance that leads to quality remains uncertain using our current methodology.-

Dr. Sidney Goldstein is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The measurement of quality of care has been the mantra of health policy care for the past decade, and has become as American as apple pie and Chevrolet. Yet there have been few data showing that the institution of quality of care guidelines has had any impact on mortality or morbidity.

Despite this lack of data, hospitals are being financially rewarded or penalized based on their ability to meet guidelines established by the Center for Medicare and Medicaid Services in conjunction with the American College of Cardiology and the American Heart Association. Two recent reports provide insight on the progress we have achieved with guidelines in heart failure and in instituting the shortening of the door-to-balloon time (D2B) for percutaneous coronary artery intervention (PCI) in ST-segment elevation MI.

Decreasing heart failure readmission within 30 days, which occurs in approximately one-third of hospitalized patients, has become a target for the quality improvement process. Using the "Get With the Guidelines Heart Failure" registry, a recent analysis indicates that there is a very poor correlation between the achievement or those standards and the 30 day mortality and readmission rate (Circulation 2011;124:712-9).

The guidelines include measurement of cardiac function, application of the usual heart failure medications, and discharge instructions. Data were collected in almost 20,000 patients in 153 hospitals during 2005. Adherence to these guidelines was quite good and was achieved in more than 75% of the hospitals, yet it was unrelated to the 30 day mortality or hospital readmission.

The authors emphasized that the factors that affect survival and readmission are very heterogeneous. Basing pay-for-performance standards on a single measure (such as readmission rates) may penalize institutions that face impediments that are unrelated to performance measurements. Penalizing hospitals that have high readmission rates as a result of a large populations of vulnerable patients may penalize institutions that actually could benefit from more resources in order to achieve better outcomes.

The effectiveness of PCI, when it is performed in less than 90 minutes in STEMI patients, has been supported by clinical data from selected cardiac centers. The application to the larger patient population of the guideline to shorten D2B time to less than 90 minutes has been championed by the ACC, which launched the D2B Alliance in 2006 and by the AHA in 2007 with its Mission: Lifeline program.

The success of these efforts was reported in August (Circulation 2011;124:1038-45) and indicates that in a selected group of CMS-reporting hospitals, D2B time decreased from 96 minutes in 2005 to 64 minutes in 2010. In addition, the percentage of patients with a D2B time of less than 90 minutes increased from 44% to 91%, and that of patients with D2B of less than 75 minutes rose from 27% to 70%. The success of this effort is to be applauded, but the report is striking for its absence of any information regarding outcomes of the shortened D2B time. Unfortunately, there is little outcome information available, with the exception of data from Michigan on all Medicare providers in that state, which indicates that although D2B time decreased by 90 minutes, there was no significant benefit.

Measurement of quality remains elusive, in spite of the good intentions of physicians and health planners to use a variety of seemingly beneficial criteria for its definition.

As consumers, we know that quality is not easy to measure. Most of us can compare the quality of American automobiles vs. their foreign competitors by "kicking the tires," that is, by doing a little research. But even with this knowledge, we are not always sure that the particular car we buy will be better or last longer. Health care faces the same problem. Establishing quality care measurements will require a great deal of further research before we can reward or penalize hospitals and physicians for their performance.

It is possible that in our zeal to measure what we can, we are confusing process with content. How to put a number on the performance that leads to quality remains uncertain using our current methodology.-

Dr. Sidney Goldstein is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

SAN FRANCISCO – The color of a bruise indicates its age. You’ll almost always see bruising when a child has a fracture. Sexual abuse leaves behind physical exam findings.

These are all myths that can get in the way of physicians recognizing abuse of an infant or child. Physicians are required by law to report all suspicions of nonaccidental trauma, a catch-all term for child abuse, shaken baby syndrome, and battered-child syndrome.

Physicians can meet that obligation by ignoring these myths, recognizing red flags for nonaccidental trauma, and being familiar with signs of accidental trauma or medical conditions that can mimic the physical findings of nonaccidental trauma, Dr. Maureen D. McCollough said at the annual meeting of the American College of Emergency Physicians.

Myth: The age of bruises can be accurately determined by their color – red, purple, yellow, green, or brown. In reality, there is no predictable order or chronology of color in bruising, and even in the same person bruises of similar ages may have different colors, said Dr. McCollough of the University of Southern California, Los Angeles, and director of pediatric emergency medicine at Los Angeles County USC Medical Center.

Studies have shown poor interobserver reliability in assessing bruise coloring and poor physician accuracy in characterizing coloring.

Red flags of suspicion should go up if you see multiple bruises or lacerations, or see them in unusual locations. Accidental toddler tumbles can produce multiple bruises, but generally these are on bony prominences. Unusual locations for pediatric bruising include the lower back, buttocks, cheeks, ears, or neck. Bruising anywhere in an infant who is not yet mobile is suspicious.

"Remember, if you don’t cruise, you don’t bruise," she said.

Be suspicious if the pattern of the marks, bruises, or lacerations remind you of an object like a hand, hairbrush, belt, or buckle. Bruises around wrists or extremities may be from the child being tied up. Tight elastic socks can leave a mark around an infant’s leg that mimics this, in which case the parent should be able to provide a sock with dimensions that match the bruising.

Visible injuries around a baby’s mouth or frenulum should raise a red flag for forced feeding. Genital injuries may indicate forced toilet training. Hair pulling produces characteristic marks of traumatic alopecia – an incompletely bald child with diffuse alopecia, broken hairs, and no loose hairs at the periphery.

A wide variety of problems can mimic the visual signs of nonaccidental bruising, including dermal melanosis, vitamin K deficiency, leukemia, hemophilia, millipede secretions, Ehlers-Danlos syndrome, dermatitis, lice, and more.

An equally impressive array of events can mimic the look of abusive burns, bullae, and erythema. These include the cultural practices of coining, cupping, spooning, or moxibustion, skin infections, allergic reactions, herpes or varicella infection, diaper dermatitis, impetigo, and more.

Accidental burns usually have a typical "splash" pattern if liquid is involved, or a child who grasps something hot will have burns on the volar aspect of the fingers and palm. Accidental cigarette burns usually have a streaky appearance.

If there are no splash marks, or there is a sharp line of demarcation, or burns are limited to the perineum, consider that the child may have been forcibly immersed in something hot. Intentional cigarette burns tend to be similar in size – often 5-mm circles – and create injuries from bullae to deep craters that scab over. These usually are on the palms or soles but can be anywhere on the body. Again, be suspicious if you see a burn mark that looks like an object, such as a radiator or an iron.

Myth: Fractures usually are associated with overlying bruising. In fact, children with inflicted skeletal fractures often have no associated bruising. Bruising is present in only 43% of skull fractures and less than 20% of lower extremity fractures in cases of abuse, Dr. McCollough said.

Infants who can’t walk shouldn’t fracture. Spiral fractures caused by the twisting of a long bone such as the femur suggest nonaccidental trauma. Toddler spiral fractures of the tibia, on the other hand, are very common, caused when a leg is trapped under the body during a fall, such as getting a leg caught in a couch. "This is not abuse," she said.

Raise the red flags when you see swelling of a body part that is out of proportion to a described injury; this may indicate an underlying fracture. A diaphyseal (midshaft) fracture in a child less than 3 years old is suspect, and metaphyseal or epiphyseal fractures beyond the newborn period (also called corner fractures or bucket handle fractures) are virtually diagnostic of abuse.

The posterior ribs are the most common area of nonaccidental rib fractures.

Suspect head injuries and possible abuse if the child has unexplained seizures, vomiting, changes in neurological or mental status, or large scalp hematomas. Be suspicious if the parents’ explanation changes over time, if there is intracranial bleeds after "minimal" trauma, or if you find retinal hemorrhages outside of the newborn period, she said.

Myth: Sexual abuse leaves physical findings. More myths: A colposcope is needed to detect sexual abuse, and some girls are born without hymens.

Although hymens come in a wide variety of shapes and sizes, a study of more than 1,100 newborn girls showed that all of them had one, she noted. Reviews of cases of sexual abuse show that physical exam findings of pediatric sexual abuse are rare because the tissue is very elastic and heals quickly.

Physical evidence will be more likely if force was used, if the child resisted, if there are great differences in the sizes and ages of the perpetrator and victim, and if a foreign object was forced into the mouth, vagina, or anus. Bruising or bite marks on a child’s penis may suggest nonaccidental trauma from forced toilet training.

When you see visible clues to what may be abuse, photograph or draw what you see and include something in the image to show size or scale. Don’t just rely on written notes, she said.

SAN FRANCISCO – The color of a bruise indicates its age. You’ll almost always see bruising when a child has a fracture. Sexual abuse leaves behind physical exam findings.

These are all myths that can get in the way of physicians recognizing abuse of an infant or child. Physicians are required by law to report all suspicions of nonaccidental trauma, a catch-all term for child abuse, shaken baby syndrome, and battered-child syndrome.

Physicians can meet that obligation by ignoring these myths, recognizing red flags for nonaccidental trauma, and being familiar with signs of accidental trauma or medical conditions that can mimic the physical findings of nonaccidental trauma, Dr. Maureen D. McCollough said at the annual meeting of the American College of Emergency Physicians.

Myth: The age of bruises can be accurately determined by their color – red, purple, yellow, green, or brown. In reality, there is no predictable order or chronology of color in bruising, and even in the same person bruises of similar ages may have different colors, said Dr. McCollough of the University of Southern California, Los Angeles, and director of pediatric emergency medicine at Los Angeles County USC Medical Center.

Studies have shown poor interobserver reliability in assessing bruise coloring and poor physician accuracy in characterizing coloring.

Red flags of suspicion should go up if you see multiple bruises or lacerations, or see them in unusual locations. Accidental toddler tumbles can produce multiple bruises, but generally these are on bony prominences. Unusual locations for pediatric bruising include the lower back, buttocks, cheeks, ears, or neck. Bruising anywhere in an infant who is not yet mobile is suspicious.

"Remember, if you don’t cruise, you don’t bruise," she said.

Be suspicious if the pattern of the marks, bruises, or lacerations remind you of an object like a hand, hairbrush, belt, or buckle. Bruises around wrists or extremities may be from the child being tied up. Tight elastic socks can leave a mark around an infant’s leg that mimics this, in which case the parent should be able to provide a sock with dimensions that match the bruising.

Visible injuries around a baby’s mouth or frenulum should raise a red flag for forced feeding. Genital injuries may indicate forced toilet training. Hair pulling produces characteristic marks of traumatic alopecia – an incompletely bald child with diffuse alopecia, broken hairs, and no loose hairs at the periphery.

A wide variety of problems can mimic the visual signs of nonaccidental bruising, including dermal melanosis, vitamin K deficiency, leukemia, hemophilia, millipede secretions, Ehlers-Danlos syndrome, dermatitis, lice, and more.

An equally impressive array of events can mimic the look of abusive burns, bullae, and erythema. These include the cultural practices of coining, cupping, spooning, or moxibustion, skin infections, allergic reactions, herpes or varicella infection, diaper dermatitis, impetigo, and more.

Accidental burns usually have a typical "splash" pattern if liquid is involved, or a child who grasps something hot will have burns on the volar aspect of the fingers and palm. Accidental cigarette burns usually have a streaky appearance.

If there are no splash marks, or there is a sharp line of demarcation, or burns are limited to the perineum, consider that the child may have been forcibly immersed in something hot. Intentional cigarette burns tend to be similar in size – often 5-mm circles – and create injuries from bullae to deep craters that scab over. These usually are on the palms or soles but can be anywhere on the body. Again, be suspicious if you see a burn mark that looks like an object, such as a radiator or an iron.

Myth: Fractures usually are associated with overlying bruising. In fact, children with inflicted skeletal fractures often have no associated bruising. Bruising is present in only 43% of skull fractures and less than 20% of lower extremity fractures in cases of abuse, Dr. McCollough said.

Infants who can’t walk shouldn’t fracture. Spiral fractures caused by the twisting of a long bone such as the femur suggest nonaccidental trauma. Toddler spiral fractures of the tibia, on the other hand, are very common, caused when a leg is trapped under the body during a fall, such as getting a leg caught in a couch. "This is not abuse," she said.

Raise the red flags when you see swelling of a body part that is out of proportion to a described injury; this may indicate an underlying fracture. A diaphyseal (midshaft) fracture in a child less than 3 years old is suspect, and metaphyseal or epiphyseal fractures beyond the newborn period (also called corner fractures or bucket handle fractures) are virtually diagnostic of abuse.

The posterior ribs are the most common area of nonaccidental rib fractures.

Suspect head injuries and possible abuse if the child has unexplained seizures, vomiting, changes in neurological or mental status, or large scalp hematomas. Be suspicious if the parents’ explanation changes over time, if there is intracranial bleeds after "minimal" trauma, or if you find retinal hemorrhages outside of the newborn period, she said.

Myth: Sexual abuse leaves physical findings. More myths: A colposcope is needed to detect sexual abuse, and some girls are born without hymens.

Although hymens come in a wide variety of shapes and sizes, a study of more than 1,100 newborn girls showed that all of them had one, she noted. Reviews of cases of sexual abuse show that physical exam findings of pediatric sexual abuse are rare because the tissue is very elastic and heals quickly.

Physical evidence will be more likely if force was used, if the child resisted, if there are great differences in the sizes and ages of the perpetrator and victim, and if a foreign object was forced into the mouth, vagina, or anus. Bruising or bite marks on a child’s penis may suggest nonaccidental trauma from forced toilet training.

When you see visible clues to what may be abuse, photograph or draw what you see and include something in the image to show size or scale. Don’t just rely on written notes, she said.

SAN FRANCISCO – The color of a bruise indicates its age. You’ll almost always see bruising when a child has a fracture. Sexual abuse leaves behind physical exam findings.

These are all myths that can get in the way of physicians recognizing abuse of an infant or child. Physicians are required by law to report all suspicions of nonaccidental trauma, a catch-all term for child abuse, shaken baby syndrome, and battered-child syndrome.

Physicians can meet that obligation by ignoring these myths, recognizing red flags for nonaccidental trauma, and being familiar with signs of accidental trauma or medical conditions that can mimic the physical findings of nonaccidental trauma, Dr. Maureen D. McCollough said at the annual meeting of the American College of Emergency Physicians.

Myth: The age of bruises can be accurately determined by their color – red, purple, yellow, green, or brown. In reality, there is no predictable order or chronology of color in bruising, and even in the same person bruises of similar ages may have different colors, said Dr. McCollough of the University of Southern California, Los Angeles, and director of pediatric emergency medicine at Los Angeles County USC Medical Center.

Studies have shown poor interobserver reliability in assessing bruise coloring and poor physician accuracy in characterizing coloring.

Red flags of suspicion should go up if you see multiple bruises or lacerations, or see them in unusual locations. Accidental toddler tumbles can produce multiple bruises, but generally these are on bony prominences. Unusual locations for pediatric bruising include the lower back, buttocks, cheeks, ears, or neck. Bruising anywhere in an infant who is not yet mobile is suspicious.

"Remember, if you don’t cruise, you don’t bruise," she said.

Be suspicious if the pattern of the marks, bruises, or lacerations remind you of an object like a hand, hairbrush, belt, or buckle. Bruises around wrists or extremities may be from the child being tied up. Tight elastic socks can leave a mark around an infant’s leg that mimics this, in which case the parent should be able to provide a sock with dimensions that match the bruising.

Visible injuries around a baby’s mouth or frenulum should raise a red flag for forced feeding. Genital injuries may indicate forced toilet training. Hair pulling produces characteristic marks of traumatic alopecia – an incompletely bald child with diffuse alopecia, broken hairs, and no loose hairs at the periphery.

A wide variety of problems can mimic the visual signs of nonaccidental bruising, including dermal melanosis, vitamin K deficiency, leukemia, hemophilia, millipede secretions, Ehlers-Danlos syndrome, dermatitis, lice, and more.

An equally impressive array of events can mimic the look of abusive burns, bullae, and erythema. These include the cultural practices of coining, cupping, spooning, or moxibustion, skin infections, allergic reactions, herpes or varicella infection, diaper dermatitis, impetigo, and more.

Accidental burns usually have a typical "splash" pattern if liquid is involved, or a child who grasps something hot will have burns on the volar aspect of the fingers and palm. Accidental cigarette burns usually have a streaky appearance.

If there are no splash marks, or there is a sharp line of demarcation, or burns are limited to the perineum, consider that the child may have been forcibly immersed in something hot. Intentional cigarette burns tend to be similar in size – often 5-mm circles – and create injuries from bullae to deep craters that scab over. These usually are on the palms or soles but can be anywhere on the body. Again, be suspicious if you see a burn mark that looks like an object, such as a radiator or an iron.

Myth: Fractures usually are associated with overlying bruising. In fact, children with inflicted skeletal fractures often have no associated bruising. Bruising is present in only 43% of skull fractures and less than 20% of lower extremity fractures in cases of abuse, Dr. McCollough said.

Infants who can’t walk shouldn’t fracture. Spiral fractures caused by the twisting of a long bone such as the femur suggest nonaccidental trauma. Toddler spiral fractures of the tibia, on the other hand, are very common, caused when a leg is trapped under the body during a fall, such as getting a leg caught in a couch. "This is not abuse," she said.

Raise the red flags when you see swelling of a body part that is out of proportion to a described injury; this may indicate an underlying fracture. A diaphyseal (midshaft) fracture in a child less than 3 years old is suspect, and metaphyseal or epiphyseal fractures beyond the newborn period (also called corner fractures or bucket handle fractures) are virtually diagnostic of abuse.

The posterior ribs are the most common area of nonaccidental rib fractures.

Suspect head injuries and possible abuse if the child has unexplained seizures, vomiting, changes in neurological or mental status, or large scalp hematomas. Be suspicious if the parents’ explanation changes over time, if there is intracranial bleeds after "minimal" trauma, or if you find retinal hemorrhages outside of the newborn period, she said.

Myth: Sexual abuse leaves physical findings. More myths: A colposcope is needed to detect sexual abuse, and some girls are born without hymens.

Although hymens come in a wide variety of shapes and sizes, a study of more than 1,100 newborn girls showed that all of them had one, she noted. Reviews of cases of sexual abuse show that physical exam findings of pediatric sexual abuse are rare because the tissue is very elastic and heals quickly.

Physical evidence will be more likely if force was used, if the child resisted, if there are great differences in the sizes and ages of the perpetrator and victim, and if a foreign object was forced into the mouth, vagina, or anus. Bruising or bite marks on a child’s penis may suggest nonaccidental trauma from forced toilet training.

When you see visible clues to what may be abuse, photograph or draw what you see and include something in the image to show size or scale. Don’t just rely on written notes, she said.

Growth is a terrific biomarker for general health, and a slowing of growth may be a sign of underlying disease. So which children deserve an evaluation?

Short stature is defined as growth below the third percentile. In addition to these children, a child who is crossing one percentile line on the growth chart also deserves evaluation. The sole exception is an otherwise healthy child developing well who may, in the second year of life, adjust to genetics (for example, a big baby born to short parents).

The key is to identify the short child by monitoring the growth pattern, evaluating him to find a specific diagnosis, and then targeting the clinical intervention.

Consistent measurement of a child’s height at every health care encounter is the most important strategy to identify a child with short stature. Some children do not go for regular well-child visits once they have most of their immunizations completed and may show up for sick visits only. In many cases, only weight but not height is measured during these acute care visits. For example, in my pediatric endocrinology practice, it is not unusual to see children who are 12 years old without a height measurement for the previous 7 years because the family did not present to the primary care physician for well care.

The benefits of these routine measurements go beyond identification of short stature. Any child with poor growth needs to be evaluated by a specialist who can go through an extensive differential diagnosis.

Helpful guidelines include the 2009 "Evidence-Based Clinical Practice Guideline on Linear Growth Measurement of Children" from clinicians at Blanks Children’s Hospital in Des Moines, Iowa, and "Development of an Evidence-Based Clinical Practice Guideline on Linear Growth Measurement of Children"’ (J. Pediatr. Nursing 2011;26:312-24).

Sometimes I hear families or primary care physicians say, "Let’s just wait and see." It is advisable to see a child back in 6 months to monitor growth velocity, but watching poor linear growth year after year will not optimize the height outcome. The problem with later intervention is that the older child with short stature does not have enough "catch up" time. Therefore, additional evaluation is warranted if you diagnose short stature and you remain concerned after 6 months.

For a child who warrants this additional evaluation, a bone age x-ray is helpful (although not diagnostic of a specific condition). Other recommended studies include a complete blood count; chemistry panel; free thyroxine (free T4) with thyroid stimulating hormone (TSH); insulinlike growth factor 1 (IGF-1), C-reactive protein, urinalysis, and a celiac panel (IgG and IgA class of anti–tissue transglutaminase [anti-tTG]; antiendomysial antibodies, IgA class [EMA-IgA]; and quantitative IgA). In addition, for girls, a karyotype can rule out Turner’s syndrome.

Obtaining the correct test can sometimes be a problem. For example, IGF-1 is similar to many other test names on a laboratory test list. The odds of a lab technician performing the right test are low, because on their alphabetical test list, IGF BP 1 appears at the top (and this test is not useful at all!). This pitfall can be avoided by including the lab specific test code for IGF-1, which your local pediatric endocrinologist can help you find.

Other testing may be warranted, based on history and physical findings. For example, if a child has a history of pneumonia and frequent sinusitis, I would order a sweat chloride test to rule out cystic fibrosis.

If there is no clear explanation, and the slowed growth does not respond to your intervention, refer the patient to a specialist.

The growth chart will help guide the type of referral. If linear growth is poor and weight gain is appropriate (that is, their body mass index is normal), consider referral to a pediatric endocrinologist.

If linear growth is poor, but weight gain is more strikingly affected (that is, BMI is low for age), consider referral instead to a pediatric gastroenterologist.

If testing reveals electrolyte abnormalities, consider referral to pediatric nephrology.

If the child has congenital anomalies or a developmental delay in addition to short stature, then referral to a geneticist becomes appropriate.

Once a short stature diagnosis is established, a targeted approach to optimization of growth can be planned. Human growth hormone therapy, for example, typically is ordered by a pediatric endocrinologist for a number of diagnoses. Indications include growth hormone deficiency, Turner’s syndrome, Noonan’s syndrome, Prader-Willi syndrome, and children born small for gestational age who fail to catch up. A pediatric nephrologist also might prescribe this therapy for a child with renal failure who is not growing.

Dr. Counts is an associate professor of pediatrics and chief of the division of pediatric endocrinology at the University of Maryland, Baltimore. She works on multiple research studies with funding to the University of Maryland, Baltimore, from Eli Lilly, Pfizer, and Novo Nordisk. 

Growth is a terrific biomarker for general health, and a slowing of growth may be a sign of underlying disease. So which children deserve an evaluation?

Short stature is defined as growth below the third percentile. In addition to these children, a child who is crossing one percentile line on the growth chart also deserves evaluation. The sole exception is an otherwise healthy child developing well who may, in the second year of life, adjust to genetics (for example, a big baby born to short parents).

The key is to identify the short child by monitoring the growth pattern, evaluating him to find a specific diagnosis, and then targeting the clinical intervention.

Consistent measurement of a child’s height at every health care encounter is the most important strategy to identify a child with short stature. Some children do not go for regular well-child visits once they have most of their immunizations completed and may show up for sick visits only. In many cases, only weight but not height is measured during these acute care visits. For example, in my pediatric endocrinology practice, it is not unusual to see children who are 12 years old without a height measurement for the previous 7 years because the family did not present to the primary care physician for well care.

The benefits of these routine measurements go beyond identification of short stature. Any child with poor growth needs to be evaluated by a specialist who can go through an extensive differential diagnosis.

Helpful guidelines include the 2009 "Evidence-Based Clinical Practice Guideline on Linear Growth Measurement of Children" from clinicians at Blanks Children’s Hospital in Des Moines, Iowa, and "Development of an Evidence-Based Clinical Practice Guideline on Linear Growth Measurement of Children"’ (J. Pediatr. Nursing 2011;26:312-24).

Sometimes I hear families or primary care physicians say, "Let’s just wait and see." It is advisable to see a child back in 6 months to monitor growth velocity, but watching poor linear growth year after year will not optimize the height outcome. The problem with later intervention is that the older child with short stature does not have enough "catch up" time. Therefore, additional evaluation is warranted if you diagnose short stature and you remain concerned after 6 months.

For a child who warrants this additional evaluation, a bone age x-ray is helpful (although not diagnostic of a specific condition). Other recommended studies include a complete blood count; chemistry panel; free thyroxine (free T4) with thyroid stimulating hormone (TSH); insulinlike growth factor 1 (IGF-1), C-reactive protein, urinalysis, and a celiac panel (IgG and IgA class of anti–tissue transglutaminase [anti-tTG]; antiendomysial antibodies, IgA class [EMA-IgA]; and quantitative IgA). In addition, for girls, a karyotype can rule out Turner’s syndrome.

Obtaining the correct test can sometimes be a problem. For example, IGF-1 is similar to many other test names on a laboratory test list. The odds of a lab technician performing the right test are low, because on their alphabetical test list, IGF BP 1 appears at the top (and this test is not useful at all!). This pitfall can be avoided by including the lab specific test code for IGF-1, which your local pediatric endocrinologist can help you find.

Other testing may be warranted, based on history and physical findings. For example, if a child has a history of pneumonia and frequent sinusitis, I would order a sweat chloride test to rule out cystic fibrosis.

If there is no clear explanation, and the slowed growth does not respond to your intervention, refer the patient to a specialist.

The growth chart will help guide the type of referral. If linear growth is poor and weight gain is appropriate (that is, their body mass index is normal), consider referral to a pediatric endocrinologist.

If linear growth is poor, but weight gain is more strikingly affected (that is, BMI is low for age), consider referral instead to a pediatric gastroenterologist.

If testing reveals electrolyte abnormalities, consider referral to pediatric nephrology.

If the child has congenital anomalies or a developmental delay in addition to short stature, then referral to a geneticist becomes appropriate.

Once a short stature diagnosis is established, a targeted approach to optimization of growth can be planned. Human growth hormone therapy, for example, typically is ordered by a pediatric endocrinologist for a number of diagnoses. Indications include growth hormone deficiency, Turner’s syndrome, Noonan’s syndrome, Prader-Willi syndrome, and children born small for gestational age who fail to catch up. A pediatric nephrologist also might prescribe this therapy for a child with renal failure who is not growing.

Dr. Counts is an associate professor of pediatrics and chief of the division of pediatric endocrinology at the University of Maryland, Baltimore. She works on multiple research studies with funding to the University of Maryland, Baltimore, from Eli Lilly, Pfizer, and Novo Nordisk. 

Growth is a terrific biomarker for general health, and a slowing of growth may be a sign of underlying disease. So which children deserve an evaluation?

Short stature is defined as growth below the third percentile. In addition to these children, a child who is crossing one percentile line on the growth chart also deserves evaluation. The sole exception is an otherwise healthy child developing well who may, in the second year of life, adjust to genetics (for example, a big baby born to short parents).

The key is to identify the short child by monitoring the growth pattern, evaluating him to find a specific diagnosis, and then targeting the clinical intervention.

Consistent measurement of a child’s height at every health care encounter is the most important strategy to identify a child with short stature. Some children do not go for regular well-child visits once they have most of their immunizations completed and may show up for sick visits only. In many cases, only weight but not height is measured during these acute care visits. For example, in my pediatric endocrinology practice, it is not unusual to see children who are 12 years old without a height measurement for the previous 7 years because the family did not present to the primary care physician for well care.

The benefits of these routine measurements go beyond identification of short stature. Any child with poor growth needs to be evaluated by a specialist who can go through an extensive differential diagnosis.

Helpful guidelines include the 2009 "Evidence-Based Clinical Practice Guideline on Linear Growth Measurement of Children" from clinicians at Blanks Children’s Hospital in Des Moines, Iowa, and "Development of an Evidence-Based Clinical Practice Guideline on Linear Growth Measurement of Children"’ (J. Pediatr. Nursing 2011;26:312-24).

Sometimes I hear families or primary care physicians say, "Let’s just wait and see." It is advisable to see a child back in 6 months to monitor growth velocity, but watching poor linear growth year after year will not optimize the height outcome. The problem with later intervention is that the older child with short stature does not have enough "catch up" time. Therefore, additional evaluation is warranted if you diagnose short stature and you remain concerned after 6 months.

For a child who warrants this additional evaluation, a bone age x-ray is helpful (although not diagnostic of a specific condition). Other recommended studies include a complete blood count; chemistry panel; free thyroxine (free T4) with thyroid stimulating hormone (TSH); insulinlike growth factor 1 (IGF-1), C-reactive protein, urinalysis, and a celiac panel (IgG and IgA class of anti–tissue transglutaminase [anti-tTG]; antiendomysial antibodies, IgA class [EMA-IgA]; and quantitative IgA). In addition, for girls, a karyotype can rule out Turner’s syndrome.

Obtaining the correct test can sometimes be a problem. For example, IGF-1 is similar to many other test names on a laboratory test list. The odds of a lab technician performing the right test are low, because on their alphabetical test list, IGF BP 1 appears at the top (and this test is not useful at all!). This pitfall can be avoided by including the lab specific test code for IGF-1, which your local pediatric endocrinologist can help you find.

Other testing may be warranted, based on history and physical findings. For example, if a child has a history of pneumonia and frequent sinusitis, I would order a sweat chloride test to rule out cystic fibrosis.

If there is no clear explanation, and the slowed growth does not respond to your intervention, refer the patient to a specialist.

The growth chart will help guide the type of referral. If linear growth is poor and weight gain is appropriate (that is, their body mass index is normal), consider referral to a pediatric endocrinologist.

If linear growth is poor, but weight gain is more strikingly affected (that is, BMI is low for age), consider referral instead to a pediatric gastroenterologist.

If testing reveals electrolyte abnormalities, consider referral to pediatric nephrology.

If the child has congenital anomalies or a developmental delay in addition to short stature, then referral to a geneticist becomes appropriate.

Once a short stature diagnosis is established, a targeted approach to optimization of growth can be planned. Human growth hormone therapy, for example, typically is ordered by a pediatric endocrinologist for a number of diagnoses. Indications include growth hormone deficiency, Turner’s syndrome, Noonan’s syndrome, Prader-Willi syndrome, and children born small for gestational age who fail to catch up. A pediatric nephrologist also might prescribe this therapy for a child with renal failure who is not growing.

Dr. Counts is an associate professor of pediatrics and chief of the division of pediatric endocrinology at the University of Maryland, Baltimore. She works on multiple research studies with funding to the University of Maryland, Baltimore, from Eli Lilly, Pfizer, and Novo Nordisk. 

Some people adopt a “Chicken Little” mentality when faced with making big changes, says Kathy DeVault, RHIS, CCS, CCS-P, manager of professional practice resources for the American Health Information Management Association (AHIMA). The change she’s referring to is the switch from the current version of the International Statistical Classification of Diseases coding system (ICD-9-CM) to the ICD-10-CM/ICD-10-PCS, which must be effective in hospitals by Oct. 1, 2013.

Hospitalist Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine and director of the Mobile ACE Service at Mount Sinai Hospital in New York City, also is director of the Clinical Documentation Improvement Department at Mount Sinai. He already is intimately involved with his hospital’s ICD-10 implementation process.

“For hospitals, this is a very big deal,” Dr. Farber says, “because it affects not just the coding department, but quality, compliance, and public reporting. On the physician side, there will be major changes in clinical documentation. Hospitalists who also do procedures, even bedside procedures, need to understand what is required.”

Why the Change?

Surprisingly, the U.S. is the last industrialized country in the world to upgrade to the ICD-10 system. The older system, in use since 1979, does not reflect three decades of change in medicine. “ICD-10 allows for a much better capture of specific types of treated diagnoses, provided services, and performed procedures,” Dr. Farber says, “and allows a lot more room to grow for the future.”

At first glance, the sheer numbers of new codes appear daunting. For example, procedures codes will increase from the current 4,000 to approximately 87,000. Hospitalists who perform procedures must include more description in their notes, including devices used and anatomical location of device placement.

Even if you’re not doing procedures, you may not relish the prospect of going from the current 14,000 ICD-9-CM diagnoses codes to nearly 70,000 ICD-10 codes. But, Dr. Farber explains, many of the increased descriptors have to do with laterality, which previously was not captured. To note a diagnosis of stroke, you will have to write not only whether it occurred in the posterior cerebral blood vessel, but also whether it was right or left posterior cerebral.

Ultimately, he believes, this type of specificity will relieve a burden on hospitalists, because providing more specific documentation should reduce queries from coders.

Common-Sense Approach

The October 2013 deadline allows plenty of time for physician training, says DeVault, who has been training coders through AHIMA’s ICD-10 Academy the past two years. Breaking the process down into manageable steps is helpful, she says.

“Look at your group’s most common, acute conditions, for example, and ask, ‘What is missing in the documentation?’ Especially if you can make bridges with your health information management (HIM) department, you will find that there are many opportunities to teach each other,” she says.

Hospitalists can do several things to ready their group for ICD-10, Dr. Farber says. Take a proactive stance, he advises, and select your group’s top 25 diagnoses. Then work with coding staff to map them from ICD-9 to ICD-10. On a macro level, understand what your hospital’s timeline is for the change. DeVault says that HIM departments are eager to collaborate with physician champions.

The good news: The sky isn’t really falling, according to DeVault. And the change to ICD-10 actually offers lots of opportunities for collaborations between hospitalists and health information departments.

Gretchen Henkel is a freelance writer based in California. 

Some people adopt a “Chicken Little” mentality when faced with making big changes, says Kathy DeVault, RHIS, CCS, CCS-P, manager of professional practice resources for the American Health Information Management Association (AHIMA). The change she’s referring to is the switch from the current version of the International Statistical Classification of Diseases coding system (ICD-9-CM) to the ICD-10-CM/ICD-10-PCS, which must be effective in hospitals by Oct. 1, 2013.

Hospitalist Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine and director of the Mobile ACE Service at Mount Sinai Hospital in New York City, also is director of the Clinical Documentation Improvement Department at Mount Sinai. He already is intimately involved with his hospital’s ICD-10 implementation process.

“For hospitals, this is a very big deal,” Dr. Farber says, “because it affects not just the coding department, but quality, compliance, and public reporting. On the physician side, there will be major changes in clinical documentation. Hospitalists who also do procedures, even bedside procedures, need to understand what is required.”

Why the Change?

Surprisingly, the U.S. is the last industrialized country in the world to upgrade to the ICD-10 system. The older system, in use since 1979, does not reflect three decades of change in medicine. “ICD-10 allows for a much better capture of specific types of treated diagnoses, provided services, and performed procedures,” Dr. Farber says, “and allows a lot more room to grow for the future.”

At first glance, the sheer numbers of new codes appear daunting. For example, procedures codes will increase from the current 4,000 to approximately 87,000. Hospitalists who perform procedures must include more description in their notes, including devices used and anatomical location of device placement.

Even if you’re not doing procedures, you may not relish the prospect of going from the current 14,000 ICD-9-CM diagnoses codes to nearly 70,000 ICD-10 codes. But, Dr. Farber explains, many of the increased descriptors have to do with laterality, which previously was not captured. To note a diagnosis of stroke, you will have to write not only whether it occurred in the posterior cerebral blood vessel, but also whether it was right or left posterior cerebral.

Ultimately, he believes, this type of specificity will relieve a burden on hospitalists, because providing more specific documentation should reduce queries from coders.

Common-Sense Approach

The October 2013 deadline allows plenty of time for physician training, says DeVault, who has been training coders through AHIMA’s ICD-10 Academy the past two years. Breaking the process down into manageable steps is helpful, she says.

“Look at your group’s most common, acute conditions, for example, and ask, ‘What is missing in the documentation?’ Especially if you can make bridges with your health information management (HIM) department, you will find that there are many opportunities to teach each other,” she says.

Hospitalists can do several things to ready their group for ICD-10, Dr. Farber says. Take a proactive stance, he advises, and select your group’s top 25 diagnoses. Then work with coding staff to map them from ICD-9 to ICD-10. On a macro level, understand what your hospital’s timeline is for the change. DeVault says that HIM departments are eager to collaborate with physician champions.

The good news: The sky isn’t really falling, according to DeVault. And the change to ICD-10 actually offers lots of opportunities for collaborations between hospitalists and health information departments.

Gretchen Henkel is a freelance writer based in California. 

Some people adopt a “Chicken Little” mentality when faced with making big changes, says Kathy DeVault, RHIS, CCS, CCS-P, manager of professional practice resources for the American Health Information Management Association (AHIMA). The change she’s referring to is the switch from the current version of the International Statistical Classification of Diseases coding system (ICD-9-CM) to the ICD-10-CM/ICD-10-PCS, which must be effective in hospitals by Oct. 1, 2013.

Hospitalist Jeffrey Farber, MD, assistant professor of geriatrics and palliative medicine and director of the Mobile ACE Service at Mount Sinai Hospital in New York City, also is director of the Clinical Documentation Improvement Department at Mount Sinai. He already is intimately involved with his hospital’s ICD-10 implementation process.

“For hospitals, this is a very big deal,” Dr. Farber says, “because it affects not just the coding department, but quality, compliance, and public reporting. On the physician side, there will be major changes in clinical documentation. Hospitalists who also do procedures, even bedside procedures, need to understand what is required.”

Why the Change?

Surprisingly, the U.S. is the last industrialized country in the world to upgrade to the ICD-10 system. The older system, in use since 1979, does not reflect three decades of change in medicine. “ICD-10 allows for a much better capture of specific types of treated diagnoses, provided services, and performed procedures,” Dr. Farber says, “and allows a lot more room to grow for the future.”

At first glance, the sheer numbers of new codes appear daunting. For example, procedures codes will increase from the current 4,000 to approximately 87,000. Hospitalists who perform procedures must include more description in their notes, including devices used and anatomical location of device placement.

Even if you’re not doing procedures, you may not relish the prospect of going from the current 14,000 ICD-9-CM diagnoses codes to nearly 70,000 ICD-10 codes. But, Dr. Farber explains, many of the increased descriptors have to do with laterality, which previously was not captured. To note a diagnosis of stroke, you will have to write not only whether it occurred in the posterior cerebral blood vessel, but also whether it was right or left posterior cerebral.

Ultimately, he believes, this type of specificity will relieve a burden on hospitalists, because providing more specific documentation should reduce queries from coders.

Common-Sense Approach

The October 2013 deadline allows plenty of time for physician training, says DeVault, who has been training coders through AHIMA’s ICD-10 Academy the past two years. Breaking the process down into manageable steps is helpful, she says.

“Look at your group’s most common, acute conditions, for example, and ask, ‘What is missing in the documentation?’ Especially if you can make bridges with your health information management (HIM) department, you will find that there are many opportunities to teach each other,” she says.

Hospitalists can do several things to ready their group for ICD-10, Dr. Farber says. Take a proactive stance, he advises, and select your group’s top 25 diagnoses. Then work with coding staff to map them from ICD-9 to ICD-10. On a macro level, understand what your hospital’s timeline is for the change. DeVault says that HIM departments are eager to collaborate with physician champions.

The good news: The sky isn’t really falling, according to DeVault. And the change to ICD-10 actually offers lots of opportunities for collaborations between hospitalists and health information departments.

Gretchen Henkel is a freelance writer based in California. 

Malaria-infected red blood cell
Credit: St Jude Children’s
Research Hospital

First results from a phase 3 trial of the vaccine candidate RTS,S/AS01 indicate it provides young African children with protection against clinical and severe malaria.

The researchers also said RTS,S/AS01 has an acceptable safety and tolerability profile.

These results were announced October 19 at the Malaria Forum, hosted by the Bill & Melinda Gates Foundation in Seattle, Washington.

The findings were also published online in The New England Journal of Medicine.

“The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S/AS01,” said Irving Hoffman, PA, MPH, co-principal investigator at a study site in Lilongwe, Malawi.

The trial is still ongoing, being conducted at 11 sites in 7 countries across sub-Saharan Africa. But the researchers have performed an initial analysis of results in the first 6000 children enrolled, who were aged 5 months to 17 months at the time of enrollment.

The children received 3 doses of RTS,S/AS01 and were followed for a 12-month period. RTS,S/AS01 reduced the risk of clinical malaria in these children by 56% and the risk of severe malaria by 47%.

“These results confirm findings from previous phase 2 studies and support ongoing efforts to advance the development of this malaria vaccine candidate,” Hoffman said.

Efficacy and safety results in 6- to 12-week-old infants are expected by the end of 2012, according to the investigators. However, they have performed an analysis of severe malaria episodes reported thus far in all 15,460 children enrolled in the trial, ranging from 6 weeks to 17 months of age.

The analysis showed that RTS,S/AS01 had 35% efficacy over a follow-up period ranging between 0 months and 22 months (average, 11.5 months). Further information about the longer-term effects of RTS,S/AS01—30 months after the third dose—should be available by the end of 2014, the researchers said.

The overall incidence of serious adverse events in this trial was comparable between RTS,S/AS01 recipients (18%) and those receiving a control vaccine (22%)

There were differences in the rates of certain serious adverse events between the vaccine groups. Seizures and meningitis were both more frequent in the RTS,S/AS01 group. Seizures were linked to fever, and meningitis was considered unlikely to be vaccine-related.

RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, together with African research centers. The partners are all represented on the Clinical Trials Partnership Committee, which is responsible for the conduct of the trial.

Major funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation.

Malaria-infected red blood cell
Credit: St Jude Children’s
Research Hospital

First results from a phase 3 trial of the vaccine candidate RTS,S/AS01 indicate it provides young African children with protection against clinical and severe malaria.

The researchers also said RTS,S/AS01 has an acceptable safety and tolerability profile.

These results were announced October 19 at the Malaria Forum, hosted by the Bill & Melinda Gates Foundation in Seattle, Washington.

The findings were also published online in The New England Journal of Medicine.

“The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S/AS01,” said Irving Hoffman, PA, MPH, co-principal investigator at a study site in Lilongwe, Malawi.

The trial is still ongoing, being conducted at 11 sites in 7 countries across sub-Saharan Africa. But the researchers have performed an initial analysis of results in the first 6000 children enrolled, who were aged 5 months to 17 months at the time of enrollment.

The children received 3 doses of RTS,S/AS01 and were followed for a 12-month period. RTS,S/AS01 reduced the risk of clinical malaria in these children by 56% and the risk of severe malaria by 47%.

“These results confirm findings from previous phase 2 studies and support ongoing efforts to advance the development of this malaria vaccine candidate,” Hoffman said.

Efficacy and safety results in 6- to 12-week-old infants are expected by the end of 2012, according to the investigators. However, they have performed an analysis of severe malaria episodes reported thus far in all 15,460 children enrolled in the trial, ranging from 6 weeks to 17 months of age.

The analysis showed that RTS,S/AS01 had 35% efficacy over a follow-up period ranging between 0 months and 22 months (average, 11.5 months). Further information about the longer-term effects of RTS,S/AS01—30 months after the third dose—should be available by the end of 2014, the researchers said.

The overall incidence of serious adverse events in this trial was comparable between RTS,S/AS01 recipients (18%) and those receiving a control vaccine (22%)

There were differences in the rates of certain serious adverse events between the vaccine groups. Seizures and meningitis were both more frequent in the RTS,S/AS01 group. Seizures were linked to fever, and meningitis was considered unlikely to be vaccine-related.

RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, together with African research centers. The partners are all represented on the Clinical Trials Partnership Committee, which is responsible for the conduct of the trial.

Major funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation.

Malaria-infected red blood cell
Credit: St Jude Children’s
Research Hospital

First results from a phase 3 trial of the vaccine candidate RTS,S/AS01 indicate it provides young African children with protection against clinical and severe malaria.

The researchers also said RTS,S/AS01 has an acceptable safety and tolerability profile.

These results were announced October 19 at the Malaria Forum, hosted by the Bill & Melinda Gates Foundation in Seattle, Washington.

The findings were also published online in The New England Journal of Medicine.

“The publication of the first results in children aged 5 to 17 months marks an important milestone in the development of RTS,S/AS01,” said Irving Hoffman, PA, MPH, co-principal investigator at a study site in Lilongwe, Malawi.

The trial is still ongoing, being conducted at 11 sites in 7 countries across sub-Saharan Africa. But the researchers have performed an initial analysis of results in the first 6000 children enrolled, who were aged 5 months to 17 months at the time of enrollment.

The children received 3 doses of RTS,S/AS01 and were followed for a 12-month period. RTS,S/AS01 reduced the risk of clinical malaria in these children by 56% and the risk of severe malaria by 47%.

“These results confirm findings from previous phase 2 studies and support ongoing efforts to advance the development of this malaria vaccine candidate,” Hoffman said.

Efficacy and safety results in 6- to 12-week-old infants are expected by the end of 2012, according to the investigators. However, they have performed an analysis of severe malaria episodes reported thus far in all 15,460 children enrolled in the trial, ranging from 6 weeks to 17 months of age.

The analysis showed that RTS,S/AS01 had 35% efficacy over a follow-up period ranging between 0 months and 22 months (average, 11.5 months). Further information about the longer-term effects of RTS,S/AS01—30 months after the third dose—should be available by the end of 2014, the researchers said.

The overall incidence of serious adverse events in this trial was comparable between RTS,S/AS01 recipients (18%) and those receiving a control vaccine (22%)

There were differences in the rates of certain serious adverse events between the vaccine groups. Seizures and meningitis were both more frequent in the RTS,S/AS01 group. Seizures were linked to fever, and meningitis was considered unlikely to be vaccine-related.

RTS,S/AS01 is being developed by GlaxoSmithKline and the PATH Malaria Vaccine Initiative, together with African research centers. The partners are all represented on the Clinical Trials Partnership Committee, which is responsible for the conduct of the trial.

Major funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation.