Heidi Splete

It’s late October, and a 70-year-old woman with a past medical history of type 2 diabetes and hypothyroidism, as well as a remote history of laryngeal cancer, presents with a COPD exacerbation. The records say she hasn’t had a flu shot. Would she get one at your center?

Experience says if there’s protocol in place designed for people like her, she’s in luck. But if there’s not ... her case points to room for quality improvement.

"The reason vaccinating patients has become a safety measure is that we have found that many patients will encounter health care by being seen in an emergency department, being admitted to a hospital, or being seen by their physician, and not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn.

"These are missed opportunities when we have had patients in our health care system and haven’t taken advantage of the opportunity to vaccinate them," Dr. Talbot said.

"That has been the impetus for a lot of new quality measures for those patients who are admitted to the hospital. Once their acute issue has been cared for and they are getting ready to go home, get them their vaccines while you have them there," to protect them against influenza, and also pneumococcal disease, he said.

But it’s not always an easy thing to do, Dr. Talbot said.

"It is challenging to implement an inpatient vaccination program," he said. "During a hospitalization, you are trying to get the patient supported for the illness that brought them into the hospital. You don’t want to do anything that may interrupt that care plan," he said.

"I think the places that have seemed to hard-wire [a vaccination program] have locked it into a nurse-directed order set that may be implemented upon discharge, along with education. Or, [it] may be implemented a few days into the hospitalization so as to avoid that first 48 hours when a lot of activity is happening around the acute illness," Dr. Talbot said. This approach helps ensure that vaccination doesn’t fall off the radar, and allows time to get the vaccine as well as educate patients, he said.

"One of the challenges with this type of program is making sure that the patient’s outpatient provider is aware that they have received immunizations," Dr. Talbot added. "We don’t want individuals to get an unnecessary additional flu shot or pneumococcal vaccination," he said. Documentation and communication are key factors, as is having a mechanism in the hospital to track vaccinations so a returning patient does not receive a second vaccine unnecessarily, he said.

Another challenge to implementing inpatient immunization is the concern that some sick patients who receive a flu vaccine won’t mount the same immune response as they would while healthy, Dr. Talbot said.

"In particular populations, such as those immediately post transplant, where we know that the immune response would not be robust, immunization should be deferred," he emphasized.

©Micah Young/istockphoto.com

"However, there is no evidence to suggest that giving a vaccine during a hospitalization will adversely impact the course of most illnesses for which people are admitted," he said.

Dr. Talbot also emphasized the importance of vaccination for health care workers.

In developing its Hospital Inpatient Quality measures, the Joint Commission looked to a 2006 National Quality Forum work group recommendation that "influenza and pneumococcal vaccination measures should apply to all patients regardless of diagnosis."

As of August 2012, a proposal from the Centers for Medicare and Medicaid Services requiring certain Medicare providers and suppliers to offer all eligible and consenting patients flu vaccination during flu season had not been approved, and flu vaccination policies and practices vary among hospitals.

But last January 1, inpatient immunization for pneu­monia and influenza officially  became a new Joint Commission core measure set for hospital accreditation programs.  Because it is a such a new program, quar­terly data have only recently begun to be categorized in this way, the commission said.

Polishing a Protocol

An inpatient immunization program is working in Boston at Beth Israel Deaconess Medical Center. BIDMC first initiated an inpatient flu immunization protocol in 2006, and it has been refined over time, said Dr. Alexander Carbo, a hospitalist in the division of general medicine and primary care at BIDMC, Jaime Levash, project administrator for QI and professional development, and Margie Serrano, RN, who work together as part of the medical center’s Influenza Inpatient Immunization Initiative. They described the BIDMC protocol as follows:

– When adult patients (aged 18 years and older) are admitted to BIDMC, the online medical record automatically checks to see when patients have been immunized (or have contraindications such as an allergy).

– If the patient’s vaccine status is unknown in our system, or if the patient previously refused vaccine, upon admission, the ordering providers are prompted to write for the influenza vaccine protocol, or to provide a reason for not initiating the protocol (such as a prior immunization, or allergy).

– If the protocol is initiated, the nursing staff screens the patient for appropriateness for vaccine and then either provides vaccine (with documentation) or documents the contraindication in the online medical record.

– During subsequent admissions, providers will be re-prompted to write for the vaccine protocol if the patient previously refused vaccine or if vaccine was not given (for a reason other than listed contraindications); otherwise, the prompt will not appear (the computer system tracks prior immunizations and contraindications, so as not to revaccinate patients or reprompt for patients with contraindications during the same influenza season).

The BIDMC team has tweaked the protocol over time to make it more effective at the 650-bed center, Dr. Carbo said. "We have added a hard stop at discharge to ensure that each patient’s immunization status is accounted for during their admission," he said.

Plans for the 2012-2013 flu season are similar to last year’s protocols, but will incorporate some of the newer CDC guidelines for immunizing patients with egg allergies, Dr. Carbo said.

©Catherine Lane/iStockphoto.com

In addition, "BIDMC mandates immunization for all employees in patient care areas (allowing exceptions for previously noted contraindications) and strongly encourages vaccination for all other staff," he noted.

Dr. Carbo’s advice to hospitalists about how to succeed in inpatient immunizations: "Work with a multidisciplinary team," he said. "When we started in 2006, I did this in collaboration with one of the nursing leaders. Now we have a multidisciplinary team that includes representatives from the nursing staff, the pharmacy staff, information systems, and communications," he said.

Read the Sign

The 566-bed University of Wisconsin Hospital Center (UWHC) in Madison is also harnessing the power of protocol.

"We realized that, as one of our quality control measures, we were monitoring what proportion of our patient population was being vaccinated against pneumonia and influenza and we weren’t doing as well as we would have liked," said Dr. Nasia Safdar, hospital epidemiologist for the UWHC.

Immunizing inpatients was a top choice among UWHC’s efforts to optimize vaccination, but, said Dr. Safdar: "It turned out quickly that it was easier said than done." But the Wisconsin hospital faced the challenge with a protocol similar to the one used at BIDMC. "It took a lot of the repeated questioning and thinking out of the equation because everyone is familiar with the protocol," Dr. Safdar said. "If a patient meets the criteria, they will be vaccinated."

Status is checked upon admission, and barring any specific objection or event, eligible patients get the vaccine at some point during their relationship with the Wisconsin hospital. For example, a transplant patient would not receive a vaccine at the time of the hospital stay for the transplant, but could be vaccinated at a follow-up visit 6 months later, she explained.

"Another thing we have done is to put notices on patients’ doors that say, ‘Eligible for Vaccination Before Discharge,’ and the pharmacist, who is typically involved in the discharge medication process, knows right away that this is a patient who needs to be vaccinated," she said. "It is a visible marker of something that needs to be done," Dr. Safdar said.

Dr. Talbot, Dr. Carbo, and Dr. Safdar reported having no financial conflicts to disclose.

**This story was updated Sept. 6, 2012.

It’s late October, and a 70-year-old woman with a past medical history of type 2 diabetes and hypothyroidism, as well as a remote history of laryngeal cancer, presents with a COPD exacerbation. The records say she hasn’t had a flu shot. Would she get one at your center?

Experience says if there’s protocol in place designed for people like her, she’s in luck. But if there’s not ... her case points to room for quality improvement.

"The reason vaccinating patients has become a safety measure is that we have found that many patients will encounter health care by being seen in an emergency department, being admitted to a hospital, or being seen by their physician, and not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn.

"These are missed opportunities when we have had patients in our health care system and haven’t taken advantage of the opportunity to vaccinate them," Dr. Talbot said.

"That has been the impetus for a lot of new quality measures for those patients who are admitted to the hospital. Once their acute issue has been cared for and they are getting ready to go home, get them their vaccines while you have them there," to protect them against influenza, and also pneumococcal disease, he said.

But it’s not always an easy thing to do, Dr. Talbot said.

"It is challenging to implement an inpatient vaccination program," he said. "During a hospitalization, you are trying to get the patient supported for the illness that brought them into the hospital. You don’t want to do anything that may interrupt that care plan," he said.

"I think the places that have seemed to hard-wire [a vaccination program] have locked it into a nurse-directed order set that may be implemented upon discharge, along with education. Or, [it] may be implemented a few days into the hospitalization so as to avoid that first 48 hours when a lot of activity is happening around the acute illness," Dr. Talbot said. This approach helps ensure that vaccination doesn’t fall off the radar, and allows time to get the vaccine as well as educate patients, he said.

"One of the challenges with this type of program is making sure that the patient’s outpatient provider is aware that they have received immunizations," Dr. Talbot added. "We don’t want individuals to get an unnecessary additional flu shot or pneumococcal vaccination," he said. Documentation and communication are key factors, as is having a mechanism in the hospital to track vaccinations so a returning patient does not receive a second vaccine unnecessarily, he said.

Another challenge to implementing inpatient immunization is the concern that some sick patients who receive a flu vaccine won’t mount the same immune response as they would while healthy, Dr. Talbot said.

"In particular populations, such as those immediately post transplant, where we know that the immune response would not be robust, immunization should be deferred," he emphasized.

©Micah Young/istockphoto.com

"However, there is no evidence to suggest that giving a vaccine during a hospitalization will adversely impact the course of most illnesses for which people are admitted," he said.

Dr. Talbot also emphasized the importance of vaccination for health care workers.

In developing its Hospital Inpatient Quality measures, the Joint Commission looked to a 2006 National Quality Forum work group recommendation that "influenza and pneumococcal vaccination measures should apply to all patients regardless of diagnosis."

As of August 2012, a proposal from the Centers for Medicare and Medicaid Services requiring certain Medicare providers and suppliers to offer all eligible and consenting patients flu vaccination during flu season had not been approved, and flu vaccination policies and practices vary among hospitals.

But last January 1, inpatient immunization for pneu­monia and influenza officially  became a new Joint Commission core measure set for hospital accreditation programs.  Because it is a such a new program, quar­terly data have only recently begun to be categorized in this way, the commission said.

Polishing a Protocol

An inpatient immunization program is working in Boston at Beth Israel Deaconess Medical Center. BIDMC first initiated an inpatient flu immunization protocol in 2006, and it has been refined over time, said Dr. Alexander Carbo, a hospitalist in the division of general medicine and primary care at BIDMC, Jaime Levash, project administrator for QI and professional development, and Margie Serrano, RN, who work together as part of the medical center’s Influenza Inpatient Immunization Initiative. They described the BIDMC protocol as follows:

– When adult patients (aged 18 years and older) are admitted to BIDMC, the online medical record automatically checks to see when patients have been immunized (or have contraindications such as an allergy).

– If the patient’s vaccine status is unknown in our system, or if the patient previously refused vaccine, upon admission, the ordering providers are prompted to write for the influenza vaccine protocol, or to provide a reason for not initiating the protocol (such as a prior immunization, or allergy).

– If the protocol is initiated, the nursing staff screens the patient for appropriateness for vaccine and then either provides vaccine (with documentation) or documents the contraindication in the online medical record.

– During subsequent admissions, providers will be re-prompted to write for the vaccine protocol if the patient previously refused vaccine or if vaccine was not given (for a reason other than listed contraindications); otherwise, the prompt will not appear (the computer system tracks prior immunizations and contraindications, so as not to revaccinate patients or reprompt for patients with contraindications during the same influenza season).

The BIDMC team has tweaked the protocol over time to make it more effective at the 650-bed center, Dr. Carbo said. "We have added a hard stop at discharge to ensure that each patient’s immunization status is accounted for during their admission," he said.

Plans for the 2012-2013 flu season are similar to last year’s protocols, but will incorporate some of the newer CDC guidelines for immunizing patients with egg allergies, Dr. Carbo said.

©Catherine Lane/iStockphoto.com

In addition, "BIDMC mandates immunization for all employees in patient care areas (allowing exceptions for previously noted contraindications) and strongly encourages vaccination for all other staff," he noted.

Dr. Carbo’s advice to hospitalists about how to succeed in inpatient immunizations: "Work with a multidisciplinary team," he said. "When we started in 2006, I did this in collaboration with one of the nursing leaders. Now we have a multidisciplinary team that includes representatives from the nursing staff, the pharmacy staff, information systems, and communications," he said.

Read the Sign

The 566-bed University of Wisconsin Hospital Center (UWHC) in Madison is also harnessing the power of protocol.

"We realized that, as one of our quality control measures, we were monitoring what proportion of our patient population was being vaccinated against pneumonia and influenza and we weren’t doing as well as we would have liked," said Dr. Nasia Safdar, hospital epidemiologist for the UWHC.

Immunizing inpatients was a top choice among UWHC’s efforts to optimize vaccination, but, said Dr. Safdar: "It turned out quickly that it was easier said than done." But the Wisconsin hospital faced the challenge with a protocol similar to the one used at BIDMC. "It took a lot of the repeated questioning and thinking out of the equation because everyone is familiar with the protocol," Dr. Safdar said. "If a patient meets the criteria, they will be vaccinated."

Status is checked upon admission, and barring any specific objection or event, eligible patients get the vaccine at some point during their relationship with the Wisconsin hospital. For example, a transplant patient would not receive a vaccine at the time of the hospital stay for the transplant, but could be vaccinated at a follow-up visit 6 months later, she explained.

"Another thing we have done is to put notices on patients’ doors that say, ‘Eligible for Vaccination Before Discharge,’ and the pharmacist, who is typically involved in the discharge medication process, knows right away that this is a patient who needs to be vaccinated," she said. "It is a visible marker of something that needs to be done," Dr. Safdar said.

Dr. Talbot, Dr. Carbo, and Dr. Safdar reported having no financial conflicts to disclose.

**This story was updated Sept. 6, 2012.

It’s late October, and a 70-year-old woman with a past medical history of type 2 diabetes and hypothyroidism, as well as a remote history of laryngeal cancer, presents with a COPD exacerbation. The records say she hasn’t had a flu shot. Would she get one at your center?

Experience says if there’s protocol in place designed for people like her, she’s in luck. But if there’s not ... her case points to room for quality improvement.

"The reason vaccinating patients has become a safety measure is that we have found that many patients will encounter health care by being seen in an emergency department, being admitted to a hospital, or being seen by their physician, and not receive the recommended vaccines, and later go on to develop illnesses that might be quite serious," said Dr. Thomas Talbot, author of the Society for Healthcare Epidemiology’s vaccination guidelines and chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, Tenn.

"These are missed opportunities when we have had patients in our health care system and haven’t taken advantage of the opportunity to vaccinate them," Dr. Talbot said.

"That has been the impetus for a lot of new quality measures for those patients who are admitted to the hospital. Once their acute issue has been cared for and they are getting ready to go home, get them their vaccines while you have them there," to protect them against influenza, and also pneumococcal disease, he said.

But it’s not always an easy thing to do, Dr. Talbot said.

"It is challenging to implement an inpatient vaccination program," he said. "During a hospitalization, you are trying to get the patient supported for the illness that brought them into the hospital. You don’t want to do anything that may interrupt that care plan," he said.

"I think the places that have seemed to hard-wire [a vaccination program] have locked it into a nurse-directed order set that may be implemented upon discharge, along with education. Or, [it] may be implemented a few days into the hospitalization so as to avoid that first 48 hours when a lot of activity is happening around the acute illness," Dr. Talbot said. This approach helps ensure that vaccination doesn’t fall off the radar, and allows time to get the vaccine as well as educate patients, he said.

"One of the challenges with this type of program is making sure that the patient’s outpatient provider is aware that they have received immunizations," Dr. Talbot added. "We don’t want individuals to get an unnecessary additional flu shot or pneumococcal vaccination," he said. Documentation and communication are key factors, as is having a mechanism in the hospital to track vaccinations so a returning patient does not receive a second vaccine unnecessarily, he said.

Another challenge to implementing inpatient immunization is the concern that some sick patients who receive a flu vaccine won’t mount the same immune response as they would while healthy, Dr. Talbot said.

"In particular populations, such as those immediately post transplant, where we know that the immune response would not be robust, immunization should be deferred," he emphasized.

©Micah Young/istockphoto.com

"However, there is no evidence to suggest that giving a vaccine during a hospitalization will adversely impact the course of most illnesses for which people are admitted," he said.

Dr. Talbot also emphasized the importance of vaccination for health care workers.

In developing its Hospital Inpatient Quality measures, the Joint Commission looked to a 2006 National Quality Forum work group recommendation that "influenza and pneumococcal vaccination measures should apply to all patients regardless of diagnosis."

As of August 2012, a proposal from the Centers for Medicare and Medicaid Services requiring certain Medicare providers and suppliers to offer all eligible and consenting patients flu vaccination during flu season had not been approved, and flu vaccination policies and practices vary among hospitals.

But last January 1, inpatient immunization for pneu­monia and influenza officially  became a new Joint Commission core measure set for hospital accreditation programs.  Because it is a such a new program, quar­terly data have only recently begun to be categorized in this way, the commission said.

Polishing a Protocol

An inpatient immunization program is working in Boston at Beth Israel Deaconess Medical Center. BIDMC first initiated an inpatient flu immunization protocol in 2006, and it has been refined over time, said Dr. Alexander Carbo, a hospitalist in the division of general medicine and primary care at BIDMC, Jaime Levash, project administrator for QI and professional development, and Margie Serrano, RN, who work together as part of the medical center’s Influenza Inpatient Immunization Initiative. They described the BIDMC protocol as follows:

– When adult patients (aged 18 years and older) are admitted to BIDMC, the online medical record automatically checks to see when patients have been immunized (or have contraindications such as an allergy).

– If the patient’s vaccine status is unknown in our system, or if the patient previously refused vaccine, upon admission, the ordering providers are prompted to write for the influenza vaccine protocol, or to provide a reason for not initiating the protocol (such as a prior immunization, or allergy).

– If the protocol is initiated, the nursing staff screens the patient for appropriateness for vaccine and then either provides vaccine (with documentation) or documents the contraindication in the online medical record.

– During subsequent admissions, providers will be re-prompted to write for the vaccine protocol if the patient previously refused vaccine or if vaccine was not given (for a reason other than listed contraindications); otherwise, the prompt will not appear (the computer system tracks prior immunizations and contraindications, so as not to revaccinate patients or reprompt for patients with contraindications during the same influenza season).

The BIDMC team has tweaked the protocol over time to make it more effective at the 650-bed center, Dr. Carbo said. "We have added a hard stop at discharge to ensure that each patient’s immunization status is accounted for during their admission," he said.

Plans for the 2012-2013 flu season are similar to last year’s protocols, but will incorporate some of the newer CDC guidelines for immunizing patients with egg allergies, Dr. Carbo said.

©Catherine Lane/iStockphoto.com

In addition, "BIDMC mandates immunization for all employees in patient care areas (allowing exceptions for previously noted contraindications) and strongly encourages vaccination for all other staff," he noted.

Dr. Carbo’s advice to hospitalists about how to succeed in inpatient immunizations: "Work with a multidisciplinary team," he said. "When we started in 2006, I did this in collaboration with one of the nursing leaders. Now we have a multidisciplinary team that includes representatives from the nursing staff, the pharmacy staff, information systems, and communications," he said.

Read the Sign

The 566-bed University of Wisconsin Hospital Center (UWHC) in Madison is also harnessing the power of protocol.

"We realized that, as one of our quality control measures, we were monitoring what proportion of our patient population was being vaccinated against pneumonia and influenza and we weren’t doing as well as we would have liked," said Dr. Nasia Safdar, hospital epidemiologist for the UWHC.

Immunizing inpatients was a top choice among UWHC’s efforts to optimize vaccination, but, said Dr. Safdar: "It turned out quickly that it was easier said than done." But the Wisconsin hospital faced the challenge with a protocol similar to the one used at BIDMC. "It took a lot of the repeated questioning and thinking out of the equation because everyone is familiar with the protocol," Dr. Safdar said. "If a patient meets the criteria, they will be vaccinated."

Status is checked upon admission, and barring any specific objection or event, eligible patients get the vaccine at some point during their relationship with the Wisconsin hospital. For example, a transplant patient would not receive a vaccine at the time of the hospital stay for the transplant, but could be vaccinated at a follow-up visit 6 months later, she explained.

"Another thing we have done is to put notices on patients’ doors that say, ‘Eligible for Vaccination Before Discharge,’ and the pharmacist, who is typically involved in the discharge medication process, knows right away that this is a patient who needs to be vaccinated," she said. "It is a visible marker of something that needs to be done," Dr. Safdar said.

Dr. Talbot, Dr. Carbo, and Dr. Safdar reported having no financial conflicts to disclose.

**This story was updated Sept. 6, 2012.

Two blood cancer drugs, romidepsin and decitabine, may form a partnership that can treat specific types of breast and kidney cancers, based on data from a stem cell study published online in Molecular Cancer Therapeutics.

Each drug is approved by the Food and Drug Administration to treat hematologic cancer, but this study uniquely combined romidepsin (Istodax) and decitabine (Dacogen) to activate a tumor suppressor gene that is inactive in triple-negative breast cancer and clear cell renal cell carcinoma.

Activating the gene known as secreted frizzled-related protein 1 (sFRP1) killed kidney and breast cancer cells in multiple cell lines tested, but only when the drugs were used in tandem (Mol. Cancer Ther. July 23, 2012 [doi:10.1158/1535-7163.MCT-11-0873]).

Ultimately, clinicians may be able to target treatment of triple-negative breast cancer and clear cell renal cell carcinoma by identifying which patients have tumors in which sFRP1 is inactivated, the researchers noted. "We predict that there are a number of drug targetable genes that are re-expressed after combinatorial treatment that possess antitumor activity," they said.

"We now have the basis for a clinical trial aimed at providing effective therapy for two drug-resistant cancers and perhaps many more tumor types in the future," senior author John A. Copland, Ph.D., of the Mayo Clinic in Jacksonville, Florida, added in a statement issued July 31 by the Mayo Clinic.

The researchers had no financial conflicts to disclose. The study was funded in part by grants from several organizations, including the National Cancer Institute; Kidney Cancer Research at Mayo Clinic, Florida; and the Breast Cancer Research Foundation.

Two blood cancer drugs, romidepsin and decitabine, may form a partnership that can treat specific types of breast and kidney cancers, based on data from a stem cell study published online in Molecular Cancer Therapeutics.

Each drug is approved by the Food and Drug Administration to treat hematologic cancer, but this study uniquely combined romidepsin (Istodax) and decitabine (Dacogen) to activate a tumor suppressor gene that is inactive in triple-negative breast cancer and clear cell renal cell carcinoma.

Activating the gene known as secreted frizzled-related protein 1 (sFRP1) killed kidney and breast cancer cells in multiple cell lines tested, but only when the drugs were used in tandem (Mol. Cancer Ther. July 23, 2012 [doi:10.1158/1535-7163.MCT-11-0873]).

Ultimately, clinicians may be able to target treatment of triple-negative breast cancer and clear cell renal cell carcinoma by identifying which patients have tumors in which sFRP1 is inactivated, the researchers noted. "We predict that there are a number of drug targetable genes that are re-expressed after combinatorial treatment that possess antitumor activity," they said.

"We now have the basis for a clinical trial aimed at providing effective therapy for two drug-resistant cancers and perhaps many more tumor types in the future," senior author John A. Copland, Ph.D., of the Mayo Clinic in Jacksonville, Florida, added in a statement issued July 31 by the Mayo Clinic.

The researchers had no financial conflicts to disclose. The study was funded in part by grants from several organizations, including the National Cancer Institute; Kidney Cancer Research at Mayo Clinic, Florida; and the Breast Cancer Research Foundation.

Two blood cancer drugs, romidepsin and decitabine, may form a partnership that can treat specific types of breast and kidney cancers, based on data from a stem cell study published online in Molecular Cancer Therapeutics.

Each drug is approved by the Food and Drug Administration to treat hematologic cancer, but this study uniquely combined romidepsin (Istodax) and decitabine (Dacogen) to activate a tumor suppressor gene that is inactive in triple-negative breast cancer and clear cell renal cell carcinoma.

Activating the gene known as secreted frizzled-related protein 1 (sFRP1) killed kidney and breast cancer cells in multiple cell lines tested, but only when the drugs were used in tandem (Mol. Cancer Ther. July 23, 2012 [doi:10.1158/1535-7163.MCT-11-0873]).

Ultimately, clinicians may be able to target treatment of triple-negative breast cancer and clear cell renal cell carcinoma by identifying which patients have tumors in which sFRP1 is inactivated, the researchers noted. "We predict that there are a number of drug targetable genes that are re-expressed after combinatorial treatment that possess antitumor activity," they said.

"We now have the basis for a clinical trial aimed at providing effective therapy for two drug-resistant cancers and perhaps many more tumor types in the future," senior author John A. Copland, Ph.D., of the Mayo Clinic in Jacksonville, Florida, added in a statement issued July 31 by the Mayo Clinic.

The researchers had no financial conflicts to disclose. The study was funded in part by grants from several organizations, including the National Cancer Institute; Kidney Cancer Research at Mayo Clinic, Florida; and the Breast Cancer Research Foundation.

New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.

The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.

"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.

According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."

The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.

The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.

Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.

New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.

The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.

"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.

According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."

The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.

The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.

Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.

New labeling changes approved by the Food and Drug Administration limit the patients eligible for treatment with the Stryker Wingspan Stent System, according to a statement and safety communication issued by the agency on Aug. 8.

The changes specify the patients most likely to benefit from treatment with the stent system. Data from studies conducted since the system’s approval in 2005 suggest that the risks, including stroke and death, may outweigh the benefits for some patients, according to the press release.

"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

Under the new label, the Wingspan system is approved only for patients aged 22-80 years who meet four specific criteria: two or more strokes despite aggressive medical management; a most recent stroke more than 7 days prior to planned treatment with the Wingspan system; 70%-99% stenosis (due to atherosclerosis of the intracranial artery related to the recurrent strokes); and good recovery from previous strokes, defined in part by a modified Rankin score of 3 or less before treatment with the Wingspan system.

According to the safety communication, the Wingspan system should not be used for "the treatment of stroke with an onset of symptoms within 7 days or less of treatment; or for the treatment of transient ischemic attacks (TIAs)."

The FDA approved the changes after reviewing data from the original clinical study, postapproval studies, and the SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) study.

The safety communication states that "a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician’s Institutional Review Board (IRB)," and that the physician is responsible for obtaining IRB approval before treating a patient with the Wingspan system.

Clinicians can report adverse events associated with the Wingspan system to the FDA via the MedWatch program. The safety communication can be viewed here.

WASHINGTON – Exposure to violence in childhood significantly increased the odds of early dating and sexual behavior in adolescents, based on data from 177 high-risk black girls in a low-income urban setting. The findings were presented at the annual meeting of the Society for Prevention Research.

"Currently, young African American adolescent girls are at disproportionate risk for poor sexual health outcomes," said Helen Wilson, Ph.D., of the college of health professions at the Rosalind Franklin University of Medicine and Science, Chicago.

Data from the Centers for Disease Control and Prevention indicate that black women aged 15-24 years have the highest rates of gonorrhea and chlamydia in the United States, she added.

However, there is not consistent evidence that black girls are more likely to take sexual risks, she said.

"There is growing recognition that violence exposure is associated with sexual risk," she said. Violence exposure also disproportionately affects youths who grow up in low-income, urban communities, she noted.

In this study, Dr. Wilson and her colleagues reviewed data from 177 girls who were participating in a longitudinal study on mother-daughter relationships and HIV risk behavior. Data were initially collected at baseline (when the girls were aged 12-16 years) and at 6, 12, 18, and 24 months.

"There is growing recognition that violence exposure is associated with sexual risk."

In a recent follow-up, the same participants responded to questions using the Lifetime Trauma and Victimization History. Sexual behavior was assessed via the AIDS Risk Behavior Assessment at all time points during the study.

Overall, 44% of the girls reported some type of violence during childhood (defined as having experienced physical or sexual victimization and/or having witnessed violence before 12 years of age).

The girls who reported exposure to childhood violence were significantly more likely than those who reported no childhood violence exposure to report sexual experience, inconsistent condom use, and a higher number of sexual partners. This trend persisted across all six time points. In addition, more extensive involvement in dating relationships in early adolescence helped to explain this relationship, said Dr. Wilson.

The results were limited by the retrospective nature of the self-reports and a lack of data about sexual partners, Dr. Wilson said, as well as a lack of generalizability of the findings to other adolescent girls. But these findings suggest that early interventions in this population might help to delay sexual activity and reduce sexual risk in low-income girls with histories of exposure to violence.

"Addressing general dating behavior should be part of such interventions," Dr. Wilson said. "Girls who are already involved in dating relationships may benefit most from early interventions to promote healthy romantic relationships and reduce sexual risk," she noted.

More research is needed about the role of partner relationships in linking violence exposure to sexual risk in high-risk adolescent girls, said Dr. Wilson. Prospective studies beginning with clear evidence of violence exposure in childhood would support stronger conclusions about this relationship, she added.

Dr. Wilson had no financial conflicts to disclose. The research was supported by a grant from the National Institute of Mental Health.

WASHINGTON – Exposure to violence in childhood significantly increased the odds of early dating and sexual behavior in adolescents, based on data from 177 high-risk black girls in a low-income urban setting. The findings were presented at the annual meeting of the Society for Prevention Research.

"Currently, young African American adolescent girls are at disproportionate risk for poor sexual health outcomes," said Helen Wilson, Ph.D., of the college of health professions at the Rosalind Franklin University of Medicine and Science, Chicago.

Data from the Centers for Disease Control and Prevention indicate that black women aged 15-24 years have the highest rates of gonorrhea and chlamydia in the United States, she added.

However, there is not consistent evidence that black girls are more likely to take sexual risks, she said.

"There is growing recognition that violence exposure is associated with sexual risk," she said. Violence exposure also disproportionately affects youths who grow up in low-income, urban communities, she noted.

In this study, Dr. Wilson and her colleagues reviewed data from 177 girls who were participating in a longitudinal study on mother-daughter relationships and HIV risk behavior. Data were initially collected at baseline (when the girls were aged 12-16 years) and at 6, 12, 18, and 24 months.

"There is growing recognition that violence exposure is associated with sexual risk."

In a recent follow-up, the same participants responded to questions using the Lifetime Trauma and Victimization History. Sexual behavior was assessed via the AIDS Risk Behavior Assessment at all time points during the study.

Overall, 44% of the girls reported some type of violence during childhood (defined as having experienced physical or sexual victimization and/or having witnessed violence before 12 years of age).

The girls who reported exposure to childhood violence were significantly more likely than those who reported no childhood violence exposure to report sexual experience, inconsistent condom use, and a higher number of sexual partners. This trend persisted across all six time points. In addition, more extensive involvement in dating relationships in early adolescence helped to explain this relationship, said Dr. Wilson.

The results were limited by the retrospective nature of the self-reports and a lack of data about sexual partners, Dr. Wilson said, as well as a lack of generalizability of the findings to other adolescent girls. But these findings suggest that early interventions in this population might help to delay sexual activity and reduce sexual risk in low-income girls with histories of exposure to violence.

"Addressing general dating behavior should be part of such interventions," Dr. Wilson said. "Girls who are already involved in dating relationships may benefit most from early interventions to promote healthy romantic relationships and reduce sexual risk," she noted.

More research is needed about the role of partner relationships in linking violence exposure to sexual risk in high-risk adolescent girls, said Dr. Wilson. Prospective studies beginning with clear evidence of violence exposure in childhood would support stronger conclusions about this relationship, she added.

Dr. Wilson had no financial conflicts to disclose. The research was supported by a grant from the National Institute of Mental Health.

WASHINGTON – Exposure to violence in childhood significantly increased the odds of early dating and sexual behavior in adolescents, based on data from 177 high-risk black girls in a low-income urban setting. The findings were presented at the annual meeting of the Society for Prevention Research.

"Currently, young African American adolescent girls are at disproportionate risk for poor sexual health outcomes," said Helen Wilson, Ph.D., of the college of health professions at the Rosalind Franklin University of Medicine and Science, Chicago.

Data from the Centers for Disease Control and Prevention indicate that black women aged 15-24 years have the highest rates of gonorrhea and chlamydia in the United States, she added.

However, there is not consistent evidence that black girls are more likely to take sexual risks, she said.

"There is growing recognition that violence exposure is associated with sexual risk," she said. Violence exposure also disproportionately affects youths who grow up in low-income, urban communities, she noted.

In this study, Dr. Wilson and her colleagues reviewed data from 177 girls who were participating in a longitudinal study on mother-daughter relationships and HIV risk behavior. Data were initially collected at baseline (when the girls were aged 12-16 years) and at 6, 12, 18, and 24 months.

"There is growing recognition that violence exposure is associated with sexual risk."

In a recent follow-up, the same participants responded to questions using the Lifetime Trauma and Victimization History. Sexual behavior was assessed via the AIDS Risk Behavior Assessment at all time points during the study.

Overall, 44% of the girls reported some type of violence during childhood (defined as having experienced physical or sexual victimization and/or having witnessed violence before 12 years of age).

The girls who reported exposure to childhood violence were significantly more likely than those who reported no childhood violence exposure to report sexual experience, inconsistent condom use, and a higher number of sexual partners. This trend persisted across all six time points. In addition, more extensive involvement in dating relationships in early adolescence helped to explain this relationship, said Dr. Wilson.

The results were limited by the retrospective nature of the self-reports and a lack of data about sexual partners, Dr. Wilson said, as well as a lack of generalizability of the findings to other adolescent girls. But these findings suggest that early interventions in this population might help to delay sexual activity and reduce sexual risk in low-income girls with histories of exposure to violence.

"Addressing general dating behavior should be part of such interventions," Dr. Wilson said. "Girls who are already involved in dating relationships may benefit most from early interventions to promote healthy romantic relationships and reduce sexual risk," she noted.

More research is needed about the role of partner relationships in linking violence exposure to sexual risk in high-risk adolescent girls, said Dr. Wilson. Prospective studies beginning with clear evidence of violence exposure in childhood would support stronger conclusions about this relationship, she added.

Dr. Wilson had no financial conflicts to disclose. The research was supported by a grant from the National Institute of Mental Health.

WASHINGTON  – A culturally tailored family intervention program significantly reduced current drug use and risky sexual behaviors in high-risk Hispanic youth, in a randomized trial of more than 200 teens.

Data from the Monitoring the Future survey showed high rates of problem behavior in Hispanic youth, said Guillermo Prado, Ph.D., of the division of epidemiology and population health sciences at the University of Miami. He and his colleagues hypothesized that a family-centered intervention (called Familias Unidas) could reduce these behaviors.

The multiparent group intervention focused on positive parenting, communication with teens about sex, and family support. "Part of the group session is dedicated to helping the parents create social support networks," similar to what they might have had in their countries of origin, he said. "We hypothesized that our family intervention would have an impact and that the results would be mediated by improvements in family function."

The researchers recruited 242 Hispanic delinquent youth and their families from the juvenile justice system or the Miami–Dade County Public Schools system. The youth were randomized to either Familias Unidas (120) or a community practice program that served as a control (122). The average age of the participants was 15 years, and 35% were foreign born. The average household income ranged from $15,000 to $19,000 annually.

Overall, teens in the intervention group showed a significant drop in reported illicit drug use, compared with the controls, Dr. Prado reported at the annual meeting of the Society for Prevention Research.

Approximately 30% of teens in the intervention group were using drugs at baseline, but this number dropped to 20% at 6 months, followed by a leveling off of drug use, compared with steady increases in the control group over time.

Alcohol dependence was not a formal diagnosis, Dr. Prado noted. However, the trajectory for alcohol dependence among controls was very flat; while the intervention group showed a decrease from 15% at baseline to 5% by 12 months’ follow-up. The lack of impact of the intervention on current alcohol use (as opposed to dependence) was an interesting finding, he said.

"In Hispanic culture, alcohol use is considered more normative," and parents are less likely to notice teens’ alcohol consumption until there are signs of alcohol dependence, which might explain this finding, he said.

With respect to the percentage of youth who have sex while under the influence of alcohol or drugs, there was a significant increase in the control group over time, compared with a steady level in the intervention group.

On further analysis, "our family-based intervention is most efficacious for families who report high family risk (such as poor communication and low parental involvement)," Dr. Prado noted.

Data from a post hoc analysis suggests that the effectiveness of Familias Unidas varies by parental environmental exposure, including levels of immigration stress and levels of social support, which could be areas for future research, he noted.

Dr. Prado said he had no relevant financial conflicts.

WASHINGTON  – A culturally tailored family intervention program significantly reduced current drug use and risky sexual behaviors in high-risk Hispanic youth, in a randomized trial of more than 200 teens.

Data from the Monitoring the Future survey showed high rates of problem behavior in Hispanic youth, said Guillermo Prado, Ph.D., of the division of epidemiology and population health sciences at the University of Miami. He and his colleagues hypothesized that a family-centered intervention (called Familias Unidas) could reduce these behaviors.

The multiparent group intervention focused on positive parenting, communication with teens about sex, and family support. "Part of the group session is dedicated to helping the parents create social support networks," similar to what they might have had in their countries of origin, he said. "We hypothesized that our family intervention would have an impact and that the results would be mediated by improvements in family function."

The researchers recruited 242 Hispanic delinquent youth and their families from the juvenile justice system or the Miami–Dade County Public Schools system. The youth were randomized to either Familias Unidas (120) or a community practice program that served as a control (122). The average age of the participants was 15 years, and 35% were foreign born. The average household income ranged from $15,000 to $19,000 annually.

Overall, teens in the intervention group showed a significant drop in reported illicit drug use, compared with the controls, Dr. Prado reported at the annual meeting of the Society for Prevention Research.

Approximately 30% of teens in the intervention group were using drugs at baseline, but this number dropped to 20% at 6 months, followed by a leveling off of drug use, compared with steady increases in the control group over time.

Alcohol dependence was not a formal diagnosis, Dr. Prado noted. However, the trajectory for alcohol dependence among controls was very flat; while the intervention group showed a decrease from 15% at baseline to 5% by 12 months’ follow-up. The lack of impact of the intervention on current alcohol use (as opposed to dependence) was an interesting finding, he said.

"In Hispanic culture, alcohol use is considered more normative," and parents are less likely to notice teens’ alcohol consumption until there are signs of alcohol dependence, which might explain this finding, he said.

With respect to the percentage of youth who have sex while under the influence of alcohol or drugs, there was a significant increase in the control group over time, compared with a steady level in the intervention group.

On further analysis, "our family-based intervention is most efficacious for families who report high family risk (such as poor communication and low parental involvement)," Dr. Prado noted.

Data from a post hoc analysis suggests that the effectiveness of Familias Unidas varies by parental environmental exposure, including levels of immigration stress and levels of social support, which could be areas for future research, he noted.

Dr. Prado said he had no relevant financial conflicts.

WASHINGTON  – A culturally tailored family intervention program significantly reduced current drug use and risky sexual behaviors in high-risk Hispanic youth, in a randomized trial of more than 200 teens.

Data from the Monitoring the Future survey showed high rates of problem behavior in Hispanic youth, said Guillermo Prado, Ph.D., of the division of epidemiology and population health sciences at the University of Miami. He and his colleagues hypothesized that a family-centered intervention (called Familias Unidas) could reduce these behaviors.

The multiparent group intervention focused on positive parenting, communication with teens about sex, and family support. "Part of the group session is dedicated to helping the parents create social support networks," similar to what they might have had in their countries of origin, he said. "We hypothesized that our family intervention would have an impact and that the results would be mediated by improvements in family function."

The researchers recruited 242 Hispanic delinquent youth and their families from the juvenile justice system or the Miami–Dade County Public Schools system. The youth were randomized to either Familias Unidas (120) or a community practice program that served as a control (122). The average age of the participants was 15 years, and 35% were foreign born. The average household income ranged from $15,000 to $19,000 annually.

Overall, teens in the intervention group showed a significant drop in reported illicit drug use, compared with the controls, Dr. Prado reported at the annual meeting of the Society for Prevention Research.

Approximately 30% of teens in the intervention group were using drugs at baseline, but this number dropped to 20% at 6 months, followed by a leveling off of drug use, compared with steady increases in the control group over time.

Alcohol dependence was not a formal diagnosis, Dr. Prado noted. However, the trajectory for alcohol dependence among controls was very flat; while the intervention group showed a decrease from 15% at baseline to 5% by 12 months’ follow-up. The lack of impact of the intervention on current alcohol use (as opposed to dependence) was an interesting finding, he said.

"In Hispanic culture, alcohol use is considered more normative," and parents are less likely to notice teens’ alcohol consumption until there are signs of alcohol dependence, which might explain this finding, he said.

With respect to the percentage of youth who have sex while under the influence of alcohol or drugs, there was a significant increase in the control group over time, compared with a steady level in the intervention group.

On further analysis, "our family-based intervention is most efficacious for families who report high family risk (such as poor communication and low parental involvement)," Dr. Prado noted.

Data from a post hoc analysis suggests that the effectiveness of Familias Unidas varies by parental environmental exposure, including levels of immigration stress and levels of social support, which could be areas for future research, he noted.

Dr. Prado said he had no relevant financial conflicts.

In the wake of a cholera outbreak in Haiti in 2010, Partners in Health, the Boston-based nonprofit advocacy and global health organization, developed an ambitious pilot program to vaccinate against cholera, with Dr. Max Raymond in charge of the implementation. Dr. Raymond was born in Haiti and earned his medical degree there in 2004, at the Université Notre Dame d’Haiti, Port-au-Prince.

He first became involved with PIH (and its sister organization in Haiti, Zanmi Lasante) shortly after completing his medical studies, when he was invited to manage a program to combat sexually transmitted infections, tuberculosis, and HIV/AIDS in a commune of the Artibonite Valley.

Courtesy Dr. Max Raymond

"I accepted this position because I knew about the high quality work that PIH/ZL was doing in another region of the country, particularly its social justice-based mission to provide a preferential option for the poor in health care," he said.

How did you become involved in the cholera vaccination project in Haiti, and what were the goals of the project?

In the summer of 2011, I returned to Haiti after earning a master’s degree in public health at the Institute of Tropical Medicine of Antwerp, Belgium, on a Joint Japan/World Bank scholarship, when one of my mentors, Dr. Louise Ivers, PIH’s senior health and policy adviser, asked me to be the cholera vaccine project coordinator. The pilot project launched in one of the rural sections of Saint-Marc, which was where the first cases were reported during the outbreak in October 2010.

In addition to immunologically protecting this high-risk population, a secondary goal was to demonstrate the feasibility of the vaccine campaign because some experts believed it could not be executed successfully because of logistical constraints, costs, and social unrest. Oral cholera vaccines also were in short supply.

If successful, we wanted to use the results of this pilot program to advocate for more investment in cholera vaccine and a possible nationwide scale-up as one of the integral responses to the current epidemic, and upcoming endemicity.

Describe the cholera vaccination efforts overall.

The project was executed concomitantly by two organizations: By PIH/ZL in the rural setting of Saint-Marc and by the nongovernmental organization GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections) in an urban setting in the capital, Port-au-Prince.

The cholera vaccine consists of two oral doses administered 2-6 weeks apart. Children younger than 1 year and pregnant women were excluded. Before the immunization, we conducted a census in the target area to preregister those who were eligible and to give them a vaccine card with a barcode that would give them access to their doses. We sent a team of 50 enumerators to the field and each recorded demographic data and eligibility status of the people living in the households via electronic data collection using Samsung Galaxy tablets. This census gave us the chance to explain the vaccine’s benefits, while educating the population about hygiene and sanitation, regardless of whether they were eligible to receive the vaccine.

We were not able to implement the campaign exactly as planned, because of a concurrent national vaccination campaign, which targeted newborns through children aged 9 years and also included the polio vaccine (polio and cholera vaccines must be administered 2 weeks apart because of possible interactions).

To avoid interfering with the national campaign, we split our campaign into two phases: the phase I vaccination was for individuals aged 10 years and older, and phase II included children aged 9 years and younger. The campaign lasted more than 1 month, with some breaks between the phases and the doses.

We had 40 teams (each team had two vaccinators and one registrar with the tablet) who were sent to various posts within the targeted area to vaccinate the eligible people. The community health workers and a sound truck service raised awareness before, during, and after each dose and each phase. First, the teams started at fixed vaccinations posts to capture as many people as possible. When fewer people showed up at the fixed posts, the teams started mobile posts to connect with the people who are farther away. Finally, when the number of the vaccinees was low at the mobile posts, we gave a list of the people left to be vaccinated to the teams and they started going door-to-door to do active case finding.

What were some of the challenges of administering the vaccines in a setting with limited medical resources?

The delay from the national polio vaccination campaign made our campaign last longer than we expected. Logistically, this resulted in greater challenges to keep the vaccines in cold chain and to reach some remote areas before the rainy season. Despite these challenges, we had a motivated, committed, and vigilant staff that worked hard to monitor the cold chain, and continually conducted regular thermometer readings and inspections of the cold container, cold boxes, and vaccine carriers (thermoses). Many of our teams did not hesitate to take canoes or donkeys or even to cross flooded rivers to reach vaccine recipients when our trucks could not reach those areas.

We experienced some issues with the technology used for data collection, though we did anticipate some problems. We had a team in United States and another in Haiti who were able to work together to respond quickly and effectively and resolve hardware, software, and Internet connection problems. The teams worked late nights to address those issues and to produce data reports, which allowed us to strategize our activities more effectively and efficiently. We also had a team on standby in our Saint-Marc office that could help locate the unique ID of a vaccine recipient in case the registrar in the field was unable to find the record on their tablet.

Another hurdle involved a group of farmers who we could not find during the daily vaccination periods because they were working late on their land. We sent some teams on later shifts, starting in the field in the afternoon and staying late into the evening in order to catch those recipients.

What are the plans for the vaccination program going forward?

We finished the vaccination campaign on June 19, 2012. We vaccinated more than 40,000 people. The next step is to evaluate the feasibility and the effectiveness of the project by assessing the operational activities, community acceptance, and cost effectiveness. We also are planning a case-control study. The vaccine already has been proven to be safe and effective.

What have you found most rewarding about your work on this program?

For me, the most rewarding part of this program was that we were able to deliver vaccine to this vulnerable population and protect them from this deadly disease. Ideally, this will help them maintain good health, so that they can continue to work and be productive to help their families survive. Seeing not only this population’s poor life conditions but also their acceptance of the vaccine inspired me and gave me more strength to continue the advocacy and the fight for a national scale-up vaccine campaign.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column at www.internalmedicinenews.com or send an e-mail to [email protected].

In the wake of a cholera outbreak in Haiti in 2010, Partners in Health, the Boston-based nonprofit advocacy and global health organization, developed an ambitious pilot program to vaccinate against cholera, with Dr. Max Raymond in charge of the implementation. Dr. Raymond was born in Haiti and earned his medical degree there in 2004, at the Université Notre Dame d’Haiti, Port-au-Prince.

He first became involved with PIH (and its sister organization in Haiti, Zanmi Lasante) shortly after completing his medical studies, when he was invited to manage a program to combat sexually transmitted infections, tuberculosis, and HIV/AIDS in a commune of the Artibonite Valley.

Courtesy Dr. Max Raymond

"I accepted this position because I knew about the high quality work that PIH/ZL was doing in another region of the country, particularly its social justice-based mission to provide a preferential option for the poor in health care," he said.

How did you become involved in the cholera vaccination project in Haiti, and what were the goals of the project?

In the summer of 2011, I returned to Haiti after earning a master’s degree in public health at the Institute of Tropical Medicine of Antwerp, Belgium, on a Joint Japan/World Bank scholarship, when one of my mentors, Dr. Louise Ivers, PIH’s senior health and policy adviser, asked me to be the cholera vaccine project coordinator. The pilot project launched in one of the rural sections of Saint-Marc, which was where the first cases were reported during the outbreak in October 2010.

In addition to immunologically protecting this high-risk population, a secondary goal was to demonstrate the feasibility of the vaccine campaign because some experts believed it could not be executed successfully because of logistical constraints, costs, and social unrest. Oral cholera vaccines also were in short supply.

If successful, we wanted to use the results of this pilot program to advocate for more investment in cholera vaccine and a possible nationwide scale-up as one of the integral responses to the current epidemic, and upcoming endemicity.

Describe the cholera vaccination efforts overall.

The project was executed concomitantly by two organizations: By PIH/ZL in the rural setting of Saint-Marc and by the nongovernmental organization GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections) in an urban setting in the capital, Port-au-Prince.

The cholera vaccine consists of two oral doses administered 2-6 weeks apart. Children younger than 1 year and pregnant women were excluded. Before the immunization, we conducted a census in the target area to preregister those who were eligible and to give them a vaccine card with a barcode that would give them access to their doses. We sent a team of 50 enumerators to the field and each recorded demographic data and eligibility status of the people living in the households via electronic data collection using Samsung Galaxy tablets. This census gave us the chance to explain the vaccine’s benefits, while educating the population about hygiene and sanitation, regardless of whether they were eligible to receive the vaccine.

We were not able to implement the campaign exactly as planned, because of a concurrent national vaccination campaign, which targeted newborns through children aged 9 years and also included the polio vaccine (polio and cholera vaccines must be administered 2 weeks apart because of possible interactions).

To avoid interfering with the national campaign, we split our campaign into two phases: the phase I vaccination was for individuals aged 10 years and older, and phase II included children aged 9 years and younger. The campaign lasted more than 1 month, with some breaks between the phases and the doses.

We had 40 teams (each team had two vaccinators and one registrar with the tablet) who were sent to various posts within the targeted area to vaccinate the eligible people. The community health workers and a sound truck service raised awareness before, during, and after each dose and each phase. First, the teams started at fixed vaccinations posts to capture as many people as possible. When fewer people showed up at the fixed posts, the teams started mobile posts to connect with the people who are farther away. Finally, when the number of the vaccinees was low at the mobile posts, we gave a list of the people left to be vaccinated to the teams and they started going door-to-door to do active case finding.

What were some of the challenges of administering the vaccines in a setting with limited medical resources?

The delay from the national polio vaccination campaign made our campaign last longer than we expected. Logistically, this resulted in greater challenges to keep the vaccines in cold chain and to reach some remote areas before the rainy season. Despite these challenges, we had a motivated, committed, and vigilant staff that worked hard to monitor the cold chain, and continually conducted regular thermometer readings and inspections of the cold container, cold boxes, and vaccine carriers (thermoses). Many of our teams did not hesitate to take canoes or donkeys or even to cross flooded rivers to reach vaccine recipients when our trucks could not reach those areas.

We experienced some issues with the technology used for data collection, though we did anticipate some problems. We had a team in United States and another in Haiti who were able to work together to respond quickly and effectively and resolve hardware, software, and Internet connection problems. The teams worked late nights to address those issues and to produce data reports, which allowed us to strategize our activities more effectively and efficiently. We also had a team on standby in our Saint-Marc office that could help locate the unique ID of a vaccine recipient in case the registrar in the field was unable to find the record on their tablet.

Another hurdle involved a group of farmers who we could not find during the daily vaccination periods because they were working late on their land. We sent some teams on later shifts, starting in the field in the afternoon and staying late into the evening in order to catch those recipients.

What are the plans for the vaccination program going forward?

We finished the vaccination campaign on June 19, 2012. We vaccinated more than 40,000 people. The next step is to evaluate the feasibility and the effectiveness of the project by assessing the operational activities, community acceptance, and cost effectiveness. We also are planning a case-control study. The vaccine already has been proven to be safe and effective.

What have you found most rewarding about your work on this program?

For me, the most rewarding part of this program was that we were able to deliver vaccine to this vulnerable population and protect them from this deadly disease. Ideally, this will help them maintain good health, so that they can continue to work and be productive to help their families survive. Seeing not only this population’s poor life conditions but also their acceptance of the vaccine inspired me and gave me more strength to continue the advocacy and the fight for a national scale-up vaccine campaign.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column at www.internalmedicinenews.com or send an e-mail to [email protected].

In the wake of a cholera outbreak in Haiti in 2010, Partners in Health, the Boston-based nonprofit advocacy and global health organization, developed an ambitious pilot program to vaccinate against cholera, with Dr. Max Raymond in charge of the implementation. Dr. Raymond was born in Haiti and earned his medical degree there in 2004, at the Université Notre Dame d’Haiti, Port-au-Prince.

He first became involved with PIH (and its sister organization in Haiti, Zanmi Lasante) shortly after completing his medical studies, when he was invited to manage a program to combat sexually transmitted infections, tuberculosis, and HIV/AIDS in a commune of the Artibonite Valley.

Courtesy Dr. Max Raymond

"I accepted this position because I knew about the high quality work that PIH/ZL was doing in another region of the country, particularly its social justice-based mission to provide a preferential option for the poor in health care," he said.

How did you become involved in the cholera vaccination project in Haiti, and what were the goals of the project?

In the summer of 2011, I returned to Haiti after earning a master’s degree in public health at the Institute of Tropical Medicine of Antwerp, Belgium, on a Joint Japan/World Bank scholarship, when one of my mentors, Dr. Louise Ivers, PIH’s senior health and policy adviser, asked me to be the cholera vaccine project coordinator. The pilot project launched in one of the rural sections of Saint-Marc, which was where the first cases were reported during the outbreak in October 2010.

In addition to immunologically protecting this high-risk population, a secondary goal was to demonstrate the feasibility of the vaccine campaign because some experts believed it could not be executed successfully because of logistical constraints, costs, and social unrest. Oral cholera vaccines also were in short supply.

If successful, we wanted to use the results of this pilot program to advocate for more investment in cholera vaccine and a possible nationwide scale-up as one of the integral responses to the current epidemic, and upcoming endemicity.

Describe the cholera vaccination efforts overall.

The project was executed concomitantly by two organizations: By PIH/ZL in the rural setting of Saint-Marc and by the nongovernmental organization GHESKIO (Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections) in an urban setting in the capital, Port-au-Prince.

The cholera vaccine consists of two oral doses administered 2-6 weeks apart. Children younger than 1 year and pregnant women were excluded. Before the immunization, we conducted a census in the target area to preregister those who were eligible and to give them a vaccine card with a barcode that would give them access to their doses. We sent a team of 50 enumerators to the field and each recorded demographic data and eligibility status of the people living in the households via electronic data collection using Samsung Galaxy tablets. This census gave us the chance to explain the vaccine’s benefits, while educating the population about hygiene and sanitation, regardless of whether they were eligible to receive the vaccine.

We were not able to implement the campaign exactly as planned, because of a concurrent national vaccination campaign, which targeted newborns through children aged 9 years and also included the polio vaccine (polio and cholera vaccines must be administered 2 weeks apart because of possible interactions).

To avoid interfering with the national campaign, we split our campaign into two phases: the phase I vaccination was for individuals aged 10 years and older, and phase II included children aged 9 years and younger. The campaign lasted more than 1 month, with some breaks between the phases and the doses.

We had 40 teams (each team had two vaccinators and one registrar with the tablet) who were sent to various posts within the targeted area to vaccinate the eligible people. The community health workers and a sound truck service raised awareness before, during, and after each dose and each phase. First, the teams started at fixed vaccinations posts to capture as many people as possible. When fewer people showed up at the fixed posts, the teams started mobile posts to connect with the people who are farther away. Finally, when the number of the vaccinees was low at the mobile posts, we gave a list of the people left to be vaccinated to the teams and they started going door-to-door to do active case finding.

What were some of the challenges of administering the vaccines in a setting with limited medical resources?

The delay from the national polio vaccination campaign made our campaign last longer than we expected. Logistically, this resulted in greater challenges to keep the vaccines in cold chain and to reach some remote areas before the rainy season. Despite these challenges, we had a motivated, committed, and vigilant staff that worked hard to monitor the cold chain, and continually conducted regular thermometer readings and inspections of the cold container, cold boxes, and vaccine carriers (thermoses). Many of our teams did not hesitate to take canoes or donkeys or even to cross flooded rivers to reach vaccine recipients when our trucks could not reach those areas.

We experienced some issues with the technology used for data collection, though we did anticipate some problems. We had a team in United States and another in Haiti who were able to work together to respond quickly and effectively and resolve hardware, software, and Internet connection problems. The teams worked late nights to address those issues and to produce data reports, which allowed us to strategize our activities more effectively and efficiently. We also had a team on standby in our Saint-Marc office that could help locate the unique ID of a vaccine recipient in case the registrar in the field was unable to find the record on their tablet.

Another hurdle involved a group of farmers who we could not find during the daily vaccination periods because they were working late on their land. We sent some teams on later shifts, starting in the field in the afternoon and staying late into the evening in order to catch those recipients.

What are the plans for the vaccination program going forward?

We finished the vaccination campaign on June 19, 2012. We vaccinated more than 40,000 people. The next step is to evaluate the feasibility and the effectiveness of the project by assessing the operational activities, community acceptance, and cost effectiveness. We also are planning a case-control study. The vaccine already has been proven to be safe and effective.

What have you found most rewarding about your work on this program?

For me, the most rewarding part of this program was that we were able to deliver vaccine to this vulnerable population and protect them from this deadly disease. Ideally, this will help them maintain good health, so that they can continue to work and be productive to help their families survive. Seeing not only this population’s poor life conditions but also their acceptance of the vaccine inspired me and gave me more strength to continue the advocacy and the fight for a national scale-up vaccine campaign.

Think globally. Practice locally.

U.S.-trained internists who have practiced abroad will receive a $100 stipend for contributing to this column. For details, visit the World Wide Med column at www.internalmedicinenews.com or send an e-mail to [email protected].

A new multisociety sedation curriculum for gastrointestinal endoscopy spells out the essential elements of procedural sedation and should be useful to fellows and established practitioners alike. The complete curriculum was published in the July 2012 issue of Gastroenterology.

"It came to the attention of many practitioners, educators, and researchers that we needed to develop a standardized, competency-based curriculum for procedural sedation," Dr. John J. Vargo, committee chair and editor of the curriculum and one of the team of contributing experts, said in an interview. Such a curriculum would house all facets of procedural sedation, including patient assessment, pharmacology of relevant agents, and patient recovery parameters, in one core document, he explained.

"Ideally, we will be giving our fellows and their mentors a competency-based training platform for procedural sedation," he said.

The curriculum also provides practicing clinicians with an opportunity to review the information and identify areas in their procedural sedation practices that might need updating, noted Dr. Vargo. "Medicine is now a journey of continuous education and training, and this is a document that could serve established practitioners in that vein," he said.

"Sedation is a necessary core component for safe and effective performance of GI endoscopic procedures," said Dr. David R. Lichtenstein of Boston University, who was not involved in writing the curriculum.

In an interview, Dr. Lichtenstein noted that "Sedation is intended primarily to reduce our patients’ anxiety and discomfort, resulting in improved tolerability and satisfaction for the procedure."

However, use of sedation has both pros and cons, he said. "Sedation delays patient recovery and discharge, increases the risk of cardiopulmonary complications, and adds to the overall cost of the endoscopic procedure."

The curriculum, known as the Multisociety Sedation Curriculum for Gastrointestinal Endoscopy (MSCGE), is a joint effort of the American Association for the Study of Liver Diseases, the American College of Gastroenterology, the AGA Institute, and the American Society for Gastrointestinal Endoscopy. The Society for Gastroenterology Nurses and Associates also was involved in developing the curriculum, which was published simultaneously in Gastroenterology, the American Journal of Gastroenterology, Gastrointestinal Endoscopy, and Hepatology, and on the website of the Society of Gastroenterology Nurses and Associates (Gastroenterology 2012;143:e18-e41).

The sponsoring societies divided the curriculum into 11 sections: sedation pharmacology; informed consent for endoscopic sedation; periprocedure assessment for endoscopic procedures, levels of sedation; training in the administration of specific agents for moderate sedation; training in airway/rescue techniques and management of complications; anesthesiologist assistance for endoscopic procedures; intraprocedure monitoring; post-procedure assessment training; endoscopy in pregnant and lactating women; and an assessment of competency in endoscopic sedation.

The curriculum "serves as the societies’ vision of best practices in procedural sedation based on evidence-based publications and expert opinion," said Dr. Lichtenstein. "For the practicing gastroenterologist, the MSCGE can serve to validate an existing knowledge base and skill set while providing a curriculum to update deficiencies that may exist. For those individuals in training, the document serves as a reference [for] both the trainee and mentor, ensuring that the goals of training and assessment of competency have been achieved," he said.

Although some patients can undergo endoscopic procedures without sedation, most of these procedures in the United States do involve sedation and anesthesia, Dr. Lichtenstein said.

The curriculum attempts to address some of the challenges in endoscopic sedation. "The most difficult challenge facing our profession resides in the tailoring of the level of sedation to the individual patient and procedure, and selecting the most appropriate provider to deliver the sedation in an environment focused on optimizing patient safety [and] satisfaction, while maintaining fiscal responsibility," he said.

Despite these challenges, "the use of sedation during endoscopy and in particular the use of anesthesiologists and nurse anesthetists during routine ‘low risk’ gastrointestinal endoscopy continues to increase throughout the world," Dr. Lichtenstein noted. "Use of anesthesia services offers the opportunity for deeper sedation or general anesthesia requiring increased physiological monitoring and additional skills for airway management when compared with the lighter ‘moderate sedation’ typically provided by nurses under the direct supervision of the endoscopist," he said.

What does the future hold for endoscopic sedation? A key question is whether anesthesia services should be offered only to patients with absolute need, based on high- risk profiles, Dr. Lichtenstein said. Some examples of high-risk patients include those predicted to have a suboptimal response to sedation because of underlying substance abuse or those with a high-risk airway, he noted.

"We must demonstrate added value for our patients to justify the utilization of anesthesia services for our low-risk patients," he said. Questions to address in clinical practice include the following, he added: Are patients more satisfied? Are patients more likely to return for surveillance exam? Can patients recover faster and return to their preprocedure level of activity earlier? Can we increase efficiency in our endoscopy units? Is gastroenterologist-directed propofol administration off the table permanently or can we reintroduce this practice with appropriate training as outlined in prior societal guidelines?

"Additional research will address these and other future questions as we advance our knowledge within the sedation field," Dr. Lichtenstein said.

The curriculum will be subject to periodic review, Dr. Vargo said. "If this document remains static, we have not done a service to our patients or to those that we train," he said. As the techniques of sedation evolve, the curriculum will change to reflect the appropriate techniques and necessary competencies, he said.

As for implementation, "One of the ways to assess how this document is being used is through the training committees of the sponsoring societies," he noted. "This will give us a great opportunity to see where the needs are.

"One of the important aspects of this curriculum was that we tried to bring all the stakeholders in procedural sedation and gastrointestinal endoscopy together," Dr. Vargo said. The involvement of the Society for Gastroenterology Nurses was especially valuable, he noted. "When you are administering sedation to a patient, it is a physician and nurse team, and that really resonates in this document."

Neither Dr. Vargo nor Dr. Lichtenstein had any financial conflicts to disclose.

A new multisociety sedation curriculum for gastrointestinal endoscopy spells out the essential elements of procedural sedation and should be useful to fellows and established practitioners alike. The complete curriculum was published in the July 2012 issue of Gastroenterology.

"It came to the attention of many practitioners, educators, and researchers that we needed to develop a standardized, competency-based curriculum for procedural sedation," Dr. John J. Vargo, committee chair and editor of the curriculum and one of the team of contributing experts, said in an interview. Such a curriculum would house all facets of procedural sedation, including patient assessment, pharmacology of relevant agents, and patient recovery parameters, in one core document, he explained.

"Ideally, we will be giving our fellows and their mentors a competency-based training platform for procedural sedation," he said.

The curriculum also provides practicing clinicians with an opportunity to review the information and identify areas in their procedural sedation practices that might need updating, noted Dr. Vargo. "Medicine is now a journey of continuous education and training, and this is a document that could serve established practitioners in that vein," he said.

"Sedation is a necessary core component for safe and effective performance of GI endoscopic procedures," said Dr. David R. Lichtenstein of Boston University, who was not involved in writing the curriculum.

In an interview, Dr. Lichtenstein noted that "Sedation is intended primarily to reduce our patients’ anxiety and discomfort, resulting in improved tolerability and satisfaction for the procedure."

However, use of sedation has both pros and cons, he said. "Sedation delays patient recovery and discharge, increases the risk of cardiopulmonary complications, and adds to the overall cost of the endoscopic procedure."

The curriculum, known as the Multisociety Sedation Curriculum for Gastrointestinal Endoscopy (MSCGE), is a joint effort of the American Association for the Study of Liver Diseases, the American College of Gastroenterology, the AGA Institute, and the American Society for Gastrointestinal Endoscopy. The Society for Gastroenterology Nurses and Associates also was involved in developing the curriculum, which was published simultaneously in Gastroenterology, the American Journal of Gastroenterology, Gastrointestinal Endoscopy, and Hepatology, and on the website of the Society of Gastroenterology Nurses and Associates (Gastroenterology 2012;143:e18-e41).

The sponsoring societies divided the curriculum into 11 sections: sedation pharmacology; informed consent for endoscopic sedation; periprocedure assessment for endoscopic procedures, levels of sedation; training in the administration of specific agents for moderate sedation; training in airway/rescue techniques and management of complications; anesthesiologist assistance for endoscopic procedures; intraprocedure monitoring; post-procedure assessment training; endoscopy in pregnant and lactating women; and an assessment of competency in endoscopic sedation.

The curriculum "serves as the societies’ vision of best practices in procedural sedation based on evidence-based publications and expert opinion," said Dr. Lichtenstein. "For the practicing gastroenterologist, the MSCGE can serve to validate an existing knowledge base and skill set while providing a curriculum to update deficiencies that may exist. For those individuals in training, the document serves as a reference [for] both the trainee and mentor, ensuring that the goals of training and assessment of competency have been achieved," he said.

Although some patients can undergo endoscopic procedures without sedation, most of these procedures in the United States do involve sedation and anesthesia, Dr. Lichtenstein said.

The curriculum attempts to address some of the challenges in endoscopic sedation. "The most difficult challenge facing our profession resides in the tailoring of the level of sedation to the individual patient and procedure, and selecting the most appropriate provider to deliver the sedation in an environment focused on optimizing patient safety [and] satisfaction, while maintaining fiscal responsibility," he said.

Despite these challenges, "the use of sedation during endoscopy and in particular the use of anesthesiologists and nurse anesthetists during routine ‘low risk’ gastrointestinal endoscopy continues to increase throughout the world," Dr. Lichtenstein noted. "Use of anesthesia services offers the opportunity for deeper sedation or general anesthesia requiring increased physiological monitoring and additional skills for airway management when compared with the lighter ‘moderate sedation’ typically provided by nurses under the direct supervision of the endoscopist," he said.

What does the future hold for endoscopic sedation? A key question is whether anesthesia services should be offered only to patients with absolute need, based on high- risk profiles, Dr. Lichtenstein said. Some examples of high-risk patients include those predicted to have a suboptimal response to sedation because of underlying substance abuse or those with a high-risk airway, he noted.

"We must demonstrate added value for our patients to justify the utilization of anesthesia services for our low-risk patients," he said. Questions to address in clinical practice include the following, he added: Are patients more satisfied? Are patients more likely to return for surveillance exam? Can patients recover faster and return to their preprocedure level of activity earlier? Can we increase efficiency in our endoscopy units? Is gastroenterologist-directed propofol administration off the table permanently or can we reintroduce this practice with appropriate training as outlined in prior societal guidelines?

"Additional research will address these and other future questions as we advance our knowledge within the sedation field," Dr. Lichtenstein said.

The curriculum will be subject to periodic review, Dr. Vargo said. "If this document remains static, we have not done a service to our patients or to those that we train," he said. As the techniques of sedation evolve, the curriculum will change to reflect the appropriate techniques and necessary competencies, he said.

As for implementation, "One of the ways to assess how this document is being used is through the training committees of the sponsoring societies," he noted. "This will give us a great opportunity to see where the needs are.

"One of the important aspects of this curriculum was that we tried to bring all the stakeholders in procedural sedation and gastrointestinal endoscopy together," Dr. Vargo said. The involvement of the Society for Gastroenterology Nurses was especially valuable, he noted. "When you are administering sedation to a patient, it is a physician and nurse team, and that really resonates in this document."

Neither Dr. Vargo nor Dr. Lichtenstein had any financial conflicts to disclose.

A new multisociety sedation curriculum for gastrointestinal endoscopy spells out the essential elements of procedural sedation and should be useful to fellows and established practitioners alike. The complete curriculum was published in the July 2012 issue of Gastroenterology.

"It came to the attention of many practitioners, educators, and researchers that we needed to develop a standardized, competency-based curriculum for procedural sedation," Dr. John J. Vargo, committee chair and editor of the curriculum and one of the team of contributing experts, said in an interview. Such a curriculum would house all facets of procedural sedation, including patient assessment, pharmacology of relevant agents, and patient recovery parameters, in one core document, he explained.

"Ideally, we will be giving our fellows and their mentors a competency-based training platform for procedural sedation," he said.

The curriculum also provides practicing clinicians with an opportunity to review the information and identify areas in their procedural sedation practices that might need updating, noted Dr. Vargo. "Medicine is now a journey of continuous education and training, and this is a document that could serve established practitioners in that vein," he said.

"Sedation is a necessary core component for safe and effective performance of GI endoscopic procedures," said Dr. David R. Lichtenstein of Boston University, who was not involved in writing the curriculum.

In an interview, Dr. Lichtenstein noted that "Sedation is intended primarily to reduce our patients’ anxiety and discomfort, resulting in improved tolerability and satisfaction for the procedure."

However, use of sedation has both pros and cons, he said. "Sedation delays patient recovery and discharge, increases the risk of cardiopulmonary complications, and adds to the overall cost of the endoscopic procedure."

The curriculum, known as the Multisociety Sedation Curriculum for Gastrointestinal Endoscopy (MSCGE), is a joint effort of the American Association for the Study of Liver Diseases, the American College of Gastroenterology, the AGA Institute, and the American Society for Gastrointestinal Endoscopy. The Society for Gastroenterology Nurses and Associates also was involved in developing the curriculum, which was published simultaneously in Gastroenterology, the American Journal of Gastroenterology, Gastrointestinal Endoscopy, and Hepatology, and on the website of the Society of Gastroenterology Nurses and Associates (Gastroenterology 2012;143:e18-e41).

The sponsoring societies divided the curriculum into 11 sections: sedation pharmacology; informed consent for endoscopic sedation; periprocedure assessment for endoscopic procedures, levels of sedation; training in the administration of specific agents for moderate sedation; training in airway/rescue techniques and management of complications; anesthesiologist assistance for endoscopic procedures; intraprocedure monitoring; post-procedure assessment training; endoscopy in pregnant and lactating women; and an assessment of competency in endoscopic sedation.

The curriculum "serves as the societies’ vision of best practices in procedural sedation based on evidence-based publications and expert opinion," said Dr. Lichtenstein. "For the practicing gastroenterologist, the MSCGE can serve to validate an existing knowledge base and skill set while providing a curriculum to update deficiencies that may exist. For those individuals in training, the document serves as a reference [for] both the trainee and mentor, ensuring that the goals of training and assessment of competency have been achieved," he said.

Although some patients can undergo endoscopic procedures without sedation, most of these procedures in the United States do involve sedation and anesthesia, Dr. Lichtenstein said.

The curriculum attempts to address some of the challenges in endoscopic sedation. "The most difficult challenge facing our profession resides in the tailoring of the level of sedation to the individual patient and procedure, and selecting the most appropriate provider to deliver the sedation in an environment focused on optimizing patient safety [and] satisfaction, while maintaining fiscal responsibility," he said.

Despite these challenges, "the use of sedation during endoscopy and in particular the use of anesthesiologists and nurse anesthetists during routine ‘low risk’ gastrointestinal endoscopy continues to increase throughout the world," Dr. Lichtenstein noted. "Use of anesthesia services offers the opportunity for deeper sedation or general anesthesia requiring increased physiological monitoring and additional skills for airway management when compared with the lighter ‘moderate sedation’ typically provided by nurses under the direct supervision of the endoscopist," he said.

What does the future hold for endoscopic sedation? A key question is whether anesthesia services should be offered only to patients with absolute need, based on high- risk profiles, Dr. Lichtenstein said. Some examples of high-risk patients include those predicted to have a suboptimal response to sedation because of underlying substance abuse or those with a high-risk airway, he noted.

"We must demonstrate added value for our patients to justify the utilization of anesthesia services for our low-risk patients," he said. Questions to address in clinical practice include the following, he added: Are patients more satisfied? Are patients more likely to return for surveillance exam? Can patients recover faster and return to their preprocedure level of activity earlier? Can we increase efficiency in our endoscopy units? Is gastroenterologist-directed propofol administration off the table permanently or can we reintroduce this practice with appropriate training as outlined in prior societal guidelines?

"Additional research will address these and other future questions as we advance our knowledge within the sedation field," Dr. Lichtenstein said.

The curriculum will be subject to periodic review, Dr. Vargo said. "If this document remains static, we have not done a service to our patients or to those that we train," he said. As the techniques of sedation evolve, the curriculum will change to reflect the appropriate techniques and necessary competencies, he said.

As for implementation, "One of the ways to assess how this document is being used is through the training committees of the sponsoring societies," he noted. "This will give us a great opportunity to see where the needs are.

"One of the important aspects of this curriculum was that we tried to bring all the stakeholders in procedural sedation and gastrointestinal endoscopy together," Dr. Vargo said. The involvement of the Society for Gastroenterology Nurses was especially valuable, he noted. "When you are administering sedation to a patient, it is a physician and nurse team, and that really resonates in this document."

Neither Dr. Vargo nor Dr. Lichtenstein had any financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

The administration of oral antibiotics prior to elective colorectal resections is associated with significantly reduced infection rates, based on data from more than 9,000 patients.

Surgical-site infection remains a problem in colorectal resections, said Dr. Jamie A. Cannon of the department of surgery at the University of Alabama at Birmingham. To assess the value of oral antibiotics as part of the surgery preparation, Dr. Cannon and colleagues reviewed data from 9,940 patients from VASQIP (Veterans’ Affairs Surgical Quality Improvement Program) who underwent colorectal resections between 2005 and 2009. The findings were presented at the annual meeting of the American Society of Colon and Rectal Surgeons.

After controlling for multiple variables, the researchers found that patients who had an oral antibiotic along with their mechanical bowel prep had a 57% reduction in risk of surgical-site infection.

A total of 1,978 patients had no bowel prep prior to their colorectal resections, 3,839 had mechanical prep only, 723 had only oral antibiotics, and 3,400 had mechanical and oral prep. The rate of surgical-site infections in the oral and mechanical prep group was 9%, which was similar to the rate of those who only received oral antibiotics (8%), and significantly lower than the rates of both the no-prep (18%) and mechanical prep–only (20%) groups.

The timely administration of an appropriate parenteral antibiotic (SCIP-1, the first measure in the Surgical Care Improvement Project) was associated with a modest risk reduction, but no notable effects were seen from other SCIP measures, the researchers said.

They noted that decisions about the use of oral antibiotics and mechanical bowel prep were based on retrospective prescription data, and they could not determine the timing of actual administration. However, they believed that their results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections.

"The efficacy of preoperative oral antibiotics in reducing surgical site infections, with or without a mechanical preparation, should be further studied in a randomized trial," they concluded.

Dr. Cannon had no financial conflicts to disclose.

More than half of American teens have been asked to send a "sext," based on data from 948 high school students. The findings were published online July 2 in the Archives of Pediatrics and Adolescent Medicine.

Sexting, the sending of explicit electronic messages, may predict real-life sexual behavior in teenagers, the study investigators wrote.  Although teen sexting has received much media attention, data on the public health implications of this behavior are limited, the researchers said.

Photo credit: Arkady Chubykin/Fotolia.com

To determine the prevalence of teen sexting and how it relates to dating and sexual activity, Jeff R. Temple, Ph.D., of the University of Texas, Galveston, and his colleagues surveyed high school students from seven public high schools in Texas (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:  10.1001/archpediatrics.2012.835]).

Overall, 28% of the teens reported sending a naked picture of themselves via text or e-mail (a "sext"), and 31% reported asking someone to send them a sext. Approximately 28% of both genders reported sending a sext, but significantly more girls than boys reported having been asked for a sext (69% vs. 42%) and significantly more boys than girls reported having asked someone for a sext (46% vs. 21%).

"Among girls, there was a significant association between all sexting behaviors and all dating, sex, and risky sex behaviors," the researchers said. Of the girls who reported sending a sext, 77% also reported having sex, compared with 42% of girls who did not report sending a sext. In addition, 96% of girls who said that they weren’t bothered by being asked for a sext reported having had sex, compared with 45%-71% of girls who said they were at least somewhat bothered by being asked for a sext.

Among boys, 82% of those who reported sending a sext also reported having sex, compared with 45% of boys who did not report sending a sext. In addition, 76% of boys who reported being asked for a sext also reported having sex, compared with 38% of boys who had not been asked for a sext.

Overall, "teens who engaged in sexting behaviors were more likely to have begun dating and to have had sex than those who did not sext," Dr. Temple and his associates wrote.

Despite the associations between sexting and sexual activity, however, "we found that teens are genuinely bothered by being asked to send a naked picture," the researchers said. Fewer than 10% of girls and 50% of boys were "not at all bothered" by a request for a sext, they said, but future research should be more clear about whether "bothered" means "annoyed" or "embarrassed," they said.

The students surveyed were 14-19 years of age and were in 10th or 11th grade. Approximately 56% were girls, 27% were black, 30% were white, 32% were Hispanic, 3% were Asian, and 8% were of mixed/other race. The study was conducted during school hours, and students received $10 gift cards for participating.

The study was limited by the use of self-reports and by the lack of data on whether risky sex behaviors occurred before or after sexting, but the study is the first to show a link between sexting and sexual behavior in a diverse, school-based sample of teens. "These findings reinforce calls by the American Academy of Pediatrics to discuss teen sexting with patients and patients’ parents," they noted.

In an accompanying editorial, Dr. Megan A. Moreno and Jennifer M. Whitehill, Ph.D., wrote that "sexting appears to be a media expression of adolescent sexual intent or behavior, rather than a distinct phenomenon limited to the digital world" (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:10.1001/archpediatrics.2012.1320]).

The current study findings suggest that clinicians "may consider sexual disclosures in a social media setting as an expression of adolescents’ offline sexual intentions or behaviors," said Dr. Moreno of the department of pediatrics at the University of Wisconsin, Madison, and Dr. Whitehill of the department of pediatrics at the University of Washington, Seattle.

Social media present unique challenges to those concerned with teen health because of the large amounts of time, largely unsupervised, that teens spend using social media. The social media, however, also can be an entry for clinicians and parents to talk to teens about sexual health and a tool for education and prevention efforts, they added.

Dr. Temple and his associates did not report any financial conflicts. Neither Dr. Moreno nor Dr. Whitehill had any financial conflicts to disclose.

More than half of American teens have been asked to send a "sext," based on data from 948 high school students. The findings were published online July 2 in the Archives of Pediatrics and Adolescent Medicine.

Sexting, the sending of explicit electronic messages, may predict real-life sexual behavior in teenagers, the study investigators wrote.  Although teen sexting has received much media attention, data on the public health implications of this behavior are limited, the researchers said.

Photo credit: Arkady Chubykin/Fotolia.com

To determine the prevalence of teen sexting and how it relates to dating and sexual activity, Jeff R. Temple, Ph.D., of the University of Texas, Galveston, and his colleagues surveyed high school students from seven public high schools in Texas (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:  10.1001/archpediatrics.2012.835]).

Overall, 28% of the teens reported sending a naked picture of themselves via text or e-mail (a "sext"), and 31% reported asking someone to send them a sext. Approximately 28% of both genders reported sending a sext, but significantly more girls than boys reported having been asked for a sext (69% vs. 42%) and significantly more boys than girls reported having asked someone for a sext (46% vs. 21%).

"Among girls, there was a significant association between all sexting behaviors and all dating, sex, and risky sex behaviors," the researchers said. Of the girls who reported sending a sext, 77% also reported having sex, compared with 42% of girls who did not report sending a sext. In addition, 96% of girls who said that they weren’t bothered by being asked for a sext reported having had sex, compared with 45%-71% of girls who said they were at least somewhat bothered by being asked for a sext.

Among boys, 82% of those who reported sending a sext also reported having sex, compared with 45% of boys who did not report sending a sext. In addition, 76% of boys who reported being asked for a sext also reported having sex, compared with 38% of boys who had not been asked for a sext.

Overall, "teens who engaged in sexting behaviors were more likely to have begun dating and to have had sex than those who did not sext," Dr. Temple and his associates wrote.

Despite the associations between sexting and sexual activity, however, "we found that teens are genuinely bothered by being asked to send a naked picture," the researchers said. Fewer than 10% of girls and 50% of boys were "not at all bothered" by a request for a sext, they said, but future research should be more clear about whether "bothered" means "annoyed" or "embarrassed," they said.

The students surveyed were 14-19 years of age and were in 10th or 11th grade. Approximately 56% were girls, 27% were black, 30% were white, 32% were Hispanic, 3% were Asian, and 8% were of mixed/other race. The study was conducted during school hours, and students received $10 gift cards for participating.

The study was limited by the use of self-reports and by the lack of data on whether risky sex behaviors occurred before or after sexting, but the study is the first to show a link between sexting and sexual behavior in a diverse, school-based sample of teens. "These findings reinforce calls by the American Academy of Pediatrics to discuss teen sexting with patients and patients’ parents," they noted.

In an accompanying editorial, Dr. Megan A. Moreno and Jennifer M. Whitehill, Ph.D., wrote that "sexting appears to be a media expression of adolescent sexual intent or behavior, rather than a distinct phenomenon limited to the digital world" (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:10.1001/archpediatrics.2012.1320]).

The current study findings suggest that clinicians "may consider sexual disclosures in a social media setting as an expression of adolescents’ offline sexual intentions or behaviors," said Dr. Moreno of the department of pediatrics at the University of Wisconsin, Madison, and Dr. Whitehill of the department of pediatrics at the University of Washington, Seattle.

Social media present unique challenges to those concerned with teen health because of the large amounts of time, largely unsupervised, that teens spend using social media. The social media, however, also can be an entry for clinicians and parents to talk to teens about sexual health and a tool for education and prevention efforts, they added.

Dr. Temple and his associates did not report any financial conflicts. Neither Dr. Moreno nor Dr. Whitehill had any financial conflicts to disclose.

More than half of American teens have been asked to send a "sext," based on data from 948 high school students. The findings were published online July 2 in the Archives of Pediatrics and Adolescent Medicine.

Sexting, the sending of explicit electronic messages, may predict real-life sexual behavior in teenagers, the study investigators wrote.  Although teen sexting has received much media attention, data on the public health implications of this behavior are limited, the researchers said.

Photo credit: Arkady Chubykin/Fotolia.com

To determine the prevalence of teen sexting and how it relates to dating and sexual activity, Jeff R. Temple, Ph.D., of the University of Texas, Galveston, and his colleagues surveyed high school students from seven public high schools in Texas (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:  10.1001/archpediatrics.2012.835]).

Overall, 28% of the teens reported sending a naked picture of themselves via text or e-mail (a "sext"), and 31% reported asking someone to send them a sext. Approximately 28% of both genders reported sending a sext, but significantly more girls than boys reported having been asked for a sext (69% vs. 42%) and significantly more boys than girls reported having asked someone for a sext (46% vs. 21%).

"Among girls, there was a significant association between all sexting behaviors and all dating, sex, and risky sex behaviors," the researchers said. Of the girls who reported sending a sext, 77% also reported having sex, compared with 42% of girls who did not report sending a sext. In addition, 96% of girls who said that they weren’t bothered by being asked for a sext reported having had sex, compared with 45%-71% of girls who said they were at least somewhat bothered by being asked for a sext.

Among boys, 82% of those who reported sending a sext also reported having sex, compared with 45% of boys who did not report sending a sext. In addition, 76% of boys who reported being asked for a sext also reported having sex, compared with 38% of boys who had not been asked for a sext.

Overall, "teens who engaged in sexting behaviors were more likely to have begun dating and to have had sex than those who did not sext," Dr. Temple and his associates wrote.

Despite the associations between sexting and sexual activity, however, "we found that teens are genuinely bothered by being asked to send a naked picture," the researchers said. Fewer than 10% of girls and 50% of boys were "not at all bothered" by a request for a sext, they said, but future research should be more clear about whether "bothered" means "annoyed" or "embarrassed," they said.

The students surveyed were 14-19 years of age and were in 10th or 11th grade. Approximately 56% were girls, 27% were black, 30% were white, 32% were Hispanic, 3% were Asian, and 8% were of mixed/other race. The study was conducted during school hours, and students received $10 gift cards for participating.

The study was limited by the use of self-reports and by the lack of data on whether risky sex behaviors occurred before or after sexting, but the study is the first to show a link between sexting and sexual behavior in a diverse, school-based sample of teens. "These findings reinforce calls by the American Academy of Pediatrics to discuss teen sexting with patients and patients’ parents," they noted.

In an accompanying editorial, Dr. Megan A. Moreno and Jennifer M. Whitehill, Ph.D., wrote that "sexting appears to be a media expression of adolescent sexual intent or behavior, rather than a distinct phenomenon limited to the digital world" (Arch. Pediatr. Adolesc. Med. 2012; July 2 [doi:10.1001/archpediatrics.2012.1320]).

The current study findings suggest that clinicians "may consider sexual disclosures in a social media setting as an expression of adolescents’ offline sexual intentions or behaviors," said Dr. Moreno of the department of pediatrics at the University of Wisconsin, Madison, and Dr. Whitehill of the department of pediatrics at the University of Washington, Seattle.

Social media present unique challenges to those concerned with teen health because of the large amounts of time, largely unsupervised, that teens spend using social media. The social media, however, also can be an entry for clinicians and parents to talk to teens about sexual health and a tool for education and prevention efforts, they added.

Dr. Temple and his associates did not report any financial conflicts. Neither Dr. Moreno nor Dr. Whitehill had any financial conflicts to disclose.