Wednesday 29 April 2015

Increased risk of spreading HIV while circumcision wounds heal



Tuesday 28 April 2015

As circumcision wounds heal, HIV-positive men may spread virus to female partners: Uganda study

In the midst of an international campaign to slow the spread of HIV in sub-Saharan Africa, the World Health Organization recommends male circumcision (the surgical removal of foreskin from the penis) which reduces HIV acquisition by 50-60%. However, scientists report that a new study of HIV-infected men in Uganda has identified a temporary, but potentially troublesome unintended consequence of the procedure: a possible increased risk of infecting female sexual partners while circumcision wounds heal.

In a study by researchers from the Johns Hopkins University School of Medicine, the Johns Hopkins University Bloomberg School of Public Health and Rakai Health Sciences Program, 223 HIV-positive Ugandan men were medically circumcised. Health workers poured 5 milliliters (about a teaspoon) of saline solution over the circumcision site near the neck of the penis and collected the solution for testing just before surgery, during the operation, and once a week for 12 weeks.

Data showed that among the 183 men not taking anti-retroviral drugs, less than 10 percent were shedding HIV before circumcision, but nearly 30 percent were shedding the virus two weeks after surgery. The percentages dropped sharply as the men's wounds healed, to less than three percent at six weeks and less than two percent at 12 weeks.

Circumcision reduced the number of HIV-positive men who were shedding the virus more than five-fold over the long term, but it had the opposite effect in the weeks right after the surgery.

"There is a window of a few weeks after circumcision when the risk that an HIV-infected man could transmit the virus to a female partner actually increases," says Aaron A.R. Tobian, M.D., Ph.D., an associate professor of pathology at the Johns Hopkins University School of Medicine and the study's first author. "During that time, more HIV-infected men are shedding the virus, and on average they are shedding greater amounts of it, than before circumcision," he adds.

"We don't know for certain if this increase in the amount of virus the men are shedding actually leads to more cases of HIV transmission to their female partners," says co-author Ronald Gray, MD, MSc, a professor of epidemiology at the Bloomberg School. "But we do know that HIV-infected men who engage in sex before their circumcision wound heals have higher rates of transmission to their partners. Also, the higher an HIV-infected person's viral load, the greater the risk of transmitting the virus to a partner. So it is plausible that the risk goes up during that time."

A report on the study, published April 28 in PLOS Medicine, cites two factors -- the passage of time, and treatment with anti-retroviral drugs -- that dramatically reduced the virus' prevalence in HIV-positive, recently circumcised men.

Case by case, the likelihood of HIV transmission from a newly-circumcised man to his female partner is less than one-tenth of one percent, the researchers estimated. But with the World Health Organization seeking to circumcise nearly 29 million men, the study projects that this small increase could add up to 17,000 new infections among female partners of newly circumcised HIV-infected men.

Medical circumcision has been shown to cut the odds of contracting HIV by 50-60% in adult men; greatly reduce cases of genital herpes and human papillomavirus; and reduce the prevalence of some sexually transmitted infections in female partners. The World Health Organization has set a goal of circumcising about four out of five men aged 15 to 49 in southern and eastern Africa. Adolescent and adult circumcision programs are ongoing, and include HIV testing and counseling. Studies show about six percent of the men seeking circumcision are HIV-positive.

"All male circumcision programs are counseling men to abstain from sex while their wounds are healing, "says co-author Dr. Godfrey Kigozi at the Rakai Health Sciences Program. "But several programs have reported that greater than 30% of the men have sex with female partners during the healing period."

"Although we're counseling men not to have sexual intercourse while their wounds are healing, we know that they are," Tobian says, "and it's important to take steps to reduce the risk that they'll transmit the virus to their female partners during this time."

The solution, he says, may lie in another one of the study's findings. "If the men are on anti-retroviral drugs, this reduces the risk of their shedding the virus by about 90 percent," Tobian says. "Thus, it is logical for HIV-infected men to begin anti-retroviral therapy at the time of circumcision. However, we will need further studies to find out exactly which drugs and for how long."

Also participating in the study were David Serwadda of the Institute of Public Health, Makere University, Kampala, Uganda; Jordyn Manucci, Andrew D. Redd, Steven J. Reynolds, Oliver Laeyendecker and Thomas Quinn of the Johns Hopkins University School of Medicine; Mary K. Grabowski, Justin Lessler, Ronald H. Gray and Maria Wawer of the Johns Hopkins Bloomberg School of Public Health; and Godfrey Kigozi, Richard Musoke, Fred Nalugoda and Nehemiah Kighoma of the Rakai Health Sciences Program, Entebbe, Uganda. This study was funded by the Bill and Melinda Gates Foundation, the Doris Duke Charitable Foundation, the National Institute of Allergy and Infectious Diseases, and the Fogarty International Center.



As circumcision wounds heal, HIV-positive men may spread virus to female partners: Uganda study

In the midst of an international campaign to slow the spread of HIV in sub-Saharan Africa, the World Health Organization recommends male circumcision (the surgical removal of foreskin from the penis) which reduces HIV acquisition by 50-60%. However, scientists report that a new study of HIV-infected men in Uganda has identified a temporary, but potentially troublesome unintended consequence of the procedure: a possible increased risk of infecting female sexual partners while circumcision wounds heal.

In a study by researchers from the Johns Hopkins University School of Medicine, the Johns Hopkins University Bloomberg School of Public Health and Rakai Health Sciences Program, 223 HIV-positive Ugandan men were medically circumcised. Health workers poured 5 milliliters (about a teaspoon) of saline solution over the circumcision site near the neck of the penis and collected the solution for testing just before surgery, during the operation, and once a week for 12 weeks.

Data showed that among the 183 men not taking anti-retroviral drugs, less than 10 percent were shedding HIV before circumcision, but nearly 30 percent were shedding the virus two weeks after surgery. The percentages dropped sharply as the men's wounds healed, to less than three percent at six weeks and less than two percent at 12 weeks.

Circumcision reduced the number of HIV-positive men who were shedding the virus more than five-fold over the long term, but it had the opposite effect in the weeks right after the surgery.

"There is a window of a few weeks after circumcision when the risk that an HIV-infected man could transmit the virus to a female partner actually increases," says Aaron A.R. Tobian, M.D., Ph.D., an associate professor of pathology at the Johns Hopkins University School of Medicine and the study's first author. "During that time, more HIV-infected men are shedding the virus, and on average they are shedding greater amounts of it, than before circumcision," he adds.

"We don't know for certain if this increase in the amount of virus the men are shedding actually leads to more cases of HIV transmission to their female partners," says co-author Ronald Gray, MD, MSc, a professor of epidemiology at the Bloomberg School. "But we do know that HIV-infected men who engage in sex before their circumcision wound heals have higher rates of transmission to their partners. Also, the higher an HIV-infected person's viral load, the greater the risk of transmitting the virus to a partner. So it is plausible that the risk goes up during that time."

A report on the study, published April 28 in PLOS Medicine, cites two factors -- the passage of time, and treatment with anti-retroviral drugs -- that dramatically reduced the virus' prevalence in HIV-positive, recently circumcised men.

Case by case, the likelihood of HIV transmission from a newly-circumcised man to his female partner is less than one-tenth of one percent, the researchers estimated. But with the World Health Organization seeking to circumcise nearly 29 million men, the study projects that this small increase could add up to 17,000 new infections among female partners of newly circumcised HIV-infected men.

Medical circumcision has been shown to cut the odds of contracting HIV by 50-60% in adult men; greatly reduce cases of genital herpes and human papillomavirus; and reduce the prevalence of some sexually transmitted infections in female partners. The World Health Organization has set a goal of circumcising about four out of five men aged 15 to 49 in southern and eastern Africa. Adolescent and adult circumcision programs are ongoing, and include HIV testing and counseling. Studies show about six percent of the men seeking circumcision are HIV-positive.

"All male circumcision programs are counseling men to abstain from sex while their wounds are healing, "says co-author Dr. Godfrey Kigozi at the Rakai Health Sciences Program. "But several programs have reported that greater than 30% of the men have sex with female partners during the healing period."

"Although we're counseling men not to have sexual intercourse while their wounds are healing, we know that they are," Tobian says, "and it's important to take steps to reduce the risk that they'll transmit the virus to their female partners during this time."

The solution, he says, may lie in another one of the study's findings. "If the men are on anti-retroviral drugs, this reduces the risk of their shedding the virus by about 90 percent," Tobian says. "Thus, it is logical for HIV-infected men to begin anti-retroviral therapy at the time of circumcision. However, we will need further studies to find out exactly which drugs and for how long."

Also participating in the study were David Serwadda of the Institute of Public Health, Makere University, Kampala, Uganda; Jordyn Manucci, Andrew D. Redd, Steven J. Reynolds, Oliver Laeyendecker and Thomas Quinn of the Johns Hopkins University School of Medicine; Mary K. Grabowski, Justin Lessler, Ronald H. Gray and Maria Wawer of the Johns Hopkins Bloomberg School of Public Health; and Godfrey Kigozi, Richard Musoke, Fred Nalugoda and Nehemiah Kighoma of the Rakai Health Sciences Program, Entebbe, Uganda. This study was funded by the Bill and Melinda Gates Foundation, the Doris Duke Charitable Foundation, the National Institute of Allergy and Infectious Diseases, and the Fogarty International Center.



Simple, active intervention program after major thoracic surgery reduces ER visits and saves money

Post-surgical hospital readmission after discharge and repeat emergency room (ER) visits are not unusual for patients who have undergone major thoracic surgery. Recognizing this problem, clinicians at McMaster University have implemented an innovative, active post-discharge intervention for thoracic surgery patients that is based on the principle of a "one team-one approach" that is initiated while the patient is still hospitalized. The program, known as the Integrated Comprehensive Care (ICC) Project, resulted in shorter hospital stays, fewer ER visits, cost savings, and no increase in adverse outcomes, as well as a trend toward fewer hospital admissions, according to Yaron Shargall, MD, who will be presenting the results of this research at the 95th AATS Annual Meeting in Seattle on April 28.

"Given the simplicity of the ICC model, we believe that it could straightforwardly be duplicated within other healthcare systems and will likely result in better outcomes and reduced costing. Indeed, the Ministry of Health and Long Term Care in Ontario has just approved the expansion of the ICC program regionally and to other patient groups. Our hospital is leading this initiative," explained Dr. Shargall, who is Head of the Division of Thoracic Surgery and holds the Juravinski Professorship in Thoracic Surgery at McMaster University (Hamilton, ON).

The ICC team consists of a nurse coordinator, eight registered and practical nurses, and six physiotherapists, with additional support available as needed from respiratory therapists, dietitians, and occupational therapists. Within the first 48 hours after surgery, the nurse coordinator meets with the patients and families to develop a discharge plan. Pertinent data regarding pre-operative co-morbidities, surgical procedure, and post-operative course are electronically stored for access by the designated homecare team. The homecare team contacts each patient within 24 hours of arrival at home and develops a visit plan based on the patient's needs. Patients have round-the-clock telephone access to the ICC coordinator, who in turn can quickly consult with staff surgeons.

To evaluate the effectiveness of the ICC project, the researchers conducted a retrospective case-control analysis of a prospective database. They compared 355 patients who underwent major between April 1, 2012 and March 31, 2013 and received ICC care to a historical control group of 331 patients who underwent similar major thoracic surgeries between April 1, 2011 and March 31, 2012, prior to the implementation of ICC. Patients were operated on for primary lung cancer, metastases, and benign conditions. Surgeries included lung resections and pleural decortication. The median follow-up was 22 months for the ICC group and 20 months for controls.

Three-quarters of the ICC patients made use of telephone support from the ICC coordinator. Overall, each ICC patient received an average of six hours of homecare during 8.7 visits post discharge, with an average cost of $500 per patient enrolled. Registered practical nurses saw 75% of the patients. As needed, assistance was provided by respiratory therapists, occupational therapists, dietitians, and speech pathologists. Patient satisfaction with the program was high, with more than 90% rating it as excellent or very good.

The researchers compared the ICC vs. control groups by stratifying by type and extent of resection to minimize selection bias (i.e. open partial, open total, VATS partial, VATS total). Sixty-day mortality was similar for both groups (1%). Overall, no significant differences were found in 60-day readmission rates (8.4% ICC vs. 12.2% controls, p=0.105), although there was a trend for fewer readmissions in the subgroups (e.g. open partial: 7.0% ICC vs. 18.3% controls, p=0.145).

Within 30-days post-discharge, ICC patients made fewer visits to the ER. For example, in the open total subgroup 18.3% of patients enrolled in the ICC made ER visits compared to 30.0% of controls (p=0.042) and in the VATS total subgroups the rates were 10.2% vs. 23.5% (p=0.048, respectively). Hospital length of stay tended to be lower in the ICC groups, but the differences reached statistical significance only in the open partial subgroups.

The ICC program yielded economic benefits, too. For example, total costs in the VATS partial ICC group were $8,505 compared to $11,038 for controls (p=0.007). Part of these savings comes from the training of relatively low-cost personal support workers or registered practical nurses, who are taught to recognize post-thoracic surgical complications early.

Another advantage of the ICC program is that when ICC patients do require hospital re-admission, they do so to the hospital where their surgery took place. Dr. Shargall noted that studies have shown that the risk of mortality is higher for patients who are readmitted into a hospital that is different from the one where the initial surgery occurred. Factors influencing this outcome include the facility not knowing the details of the patient's history or differences in healthcare practice. All of the ICC were admitted back into the releasing hospital, in part because of the earlier and more rapid communication available through the ICC program.

More information: "The Integrated Comprehensive Care (ICC) program: A novel homecare initiative after major thoracic surgery," 95th AATS Annual Meeting in Seattle on April 28.

Provided by American Association for Thoracic Surgery

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Post-surgical hospital readmission after discharge and repeat emergency room (ER) visits are not unusual for patients who have undergone major thoracic surgery. Recognizing this problem, clinicians at McMaster University have implemented an innovative, active post-discharge intervention for thoracic surgery patients that is based on the principle of a "one team-one approach" that is initiated while the patient is still hospitalized. The program, known as the Integrated Comprehensive Care (ICC) Project, resulted in shorter hospital stays, fewer ER visits, cost savings, and no increase in adverse outcomes, as well as a trend toward fewer hospital admissions, according to Yaron Shargall, MD, who will be presenting the results of this research at the 95th AATS Annual Meeting in Seattle on April 28.

"Given the simplicity of the ICC model, we believe that it could straightforwardly be duplicated within other healthcare systems and will likely result in better outcomes and reduced costing. Indeed, the Ministry of Health and Long Term Care in Ontario has just approved the expansion of the ICC program regionally and to other patient groups. Our hospital is leading this initiative," explained Dr. Shargall, who is Head of the Division of Thoracic Surgery and holds the Juravinski Professorship in Thoracic Surgery at McMaster University (Hamilton, ON).

The ICC team consists of a nurse coordinator, eight registered and practical nurses, and six physiotherapists, with additional support available as needed from respiratory therapists, dietitians, and occupational therapists. Within the first 48 hours after surgery, the nurse coordinator meets with the patients and families to develop a discharge plan. Pertinent data regarding pre-operative co-morbidities, surgical procedure, and post-operative course are electronically stored for access by the designated homecare team. The homecare team contacts each patient within 24 hours of arrival at home and develops a visit plan based on the patient's needs. Patients have round-the-clock telephone access to the ICC coordinator, who in turn can quickly consult with staff surgeons.

To evaluate the effectiveness of the ICC project, the researchers conducted a retrospective case-control analysis of a prospective database. They compared 355 patients who underwent major between April 1, 2012 and March 31, 2013 and received ICC care to a historical control group of 331 patients who underwent similar major thoracic surgeries between April 1, 2011 and March 31, 2012, prior to the implementation of ICC. Patients were operated on for primary lung cancer, metastases, and benign conditions. Surgeries included lung resections and pleural decortication. The median follow-up was 22 months for the ICC group and 20 months for controls.

Three-quarters of the ICC patients made use of telephone support from the ICC coordinator. Overall, each ICC patient received an average of six hours of homecare during 8.7 visits post discharge, with an average cost of $500 per patient enrolled. Registered practical nurses saw 75% of the patients. As needed, assistance was provided by respiratory therapists, occupational therapists, dietitians, and speech pathologists. Patient satisfaction with the program was high, with more than 90% rating it as excellent or very good.

The researchers compared the ICC vs. control groups by stratifying by type and extent of resection to minimize selection bias (i.e. open partial, open total, VATS partial, VATS total). Sixty-day mortality was similar for both groups (1%). Overall, no significant differences were found in 60-day readmission rates (8.4% ICC vs. 12.2% controls, p=0.105), although there was a trend for fewer readmissions in the subgroups (e.g. open partial: 7.0% ICC vs. 18.3% controls, p=0.145).

Within 30-days post-discharge, ICC patients made fewer visits to the ER. For example, in the open total subgroup 18.3% of patients enrolled in the ICC made ER visits compared to 30.0% of controls (p=0.042) and in the VATS total subgroups the rates were 10.2% vs. 23.5% (p=0.048, respectively). Hospital length of stay tended to be lower in the ICC groups, but the differences reached statistical significance only in the open partial subgroups.

The ICC program yielded economic benefits, too. For example, total costs in the VATS partial ICC group were $8,505 compared to $11,038 for controls (p=0.007). Part of these savings comes from the training of relatively low-cost personal support workers or registered practical nurses, who are taught to recognize post-thoracic surgical complications early.

Another advantage of the ICC program is that when ICC patients do require hospital re-admission, they do so to the hospital where their surgery took place. Dr. Shargall noted that studies have shown that the risk of mortality is higher for patients who are readmitted into a hospital that is different from the one where the initial surgery occurred. Factors influencing this outcome include the facility not knowing the details of the patient's history or differences in healthcare practice. All of the ICC were admitted back into the releasing hospital, in part because of the earlier and more rapid communication available through the ICC program.

More information: "The Integrated Comprehensive Care (ICC) program: A novel homecare initiative after major thoracic surgery," 95th AATS Annual Meeting in Seattle on April 28.

Provided by American Association for Thoracic Surgery

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Study shows surgeon's experience may be a contributing factor for non-small cell lung cancer patients

Researchers at McMaster University (Hamilton, ON) explored whether a surgeon's expertise influences procedural choice. The results of a new study of more than 8000 non-small cell lung cancer (NSCLC) patients undergoing surgical resection by 124 physicians showed that surgeons who perform more surgeries are less likely to perform high-risk pneumonectomies. Christian J. Finley, MD, MPH, will be presenting the results of this research at the 95th AATS Annual Meeting in Seattle, WA on April 28, 2015.

For patients in the early stages of NSCLC, lung surgery is associated with the best long-term survival. However, surgical and long-term outcomes vary depending on the choice of resection procedure. For example, removal of the whole lung (pneumonectomy) is associated with significantly higher morbidity and mortality rates compared to procedures in which smaller amounts of the lung are removed (lobectomies or sub-lobar resections), but can be less technically challenging than other procedures.

"If a surgeon with high surgical volumes is less likely to perform higher risk pneumonectomy procedures than one with lower volumes, this may translate to a significant reduction in adverse events. Surgeon volume should be considered an important component in how care is delivered in this population," explained Dr. Finley, who is affiliated with the Department of Surgery, St. Joseph's Healthcare Hamilton, McMaster University.

The researchers analyzed information on patients who underwent any pulmonary resection for primary NSCLC during 2004-2011 from an Ontario population-based database. They looked at patient demographics, co-morbidities, year of surgery, and institutional and surgical factors. All surgeons were trained as general thoracic surgeons. The volume of cases per surgeon per year was used as a surrogate for experience.

The resections were performed by 124 physicians at 45 institutions. Of the 8070 patients, 842 (10.4%) underwent pneumonectomy, 6212 (77.0%) underwent lobectomy, and 1002 (12.4%) wedge resection. The 90-day mortality was 12.6% for pneumonectomy, compared to 3.9% for lobectomy and 5.7% for wedge resection.

Odds ratios based on regression models for the three procedures revealed that physician volume was predictive of selecting pneumonectomy (OR 0.91, 95% CI 0.83 - 1.00, p=0.04). In fact, for each additional 10-unit increase in physician volume, the risk of performing a pneumonectomy decreased by 9.1% (p=0.04). As surgical volume increased, the number of wedge resections also decreased while the number of lobectomies increased. Other factors predictive of pneumonectomy were patient age, year of procedure, patient gender, and patient co-morbidities. No association was found between surgical volume and disease stage.

Variables, such as tumor biology and location, disease stage, and patient-specific factors such as age, pulmonary function and general health, are commonly taken into account when determining whether a patient with NSCLC will undergo surgery and what kind of surgery. "Only over the past decade have surgeon-specific factors such as experience, training, and volume been identified and examined as other important determinants of outcomes in patients," noted Dr. Finley. "This study possibly provides more evidence that surgeries are more likely to be successful if they are performed by surgeons who have a high annual case volume."

More information: "The effect of surgeon volume on procedure selection in non-small cell lung cancer surgeries," 95th AATS Annual Meeting in Seattle, WA on April 28, 2015.

Provided by American Association for Thoracic Surgery

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Researchers at McMaster University (Hamilton, ON) explored whether a surgeon's expertise influences procedural choice. The results of a new study of more than 8000 non-small cell lung cancer (NSCLC) patients undergoing surgical resection by 124 physicians showed that surgeons who perform more surgeries are less likely to perform high-risk pneumonectomies. Christian J. Finley, MD, MPH, will be presenting the results of this research at the 95th AATS Annual Meeting in Seattle, WA on April 28, 2015.

For patients in the early stages of NSCLC, lung surgery is associated with the best long-term survival. However, surgical and long-term outcomes vary depending on the choice of resection procedure. For example, removal of the whole lung (pneumonectomy) is associated with significantly higher morbidity and mortality rates compared to procedures in which smaller amounts of the lung are removed (lobectomies or sub-lobar resections), but can be less technically challenging than other procedures.

"If a surgeon with high surgical volumes is less likely to perform higher risk pneumonectomy procedures than one with lower volumes, this may translate to a significant reduction in adverse events. Surgeon volume should be considered an important component in how care is delivered in this population," explained Dr. Finley, who is affiliated with the Department of Surgery, St. Joseph's Healthcare Hamilton, McMaster University.

The researchers analyzed information on patients who underwent any pulmonary resection for primary NSCLC during 2004-2011 from an Ontario population-based database. They looked at patient demographics, co-morbidities, year of surgery, and institutional and surgical factors. All surgeons were trained as general thoracic surgeons. The volume of cases per surgeon per year was used as a surrogate for experience.

The resections were performed by 124 physicians at 45 institutions. Of the 8070 patients, 842 (10.4%) underwent pneumonectomy, 6212 (77.0%) underwent lobectomy, and 1002 (12.4%) wedge resection. The 90-day mortality was 12.6% for pneumonectomy, compared to 3.9% for lobectomy and 5.7% for wedge resection.

Odds ratios based on regression models for the three procedures revealed that physician volume was predictive of selecting pneumonectomy (OR 0.91, 95% CI 0.83 - 1.00, p=0.04). In fact, for each additional 10-unit increase in physician volume, the risk of performing a pneumonectomy decreased by 9.1% (p=0.04). As surgical volume increased, the number of wedge resections also decreased while the number of lobectomies increased. Other factors predictive of pneumonectomy were patient age, year of procedure, patient gender, and patient co-morbidities. No association was found between surgical volume and disease stage.

Variables, such as tumor biology and location, disease stage, and patient-specific factors such as age, pulmonary function and general health, are commonly taken into account when determining whether a patient with NSCLC will undergo surgery and what kind of surgery. "Only over the past decade have surgeon-specific factors such as experience, training, and volume been identified and examined as other important determinants of outcomes in patients," noted Dr. Finley. "This study possibly provides more evidence that surgeries are more likely to be successful if they are performed by surgeons who have a high annual case volume."

More information: "The effect of surgeon volume on procedure selection in non-small cell lung cancer surgeries," 95th AATS Annual Meeting in Seattle, WA on April 28, 2015.

Provided by American Association for Thoracic Surgery

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