ORLANDO – Want to know if you must participate in the new MIPS program? CMS is about to let you know.

Physicians who are right around the eligibility threshold for participation in the Quality Payment Program “want to know if they are eligible” for the Merit-based Incentive Payment System (MIPS), one of the QPP’s two tracks, Kate Goodrich, MD, said at the annual meeting of the Healthcare Information Management Systems Society. Within the next 6 weeks – about the first week of April – the Centers for Medicare & Medicaid Services will notify practices with less than $30,000 in Medicare payments or that serve less than 100 Medicare patients if they are exempt.

Gregory Twachtman/Frontline Medical News

• Do the bare minimum and face no penalties.
• Submit 90 days worth of data and be eligible for a small bonus payment.
• Submit for the full year and be eligible for the full bonus that is to be determined.

Doing absolutely nothing will result in a 4% reduction in Medicare fee schedule payments in 2019.

“We have to expect that we will have some folks who do the minimum” in 2017, Dr. Goodrich, director of the Center for Clinical Standards and Quality and the chief medical officer for CMS, said. “They are just not ready to go beyond that. But even for folks who haven’t participated previously [in reporting programs], we are hearing they want to at least try to do more than just the bare minimum because they want to get ready for future years of the program.”

She said that CMS officials “are definitely hearing from some larger health systems, but even some medium and smaller practices that were really familiar with what we now call legacy programs, so meaningful use and PQRS [Physician Quality Reporting System] and so forth, that they’re ready.”

[email protected]

ORLANDO – Want to know if you must participate in the new MIPS program? CMS is about to let you know.

Physicians who are right around the eligibility threshold for participation in the Quality Payment Program “want to know if they are eligible” for the Merit-based Incentive Payment System (MIPS), one of the QPP’s two tracks, Kate Goodrich, MD, said at the annual meeting of the Healthcare Information Management Systems Society. Within the next 6 weeks – about the first week of April – the Centers for Medicare & Medicaid Services will notify practices with less than $30,000 in Medicare payments or that serve less than 100 Medicare patients if they are exempt.

Gregory Twachtman/Frontline Medical News

• Do the bare minimum and face no penalties.
• Submit 90 days worth of data and be eligible for a small bonus payment.
• Submit for the full year and be eligible for the full bonus that is to be determined.

Doing absolutely nothing will result in a 4% reduction in Medicare fee schedule payments in 2019.

“We have to expect that we will have some folks who do the minimum” in 2017, Dr. Goodrich, director of the Center for Clinical Standards and Quality and the chief medical officer for CMS, said. “They are just not ready to go beyond that. But even for folks who haven’t participated previously [in reporting programs], we are hearing they want to at least try to do more than just the bare minimum because they want to get ready for future years of the program.”

She said that CMS officials “are definitely hearing from some larger health systems, but even some medium and smaller practices that were really familiar with what we now call legacy programs, so meaningful use and PQRS [Physician Quality Reporting System] and so forth, that they’re ready.”

[email protected]

ORLANDO – Want to know if you must participate in the new MIPS program? CMS is about to let you know.

Physicians who are right around the eligibility threshold for participation in the Quality Payment Program “want to know if they are eligible” for the Merit-based Incentive Payment System (MIPS), one of the QPP’s two tracks, Kate Goodrich, MD, said at the annual meeting of the Healthcare Information Management Systems Society. Within the next 6 weeks – about the first week of April – the Centers for Medicare & Medicaid Services will notify practices with less than $30,000 in Medicare payments or that serve less than 100 Medicare patients if they are exempt.

Gregory Twachtman/Frontline Medical News

• Do the bare minimum and face no penalties.
• Submit 90 days worth of data and be eligible for a small bonus payment.
• Submit for the full year and be eligible for the full bonus that is to be determined.

Doing absolutely nothing will result in a 4% reduction in Medicare fee schedule payments in 2019.

“We have to expect that we will have some folks who do the minimum” in 2017, Dr. Goodrich, director of the Center for Clinical Standards and Quality and the chief medical officer for CMS, said. “They are just not ready to go beyond that. But even for folks who haven’t participated previously [in reporting programs], we are hearing they want to at least try to do more than just the bare minimum because they want to get ready for future years of the program.”

She said that CMS officials “are definitely hearing from some larger health systems, but even some medium and smaller practices that were really familiar with what we now call legacy programs, so meaningful use and PQRS [Physician Quality Reporting System] and so forth, that they’re ready.”

[email protected]

SEATTLE – Pre-exposure prophylaxis therapy combined with antiretroviral therapy (ART) appears to be safe in pregnant women, according to an open-label study of high-risk women in Kenya and Uganda who were part of HIV-serodiscordant couples.

The safety profile of the drugs has not been well studied in pregnant women because, in the registration trials of Truvada (emtricitabine and tenofovir disoproxil fumarate; Gilead), women were instructed to stop taking the drugs when they became pregnant. Current guidelines offer counseling and the choice to continue PrEP after a woman becomes pregnant.

The study was funded by the Bill & Melinda Gates Foundation, the National Institute of Mental Health, and the United States Agency for International Development. Dr Heffron reported having no financial disclosures.

[email protected]

SEATTLE – Pre-exposure prophylaxis therapy combined with antiretroviral therapy (ART) appears to be safe in pregnant women, according to an open-label study of high-risk women in Kenya and Uganda who were part of HIV-serodiscordant couples.

The safety profile of the drugs has not been well studied in pregnant women because, in the registration trials of Truvada (emtricitabine and tenofovir disoproxil fumarate; Gilead), women were instructed to stop taking the drugs when they became pregnant. Current guidelines offer counseling and the choice to continue PrEP after a woman becomes pregnant.

The study was funded by the Bill & Melinda Gates Foundation, the National Institute of Mental Health, and the United States Agency for International Development. Dr Heffron reported having no financial disclosures.

[email protected]

SEATTLE – Pre-exposure prophylaxis therapy combined with antiretroviral therapy (ART) appears to be safe in pregnant women, according to an open-label study of high-risk women in Kenya and Uganda who were part of HIV-serodiscordant couples.

The safety profile of the drugs has not been well studied in pregnant women because, in the registration trials of Truvada (emtricitabine and tenofovir disoproxil fumarate; Gilead), women were instructed to stop taking the drugs when they became pregnant. Current guidelines offer counseling and the choice to continue PrEP after a woman becomes pregnant.

The study was funded by the Bill & Melinda Gates Foundation, the National Institute of Mental Health, and the United States Agency for International Development. Dr Heffron reported having no financial disclosures.

[email protected]

Mohs micrographic surgery (MMS) remains the gold standard for the removal of skin cancers in high-risk areas of the body while offering an excellent safety profile and sparing tissue.¹ In the current health care environment, online patient reviews have grown in popularity and influence. More than 60% of consumers consult social media before making health care decisions.² A recent analysis of online patient reviews of general dermatology practices demonstrated the perceived importance of physician empathy, thoroughness, and cognizance of cost in relation to patient-reported satisfaction.³ Because MMS is a well-recognized and unique outpatient-based surgical procedure, a review and analysis of online patient reviews specific to MMS can provide useful practice insights.

Materials and Methods

This study was conducted using an online platform (RealSelf [http://www.realself.com]) that connects patients and providers offering aesthetically oriented procedures; the site has 35 million unique visitors yearly.⁴ The community’s directory was used to identify and analyze all cumulative patient reviews from 2006 to December 20, 2015, using the search terms Mohs surgery or Mohs micrographic surgery. The study was exempt by the Northwestern University (Chicago, Illinois) institutional review board.

A standardized qualitative coding methodology was created and applied to all available comments regarding MMS. A broad list of positive and negative patient experiences was first created and agreed upon by all 3 investigators. Each individual comment was then attributed to 1 or more of these positive or negative themes. Of these comments, 10% were coded by 2 investigators (S.X. and Z.A.) to ensure internal validity; 1 investigator coded the remaining statements by patients (Z.A.). Patient-reported satisfaction ratings categorized as “worth it” or “not worth it” (as used by RealSelf to describe the patient-perceived value and utility of a given procedure) as well as cost of MMS were gathered. Cumulative patient ratings were collected for the procedure overall, physician’s bedside manner, answered questions, aftercare follow-up, time spent with patients, telephone/email responsiveness, staff professionalism/courtesy, payment process, and wait times. Patient-reported characteristics of MMS also were evaluated including physician specialty, lesion location, type of skin cancer, and type of closure. For lesion location, we graded whether the location represented a high-risk area as defined by the American Academy of Dermatology, American College of Mohs Surgery, and American Society for Dermatologic Surgery.⁵

Results

A total of 219 reviews related to MMS were collected as of December 20, 2015. Overall, MMS was considered “worth it” by 89% of patients (Table 1). Only 2% of patients described MMS as “not worth it.” There was a wide range reported for the cost of the procedure ($1–$100,000 [median, $1800]). Of those patients who reported their sex, females were 2.5-times more likely to post a review compared to males (51% vs 20%); however, 30% of reviewers did not report their sex. The mean (standard deviation) overall satisfaction rating was 4.8 (0.8). With regard to category-specific ratings (eg, bedside manner, aftercare follow-up, time spent with patients), the mean scores were all 4.7 or greater (Table 2).

Regarding the surgical aspects of the procedure, the majority of patients reported that the excision of the lesion was performed by a dermatologist (62%). However, a notable portion of patients reported that the excision was performed by a plastic surgeon (21%). Physician specialty was not reported in 16% of the reviews. For the lesion closure, the patient-reported specialty of the physician was only slightly higher for dermatologists versus plastic surgeons (46% vs 44%)(Table 3).

The majority of patients who reported the location of the lesion treated with MMS identified a high-risk location (45%), a medium-risk location (18%), or an unspecified region of the face (15%), according to the appropriate-use criteria for MMS (Table 3).⁵ Patients did not specify the site of surgery 17% of the time. Only 5% of reported procedures were performed on low-risk areas.

Basal cell carcinomas were the most commonly reported lesions removed by MMS (38%), though 48% of reviews did not specify the type of tumor being treated (Table 3). A large majority (76%) did not specify the type of closure performed. When specified, secondary intention was used 10% of the time, followed by either a flap (6%) or skin graft (6%). Only 5% of patients reported an estimated size of the primary lesion in our study (data not shown).

The qualitative analysis demonstrated variance in themes for positive and negative characteristics (Table 4). Surgeon characteristics encompassed the 3 most commonly cited themes of positive remarks, including bedside manner (78%), communication skills (74%), and perceived expertise (58%). Specific to MMS, the tissue-sparing nature of the technique was cited by 14% of reviews as a positive theme. The most commonly cited themes of negative remarks were intraoperative and postoperative concerns, including postoperative disfigurement (16%), large scar (9%), healing time (9%), and procedural or postoperative pain (8%). A subtheme analysis of postoperative disfigurement revealed that eyelid or eyebrow distortion was the most common concern (29%), followed by redness and swelling (23%), an open wound (14%), and nostril/nose distortion (14%)(data not shown). Themes not commonly cited as either positive or negative included office environment, cost, and procedure time (data not shown).

Comment

The overall satisfaction with MMS (89%) was one of the highest for any procedure on this online patient review site, albeit based on fewer reviews compared to other common aesthetic surgical procedures. In comparison, 78% of 13,500 reviewers rated breast augmentation as “worth it,” while 60% of 6800 reviewers rated rhinoplasty as “worth it” (as of December 2015). Overall, the online patient reviews evaluated in this study were consistent with a previously published structured data report on patient satisfaction with MMS.⁶

The results show a greater than expected proportion of both the MMS excision and closure being performed by plastic surgeons compared to dermatologists. In reality, the majority of MMS excisions are performed by dermatologists. Based on a survey of American College of Mohs Surgery (ACMS) members, only 6% of procedures were sent to other specialties for closure.⁷ Our results may reflect reporting bias or patients misconstruing true MMS with an excision and standard frozen sections, techniques that have lower cure rates. If so, there may be a need to educate patients regarding the specifics of MMS. Other possible explanations for the discrepancy between the online patient reviews and ACMS data include misinterpretation by patients on the exact definition of MMS or that a higher than expected number of procedures were performed by non-ACMS Mohs surgeons.

Our qualitative analysis revealed that patients most frequently commented on the interpersonal skills of their surgeons (eg, bedside manner, communication) as positive themes during MMS, similar to prior analyses of general dermatology practices.³ In comparison to a recent study assessing patient satisfaction with rhinoplasty on RealSelf, the final appearance of the nose represented the most common positive- and negative-cited theme.⁸ Mohs micrographic surgery procedures typically are done under local anesthesia, which may explain the greater importance of bedside manner and communication intraoperatively in comparison to final surgical outcomes for patient satisfaction. For negative themes, 3 of 4 most common concerns were directly related to the intraoperative and postoperative periods. Providers may be able to improve patient satisfaction by explaining the postoperative course, such as healing time and temporary physical restrictions, as well as possible sequelae in greater detail, which may be particularly pertinent for MMS involving the nose or near the eyes.

The global ratings for MMS are high, as shown in our data set of patient reviews; however, patient reviews are highly susceptible to reporting bias, recall bias, and missing information. Prior work using this online patient review website to investigate laser and light procedures also demonstrated the risk for imperfect information associated with patient reviews.⁹ Even so, the data does provide a glimpse into what is considered important to patients. Surgeon interpersonal skills and communication were the most frequently cited positive themes for MMS. The best surgical aspects of MMS focused on the unique tissue-sparing nature of the procedure and the removal of a cancerous lesion. Potential areas for improvement include a more thorough explanation of the intraoperative and postoperative process, specifically potential asymmetry related to the nose or the eyes, healing time, and scarring. These patient reviews underscore the importance of setting appropriate patient expectations. As patients become more connected and utilize online platforms to report their experiences, Mohs surgeons can take insights derived from online patient reviews for their own practice or geographic area to improve satisfaction and manage expectations.

Mohs micrographic surgery (MMS) remains the gold standard for the removal of skin cancers in high-risk areas of the body while offering an excellent safety profile and sparing tissue.¹ In the current health care environment, online patient reviews have grown in popularity and influence. More than 60% of consumers consult social media before making health care decisions.² A recent analysis of online patient reviews of general dermatology practices demonstrated the perceived importance of physician empathy, thoroughness, and cognizance of cost in relation to patient-reported satisfaction.³ Because MMS is a well-recognized and unique outpatient-based surgical procedure, a review and analysis of online patient reviews specific to MMS can provide useful practice insights.

Materials and Methods

This study was conducted using an online platform (RealSelf [http://www.realself.com]) that connects patients and providers offering aesthetically oriented procedures; the site has 35 million unique visitors yearly.⁴ The community’s directory was used to identify and analyze all cumulative patient reviews from 2006 to December 20, 2015, using the search terms Mohs surgery or Mohs micrographic surgery. The study was exempt by the Northwestern University (Chicago, Illinois) institutional review board.

A standardized qualitative coding methodology was created and applied to all available comments regarding MMS. A broad list of positive and negative patient experiences was first created and agreed upon by all 3 investigators. Each individual comment was then attributed to 1 or more of these positive or negative themes. Of these comments, 10% were coded by 2 investigators (S.X. and Z.A.) to ensure internal validity; 1 investigator coded the remaining statements by patients (Z.A.). Patient-reported satisfaction ratings categorized as “worth it” or “not worth it” (as used by RealSelf to describe the patient-perceived value and utility of a given procedure) as well as cost of MMS were gathered. Cumulative patient ratings were collected for the procedure overall, physician’s bedside manner, answered questions, aftercare follow-up, time spent with patients, telephone/email responsiveness, staff professionalism/courtesy, payment process, and wait times. Patient-reported characteristics of MMS also were evaluated including physician specialty, lesion location, type of skin cancer, and type of closure. For lesion location, we graded whether the location represented a high-risk area as defined by the American Academy of Dermatology, American College of Mohs Surgery, and American Society for Dermatologic Surgery.⁵

Results

A total of 219 reviews related to MMS were collected as of December 20, 2015. Overall, MMS was considered “worth it” by 89% of patients (Table 1). Only 2% of patients described MMS as “not worth it.” There was a wide range reported for the cost of the procedure ($1–$100,000 [median, $1800]). Of those patients who reported their sex, females were 2.5-times more likely to post a review compared to males (51% vs 20%); however, 30% of reviewers did not report their sex. The mean (standard deviation) overall satisfaction rating was 4.8 (0.8). With regard to category-specific ratings (eg, bedside manner, aftercare follow-up, time spent with patients), the mean scores were all 4.7 or greater (Table 2).

Regarding the surgical aspects of the procedure, the majority of patients reported that the excision of the lesion was performed by a dermatologist (62%). However, a notable portion of patients reported that the excision was performed by a plastic surgeon (21%). Physician specialty was not reported in 16% of the reviews. For the lesion closure, the patient-reported specialty of the physician was only slightly higher for dermatologists versus plastic surgeons (46% vs 44%)(Table 3).

The majority of patients who reported the location of the lesion treated with MMS identified a high-risk location (45%), a medium-risk location (18%), or an unspecified region of the face (15%), according to the appropriate-use criteria for MMS (Table 3).⁵ Patients did not specify the site of surgery 17% of the time. Only 5% of reported procedures were performed on low-risk areas.

Basal cell carcinomas were the most commonly reported lesions removed by MMS (38%), though 48% of reviews did not specify the type of tumor being treated (Table 3). A large majority (76%) did not specify the type of closure performed. When specified, secondary intention was used 10% of the time, followed by either a flap (6%) or skin graft (6%). Only 5% of patients reported an estimated size of the primary lesion in our study (data not shown).

The qualitative analysis demonstrated variance in themes for positive and negative characteristics (Table 4). Surgeon characteristics encompassed the 3 most commonly cited themes of positive remarks, including bedside manner (78%), communication skills (74%), and perceived expertise (58%). Specific to MMS, the tissue-sparing nature of the technique was cited by 14% of reviews as a positive theme. The most commonly cited themes of negative remarks were intraoperative and postoperative concerns, including postoperative disfigurement (16%), large scar (9%), healing time (9%), and procedural or postoperative pain (8%). A subtheme analysis of postoperative disfigurement revealed that eyelid or eyebrow distortion was the most common concern (29%), followed by redness and swelling (23%), an open wound (14%), and nostril/nose distortion (14%)(data not shown). Themes not commonly cited as either positive or negative included office environment, cost, and procedure time (data not shown).

Comment

The overall satisfaction with MMS (89%) was one of the highest for any procedure on this online patient review site, albeit based on fewer reviews compared to other common aesthetic surgical procedures. In comparison, 78% of 13,500 reviewers rated breast augmentation as “worth it,” while 60% of 6800 reviewers rated rhinoplasty as “worth it” (as of December 2015). Overall, the online patient reviews evaluated in this study were consistent with a previously published structured data report on patient satisfaction with MMS.⁶

The results show a greater than expected proportion of both the MMS excision and closure being performed by plastic surgeons compared to dermatologists. In reality, the majority of MMS excisions are performed by dermatologists. Based on a survey of American College of Mohs Surgery (ACMS) members, only 6% of procedures were sent to other specialties for closure.⁷ Our results may reflect reporting bias or patients misconstruing true MMS with an excision and standard frozen sections, techniques that have lower cure rates. If so, there may be a need to educate patients regarding the specifics of MMS. Other possible explanations for the discrepancy between the online patient reviews and ACMS data include misinterpretation by patients on the exact definition of MMS or that a higher than expected number of procedures were performed by non-ACMS Mohs surgeons.

Our qualitative analysis revealed that patients most frequently commented on the interpersonal skills of their surgeons (eg, bedside manner, communication) as positive themes during MMS, similar to prior analyses of general dermatology practices.³ In comparison to a recent study assessing patient satisfaction with rhinoplasty on RealSelf, the final appearance of the nose represented the most common positive- and negative-cited theme.⁸ Mohs micrographic surgery procedures typically are done under local anesthesia, which may explain the greater importance of bedside manner and communication intraoperatively in comparison to final surgical outcomes for patient satisfaction. For negative themes, 3 of 4 most common concerns were directly related to the intraoperative and postoperative periods. Providers may be able to improve patient satisfaction by explaining the postoperative course, such as healing time and temporary physical restrictions, as well as possible sequelae in greater detail, which may be particularly pertinent for MMS involving the nose or near the eyes.

The global ratings for MMS are high, as shown in our data set of patient reviews; however, patient reviews are highly susceptible to reporting bias, recall bias, and missing information. Prior work using this online patient review website to investigate laser and light procedures also demonstrated the risk for imperfect information associated with patient reviews.⁹ Even so, the data does provide a glimpse into what is considered important to patients. Surgeon interpersonal skills and communication were the most frequently cited positive themes for MMS. The best surgical aspects of MMS focused on the unique tissue-sparing nature of the procedure and the removal of a cancerous lesion. Potential areas for improvement include a more thorough explanation of the intraoperative and postoperative process, specifically potential asymmetry related to the nose or the eyes, healing time, and scarring. These patient reviews underscore the importance of setting appropriate patient expectations. As patients become more connected and utilize online platforms to report their experiences, Mohs surgeons can take insights derived from online patient reviews for their own practice or geographic area to improve satisfaction and manage expectations.

Mohs micrographic surgery (MMS) remains the gold standard for the removal of skin cancers in high-risk areas of the body while offering an excellent safety profile and sparing tissue.¹ In the current health care environment, online patient reviews have grown in popularity and influence. More than 60% of consumers consult social media before making health care decisions.² A recent analysis of online patient reviews of general dermatology practices demonstrated the perceived importance of physician empathy, thoroughness, and cognizance of cost in relation to patient-reported satisfaction.³ Because MMS is a well-recognized and unique outpatient-based surgical procedure, a review and analysis of online patient reviews specific to MMS can provide useful practice insights.

Materials and Methods

This study was conducted using an online platform (RealSelf [http://www.realself.com]) that connects patients and providers offering aesthetically oriented procedures; the site has 35 million unique visitors yearly.⁴ The community’s directory was used to identify and analyze all cumulative patient reviews from 2006 to December 20, 2015, using the search terms Mohs surgery or Mohs micrographic surgery. The study was exempt by the Northwestern University (Chicago, Illinois) institutional review board.

A standardized qualitative coding methodology was created and applied to all available comments regarding MMS. A broad list of positive and negative patient experiences was first created and agreed upon by all 3 investigators. Each individual comment was then attributed to 1 or more of these positive or negative themes. Of these comments, 10% were coded by 2 investigators (S.X. and Z.A.) to ensure internal validity; 1 investigator coded the remaining statements by patients (Z.A.). Patient-reported satisfaction ratings categorized as “worth it” or “not worth it” (as used by RealSelf to describe the patient-perceived value and utility of a given procedure) as well as cost of MMS were gathered. Cumulative patient ratings were collected for the procedure overall, physician’s bedside manner, answered questions, aftercare follow-up, time spent with patients, telephone/email responsiveness, staff professionalism/courtesy, payment process, and wait times. Patient-reported characteristics of MMS also were evaluated including physician specialty, lesion location, type of skin cancer, and type of closure. For lesion location, we graded whether the location represented a high-risk area as defined by the American Academy of Dermatology, American College of Mohs Surgery, and American Society for Dermatologic Surgery.⁵

Results

A total of 219 reviews related to MMS were collected as of December 20, 2015. Overall, MMS was considered “worth it” by 89% of patients (Table 1). Only 2% of patients described MMS as “not worth it.” There was a wide range reported for the cost of the procedure ($1–$100,000 [median, $1800]). Of those patients who reported their sex, females were 2.5-times more likely to post a review compared to males (51% vs 20%); however, 30% of reviewers did not report their sex. The mean (standard deviation) overall satisfaction rating was 4.8 (0.8). With regard to category-specific ratings (eg, bedside manner, aftercare follow-up, time spent with patients), the mean scores were all 4.7 or greater (Table 2).

Regarding the surgical aspects of the procedure, the majority of patients reported that the excision of the lesion was performed by a dermatologist (62%). However, a notable portion of patients reported that the excision was performed by a plastic surgeon (21%). Physician specialty was not reported in 16% of the reviews. For the lesion closure, the patient-reported specialty of the physician was only slightly higher for dermatologists versus plastic surgeons (46% vs 44%)(Table 3).

The majority of patients who reported the location of the lesion treated with MMS identified a high-risk location (45%), a medium-risk location (18%), or an unspecified region of the face (15%), according to the appropriate-use criteria for MMS (Table 3).⁵ Patients did not specify the site of surgery 17% of the time. Only 5% of reported procedures were performed on low-risk areas.

Basal cell carcinomas were the most commonly reported lesions removed by MMS (38%), though 48% of reviews did not specify the type of tumor being treated (Table 3). A large majority (76%) did not specify the type of closure performed. When specified, secondary intention was used 10% of the time, followed by either a flap (6%) or skin graft (6%). Only 5% of patients reported an estimated size of the primary lesion in our study (data not shown).

The qualitative analysis demonstrated variance in themes for positive and negative characteristics (Table 4). Surgeon characteristics encompassed the 3 most commonly cited themes of positive remarks, including bedside manner (78%), communication skills (74%), and perceived expertise (58%). Specific to MMS, the tissue-sparing nature of the technique was cited by 14% of reviews as a positive theme. The most commonly cited themes of negative remarks were intraoperative and postoperative concerns, including postoperative disfigurement (16%), large scar (9%), healing time (9%), and procedural or postoperative pain (8%). A subtheme analysis of postoperative disfigurement revealed that eyelid or eyebrow distortion was the most common concern (29%), followed by redness and swelling (23%), an open wound (14%), and nostril/nose distortion (14%)(data not shown). Themes not commonly cited as either positive or negative included office environment, cost, and procedure time (data not shown).

Comment

The overall satisfaction with MMS (89%) was one of the highest for any procedure on this online patient review site, albeit based on fewer reviews compared to other common aesthetic surgical procedures. In comparison, 78% of 13,500 reviewers rated breast augmentation as “worth it,” while 60% of 6800 reviewers rated rhinoplasty as “worth it” (as of December 2015). Overall, the online patient reviews evaluated in this study were consistent with a previously published structured data report on patient satisfaction with MMS.⁶

The results show a greater than expected proportion of both the MMS excision and closure being performed by plastic surgeons compared to dermatologists. In reality, the majority of MMS excisions are performed by dermatologists. Based on a survey of American College of Mohs Surgery (ACMS) members, only 6% of procedures were sent to other specialties for closure.⁷ Our results may reflect reporting bias or patients misconstruing true MMS with an excision and standard frozen sections, techniques that have lower cure rates. If so, there may be a need to educate patients regarding the specifics of MMS. Other possible explanations for the discrepancy between the online patient reviews and ACMS data include misinterpretation by patients on the exact definition of MMS or that a higher than expected number of procedures were performed by non-ACMS Mohs surgeons.

Our qualitative analysis revealed that patients most frequently commented on the interpersonal skills of their surgeons (eg, bedside manner, communication) as positive themes during MMS, similar to prior analyses of general dermatology practices.³ In comparison to a recent study assessing patient satisfaction with rhinoplasty on RealSelf, the final appearance of the nose represented the most common positive- and negative-cited theme.⁸ Mohs micrographic surgery procedures typically are done under local anesthesia, which may explain the greater importance of bedside manner and communication intraoperatively in comparison to final surgical outcomes for patient satisfaction. For negative themes, 3 of 4 most common concerns were directly related to the intraoperative and postoperative periods. Providers may be able to improve patient satisfaction by explaining the postoperative course, such as healing time and temporary physical restrictions, as well as possible sequelae in greater detail, which may be particularly pertinent for MMS involving the nose or near the eyes.

The global ratings for MMS are high, as shown in our data set of patient reviews; however, patient reviews are highly susceptible to reporting bias, recall bias, and missing information. Prior work using this online patient review website to investigate laser and light procedures also demonstrated the risk for imperfect information associated with patient reviews.⁹ Even so, the data does provide a glimpse into what is considered important to patients. Surgeon interpersonal skills and communication were the most frequently cited positive themes for MMS. The best surgical aspects of MMS focused on the unique tissue-sparing nature of the procedure and the removal of a cancerous lesion. Potential areas for improvement include a more thorough explanation of the intraoperative and postoperative process, specifically potential asymmetry related to the nose or the eyes, healing time, and scarring. These patient reviews underscore the importance of setting appropriate patient expectations. As patients become more connected and utilize online platforms to report their experiences, Mohs surgeons can take insights derived from online patient reviews for their own practice or geographic area to improve satisfaction and manage expectations.

SEATTLE – In a phase II trial, an antibody that targets domain 1 of the CD4 receptor maintained viral suppression among patients who had been taking combination antiretroviral therapy (cART). The study lasted up to 16 weeks, and no viral rebound was seen.

In vitro studies showed that UB-421 can neutralize more than 850 strains of HIV-1, and it binds to the CD4 receptor with an affinity about 100 times greater than that of the gp120, essentially outcompeting the virus for access to T cells.

(Photo: Cynthia Goldsmith, CDC)

[email protected]

SEATTLE – In a phase II trial, an antibody that targets domain 1 of the CD4 receptor maintained viral suppression among patients who had been taking combination antiretroviral therapy (cART). The study lasted up to 16 weeks, and no viral rebound was seen.

In vitro studies showed that UB-421 can neutralize more than 850 strains of HIV-1, and it binds to the CD4 receptor with an affinity about 100 times greater than that of the gp120, essentially outcompeting the virus for access to T cells.

(Photo: Cynthia Goldsmith, CDC)

[email protected]

SEATTLE – In a phase II trial, an antibody that targets domain 1 of the CD4 receptor maintained viral suppression among patients who had been taking combination antiretroviral therapy (cART). The study lasted up to 16 weeks, and no viral rebound was seen.

In vitro studies showed that UB-421 can neutralize more than 850 strains of HIV-1, and it binds to the CD4 receptor with an affinity about 100 times greater than that of the gp120, essentially outcompeting the virus for access to T cells.

(Photo: Cynthia Goldsmith, CDC)

[email protected]

SNOWMASS, COLO. – Ultraslow infusion of a very-low-dose thrombolytic agent for treatment of mechanical prosthetic valve thrombosis appears to be as effective as surgery – the former first-line therapy – and sports a far lower stroke risk, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

“I’m not saying you have to use this, but I think it’s reasonable to consider it, especially if the patient is at high risk for surgery and low risk for thrombolysis,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/Frontline Medical News

[email protected]

SNOWMASS, COLO. – Ultraslow infusion of a very-low-dose thrombolytic agent for treatment of mechanical prosthetic valve thrombosis appears to be as effective as surgery – the former first-line therapy – and sports a far lower stroke risk, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

“I’m not saying you have to use this, but I think it’s reasonable to consider it, especially if the patient is at high risk for surgery and low risk for thrombolysis,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/Frontline Medical News

[email protected]

SNOWMASS, COLO. – Ultraslow infusion of a very-low-dose thrombolytic agent for treatment of mechanical prosthetic valve thrombosis appears to be as effective as surgery – the former first-line therapy – and sports a far lower stroke risk, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

“I’m not saying you have to use this, but I think it’s reasonable to consider it, especially if the patient is at high risk for surgery and low risk for thrombolysis,” according to Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Bruce Jancin/Frontline Medical News

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The Cardiovascular Insights for Primary Care Physicians eNewsletter Series summarizes key information and data on common cardiovascular issues facing primary care physicians today.

Click here to read the supplement

The Cardiovascular Insights for Primary Care Physicians eNewsletter Series summarizes key information and data on common cardiovascular issues facing primary care physicians today.

Click here to read the supplement

The Cardiovascular Insights for Primary Care Physicians eNewsletter Series summarizes key information and data on common cardiovascular issues facing primary care physicians today.

Click here to read the supplement

Seattle – The antibody ibalizumab combined with an optimized background regimen maintained viral suppression out to 24 weeks, in an open-label extension study of patients with multidrug-resistant HIV-1 infections.

The researchers had previously shown that the drug achieved viral suppression after 7 days in many patients.

Ibalizumab works by blocking an epitope on the second extracellular domain of the CD4 receptor, preventing the HIV virus from entering the cell. The 40 patients in the study had failed on at least one drug in three different classes, though they had to have sensitivity to at least one antiretroviral drug, which was used to construct the optimized background regimen (OBR).

“These patients are the most vulnerable and most at risk in terms of needing a new class of drugs. This is the first new class of drug that will go for approval in a decade,” said Brinda Emu, MD, of the deparment of internal medicine at Yale University, New Haven, Conn., who presented the study in a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

The average duration of HIV infection among patients was 21 years. Forty-three percent had to take the investigational agent fostemsavir as part of their OBR. After a 7-day monitoring period, patients received a 2,000-mg IV dose of ibalizumab. Seven days later, at day 14, 83% had achieved at least a 0.5 log₁₀ reduction in viral load, compared with 3% during the monitoring period (P less than .0001); 60% achieved at least a 1 log₁₀ reduction, compared with 0% during the monitoring period (P less than .0001).

The OBR was then started at week 14, and patients received an injection of 800 mg ibalizumab every 2 weeks beginning at day 21 and continuing until week 24.

The current research reports the results of the extension study. At week 24, the mean viral load had decreased 1.6 log_10, compared with baseline – 55% of patients had a decrease of at least 1 log₁₀, and 48% had a reduction of at least 2 log₁₀; 43% of patients had undetectable levels of virus, and 50% had fewer than 200 copies/mL.

Nine patients reported a total of 17 serious adverse events, 1 of which led to drug discontinuation. Overall. there were nine discontinuations due to four deaths, three consent withdrawals, and two losses to follow-up.

“In an indication with very resistant virus and limited options, combining ibalizumab with at least one other active agent can provide a way to decrease viral load and increase CD4+ T cells. What I want to know is, What if we started this a little bit earlier as we do with many of our other drugs?” asked Dr. Emu.

She said that some providers had had concerns that adherence may be low with an injectable drug, but the results were reassuring. “I will say anecdotally that I’ve seen the complete opposite. One of the things we noticed is that seeing these patients every 2 weeks to give them their IV infusions has made them more adherent to the rest of their regimen. Perhaps it’s that ability to check in, and the relationship that builds up over time with your providers. Despite it being an infusional agent, or perhaps because of that, adherence has been pretty good.”

The study was funded by TaiMed Biologics. Dr. Emu has served on TaiMed’s advisory board.
 

[email protected]

Seattle – The antibody ibalizumab combined with an optimized background regimen maintained viral suppression out to 24 weeks, in an open-label extension study of patients with multidrug-resistant HIV-1 infections.

The researchers had previously shown that the drug achieved viral suppression after 7 days in many patients.

Ibalizumab works by blocking an epitope on the second extracellular domain of the CD4 receptor, preventing the HIV virus from entering the cell. The 40 patients in the study had failed on at least one drug in three different classes, though they had to have sensitivity to at least one antiretroviral drug, which was used to construct the optimized background regimen (OBR).

“These patients are the most vulnerable and most at risk in terms of needing a new class of drugs. This is the first new class of drug that will go for approval in a decade,” said Brinda Emu, MD, of the deparment of internal medicine at Yale University, New Haven, Conn., who presented the study in a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

The average duration of HIV infection among patients was 21 years. Forty-three percent had to take the investigational agent fostemsavir as part of their OBR. After a 7-day monitoring period, patients received a 2,000-mg IV dose of ibalizumab. Seven days later, at day 14, 83% had achieved at least a 0.5 log₁₀ reduction in viral load, compared with 3% during the monitoring period (P less than .0001); 60% achieved at least a 1 log₁₀ reduction, compared with 0% during the monitoring period (P less than .0001).

The OBR was then started at week 14, and patients received an injection of 800 mg ibalizumab every 2 weeks beginning at day 21 and continuing until week 24.

The current research reports the results of the extension study. At week 24, the mean viral load had decreased 1.6 log_10, compared with baseline – 55% of patients had a decrease of at least 1 log₁₀, and 48% had a reduction of at least 2 log₁₀; 43% of patients had undetectable levels of virus, and 50% had fewer than 200 copies/mL.

Nine patients reported a total of 17 serious adverse events, 1 of which led to drug discontinuation. Overall. there were nine discontinuations due to four deaths, three consent withdrawals, and two losses to follow-up.

“In an indication with very resistant virus and limited options, combining ibalizumab with at least one other active agent can provide a way to decrease viral load and increase CD4+ T cells. What I want to know is, What if we started this a little bit earlier as we do with many of our other drugs?” asked Dr. Emu.

She said that some providers had had concerns that adherence may be low with an injectable drug, but the results were reassuring. “I will say anecdotally that I’ve seen the complete opposite. One of the things we noticed is that seeing these patients every 2 weeks to give them their IV infusions has made them more adherent to the rest of their regimen. Perhaps it’s that ability to check in, and the relationship that builds up over time with your providers. Despite it being an infusional agent, or perhaps because of that, adherence has been pretty good.”

The study was funded by TaiMed Biologics. Dr. Emu has served on TaiMed’s advisory board.
 

[email protected]

Seattle – The antibody ibalizumab combined with an optimized background regimen maintained viral suppression out to 24 weeks, in an open-label extension study of patients with multidrug-resistant HIV-1 infections.

The researchers had previously shown that the drug achieved viral suppression after 7 days in many patients.

Ibalizumab works by blocking an epitope on the second extracellular domain of the CD4 receptor, preventing the HIV virus from entering the cell. The 40 patients in the study had failed on at least one drug in three different classes, though they had to have sensitivity to at least one antiretroviral drug, which was used to construct the optimized background regimen (OBR).

“These patients are the most vulnerable and most at risk in terms of needing a new class of drugs. This is the first new class of drug that will go for approval in a decade,” said Brinda Emu, MD, of the deparment of internal medicine at Yale University, New Haven, Conn., who presented the study in a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

The average duration of HIV infection among patients was 21 years. Forty-three percent had to take the investigational agent fostemsavir as part of their OBR. After a 7-day monitoring period, patients received a 2,000-mg IV dose of ibalizumab. Seven days later, at day 14, 83% had achieved at least a 0.5 log₁₀ reduction in viral load, compared with 3% during the monitoring period (P less than .0001); 60% achieved at least a 1 log₁₀ reduction, compared with 0% during the monitoring period (P less than .0001).

The OBR was then started at week 14, and patients received an injection of 800 mg ibalizumab every 2 weeks beginning at day 21 and continuing until week 24.

The current research reports the results of the extension study. At week 24, the mean viral load had decreased 1.6 log_10, compared with baseline – 55% of patients had a decrease of at least 1 log₁₀, and 48% had a reduction of at least 2 log₁₀; 43% of patients had undetectable levels of virus, and 50% had fewer than 200 copies/mL.

Nine patients reported a total of 17 serious adverse events, 1 of which led to drug discontinuation. Overall. there were nine discontinuations due to four deaths, three consent withdrawals, and two losses to follow-up.

“In an indication with very resistant virus and limited options, combining ibalizumab with at least one other active agent can provide a way to decrease viral load and increase CD4+ T cells. What I want to know is, What if we started this a little bit earlier as we do with many of our other drugs?” asked Dr. Emu.

She said that some providers had had concerns that adherence may be low with an injectable drug, but the results were reassuring. “I will say anecdotally that I’ve seen the complete opposite. One of the things we noticed is that seeing these patients every 2 weeks to give them their IV infusions has made them more adherent to the rest of their regimen. Perhaps it’s that ability to check in, and the relationship that builds up over time with your providers. Despite it being an infusional agent, or perhaps because of that, adherence has been pretty good.”

The study was funded by TaiMed Biologics. Dr. Emu has served on TaiMed’s advisory board.
 

[email protected]

SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.

The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.

The mortality rate among study participants was less than 6%.

“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.

Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.

Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.

Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.

Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.

Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.

Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.

The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.

Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.

SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.

The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.

The mortality rate among study participants was less than 6%.

“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.

Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.

Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.

Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.

Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.

Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.

Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.

The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.

Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.

SEATTLE – An all-oral drug combination achieved negative bacterial culture in 100% of patients with extensively drug resistant (XDR) or multidrug resistant (MDR) tuberculosis at 4 months, according to a study.

The drugs used were bedaquiline (400 mg once daily for 2 weeks followed by 200 mg three times per week), pretomanid (200 mg once daily), and linezolid (600 mg twice daily). The study, Nix-TB, was an open-label, two-site trial that examined a simplified and shortened all-oral regimen. Pretomanid is an experimental drug, while bedaquiline and linezolid are both approved medications.

The mortality rate among study participants was less than 6%.

“I was surprised at how successful this study was. These are patients who are generally very ill, with a very poor prognosis,” noted Francesca Conradie, MD, deputy director of the clinical HIV unit at the University of Witwatersrand (Johannesburg, South Africa), who presented the results at a poster session at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

To date, the trial has enrolled 72 subjects (51% HIV positive, 65% XDR-TB, 35% MDR-TB). HIV-infected subjects had to have CD4 counts of at least 50 cell/mcL. The researchers evaluated clinical, laboratory, and sputum liquid cultures at baseline and at weeks 1, 2, 4, 6, and 8, and then every 4-6 weeks throughout the 6-month treatment period.

Forty patients have finished 6 months of therapy and 31 have completed 6-months of posttherapy follow-up.

Four patients died during the first 8 weeks of therapy. Of the survivors, 74% were culture negative at 8 weeks, and all were culture negative at 4 months. Two patients experienced relapses or reinfections at 6 months following therapy.

Twenty-seven percent of patients experienced serious adverse events, but no patients withdrew from the trials for clinical adverse events or laboratory abnormalities.

Linezolid-associated peripheral neuropathy and myelosuppression occurred, with 71% of patients having experienced at least one dose interruption as a result. Seven patients experienced grade 3 or 4 transaminitis, but all such cases resolved and those patients continued the study regimen.

Some hepatic enzyme changes were seen among patients. A total of 14.1% developed alanine transaminase levels greater than 3 times the upper limit of normal (ULN), and 7.0% had levels greater than 5 x ULN. A total of 14.9% had aspartate transaminase (AST) enzymes at greater than 3 x ULN, and 2.8% had AST levels greater than 5 x ULN. A total of 4.2% had alkaline phosphatase levels reaching greater than 3 x ULN. In all cases, the values returned to normal with a pause in therapy.

Dr. Conradie characterized these results as reassuring, in light of the fact that the STAND study of pretomanid in combination with moxifloxacin and pyrazinamide was ended prematurely because of liver safety concerns.

The linezolid side effect profile is concerning, and the study will continue with modified linezolid doses, Dr. Conradie acknowledged. “We’re looking to see if we could do a study with a lower dose” of linezolid or a study that doesn’t involve giving linezolid for the entire period of the treatment, she noted.

Dr Conradie has served on advisory boards for ViiV, Janssen, Merck, GSK, Mylan, and Sanofi Aventis. The study was funded by the TB Foundation.

SEATTLE – In HIV patients with suppressed virus and no history of virologic failure, a two-drug combination of dolutegravir and rilpivirine (DTG+RPV) proved noninferior to three- and four-drug regimens in maintaining viral RNA counts at less than 50 copies/mL.

The results come from an integrated analysis of two open-label, multicenter phase III clinical trials – SWORD 1 and SWORD 2 – the results of which were presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

xrender/thinkstock

[email protected]

SEATTLE – In HIV patients with suppressed virus and no history of virologic failure, a two-drug combination of dolutegravir and rilpivirine (DTG+RPV) proved noninferior to three- and four-drug regimens in maintaining viral RNA counts at less than 50 copies/mL.

The results come from an integrated analysis of two open-label, multicenter phase III clinical trials – SWORD 1 and SWORD 2 – the results of which were presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

xrender/thinkstock

[email protected]

SEATTLE – In HIV patients with suppressed virus and no history of virologic failure, a two-drug combination of dolutegravir and rilpivirine (DTG+RPV) proved noninferior to three- and four-drug regimens in maintaining viral RNA counts at less than 50 copies/mL.

The results come from an integrated analysis of two open-label, multicenter phase III clinical trials – SWORD 1 and SWORD 2 – the results of which were presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

xrender/thinkstock

[email protected]

Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.

In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.

“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.

Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).

Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.

However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.

“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”

Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.

Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.

However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.

“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.

The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.

Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.

In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.

“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.

Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).

Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.

However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.

“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”

Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.

Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.

However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.

“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.

The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.

Nearly three-quarters of lung transplant recipients are likely to gain at least 2 years of survival, according to new research.

In a study published in the February issue of the Annals of the American Thoracic Society, researchers used data from 13,040 adults listed for lung transplantation between May 2005 and September 2011 to develop a structural nested accelerated failure time model of the survival benefit of lung transplantation over time.

“A ‘structural nested model’ is [used to] compare the distribution of counterfactual residual survival if a patient were to receive a transplanted organ with the survival distribution if the patient did not receive that organ and never received one subsequently,” wrote David M. Vock, PhD, from the University of Minnesota, and coauthors.

Using this approach, they calculated that 73.8% of transplant recipients were predicted to achieve a 2-year survival benefit with transplantation. At 1 year posttransplantation, the relative survival benefit was 1.59, at 2 years it was 1.93, and at 3 years it was 2.23 (Ann Am Thorac Soc. 2017;14:172-81. doi: 10.1513/AnnalsATS.201606-507OC).

Patients’ lung allocation score at transplantation (LAS-T) – the score used to prioritize donated lungs for transplantation – had a significant impact on the survival benefit from transplantation. The relative survival benefit of transplantation increased by 59.4% as the lung allocation score increased from 30 to 35, and increased by 45.1% as the lung allocation score increased from 50 to 55.

However patients with a lung allocation score of 32.5 or less were more likely to die with a transplant than without, even over the long term, while patients with a score of 35 or more always gained a survival advantage from transplantation, even if their scores were as high as 50-100. The authors said this showed there should be no upper limit for the lung allocation score.

“It has been suggested that the LAS system may encourage patients who have clinically deteriorated to undergo transplantation even though it would be futile,” they wrote. “Our results reinforce the notion that lung transplantation should be considered an appropriate treatment option for patients with most advanced lung diseases and is expected to confer survival benefit in appropriately selected patients.”

Researchers also observed an interesting, borderline significant association between disease group and survival benefit, with individuals with obstructive lung disease showing the lowest relative survival gains and those with cystic fibrosis showing the highest. Head to head, the relative survival benefit of transplantation for those with cystic fibrosis was 54.4% greater than for those with obstructive lung disease.

Other factors such as transplant type, age, smoking, and center volume also influenced relative survival benefit. Bilateral transplants were associated with a 13.4% greater relative survival benefit, lungs from donors aged under 55 years showed a 17.9% relative survival benefit, and lungs from donors without a history of smoking showed a 10.5% increase in relative survival benefit.

However the researchers noted that their modeling focused on only the survival benefit of transplantation and did not take into account improvements in quality of life. This was likely to be particularly relevant in conditions such as chronic obstructive pulmonary disease where the quality of life benefits might justify transplantation even in the absence of a clear survival benefit.

“A comprehensive understanding of the survival benefit of lung transplantation and how that benefit varies by recipient characteristics is imperative to inform recipient selection, to justify the intensive health care resources allocated to this treatment, and to achieve an equitable allocation of donor lungs,” the researchers said.

The study was supported by the National Heart, Lung, and Blood Institute; the National Cancer Institute; and the National Institute of Allergy and Infectious Diseases. One author declared grants and personal fees from private industry for consultation on lung transplantation. No other conflicts of interest were declared.