Insulin resistance in 22% of men with acne

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Insulin resistance in 22% of men with acne

Young adult men with acne were more likely to have insulin resistance and to have higher fasting plasma glucose levels than were men of the same age who did not have acne, in a cross-sectional study of 20 to 32 year old men in India.

In a study published online in JAMA Dermatology, on Dec. 23 (doi: 10.1001/jamadermatol.2015.4499), Dr. Mohit Nagpal, of the Postgraduate Institute of Medical Education and Research, Chandigarh, India, and associates, wrote that “Insulin resistance may be a stage of prediabetes, and the patients may develop hyperinsulinemia or type 2 diabetes in the future. These patients should be followed up to determine whether they develop conditions associated with insulin resistance.”

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The researchers compared 100 men with acne, aged 20 to 32 years, with 100 age-matched men who did not have acne and were being treated for non-acne dermatoses; all were being treated at the Institute’s dermatology outpatient department. Insulin resistance, as defined by a Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) value greater than 2.5, was present in 22% of those with acne, vs. 11% of those without acne, a significant difference (P = .036). Metabolic syndrome, based on criteria of the modified National Cholesterol Education Program’s Adult Treatment Panel III (NCEP-ATP III), was more common among those with acne (17% vs. 9%), but the difference was not significant (P = .09).

The mean diastolic and systolic blood pressure values were also significantly higher among those with acne, compared with controls, as were mean fasting plasma glucose levels.

When evaluated by acne severity (mild, moderate, severe, or very severe), there were no significant differences in the prevalence of insulin resistance or metabolic syndrome between the four groups. However, the mean body mass index and the mean weights among those with very severe acne were significantly higher than among those with mild acne (P = .04).

The cross-sectional design of the study was a limitation, the authors noted, and future studies will “follow up patients with acne to assess the development of clinical conditions associated with insulin resistance,” such as acanthosis nigricans and metabolic syndrome.

In an accompanying editorial, Dr. Rachel V. Reynolds of Beth Israel Deaconess Medical Center, Boston, wrote that this study, and another study published in the same issue regarding insulin resistance and polycystic ovary syndrome, “highlight the important role that the dermatologist plays in identifying and characterizing patients with common skin disorders who may be at risk for metabolic and androgen-mediated disease.” The study, “to our knowledge, [is] the largest cohort to date examining the prevalence of insulin resistance and metabolic syndrome in postadolescent males with acne of varying severity,” she added (doi: 10.1001/jamadermatol.2015.4500).

The authors of the study had no disclosures.

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Young adult men with acne were more likely to have insulin resistance and to have higher fasting plasma glucose levels than were men of the same age who did not have acne, in a cross-sectional study of 20 to 32 year old men in India.

In a study published online in JAMA Dermatology, on Dec. 23 (doi: 10.1001/jamadermatol.2015.4499), Dr. Mohit Nagpal, of the Postgraduate Institute of Medical Education and Research, Chandigarh, India, and associates, wrote that “Insulin resistance may be a stage of prediabetes, and the patients may develop hyperinsulinemia or type 2 diabetes in the future. These patients should be followed up to determine whether they develop conditions associated with insulin resistance.”

© Ocskay Bence /Fotolia.com

The researchers compared 100 men with acne, aged 20 to 32 years, with 100 age-matched men who did not have acne and were being treated for non-acne dermatoses; all were being treated at the Institute’s dermatology outpatient department. Insulin resistance, as defined by a Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) value greater than 2.5, was present in 22% of those with acne, vs. 11% of those without acne, a significant difference (P = .036). Metabolic syndrome, based on criteria of the modified National Cholesterol Education Program’s Adult Treatment Panel III (NCEP-ATP III), was more common among those with acne (17% vs. 9%), but the difference was not significant (P = .09).

The mean diastolic and systolic blood pressure values were also significantly higher among those with acne, compared with controls, as were mean fasting plasma glucose levels.

When evaluated by acne severity (mild, moderate, severe, or very severe), there were no significant differences in the prevalence of insulin resistance or metabolic syndrome between the four groups. However, the mean body mass index and the mean weights among those with very severe acne were significantly higher than among those with mild acne (P = .04).

The cross-sectional design of the study was a limitation, the authors noted, and future studies will “follow up patients with acne to assess the development of clinical conditions associated with insulin resistance,” such as acanthosis nigricans and metabolic syndrome.

In an accompanying editorial, Dr. Rachel V. Reynolds of Beth Israel Deaconess Medical Center, Boston, wrote that this study, and another study published in the same issue regarding insulin resistance and polycystic ovary syndrome, “highlight the important role that the dermatologist plays in identifying and characterizing patients with common skin disorders who may be at risk for metabolic and androgen-mediated disease.” The study, “to our knowledge, [is] the largest cohort to date examining the prevalence of insulin resistance and metabolic syndrome in postadolescent males with acne of varying severity,” she added (doi: 10.1001/jamadermatol.2015.4500).

The authors of the study had no disclosures.

[email protected]

Young adult men with acne were more likely to have insulin resistance and to have higher fasting plasma glucose levels than were men of the same age who did not have acne, in a cross-sectional study of 20 to 32 year old men in India.

In a study published online in JAMA Dermatology, on Dec. 23 (doi: 10.1001/jamadermatol.2015.4499), Dr. Mohit Nagpal, of the Postgraduate Institute of Medical Education and Research, Chandigarh, India, and associates, wrote that “Insulin resistance may be a stage of prediabetes, and the patients may develop hyperinsulinemia or type 2 diabetes in the future. These patients should be followed up to determine whether they develop conditions associated with insulin resistance.”

© Ocskay Bence /Fotolia.com

The researchers compared 100 men with acne, aged 20 to 32 years, with 100 age-matched men who did not have acne and were being treated for non-acne dermatoses; all were being treated at the Institute’s dermatology outpatient department. Insulin resistance, as defined by a Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) value greater than 2.5, was present in 22% of those with acne, vs. 11% of those without acne, a significant difference (P = .036). Metabolic syndrome, based on criteria of the modified National Cholesterol Education Program’s Adult Treatment Panel III (NCEP-ATP III), was more common among those with acne (17% vs. 9%), but the difference was not significant (P = .09).

The mean diastolic and systolic blood pressure values were also significantly higher among those with acne, compared with controls, as were mean fasting plasma glucose levels.

When evaluated by acne severity (mild, moderate, severe, or very severe), there were no significant differences in the prevalence of insulin resistance or metabolic syndrome between the four groups. However, the mean body mass index and the mean weights among those with very severe acne were significantly higher than among those with mild acne (P = .04).

The cross-sectional design of the study was a limitation, the authors noted, and future studies will “follow up patients with acne to assess the development of clinical conditions associated with insulin resistance,” such as acanthosis nigricans and metabolic syndrome.

In an accompanying editorial, Dr. Rachel V. Reynolds of Beth Israel Deaconess Medical Center, Boston, wrote that this study, and another study published in the same issue regarding insulin resistance and polycystic ovary syndrome, “highlight the important role that the dermatologist plays in identifying and characterizing patients with common skin disorders who may be at risk for metabolic and androgen-mediated disease.” The study, “to our knowledge, [is] the largest cohort to date examining the prevalence of insulin resistance and metabolic syndrome in postadolescent males with acne of varying severity,” she added (doi: 10.1001/jamadermatol.2015.4500).

The authors of the study had no disclosures.

[email protected]

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Key clinical point: Acne in young men may be a sign of insulin resistance.

Major finding: 22% of the young men with acne had insulin resistance, compared with 11% of the age-matched controls, a significant difference (P = .036).

Data source: The cross-sectional study compared the prevalence of insulin resistance and metabolic syndrome in 100 men aged 20-32 years with acne and 100 age-matched controls without acne.

Disclosures: The authors had no disclosures.

Study: One-third of patients with bipolar disorders abnormally metabolized glucose

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Study: One-third of patients with bipolar disorders abnormally metabolized glucose

One-third of patients with bipolar disorders abnormally metabolized glucose, in a study of outpatients from two university hospitals in Germany.

The study included 85 euthymic patients with bipolar disorders, who underwent an oral glucose tolerance test, laboratory screening, and clinical measurements.

©donskarpo/thinkstockphotos.com

Seven percent of the patients tested positive for diabetes mellitus, while 27% of the patients showed prediabetic abnormalities, including abnormalities in glucose metabolism. Patients in both of these groups had significantly lower quality of life and global functioning.

Additional study findings were that higher body mass index, leptin, triglycerides, and C-reactive protein levels significantly increased the likelihood of an individual having pre-diabetes abnormalities or diabetes.

Low sample size was a weakness of the study, according to Karolina Leopold and her colleagues.

Read the full study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.041).

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One-third of patients with bipolar disorders abnormally metabolized glucose, in a study of outpatients from two university hospitals in Germany.

The study included 85 euthymic patients with bipolar disorders, who underwent an oral glucose tolerance test, laboratory screening, and clinical measurements.

©donskarpo/thinkstockphotos.com

Seven percent of the patients tested positive for diabetes mellitus, while 27% of the patients showed prediabetic abnormalities, including abnormalities in glucose metabolism. Patients in both of these groups had significantly lower quality of life and global functioning.

Additional study findings were that higher body mass index, leptin, triglycerides, and C-reactive protein levels significantly increased the likelihood of an individual having pre-diabetes abnormalities or diabetes.

Low sample size was a weakness of the study, according to Karolina Leopold and her colleagues.

Read the full study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.041).

[email protected]

One-third of patients with bipolar disorders abnormally metabolized glucose, in a study of outpatients from two university hospitals in Germany.

The study included 85 euthymic patients with bipolar disorders, who underwent an oral glucose tolerance test, laboratory screening, and clinical measurements.

©donskarpo/thinkstockphotos.com

Seven percent of the patients tested positive for diabetes mellitus, while 27% of the patients showed prediabetic abnormalities, including abnormalities in glucose metabolism. Patients in both of these groups had significantly lower quality of life and global functioning.

Additional study findings were that higher body mass index, leptin, triglycerides, and C-reactive protein levels significantly increased the likelihood of an individual having pre-diabetes abnormalities or diabetes.

Low sample size was a weakness of the study, according to Karolina Leopold and her colleagues.

Read the full study in the Journal of Affective Disorders (doi: 10.1016/j.jad.2015.09.041).

[email protected]

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Long spine fusions can give patients improved quality of life

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Long spine fusions can give patients improved quality of life

SAN DIEGO – When necessary, long fusions that extend from the C-spine to the pelvis can result in health-related quality of life improvements, results from a multicenter study suggest.

“Patients with spinal deformities will sometimes require long fusion constructs that extend into the cervical spine,” lead study author Dr. Han-Jo Kim said at the annual meeting of the Cervical Spine Research Society. “The prevalence of these cases is increasing, especially as revision surgery for conditions such as proximal junctional kyphosis increase. They are also indicated for other diagnoses, such a progressive cervical deformity, cervical myelopathy as well as neuromuscular disorders.”

 

Dr. Han-Jo Kim

Prior investigations that have examined outcomes for these long constructs usually focus on patients who have had fusions from the upper thoracic spine to the pelvis, added Dr. Kim, an orthopedic spine surgeon at the Hospital for Special Surgery, New York. “To my knowledge, there are no studies in the literature that report on the subset of patients who have had fusions from the cervical spine to the pelvis,” he said. “The question is, even though these revisions may be necessary, does surgical intervention result in improved outcomes for these patients despite the extent of these long fusions?”

In an effort to determine the outcomes and rates of complications in patients who had fusions from the cervical spine to the pelvis, Dr. Kim and his associates conducted a retrospective review of patients who underwent fusions from the cervical spine to the pelvis at four institutions during 2003-2014. The researchers administered outcome scores utilizing the Scoliosis Research Society 22 (SRS-22r) questionnaire; the Oswestry Disability Index (ODI); and the Neck Disability Index (NDI); and collected demographic data including age, body mass index, and follow-up time; medical history including comorbidity data, operative details, radiographic and articular outcomes data; and postoperative complications.

Of 55 patients initially included in the study, complete data were available for 46 (84%). Their average age was 42 years, nearly one-third (30%) were classified as ASA III, 4.2% were smokers, and the average follow-up time was 2.7 years. “The majority of these cases were revision operations, and osteotomies were performed in close to 60% of these patients,” Dr. Kim said. “The average operating time was over 300 minutes, and there was an average of over 2 L of blood loss for these cases.”

The researchers observed improvements in the activity, pain, and mental health domains of the SRS, as well as an improvement in the SRS total score, which improved from an average of 3.0 preoperatively to 3.5 postoperatively (P less than .01). This was greater than the minimally clinically important difference for the SRS-22r. “At least one [minimally clinically important difference] was met in all of the SRS domains, as well as in the NDI,” Dr. Kim said. “There was no change in the ODI, as we would expect for this patient subset.”

Radiographic outcomes improved significantly, he continued, with an average 31-degree correction in maximum kyphosis and a 3.3-cm improvement in sagittal vertical axis. The overall rate of complications was 71%, with major complications comprising about 39% of these cases. Medical complications were high as well (a rate of 61%), as was the rate of surgical complications (43%). More than half of the patients (54%) required reoperation during the follow-up period, and the rate of pseudarthrosis was 29%.

“These results demonstrate improved outcomes following cervical to pelvic fusions, despite the magnitude of their operations and extent of fusion,” Dr. Kim concluded. “In addition, despite the high rate of complications and reoperations, we noted a significant improvement in radiographic and clinical outcomes.”

Dr. Kim disclosed that he is a consultant for Zimmer Biomet and K2M.

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SAN DIEGO – When necessary, long fusions that extend from the C-spine to the pelvis can result in health-related quality of life improvements, results from a multicenter study suggest.

“Patients with spinal deformities will sometimes require long fusion constructs that extend into the cervical spine,” lead study author Dr. Han-Jo Kim said at the annual meeting of the Cervical Spine Research Society. “The prevalence of these cases is increasing, especially as revision surgery for conditions such as proximal junctional kyphosis increase. They are also indicated for other diagnoses, such a progressive cervical deformity, cervical myelopathy as well as neuromuscular disorders.”

 

Dr. Han-Jo Kim

Prior investigations that have examined outcomes for these long constructs usually focus on patients who have had fusions from the upper thoracic spine to the pelvis, added Dr. Kim, an orthopedic spine surgeon at the Hospital for Special Surgery, New York. “To my knowledge, there are no studies in the literature that report on the subset of patients who have had fusions from the cervical spine to the pelvis,” he said. “The question is, even though these revisions may be necessary, does surgical intervention result in improved outcomes for these patients despite the extent of these long fusions?”

In an effort to determine the outcomes and rates of complications in patients who had fusions from the cervical spine to the pelvis, Dr. Kim and his associates conducted a retrospective review of patients who underwent fusions from the cervical spine to the pelvis at four institutions during 2003-2014. The researchers administered outcome scores utilizing the Scoliosis Research Society 22 (SRS-22r) questionnaire; the Oswestry Disability Index (ODI); and the Neck Disability Index (NDI); and collected demographic data including age, body mass index, and follow-up time; medical history including comorbidity data, operative details, radiographic and articular outcomes data; and postoperative complications.

Of 55 patients initially included in the study, complete data were available for 46 (84%). Their average age was 42 years, nearly one-third (30%) were classified as ASA III, 4.2% were smokers, and the average follow-up time was 2.7 years. “The majority of these cases were revision operations, and osteotomies were performed in close to 60% of these patients,” Dr. Kim said. “The average operating time was over 300 minutes, and there was an average of over 2 L of blood loss for these cases.”

The researchers observed improvements in the activity, pain, and mental health domains of the SRS, as well as an improvement in the SRS total score, which improved from an average of 3.0 preoperatively to 3.5 postoperatively (P less than .01). This was greater than the minimally clinically important difference for the SRS-22r. “At least one [minimally clinically important difference] was met in all of the SRS domains, as well as in the NDI,” Dr. Kim said. “There was no change in the ODI, as we would expect for this patient subset.”

Radiographic outcomes improved significantly, he continued, with an average 31-degree correction in maximum kyphosis and a 3.3-cm improvement in sagittal vertical axis. The overall rate of complications was 71%, with major complications comprising about 39% of these cases. Medical complications were high as well (a rate of 61%), as was the rate of surgical complications (43%). More than half of the patients (54%) required reoperation during the follow-up period, and the rate of pseudarthrosis was 29%.

“These results demonstrate improved outcomes following cervical to pelvic fusions, despite the magnitude of their operations and extent of fusion,” Dr. Kim concluded. “In addition, despite the high rate of complications and reoperations, we noted a significant improvement in radiographic and clinical outcomes.”

Dr. Kim disclosed that he is a consultant for Zimmer Biomet and K2M.

[email protected]

SAN DIEGO – When necessary, long fusions that extend from the C-spine to the pelvis can result in health-related quality of life improvements, results from a multicenter study suggest.

“Patients with spinal deformities will sometimes require long fusion constructs that extend into the cervical spine,” lead study author Dr. Han-Jo Kim said at the annual meeting of the Cervical Spine Research Society. “The prevalence of these cases is increasing, especially as revision surgery for conditions such as proximal junctional kyphosis increase. They are also indicated for other diagnoses, such a progressive cervical deformity, cervical myelopathy as well as neuromuscular disorders.”

 

Dr. Han-Jo Kim

Prior investigations that have examined outcomes for these long constructs usually focus on patients who have had fusions from the upper thoracic spine to the pelvis, added Dr. Kim, an orthopedic spine surgeon at the Hospital for Special Surgery, New York. “To my knowledge, there are no studies in the literature that report on the subset of patients who have had fusions from the cervical spine to the pelvis,” he said. “The question is, even though these revisions may be necessary, does surgical intervention result in improved outcomes for these patients despite the extent of these long fusions?”

In an effort to determine the outcomes and rates of complications in patients who had fusions from the cervical spine to the pelvis, Dr. Kim and his associates conducted a retrospective review of patients who underwent fusions from the cervical spine to the pelvis at four institutions during 2003-2014. The researchers administered outcome scores utilizing the Scoliosis Research Society 22 (SRS-22r) questionnaire; the Oswestry Disability Index (ODI); and the Neck Disability Index (NDI); and collected demographic data including age, body mass index, and follow-up time; medical history including comorbidity data, operative details, radiographic and articular outcomes data; and postoperative complications.

Of 55 patients initially included in the study, complete data were available for 46 (84%). Their average age was 42 years, nearly one-third (30%) were classified as ASA III, 4.2% were smokers, and the average follow-up time was 2.7 years. “The majority of these cases were revision operations, and osteotomies were performed in close to 60% of these patients,” Dr. Kim said. “The average operating time was over 300 minutes, and there was an average of over 2 L of blood loss for these cases.”

The researchers observed improvements in the activity, pain, and mental health domains of the SRS, as well as an improvement in the SRS total score, which improved from an average of 3.0 preoperatively to 3.5 postoperatively (P less than .01). This was greater than the minimally clinically important difference for the SRS-22r. “At least one [minimally clinically important difference] was met in all of the SRS domains, as well as in the NDI,” Dr. Kim said. “There was no change in the ODI, as we would expect for this patient subset.”

Radiographic outcomes improved significantly, he continued, with an average 31-degree correction in maximum kyphosis and a 3.3-cm improvement in sagittal vertical axis. The overall rate of complications was 71%, with major complications comprising about 39% of these cases. Medical complications were high as well (a rate of 61%), as was the rate of surgical complications (43%). More than half of the patients (54%) required reoperation during the follow-up period, and the rate of pseudarthrosis was 29%.

“These results demonstrate improved outcomes following cervical to pelvic fusions, despite the magnitude of their operations and extent of fusion,” Dr. Kim concluded. “In addition, despite the high rate of complications and reoperations, we noted a significant improvement in radiographic and clinical outcomes.”

Dr. Kim disclosed that he is a consultant for Zimmer Biomet and K2M.

[email protected]

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Key clinical point: Following cervical to pelvic fusions, patients can achieve improved clinical and quality of life outcomes.

Major finding: The Scoliosis Research Society total score improved from an average of 3.0 preoperatively to 3.5 postoperatively (P less than .01).

Data source: A retrospective review of 55 patients who underwent fusions from the cervical spine to the pelvis at four institutions during 2003-2014.

Disclosures: Dr. Kim disclosed that he is a consultant for Zimmer Biomet and K2M.

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Resident Guide to Advocacy in Dermatology

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Resident Guide to Advocacy in Dermatology

It is never too early (or too late!) to get involved in dermatology advocacy. Residency is an ideal time to start learning about advocating on behalf of the specialty of dermatology as well as on behalf of our patients. Many opportunities are available for residents to gain experience and become advocates on national and grassroots levels. As residents, participating in these efforts can help set a solid foundation for future involvement in advocacy, regardless of our ultimate career goals.

American Medical Association

The mission of the American Medical Association (AMA) is “to promote the art and science of medicine and the betterment of public health.”1 Joining the AMA costs $45 for 1 year of resident membership (with a discounted rate for multiyear memberships). As a member, you are given the opportunity to cast a ballot for the national medical specialty society that best represents you in the House of Delegates, the AMA’s principle policy-making body.2 The more votes a particular society receives, the more delegates from that society are added to the House of Delegates, meaning more representation for that specialty organization. It is advised that members choose the society that best represents them: for dermatologists, this most likely would be the American Academy of Dermatology (AAD), among other dermatology organizations that are candidates (ie, the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the Society for Investigative Dermatology). This representation is key for a specialty like dermatology, which has a relatively smaller number of physicians compared to other larger specialties and therefore has less representation in the House of Delegates.

Additionally, AMA membership grants you access to the entire Journal of the American Medical Association network including a subscription to the specialty journal of your choice.

Patient Advocacy

Patient advocacy groups generally have 3 main goals: education (for patients, patient support networks, and the layperson), research, and lobbying for issues that are in the interest of patients and treatment of dermatologic conditions (eg, funding support, regulation of medical devices, etc).3 In dermatology, the number of patient advocacy groups is growing to represent a myriad of dermatologic conditions, from common conditions like psoriasis to rare genodermatoses (Table). As dermatologists in training, it is key for residents to be involved in patient advocacy and to be aware of the resources that exist for patients to access educational information and support for their respective conditions. These educational materials can help provide more comprehensive care for patients and give patients more autonomy in choosing a physician or hospital to manage their care, help patients become more knowledgeable about available treatment options, and arm patients with more information to address questions that may arise from laypeople regarding their condition.

In terms of patient education, the resources available to patients include informational websites, access to educational materials like pamphlets and multimedia (eg, videos), and special events; for example, the National Psoriasis Foundation hosts walks for patients and their friends and family to raise money for the organization as well as to promote psoriasis awareness and give patients an opportunity to build a support network. Patient advocacy groups also help raise funding for research and have shown to be influential in research initiatives that are granted funding.3 Often, these groups also play a political role and take part in lobbying efforts by patients and support groups by working with politicians to raise awareness or request financial support for particular skin diseases.

The Society for Investigative Dermatology sponsors an application for mobile devices that can assist residents in referring patients to support and advocacy groups (http://www.skinadvocateapp.com).

 

 

Grassroots Advocacy

Grassroots advocacy in dermatology means that an individual or group of individuals (in this case, a resident or group of residents) is motivated to take action by contacting legislators and other government officials about gaps in funding and regulation for particular dermatology issues. These efforts often are noticed and taken into consideration by politicians because it is in their best interest to listen to their constituents rather than risk losing support.

The American Academy of Dermatology Association, the advocacy entity of the AAD, hosts the Dermatology Advocacy Network (www.aad-dan.com/default.aspx), which is dedicated to helping dermatologists become advocates. The DAN website helps residents easily identify and contact their local, state,  and national legislators to discuss issues or concerns related to the dermatology specialty and medicine as a whole. For example, tanning bed regulation currently is a priority among dermatologists, and the DAN website provides customizable form letters that can be sent electronically to legislators for review.

Furthermore, the AAD offers helpful resources and suggestions for dermatologists and dermatology residents who want to get involved with grassroots advocacy efforts. The website (www.aad.org/advocacy) details current AAD advocacy priorities as well as specific topics such as Medicare physician payment, skin cancer and indoor tanning, drug pricing and availability, state policy, and network adequacy, as these are high-priority issues identified by the AAD that would benefit from action by its members.

Final Thoughts

Many opportunities exist for dermatology residents to get involved in advocacy, from opportunities on the national level with the AMA to patient advocacy and grassroots efforts. It is important for dermatology residents to get involved in advocacy efforts during their training so they may continue to be involved in these efforts as their careers develop. Advocacy helps keep the dermatology specialty relevant and maintain its voice in the national medical arena. It also enhances the dermatology resident’s ability to provide comprehensive quality care for patients by addressing some of their educational and supportive needs that perhaps cannot be addressed in a clinic visit alone. Advocacy also gives residents the opportunity to network and meet colleagues and other individuals with similar goals and interests, which may be beneficial for their future careers. Thus, early involvement in advocacy may be a productive and interesting part of dermatology residency for trainees to be further involved in the specialty.

References
  1. AMA mission & guiding principles. American Medical Association Web site. http://www.ama-assn.org/ama/pub/about-ama.page?. Accessed December 22, 2015.
  2. Specialty Society Representation Ballot. American Medical Association Web site. http://www.ama-assn.org/ama/pub/about-ama/our-people/the-federation-medicine/specialty-society-ballot.page. Accessed December 22, 2015.
  3. Nijsten T, Bergstresser PR. Patient advocacy groups: let’s stick together. J Invest Dermatol. 2010;130:1757-1759.
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Correspondence: Kelly K. Park, MD, MSL, Loyola University Medical Center, 2160 S First Ave, Bldg 54, Room 101, Maywood, IL 60153 
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Related Articles

It is never too early (or too late!) to get involved in dermatology advocacy. Residency is an ideal time to start learning about advocating on behalf of the specialty of dermatology as well as on behalf of our patients. Many opportunities are available for residents to gain experience and become advocates on national and grassroots levels. As residents, participating in these efforts can help set a solid foundation for future involvement in advocacy, regardless of our ultimate career goals.

American Medical Association

The mission of the American Medical Association (AMA) is “to promote the art and science of medicine and the betterment of public health.”1 Joining the AMA costs $45 for 1 year of resident membership (with a discounted rate for multiyear memberships). As a member, you are given the opportunity to cast a ballot for the national medical specialty society that best represents you in the House of Delegates, the AMA’s principle policy-making body.2 The more votes a particular society receives, the more delegates from that society are added to the House of Delegates, meaning more representation for that specialty organization. It is advised that members choose the society that best represents them: for dermatologists, this most likely would be the American Academy of Dermatology (AAD), among other dermatology organizations that are candidates (ie, the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the Society for Investigative Dermatology). This representation is key for a specialty like dermatology, which has a relatively smaller number of physicians compared to other larger specialties and therefore has less representation in the House of Delegates.

Additionally, AMA membership grants you access to the entire Journal of the American Medical Association network including a subscription to the specialty journal of your choice.

Patient Advocacy

Patient advocacy groups generally have 3 main goals: education (for patients, patient support networks, and the layperson), research, and lobbying for issues that are in the interest of patients and treatment of dermatologic conditions (eg, funding support, regulation of medical devices, etc).3 In dermatology, the number of patient advocacy groups is growing to represent a myriad of dermatologic conditions, from common conditions like psoriasis to rare genodermatoses (Table). As dermatologists in training, it is key for residents to be involved in patient advocacy and to be aware of the resources that exist for patients to access educational information and support for their respective conditions. These educational materials can help provide more comprehensive care for patients and give patients more autonomy in choosing a physician or hospital to manage their care, help patients become more knowledgeable about available treatment options, and arm patients with more information to address questions that may arise from laypeople regarding their condition.

In terms of patient education, the resources available to patients include informational websites, access to educational materials like pamphlets and multimedia (eg, videos), and special events; for example, the National Psoriasis Foundation hosts walks for patients and their friends and family to raise money for the organization as well as to promote psoriasis awareness and give patients an opportunity to build a support network. Patient advocacy groups also help raise funding for research and have shown to be influential in research initiatives that are granted funding.3 Often, these groups also play a political role and take part in lobbying efforts by patients and support groups by working with politicians to raise awareness or request financial support for particular skin diseases.

The Society for Investigative Dermatology sponsors an application for mobile devices that can assist residents in referring patients to support and advocacy groups (http://www.skinadvocateapp.com).

 

 

Grassroots Advocacy

Grassroots advocacy in dermatology means that an individual or group of individuals (in this case, a resident or group of residents) is motivated to take action by contacting legislators and other government officials about gaps in funding and regulation for particular dermatology issues. These efforts often are noticed and taken into consideration by politicians because it is in their best interest to listen to their constituents rather than risk losing support.

The American Academy of Dermatology Association, the advocacy entity of the AAD, hosts the Dermatology Advocacy Network (www.aad-dan.com/default.aspx), which is dedicated to helping dermatologists become advocates. The DAN website helps residents easily identify and contact their local, state,  and national legislators to discuss issues or concerns related to the dermatology specialty and medicine as a whole. For example, tanning bed regulation currently is a priority among dermatologists, and the DAN website provides customizable form letters that can be sent electronically to legislators for review.

Furthermore, the AAD offers helpful resources and suggestions for dermatologists and dermatology residents who want to get involved with grassroots advocacy efforts. The website (www.aad.org/advocacy) details current AAD advocacy priorities as well as specific topics such as Medicare physician payment, skin cancer and indoor tanning, drug pricing and availability, state policy, and network adequacy, as these are high-priority issues identified by the AAD that would benefit from action by its members.

Final Thoughts

Many opportunities exist for dermatology residents to get involved in advocacy, from opportunities on the national level with the AMA to patient advocacy and grassroots efforts. It is important for dermatology residents to get involved in advocacy efforts during their training so they may continue to be involved in these efforts as their careers develop. Advocacy helps keep the dermatology specialty relevant and maintain its voice in the national medical arena. It also enhances the dermatology resident’s ability to provide comprehensive quality care for patients by addressing some of their educational and supportive needs that perhaps cannot be addressed in a clinic visit alone. Advocacy also gives residents the opportunity to network and meet colleagues and other individuals with similar goals and interests, which may be beneficial for their future careers. Thus, early involvement in advocacy may be a productive and interesting part of dermatology residency for trainees to be further involved in the specialty.

It is never too early (or too late!) to get involved in dermatology advocacy. Residency is an ideal time to start learning about advocating on behalf of the specialty of dermatology as well as on behalf of our patients. Many opportunities are available for residents to gain experience and become advocates on national and grassroots levels. As residents, participating in these efforts can help set a solid foundation for future involvement in advocacy, regardless of our ultimate career goals.

American Medical Association

The mission of the American Medical Association (AMA) is “to promote the art and science of medicine and the betterment of public health.”1 Joining the AMA costs $45 for 1 year of resident membership (with a discounted rate for multiyear memberships). As a member, you are given the opportunity to cast a ballot for the national medical specialty society that best represents you in the House of Delegates, the AMA’s principle policy-making body.2 The more votes a particular society receives, the more delegates from that society are added to the House of Delegates, meaning more representation for that specialty organization. It is advised that members choose the society that best represents them: for dermatologists, this most likely would be the American Academy of Dermatology (AAD), among other dermatology organizations that are candidates (ie, the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the Society for Investigative Dermatology). This representation is key for a specialty like dermatology, which has a relatively smaller number of physicians compared to other larger specialties and therefore has less representation in the House of Delegates.

Additionally, AMA membership grants you access to the entire Journal of the American Medical Association network including a subscription to the specialty journal of your choice.

Patient Advocacy

Patient advocacy groups generally have 3 main goals: education (for patients, patient support networks, and the layperson), research, and lobbying for issues that are in the interest of patients and treatment of dermatologic conditions (eg, funding support, regulation of medical devices, etc).3 In dermatology, the number of patient advocacy groups is growing to represent a myriad of dermatologic conditions, from common conditions like psoriasis to rare genodermatoses (Table). As dermatologists in training, it is key for residents to be involved in patient advocacy and to be aware of the resources that exist for patients to access educational information and support for their respective conditions. These educational materials can help provide more comprehensive care for patients and give patients more autonomy in choosing a physician or hospital to manage their care, help patients become more knowledgeable about available treatment options, and arm patients with more information to address questions that may arise from laypeople regarding their condition.

In terms of patient education, the resources available to patients include informational websites, access to educational materials like pamphlets and multimedia (eg, videos), and special events; for example, the National Psoriasis Foundation hosts walks for patients and their friends and family to raise money for the organization as well as to promote psoriasis awareness and give patients an opportunity to build a support network. Patient advocacy groups also help raise funding for research and have shown to be influential in research initiatives that are granted funding.3 Often, these groups also play a political role and take part in lobbying efforts by patients and support groups by working with politicians to raise awareness or request financial support for particular skin diseases.

The Society for Investigative Dermatology sponsors an application for mobile devices that can assist residents in referring patients to support and advocacy groups (http://www.skinadvocateapp.com).

 

 

Grassroots Advocacy

Grassroots advocacy in dermatology means that an individual or group of individuals (in this case, a resident or group of residents) is motivated to take action by contacting legislators and other government officials about gaps in funding and regulation for particular dermatology issues. These efforts often are noticed and taken into consideration by politicians because it is in their best interest to listen to their constituents rather than risk losing support.

The American Academy of Dermatology Association, the advocacy entity of the AAD, hosts the Dermatology Advocacy Network (www.aad-dan.com/default.aspx), which is dedicated to helping dermatologists become advocates. The DAN website helps residents easily identify and contact their local, state,  and national legislators to discuss issues or concerns related to the dermatology specialty and medicine as a whole. For example, tanning bed regulation currently is a priority among dermatologists, and the DAN website provides customizable form letters that can be sent electronically to legislators for review.

Furthermore, the AAD offers helpful resources and suggestions for dermatologists and dermatology residents who want to get involved with grassroots advocacy efforts. The website (www.aad.org/advocacy) details current AAD advocacy priorities as well as specific topics such as Medicare physician payment, skin cancer and indoor tanning, drug pricing and availability, state policy, and network adequacy, as these are high-priority issues identified by the AAD that would benefit from action by its members.

Final Thoughts

Many opportunities exist for dermatology residents to get involved in advocacy, from opportunities on the national level with the AMA to patient advocacy and grassroots efforts. It is important for dermatology residents to get involved in advocacy efforts during their training so they may continue to be involved in these efforts as their careers develop. Advocacy helps keep the dermatology specialty relevant and maintain its voice in the national medical arena. It also enhances the dermatology resident’s ability to provide comprehensive quality care for patients by addressing some of their educational and supportive needs that perhaps cannot be addressed in a clinic visit alone. Advocacy also gives residents the opportunity to network and meet colleagues and other individuals with similar goals and interests, which may be beneficial for their future careers. Thus, early involvement in advocacy may be a productive and interesting part of dermatology residency for trainees to be further involved in the specialty.

References
  1. AMA mission & guiding principles. American Medical Association Web site. http://www.ama-assn.org/ama/pub/about-ama.page?. Accessed December 22, 2015.
  2. Specialty Society Representation Ballot. American Medical Association Web site. http://www.ama-assn.org/ama/pub/about-ama/our-people/the-federation-medicine/specialty-society-ballot.page. Accessed December 22, 2015.
  3. Nijsten T, Bergstresser PR. Patient advocacy groups: let’s stick together. J Invest Dermatol. 2010;130:1757-1759.
References
  1. AMA mission & guiding principles. American Medical Association Web site. http://www.ama-assn.org/ama/pub/about-ama.page?. Accessed December 22, 2015.
  2. Specialty Society Representation Ballot. American Medical Association Web site. http://www.ama-assn.org/ama/pub/about-ama/our-people/the-federation-medicine/specialty-society-ballot.page. Accessed December 22, 2015.
  3. Nijsten T, Bergstresser PR. Patient advocacy groups: let’s stick together. J Invest Dermatol. 2010;130:1757-1759.
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Move to Allow Patients to Request 'Refund' Appealing and Risky

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We’ve all seen hundreds of commercials from companies advertising products and services with a money-back guarantee. The Men’s Warehouse, for example, has been promising men across the globe for over a decade, “You’re going to like the way you look. I guarantee it!” But to date, no one has made such a “guarantee” in the healthcare industry. Buying a suit is not exactly like getting your gallbladder removed.

Image Credit: Shutterstock.com

We know that medical diagnoses and treatments are filled with uncertainty in expected processes and outcomes, because the factors that are dependent on these processes and outcomes are endless. These include patient factors (overall health, functional status, comorbid conditions), procedural factors (emergency versus elective, time of day or night), and facility factors (having the optimal team with skills that match the patient need, having all the right products and equipment). Although we know that many medical procedures have a relatively predictable risk of complications, unpredictable complications still occur, so how can we ever offer a guarantee for the interventions we perform on patients?

First of Its Kind

David Feinberg, MD, MBA, president and CEO of Geisinger Health System, is doing just that. This healthcare system has developed an application, called the Geisinger ProvenExperience, which can be downloaded onto a smartphone. After a procedure, each patient is given a code for the condition that was treated. With that code, the patient can enter feedback on the services provided and can then request a refund if they are not fully satisfied.

Most remarkably, the request for a refund is based on the judgment of the recipient, not on that of the provider(s). At a recent public meeting, Dr. Feinberg said of the new program: “We’re going to do everything right. That’s our job, that’s our promise to you … and you’re the judge. If you don’t think so, we’re going to apologize, we’re going to try to fix it for the next guy, and, as a small token of appreciation, we’re going to give you some money back.”1

Although many are skeptical about whether or not the program will be successful, much less viable, Dr. Feinberg contends that early feedback on the program has shown that most patients don’t actually want their money back. Instead, if their needs have not been met, most have just wanted a sincere apology and a commitment to make things better for others. Dr. Feinberg also contests that even if this is not the best or only approach to improving healthcare (quickly), we should all feel compelled to do something about our repeated failures in meeting patient expectations in the quality and/or experience of their care; and because no other industry works this way, other than healthcare. Typically, when consumers get fed up with poor service in other industries, disruptive innovations (Uber, for example) are created to satisfy customers’ desires.

A New Paradigm?

In healthcare, patients certainly should be dissatisfied if they experience a preventable harm event. Some types of harm are considered “always preventable,” such as wrong-site surgery. These events are extremely rare and, thus, do not constitute most cases of harm in hospitals these days. Such “never events” are relatively well defined and have been adopted for nonpayment by Medicare and other insurers, which can serve to buffer a patient’s financial liability in the small number of these cases. For other, more common, types of preventable harm, some hospitals have instituted apology and disclosure policies, and some will also relieve the patient of the portion of the bill attributable to the preventable harm. But not all hospitals have adopted such policies, despite the fact that they are widely endorsed by influential agencies, including The Joint Commission, the American Medical Association, Leapfrog Group, the National Quality Forum, and the Agency for Healthcare Research and Quality.

 

 

And, even for hospitals that have adopted such “best practice” policies, there is not always clear consensus on what constitutes preventable harm. Generally, the “judgment call” about what constitutes preventable harm is made by healthcare systems and providers—not patients. In addition, many cases of harm that are not necessarily preventable can often result in great dissatisfaction for the patient. There are countless stories of patients who are unfortunately harmed in the course of medical procedures, but who were informed of the possible risks of the procedure and consented to have the procedure performed despite the risks. These situations, which are agonizingly difficult for the system, the providers, and the patients, have no good solutions. Systems cannot “own” all harm, such as those resulting from the disease process itself or from risky and invasive procedures intended to benefit the patient. And there is ongoing inconsistency in healthcare systems when it comes to their willingness and ability to consistently define preventable harm or to disclose, apologize, and forgive payments in such cases.

So, while this move to allow patients to ask for a “refund” seems both extremely appealing and extremely risky, it certainly seems as though it will greatly enhance the trust of patients and their families in the Geisinger Health System.

I, among others, will eagerly follow the results of this program; while getting a cholecystectomy is not the same as buying a men’s suit, I do hope that someday, I will be able to say to every patient entering my healthcare system that before they leave, “You’re going to like the way you feel. I guarantee it!” TH


Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at [email protected].

 

References

1. Guydish M. Geisinger CEO: money-back guarantee for health care coming. November 6, 2015. Times Leader website. Available at: http://timesleader.com/news/492790/geisinger-ceo-money-back-guarantee-for-health-car-coming. Accessed December 5, 2015.

2. Luthra S. When something goes wrong at the hospital, who pays? November 11, 2015. Kaiser Health News. Available at: http://khn.org/news/when-something-goes-wrong-at-the-hospital-who-pays/?utm_source=Managed&utm_campaign=9e17712a95-Quality+%26+Patient+Safety+Update&utm_medium=email&utm_term=0_ebe1fa6178-9e17712a95-319388717. Accessed December 5, 2015.

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We’ve all seen hundreds of commercials from companies advertising products and services with a money-back guarantee. The Men’s Warehouse, for example, has been promising men across the globe for over a decade, “You’re going to like the way you look. I guarantee it!” But to date, no one has made such a “guarantee” in the healthcare industry. Buying a suit is not exactly like getting your gallbladder removed.

Image Credit: Shutterstock.com

We know that medical diagnoses and treatments are filled with uncertainty in expected processes and outcomes, because the factors that are dependent on these processes and outcomes are endless. These include patient factors (overall health, functional status, comorbid conditions), procedural factors (emergency versus elective, time of day or night), and facility factors (having the optimal team with skills that match the patient need, having all the right products and equipment). Although we know that many medical procedures have a relatively predictable risk of complications, unpredictable complications still occur, so how can we ever offer a guarantee for the interventions we perform on patients?

First of Its Kind

David Feinberg, MD, MBA, president and CEO of Geisinger Health System, is doing just that. This healthcare system has developed an application, called the Geisinger ProvenExperience, which can be downloaded onto a smartphone. After a procedure, each patient is given a code for the condition that was treated. With that code, the patient can enter feedback on the services provided and can then request a refund if they are not fully satisfied.

Most remarkably, the request for a refund is based on the judgment of the recipient, not on that of the provider(s). At a recent public meeting, Dr. Feinberg said of the new program: “We’re going to do everything right. That’s our job, that’s our promise to you … and you’re the judge. If you don’t think so, we’re going to apologize, we’re going to try to fix it for the next guy, and, as a small token of appreciation, we’re going to give you some money back.”1

Although many are skeptical about whether or not the program will be successful, much less viable, Dr. Feinberg contends that early feedback on the program has shown that most patients don’t actually want their money back. Instead, if their needs have not been met, most have just wanted a sincere apology and a commitment to make things better for others. Dr. Feinberg also contests that even if this is not the best or only approach to improving healthcare (quickly), we should all feel compelled to do something about our repeated failures in meeting patient expectations in the quality and/or experience of their care; and because no other industry works this way, other than healthcare. Typically, when consumers get fed up with poor service in other industries, disruptive innovations (Uber, for example) are created to satisfy customers’ desires.

A New Paradigm?

In healthcare, patients certainly should be dissatisfied if they experience a preventable harm event. Some types of harm are considered “always preventable,” such as wrong-site surgery. These events are extremely rare and, thus, do not constitute most cases of harm in hospitals these days. Such “never events” are relatively well defined and have been adopted for nonpayment by Medicare and other insurers, which can serve to buffer a patient’s financial liability in the small number of these cases. For other, more common, types of preventable harm, some hospitals have instituted apology and disclosure policies, and some will also relieve the patient of the portion of the bill attributable to the preventable harm. But not all hospitals have adopted such policies, despite the fact that they are widely endorsed by influential agencies, including The Joint Commission, the American Medical Association, Leapfrog Group, the National Quality Forum, and the Agency for Healthcare Research and Quality.

 

 

And, even for hospitals that have adopted such “best practice” policies, there is not always clear consensus on what constitutes preventable harm. Generally, the “judgment call” about what constitutes preventable harm is made by healthcare systems and providers—not patients. In addition, many cases of harm that are not necessarily preventable can often result in great dissatisfaction for the patient. There are countless stories of patients who are unfortunately harmed in the course of medical procedures, but who were informed of the possible risks of the procedure and consented to have the procedure performed despite the risks. These situations, which are agonizingly difficult for the system, the providers, and the patients, have no good solutions. Systems cannot “own” all harm, such as those resulting from the disease process itself or from risky and invasive procedures intended to benefit the patient. And there is ongoing inconsistency in healthcare systems when it comes to their willingness and ability to consistently define preventable harm or to disclose, apologize, and forgive payments in such cases.

So, while this move to allow patients to ask for a “refund” seems both extremely appealing and extremely risky, it certainly seems as though it will greatly enhance the trust of patients and their families in the Geisinger Health System.

I, among others, will eagerly follow the results of this program; while getting a cholecystectomy is not the same as buying a men’s suit, I do hope that someday, I will be able to say to every patient entering my healthcare system that before they leave, “You’re going to like the way you feel. I guarantee it!” TH


Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at [email protected].

 

References

1. Guydish M. Geisinger CEO: money-back guarantee for health care coming. November 6, 2015. Times Leader website. Available at: http://timesleader.com/news/492790/geisinger-ceo-money-back-guarantee-for-health-car-coming. Accessed December 5, 2015.

2. Luthra S. When something goes wrong at the hospital, who pays? November 11, 2015. Kaiser Health News. Available at: http://khn.org/news/when-something-goes-wrong-at-the-hospital-who-pays/?utm_source=Managed&utm_campaign=9e17712a95-Quality+%26+Patient+Safety+Update&utm_medium=email&utm_term=0_ebe1fa6178-9e17712a95-319388717. Accessed December 5, 2015.

We’ve all seen hundreds of commercials from companies advertising products and services with a money-back guarantee. The Men’s Warehouse, for example, has been promising men across the globe for over a decade, “You’re going to like the way you look. I guarantee it!” But to date, no one has made such a “guarantee” in the healthcare industry. Buying a suit is not exactly like getting your gallbladder removed.

Image Credit: Shutterstock.com

We know that medical diagnoses and treatments are filled with uncertainty in expected processes and outcomes, because the factors that are dependent on these processes and outcomes are endless. These include patient factors (overall health, functional status, comorbid conditions), procedural factors (emergency versus elective, time of day or night), and facility factors (having the optimal team with skills that match the patient need, having all the right products and equipment). Although we know that many medical procedures have a relatively predictable risk of complications, unpredictable complications still occur, so how can we ever offer a guarantee for the interventions we perform on patients?

First of Its Kind

David Feinberg, MD, MBA, president and CEO of Geisinger Health System, is doing just that. This healthcare system has developed an application, called the Geisinger ProvenExperience, which can be downloaded onto a smartphone. After a procedure, each patient is given a code for the condition that was treated. With that code, the patient can enter feedback on the services provided and can then request a refund if they are not fully satisfied.

Most remarkably, the request for a refund is based on the judgment of the recipient, not on that of the provider(s). At a recent public meeting, Dr. Feinberg said of the new program: “We’re going to do everything right. That’s our job, that’s our promise to you … and you’re the judge. If you don’t think so, we’re going to apologize, we’re going to try to fix it for the next guy, and, as a small token of appreciation, we’re going to give you some money back.”1

Although many are skeptical about whether or not the program will be successful, much less viable, Dr. Feinberg contends that early feedback on the program has shown that most patients don’t actually want their money back. Instead, if their needs have not been met, most have just wanted a sincere apology and a commitment to make things better for others. Dr. Feinberg also contests that even if this is not the best or only approach to improving healthcare (quickly), we should all feel compelled to do something about our repeated failures in meeting patient expectations in the quality and/or experience of their care; and because no other industry works this way, other than healthcare. Typically, when consumers get fed up with poor service in other industries, disruptive innovations (Uber, for example) are created to satisfy customers’ desires.

A New Paradigm?

In healthcare, patients certainly should be dissatisfied if they experience a preventable harm event. Some types of harm are considered “always preventable,” such as wrong-site surgery. These events are extremely rare and, thus, do not constitute most cases of harm in hospitals these days. Such “never events” are relatively well defined and have been adopted for nonpayment by Medicare and other insurers, which can serve to buffer a patient’s financial liability in the small number of these cases. For other, more common, types of preventable harm, some hospitals have instituted apology and disclosure policies, and some will also relieve the patient of the portion of the bill attributable to the preventable harm. But not all hospitals have adopted such policies, despite the fact that they are widely endorsed by influential agencies, including The Joint Commission, the American Medical Association, Leapfrog Group, the National Quality Forum, and the Agency for Healthcare Research and Quality.

 

 

And, even for hospitals that have adopted such “best practice” policies, there is not always clear consensus on what constitutes preventable harm. Generally, the “judgment call” about what constitutes preventable harm is made by healthcare systems and providers—not patients. In addition, many cases of harm that are not necessarily preventable can often result in great dissatisfaction for the patient. There are countless stories of patients who are unfortunately harmed in the course of medical procedures, but who were informed of the possible risks of the procedure and consented to have the procedure performed despite the risks. These situations, which are agonizingly difficult for the system, the providers, and the patients, have no good solutions. Systems cannot “own” all harm, such as those resulting from the disease process itself or from risky and invasive procedures intended to benefit the patient. And there is ongoing inconsistency in healthcare systems when it comes to their willingness and ability to consistently define preventable harm or to disclose, apologize, and forgive payments in such cases.

So, while this move to allow patients to ask for a “refund” seems both extremely appealing and extremely risky, it certainly seems as though it will greatly enhance the trust of patients and their families in the Geisinger Health System.

I, among others, will eagerly follow the results of this program; while getting a cholecystectomy is not the same as buying a men’s suit, I do hope that someday, I will be able to say to every patient entering my healthcare system that before they leave, “You’re going to like the way you feel. I guarantee it!” TH


Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at [email protected].

 

References

1. Guydish M. Geisinger CEO: money-back guarantee for health care coming. November 6, 2015. Times Leader website. Available at: http://timesleader.com/news/492790/geisinger-ceo-money-back-guarantee-for-health-car-coming. Accessed December 5, 2015.

2. Luthra S. When something goes wrong at the hospital, who pays? November 11, 2015. Kaiser Health News. Available at: http://khn.org/news/when-something-goes-wrong-at-the-hospital-who-pays/?utm_source=Managed&utm_campaign=9e17712a95-Quality+%26+Patient+Safety+Update&utm_medium=email&utm_term=0_ebe1fa6178-9e17712a95-319388717. Accessed December 5, 2015.

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Hospitalist Jaime Upegui, MD, Links Passion for Work to Love of Motorcycle Travel, Sports, Dance

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Hospitalist Jaime Upegui, MD, division president at Apogee Physicians in Coeur d’Alene, Idaho, knows exactly what he wants to do when he retires years from now: sell everything he owns and ride his motorcycle around the world.

So far, the 39-year-old physician leader has driven across the U.S. at least five times, including a 24-day, 11,700-mile trip during which he visited every state that bordered Canada, Mexico, the Gulf of Mexico, and the Pacific and Atlantic oceans. In spite of snow, ice, rain, wind, and searing 126-degree Farenheit heat, nothing stopped him.

Dr. Upegui is a modern-day explorer who enjoys making the journey as much as getting to the destination. Riding is his personal form of yoga, a meditative experience that demands he stay in the moment and allows him to escape life’s daily frustrations. Ever since he started riding motorcycles at age five, he’s been hooked and has no plans of shifting into neutral.

Driven by Change

Every day at work, Dr. Upegui, an internal medicine specialist, helps hospitalists thrive in a changing medical world where they’re constantly being pushed and pulled in multiple directions. “It’s an exciting career that’s full of unexpected changes,” he says. “I work hard every day on building great teams that produce stellar results.”

He brings that same level of enthusiasm to his after-work activities, which include skydiving, tango dancing, scuba diving, snowboarding, and rock climbing. His passion for change and adventure stems from his childhood.

Listen to more of our interview with Dr. Upegui.

Dr. Upegui was born in Colombia and raised predominantly in the cities of Cali and Medellín. His mother, Rocio, was a painter and ballet dancer; his father, Jaime Sr., was a poet and musician. He spent most of his childhood with his mother, who moved frequently in search of new inspirations. During his childhood, he attended 13 different schools and lived in more than 30 different homes in the U.S., Colombia, and Spain. In 2003, he finished medical school, graduating from Universidad Pontificia Bolivariana in Medellín. He worked as an attending physician in the emergency department there for three years before moving to New York City to complete his residency in internal medicine at St. Luke’s–Roosevelt Hospital Center.

Throughout medical school and his residency, Dr. Upegui’s personal interests extended beyond motorcycling to skydiving and tango dancing, a skill he initially learned to love from his father. Dr. Upegui says he enjoys nothing more than learning, so he’s attracted to activities that require a high degree of training or technical expertise.

“I like to do things that make me feel like I’m proficient at something that’s difficult,” he says.

He vividly remembers the first time he jumped out of a plane, in 2002.

“It was thrilling, it was exciting, it was ego-boosting, it was self-gratifying, it was an adrenaline rush,” Dr. Upegui explains, adding that he taught English to the owner of the skydiving center in Colombia in exchange for free jumps. “The most exciting part is the decision to take the leap. That critical moment still gives me butterflies.”

Over the next six years, he jumped approximately 150 times, then stopped for roughly seven years to handle the demands of school and work, and to avoid the actual cost of skydiving, which is pricey at roughly a few hundred dollars per jump. But, over the years, he missed it, so he resumed skydiving earlier this year.

In between, he learned to tango through private and group lessons. Last year, he traveled to Buenos Aires, Argentina, for an intensive weeklong course and an international tango gathering. He also travels to “milongas,” get-togethers for professional and student tango dancers that are held in various cities worldwide.

 

 

“Tango has two core elements: showing your intention to move forward and allowing your partner to accept the invitation to follow your lead,” he says. “It’s a beautiful combination of assertiveness, determination, and then negotiation, followed by permission to proceed, depending upon how the conversation is going during the dance.”

No Regrets

Procrastination is not a familiar word to Dr. Upegui.

“The time frame between something that I want to do and [actually] doing it is very short,” he says. “If I want to do something, I just look at how I can get to it as soon as it’s available.”

Motorcycling ranks as his number one passion. Last year, he completed a 7,000-mile trip without taking any time off from his current job, which requires him to lead, manage, and often meet with hospitalist teams nationwide. He traveled via back roads on weekends to a major city, left his bike at the airport, and then hopped on a plane to wherever he needed to be for work. Instead of flying home for the weekend, he’d return to the airport to pick up his bike and travel to the next city he wanted to visit, which could be 1,000 miles away.

“The cool thing about the road is that random people help you,” he says. “The hotels would keep my clothes and luggage, and airport parking employees would help me park my motorcycle in a safe place and keep my helmet in their office.”

Dr. Upegui says childhood experiences that focused on momentum and movement laid the foundation for his mobile and adventuresome lifestyle. Movement, variability, and change have become the guiding factors in his life. Perhaps that’s why he chose to be a hospitalist. Among the youngest fields in medicine, the specialty is always growing, changing, and evolving.

“If you take any change in life as just a new stage of a new moment and you just perform your best in this current situation, then that will allow you to always be flexible to what’s happening in front of you,” Dr. Upegui says. “I love my work, family, Apogee, and the opportunities I have had. I could die completely satisfied today, knowing that I’ve done the best I could and searched for happiness every day.”


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Hospitalist Jaime Upegui, MD, division president at Apogee Physicians in Coeur d’Alene, Idaho, knows exactly what he wants to do when he retires years from now: sell everything he owns and ride his motorcycle around the world.

So far, the 39-year-old physician leader has driven across the U.S. at least five times, including a 24-day, 11,700-mile trip during which he visited every state that bordered Canada, Mexico, the Gulf of Mexico, and the Pacific and Atlantic oceans. In spite of snow, ice, rain, wind, and searing 126-degree Farenheit heat, nothing stopped him.

Dr. Upegui is a modern-day explorer who enjoys making the journey as much as getting to the destination. Riding is his personal form of yoga, a meditative experience that demands he stay in the moment and allows him to escape life’s daily frustrations. Ever since he started riding motorcycles at age five, he’s been hooked and has no plans of shifting into neutral.

Driven by Change

Every day at work, Dr. Upegui, an internal medicine specialist, helps hospitalists thrive in a changing medical world where they’re constantly being pushed and pulled in multiple directions. “It’s an exciting career that’s full of unexpected changes,” he says. “I work hard every day on building great teams that produce stellar results.”

He brings that same level of enthusiasm to his after-work activities, which include skydiving, tango dancing, scuba diving, snowboarding, and rock climbing. His passion for change and adventure stems from his childhood.

Listen to more of our interview with Dr. Upegui.

Dr. Upegui was born in Colombia and raised predominantly in the cities of Cali and Medellín. His mother, Rocio, was a painter and ballet dancer; his father, Jaime Sr., was a poet and musician. He spent most of his childhood with his mother, who moved frequently in search of new inspirations. During his childhood, he attended 13 different schools and lived in more than 30 different homes in the U.S., Colombia, and Spain. In 2003, he finished medical school, graduating from Universidad Pontificia Bolivariana in Medellín. He worked as an attending physician in the emergency department there for three years before moving to New York City to complete his residency in internal medicine at St. Luke’s–Roosevelt Hospital Center.

Throughout medical school and his residency, Dr. Upegui’s personal interests extended beyond motorcycling to skydiving and tango dancing, a skill he initially learned to love from his father. Dr. Upegui says he enjoys nothing more than learning, so he’s attracted to activities that require a high degree of training or technical expertise.

“I like to do things that make me feel like I’m proficient at something that’s difficult,” he says.

He vividly remembers the first time he jumped out of a plane, in 2002.

“It was thrilling, it was exciting, it was ego-boosting, it was self-gratifying, it was an adrenaline rush,” Dr. Upegui explains, adding that he taught English to the owner of the skydiving center in Colombia in exchange for free jumps. “The most exciting part is the decision to take the leap. That critical moment still gives me butterflies.”

Over the next six years, he jumped approximately 150 times, then stopped for roughly seven years to handle the demands of school and work, and to avoid the actual cost of skydiving, which is pricey at roughly a few hundred dollars per jump. But, over the years, he missed it, so he resumed skydiving earlier this year.

In between, he learned to tango through private and group lessons. Last year, he traveled to Buenos Aires, Argentina, for an intensive weeklong course and an international tango gathering. He also travels to “milongas,” get-togethers for professional and student tango dancers that are held in various cities worldwide.

 

 

“Tango has two core elements: showing your intention to move forward and allowing your partner to accept the invitation to follow your lead,” he says. “It’s a beautiful combination of assertiveness, determination, and then negotiation, followed by permission to proceed, depending upon how the conversation is going during the dance.”

No Regrets

Procrastination is not a familiar word to Dr. Upegui.

“The time frame between something that I want to do and [actually] doing it is very short,” he says. “If I want to do something, I just look at how I can get to it as soon as it’s available.”

Motorcycling ranks as his number one passion. Last year, he completed a 7,000-mile trip without taking any time off from his current job, which requires him to lead, manage, and often meet with hospitalist teams nationwide. He traveled via back roads on weekends to a major city, left his bike at the airport, and then hopped on a plane to wherever he needed to be for work. Instead of flying home for the weekend, he’d return to the airport to pick up his bike and travel to the next city he wanted to visit, which could be 1,000 miles away.

“The cool thing about the road is that random people help you,” he says. “The hotels would keep my clothes and luggage, and airport parking employees would help me park my motorcycle in a safe place and keep my helmet in their office.”

Dr. Upegui says childhood experiences that focused on momentum and movement laid the foundation for his mobile and adventuresome lifestyle. Movement, variability, and change have become the guiding factors in his life. Perhaps that’s why he chose to be a hospitalist. Among the youngest fields in medicine, the specialty is always growing, changing, and evolving.

“If you take any change in life as just a new stage of a new moment and you just perform your best in this current situation, then that will allow you to always be flexible to what’s happening in front of you,” Dr. Upegui says. “I love my work, family, Apogee, and the opportunities I have had. I could die completely satisfied today, knowing that I’ve done the best I could and searched for happiness every day.”


Hospitalist Jaime Upegui, MD, division president at Apogee Physicians in Coeur d’Alene, Idaho, knows exactly what he wants to do when he retires years from now: sell everything he owns and ride his motorcycle around the world.

So far, the 39-year-old physician leader has driven across the U.S. at least five times, including a 24-day, 11,700-mile trip during which he visited every state that bordered Canada, Mexico, the Gulf of Mexico, and the Pacific and Atlantic oceans. In spite of snow, ice, rain, wind, and searing 126-degree Farenheit heat, nothing stopped him.

Dr. Upegui is a modern-day explorer who enjoys making the journey as much as getting to the destination. Riding is his personal form of yoga, a meditative experience that demands he stay in the moment and allows him to escape life’s daily frustrations. Ever since he started riding motorcycles at age five, he’s been hooked and has no plans of shifting into neutral.

Driven by Change

Every day at work, Dr. Upegui, an internal medicine specialist, helps hospitalists thrive in a changing medical world where they’re constantly being pushed and pulled in multiple directions. “It’s an exciting career that’s full of unexpected changes,” he says. “I work hard every day on building great teams that produce stellar results.”

He brings that same level of enthusiasm to his after-work activities, which include skydiving, tango dancing, scuba diving, snowboarding, and rock climbing. His passion for change and adventure stems from his childhood.

Listen to more of our interview with Dr. Upegui.

Dr. Upegui was born in Colombia and raised predominantly in the cities of Cali and Medellín. His mother, Rocio, was a painter and ballet dancer; his father, Jaime Sr., was a poet and musician. He spent most of his childhood with his mother, who moved frequently in search of new inspirations. During his childhood, he attended 13 different schools and lived in more than 30 different homes in the U.S., Colombia, and Spain. In 2003, he finished medical school, graduating from Universidad Pontificia Bolivariana in Medellín. He worked as an attending physician in the emergency department there for three years before moving to New York City to complete his residency in internal medicine at St. Luke’s–Roosevelt Hospital Center.

Throughout medical school and his residency, Dr. Upegui’s personal interests extended beyond motorcycling to skydiving and tango dancing, a skill he initially learned to love from his father. Dr. Upegui says he enjoys nothing more than learning, so he’s attracted to activities that require a high degree of training or technical expertise.

“I like to do things that make me feel like I’m proficient at something that’s difficult,” he says.

He vividly remembers the first time he jumped out of a plane, in 2002.

“It was thrilling, it was exciting, it was ego-boosting, it was self-gratifying, it was an adrenaline rush,” Dr. Upegui explains, adding that he taught English to the owner of the skydiving center in Colombia in exchange for free jumps. “The most exciting part is the decision to take the leap. That critical moment still gives me butterflies.”

Over the next six years, he jumped approximately 150 times, then stopped for roughly seven years to handle the demands of school and work, and to avoid the actual cost of skydiving, which is pricey at roughly a few hundred dollars per jump. But, over the years, he missed it, so he resumed skydiving earlier this year.

In between, he learned to tango through private and group lessons. Last year, he traveled to Buenos Aires, Argentina, for an intensive weeklong course and an international tango gathering. He also travels to “milongas,” get-togethers for professional and student tango dancers that are held in various cities worldwide.

 

 

“Tango has two core elements: showing your intention to move forward and allowing your partner to accept the invitation to follow your lead,” he says. “It’s a beautiful combination of assertiveness, determination, and then negotiation, followed by permission to proceed, depending upon how the conversation is going during the dance.”

No Regrets

Procrastination is not a familiar word to Dr. Upegui.

“The time frame between something that I want to do and [actually] doing it is very short,” he says. “If I want to do something, I just look at how I can get to it as soon as it’s available.”

Motorcycling ranks as his number one passion. Last year, he completed a 7,000-mile trip without taking any time off from his current job, which requires him to lead, manage, and often meet with hospitalist teams nationwide. He traveled via back roads on weekends to a major city, left his bike at the airport, and then hopped on a plane to wherever he needed to be for work. Instead of flying home for the weekend, he’d return to the airport to pick up his bike and travel to the next city he wanted to visit, which could be 1,000 miles away.

“The cool thing about the road is that random people help you,” he says. “The hotels would keep my clothes and luggage, and airport parking employees would help me park my motorcycle in a safe place and keep my helmet in their office.”

Dr. Upegui says childhood experiences that focused on momentum and movement laid the foundation for his mobile and adventuresome lifestyle. Movement, variability, and change have become the guiding factors in his life. Perhaps that’s why he chose to be a hospitalist. Among the youngest fields in medicine, the specialty is always growing, changing, and evolving.

“If you take any change in life as just a new stage of a new moment and you just perform your best in this current situation, then that will allow you to always be flexible to what’s happening in front of you,” Dr. Upegui says. “I love my work, family, Apogee, and the opportunities I have had. I could die completely satisfied today, knowing that I’ve done the best I could and searched for happiness every day.”


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Frailty in HSCT population not dependent on age

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Frailty in HSCT population not dependent on age

Woman exercising in a park

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ORLANDO, FL—Frailty after hematopoietic stem cell transplant (HSCT), while associated with higher mortality, is not necessarily a function of age, according to investigators studying the impact of frailty on transplant outcomes.

Instead, other factors, such as increasing time from transplant, employment status, medical leave or disability, and limitations of social activities, were significantly associated with higher odds of frailty.

The investigators prospectively studied 96 HSCT recipients, age 40 and older, to determine the prevalence of frailty in HSCT populations and its impact on outcomes, including early post-transplant non-relapse mortality (NRM).

Mukta Arora, MD, of the University of Minnesota in Minneapolis, reported the findings at the 2015 ASH Annual Meeting (abstract 388*).

The investigators defined frailty as the presence of 3 or more of the following criteria: low grip strength, exhaustion, slowed walking speed, low physical activity, and unintentional weight loss. They defined pre-frailty as having 1 or 2 of these characteristics.

The investigators conducted multi-domain geriatric assessments of patients prior to HSCT and after transplant at 100 days, 6 months, and 1 year. The assessment included function, comorbidity, cognition, psychological state, social activity/support, nutritional status, and demographic, transplant, and disease-related information.

Forty-eight patients were in the younger age group (40–59), and 48 were in the older age group (60–74). All had undergone HSCT between February 2014 and April 2015.

Patient demographics

Patients in the younger group were a median age of 54 (range, 40–59) at transplant. Sixty-five percent were male, 58% had an autologous transplant, and 79% received myeloablative conditioning.

Patients in the older group were a median age of 65 (range, 60–73) at transplant. Fifty-four percent were male, 46% had an autologous transplant, and 46% had myeloablative conditioning.

The difference between the older and younger groups in their conditioning regimen was significant (P<0.01).

The groups were comparable in terms of the HSCT comorbidity index but were significantly different in employment status (P<0.01).

“As expected,” Dr Arora said, “there were more patients who were retired in the older group.”

In the younger group, 31% were employed, 3% retired, 56% on medical leave or disabled, and 10% unemployed.

In the older group, 6% were employed, 62% retired, 28% on medical leave or disabled, and 4% unemployed.

“There was no difference in the social activity and social support scores between the 2 groups,” Dr Arora observed.

Frailty assessments

In the younger group, at baseline, the prevalence of pre-frailty was 47%, and the prevalence of frailty was 11%. At 6 months after HSCT, the prevalence of pre-frailty was 45%, and the prevalence of frailty was 41% (P<0.01).

In the older group, at baseline, the prevalence of pre-frailty was 42%, and the prevalence of frailty was 6%. At 6 months, the prevalence of pre-frailty was 44%, and the prevalence of frailty was 38% (P<0.01).

The investigators then estimated the predictors of frailty.

Significant predictors of frailty included time since HSCT (odds ratio [OR]=3.7, 95% CI: 1.9-7.2, P<0.01), employment status (retired: OR=7.3, 95% CI 1.2 – 46.2, P=0.03), on medical leave or disabled (OR=11.2, 95% CI: 1.8 – 67.7, P=0.01), limitations in social activities (OR=1.04, 95% CI: 1.01 – 1.08, P=0.01), and baseline pre-frailty (OR=3.1, 95% CI: 2.3 – 45.5, P<0.01).

Allogeneic transplant was associated with higher odds of frailty than autologous (OR=3.1, 95% CI: 0.9 – 10.2), although it did not reach significance (P=0.06).

Investigators next estimated the impact of frailty or pre-frailty on NRM and identified a trend toward increased NRM in frail patients.

 

 

The 46 patients classified as not frail at baseline had a 7% cumulative incidence of NRM (P=0.07). The 42 patients classified as pre-frail had a 23% cumulative incidence of NRM, while the 8 patients classified as frail at baseline had a 28% cumulative incidence of NRM.

“So, to conclude, in this early study, frailty was noted in 8% and pre-frailty in 44% of the transplant population prior to transplant, and was not dependent on age,” Dr Arora said. “Frailty is a transitional state and appears to reflect a dynamic progression from robustness to functional decline with time since [HSCT].”

Because frailty is associated with higher mortality, the investigators believe vulnerable populations should be identified and their need for specific interventions defined.

This research was funded by the Leukemia & Lymphoma Society.

*Data in the abstract differ from the presentation.

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Woman exercising in a park

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ORLANDO, FL—Frailty after hematopoietic stem cell transplant (HSCT), while associated with higher mortality, is not necessarily a function of age, according to investigators studying the impact of frailty on transplant outcomes.

Instead, other factors, such as increasing time from transplant, employment status, medical leave or disability, and limitations of social activities, were significantly associated with higher odds of frailty.

The investigators prospectively studied 96 HSCT recipients, age 40 and older, to determine the prevalence of frailty in HSCT populations and its impact on outcomes, including early post-transplant non-relapse mortality (NRM).

Mukta Arora, MD, of the University of Minnesota in Minneapolis, reported the findings at the 2015 ASH Annual Meeting (abstract 388*).

The investigators defined frailty as the presence of 3 or more of the following criteria: low grip strength, exhaustion, slowed walking speed, low physical activity, and unintentional weight loss. They defined pre-frailty as having 1 or 2 of these characteristics.

The investigators conducted multi-domain geriatric assessments of patients prior to HSCT and after transplant at 100 days, 6 months, and 1 year. The assessment included function, comorbidity, cognition, psychological state, social activity/support, nutritional status, and demographic, transplant, and disease-related information.

Forty-eight patients were in the younger age group (40–59), and 48 were in the older age group (60–74). All had undergone HSCT between February 2014 and April 2015.

Patient demographics

Patients in the younger group were a median age of 54 (range, 40–59) at transplant. Sixty-five percent were male, 58% had an autologous transplant, and 79% received myeloablative conditioning.

Patients in the older group were a median age of 65 (range, 60–73) at transplant. Fifty-four percent were male, 46% had an autologous transplant, and 46% had myeloablative conditioning.

The difference between the older and younger groups in their conditioning regimen was significant (P<0.01).

The groups were comparable in terms of the HSCT comorbidity index but were significantly different in employment status (P<0.01).

“As expected,” Dr Arora said, “there were more patients who were retired in the older group.”

In the younger group, 31% were employed, 3% retired, 56% on medical leave or disabled, and 10% unemployed.

In the older group, 6% were employed, 62% retired, 28% on medical leave or disabled, and 4% unemployed.

“There was no difference in the social activity and social support scores between the 2 groups,” Dr Arora observed.

Frailty assessments

In the younger group, at baseline, the prevalence of pre-frailty was 47%, and the prevalence of frailty was 11%. At 6 months after HSCT, the prevalence of pre-frailty was 45%, and the prevalence of frailty was 41% (P<0.01).

In the older group, at baseline, the prevalence of pre-frailty was 42%, and the prevalence of frailty was 6%. At 6 months, the prevalence of pre-frailty was 44%, and the prevalence of frailty was 38% (P<0.01).

The investigators then estimated the predictors of frailty.

Significant predictors of frailty included time since HSCT (odds ratio [OR]=3.7, 95% CI: 1.9-7.2, P<0.01), employment status (retired: OR=7.3, 95% CI 1.2 – 46.2, P=0.03), on medical leave or disabled (OR=11.2, 95% CI: 1.8 – 67.7, P=0.01), limitations in social activities (OR=1.04, 95% CI: 1.01 – 1.08, P=0.01), and baseline pre-frailty (OR=3.1, 95% CI: 2.3 – 45.5, P<0.01).

Allogeneic transplant was associated with higher odds of frailty than autologous (OR=3.1, 95% CI: 0.9 – 10.2), although it did not reach significance (P=0.06).

Investigators next estimated the impact of frailty or pre-frailty on NRM and identified a trend toward increased NRM in frail patients.

 

 

The 46 patients classified as not frail at baseline had a 7% cumulative incidence of NRM (P=0.07). The 42 patients classified as pre-frail had a 23% cumulative incidence of NRM, while the 8 patients classified as frail at baseline had a 28% cumulative incidence of NRM.

“So, to conclude, in this early study, frailty was noted in 8% and pre-frailty in 44% of the transplant population prior to transplant, and was not dependent on age,” Dr Arora said. “Frailty is a transitional state and appears to reflect a dynamic progression from robustness to functional decline with time since [HSCT].”

Because frailty is associated with higher mortality, the investigators believe vulnerable populations should be identified and their need for specific interventions defined.

This research was funded by the Leukemia & Lymphoma Society.

*Data in the abstract differ from the presentation.

Woman exercising in a park

Photo by Peter Griffin

ORLANDO, FL—Frailty after hematopoietic stem cell transplant (HSCT), while associated with higher mortality, is not necessarily a function of age, according to investigators studying the impact of frailty on transplant outcomes.

Instead, other factors, such as increasing time from transplant, employment status, medical leave or disability, and limitations of social activities, were significantly associated with higher odds of frailty.

The investigators prospectively studied 96 HSCT recipients, age 40 and older, to determine the prevalence of frailty in HSCT populations and its impact on outcomes, including early post-transplant non-relapse mortality (NRM).

Mukta Arora, MD, of the University of Minnesota in Minneapolis, reported the findings at the 2015 ASH Annual Meeting (abstract 388*).

The investigators defined frailty as the presence of 3 or more of the following criteria: low grip strength, exhaustion, slowed walking speed, low physical activity, and unintentional weight loss. They defined pre-frailty as having 1 or 2 of these characteristics.

The investigators conducted multi-domain geriatric assessments of patients prior to HSCT and after transplant at 100 days, 6 months, and 1 year. The assessment included function, comorbidity, cognition, psychological state, social activity/support, nutritional status, and demographic, transplant, and disease-related information.

Forty-eight patients were in the younger age group (40–59), and 48 were in the older age group (60–74). All had undergone HSCT between February 2014 and April 2015.

Patient demographics

Patients in the younger group were a median age of 54 (range, 40–59) at transplant. Sixty-five percent were male, 58% had an autologous transplant, and 79% received myeloablative conditioning.

Patients in the older group were a median age of 65 (range, 60–73) at transplant. Fifty-four percent were male, 46% had an autologous transplant, and 46% had myeloablative conditioning.

The difference between the older and younger groups in their conditioning regimen was significant (P<0.01).

The groups were comparable in terms of the HSCT comorbidity index but were significantly different in employment status (P<0.01).

“As expected,” Dr Arora said, “there were more patients who were retired in the older group.”

In the younger group, 31% were employed, 3% retired, 56% on medical leave or disabled, and 10% unemployed.

In the older group, 6% were employed, 62% retired, 28% on medical leave or disabled, and 4% unemployed.

“There was no difference in the social activity and social support scores between the 2 groups,” Dr Arora observed.

Frailty assessments

In the younger group, at baseline, the prevalence of pre-frailty was 47%, and the prevalence of frailty was 11%. At 6 months after HSCT, the prevalence of pre-frailty was 45%, and the prevalence of frailty was 41% (P<0.01).

In the older group, at baseline, the prevalence of pre-frailty was 42%, and the prevalence of frailty was 6%. At 6 months, the prevalence of pre-frailty was 44%, and the prevalence of frailty was 38% (P<0.01).

The investigators then estimated the predictors of frailty.

Significant predictors of frailty included time since HSCT (odds ratio [OR]=3.7, 95% CI: 1.9-7.2, P<0.01), employment status (retired: OR=7.3, 95% CI 1.2 – 46.2, P=0.03), on medical leave or disabled (OR=11.2, 95% CI: 1.8 – 67.7, P=0.01), limitations in social activities (OR=1.04, 95% CI: 1.01 – 1.08, P=0.01), and baseline pre-frailty (OR=3.1, 95% CI: 2.3 – 45.5, P<0.01).

Allogeneic transplant was associated with higher odds of frailty than autologous (OR=3.1, 95% CI: 0.9 – 10.2), although it did not reach significance (P=0.06).

Investigators next estimated the impact of frailty or pre-frailty on NRM and identified a trend toward increased NRM in frail patients.

 

 

The 46 patients classified as not frail at baseline had a 7% cumulative incidence of NRM (P=0.07). The 42 patients classified as pre-frail had a 23% cumulative incidence of NRM, while the 8 patients classified as frail at baseline had a 28% cumulative incidence of NRM.

“So, to conclude, in this early study, frailty was noted in 8% and pre-frailty in 44% of the transplant population prior to transplant, and was not dependent on age,” Dr Arora said. “Frailty is a transitional state and appears to reflect a dynamic progression from robustness to functional decline with time since [HSCT].”

Because frailty is associated with higher mortality, the investigators believe vulnerable populations should be identified and their need for specific interventions defined.

This research was funded by the Leukemia & Lymphoma Society.

*Data in the abstract differ from the presentation.

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Combo deepens responses and improves PFS in MM

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Combo deepens responses and improves PFS in MM

Jesús San-Miguel, MD, PhD

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University of Navarra

ORLANDO, FL—The addition of panobinostat to bortezomib-dexamethasone therapy in relapsed or refractory multiple myeloma (MM) patients can double the rate of deep responses and prolong progression-free survival (PFS), according to an updated analysis of data from the PANORMA 1 trial.

Panobinostat, a pan-deacetylase inhibitor, was the first agent of its class to produce a statistically significant and clinically meaningful increase in the median PFS of patients with relapsed/refractory MM in a phase 3 trial, noted Jesús F. San-Miguel, MD, PhD, of the University of Navarra in Pamplona, Spain.

Dr San-Miguel presented results of the updated analysis at the 2015 ASH Annual Meeting (abstract 4230).

In the PANORAMA 1 trial, patients receiving panobinostat plus bortezomib and dexamethasone had a significantly prolonged median PFS of 12 months versus 8.1 months in patients treated with placebo-bortezomib-dexamethasone.

A subgroup analysis showed that the PFS benefit was improved in patients with previous exposure to bortezomib and immunomodulatory drugs (IMiDs). The addition of panobinostat to bortezomib-dexamethasone also led to a significant increase in high-quality responses.

With their analysis, Dr San-Miguel and his colleagues set out to determine the effect of responses on clinical outcomes of patients treated in PANORAMA 1, including those with prior exposure to bortezomib and IMiDs.

The researchers conducted a landmark analysis at 12, 18, and 24 weeks to assess the median PFS in patients who achieved a complete response (CR)/near complete response (nCR) or partial response (PR).

“For the total study population, the rates of high-quality responses [CR/nCR rate] were significantly higher in the panobinostat-bortezomib-dexamethasone arm [28%] than in the control arm [16%],” Dr San-Miguel said.

Among the subgroup with prior exposure to bortezomib and IMiDs, the CR/nCR rate was also higher in the triple-drug arm (22.3%) than in the 2-drug arm (9.9%).

Among patients who took panobinostat-bortezomib-dexamethasone, the duration of response was twice as long in those who achieved CR/nCR (18.4 months) as in those who achieved a PR (9 months).

The median PFS at 12 weeks for patients who received panobinostat-bortezomib-dexamethasone was increased in patients achieving high-quality responses: 16.5 months for nCR as compared to 10.3 months for PR.

The subgroup of patients with prior exposure to bortezomib and IMiDs who achieved deeper responses also demonstrated longer PFS at 12 weeks: a median of 13.7 months for nCR and 8.1 months for PR.

“In both the overall study population and the subgroup of patients with prior exposure to bortezomib and IMiDs, a 2-fold increase in deep responses was achieved with panobinostat-bortezomib-dexamethasone compared with placebo-bortezomib-dexamethasone,” Dr San-Miguel said. “In both groups, deep responses were associated with a prolonged PFS and a longer duration of response.”

He noted that the magnitude of benefit at each time point appeared greater among patients who received the triple-drug combination.

“These data further support achievement of deeper responses as a treatment goal and a robust and consistent benefit of panobinostat in the phase 3 study in patients with relapsed/refractory multiple myeloma, including those with prior exposure to bortezomib and IMiDs,” Dr San-Miguel said.

The PANORAMA 1 trial was sponsored by Novartis, the company developing panobinostat. Three researchers involved in the current analysis are employees of Novartis, and other researchers reported having relationships (receiving research funding, consulting, etc.) with a range of other pharmaceutical companies.

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Jesús San-Miguel, MD, PhD

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University of Navarra

ORLANDO, FL—The addition of panobinostat to bortezomib-dexamethasone therapy in relapsed or refractory multiple myeloma (MM) patients can double the rate of deep responses and prolong progression-free survival (PFS), according to an updated analysis of data from the PANORMA 1 trial.

Panobinostat, a pan-deacetylase inhibitor, was the first agent of its class to produce a statistically significant and clinically meaningful increase in the median PFS of patients with relapsed/refractory MM in a phase 3 trial, noted Jesús F. San-Miguel, MD, PhD, of the University of Navarra in Pamplona, Spain.

Dr San-Miguel presented results of the updated analysis at the 2015 ASH Annual Meeting (abstract 4230).

In the PANORAMA 1 trial, patients receiving panobinostat plus bortezomib and dexamethasone had a significantly prolonged median PFS of 12 months versus 8.1 months in patients treated with placebo-bortezomib-dexamethasone.

A subgroup analysis showed that the PFS benefit was improved in patients with previous exposure to bortezomib and immunomodulatory drugs (IMiDs). The addition of panobinostat to bortezomib-dexamethasone also led to a significant increase in high-quality responses.

With their analysis, Dr San-Miguel and his colleagues set out to determine the effect of responses on clinical outcomes of patients treated in PANORAMA 1, including those with prior exposure to bortezomib and IMiDs.

The researchers conducted a landmark analysis at 12, 18, and 24 weeks to assess the median PFS in patients who achieved a complete response (CR)/near complete response (nCR) or partial response (PR).

“For the total study population, the rates of high-quality responses [CR/nCR rate] were significantly higher in the panobinostat-bortezomib-dexamethasone arm [28%] than in the control arm [16%],” Dr San-Miguel said.

Among the subgroup with prior exposure to bortezomib and IMiDs, the CR/nCR rate was also higher in the triple-drug arm (22.3%) than in the 2-drug arm (9.9%).

Among patients who took panobinostat-bortezomib-dexamethasone, the duration of response was twice as long in those who achieved CR/nCR (18.4 months) as in those who achieved a PR (9 months).

The median PFS at 12 weeks for patients who received panobinostat-bortezomib-dexamethasone was increased in patients achieving high-quality responses: 16.5 months for nCR as compared to 10.3 months for PR.

The subgroup of patients with prior exposure to bortezomib and IMiDs who achieved deeper responses also demonstrated longer PFS at 12 weeks: a median of 13.7 months for nCR and 8.1 months for PR.

“In both the overall study population and the subgroup of patients with prior exposure to bortezomib and IMiDs, a 2-fold increase in deep responses was achieved with panobinostat-bortezomib-dexamethasone compared with placebo-bortezomib-dexamethasone,” Dr San-Miguel said. “In both groups, deep responses were associated with a prolonged PFS and a longer duration of response.”

He noted that the magnitude of benefit at each time point appeared greater among patients who received the triple-drug combination.

“These data further support achievement of deeper responses as a treatment goal and a robust and consistent benefit of panobinostat in the phase 3 study in patients with relapsed/refractory multiple myeloma, including those with prior exposure to bortezomib and IMiDs,” Dr San-Miguel said.

The PANORAMA 1 trial was sponsored by Novartis, the company developing panobinostat. Three researchers involved in the current analysis are employees of Novartis, and other researchers reported having relationships (receiving research funding, consulting, etc.) with a range of other pharmaceutical companies.

Jesús San-Miguel, MD, PhD

Photo courtesy of the

University of Navarra

ORLANDO, FL—The addition of panobinostat to bortezomib-dexamethasone therapy in relapsed or refractory multiple myeloma (MM) patients can double the rate of deep responses and prolong progression-free survival (PFS), according to an updated analysis of data from the PANORMA 1 trial.

Panobinostat, a pan-deacetylase inhibitor, was the first agent of its class to produce a statistically significant and clinically meaningful increase in the median PFS of patients with relapsed/refractory MM in a phase 3 trial, noted Jesús F. San-Miguel, MD, PhD, of the University of Navarra in Pamplona, Spain.

Dr San-Miguel presented results of the updated analysis at the 2015 ASH Annual Meeting (abstract 4230).

In the PANORAMA 1 trial, patients receiving panobinostat plus bortezomib and dexamethasone had a significantly prolonged median PFS of 12 months versus 8.1 months in patients treated with placebo-bortezomib-dexamethasone.

A subgroup analysis showed that the PFS benefit was improved in patients with previous exposure to bortezomib and immunomodulatory drugs (IMiDs). The addition of panobinostat to bortezomib-dexamethasone also led to a significant increase in high-quality responses.

With their analysis, Dr San-Miguel and his colleagues set out to determine the effect of responses on clinical outcomes of patients treated in PANORAMA 1, including those with prior exposure to bortezomib and IMiDs.

The researchers conducted a landmark analysis at 12, 18, and 24 weeks to assess the median PFS in patients who achieved a complete response (CR)/near complete response (nCR) or partial response (PR).

“For the total study population, the rates of high-quality responses [CR/nCR rate] were significantly higher in the panobinostat-bortezomib-dexamethasone arm [28%] than in the control arm [16%],” Dr San-Miguel said.

Among the subgroup with prior exposure to bortezomib and IMiDs, the CR/nCR rate was also higher in the triple-drug arm (22.3%) than in the 2-drug arm (9.9%).

Among patients who took panobinostat-bortezomib-dexamethasone, the duration of response was twice as long in those who achieved CR/nCR (18.4 months) as in those who achieved a PR (9 months).

The median PFS at 12 weeks for patients who received panobinostat-bortezomib-dexamethasone was increased in patients achieving high-quality responses: 16.5 months for nCR as compared to 10.3 months for PR.

The subgroup of patients with prior exposure to bortezomib and IMiDs who achieved deeper responses also demonstrated longer PFS at 12 weeks: a median of 13.7 months for nCR and 8.1 months for PR.

“In both the overall study population and the subgroup of patients with prior exposure to bortezomib and IMiDs, a 2-fold increase in deep responses was achieved with panobinostat-bortezomib-dexamethasone compared with placebo-bortezomib-dexamethasone,” Dr San-Miguel said. “In both groups, deep responses were associated with a prolonged PFS and a longer duration of response.”

He noted that the magnitude of benefit at each time point appeared greater among patients who received the triple-drug combination.

“These data further support achievement of deeper responses as a treatment goal and a robust and consistent benefit of panobinostat in the phase 3 study in patients with relapsed/refractory multiple myeloma, including those with prior exposure to bortezomib and IMiDs,” Dr San-Miguel said.

The PANORAMA 1 trial was sponsored by Novartis, the company developing panobinostat. Three researchers involved in the current analysis are employees of Novartis, and other researchers reported having relationships (receiving research funding, consulting, etc.) with a range of other pharmaceutical companies.

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Factors predict low accrual in cancer clinical trials

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Factors predict low accrual in cancer clinical trials

Preparing treatment

for a clinical trial

Photo by Esther Dyson

Twelve factors may predict low patient accrual in cancer clinical trials, according to research published in JNCI.

Many studies have been conducted to investigate the perceived barriers to clinical trial accrual from the patient or provider perspective.

However, researchers have rarely taken a trial-level view and investigated why certain trials are able to accrue patients faster than expected while others fail to attract even a fraction of the intended number of participants.

Caroline S. Bennette, PhD, of the University of Washington in Seattle, and her colleagues conducted their study to do just that.

They analyzed information on 787 phase 2/3 clinical trials sponsored by the National Clinical Trials Network (NCTN; formerly the Cooperative Group Program) launched between 2000 and 2011.

After excluding trials that closed because of toxicity or interim results, the researchers found that 145 (18%) NCTN trials closed with low accrual or were accruing at less than 50% of target accrual 3 years or more after opening.

The team identified potential risk factors from the literature and interviews with clinical trial experts and found multiple trial-level factors that were associated with poor accrual to NCTN trials, such as increased competition for patients from currently ongoing trials, planning to enroll a higher proportion of the available patient population, and not evaluating a new investigational agent or targeted therapy.

The researchers then developed a multivariable prediction model of low accrual using 12 trial-level risk factors. The team said these factors had good agreement between predicted and observed risks of low accrual in a preliminary validation using 46 trials opened between 2012 and 2013.

Those 12 risk factors are:

  1. The number of competing trials per 10,000 eligible patients per year (odds ratio [OR]=1.88)
  2. Phase 3 vs phase 2 trial (OR=1.86)
  3. Enrollment as percentage of eligible population for targeted therapy (OR=0.57)
  4. Enrollment as percentage of eligible population for radiation therapy (OR=1.81)
  5. Annual incidence of clinical condition(s) per 10,000 (OR=0.99)
  6. Tissue sample required to assess eligibility (OR=1.26)
  7. Investigational new drug (OR=0.34)
  8. Metastatic setting (OR=1.46)
  9. Sample size per 100 (OR=0.95)
  10. More than one condition evaluated (OR=1.98)
  11. Common solid cancer (prostate, breast, lung, or colon) vs liquid or rare solid cancers (OR=2.32)
  12. Interaction term (phase 3 x investigational new drug, OR=2.47).

The researchers concluded that systematically considering the overall influence of these risk factors could aid in the design and prioritization of future clinical trials.

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Preparing treatment

for a clinical trial

Photo by Esther Dyson

Twelve factors may predict low patient accrual in cancer clinical trials, according to research published in JNCI.

Many studies have been conducted to investigate the perceived barriers to clinical trial accrual from the patient or provider perspective.

However, researchers have rarely taken a trial-level view and investigated why certain trials are able to accrue patients faster than expected while others fail to attract even a fraction of the intended number of participants.

Caroline S. Bennette, PhD, of the University of Washington in Seattle, and her colleagues conducted their study to do just that.

They analyzed information on 787 phase 2/3 clinical trials sponsored by the National Clinical Trials Network (NCTN; formerly the Cooperative Group Program) launched between 2000 and 2011.

After excluding trials that closed because of toxicity or interim results, the researchers found that 145 (18%) NCTN trials closed with low accrual or were accruing at less than 50% of target accrual 3 years or more after opening.

The team identified potential risk factors from the literature and interviews with clinical trial experts and found multiple trial-level factors that were associated with poor accrual to NCTN trials, such as increased competition for patients from currently ongoing trials, planning to enroll a higher proportion of the available patient population, and not evaluating a new investigational agent or targeted therapy.

The researchers then developed a multivariable prediction model of low accrual using 12 trial-level risk factors. The team said these factors had good agreement between predicted and observed risks of low accrual in a preliminary validation using 46 trials opened between 2012 and 2013.

Those 12 risk factors are:

  1. The number of competing trials per 10,000 eligible patients per year (odds ratio [OR]=1.88)
  2. Phase 3 vs phase 2 trial (OR=1.86)
  3. Enrollment as percentage of eligible population for targeted therapy (OR=0.57)
  4. Enrollment as percentage of eligible population for radiation therapy (OR=1.81)
  5. Annual incidence of clinical condition(s) per 10,000 (OR=0.99)
  6. Tissue sample required to assess eligibility (OR=1.26)
  7. Investigational new drug (OR=0.34)
  8. Metastatic setting (OR=1.46)
  9. Sample size per 100 (OR=0.95)
  10. More than one condition evaluated (OR=1.98)
  11. Common solid cancer (prostate, breast, lung, or colon) vs liquid or rare solid cancers (OR=2.32)
  12. Interaction term (phase 3 x investigational new drug, OR=2.47).

The researchers concluded that systematically considering the overall influence of these risk factors could aid in the design and prioritization of future clinical trials.

Preparing treatment

for a clinical trial

Photo by Esther Dyson

Twelve factors may predict low patient accrual in cancer clinical trials, according to research published in JNCI.

Many studies have been conducted to investigate the perceived barriers to clinical trial accrual from the patient or provider perspective.

However, researchers have rarely taken a trial-level view and investigated why certain trials are able to accrue patients faster than expected while others fail to attract even a fraction of the intended number of participants.

Caroline S. Bennette, PhD, of the University of Washington in Seattle, and her colleagues conducted their study to do just that.

They analyzed information on 787 phase 2/3 clinical trials sponsored by the National Clinical Trials Network (NCTN; formerly the Cooperative Group Program) launched between 2000 and 2011.

After excluding trials that closed because of toxicity or interim results, the researchers found that 145 (18%) NCTN trials closed with low accrual or were accruing at less than 50% of target accrual 3 years or more after opening.

The team identified potential risk factors from the literature and interviews with clinical trial experts and found multiple trial-level factors that were associated with poor accrual to NCTN trials, such as increased competition for patients from currently ongoing trials, planning to enroll a higher proportion of the available patient population, and not evaluating a new investigational agent or targeted therapy.

The researchers then developed a multivariable prediction model of low accrual using 12 trial-level risk factors. The team said these factors had good agreement between predicted and observed risks of low accrual in a preliminary validation using 46 trials opened between 2012 and 2013.

Those 12 risk factors are:

  1. The number of competing trials per 10,000 eligible patients per year (odds ratio [OR]=1.88)
  2. Phase 3 vs phase 2 trial (OR=1.86)
  3. Enrollment as percentage of eligible population for targeted therapy (OR=0.57)
  4. Enrollment as percentage of eligible population for radiation therapy (OR=1.81)
  5. Annual incidence of clinical condition(s) per 10,000 (OR=0.99)
  6. Tissue sample required to assess eligibility (OR=1.26)
  7. Investigational new drug (OR=0.34)
  8. Metastatic setting (OR=1.46)
  9. Sample size per 100 (OR=0.95)
  10. More than one condition evaluated (OR=1.98)
  11. Common solid cancer (prostate, breast, lung, or colon) vs liquid or rare solid cancers (OR=2.32)
  12. Interaction term (phase 3 x investigational new drug, OR=2.47).

The researchers concluded that systematically considering the overall influence of these risk factors could aid in the design and prioritization of future clinical trials.

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Factors predict low accrual in cancer clinical trials
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Why it’s hard to develop immunity against malaria

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Why it’s hard to develop immunity against malaria

Axel Kallies, PhD, and

Diana Hansen, PhD

Photo courtesy of the Walter

and Eliza Hall Institute

Results of preclinical research appear to explain how the malaria parasite Plasmodium falciparum causes an inflammatory reaction that sabotages the body’s ability to protect itself from malaria.

Researchers found evidence to suggest that the same inflammatory molecules that drive the immune response in clinical and severe malaria also prevent the body from developing protective antibodies against the parasite.

They said this discovery opens up the possibility of improving new or existing malaria vaccines by boosting immune cells needed for long-lasting immunity.

Diana Hansen, PhD, of the Walter and Eliza Hall Institute of Medical Research in Parkville, Victoria, Australia, and her colleagues described this work in Cell Reports.

Dr Hansen said this is the first time scientists have pinpointed why the immune system fails to develop immunity during malaria infection.

“With many infections, a single exposure to the pathogen is enough to induce production of antibodies that will protect you for the rest of your life,” she explained. “However, with malaria, it can take up to 20 years for someone to build up sufficient immunity to be protected.”

The fact that the body is not good at developing long-lasting immunity to the parasite has hampered vaccine development, Dr Hansen added.

“This was complicated by the fact that we didn’t know whether it was the malaria parasite itself or the inflammatory reaction to malaria that was actually inhibiting the ability to develop protective immunity,” she said.

“We have now shown that it was a double-edged sword. The strong inflammatory reaction that accompanies and, in fact, drives severe clinical malaria is also responsible for silencing the key immune cells needed for long-term protection against the parasite.”

Dr Hansen and her colleagues conducted experiments in mouse models of malaria and found that inflammatory molecules released by the body to fight the infection were preventing protective antibodies from being made.

“Specialized immune cells called helper T cells join forces with B cells to generate these protective antibodies,” said Axel Kallies, PhD, of the Walter and Eliza Hall Institute of Medical Research.

“However, we showed that, during malaria infection, critical inflammatory molecules actually arrest development of helper T cells, and, therefore, the B cells don’t get the necessary instructions to make antibodies.”

Specifically, the researchers found that severe malaria infection inhibited the establishment of germinal centers in the spleens of the mice. And malaria infection induced high frequencies of T-follicular-helper cell precursors but resulted in impaired T-follicular-helper cell differentiation.

Precursor T-follicular-helper cells induced during infection had low levels of PD-1 and CXCR5 and co-expressed Th1-associated molecules such as T-bet and CXCR3.

However, when the researchers blocked the inflammatory cytokines TNF and IFN-γ or deleted T-bet, they were able to restore T-follicular-helper cell differentiation and germinal center responses to infection.

Dr Hansen said these findings could lead to new avenues in the search for effective malaria vaccines.

“This research opens the door to therapeutic approaches to accelerate development of protective immunity to malaria and improve efficacy of malaria vaccines,” she said.

“Until now, malaria vaccines have had disappointing results. We can now see a way of improving these responses by tailoring or augmenting the vaccine to boost development of helper T cells that will enable the body to make protective antibodies that target the malaria parasites.”

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Axel Kallies, PhD, and

Diana Hansen, PhD

Photo courtesy of the Walter

and Eliza Hall Institute

Results of preclinical research appear to explain how the malaria parasite Plasmodium falciparum causes an inflammatory reaction that sabotages the body’s ability to protect itself from malaria.

Researchers found evidence to suggest that the same inflammatory molecules that drive the immune response in clinical and severe malaria also prevent the body from developing protective antibodies against the parasite.

They said this discovery opens up the possibility of improving new or existing malaria vaccines by boosting immune cells needed for long-lasting immunity.

Diana Hansen, PhD, of the Walter and Eliza Hall Institute of Medical Research in Parkville, Victoria, Australia, and her colleagues described this work in Cell Reports.

Dr Hansen said this is the first time scientists have pinpointed why the immune system fails to develop immunity during malaria infection.

“With many infections, a single exposure to the pathogen is enough to induce production of antibodies that will protect you for the rest of your life,” she explained. “However, with malaria, it can take up to 20 years for someone to build up sufficient immunity to be protected.”

The fact that the body is not good at developing long-lasting immunity to the parasite has hampered vaccine development, Dr Hansen added.

“This was complicated by the fact that we didn’t know whether it was the malaria parasite itself or the inflammatory reaction to malaria that was actually inhibiting the ability to develop protective immunity,” she said.

“We have now shown that it was a double-edged sword. The strong inflammatory reaction that accompanies and, in fact, drives severe clinical malaria is also responsible for silencing the key immune cells needed for long-term protection against the parasite.”

Dr Hansen and her colleagues conducted experiments in mouse models of malaria and found that inflammatory molecules released by the body to fight the infection were preventing protective antibodies from being made.

“Specialized immune cells called helper T cells join forces with B cells to generate these protective antibodies,” said Axel Kallies, PhD, of the Walter and Eliza Hall Institute of Medical Research.

“However, we showed that, during malaria infection, critical inflammatory molecules actually arrest development of helper T cells, and, therefore, the B cells don’t get the necessary instructions to make antibodies.”

Specifically, the researchers found that severe malaria infection inhibited the establishment of germinal centers in the spleens of the mice. And malaria infection induced high frequencies of T-follicular-helper cell precursors but resulted in impaired T-follicular-helper cell differentiation.

Precursor T-follicular-helper cells induced during infection had low levels of PD-1 and CXCR5 and co-expressed Th1-associated molecules such as T-bet and CXCR3.

However, when the researchers blocked the inflammatory cytokines TNF and IFN-γ or deleted T-bet, they were able to restore T-follicular-helper cell differentiation and germinal center responses to infection.

Dr Hansen said these findings could lead to new avenues in the search for effective malaria vaccines.

“This research opens the door to therapeutic approaches to accelerate development of protective immunity to malaria and improve efficacy of malaria vaccines,” she said.

“Until now, malaria vaccines have had disappointing results. We can now see a way of improving these responses by tailoring or augmenting the vaccine to boost development of helper T cells that will enable the body to make protective antibodies that target the malaria parasites.”

Axel Kallies, PhD, and

Diana Hansen, PhD

Photo courtesy of the Walter

and Eliza Hall Institute

Results of preclinical research appear to explain how the malaria parasite Plasmodium falciparum causes an inflammatory reaction that sabotages the body’s ability to protect itself from malaria.

Researchers found evidence to suggest that the same inflammatory molecules that drive the immune response in clinical and severe malaria also prevent the body from developing protective antibodies against the parasite.

They said this discovery opens up the possibility of improving new or existing malaria vaccines by boosting immune cells needed for long-lasting immunity.

Diana Hansen, PhD, of the Walter and Eliza Hall Institute of Medical Research in Parkville, Victoria, Australia, and her colleagues described this work in Cell Reports.

Dr Hansen said this is the first time scientists have pinpointed why the immune system fails to develop immunity during malaria infection.

“With many infections, a single exposure to the pathogen is enough to induce production of antibodies that will protect you for the rest of your life,” she explained. “However, with malaria, it can take up to 20 years for someone to build up sufficient immunity to be protected.”

The fact that the body is not good at developing long-lasting immunity to the parasite has hampered vaccine development, Dr Hansen added.

“This was complicated by the fact that we didn’t know whether it was the malaria parasite itself or the inflammatory reaction to malaria that was actually inhibiting the ability to develop protective immunity,” she said.

“We have now shown that it was a double-edged sword. The strong inflammatory reaction that accompanies and, in fact, drives severe clinical malaria is also responsible for silencing the key immune cells needed for long-term protection against the parasite.”

Dr Hansen and her colleagues conducted experiments in mouse models of malaria and found that inflammatory molecules released by the body to fight the infection were preventing protective antibodies from being made.

“Specialized immune cells called helper T cells join forces with B cells to generate these protective antibodies,” said Axel Kallies, PhD, of the Walter and Eliza Hall Institute of Medical Research.

“However, we showed that, during malaria infection, critical inflammatory molecules actually arrest development of helper T cells, and, therefore, the B cells don’t get the necessary instructions to make antibodies.”

Specifically, the researchers found that severe malaria infection inhibited the establishment of germinal centers in the spleens of the mice. And malaria infection induced high frequencies of T-follicular-helper cell precursors but resulted in impaired T-follicular-helper cell differentiation.

Precursor T-follicular-helper cells induced during infection had low levels of PD-1 and CXCR5 and co-expressed Th1-associated molecules such as T-bet and CXCR3.

However, when the researchers blocked the inflammatory cytokines TNF and IFN-γ or deleted T-bet, they were able to restore T-follicular-helper cell differentiation and germinal center responses to infection.

Dr Hansen said these findings could lead to new avenues in the search for effective malaria vaccines.

“This research opens the door to therapeutic approaches to accelerate development of protective immunity to malaria and improve efficacy of malaria vaccines,” she said.

“Until now, malaria vaccines have had disappointing results. We can now see a way of improving these responses by tailoring or augmenting the vaccine to boost development of helper T cells that will enable the body to make protective antibodies that target the malaria parasites.”

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