ORLANDO – Adding the PI3K inhibitor idelalisib to a standard regimen of bendamustine and rituximab significantly reduced the risk of both disease progression and death for patients with relapsed and/or refractory chronic lymphocytic leukemia, results of a phase III randomized trial showed.

At a median follow-up of 12 months, the primary endpoint of median progression-free survival was 23.1 months for patients treated with idelalisib (Zydelig), bendamustine, and rituximab (idel+BR), compared with 11.1 months for bendamustine and rituximab (BR) plus a placebo, reported Dr. Andrew Zelenetz of Memorial Sloan Kettering Cancer Center, New York.

“Median overall survival was not reached in either arm. However, there was a significant improvement in overall survival, with a 45% reduction in the risk of death [with idel+BR],” he said in a late-breaking abstract session at the annual meeting of the American Society of Hematology.

The trial was stopped early after a data review at the first planned interim analysis showed significant superiority for the three-drug combination.

The results were consistent across subgroups, including patients with high-risk features such as deletion 17p and mutated TP53 (del[17p]/TP53), unmutated immunoglobulin heavy chain variable region (IgHV), and treatment-refractory disease.

The rationale behind adding idelalisib, an inhibitor of the phosphatidylinositol-3 kinase (PI3K), is that signaling via the PI3K pathway is hyperactive and can be targeted, Dr. Zelenetz explained.

Study 115 was a phase III trial with accrual from June 2012 through August 2015. Investigators enrolled 416 patients with relapsed /refractory CLL and randomly assigned them to receive BR for six 28-day cycles of bendamustine (70 mg/m² on days 1 and 2 of each cycle) and rituximab (375 mg/m² for cycle 1, and 500 mg/m² for cycles 2 through 6), plus either idelalisib 150 mg b.i.d. or placebo, each administered continuously until disease progression, intolerable toxicity, withdrawal of consent, or death.

The patients were stratified by mutational and disease status (refractory defined as CLL progression less than 6 months from completion of prior therapy, or relapsed CLL progression 6 months or more from completion of prior therapy.

The trial was halted early after the first planned interim analysis, which was conducted after 75% of the total number of 260 planned events of CLL progression or death from any cause had occurred. The data cutoff was June 15, 2015.

The intention-to-treat analysis included 207 patients assigned to idelalisib and 209 assigned to placebo. Three-fourths (76%) of the patients were male.

In all, 46% of patients had Rai stage III/IV disease. The median time since the completion of the last therapy was 16 months.

The proportions of patients with high-risk features included del(17p)/p53 mutation in 32.9%, unmutated IgHV in 83.2%, and treatment-refractory disease in 29.8%.

As noted, the median progression-free survival with idelalisib at a median follow-up of 12 months was 23.1 months vs. 11.1 months for placebo. That translated into a hazard ratio of 0.33 (P less than .0001).

Among patients with neither del(17p) nor TP53 mutations, the HR for progression was 0.22. Among patients with either del(17p) or a TP53 mutation, the HR was 0.50 (95% confidence intervals show statistical significance for both).

Overall response rates were 68% among patients who received idelalisib, and 45% for those who received placebo. There were five complete responses (2%) in the idelalisib group and none in the placebo group.

The idelalisib group also had a higher proportion of patients with a greater than 50% reduction in involved lymph nodes (96% vs. 61%), and had better organomegaly responses (spleen and liver) and hematologic responses (hemoglobin, neutrophils, and platelets).

Grade 3 or greater adverse events occurred in 93% of patients on idelalisib, compared with 76% of those on placebo. The proportion of patients with any serious adverse event was 66% vs. 44%, respectively.

Adverse events leading to drug dose reduction were seen in 11% of idelalisib-treated patients, compared with 6% of placebo controls, and therapy was discontinued in 26% vs. 13%, respectively.

Ten patients in the idelalisib arm and seven in the placebo arm died during the study.

Adverse events that occurred more commonly with idelalisib included neutropenia, pyrexia, diarrhea, febrile neutropenia, pneumonia, rash, and elevated liver enzymes.

Session moderator Dr. David P. Steensma of the Dana-Farber Cancer Institute in Boston asked Dr. Zelenetz how idelalisib plus BR stacked up to ibrutinib (Imbruvica) plus BR in this population.

Dr. Zelenetz noted that patients were excluded from the HELIOS trial of ibrutinib plus BR if they had del(17p). Comparing the subset of patients in Study 115 without del(17p) with patients in the ibrutinib study, “the results are virtually superimposable,” Dr. Zelenetz said, and “the two treatments are really remarkably similar.”

The overall survival benefit was larger in the HELIOS trial, Dr. Zelenetz noted, but that was largely because the trial allowed patients to cross over from placebo to the active drug.

Gilead Sciences funded Study 115. Dr. Zelenetz disclosed receiving research funding from the company and discussing off-label use of idelalisib for relapsed/refractory CLL.

ORLANDO – Adding the PI3K inhibitor idelalisib to a standard regimen of bendamustine and rituximab significantly reduced the risk of both disease progression and death for patients with relapsed and/or refractory chronic lymphocytic leukemia, results of a phase III randomized trial showed.

At a median follow-up of 12 months, the primary endpoint of median progression-free survival was 23.1 months for patients treated with idelalisib (Zydelig), bendamustine, and rituximab (idel+BR), compared with 11.1 months for bendamustine and rituximab (BR) plus a placebo, reported Dr. Andrew Zelenetz of Memorial Sloan Kettering Cancer Center, New York.

“Median overall survival was not reached in either arm. However, there was a significant improvement in overall survival, with a 45% reduction in the risk of death [with idel+BR],” he said in a late-breaking abstract session at the annual meeting of the American Society of Hematology.

The trial was stopped early after a data review at the first planned interim analysis showed significant superiority for the three-drug combination.

The results were consistent across subgroups, including patients with high-risk features such as deletion 17p and mutated TP53 (del[17p]/TP53), unmutated immunoglobulin heavy chain variable region (IgHV), and treatment-refractory disease.

The rationale behind adding idelalisib, an inhibitor of the phosphatidylinositol-3 kinase (PI3K), is that signaling via the PI3K pathway is hyperactive and can be targeted, Dr. Zelenetz explained.

Study 115 was a phase III trial with accrual from June 2012 through August 2015. Investigators enrolled 416 patients with relapsed /refractory CLL and randomly assigned them to receive BR for six 28-day cycles of bendamustine (70 mg/m² on days 1 and 2 of each cycle) and rituximab (375 mg/m² for cycle 1, and 500 mg/m² for cycles 2 through 6), plus either idelalisib 150 mg b.i.d. or placebo, each administered continuously until disease progression, intolerable toxicity, withdrawal of consent, or death.

The patients were stratified by mutational and disease status (refractory defined as CLL progression less than 6 months from completion of prior therapy, or relapsed CLL progression 6 months or more from completion of prior therapy.

The trial was halted early after the first planned interim analysis, which was conducted after 75% of the total number of 260 planned events of CLL progression or death from any cause had occurred. The data cutoff was June 15, 2015.

The intention-to-treat analysis included 207 patients assigned to idelalisib and 209 assigned to placebo. Three-fourths (76%) of the patients were male.

In all, 46% of patients had Rai stage III/IV disease. The median time since the completion of the last therapy was 16 months.

The proportions of patients with high-risk features included del(17p)/p53 mutation in 32.9%, unmutated IgHV in 83.2%, and treatment-refractory disease in 29.8%.

As noted, the median progression-free survival with idelalisib at a median follow-up of 12 months was 23.1 months vs. 11.1 months for placebo. That translated into a hazard ratio of 0.33 (P less than .0001).

Among patients with neither del(17p) nor TP53 mutations, the HR for progression was 0.22. Among patients with either del(17p) or a TP53 mutation, the HR was 0.50 (95% confidence intervals show statistical significance for both).

Overall response rates were 68% among patients who received idelalisib, and 45% for those who received placebo. There were five complete responses (2%) in the idelalisib group and none in the placebo group.

The idelalisib group also had a higher proportion of patients with a greater than 50% reduction in involved lymph nodes (96% vs. 61%), and had better organomegaly responses (spleen and liver) and hematologic responses (hemoglobin, neutrophils, and platelets).

Grade 3 or greater adverse events occurred in 93% of patients on idelalisib, compared with 76% of those on placebo. The proportion of patients with any serious adverse event was 66% vs. 44%, respectively.

Adverse events leading to drug dose reduction were seen in 11% of idelalisib-treated patients, compared with 6% of placebo controls, and therapy was discontinued in 26% vs. 13%, respectively.

Ten patients in the idelalisib arm and seven in the placebo arm died during the study.

Adverse events that occurred more commonly with idelalisib included neutropenia, pyrexia, diarrhea, febrile neutropenia, pneumonia, rash, and elevated liver enzymes.

Session moderator Dr. David P. Steensma of the Dana-Farber Cancer Institute in Boston asked Dr. Zelenetz how idelalisib plus BR stacked up to ibrutinib (Imbruvica) plus BR in this population.

Dr. Zelenetz noted that patients were excluded from the HELIOS trial of ibrutinib plus BR if they had del(17p). Comparing the subset of patients in Study 115 without del(17p) with patients in the ibrutinib study, “the results are virtually superimposable,” Dr. Zelenetz said, and “the two treatments are really remarkably similar.”

The overall survival benefit was larger in the HELIOS trial, Dr. Zelenetz noted, but that was largely because the trial allowed patients to cross over from placebo to the active drug.

Gilead Sciences funded Study 115. Dr. Zelenetz disclosed receiving research funding from the company and discussing off-label use of idelalisib for relapsed/refractory CLL.

ORLANDO – Adding the PI3K inhibitor idelalisib to a standard regimen of bendamustine and rituximab significantly reduced the risk of both disease progression and death for patients with relapsed and/or refractory chronic lymphocytic leukemia, results of a phase III randomized trial showed.

At a median follow-up of 12 months, the primary endpoint of median progression-free survival was 23.1 months for patients treated with idelalisib (Zydelig), bendamustine, and rituximab (idel+BR), compared with 11.1 months for bendamustine and rituximab (BR) plus a placebo, reported Dr. Andrew Zelenetz of Memorial Sloan Kettering Cancer Center, New York.

“Median overall survival was not reached in either arm. However, there was a significant improvement in overall survival, with a 45% reduction in the risk of death [with idel+BR],” he said in a late-breaking abstract session at the annual meeting of the American Society of Hematology.

The trial was stopped early after a data review at the first planned interim analysis showed significant superiority for the three-drug combination.

The results were consistent across subgroups, including patients with high-risk features such as deletion 17p and mutated TP53 (del[17p]/TP53), unmutated immunoglobulin heavy chain variable region (IgHV), and treatment-refractory disease.

The rationale behind adding idelalisib, an inhibitor of the phosphatidylinositol-3 kinase (PI3K), is that signaling via the PI3K pathway is hyperactive and can be targeted, Dr. Zelenetz explained.

Study 115 was a phase III trial with accrual from June 2012 through August 2015. Investigators enrolled 416 patients with relapsed /refractory CLL and randomly assigned them to receive BR for six 28-day cycles of bendamustine (70 mg/m² on days 1 and 2 of each cycle) and rituximab (375 mg/m² for cycle 1, and 500 mg/m² for cycles 2 through 6), plus either idelalisib 150 mg b.i.d. or placebo, each administered continuously until disease progression, intolerable toxicity, withdrawal of consent, or death.

The patients were stratified by mutational and disease status (refractory defined as CLL progression less than 6 months from completion of prior therapy, or relapsed CLL progression 6 months or more from completion of prior therapy.

The trial was halted early after the first planned interim analysis, which was conducted after 75% of the total number of 260 planned events of CLL progression or death from any cause had occurred. The data cutoff was June 15, 2015.

The intention-to-treat analysis included 207 patients assigned to idelalisib and 209 assigned to placebo. Three-fourths (76%) of the patients were male.

In all, 46% of patients had Rai stage III/IV disease. The median time since the completion of the last therapy was 16 months.

The proportions of patients with high-risk features included del(17p)/p53 mutation in 32.9%, unmutated IgHV in 83.2%, and treatment-refractory disease in 29.8%.

As noted, the median progression-free survival with idelalisib at a median follow-up of 12 months was 23.1 months vs. 11.1 months for placebo. That translated into a hazard ratio of 0.33 (P less than .0001).

Among patients with neither del(17p) nor TP53 mutations, the HR for progression was 0.22. Among patients with either del(17p) or a TP53 mutation, the HR was 0.50 (95% confidence intervals show statistical significance for both).

Overall response rates were 68% among patients who received idelalisib, and 45% for those who received placebo. There were five complete responses (2%) in the idelalisib group and none in the placebo group.

The idelalisib group also had a higher proportion of patients with a greater than 50% reduction in involved lymph nodes (96% vs. 61%), and had better organomegaly responses (spleen and liver) and hematologic responses (hemoglobin, neutrophils, and platelets).

Grade 3 or greater adverse events occurred in 93% of patients on idelalisib, compared with 76% of those on placebo. The proportion of patients with any serious adverse event was 66% vs. 44%, respectively.

Adverse events leading to drug dose reduction were seen in 11% of idelalisib-treated patients, compared with 6% of placebo controls, and therapy was discontinued in 26% vs. 13%, respectively.

Ten patients in the idelalisib arm and seven in the placebo arm died during the study.

Adverse events that occurred more commonly with idelalisib included neutropenia, pyrexia, diarrhea, febrile neutropenia, pneumonia, rash, and elevated liver enzymes.

Session moderator Dr. David P. Steensma of the Dana-Farber Cancer Institute in Boston asked Dr. Zelenetz how idelalisib plus BR stacked up to ibrutinib (Imbruvica) plus BR in this population.

Dr. Zelenetz noted that patients were excluded from the HELIOS trial of ibrutinib plus BR if they had del(17p). Comparing the subset of patients in Study 115 without del(17p) with patients in the ibrutinib study, “the results are virtually superimposable,” Dr. Zelenetz said, and “the two treatments are really remarkably similar.”

The overall survival benefit was larger in the HELIOS trial, Dr. Zelenetz noted, but that was largely because the trial allowed patients to cross over from placebo to the active drug.

Gilead Sciences funded Study 115. Dr. Zelenetz disclosed receiving research funding from the company and discussing off-label use of idelalisib for relapsed/refractory CLL.

Who is in this video: Dr. Lawrence “Bopper” Deyton is the senior associate dean for clinical public health and a professor of medicine and of health policy and management at George Washington University School of Medicine, Washington; and Lauren Alfred, policy director at the Kennedy Forum.

Dr. Deyton: We’re in a bit of a transition now in terms of the structure of the health care enterprise, and how the incentives, and the funding, and how we’re organized? If we believe that the “triple aim” will work, that is, that the Affordable Care Act’s priorities – improving quality, decreasing cost, improving patient satisfaction in the system – then aren’t we on the cusp of potentially being able to put the distress diagnoses, finding those out, at the top, or close to the top, of the differential list when anybody comes in for any medical interaction?

At least in the literature that I know about – I’m thinking about chronic diseases – people come in with all kinds of behavioral, and emotional, and mental health distress issues, as well as serious mental illness. I think that we are missing opportunities with every interaction to ask about, to screen, and to have a treatment plan for those behavioral and mental health problems.
 
Now, aren’t we at the cusp of a reimbursement system that should reward for that and help catalyze our systems to change how they are structured?

Lauren Alfred: Absolutely. I think we’re having this conversation, fundamentally, for two reasons. One, because we recognize that the vast majority of patients are going to get this care in the primary care setting. That’s why we’re talking about mental health in primary care. There’s recognition of that by policy makers to say, “I have to address this problem across the continuum of care, but this is where I can make the biggest impact.” They’re driven by dollars, and so this is Then two, back to the idea of education, and the burden that we would be placing on primary care physicians and on our residents to be learning, there is only so much we can do, I would say, given the evidence of education in mental health for these physicians. It’ll only take them so far, and then at some point we have to talk about collaborative care and where we’re going to bring the specialists into the equation.

I think we get into this policy discussion, certainly with medicine, but also with teachers. It’s “How much more are we going to pile onto educators in terms of the things that they have to do for their students?” They have to be the social worker, the mom, the dad, and they have to be thinking about their mental health and about addiction. There are only so many [14:50] things we can expect our primary care physicians to do.

We need to bring them all up to a certain standard and at that point decide, “What are the payment structures, mechanisms, and teams that are in place that then carry us the rest of the way?” Making sure that there is a fundamental understanding of this difference between disorder and distress is certainly a good place to start.
 

Who is in this video: Dr. Lawrence “Bopper” Deyton is the senior associate dean for clinical public health and a professor of medicine and of health policy and management at George Washington University School of Medicine, Washington; and Lauren Alfred, policy director at the Kennedy Forum.

Dr. Deyton: We’re in a bit of a transition now in terms of the structure of the health care enterprise, and how the incentives, and the funding, and how we’re organized? If we believe that the “triple aim” will work, that is, that the Affordable Care Act’s priorities – improving quality, decreasing cost, improving patient satisfaction in the system – then aren’t we on the cusp of potentially being able to put the distress diagnoses, finding those out, at the top, or close to the top, of the differential list when anybody comes in for any medical interaction?

At least in the literature that I know about – I’m thinking about chronic diseases – people come in with all kinds of behavioral, and emotional, and mental health distress issues, as well as serious mental illness. I think that we are missing opportunities with every interaction to ask about, to screen, and to have a treatment plan for those behavioral and mental health problems.
 
Now, aren’t we at the cusp of a reimbursement system that should reward for that and help catalyze our systems to change how they are structured?

Lauren Alfred: Absolutely. I think we’re having this conversation, fundamentally, for two reasons. One, because we recognize that the vast majority of patients are going to get this care in the primary care setting. That’s why we’re talking about mental health in primary care. There’s recognition of that by policy makers to say, “I have to address this problem across the continuum of care, but this is where I can make the biggest impact.” They’re driven by dollars, and so this is Then two, back to the idea of education, and the burden that we would be placing on primary care physicians and on our residents to be learning, there is only so much we can do, I would say, given the evidence of education in mental health for these physicians. It’ll only take them so far, and then at some point we have to talk about collaborative care and where we’re going to bring the specialists into the equation.

I think we get into this policy discussion, certainly with medicine, but also with teachers. It’s “How much more are we going to pile onto educators in terms of the things that they have to do for their students?” They have to be the social worker, the mom, the dad, and they have to be thinking about their mental health and about addiction. There are only so many [14:50] things we can expect our primary care physicians to do.

We need to bring them all up to a certain standard and at that point decide, “What are the payment structures, mechanisms, and teams that are in place that then carry us the rest of the way?” Making sure that there is a fundamental understanding of this difference between disorder and distress is certainly a good place to start.
 

Who is in this video: Dr. Lawrence “Bopper” Deyton is the senior associate dean for clinical public health and a professor of medicine and of health policy and management at George Washington University School of Medicine, Washington; and Lauren Alfred, policy director at the Kennedy Forum.

Dr. Deyton: We’re in a bit of a transition now in terms of the structure of the health care enterprise, and how the incentives, and the funding, and how we’re organized? If we believe that the “triple aim” will work, that is, that the Affordable Care Act’s priorities – improving quality, decreasing cost, improving patient satisfaction in the system – then aren’t we on the cusp of potentially being able to put the distress diagnoses, finding those out, at the top, or close to the top, of the differential list when anybody comes in for any medical interaction?

At least in the literature that I know about – I’m thinking about chronic diseases – people come in with all kinds of behavioral, and emotional, and mental health distress issues, as well as serious mental illness. I think that we are missing opportunities with every interaction to ask about, to screen, and to have a treatment plan for those behavioral and mental health problems.
 
Now, aren’t we at the cusp of a reimbursement system that should reward for that and help catalyze our systems to change how they are structured?

Lauren Alfred: Absolutely. I think we’re having this conversation, fundamentally, for two reasons. One, because we recognize that the vast majority of patients are going to get this care in the primary care setting. That’s why we’re talking about mental health in primary care. There’s recognition of that by policy makers to say, “I have to address this problem across the continuum of care, but this is where I can make the biggest impact.” They’re driven by dollars, and so this is Then two, back to the idea of education, and the burden that we would be placing on primary care physicians and on our residents to be learning, there is only so much we can do, I would say, given the evidence of education in mental health for these physicians. It’ll only take them so far, and then at some point we have to talk about collaborative care and where we’re going to bring the specialists into the equation.

I think we get into this policy discussion, certainly with medicine, but also with teachers. It’s “How much more are we going to pile onto educators in terms of the things that they have to do for their students?” They have to be the social worker, the mom, the dad, and they have to be thinking about their mental health and about addiction. There are only so many [14:50] things we can expect our primary care physicians to do.

We need to bring them all up to a certain standard and at that point decide, “What are the payment structures, mechanisms, and teams that are in place that then carry us the rest of the way?” Making sure that there is a fundamental understanding of this difference between disorder and distress is certainly a good place to start.
 

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, editorial board member of Clinical Psychiatry News and cohost of Mental Health Consult, and an assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs, and the medical director of psychiatric and behavioral services at George Washington University Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington, and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine in Baltimore  and at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Dr. Lillian Beard: In fact, the written note is sometimes inhibiting to the communication because we are each so aware of what we put in writing [20:00] to even send to a colleague. We can have a conversation, a dialogue about the patient and glean a lot more information.

Whitney: Do you mean you actually omit things on purpose?

Dr. Beard: It is not about omitting, it is about how you state it, because first of all our patients will eventually have access to everything we have written. They are getting more and more access with patient portals. I find for instance even in my notes, so that even if my colleagues in my practice were to see this patient they would know there are certain code terms. I say "high risk for" or I will not do that now because much of that will go to the patient portal. I will come up with other kinds of words so they know to check with me to find out what I meant about that. There are some toxic families, I do not write "toxic family" in my notes.

Dr. Pickar: I agree with you. I could not agree with you more, and in psychiatry, actually there is some protection against not having to share notes. I do not know if you are aware of that. Medical records for sure, but your notes can remain private about a patient. Maybe you know more about that. Help me with that.

Dr. Norris: It is a little bit. Once you get into the problem of keeping dual records, which becomes an issue. You cannot do that. Particularly with electronic medical records, this is now one that patients do and should have access to it. It is a medical legal document and many different people can look at that, so as clinicians, we must be aware, not just for our patients and ourselves, what we put in the note. You cannot have team-based care unless you actually know your teammate. When I am working with a clinician, I want to know their thought process. I want to know a little bit of their philosophy. Do they like stimulants, do they believe in them? When they are also treating, do they screen for first-episode psychosis? Is it on their radar? Are they screening for comorbid depression and bipolar disorder?

Whitney: Should that be legislated or should that be the individual choice of the practice?

Dr. Norris: You can legislate it all you want. This gets into the duty that we as clinicians have to our patients and how we treat them. The first law is to do no harm. I am not saying anything fancy. This is just basic, solid medical care, which takes a certain amount of time, which is not usually 15 minutes.
 

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, editorial board member of Clinical Psychiatry News and cohost of Mental Health Consult, and an assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs, and the medical director of psychiatric and behavioral services at George Washington University Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington, and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine in Baltimore  and at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Dr. Lillian Beard: In fact, the written note is sometimes inhibiting to the communication because we are each so aware of what we put in writing [20:00] to even send to a colleague. We can have a conversation, a dialogue about the patient and glean a lot more information.

Whitney: Do you mean you actually omit things on purpose?

Dr. Beard: It is not about omitting, it is about how you state it, because first of all our patients will eventually have access to everything we have written. They are getting more and more access with patient portals. I find for instance even in my notes, so that even if my colleagues in my practice were to see this patient they would know there are certain code terms. I say "high risk for" or I will not do that now because much of that will go to the patient portal. I will come up with other kinds of words so they know to check with me to find out what I meant about that. There are some toxic families, I do not write "toxic family" in my notes.

Dr. Pickar: I agree with you. I could not agree with you more, and in psychiatry, actually there is some protection against not having to share notes. I do not know if you are aware of that. Medical records for sure, but your notes can remain private about a patient. Maybe you know more about that. Help me with that.

Dr. Norris: It is a little bit. Once you get into the problem of keeping dual records, which becomes an issue. You cannot do that. Particularly with electronic medical records, this is now one that patients do and should have access to it. It is a medical legal document and many different people can look at that, so as clinicians, we must be aware, not just for our patients and ourselves, what we put in the note. You cannot have team-based care unless you actually know your teammate. When I am working with a clinician, I want to know their thought process. I want to know a little bit of their philosophy. Do they like stimulants, do they believe in them? When they are also treating, do they screen for first-episode psychosis? Is it on their radar? Are they screening for comorbid depression and bipolar disorder?

Whitney: Should that be legislated or should that be the individual choice of the practice?

Dr. Norris: You can legislate it all you want. This gets into the duty that we as clinicians have to our patients and how we treat them. The first law is to do no harm. I am not saying anything fancy. This is just basic, solid medical care, which takes a certain amount of time, which is not usually 15 minutes.
 

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, editorial board member of Clinical Psychiatry News and cohost of Mental Health Consult, and an assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs, and the medical director of psychiatric and behavioral services at George Washington University Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington, and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine in Baltimore  and at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Dr. Lillian Beard: In fact, the written note is sometimes inhibiting to the communication because we are each so aware of what we put in writing [20:00] to even send to a colleague. We can have a conversation, a dialogue about the patient and glean a lot more information.

Whitney: Do you mean you actually omit things on purpose?

Dr. Beard: It is not about omitting, it is about how you state it, because first of all our patients will eventually have access to everything we have written. They are getting more and more access with patient portals. I find for instance even in my notes, so that even if my colleagues in my practice were to see this patient they would know there are certain code terms. I say "high risk for" or I will not do that now because much of that will go to the patient portal. I will come up with other kinds of words so they know to check with me to find out what I meant about that. There are some toxic families, I do not write "toxic family" in my notes.

Dr. Pickar: I agree with you. I could not agree with you more, and in psychiatry, actually there is some protection against not having to share notes. I do not know if you are aware of that. Medical records for sure, but your notes can remain private about a patient. Maybe you know more about that. Help me with that.

Dr. Norris: It is a little bit. Once you get into the problem of keeping dual records, which becomes an issue. You cannot do that. Particularly with electronic medical records, this is now one that patients do and should have access to it. It is a medical legal document and many different people can look at that, so as clinicians, we must be aware, not just for our patients and ourselves, what we put in the note. You cannot have team-based care unless you actually know your teammate. When I am working with a clinician, I want to know their thought process. I want to know a little bit of their philosophy. Do they like stimulants, do they believe in them? When they are also treating, do they screen for first-episode psychosis? Is it on their radar? Are they screening for comorbid depression and bipolar disorder?

Whitney: Should that be legislated or should that be the individual choice of the practice?

Dr. Norris: You can legislate it all you want. This gets into the duty that we as clinicians have to our patients and how we treat them. The first law is to do no harm. I am not saying anything fancy. This is just basic, solid medical care, which takes a certain amount of time, which is not usually 15 minutes.
 

Who is in this video: Dr. James Griffith, the Leon M. Yochelson Professor of Psychiatry and Behavioral Sciences, and chair of psychiatry and psychosomatic medicine at George Washington University School of Medicine. Lauren Alfred is policy director at the Kennedy Forum.

Dr. Griffith: There’s also the training of our educators. There has been too much focus simply on counting symptoms. If you have sleep problems, if you have no energy, if you’re not enjoying things, then you have depression. That kind of definition of depression catches too many different things that shouldn’t be addressed in the same way.

“There has been too much focus simply on counting symptoms.”
– Dr. James GriffithThat’s distress. In primary care there are a lot of people with, often, very malignant mood disorders – major depression, bipolar disorder. They generally need not just a prescription; they need a program. Medication may be part of it. It also needs to address lifestyle. It also needs to address relationship problems. Many different things, which if done well can help people live good lives without being held hostage to having a psychiatric diagnosis.

When I said distress – these are not mental illnesses, but yet it all gets called depression. Often in the public discussions, it’s treated – “We just need to identify the depressed patients, give them medications.” That serves few people well. There are ways of doing very effective, targeted work depending upon, initially, an accurate assessment of what is the problem. Is it demoralization? Is it grief? Is this a relationship that is abusive, for example?

Now the other piece - and this is a big one. This is one that we’ve got to figure out how to address, and this is no different in the Middle East, where I’m doing work, as it is here. People come into primary care complaining of dizziness, headaches, physical pain problems, not sleeping well, fatigue. Wherever in the world you’ll go, what they get is a lot of tests, vitamins – not identifying or addressing that underneath this there is psychological distress or a mental illness driving it.

This puts a focus on detection and formulation of the problem. You’re right, the doctors aren’t going to do all the treatment, but this is where the doctor pretty much does have to do, on the front end, the identification. That’s our training issue.
 

Who is in this video: Dr. James Griffith, the Leon M. Yochelson Professor of Psychiatry and Behavioral Sciences, and chair of psychiatry and psychosomatic medicine at George Washington University School of Medicine. Lauren Alfred is policy director at the Kennedy Forum.

Dr. Griffith: There’s also the training of our educators. There has been too much focus simply on counting symptoms. If you have sleep problems, if you have no energy, if you’re not enjoying things, then you have depression. That kind of definition of depression catches too many different things that shouldn’t be addressed in the same way.

“There has been too much focus simply on counting symptoms.”
– Dr. James GriffithThat’s distress. In primary care there are a lot of people with, often, very malignant mood disorders – major depression, bipolar disorder. They generally need not just a prescription; they need a program. Medication may be part of it. It also needs to address lifestyle. It also needs to address relationship problems. Many different things, which if done well can help people live good lives without being held hostage to having a psychiatric diagnosis.

When I said distress – these are not mental illnesses, but yet it all gets called depression. Often in the public discussions, it’s treated – “We just need to identify the depressed patients, give them medications.” That serves few people well. There are ways of doing very effective, targeted work depending upon, initially, an accurate assessment of what is the problem. Is it demoralization? Is it grief? Is this a relationship that is abusive, for example?

Now the other piece - and this is a big one. This is one that we’ve got to figure out how to address, and this is no different in the Middle East, where I’m doing work, as it is here. People come into primary care complaining of dizziness, headaches, physical pain problems, not sleeping well, fatigue. Wherever in the world you’ll go, what they get is a lot of tests, vitamins – not identifying or addressing that underneath this there is psychological distress or a mental illness driving it.

This puts a focus on detection and formulation of the problem. You’re right, the doctors aren’t going to do all the treatment, but this is where the doctor pretty much does have to do, on the front end, the identification. That’s our training issue.
 

Who is in this video: Dr. James Griffith, the Leon M. Yochelson Professor of Psychiatry and Behavioral Sciences, and chair of psychiatry and psychosomatic medicine at George Washington University School of Medicine. Lauren Alfred is policy director at the Kennedy Forum.

Dr. Griffith: There’s also the training of our educators. There has been too much focus simply on counting symptoms. If you have sleep problems, if you have no energy, if you’re not enjoying things, then you have depression. That kind of definition of depression catches too many different things that shouldn’t be addressed in the same way.

“There has been too much focus simply on counting symptoms.”
– Dr. James GriffithThat’s distress. In primary care there are a lot of people with, often, very malignant mood disorders – major depression, bipolar disorder. They generally need not just a prescription; they need a program. Medication may be part of it. It also needs to address lifestyle. It also needs to address relationship problems. Many different things, which if done well can help people live good lives without being held hostage to having a psychiatric diagnosis.

When I said distress – these are not mental illnesses, but yet it all gets called depression. Often in the public discussions, it’s treated – “We just need to identify the depressed patients, give them medications.” That serves few people well. There are ways of doing very effective, targeted work depending upon, initially, an accurate assessment of what is the problem. Is it demoralization? Is it grief? Is this a relationship that is abusive, for example?

Now the other piece - and this is a big one. This is one that we’ve got to figure out how to address, and this is no different in the Middle East, where I’m doing work, as it is here. People come into primary care complaining of dizziness, headaches, physical pain problems, not sleeping well, fatigue. Wherever in the world you’ll go, what they get is a lot of tests, vitamins – not identifying or addressing that underneath this there is psychological distress or a mental illness driving it.

This puts a focus on detection and formulation of the problem. You’re right, the doctors aren’t going to do all the treatment, but this is where the doctor pretty much does have to do, on the front end, the identification. That’s our training issue.
 

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, an editorial board member for Clinical Psychiatry News, and assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs at G.W. University School of Medicine & Health Sciences, and the medical director of psychiatric and behavioral services at G.W.U. Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington,  and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine in Baltimore and at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Dr. Pickar: Let me just say one thing about that training issue and so forth. There is a common ground in primary care medicine and psychiatry and that is the patient. You guys in primary care, you know patients. We do not use – I use stethoscopes – to make me feel like an internist again.

However, we psychiatrists really do not have to.

Whitney: Is that like “I’m not a doctor but I play one on TV”?

Dr. Pickar: I do that one, too, but in fact the real first step of evidence-based medicine is the patient. You just described it beautifully. Sometimes, I feel badly if the primary physician does not give him or herself credit for that first line of clinical observation. It is huge. Affect is the feeling state. You observe the affect: “He looks down or agitated, anxious.” That is affect, whereas the symptoms are if he is feeling sad, feeling anxious. That is what you do for a living, you find out these things. You get that piece going. We know we psychiatrists are going to need help in that direction. The issue around reimbursement for psychiatry and so forth, I am going to take a deep breath on that one.

I have plenty of feelings about that, but I just want to make sure that the primary care physician that may be watching this understands that he or she is not just the first line but he or she has good skills at observing the first pass what is going on with a patient.

Dr. Norris: Not only are they the first line, but frequently, if you are the person the patient has the relationship with – Dr. Beard, Dr. Barbour – the patient is more inclined to listen to you than to just some random specialist you refer them to.

Dr. Pickar: On the other side of that, even when you have collaborated with a primary care doctor, and times are changing and the meds are tricky, I like to be able to talk to the primary care person and say “Look, I am thinking this way …” The primary doctor might say, “I saw them and they were not looking bad,” that is helpful to hear, or “Yeah, boy we need to ...” That is helpful.

Dr. Norris: Not just a digital note on a shared electronic medical records. Talk … dialogue. There is a difference. This is an important point, there is a difference between clinicians dialogue on a shared patient versus I am reading your notes and you are reading my notes. I do not consider that dialogue.
 

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, an editorial board member for Clinical Psychiatry News, and assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs at G.W. University School of Medicine & Health Sciences, and the medical director of psychiatric and behavioral services at G.W.U. Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington,  and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine in Baltimore and at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Dr. Pickar: Let me just say one thing about that training issue and so forth. There is a common ground in primary care medicine and psychiatry and that is the patient. You guys in primary care, you know patients. We do not use – I use stethoscopes – to make me feel like an internist again.

However, we psychiatrists really do not have to.

Whitney: Is that like “I’m not a doctor but I play one on TV”?

Dr. Pickar: I do that one, too, but in fact the real first step of evidence-based medicine is the patient. You just described it beautifully. Sometimes, I feel badly if the primary physician does not give him or herself credit for that first line of clinical observation. It is huge. Affect is the feeling state. You observe the affect: “He looks down or agitated, anxious.” That is affect, whereas the symptoms are if he is feeling sad, feeling anxious. That is what you do for a living, you find out these things. You get that piece going. We know we psychiatrists are going to need help in that direction. The issue around reimbursement for psychiatry and so forth, I am going to take a deep breath on that one.

I have plenty of feelings about that, but I just want to make sure that the primary care physician that may be watching this understands that he or she is not just the first line but he or she has good skills at observing the first pass what is going on with a patient.

Dr. Norris: Not only are they the first line, but frequently, if you are the person the patient has the relationship with – Dr. Beard, Dr. Barbour – the patient is more inclined to listen to you than to just some random specialist you refer them to.

Dr. Pickar: On the other side of that, even when you have collaborated with a primary care doctor, and times are changing and the meds are tricky, I like to be able to talk to the primary care person and say “Look, I am thinking this way …” The primary doctor might say, “I saw them and they were not looking bad,” that is helpful to hear, or “Yeah, boy we need to ...” That is helpful.

Dr. Norris: Not just a digital note on a shared electronic medical records. Talk … dialogue. There is a difference. This is an important point, there is a difference between clinicians dialogue on a shared patient versus I am reading your notes and you are reading my notes. I do not consider that dialogue.
 

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, an editorial board member for Clinical Psychiatry News, and assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs at G.W. University School of Medicine & Health Sciences, and the medical director of psychiatric and behavioral services at G.W.U. Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington,  and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine in Baltimore and at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Dr. Pickar: Let me just say one thing about that training issue and so forth. There is a common ground in primary care medicine and psychiatry and that is the patient. You guys in primary care, you know patients. We do not use – I use stethoscopes – to make me feel like an internist again.

However, we psychiatrists really do not have to.

Whitney: Is that like “I’m not a doctor but I play one on TV”?

Dr. Pickar: I do that one, too, but in fact the real first step of evidence-based medicine is the patient. You just described it beautifully. Sometimes, I feel badly if the primary physician does not give him or herself credit for that first line of clinical observation. It is huge. Affect is the feeling state. You observe the affect: “He looks down or agitated, anxious.” That is affect, whereas the symptoms are if he is feeling sad, feeling anxious. That is what you do for a living, you find out these things. You get that piece going. We know we psychiatrists are going to need help in that direction. The issue around reimbursement for psychiatry and so forth, I am going to take a deep breath on that one.

I have plenty of feelings about that, but I just want to make sure that the primary care physician that may be watching this understands that he or she is not just the first line but he or she has good skills at observing the first pass what is going on with a patient.

Dr. Norris: Not only are they the first line, but frequently, if you are the person the patient has the relationship with – Dr. Beard, Dr. Barbour – the patient is more inclined to listen to you than to just some random specialist you refer them to.

Dr. Pickar: On the other side of that, even when you have collaborated with a primary care doctor, and times are changing and the meds are tricky, I like to be able to talk to the primary care person and say “Look, I am thinking this way …” The primary doctor might say, “I saw them and they were not looking bad,” that is helpful to hear, or “Yeah, boy we need to ...” That is helpful.

Dr. Norris: Not just a digital note on a shared electronic medical records. Talk … dialogue. There is a difference. This is an important point, there is a difference between clinicians dialogue on a shared patient versus I am reading your notes and you are reading my notes. I do not consider that dialogue.
 

People in this video: Dr. James Griffith, the Leon M. Yochelson Professor of Psychiatry and Behavioral Sciences, and chair of psychiatry and psychosomatic medicine at George Washington University School of Medicine, Washington; Whitney McKnight, cohost and producer of Mental Health Consult.

Whitney: I think we need to step back and define mental illness. For that, I’m going to go to you, Griff, because I think it’s important that we remember not all primary care doctors really do have an understanding of the nuances to definitions of mental health.

You and I were having a discussion about “How do you define depression?” There’s clinical diagnosis of it, but then there are other ways that it gets used.

Dr. James Griffith: There’s a big push in medical education to shorten it, to do more in less time, but this is complex. There has not been much acknowledgment of the complexity. I’ll give you two difficult scenarios.

“Huge numbers of people treated in primary care who would have high scores on the PHQ-9 are in fact just lonely.” – Dr. James GriffithOne is disorder versus distress. If you simply download a Patient Health Questionnaire-9 off the Internet, give it to people: They have a high score; we say they’re depressed, give them an antidepressant. Huge numbers of people in primary care who would have high depression scores, in fact, are lonely; they’re in abusive relationships; they’re grieving losses; they are demoralized because their aspirations in life won’t take place – none of these problems are helped by an antidepressant.

Medical students, or for that matter, psychiatry residents, are not well taught in how to distinguish disorder from distress. All of these are solvable problems. There’s sort of a myth of the depressed patient that if only we would recognize depressed people, give them a prescription, everything would be okay, but it doesn’t.

Whitney: How do you teach that, then? What is missing in the curriculum?

Dr. Griffith: It’s a little bit like what Dr. Kirschner said about money and teams. You don’t have teams, if you don’t have funding. You don’t have teaching, if you don’t have time, and that’s one of our first issues.

People in this video: Dr. James Griffith, the Leon M. Yochelson Professor of Psychiatry and Behavioral Sciences, and chair of psychiatry and psychosomatic medicine at George Washington University School of Medicine, Washington; Whitney McKnight, cohost and producer of Mental Health Consult.

Whitney: I think we need to step back and define mental illness. For that, I’m going to go to you, Griff, because I think it’s important that we remember not all primary care doctors really do have an understanding of the nuances to definitions of mental health.

You and I were having a discussion about “How do you define depression?” There’s clinical diagnosis of it, but then there are other ways that it gets used.

Dr. James Griffith: There’s a big push in medical education to shorten it, to do more in less time, but this is complex. There has not been much acknowledgment of the complexity. I’ll give you two difficult scenarios.

“Huge numbers of people treated in primary care who would have high scores on the PHQ-9 are in fact just lonely.” – Dr. James GriffithOne is disorder versus distress. If you simply download a Patient Health Questionnaire-9 off the Internet, give it to people: They have a high score; we say they’re depressed, give them an antidepressant. Huge numbers of people in primary care who would have high depression scores, in fact, are lonely; they’re in abusive relationships; they’re grieving losses; they are demoralized because their aspirations in life won’t take place – none of these problems are helped by an antidepressant.

Medical students, or for that matter, psychiatry residents, are not well taught in how to distinguish disorder from distress. All of these are solvable problems. There’s sort of a myth of the depressed patient that if only we would recognize depressed people, give them a prescription, everything would be okay, but it doesn’t.

Whitney: How do you teach that, then? What is missing in the curriculum?

Dr. Griffith: It’s a little bit like what Dr. Kirschner said about money and teams. You don’t have teams, if you don’t have funding. You don’t have teaching, if you don’t have time, and that’s one of our first issues.

People in this video: Dr. James Griffith, the Leon M. Yochelson Professor of Psychiatry and Behavioral Sciences, and chair of psychiatry and psychosomatic medicine at George Washington University School of Medicine, Washington; Whitney McKnight, cohost and producer of Mental Health Consult.

Whitney: I think we need to step back and define mental illness. For that, I’m going to go to you, Griff, because I think it’s important that we remember not all primary care doctors really do have an understanding of the nuances to definitions of mental health.

You and I were having a discussion about “How do you define depression?” There’s clinical diagnosis of it, but then there are other ways that it gets used.

Dr. James Griffith: There’s a big push in medical education to shorten it, to do more in less time, but this is complex. There has not been much acknowledgment of the complexity. I’ll give you two difficult scenarios.

“Huge numbers of people treated in primary care who would have high scores on the PHQ-9 are in fact just lonely.” – Dr. James GriffithOne is disorder versus distress. If you simply download a Patient Health Questionnaire-9 off the Internet, give it to people: They have a high score; we say they’re depressed, give them an antidepressant. Huge numbers of people in primary care who would have high depression scores, in fact, are lonely; they’re in abusive relationships; they’re grieving losses; they are demoralized because their aspirations in life won’t take place – none of these problems are helped by an antidepressant.

Medical students, or for that matter, psychiatry residents, are not well taught in how to distinguish disorder from distress. All of these are solvable problems. There’s sort of a myth of the depressed patient that if only we would recognize depressed people, give them a prescription, everything would be okay, but it doesn’t.

Whitney: How do you teach that, then? What is missing in the curriculum?

Dr. Griffith: It’s a little bit like what Dr. Kirschner said about money and teams. You don’t have teams, if you don’t have funding. You don’t have teaching, if you don’t have time, and that’s one of our first issues.

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, editorial board member of Clinical Psychiatry News and cohost of Mental Health Consult, and assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs at G.W. University School of Medicine & Health Sciences, and the medical director of psychiatric and behavioral services at G.W.U. Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington, and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine, Baltimore, and at the Uniformed Services University of the Health Sciences in Bethesda, Md.; Dr. April Barbour, an associate professor of medicine and the director of general internal medicine and of the primary care residency program at G.W.U. School of Medicine, Washington.

Dr. Beard: This is one of the major frustrations. You've hit it right on the head. I will take anywhere from 45-50 minutes to do this, and I will have others who are waiting in my reception area or I will have a tap on the door. It takes that kind of time and the unfortunate thing is, I am never adequately reimbursed for the time that it really takes. Often, what I do is ask my front desk to screen patients when they call. If they say it is a routine check-up, the front desk knows to ask, "Are there any particular concerns that you have this year. Anything you would like the doctor to focus on?" If they do, then what I have to do is block out three of my regular times and that is very costly.
 
Whitney: As we move into a world in which it is not fee-for-service—based and “I think if it’s possible to have a mental health professional on site [in your practice], it is a win-win situation.” – Dr. Lillian Beardwe have to create these new metrics, I say “we,” but the health care system is moving toward setting up new accountable care organizations or other sorts of bundle payments. When we have the new legislation take effect, the MACRA (Medicaid Access and CHIP Reauthorization Act) legislation, are you building into the metrics that you are going to be reimbursed through your third-party payers to include these 50-minute sessions or is there no way to do that?

Dr. Beard: I do not know of a way to do it. I really do not.

Whitney: How is that going to impact outcomes and reimbursement?

Dr. Beard: Well, it is definitely going to impact outcomes. One of the areas of interest that I have is the feasibility of having a mental health specialist in my actual primary care site. Even if it is for a few segments a week, it would be a tremendous help. Just having that individual present removes certain barriers. For example, there are times that, even during the primary care encounter, the mental health specialist is able to say to the patient’s parents, “We’ll be glad to make an appointment and discuss that with you at a future time, so we can go more in depth.” Just that introduction lowers the barrier. Otherwise, there is more resistance if I say, “I am going to refer you to Dr. Pickar he is an associate who…” They object, and want to know, “Well, what kind of doctor is Dr. Pickar? He is a psychiatrist?”  It depends on what association they have with the word “psychiatrist.” The parents might object, “My kid’s not crazy.” I have to explain that this is a mental health disorder that we can do something about, and the psychiatrist is going to assist us with that.

Dr. Pickar: That is a great model.

Whitney: Yes but is it feasible with all the new legislation that is coming down the line?

Dr. Barbour: I think there are very dramatic differences between the pediatric model of care, which tends to be more wraparound care that you are describing; (should this be “that” or “than”?) and the adult model of care, which is more consumer driven and in which we expect a lot of our patients. We find particularly that young people transitioning to their early 20s often have a hard time understanding how to interact in the adult model of care. Particularly the patients that we have worked on have had significant health problems, many of which include mental health disorders. The program that we put in place has some psychiatric services available in the clinic. That is not feasible – I think – in our current payment structure to do that everywhere, in all adult medicine clinics.

I think these patients are particularly vulnerable. They do not understand the health care systems. They come in with these diagnoses. You bring up ADHD and that is something an internist is not as comfortable in providing care for as you are, and that I think causes a lot of roadblocks for patients to get the medicines they need. It has worked well for them, but the new doctor is not as comfortable prescribing the medicine or making the diagnosis. There are issues around that.

Dr. Norris: This is one of points of the roundtable. Who should be delivering this treatment? If you can create a team based atmosphere where what Dr. Beard illustrated, just the introduction. "I want to introduce you to my colleague so that we can start treatment." That one element, just starting that can make a huge difference, but how do you make that fiscally viable? In the George Washington University Hospital Thriving After Cancer clinic, we used resident psychiatrist in training. These are senior-level residents who are very good at that or are supervised by a psychiatrist. If you were to put a psychiatrist in the TAC clinic and bill for their hours, it just would not work, Dr. Barbour is shaking her head like no way.

Dr. Barbour: I could not afford it.

Dr. Beard: What I am thinking is that this other professional, be it a psychiatrist or psychologist, a licensed clinical social worker, whatever, will have the capability of billing for his or her services. I think if it is possible to have that professional in your site it is a win/win situation.

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, editorial board member of Clinical Psychiatry News and cohost of Mental Health Consult, and assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs at G.W. University School of Medicine & Health Sciences, and the medical director of psychiatric and behavioral services at G.W.U. Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington, and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine, Baltimore, and at the Uniformed Services University of the Health Sciences in Bethesda, Md.; Dr. April Barbour, an associate professor of medicine and the director of general internal medicine and of the primary care residency program at G.W.U. School of Medicine, Washington.

Dr. Beard: This is one of the major frustrations. You've hit it right on the head. I will take anywhere from 45-50 minutes to do this, and I will have others who are waiting in my reception area or I will have a tap on the door. It takes that kind of time and the unfortunate thing is, I am never adequately reimbursed for the time that it really takes. Often, what I do is ask my front desk to screen patients when they call. If they say it is a routine check-up, the front desk knows to ask, "Are there any particular concerns that you have this year. Anything you would like the doctor to focus on?" If they do, then what I have to do is block out three of my regular times and that is very costly.
 
Whitney: As we move into a world in which it is not fee-for-service—based and “I think if it’s possible to have a mental health professional on site [in your practice], it is a win-win situation.” – Dr. Lillian Beardwe have to create these new metrics, I say “we,” but the health care system is moving toward setting up new accountable care organizations or other sorts of bundle payments. When we have the new legislation take effect, the MACRA (Medicaid Access and CHIP Reauthorization Act) legislation, are you building into the metrics that you are going to be reimbursed through your third-party payers to include these 50-minute sessions or is there no way to do that?

Dr. Beard: I do not know of a way to do it. I really do not.

Whitney: How is that going to impact outcomes and reimbursement?

Dr. Beard: Well, it is definitely going to impact outcomes. One of the areas of interest that I have is the feasibility of having a mental health specialist in my actual primary care site. Even if it is for a few segments a week, it would be a tremendous help. Just having that individual present removes certain barriers. For example, there are times that, even during the primary care encounter, the mental health specialist is able to say to the patient’s parents, “We’ll be glad to make an appointment and discuss that with you at a future time, so we can go more in depth.” Just that introduction lowers the barrier. Otherwise, there is more resistance if I say, “I am going to refer you to Dr. Pickar he is an associate who…” They object, and want to know, “Well, what kind of doctor is Dr. Pickar? He is a psychiatrist?”  It depends on what association they have with the word “psychiatrist.” The parents might object, “My kid’s not crazy.” I have to explain that this is a mental health disorder that we can do something about, and the psychiatrist is going to assist us with that.

Dr. Pickar: That is a great model.

Whitney: Yes but is it feasible with all the new legislation that is coming down the line?

Dr. Barbour: I think there are very dramatic differences between the pediatric model of care, which tends to be more wraparound care that you are describing; (should this be “that” or “than”?) and the adult model of care, which is more consumer driven and in which we expect a lot of our patients. We find particularly that young people transitioning to their early 20s often have a hard time understanding how to interact in the adult model of care. Particularly the patients that we have worked on have had significant health problems, many of which include mental health disorders. The program that we put in place has some psychiatric services available in the clinic. That is not feasible – I think – in our current payment structure to do that everywhere, in all adult medicine clinics.

I think these patients are particularly vulnerable. They do not understand the health care systems. They come in with these diagnoses. You bring up ADHD and that is something an internist is not as comfortable in providing care for as you are, and that I think causes a lot of roadblocks for patients to get the medicines they need. It has worked well for them, but the new doctor is not as comfortable prescribing the medicine or making the diagnosis. There are issues around that.

Dr. Norris: This is one of points of the roundtable. Who should be delivering this treatment? If you can create a team based atmosphere where what Dr. Beard illustrated, just the introduction. "I want to introduce you to my colleague so that we can start treatment." That one element, just starting that can make a huge difference, but how do you make that fiscally viable? In the George Washington University Hospital Thriving After Cancer clinic, we used resident psychiatrist in training. These are senior-level residents who are very good at that or are supervised by a psychiatrist. If you were to put a psychiatrist in the TAC clinic and bill for their hours, it just would not work, Dr. Barbour is shaking her head like no way.

Dr. Barbour: I could not afford it.

Dr. Beard: What I am thinking is that this other professional, be it a psychiatrist or psychologist, a licensed clinical social worker, whatever, will have the capability of billing for his or her services. I think if it is possible to have that professional in your site it is a win/win situation.

People in this video: Whitney McKnight, cohost and producer of Mental Health Consult; Dr. Lorenzo Norris, editorial board member of Clinical Psychiatry News and cohost of Mental Health Consult, and assistant professor of psychiatry and behavioral sciences, assistant dean of student affairs at G.W. University School of Medicine & Health Sciences, and the medical director of psychiatric and behavioral services at G.W.U. Hospital, Washington; Dr. Lillian Beard, pediatrician with Children’s National Hospital Network, Washington, and a Pediatric News editorial board member; Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins University School of Medicine, Baltimore, and at the Uniformed Services University of the Health Sciences in Bethesda, Md.; Dr. April Barbour, an associate professor of medicine and the director of general internal medicine and of the primary care residency program at G.W.U. School of Medicine, Washington.

Dr. Beard: This is one of the major frustrations. You've hit it right on the head. I will take anywhere from 45-50 minutes to do this, and I will have others who are waiting in my reception area or I will have a tap on the door. It takes that kind of time and the unfortunate thing is, I am never adequately reimbursed for the time that it really takes. Often, what I do is ask my front desk to screen patients when they call. If they say it is a routine check-up, the front desk knows to ask, "Are there any particular concerns that you have this year. Anything you would like the doctor to focus on?" If they do, then what I have to do is block out three of my regular times and that is very costly.
 
Whitney: As we move into a world in which it is not fee-for-service—based and “I think if it’s possible to have a mental health professional on site [in your practice], it is a win-win situation.” – Dr. Lillian Beardwe have to create these new metrics, I say “we,” but the health care system is moving toward setting up new accountable care organizations or other sorts of bundle payments. When we have the new legislation take effect, the MACRA (Medicaid Access and CHIP Reauthorization Act) legislation, are you building into the metrics that you are going to be reimbursed through your third-party payers to include these 50-minute sessions or is there no way to do that?

Dr. Beard: I do not know of a way to do it. I really do not.

Whitney: How is that going to impact outcomes and reimbursement?

Dr. Beard: Well, it is definitely going to impact outcomes. One of the areas of interest that I have is the feasibility of having a mental health specialist in my actual primary care site. Even if it is for a few segments a week, it would be a tremendous help. Just having that individual present removes certain barriers. For example, there are times that, even during the primary care encounter, the mental health specialist is able to say to the patient’s parents, “We’ll be glad to make an appointment and discuss that with you at a future time, so we can go more in depth.” Just that introduction lowers the barrier. Otherwise, there is more resistance if I say, “I am going to refer you to Dr. Pickar he is an associate who…” They object, and want to know, “Well, what kind of doctor is Dr. Pickar? He is a psychiatrist?”  It depends on what association they have with the word “psychiatrist.” The parents might object, “My kid’s not crazy.” I have to explain that this is a mental health disorder that we can do something about, and the psychiatrist is going to assist us with that.

Dr. Pickar: That is a great model.

Whitney: Yes but is it feasible with all the new legislation that is coming down the line?

Dr. Barbour: I think there are very dramatic differences between the pediatric model of care, which tends to be more wraparound care that you are describing; (should this be “that” or “than”?) and the adult model of care, which is more consumer driven and in which we expect a lot of our patients. We find particularly that young people transitioning to their early 20s often have a hard time understanding how to interact in the adult model of care. Particularly the patients that we have worked on have had significant health problems, many of which include mental health disorders. The program that we put in place has some psychiatric services available in the clinic. That is not feasible – I think – in our current payment structure to do that everywhere, in all adult medicine clinics.

I think these patients are particularly vulnerable. They do not understand the health care systems. They come in with these diagnoses. You bring up ADHD and that is something an internist is not as comfortable in providing care for as you are, and that I think causes a lot of roadblocks for patients to get the medicines they need. It has worked well for them, but the new doctor is not as comfortable prescribing the medicine or making the diagnosis. There are issues around that.

Dr. Norris: This is one of points of the roundtable. Who should be delivering this treatment? If you can create a team based atmosphere where what Dr. Beard illustrated, just the introduction. "I want to introduce you to my colleague so that we can start treatment." That one element, just starting that can make a huge difference, but how do you make that fiscally viable? In the George Washington University Hospital Thriving After Cancer clinic, we used resident psychiatrist in training. These are senior-level residents who are very good at that or are supervised by a psychiatrist. If you were to put a psychiatrist in the TAC clinic and bill for their hours, it just would not work, Dr. Barbour is shaking her head like no way.

Dr. Barbour: I could not afford it.

Dr. Beard: What I am thinking is that this other professional, be it a psychiatrist or psychologist, a licensed clinical social worker, whatever, will have the capability of billing for his or her services. I think if it is possible to have that professional in your site it is a win/win situation.

When I think of the word “relationship,” I imagine gazing into the loving eyes of my husband, playing hide and seek with my children, or texting my best friend for no good reason other than to just say hello.

There is a special comfort zone we expect from people who are close to us; a feeling of love and acceptance that we can’t find elsewhere.

But in a much broader sense, our important relationships extend far beyond our inner circle to include every single person who is involved with our health care team. Our team includes the hospital executives who create new safety initiatives, develop budgets, and oversee a host of other patient care and fiscal functions. The physical therapists who evaluate our patients and make recommendations on how to safely transition them out of the hospital are on our team. The housekeepers who scrub the toilets and wash the linens to prevent nosocomial infections are on our team. They, along with many others, play a pivotal role in our patients’ care, although many important players make their impact behind the scenes.

Yet, of course, our most important professional relationships are not with the CEO, the pharmacist, or even the nursing staff. Our most important relationships are with our patients and their families. I recently attended an all-day conference on a little-known gem called Relationship-Based Care (RBC), a culture transformation and operational model that is gaining steam globally. The RBC model focuses not only on well-known metrics, such as patient safety, quality care, and patient satisfaction; it also emphasizes staff satisfaction by improving each and every relationship. Specifically, it creates therapeutic relationships between caregivers and the patients and families they serve, strengthens relationships between members of the health care team, and last, but certainly not least, it nurtures each caregiver’s relationship with himself or herself. What a novel, and much needed concept!

Numerous hospitals that have implemented this training model have achieved impressive outcomes, including significant improvement in HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, and staff satisfaction survey scores so high that one hospital gained national recognition as one of the best places to work in America.

I look forward to future training on RBC and am glad to see that addressing the needs of caregivers, not just care receivers, is starting to take center stage, as it rightfully should. After all, how can we give our all to our patients when we are not whole?

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

When I think of the word “relationship,” I imagine gazing into the loving eyes of my husband, playing hide and seek with my children, or texting my best friend for no good reason other than to just say hello.

There is a special comfort zone we expect from people who are close to us; a feeling of love and acceptance that we can’t find elsewhere.

But in a much broader sense, our important relationships extend far beyond our inner circle to include every single person who is involved with our health care team. Our team includes the hospital executives who create new safety initiatives, develop budgets, and oversee a host of other patient care and fiscal functions. The physical therapists who evaluate our patients and make recommendations on how to safely transition them out of the hospital are on our team. The housekeepers who scrub the toilets and wash the linens to prevent nosocomial infections are on our team. They, along with many others, play a pivotal role in our patients’ care, although many important players make their impact behind the scenes.

Yet, of course, our most important professional relationships are not with the CEO, the pharmacist, or even the nursing staff. Our most important relationships are with our patients and their families. I recently attended an all-day conference on a little-known gem called Relationship-Based Care (RBC), a culture transformation and operational model that is gaining steam globally. The RBC model focuses not only on well-known metrics, such as patient safety, quality care, and patient satisfaction; it also emphasizes staff satisfaction by improving each and every relationship. Specifically, it creates therapeutic relationships between caregivers and the patients and families they serve, strengthens relationships between members of the health care team, and last, but certainly not least, it nurtures each caregiver’s relationship with himself or herself. What a novel, and much needed concept!

Numerous hospitals that have implemented this training model have achieved impressive outcomes, including significant improvement in HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, and staff satisfaction survey scores so high that one hospital gained national recognition as one of the best places to work in America.

I look forward to future training on RBC and am glad to see that addressing the needs of caregivers, not just care receivers, is starting to take center stage, as it rightfully should. After all, how can we give our all to our patients when we are not whole?

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

When I think of the word “relationship,” I imagine gazing into the loving eyes of my husband, playing hide and seek with my children, or texting my best friend for no good reason other than to just say hello.

There is a special comfort zone we expect from people who are close to us; a feeling of love and acceptance that we can’t find elsewhere.

But in a much broader sense, our important relationships extend far beyond our inner circle to include every single person who is involved with our health care team. Our team includes the hospital executives who create new safety initiatives, develop budgets, and oversee a host of other patient care and fiscal functions. The physical therapists who evaluate our patients and make recommendations on how to safely transition them out of the hospital are on our team. The housekeepers who scrub the toilets and wash the linens to prevent nosocomial infections are on our team. They, along with many others, play a pivotal role in our patients’ care, although many important players make their impact behind the scenes.

Yet, of course, our most important professional relationships are not with the CEO, the pharmacist, or even the nursing staff. Our most important relationships are with our patients and their families. I recently attended an all-day conference on a little-known gem called Relationship-Based Care (RBC), a culture transformation and operational model that is gaining steam globally. The RBC model focuses not only on well-known metrics, such as patient safety, quality care, and patient satisfaction; it also emphasizes staff satisfaction by improving each and every relationship. Specifically, it creates therapeutic relationships between caregivers and the patients and families they serve, strengthens relationships between members of the health care team, and last, but certainly not least, it nurtures each caregiver’s relationship with himself or herself. What a novel, and much needed concept!

Numerous hospitals that have implemented this training model have achieved impressive outcomes, including significant improvement in HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, and staff satisfaction survey scores so high that one hospital gained national recognition as one of the best places to work in America.

I look forward to future training on RBC and am glad to see that addressing the needs of caregivers, not just care receivers, is starting to take center stage, as it rightfully should. After all, how can we give our all to our patients when we are not whole?

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Radiography detected up to 16% of cases of hip osteoarthritis among older patients with frequent hip pain in an analysis of participants in the Framingham Osteoarthritis Study and the Osteoarthritis Initiative.

“In older patients, inadequate recognition of osteoarthritis has consequences. Decreased functional status from osteoarthritis significantly increases morbidity from coronary heart disease, lung disease, diabetes, obesity, falls, frailty, and various other ailments,” said Dr. Chan Kim of Boston University and his associates. “Because many patients with hip pain do not have radiographic hip osteoarthritis, a health professional should continue with the evaluation and treatment of osteoarthritis, despite negative radiographic findings.”

© iStock / ThinkStockPhotos.com

Radiographic pathology often is detected late in the course of knee OA and correlates poorly with knee pain, but few studies have examined these trends for the hip. The researchers analyzed pelvic radiographs and hip pain among 946 participants in the Framingham Osteoarthritis Study and 4,366 participants in the Osteoarthritis Initiative. They defined radiographic hip OA as a Kellgren-Lawrence grade of 2 or more – that is, definite superolateral or superomedial joint space narrowing and a definite osteophyte. They used various clinical symptoms of hip OA for comparison. Participants in both studies were older than 45 years, and tended to be in their early 60s (BMJ 2015 Dec 2. doi: 10.1136/bmj.h5983).

The most sensitive criterion in the study was groin pain, for which radiography was positive in 37% of hips in the Framingham Study and 17% of hips in the Osteoarthritis Initiative, the researchers said. Other clinical criteria were less sensitive, including anterior thigh pain, frequent hip pain, and painful internal rotation. Moreover, about 21%-24% of hips with radiographic OA were frequently painful.

The study did not evaluate MRI findings, the investigators noted. They suggested that such results would resemble those for the knee, in which MRI is “more sensitive than radiography, [but] it is far less specific for abnormalities suggestive of osteoarthritis in most middle-aged and older people.”

The National Institute of Arthritis and Musculoskeletal and Skin Diseases funded the study. The Osteoarthritis Initiative is funded by the National Institutes of Health, Merck Research Laboratories, Novartis, GlaxoSmithKline, and Pfizer. The researchers had no disclosures.

Radiography detected up to 16% of cases of hip osteoarthritis among older patients with frequent hip pain in an analysis of participants in the Framingham Osteoarthritis Study and the Osteoarthritis Initiative.

“In older patients, inadequate recognition of osteoarthritis has consequences. Decreased functional status from osteoarthritis significantly increases morbidity from coronary heart disease, lung disease, diabetes, obesity, falls, frailty, and various other ailments,” said Dr. Chan Kim of Boston University and his associates. “Because many patients with hip pain do not have radiographic hip osteoarthritis, a health professional should continue with the evaluation and treatment of osteoarthritis, despite negative radiographic findings.”

© iStock / ThinkStockPhotos.com

Radiographic pathology often is detected late in the course of knee OA and correlates poorly with knee pain, but few studies have examined these trends for the hip. The researchers analyzed pelvic radiographs and hip pain among 946 participants in the Framingham Osteoarthritis Study and 4,366 participants in the Osteoarthritis Initiative. They defined radiographic hip OA as a Kellgren-Lawrence grade of 2 or more – that is, definite superolateral or superomedial joint space narrowing and a definite osteophyte. They used various clinical symptoms of hip OA for comparison. Participants in both studies were older than 45 years, and tended to be in their early 60s (BMJ 2015 Dec 2. doi: 10.1136/bmj.h5983).

The most sensitive criterion in the study was groin pain, for which radiography was positive in 37% of hips in the Framingham Study and 17% of hips in the Osteoarthritis Initiative, the researchers said. Other clinical criteria were less sensitive, including anterior thigh pain, frequent hip pain, and painful internal rotation. Moreover, about 21%-24% of hips with radiographic OA were frequently painful.

The study did not evaluate MRI findings, the investigators noted. They suggested that such results would resemble those for the knee, in which MRI is “more sensitive than radiography, [but] it is far less specific for abnormalities suggestive of osteoarthritis in most middle-aged and older people.”

The National Institute of Arthritis and Musculoskeletal and Skin Diseases funded the study. The Osteoarthritis Initiative is funded by the National Institutes of Health, Merck Research Laboratories, Novartis, GlaxoSmithKline, and Pfizer. The researchers had no disclosures.

Radiography detected up to 16% of cases of hip osteoarthritis among older patients with frequent hip pain in an analysis of participants in the Framingham Osteoarthritis Study and the Osteoarthritis Initiative.

“In older patients, inadequate recognition of osteoarthritis has consequences. Decreased functional status from osteoarthritis significantly increases morbidity from coronary heart disease, lung disease, diabetes, obesity, falls, frailty, and various other ailments,” said Dr. Chan Kim of Boston University and his associates. “Because many patients with hip pain do not have radiographic hip osteoarthritis, a health professional should continue with the evaluation and treatment of osteoarthritis, despite negative radiographic findings.”

© iStock / ThinkStockPhotos.com

Radiographic pathology often is detected late in the course of knee OA and correlates poorly with knee pain, but few studies have examined these trends for the hip. The researchers analyzed pelvic radiographs and hip pain among 946 participants in the Framingham Osteoarthritis Study and 4,366 participants in the Osteoarthritis Initiative. They defined radiographic hip OA as a Kellgren-Lawrence grade of 2 or more – that is, definite superolateral or superomedial joint space narrowing and a definite osteophyte. They used various clinical symptoms of hip OA for comparison. Participants in both studies were older than 45 years, and tended to be in their early 60s (BMJ 2015 Dec 2. doi: 10.1136/bmj.h5983).

The most sensitive criterion in the study was groin pain, for which radiography was positive in 37% of hips in the Framingham Study and 17% of hips in the Osteoarthritis Initiative, the researchers said. Other clinical criteria were less sensitive, including anterior thigh pain, frequent hip pain, and painful internal rotation. Moreover, about 21%-24% of hips with radiographic OA were frequently painful.

The study did not evaluate MRI findings, the investigators noted. They suggested that such results would resemble those for the knee, in which MRI is “more sensitive than radiography, [but] it is far less specific for abnormalities suggestive of osteoarthritis in most middle-aged and older people.”

The National Institute of Arthritis and Musculoskeletal and Skin Diseases funded the study. The Osteoarthritis Initiative is funded by the National Institutes of Health, Merck Research Laboratories, Novartis, GlaxoSmithKline, and Pfizer. The researchers had no disclosures.

Lateral wedge insoles worn by people with medial knee osteoarthritis (OA) provide a limited amount of immediate biomechanical improvement during walking and may be best suited to people who have biomechanical phenotypes that would benefit the most, according to findings from a systematic review and meta-analysis of studies examining the intraindividual effects of the insoles.

“This review is ... the most definitive, up-to-date and comprehensive analysis on this issue to clarify the effects of lateral wedge insoles on biomechanical risk factors for knee OA progression,” wrote lead investigator John Arnold, Ph.D., of the University of South Australia, Adelaide, and his colleagues (Arthritis Care Res. 2015 Nov 25. doi: 10.1002/acr.22797).

Courtesy National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The investigators reviewed 18 studies with a total of 534 participants and found small, but statistically significant reductions in estimates of knee joint loading based on the surrogate measures of external knee adduction moment (EKAM) and the knee adduction angular impulse (KAAI).

Most studies (14) tested full-length insoles, and the remaining four allowed a customized amount based on comfort and/or pain level. Another two used heel wedges, and two others tested both. The inclination angle of the insoles was most commonly 5 degrees, but ranged from 4 to 11 degrees. Some studies used a concomitant medial arch support; these were of a generic design in four studies and were made to order in another three. The lateral wedge insoles were compared against flat insoles, the patients’ own footwear, or standardized footwear.

The pooled effect sizes of both the first and second peak EKAM reductions were small, with standard mean differences of –0.20 to –0.25. For the first EKAM, the effect sizes did not vary according to whether studies used flat insoles or shoes only as comparators, whereas for the eight studies that reported second EKAM outcomes, there was a larger pooled effect size for comparisons against shoe-only than for one study that made flat insole comparisons. The pooled estimate for the standard mean difference in nine studies that reported KAAI was –0.14.

There was only weak evidence for publication bias in all the comparisons for the surrogate measures, and most had a low level of statistical heterogeneity between the outcomes of the studies.

The investigators noted that this meta-analysis of surrogate measures for knee joint loading does not take cumulative loading into account, so that even though the reduction in peak EKAM and KAAI was small, it may amount “to a large cumulative effect imparted on the knee over the course of the day. This should be considered when interpreting the findings of this review and future research on load modifying interventions in knee osteoarthritis.” They said that while EKAM has been associated with OA progression, KAAI has been thought to be a better measure of the duration and magnitude of loading in knee OA and has been associated with medial tibiofemoral cartilage loss over 1-2 years.

“Prescription [for lateral wedge insoles] based on biomechanical response and use of insoles only in individuals who show reductions in knee joint loading (biomechanical phenotypes) appears more appropriate to increase the likelihood of a favorable long-term response regarding the attenuation of structural changes. This would limit their application and benefit to a smaller number of individuals, but is still likely to be significant considering the overall prevalence of knee OA and projected rise due to population aging and rising obesity levels,” the authors concluded.

The investigators had no outside funding source for their systematic review. One of the authors may receive royalties from Salford Insole, a manufacturer of lateral wedge insoles.

[email protected]

Lateral wedge insoles worn by people with medial knee osteoarthritis (OA) provide a limited amount of immediate biomechanical improvement during walking and may be best suited to people who have biomechanical phenotypes that would benefit the most, according to findings from a systematic review and meta-analysis of studies examining the intraindividual effects of the insoles.

“This review is ... the most definitive, up-to-date and comprehensive analysis on this issue to clarify the effects of lateral wedge insoles on biomechanical risk factors for knee OA progression,” wrote lead investigator John Arnold, Ph.D., of the University of South Australia, Adelaide, and his colleagues (Arthritis Care Res. 2015 Nov 25. doi: 10.1002/acr.22797).

Courtesy National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The investigators reviewed 18 studies with a total of 534 participants and found small, but statistically significant reductions in estimates of knee joint loading based on the surrogate measures of external knee adduction moment (EKAM) and the knee adduction angular impulse (KAAI).

Most studies (14) tested full-length insoles, and the remaining four allowed a customized amount based on comfort and/or pain level. Another two used heel wedges, and two others tested both. The inclination angle of the insoles was most commonly 5 degrees, but ranged from 4 to 11 degrees. Some studies used a concomitant medial arch support; these were of a generic design in four studies and were made to order in another three. The lateral wedge insoles were compared against flat insoles, the patients’ own footwear, or standardized footwear.

The pooled effect sizes of both the first and second peak EKAM reductions were small, with standard mean differences of –0.20 to –0.25. For the first EKAM, the effect sizes did not vary according to whether studies used flat insoles or shoes only as comparators, whereas for the eight studies that reported second EKAM outcomes, there was a larger pooled effect size for comparisons against shoe-only than for one study that made flat insole comparisons. The pooled estimate for the standard mean difference in nine studies that reported KAAI was –0.14.

There was only weak evidence for publication bias in all the comparisons for the surrogate measures, and most had a low level of statistical heterogeneity between the outcomes of the studies.

The investigators noted that this meta-analysis of surrogate measures for knee joint loading does not take cumulative loading into account, so that even though the reduction in peak EKAM and KAAI was small, it may amount “to a large cumulative effect imparted on the knee over the course of the day. This should be considered when interpreting the findings of this review and future research on load modifying interventions in knee osteoarthritis.” They said that while EKAM has been associated with OA progression, KAAI has been thought to be a better measure of the duration and magnitude of loading in knee OA and has been associated with medial tibiofemoral cartilage loss over 1-2 years.

“Prescription [for lateral wedge insoles] based on biomechanical response and use of insoles only in individuals who show reductions in knee joint loading (biomechanical phenotypes) appears more appropriate to increase the likelihood of a favorable long-term response regarding the attenuation of structural changes. This would limit their application and benefit to a smaller number of individuals, but is still likely to be significant considering the overall prevalence of knee OA and projected rise due to population aging and rising obesity levels,” the authors concluded.

The investigators had no outside funding source for their systematic review. One of the authors may receive royalties from Salford Insole, a manufacturer of lateral wedge insoles.

[email protected]

Lateral wedge insoles worn by people with medial knee osteoarthritis (OA) provide a limited amount of immediate biomechanical improvement during walking and may be best suited to people who have biomechanical phenotypes that would benefit the most, according to findings from a systematic review and meta-analysis of studies examining the intraindividual effects of the insoles.

“This review is ... the most definitive, up-to-date and comprehensive analysis on this issue to clarify the effects of lateral wedge insoles on biomechanical risk factors for knee OA progression,” wrote lead investigator John Arnold, Ph.D., of the University of South Australia, Adelaide, and his colleagues (Arthritis Care Res. 2015 Nov 25. doi: 10.1002/acr.22797).

Courtesy National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The investigators reviewed 18 studies with a total of 534 participants and found small, but statistically significant reductions in estimates of knee joint loading based on the surrogate measures of external knee adduction moment (EKAM) and the knee adduction angular impulse (KAAI).

Most studies (14) tested full-length insoles, and the remaining four allowed a customized amount based on comfort and/or pain level. Another two used heel wedges, and two others tested both. The inclination angle of the insoles was most commonly 5 degrees, but ranged from 4 to 11 degrees. Some studies used a concomitant medial arch support; these were of a generic design in four studies and were made to order in another three. The lateral wedge insoles were compared against flat insoles, the patients’ own footwear, or standardized footwear.

The pooled effect sizes of both the first and second peak EKAM reductions were small, with standard mean differences of –0.20 to –0.25. For the first EKAM, the effect sizes did not vary according to whether studies used flat insoles or shoes only as comparators, whereas for the eight studies that reported second EKAM outcomes, there was a larger pooled effect size for comparisons against shoe-only than for one study that made flat insole comparisons. The pooled estimate for the standard mean difference in nine studies that reported KAAI was –0.14.

There was only weak evidence for publication bias in all the comparisons for the surrogate measures, and most had a low level of statistical heterogeneity between the outcomes of the studies.

The investigators noted that this meta-analysis of surrogate measures for knee joint loading does not take cumulative loading into account, so that even though the reduction in peak EKAM and KAAI was small, it may amount “to a large cumulative effect imparted on the knee over the course of the day. This should be considered when interpreting the findings of this review and future research on load modifying interventions in knee osteoarthritis.” They said that while EKAM has been associated with OA progression, KAAI has been thought to be a better measure of the duration and magnitude of loading in knee OA and has been associated with medial tibiofemoral cartilage loss over 1-2 years.

“Prescription [for lateral wedge insoles] based on biomechanical response and use of insoles only in individuals who show reductions in knee joint loading (biomechanical phenotypes) appears more appropriate to increase the likelihood of a favorable long-term response regarding the attenuation of structural changes. This would limit their application and benefit to a smaller number of individuals, but is still likely to be significant considering the overall prevalence of knee OA and projected rise due to population aging and rising obesity levels,” the authors concluded.

The investigators had no outside funding source for their systematic review. One of the authors may receive royalties from Salford Insole, a manufacturer of lateral wedge insoles.

[email protected]