Receiving a statin prescription within a year after diagnosis of chronic obstructive pulmonary disease was associated with a 21% decrease in the subsequent risk of all-cause mortality and a 45% drop in risk of pulmonary mortality, according to the results of a large retrospective administrative database study.

The findings belie those of the recent Simvastatin in the Prevention of COPD Exacerbation (STATCOPE) trial, in which daily simvastatin (40 mg) did not affect exacerbation rates or time to first exacerbation in high-risk COPD patients, wrote Adam Raymakers, MSc, a doctoral candidate at the University of British Columbia, Vancouver, and his associates. Their study was observational, but the association between statin use and decreased mortality “persisted across several measures of statin exposure,” they wrote. “Our findings, in conjunction with previously reported evidence, suggests that there may be a specific subtype of COPD patients that may benefit from statin use.” The study appears in the September issue of Chest (2017;152;486-93).

copyright designer491/Thinkstock

Receiving a statin prescription within a year after diagnosis of chronic obstructive pulmonary disease was associated with a 21% decrease in the subsequent risk of all-cause mortality and a 45% drop in risk of pulmonary mortality, according to the results of a large retrospective administrative database study.

The findings belie those of the recent Simvastatin in the Prevention of COPD Exacerbation (STATCOPE) trial, in which daily simvastatin (40 mg) did not affect exacerbation rates or time to first exacerbation in high-risk COPD patients, wrote Adam Raymakers, MSc, a doctoral candidate at the University of British Columbia, Vancouver, and his associates. Their study was observational, but the association between statin use and decreased mortality “persisted across several measures of statin exposure,” they wrote. “Our findings, in conjunction with previously reported evidence, suggests that there may be a specific subtype of COPD patients that may benefit from statin use.” The study appears in the September issue of Chest (2017;152;486-93).

copyright designer491/Thinkstock

Receiving a statin prescription within a year after diagnosis of chronic obstructive pulmonary disease was associated with a 21% decrease in the subsequent risk of all-cause mortality and a 45% drop in risk of pulmonary mortality, according to the results of a large retrospective administrative database study.

The findings belie those of the recent Simvastatin in the Prevention of COPD Exacerbation (STATCOPE) trial, in which daily simvastatin (40 mg) did not affect exacerbation rates or time to first exacerbation in high-risk COPD patients, wrote Adam Raymakers, MSc, a doctoral candidate at the University of British Columbia, Vancouver, and his associates. Their study was observational, but the association between statin use and decreased mortality “persisted across several measures of statin exposure,” they wrote. “Our findings, in conjunction with previously reported evidence, suggests that there may be a specific subtype of COPD patients that may benefit from statin use.” The study appears in the September issue of Chest (2017;152;486-93).

copyright designer491/Thinkstock

While palliative care grows as an interdisciplinary specialty, more clinicians are asking how it can benefit certain patients with severe mental illness.

Palliative care, which developed with the founding of hospices in the 1960s, initially focused on patients who were dying from cancer. The specialty – which emphasizes improving patients’ quality of life rather than finding a cure, and which is different from hospice – can now be used for patients with noncancer diagnoses such as dementia and HIV/AIDS (Psychiatry. 2009 Jun;8[6]:212-15).

Some psychiatrists think that certain patients with another diagnosis would benefit from palliative care: those with severe persistent mental illness.

In fact, this approach might apply to psychiatric patients who are in long-term residential care with “severe/chronic schizophrenia and insufficient quality of life, those with therapy-refractory depressions and repeated suicide attempts, and those with severe long-standing therapy-refractory anorexia nervosa,” wrote Manuel Trachsel, MD, PhD, and his colleagues (BMC Psychiatry (2016 Jul 14:1-9).

Scott A. Irwin, MD, PhD, who coauthored that article and a letter examining these issues, said Dr. Trachsel’s theories lie on the frontiers of current thinking about incorporating palliative care and psychiatric medicine.

Meanwhile, both Dr. Irwin and Maria I. Lapid, MD, another psychiatrist with expertise in palliative care, said that in many ways, the field of psychiatry is inherently palliative in nature.
 

Palliative ‘approach’ in SPMI

Dr. Trachsel presented unpublished results from a survey of U.S. psychiatrists at the annual meeting of the American Psychiatric Association in May that sought to discern whether they favored supporting short-term quality of life rather than long-term disease modification in certain patients with severe and persistent mental illness (SPMI) – defined as mental illness that is chronic or recurring, requires ongoing intensive psychiatric treatment, and seriously impairs functioning.

Courtesy Dr. Trachsel

Futility difficult to define

Dr. Irwin said in an interview that the ideas in the letter (Lancet Psychiatry. 2016 Mar;3[3]:200) in which he and a few other colleagues collaborated with Dr. Trachsel were essentially “a thought experiment and very philosophical.” In addition, the letter, which proposed palliative psychiatry “as a means to improve quality of care, person-centeredness, and autonomy” for patients with SPMI, was supported by a handful of case studies, most of them in patients with end-stage anorexia, he said. Furthermore, end-of-life interventions are only a subset of what palliative care brings to the table, said Dr. Irwin, palliative care psychiatrist at Cedars-Sinai Health System’s Samuel Oschin Comprehensive Cancer Center in Los Angeles.

With a psychiatric illness, the goals are usually around symptom management and quality of life, and for certain palliative care interventions reserved for end-of-life situations, “there’s usually not something knocking at the door that’s putting that end-of-life question into focus,” Dr. Irwin said. To create end-of-life protocols for SPMI, “you would need to know what the prognosis and trajectory are of each stage of these illnesses. And we don’t have good evidence guiding us.

“If we have a patient who is depressed and wants to commit suicide, who knows how many years they could have left if we intervene?” said Dr. Irwin, who has mentored Dr. Trachsel. “If we had the data that this person’s 90% likely to complete a suicide within the next year, it might change the conversation and treatment decisions.”

Dr. Lapid, a board-certified practitioner of palliative and hospice medicine and geriatric psychiatry at the Mayo Clinic in Rochester, Minn., agreed in an interview that for patients with an SPMI and no life-limiting comorbidity, it becomes complicated to attempt to define futility.

Obstacles to access

Patients with SPMI die 25 years earlier than do their peers without SPMI. Most of the premature mortality associated with SPMI, which cuts across age groups, is attributable to chronic diseases rather than to violence or suicide. Less overall engagement with the health care system, leading to late treatment or undertreatment of disease, is one explanation for the premature mortality found among some people in this demographic.

In addition, studies have shown that individuals with SPMI have less access to palliative and hospice care. One study, for example, found that people with schizophrenia and a terminal illness went into hospice half as often as did people without SPMI (Schizophr Res. 2012 Nov;141:241-6). In a recent editorial, a team of psychiatrists and pain specialists called such disparities “unacceptable” and demanded cross-collaboration to resolve them (Gen Hospital Psych. 2017 Jan-Feb;44:1-3).

Dr. Lapid said one reason people with SPMI – with or without a life-limiting comorbidity – end up with less access to palliative and hospice care is that “the art of what we do in hospice and palliative care, advanced planning – is not something we do well or routinely in psychiatry.”

And palliative care specialists may find that for some people with severe mental illness, “it can be hard to really palliate their symptoms,” Dr. Lapid said.

Dr. Irwin noted that patients with SPMI and a terminal illness generally are not extended the same level of agency over their treatment choices as are people without it. Cancer patients, for example, can elect not to receive a treatment even when their prognosis is good. People with serious mental illness – even when they have life-limiting medical comorbidities – may not be given the option of deciding whether to opt for treatment.

Rebecca L. Bauer, MD, a psychosomatic medicine fellow at the Medical College of Wisconsin in Milwaukee, said that psychiatrists, including those with outpatient practices, are well positioned to help patients gain greater access to palliative care and end-of-life planning.

While palliative care grows as an interdisciplinary specialty, more clinicians are asking how it can benefit certain patients with severe mental illness.

Palliative care, which developed with the founding of hospices in the 1960s, initially focused on patients who were dying from cancer. The specialty – which emphasizes improving patients’ quality of life rather than finding a cure, and which is different from hospice – can now be used for patients with noncancer diagnoses such as dementia and HIV/AIDS (Psychiatry. 2009 Jun;8[6]:212-15).

Some psychiatrists think that certain patients with another diagnosis would benefit from palliative care: those with severe persistent mental illness.

In fact, this approach might apply to psychiatric patients who are in long-term residential care with “severe/chronic schizophrenia and insufficient quality of life, those with therapy-refractory depressions and repeated suicide attempts, and those with severe long-standing therapy-refractory anorexia nervosa,” wrote Manuel Trachsel, MD, PhD, and his colleagues (BMC Psychiatry (2016 Jul 14:1-9).

Scott A. Irwin, MD, PhD, who coauthored that article and a letter examining these issues, said Dr. Trachsel’s theories lie on the frontiers of current thinking about incorporating palliative care and psychiatric medicine.

Meanwhile, both Dr. Irwin and Maria I. Lapid, MD, another psychiatrist with expertise in palliative care, said that in many ways, the field of psychiatry is inherently palliative in nature.
 

Palliative ‘approach’ in SPMI

Dr. Trachsel presented unpublished results from a survey of U.S. psychiatrists at the annual meeting of the American Psychiatric Association in May that sought to discern whether they favored supporting short-term quality of life rather than long-term disease modification in certain patients with severe and persistent mental illness (SPMI) – defined as mental illness that is chronic or recurring, requires ongoing intensive psychiatric treatment, and seriously impairs functioning.

Courtesy Dr. Trachsel

Futility difficult to define

Dr. Irwin said in an interview that the ideas in the letter (Lancet Psychiatry. 2016 Mar;3[3]:200) in which he and a few other colleagues collaborated with Dr. Trachsel were essentially “a thought experiment and very philosophical.” In addition, the letter, which proposed palliative psychiatry “as a means to improve quality of care, person-centeredness, and autonomy” for patients with SPMI, was supported by a handful of case studies, most of them in patients with end-stage anorexia, he said. Furthermore, end-of-life interventions are only a subset of what palliative care brings to the table, said Dr. Irwin, palliative care psychiatrist at Cedars-Sinai Health System’s Samuel Oschin Comprehensive Cancer Center in Los Angeles.

With a psychiatric illness, the goals are usually around symptom management and quality of life, and for certain palliative care interventions reserved for end-of-life situations, “there’s usually not something knocking at the door that’s putting that end-of-life question into focus,” Dr. Irwin said. To create end-of-life protocols for SPMI, “you would need to know what the prognosis and trajectory are of each stage of these illnesses. And we don’t have good evidence guiding us.

“If we have a patient who is depressed and wants to commit suicide, who knows how many years they could have left if we intervene?” said Dr. Irwin, who has mentored Dr. Trachsel. “If we had the data that this person’s 90% likely to complete a suicide within the next year, it might change the conversation and treatment decisions.”

Dr. Lapid, a board-certified practitioner of palliative and hospice medicine and geriatric psychiatry at the Mayo Clinic in Rochester, Minn., agreed in an interview that for patients with an SPMI and no life-limiting comorbidity, it becomes complicated to attempt to define futility.

Obstacles to access

Patients with SPMI die 25 years earlier than do their peers without SPMI. Most of the premature mortality associated with SPMI, which cuts across age groups, is attributable to chronic diseases rather than to violence or suicide. Less overall engagement with the health care system, leading to late treatment or undertreatment of disease, is one explanation for the premature mortality found among some people in this demographic.

In addition, studies have shown that individuals with SPMI have less access to palliative and hospice care. One study, for example, found that people with schizophrenia and a terminal illness went into hospice half as often as did people without SPMI (Schizophr Res. 2012 Nov;141:241-6). In a recent editorial, a team of psychiatrists and pain specialists called such disparities “unacceptable” and demanded cross-collaboration to resolve them (Gen Hospital Psych. 2017 Jan-Feb;44:1-3).

Dr. Lapid said one reason people with SPMI – with or without a life-limiting comorbidity – end up with less access to palliative and hospice care is that “the art of what we do in hospice and palliative care, advanced planning – is not something we do well or routinely in psychiatry.”

And palliative care specialists may find that for some people with severe mental illness, “it can be hard to really palliate their symptoms,” Dr. Lapid said.

Dr. Irwin noted that patients with SPMI and a terminal illness generally are not extended the same level of agency over their treatment choices as are people without it. Cancer patients, for example, can elect not to receive a treatment even when their prognosis is good. People with serious mental illness – even when they have life-limiting medical comorbidities – may not be given the option of deciding whether to opt for treatment.

Rebecca L. Bauer, MD, a psychosomatic medicine fellow at the Medical College of Wisconsin in Milwaukee, said that psychiatrists, including those with outpatient practices, are well positioned to help patients gain greater access to palliative care and end-of-life planning.

While palliative care grows as an interdisciplinary specialty, more clinicians are asking how it can benefit certain patients with severe mental illness.

Palliative care, which developed with the founding of hospices in the 1960s, initially focused on patients who were dying from cancer. The specialty – which emphasizes improving patients’ quality of life rather than finding a cure, and which is different from hospice – can now be used for patients with noncancer diagnoses such as dementia and HIV/AIDS (Psychiatry. 2009 Jun;8[6]:212-15).

Some psychiatrists think that certain patients with another diagnosis would benefit from palliative care: those with severe persistent mental illness.

In fact, this approach might apply to psychiatric patients who are in long-term residential care with “severe/chronic schizophrenia and insufficient quality of life, those with therapy-refractory depressions and repeated suicide attempts, and those with severe long-standing therapy-refractory anorexia nervosa,” wrote Manuel Trachsel, MD, PhD, and his colleagues (BMC Psychiatry (2016 Jul 14:1-9).

Scott A. Irwin, MD, PhD, who coauthored that article and a letter examining these issues, said Dr. Trachsel’s theories lie on the frontiers of current thinking about incorporating palliative care and psychiatric medicine.

Meanwhile, both Dr. Irwin and Maria I. Lapid, MD, another psychiatrist with expertise in palliative care, said that in many ways, the field of psychiatry is inherently palliative in nature.
 

Palliative ‘approach’ in SPMI

Dr. Trachsel presented unpublished results from a survey of U.S. psychiatrists at the annual meeting of the American Psychiatric Association in May that sought to discern whether they favored supporting short-term quality of life rather than long-term disease modification in certain patients with severe and persistent mental illness (SPMI) – defined as mental illness that is chronic or recurring, requires ongoing intensive psychiatric treatment, and seriously impairs functioning.

Courtesy Dr. Trachsel

Futility difficult to define

Dr. Irwin said in an interview that the ideas in the letter (Lancet Psychiatry. 2016 Mar;3[3]:200) in which he and a few other colleagues collaborated with Dr. Trachsel were essentially “a thought experiment and very philosophical.” In addition, the letter, which proposed palliative psychiatry “as a means to improve quality of care, person-centeredness, and autonomy” for patients with SPMI, was supported by a handful of case studies, most of them in patients with end-stage anorexia, he said. Furthermore, end-of-life interventions are only a subset of what palliative care brings to the table, said Dr. Irwin, palliative care psychiatrist at Cedars-Sinai Health System’s Samuel Oschin Comprehensive Cancer Center in Los Angeles.

With a psychiatric illness, the goals are usually around symptom management and quality of life, and for certain palliative care interventions reserved for end-of-life situations, “there’s usually not something knocking at the door that’s putting that end-of-life question into focus,” Dr. Irwin said. To create end-of-life protocols for SPMI, “you would need to know what the prognosis and trajectory are of each stage of these illnesses. And we don’t have good evidence guiding us.

“If we have a patient who is depressed and wants to commit suicide, who knows how many years they could have left if we intervene?” said Dr. Irwin, who has mentored Dr. Trachsel. “If we had the data that this person’s 90% likely to complete a suicide within the next year, it might change the conversation and treatment decisions.”

Dr. Lapid, a board-certified practitioner of palliative and hospice medicine and geriatric psychiatry at the Mayo Clinic in Rochester, Minn., agreed in an interview that for patients with an SPMI and no life-limiting comorbidity, it becomes complicated to attempt to define futility.

Obstacles to access

Patients with SPMI die 25 years earlier than do their peers without SPMI. Most of the premature mortality associated with SPMI, which cuts across age groups, is attributable to chronic diseases rather than to violence or suicide. Less overall engagement with the health care system, leading to late treatment or undertreatment of disease, is one explanation for the premature mortality found among some people in this demographic.

In addition, studies have shown that individuals with SPMI have less access to palliative and hospice care. One study, for example, found that people with schizophrenia and a terminal illness went into hospice half as often as did people without SPMI (Schizophr Res. 2012 Nov;141:241-6). In a recent editorial, a team of psychiatrists and pain specialists called such disparities “unacceptable” and demanded cross-collaboration to resolve them (Gen Hospital Psych. 2017 Jan-Feb;44:1-3).

Dr. Lapid said one reason people with SPMI – with or without a life-limiting comorbidity – end up with less access to palliative and hospice care is that “the art of what we do in hospice and palliative care, advanced planning – is not something we do well or routinely in psychiatry.”

And palliative care specialists may find that for some people with severe mental illness, “it can be hard to really palliate their symptoms,” Dr. Lapid said.

Dr. Irwin noted that patients with SPMI and a terminal illness generally are not extended the same level of agency over their treatment choices as are people without it. Cancer patients, for example, can elect not to receive a treatment even when their prognosis is good. People with serious mental illness – even when they have life-limiting medical comorbidities – may not be given the option of deciding whether to opt for treatment.

Rebecca L. Bauer, MD, a psychosomatic medicine fellow at the Medical College of Wisconsin in Milwaukee, said that psychiatrists, including those with outpatient practices, are well positioned to help patients gain greater access to palliative care and end-of-life planning.

I supervise the family clinic in the outpatient psychiatry resident-run clinic. The Suttons are a typical couple, encountered by the new resident, whom I will call Dr. Suraj. Initially, Dr. Suraj is enthusiastic in his meeting with the Suttons, but soon enters into a conundrum and brings the case to supervision. The couple has an intricate inexplicable dance, leaving the resident baffled. Let’s review the case. (I have changed several key details to protect the couple’s confidentiality.)

Ms. Sutton presents with complaints of “depression,” and slowly, it becomes clear that her complaints center on her spouse’s deficiencies. “He doesn’t understand me; he doesn’t know what it is like being depressed.”

Other complaints follow; some are practical, such as: “He doesn’t help around the house.” Ms. Sutton’s complaints mostly reflect her perception that either her spouse does not care for her adequately, he has lost interest in her, or he is fundamentally unable to respond adequately to her needs. “He says bad things to me, like ‘Just get over it,’ or ‘Don’t make such a fuss about things.’ ”

After three further sessions of listening to her complaints, and a general lack of response to prior and current medications, Dr. Suraj decides that Mr. Sutton needs to come in. Dr. Suraj follows what he has been taught so far: Get a history from the partner to validate symptoms, functioning, and quality of life. Mostly, the session goes as predicted, ending with Dr. Suraj’s attempt to educate Mr. Sutton about the signs and symptoms of depression. It doesn’t come out right, because the impression that Mr. Sutton gets is that Dr. Suraj is siding with his wife. This seems to make things worse, as Mr. Sutton then complains to his wife that “The doctor doesn’t know what he’s talking about,” “is too young to understand,” or a myriad of other put-downs. Ms. Sutton, of course, tells Dr. Suraj about all of this, following it up with “Don’t worry Doc; you are doing a great job.” Other comments are more in the way of commentary: “I told my husband what you said last week, and he disagrees with you.”

Dr. Suraj realizes that “something is amiss;” the case is stuck, and worse, he is stuck in the middle. The general impression, says Dr. Suraj, “is of a woman who feels victimized, neglected, or overlooked, but somehow, she has the power. She presents as the victim but also is the victimizer. He seems to be the victimizer and tormenter, but all in all, just as much the victim of her torments! I do not know how to think about this couple: They seem stuck, unhappily but inexorably stuck together in perpetuity.” Can anything be done to change this relationship?

Dr. Suraj’s uncensored thoughts: Perhaps they should break up or at least stop complaining. What is it that makes people keep complaining about their relationships? Either they accept it or they leave.
 

Initial areas of focus

Interpersonal violence. The archetypal extreme is that of an abusive relationship, where the victim is subjected to domestic violence. As I wrote in Advances in Psychiatric Treatment, many relationships where violence is present are bidirectional (2007;13[5]:376-83). Couples may not voice this concern for fear of the spouse being turned over to the police. I usually include a question such as: “How many times do your arguments include pushing or shoving or things like that?”

Asking about income, specifically, who controls the finances and how money is spent, clarifies whether one person feels that he or she has no option but to stay in the relationship.

If intimate partner violence (IPV) exists, there are typical protocols for helping the victim leave. When IPV is not a consideration, the resident wonders about the Suttons, when the victim and abuser change or share roles. Why do they keep up this struggle if they are unhappy?

Life expectations. Many couples do not discuss their expectations or what they imagine will happen when they get married. There may be unspoken fantasies such as “I always assumed that you would retire at 65, and we would go traveling together.” People may change their minds, or life circumstances change so that expectations and fantasies about their life together can no longer be sustained. Are there goals that have changed? Are there dependent relatives that prevent marital goals from being achieved? Is there a lack of agreement about what are important life goals?

Change! One spouse may try to make the other person change, according to his or her preferences. In the psychiatrist’s office, this can take the form of pathologizing: He just wasn’t brought up to talk about feelings, meaning he needs to talk about feelings. We hear questions such as: “Can you take him on in therapy?”; “He doesn’t listen ... can you check him for hearing loss?”; “She doesn’t remember what I said: Can you check her for dementia?” These complaints may come up at the beginning of a relationship or later in life, for example, after retirement when the couple is home together for extended periods of time. Is the expectation that each person should be able to fulfill the partner’s every wish and desire? Be all things? That is a tough order.

The Suttons report that change is the main thing they want from each other. After a full family assessment, it is clear that roles are evenly and acceptably shared; they have no differences in family rules; they both enjoy the same hobbies, care for each other, and work together to solve family crises. However, they cannot accept each other the way they are. When the children were young, she said: “I was too busy to get depressed.” Mr. Sutton states that she now wants him to be attentive to her but he is too tired after a lifetime of work, and anyway, she is so whiny he does not want to be around her. So they bicker back and forth, neither giving an inch.
 

Useful theories

A. Dr. Gottman’s typology. John Gottman, PhD, categorizes couples into five types: Conflict-Avoiding, Validating, Volatile, Hostile, and Hostile-Detached. The three happy couple types (Conflict-Avoiding, Validating, and Volatile) are very different from one another, and each type has its own benefits and risks. Of the two unhappy couple types, hostile couples stayed unhappily married. He derived this categorization from observations of couples in his lab (https://www.gottman.com).

Conflict-Avoiding: Conflict avoiders minimize persuasion attempts and instead emphasize their areas of common ground. They avoid conflict, avoid expressing what they need from one another, and congratulate their relationship for being generally happy. Conflict-avoiding couples balance independence and interdependence. They have clear boundaries, and are separate people with separate interests. They can be connected and caring in areas of overlap where they are interdependent. While they are minimally emotionally expressive, they maintain a ratio of positive-to-negative affect around 5 to 1. Their interaction is good enough for them.

Validating: The interaction of these couples is characterized by ease and calm. They are somewhat expressive but mostly neutral. They are intermediate between avoiders and the volatile couples. They put a lot of emphasis on supporting and understanding their partner’s point of view, and are often empathetic about their partner’s feelings. They will confront their differences, but only on some topics and not on others. They can become highly competitive on some issues, which can turn into a power struggle, but they usually calm down and compromise. The ratio of positive-to-negative comments is 5 to 1.

Volatile: Volatile couples are intensely emotional. During a conflict discussion, they begin persuasion immediately, and they debate with laughter and humor. They are not disrespectful or insulting. Their positive-to-negative comments ratio is 5 to 1. Anger and feelings of insecurity are expressed, but not contempt. They have no clear boundaries around their individual worlds. While they argue about their roles, they emphasize connection and honesty in their communication.

Hostile: Hostile couples are like validators, except there are high levels of defensiveness on the part of both partners. In Dr. Gottman’s lab, the husband was usually the validator and the wife was the avoider.

Hostile-Detached: These couples are like two armies engaged in a standoff. They snipe at one another during conflict, although the air is one of emotional detachment and resignation. In Dr. Gottman’s lab, usually there was a validator husband with a volatile wife. Escalating conflict will occur between two validators, but then one of them will back down. But the volatile will not let the validator withdraw. Dr. Gottman notes that there is a superiority involved in the woman: that the man needs to be taught the right way to be. The woman does not see the need to change.
 

B. The approach/avoidance dance

The approach/avoidance dance is based on the motivation of each person (Psychol Sci. 2008 Oct 19;[10]:1030-6). A partner with approach goals focuses on attaining positive outcomes, such as intimacy and growth. A partner with avoidance goals focuses away from negative outcomes, such as conflict and rejection (Educational Psychologist. 1999;34:169-89). For example, in a discussion about child care, a husband who has strong approach goals may be concerned with wanting the discussion to go smoothly and wanting both partners to be happy with the outcome. In contrast, a husband with strong avoidance goals may be more concerned with avoiding conflict about child care and preventing both partners from being unhappy with the outcome. People who are not motivated by approach goals are not particularly interested in pursuing positive experiences in their relationships, such as bonding, intimacy, or fun activities. In contrast, people who are motivated by avoidance goals are interested in avoiding negative experiences, such as conflict, betrayal, or rejection by a romantic partner.

C. Attachment

Both of the previously discussed theories have attachment theory at their core, and are organized around anxiety and avoidance. The anxiety would be tied to concern that the partner may not be available or supportive in times of need, and the avoidance piece would be tied to worry that the partner cannot be fully trusted (Fam Process. 2002 Fall;41[3]:546-50). A low score on both of these indices means a secure attachment style. For unhappy couples with cemented attachments, there is no thought that one would leave. They are bound together in unhappiness (Current Opin Psychol. 2017 Feb;13:60-4).

Nice guy husband/borderline wife relationship or hysterical wife/obsessive-compulsive husband: These relationship can be explained using an attachment framework. This male personality type truly enjoys giving and often finds that he needs nothing more in return than a feeling of being appreciated.
 

D. Emotionally focused therapy

Sue Johnson, EdD, has an evidence-based couples therapy called emotionally focused couples and family therapy. She would interpret the Suttons as a couple caught in a dance of negativity. The goal of therapy is to help couples let down defenses enough to be vulnerable and then to help them express emotional needs to each other. Dr. Johnson helps each person meet the emotional needs of the other. (See http://drsuejohnson.com/)

E. The game of struggle for power and control

In most relationships, there is a minimizer and a maximizer. The minimizer is more subdued within the relationship, while the maximizer is more evocative. When this turns into a game of “Who has the power,” then minimizing and maximizing turns into submission and dominance. Typically, the minimizer becomes dominant, and the maximizer becomes submissive. One partner can become parentalized and the other infantilized. Most often, the maximizer, being more emotional, tends to become infantilized and submissive for fear of angering or disappointing his or her partner. The minimizer, being more contained, tends to gather the power in the relationship, whether by intention or default, and, in this way, becomes parentalized.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

I supervise the family clinic in the outpatient psychiatry resident-run clinic. The Suttons are a typical couple, encountered by the new resident, whom I will call Dr. Suraj. Initially, Dr. Suraj is enthusiastic in his meeting with the Suttons, but soon enters into a conundrum and brings the case to supervision. The couple has an intricate inexplicable dance, leaving the resident baffled. Let’s review the case. (I have changed several key details to protect the couple’s confidentiality.)

Ms. Sutton presents with complaints of “depression,” and slowly, it becomes clear that her complaints center on her spouse’s deficiencies. “He doesn’t understand me; he doesn’t know what it is like being depressed.”

Other complaints follow; some are practical, such as: “He doesn’t help around the house.” Ms. Sutton’s complaints mostly reflect her perception that either her spouse does not care for her adequately, he has lost interest in her, or he is fundamentally unable to respond adequately to her needs. “He says bad things to me, like ‘Just get over it,’ or ‘Don’t make such a fuss about things.’ ”

After three further sessions of listening to her complaints, and a general lack of response to prior and current medications, Dr. Suraj decides that Mr. Sutton needs to come in. Dr. Suraj follows what he has been taught so far: Get a history from the partner to validate symptoms, functioning, and quality of life. Mostly, the session goes as predicted, ending with Dr. Suraj’s attempt to educate Mr. Sutton about the signs and symptoms of depression. It doesn’t come out right, because the impression that Mr. Sutton gets is that Dr. Suraj is siding with his wife. This seems to make things worse, as Mr. Sutton then complains to his wife that “The doctor doesn’t know what he’s talking about,” “is too young to understand,” or a myriad of other put-downs. Ms. Sutton, of course, tells Dr. Suraj about all of this, following it up with “Don’t worry Doc; you are doing a great job.” Other comments are more in the way of commentary: “I told my husband what you said last week, and he disagrees with you.”

Dr. Suraj realizes that “something is amiss;” the case is stuck, and worse, he is stuck in the middle. The general impression, says Dr. Suraj, “is of a woman who feels victimized, neglected, or overlooked, but somehow, she has the power. She presents as the victim but also is the victimizer. He seems to be the victimizer and tormenter, but all in all, just as much the victim of her torments! I do not know how to think about this couple: They seem stuck, unhappily but inexorably stuck together in perpetuity.” Can anything be done to change this relationship?

Dr. Suraj’s uncensored thoughts: Perhaps they should break up or at least stop complaining. What is it that makes people keep complaining about their relationships? Either they accept it or they leave.
 

Initial areas of focus

Interpersonal violence. The archetypal extreme is that of an abusive relationship, where the victim is subjected to domestic violence. As I wrote in Advances in Psychiatric Treatment, many relationships where violence is present are bidirectional (2007;13[5]:376-83). Couples may not voice this concern for fear of the spouse being turned over to the police. I usually include a question such as: “How many times do your arguments include pushing or shoving or things like that?”

Asking about income, specifically, who controls the finances and how money is spent, clarifies whether one person feels that he or she has no option but to stay in the relationship.

If intimate partner violence (IPV) exists, there are typical protocols for helping the victim leave. When IPV is not a consideration, the resident wonders about the Suttons, when the victim and abuser change or share roles. Why do they keep up this struggle if they are unhappy?

Life expectations. Many couples do not discuss their expectations or what they imagine will happen when they get married. There may be unspoken fantasies such as “I always assumed that you would retire at 65, and we would go traveling together.” People may change their minds, or life circumstances change so that expectations and fantasies about their life together can no longer be sustained. Are there goals that have changed? Are there dependent relatives that prevent marital goals from being achieved? Is there a lack of agreement about what are important life goals?

Change! One spouse may try to make the other person change, according to his or her preferences. In the psychiatrist’s office, this can take the form of pathologizing: He just wasn’t brought up to talk about feelings, meaning he needs to talk about feelings. We hear questions such as: “Can you take him on in therapy?”; “He doesn’t listen ... can you check him for hearing loss?”; “She doesn’t remember what I said: Can you check her for dementia?” These complaints may come up at the beginning of a relationship or later in life, for example, after retirement when the couple is home together for extended periods of time. Is the expectation that each person should be able to fulfill the partner’s every wish and desire? Be all things? That is a tough order.

The Suttons report that change is the main thing they want from each other. After a full family assessment, it is clear that roles are evenly and acceptably shared; they have no differences in family rules; they both enjoy the same hobbies, care for each other, and work together to solve family crises. However, they cannot accept each other the way they are. When the children were young, she said: “I was too busy to get depressed.” Mr. Sutton states that she now wants him to be attentive to her but he is too tired after a lifetime of work, and anyway, she is so whiny he does not want to be around her. So they bicker back and forth, neither giving an inch.
 

Useful theories

A. Dr. Gottman’s typology. John Gottman, PhD, categorizes couples into five types: Conflict-Avoiding, Validating, Volatile, Hostile, and Hostile-Detached. The three happy couple types (Conflict-Avoiding, Validating, and Volatile) are very different from one another, and each type has its own benefits and risks. Of the two unhappy couple types, hostile couples stayed unhappily married. He derived this categorization from observations of couples in his lab (https://www.gottman.com).

Conflict-Avoiding: Conflict avoiders minimize persuasion attempts and instead emphasize their areas of common ground. They avoid conflict, avoid expressing what they need from one another, and congratulate their relationship for being generally happy. Conflict-avoiding couples balance independence and interdependence. They have clear boundaries, and are separate people with separate interests. They can be connected and caring in areas of overlap where they are interdependent. While they are minimally emotionally expressive, they maintain a ratio of positive-to-negative affect around 5 to 1. Their interaction is good enough for them.

Validating: The interaction of these couples is characterized by ease and calm. They are somewhat expressive but mostly neutral. They are intermediate between avoiders and the volatile couples. They put a lot of emphasis on supporting and understanding their partner’s point of view, and are often empathetic about their partner’s feelings. They will confront their differences, but only on some topics and not on others. They can become highly competitive on some issues, which can turn into a power struggle, but they usually calm down and compromise. The ratio of positive-to-negative comments is 5 to 1.

Volatile: Volatile couples are intensely emotional. During a conflict discussion, they begin persuasion immediately, and they debate with laughter and humor. They are not disrespectful or insulting. Their positive-to-negative comments ratio is 5 to 1. Anger and feelings of insecurity are expressed, but not contempt. They have no clear boundaries around their individual worlds. While they argue about their roles, they emphasize connection and honesty in their communication.

Hostile: Hostile couples are like validators, except there are high levels of defensiveness on the part of both partners. In Dr. Gottman’s lab, the husband was usually the validator and the wife was the avoider.

Hostile-Detached: These couples are like two armies engaged in a standoff. They snipe at one another during conflict, although the air is one of emotional detachment and resignation. In Dr. Gottman’s lab, usually there was a validator husband with a volatile wife. Escalating conflict will occur between two validators, but then one of them will back down. But the volatile will not let the validator withdraw. Dr. Gottman notes that there is a superiority involved in the woman: that the man needs to be taught the right way to be. The woman does not see the need to change.
 

B. The approach/avoidance dance

The approach/avoidance dance is based on the motivation of each person (Psychol Sci. 2008 Oct 19;[10]:1030-6). A partner with approach goals focuses on attaining positive outcomes, such as intimacy and growth. A partner with avoidance goals focuses away from negative outcomes, such as conflict and rejection (Educational Psychologist. 1999;34:169-89). For example, in a discussion about child care, a husband who has strong approach goals may be concerned with wanting the discussion to go smoothly and wanting both partners to be happy with the outcome. In contrast, a husband with strong avoidance goals may be more concerned with avoiding conflict about child care and preventing both partners from being unhappy with the outcome. People who are not motivated by approach goals are not particularly interested in pursuing positive experiences in their relationships, such as bonding, intimacy, or fun activities. In contrast, people who are motivated by avoidance goals are interested in avoiding negative experiences, such as conflict, betrayal, or rejection by a romantic partner.

C. Attachment

Both of the previously discussed theories have attachment theory at their core, and are organized around anxiety and avoidance. The anxiety would be tied to concern that the partner may not be available or supportive in times of need, and the avoidance piece would be tied to worry that the partner cannot be fully trusted (Fam Process. 2002 Fall;41[3]:546-50). A low score on both of these indices means a secure attachment style. For unhappy couples with cemented attachments, there is no thought that one would leave. They are bound together in unhappiness (Current Opin Psychol. 2017 Feb;13:60-4).

Nice guy husband/borderline wife relationship or hysterical wife/obsessive-compulsive husband: These relationship can be explained using an attachment framework. This male personality type truly enjoys giving and often finds that he needs nothing more in return than a feeling of being appreciated.
 

D. Emotionally focused therapy

Sue Johnson, EdD, has an evidence-based couples therapy called emotionally focused couples and family therapy. She would interpret the Suttons as a couple caught in a dance of negativity. The goal of therapy is to help couples let down defenses enough to be vulnerable and then to help them express emotional needs to each other. Dr. Johnson helps each person meet the emotional needs of the other. (See http://drsuejohnson.com/)

E. The game of struggle for power and control

In most relationships, there is a minimizer and a maximizer. The minimizer is more subdued within the relationship, while the maximizer is more evocative. When this turns into a game of “Who has the power,” then minimizing and maximizing turns into submission and dominance. Typically, the minimizer becomes dominant, and the maximizer becomes submissive. One partner can become parentalized and the other infantilized. Most often, the maximizer, being more emotional, tends to become infantilized and submissive for fear of angering or disappointing his or her partner. The minimizer, being more contained, tends to gather the power in the relationship, whether by intention or default, and, in this way, becomes parentalized.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

I supervise the family clinic in the outpatient psychiatry resident-run clinic. The Suttons are a typical couple, encountered by the new resident, whom I will call Dr. Suraj. Initially, Dr. Suraj is enthusiastic in his meeting with the Suttons, but soon enters into a conundrum and brings the case to supervision. The couple has an intricate inexplicable dance, leaving the resident baffled. Let’s review the case. (I have changed several key details to protect the couple’s confidentiality.)

Ms. Sutton presents with complaints of “depression,” and slowly, it becomes clear that her complaints center on her spouse’s deficiencies. “He doesn’t understand me; he doesn’t know what it is like being depressed.”

Other complaints follow; some are practical, such as: “He doesn’t help around the house.” Ms. Sutton’s complaints mostly reflect her perception that either her spouse does not care for her adequately, he has lost interest in her, or he is fundamentally unable to respond adequately to her needs. “He says bad things to me, like ‘Just get over it,’ or ‘Don’t make such a fuss about things.’ ”

After three further sessions of listening to her complaints, and a general lack of response to prior and current medications, Dr. Suraj decides that Mr. Sutton needs to come in. Dr. Suraj follows what he has been taught so far: Get a history from the partner to validate symptoms, functioning, and quality of life. Mostly, the session goes as predicted, ending with Dr. Suraj’s attempt to educate Mr. Sutton about the signs and symptoms of depression. It doesn’t come out right, because the impression that Mr. Sutton gets is that Dr. Suraj is siding with his wife. This seems to make things worse, as Mr. Sutton then complains to his wife that “The doctor doesn’t know what he’s talking about,” “is too young to understand,” or a myriad of other put-downs. Ms. Sutton, of course, tells Dr. Suraj about all of this, following it up with “Don’t worry Doc; you are doing a great job.” Other comments are more in the way of commentary: “I told my husband what you said last week, and he disagrees with you.”

Dr. Suraj realizes that “something is amiss;” the case is stuck, and worse, he is stuck in the middle. The general impression, says Dr. Suraj, “is of a woman who feels victimized, neglected, or overlooked, but somehow, she has the power. She presents as the victim but also is the victimizer. He seems to be the victimizer and tormenter, but all in all, just as much the victim of her torments! I do not know how to think about this couple: They seem stuck, unhappily but inexorably stuck together in perpetuity.” Can anything be done to change this relationship?

Dr. Suraj’s uncensored thoughts: Perhaps they should break up or at least stop complaining. What is it that makes people keep complaining about their relationships? Either they accept it or they leave.
 

Initial areas of focus

Interpersonal violence. The archetypal extreme is that of an abusive relationship, where the victim is subjected to domestic violence. As I wrote in Advances in Psychiatric Treatment, many relationships where violence is present are bidirectional (2007;13[5]:376-83). Couples may not voice this concern for fear of the spouse being turned over to the police. I usually include a question such as: “How many times do your arguments include pushing or shoving or things like that?”

Asking about income, specifically, who controls the finances and how money is spent, clarifies whether one person feels that he or she has no option but to stay in the relationship.

If intimate partner violence (IPV) exists, there are typical protocols for helping the victim leave. When IPV is not a consideration, the resident wonders about the Suttons, when the victim and abuser change or share roles. Why do they keep up this struggle if they are unhappy?

Life expectations. Many couples do not discuss their expectations or what they imagine will happen when they get married. There may be unspoken fantasies such as “I always assumed that you would retire at 65, and we would go traveling together.” People may change their minds, or life circumstances change so that expectations and fantasies about their life together can no longer be sustained. Are there goals that have changed? Are there dependent relatives that prevent marital goals from being achieved? Is there a lack of agreement about what are important life goals?

Change! One spouse may try to make the other person change, according to his or her preferences. In the psychiatrist’s office, this can take the form of pathologizing: He just wasn’t brought up to talk about feelings, meaning he needs to talk about feelings. We hear questions such as: “Can you take him on in therapy?”; “He doesn’t listen ... can you check him for hearing loss?”; “She doesn’t remember what I said: Can you check her for dementia?” These complaints may come up at the beginning of a relationship or later in life, for example, after retirement when the couple is home together for extended periods of time. Is the expectation that each person should be able to fulfill the partner’s every wish and desire? Be all things? That is a tough order.

The Suttons report that change is the main thing they want from each other. After a full family assessment, it is clear that roles are evenly and acceptably shared; they have no differences in family rules; they both enjoy the same hobbies, care for each other, and work together to solve family crises. However, they cannot accept each other the way they are. When the children were young, she said: “I was too busy to get depressed.” Mr. Sutton states that she now wants him to be attentive to her but he is too tired after a lifetime of work, and anyway, she is so whiny he does not want to be around her. So they bicker back and forth, neither giving an inch.
 

Useful theories

A. Dr. Gottman’s typology. John Gottman, PhD, categorizes couples into five types: Conflict-Avoiding, Validating, Volatile, Hostile, and Hostile-Detached. The three happy couple types (Conflict-Avoiding, Validating, and Volatile) are very different from one another, and each type has its own benefits and risks. Of the two unhappy couple types, hostile couples stayed unhappily married. He derived this categorization from observations of couples in his lab (https://www.gottman.com).

Conflict-Avoiding: Conflict avoiders minimize persuasion attempts and instead emphasize their areas of common ground. They avoid conflict, avoid expressing what they need from one another, and congratulate their relationship for being generally happy. Conflict-avoiding couples balance independence and interdependence. They have clear boundaries, and are separate people with separate interests. They can be connected and caring in areas of overlap where they are interdependent. While they are minimally emotionally expressive, they maintain a ratio of positive-to-negative affect around 5 to 1. Their interaction is good enough for them.

Validating: The interaction of these couples is characterized by ease and calm. They are somewhat expressive but mostly neutral. They are intermediate between avoiders and the volatile couples. They put a lot of emphasis on supporting and understanding their partner’s point of view, and are often empathetic about their partner’s feelings. They will confront their differences, but only on some topics and not on others. They can become highly competitive on some issues, which can turn into a power struggle, but they usually calm down and compromise. The ratio of positive-to-negative comments is 5 to 1.

Volatile: Volatile couples are intensely emotional. During a conflict discussion, they begin persuasion immediately, and they debate with laughter and humor. They are not disrespectful or insulting. Their positive-to-negative comments ratio is 5 to 1. Anger and feelings of insecurity are expressed, but not contempt. They have no clear boundaries around their individual worlds. While they argue about their roles, they emphasize connection and honesty in their communication.

Hostile: Hostile couples are like validators, except there are high levels of defensiveness on the part of both partners. In Dr. Gottman’s lab, the husband was usually the validator and the wife was the avoider.

Hostile-Detached: These couples are like two armies engaged in a standoff. They snipe at one another during conflict, although the air is one of emotional detachment and resignation. In Dr. Gottman’s lab, usually there was a validator husband with a volatile wife. Escalating conflict will occur between two validators, but then one of them will back down. But the volatile will not let the validator withdraw. Dr. Gottman notes that there is a superiority involved in the woman: that the man needs to be taught the right way to be. The woman does not see the need to change.
 

B. The approach/avoidance dance

The approach/avoidance dance is based on the motivation of each person (Psychol Sci. 2008 Oct 19;[10]:1030-6). A partner with approach goals focuses on attaining positive outcomes, such as intimacy and growth. A partner with avoidance goals focuses away from negative outcomes, such as conflict and rejection (Educational Psychologist. 1999;34:169-89). For example, in a discussion about child care, a husband who has strong approach goals may be concerned with wanting the discussion to go smoothly and wanting both partners to be happy with the outcome. In contrast, a husband with strong avoidance goals may be more concerned with avoiding conflict about child care and preventing both partners from being unhappy with the outcome. People who are not motivated by approach goals are not particularly interested in pursuing positive experiences in their relationships, such as bonding, intimacy, or fun activities. In contrast, people who are motivated by avoidance goals are interested in avoiding negative experiences, such as conflict, betrayal, or rejection by a romantic partner.

C. Attachment

Both of the previously discussed theories have attachment theory at their core, and are organized around anxiety and avoidance. The anxiety would be tied to concern that the partner may not be available or supportive in times of need, and the avoidance piece would be tied to worry that the partner cannot be fully trusted (Fam Process. 2002 Fall;41[3]:546-50). A low score on both of these indices means a secure attachment style. For unhappy couples with cemented attachments, there is no thought that one would leave. They are bound together in unhappiness (Current Opin Psychol. 2017 Feb;13:60-4).

Nice guy husband/borderline wife relationship or hysterical wife/obsessive-compulsive husband: These relationship can be explained using an attachment framework. This male personality type truly enjoys giving and often finds that he needs nothing more in return than a feeling of being appreciated.
 

D. Emotionally focused therapy

Sue Johnson, EdD, has an evidence-based couples therapy called emotionally focused couples and family therapy. She would interpret the Suttons as a couple caught in a dance of negativity. The goal of therapy is to help couples let down defenses enough to be vulnerable and then to help them express emotional needs to each other. Dr. Johnson helps each person meet the emotional needs of the other. (See http://drsuejohnson.com/)

E. The game of struggle for power and control

In most relationships, there is a minimizer and a maximizer. The minimizer is more subdued within the relationship, while the maximizer is more evocative. When this turns into a game of “Who has the power,” then minimizing and maximizing turns into submission and dominance. Typically, the minimizer becomes dominant, and the maximizer becomes submissive. One partner can become parentalized and the other infantilized. Most often, the maximizer, being more emotional, tends to become infantilized and submissive for fear of angering or disappointing his or her partner. The minimizer, being more contained, tends to gather the power in the relationship, whether by intention or default, and, in this way, becomes parentalized.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose.

With the Hospital Readmissions Reduction Program (HRRP) in its 5th year, what has been the impact on hospitals and on hospitalists?

First of all, a lot of penalties have been paid by hospitals. According to an analysis by Kaiser Health News,¹ the Centers for Medicare and Medicaid Services will withhold $528 million from 2,597 hospitals in the current fiscal year, Oct. 1, 2016 to Sept. 30, 2017, for readmissions for six diagnoses that occurred between July 2012 and June 2015. The number of penalized hospitals is down slightly from 2,665 the year before, but the total annual withhold will go up by $108 million.

HRRP exacts Medicare payment penalties from hospitals that have rates of readmissions – within 30 days of discharge – that are higher than expected, based on national rates and the health of their patient population. The maximum penalty is now up to 3% of a hospital’s Medicare reimbursement. Hospitals are being penalized an average of 0.73% of their annual Medicare reimbursement, and cumulative HRRP penalties will reach nearly $1.9 billion by the end of the fiscal year, Kaiser Health News reports.²

What have we learned about readmissions in 5 years?

A lot of recently published research about readmissions has documented modest decreases in overall readmissions nationally, from over 21% to under 18% between 2007 and 2014, although most of the reduction occurred in the first couple of years after HRRP was announced and it has since largely leveled off.

Other research has tried to explore the relationship between readmissions rates and other outcomes that might matter more to patients or that might be better proxies for the quality of the hospital experience. Is readmission rate a true measure of quality, or just a utilization measure? Research has also tried to document what works: what are the best strategies for preventing avoidable readmissions by improving the discharge process, care transitions, and the coordination of care postdischarge in the community – although no silver bullet has yet been identified.

A recent effort to inject more equity into the penalties program, contained in the wide-ranging 21st Century Cures Act signed into law by President Obama in December 2016, requires Medicare to account for patients’ socio-economic backgrounds when it calculates reductions in its payments to hospitals under HRRP. The law directs the government to change the way pay for performance is applied to safety net hospitals by setting different penalty thresholds for hospitals based on the proportion of their patients who are dually eligible for Medicare and Medicaid.

It remains to be seen how this will be implemented and with what impact. But some critics have continued to question whether hospitals should be held accountable for readmissions, whether 30 days is the correct time frame for that accountability, and whether some hospitals might be simply taking the penalty hit rather than investing in the hard work of care transitions.
 

Impact on working hospitalists

One expert, Ashish Jha, MD, MPH, director of Harvard’s Global Health Institute, wants to see hospitalists get more engaged in the conversation about how to improve hospital care overall.

Readmissions at the front lines

Preetham Talari, MD, FACP, FHM, hospitalist at University of Kentucky HealthCare in Lexington, has an interest in health care safety, quality improvement, and value. He has led the university’s site participation in Project BOOST, the Society of Hospital Medicine’s national mentored quality improvement initiative for care transitions. Dr. Talari also led a quality initiative at the university called the Interprofessional Teamwork Innovation Model to systematize teamwork, first piloted on a 30-bed hospitalist unit where he is medical director.

Better interventions, better infrastructure

Leora Horwitz, MD, MHS, director of the Center for Healthcare Innovation and Delivery Science at New York University School of Public Health, says the biggest change she has seen resulting from readmissions penalties is that transitions of care are now understood to be both important and the responsibility of front line hospitalists. “That was not true 5 or 10 years ago. We used to spend hours admitting patients to the hospital and then 5 minutes on their discharge.”

Recent research on readmissions penalties

A survey by Yale researchers, published in JAMA in December 2016, found that hospitals financially penalized under HRRP reduced their readmissions rates at a higher rate than nonpenalized hospitals, “which implies that penalties can improve quality and readmission performance for hospitals with the most room for improvement,” coauthor Kumar Dharmarajan, MD, MBA, said in a statement.⁴ The hospitals responded to external pressures – in other words, financial penalties worked. But most of the reduction happened in the 2 years before actual penalties went into effect, which suggests that further improvement will not be easy, the authors note.

A survey of the attitudes of hospital leaders on the HRRP found that it has had a major impact on their efforts to reduce readmissions rates, although the failure to take sociodemographic factors into account was a major complaint for these leaders.⁵ Most said the penalties were too large, but 42.5% believed HRRP was likely to improve quality.

Some have questioned whether readmissions penalties were just encouraging hospitals to reduce their rates by keeping returning patients in observation units rather than formally readmitting them. Zuckerman et al. in the New England Journal of Medicine found no evidence that changes in observation unit stays accounted for the documented decrease in readmissions.⁶

But according to Papanicolas et al. in Health Affairs, patient hospital experience has improved only modestly under hospital value-based purchasing for U.S. hospitals, with no evidence that the program has had a beneficial effect on overall patient experience.⁷ Another study from Harvard by Figueroa et al. found that evidence is lacking that hospital value-based purchasing leads to lower mortality rates.⁸

References

1. Rau J. Medicare’s Readmission Penalties Hit New High. Kaiser Health News. 2016 Aug 2.

2. Boccuti C, Casillas G. Aiming for Fewer Hospital U-turns: The Medicare Hospital Readmission Reduction Program. Kaiser Health News, 2016 Sep 30.

3. Keenan PS, Normand SLT, Lin Z, et al. An administrative claims measure suitable for profiling hospital performance on the basis of 30-day all-cause readmission rates among patients with heart failure. Circ Cardiovasc Qual Outcomes. 2008;1:29-37.

4. Desai NR, Ross JS, Kwon JY, et al. Association between hospital penalty status under the Hospital Readmission Reduction Program and readmission rates for target and nontarget conditions. JAMA. 2016 Dec 27;316(24):2647-56.

5. Joynt KE, Figueroa JF, Orav EJ, Jha AK. Opinions on the Hospital Readmissions Reduction Program: Results of a national survey of hospital leaders. Am J Manag Care. 2016 Aug 1;222(8):e287-94.

6. Zuckerman RB, Sheingold SH, Orav EJ, et al. Readmissions, observation, and the Hospital Readmissions Reduction Program. N Engl J Med. 2016 Apr 21;374(16):1543-51.

7. Papanicolas I, Figueroa JF, Orav EJ, Jha AK. Patient hospital experience improved modestly, but no evidence Medicare incentives promoted meaningful gain. Health Aff (Millwood). 2017 Jan;36(1):133-40.

8. Figueroa JF, Tsugawa Y, Zheng J, et al. Association between the value-based purchasing pay for performance program and patient mortality in US hospitals: observational study. BMJ. 2016;353:i2214.

With the Hospital Readmissions Reduction Program (HRRP) in its 5th year, what has been the impact on hospitals and on hospitalists?

First of all, a lot of penalties have been paid by hospitals. According to an analysis by Kaiser Health News,¹ the Centers for Medicare and Medicaid Services will withhold $528 million from 2,597 hospitals in the current fiscal year, Oct. 1, 2016 to Sept. 30, 2017, for readmissions for six diagnoses that occurred between July 2012 and June 2015. The number of penalized hospitals is down slightly from 2,665 the year before, but the total annual withhold will go up by $108 million.

HRRP exacts Medicare payment penalties from hospitals that have rates of readmissions – within 30 days of discharge – that are higher than expected, based on national rates and the health of their patient population. The maximum penalty is now up to 3% of a hospital’s Medicare reimbursement. Hospitals are being penalized an average of 0.73% of their annual Medicare reimbursement, and cumulative HRRP penalties will reach nearly $1.9 billion by the end of the fiscal year, Kaiser Health News reports.²

What have we learned about readmissions in 5 years?

A lot of recently published research about readmissions has documented modest decreases in overall readmissions nationally, from over 21% to under 18% between 2007 and 2014, although most of the reduction occurred in the first couple of years after HRRP was announced and it has since largely leveled off.

Other research has tried to explore the relationship between readmissions rates and other outcomes that might matter more to patients or that might be better proxies for the quality of the hospital experience. Is readmission rate a true measure of quality, or just a utilization measure? Research has also tried to document what works: what are the best strategies for preventing avoidable readmissions by improving the discharge process, care transitions, and the coordination of care postdischarge in the community – although no silver bullet has yet been identified.

A recent effort to inject more equity into the penalties program, contained in the wide-ranging 21st Century Cures Act signed into law by President Obama in December 2016, requires Medicare to account for patients’ socio-economic backgrounds when it calculates reductions in its payments to hospitals under HRRP. The law directs the government to change the way pay for performance is applied to safety net hospitals by setting different penalty thresholds for hospitals based on the proportion of their patients who are dually eligible for Medicare and Medicaid.

It remains to be seen how this will be implemented and with what impact. But some critics have continued to question whether hospitals should be held accountable for readmissions, whether 30 days is the correct time frame for that accountability, and whether some hospitals might be simply taking the penalty hit rather than investing in the hard work of care transitions.
 

Impact on working hospitalists

One expert, Ashish Jha, MD, MPH, director of Harvard’s Global Health Institute, wants to see hospitalists get more engaged in the conversation about how to improve hospital care overall.

Readmissions at the front lines

Preetham Talari, MD, FACP, FHM, hospitalist at University of Kentucky HealthCare in Lexington, has an interest in health care safety, quality improvement, and value. He has led the university’s site participation in Project BOOST, the Society of Hospital Medicine’s national mentored quality improvement initiative for care transitions. Dr. Talari also led a quality initiative at the university called the Interprofessional Teamwork Innovation Model to systematize teamwork, first piloted on a 30-bed hospitalist unit where he is medical director.

Better interventions, better infrastructure

Leora Horwitz, MD, MHS, director of the Center for Healthcare Innovation and Delivery Science at New York University School of Public Health, says the biggest change she has seen resulting from readmissions penalties is that transitions of care are now understood to be both important and the responsibility of front line hospitalists. “That was not true 5 or 10 years ago. We used to spend hours admitting patients to the hospital and then 5 minutes on their discharge.”

Recent research on readmissions penalties

A survey by Yale researchers, published in JAMA in December 2016, found that hospitals financially penalized under HRRP reduced their readmissions rates at a higher rate than nonpenalized hospitals, “which implies that penalties can improve quality and readmission performance for hospitals with the most room for improvement,” coauthor Kumar Dharmarajan, MD, MBA, said in a statement.⁴ The hospitals responded to external pressures – in other words, financial penalties worked. But most of the reduction happened in the 2 years before actual penalties went into effect, which suggests that further improvement will not be easy, the authors note.

A survey of the attitudes of hospital leaders on the HRRP found that it has had a major impact on their efforts to reduce readmissions rates, although the failure to take sociodemographic factors into account was a major complaint for these leaders.⁵ Most said the penalties were too large, but 42.5% believed HRRP was likely to improve quality.

Some have questioned whether readmissions penalties were just encouraging hospitals to reduce their rates by keeping returning patients in observation units rather than formally readmitting them. Zuckerman et al. in the New England Journal of Medicine found no evidence that changes in observation unit stays accounted for the documented decrease in readmissions.⁶

But according to Papanicolas et al. in Health Affairs, patient hospital experience has improved only modestly under hospital value-based purchasing for U.S. hospitals, with no evidence that the program has had a beneficial effect on overall patient experience.⁷ Another study from Harvard by Figueroa et al. found that evidence is lacking that hospital value-based purchasing leads to lower mortality rates.⁸

References

1. Rau J. Medicare’s Readmission Penalties Hit New High. Kaiser Health News. 2016 Aug 2.

2. Boccuti C, Casillas G. Aiming for Fewer Hospital U-turns: The Medicare Hospital Readmission Reduction Program. Kaiser Health News, 2016 Sep 30.

3. Keenan PS, Normand SLT, Lin Z, et al. An administrative claims measure suitable for profiling hospital performance on the basis of 30-day all-cause readmission rates among patients with heart failure. Circ Cardiovasc Qual Outcomes. 2008;1:29-37.

4. Desai NR, Ross JS, Kwon JY, et al. Association between hospital penalty status under the Hospital Readmission Reduction Program and readmission rates for target and nontarget conditions. JAMA. 2016 Dec 27;316(24):2647-56.

5. Joynt KE, Figueroa JF, Orav EJ, Jha AK. Opinions on the Hospital Readmissions Reduction Program: Results of a national survey of hospital leaders. Am J Manag Care. 2016 Aug 1;222(8):e287-94.

6. Zuckerman RB, Sheingold SH, Orav EJ, et al. Readmissions, observation, and the Hospital Readmissions Reduction Program. N Engl J Med. 2016 Apr 21;374(16):1543-51.

7. Papanicolas I, Figueroa JF, Orav EJ, Jha AK. Patient hospital experience improved modestly, but no evidence Medicare incentives promoted meaningful gain. Health Aff (Millwood). 2017 Jan;36(1):133-40.

8. Figueroa JF, Tsugawa Y, Zheng J, et al. Association between the value-based purchasing pay for performance program and patient mortality in US hospitals: observational study. BMJ. 2016;353:i2214.

With the Hospital Readmissions Reduction Program (HRRP) in its 5th year, what has been the impact on hospitals and on hospitalists?

First of all, a lot of penalties have been paid by hospitals. According to an analysis by Kaiser Health News,¹ the Centers for Medicare and Medicaid Services will withhold $528 million from 2,597 hospitals in the current fiscal year, Oct. 1, 2016 to Sept. 30, 2017, for readmissions for six diagnoses that occurred between July 2012 and June 2015. The number of penalized hospitals is down slightly from 2,665 the year before, but the total annual withhold will go up by $108 million.

HRRP exacts Medicare payment penalties from hospitals that have rates of readmissions – within 30 days of discharge – that are higher than expected, based on national rates and the health of their patient population. The maximum penalty is now up to 3% of a hospital’s Medicare reimbursement. Hospitals are being penalized an average of 0.73% of their annual Medicare reimbursement, and cumulative HRRP penalties will reach nearly $1.9 billion by the end of the fiscal year, Kaiser Health News reports.²

What have we learned about readmissions in 5 years?

A lot of recently published research about readmissions has documented modest decreases in overall readmissions nationally, from over 21% to under 18% between 2007 and 2014, although most of the reduction occurred in the first couple of years after HRRP was announced and it has since largely leveled off.

Other research has tried to explore the relationship between readmissions rates and other outcomes that might matter more to patients or that might be better proxies for the quality of the hospital experience. Is readmission rate a true measure of quality, or just a utilization measure? Research has also tried to document what works: what are the best strategies for preventing avoidable readmissions by improving the discharge process, care transitions, and the coordination of care postdischarge in the community – although no silver bullet has yet been identified.

A recent effort to inject more equity into the penalties program, contained in the wide-ranging 21st Century Cures Act signed into law by President Obama in December 2016, requires Medicare to account for patients’ socio-economic backgrounds when it calculates reductions in its payments to hospitals under HRRP. The law directs the government to change the way pay for performance is applied to safety net hospitals by setting different penalty thresholds for hospitals based on the proportion of their patients who are dually eligible for Medicare and Medicaid.

It remains to be seen how this will be implemented and with what impact. But some critics have continued to question whether hospitals should be held accountable for readmissions, whether 30 days is the correct time frame for that accountability, and whether some hospitals might be simply taking the penalty hit rather than investing in the hard work of care transitions.
 

Impact on working hospitalists

One expert, Ashish Jha, MD, MPH, director of Harvard’s Global Health Institute, wants to see hospitalists get more engaged in the conversation about how to improve hospital care overall.

Readmissions at the front lines

Preetham Talari, MD, FACP, FHM, hospitalist at University of Kentucky HealthCare in Lexington, has an interest in health care safety, quality improvement, and value. He has led the university’s site participation in Project BOOST, the Society of Hospital Medicine’s national mentored quality improvement initiative for care transitions. Dr. Talari also led a quality initiative at the university called the Interprofessional Teamwork Innovation Model to systematize teamwork, first piloted on a 30-bed hospitalist unit where he is medical director.

Better interventions, better infrastructure

Leora Horwitz, MD, MHS, director of the Center for Healthcare Innovation and Delivery Science at New York University School of Public Health, says the biggest change she has seen resulting from readmissions penalties is that transitions of care are now understood to be both important and the responsibility of front line hospitalists. “That was not true 5 or 10 years ago. We used to spend hours admitting patients to the hospital and then 5 minutes on their discharge.”

Recent research on readmissions penalties

A survey by Yale researchers, published in JAMA in December 2016, found that hospitals financially penalized under HRRP reduced their readmissions rates at a higher rate than nonpenalized hospitals, “which implies that penalties can improve quality and readmission performance for hospitals with the most room for improvement,” coauthor Kumar Dharmarajan, MD, MBA, said in a statement.⁴ The hospitals responded to external pressures – in other words, financial penalties worked. But most of the reduction happened in the 2 years before actual penalties went into effect, which suggests that further improvement will not be easy, the authors note.

A survey of the attitudes of hospital leaders on the HRRP found that it has had a major impact on their efforts to reduce readmissions rates, although the failure to take sociodemographic factors into account was a major complaint for these leaders.⁵ Most said the penalties were too large, but 42.5% believed HRRP was likely to improve quality.

Some have questioned whether readmissions penalties were just encouraging hospitals to reduce their rates by keeping returning patients in observation units rather than formally readmitting them. Zuckerman et al. in the New England Journal of Medicine found no evidence that changes in observation unit stays accounted for the documented decrease in readmissions.⁶

But according to Papanicolas et al. in Health Affairs, patient hospital experience has improved only modestly under hospital value-based purchasing for U.S. hospitals, with no evidence that the program has had a beneficial effect on overall patient experience.⁷ Another study from Harvard by Figueroa et al. found that evidence is lacking that hospital value-based purchasing leads to lower mortality rates.⁸

References

1. Rau J. Medicare’s Readmission Penalties Hit New High. Kaiser Health News. 2016 Aug 2.

2. Boccuti C, Casillas G. Aiming for Fewer Hospital U-turns: The Medicare Hospital Readmission Reduction Program. Kaiser Health News, 2016 Sep 30.

3. Keenan PS, Normand SLT, Lin Z, et al. An administrative claims measure suitable for profiling hospital performance on the basis of 30-day all-cause readmission rates among patients with heart failure. Circ Cardiovasc Qual Outcomes. 2008;1:29-37.

4. Desai NR, Ross JS, Kwon JY, et al. Association between hospital penalty status under the Hospital Readmission Reduction Program and readmission rates for target and nontarget conditions. JAMA. 2016 Dec 27;316(24):2647-56.

5. Joynt KE, Figueroa JF, Orav EJ, Jha AK. Opinions on the Hospital Readmissions Reduction Program: Results of a national survey of hospital leaders. Am J Manag Care. 2016 Aug 1;222(8):e287-94.

6. Zuckerman RB, Sheingold SH, Orav EJ, et al. Readmissions, observation, and the Hospital Readmissions Reduction Program. N Engl J Med. 2016 Apr 21;374(16):1543-51.

7. Papanicolas I, Figueroa JF, Orav EJ, Jha AK. Patient hospital experience improved modestly, but no evidence Medicare incentives promoted meaningful gain. Health Aff (Millwood). 2017 Jan;36(1):133-40.

8. Figueroa JF, Tsugawa Y, Zheng J, et al. Association between the value-based purchasing pay for performance program and patient mortality in US hospitals: observational study. BMJ. 2016;353:i2214.

Research Hospital

Life-long hematopoiesis relies on hundreds more blood progenitors than previously reported, according to preclinical research published in Nature Cell Biology.

Previous studies linked life-long mammalian blood production to just a handful of precursor cells that emerge during prenatal development.

In the current study, researchers found that, in mice, roughly 600 to 700 developmental precursors contribute to life-long hematopoiesis.

The number of precursor cells in humans is likely at least 10 times greater, according to researchers.

“All previous studies had reported that very few precursor cells are involved in establishing the blood system,” said study author Shannon McKinney-Freeman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“But data in this study show that, actually, hundreds of cells are involved and that the developing blood system is more complex and may be shaped, in part, by regulatory bottlenecks that occur late in development and serve to restrict the number of blood-forming stem cells.”

For this study, Miguel Ganuza, PhD, a fellow in Dr McKinney-Freeman’s lab, adapted a system used to study the cellular makeup of solid tumors. The multi-colored labeling system is activated by genes expressed during specific windows of development.

Dr Ganuza used the system to label and track the fate of precursor cells from various developmental stages in mice.

“We wanted to understand what was happening with different progenitor cells at different stages of development when we knew important decisions on the fate of cells occurred,” Dr Ganuza said.

David Finkelstein, PhD, of the St. Jude Department of Computational Biology, then used mathematical modeling to work backward from peripheral blood in adult mice to track the contribution of precursor cells from the early, middle, and late stages of prenatal development.

The results showed that far more precursor cells than expected contribute to life-long hematopoiesis in adult mice.

The researchers found about 719 Flk1⁺ mesodermal precursors emerged at embryonic days 7 to 8.5, 633 VE-cadherin⁺ endothelial precursors emerged at embryonic days 8.5 to 11.5, and 545 Vav1⁺ nascent hematopoietic stem and progenitor cells emerged at embryonic days 11.5 to 14.5.

The team also said specification of hemogenic endothelial cells begins at embryonic day 8.5 and ends by embryonic day 10.5. After that, it cannot be reactivated.

Finally, the researchers found that intra-aortic hematopoietic clusters are polyclonal in origin.

The team said these findings raised questions about the role of the fetal liver in hematopoiesis.

“For decades, the fetal liver was thought to be where the number of blood stem cells expanded dramatically,” Dr McKinney-Freeman said.

“The results in this study raise questions about that model and even suggest the presence of developmental bottlenecks in the fetal liver or at later stages of development that restrict the blood stem cell population. This is when science is most interesting, when you see things you didn’t expect.”

While unexpected, the newly revealed size and complexity of the emerging blood system make sense developmentally, Dr McKinney-Freeman said.

“Producing hundreds of progenitor cells during different developmental stages means the organism has greater flexibility to adapt to issues and problems that might emerge as development progresses,” she noted.

The findings also have clinical implications, according to Dr McKinney-Freeman.

“Understanding how the blood system emerges, including the number and complexity of the progenitor cells involved, will help us unravel the origins of disease and identify cells that might be susceptible to disease-causing mutations,” she concluded.

Research Hospital

Life-long hematopoiesis relies on hundreds more blood progenitors than previously reported, according to preclinical research published in Nature Cell Biology.

Previous studies linked life-long mammalian blood production to just a handful of precursor cells that emerge during prenatal development.

In the current study, researchers found that, in mice, roughly 600 to 700 developmental precursors contribute to life-long hematopoiesis.

The number of precursor cells in humans is likely at least 10 times greater, according to researchers.

“All previous studies had reported that very few precursor cells are involved in establishing the blood system,” said study author Shannon McKinney-Freeman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“But data in this study show that, actually, hundreds of cells are involved and that the developing blood system is more complex and may be shaped, in part, by regulatory bottlenecks that occur late in development and serve to restrict the number of blood-forming stem cells.”

For this study, Miguel Ganuza, PhD, a fellow in Dr McKinney-Freeman’s lab, adapted a system used to study the cellular makeup of solid tumors. The multi-colored labeling system is activated by genes expressed during specific windows of development.

Dr Ganuza used the system to label and track the fate of precursor cells from various developmental stages in mice.

“We wanted to understand what was happening with different progenitor cells at different stages of development when we knew important decisions on the fate of cells occurred,” Dr Ganuza said.

David Finkelstein, PhD, of the St. Jude Department of Computational Biology, then used mathematical modeling to work backward from peripheral blood in adult mice to track the contribution of precursor cells from the early, middle, and late stages of prenatal development.

The results showed that far more precursor cells than expected contribute to life-long hematopoiesis in adult mice.

The researchers found about 719 Flk1⁺ mesodermal precursors emerged at embryonic days 7 to 8.5, 633 VE-cadherin⁺ endothelial precursors emerged at embryonic days 8.5 to 11.5, and 545 Vav1⁺ nascent hematopoietic stem and progenitor cells emerged at embryonic days 11.5 to 14.5.

The team also said specification of hemogenic endothelial cells begins at embryonic day 8.5 and ends by embryonic day 10.5. After that, it cannot be reactivated.

Finally, the researchers found that intra-aortic hematopoietic clusters are polyclonal in origin.

The team said these findings raised questions about the role of the fetal liver in hematopoiesis.

“For decades, the fetal liver was thought to be where the number of blood stem cells expanded dramatically,” Dr McKinney-Freeman said.

“The results in this study raise questions about that model and even suggest the presence of developmental bottlenecks in the fetal liver or at later stages of development that restrict the blood stem cell population. This is when science is most interesting, when you see things you didn’t expect.”

While unexpected, the newly revealed size and complexity of the emerging blood system make sense developmentally, Dr McKinney-Freeman said.

“Producing hundreds of progenitor cells during different developmental stages means the organism has greater flexibility to adapt to issues and problems that might emerge as development progresses,” she noted.

The findings also have clinical implications, according to Dr McKinney-Freeman.

“Understanding how the blood system emerges, including the number and complexity of the progenitor cells involved, will help us unravel the origins of disease and identify cells that might be susceptible to disease-causing mutations,” she concluded.

Research Hospital

Life-long hematopoiesis relies on hundreds more blood progenitors than previously reported, according to preclinical research published in Nature Cell Biology.

Previous studies linked life-long mammalian blood production to just a handful of precursor cells that emerge during prenatal development.

In the current study, researchers found that, in mice, roughly 600 to 700 developmental precursors contribute to life-long hematopoiesis.

The number of precursor cells in humans is likely at least 10 times greater, according to researchers.

“All previous studies had reported that very few precursor cells are involved in establishing the blood system,” said study author Shannon McKinney-Freeman, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“But data in this study show that, actually, hundreds of cells are involved and that the developing blood system is more complex and may be shaped, in part, by regulatory bottlenecks that occur late in development and serve to restrict the number of blood-forming stem cells.”

For this study, Miguel Ganuza, PhD, a fellow in Dr McKinney-Freeman’s lab, adapted a system used to study the cellular makeup of solid tumors. The multi-colored labeling system is activated by genes expressed during specific windows of development.

Dr Ganuza used the system to label and track the fate of precursor cells from various developmental stages in mice.

“We wanted to understand what was happening with different progenitor cells at different stages of development when we knew important decisions on the fate of cells occurred,” Dr Ganuza said.

David Finkelstein, PhD, of the St. Jude Department of Computational Biology, then used mathematical modeling to work backward from peripheral blood in adult mice to track the contribution of precursor cells from the early, middle, and late stages of prenatal development.

The results showed that far more precursor cells than expected contribute to life-long hematopoiesis in adult mice.

The researchers found about 719 Flk1⁺ mesodermal precursors emerged at embryonic days 7 to 8.5, 633 VE-cadherin⁺ endothelial precursors emerged at embryonic days 8.5 to 11.5, and 545 Vav1⁺ nascent hematopoietic stem and progenitor cells emerged at embryonic days 11.5 to 14.5.

The team also said specification of hemogenic endothelial cells begins at embryonic day 8.5 and ends by embryonic day 10.5. After that, it cannot be reactivated.

Finally, the researchers found that intra-aortic hematopoietic clusters are polyclonal in origin.

The team said these findings raised questions about the role of the fetal liver in hematopoiesis.

“For decades, the fetal liver was thought to be where the number of blood stem cells expanded dramatically,” Dr McKinney-Freeman said.

“The results in this study raise questions about that model and even suggest the presence of developmental bottlenecks in the fetal liver or at later stages of development that restrict the blood stem cell population. This is when science is most interesting, when you see things you didn’t expect.”

While unexpected, the newly revealed size and complexity of the emerging blood system make sense developmentally, Dr McKinney-Freeman said.

“Producing hundreds of progenitor cells during different developmental stages means the organism has greater flexibility to adapt to issues and problems that might emerge as development progresses,” she noted.

The findings also have clinical implications, according to Dr McKinney-Freeman.

“Understanding how the blood system emerges, including the number and complexity of the progenitor cells involved, will help us unravel the origins of disease and identify cells that might be susceptible to disease-causing mutations,” she concluded.

Photo from Genentech

Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq).

One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma.

The other is a phase 1b study (NCT02431208) of atezolizumab alone or in combination with an immunomodulatory drug and/or daratumumab in patients with multiple myeloma (MM).

The partial clinical hold on these trials means patients who are currently enrolled and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled.

The decision to place these trials on hold is related to risks identified in 2 trials of the anti-PD-1 agent pembrolizumab. Results from these trials showed that combining pembrolizumab with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) increases the risk of death in patients with MM.

The results led to clinical holds on these trials (and a third trial of pembrolizumab) as well as an investigation by the US Food and Drug Administration (FDA).

The FDA has stressed its belief that the benefits of taking pembrolizumab and other PD-1/PD-L1 inhibitors for their approved uses continue to outweigh the risks.

However, the agency also thinks there may be an unfavorable risk-benefit ratio for patients receiving PD-1/PD-L1 treatment alone or in other combinations in unapproved indications.

Therefore, the FDA is investigating trials of PD-1/PD-L1 inhibitors being studied in combination with immunomodulatory agents or other classes of drugs in patients with hematologic malignancies.

In the course of this investigation, the FDA has placed holds on trials of nivolumab and durvalumab as well as atezolizumab.

According to Roche, there is no evidence of an increased risk of death or serious events with the use of atezolizumab in combination with immunomodulatory agents.

Photo from Genentech

Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq).

One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma.

The other is a phase 1b study (NCT02431208) of atezolizumab alone or in combination with an immunomodulatory drug and/or daratumumab in patients with multiple myeloma (MM).

The partial clinical hold on these trials means patients who are currently enrolled and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled.

The decision to place these trials on hold is related to risks identified in 2 trials of the anti-PD-1 agent pembrolizumab. Results from these trials showed that combining pembrolizumab with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) increases the risk of death in patients with MM.

The results led to clinical holds on these trials (and a third trial of pembrolizumab) as well as an investigation by the US Food and Drug Administration (FDA).

The FDA has stressed its belief that the benefits of taking pembrolizumab and other PD-1/PD-L1 inhibitors for their approved uses continue to outweigh the risks.

However, the agency also thinks there may be an unfavorable risk-benefit ratio for patients receiving PD-1/PD-L1 treatment alone or in other combinations in unapproved indications.

Therefore, the FDA is investigating trials of PD-1/PD-L1 inhibitors being studied in combination with immunomodulatory agents or other classes of drugs in patients with hematologic malignancies.

In the course of this investigation, the FDA has placed holds on trials of nivolumab and durvalumab as well as atezolizumab.

According to Roche, there is no evidence of an increased risk of death or serious events with the use of atezolizumab in combination with immunomodulatory agents.

Photo from Genentech

Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq).

One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma.

The other is a phase 1b study (NCT02431208) of atezolizumab alone or in combination with an immunomodulatory drug and/or daratumumab in patients with multiple myeloma (MM).

The partial clinical hold on these trials means patients who are currently enrolled and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled.

The decision to place these trials on hold is related to risks identified in 2 trials of the anti-PD-1 agent pembrolizumab. Results from these trials showed that combining pembrolizumab with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) increases the risk of death in patients with MM.

The results led to clinical holds on these trials (and a third trial of pembrolizumab) as well as an investigation by the US Food and Drug Administration (FDA).

The FDA has stressed its belief that the benefits of taking pembrolizumab and other PD-1/PD-L1 inhibitors for their approved uses continue to outweigh the risks.

However, the agency also thinks there may be an unfavorable risk-benefit ratio for patients receiving PD-1/PD-L1 treatment alone or in other combinations in unapproved indications.

Therefore, the FDA is investigating trials of PD-1/PD-L1 inhibitors being studied in combination with immunomodulatory agents or other classes of drugs in patients with hematologic malignancies.

In the course of this investigation, the FDA has placed holds on trials of nivolumab and durvalumab as well as atezolizumab.

According to Roche, there is no evidence of an increased risk of death or serious events with the use of atezolizumab in combination with immunomodulatory agents.

Antihemophilic factor

The European Medicines Agency (EMA) has concluded there is “no clear and consistent evidence” of a difference in inhibitor development between the 2 classes of factor VIII (FVIII) products.

A review of data from several studies has suggested that hemophilia A patients are no more likely to develop inhibitors if they receive a recombinant FVIII product rather than a plasma-derived FVIII product.

The review began after publication of the SIPPET study¹, which suggested that patients who received plasma-derived FVIII had a lower incidence of inhibitors than patients treated with recombinant FVIII.

To test this conclusion, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed data on all FVIII products authorized for use in the European Union. This includes products containing the active substances human coagulation FVIII, efmoroctocog alfa, moroctocog alfa, octocog alfa, simoctocog alfa, susoctocog alfa, and turoctocog alfa.

The PRAC examined data from the SIPPET study and additional clinical trials and observational studies.^2-5

The data did not show any statistically significant or clinically meaningful difference in inhibitor risk between FVIII classes.

The PRAC said results of the SIPPET study cannot be extrapolated to individual products, as the study only included a small number of FVIII products.

The PRAC’s conclusion was sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for adoption of the EMA’s final opinion. And the CHMP has adopted the opinion that there is “no clear and consistent evidence” of a difference in inhibitor development.

The CHMP’s opinion will be forwarded to the European Commission, which will issue a final, legally binding decision applicable in all European Union member states. The European Commission typically adheres to the CHMP’s recommendations.

The EMA said prescribing information for FVIII products will be updated as appropriate to add inhibitor development as a very common side effect in previously untreated patients and as uncommon in previously treated patients.

The warning on inhibitor development will be amended to state that low titers of inhibitors pose less risk of insufficient response than high titers.

1. Peyvandi F, Mannucci PM, Garagiola I et al. A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. N Engl J Med (2016), 374:2054-64.

2. Gouw SC et al. Treatment-related risk factors of inhibitor development in previously untreated patients with hemophilia A: the CANAL cohort study. Blood (2007), 109:4648-54.

3. Gouw SC et al. PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med (2013), 368:231-9.

4. Iorio A et al. Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series. Haemophilia (2017), 23:255-63.

5. Fischer K et al. Inhibitor development in haemophilia according to concentrate. Four-year results from the European HAemophilia Safety Surveillance (EUHASS) project. Thromb Haemost (2015) 113:968-75.

Antihemophilic factor

The European Medicines Agency (EMA) has concluded there is “no clear and consistent evidence” of a difference in inhibitor development between the 2 classes of factor VIII (FVIII) products.

A review of data from several studies has suggested that hemophilia A patients are no more likely to develop inhibitors if they receive a recombinant FVIII product rather than a plasma-derived FVIII product.

The review began after publication of the SIPPET study¹, which suggested that patients who received plasma-derived FVIII had a lower incidence of inhibitors than patients treated with recombinant FVIII.

To test this conclusion, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed data on all FVIII products authorized for use in the European Union. This includes products containing the active substances human coagulation FVIII, efmoroctocog alfa, moroctocog alfa, octocog alfa, simoctocog alfa, susoctocog alfa, and turoctocog alfa.

The PRAC examined data from the SIPPET study and additional clinical trials and observational studies.^2-5

The data did not show any statistically significant or clinically meaningful difference in inhibitor risk between FVIII classes.

The PRAC said results of the SIPPET study cannot be extrapolated to individual products, as the study only included a small number of FVIII products.

The PRAC’s conclusion was sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for adoption of the EMA’s final opinion. And the CHMP has adopted the opinion that there is “no clear and consistent evidence” of a difference in inhibitor development.

The CHMP’s opinion will be forwarded to the European Commission, which will issue a final, legally binding decision applicable in all European Union member states. The European Commission typically adheres to the CHMP’s recommendations.

The EMA said prescribing information for FVIII products will be updated as appropriate to add inhibitor development as a very common side effect in previously untreated patients and as uncommon in previously treated patients.

The warning on inhibitor development will be amended to state that low titers of inhibitors pose less risk of insufficient response than high titers.

1. Peyvandi F, Mannucci PM, Garagiola I et al. A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. N Engl J Med (2016), 374:2054-64.

2. Gouw SC et al. Treatment-related risk factors of inhibitor development in previously untreated patients with hemophilia A: the CANAL cohort study. Blood (2007), 109:4648-54.

3. Gouw SC et al. PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med (2013), 368:231-9.

4. Iorio A et al. Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series. Haemophilia (2017), 23:255-63.

5. Fischer K et al. Inhibitor development in haemophilia according to concentrate. Four-year results from the European HAemophilia Safety Surveillance (EUHASS) project. Thromb Haemost (2015) 113:968-75.

Antihemophilic factor

The European Medicines Agency (EMA) has concluded there is “no clear and consistent evidence” of a difference in inhibitor development between the 2 classes of factor VIII (FVIII) products.

A review of data from several studies has suggested that hemophilia A patients are no more likely to develop inhibitors if they receive a recombinant FVIII product rather than a plasma-derived FVIII product.

The review began after publication of the SIPPET study¹, which suggested that patients who received plasma-derived FVIII had a lower incidence of inhibitors than patients treated with recombinant FVIII.

To test this conclusion, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed data on all FVIII products authorized for use in the European Union. This includes products containing the active substances human coagulation FVIII, efmoroctocog alfa, moroctocog alfa, octocog alfa, simoctocog alfa, susoctocog alfa, and turoctocog alfa.

The PRAC examined data from the SIPPET study and additional clinical trials and observational studies.^2-5

The data did not show any statistically significant or clinically meaningful difference in inhibitor risk between FVIII classes.

The PRAC said results of the SIPPET study cannot be extrapolated to individual products, as the study only included a small number of FVIII products.

The PRAC’s conclusion was sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for adoption of the EMA’s final opinion. And the CHMP has adopted the opinion that there is “no clear and consistent evidence” of a difference in inhibitor development.

The CHMP’s opinion will be forwarded to the European Commission, which will issue a final, legally binding decision applicable in all European Union member states. The European Commission typically adheres to the CHMP’s recommendations.

The EMA said prescribing information for FVIII products will be updated as appropriate to add inhibitor development as a very common side effect in previously untreated patients and as uncommon in previously treated patients.

The warning on inhibitor development will be amended to state that low titers of inhibitors pose less risk of insufficient response than high titers.

1. Peyvandi F, Mannucci PM, Garagiola I et al. A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. N Engl J Med (2016), 374:2054-64.

2. Gouw SC et al. Treatment-related risk factors of inhibitor development in previously untreated patients with hemophilia A: the CANAL cohort study. Blood (2007), 109:4648-54.

3. Gouw SC et al. PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med (2013), 368:231-9.

4. Iorio A et al. Natural history and clinical characteristics of inhibitors in previously treated haemophilia A patients: a case series. Haemophilia (2017), 23:255-63.

5. Fischer K et al. Inhibitor development in haemophilia according to concentrate. Four-year results from the European HAemophilia Safety Surveillance (EUHASS) project. Thromb Haemost (2015) 113:968-75.

Switching to riociguat may be an effective strategy for pulmonary arterial hypertension (PAH) patients who respond inadequately to phosphodiesterase-5 inhibitors, results from a small open-label study demonstrated.

“This study represents an important step towards determining if this new treatment strategy is an effective approach to the management of patients with PAH, although additional data from larger, randomised, controlled studies are needed to further establish the safety and efficacy of this approach,” researchers led by Marius M. Hoeper, MD, wrote in a study published online Sept. 9, 2017, in the European Respiratory Journal.

Current clinical data indicate that many patients with PAH who receive phosphodiesterase-5 inhibitors do not reach treatment goals. “For example, in the AMBITION study, 73% of patients with PAH receiving tadalafil monotherapy and 61% of those receiving tadalafil in combination with ambrisentan did not achieve a satisfactory clinical response at week 24 of the study (N Engl J Med. 2015;373:834-44),” Dr. Hoeper of the Clinic for Respiratory Medicine at Hannover Medical School Germany and his associates wrote. “Furthermore, in the SERAPHIN study, event-free survival of patients receiving [phosphodiesterase-5 inhibitors] monotherapy was approximately 50% at 3 years (N Engl J Med. 2013;369:809-18).”

For the current trial, known as RESPITE, investigators from nine countries in Europe and North America enrolled 61 PAH patients in a 24-week, open-label uncontrolled analysis to investigate the safety, feasibility, and benefit of switching them from phosphodiesterase-5 inhibitors to riociguat. The patients underwent 1-3 days free of phosphodiesterase-5 inhibitors before receiving riociguat in a maximum dose of up to 2.5 mg t.i.d. Most patients (74%) were female, and 92% were Caucasian. In all, 51 patients (84%) completed all 24 weeks of treatment, while the remaining 10 discontinued treatment, 4 of whom due to adverse events.

Among those who completed all 24 weeks of the trial, their mean 6-minute walking distance had increased by a mean of 31 meters and their N-terminal pro b-type natriuretic peptide level decreased by a mean of 347 pg/mL^. Additionally, 54% of the patients studied experienced an improvement in their the World Health Organization Functional Class. However, 32 patients (52%) experienced study drug–related adverse events and 10 (16%) experienced serious adverse events, two of which were related to the drug being studied. Six patients (10%) experienced clinical worsening, including death in two, though the deaths were deemed to be unrelated to the drug being studied.

“Although not mechanistically studied, the findings of RESPITE support the hypothesis that a defective [nitric oxide–soluble guanylate cyclase–cyclic guanosine monophosphate] pathway might explain why some patients have no sufficient or sustained response to [phosphodiesterase-5 inhibitors] therapy,” the researchers noted. “In such patients, direct stimulation of [soluble guanylate cyclase] may be more effective than inhibition of [phosphodiesterase-5], but this hypothesis is still unproven.”

They acknowledged certain limitations of the study, including its prospective design and the relatively homogenous patient population. “Other limitations include the lack of a long-term continuation phase, and the absence of mechanistic data allowing identification of patients likely to respond or not respond to switching,” they wrote. “Two deaths were observed in this study, which might raise concerns, although neither of the deaths (one due to pneumonia and one due to subdural haematoma) was considered by the investigators to be study drug-related or due to worsening PAH. Given the lack of a control group and the rate of study withdrawals and clinical worsening events, further evaluation to clarify the safety of switching is required.”

The study was funded by Bayer AG, Berlin. Dr. Hoeper and his coauthors disclosed having financial ties to numerous pharmaceutical companies, including Bayer, which makes riociguat.

dbrunk@frontlinemedcom.com

PRIMARY SOURCE: Eur Respir J. 2017 Sep 9. doi: 10.1183/13993003.02425-2016.

Switching to riociguat may be an effective strategy for pulmonary arterial hypertension (PAH) patients who respond inadequately to phosphodiesterase-5 inhibitors, results from a small open-label study demonstrated.

“This study represents an important step towards determining if this new treatment strategy is an effective approach to the management of patients with PAH, although additional data from larger, randomised, controlled studies are needed to further establish the safety and efficacy of this approach,” researchers led by Marius M. Hoeper, MD, wrote in a study published online Sept. 9, 2017, in the European Respiratory Journal.

Current clinical data indicate that many patients with PAH who receive phosphodiesterase-5 inhibitors do not reach treatment goals. “For example, in the AMBITION study, 73% of patients with PAH receiving tadalafil monotherapy and 61% of those receiving tadalafil in combination with ambrisentan did not achieve a satisfactory clinical response at week 24 of the study (N Engl J Med. 2015;373:834-44),” Dr. Hoeper of the Clinic for Respiratory Medicine at Hannover Medical School Germany and his associates wrote. “Furthermore, in the SERAPHIN study, event-free survival of patients receiving [phosphodiesterase-5 inhibitors] monotherapy was approximately 50% at 3 years (N Engl J Med. 2013;369:809-18).”

For the current trial, known as RESPITE, investigators from nine countries in Europe and North America enrolled 61 PAH patients in a 24-week, open-label uncontrolled analysis to investigate the safety, feasibility, and benefit of switching them from phosphodiesterase-5 inhibitors to riociguat. The patients underwent 1-3 days free of phosphodiesterase-5 inhibitors before receiving riociguat in a maximum dose of up to 2.5 mg t.i.d. Most patients (74%) were female, and 92% were Caucasian. In all, 51 patients (84%) completed all 24 weeks of treatment, while the remaining 10 discontinued treatment, 4 of whom due to adverse events.

Among those who completed all 24 weeks of the trial, their mean 6-minute walking distance had increased by a mean of 31 meters and their N-terminal pro b-type natriuretic peptide level decreased by a mean of 347 pg/mL^. Additionally, 54% of the patients studied experienced an improvement in their the World Health Organization Functional Class. However, 32 patients (52%) experienced study drug–related adverse events and 10 (16%) experienced serious adverse events, two of which were related to the drug being studied. Six patients (10%) experienced clinical worsening, including death in two, though the deaths were deemed to be unrelated to the drug being studied.

“Although not mechanistically studied, the findings of RESPITE support the hypothesis that a defective [nitric oxide–soluble guanylate cyclase–cyclic guanosine monophosphate] pathway might explain why some patients have no sufficient or sustained response to [phosphodiesterase-5 inhibitors] therapy,” the researchers noted. “In such patients, direct stimulation of [soluble guanylate cyclase] may be more effective than inhibition of [phosphodiesterase-5], but this hypothesis is still unproven.”

They acknowledged certain limitations of the study, including its prospective design and the relatively homogenous patient population. “Other limitations include the lack of a long-term continuation phase, and the absence of mechanistic data allowing identification of patients likely to respond or not respond to switching,” they wrote. “Two deaths were observed in this study, which might raise concerns, although neither of the deaths (one due to pneumonia and one due to subdural haematoma) was considered by the investigators to be study drug-related or due to worsening PAH. Given the lack of a control group and the rate of study withdrawals and clinical worsening events, further evaluation to clarify the safety of switching is required.”

The study was funded by Bayer AG, Berlin. Dr. Hoeper and his coauthors disclosed having financial ties to numerous pharmaceutical companies, including Bayer, which makes riociguat.

dbrunk@frontlinemedcom.com

PRIMARY SOURCE: Eur Respir J. 2017 Sep 9. doi: 10.1183/13993003.02425-2016.

Switching to riociguat may be an effective strategy for pulmonary arterial hypertension (PAH) patients who respond inadequately to phosphodiesterase-5 inhibitors, results from a small open-label study demonstrated.

“This study represents an important step towards determining if this new treatment strategy is an effective approach to the management of patients with PAH, although additional data from larger, randomised, controlled studies are needed to further establish the safety and efficacy of this approach,” researchers led by Marius M. Hoeper, MD, wrote in a study published online Sept. 9, 2017, in the European Respiratory Journal.

Current clinical data indicate that many patients with PAH who receive phosphodiesterase-5 inhibitors do not reach treatment goals. “For example, in the AMBITION study, 73% of patients with PAH receiving tadalafil monotherapy and 61% of those receiving tadalafil in combination with ambrisentan did not achieve a satisfactory clinical response at week 24 of the study (N Engl J Med. 2015;373:834-44),” Dr. Hoeper of the Clinic for Respiratory Medicine at Hannover Medical School Germany and his associates wrote. “Furthermore, in the SERAPHIN study, event-free survival of patients receiving [phosphodiesterase-5 inhibitors] monotherapy was approximately 50% at 3 years (N Engl J Med. 2013;369:809-18).”

For the current trial, known as RESPITE, investigators from nine countries in Europe and North America enrolled 61 PAH patients in a 24-week, open-label uncontrolled analysis to investigate the safety, feasibility, and benefit of switching them from phosphodiesterase-5 inhibitors to riociguat. The patients underwent 1-3 days free of phosphodiesterase-5 inhibitors before receiving riociguat in a maximum dose of up to 2.5 mg t.i.d. Most patients (74%) were female, and 92% were Caucasian. In all, 51 patients (84%) completed all 24 weeks of treatment, while the remaining 10 discontinued treatment, 4 of whom due to adverse events.

Among those who completed all 24 weeks of the trial, their mean 6-minute walking distance had increased by a mean of 31 meters and their N-terminal pro b-type natriuretic peptide level decreased by a mean of 347 pg/mL^. Additionally, 54% of the patients studied experienced an improvement in their the World Health Organization Functional Class. However, 32 patients (52%) experienced study drug–related adverse events and 10 (16%) experienced serious adverse events, two of which were related to the drug being studied. Six patients (10%) experienced clinical worsening, including death in two, though the deaths were deemed to be unrelated to the drug being studied.

“Although not mechanistically studied, the findings of RESPITE support the hypothesis that a defective [nitric oxide–soluble guanylate cyclase–cyclic guanosine monophosphate] pathway might explain why some patients have no sufficient or sustained response to [phosphodiesterase-5 inhibitors] therapy,” the researchers noted. “In such patients, direct stimulation of [soluble guanylate cyclase] may be more effective than inhibition of [phosphodiesterase-5], but this hypothesis is still unproven.”

They acknowledged certain limitations of the study, including its prospective design and the relatively homogenous patient population. “Other limitations include the lack of a long-term continuation phase, and the absence of mechanistic data allowing identification of patients likely to respond or not respond to switching,” they wrote. “Two deaths were observed in this study, which might raise concerns, although neither of the deaths (one due to pneumonia and one due to subdural haematoma) was considered by the investigators to be study drug-related or due to worsening PAH. Given the lack of a control group and the rate of study withdrawals and clinical worsening events, further evaluation to clarify the safety of switching is required.”

The study was funded by Bayer AG, Berlin. Dr. Hoeper and his coauthors disclosed having financial ties to numerous pharmaceutical companies, including Bayer, which makes riociguat.

dbrunk@frontlinemedcom.com

PRIMARY SOURCE: Eur Respir J. 2017 Sep 9. doi: 10.1183/13993003.02425-2016.

CHICAGO – The challenge of addressing marijuana use by children and teens is increasing with its wider availability; 29 states have now legalized cannabis for medical use, and 8 of them plus the District of Columbia have legalized recreational marijuana use.

“Past-month marijuana use is now higher than past-month use of cigarettes” based on teens’ responses to surveys from the National Institute on Drug Abuse (NIDA), Karen M. Wilson, MD, said at the annual meeting of the American Academy of Pediatrics.

CHICAGO – The challenge of addressing marijuana use by children and teens is increasing with its wider availability; 29 states have now legalized cannabis for medical use, and 8 of them plus the District of Columbia have legalized recreational marijuana use.

“Past-month marijuana use is now higher than past-month use of cigarettes” based on teens’ responses to surveys from the National Institute on Drug Abuse (NIDA), Karen M. Wilson, MD, said at the annual meeting of the American Academy of Pediatrics.

CHICAGO – The challenge of addressing marijuana use by children and teens is increasing with its wider availability; 29 states have now legalized cannabis for medical use, and 8 of them plus the District of Columbia have legalized recreational marijuana use.

“Past-month marijuana use is now higher than past-month use of cigarettes” based on teens’ responses to surveys from the National Institute on Drug Abuse (NIDA), Karen M. Wilson, MD, said at the annual meeting of the American Academy of Pediatrics.

The first single-dose, oral treatment for bacterial vaginosis will be available by prescription in early 2018, thanks to its approval by the Food and Drug Administration.

Symbiomix Therapeutics announced Sept. 18 that the FDA had granted approval to secnidazole (Solosec) 2 g oral granules for the treatment of bacterial vaginosis in adult women. Clinical trials of the 5-nitroimidazole antibiotic have shown it to be effective in a single dose, offering the potential for greater patient adherence to treatment over the common regimen of twice-a-day dosing for 7 days.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The first single-dose, oral treatment for bacterial vaginosis will be available by prescription in early 2018, thanks to its approval by the Food and Drug Administration.

Symbiomix Therapeutics announced Sept. 18 that the FDA had granted approval to secnidazole (Solosec) 2 g oral granules for the treatment of bacterial vaginosis in adult women. Clinical trials of the 5-nitroimidazole antibiotic have shown it to be effective in a single dose, offering the potential for greater patient adherence to treatment over the common regimen of twice-a-day dosing for 7 days.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The first single-dose, oral treatment for bacterial vaginosis will be available by prescription in early 2018, thanks to its approval by the Food and Drug Administration.

Symbiomix Therapeutics announced Sept. 18 that the FDA had granted approval to secnidazole (Solosec) 2 g oral granules for the treatment of bacterial vaginosis in adult women. Clinical trials of the 5-nitroimidazole antibiotic have shown it to be effective in a single dose, offering the potential for greater patient adherence to treatment over the common regimen of twice-a-day dosing for 7 days.

mschneider@frontlinemedcom.com

On Twitter @maryellenny