Communication and relationships cannot be taken for granted, particularly in the physician-patient relationship, where life-altering diagnoses may be given. With one diagnosis, someone’s life may be changed, and both physicians and patients need to be cognizant of the importance of a strong relationship and clear communication.

In the current US health care system, both physicians and patients often are not getting their needs met, and studies that include factors of race, ethnicity, and socioeconomic status suggest that physician-patient relationship barriers contribute to racial disparities in health care.^1,2 Although patient-centered care is a widely recognized and upheld model, relationship-centered care between physician and patient involves focusing on the patient and the physician-patient relationship through recognizing personhood, affect (being empathic), and reciprocal influence.^3,4 Although it is not necessarily intuitive because it can appear to be yet another task for busy physicians, relationship-centered care improves health care delivery for both physicians and patients through decreased physician burnout, reduced medical errors, and better patient outcomes and satisfaction.^5,6

Every physician, patient, and physician-patient relationship is different; unlike the standard questions directed at a routine patient history focused on gathering data, there is no one-size-fits-all relationship-centered conversation.^7-10 As with any successful interaction between 2 people, there is a certain amount of necessary self-awareness (Table 1)¹¹ that allows for improvisation and appropriate responsiveness to what is seen, heard, and felt. Rather than attending solely to disease states, the focus of relationship-centered care is on patients, interpersonal interaction, and promoting health and well-being.¹⁵

This review summarizes the existing literature on relationship-centered care, introduces the use of metacognition (Table 1), and suggests creating simple habits to promote such care. The following databases were searched from inception through November 23, 2020, using the term relationship-centered care: MEDLINE (Ovid), EMBASE (Ovid), APA PsycInfo (Ovid), Scopus, Web of Science Core Collection, CINAHL Complete (EBSCO), Academic Search Premier (EBSCOhost), and ERIC (ProQuest). A total of 1772 records were retrieved through searches, and after deduplication of 1116 studies, 350 records were screened through a 2-part process. Articles were first screened by title and abstract for relevance to the relationship between physician and patient, with 185 studies deemed irrelevant (eg, pertaining to the relationship of veterinarian to animal). The remaining 165 studies were assessed for eligibility, with 69 further studies excluded for various reasons. The screening process resulted in 96 articles considered in this review.

Definitions/key terms, as used in this article, are listed in Table 1.

Background of Relationship-Centered Care

Given time constraints, the diagnosis and treatment of medical problems often are the focus of physicians. Although proper medical diagnosis and treatment are important, and their delivery is made possible by the physician having the appropriate knowledge, a physician-patient relationship that focuses solely on disease without acknowledging the patient creates a system that ultimately neglects both patients and physicians.¹⁵ This prevailing physician-patient relationship paradigm is suboptimal, and a proposed remedy is relationship-centered care, which focuses on relationships among the human beings in health care interactions.³ Relationship-centered care has 4 principles: (1) the personhood of each party must be recognized, (2) emotion is part of relationships, (3) relationships are reciprocal and not just one way, and (4) creating these types of relationships is morally valuable³ and beneficial to patient care.¹⁶

Assessment of the Need for Relationship-Centered Care

Relationship-centered care has been studied in physician-patient interactions in various health care settings.^17-23 For at least 2 decades, relationship-centered care has been set forth as a model,^4,24,25 but there are challenges. Physicians tend to overrate or underrate their communication skills in patient interactions.^26,27 A given physician’s preferences often still seem to supersede those of the patient.^3,28,29 The impetus to develop relationship-centered care skills generally needs to be internally driven,^4,30 as, ultimately, physicians and patients have varying needs.^4,31 However, providing physicians with a potential structure is helpful.³²

A Solution: Metacognition in the Physician-Patient Interaction

Metacognition is important to integrating basic science knowledge into medical learning and practice,^33,34 and it is no less important in translating interpersonal knowledge to the physician-patient interaction. Decreased metacognitive effort³⁵ may underpin the decline in empathy seen with increasing medical training.^36,37 Understanding how metacognitive practices foster relationship-centered care is important for teaching, developing, and maintaining that care.

Metacognition is already embedded in the fabric of the physician-patient interaction.^33,34 The complex interplay of the physician-patient interview, patient examination, and integration of physical as well as ancillary data requires higher-order thinking and the ability to parse out that thinking successfully. As a concrete example, coming to a diagnosis requires thinking about what has been presented during the physician-patient interaction and considering what supports and suggests the disease while a list of potential differential diagnosis alternatives is being generated. Physicians are trained to apply this clinical reasoning approach to their patient care.

Conversely, although communication skills are a key component of doctoring,³⁸ both between physician and patient as well as among other colleagues and staff, many physicians have never received formal training in communication skills,^26,32,39 though it is now an integral part of medical school curricula.⁴⁰ When such training is mandatory, less than 1% of physicians continue to believe that there was no benefit, even from a single 8-hour communications skills training session.⁴¹ Communication cannot be taught comprehensively in 8 hours; thus, the benefit of such training may be the end result of metacognition and increased self-awareness (Table 1).^42,43

Building Relationship-Centered Care Through Metacognitive Attention

Metacognition as manifested by such self-awareness can build relationship-centered care.⁴ Self-awareness can be taught through mentorship or role models.⁴⁴ Journaling,⁴⁰ meditation, and appreciation of beauty and the arts⁴⁵ can contribute, as well as more formal training programs,^32,38,42 as offered by the Academy of Communication in Healthcare. Creating opportunities for patient empowerment also supports relationship-centered care, as does applying knowledge of implicit bias.⁴⁶

Even without formal training, relationship-centered care can be built through attention to cues⁹—visual (eg, sitting down, other body language),^47,48 auditory (eg, knocking, language, tone, conversational flow),^48,49 and emotional (eg, clinical empathy, emotional intelligence)(Table 2). Such attention is familiar to everyone, not just physicians or patients, through interactions outside of health care; inattention may be due to the hidden curriculum or culture of medicine⁴⁰ as well as real-time changes, such as the introduction of the electronic health record.⁵¹ Inattention to these cues also may be a result of context-specific knowledge, in which a physician’s real-life communication skills are not applied to the unique context of patient care.

Metacognitive Attention Can Generate Habit

Taking metacognition a step further, these small interventions can become habit^11,14,39 through self-awareness, deliberate practice, and feedback.⁴³ Habit is generated by linking a given intervention to another defined cue. For example, placing a hand on a doorknob to enter an examination room can be the cue to generate a habit of entering with presence.¹⁴ Alternatively, before entering an examination room, taking 3 deep breaths can be the cue to trigger presence.¹⁴ Habits can be created in just 3 weeks,⁵⁷ and other proposed cues to generate habits toward relationship-centered care are listed in Table 2. By creating habit through metacognitive attention, relationship-centered care will become something that happens subconsciously without further burdening physicians with another task. Asking patients for permission to record video of an interaction also can create opportunities for self-awareness and self-evaluation through rewatching the video.⁵⁸

Final Thoughts

Physicians already have the tools to create relationship-centered care in physician-patient interactions. A critical mental shift is to develop habits and apply thinking patterns toward understanding and responding appropriately to patients of all ethnicities and their emotions in the physician-patient interaction. This shift is aided by metacognitive awareness (Table 1) and the development of useful habits (Table 2).

Communication and relationships cannot be taken for granted, particularly in the physician-patient relationship, where life-altering diagnoses may be given. With one diagnosis, someone’s life may be changed, and both physicians and patients need to be cognizant of the importance of a strong relationship and clear communication.

In the current US health care system, both physicians and patients often are not getting their needs met, and studies that include factors of race, ethnicity, and socioeconomic status suggest that physician-patient relationship barriers contribute to racial disparities in health care.^1,2 Although patient-centered care is a widely recognized and upheld model, relationship-centered care between physician and patient involves focusing on the patient and the physician-patient relationship through recognizing personhood, affect (being empathic), and reciprocal influence.^3,4 Although it is not necessarily intuitive because it can appear to be yet another task for busy physicians, relationship-centered care improves health care delivery for both physicians and patients through decreased physician burnout, reduced medical errors, and better patient outcomes and satisfaction.^5,6

Every physician, patient, and physician-patient relationship is different; unlike the standard questions directed at a routine patient history focused on gathering data, there is no one-size-fits-all relationship-centered conversation.^7-10 As with any successful interaction between 2 people, there is a certain amount of necessary self-awareness (Table 1)¹¹ that allows for improvisation and appropriate responsiveness to what is seen, heard, and felt. Rather than attending solely to disease states, the focus of relationship-centered care is on patients, interpersonal interaction, and promoting health and well-being.¹⁵

This review summarizes the existing literature on relationship-centered care, introduces the use of metacognition (Table 1), and suggests creating simple habits to promote such care. The following databases were searched from inception through November 23, 2020, using the term relationship-centered care: MEDLINE (Ovid), EMBASE (Ovid), APA PsycInfo (Ovid), Scopus, Web of Science Core Collection, CINAHL Complete (EBSCO), Academic Search Premier (EBSCOhost), and ERIC (ProQuest). A total of 1772 records were retrieved through searches, and after deduplication of 1116 studies, 350 records were screened through a 2-part process. Articles were first screened by title and abstract for relevance to the relationship between physician and patient, with 185 studies deemed irrelevant (eg, pertaining to the relationship of veterinarian to animal). The remaining 165 studies were assessed for eligibility, with 69 further studies excluded for various reasons. The screening process resulted in 96 articles considered in this review.

Definitions/key terms, as used in this article, are listed in Table 1.

Background of Relationship-Centered Care

Given time constraints, the diagnosis and treatment of medical problems often are the focus of physicians. Although proper medical diagnosis and treatment are important, and their delivery is made possible by the physician having the appropriate knowledge, a physician-patient relationship that focuses solely on disease without acknowledging the patient creates a system that ultimately neglects both patients and physicians.¹⁵ This prevailing physician-patient relationship paradigm is suboptimal, and a proposed remedy is relationship-centered care, which focuses on relationships among the human beings in health care interactions.³ Relationship-centered care has 4 principles: (1) the personhood of each party must be recognized, (2) emotion is part of relationships, (3) relationships are reciprocal and not just one way, and (4) creating these types of relationships is morally valuable³ and beneficial to patient care.¹⁶

Assessment of the Need for Relationship-Centered Care

Relationship-centered care has been studied in physician-patient interactions in various health care settings.^17-23 For at least 2 decades, relationship-centered care has been set forth as a model,^4,24,25 but there are challenges. Physicians tend to overrate or underrate their communication skills in patient interactions.^26,27 A given physician’s preferences often still seem to supersede those of the patient.^3,28,29 The impetus to develop relationship-centered care skills generally needs to be internally driven,^4,30 as, ultimately, physicians and patients have varying needs.^4,31 However, providing physicians with a potential structure is helpful.³²

A Solution: Metacognition in the Physician-Patient Interaction

Metacognition is important to integrating basic science knowledge into medical learning and practice,^33,34 and it is no less important in translating interpersonal knowledge to the physician-patient interaction. Decreased metacognitive effort³⁵ may underpin the decline in empathy seen with increasing medical training.^36,37 Understanding how metacognitive practices foster relationship-centered care is important for teaching, developing, and maintaining that care.

Metacognition is already embedded in the fabric of the physician-patient interaction.^33,34 The complex interplay of the physician-patient interview, patient examination, and integration of physical as well as ancillary data requires higher-order thinking and the ability to parse out that thinking successfully. As a concrete example, coming to a diagnosis requires thinking about what has been presented during the physician-patient interaction and considering what supports and suggests the disease while a list of potential differential diagnosis alternatives is being generated. Physicians are trained to apply this clinical reasoning approach to their patient care.

Conversely, although communication skills are a key component of doctoring,³⁸ both between physician and patient as well as among other colleagues and staff, many physicians have never received formal training in communication skills,^26,32,39 though it is now an integral part of medical school curricula.⁴⁰ When such training is mandatory, less than 1% of physicians continue to believe that there was no benefit, even from a single 8-hour communications skills training session.⁴¹ Communication cannot be taught comprehensively in 8 hours; thus, the benefit of such training may be the end result of metacognition and increased self-awareness (Table 1).^42,43

Building Relationship-Centered Care Through Metacognitive Attention

Metacognition as manifested by such self-awareness can build relationship-centered care.⁴ Self-awareness can be taught through mentorship or role models.⁴⁴ Journaling,⁴⁰ meditation, and appreciation of beauty and the arts⁴⁵ can contribute, as well as more formal training programs,^32,38,42 as offered by the Academy of Communication in Healthcare. Creating opportunities for patient empowerment also supports relationship-centered care, as does applying knowledge of implicit bias.⁴⁶

Even without formal training, relationship-centered care can be built through attention to cues⁹—visual (eg, sitting down, other body language),^47,48 auditory (eg, knocking, language, tone, conversational flow),^48,49 and emotional (eg, clinical empathy, emotional intelligence)(Table 2). Such attention is familiar to everyone, not just physicians or patients, through interactions outside of health care; inattention may be due to the hidden curriculum or culture of medicine⁴⁰ as well as real-time changes, such as the introduction of the electronic health record.⁵¹ Inattention to these cues also may be a result of context-specific knowledge, in which a physician’s real-life communication skills are not applied to the unique context of patient care.

Metacognitive Attention Can Generate Habit

Taking metacognition a step further, these small interventions can become habit^11,14,39 through self-awareness, deliberate practice, and feedback.⁴³ Habit is generated by linking a given intervention to another defined cue. For example, placing a hand on a doorknob to enter an examination room can be the cue to generate a habit of entering with presence.¹⁴ Alternatively, before entering an examination room, taking 3 deep breaths can be the cue to trigger presence.¹⁴ Habits can be created in just 3 weeks,⁵⁷ and other proposed cues to generate habits toward relationship-centered care are listed in Table 2. By creating habit through metacognitive attention, relationship-centered care will become something that happens subconsciously without further burdening physicians with another task. Asking patients for permission to record video of an interaction also can create opportunities for self-awareness and self-evaluation through rewatching the video.⁵⁸

Final Thoughts

Physicians already have the tools to create relationship-centered care in physician-patient interactions. A critical mental shift is to develop habits and apply thinking patterns toward understanding and responding appropriately to patients of all ethnicities and their emotions in the physician-patient interaction. This shift is aided by metacognitive awareness (Table 1) and the development of useful habits (Table 2).

Communication and relationships cannot be taken for granted, particularly in the physician-patient relationship, where life-altering diagnoses may be given. With one diagnosis, someone’s life may be changed, and both physicians and patients need to be cognizant of the importance of a strong relationship and clear communication.

In the current US health care system, both physicians and patients often are not getting their needs met, and studies that include factors of race, ethnicity, and socioeconomic status suggest that physician-patient relationship barriers contribute to racial disparities in health care.^1,2 Although patient-centered care is a widely recognized and upheld model, relationship-centered care between physician and patient involves focusing on the patient and the physician-patient relationship through recognizing personhood, affect (being empathic), and reciprocal influence.^3,4 Although it is not necessarily intuitive because it can appear to be yet another task for busy physicians, relationship-centered care improves health care delivery for both physicians and patients through decreased physician burnout, reduced medical errors, and better patient outcomes and satisfaction.^5,6

Every physician, patient, and physician-patient relationship is different; unlike the standard questions directed at a routine patient history focused on gathering data, there is no one-size-fits-all relationship-centered conversation.^7-10 As with any successful interaction between 2 people, there is a certain amount of necessary self-awareness (Table 1)¹¹ that allows for improvisation and appropriate responsiveness to what is seen, heard, and felt. Rather than attending solely to disease states, the focus of relationship-centered care is on patients, interpersonal interaction, and promoting health and well-being.¹⁵

This review summarizes the existing literature on relationship-centered care, introduces the use of metacognition (Table 1), and suggests creating simple habits to promote such care. The following databases were searched from inception through November 23, 2020, using the term relationship-centered care: MEDLINE (Ovid), EMBASE (Ovid), APA PsycInfo (Ovid), Scopus, Web of Science Core Collection, CINAHL Complete (EBSCO), Academic Search Premier (EBSCOhost), and ERIC (ProQuest). A total of 1772 records were retrieved through searches, and after deduplication of 1116 studies, 350 records were screened through a 2-part process. Articles were first screened by title and abstract for relevance to the relationship between physician and patient, with 185 studies deemed irrelevant (eg, pertaining to the relationship of veterinarian to animal). The remaining 165 studies were assessed for eligibility, with 69 further studies excluded for various reasons. The screening process resulted in 96 articles considered in this review.

Definitions/key terms, as used in this article, are listed in Table 1.

Background of Relationship-Centered Care

Given time constraints, the diagnosis and treatment of medical problems often are the focus of physicians. Although proper medical diagnosis and treatment are important, and their delivery is made possible by the physician having the appropriate knowledge, a physician-patient relationship that focuses solely on disease without acknowledging the patient creates a system that ultimately neglects both patients and physicians.¹⁵ This prevailing physician-patient relationship paradigm is suboptimal, and a proposed remedy is relationship-centered care, which focuses on relationships among the human beings in health care interactions.³ Relationship-centered care has 4 principles: (1) the personhood of each party must be recognized, (2) emotion is part of relationships, (3) relationships are reciprocal and not just one way, and (4) creating these types of relationships is morally valuable³ and beneficial to patient care.¹⁶

Assessment of the Need for Relationship-Centered Care

Relationship-centered care has been studied in physician-patient interactions in various health care settings.^17-23 For at least 2 decades, relationship-centered care has been set forth as a model,^4,24,25 but there are challenges. Physicians tend to overrate or underrate their communication skills in patient interactions.^26,27 A given physician’s preferences often still seem to supersede those of the patient.^3,28,29 The impetus to develop relationship-centered care skills generally needs to be internally driven,^4,30 as, ultimately, physicians and patients have varying needs.^4,31 However, providing physicians with a potential structure is helpful.³²

A Solution: Metacognition in the Physician-Patient Interaction

Metacognition is important to integrating basic science knowledge into medical learning and practice,^33,34 and it is no less important in translating interpersonal knowledge to the physician-patient interaction. Decreased metacognitive effort³⁵ may underpin the decline in empathy seen with increasing medical training.^36,37 Understanding how metacognitive practices foster relationship-centered care is important for teaching, developing, and maintaining that care.

Metacognition is already embedded in the fabric of the physician-patient interaction.^33,34 The complex interplay of the physician-patient interview, patient examination, and integration of physical as well as ancillary data requires higher-order thinking and the ability to parse out that thinking successfully. As a concrete example, coming to a diagnosis requires thinking about what has been presented during the physician-patient interaction and considering what supports and suggests the disease while a list of potential differential diagnosis alternatives is being generated. Physicians are trained to apply this clinical reasoning approach to their patient care.

Conversely, although communication skills are a key component of doctoring,³⁸ both between physician and patient as well as among other colleagues and staff, many physicians have never received formal training in communication skills,^26,32,39 though it is now an integral part of medical school curricula.⁴⁰ When such training is mandatory, less than 1% of physicians continue to believe that there was no benefit, even from a single 8-hour communications skills training session.⁴¹ Communication cannot be taught comprehensively in 8 hours; thus, the benefit of such training may be the end result of metacognition and increased self-awareness (Table 1).^42,43

Building Relationship-Centered Care Through Metacognitive Attention

Metacognition as manifested by such self-awareness can build relationship-centered care.⁴ Self-awareness can be taught through mentorship or role models.⁴⁴ Journaling,⁴⁰ meditation, and appreciation of beauty and the arts⁴⁵ can contribute, as well as more formal training programs,^32,38,42 as offered by the Academy of Communication in Healthcare. Creating opportunities for patient empowerment also supports relationship-centered care, as does applying knowledge of implicit bias.⁴⁶

Even without formal training, relationship-centered care can be built through attention to cues⁹—visual (eg, sitting down, other body language),^47,48 auditory (eg, knocking, language, tone, conversational flow),^48,49 and emotional (eg, clinical empathy, emotional intelligence)(Table 2). Such attention is familiar to everyone, not just physicians or patients, through interactions outside of health care; inattention may be due to the hidden curriculum or culture of medicine⁴⁰ as well as real-time changes, such as the introduction of the electronic health record.⁵¹ Inattention to these cues also may be a result of context-specific knowledge, in which a physician’s real-life communication skills are not applied to the unique context of patient care.

Metacognitive Attention Can Generate Habit

Taking metacognition a step further, these small interventions can become habit^11,14,39 through self-awareness, deliberate practice, and feedback.⁴³ Habit is generated by linking a given intervention to another defined cue. For example, placing a hand on a doorknob to enter an examination room can be the cue to generate a habit of entering with presence.¹⁴ Alternatively, before entering an examination room, taking 3 deep breaths can be the cue to trigger presence.¹⁴ Habits can be created in just 3 weeks,⁵⁷ and other proposed cues to generate habits toward relationship-centered care are listed in Table 2. By creating habit through metacognitive attention, relationship-centered care will become something that happens subconsciously without further burdening physicians with another task. Asking patients for permission to record video of an interaction also can create opportunities for self-awareness and self-evaluation through rewatching the video.⁵⁸

Final Thoughts

Physicians already have the tools to create relationship-centered care in physician-patient interactions. A critical mental shift is to develop habits and apply thinking patterns toward understanding and responding appropriately to patients of all ethnicities and their emotions in the physician-patient interaction. This shift is aided by metacognitive awareness (Table 1) and the development of useful habits (Table 2).

Background: Current U.S. guidelines recommend colonoscopy within 24 hours for patients presenting with high-risk or severe acute lower gastrointestinal bleeding. However, prior meta-analyses of the timing of colonoscopy relied primarily on observational studies, and a recent multicenter randomized, controlled trial suggests no substantial benefit for early colonoscopy.

Synopsis: The authors identified four randomized, controlled trials that compared early colonoscopy (defined as within 24 hours) with elective colonoscopy (defined as beyond 24 hours) and/or other diagnostic tests for patients presenting with acute lower GI bleeding. They performed a meta-analysis, including 463 patients, which showed no significant difference in risk of persistent or recurrent bleeding for early versus elective colonoscopy. The authors also found no significant differences in secondary outcomes of mortality, endoscopic intervention, primary hemostatic intervention, or identification of bleeding source. Limitations of this research include the relatively small number of studies included, and potential for selection bias in the original studies. Notably two of the four studies included were prematurely terminated before their planned sample sizes were reached.

Bottom line: In patients hospitalized with acute lower GI bleeding, colonoscopy within 24 hours may not reduce further bleeding or mortality when compared with elective colonoscopy.

Citation: Tsay C et al. Early colonoscopy does not improve outcomes of patients with lower gastrointestinal bleeding: Systematic review of randomized trials. Clin Gastroenterol Hepatol. 2019 Dec 13. doi: 10.1016/j.cgh.2019.11.061.

Dr. Hu is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

Background: Current U.S. guidelines recommend colonoscopy within 24 hours for patients presenting with high-risk or severe acute lower gastrointestinal bleeding. However, prior meta-analyses of the timing of colonoscopy relied primarily on observational studies, and a recent multicenter randomized, controlled trial suggests no substantial benefit for early colonoscopy.

Synopsis: The authors identified four randomized, controlled trials that compared early colonoscopy (defined as within 24 hours) with elective colonoscopy (defined as beyond 24 hours) and/or other diagnostic tests for patients presenting with acute lower GI bleeding. They performed a meta-analysis, including 463 patients, which showed no significant difference in risk of persistent or recurrent bleeding for early versus elective colonoscopy. The authors also found no significant differences in secondary outcomes of mortality, endoscopic intervention, primary hemostatic intervention, or identification of bleeding source. Limitations of this research include the relatively small number of studies included, and potential for selection bias in the original studies. Notably two of the four studies included were prematurely terminated before their planned sample sizes were reached.

Bottom line: In patients hospitalized with acute lower GI bleeding, colonoscopy within 24 hours may not reduce further bleeding or mortality when compared with elective colonoscopy.

Citation: Tsay C et al. Early colonoscopy does not improve outcomes of patients with lower gastrointestinal bleeding: Systematic review of randomized trials. Clin Gastroenterol Hepatol. 2019 Dec 13. doi: 10.1016/j.cgh.2019.11.061.

Dr. Hu is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

Background: Current U.S. guidelines recommend colonoscopy within 24 hours for patients presenting with high-risk or severe acute lower gastrointestinal bleeding. However, prior meta-analyses of the timing of colonoscopy relied primarily on observational studies, and a recent multicenter randomized, controlled trial suggests no substantial benefit for early colonoscopy.

Synopsis: The authors identified four randomized, controlled trials that compared early colonoscopy (defined as within 24 hours) with elective colonoscopy (defined as beyond 24 hours) and/or other diagnostic tests for patients presenting with acute lower GI bleeding. They performed a meta-analysis, including 463 patients, which showed no significant difference in risk of persistent or recurrent bleeding for early versus elective colonoscopy. The authors also found no significant differences in secondary outcomes of mortality, endoscopic intervention, primary hemostatic intervention, or identification of bleeding source. Limitations of this research include the relatively small number of studies included, and potential for selection bias in the original studies. Notably two of the four studies included were prematurely terminated before their planned sample sizes were reached.

Bottom line: In patients hospitalized with acute lower GI bleeding, colonoscopy within 24 hours may not reduce further bleeding or mortality when compared with elective colonoscopy.

Citation: Tsay C et al. Early colonoscopy does not improve outcomes of patients with lower gastrointestinal bleeding: Systematic review of randomized trials. Clin Gastroenterol Hepatol. 2019 Dec 13. doi: 10.1016/j.cgh.2019.11.061.

Dr. Hu is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, both in Boston.

A 56-year-old woman with type 2 diabetes presents for evaluation of painful neuropathy. She has had a diagnosis of type 2 diabetes for the past 4 years. She initially presented with polyuria/polydipsia and a hemoglobin A1c level of 9.5. She has previously not tolerated metformin, and did not want to take any subsequent medications. She was seen 4 months ago and at that time had an A1c level of 12.5. She decided she wanted to really treat her diabetes as well as she could. She started consuming a low carbohydrate diet, restarted metformin and began using a continuous glucose monitor. She also started taking nighttime glargine insulin, and mealtime insulin apart. She reports she lost 20 pounds over the past 4 months, her blood sugars now run between 100-120 fasting, and up to 180 before meals. She has had a severe, sharp pain in both of her feet over the past month that is interfering with sleep and makes walking painful for her. An exam reveals hyperesthesia of both feet, and her A1c level is 7.5. What is the most likely cause of her neuropathic symptoms?

A. Vitamin B₁₂ deficiency

B. Diabetic neuropathy

C. Insulin neuritis

D. Charcot-Marie-Tooth disease

The most likely cause

In this case, certainly considering vitamin B₁₂ deficiency is reasonable. It is highly unlikely though, given the rapidity of onset of symptoms, and that the patient has been on metformin for a very short period of time. Chronic metformin use is associated with low B₁₂ levels, and the American Diabetes Association has advised that regular monitoring of vitamin B₁₂ levels should be done on patients who are on long-term metformin.¹

Diabetic neuropathy is also unlikely, given the rapidity of symptoms in this patient. What is most likely in this patient is treatment-induced neuropathy (TIN), first described with the name “insulin neuritis”.
 

Research on TIN

Gibbons and colleagues evaluated 16 patients with diabetes with recent marked, rapid improvement in glycemic control who developed a sudden, painful neuropathy.² All developed symptoms within 8 weeks of intensive glucose control, with 69% having autonomic dysfunction as well, and all developing worsening retinopathy.

Gibbons and Freeman did a retrospective study of patients referred to a diabetic neuropathy clinic over a 5-year period to try to understand how prevalent TIN is.³

A total of 954 patients were evaluated for diabetic neuropathy. Treatment induced neuropathy was defined as a painful neuropathy and/or autonomic dysfunction occurring within 8 weeks of intensified treatment and a drop of the A1c level greater than 2 over a 3-month period.

A total of 104 patients (10.9%) met the criteria for treatment induced neuropathy. Patients who had a decrease in A1c had a much greater chance of developing a painful or autonomic neuropathy than patients who had no change in A1c (P < .0001). The same patients had a much higher risk of developing retinopathy (P < .001). The greater the reduction in A1c, the greater the risk. Patients whose A1c decreased by 2%-3% over 3 months had an absolute risk of 20%, whereas those with a A1c decease of greater than 4% had an 80% absolute risk.

Siddique and colleagues reported on three cases with very different clinical presentations of TIN.⁴ One patient had an acute third nerve palsy, another patient had a lumbosacral radiculoplexus neuropathy, and the third patient presented with a diffuse painful sensory neuropathy and postural hypotension.

Most patients improve over time from their neuropathic symptoms, with better recovery in patients with type 1 diabetes.²

Pearl

Strongly consider treatment induced neuropathy in your patients with diabetes who present with acute painful neuropathy and/or autonomic dysfunction in the setting of rapid improvement of glucose control.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. American Diabetes Association. Diabetes Care. 2019 Jan;42(Suppl 1):S90-102.

2. Gibbons CH and Freeman R. Ann Neurol 2010; 67:534–41.

3. Gibbons CH and Freeman R. Brain. 2015;138:43-52.

4. Siddique N et al. Endocrinol Diabetes Metab Case Rep. 2020 Feb 26;2020:19-0140.

A 56-year-old woman with type 2 diabetes presents for evaluation of painful neuropathy. She has had a diagnosis of type 2 diabetes for the past 4 years. She initially presented with polyuria/polydipsia and a hemoglobin A1c level of 9.5. She has previously not tolerated metformin, and did not want to take any subsequent medications. She was seen 4 months ago and at that time had an A1c level of 12.5. She decided she wanted to really treat her diabetes as well as she could. She started consuming a low carbohydrate diet, restarted metformin and began using a continuous glucose monitor. She also started taking nighttime glargine insulin, and mealtime insulin apart. She reports she lost 20 pounds over the past 4 months, her blood sugars now run between 100-120 fasting, and up to 180 before meals. She has had a severe, sharp pain in both of her feet over the past month that is interfering with sleep and makes walking painful for her. An exam reveals hyperesthesia of both feet, and her A1c level is 7.5. What is the most likely cause of her neuropathic symptoms?

A. Vitamin B₁₂ deficiency

B. Diabetic neuropathy

C. Insulin neuritis

D. Charcot-Marie-Tooth disease

The most likely cause

In this case, certainly considering vitamin B₁₂ deficiency is reasonable. It is highly unlikely though, given the rapidity of onset of symptoms, and that the patient has been on metformin for a very short period of time. Chronic metformin use is associated with low B₁₂ levels, and the American Diabetes Association has advised that regular monitoring of vitamin B₁₂ levels should be done on patients who are on long-term metformin.¹

Diabetic neuropathy is also unlikely, given the rapidity of symptoms in this patient. What is most likely in this patient is treatment-induced neuropathy (TIN), first described with the name “insulin neuritis”.
 

Research on TIN

Gibbons and colleagues evaluated 16 patients with diabetes with recent marked, rapid improvement in glycemic control who developed a sudden, painful neuropathy.² All developed symptoms within 8 weeks of intensive glucose control, with 69% having autonomic dysfunction as well, and all developing worsening retinopathy.

Gibbons and Freeman did a retrospective study of patients referred to a diabetic neuropathy clinic over a 5-year period to try to understand how prevalent TIN is.³

A total of 954 patients were evaluated for diabetic neuropathy. Treatment induced neuropathy was defined as a painful neuropathy and/or autonomic dysfunction occurring within 8 weeks of intensified treatment and a drop of the A1c level greater than 2 over a 3-month period.

A total of 104 patients (10.9%) met the criteria for treatment induced neuropathy. Patients who had a decrease in A1c had a much greater chance of developing a painful or autonomic neuropathy than patients who had no change in A1c (P < .0001). The same patients had a much higher risk of developing retinopathy (P < .001). The greater the reduction in A1c, the greater the risk. Patients whose A1c decreased by 2%-3% over 3 months had an absolute risk of 20%, whereas those with a A1c decease of greater than 4% had an 80% absolute risk.

Siddique and colleagues reported on three cases with very different clinical presentations of TIN.⁴ One patient had an acute third nerve palsy, another patient had a lumbosacral radiculoplexus neuropathy, and the third patient presented with a diffuse painful sensory neuropathy and postural hypotension.

Most patients improve over time from their neuropathic symptoms, with better recovery in patients with type 1 diabetes.²

Pearl

Strongly consider treatment induced neuropathy in your patients with diabetes who present with acute painful neuropathy and/or autonomic dysfunction in the setting of rapid improvement of glucose control.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. American Diabetes Association. Diabetes Care. 2019 Jan;42(Suppl 1):S90-102.

2. Gibbons CH and Freeman R. Ann Neurol 2010; 67:534–41.

3. Gibbons CH and Freeman R. Brain. 2015;138:43-52.

4. Siddique N et al. Endocrinol Diabetes Metab Case Rep. 2020 Feb 26;2020:19-0140.

A 56-year-old woman with type 2 diabetes presents for evaluation of painful neuropathy. She has had a diagnosis of type 2 diabetes for the past 4 years. She initially presented with polyuria/polydipsia and a hemoglobin A1c level of 9.5. She has previously not tolerated metformin, and did not want to take any subsequent medications. She was seen 4 months ago and at that time had an A1c level of 12.5. She decided she wanted to really treat her diabetes as well as she could. She started consuming a low carbohydrate diet, restarted metformin and began using a continuous glucose monitor. She also started taking nighttime glargine insulin, and mealtime insulin apart. She reports she lost 20 pounds over the past 4 months, her blood sugars now run between 100-120 fasting, and up to 180 before meals. She has had a severe, sharp pain in both of her feet over the past month that is interfering with sleep and makes walking painful for her. An exam reveals hyperesthesia of both feet, and her A1c level is 7.5. What is the most likely cause of her neuropathic symptoms?

A. Vitamin B₁₂ deficiency

B. Diabetic neuropathy

C. Insulin neuritis

D. Charcot-Marie-Tooth disease

The most likely cause

In this case, certainly considering vitamin B₁₂ deficiency is reasonable. It is highly unlikely though, given the rapidity of onset of symptoms, and that the patient has been on metformin for a very short period of time. Chronic metformin use is associated with low B₁₂ levels, and the American Diabetes Association has advised that regular monitoring of vitamin B₁₂ levels should be done on patients who are on long-term metformin.¹

Diabetic neuropathy is also unlikely, given the rapidity of symptoms in this patient. What is most likely in this patient is treatment-induced neuropathy (TIN), first described with the name “insulin neuritis”.
 

Research on TIN

Gibbons and colleagues evaluated 16 patients with diabetes with recent marked, rapid improvement in glycemic control who developed a sudden, painful neuropathy.² All developed symptoms within 8 weeks of intensive glucose control, with 69% having autonomic dysfunction as well, and all developing worsening retinopathy.

Gibbons and Freeman did a retrospective study of patients referred to a diabetic neuropathy clinic over a 5-year period to try to understand how prevalent TIN is.³

A total of 954 patients were evaluated for diabetic neuropathy. Treatment induced neuropathy was defined as a painful neuropathy and/or autonomic dysfunction occurring within 8 weeks of intensified treatment and a drop of the A1c level greater than 2 over a 3-month period.

A total of 104 patients (10.9%) met the criteria for treatment induced neuropathy. Patients who had a decrease in A1c had a much greater chance of developing a painful or autonomic neuropathy than patients who had no change in A1c (P < .0001). The same patients had a much higher risk of developing retinopathy (P < .001). The greater the reduction in A1c, the greater the risk. Patients whose A1c decreased by 2%-3% over 3 months had an absolute risk of 20%, whereas those with a A1c decease of greater than 4% had an 80% absolute risk.

Siddique and colleagues reported on three cases with very different clinical presentations of TIN.⁴ One patient had an acute third nerve palsy, another patient had a lumbosacral radiculoplexus neuropathy, and the third patient presented with a diffuse painful sensory neuropathy and postural hypotension.

Most patients improve over time from their neuropathic symptoms, with better recovery in patients with type 1 diabetes.²

Pearl

Strongly consider treatment induced neuropathy in your patients with diabetes who present with acute painful neuropathy and/or autonomic dysfunction in the setting of rapid improvement of glucose control.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at [email protected].

References

1. American Diabetes Association. Diabetes Care. 2019 Jan;42(Suppl 1):S90-102.

2. Gibbons CH and Freeman R. Ann Neurol 2010; 67:534–41.

3. Gibbons CH and Freeman R. Brain. 2015;138:43-52.

4. Siddique N et al. Endocrinol Diabetes Metab Case Rep. 2020 Feb 26;2020:19-0140.

Updated guidelines from the American College of Gastroenterology address upper gastrointestinal and ulcer bleeding. Many recommendations are similar to the 2012 version, but some important changes place an emphasis on risk-stratification tools to reduce hospitalization in low-risk patients, and the timing of endoscopy for patients who are admitted to the hospital.

The guidelines were published in the American Journal of Gastroenterology.

One key change was the expansion of the Glasgow-Blatchford score (GBS) that could be used to identify patients at very low risk for a hospital intervention, from 0 in the 2012 guidelines to 0-1 in the current version. That expands the group of patients that could be discharged with outpatient follow-up.

A cutoff score of 0 identifies very few people, said Neil Sengupta, MD, who is an assistant professor of medicine at University of Chicago Medicine. Although expanding the qualification to 0-1 can increase the number of patients sent home, “which is certainly a good thing,” Dr. Sengupta said, it may be difficult to put into practice – especially in EDs. In most situations, GBS requires manual inputs. A few hospital systems have implemented automatic calculation of GBS from medical records, but the practice is not widespread.

“No. 1, the compliance of measuring the score is pretty low. No. 2, it’s difficult for an emergency room physician to discharge a patient with upper GI bleeding if patients don’t have good social support, or if they don’t have a good follow-up plan. So it’s hard to know whether this will really make a difference in terms of the number of people being discharged,” said Dr. Sengupta, who served as a monitor for the ACG committee that produced this guideline, and will become chair of the ACG guideline committee in October.

Another key message in the updated guidelines centers around timing of endoscopy. The 2012 guidelines recommended considering endoscopy within 12 hours for patients with high-risk clinical features. The new guidelines recommend that all patients should undergo endoscopy within 24 hours, and they do not specifically recommend endoscopy within 12 hours. Earlier endoscopy can lead to a more accurate prognosis, but can also cause mortality or complications if resuscitation and management of active comorbidities is insufficient, and outcomes can be worse during after-hours endoscopies. The change is based on a recent randomized, controlled trial that showed no 30-day mortality benefit to endoscopy performed within 6 hours of a consult, versus endoscopy performed between 6 and 24 hours.

That change still leaves uncertainty, because there may be some patients who would potentially benefit from earlier endoscopy. “I think that’s kind of the unknown: Whether there’s a subset of people who may benefit from going in very early and limiting the amount of resuscitation they get,” Dr. Sengupta said.

Another important message in the new guideline addresses proton pump inhibitor (PPI) therapy before endoscopy. Although the 2012 guidelines recommended considering pre-endoscopy PPI infusions, the new version states that there is no clear benefit for clinical outcomes. The authors of the guidelines did not recommend against it, either, because it is associated with a modest reduction in the need to perform endoscopic therapy. “And there’s a theoretical possibility that PPIs may benefit a minority of patients in whom endoscopy may not be possible in a timely fashion,” he said.

This advice may generate some controversy, since PPI use is very common prior to endoscopy, and in some places in the world, it might not be possible to complete an endoscopy within 24 hours. “As such, a lot of providers use PPIs routinely prior to endoscopy. It’s a little challenging just because this is such a common clinical scenario, and PPI use is so widespread that I don’t think it’s likely that practice is going to change based on this guideline,” Dr. Sengupta said. He did suggest that the benefit of PPIs after endoscopic therapy is well established, “so it’s going to be important to identify people who are at high risk (after an endoscopic treatment).

“The other the other thing is that you don’t really have too much guidance on whether there’s a benefit of using a continuous intravenous PPI versus intermittent PPI [either oral or intravenous] after endoscopy in high-risk patients, primarily [because of] the lack of high-quality data,” Dr. Sengupta said.

There is also good evidence that patients with ulcers and high-risk stigmata should receive endoscopic therapy, and these patients can benefit from posttherapy high-dose PPIs for 3 days.

Some guideline authors reported relationships with Phathom Pharmaceuticals, Olympus, and Cook. Dr. Sengupta is the upcoming chair of the ACG Practice Parameters Committees, which oversees the commissioning, updating, and review of all ACG clinical practice guidelines.

Updated guidelines from the American College of Gastroenterology address upper gastrointestinal and ulcer bleeding. Many recommendations are similar to the 2012 version, but some important changes place an emphasis on risk-stratification tools to reduce hospitalization in low-risk patients, and the timing of endoscopy for patients who are admitted to the hospital.

The guidelines were published in the American Journal of Gastroenterology.

One key change was the expansion of the Glasgow-Blatchford score (GBS) that could be used to identify patients at very low risk for a hospital intervention, from 0 in the 2012 guidelines to 0-1 in the current version. That expands the group of patients that could be discharged with outpatient follow-up.

A cutoff score of 0 identifies very few people, said Neil Sengupta, MD, who is an assistant professor of medicine at University of Chicago Medicine. Although expanding the qualification to 0-1 can increase the number of patients sent home, “which is certainly a good thing,” Dr. Sengupta said, it may be difficult to put into practice – especially in EDs. In most situations, GBS requires manual inputs. A few hospital systems have implemented automatic calculation of GBS from medical records, but the practice is not widespread.

“No. 1, the compliance of measuring the score is pretty low. No. 2, it’s difficult for an emergency room physician to discharge a patient with upper GI bleeding if patients don’t have good social support, or if they don’t have a good follow-up plan. So it’s hard to know whether this will really make a difference in terms of the number of people being discharged,” said Dr. Sengupta, who served as a monitor for the ACG committee that produced this guideline, and will become chair of the ACG guideline committee in October.

Another key message in the updated guidelines centers around timing of endoscopy. The 2012 guidelines recommended considering endoscopy within 12 hours for patients with high-risk clinical features. The new guidelines recommend that all patients should undergo endoscopy within 24 hours, and they do not specifically recommend endoscopy within 12 hours. Earlier endoscopy can lead to a more accurate prognosis, but can also cause mortality or complications if resuscitation and management of active comorbidities is insufficient, and outcomes can be worse during after-hours endoscopies. The change is based on a recent randomized, controlled trial that showed no 30-day mortality benefit to endoscopy performed within 6 hours of a consult, versus endoscopy performed between 6 and 24 hours.

That change still leaves uncertainty, because there may be some patients who would potentially benefit from earlier endoscopy. “I think that’s kind of the unknown: Whether there’s a subset of people who may benefit from going in very early and limiting the amount of resuscitation they get,” Dr. Sengupta said.

Another important message in the new guideline addresses proton pump inhibitor (PPI) therapy before endoscopy. Although the 2012 guidelines recommended considering pre-endoscopy PPI infusions, the new version states that there is no clear benefit for clinical outcomes. The authors of the guidelines did not recommend against it, either, because it is associated with a modest reduction in the need to perform endoscopic therapy. “And there’s a theoretical possibility that PPIs may benefit a minority of patients in whom endoscopy may not be possible in a timely fashion,” he said.

This advice may generate some controversy, since PPI use is very common prior to endoscopy, and in some places in the world, it might not be possible to complete an endoscopy within 24 hours. “As such, a lot of providers use PPIs routinely prior to endoscopy. It’s a little challenging just because this is such a common clinical scenario, and PPI use is so widespread that I don’t think it’s likely that practice is going to change based on this guideline,” Dr. Sengupta said. He did suggest that the benefit of PPIs after endoscopic therapy is well established, “so it’s going to be important to identify people who are at high risk (after an endoscopic treatment).

“The other the other thing is that you don’t really have too much guidance on whether there’s a benefit of using a continuous intravenous PPI versus intermittent PPI [either oral or intravenous] after endoscopy in high-risk patients, primarily [because of] the lack of high-quality data,” Dr. Sengupta said.

There is also good evidence that patients with ulcers and high-risk stigmata should receive endoscopic therapy, and these patients can benefit from posttherapy high-dose PPIs for 3 days.

Some guideline authors reported relationships with Phathom Pharmaceuticals, Olympus, and Cook. Dr. Sengupta is the upcoming chair of the ACG Practice Parameters Committees, which oversees the commissioning, updating, and review of all ACG clinical practice guidelines.

Updated guidelines from the American College of Gastroenterology address upper gastrointestinal and ulcer bleeding. Many recommendations are similar to the 2012 version, but some important changes place an emphasis on risk-stratification tools to reduce hospitalization in low-risk patients, and the timing of endoscopy for patients who are admitted to the hospital.

The guidelines were published in the American Journal of Gastroenterology.

One key change was the expansion of the Glasgow-Blatchford score (GBS) that could be used to identify patients at very low risk for a hospital intervention, from 0 in the 2012 guidelines to 0-1 in the current version. That expands the group of patients that could be discharged with outpatient follow-up.

A cutoff score of 0 identifies very few people, said Neil Sengupta, MD, who is an assistant professor of medicine at University of Chicago Medicine. Although expanding the qualification to 0-1 can increase the number of patients sent home, “which is certainly a good thing,” Dr. Sengupta said, it may be difficult to put into practice – especially in EDs. In most situations, GBS requires manual inputs. A few hospital systems have implemented automatic calculation of GBS from medical records, but the practice is not widespread.

“No. 1, the compliance of measuring the score is pretty low. No. 2, it’s difficult for an emergency room physician to discharge a patient with upper GI bleeding if patients don’t have good social support, or if they don’t have a good follow-up plan. So it’s hard to know whether this will really make a difference in terms of the number of people being discharged,” said Dr. Sengupta, who served as a monitor for the ACG committee that produced this guideline, and will become chair of the ACG guideline committee in October.

Another key message in the updated guidelines centers around timing of endoscopy. The 2012 guidelines recommended considering endoscopy within 12 hours for patients with high-risk clinical features. The new guidelines recommend that all patients should undergo endoscopy within 24 hours, and they do not specifically recommend endoscopy within 12 hours. Earlier endoscopy can lead to a more accurate prognosis, but can also cause mortality or complications if resuscitation and management of active comorbidities is insufficient, and outcomes can be worse during after-hours endoscopies. The change is based on a recent randomized, controlled trial that showed no 30-day mortality benefit to endoscopy performed within 6 hours of a consult, versus endoscopy performed between 6 and 24 hours.

That change still leaves uncertainty, because there may be some patients who would potentially benefit from earlier endoscopy. “I think that’s kind of the unknown: Whether there’s a subset of people who may benefit from going in very early and limiting the amount of resuscitation they get,” Dr. Sengupta said.

Another important message in the new guideline addresses proton pump inhibitor (PPI) therapy before endoscopy. Although the 2012 guidelines recommended considering pre-endoscopy PPI infusions, the new version states that there is no clear benefit for clinical outcomes. The authors of the guidelines did not recommend against it, either, because it is associated with a modest reduction in the need to perform endoscopic therapy. “And there’s a theoretical possibility that PPIs may benefit a minority of patients in whom endoscopy may not be possible in a timely fashion,” he said.

This advice may generate some controversy, since PPI use is very common prior to endoscopy, and in some places in the world, it might not be possible to complete an endoscopy within 24 hours. “As such, a lot of providers use PPIs routinely prior to endoscopy. It’s a little challenging just because this is such a common clinical scenario, and PPI use is so widespread that I don’t think it’s likely that practice is going to change based on this guideline,” Dr. Sengupta said. He did suggest that the benefit of PPIs after endoscopic therapy is well established, “so it’s going to be important to identify people who are at high risk (after an endoscopic treatment).

“The other the other thing is that you don’t really have too much guidance on whether there’s a benefit of using a continuous intravenous PPI versus intermittent PPI [either oral or intravenous] after endoscopy in high-risk patients, primarily [because of] the lack of high-quality data,” Dr. Sengupta said.

There is also good evidence that patients with ulcers and high-risk stigmata should receive endoscopic therapy, and these patients can benefit from posttherapy high-dose PPIs for 3 days.

Some guideline authors reported relationships with Phathom Pharmaceuticals, Olympus, and Cook. Dr. Sengupta is the upcoming chair of the ACG Practice Parameters Committees, which oversees the commissioning, updating, and review of all ACG clinical practice guidelines.

Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.

The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.

The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”

In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.

In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.

A version of this article first appeared on Medscape.com.

Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.

The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.

The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”

In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.

In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.

A version of this article first appeared on Medscape.com.

Imagine a hospitalist, part of a group with 35 hospitalists, is in her second year of practice and is caring for a 55-year-old woman with a history of congestive heart failure and cirrhosis from hepatitis C due to heroin use. The patient was hospitalized with acute back pain and found to have vertebral osteomyelitis confirmed on MRI.

The hospitalist calls a surgeon to get a biopsy so that antibiotic therapy can be chosen. The surgeon says it’s the second time the patient has been hospitalized for this condition, and asks, “Why do you need me to see this patient?” He says the hospitalist should just give IV antibiotics and consult infectious disease.

The hospitalist says, “The patient needs this biopsy. I’ll just call your chair.”

In the course of a busy day, conflicts arise all the time in the hospital – between clinicians, between patients and clinicians, and as internal battles when clinicians face uncertain situations. There are ways to make these conflicts less tense and more in tune with patient care, panelists said recently during a session at SHM Converge, the annual conference of the Society of Hospital Medicine.

In the case of vertebral osteomyelitis, for instance, the hospitalist was using a “position-based” strategy to deal with the conflict with the surgeon – she came in knowing she wanted a biopsy – rather than an “interest-based” strategy, or what is in the patient’s interest, said Patrick Rendon, MD, FHM, assistant professor in the hospital medicine division at the University of New Mexico, Albuquerque.

A version of this article first appeared on Medscape.com.

Subthalamic nucleus deep brain stimulation (STN-DBS) continues to be effective for patients with Parkinson’s disease more than 15 years after device implantation, with significant improvement in motor complications and a stable reduction in dopaminergic drug use, new research indicates.

“Subthalamic nucleus stimulation is a well recognized treatment used for improving motor conditions and quality of life in people with Parkinson’s disease. Our study, for the first time, supports its efficacy in the very long term – 15 years after surgery and 25 years since the Parkinson’s disease diagnosis,” said Elena Moro, MD, PhD, Grenoble Alpes University, Grenoble, France.

“This information is relevant for physicians, patients, and their families when they need to decide about the surgical option to deal with Parkinson’s disease,” said Dr. Moro.

The study was published online June 2 in Neurology.
 

‘Don’t delay’

The findings are based on 51 patients with Parkinson’s disease who underwent treatment with bilateral STN-DBS for an average of 17 years (range, 15-24 years). Their average age at diagnosis was 40 years, and the average age at device implantation was 51 years.

The results demonstrate that STN-DBS continues to be effective for motor complications for longer than 15 years, reducing time spent with dyskinesia by 75% and time spent in the off-state by 58.7%. This is similar to the amount of improvement seen 1 year after surgery.

Doses of dopaminergic medications continued to be low at long-term follow-up; dosing was reduced by 50.6% compared with baseline.

There was also continued improvement in quality of life. Scores on the Parkinson’s Disease Quality of Life Questionnaire in the very long term were 13.8% better compared with baseline.

“Few and mostly manageable device-related adverse events were observed during the follow-up,” the authors reported in their article.

“Deep brain stimulation is already recommended when a patient’s conditions are not optimized by medical treatment. Patients with Parkinson’s disease without dementia and in good general health conditions are the best candidates for this surgery,” said Dr. Moro.

“Taking into account our results and the data available in the literature, DBS surgery should not be delayed when motor conditions and quality of life decline despite medical treatment, if patients meet the inclusion criteria,” she added.
 

A revolutionary treatment

The authors of an accompanying editorial say these results, which indicate better motor outcomes with less medication, “reinforce why STN-DBS has revolutionized treatment for advanced Parkinson’s disease.”

Kelvin Chou, MD, of the University of Michigan, Ann Arbor, and David Charles, MD, of Vanderbilt University, Nashville, Tenn., pointed out that longer disease duration is associated with an increase in the likelihood of cognitive impairment and psychosis, both of which are risk factors for nursing home placement, and they limit the ability to use dopaminergic medications.

Although many of the patients in this cohort experienced hallucinations and psychosis over the long follow-up period, “one can imagine that the number and severity would be higher without DBS therapy,” they wrote.

Key caveats, said Dr. Chou and Dr. Charles, are that the results are based on a highly selected cohort and that the patients were managed by experts in the field of movement disorders and DBS.

Additionally, the patients’ conditions were highly responsive to levodopa; there was a 75.3% baseline improvement in Unified Parkinson’s Disease Rating Scale motor scores from the off-state to the on-state. In general, most DBS centers consider a levodopa response of approximately 30% as an acceptable cutoff for moving forward with STN-DBS, they noted.

Despite these caveats and limitations, the results of the study are important with respect to counseling potential candidates for DBS, Dr. Chou and Dr. Charles said.

“A common question that patients have is, ‘How long do the benefits of DBS last?’ We can now reassure them that, at least for STN-DBS, improvement in motor complications lasts beyond 15 years and is often accompanied by improvement in quality of life. In other words, with STN-DBS, we can uncomplicate their motor complications for the long haul,” the editorial writers concluded.

The research had no targeted funding. Moro has received honoraria from Medtronic and Abbott for consulting and lecturing and an educational grant from Boston and Newronika. A complete list of disclosures is available with the original articles.

A version of this article first appeared on Medscape.com.

Subthalamic nucleus deep brain stimulation (STN-DBS) continues to be effective for patients with Parkinson’s disease more than 15 years after device implantation, with significant improvement in motor complications and a stable reduction in dopaminergic drug use, new research indicates.

“Subthalamic nucleus stimulation is a well recognized treatment used for improving motor conditions and quality of life in people with Parkinson’s disease. Our study, for the first time, supports its efficacy in the very long term – 15 years after surgery and 25 years since the Parkinson’s disease diagnosis,” said Elena Moro, MD, PhD, Grenoble Alpes University, Grenoble, France.

“This information is relevant for physicians, patients, and their families when they need to decide about the surgical option to deal with Parkinson’s disease,” said Dr. Moro.

The study was published online June 2 in Neurology.
 

‘Don’t delay’

The findings are based on 51 patients with Parkinson’s disease who underwent treatment with bilateral STN-DBS for an average of 17 years (range, 15-24 years). Their average age at diagnosis was 40 years, and the average age at device implantation was 51 years.

The results demonstrate that STN-DBS continues to be effective for motor complications for longer than 15 years, reducing time spent with dyskinesia by 75% and time spent in the off-state by 58.7%. This is similar to the amount of improvement seen 1 year after surgery.

Doses of dopaminergic medications continued to be low at long-term follow-up; dosing was reduced by 50.6% compared with baseline.

There was also continued improvement in quality of life. Scores on the Parkinson’s Disease Quality of Life Questionnaire in the very long term were 13.8% better compared with baseline.

“Few and mostly manageable device-related adverse events were observed during the follow-up,” the authors reported in their article.

“Deep brain stimulation is already recommended when a patient’s conditions are not optimized by medical treatment. Patients with Parkinson’s disease without dementia and in good general health conditions are the best candidates for this surgery,” said Dr. Moro.

“Taking into account our results and the data available in the literature, DBS surgery should not be delayed when motor conditions and quality of life decline despite medical treatment, if patients meet the inclusion criteria,” she added.
 

A revolutionary treatment

The authors of an accompanying editorial say these results, which indicate better motor outcomes with less medication, “reinforce why STN-DBS has revolutionized treatment for advanced Parkinson’s disease.”

Kelvin Chou, MD, of the University of Michigan, Ann Arbor, and David Charles, MD, of Vanderbilt University, Nashville, Tenn., pointed out that longer disease duration is associated with an increase in the likelihood of cognitive impairment and psychosis, both of which are risk factors for nursing home placement, and they limit the ability to use dopaminergic medications.

Although many of the patients in this cohort experienced hallucinations and psychosis over the long follow-up period, “one can imagine that the number and severity would be higher without DBS therapy,” they wrote.

Key caveats, said Dr. Chou and Dr. Charles, are that the results are based on a highly selected cohort and that the patients were managed by experts in the field of movement disorders and DBS.

Additionally, the patients’ conditions were highly responsive to levodopa; there was a 75.3% baseline improvement in Unified Parkinson’s Disease Rating Scale motor scores from the off-state to the on-state. In general, most DBS centers consider a levodopa response of approximately 30% as an acceptable cutoff for moving forward with STN-DBS, they noted.

Despite these caveats and limitations, the results of the study are important with respect to counseling potential candidates for DBS, Dr. Chou and Dr. Charles said.

“A common question that patients have is, ‘How long do the benefits of DBS last?’ We can now reassure them that, at least for STN-DBS, improvement in motor complications lasts beyond 15 years and is often accompanied by improvement in quality of life. In other words, with STN-DBS, we can uncomplicate their motor complications for the long haul,” the editorial writers concluded.

The research had no targeted funding. Moro has received honoraria from Medtronic and Abbott for consulting and lecturing and an educational grant from Boston and Newronika. A complete list of disclosures is available with the original articles.

A version of this article first appeared on Medscape.com.

Subthalamic nucleus deep brain stimulation (STN-DBS) continues to be effective for patients with Parkinson’s disease more than 15 years after device implantation, with significant improvement in motor complications and a stable reduction in dopaminergic drug use, new research indicates.

“Subthalamic nucleus stimulation is a well recognized treatment used for improving motor conditions and quality of life in people with Parkinson’s disease. Our study, for the first time, supports its efficacy in the very long term – 15 years after surgery and 25 years since the Parkinson’s disease diagnosis,” said Elena Moro, MD, PhD, Grenoble Alpes University, Grenoble, France.

“This information is relevant for physicians, patients, and their families when they need to decide about the surgical option to deal with Parkinson’s disease,” said Dr. Moro.

The study was published online June 2 in Neurology.
 

‘Don’t delay’

The findings are based on 51 patients with Parkinson’s disease who underwent treatment with bilateral STN-DBS for an average of 17 years (range, 15-24 years). Their average age at diagnosis was 40 years, and the average age at device implantation was 51 years.

The results demonstrate that STN-DBS continues to be effective for motor complications for longer than 15 years, reducing time spent with dyskinesia by 75% and time spent in the off-state by 58.7%. This is similar to the amount of improvement seen 1 year after surgery.

Doses of dopaminergic medications continued to be low at long-term follow-up; dosing was reduced by 50.6% compared with baseline.

There was also continued improvement in quality of life. Scores on the Parkinson’s Disease Quality of Life Questionnaire in the very long term were 13.8% better compared with baseline.

“Few and mostly manageable device-related adverse events were observed during the follow-up,” the authors reported in their article.

“Deep brain stimulation is already recommended when a patient’s conditions are not optimized by medical treatment. Patients with Parkinson’s disease without dementia and in good general health conditions are the best candidates for this surgery,” said Dr. Moro.

“Taking into account our results and the data available in the literature, DBS surgery should not be delayed when motor conditions and quality of life decline despite medical treatment, if patients meet the inclusion criteria,” she added.
 

A revolutionary treatment

The authors of an accompanying editorial say these results, which indicate better motor outcomes with less medication, “reinforce why STN-DBS has revolutionized treatment for advanced Parkinson’s disease.”

Kelvin Chou, MD, of the University of Michigan, Ann Arbor, and David Charles, MD, of Vanderbilt University, Nashville, Tenn., pointed out that longer disease duration is associated with an increase in the likelihood of cognitive impairment and psychosis, both of which are risk factors for nursing home placement, and they limit the ability to use dopaminergic medications.

Although many of the patients in this cohort experienced hallucinations and psychosis over the long follow-up period, “one can imagine that the number and severity would be higher without DBS therapy,” they wrote.

Key caveats, said Dr. Chou and Dr. Charles, are that the results are based on a highly selected cohort and that the patients were managed by experts in the field of movement disorders and DBS.

Additionally, the patients’ conditions were highly responsive to levodopa; there was a 75.3% baseline improvement in Unified Parkinson’s Disease Rating Scale motor scores from the off-state to the on-state. In general, most DBS centers consider a levodopa response of approximately 30% as an acceptable cutoff for moving forward with STN-DBS, they noted.

Despite these caveats and limitations, the results of the study are important with respect to counseling potential candidates for DBS, Dr. Chou and Dr. Charles said.

“A common question that patients have is, ‘How long do the benefits of DBS last?’ We can now reassure them that, at least for STN-DBS, improvement in motor complications lasts beyond 15 years and is often accompanied by improvement in quality of life. In other words, with STN-DBS, we can uncomplicate their motor complications for the long haul,” the editorial writers concluded.

The research had no targeted funding. Moro has received honoraria from Medtronic and Abbott for consulting and lecturing and an educational grant from Boston and Newronika. A complete list of disclosures is available with the original articles.

A version of this article first appeared on Medscape.com.

Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

Key clinical point: Joint tenderness showed poor association with imaging signs of inflammation in patients with psoriatic arthritis (PsA).

Major finding: Tender or swollen joint count showed no significant correlations with imaging inflammation sum-scores. Negligible to weak correlation (rho, −0.31 to 0.38) was observed between imaging inflammation sum-scores and the respective clinical joint counts, patient-reported outcomes, and composite scores with no consistently significant results.

Study details: This was a cross-sectional study of 41 patients with active PsA assessed by ultrasound and magnetic resonance imaging (MRI) for joint swelling.

Disclosures: The study was financially supported by AbbVie. Some of the authors reported receiving research grants, consulting fees, and speaker fees from various sources including AbbVie.

Source: Felbo SK et al. Rheumatology (Oxford). 2021 Apr 24. doi: 10.1093/rheumatology/keab384.

Key clinical point: Joint tenderness showed poor association with imaging signs of inflammation in patients with psoriatic arthritis (PsA).

Major finding: Tender or swollen joint count showed no significant correlations with imaging inflammation sum-scores. Negligible to weak correlation (rho, −0.31 to 0.38) was observed between imaging inflammation sum-scores and the respective clinical joint counts, patient-reported outcomes, and composite scores with no consistently significant results.

Study details: This was a cross-sectional study of 41 patients with active PsA assessed by ultrasound and magnetic resonance imaging (MRI) for joint swelling.

Disclosures: The study was financially supported by AbbVie. Some of the authors reported receiving research grants, consulting fees, and speaker fees from various sources including AbbVie.

Source: Felbo SK et al. Rheumatology (Oxford). 2021 Apr 24. doi: 10.1093/rheumatology/keab384.

Key clinical point: Joint tenderness showed poor association with imaging signs of inflammation in patients with psoriatic arthritis (PsA).

Major finding: Tender or swollen joint count showed no significant correlations with imaging inflammation sum-scores. Negligible to weak correlation (rho, −0.31 to 0.38) was observed between imaging inflammation sum-scores and the respective clinical joint counts, patient-reported outcomes, and composite scores with no consistently significant results.

Study details: This was a cross-sectional study of 41 patients with active PsA assessed by ultrasound and magnetic resonance imaging (MRI) for joint swelling.

Disclosures: The study was financially supported by AbbVie. Some of the authors reported receiving research grants, consulting fees, and speaker fees from various sources including AbbVie.

Source: Felbo SK et al. Rheumatology (Oxford). 2021 Apr 24. doi: 10.1093/rheumatology/keab384.

A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.

The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.

“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.

The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
 

Adherence is key

About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.

“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.

The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.

Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days. 

They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.

LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.

The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.

Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.

“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.

LYN-005 was well tolerated in the 85% of study participants who received all three doses.

Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.

The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.

Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.

Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
 

An important development

Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”

“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research

Long-acting preparations for chronic mental illness represent a significant advance, he said.

“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.

“That said, having an effective, longer-acting oral for those who refuse injections is helpful. It’s an important development, and it’s part of the advance the whole field is moving toward, to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”

Dr. Glick has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.

The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.

“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.

The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
 

Adherence is key

About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.

“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.

The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.

Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days. 

They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.

LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.

The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.

Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.

“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.

LYN-005 was well tolerated in the 85% of study participants who received all three doses.

Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.

The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.

Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.

Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
 

An important development

Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”

“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research

Long-acting preparations for chronic mental illness represent a significant advance, he said.

“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.

“That said, having an effective, longer-acting oral for those who refuse injections is helpful. It’s an important development, and it’s part of the advance the whole field is moving toward, to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”

Dr. Glick has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.

The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.

“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.

The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
 

Adherence is key

About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.

“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.

The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.

Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days. 

They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.

LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.

The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.

Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.

“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.

LYN-005 was well tolerated in the 85% of study participants who received all three doses.

Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.

The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.

Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.

Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
 

An important development

Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”

“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research

Long-acting preparations for chronic mental illness represent a significant advance, he said.

“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.

“That said, having an effective, longer-acting oral for those who refuse injections is helpful. It’s an important development, and it’s part of the advance the whole field is moving toward, to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”

Dr. Glick has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: In a cohort of at-risk patients with symptoms suggestive of coronary artery disease (CAD), the prevalence of coronary artery calcification (CAC) was higher in patients with psoriatic arthritis (PsA) compared with those without psoriasis or PsA.

Major finding: The prevalence of CAC score greater than 0 was significantly higher in patients with PsA vs. those without psoriasis or PsA (adjusted odds ratio, 1.28; 95% confidence interval, 1.00-1.64).

Study details: This was a cross-sectional study of 46,022 patient’s at-risk patients with symptoms suggestive of CAD from the Danish national computed tomography angiography registry, among which 1,356 had psoriasis, 370 had PsA whereas, 44,296 patients formed the reference nonpsoriasis/PsA cohort.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Tinggaard AB et al. J Intern Med. 2021 May 12. doi: 10.1111/joim.13311.

Key clinical point: In a cohort of at-risk patients with symptoms suggestive of coronary artery disease (CAD), the prevalence of coronary artery calcification (CAC) was higher in patients with psoriatic arthritis (PsA) compared with those without psoriasis or PsA.

Major finding: The prevalence of CAC score greater than 0 was significantly higher in patients with PsA vs. those without psoriasis or PsA (adjusted odds ratio, 1.28; 95% confidence interval, 1.00-1.64).

Study details: This was a cross-sectional study of 46,022 patient’s at-risk patients with symptoms suggestive of CAD from the Danish national computed tomography angiography registry, among which 1,356 had psoriasis, 370 had PsA whereas, 44,296 patients formed the reference nonpsoriasis/PsA cohort.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Tinggaard AB et al. J Intern Med. 2021 May 12. doi: 10.1111/joim.13311.

Key clinical point: In a cohort of at-risk patients with symptoms suggestive of coronary artery disease (CAD), the prevalence of coronary artery calcification (CAC) was higher in patients with psoriatic arthritis (PsA) compared with those without psoriasis or PsA.

Major finding: The prevalence of CAC score greater than 0 was significantly higher in patients with PsA vs. those without psoriasis or PsA (adjusted odds ratio, 1.28; 95% confidence interval, 1.00-1.64).

Study details: This was a cross-sectional study of 46,022 patient’s at-risk patients with symptoms suggestive of CAD from the Danish national computed tomography angiography registry, among which 1,356 had psoriasis, 370 had PsA whereas, 44,296 patients formed the reference nonpsoriasis/PsA cohort.

Disclosures: The study did not report any source of funding. No conflicts of interest were reported.

Source: Tinggaard AB et al. J Intern Med. 2021 May 12. doi: 10.1111/joim.13311.