Cluster headache is associated with increased suicidality

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Cluster headache is associated with increased suicidality during the ictal and interictal periods, compared with the periods between bouts. Short- and long-term cluster headache disease burden, as well as depressive symptoms, contributes to suicidality, according to research published online Cephalalgia. Development of treatments that reduce the headache-related burden and prevent future bouts could reduce suicidality, said the researchers.

Although cluster headache has been called the “suicide headache,” few studies have examined suicidality in patients with cluster headache. Research by Rozen et al. found that the rate of suicidal attempt among patients was similar to that among the general population. The results have not been replicated, however, and the investigators did not examine whether suicidality varied according to the phases of the disorder.
 

A prospective, multicenter study

Mi Ji Lee, MD, PhD, clinical assistant professor of neurology at Samsung Medical Center in Seoul, South Korea, and colleagues conducted a prospective study to investigate the suicidality associated with cluster headache and the factors associated with increased suicidality in that disorder. The researchers enrolled 193 consecutive patients with cluster headache between September 2016 and August 2018 at 15 hospitals. They examined the patients and used the Patient Health Questionnaire–9 (PHQ-9) and the General Anxiety Disorder–7 item scale (GAD-7) screening tools. During the ictal and interictal phases, the researchers asked the patients whether they had had passive suicidal ideation, active suicidal ideation, suicidal planning, or suicidal attempt. Dr. Ji Lee and colleagues performed univariable and multivariable logistic regression analyses to evaluate the factors associated with high ictal suicidality, which was defined as two or more positive responses during the ictal phase. Participants were followed up during the between-bout phase.

The researchers excluded 18 patients from analysis because they were between bouts at enrollment. The mean age of the remaining 175 patients was 38.4 years. Mean age at onset was 29.9 years. About 85% of the patients were male. The diagnosis was definite cluster headache for 87.4% of the sample and probable cluster headache for 12.6%. In addition, 88% of the population had episodic cluster headache.
 

Suicidal ideation increased during the ictal phase

During the ictal phase, 64.2% of participants reported passive suicidal ideation, and 35.8% reported active suicidal ideation. Furthermore, 5.8% of patients had a suicidal plan, and 2.3% attempted suicide. In the interictal phase, 4.0% of patients reported passive suicidal ideation, and 3.5% reported active suicidal ideation. Interictal suicidal planning was reported by 2.9% of participants, and 1.2% of participants attempted suicide interictally. The results were similar between patients with definite and probable cluster headache.

The ictal phase increased the odds of passive suicidal ideation (odds ratio [OR], 42.46), active suicidal ideation (OR, 15.55), suicidal planning (OR, 2.06), and suicidal attempt (OR, 2.02), compared with the interictal phase. The differences in suicidal planning and suicidal attempt between the ictal and interictal phases, however, were not statistically significant.

Longer disease duration, higher attack intensity, higher Headache Impact Test–6 (HIT-6) score, GAD-7 score, and PHQ-9 score were associated with high ictal suicidality. Disease duration, HIT-6, and PHQ-9 remained significantly associated with high ictal suicidality in the multivariate analysis. Younger age at onset, longer disease duration, total number of lifetime bouts, and higher GAD-7 and PHQ-9 scores were significantly associated with interictal suicidality in the univariable analysis. The total number of lifetime bouts and the PHQ-9 scores remained significant in the multivariable analysis.

In all, 54 patients were followed up between bouts. None reported passive suicidal ideation, 1.9% reported active suicidal ideation, 1.9% reported suicidal planning, and none reported suicidal attempt. Compared with the between-bouts period, the ictal phase was associated with significantly higher odds of active suicidal ideation (OR, 37.32) and nonsignificantly increased suicidal planning (OR, 3.20).
 

 

 

Patients need a disease-modifying treatment

Taken together, the study results underscore the importance of proper management of cluster headache to reduce its burden, said the authors. “Given that greater headache-related impact was independently associated with ictal suicidality, an intensive treatment to reduce the headache-related impact might be beneficial to prevent suicide in cluster headache patients,” they said. In addition to reducing headache-related impact and headache intensity, “a disease-modifying treatment to prevent further bouts is warranted to decrease suicidality in cluster headache patients.”

Although patients with cluster headache had increased suicidality in the ictal and interictal phases, they had lower suicidality between bouts, compared with the general population. This result suggests that patients remain mentally healthy when the bouts are over, and that “a strategy to shorten the length of bout is warranted,” said Dr. Ji Lee and colleagues. Furthermore, the fact that suicidality did not differ significantly between patients with definite cluster headache and those with probable cluster headache “prompts clinicians for an increased identification and intensive treatment strategy for probable cluster headache.”

The current study is the first prospective investigation of suicidality in the various phases of cluster headache, according to the investigators. It nevertheless has several limitations. The prevalence of chronic cluster headache was low in the study population, and not all patients presented for follow-up during the period between bouts. In addition, the data were obtained from recall, and consequently may be less accurate than those gained from prospective recording. Finally, Dr. Ji Lee and colleagues did not gather information on personality disorders, insomnia, substance abuse, or addiction, even though these factors can influence suicidality in patients with chronic pain.

The investigators reported no conflicts of interest related to their research. The study was supported by a grant from the Korean Neurological Association.

SOURCE: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.

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Cluster headache is associated with increased suicidality during the ictal and interictal periods, compared with the periods between bouts. Short- and long-term cluster headache disease burden, as well as depressive symptoms, contributes to suicidality, according to research published online Cephalalgia. Development of treatments that reduce the headache-related burden and prevent future bouts could reduce suicidality, said the researchers.

Although cluster headache has been called the “suicide headache,” few studies have examined suicidality in patients with cluster headache. Research by Rozen et al. found that the rate of suicidal attempt among patients was similar to that among the general population. The results have not been replicated, however, and the investigators did not examine whether suicidality varied according to the phases of the disorder.
 

A prospective, multicenter study

Mi Ji Lee, MD, PhD, clinical assistant professor of neurology at Samsung Medical Center in Seoul, South Korea, and colleagues conducted a prospective study to investigate the suicidality associated with cluster headache and the factors associated with increased suicidality in that disorder. The researchers enrolled 193 consecutive patients with cluster headache between September 2016 and August 2018 at 15 hospitals. They examined the patients and used the Patient Health Questionnaire–9 (PHQ-9) and the General Anxiety Disorder–7 item scale (GAD-7) screening tools. During the ictal and interictal phases, the researchers asked the patients whether they had had passive suicidal ideation, active suicidal ideation, suicidal planning, or suicidal attempt. Dr. Ji Lee and colleagues performed univariable and multivariable logistic regression analyses to evaluate the factors associated with high ictal suicidality, which was defined as two or more positive responses during the ictal phase. Participants were followed up during the between-bout phase.

The researchers excluded 18 patients from analysis because they were between bouts at enrollment. The mean age of the remaining 175 patients was 38.4 years. Mean age at onset was 29.9 years. About 85% of the patients were male. The diagnosis was definite cluster headache for 87.4% of the sample and probable cluster headache for 12.6%. In addition, 88% of the population had episodic cluster headache.
 

Suicidal ideation increased during the ictal phase

During the ictal phase, 64.2% of participants reported passive suicidal ideation, and 35.8% reported active suicidal ideation. Furthermore, 5.8% of patients had a suicidal plan, and 2.3% attempted suicide. In the interictal phase, 4.0% of patients reported passive suicidal ideation, and 3.5% reported active suicidal ideation. Interictal suicidal planning was reported by 2.9% of participants, and 1.2% of participants attempted suicide interictally. The results were similar between patients with definite and probable cluster headache.

The ictal phase increased the odds of passive suicidal ideation (odds ratio [OR], 42.46), active suicidal ideation (OR, 15.55), suicidal planning (OR, 2.06), and suicidal attempt (OR, 2.02), compared with the interictal phase. The differences in suicidal planning and suicidal attempt between the ictal and interictal phases, however, were not statistically significant.

Longer disease duration, higher attack intensity, higher Headache Impact Test–6 (HIT-6) score, GAD-7 score, and PHQ-9 score were associated with high ictal suicidality. Disease duration, HIT-6, and PHQ-9 remained significantly associated with high ictal suicidality in the multivariate analysis. Younger age at onset, longer disease duration, total number of lifetime bouts, and higher GAD-7 and PHQ-9 scores were significantly associated with interictal suicidality in the univariable analysis. The total number of lifetime bouts and the PHQ-9 scores remained significant in the multivariable analysis.

In all, 54 patients were followed up between bouts. None reported passive suicidal ideation, 1.9% reported active suicidal ideation, 1.9% reported suicidal planning, and none reported suicidal attempt. Compared with the between-bouts period, the ictal phase was associated with significantly higher odds of active suicidal ideation (OR, 37.32) and nonsignificantly increased suicidal planning (OR, 3.20).
 

 

 

Patients need a disease-modifying treatment

Taken together, the study results underscore the importance of proper management of cluster headache to reduce its burden, said the authors. “Given that greater headache-related impact was independently associated with ictal suicidality, an intensive treatment to reduce the headache-related impact might be beneficial to prevent suicide in cluster headache patients,” they said. In addition to reducing headache-related impact and headache intensity, “a disease-modifying treatment to prevent further bouts is warranted to decrease suicidality in cluster headache patients.”

Although patients with cluster headache had increased suicidality in the ictal and interictal phases, they had lower suicidality between bouts, compared with the general population. This result suggests that patients remain mentally healthy when the bouts are over, and that “a strategy to shorten the length of bout is warranted,” said Dr. Ji Lee and colleagues. Furthermore, the fact that suicidality did not differ significantly between patients with definite cluster headache and those with probable cluster headache “prompts clinicians for an increased identification and intensive treatment strategy for probable cluster headache.”

The current study is the first prospective investigation of suicidality in the various phases of cluster headache, according to the investigators. It nevertheless has several limitations. The prevalence of chronic cluster headache was low in the study population, and not all patients presented for follow-up during the period between bouts. In addition, the data were obtained from recall, and consequently may be less accurate than those gained from prospective recording. Finally, Dr. Ji Lee and colleagues did not gather information on personality disorders, insomnia, substance abuse, or addiction, even though these factors can influence suicidality in patients with chronic pain.

The investigators reported no conflicts of interest related to their research. The study was supported by a grant from the Korean Neurological Association.

SOURCE: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.

Cluster headache is associated with increased suicidality during the ictal and interictal periods, compared with the periods between bouts. Short- and long-term cluster headache disease burden, as well as depressive symptoms, contributes to suicidality, according to research published online Cephalalgia. Development of treatments that reduce the headache-related burden and prevent future bouts could reduce suicidality, said the researchers.

Although cluster headache has been called the “suicide headache,” few studies have examined suicidality in patients with cluster headache. Research by Rozen et al. found that the rate of suicidal attempt among patients was similar to that among the general population. The results have not been replicated, however, and the investigators did not examine whether suicidality varied according to the phases of the disorder.
 

A prospective, multicenter study

Mi Ji Lee, MD, PhD, clinical assistant professor of neurology at Samsung Medical Center in Seoul, South Korea, and colleagues conducted a prospective study to investigate the suicidality associated with cluster headache and the factors associated with increased suicidality in that disorder. The researchers enrolled 193 consecutive patients with cluster headache between September 2016 and August 2018 at 15 hospitals. They examined the patients and used the Patient Health Questionnaire–9 (PHQ-9) and the General Anxiety Disorder–7 item scale (GAD-7) screening tools. During the ictal and interictal phases, the researchers asked the patients whether they had had passive suicidal ideation, active suicidal ideation, suicidal planning, or suicidal attempt. Dr. Ji Lee and colleagues performed univariable and multivariable logistic regression analyses to evaluate the factors associated with high ictal suicidality, which was defined as two or more positive responses during the ictal phase. Participants were followed up during the between-bout phase.

The researchers excluded 18 patients from analysis because they were between bouts at enrollment. The mean age of the remaining 175 patients was 38.4 years. Mean age at onset was 29.9 years. About 85% of the patients were male. The diagnosis was definite cluster headache for 87.4% of the sample and probable cluster headache for 12.6%. In addition, 88% of the population had episodic cluster headache.
 

Suicidal ideation increased during the ictal phase

During the ictal phase, 64.2% of participants reported passive suicidal ideation, and 35.8% reported active suicidal ideation. Furthermore, 5.8% of patients had a suicidal plan, and 2.3% attempted suicide. In the interictal phase, 4.0% of patients reported passive suicidal ideation, and 3.5% reported active suicidal ideation. Interictal suicidal planning was reported by 2.9% of participants, and 1.2% of participants attempted suicide interictally. The results were similar between patients with definite and probable cluster headache.

The ictal phase increased the odds of passive suicidal ideation (odds ratio [OR], 42.46), active suicidal ideation (OR, 15.55), suicidal planning (OR, 2.06), and suicidal attempt (OR, 2.02), compared with the interictal phase. The differences in suicidal planning and suicidal attempt between the ictal and interictal phases, however, were not statistically significant.

Longer disease duration, higher attack intensity, higher Headache Impact Test–6 (HIT-6) score, GAD-7 score, and PHQ-9 score were associated with high ictal suicidality. Disease duration, HIT-6, and PHQ-9 remained significantly associated with high ictal suicidality in the multivariate analysis. Younger age at onset, longer disease duration, total number of lifetime bouts, and higher GAD-7 and PHQ-9 scores were significantly associated with interictal suicidality in the univariable analysis. The total number of lifetime bouts and the PHQ-9 scores remained significant in the multivariable analysis.

In all, 54 patients were followed up between bouts. None reported passive suicidal ideation, 1.9% reported active suicidal ideation, 1.9% reported suicidal planning, and none reported suicidal attempt. Compared with the between-bouts period, the ictal phase was associated with significantly higher odds of active suicidal ideation (OR, 37.32) and nonsignificantly increased suicidal planning (OR, 3.20).
 

 

 

Patients need a disease-modifying treatment

Taken together, the study results underscore the importance of proper management of cluster headache to reduce its burden, said the authors. “Given that greater headache-related impact was independently associated with ictal suicidality, an intensive treatment to reduce the headache-related impact might be beneficial to prevent suicide in cluster headache patients,” they said. In addition to reducing headache-related impact and headache intensity, “a disease-modifying treatment to prevent further bouts is warranted to decrease suicidality in cluster headache patients.”

Although patients with cluster headache had increased suicidality in the ictal and interictal phases, they had lower suicidality between bouts, compared with the general population. This result suggests that patients remain mentally healthy when the bouts are over, and that “a strategy to shorten the length of bout is warranted,” said Dr. Ji Lee and colleagues. Furthermore, the fact that suicidality did not differ significantly between patients with definite cluster headache and those with probable cluster headache “prompts clinicians for an increased identification and intensive treatment strategy for probable cluster headache.”

The current study is the first prospective investigation of suicidality in the various phases of cluster headache, according to the investigators. It nevertheless has several limitations. The prevalence of chronic cluster headache was low in the study population, and not all patients presented for follow-up during the period between bouts. In addition, the data were obtained from recall, and consequently may be less accurate than those gained from prospective recording. Finally, Dr. Ji Lee and colleagues did not gather information on personality disorders, insomnia, substance abuse, or addiction, even though these factors can influence suicidality in patients with chronic pain.

The investigators reported no conflicts of interest related to their research. The study was supported by a grant from the Korean Neurological Association.

SOURCE: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.

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FROM CEPHALAGIA

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Key clinical point: Cluster headache is associated with increased suicidality during attacks and within the active period.

Major finding: Cluster headache attacks increased the risk of active suicidal ideation (odds ratio, 15.55).

Study details: A prospective, multicenter study of 175 patients with cluster headache.

Disclosures: The study was supported by a grant from the Korean Neurological Association.

Source: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.

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ASCO: Deintensified treatment in p16+ oropharyngeal cancer needs evaluation

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Treatment deintensification for patients with p16+ oropharyngeal cancer (OPC) should occur only in the context of a clinical trial, according to a provisional clinical opinion released by the American Society of Clinical Oncology (ASCO).

“The hypothesis that deescalation of treatment intensity for patients with p16+ OPC can reduce long-term toxicity without compromising survival is compelling and necessitates careful study and the analysis of well-designed clinical trials before changing current treatment standards, wrote David J. Adelstein, MD, of Case Western Reserve University, Cleveland, along with his associates on the expert panel. Their report is in the Journal of Clinical Oncology.

The panel undertook a review of the literature for evidence pertaining to the treatment of patients with HPV-mediated p16+ OPC with radiation, transoral surgery, concomitant chemoradiotherapy, and chemotherapy, in addition to immunotherapy and targeted therapy. Both randomized and nonrandomized studies were included in the review, and expert consensus opinion was taken into consideration.

After the review, the panelists concluded that the presumption that deintensified treatment in patients with p16+ OPC can lower long-term adverse effects without impacting survival is still a hypothesis that warrants further testing. While early findings of deintensified treatment techniques show promise, current treatment recommendations have not changed, they said.

“The standard of care for the definitive nonoperative management of cisplatin-eligible patients with advanced disease is concurrent chemoradiation with high-dose cisplatin given every 3 weeks,” the panel wrote. “For patients undergoing initial surgical resection, adjuvant chemoradiation with concurrent high-dose cisplatin given every 3 weeks is recommended for patients with positive margins and/or extranodal tumor extension,” they added.

At present, they recommend that deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.

The panel acknowledged that establishing definitive recommendations for all possible clinical scenarios is challenging because of restrictive exclusion criteria in key clinical trials. As a result, the accuracy of outcome data may be limited to specific patient populations.

More information on the provisional clinical opinion is available on the ASCO website.

ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.

SOURCE: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.

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Treatment deintensification for patients with p16+ oropharyngeal cancer (OPC) should occur only in the context of a clinical trial, according to a provisional clinical opinion released by the American Society of Clinical Oncology (ASCO).

“The hypothesis that deescalation of treatment intensity for patients with p16+ OPC can reduce long-term toxicity without compromising survival is compelling and necessitates careful study and the analysis of well-designed clinical trials before changing current treatment standards, wrote David J. Adelstein, MD, of Case Western Reserve University, Cleveland, along with his associates on the expert panel. Their report is in the Journal of Clinical Oncology.

The panel undertook a review of the literature for evidence pertaining to the treatment of patients with HPV-mediated p16+ OPC with radiation, transoral surgery, concomitant chemoradiotherapy, and chemotherapy, in addition to immunotherapy and targeted therapy. Both randomized and nonrandomized studies were included in the review, and expert consensus opinion was taken into consideration.

After the review, the panelists concluded that the presumption that deintensified treatment in patients with p16+ OPC can lower long-term adverse effects without impacting survival is still a hypothesis that warrants further testing. While early findings of deintensified treatment techniques show promise, current treatment recommendations have not changed, they said.

“The standard of care for the definitive nonoperative management of cisplatin-eligible patients with advanced disease is concurrent chemoradiation with high-dose cisplatin given every 3 weeks,” the panel wrote. “For patients undergoing initial surgical resection, adjuvant chemoradiation with concurrent high-dose cisplatin given every 3 weeks is recommended for patients with positive margins and/or extranodal tumor extension,” they added.

At present, they recommend that deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.

The panel acknowledged that establishing definitive recommendations for all possible clinical scenarios is challenging because of restrictive exclusion criteria in key clinical trials. As a result, the accuracy of outcome data may be limited to specific patient populations.

More information on the provisional clinical opinion is available on the ASCO website.

ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.

SOURCE: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.

Treatment deintensification for patients with p16+ oropharyngeal cancer (OPC) should occur only in the context of a clinical trial, according to a provisional clinical opinion released by the American Society of Clinical Oncology (ASCO).

“The hypothesis that deescalation of treatment intensity for patients with p16+ OPC can reduce long-term toxicity without compromising survival is compelling and necessitates careful study and the analysis of well-designed clinical trials before changing current treatment standards, wrote David J. Adelstein, MD, of Case Western Reserve University, Cleveland, along with his associates on the expert panel. Their report is in the Journal of Clinical Oncology.

The panel undertook a review of the literature for evidence pertaining to the treatment of patients with HPV-mediated p16+ OPC with radiation, transoral surgery, concomitant chemoradiotherapy, and chemotherapy, in addition to immunotherapy and targeted therapy. Both randomized and nonrandomized studies were included in the review, and expert consensus opinion was taken into consideration.

After the review, the panelists concluded that the presumption that deintensified treatment in patients with p16+ OPC can lower long-term adverse effects without impacting survival is still a hypothesis that warrants further testing. While early findings of deintensified treatment techniques show promise, current treatment recommendations have not changed, they said.

“The standard of care for the definitive nonoperative management of cisplatin-eligible patients with advanced disease is concurrent chemoradiation with high-dose cisplatin given every 3 weeks,” the panel wrote. “For patients undergoing initial surgical resection, adjuvant chemoradiation with concurrent high-dose cisplatin given every 3 weeks is recommended for patients with positive margins and/or extranodal tumor extension,” they added.

At present, they recommend that deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.

The panel acknowledged that establishing definitive recommendations for all possible clinical scenarios is challenging because of restrictive exclusion criteria in key clinical trials. As a result, the accuracy of outcome data may be limited to specific patient populations.

More information on the provisional clinical opinion is available on the ASCO website.

ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.

SOURCE: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.

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FROM THE JOURNAL OF CLINICAL ONCOLOGY

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Key clinical point: The hypothesis that deintensified treatment in patients with p16+ oropharyngeal cancer (OPC) can lower long-term adverse effects without impacting survival warrants further evaluation.

Major finding: Deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.

Study details: A provisional clinical opinion released by ASCO.

Disclosures: ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.

Source: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.

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Good news for ObGyns: Medical liability claims resulting in payment are decreasing!

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Medical professional liability claims (claims) are a major cause of worry and agony for physicians who are dedicated to optimizing the health of all their patients. Among physicians, those who practice neurosurgery, thoracic surgery, plastic surgery, and obstetrics and gynecology have the greatest rate of making a payment on a claim per year of practice.1 Physicians who practice psychiatry, pediatrics, pathology, and internal medicine have the lowest rate of making a payment on a claim. Among the physicians in high-risk specialties, greater than 90% will have a claim filed against them during their career.2 Although professional liability exposure reached a crisis during the 1980s and 1990s, recent data have shown a decrease in overall professional liability risk.

The good news: Paid claims per 1,000 ObGyns have decreased greatly

In a review of all paid claims reported to the National Practitioner Data Bank from 1992 to 2014, the annual rate of paid claims per 1,000 ObGyn physician-years was determined.1 For the time periods 1992–1996, 1997–2002, 2003–2008,and 2009–2014, the annual rate of paid claims per 1,000 ObGyn physician-years was 57.6, 51.5, 40.0, and 25.9, representing an astounding 55% decrease in paid claims from 1992 to 2014 (FIGURE).1

The majority of claims result in no payment

In a review of the experience of a nationwide professional liability insurer from 1991 to 2005, only 22% of claims resulted in a payment.2 In this study, for obstetrics and gynecology and gynecologic surgery, only 11% and 8% of claims, respectively, resulted in a payment.2 However, being named in a malpractice claim results in significant stress for a physician and requires a great deal of work and time to defend.

In another study using data from the Physician Insurer’s Association of America, among 10,915 claims closed from 2005 to 2014, 59.5% were dropped, withdrawn, or dismissed; 27.7% were settled; 2.5% were resolved using an alternative dispute resolution process; 1.8% were uncategorized; and 8.6% went to trial.3 Of the cases that went to trial, 87% resulted in a verdict for the physician and 13% resulted in a verdict for the plaintiff.3

Not as good news: Payments per claim and claims settling for a payment > $1 million are increasing

In the period 1992–1996, the average payment per paid claim in the field of obstetrics and gynecology was $387,186, rising to $447,034 in 2009–2014—a 16% increase.1 From 2004 to 2010, million dollar payments occurred in about 8% of cases of paid claims, but they represent 36% of the total of all paid claims.4 In the time periods 1992–1996 and 2009–2014, payments greater than $1 million occurred in 6% and 8% of paid claims, respectively.1

Claims settled for much more than $1 million are of great concern to physicians because the payment may exceed their policy limit, creating a complex legal problem that may take time to resolve. In some cases, where the award is greater than the insurance policy limit, aggressive plaintiff attorneys have obtained a lien on the defendant physician’s home pending settlement of the case. When a multimillion dollar payment is made to settle a professional liability claim, it can greatly influence physician practice and change hospital policies. Frequently, following a multimillion dollar payment a physician may decide to limit their practice to low-risk cases or retire from the practice of medicine.

Liability premiums are stable or decreasing

From 2014 to 2019, my ObGyn professional liability insurance premiums decreased by 18%. During the same time period, my colleagues who practice surgical gynecology (no obstetrics) had a premium decrease of 22%. Insurers use a complex algorithm to determine annual liability insurance premiums, and premiums for ObGyns may not have stabilized or decreased in all regions. Take this Instant Poll:

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Reform of the liability tort system

Litigation policies and practices that reduce liability risk reduce total medical liability losses. Policies that have helped to constrain medical liability risk include state constitutional amendments limiting payments for pain and suffering, caps on compensation to plaintiff attorneys, increased early resolution programs that compensate patients who experience an adverse event and no-fault conflict resolution programs.5 In 2003, Texas implemented a comprehensive package of tort reform laws. Experts believe the reforms decreased the financial burden of professional liability insurance6 and led to less defensive medical practices, reducing excessive use of imaging and laboratory tests.

Medical factors contributing to a decrease in claims

In 1999, the Institute of Medicine released the report, “To Err is Human,” which galvanized health care systems to deploy systems of care that reduce the rate of adverse patient outcomes.7 Over the past 20 years, health systems have implemented quality improvement programs in obstetrics and gynecology that have contributed to a reduction in the rate of adverse patient outcomes. This may have contributed to the decrease in the rate of paid claims.

In a quasi-experimental study performed in 13 health systems, 7 interventions were implemented with the goal of improving outcomes and reducing medical liability. The 7 interventions included8:

  1. an elective induction bundle focused on the safe use of oxytocin
  2. an augmentation bundle focused on early intervention for possible fetal metabolic acidosis
  3. an operative vaginal delivery bundle
  4. TeamSTEPPS teamwork training to improve the quality of communication
  5. best practices education with a focus on electronic fetal monitoring
  6. regular performance feedback to hospitals and clinicians
  7. implementation of a quality improvement collaboration to support implementation of the interventions.

During the two-year baseline period prior to the intervention there were 185,373 deliveries with 6.7 perinatal claims made per 10,000 deliveries and 1.3 claims paid per 10,000 deliveries. Following the intervention, the rate of claims made and claims paid per 10,000 deliveries decreased by 22% and 37%, respectively. In addition there was a marked decrease in claims over $1 million paid, greatly limiting total financial liability losses.

Experts with vast experience in obstetrics and obstetric liability litigation have identified 4 priority interventions that may improve outcomes and mitigate liability risk, including: 1) 24-hour in-house physician coverage of an obstetrics service, 2) a conservative approach to trial of labor after a prior cesarean delivery, 3) utilization of a comprehensive, standardized event note in cases of a shoulder dystocia, and 4) judicious use of oxytocin, misoprostol, and magnesium sulfate.9

Other health system interventions that may contribute to a reduction in claims include:

  • systematic improvement in the quality of communication among physicians and nurses through the use of team training, preprocedure huddles, and time-out processes10
  • rapid response systems to rescue hospital patients with worrisome vital signs11
  • standardized responses to a worrisome category 2 or 3 fetal heart-rate tracing12
  • rapid recognition, evaluation, and treatment of women with hemorrhage, severe hypertension, sepsis, and venous thromboembolism13
  • identification and referral of high-risk patients to tertiary centers14
  • closed loop communication of critical imaging and laboratory results15
  • universal insurance coverage for health care including contraception, obstetrics, and pediatric care.

Medical liability risk is an important practice issue because it causes excessive use of imaging and laboratory tests and often traumatizes clinicians, which can result in burnout. In the 1980s and 1990s, medical liability litigation reached a crescendo and was a prominent concern among obstetrician-gynecologists. The good news is that, for ObGyns, liability risk has stabilized. Hopefully our resolute efforts to continuously improve the quality of care will result in a long-term reduction in medical liability risk.

References
  1. Schaffer AC, Jena AB, Seabury SA, et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992–2014. JAMA Intern Med. 2017;177:710-718.
  2. Jena AB, Seabury S, Lakdawalla D, et al. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:629-636.
  3. Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217:340.e1-e6.
  4. Bixenstine PJ, Shore AD, Mehtsun WT, et al. Catastrophic medical malpractice payouts in the United States. J Healthc Quality. 2014;36:43-53.
  5. Cardoso R, Zarin W, Nincic V, et al. Evaluative reports on medical malpractice policies in obstetrics: a rapid scoping review. Syst Rev. 2017;6:181.
  6. Stewart RM, Geoghegan K, Myers JG, et al. Malpractice risk and costs are significantly reduced after tort reform. J Am Coll Surg. 2011;212:463-467.
  7. Institute of Medicine Committee on Quality Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.
  8. Riley W, Meredith LW, Price R, et al. Decreasing malpractice claims by reducing preventable perinatal harm. Health Serv Res. 2016;51(suppl 3):2453-2471.
  9. Clark SL, Belfort MA, Dildy GA, et al. Reducing obstetric litigation through alterations in practice patterns. Obstet Gynecol. 2008;112:1279-1283.
  10. Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-499.
  11. Patel S, Gillon SA, Jones DA. Rapid response systems: recognition and rescue of the deteriorating hospital patient. Br J Hosp Med (Lond). 2017;78:143-148.
  12. Clark SL, Hamilton EF, Garite TJ, et al. The limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia. Am J Obstet Gynecol. 2017;216:163.e1-163.e6.
  13. The Council on Patient Safety in Women’s Healthcare website. www.safehealthcareforeverywoman.org. Accessed April 12, 2019.
  14. Zahn CM, Remick A, Catalano A, et al. Levels of maternal care verification pilot: translating guidance into practice. Obstet Gynecol. 2018;132:1401-1406.
  15. Zuccotti G, Maloney FL, Feblowitz J, et al. Reducing risk with clinical decision support: a study of closed malpractice claims. Appl Clin Inform. 2014;5:746-756.
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    Gynecology and Reproductive Biology 
Harvard Medical School, Boston

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    Gynecology and Reproductive Biology 
Harvard Medical School, Boston

Dr. Barbieri reports no financial relationships relevant to this article.

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Chair, Obstetrics and Gynecology
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    Gynecology and Reproductive Biology 
Harvard Medical School, Boston

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Medical professional liability claims (claims) are a major cause of worry and agony for physicians who are dedicated to optimizing the health of all their patients. Among physicians, those who practice neurosurgery, thoracic surgery, plastic surgery, and obstetrics and gynecology have the greatest rate of making a payment on a claim per year of practice.1 Physicians who practice psychiatry, pediatrics, pathology, and internal medicine have the lowest rate of making a payment on a claim. Among the physicians in high-risk specialties, greater than 90% will have a claim filed against them during their career.2 Although professional liability exposure reached a crisis during the 1980s and 1990s, recent data have shown a decrease in overall professional liability risk.

The good news: Paid claims per 1,000 ObGyns have decreased greatly

In a review of all paid claims reported to the National Practitioner Data Bank from 1992 to 2014, the annual rate of paid claims per 1,000 ObGyn physician-years was determined.1 For the time periods 1992–1996, 1997–2002, 2003–2008,and 2009–2014, the annual rate of paid claims per 1,000 ObGyn physician-years was 57.6, 51.5, 40.0, and 25.9, representing an astounding 55% decrease in paid claims from 1992 to 2014 (FIGURE).1

The majority of claims result in no payment

In a review of the experience of a nationwide professional liability insurer from 1991 to 2005, only 22% of claims resulted in a payment.2 In this study, for obstetrics and gynecology and gynecologic surgery, only 11% and 8% of claims, respectively, resulted in a payment.2 However, being named in a malpractice claim results in significant stress for a physician and requires a great deal of work and time to defend.

In another study using data from the Physician Insurer’s Association of America, among 10,915 claims closed from 2005 to 2014, 59.5% were dropped, withdrawn, or dismissed; 27.7% were settled; 2.5% were resolved using an alternative dispute resolution process; 1.8% were uncategorized; and 8.6% went to trial.3 Of the cases that went to trial, 87% resulted in a verdict for the physician and 13% resulted in a verdict for the plaintiff.3

Not as good news: Payments per claim and claims settling for a payment > $1 million are increasing

In the period 1992–1996, the average payment per paid claim in the field of obstetrics and gynecology was $387,186, rising to $447,034 in 2009–2014—a 16% increase.1 From 2004 to 2010, million dollar payments occurred in about 8% of cases of paid claims, but they represent 36% of the total of all paid claims.4 In the time periods 1992–1996 and 2009–2014, payments greater than $1 million occurred in 6% and 8% of paid claims, respectively.1

Claims settled for much more than $1 million are of great concern to physicians because the payment may exceed their policy limit, creating a complex legal problem that may take time to resolve. In some cases, where the award is greater than the insurance policy limit, aggressive plaintiff attorneys have obtained a lien on the defendant physician’s home pending settlement of the case. When a multimillion dollar payment is made to settle a professional liability claim, it can greatly influence physician practice and change hospital policies. Frequently, following a multimillion dollar payment a physician may decide to limit their practice to low-risk cases or retire from the practice of medicine.

Liability premiums are stable or decreasing

From 2014 to 2019, my ObGyn professional liability insurance premiums decreased by 18%. During the same time period, my colleagues who practice surgical gynecology (no obstetrics) had a premium decrease of 22%. Insurers use a complex algorithm to determine annual liability insurance premiums, and premiums for ObGyns may not have stabilized or decreased in all regions. Take this Instant Poll:

Create your own user feedback survey

Reform of the liability tort system

Litigation policies and practices that reduce liability risk reduce total medical liability losses. Policies that have helped to constrain medical liability risk include state constitutional amendments limiting payments for pain and suffering, caps on compensation to plaintiff attorneys, increased early resolution programs that compensate patients who experience an adverse event and no-fault conflict resolution programs.5 In 2003, Texas implemented a comprehensive package of tort reform laws. Experts believe the reforms decreased the financial burden of professional liability insurance6 and led to less defensive medical practices, reducing excessive use of imaging and laboratory tests.

Medical factors contributing to a decrease in claims

In 1999, the Institute of Medicine released the report, “To Err is Human,” which galvanized health care systems to deploy systems of care that reduce the rate of adverse patient outcomes.7 Over the past 20 years, health systems have implemented quality improvement programs in obstetrics and gynecology that have contributed to a reduction in the rate of adverse patient outcomes. This may have contributed to the decrease in the rate of paid claims.

In a quasi-experimental study performed in 13 health systems, 7 interventions were implemented with the goal of improving outcomes and reducing medical liability. The 7 interventions included8:

  1. an elective induction bundle focused on the safe use of oxytocin
  2. an augmentation bundle focused on early intervention for possible fetal metabolic acidosis
  3. an operative vaginal delivery bundle
  4. TeamSTEPPS teamwork training to improve the quality of communication
  5. best practices education with a focus on electronic fetal monitoring
  6. regular performance feedback to hospitals and clinicians
  7. implementation of a quality improvement collaboration to support implementation of the interventions.

During the two-year baseline period prior to the intervention there were 185,373 deliveries with 6.7 perinatal claims made per 10,000 deliveries and 1.3 claims paid per 10,000 deliveries. Following the intervention, the rate of claims made and claims paid per 10,000 deliveries decreased by 22% and 37%, respectively. In addition there was a marked decrease in claims over $1 million paid, greatly limiting total financial liability losses.

Experts with vast experience in obstetrics and obstetric liability litigation have identified 4 priority interventions that may improve outcomes and mitigate liability risk, including: 1) 24-hour in-house physician coverage of an obstetrics service, 2) a conservative approach to trial of labor after a prior cesarean delivery, 3) utilization of a comprehensive, standardized event note in cases of a shoulder dystocia, and 4) judicious use of oxytocin, misoprostol, and magnesium sulfate.9

Other health system interventions that may contribute to a reduction in claims include:

  • systematic improvement in the quality of communication among physicians and nurses through the use of team training, preprocedure huddles, and time-out processes10
  • rapid response systems to rescue hospital patients with worrisome vital signs11
  • standardized responses to a worrisome category 2 or 3 fetal heart-rate tracing12
  • rapid recognition, evaluation, and treatment of women with hemorrhage, severe hypertension, sepsis, and venous thromboembolism13
  • identification and referral of high-risk patients to tertiary centers14
  • closed loop communication of critical imaging and laboratory results15
  • universal insurance coverage for health care including contraception, obstetrics, and pediatric care.

Medical liability risk is an important practice issue because it causes excessive use of imaging and laboratory tests and often traumatizes clinicians, which can result in burnout. In the 1980s and 1990s, medical liability litigation reached a crescendo and was a prominent concern among obstetrician-gynecologists. The good news is that, for ObGyns, liability risk has stabilized. Hopefully our resolute efforts to continuously improve the quality of care will result in a long-term reduction in medical liability risk.

Medical professional liability claims (claims) are a major cause of worry and agony for physicians who are dedicated to optimizing the health of all their patients. Among physicians, those who practice neurosurgery, thoracic surgery, plastic surgery, and obstetrics and gynecology have the greatest rate of making a payment on a claim per year of practice.1 Physicians who practice psychiatry, pediatrics, pathology, and internal medicine have the lowest rate of making a payment on a claim. Among the physicians in high-risk specialties, greater than 90% will have a claim filed against them during their career.2 Although professional liability exposure reached a crisis during the 1980s and 1990s, recent data have shown a decrease in overall professional liability risk.

The good news: Paid claims per 1,000 ObGyns have decreased greatly

In a review of all paid claims reported to the National Practitioner Data Bank from 1992 to 2014, the annual rate of paid claims per 1,000 ObGyn physician-years was determined.1 For the time periods 1992–1996, 1997–2002, 2003–2008,and 2009–2014, the annual rate of paid claims per 1,000 ObGyn physician-years was 57.6, 51.5, 40.0, and 25.9, representing an astounding 55% decrease in paid claims from 1992 to 2014 (FIGURE).1

The majority of claims result in no payment

In a review of the experience of a nationwide professional liability insurer from 1991 to 2005, only 22% of claims resulted in a payment.2 In this study, for obstetrics and gynecology and gynecologic surgery, only 11% and 8% of claims, respectively, resulted in a payment.2 However, being named in a malpractice claim results in significant stress for a physician and requires a great deal of work and time to defend.

In another study using data from the Physician Insurer’s Association of America, among 10,915 claims closed from 2005 to 2014, 59.5% were dropped, withdrawn, or dismissed; 27.7% were settled; 2.5% were resolved using an alternative dispute resolution process; 1.8% were uncategorized; and 8.6% went to trial.3 Of the cases that went to trial, 87% resulted in a verdict for the physician and 13% resulted in a verdict for the plaintiff.3

Not as good news: Payments per claim and claims settling for a payment > $1 million are increasing

In the period 1992–1996, the average payment per paid claim in the field of obstetrics and gynecology was $387,186, rising to $447,034 in 2009–2014—a 16% increase.1 From 2004 to 2010, million dollar payments occurred in about 8% of cases of paid claims, but they represent 36% of the total of all paid claims.4 In the time periods 1992–1996 and 2009–2014, payments greater than $1 million occurred in 6% and 8% of paid claims, respectively.1

Claims settled for much more than $1 million are of great concern to physicians because the payment may exceed their policy limit, creating a complex legal problem that may take time to resolve. In some cases, where the award is greater than the insurance policy limit, aggressive plaintiff attorneys have obtained a lien on the defendant physician’s home pending settlement of the case. When a multimillion dollar payment is made to settle a professional liability claim, it can greatly influence physician practice and change hospital policies. Frequently, following a multimillion dollar payment a physician may decide to limit their practice to low-risk cases or retire from the practice of medicine.

Liability premiums are stable or decreasing

From 2014 to 2019, my ObGyn professional liability insurance premiums decreased by 18%. During the same time period, my colleagues who practice surgical gynecology (no obstetrics) had a premium decrease of 22%. Insurers use a complex algorithm to determine annual liability insurance premiums, and premiums for ObGyns may not have stabilized or decreased in all regions. Take this Instant Poll:

Create your own user feedback survey

Reform of the liability tort system

Litigation policies and practices that reduce liability risk reduce total medical liability losses. Policies that have helped to constrain medical liability risk include state constitutional amendments limiting payments for pain and suffering, caps on compensation to plaintiff attorneys, increased early resolution programs that compensate patients who experience an adverse event and no-fault conflict resolution programs.5 In 2003, Texas implemented a comprehensive package of tort reform laws. Experts believe the reforms decreased the financial burden of professional liability insurance6 and led to less defensive medical practices, reducing excessive use of imaging and laboratory tests.

Medical factors contributing to a decrease in claims

In 1999, the Institute of Medicine released the report, “To Err is Human,” which galvanized health care systems to deploy systems of care that reduce the rate of adverse patient outcomes.7 Over the past 20 years, health systems have implemented quality improvement programs in obstetrics and gynecology that have contributed to a reduction in the rate of adverse patient outcomes. This may have contributed to the decrease in the rate of paid claims.

In a quasi-experimental study performed in 13 health systems, 7 interventions were implemented with the goal of improving outcomes and reducing medical liability. The 7 interventions included8:

  1. an elective induction bundle focused on the safe use of oxytocin
  2. an augmentation bundle focused on early intervention for possible fetal metabolic acidosis
  3. an operative vaginal delivery bundle
  4. TeamSTEPPS teamwork training to improve the quality of communication
  5. best practices education with a focus on electronic fetal monitoring
  6. regular performance feedback to hospitals and clinicians
  7. implementation of a quality improvement collaboration to support implementation of the interventions.

During the two-year baseline period prior to the intervention there were 185,373 deliveries with 6.7 perinatal claims made per 10,000 deliveries and 1.3 claims paid per 10,000 deliveries. Following the intervention, the rate of claims made and claims paid per 10,000 deliveries decreased by 22% and 37%, respectively. In addition there was a marked decrease in claims over $1 million paid, greatly limiting total financial liability losses.

Experts with vast experience in obstetrics and obstetric liability litigation have identified 4 priority interventions that may improve outcomes and mitigate liability risk, including: 1) 24-hour in-house physician coverage of an obstetrics service, 2) a conservative approach to trial of labor after a prior cesarean delivery, 3) utilization of a comprehensive, standardized event note in cases of a shoulder dystocia, and 4) judicious use of oxytocin, misoprostol, and magnesium sulfate.9

Other health system interventions that may contribute to a reduction in claims include:

  • systematic improvement in the quality of communication among physicians and nurses through the use of team training, preprocedure huddles, and time-out processes10
  • rapid response systems to rescue hospital patients with worrisome vital signs11
  • standardized responses to a worrisome category 2 or 3 fetal heart-rate tracing12
  • rapid recognition, evaluation, and treatment of women with hemorrhage, severe hypertension, sepsis, and venous thromboembolism13
  • identification and referral of high-risk patients to tertiary centers14
  • closed loop communication of critical imaging and laboratory results15
  • universal insurance coverage for health care including contraception, obstetrics, and pediatric care.

Medical liability risk is an important practice issue because it causes excessive use of imaging and laboratory tests and often traumatizes clinicians, which can result in burnout. In the 1980s and 1990s, medical liability litigation reached a crescendo and was a prominent concern among obstetrician-gynecologists. The good news is that, for ObGyns, liability risk has stabilized. Hopefully our resolute efforts to continuously improve the quality of care will result in a long-term reduction in medical liability risk.

References
  1. Schaffer AC, Jena AB, Seabury SA, et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992–2014. JAMA Intern Med. 2017;177:710-718.
  2. Jena AB, Seabury S, Lakdawalla D, et al. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:629-636.
  3. Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217:340.e1-e6.
  4. Bixenstine PJ, Shore AD, Mehtsun WT, et al. Catastrophic medical malpractice payouts in the United States. J Healthc Quality. 2014;36:43-53.
  5. Cardoso R, Zarin W, Nincic V, et al. Evaluative reports on medical malpractice policies in obstetrics: a rapid scoping review. Syst Rev. 2017;6:181.
  6. Stewart RM, Geoghegan K, Myers JG, et al. Malpractice risk and costs are significantly reduced after tort reform. J Am Coll Surg. 2011;212:463-467.
  7. Institute of Medicine Committee on Quality Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.
  8. Riley W, Meredith LW, Price R, et al. Decreasing malpractice claims by reducing preventable perinatal harm. Health Serv Res. 2016;51(suppl 3):2453-2471.
  9. Clark SL, Belfort MA, Dildy GA, et al. Reducing obstetric litigation through alterations in practice patterns. Obstet Gynecol. 2008;112:1279-1283.
  10. Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-499.
  11. Patel S, Gillon SA, Jones DA. Rapid response systems: recognition and rescue of the deteriorating hospital patient. Br J Hosp Med (Lond). 2017;78:143-148.
  12. Clark SL, Hamilton EF, Garite TJ, et al. The limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia. Am J Obstet Gynecol. 2017;216:163.e1-163.e6.
  13. The Council on Patient Safety in Women’s Healthcare website. www.safehealthcareforeverywoman.org. Accessed April 12, 2019.
  14. Zahn CM, Remick A, Catalano A, et al. Levels of maternal care verification pilot: translating guidance into practice. Obstet Gynecol. 2018;132:1401-1406.
  15. Zuccotti G, Maloney FL, Feblowitz J, et al. Reducing risk with clinical decision support: a study of closed malpractice claims. Appl Clin Inform. 2014;5:746-756.
References
  1. Schaffer AC, Jena AB, Seabury SA, et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992–2014. JAMA Intern Med. 2017;177:710-718.
  2. Jena AB, Seabury S, Lakdawalla D, et al. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:629-636.
  3. Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217:340.e1-e6.
  4. Bixenstine PJ, Shore AD, Mehtsun WT, et al. Catastrophic medical malpractice payouts in the United States. J Healthc Quality. 2014;36:43-53.
  5. Cardoso R, Zarin W, Nincic V, et al. Evaluative reports on medical malpractice policies in obstetrics: a rapid scoping review. Syst Rev. 2017;6:181.
  6. Stewart RM, Geoghegan K, Myers JG, et al. Malpractice risk and costs are significantly reduced after tort reform. J Am Coll Surg. 2011;212:463-467.
  7. Institute of Medicine Committee on Quality Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.
  8. Riley W, Meredith LW, Price R, et al. Decreasing malpractice claims by reducing preventable perinatal harm. Health Serv Res. 2016;51(suppl 3):2453-2471.
  9. Clark SL, Belfort MA, Dildy GA, et al. Reducing obstetric litigation through alterations in practice patterns. Obstet Gynecol. 2008;112:1279-1283.
  10. Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-499.
  11. Patel S, Gillon SA, Jones DA. Rapid response systems: recognition and rescue of the deteriorating hospital patient. Br J Hosp Med (Lond). 2017;78:143-148.
  12. Clark SL, Hamilton EF, Garite TJ, et al. The limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia. Am J Obstet Gynecol. 2017;216:163.e1-163.e6.
  13. The Council on Patient Safety in Women’s Healthcare website. www.safehealthcareforeverywoman.org. Accessed April 12, 2019.
  14. Zahn CM, Remick A, Catalano A, et al. Levels of maternal care verification pilot: translating guidance into practice. Obstet Gynecol. 2018;132:1401-1406.
  15. Zuccotti G, Maloney FL, Feblowitz J, et al. Reducing risk with clinical decision support: a study of closed malpractice claims. Appl Clin Inform. 2014;5:746-756.
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CBO’s report on single-payer health care holds more questions than answers

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Progressive Democrats have rallied around “Medicare-for-all,” a single-payer health plan popularized by Sen. Bernie Sanders (I-Vt.). Now, some of Washington’s official bean counters are trying to add a new framework around what it might look like. The picture they offer highlights just how complicated that shift might be.

AaronAmat/iStock/Getty Images Plus

A report released May 1 by the nonpartisan Congressional Budget Office outlined a laundry list of options and technicalities lawmakers would need to consider if they are serious about such a proposal.

“The conversation about single-payer is getting more in the weeds, more detailed, which is a good thing because it’s such a complicated issue,” said Jodi Liu, an associate policy researcher at the Rand Corp. who studies single-payer proposals.

The takeaway: There’s a lot left to be answered about the concepts of Medicare-for-all specifically and the category of single-payer more broadly before policymakers and voters can come close to understanding what it would mean in practice. The term “single-payer” generally refers to a system in which health care is paid for by a single public authority.

“Even single-payer systems around the globe vary from each other in many, many ways,” said John McDonough, a Harvard health policy professor who helped draft the Affordable Care Act. “There’s just so many aspects of it that differ from a Canada to a Sweden to a Taiwan – and those are all intensely consequential.”

The report comes as this once-lefty pipe dream becomes officially mainstream.

Medicare-for-all has been name-checked by Democrats running for president. On April 30, Democrats and Republicans alike put the proposal under the microscope at a House Rules Committee hearing. And that won’t be the last time that happens. House Ways and Means Committee Chairman Richard Neal (D-Mass.) said he, too, intends to hold a hearing on the issue this session. Meanwhile, Sanders’ latest Medicare-for-all bill, reintroduced in the Senate in April, and a similar House bill, have 14 and 108 cosponsors, respectively.

Let’s break down the most crucial issues raised by the CBO report – what single-payer might cover, why “what it would cost” isn’t easy to determine, and what it could mean for how Americans get their health care.
 

Medicare-for-all backers say the program would cover all medically necessary services. But what does that truly mean?

What may seem obvious – the notion of medical necessity – isn’t so easy to distill into policy rules. And different single-payer systems around the world handle the benefits question differently, the CBO noted.

For instance, Canada doesn’t cover prescription drugs, but the United Kingdom and Sweden do. Of those three, only Sweden fully covers long-term support services, according to the report.

There are two questions at the heart of it, said Robert Berenson, a health policy analyst at the Urban Institute, a left-leaning think tank.

What benefits would be covered? Would it include dental care or prescription drugs or vision, as Sanders’ bill would? And, how does one determine the discrete services included within those benefits categories?

Single-payer architects could look at existing standards, such as the so-called essential health benefits that govern Obamacare health plans, to determine what’s covered. They could be more generous by including long-term care, which isn’t currently covered by Medicare or most private insurance plans.

Even the two “Medicare-for-all” bills in Congress have slightly different takes. Though both provide for long-term support and services, they diverge on how to pay for it. Sanders’ bill covers only at-home long-term care and keeps Medicaid intact for services provided in institutions. The House bill by Rep. Pramila Jayapal (D-Wash.) covers both.

And there are questions about new medical treatments, and how to determine whether they provide added value. The CBO report suggested some kind of “cost-effectiveness criterion” could determine what the government is willing to cover. In practice, though, that standard could be difficult to develop and could fall victim to political lobbying or trigger contentious debate.

Separately from the CBO report, Mr. McDonough noted, controversial medical services could bring up different kinds of political baggage – whether this plan would cover abortion, for instance, likely would change the single-payer debate.
 

 

 

Next: Single-payer health care would probably require new taxes. Just what level of taxes, though, and who they would hit hardest remain open questions.

Notably, the CBO report avoids a question that critics frequently surface: How much would this cost? How would you pay for it?

That’s because there’s no uniform cost estimate for single-payer and no easy formula to apply.

For one thing, the price tag depends on what services are covered – something like long-term care would make the idea much more expensive.

There’s also the question of cost sharing. In some single-payer systems, people must pay a copay, meet a deductible, or pay a premium as part of the health plan. That would alleviate some need for new taxes.

“I don’t think you can put numbers on it until someone defines a benefit package and defines cost sharing,” Mr. Berenson said.

The current Medicare-for-all bills eschew cost sharing. Other health reform proposals would keep premiums intact to help foot some of the bill.

The CBO report suggests that new taxes would likely play a role in financing a new single-payer plan. But what kind of taxes – a payroll tax, an income tax, or a sales tax, for instance – has not yet been stipulated. And each would have different consequences.
 

The single-payer approach could bring down health expenses, or at least increase value. But how effectively it would do so – and its larger economic impact – would depend on other design choices.

Single-payer backers dismiss the “pay-for” questions because, the reasoning goes, this approach would save lots of money in other ways, ultimately making it a good deal.

Yet again, though, the CBO said, whether that actually happens depends on the system’s design.

By eliminating most private insurers, a single-payer system would likely slash hospitals’ administrative overhead. The government could then pay a rate that better reflects reduced hospital costs, according to the CBO report.

But, ultimately, the single-payer bottom line depends on what the system pays hospitals, doctors, and drug companies for different services and products. That answer also would inform other economic assessments – ascertaining, for instance, how single-payer affects a small town where the hospital is the main employer.

Even without clear answers, outlining those questions moves the ball, Liu said.

“This area is moving really fast,” she said. “To me, it seems like this is the beginning of a longer conversation.”
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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Progressive Democrats have rallied around “Medicare-for-all,” a single-payer health plan popularized by Sen. Bernie Sanders (I-Vt.). Now, some of Washington’s official bean counters are trying to add a new framework around what it might look like. The picture they offer highlights just how complicated that shift might be.

AaronAmat/iStock/Getty Images Plus

A report released May 1 by the nonpartisan Congressional Budget Office outlined a laundry list of options and technicalities lawmakers would need to consider if they are serious about such a proposal.

“The conversation about single-payer is getting more in the weeds, more detailed, which is a good thing because it’s such a complicated issue,” said Jodi Liu, an associate policy researcher at the Rand Corp. who studies single-payer proposals.

The takeaway: There’s a lot left to be answered about the concepts of Medicare-for-all specifically and the category of single-payer more broadly before policymakers and voters can come close to understanding what it would mean in practice. The term “single-payer” generally refers to a system in which health care is paid for by a single public authority.

“Even single-payer systems around the globe vary from each other in many, many ways,” said John McDonough, a Harvard health policy professor who helped draft the Affordable Care Act. “There’s just so many aspects of it that differ from a Canada to a Sweden to a Taiwan – and those are all intensely consequential.”

The report comes as this once-lefty pipe dream becomes officially mainstream.

Medicare-for-all has been name-checked by Democrats running for president. On April 30, Democrats and Republicans alike put the proposal under the microscope at a House Rules Committee hearing. And that won’t be the last time that happens. House Ways and Means Committee Chairman Richard Neal (D-Mass.) said he, too, intends to hold a hearing on the issue this session. Meanwhile, Sanders’ latest Medicare-for-all bill, reintroduced in the Senate in April, and a similar House bill, have 14 and 108 cosponsors, respectively.

Let’s break down the most crucial issues raised by the CBO report – what single-payer might cover, why “what it would cost” isn’t easy to determine, and what it could mean for how Americans get their health care.
 

Medicare-for-all backers say the program would cover all medically necessary services. But what does that truly mean?

What may seem obvious – the notion of medical necessity – isn’t so easy to distill into policy rules. And different single-payer systems around the world handle the benefits question differently, the CBO noted.

For instance, Canada doesn’t cover prescription drugs, but the United Kingdom and Sweden do. Of those three, only Sweden fully covers long-term support services, according to the report.

There are two questions at the heart of it, said Robert Berenson, a health policy analyst at the Urban Institute, a left-leaning think tank.

What benefits would be covered? Would it include dental care or prescription drugs or vision, as Sanders’ bill would? And, how does one determine the discrete services included within those benefits categories?

Single-payer architects could look at existing standards, such as the so-called essential health benefits that govern Obamacare health plans, to determine what’s covered. They could be more generous by including long-term care, which isn’t currently covered by Medicare or most private insurance plans.

Even the two “Medicare-for-all” bills in Congress have slightly different takes. Though both provide for long-term support and services, they diverge on how to pay for it. Sanders’ bill covers only at-home long-term care and keeps Medicaid intact for services provided in institutions. The House bill by Rep. Pramila Jayapal (D-Wash.) covers both.

And there are questions about new medical treatments, and how to determine whether they provide added value. The CBO report suggested some kind of “cost-effectiveness criterion” could determine what the government is willing to cover. In practice, though, that standard could be difficult to develop and could fall victim to political lobbying or trigger contentious debate.

Separately from the CBO report, Mr. McDonough noted, controversial medical services could bring up different kinds of political baggage – whether this plan would cover abortion, for instance, likely would change the single-payer debate.
 

 

 

Next: Single-payer health care would probably require new taxes. Just what level of taxes, though, and who they would hit hardest remain open questions.

Notably, the CBO report avoids a question that critics frequently surface: How much would this cost? How would you pay for it?

That’s because there’s no uniform cost estimate for single-payer and no easy formula to apply.

For one thing, the price tag depends on what services are covered – something like long-term care would make the idea much more expensive.

There’s also the question of cost sharing. In some single-payer systems, people must pay a copay, meet a deductible, or pay a premium as part of the health plan. That would alleviate some need for new taxes.

“I don’t think you can put numbers on it until someone defines a benefit package and defines cost sharing,” Mr. Berenson said.

The current Medicare-for-all bills eschew cost sharing. Other health reform proposals would keep premiums intact to help foot some of the bill.

The CBO report suggests that new taxes would likely play a role in financing a new single-payer plan. But what kind of taxes – a payroll tax, an income tax, or a sales tax, for instance – has not yet been stipulated. And each would have different consequences.
 

The single-payer approach could bring down health expenses, or at least increase value. But how effectively it would do so – and its larger economic impact – would depend on other design choices.

Single-payer backers dismiss the “pay-for” questions because, the reasoning goes, this approach would save lots of money in other ways, ultimately making it a good deal.

Yet again, though, the CBO said, whether that actually happens depends on the system’s design.

By eliminating most private insurers, a single-payer system would likely slash hospitals’ administrative overhead. The government could then pay a rate that better reflects reduced hospital costs, according to the CBO report.

But, ultimately, the single-payer bottom line depends on what the system pays hospitals, doctors, and drug companies for different services and products. That answer also would inform other economic assessments – ascertaining, for instance, how single-payer affects a small town where the hospital is the main employer.

Even without clear answers, outlining those questions moves the ball, Liu said.

“This area is moving really fast,” she said. “To me, it seems like this is the beginning of a longer conversation.”
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

 

Progressive Democrats have rallied around “Medicare-for-all,” a single-payer health plan popularized by Sen. Bernie Sanders (I-Vt.). Now, some of Washington’s official bean counters are trying to add a new framework around what it might look like. The picture they offer highlights just how complicated that shift might be.

AaronAmat/iStock/Getty Images Plus

A report released May 1 by the nonpartisan Congressional Budget Office outlined a laundry list of options and technicalities lawmakers would need to consider if they are serious about such a proposal.

“The conversation about single-payer is getting more in the weeds, more detailed, which is a good thing because it’s such a complicated issue,” said Jodi Liu, an associate policy researcher at the Rand Corp. who studies single-payer proposals.

The takeaway: There’s a lot left to be answered about the concepts of Medicare-for-all specifically and the category of single-payer more broadly before policymakers and voters can come close to understanding what it would mean in practice. The term “single-payer” generally refers to a system in which health care is paid for by a single public authority.

“Even single-payer systems around the globe vary from each other in many, many ways,” said John McDonough, a Harvard health policy professor who helped draft the Affordable Care Act. “There’s just so many aspects of it that differ from a Canada to a Sweden to a Taiwan – and those are all intensely consequential.”

The report comes as this once-lefty pipe dream becomes officially mainstream.

Medicare-for-all has been name-checked by Democrats running for president. On April 30, Democrats and Republicans alike put the proposal under the microscope at a House Rules Committee hearing. And that won’t be the last time that happens. House Ways and Means Committee Chairman Richard Neal (D-Mass.) said he, too, intends to hold a hearing on the issue this session. Meanwhile, Sanders’ latest Medicare-for-all bill, reintroduced in the Senate in April, and a similar House bill, have 14 and 108 cosponsors, respectively.

Let’s break down the most crucial issues raised by the CBO report – what single-payer might cover, why “what it would cost” isn’t easy to determine, and what it could mean for how Americans get their health care.
 

Medicare-for-all backers say the program would cover all medically necessary services. But what does that truly mean?

What may seem obvious – the notion of medical necessity – isn’t so easy to distill into policy rules. And different single-payer systems around the world handle the benefits question differently, the CBO noted.

For instance, Canada doesn’t cover prescription drugs, but the United Kingdom and Sweden do. Of those three, only Sweden fully covers long-term support services, according to the report.

There are two questions at the heart of it, said Robert Berenson, a health policy analyst at the Urban Institute, a left-leaning think tank.

What benefits would be covered? Would it include dental care or prescription drugs or vision, as Sanders’ bill would? And, how does one determine the discrete services included within those benefits categories?

Single-payer architects could look at existing standards, such as the so-called essential health benefits that govern Obamacare health plans, to determine what’s covered. They could be more generous by including long-term care, which isn’t currently covered by Medicare or most private insurance plans.

Even the two “Medicare-for-all” bills in Congress have slightly different takes. Though both provide for long-term support and services, they diverge on how to pay for it. Sanders’ bill covers only at-home long-term care and keeps Medicaid intact for services provided in institutions. The House bill by Rep. Pramila Jayapal (D-Wash.) covers both.

And there are questions about new medical treatments, and how to determine whether they provide added value. The CBO report suggested some kind of “cost-effectiveness criterion” could determine what the government is willing to cover. In practice, though, that standard could be difficult to develop and could fall victim to political lobbying or trigger contentious debate.

Separately from the CBO report, Mr. McDonough noted, controversial medical services could bring up different kinds of political baggage – whether this plan would cover abortion, for instance, likely would change the single-payer debate.
 

 

 

Next: Single-payer health care would probably require new taxes. Just what level of taxes, though, and who they would hit hardest remain open questions.

Notably, the CBO report avoids a question that critics frequently surface: How much would this cost? How would you pay for it?

That’s because there’s no uniform cost estimate for single-payer and no easy formula to apply.

For one thing, the price tag depends on what services are covered – something like long-term care would make the idea much more expensive.

There’s also the question of cost sharing. In some single-payer systems, people must pay a copay, meet a deductible, or pay a premium as part of the health plan. That would alleviate some need for new taxes.

“I don’t think you can put numbers on it until someone defines a benefit package and defines cost sharing,” Mr. Berenson said.

The current Medicare-for-all bills eschew cost sharing. Other health reform proposals would keep premiums intact to help foot some of the bill.

The CBO report suggests that new taxes would likely play a role in financing a new single-payer plan. But what kind of taxes – a payroll tax, an income tax, or a sales tax, for instance – has not yet been stipulated. And each would have different consequences.
 

The single-payer approach could bring down health expenses, or at least increase value. But how effectively it would do so – and its larger economic impact – would depend on other design choices.

Single-payer backers dismiss the “pay-for” questions because, the reasoning goes, this approach would save lots of money in other ways, ultimately making it a good deal.

Yet again, though, the CBO said, whether that actually happens depends on the system’s design.

By eliminating most private insurers, a single-payer system would likely slash hospitals’ administrative overhead. The government could then pay a rate that better reflects reduced hospital costs, according to the CBO report.

But, ultimately, the single-payer bottom line depends on what the system pays hospitals, doctors, and drug companies for different services and products. That answer also would inform other economic assessments – ascertaining, for instance, how single-payer affects a small town where the hospital is the main employer.

Even without clear answers, outlining those questions moves the ball, Liu said.

“This area is moving really fast,” she said. “To me, it seems like this is the beginning of a longer conversation.”
 

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

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Are sweeping efforts to reduce primary CD rates associated with an increase in maternal or neonatal AEs?

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EXPERT COMMENTARY

Main EK, Chang SC, Cape V, et al. Safety assessment of a large-scale improvement collaborative to reduce nulliparous cesarean delivery rates. Obstet Gynecol. 2019;133:613-623.

Cesarean delivery can be lifesaving for both mother and infant. When compared with successful vaginal delivery, however, CD is associated with higher maternal complication rates (including excessive blood loss requiring blood product transfusion, infectious morbidity, and venous thromboembolic events), longer hospital length of stay, and higher cost. While the optimal CD rate is not well defined, it is generally accepted that the CD rate in the United States is excessively high. As such, efforts to reduce the CD rate should be encouraged, but not at the expense of patient safety.

Details about the study

In keeping with the dictum that the most important CD to prevent is the first one, the California Maternal Quality Care Collaborative (CMQCC) in 2016 introduced a large-scale quality improvement project designed to reduce nulliparous, term, singleton, vertex (NTSV) CDs across the state. This bundle included education around joint guidelines issued by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on reducing primary CDs,1 introduction of a CMQCC toolkit, increased nursing labor support, and monthly meetings to share best practices across all collaborating sites. The NTSV CD rate in these hospitals did decrease from 29.3% in 2015 to 25.0% in 2017 (adjusted odds ratio, 0.76; 95% confidence interval, 0.73–0.78).

Whether or not implementation of the bundle resulted in an inappropriate delay in indicated CDs and, as such, in an increase in maternal or neonatal morbidity is not known. To address this issue, Main and colleagues collected cross-sectional data from more than 50 hospitals with more than 119,000 deliveries throughout California and measured rates of chorioamnionitis, blood transfusions, third- or fourth-degree perineal lacerations, operative vaginal delivery, severe unexpected newborn complications, and 5-minute Apgar scores of less than 5. None of the 6 safety measures showed any difference when comparing 2017 (after implementation of the CMQCC bundle) to 2015 (before implementation), suggesting that patient safety was not compromised significantly.

Study strengths and weaknesses

Strengths of this study include its large sample size and multicenter design with inclusion of a variety of collaborating hospitals. Earlier studies examining the effect of standardized protocols to reduce CD rates have been largely underpowered and conducted at single institutions.2-6 Moreover, results have been mixed, with some studies reporting an increase in maternal/neonatal adverse events,2-4 while others suggesting an improvement in select newborn quality outcome metrics.5 The current study provides reassurance to providers and institutions employing strategies to reduce NTSV CD rates that such efforts are safe.

Continue to: This study has several limitations...

 

 

This study has several limitations. Data collection relied on birth certificate and discharge diagnoses without a robust quality audit. As such, ascertainment bias, random error, and undercounting cannot be excluded. Although the population was heterogeneous, most women had more than a high school education and private insurance, and only 1 in 5 were obese. Whether these findings are generalizable to other areas within the United States is not known.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
All reasonable efforts to decrease the CD rate in the United States should be encouraged, with particular attention paid to avoiding the first CD. However, this should not be done at the expense of patient safety. Large-scale quality improvement initiatives, similar to CMQCC efforts in California in 2016, appear to be one such strategy. Other successful strategies may include, for example, routine induction of labor for all low-risk nulliparous women at 39 weeks' gestation.7 The current report suggests that implementing a large-scale quality improvement initiative to reduce the primary CD rate can likely be done safely, without a significant increase in maternal or neonatal morbidity.

 

References
  1. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. ACOG Obstetric care consensus no. 1: safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014;123:693-711.  
  2. Rosenbloom JI, Stout MJ, Tuuli MG, et al. New labor management guidelines and changes in cesarean delivery patterns. Am J Obstet Gynecol. 2017;217:689.e1-689.e8. 
  3. Vadnais MA, Hacker MR, Shah NT, et al. Quality improvement initiatives lead to reduction in nulliparous term singleton vertex cesarean delivery rate. Jt Comm J Qual Patient Saf. 2017;43:53-61. 
  4. Zipori Y, Grunwald O, Ginsberg Y, et al. The impact of extending the second stage of labor to prevent primary cesarean delivery on maternal and neonatal outcomes. Am J Obstet Gynecol. 2019; 220:191.e1-191.e7. 
  5. Thuillier C, Roy S, Peyronnet V, et al. Impact of recommended changes in labor management for prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2018;218:341.e1-341.e9. 
  6. Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016;214:361.e1-361.e6. 
  7. Grobman WA, Rice MM, Reddy UM, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.
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Errol R. Norwitz, MD, PhD, MBA, is Louis E. Phaneuf Professor of Obstetrics & Gynecology, Tufts University School of Medicine, and Chief Scientific Officer and Chair, Department of Obstetrics & Gynecology, Tufts Medical Center, Boston, Massachusetts. Dr. Norwitz serves on the OBG Management Board of Editors.

Ashley T. Peterson, MD, is Fellow, Tufts University School of Medicine, Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, Tufts Medical Center.

The authors report no financial relationships related to this article.

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Errol R. Norwitz, MD, PhD, MBA, is Louis E. Phaneuf Professor of Obstetrics & Gynecology, Tufts University School of Medicine, and Chief Scientific Officer and Chair, Department of Obstetrics & Gynecology, Tufts Medical Center, Boston, Massachusetts. Dr. Norwitz serves on the OBG Management Board of Editors.

Ashley T. Peterson, MD, is Fellow, Tufts University School of Medicine, Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, Tufts Medical Center.

The authors report no financial relationships related to this article.

Author and Disclosure Information

Errol R. Norwitz, MD, PhD, MBA, is Louis E. Phaneuf Professor of Obstetrics & Gynecology, Tufts University School of Medicine, and Chief Scientific Officer and Chair, Department of Obstetrics & Gynecology, Tufts Medical Center, Boston, Massachusetts. Dr. Norwitz serves on the OBG Management Board of Editors.

Ashley T. Peterson, MD, is Fellow, Tufts University School of Medicine, Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, Tufts Medical Center.

The authors report no financial relationships related to this article.

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EXPERT COMMENTARY

Main EK, Chang SC, Cape V, et al. Safety assessment of a large-scale improvement collaborative to reduce nulliparous cesarean delivery rates. Obstet Gynecol. 2019;133:613-623.

Cesarean delivery can be lifesaving for both mother and infant. When compared with successful vaginal delivery, however, CD is associated with higher maternal complication rates (including excessive blood loss requiring blood product transfusion, infectious morbidity, and venous thromboembolic events), longer hospital length of stay, and higher cost. While the optimal CD rate is not well defined, it is generally accepted that the CD rate in the United States is excessively high. As such, efforts to reduce the CD rate should be encouraged, but not at the expense of patient safety.

Details about the study

In keeping with the dictum that the most important CD to prevent is the first one, the California Maternal Quality Care Collaborative (CMQCC) in 2016 introduced a large-scale quality improvement project designed to reduce nulliparous, term, singleton, vertex (NTSV) CDs across the state. This bundle included education around joint guidelines issued by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on reducing primary CDs,1 introduction of a CMQCC toolkit, increased nursing labor support, and monthly meetings to share best practices across all collaborating sites. The NTSV CD rate in these hospitals did decrease from 29.3% in 2015 to 25.0% in 2017 (adjusted odds ratio, 0.76; 95% confidence interval, 0.73–0.78).

Whether or not implementation of the bundle resulted in an inappropriate delay in indicated CDs and, as such, in an increase in maternal or neonatal morbidity is not known. To address this issue, Main and colleagues collected cross-sectional data from more than 50 hospitals with more than 119,000 deliveries throughout California and measured rates of chorioamnionitis, blood transfusions, third- or fourth-degree perineal lacerations, operative vaginal delivery, severe unexpected newborn complications, and 5-minute Apgar scores of less than 5. None of the 6 safety measures showed any difference when comparing 2017 (after implementation of the CMQCC bundle) to 2015 (before implementation), suggesting that patient safety was not compromised significantly.

Study strengths and weaknesses

Strengths of this study include its large sample size and multicenter design with inclusion of a variety of collaborating hospitals. Earlier studies examining the effect of standardized protocols to reduce CD rates have been largely underpowered and conducted at single institutions.2-6 Moreover, results have been mixed, with some studies reporting an increase in maternal/neonatal adverse events,2-4 while others suggesting an improvement in select newborn quality outcome metrics.5 The current study provides reassurance to providers and institutions employing strategies to reduce NTSV CD rates that such efforts are safe.

Continue to: This study has several limitations...

 

 

This study has several limitations. Data collection relied on birth certificate and discharge diagnoses without a robust quality audit. As such, ascertainment bias, random error, and undercounting cannot be excluded. Although the population was heterogeneous, most women had more than a high school education and private insurance, and only 1 in 5 were obese. Whether these findings are generalizable to other areas within the United States is not known.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
All reasonable efforts to decrease the CD rate in the United States should be encouraged, with particular attention paid to avoiding the first CD. However, this should not be done at the expense of patient safety. Large-scale quality improvement initiatives, similar to CMQCC efforts in California in 2016, appear to be one such strategy. Other successful strategies may include, for example, routine induction of labor for all low-risk nulliparous women at 39 weeks' gestation.7 The current report suggests that implementing a large-scale quality improvement initiative to reduce the primary CD rate can likely be done safely, without a significant increase in maternal or neonatal morbidity.

 

EXPERT COMMENTARY

Main EK, Chang SC, Cape V, et al. Safety assessment of a large-scale improvement collaborative to reduce nulliparous cesarean delivery rates. Obstet Gynecol. 2019;133:613-623.

Cesarean delivery can be lifesaving for both mother and infant. When compared with successful vaginal delivery, however, CD is associated with higher maternal complication rates (including excessive blood loss requiring blood product transfusion, infectious morbidity, and venous thromboembolic events), longer hospital length of stay, and higher cost. While the optimal CD rate is not well defined, it is generally accepted that the CD rate in the United States is excessively high. As such, efforts to reduce the CD rate should be encouraged, but not at the expense of patient safety.

Details about the study

In keeping with the dictum that the most important CD to prevent is the first one, the California Maternal Quality Care Collaborative (CMQCC) in 2016 introduced a large-scale quality improvement project designed to reduce nulliparous, term, singleton, vertex (NTSV) CDs across the state. This bundle included education around joint guidelines issued by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine on reducing primary CDs,1 introduction of a CMQCC toolkit, increased nursing labor support, and monthly meetings to share best practices across all collaborating sites. The NTSV CD rate in these hospitals did decrease from 29.3% in 2015 to 25.0% in 2017 (adjusted odds ratio, 0.76; 95% confidence interval, 0.73–0.78).

Whether or not implementation of the bundle resulted in an inappropriate delay in indicated CDs and, as such, in an increase in maternal or neonatal morbidity is not known. To address this issue, Main and colleagues collected cross-sectional data from more than 50 hospitals with more than 119,000 deliveries throughout California and measured rates of chorioamnionitis, blood transfusions, third- or fourth-degree perineal lacerations, operative vaginal delivery, severe unexpected newborn complications, and 5-minute Apgar scores of less than 5. None of the 6 safety measures showed any difference when comparing 2017 (after implementation of the CMQCC bundle) to 2015 (before implementation), suggesting that patient safety was not compromised significantly.

Study strengths and weaknesses

Strengths of this study include its large sample size and multicenter design with inclusion of a variety of collaborating hospitals. Earlier studies examining the effect of standardized protocols to reduce CD rates have been largely underpowered and conducted at single institutions.2-6 Moreover, results have been mixed, with some studies reporting an increase in maternal/neonatal adverse events,2-4 while others suggesting an improvement in select newborn quality outcome metrics.5 The current study provides reassurance to providers and institutions employing strategies to reduce NTSV CD rates that such efforts are safe.

Continue to: This study has several limitations...

 

 

This study has several limitations. Data collection relied on birth certificate and discharge diagnoses without a robust quality audit. As such, ascertainment bias, random error, and undercounting cannot be excluded. Although the population was heterogeneous, most women had more than a high school education and private insurance, and only 1 in 5 were obese. Whether these findings are generalizable to other areas within the United States is not known.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
All reasonable efforts to decrease the CD rate in the United States should be encouraged, with particular attention paid to avoiding the first CD. However, this should not be done at the expense of patient safety. Large-scale quality improvement initiatives, similar to CMQCC efforts in California in 2016, appear to be one such strategy. Other successful strategies may include, for example, routine induction of labor for all low-risk nulliparous women at 39 weeks' gestation.7 The current report suggests that implementing a large-scale quality improvement initiative to reduce the primary CD rate can likely be done safely, without a significant increase in maternal or neonatal morbidity.

 

References
  1. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. ACOG Obstetric care consensus no. 1: safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014;123:693-711.  
  2. Rosenbloom JI, Stout MJ, Tuuli MG, et al. New labor management guidelines and changes in cesarean delivery patterns. Am J Obstet Gynecol. 2017;217:689.e1-689.e8. 
  3. Vadnais MA, Hacker MR, Shah NT, et al. Quality improvement initiatives lead to reduction in nulliparous term singleton vertex cesarean delivery rate. Jt Comm J Qual Patient Saf. 2017;43:53-61. 
  4. Zipori Y, Grunwald O, Ginsberg Y, et al. The impact of extending the second stage of labor to prevent primary cesarean delivery on maternal and neonatal outcomes. Am J Obstet Gynecol. 2019; 220:191.e1-191.e7. 
  5. Thuillier C, Roy S, Peyronnet V, et al. Impact of recommended changes in labor management for prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2018;218:341.e1-341.e9. 
  6. Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016;214:361.e1-361.e6. 
  7. Grobman WA, Rice MM, Reddy UM, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.
References
  1. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. ACOG Obstetric care consensus no. 1: safe prevention of the primary cesarean delivery. Obstet Gynecol. 2014;123:693-711.  
  2. Rosenbloom JI, Stout MJ, Tuuli MG, et al. New labor management guidelines and changes in cesarean delivery patterns. Am J Obstet Gynecol. 2017;217:689.e1-689.e8. 
  3. Vadnais MA, Hacker MR, Shah NT, et al. Quality improvement initiatives lead to reduction in nulliparous term singleton vertex cesarean delivery rate. Jt Comm J Qual Patient Saf. 2017;43:53-61. 
  4. Zipori Y, Grunwald O, Ginsberg Y, et al. The impact of extending the second stage of labor to prevent primary cesarean delivery on maternal and neonatal outcomes. Am J Obstet Gynecol. 2019; 220:191.e1-191.e7. 
  5. Thuillier C, Roy S, Peyronnet V, et al. Impact of recommended changes in labor management for prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2018;218:341.e1-341.e9. 
  6. Gimovsky AC, Berghella V. Randomized controlled trial of prolonged second stage: extending the time limit vs usual guidelines. Am J Obstet Gynecol. 2016;214:361.e1-361.e6. 
  7. Grobman WA, Rice MM, Reddy UM, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513-523.
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Breaking the high-utilization cycle

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Hospitalists know that a small percentage of patients account for a disproportionately large percentage of overall health care spending, much of which comes from inpatient admissions. Many programs have been developed around the country to work with this population, and most of these programs are – appropriately – outpatient based. 

“However, a subset of frequently admitted patients either don’t make it to outpatient care or are unengaged with outpatient care and programs, for whom hospital stays can give us a unique opportunity to coordinate and streamline care, and to build trust that can then lead to increased patient engagement,” said Kirstin Knox, MD, PhD, of the Hospital of the University of Pennsylvania in Philadelphia, and lead author of an abstract describing a method to address this challenge. “Our program works with these patients, the ‘outliers among the outliers’ to re-engage them in care, streamline admissions, coordinate inpatient and outpatient care, and address the underlying barriers/drivers that lead to frequent hospitalization.”

Their program designed and implemented a multidisciplinary intervention targeting the highest utilizers on their inpatient general medicine service. Each was assigned an inpatient continuity team, and the patient case was then presented to a multidisciplinary high-utilizer care committee that included physicians, nurses, and social workers, as well as representatives from a community health worker program, home care, and risk management to develop a care plan.

Analysis comparing the 6 months before and after intervention showed admissions and total hospital days were reduced by 55% and 47% respectively, and 30-day readmissions were reduced by 65%. Total direct costs were reduced from $2,923,000 to $1,284,000.

The top takeaway, Dr. Knox said, is that, through efforts to coordinate care and address underlying drivers of high utilization, hospital-based programs for the most frequently admitted patients can streamline inpatient care and decrease utilization for many high-risk, high-cost patients.

“I hope that hospitalists will consider starting inpatient-based high-utilizer programs at their own institutions, if they haven’t already,” she said. “Even starting with one or two of your most frequently admitted patients can be incredibly eye opening, and streamlining/coordinating care (as well as working overtime to address the underlying drivers/barriers that lead to high utilization) for these patients is incredibly rewarding.”
 

Reference

Knox K et al. Breaking the cycle: a successful inpatient based intervention for hospital high utilizers. Abstract published at Hospital Medicine 2018; Apr 8-11; Orlando, Fla., Abstract 319. Accessed 2018 Oct 2.

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Hospitalists know that a small percentage of patients account for a disproportionately large percentage of overall health care spending, much of which comes from inpatient admissions. Many programs have been developed around the country to work with this population, and most of these programs are – appropriately – outpatient based. 

“However, a subset of frequently admitted patients either don’t make it to outpatient care or are unengaged with outpatient care and programs, for whom hospital stays can give us a unique opportunity to coordinate and streamline care, and to build trust that can then lead to increased patient engagement,” said Kirstin Knox, MD, PhD, of the Hospital of the University of Pennsylvania in Philadelphia, and lead author of an abstract describing a method to address this challenge. “Our program works with these patients, the ‘outliers among the outliers’ to re-engage them in care, streamline admissions, coordinate inpatient and outpatient care, and address the underlying barriers/drivers that lead to frequent hospitalization.”

Their program designed and implemented a multidisciplinary intervention targeting the highest utilizers on their inpatient general medicine service. Each was assigned an inpatient continuity team, and the patient case was then presented to a multidisciplinary high-utilizer care committee that included physicians, nurses, and social workers, as well as representatives from a community health worker program, home care, and risk management to develop a care plan.

Analysis comparing the 6 months before and after intervention showed admissions and total hospital days were reduced by 55% and 47% respectively, and 30-day readmissions were reduced by 65%. Total direct costs were reduced from $2,923,000 to $1,284,000.

The top takeaway, Dr. Knox said, is that, through efforts to coordinate care and address underlying drivers of high utilization, hospital-based programs for the most frequently admitted patients can streamline inpatient care and decrease utilization for many high-risk, high-cost patients.

“I hope that hospitalists will consider starting inpatient-based high-utilizer programs at their own institutions, if they haven’t already,” she said. “Even starting with one or two of your most frequently admitted patients can be incredibly eye opening, and streamlining/coordinating care (as well as working overtime to address the underlying drivers/barriers that lead to high utilization) for these patients is incredibly rewarding.”
 

Reference

Knox K et al. Breaking the cycle: a successful inpatient based intervention for hospital high utilizers. Abstract published at Hospital Medicine 2018; Apr 8-11; Orlando, Fla., Abstract 319. Accessed 2018 Oct 2.

Hospitalists know that a small percentage of patients account for a disproportionately large percentage of overall health care spending, much of which comes from inpatient admissions. Many programs have been developed around the country to work with this population, and most of these programs are – appropriately – outpatient based. 

“However, a subset of frequently admitted patients either don’t make it to outpatient care or are unengaged with outpatient care and programs, for whom hospital stays can give us a unique opportunity to coordinate and streamline care, and to build trust that can then lead to increased patient engagement,” said Kirstin Knox, MD, PhD, of the Hospital of the University of Pennsylvania in Philadelphia, and lead author of an abstract describing a method to address this challenge. “Our program works with these patients, the ‘outliers among the outliers’ to re-engage them in care, streamline admissions, coordinate inpatient and outpatient care, and address the underlying barriers/drivers that lead to frequent hospitalization.”

Their program designed and implemented a multidisciplinary intervention targeting the highest utilizers on their inpatient general medicine service. Each was assigned an inpatient continuity team, and the patient case was then presented to a multidisciplinary high-utilizer care committee that included physicians, nurses, and social workers, as well as representatives from a community health worker program, home care, and risk management to develop a care plan.

Analysis comparing the 6 months before and after intervention showed admissions and total hospital days were reduced by 55% and 47% respectively, and 30-day readmissions were reduced by 65%. Total direct costs were reduced from $2,923,000 to $1,284,000.

The top takeaway, Dr. Knox said, is that, through efforts to coordinate care and address underlying drivers of high utilization, hospital-based programs for the most frequently admitted patients can streamline inpatient care and decrease utilization for many high-risk, high-cost patients.

“I hope that hospitalists will consider starting inpatient-based high-utilizer programs at their own institutions, if they haven’t already,” she said. “Even starting with one or two of your most frequently admitted patients can be incredibly eye opening, and streamlining/coordinating care (as well as working overtime to address the underlying drivers/barriers that lead to high utilization) for these patients is incredibly rewarding.”
 

Reference

Knox K et al. Breaking the cycle: a successful inpatient based intervention for hospital high utilizers. Abstract published at Hospital Medicine 2018; Apr 8-11; Orlando, Fla., Abstract 319. Accessed 2018 Oct 2.

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Erythema on abdomen

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The FP was puzzled by the lack of response to treatment and decided to perform a 4-mm punch biopsy at the edge of the nonhealing ulcer. (Note that the correct location for a biopsy of an ulcer is on the edge, not in the middle). His differential diagnosis included pyoderma gangrenosum and a deep fungal infection. The pathologist called a week later FP with a surprising result: anaplastic large cell cutaneous T-cell lymphoma. (See the Watch & Learn video on “Punch biopsy.”) 

Anaplastic large cell cutaneous T-cell lymphoma is a rare diagnosis—especially in a teenager—and it can’t be determined by appearance only. On follow-up, the FP explained the diagnosis to the patient and her mother. He called Hematology/Oncology to facilitate the referral.

The patient was treated by the specialist with weekly oral methotrexate and her skin cleared up completely. Although she would likely need treatment for years, the prognosis was good. This case is a reminder that when a treatment is not working for an expected diagnosis, it’s time to reconsider the diagnosis and do further testing to identify the correct diagnosis.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Chacon G, Nayar A, Usatine R, Smith M. Cutaneous T-cell lymphoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1124-1131.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

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Erythema on abdomen

The FP was puzzled by the lack of response to treatment and decided to perform a 4-mm punch biopsy at the edge of the nonhealing ulcer. (Note that the correct location for a biopsy of an ulcer is on the edge, not in the middle). His differential diagnosis included pyoderma gangrenosum and a deep fungal infection. The pathologist called a week later FP with a surprising result: anaplastic large cell cutaneous T-cell lymphoma. (See the Watch & Learn video on “Punch biopsy.”) 

Anaplastic large cell cutaneous T-cell lymphoma is a rare diagnosis—especially in a teenager—and it can’t be determined by appearance only. On follow-up, the FP explained the diagnosis to the patient and her mother. He called Hematology/Oncology to facilitate the referral.

The patient was treated by the specialist with weekly oral methotrexate and her skin cleared up completely. Although she would likely need treatment for years, the prognosis was good. This case is a reminder that when a treatment is not working for an expected diagnosis, it’s time to reconsider the diagnosis and do further testing to identify the correct diagnosis.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Chacon G, Nayar A, Usatine R, Smith M. Cutaneous T-cell lymphoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1124-1131.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Erythema on abdomen

The FP was puzzled by the lack of response to treatment and decided to perform a 4-mm punch biopsy at the edge of the nonhealing ulcer. (Note that the correct location for a biopsy of an ulcer is on the edge, not in the middle). His differential diagnosis included pyoderma gangrenosum and a deep fungal infection. The pathologist called a week later FP with a surprising result: anaplastic large cell cutaneous T-cell lymphoma. (See the Watch & Learn video on “Punch biopsy.”) 

Anaplastic large cell cutaneous T-cell lymphoma is a rare diagnosis—especially in a teenager—and it can’t be determined by appearance only. On follow-up, the FP explained the diagnosis to the patient and her mother. He called Hematology/Oncology to facilitate the referral.

The patient was treated by the specialist with weekly oral methotrexate and her skin cleared up completely. Although she would likely need treatment for years, the prognosis was good. This case is a reminder that when a treatment is not working for an expected diagnosis, it’s time to reconsider the diagnosis and do further testing to identify the correct diagnosis.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Chacon G, Nayar A, Usatine R, Smith M. Cutaneous T-cell lymphoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine. 3rd ed. New York, NY: McGraw-Hill; 2019:1124-1131.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

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Outpatient program successfully tackles substance use and chronic pain

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– An interdisciplinary intensive outpatient treatment program addressing chronic pain and substance use disorder effectively addressed both diagnoses in a military population.

Kari Oakes/MDedge News
Dr. Michael Stockin

Intensive outpatient programs (IOPs) frequently address these conditions within a biopsychosocial format, but it’s not common for IOPs to have this dual focus on chronic pain and substance use disorder (SUD), said Michael Stockin, MD, speaking in an interview at the scientific meeting of the American Pain Society.

Dr. Stockin said he and his collaborators recognized that, especially among a military population, the two conditions have considerable overlap, so it made sense to integrate behavioral treatment for both conditions in an intensive outpatient program. “Our hypothesis was that if you can use an intensive outpatient program to address substance use disorder, maybe you can actually add a chronic pain curriculum – like a functional restoration program to it.

“As a result of our study, we did find that there were significant differences in worst pain scores as a result of the program. In the people who took both the substance use disorder and chronic pain curriculum, we found significant reductions in total impairment, worst pain, and they also had less … substance use as well,” said Dr. Stockin.

In a quality improvement project, Dr. Stockin and collaborators compared short-term outcomes for patients who received IOP treatment addressing both chronic pain and SUD with those receiving SUD-only IOP.

For those participating in the joint IOP, scores indicating worst pain on the 0-10 numeric rating scale were reduced significantly, from 7.55 to 6.23 (P = .013). Scores on a functional measure of impairment, the Pain Outcomes Questionnaire Short Form (POQ-SF) also dropped significantly, from 84.92 to 63.50 (P = .034). The vitality domain of the POQ-SF also showed that patients had less impairment after participation in the joint IOP, with scores in that domain dropping from 20.17 to 17.25 (P = .024).

Looking at the total cohort, patient scores on the Brief Addiction Monitor (BAM) dropped significantly from baseline to the end of the intervention, indicating reduced substance use (P = .041). Mean scores for participants in the joint IOP were higher at baseline than for those in the SUD-only IOP (1.000 vs. 0.565). However, those participating in the joint IOP had lower mean postintervention BAM scores than the SUD-only cohort (0.071 vs. 0.174).

American veterans experience more severe pain and have a higher prevalence of chronic pain than nonveterans. Similarly, substance use disorders, and opioid use disorders in particular, present an urgent challenge to the military health system as part of reducing mortality from substance use, wrote Dr. Stockin, a chronic pain fellow in pain management at Walter Reed National Military Medical Center, Bethesda, Md., and colleagues in the poster presentation.

The project enrolled a total of 66 patients (10 female and 56 male). Of these, 18 participated in the joint SUD–chronic pain program, and 48 received usual treatment of the SUD-only IOP treatment. The mean overall age was 33.2 years, and 71.2% of participants were white.

Overall, 51 patients (77.3%) of participants had alcohol use disorder. Participants included active duty service members, veterans, and their dependents. Opioid and cannabis use disorders were experienced by a total of eight patients, and seven more patients had diagnoses of alcohol use disorder along with other substance use disorders.

All patients completed the BAM and received urine toxicology and alcohol breath testing at enrollment; drug and alcohol screening was completed at other points during the IOP treatment for both groups as well.

The joint IOP ran 3 full days a week, with a substance use curriculum in the morning and a pain management program in the afternoon; the SUD-only participants had three morning sessions weekly. Both interventions lasted 6 weeks, and Dr. Stockin said he and his colleagues would like to acquire longitudinal data to assess the durability of gains seen from the joint IOP.

The multidisciplinary team running the joint IOP was made up of an addiction/pain medicine physician, a clinical health psychologist, a physical therapist, social workers, and a nurse.

“This project is the first of its kind to find a significant reduction in pain burden while concurrently treating addiction and pain in an outpatient military health care setting,” Dr. Stockin and colleagues wrote in the poster accompanying the presentation.

“We had outcomes in both substance use and chronic pain that were positive, so it suggests that in the military health system, people may actually benefit from treating both chronic pain and substance use disorder concurrently. If you could harmonize those programs, you might be able to get good outcomes for soldiers and their families,” Dr. Stockin said.

Dr. Stockin reported no conflicts of interest. The project was funded by the Defense Health Agency.

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– An interdisciplinary intensive outpatient treatment program addressing chronic pain and substance use disorder effectively addressed both diagnoses in a military population.

Kari Oakes/MDedge News
Dr. Michael Stockin

Intensive outpatient programs (IOPs) frequently address these conditions within a biopsychosocial format, but it’s not common for IOPs to have this dual focus on chronic pain and substance use disorder (SUD), said Michael Stockin, MD, speaking in an interview at the scientific meeting of the American Pain Society.

Dr. Stockin said he and his collaborators recognized that, especially among a military population, the two conditions have considerable overlap, so it made sense to integrate behavioral treatment for both conditions in an intensive outpatient program. “Our hypothesis was that if you can use an intensive outpatient program to address substance use disorder, maybe you can actually add a chronic pain curriculum – like a functional restoration program to it.

“As a result of our study, we did find that there were significant differences in worst pain scores as a result of the program. In the people who took both the substance use disorder and chronic pain curriculum, we found significant reductions in total impairment, worst pain, and they also had less … substance use as well,” said Dr. Stockin.

In a quality improvement project, Dr. Stockin and collaborators compared short-term outcomes for patients who received IOP treatment addressing both chronic pain and SUD with those receiving SUD-only IOP.

For those participating in the joint IOP, scores indicating worst pain on the 0-10 numeric rating scale were reduced significantly, from 7.55 to 6.23 (P = .013). Scores on a functional measure of impairment, the Pain Outcomes Questionnaire Short Form (POQ-SF) also dropped significantly, from 84.92 to 63.50 (P = .034). The vitality domain of the POQ-SF also showed that patients had less impairment after participation in the joint IOP, with scores in that domain dropping from 20.17 to 17.25 (P = .024).

Looking at the total cohort, patient scores on the Brief Addiction Monitor (BAM) dropped significantly from baseline to the end of the intervention, indicating reduced substance use (P = .041). Mean scores for participants in the joint IOP were higher at baseline than for those in the SUD-only IOP (1.000 vs. 0.565). However, those participating in the joint IOP had lower mean postintervention BAM scores than the SUD-only cohort (0.071 vs. 0.174).

American veterans experience more severe pain and have a higher prevalence of chronic pain than nonveterans. Similarly, substance use disorders, and opioid use disorders in particular, present an urgent challenge to the military health system as part of reducing mortality from substance use, wrote Dr. Stockin, a chronic pain fellow in pain management at Walter Reed National Military Medical Center, Bethesda, Md., and colleagues in the poster presentation.

The project enrolled a total of 66 patients (10 female and 56 male). Of these, 18 participated in the joint SUD–chronic pain program, and 48 received usual treatment of the SUD-only IOP treatment. The mean overall age was 33.2 years, and 71.2% of participants were white.

Overall, 51 patients (77.3%) of participants had alcohol use disorder. Participants included active duty service members, veterans, and their dependents. Opioid and cannabis use disorders were experienced by a total of eight patients, and seven more patients had diagnoses of alcohol use disorder along with other substance use disorders.

All patients completed the BAM and received urine toxicology and alcohol breath testing at enrollment; drug and alcohol screening was completed at other points during the IOP treatment for both groups as well.

The joint IOP ran 3 full days a week, with a substance use curriculum in the morning and a pain management program in the afternoon; the SUD-only participants had three morning sessions weekly. Both interventions lasted 6 weeks, and Dr. Stockin said he and his colleagues would like to acquire longitudinal data to assess the durability of gains seen from the joint IOP.

The multidisciplinary team running the joint IOP was made up of an addiction/pain medicine physician, a clinical health psychologist, a physical therapist, social workers, and a nurse.

“This project is the first of its kind to find a significant reduction in pain burden while concurrently treating addiction and pain in an outpatient military health care setting,” Dr. Stockin and colleagues wrote in the poster accompanying the presentation.

“We had outcomes in both substance use and chronic pain that were positive, so it suggests that in the military health system, people may actually benefit from treating both chronic pain and substance use disorder concurrently. If you could harmonize those programs, you might be able to get good outcomes for soldiers and their families,” Dr. Stockin said.

Dr. Stockin reported no conflicts of interest. The project was funded by the Defense Health Agency.

– An interdisciplinary intensive outpatient treatment program addressing chronic pain and substance use disorder effectively addressed both diagnoses in a military population.

Kari Oakes/MDedge News
Dr. Michael Stockin

Intensive outpatient programs (IOPs) frequently address these conditions within a biopsychosocial format, but it’s not common for IOPs to have this dual focus on chronic pain and substance use disorder (SUD), said Michael Stockin, MD, speaking in an interview at the scientific meeting of the American Pain Society.

Dr. Stockin said he and his collaborators recognized that, especially among a military population, the two conditions have considerable overlap, so it made sense to integrate behavioral treatment for both conditions in an intensive outpatient program. “Our hypothesis was that if you can use an intensive outpatient program to address substance use disorder, maybe you can actually add a chronic pain curriculum – like a functional restoration program to it.

“As a result of our study, we did find that there were significant differences in worst pain scores as a result of the program. In the people who took both the substance use disorder and chronic pain curriculum, we found significant reductions in total impairment, worst pain, and they also had less … substance use as well,” said Dr. Stockin.

In a quality improvement project, Dr. Stockin and collaborators compared short-term outcomes for patients who received IOP treatment addressing both chronic pain and SUD with those receiving SUD-only IOP.

For those participating in the joint IOP, scores indicating worst pain on the 0-10 numeric rating scale were reduced significantly, from 7.55 to 6.23 (P = .013). Scores on a functional measure of impairment, the Pain Outcomes Questionnaire Short Form (POQ-SF) also dropped significantly, from 84.92 to 63.50 (P = .034). The vitality domain of the POQ-SF also showed that patients had less impairment after participation in the joint IOP, with scores in that domain dropping from 20.17 to 17.25 (P = .024).

Looking at the total cohort, patient scores on the Brief Addiction Monitor (BAM) dropped significantly from baseline to the end of the intervention, indicating reduced substance use (P = .041). Mean scores for participants in the joint IOP were higher at baseline than for those in the SUD-only IOP (1.000 vs. 0.565). However, those participating in the joint IOP had lower mean postintervention BAM scores than the SUD-only cohort (0.071 vs. 0.174).

American veterans experience more severe pain and have a higher prevalence of chronic pain than nonveterans. Similarly, substance use disorders, and opioid use disorders in particular, present an urgent challenge to the military health system as part of reducing mortality from substance use, wrote Dr. Stockin, a chronic pain fellow in pain management at Walter Reed National Military Medical Center, Bethesda, Md., and colleagues in the poster presentation.

The project enrolled a total of 66 patients (10 female and 56 male). Of these, 18 participated in the joint SUD–chronic pain program, and 48 received usual treatment of the SUD-only IOP treatment. The mean overall age was 33.2 years, and 71.2% of participants were white.

Overall, 51 patients (77.3%) of participants had alcohol use disorder. Participants included active duty service members, veterans, and their dependents. Opioid and cannabis use disorders were experienced by a total of eight patients, and seven more patients had diagnoses of alcohol use disorder along with other substance use disorders.

All patients completed the BAM and received urine toxicology and alcohol breath testing at enrollment; drug and alcohol screening was completed at other points during the IOP treatment for both groups as well.

The joint IOP ran 3 full days a week, with a substance use curriculum in the morning and a pain management program in the afternoon; the SUD-only participants had three morning sessions weekly. Both interventions lasted 6 weeks, and Dr. Stockin said he and his colleagues would like to acquire longitudinal data to assess the durability of gains seen from the joint IOP.

The multidisciplinary team running the joint IOP was made up of an addiction/pain medicine physician, a clinical health psychologist, a physical therapist, social workers, and a nurse.

“This project is the first of its kind to find a significant reduction in pain burden while concurrently treating addiction and pain in an outpatient military health care setting,” Dr. Stockin and colleagues wrote in the poster accompanying the presentation.

“We had outcomes in both substance use and chronic pain that were positive, so it suggests that in the military health system, people may actually benefit from treating both chronic pain and substance use disorder concurrently. If you could harmonize those programs, you might be able to get good outcomes for soldiers and their families,” Dr. Stockin said.

Dr. Stockin reported no conflicts of interest. The project was funded by the Defense Health Agency.

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Key clinical point: An intensive, 6-week joint substance use disorder and chronic pain intensive outpatient program significantly reduced both substance use and pain.

Major finding: Patients had less pain and reduced substance use after completing the program, compared with baseline (P = .013 and .041, respectively).

Study details: A quality improvement project including 66 patients at a military health facility.

Disclosures: The study was sponsored by the Defense Health Agency. Dr. Stockin reported no conflicts of interest.

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Blast crisis, no crisis? Caring for the apathetic patient

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The diagnosis was straightforward. My patient’s reaction was not.

One Saturday evening, I receive a call from the emergency room about a man with a very high white blood cell count. For the past 7 years, he had chronic myeloid leukemia – a cancer, but one of the few that can be well controlled for years. The discovery of the medications that can do it revolutionized care for the disease.

For the last 7 years, Mr. C didn’t take that medication regularly. He was young, with no other medical problems, and this was the only medication he was supposed to take. But his use was sporadic at best.

What was it, I wondered? Cost? Side effects? Not understanding the seriousness of having leukemia? No, the medication was fully covered by his insurance. No, he tolerated it well. Instead, his on-and-off medication schedule came across as a strange sense of apathy. He didn’t seem to recognize his agency in his own life.

Now, not only is his white count extremely high, but the majority are the cancerous cells. I look at his blood under the microscope – blasts everywhere. He has progressed from a chronic, indolent disease that can be kept at bay into the dreaded blast crisis, which is essentially an acute leukemia but even more challenging to treat.

It is very serious. I tell him this. “I am worried your leukemia has progressed into what we call a blast crisis,” I say. “Has anyone ever talked to you about this before?”

“Hmm, I think Dr. M may have said something,” he says. His medical chart over the last 7 years was populated with notes from his hematologist documenting their discussions of this possibility.

Dr. Ilana Yurkiewicz

“This is serious,” I continue. “You will need to come into the hospital and we need to start medication to lower your white count. Otherwise you could have a stroke.”

“Okay.”

“As the white count comes down, your cells will break open and the chemicals in them can make you very sick. So we will have to check your blood often to watch for this.”

“Got it.”

“And we will change your chemotherapy pill.” I pause, letting it sink in, then repeat for emphasis: “This is very serious.”

“Sure thing, Doc.”

“I know I’ve said a lot. What are your thoughts?”

He looks at his wife, then back at me. He seems unfazed. Just as unfazed as when his hematologist warned this could happen. Just as unfazed as the day he learned his diagnosis.

He smiles and shrugs. “What will be, will be.”

As I listened to him, I honestly couldn’t tell if this was the best coping mechanism I had ever seen or the worst.

On one hand, his apathy had hurt him, clearly and indisputably. Refusing to acknowledge his agency in his medical outcomes allowed him to be cavalier about taking the cure. The cure was in a bottle on his kitchen shelf, an arm’s reach away, and he chose to reach elsewhere.

On the other hand, it was unusual to see someone so at peace with being so critically ill. His acceptance of his new reality was refreshing. There were no heartbreaking questions about whether this was his fault. There was no agonizing over what could have been. His apathy gave him closure and his loved ones comfort.

I’ve written before about how a cancer diagnosis involves holding two seemingly competing ideas in one’s mind at once. Last month, I wrote about how it is possible to be realistic about a grim prognosis while retaining hope that a treatment may work. I discussed that realism and hopefulness are compatible beliefs, and it’s okay – preferred, even – to hold them at once.

Mr. C’s strange sense of apathy made me think about another mental limbo, this one involving control. As doctors and patients, we like when we have agency over outcomes. Take these medications, and you will be okay. Undergo this procedure, and you will reduce your risk of recurrence. At the same time, poor outcomes still occur when everything is done “right.” When that happens, it can be psychologically beneficial to relinquish control. Doing so discards the unhelpful emotions of guilt and blame in favor of acceptance.

Mr. C’s apathy seemed to be present from day 1. But now, in a dire blast crisis, what was once a harmful attitude actually became a helpful one.

His “what will be, will be” attitude wasn’t inherently maladaptive; it was ill timed. Under the right circumstances, well-placed apathy can be leveraged as a positive coping mechanism.

But alas, if only there were a switch to turn on the right emotion at the right time. There’s no right or wrong or sensible reaction to cancer. There’s only a swirl of messy, overwhelming feelings. It’s trying to bring effective emotions to light at the right time while playing whack-a-mole with the others. It’s cognitive dissonance. It’s exhausting. Cancer doesn’t create personalities; it surfaces them.

It’s the last day of Mr. C’s hospitalization. His blast crisis is amazingly under good control.

“So,” I say. “Will you take your medications now?”

“Sure,” he says instinctively. I look at him. “I mean, honestly, Doc? I’m not sure.”

As we shake hands, I wonder if I’ll ever truly understand Mr. C’s motivations. But I can’t wonder too long. I can only control my part: I hand him his medications and wish him luck.

Minor details of this story were changed to protect privacy.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

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The diagnosis was straightforward. My patient’s reaction was not.

One Saturday evening, I receive a call from the emergency room about a man with a very high white blood cell count. For the past 7 years, he had chronic myeloid leukemia – a cancer, but one of the few that can be well controlled for years. The discovery of the medications that can do it revolutionized care for the disease.

For the last 7 years, Mr. C didn’t take that medication regularly. He was young, with no other medical problems, and this was the only medication he was supposed to take. But his use was sporadic at best.

What was it, I wondered? Cost? Side effects? Not understanding the seriousness of having leukemia? No, the medication was fully covered by his insurance. No, he tolerated it well. Instead, his on-and-off medication schedule came across as a strange sense of apathy. He didn’t seem to recognize his agency in his own life.

Now, not only is his white count extremely high, but the majority are the cancerous cells. I look at his blood under the microscope – blasts everywhere. He has progressed from a chronic, indolent disease that can be kept at bay into the dreaded blast crisis, which is essentially an acute leukemia but even more challenging to treat.

It is very serious. I tell him this. “I am worried your leukemia has progressed into what we call a blast crisis,” I say. “Has anyone ever talked to you about this before?”

“Hmm, I think Dr. M may have said something,” he says. His medical chart over the last 7 years was populated with notes from his hematologist documenting their discussions of this possibility.

Dr. Ilana Yurkiewicz

“This is serious,” I continue. “You will need to come into the hospital and we need to start medication to lower your white count. Otherwise you could have a stroke.”

“Okay.”

“As the white count comes down, your cells will break open and the chemicals in them can make you very sick. So we will have to check your blood often to watch for this.”

“Got it.”

“And we will change your chemotherapy pill.” I pause, letting it sink in, then repeat for emphasis: “This is very serious.”

“Sure thing, Doc.”

“I know I’ve said a lot. What are your thoughts?”

He looks at his wife, then back at me. He seems unfazed. Just as unfazed as when his hematologist warned this could happen. Just as unfazed as the day he learned his diagnosis.

He smiles and shrugs. “What will be, will be.”

As I listened to him, I honestly couldn’t tell if this was the best coping mechanism I had ever seen or the worst.

On one hand, his apathy had hurt him, clearly and indisputably. Refusing to acknowledge his agency in his medical outcomes allowed him to be cavalier about taking the cure. The cure was in a bottle on his kitchen shelf, an arm’s reach away, and he chose to reach elsewhere.

On the other hand, it was unusual to see someone so at peace with being so critically ill. His acceptance of his new reality was refreshing. There were no heartbreaking questions about whether this was his fault. There was no agonizing over what could have been. His apathy gave him closure and his loved ones comfort.

I’ve written before about how a cancer diagnosis involves holding two seemingly competing ideas in one’s mind at once. Last month, I wrote about how it is possible to be realistic about a grim prognosis while retaining hope that a treatment may work. I discussed that realism and hopefulness are compatible beliefs, and it’s okay – preferred, even – to hold them at once.

Mr. C’s strange sense of apathy made me think about another mental limbo, this one involving control. As doctors and patients, we like when we have agency over outcomes. Take these medications, and you will be okay. Undergo this procedure, and you will reduce your risk of recurrence. At the same time, poor outcomes still occur when everything is done “right.” When that happens, it can be psychologically beneficial to relinquish control. Doing so discards the unhelpful emotions of guilt and blame in favor of acceptance.

Mr. C’s apathy seemed to be present from day 1. But now, in a dire blast crisis, what was once a harmful attitude actually became a helpful one.

His “what will be, will be” attitude wasn’t inherently maladaptive; it was ill timed. Under the right circumstances, well-placed apathy can be leveraged as a positive coping mechanism.

But alas, if only there were a switch to turn on the right emotion at the right time. There’s no right or wrong or sensible reaction to cancer. There’s only a swirl of messy, overwhelming feelings. It’s trying to bring effective emotions to light at the right time while playing whack-a-mole with the others. It’s cognitive dissonance. It’s exhausting. Cancer doesn’t create personalities; it surfaces them.

It’s the last day of Mr. C’s hospitalization. His blast crisis is amazingly under good control.

“So,” I say. “Will you take your medications now?”

“Sure,” he says instinctively. I look at him. “I mean, honestly, Doc? I’m not sure.”

As we shake hands, I wonder if I’ll ever truly understand Mr. C’s motivations. But I can’t wonder too long. I can only control my part: I hand him his medications and wish him luck.

Minor details of this story were changed to protect privacy.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

 

The diagnosis was straightforward. My patient’s reaction was not.

One Saturday evening, I receive a call from the emergency room about a man with a very high white blood cell count. For the past 7 years, he had chronic myeloid leukemia – a cancer, but one of the few that can be well controlled for years. The discovery of the medications that can do it revolutionized care for the disease.

For the last 7 years, Mr. C didn’t take that medication regularly. He was young, with no other medical problems, and this was the only medication he was supposed to take. But his use was sporadic at best.

What was it, I wondered? Cost? Side effects? Not understanding the seriousness of having leukemia? No, the medication was fully covered by his insurance. No, he tolerated it well. Instead, his on-and-off medication schedule came across as a strange sense of apathy. He didn’t seem to recognize his agency in his own life.

Now, not only is his white count extremely high, but the majority are the cancerous cells. I look at his blood under the microscope – blasts everywhere. He has progressed from a chronic, indolent disease that can be kept at bay into the dreaded blast crisis, which is essentially an acute leukemia but even more challenging to treat.

It is very serious. I tell him this. “I am worried your leukemia has progressed into what we call a blast crisis,” I say. “Has anyone ever talked to you about this before?”

“Hmm, I think Dr. M may have said something,” he says. His medical chart over the last 7 years was populated with notes from his hematologist documenting their discussions of this possibility.

Dr. Ilana Yurkiewicz

“This is serious,” I continue. “You will need to come into the hospital and we need to start medication to lower your white count. Otherwise you could have a stroke.”

“Okay.”

“As the white count comes down, your cells will break open and the chemicals in them can make you very sick. So we will have to check your blood often to watch for this.”

“Got it.”

“And we will change your chemotherapy pill.” I pause, letting it sink in, then repeat for emphasis: “This is very serious.”

“Sure thing, Doc.”

“I know I’ve said a lot. What are your thoughts?”

He looks at his wife, then back at me. He seems unfazed. Just as unfazed as when his hematologist warned this could happen. Just as unfazed as the day he learned his diagnosis.

He smiles and shrugs. “What will be, will be.”

As I listened to him, I honestly couldn’t tell if this was the best coping mechanism I had ever seen or the worst.

On one hand, his apathy had hurt him, clearly and indisputably. Refusing to acknowledge his agency in his medical outcomes allowed him to be cavalier about taking the cure. The cure was in a bottle on his kitchen shelf, an arm’s reach away, and he chose to reach elsewhere.

On the other hand, it was unusual to see someone so at peace with being so critically ill. His acceptance of his new reality was refreshing. There were no heartbreaking questions about whether this was his fault. There was no agonizing over what could have been. His apathy gave him closure and his loved ones comfort.

I’ve written before about how a cancer diagnosis involves holding two seemingly competing ideas in one’s mind at once. Last month, I wrote about how it is possible to be realistic about a grim prognosis while retaining hope that a treatment may work. I discussed that realism and hopefulness are compatible beliefs, and it’s okay – preferred, even – to hold them at once.

Mr. C’s strange sense of apathy made me think about another mental limbo, this one involving control. As doctors and patients, we like when we have agency over outcomes. Take these medications, and you will be okay. Undergo this procedure, and you will reduce your risk of recurrence. At the same time, poor outcomes still occur when everything is done “right.” When that happens, it can be psychologically beneficial to relinquish control. Doing so discards the unhelpful emotions of guilt and blame in favor of acceptance.

Mr. C’s apathy seemed to be present from day 1. But now, in a dire blast crisis, what was once a harmful attitude actually became a helpful one.

His “what will be, will be” attitude wasn’t inherently maladaptive; it was ill timed. Under the right circumstances, well-placed apathy can be leveraged as a positive coping mechanism.

But alas, if only there were a switch to turn on the right emotion at the right time. There’s no right or wrong or sensible reaction to cancer. There’s only a swirl of messy, overwhelming feelings. It’s trying to bring effective emotions to light at the right time while playing whack-a-mole with the others. It’s cognitive dissonance. It’s exhausting. Cancer doesn’t create personalities; it surfaces them.

It’s the last day of Mr. C’s hospitalization. His blast crisis is amazingly under good control.

“So,” I say. “Will you take your medications now?”

“Sure,” he says instinctively. I look at him. “I mean, honestly, Doc? I’m not sure.”

As we shake hands, I wonder if I’ll ever truly understand Mr. C’s motivations. But I can’t wonder too long. I can only control my part: I hand him his medications and wish him luck.

Minor details of this story were changed to protect privacy.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

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Ulipristal acetate tops placebo for uterine leiomyomas

Neither panacea nor Pandora’s box
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For women with symptomatic uterine leiomyomas and abnormal uterine bleeding, ulipristal acetate treatment significantly improved quality of life over placebo, according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.

Courtesy Wikimedia Commons/Hic et nunc/CC BY-SA 3.0

In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.

Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.

After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).

“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.

Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.

The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.

The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”

Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.

SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.

Body

In this study, 77%-87% of women who received ulipristal acetate reported more than a 20-point improvement in health-related quality of life, compared with only 36% of placebo recipients, Joanna L. Hatfield, MD, wrote in an accompanying editorial.

“However, women with leiomyomas report a 51-point mean improvement after hysterectomy,” she noted. “Clinicians need to keep this difference in mind when counseling women with leiomyomas.”

Ulipristal can cause fatigue and weight gain leading to treatment discontinuation, she noted. Very rare cases of liver failure also have been reported, and there is no evidence that liver enzyme screening identifies patients at risk.

Nonetheless, for the approximately half of women with symptomatic leiomyomas who desire uterine-sparing treatment, selective progesterone receptor modulators like ulipristal offer “a noninvasive way to manage bleeding and bulk symptoms,” Dr. Hatfield said.

She advocated for long-term safety studies and a large pregnancy registry, calling ulipristal “neither a panacea nor a Pandora’s box,” but a choice that “lies somewhere in the middle, just [like] nearly all options that present themselves in a woman’s life.”
 

Dr. Hatfield is director of the fibroid program at Oregon Health & Science University in Portland. She did not report having conflicts of interest. She wrote an editorial accompanying the article by AS Lukes et al. (Obstet Gynecol. 2019 May;133[5]:867-8).

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In this study, 77%-87% of women who received ulipristal acetate reported more than a 20-point improvement in health-related quality of life, compared with only 36% of placebo recipients, Joanna L. Hatfield, MD, wrote in an accompanying editorial.

“However, women with leiomyomas report a 51-point mean improvement after hysterectomy,” she noted. “Clinicians need to keep this difference in mind when counseling women with leiomyomas.”

Ulipristal can cause fatigue and weight gain leading to treatment discontinuation, she noted. Very rare cases of liver failure also have been reported, and there is no evidence that liver enzyme screening identifies patients at risk.

Nonetheless, for the approximately half of women with symptomatic leiomyomas who desire uterine-sparing treatment, selective progesterone receptor modulators like ulipristal offer “a noninvasive way to manage bleeding and bulk symptoms,” Dr. Hatfield said.

She advocated for long-term safety studies and a large pregnancy registry, calling ulipristal “neither a panacea nor a Pandora’s box,” but a choice that “lies somewhere in the middle, just [like] nearly all options that present themselves in a woman’s life.”
 

Dr. Hatfield is director of the fibroid program at Oregon Health & Science University in Portland. She did not report having conflicts of interest. She wrote an editorial accompanying the article by AS Lukes et al. (Obstet Gynecol. 2019 May;133[5]:867-8).

Body

In this study, 77%-87% of women who received ulipristal acetate reported more than a 20-point improvement in health-related quality of life, compared with only 36% of placebo recipients, Joanna L. Hatfield, MD, wrote in an accompanying editorial.

“However, women with leiomyomas report a 51-point mean improvement after hysterectomy,” she noted. “Clinicians need to keep this difference in mind when counseling women with leiomyomas.”

Ulipristal can cause fatigue and weight gain leading to treatment discontinuation, she noted. Very rare cases of liver failure also have been reported, and there is no evidence that liver enzyme screening identifies patients at risk.

Nonetheless, for the approximately half of women with symptomatic leiomyomas who desire uterine-sparing treatment, selective progesterone receptor modulators like ulipristal offer “a noninvasive way to manage bleeding and bulk symptoms,” Dr. Hatfield said.

She advocated for long-term safety studies and a large pregnancy registry, calling ulipristal “neither a panacea nor a Pandora’s box,” but a choice that “lies somewhere in the middle, just [like] nearly all options that present themselves in a woman’s life.”
 

Dr. Hatfield is director of the fibroid program at Oregon Health & Science University in Portland. She did not report having conflicts of interest. She wrote an editorial accompanying the article by AS Lukes et al. (Obstet Gynecol. 2019 May;133[5]:867-8).

Title
Neither panacea nor Pandora’s box
Neither panacea nor Pandora’s box

For women with symptomatic uterine leiomyomas and abnormal uterine bleeding, ulipristal acetate treatment significantly improved quality of life over placebo, according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.

Courtesy Wikimedia Commons/Hic et nunc/CC BY-SA 3.0

In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.

Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.

After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).

“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.

Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.

The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.

The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”

Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.

SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.

For women with symptomatic uterine leiomyomas and abnormal uterine bleeding, ulipristal acetate treatment significantly improved quality of life over placebo, according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.

Courtesy Wikimedia Commons/Hic et nunc/CC BY-SA 3.0

In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.

Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.

After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).

“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.

Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.

The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.

The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”

Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.

SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.

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Key clinical point: For women with symptomatic uterine leiomyomas, ulipristal at either 5 mg or 10 mg significantly improved both the rate of and time to amenorrhea, compared with placebo.

Major finding: Patients who received 5 or 10 mg ulipristal showed significant improvements in Uterine Fibroid Symptom Health-Related Quality of Life scales, compared with those who received placebo (P less than .001).

Study details: VENUS I and II, 12-week randomized controlled trials of ulipristal acetate or placebo in 589 women with symptomatic uterine leiomyomas and abnormal uterine bleeding.

Disclosures: Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.

Source: Lukes AS et al. Obstet Gynecol. 2019 May;133(5):869-78.

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