Chronic pain is a worldwide cause of impairment. According to data from the 2016 National Health Interview Survey, an estimated 50 million American adults suffer from chronic pain, with 19.6 million adults suffering from high-impact chronic pain.¹ This phenomenon is particularly prevalent in the older population. More than 25% of adults aged 65 to 74 years reported that they were often in pain in the past 3 months compared with just 10% of those adults between the ages of 18 and 44 years.²

The economic burdens of chronic pain disorders are well known. In 2010, Gaskin and Richard found that chronic pain has far-reaching consequences for the US economy, ranging from direct health care costs to lost productivity. This study estimated additional health care costs at about $300 billion yearly and lost productivity at $300 billion, bringing total annual costs to about $600 billion. This expense is more than heart disease alone ($309 billion), and cancer and diabetes mellitus ($243 billion and $188 billion respectively) combined.³

Opioid medications are powerful and effective pain-reducing agents that are indicated for short-term acute pain or long-term in the management of chronic, severe cancer-related pain.⁴ Although efficacious, use of these medications carries with it the inherent risks of abuse, misuse, addiction, and overdose.⁵ Since 1999, opioid-related overdose deaths have been on the rise. The CDC estimated that > 15,000 deaths were attributable specifically to prescription opioids in 2015.⁶ The estimates had risen to > 17,000 deaths in 2017, with the number increasing since that time.⁷ Cumulatively, the CDC estimates that > 200,000 deaths in the US between 1999 and 2017 are attributed to prescription opioid overdose, clearly marking this trend as a growing nationwide epidemic.⁸

In 2016, Florence and colleagues estimated costs associated with opioid overdose to be just shy of $80 billion in 2013 dollars.⁹ In October 2017, the US Department of Health and Human Services declared the opioid epidemic a public health emergency and committed $900 million to combating the crisis.¹⁰

An abundance of data exist analyzing outpatient prescribing and its impacts on opioid dependence, particularly postoperatively. A study by Brummett and colleagues indicated that the incidence of new persistent opioid use in patients who underwent surgery was 5.9% to 6.5% and did not differ between major and minor surgical procedures. This study concluded that new opioid use could be considered one of the most common complications after elective surgery.¹¹ Similarly, in 2017 Makary and colleagues found that surgeons tend to overprescribe pain medications after procedures; some prescribing as many as 50 to 60 tablets to control pain after simple procedures.¹² This is in stark contrast to pain guideline recommendations of no more than 10 tablets for most standard operative procedures.¹³

Sun and colleagues conducted a retrospective analysis of health care claims data in more than 18 million opioid-naïve patients who did and did not undergo surgery. Seven of the 11 surgical procedures were associated with an increased risk of chronic opioid use. The highest incidence of chronic opioid use in the first postoperative year was for total hip arthroplasty (1.4%, OR 5.10; 95% CI, 1.29-1.53). The study found that the risk factors most associated with chronic opioid use after surgery were male sex, aged > 50 years, and preoperative history of drug abuse, alcohol abuse, or depression, along with benzodiazepine use or antidepressant use.¹⁴ In a 2018 cohort study that evaluated predictors associated with transitioning to incident chronic opioid therapy, 4 factors were identified. These included opioid duration of action (adjusted odds ratio [AOR], 12.28; 95% CI, 8.1-06-18.72), the parent opioid compound (eg, tramadol vs codeine; AOR, 7.26; 95% CI, 5.20-10.13), the presence of conditions that are very likely to cause chronic pain (AOR, 5.47; 95% CI, 3.89-7.68), and drug use disorders (AOR, 4.02; 95% CI, 2.53-6.40).¹⁵

While there has been research into outpatient risk factors and medical practices that may contribute to chronic opioid use, a relative paucity of data exists on the contribution of hospitalization and inpatient opioid use on patient outcomes. A 2014 Canadian study assessed the impact of opioid use in the intensive care unit (ICU) on opioid use after discharge.¹⁶ This study included more than 2,500 patients who were admitted to a Canadian ICU between 2005 and 2008, and then followed after discharge for 48 months to quantify chronic opioid use. Nonopioid users increased from 87.8% in the early post-ICU period to 95.6% at 48 months after discharge. Preadmission chronic opioid use and prolonged hospital length of stay (LOS) were found to be associated with an increased risk of chronic opioid use after discharge.¹⁶ To date, there are no published studies that analyze the incidence of opioid-naïve veterans who convert to chronic opioid use after receiving opioids during an acute hospitalization.

In this retrospective analysis, we analyze the incidence of chronic opioid use after administration of opioids in the ICU as well as a variety of risk factors that may influence conversion to chronic opioid use.

Methods

This analysis was a single center, retrospective chart review conducted for patients admitted between July 1, 2017 and December 31, 2017 at the US Department of Veterans Affairs (VA) Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, Texas. MEDVAMC is a 538-bed academic\teaching hospital serving about 130,000 veterans in Southeast Texas. The hospital has 3 ICUs (medical, cardiovascular, and surgical) and 38 total ICU beds. The study was approved by the Baylor College of Medicine Institutional Review Board and MEDVAMC Research and Development Review Board. Informed consent was not required.

Inclusion criteria consisted of patients aged ≥ 18 years admitted to the ICU in the above-specified time frame, who were administered a continuous infusion of an opioid for at least 12 hours. Patients were excluded if they were not opioid naïve prior to admission, defined as receiving > 30 days of opioids in the prior 12 months. Patients who died during hospital admission, never received an opioid despite having an active order, were hospital-to-hospital transfers, or were still admitted at the time of data collection were excluded from the analysis.

All pertinent data were collected using the VA Computerized Patient Record System (CPRS) and the Critical Care Manager (Picis Clinical Solutions) ICU monitoring application. Critical Care Manager was used to track the time frame, duration, and amounts of opioid infusions administered in the ICU. Patient demographic and preadmission data, including date of birth, age, race, history of substance use/alcohol use disorder (defined as a previous diagnosis) and previous opioid prescriptions within the past year were recorded. For the inpatient admission, the ICU LOS, hospital LOS, primary admission diagnosis, type of opioid medication administered, and total duration and dose of opioid administered were collected. After discharge, opioid medication fill data at 3, 6, and 12 months were collected. This information included names of any outpatient opioids filled, dosage unit, quantity, day supply, and number of refills.

The primary outcome for this study was to determine the incidence of chronic opioid use at 3, 6, and 12 months after discharge, defined as the percentage of patients receiving outpatient opioid prescriptions at each time point. Analyses were conducted to observe the effect of age, race, history of substance use or history of alcohol use (International Classification of Diseases documented diagnosis, 9th edition), ICU type (medical, surgical, or cardiovascular), surgical/nonsurgical admission, ICU LOS, hospital LOS, total time, and amount of opioids administered during admission on risk of conversion to chronic opioid use.

Descriptive statistics were calculated to analyze the incidence of chronic opioid use. Univariate logistic regression analysis, including ORs, 95% CIs, and P values, was conducted to determine the effects of the risk factors noted earlier on chronic opioid use at each time point. A multivariate logistic regression model was performed to assess the effect of multiple independent variables on opioid use at 3, 6, and 12 months. Statistical analysis was performed using StataCorp Stata SE.

Results

During the study period, 330 patients were admitted to the ICU. After applying inclusion/exclusion criteria, 118 patients were included in the final analysis. The most frequent reasons for exclusion from the study were patient death (n = 77), a past history of opioid use (n = 56), and not having received an opioid infusion for at least 12 hours (n = 68). The average age of the patients included was 67 years (Table 1). A total of 14% and 9% of patients, respectively, had a diagnosis of alcohol use disorder or substance use disorder recorded in CPRS. After admission, the most common location for these patients was the surgical ICU (65%). All patients were male. The average hospital LOS was 18.6 days , and the ICU LOS was 8.3 days. The average duration of administration for the opioid (fentanyl) infusion was 63 hours, and the average amount of fentanyl administered to each patient was 57.1 mcg/h.

The incidence of opioid-naïve patients receiving opioids after discharge was 76.3% (n = 90) at 3 months, 19.5% (n = 23) at 6 months and 7.6% (n = 9) at 12 months (Figure). The daily morphine milligram equivalent (MME) of patients prescribed opioids at 3, 6, and 12 months was similar (3 months, 22.7; 6 months, 19.7; 12 months, 20.9). In the univariate regression analysis, several variables were found to be associated with converting to chronic opioid use. Prior history of alcohol use disorder (OR, 0.3; 95% CI, 0.10-0.88; P = .03), ICU type (OR, 3.9; 95% CI, 1.73-8.75; P = .001) and ICU LOS (OR, 0.88; 95% CI, 0.81-0.95; P = .01) had a statistically significant association on opioid use at 3 months. (Table 2). No variables evaluated had a statistically significant effect on chronic opioid use at 6 months, and only age (OR 0.93; 95% CI. 0.87-0.99; P = .02) was statistically significant at 12 months. In the multivariate logistic regression analysis, history of alcohol abuse, admission for surgery, and hospital LOS were significant at 3 months (Table 3).

Discussion

In this single-center analysis conducted at a VA academic hospital of opioid-naïve patients who were administered opioids in the ICU, the incidence of patients subsequently receiving outpatient opioid prescriptions at 12 months after discharge was 7.6%. There also was a decrease in the amount of opioids received by patients (daily MME) after discharge at 3, 6, and 12 months. This trend did not demonstrate the propensity for inpatient opioid use to convert opioid-naïve patients to chronic opioid users.

The most common outpatient opioids prescribed were hydrocodone/acetaminophen, morphine, and tramadol. Logistic regression showed few factors that correlated significantly with opioid use in the long-term (12 month) period. This finding is a deviation from the findings of Yaffe and colleagues who found hospital LOS to be one of the only predictors of long-term opioid use in their population (defined as use at 48 months).¹⁶ One important difference between our study and the Yaffe and colleagues study was that they evaluated all patients who were admitted to the ICU, regardless of the exposure to opioids during their inpatient stay. Consequently, this difference may have resulted in the differences in findings.

Strengths and Limitations

Location was a strength of our study, as this analysis was conducted at an integrated health care system that provides comprehensive inpatient and outpatient care. The VA uses a closed electronic health record, which allowed patients to be followed both in the inpatient and outpatient settings to determine which medications were prescribed at each time. In other health care systems this information would have been difficult to follow as patients often fill outpatient prescriptions at community pharmacies not affiliated with the treating hospital. However, any patient not using a VA prescriber for subsequent opioid prescriptions or patients who received opioids through other sources would not have had their continued opioid use captured. These data may be available in the states prescription monitoring program, but it was not available to query for research at this time.

This study also excluded chronic opioid users, which could have been another confounding factor to account for when analyzing the results. However, the primary objective of the study was to determine the impact of opioids prescribed in the ICU on converting previous opioid-naïve patients to chronic users. Finally, a multivariate logistic regression was incorporated to assess for factors that may predispose certain patients to convert to chronic opioid users. This analysis served to extend the applicability of our study by not only analyzing whether receiving opioids in the ICU contributed to chronic opioid use in the long-term, but also which populations may be at greatest risk. This information can be used in the future to target harm-reduction efforts toward high-risk hospitalized patients.

One limitation of this study was that it was conducted as a retrospective, single-center chart review in Houston, Texas. Because this was not a randomized controlled trial, it is difficult to imply any causation between exposure to opioids in the ICU and chronic use. In addition, because this study was conducted at a single site, the results may not be able to be generalized to other populations. VA populations tend to be elderly and predominantly male, as was reflected by the study population. These factors, along with regional variability in patient characteristics, may limit the generalizability of this study to older male patients located in Southeast Texas or other similar populations. Other limitations of this study also included the small sample size, limited period of follow-up obtained, and that other comorbidity information (pain scores during stay, use of nonopioid pain medications, past history of anxiety or depression, or other acute illnesses or surgeries that may have required opioid therapy during admission) was not collected.

This study was only able to review 118 patients for a follow-up duration of 1 year. In the Yaffe and colleagues study, more than 2,500 patients were followed over 4 years, which provided a more long-term overview of the clinical course of these patients and may be another reason for discrepant findings. However, this study did not actually assess the impact on administration of opioids on the development of chronic opioid use.¹⁶ Finally, the biggest limitation to this study may be the potential for confounding discharge prescriptions. After discharge, patients’ prescriptions were evaluated from discharge to 3 months, in between 3 and 6 months, and between 6 and 12 months for the presence of an opioid prescription. Due to this methodology, any opioid prescription a patient was discharged with was counted in the 3-month time point. Since many patients included in the study were admitted to the surgical ICU (65%), it was logical that they were discharged with opioids after their procedure. While including the immediate postdischarge prescription data was useful for evaluating the decrease in opioid use and incidence over time, it did cause the 3-month time point to appear overly inflated, potentially signaling that at 3 months after discharge many of these patients were still requiring opioid use.

The Society of Critical Care Medicine still recommends opioids as first-line therapy for non-neuropathic pain in the ICU setting.¹⁷ Additionally, postoperative pain can be difficult to manage in the surgical population and is often treated with opioids, though treatment with multimodal pain regimens is becoming more common.¹⁸ It is difficult to imagine that a finding that implicates opioid use in the hospital with conversion to chronic opioid use would prompt a cessation in the use of opioid in these settings, especially in the context of analgosedation related to mechanically ventilated patients. However, it would be plausible to use this knowledge to advocate for opioid-sparing therapies and consideration for weaning individuals at high risk for misuse after discharge from opioid-containing sedation or analgesia regimens in a timelier manner.

Though our findings did not show a clinically relevant increase in chronic opioid users, clinicians can still use this information to encourage targeted education and closer monitoring for those patients deemed as high risk at discharge to prevent unnecessary prolonged opioid use. By having more frequent follow-up in pain clinics, switching patients to nonopioid therapies after discharge, and ensuring high-risk patients are discharged with naloxone rescue kits, it would be possible to drastically reduce the number of potential overdoses for patients who previously required opioid therapy in the ICU.

Conclusion

After discharge, 7.6% of previously opioid-naïve patients who were treated with opioids in the ICU were still receiving prescriptions for opioids at 12 months. These findings did not suggest a clinically significant increase in the incidence of chronic opioid use after inpatient administration of opioids. However, these results prompt the need for larger, prospective, multicenter studies to evaluate the effect on hospitalization on converting to chronic opioid use and a deeper evaluation of other potential risk factors that may be present.

Chronic pain is a worldwide cause of impairment. According to data from the 2016 National Health Interview Survey, an estimated 50 million American adults suffer from chronic pain, with 19.6 million adults suffering from high-impact chronic pain.¹ This phenomenon is particularly prevalent in the older population. More than 25% of adults aged 65 to 74 years reported that they were often in pain in the past 3 months compared with just 10% of those adults between the ages of 18 and 44 years.²

The economic burdens of chronic pain disorders are well known. In 2010, Gaskin and Richard found that chronic pain has far-reaching consequences for the US economy, ranging from direct health care costs to lost productivity. This study estimated additional health care costs at about $300 billion yearly and lost productivity at $300 billion, bringing total annual costs to about $600 billion. This expense is more than heart disease alone ($309 billion), and cancer and diabetes mellitus ($243 billion and $188 billion respectively) combined.³

Opioid medications are powerful and effective pain-reducing agents that are indicated for short-term acute pain or long-term in the management of chronic, severe cancer-related pain.⁴ Although efficacious, use of these medications carries with it the inherent risks of abuse, misuse, addiction, and overdose.⁵ Since 1999, opioid-related overdose deaths have been on the rise. The CDC estimated that > 15,000 deaths were attributable specifically to prescription opioids in 2015.⁶ The estimates had risen to > 17,000 deaths in 2017, with the number increasing since that time.⁷ Cumulatively, the CDC estimates that > 200,000 deaths in the US between 1999 and 2017 are attributed to prescription opioid overdose, clearly marking this trend as a growing nationwide epidemic.⁸

In 2016, Florence and colleagues estimated costs associated with opioid overdose to be just shy of $80 billion in 2013 dollars.⁹ In October 2017, the US Department of Health and Human Services declared the opioid epidemic a public health emergency and committed $900 million to combating the crisis.¹⁰

An abundance of data exist analyzing outpatient prescribing and its impacts on opioid dependence, particularly postoperatively. A study by Brummett and colleagues indicated that the incidence of new persistent opioid use in patients who underwent surgery was 5.9% to 6.5% and did not differ between major and minor surgical procedures. This study concluded that new opioid use could be considered one of the most common complications after elective surgery.¹¹ Similarly, in 2017 Makary and colleagues found that surgeons tend to overprescribe pain medications after procedures; some prescribing as many as 50 to 60 tablets to control pain after simple procedures.¹² This is in stark contrast to pain guideline recommendations of no more than 10 tablets for most standard operative procedures.¹³

Sun and colleagues conducted a retrospective analysis of health care claims data in more than 18 million opioid-naïve patients who did and did not undergo surgery. Seven of the 11 surgical procedures were associated with an increased risk of chronic opioid use. The highest incidence of chronic opioid use in the first postoperative year was for total hip arthroplasty (1.4%, OR 5.10; 95% CI, 1.29-1.53). The study found that the risk factors most associated with chronic opioid use after surgery were male sex, aged > 50 years, and preoperative history of drug abuse, alcohol abuse, or depression, along with benzodiazepine use or antidepressant use.¹⁴ In a 2018 cohort study that evaluated predictors associated with transitioning to incident chronic opioid therapy, 4 factors were identified. These included opioid duration of action (adjusted odds ratio [AOR], 12.28; 95% CI, 8.1-06-18.72), the parent opioid compound (eg, tramadol vs codeine; AOR, 7.26; 95% CI, 5.20-10.13), the presence of conditions that are very likely to cause chronic pain (AOR, 5.47; 95% CI, 3.89-7.68), and drug use disorders (AOR, 4.02; 95% CI, 2.53-6.40).¹⁵

While there has been research into outpatient risk factors and medical practices that may contribute to chronic opioid use, a relative paucity of data exists on the contribution of hospitalization and inpatient opioid use on patient outcomes. A 2014 Canadian study assessed the impact of opioid use in the intensive care unit (ICU) on opioid use after discharge.¹⁶ This study included more than 2,500 patients who were admitted to a Canadian ICU between 2005 and 2008, and then followed after discharge for 48 months to quantify chronic opioid use. Nonopioid users increased from 87.8% in the early post-ICU period to 95.6% at 48 months after discharge. Preadmission chronic opioid use and prolonged hospital length of stay (LOS) were found to be associated with an increased risk of chronic opioid use after discharge.¹⁶ To date, there are no published studies that analyze the incidence of opioid-naïve veterans who convert to chronic opioid use after receiving opioids during an acute hospitalization.

In this retrospective analysis, we analyze the incidence of chronic opioid use after administration of opioids in the ICU as well as a variety of risk factors that may influence conversion to chronic opioid use.

Methods

This analysis was a single center, retrospective chart review conducted for patients admitted between July 1, 2017 and December 31, 2017 at the US Department of Veterans Affairs (VA) Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, Texas. MEDVAMC is a 538-bed academic\teaching hospital serving about 130,000 veterans in Southeast Texas. The hospital has 3 ICUs (medical, cardiovascular, and surgical) and 38 total ICU beds. The study was approved by the Baylor College of Medicine Institutional Review Board and MEDVAMC Research and Development Review Board. Informed consent was not required.

Inclusion criteria consisted of patients aged ≥ 18 years admitted to the ICU in the above-specified time frame, who were administered a continuous infusion of an opioid for at least 12 hours. Patients were excluded if they were not opioid naïve prior to admission, defined as receiving > 30 days of opioids in the prior 12 months. Patients who died during hospital admission, never received an opioid despite having an active order, were hospital-to-hospital transfers, or were still admitted at the time of data collection were excluded from the analysis.

All pertinent data were collected using the VA Computerized Patient Record System (CPRS) and the Critical Care Manager (Picis Clinical Solutions) ICU monitoring application. Critical Care Manager was used to track the time frame, duration, and amounts of opioid infusions administered in the ICU. Patient demographic and preadmission data, including date of birth, age, race, history of substance use/alcohol use disorder (defined as a previous diagnosis) and previous opioid prescriptions within the past year were recorded. For the inpatient admission, the ICU LOS, hospital LOS, primary admission diagnosis, type of opioid medication administered, and total duration and dose of opioid administered were collected. After discharge, opioid medication fill data at 3, 6, and 12 months were collected. This information included names of any outpatient opioids filled, dosage unit, quantity, day supply, and number of refills.

The primary outcome for this study was to determine the incidence of chronic opioid use at 3, 6, and 12 months after discharge, defined as the percentage of patients receiving outpatient opioid prescriptions at each time point. Analyses were conducted to observe the effect of age, race, history of substance use or history of alcohol use (International Classification of Diseases documented diagnosis, 9th edition), ICU type (medical, surgical, or cardiovascular), surgical/nonsurgical admission, ICU LOS, hospital LOS, total time, and amount of opioids administered during admission on risk of conversion to chronic opioid use.

Descriptive statistics were calculated to analyze the incidence of chronic opioid use. Univariate logistic regression analysis, including ORs, 95% CIs, and P values, was conducted to determine the effects of the risk factors noted earlier on chronic opioid use at each time point. A multivariate logistic regression model was performed to assess the effect of multiple independent variables on opioid use at 3, 6, and 12 months. Statistical analysis was performed using StataCorp Stata SE.

Results

During the study period, 330 patients were admitted to the ICU. After applying inclusion/exclusion criteria, 118 patients were included in the final analysis. The most frequent reasons for exclusion from the study were patient death (n = 77), a past history of opioid use (n = 56), and not having received an opioid infusion for at least 12 hours (n = 68). The average age of the patients included was 67 years (Table 1). A total of 14% and 9% of patients, respectively, had a diagnosis of alcohol use disorder or substance use disorder recorded in CPRS. After admission, the most common location for these patients was the surgical ICU (65%). All patients were male. The average hospital LOS was 18.6 days , and the ICU LOS was 8.3 days. The average duration of administration for the opioid (fentanyl) infusion was 63 hours, and the average amount of fentanyl administered to each patient was 57.1 mcg/h.

The incidence of opioid-naïve patients receiving opioids after discharge was 76.3% (n = 90) at 3 months, 19.5% (n = 23) at 6 months and 7.6% (n = 9) at 12 months (Figure). The daily morphine milligram equivalent (MME) of patients prescribed opioids at 3, 6, and 12 months was similar (3 months, 22.7; 6 months, 19.7; 12 months, 20.9). In the univariate regression analysis, several variables were found to be associated with converting to chronic opioid use. Prior history of alcohol use disorder (OR, 0.3; 95% CI, 0.10-0.88; P = .03), ICU type (OR, 3.9; 95% CI, 1.73-8.75; P = .001) and ICU LOS (OR, 0.88; 95% CI, 0.81-0.95; P = .01) had a statistically significant association on opioid use at 3 months. (Table 2). No variables evaluated had a statistically significant effect on chronic opioid use at 6 months, and only age (OR 0.93; 95% CI. 0.87-0.99; P = .02) was statistically significant at 12 months. In the multivariate logistic regression analysis, history of alcohol abuse, admission for surgery, and hospital LOS were significant at 3 months (Table 3).

Discussion

In this single-center analysis conducted at a VA academic hospital of opioid-naïve patients who were administered opioids in the ICU, the incidence of patients subsequently receiving outpatient opioid prescriptions at 12 months after discharge was 7.6%. There also was a decrease in the amount of opioids received by patients (daily MME) after discharge at 3, 6, and 12 months. This trend did not demonstrate the propensity for inpatient opioid use to convert opioid-naïve patients to chronic opioid users.

The most common outpatient opioids prescribed were hydrocodone/acetaminophen, morphine, and tramadol. Logistic regression showed few factors that correlated significantly with opioid use in the long-term (12 month) period. This finding is a deviation from the findings of Yaffe and colleagues who found hospital LOS to be one of the only predictors of long-term opioid use in their population (defined as use at 48 months).¹⁶ One important difference between our study and the Yaffe and colleagues study was that they evaluated all patients who were admitted to the ICU, regardless of the exposure to opioids during their inpatient stay. Consequently, this difference may have resulted in the differences in findings.

Strengths and Limitations

Location was a strength of our study, as this analysis was conducted at an integrated health care system that provides comprehensive inpatient and outpatient care. The VA uses a closed electronic health record, which allowed patients to be followed both in the inpatient and outpatient settings to determine which medications were prescribed at each time. In other health care systems this information would have been difficult to follow as patients often fill outpatient prescriptions at community pharmacies not affiliated with the treating hospital. However, any patient not using a VA prescriber for subsequent opioid prescriptions or patients who received opioids through other sources would not have had their continued opioid use captured. These data may be available in the states prescription monitoring program, but it was not available to query for research at this time.

This study also excluded chronic opioid users, which could have been another confounding factor to account for when analyzing the results. However, the primary objective of the study was to determine the impact of opioids prescribed in the ICU on converting previous opioid-naïve patients to chronic users. Finally, a multivariate logistic regression was incorporated to assess for factors that may predispose certain patients to convert to chronic opioid users. This analysis served to extend the applicability of our study by not only analyzing whether receiving opioids in the ICU contributed to chronic opioid use in the long-term, but also which populations may be at greatest risk. This information can be used in the future to target harm-reduction efforts toward high-risk hospitalized patients.

One limitation of this study was that it was conducted as a retrospective, single-center chart review in Houston, Texas. Because this was not a randomized controlled trial, it is difficult to imply any causation between exposure to opioids in the ICU and chronic use. In addition, because this study was conducted at a single site, the results may not be able to be generalized to other populations. VA populations tend to be elderly and predominantly male, as was reflected by the study population. These factors, along with regional variability in patient characteristics, may limit the generalizability of this study to older male patients located in Southeast Texas or other similar populations. Other limitations of this study also included the small sample size, limited period of follow-up obtained, and that other comorbidity information (pain scores during stay, use of nonopioid pain medications, past history of anxiety or depression, or other acute illnesses or surgeries that may have required opioid therapy during admission) was not collected.

This study was only able to review 118 patients for a follow-up duration of 1 year. In the Yaffe and colleagues study, more than 2,500 patients were followed over 4 years, which provided a more long-term overview of the clinical course of these patients and may be another reason for discrepant findings. However, this study did not actually assess the impact on administration of opioids on the development of chronic opioid use.¹⁶ Finally, the biggest limitation to this study may be the potential for confounding discharge prescriptions. After discharge, patients’ prescriptions were evaluated from discharge to 3 months, in between 3 and 6 months, and between 6 and 12 months for the presence of an opioid prescription. Due to this methodology, any opioid prescription a patient was discharged with was counted in the 3-month time point. Since many patients included in the study were admitted to the surgical ICU (65%), it was logical that they were discharged with opioids after their procedure. While including the immediate postdischarge prescription data was useful for evaluating the decrease in opioid use and incidence over time, it did cause the 3-month time point to appear overly inflated, potentially signaling that at 3 months after discharge many of these patients were still requiring opioid use.

The Society of Critical Care Medicine still recommends opioids as first-line therapy for non-neuropathic pain in the ICU setting.¹⁷ Additionally, postoperative pain can be difficult to manage in the surgical population and is often treated with opioids, though treatment with multimodal pain regimens is becoming more common.¹⁸ It is difficult to imagine that a finding that implicates opioid use in the hospital with conversion to chronic opioid use would prompt a cessation in the use of opioid in these settings, especially in the context of analgosedation related to mechanically ventilated patients. However, it would be plausible to use this knowledge to advocate for opioid-sparing therapies and consideration for weaning individuals at high risk for misuse after discharge from opioid-containing sedation or analgesia regimens in a timelier manner.

Though our findings did not show a clinically relevant increase in chronic opioid users, clinicians can still use this information to encourage targeted education and closer monitoring for those patients deemed as high risk at discharge to prevent unnecessary prolonged opioid use. By having more frequent follow-up in pain clinics, switching patients to nonopioid therapies after discharge, and ensuring high-risk patients are discharged with naloxone rescue kits, it would be possible to drastically reduce the number of potential overdoses for patients who previously required opioid therapy in the ICU.

Conclusion

After discharge, 7.6% of previously opioid-naïve patients who were treated with opioids in the ICU were still receiving prescriptions for opioids at 12 months. These findings did not suggest a clinically significant increase in the incidence of chronic opioid use after inpatient administration of opioids. However, these results prompt the need for larger, prospective, multicenter studies to evaluate the effect on hospitalization on converting to chronic opioid use and a deeper evaluation of other potential risk factors that may be present.

Chronic pain is a worldwide cause of impairment. According to data from the 2016 National Health Interview Survey, an estimated 50 million American adults suffer from chronic pain, with 19.6 million adults suffering from high-impact chronic pain.¹ This phenomenon is particularly prevalent in the older population. More than 25% of adults aged 65 to 74 years reported that they were often in pain in the past 3 months compared with just 10% of those adults between the ages of 18 and 44 years.²

The economic burdens of chronic pain disorders are well known. In 2010, Gaskin and Richard found that chronic pain has far-reaching consequences for the US economy, ranging from direct health care costs to lost productivity. This study estimated additional health care costs at about $300 billion yearly and lost productivity at $300 billion, bringing total annual costs to about $600 billion. This expense is more than heart disease alone ($309 billion), and cancer and diabetes mellitus ($243 billion and $188 billion respectively) combined.³

Opioid medications are powerful and effective pain-reducing agents that are indicated for short-term acute pain or long-term in the management of chronic, severe cancer-related pain.⁴ Although efficacious, use of these medications carries with it the inherent risks of abuse, misuse, addiction, and overdose.⁵ Since 1999, opioid-related overdose deaths have been on the rise. The CDC estimated that > 15,000 deaths were attributable specifically to prescription opioids in 2015.⁶ The estimates had risen to > 17,000 deaths in 2017, with the number increasing since that time.⁷ Cumulatively, the CDC estimates that > 200,000 deaths in the US between 1999 and 2017 are attributed to prescription opioid overdose, clearly marking this trend as a growing nationwide epidemic.⁸

In 2016, Florence and colleagues estimated costs associated with opioid overdose to be just shy of $80 billion in 2013 dollars.⁹ In October 2017, the US Department of Health and Human Services declared the opioid epidemic a public health emergency and committed $900 million to combating the crisis.¹⁰

An abundance of data exist analyzing outpatient prescribing and its impacts on opioid dependence, particularly postoperatively. A study by Brummett and colleagues indicated that the incidence of new persistent opioid use in patients who underwent surgery was 5.9% to 6.5% and did not differ between major and minor surgical procedures. This study concluded that new opioid use could be considered one of the most common complications after elective surgery.¹¹ Similarly, in 2017 Makary and colleagues found that surgeons tend to overprescribe pain medications after procedures; some prescribing as many as 50 to 60 tablets to control pain after simple procedures.¹² This is in stark contrast to pain guideline recommendations of no more than 10 tablets for most standard operative procedures.¹³

Sun and colleagues conducted a retrospective analysis of health care claims data in more than 18 million opioid-naïve patients who did and did not undergo surgery. Seven of the 11 surgical procedures were associated with an increased risk of chronic opioid use. The highest incidence of chronic opioid use in the first postoperative year was for total hip arthroplasty (1.4%, OR 5.10; 95% CI, 1.29-1.53). The study found that the risk factors most associated with chronic opioid use after surgery were male sex, aged > 50 years, and preoperative history of drug abuse, alcohol abuse, or depression, along with benzodiazepine use or antidepressant use.¹⁴ In a 2018 cohort study that evaluated predictors associated with transitioning to incident chronic opioid therapy, 4 factors were identified. These included opioid duration of action (adjusted odds ratio [AOR], 12.28; 95% CI, 8.1-06-18.72), the parent opioid compound (eg, tramadol vs codeine; AOR, 7.26; 95% CI, 5.20-10.13), the presence of conditions that are very likely to cause chronic pain (AOR, 5.47; 95% CI, 3.89-7.68), and drug use disorders (AOR, 4.02; 95% CI, 2.53-6.40).¹⁵

While there has been research into outpatient risk factors and medical practices that may contribute to chronic opioid use, a relative paucity of data exists on the contribution of hospitalization and inpatient opioid use on patient outcomes. A 2014 Canadian study assessed the impact of opioid use in the intensive care unit (ICU) on opioid use after discharge.¹⁶ This study included more than 2,500 patients who were admitted to a Canadian ICU between 2005 and 2008, and then followed after discharge for 48 months to quantify chronic opioid use. Nonopioid users increased from 87.8% in the early post-ICU period to 95.6% at 48 months after discharge. Preadmission chronic opioid use and prolonged hospital length of stay (LOS) were found to be associated with an increased risk of chronic opioid use after discharge.¹⁶ To date, there are no published studies that analyze the incidence of opioid-naïve veterans who convert to chronic opioid use after receiving opioids during an acute hospitalization.

In this retrospective analysis, we analyze the incidence of chronic opioid use after administration of opioids in the ICU as well as a variety of risk factors that may influence conversion to chronic opioid use.

Methods

This analysis was a single center, retrospective chart review conducted for patients admitted between July 1, 2017 and December 31, 2017 at the US Department of Veterans Affairs (VA) Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, Texas. MEDVAMC is a 538-bed academic\teaching hospital serving about 130,000 veterans in Southeast Texas. The hospital has 3 ICUs (medical, cardiovascular, and surgical) and 38 total ICU beds. The study was approved by the Baylor College of Medicine Institutional Review Board and MEDVAMC Research and Development Review Board. Informed consent was not required.

Inclusion criteria consisted of patients aged ≥ 18 years admitted to the ICU in the above-specified time frame, who were administered a continuous infusion of an opioid for at least 12 hours. Patients were excluded if they were not opioid naïve prior to admission, defined as receiving > 30 days of opioids in the prior 12 months. Patients who died during hospital admission, never received an opioid despite having an active order, were hospital-to-hospital transfers, or were still admitted at the time of data collection were excluded from the analysis.

All pertinent data were collected using the VA Computerized Patient Record System (CPRS) and the Critical Care Manager (Picis Clinical Solutions) ICU monitoring application. Critical Care Manager was used to track the time frame, duration, and amounts of opioid infusions administered in the ICU. Patient demographic and preadmission data, including date of birth, age, race, history of substance use/alcohol use disorder (defined as a previous diagnosis) and previous opioid prescriptions within the past year were recorded. For the inpatient admission, the ICU LOS, hospital LOS, primary admission diagnosis, type of opioid medication administered, and total duration and dose of opioid administered were collected. After discharge, opioid medication fill data at 3, 6, and 12 months were collected. This information included names of any outpatient opioids filled, dosage unit, quantity, day supply, and number of refills.

The primary outcome for this study was to determine the incidence of chronic opioid use at 3, 6, and 12 months after discharge, defined as the percentage of patients receiving outpatient opioid prescriptions at each time point. Analyses were conducted to observe the effect of age, race, history of substance use or history of alcohol use (International Classification of Diseases documented diagnosis, 9th edition), ICU type (medical, surgical, or cardiovascular), surgical/nonsurgical admission, ICU LOS, hospital LOS, total time, and amount of opioids administered during admission on risk of conversion to chronic opioid use.

Descriptive statistics were calculated to analyze the incidence of chronic opioid use. Univariate logistic regression analysis, including ORs, 95% CIs, and P values, was conducted to determine the effects of the risk factors noted earlier on chronic opioid use at each time point. A multivariate logistic regression model was performed to assess the effect of multiple independent variables on opioid use at 3, 6, and 12 months. Statistical analysis was performed using StataCorp Stata SE.

Results

During the study period, 330 patients were admitted to the ICU. After applying inclusion/exclusion criteria, 118 patients were included in the final analysis. The most frequent reasons for exclusion from the study were patient death (n = 77), a past history of opioid use (n = 56), and not having received an opioid infusion for at least 12 hours (n = 68). The average age of the patients included was 67 years (Table 1). A total of 14% and 9% of patients, respectively, had a diagnosis of alcohol use disorder or substance use disorder recorded in CPRS. After admission, the most common location for these patients was the surgical ICU (65%). All patients were male. The average hospital LOS was 18.6 days , and the ICU LOS was 8.3 days. The average duration of administration for the opioid (fentanyl) infusion was 63 hours, and the average amount of fentanyl administered to each patient was 57.1 mcg/h.

The incidence of opioid-naïve patients receiving opioids after discharge was 76.3% (n = 90) at 3 months, 19.5% (n = 23) at 6 months and 7.6% (n = 9) at 12 months (Figure). The daily morphine milligram equivalent (MME) of patients prescribed opioids at 3, 6, and 12 months was similar (3 months, 22.7; 6 months, 19.7; 12 months, 20.9). In the univariate regression analysis, several variables were found to be associated with converting to chronic opioid use. Prior history of alcohol use disorder (OR, 0.3; 95% CI, 0.10-0.88; P = .03), ICU type (OR, 3.9; 95% CI, 1.73-8.75; P = .001) and ICU LOS (OR, 0.88; 95% CI, 0.81-0.95; P = .01) had a statistically significant association on opioid use at 3 months. (Table 2). No variables evaluated had a statistically significant effect on chronic opioid use at 6 months, and only age (OR 0.93; 95% CI. 0.87-0.99; P = .02) was statistically significant at 12 months. In the multivariate logistic regression analysis, history of alcohol abuse, admission for surgery, and hospital LOS were significant at 3 months (Table 3).

Discussion

In this single-center analysis conducted at a VA academic hospital of opioid-naïve patients who were administered opioids in the ICU, the incidence of patients subsequently receiving outpatient opioid prescriptions at 12 months after discharge was 7.6%. There also was a decrease in the amount of opioids received by patients (daily MME) after discharge at 3, 6, and 12 months. This trend did not demonstrate the propensity for inpatient opioid use to convert opioid-naïve patients to chronic opioid users.

The most common outpatient opioids prescribed were hydrocodone/acetaminophen, morphine, and tramadol. Logistic regression showed few factors that correlated significantly with opioid use in the long-term (12 month) period. This finding is a deviation from the findings of Yaffe and colleagues who found hospital LOS to be one of the only predictors of long-term opioid use in their population (defined as use at 48 months).¹⁶ One important difference between our study and the Yaffe and colleagues study was that they evaluated all patients who were admitted to the ICU, regardless of the exposure to opioids during their inpatient stay. Consequently, this difference may have resulted in the differences in findings.

Strengths and Limitations

Location was a strength of our study, as this analysis was conducted at an integrated health care system that provides comprehensive inpatient and outpatient care. The VA uses a closed electronic health record, which allowed patients to be followed both in the inpatient and outpatient settings to determine which medications were prescribed at each time. In other health care systems this information would have been difficult to follow as patients often fill outpatient prescriptions at community pharmacies not affiliated with the treating hospital. However, any patient not using a VA prescriber for subsequent opioid prescriptions or patients who received opioids through other sources would not have had their continued opioid use captured. These data may be available in the states prescription monitoring program, but it was not available to query for research at this time.

This study also excluded chronic opioid users, which could have been another confounding factor to account for when analyzing the results. However, the primary objective of the study was to determine the impact of opioids prescribed in the ICU on converting previous opioid-naïve patients to chronic users. Finally, a multivariate logistic regression was incorporated to assess for factors that may predispose certain patients to convert to chronic opioid users. This analysis served to extend the applicability of our study by not only analyzing whether receiving opioids in the ICU contributed to chronic opioid use in the long-term, but also which populations may be at greatest risk. This information can be used in the future to target harm-reduction efforts toward high-risk hospitalized patients.

One limitation of this study was that it was conducted as a retrospective, single-center chart review in Houston, Texas. Because this was not a randomized controlled trial, it is difficult to imply any causation between exposure to opioids in the ICU and chronic use. In addition, because this study was conducted at a single site, the results may not be able to be generalized to other populations. VA populations tend to be elderly and predominantly male, as was reflected by the study population. These factors, along with regional variability in patient characteristics, may limit the generalizability of this study to older male patients located in Southeast Texas or other similar populations. Other limitations of this study also included the small sample size, limited period of follow-up obtained, and that other comorbidity information (pain scores during stay, use of nonopioid pain medications, past history of anxiety or depression, or other acute illnesses or surgeries that may have required opioid therapy during admission) was not collected.

This study was only able to review 118 patients for a follow-up duration of 1 year. In the Yaffe and colleagues study, more than 2,500 patients were followed over 4 years, which provided a more long-term overview of the clinical course of these patients and may be another reason for discrepant findings. However, this study did not actually assess the impact on administration of opioids on the development of chronic opioid use.¹⁶ Finally, the biggest limitation to this study may be the potential for confounding discharge prescriptions. After discharge, patients’ prescriptions were evaluated from discharge to 3 months, in between 3 and 6 months, and between 6 and 12 months for the presence of an opioid prescription. Due to this methodology, any opioid prescription a patient was discharged with was counted in the 3-month time point. Since many patients included in the study were admitted to the surgical ICU (65%), it was logical that they were discharged with opioids after their procedure. While including the immediate postdischarge prescription data was useful for evaluating the decrease in opioid use and incidence over time, it did cause the 3-month time point to appear overly inflated, potentially signaling that at 3 months after discharge many of these patients were still requiring opioid use.

The Society of Critical Care Medicine still recommends opioids as first-line therapy for non-neuropathic pain in the ICU setting.¹⁷ Additionally, postoperative pain can be difficult to manage in the surgical population and is often treated with opioids, though treatment with multimodal pain regimens is becoming more common.¹⁸ It is difficult to imagine that a finding that implicates opioid use in the hospital with conversion to chronic opioid use would prompt a cessation in the use of opioid in these settings, especially in the context of analgosedation related to mechanically ventilated patients. However, it would be plausible to use this knowledge to advocate for opioid-sparing therapies and consideration for weaning individuals at high risk for misuse after discharge from opioid-containing sedation or analgesia regimens in a timelier manner.

Though our findings did not show a clinically relevant increase in chronic opioid users, clinicians can still use this information to encourage targeted education and closer monitoring for those patients deemed as high risk at discharge to prevent unnecessary prolonged opioid use. By having more frequent follow-up in pain clinics, switching patients to nonopioid therapies after discharge, and ensuring high-risk patients are discharged with naloxone rescue kits, it would be possible to drastically reduce the number of potential overdoses for patients who previously required opioid therapy in the ICU.

Conclusion

After discharge, 7.6% of previously opioid-naïve patients who were treated with opioids in the ICU were still receiving prescriptions for opioids at 12 months. These findings did not suggest a clinically significant increase in the incidence of chronic opioid use after inpatient administration of opioids. However, these results prompt the need for larger, prospective, multicenter studies to evaluate the effect on hospitalization on converting to chronic opioid use and a deeper evaluation of other potential risk factors that may be present.

Specialization, as detailed in Adam Smith’s 1776 landmark treatise, Wealth of Nations,¹ has been an enduring trend in labor and economics for centuries. Mirroring evolution in other sectors of the economy, the healthcare workforce has become ever more specialized.² General practitioners and family doctors have ceded ground to a bevy of specialists and subspecialists ranging from pediatric endocrinologists to otolaryngology-neurotologists. Given the growth in medical knowledge over the past century, this specialization seems both necessary and good. This same specialization that serves us in good times, though, leaves us woefully underprepared for an epidemic that will require large numbers of hospitalists/generalists and intensivists, such as the current coronavirus disease 2019 (COVID-19) pandemic.

A bit on terminology before we proceed. For purposes of this paper we define generalists as physicians trained in Internal Medicine, Family Medicine, Pediatrics, or Med/Peds who provide primary hospital care to adults and children. While some may argue that hospitalists are specialists in inpatient care, we would like to focus on hospitalists as generalists who focus on inpatient care and what we have in common with the broader community of generalists. We include as generalists anyone, irrespective of clinical training, who chooses broad primary patient responsibility over the narrower consultative role. There is always a specialist in our midst who knows more about a particular disease or condition; as generalists, most of us appreciate and welcome that expertise.

Sometimes it takes a pandemic like COVID-19 to highlight a tremendous blind spot in our healthcare system that, in retrospect, seems hard to have missed. What do we do when we need more generalists and have only a surplus of specialists, many of whom were involuntarily “furloughed” by canceled elective procedures and postponed clinics? How do we “un-specialize” our specialist workforce?

We will discuss some of the most pressing problems facing hospitals working to ensure adequate staffing for general inpatient units caused by the simultaneous reductions in physician availability (because of illness and/or quarantine) and markedly increased admissions of undifferentiated COVID-19–related illnesses. We will assume that hospitals have already activated all providers practicing in areas most similar to hospital medicine, including generalists who have mixed inpatient/outpatient practices, subspecialists with significant inpatient clinical roles, fellows, and advanced practice providers (APPs) with inpatient experience. The Accreditation Council for Graduate Medical Education released guidance around the roles of physician trainees during the pandemic.³ Despite these measures, though, further workforce augmentation will be vital. To that end, several challenges to clinical staffing are enumerated below, accompanied by strategies to address them.

1. Clinicians eager to help, but out of practice in the inpatient setting: As hospitals across the country work to develop physician staffing contingency plans for scenarios in which general inpatient volumes increase by 50%-300% while 33%-50% of hospitalists either become infected or require quarantine, many hospitals are looking to bolster their physician depth. We have been extremely gratified by the tremendous response from the broader physician communities in which we work. We have encountered retired physicians who have volunteered to come back to work despite being at higher risk of severe COVID-19 complications and physician-­scientists offering to step back into clinical roles. We have found outstanding subspecialists asking to work under the tutelage of experienced hospitalists; these specialists recognize how, despite years of clinical experience, they would need significant supervision to function in the inpatient setting. The humility and self-awareness of these volunteers has been phenomenal.

Retraining researchers, subspecialists, and retirees as hospitalists requires purposeful onboarding to target key educational goals. This onboarding should stress COVID-19–specific medical management, training in infection prevention and control, and hospital-specific workflow processes (eg, shift length, sign-over). Onboarding must also include access and orientation to electronic health records, training around inpatient documentation requirements, and billing practices. Non–COVID-19 healthcare will continue; hospitals and clinical leaders will need to determine whether certain specialists should focus on COVID-19 care alone and leave others to continue with speciality practice still needed. Ready access to hospital medicine and medical subspecialty consultation will be pivotal in supervising providers asked to step into hospitalist roles.

The onboarding process we describe might best be viewed through the lens of focused professional practice evaluation (FPPE). Required by the Joint Commission, FPPE is a process for the medical staff of a facility to evaluate privilege-specific competence by clinicians and is used for any new clinical privileges and when there may be question as to a current practitioner’s capabilities. The usual FPPE process includes reassessment of provider practice, typically at 3 to 6 months. Doing so may be challenging given overall workforce stress and the timing of clinical demand—eg, time for medical record review will be limited. Consideration of a “preceptorship” with an experienced hospitalist providing verbal oversight for providers with emergency privileges may be very appropriate. Indeed the Joint Commission recently published guidance around FPPE during the COVID-19 epidemic with the suggestion that mentorship and direct observation are reasonable ways to ensure quality.⁴

Concerns around scope of practice and medicolegal liability must be rapidly addressed by professional practice organizations, state medical boards, and medical malpractice insurers to protect frontline providers, nurses, and pharmacists. In particular, Joint Commission FPPE process requirements may need to be relaxed to respond to a surge in clinical demand. Contingency and crisis standards of care permit doing so. We welcome the introduction of processes to expedite provider licensure in many hard-hit states.

2. Clinicians who should not help because of medical comorbidities or age: Individuals with certain significant comorbidities (eg, inflammatory conditions treated with immunosuppressants, pulmonary disease, cancer with active treatment) or meeting certain age criteria should be discouraged from clinical work because the dangers of illness for them and of transmission of illness are high. Judgment and a version of mutual informed consent will be needed to address fewer clear scenarios, such as whether a 35-year-old physician who requires a steroid inhaler for asthma or a 64-year-old physician who is otherwise healthy have higher risk. It is our opinion that all physicians should contribute to the care of patients with documented or suspected COVID-19 unless they meet institutionally defined exclusion criteria. We should recognize that physicians who are unable to provide direct care to patients with COVID-19 infection may have significant remorse and feelings that they are letting down their colleagues and the oath they have taken. As the COVID -19 pandemic continues, we are quickly learning that physicians who have contraindications to providing care to patients with active COVID-19 infection can still contribute in numerous mission-critical ways. This may include virtual (telehealth) visits, preceptorship via telehealth of providers completing FPPE in hospital medicine practice, postdischarge follow-up of patients who are no longer infectious, and other care-­coordination activities, such as triaging direct admission calls.

3. Clinicians who should be able to help but are fearful: All efforts must be undertaken to protect healthcare workers from acquiring COVID-19. Nevertheless, there are models predicting that ultimately the vast majority of the world’s population will be exposed, including healthcare workers.^5,6 In our personal experience as hospitalists and leaders, the vast majority (95%-plus) of our hospitalists have not only continued to do their job but taken on additional responsibilities and clinical work despite the risk. We are hesitant to co-opt words like courage and bravery that we typically would reserve for people in far more hazardous lines of work than physicians, but in the current setting perhaps courage is the correct term. In quiet conversation, many are vaguely unnerved and some significantly so, but they set their angst aside and get to work. The same can be said for the numerous subspecialists, surgeons, nurses, and others who have volunteered to help.

Alternatively, as leaders, we must manage an extremely small minority of faculty who request to not care for patients with COVID-19 despite no clear contraindication. These situations are nuanced and fraught with difficulty for leaders. As physicians we have moral and ethical obligations to society.⁷ We also have contractual obligations to our employers. Finally, we have a professional duty to our colleagues. When such cases arise, as leaders we should try to understand the perspective of the physician making the request. It is also important to remember that as leaders we are obliged to be fair and equitable to all faculty; granting exceptions to some who ask to avoid COVID-19-related work, but not to others, is difficult to justify. Moreover, granting exceptions can undermine faith in leadership and inevitably sow discord. We suggest setting clear mutual expectations of engagement and not granting unwarranted exceptions.

In this time of a global pandemic, we face a looming shortage of hospital generalists, which calls for immediate and purposeful workforce expansion facilitated by learning to “un-specialize” certain providers. We propose utilizing the framework of FPPE to educate and support those joining hospital medicine teams. Hospitalists are innovators and health systems science leaders. Let’s draw on that strength now to rise to the challenge of COVID-19.

Specialization, as detailed in Adam Smith’s 1776 landmark treatise, Wealth of Nations,¹ has been an enduring trend in labor and economics for centuries. Mirroring evolution in other sectors of the economy, the healthcare workforce has become ever more specialized.² General practitioners and family doctors have ceded ground to a bevy of specialists and subspecialists ranging from pediatric endocrinologists to otolaryngology-neurotologists. Given the growth in medical knowledge over the past century, this specialization seems both necessary and good. This same specialization that serves us in good times, though, leaves us woefully underprepared for an epidemic that will require large numbers of hospitalists/generalists and intensivists, such as the current coronavirus disease 2019 (COVID-19) pandemic.

A bit on terminology before we proceed. For purposes of this paper we define generalists as physicians trained in Internal Medicine, Family Medicine, Pediatrics, or Med/Peds who provide primary hospital care to adults and children. While some may argue that hospitalists are specialists in inpatient care, we would like to focus on hospitalists as generalists who focus on inpatient care and what we have in common with the broader community of generalists. We include as generalists anyone, irrespective of clinical training, who chooses broad primary patient responsibility over the narrower consultative role. There is always a specialist in our midst who knows more about a particular disease or condition; as generalists, most of us appreciate and welcome that expertise.

Sometimes it takes a pandemic like COVID-19 to highlight a tremendous blind spot in our healthcare system that, in retrospect, seems hard to have missed. What do we do when we need more generalists and have only a surplus of specialists, many of whom were involuntarily “furloughed” by canceled elective procedures and postponed clinics? How do we “un-specialize” our specialist workforce?

We will discuss some of the most pressing problems facing hospitals working to ensure adequate staffing for general inpatient units caused by the simultaneous reductions in physician availability (because of illness and/or quarantine) and markedly increased admissions of undifferentiated COVID-19–related illnesses. We will assume that hospitals have already activated all providers practicing in areas most similar to hospital medicine, including generalists who have mixed inpatient/outpatient practices, subspecialists with significant inpatient clinical roles, fellows, and advanced practice providers (APPs) with inpatient experience. The Accreditation Council for Graduate Medical Education released guidance around the roles of physician trainees during the pandemic.³ Despite these measures, though, further workforce augmentation will be vital. To that end, several challenges to clinical staffing are enumerated below, accompanied by strategies to address them.

1. Clinicians eager to help, but out of practice in the inpatient setting: As hospitals across the country work to develop physician staffing contingency plans for scenarios in which general inpatient volumes increase by 50%-300% while 33%-50% of hospitalists either become infected or require quarantine, many hospitals are looking to bolster their physician depth. We have been extremely gratified by the tremendous response from the broader physician communities in which we work. We have encountered retired physicians who have volunteered to come back to work despite being at higher risk of severe COVID-19 complications and physician-­scientists offering to step back into clinical roles. We have found outstanding subspecialists asking to work under the tutelage of experienced hospitalists; these specialists recognize how, despite years of clinical experience, they would need significant supervision to function in the inpatient setting. The humility and self-awareness of these volunteers has been phenomenal.

Retraining researchers, subspecialists, and retirees as hospitalists requires purposeful onboarding to target key educational goals. This onboarding should stress COVID-19–specific medical management, training in infection prevention and control, and hospital-specific workflow processes (eg, shift length, sign-over). Onboarding must also include access and orientation to electronic health records, training around inpatient documentation requirements, and billing practices. Non–COVID-19 healthcare will continue; hospitals and clinical leaders will need to determine whether certain specialists should focus on COVID-19 care alone and leave others to continue with speciality practice still needed. Ready access to hospital medicine and medical subspecialty consultation will be pivotal in supervising providers asked to step into hospitalist roles.

The onboarding process we describe might best be viewed through the lens of focused professional practice evaluation (FPPE). Required by the Joint Commission, FPPE is a process for the medical staff of a facility to evaluate privilege-specific competence by clinicians and is used for any new clinical privileges and when there may be question as to a current practitioner’s capabilities. The usual FPPE process includes reassessment of provider practice, typically at 3 to 6 months. Doing so may be challenging given overall workforce stress and the timing of clinical demand—eg, time for medical record review will be limited. Consideration of a “preceptorship” with an experienced hospitalist providing verbal oversight for providers with emergency privileges may be very appropriate. Indeed the Joint Commission recently published guidance around FPPE during the COVID-19 epidemic with the suggestion that mentorship and direct observation are reasonable ways to ensure quality.⁴

Concerns around scope of practice and medicolegal liability must be rapidly addressed by professional practice organizations, state medical boards, and medical malpractice insurers to protect frontline providers, nurses, and pharmacists. In particular, Joint Commission FPPE process requirements may need to be relaxed to respond to a surge in clinical demand. Contingency and crisis standards of care permit doing so. We welcome the introduction of processes to expedite provider licensure in many hard-hit states.

2. Clinicians who should not help because of medical comorbidities or age: Individuals with certain significant comorbidities (eg, inflammatory conditions treated with immunosuppressants, pulmonary disease, cancer with active treatment) or meeting certain age criteria should be discouraged from clinical work because the dangers of illness for them and of transmission of illness are high. Judgment and a version of mutual informed consent will be needed to address fewer clear scenarios, such as whether a 35-year-old physician who requires a steroid inhaler for asthma or a 64-year-old physician who is otherwise healthy have higher risk. It is our opinion that all physicians should contribute to the care of patients with documented or suspected COVID-19 unless they meet institutionally defined exclusion criteria. We should recognize that physicians who are unable to provide direct care to patients with COVID-19 infection may have significant remorse and feelings that they are letting down their colleagues and the oath they have taken. As the COVID -19 pandemic continues, we are quickly learning that physicians who have contraindications to providing care to patients with active COVID-19 infection can still contribute in numerous mission-critical ways. This may include virtual (telehealth) visits, preceptorship via telehealth of providers completing FPPE in hospital medicine practice, postdischarge follow-up of patients who are no longer infectious, and other care-­coordination activities, such as triaging direct admission calls.

3. Clinicians who should be able to help but are fearful: All efforts must be undertaken to protect healthcare workers from acquiring COVID-19. Nevertheless, there are models predicting that ultimately the vast majority of the world’s population will be exposed, including healthcare workers.^5,6 In our personal experience as hospitalists and leaders, the vast majority (95%-plus) of our hospitalists have not only continued to do their job but taken on additional responsibilities and clinical work despite the risk. We are hesitant to co-opt words like courage and bravery that we typically would reserve for people in far more hazardous lines of work than physicians, but in the current setting perhaps courage is the correct term. In quiet conversation, many are vaguely unnerved and some significantly so, but they set their angst aside and get to work. The same can be said for the numerous subspecialists, surgeons, nurses, and others who have volunteered to help.

Alternatively, as leaders, we must manage an extremely small minority of faculty who request to not care for patients with COVID-19 despite no clear contraindication. These situations are nuanced and fraught with difficulty for leaders. As physicians we have moral and ethical obligations to society.⁷ We also have contractual obligations to our employers. Finally, we have a professional duty to our colleagues. When such cases arise, as leaders we should try to understand the perspective of the physician making the request. It is also important to remember that as leaders we are obliged to be fair and equitable to all faculty; granting exceptions to some who ask to avoid COVID-19-related work, but not to others, is difficult to justify. Moreover, granting exceptions can undermine faith in leadership and inevitably sow discord. We suggest setting clear mutual expectations of engagement and not granting unwarranted exceptions.

In this time of a global pandemic, we face a looming shortage of hospital generalists, which calls for immediate and purposeful workforce expansion facilitated by learning to “un-specialize” certain providers. We propose utilizing the framework of FPPE to educate and support those joining hospital medicine teams. Hospitalists are innovators and health systems science leaders. Let’s draw on that strength now to rise to the challenge of COVID-19.

Specialization, as detailed in Adam Smith’s 1776 landmark treatise, Wealth of Nations,¹ has been an enduring trend in labor and economics for centuries. Mirroring evolution in other sectors of the economy, the healthcare workforce has become ever more specialized.² General practitioners and family doctors have ceded ground to a bevy of specialists and subspecialists ranging from pediatric endocrinologists to otolaryngology-neurotologists. Given the growth in medical knowledge over the past century, this specialization seems both necessary and good. This same specialization that serves us in good times, though, leaves us woefully underprepared for an epidemic that will require large numbers of hospitalists/generalists and intensivists, such as the current coronavirus disease 2019 (COVID-19) pandemic.

A bit on terminology before we proceed. For purposes of this paper we define generalists as physicians trained in Internal Medicine, Family Medicine, Pediatrics, or Med/Peds who provide primary hospital care to adults and children. While some may argue that hospitalists are specialists in inpatient care, we would like to focus on hospitalists as generalists who focus on inpatient care and what we have in common with the broader community of generalists. We include as generalists anyone, irrespective of clinical training, who chooses broad primary patient responsibility over the narrower consultative role. There is always a specialist in our midst who knows more about a particular disease or condition; as generalists, most of us appreciate and welcome that expertise.

Sometimes it takes a pandemic like COVID-19 to highlight a tremendous blind spot in our healthcare system that, in retrospect, seems hard to have missed. What do we do when we need more generalists and have only a surplus of specialists, many of whom were involuntarily “furloughed” by canceled elective procedures and postponed clinics? How do we “un-specialize” our specialist workforce?

We will discuss some of the most pressing problems facing hospitals working to ensure adequate staffing for general inpatient units caused by the simultaneous reductions in physician availability (because of illness and/or quarantine) and markedly increased admissions of undifferentiated COVID-19–related illnesses. We will assume that hospitals have already activated all providers practicing in areas most similar to hospital medicine, including generalists who have mixed inpatient/outpatient practices, subspecialists with significant inpatient clinical roles, fellows, and advanced practice providers (APPs) with inpatient experience. The Accreditation Council for Graduate Medical Education released guidance around the roles of physician trainees during the pandemic.³ Despite these measures, though, further workforce augmentation will be vital. To that end, several challenges to clinical staffing are enumerated below, accompanied by strategies to address them.

1. Clinicians eager to help, but out of practice in the inpatient setting: As hospitals across the country work to develop physician staffing contingency plans for scenarios in which general inpatient volumes increase by 50%-300% while 33%-50% of hospitalists either become infected or require quarantine, many hospitals are looking to bolster their physician depth. We have been extremely gratified by the tremendous response from the broader physician communities in which we work. We have encountered retired physicians who have volunteered to come back to work despite being at higher risk of severe COVID-19 complications and physician-­scientists offering to step back into clinical roles. We have found outstanding subspecialists asking to work under the tutelage of experienced hospitalists; these specialists recognize how, despite years of clinical experience, they would need significant supervision to function in the inpatient setting. The humility and self-awareness of these volunteers has been phenomenal.

Retraining researchers, subspecialists, and retirees as hospitalists requires purposeful onboarding to target key educational goals. This onboarding should stress COVID-19–specific medical management, training in infection prevention and control, and hospital-specific workflow processes (eg, shift length, sign-over). Onboarding must also include access and orientation to electronic health records, training around inpatient documentation requirements, and billing practices. Non–COVID-19 healthcare will continue; hospitals and clinical leaders will need to determine whether certain specialists should focus on COVID-19 care alone and leave others to continue with speciality practice still needed. Ready access to hospital medicine and medical subspecialty consultation will be pivotal in supervising providers asked to step into hospitalist roles.

The onboarding process we describe might best be viewed through the lens of focused professional practice evaluation (FPPE). Required by the Joint Commission, FPPE is a process for the medical staff of a facility to evaluate privilege-specific competence by clinicians and is used for any new clinical privileges and when there may be question as to a current practitioner’s capabilities. The usual FPPE process includes reassessment of provider practice, typically at 3 to 6 months. Doing so may be challenging given overall workforce stress and the timing of clinical demand—eg, time for medical record review will be limited. Consideration of a “preceptorship” with an experienced hospitalist providing verbal oversight for providers with emergency privileges may be very appropriate. Indeed the Joint Commission recently published guidance around FPPE during the COVID-19 epidemic with the suggestion that mentorship and direct observation are reasonable ways to ensure quality.⁴

Concerns around scope of practice and medicolegal liability must be rapidly addressed by professional practice organizations, state medical boards, and medical malpractice insurers to protect frontline providers, nurses, and pharmacists. In particular, Joint Commission FPPE process requirements may need to be relaxed to respond to a surge in clinical demand. Contingency and crisis standards of care permit doing so. We welcome the introduction of processes to expedite provider licensure in many hard-hit states.

2. Clinicians who should not help because of medical comorbidities or age: Individuals with certain significant comorbidities (eg, inflammatory conditions treated with immunosuppressants, pulmonary disease, cancer with active treatment) or meeting certain age criteria should be discouraged from clinical work because the dangers of illness for them and of transmission of illness are high. Judgment and a version of mutual informed consent will be needed to address fewer clear scenarios, such as whether a 35-year-old physician who requires a steroid inhaler for asthma or a 64-year-old physician who is otherwise healthy have higher risk. It is our opinion that all physicians should contribute to the care of patients with documented or suspected COVID-19 unless they meet institutionally defined exclusion criteria. We should recognize that physicians who are unable to provide direct care to patients with COVID-19 infection may have significant remorse and feelings that they are letting down their colleagues and the oath they have taken. As the COVID -19 pandemic continues, we are quickly learning that physicians who have contraindications to providing care to patients with active COVID-19 infection can still contribute in numerous mission-critical ways. This may include virtual (telehealth) visits, preceptorship via telehealth of providers completing FPPE in hospital medicine practice, postdischarge follow-up of patients who are no longer infectious, and other care-­coordination activities, such as triaging direct admission calls.

3. Clinicians who should be able to help but are fearful: All efforts must be undertaken to protect healthcare workers from acquiring COVID-19. Nevertheless, there are models predicting that ultimately the vast majority of the world’s population will be exposed, including healthcare workers.^5,6 In our personal experience as hospitalists and leaders, the vast majority (95%-plus) of our hospitalists have not only continued to do their job but taken on additional responsibilities and clinical work despite the risk. We are hesitant to co-opt words like courage and bravery that we typically would reserve for people in far more hazardous lines of work than physicians, but in the current setting perhaps courage is the correct term. In quiet conversation, many are vaguely unnerved and some significantly so, but they set their angst aside and get to work. The same can be said for the numerous subspecialists, surgeons, nurses, and others who have volunteered to help.

Alternatively, as leaders, we must manage an extremely small minority of faculty who request to not care for patients with COVID-19 despite no clear contraindication. These situations are nuanced and fraught with difficulty for leaders. As physicians we have moral and ethical obligations to society.⁷ We also have contractual obligations to our employers. Finally, we have a professional duty to our colleagues. When such cases arise, as leaders we should try to understand the perspective of the physician making the request. It is also important to remember that as leaders we are obliged to be fair and equitable to all faculty; granting exceptions to some who ask to avoid COVID-19-related work, but not to others, is difficult to justify. Moreover, granting exceptions can undermine faith in leadership and inevitably sow discord. We suggest setting clear mutual expectations of engagement and not granting unwarranted exceptions.

In this time of a global pandemic, we face a looming shortage of hospital generalists, which calls for immediate and purposeful workforce expansion facilitated by learning to “un-specialize” certain providers. We propose utilizing the framework of FPPE to educate and support those joining hospital medicine teams. Hospitalists are innovators and health systems science leaders. Let’s draw on that strength now to rise to the challenge of COVID-19.

Almost half of obese endometrial cancer survivors in a recent study gained weight during 12 months of follow-up, whether or not they participated in a behavioral weight loss intervention.

Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m² who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).

The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”

Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.

The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Retrospective results

At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).

“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.

At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:

• 49.2% and 47%, respectively, gained weight.
• 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
• 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
• 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
• 23.1% and 17.9%, respectively, lost 5% or more of weight.

Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m² vs. 41.7 kg/m²), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
 

How can oncologists help patients lose weight?

“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.

However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.

“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”

It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.

“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”

One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.

This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.

“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.

Dr. Zamorano reported having no disclosures. The research was funded by Washington University.

sworcester@mdedge.com

SOURCE: Zamorano A et al. SGO 2020, Abstract 20.

Almost half of obese endometrial cancer survivors in a recent study gained weight during 12 months of follow-up, whether or not they participated in a behavioral weight loss intervention.

Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m² who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).

The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”

Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.

The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Retrospective results

At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).

“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.

At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:

• 49.2% and 47%, respectively, gained weight.
• 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
• 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
• 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
• 23.1% and 17.9%, respectively, lost 5% or more of weight.

Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m² vs. 41.7 kg/m²), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
 

How can oncologists help patients lose weight?

“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.

However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.

“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”

It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.

“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”

One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.

This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.

“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.

Dr. Zamorano reported having no disclosures. The research was funded by Washington University.

sworcester@mdedge.com

SOURCE: Zamorano A et al. SGO 2020, Abstract 20.

Almost half of obese endometrial cancer survivors in a recent study gained weight during 12 months of follow-up, whether or not they participated in a behavioral weight loss intervention.

Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m² who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).

The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”

Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.

The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Retrospective results

At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).

“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.

At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:

• 49.2% and 47%, respectively, gained weight.
• 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
• 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
• 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
• 23.1% and 17.9%, respectively, lost 5% or more of weight.

Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m² vs. 41.7 kg/m²), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
 

How can oncologists help patients lose weight?

“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.

However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.

“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”

It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.

“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”

One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.

This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.

“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.

Dr. Zamorano reported having no disclosures. The research was funded by Washington University.

sworcester@mdedge.com

SOURCE: Zamorano A et al. SGO 2020, Abstract 20.

For patients with inflammatory bowel disease or other immune-mediated inflammatory diseases, Janus kinase (JAK) inhibitors appear generally safe, though they may increase the risk of herpes zoster infection, according to a large-scale systematic review and meta-analysis.

Data from more than 66,000 patients revealed no significant links between JAK inhibitors and risks of serious infections, malignancy, or major adverse cardiovascular events, reported lead author Pablo Olivera, MD, of Centro de Educación Médica e Investigación Clínica (CEMIC) in Buenos Aires and colleagues.

“To the best of our knowledge, this is the first systematic review evaluating the risk profile of JAK inhibitors in a wide spectrum of immune-mediated inflammatory diseases,” they wrote in Gastroenterology.

The investigators drew studies from the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from 1990 to 2019 and from conference databases from 2012 to 2018. Out of 973 studies identified, 82 were included in the final analysis, of which two-thirds were randomized clinical trials. In total, 101,925 subjects were included, of whom a majority had rheumatoid arthritis (n = 86,308), followed by psoriasis (n = 9,311), inflammatory bowel disease (n = 5,987), and ankylosing spondylitis (n = 319).

Meta-analysis of JAK inhibitor usage involved 66,159 patients. Four JAK inhibitors were included: tofacitinib, filgotinib, baricitinib, and upadacitinib. The primary outcomes were the incidence rates of adverse events and serious adverse events. The investigators also estimated incidence rates of herpes zoster infection, serious infections, mortality, malignancy, and major adverse cardiovascular events. These rates were compared with those of patients who received placebo or an active comparator in clinical trials.

Analysis showed that almost 9 out of 10 patients (87.16%) who were exposed to a JAK inhibitor received tofacitinib. The investigators described high variability in treatment duration and baseline characteristics of participants. Rates of adverse events and serious adverse events also fell across a broad spectrum, from 10% to 82% and from 0% to 29%, respectively.

“Most [adverse events] were mild, and included worsening of the underlying condition, probably showing lack of efficacy,” the investigators wrote.

Rates of mortality and most adverse events were not significantly associated with JAK inhibitor exposure. In contrast, relative risk of herpes zoster infection was 57% higher in patients who received a JAK inhibitor than in those who received a placebo or comparator (RR, 1.57; 95% confidence interval, 1.01-2.37).

“Regarding the risk of herpes zoster with JAK inhibitors, the largest evidence comes from the use of tofacitinib, but it appears to be a class effect, with a clear dose-dependent effect,” the investigators wrote.

Although risks of herpes zoster may be carried across the drug class, they may not be evenly distributed given that a subgroup analysis revealed that some JAK inhibitors may bring higher risks than others; specifically, tofacitinib and baricitinib were associated with higher relative risks of herpes zoster than were upadacitinib and filgotinib.

“Although this is merely a qualitative comparison, this difference could be related to the fact that both filgotinib and upadacitinib are selective JAK1 inhibitors, whereas tofacitinib is a JAK1/JAK3 inhibitor and baricitinib a JAK1/JAK2 inhibitor,” the investigators wrote. “Further studies are needed to determine if JAK isoform selectivity affects the risk of herpes zoster.”

The investigators emphasized this need for more research. While the present findings help illuminate the safety profile of JAK inhibitors, they are clouded by various other factors, such as disease-specific considerations, a lack of real-world data, and studies that are likely too short to accurately determine risk of malignancy, the investigators wrote.

“More studies with long follow-up and in the real world setting, in different conditions, will be needed to fully elucidate the safety profile of the different JAK inhibitors,” the investigators concluded.

The investigators disclosed relationships with AbbVie, Takeda, Pfizer, and others.

SOURCE: Olivera P et al. Gastroenterology. 2020 Jan 8. doi: 10.1053/j.gastro.2020.01.001.

For patients with inflammatory bowel disease or other immune-mediated inflammatory diseases, Janus kinase (JAK) inhibitors appear generally safe, though they may increase the risk of herpes zoster infection, according to a large-scale systematic review and meta-analysis.

Data from more than 66,000 patients revealed no significant links between JAK inhibitors and risks of serious infections, malignancy, or major adverse cardiovascular events, reported lead author Pablo Olivera, MD, of Centro de Educación Médica e Investigación Clínica (CEMIC) in Buenos Aires and colleagues.

“To the best of our knowledge, this is the first systematic review evaluating the risk profile of JAK inhibitors in a wide spectrum of immune-mediated inflammatory diseases,” they wrote in Gastroenterology.

The investigators drew studies from the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from 1990 to 2019 and from conference databases from 2012 to 2018. Out of 973 studies identified, 82 were included in the final analysis, of which two-thirds were randomized clinical trials. In total, 101,925 subjects were included, of whom a majority had rheumatoid arthritis (n = 86,308), followed by psoriasis (n = 9,311), inflammatory bowel disease (n = 5,987), and ankylosing spondylitis (n = 319).

Meta-analysis of JAK inhibitor usage involved 66,159 patients. Four JAK inhibitors were included: tofacitinib, filgotinib, baricitinib, and upadacitinib. The primary outcomes were the incidence rates of adverse events and serious adverse events. The investigators also estimated incidence rates of herpes zoster infection, serious infections, mortality, malignancy, and major adverse cardiovascular events. These rates were compared with those of patients who received placebo or an active comparator in clinical trials.

Analysis showed that almost 9 out of 10 patients (87.16%) who were exposed to a JAK inhibitor received tofacitinib. The investigators described high variability in treatment duration and baseline characteristics of participants. Rates of adverse events and serious adverse events also fell across a broad spectrum, from 10% to 82% and from 0% to 29%, respectively.

“Most [adverse events] were mild, and included worsening of the underlying condition, probably showing lack of efficacy,” the investigators wrote.

Rates of mortality and most adverse events were not significantly associated with JAK inhibitor exposure. In contrast, relative risk of herpes zoster infection was 57% higher in patients who received a JAK inhibitor than in those who received a placebo or comparator (RR, 1.57; 95% confidence interval, 1.01-2.37).

“Regarding the risk of herpes zoster with JAK inhibitors, the largest evidence comes from the use of tofacitinib, but it appears to be a class effect, with a clear dose-dependent effect,” the investigators wrote.

Although risks of herpes zoster may be carried across the drug class, they may not be evenly distributed given that a subgroup analysis revealed that some JAK inhibitors may bring higher risks than others; specifically, tofacitinib and baricitinib were associated with higher relative risks of herpes zoster than were upadacitinib and filgotinib.

“Although this is merely a qualitative comparison, this difference could be related to the fact that both filgotinib and upadacitinib are selective JAK1 inhibitors, whereas tofacitinib is a JAK1/JAK3 inhibitor and baricitinib a JAK1/JAK2 inhibitor,” the investigators wrote. “Further studies are needed to determine if JAK isoform selectivity affects the risk of herpes zoster.”

The investigators emphasized this need for more research. While the present findings help illuminate the safety profile of JAK inhibitors, they are clouded by various other factors, such as disease-specific considerations, a lack of real-world data, and studies that are likely too short to accurately determine risk of malignancy, the investigators wrote.

“More studies with long follow-up and in the real world setting, in different conditions, will be needed to fully elucidate the safety profile of the different JAK inhibitors,” the investigators concluded.

The investigators disclosed relationships with AbbVie, Takeda, Pfizer, and others.

SOURCE: Olivera P et al. Gastroenterology. 2020 Jan 8. doi: 10.1053/j.gastro.2020.01.001.

For patients with inflammatory bowel disease or other immune-mediated inflammatory diseases, Janus kinase (JAK) inhibitors appear generally safe, though they may increase the risk of herpes zoster infection, according to a large-scale systematic review and meta-analysis.

Data from more than 66,000 patients revealed no significant links between JAK inhibitors and risks of serious infections, malignancy, or major adverse cardiovascular events, reported lead author Pablo Olivera, MD, of Centro de Educación Médica e Investigación Clínica (CEMIC) in Buenos Aires and colleagues.

“To the best of our knowledge, this is the first systematic review evaluating the risk profile of JAK inhibitors in a wide spectrum of immune-mediated inflammatory diseases,” they wrote in Gastroenterology.

The investigators drew studies from the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from 1990 to 2019 and from conference databases from 2012 to 2018. Out of 973 studies identified, 82 were included in the final analysis, of which two-thirds were randomized clinical trials. In total, 101,925 subjects were included, of whom a majority had rheumatoid arthritis (n = 86,308), followed by psoriasis (n = 9,311), inflammatory bowel disease (n = 5,987), and ankylosing spondylitis (n = 319).

Meta-analysis of JAK inhibitor usage involved 66,159 patients. Four JAK inhibitors were included: tofacitinib, filgotinib, baricitinib, and upadacitinib. The primary outcomes were the incidence rates of adverse events and serious adverse events. The investigators also estimated incidence rates of herpes zoster infection, serious infections, mortality, malignancy, and major adverse cardiovascular events. These rates were compared with those of patients who received placebo or an active comparator in clinical trials.

Analysis showed that almost 9 out of 10 patients (87.16%) who were exposed to a JAK inhibitor received tofacitinib. The investigators described high variability in treatment duration and baseline characteristics of participants. Rates of adverse events and serious adverse events also fell across a broad spectrum, from 10% to 82% and from 0% to 29%, respectively.

“Most [adverse events] were mild, and included worsening of the underlying condition, probably showing lack of efficacy,” the investigators wrote.

Rates of mortality and most adverse events were not significantly associated with JAK inhibitor exposure. In contrast, relative risk of herpes zoster infection was 57% higher in patients who received a JAK inhibitor than in those who received a placebo or comparator (RR, 1.57; 95% confidence interval, 1.01-2.37).

“Regarding the risk of herpes zoster with JAK inhibitors, the largest evidence comes from the use of tofacitinib, but it appears to be a class effect, with a clear dose-dependent effect,” the investigators wrote.

Although risks of herpes zoster may be carried across the drug class, they may not be evenly distributed given that a subgroup analysis revealed that some JAK inhibitors may bring higher risks than others; specifically, tofacitinib and baricitinib were associated with higher relative risks of herpes zoster than were upadacitinib and filgotinib.

“Although this is merely a qualitative comparison, this difference could be related to the fact that both filgotinib and upadacitinib are selective JAK1 inhibitors, whereas tofacitinib is a JAK1/JAK3 inhibitor and baricitinib a JAK1/JAK2 inhibitor,” the investigators wrote. “Further studies are needed to determine if JAK isoform selectivity affects the risk of herpes zoster.”

The investigators emphasized this need for more research. While the present findings help illuminate the safety profile of JAK inhibitors, they are clouded by various other factors, such as disease-specific considerations, a lack of real-world data, and studies that are likely too short to accurately determine risk of malignancy, the investigators wrote.

“More studies with long follow-up and in the real world setting, in different conditions, will be needed to fully elucidate the safety profile of the different JAK inhibitors,” the investigators concluded.

The investigators disclosed relationships with AbbVie, Takeda, Pfizer, and others.

SOURCE: Olivera P et al. Gastroenterology. 2020 Jan 8. doi: 10.1053/j.gastro.2020.01.001.

The Food and Drug Administration has approved nearly two dozen tests for the novel coronavirus through its Emergency Use Authorization (EUA) policy, according to the Infectious Diseases Society of America (IDSA).

“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.

The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
 

Tests are being approved through an abbreviated process

Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.

The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.

Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.

The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
 

The time to obtain results varies

The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.

One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”

How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.

Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.

egreb@mdedge.com

The Food and Drug Administration has approved nearly two dozen tests for the novel coronavirus through its Emergency Use Authorization (EUA) policy, according to the Infectious Diseases Society of America (IDSA).

“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.

The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
 

Tests are being approved through an abbreviated process

Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.

The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.

Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.

The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
 

The time to obtain results varies

The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.

One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”

How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.

Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.

egreb@mdedge.com

The Food and Drug Administration has approved nearly two dozen tests for the novel coronavirus through its Emergency Use Authorization (EUA) policy, according to the Infectious Diseases Society of America (IDSA).

“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.

The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
 

Tests are being approved through an abbreviated process

Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.

The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.

Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.

The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
 

The time to obtain results varies

The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.

One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”

How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.

Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.

egreb@mdedge.com

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.