I’m Dr. Kenny Lin. I am a family physician and associate director of the Lancaster General Hospital Family Medicine Residency, and I blog at Common Sense Family Doctor.

I’m 47 years old. Two years ago, when the U.S. Preventive Services Task Force (USPSTF) followed the American Cancer Society and lowered the starting age for colorectal cancer (CRC) screening from 50 to 45, my family physician brought up screening options at a health maintenance visit. Although I had expressed some skepticism about this change when the ACS updated its screening guideline in 2018, I generally follow the USPSTF recommendations in my own clinical practice, so I dutifully selected a test that, fortunately, came out negative.

Not everyone in the primary care community, however, is on board with screening average-risk adults in their late 40s for colorectal cancer. The American Academy of Family Physicians (AAFP) published a notable dissent, arguing that the evidence from modeling studies cited by the USPSTF to support lowering the starting age was insufficient. The AAFP also expressed concern that devoting screening resources to younger adults could come at the expense of improving screening rates in older adults who are at higher risk for CRC and increase health care costs without corresponding benefit.

Now, the American College of Physicians has joined the AAFP by releasing an updated guidance statement for CRC screening that discourages screening asymptomatic, average-risk adults between the ages of 45 and 49. In addition to the uncertainty surrounding benefits of screening adults in this age range, the ACP pointed out that starting screening at age 45, compared with age 50, would increase the number of colonoscopies and colonoscopy complications. My colleagues and I recently published a systematic review estimating that for every 10,000 screening colonoscopies performed, 8 people suffer a bowel perforation and 16 to 36 have severe bleeding requiring hospitalization. One in 3 patients undergoing colonoscopies report minor adverse events such as abdominal pain, bloating, and abdominal discomfort in the first 2 weeks following the procedure.

Other aspects of the ACP guidance differ from other colorectal cancer screening guidelines. Unlike the USPSTF, which made no distinctions between various recommended screening tests, the ACP preferentially endorsed fecal immunochemical or high-sensitivity fecal occult blood testing every 2 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years. That leaves out stool DNA testing, which my patients increasingly request because they have seen television or online advertisements, and newer blood tests that detect methylation sequences in circulating tumor DNA.

Perhaps most controversial is the ACP’s suggestion that it is probably reasonable for some adults to start screening later than age 50 or undergo screening at longer intervals than currently recommended (for example, colonoscopy every 15 years). Recent data support extending the interval to repeat screening colonoscopy in selected populations; a large cross-sectional study found a low prevalence of advanced adenomas and colorectal cancers in colonoscopies performed 10 or more years after an initial negative colonoscopy, particularly in women and younger patients without gastrointestinal symptoms. A prominent BMJ guideline suggests that patients need not be screened until their estimated 15-year CRC risk is greater than 3% (which most people do not reach until their 60s) and then only need a single sigmoidoscopy or colonoscopy.

Despite some departures from other guidelines, it’s worth emphasizing that the ACP guideline agrees that screening for CRC is generally worthwhile between the ages of 50 and 75 years. On that front, we in primary care have more work to do; the Centers for Disease Control and Prevention estimates that 28% of American adults older than 50 are not up-to-date on CRC screening. And despite some recent debate about the relative benefits and harms of screening colonoscopy, compared with less invasive fecal tests, gastroenterologists and family physicians can agree that the best screening test is the test that gets done.

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

I’m Dr. Kenny Lin. I am a family physician and associate director of the Lancaster General Hospital Family Medicine Residency, and I blog at Common Sense Family Doctor.

I’m 47 years old. Two years ago, when the U.S. Preventive Services Task Force (USPSTF) followed the American Cancer Society and lowered the starting age for colorectal cancer (CRC) screening from 50 to 45, my family physician brought up screening options at a health maintenance visit. Although I had expressed some skepticism about this change when the ACS updated its screening guideline in 2018, I generally follow the USPSTF recommendations in my own clinical practice, so I dutifully selected a test that, fortunately, came out negative.

Not everyone in the primary care community, however, is on board with screening average-risk adults in their late 40s for colorectal cancer. The American Academy of Family Physicians (AAFP) published a notable dissent, arguing that the evidence from modeling studies cited by the USPSTF to support lowering the starting age was insufficient. The AAFP also expressed concern that devoting screening resources to younger adults could come at the expense of improving screening rates in older adults who are at higher risk for CRC and increase health care costs without corresponding benefit.

Now, the American College of Physicians has joined the AAFP by releasing an updated guidance statement for CRC screening that discourages screening asymptomatic, average-risk adults between the ages of 45 and 49. In addition to the uncertainty surrounding benefits of screening adults in this age range, the ACP pointed out that starting screening at age 45, compared with age 50, would increase the number of colonoscopies and colonoscopy complications. My colleagues and I recently published a systematic review estimating that for every 10,000 screening colonoscopies performed, 8 people suffer a bowel perforation and 16 to 36 have severe bleeding requiring hospitalization. One in 3 patients undergoing colonoscopies report minor adverse events such as abdominal pain, bloating, and abdominal discomfort in the first 2 weeks following the procedure.

Other aspects of the ACP guidance differ from other colorectal cancer screening guidelines. Unlike the USPSTF, which made no distinctions between various recommended screening tests, the ACP preferentially endorsed fecal immunochemical or high-sensitivity fecal occult blood testing every 2 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years. That leaves out stool DNA testing, which my patients increasingly request because they have seen television or online advertisements, and newer blood tests that detect methylation sequences in circulating tumor DNA.

Perhaps most controversial is the ACP’s suggestion that it is probably reasonable for some adults to start screening later than age 50 or undergo screening at longer intervals than currently recommended (for example, colonoscopy every 15 years). Recent data support extending the interval to repeat screening colonoscopy in selected populations; a large cross-sectional study found a low prevalence of advanced adenomas and colorectal cancers in colonoscopies performed 10 or more years after an initial negative colonoscopy, particularly in women and younger patients without gastrointestinal symptoms. A prominent BMJ guideline suggests that patients need not be screened until their estimated 15-year CRC risk is greater than 3% (which most people do not reach until their 60s) and then only need a single sigmoidoscopy or colonoscopy.

Despite some departures from other guidelines, it’s worth emphasizing that the ACP guideline agrees that screening for CRC is generally worthwhile between the ages of 50 and 75 years. On that front, we in primary care have more work to do; the Centers for Disease Control and Prevention estimates that 28% of American adults older than 50 are not up-to-date on CRC screening. And despite some recent debate about the relative benefits and harms of screening colonoscopy, compared with less invasive fecal tests, gastroenterologists and family physicians can agree that the best screening test is the test that gets done.

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

I’m Dr. Kenny Lin. I am a family physician and associate director of the Lancaster General Hospital Family Medicine Residency, and I blog at Common Sense Family Doctor.

I’m 47 years old. Two years ago, when the U.S. Preventive Services Task Force (USPSTF) followed the American Cancer Society and lowered the starting age for colorectal cancer (CRC) screening from 50 to 45, my family physician brought up screening options at a health maintenance visit. Although I had expressed some skepticism about this change when the ACS updated its screening guideline in 2018, I generally follow the USPSTF recommendations in my own clinical practice, so I dutifully selected a test that, fortunately, came out negative.

Not everyone in the primary care community, however, is on board with screening average-risk adults in their late 40s for colorectal cancer. The American Academy of Family Physicians (AAFP) published a notable dissent, arguing that the evidence from modeling studies cited by the USPSTF to support lowering the starting age was insufficient. The AAFP also expressed concern that devoting screening resources to younger adults could come at the expense of improving screening rates in older adults who are at higher risk for CRC and increase health care costs without corresponding benefit.

Now, the American College of Physicians has joined the AAFP by releasing an updated guidance statement for CRC screening that discourages screening asymptomatic, average-risk adults between the ages of 45 and 49. In addition to the uncertainty surrounding benefits of screening adults in this age range, the ACP pointed out that starting screening at age 45, compared with age 50, would increase the number of colonoscopies and colonoscopy complications. My colleagues and I recently published a systematic review estimating that for every 10,000 screening colonoscopies performed, 8 people suffer a bowel perforation and 16 to 36 have severe bleeding requiring hospitalization. One in 3 patients undergoing colonoscopies report minor adverse events such as abdominal pain, bloating, and abdominal discomfort in the first 2 weeks following the procedure.

Other aspects of the ACP guidance differ from other colorectal cancer screening guidelines. Unlike the USPSTF, which made no distinctions between various recommended screening tests, the ACP preferentially endorsed fecal immunochemical or high-sensitivity fecal occult blood testing every 2 years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years. That leaves out stool DNA testing, which my patients increasingly request because they have seen television or online advertisements, and newer blood tests that detect methylation sequences in circulating tumor DNA.

Perhaps most controversial is the ACP’s suggestion that it is probably reasonable for some adults to start screening later than age 50 or undergo screening at longer intervals than currently recommended (for example, colonoscopy every 15 years). Recent data support extending the interval to repeat screening colonoscopy in selected populations; a large cross-sectional study found a low prevalence of advanced adenomas and colorectal cancers in colonoscopies performed 10 or more years after an initial negative colonoscopy, particularly in women and younger patients without gastrointestinal symptoms. A prominent BMJ guideline suggests that patients need not be screened until their estimated 15-year CRC risk is greater than 3% (which most people do not reach until their 60s) and then only need a single sigmoidoscopy or colonoscopy.

Despite some departures from other guidelines, it’s worth emphasizing that the ACP guideline agrees that screening for CRC is generally worthwhile between the ages of 50 and 75 years. On that front, we in primary care have more work to do; the Centers for Disease Control and Prevention estimates that 28% of American adults older than 50 are not up-to-date on CRC screening. And despite some recent debate about the relative benefits and harms of screening colonoscopy, compared with less invasive fecal tests, gastroenterologists and family physicians can agree that the best screening test is the test that gets done.

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

COVID-19 hospitalizations continue their steady summer march upward, and now a new variant has perched atop the list of the most prevalent forms of the virus.

Called “Eris” among avid COVID trackers, the strain EG.5 now accounts for 17% of all U.S. COVID infections, according to the latest Centers for Disease Control and Prevention estimates. That’s up from 12% the week prior. 

EG.5 has been rising worldwide, just weeks after the World Health Organization added the strain to its official monitoring list. In the United Kingdom, it now accounts for 1 in 10 COVID cases, The Independent reported.

EG.5 is a descendant of the XBB strains that have dominated tracking lists in recent months. It has the same makeup as XBB.1.9.2 but carries an extra spike mutation, according to a summary published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The spike protein is the part of the virus that allows it to enter human cells. But there’s no indication so far that EG.5 is more contagious or severe than other recent variants, according to the CIDRAP summary and a recent podcast from the American Medical Association. The CDC said that current vaccines protect against the variant.

U.S. hospitals saw a 12% increase in COVID admissions during the week ending on July 22, with 8,047 people being admitted because of the virus, up from an all-time low of 6,306 the week of June 24. In 17 states, the past-week increase in hospitalizations was 20% or greater. In Minnesota, the rate jumped by 50%, and in West Virginia, it jumped by 63%. Meanwhile, deaths reached their lowest weekly rate ever for the week of data ending July 29, with just 176 deaths reported by the CDC.

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

COVID-19 hospitalizations continue their steady summer march upward, and now a new variant has perched atop the list of the most prevalent forms of the virus.

Called “Eris” among avid COVID trackers, the strain EG.5 now accounts for 17% of all U.S. COVID infections, according to the latest Centers for Disease Control and Prevention estimates. That’s up from 12% the week prior. 

EG.5 has been rising worldwide, just weeks after the World Health Organization added the strain to its official monitoring list. In the United Kingdom, it now accounts for 1 in 10 COVID cases, The Independent reported.

EG.5 is a descendant of the XBB strains that have dominated tracking lists in recent months. It has the same makeup as XBB.1.9.2 but carries an extra spike mutation, according to a summary published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The spike protein is the part of the virus that allows it to enter human cells. But there’s no indication so far that EG.5 is more contagious or severe than other recent variants, according to the CIDRAP summary and a recent podcast from the American Medical Association. The CDC said that current vaccines protect against the variant.

U.S. hospitals saw a 12% increase in COVID admissions during the week ending on July 22, with 8,047 people being admitted because of the virus, up from an all-time low of 6,306 the week of June 24. In 17 states, the past-week increase in hospitalizations was 20% or greater. In Minnesota, the rate jumped by 50%, and in West Virginia, it jumped by 63%. Meanwhile, deaths reached their lowest weekly rate ever for the week of data ending July 29, with just 176 deaths reported by the CDC.

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

COVID-19 hospitalizations continue their steady summer march upward, and now a new variant has perched atop the list of the most prevalent forms of the virus.

Called “Eris” among avid COVID trackers, the strain EG.5 now accounts for 17% of all U.S. COVID infections, according to the latest Centers for Disease Control and Prevention estimates. That’s up from 12% the week prior. 

EG.5 has been rising worldwide, just weeks after the World Health Organization added the strain to its official monitoring list. In the United Kingdom, it now accounts for 1 in 10 COVID cases, The Independent reported.

EG.5 is a descendant of the XBB strains that have dominated tracking lists in recent months. It has the same makeup as XBB.1.9.2 but carries an extra spike mutation, according to a summary published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The spike protein is the part of the virus that allows it to enter human cells. But there’s no indication so far that EG.5 is more contagious or severe than other recent variants, according to the CIDRAP summary and a recent podcast from the American Medical Association. The CDC said that current vaccines protect against the variant.

U.S. hospitals saw a 12% increase in COVID admissions during the week ending on July 22, with 8,047 people being admitted because of the virus, up from an all-time low of 6,306 the week of June 24. In 17 states, the past-week increase in hospitalizations was 20% or greater. In Minnesota, the rate jumped by 50%, and in West Virginia, it jumped by 63%. Meanwhile, deaths reached their lowest weekly rate ever for the week of data ending July 29, with just 176 deaths reported by the CDC.

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

In the dawn of artificial intelligence’s potential to inform clinical practice, the importance of understanding the intent and interpretation of prediction tools is vital. In medicine, informed decision-making promotes patient autonomy and can lead to improved patient satisfaction and engagement in their own care.

Prediction models can assist clinicians in providing comprehensive antenatal counseling that promotes discussion of potential risks and outcomes to help patients understand the implications of different management options. This shared understanding enables patients to make informed choices about their care, reducing anxiety and increasing confidence in medical decision-making.

Tufts University

In obstetric clinical practice, prediction tools have been created to assess risk of primary cesarean delivery in gestational diabetes,¹ cesarean delivery in hypertensive disorders of pregnancy,² and failed induction of labor in nulliparous patients with an unfavorable cervix.³ By assessing a patient’s risk profile, clinicians can identify high-risk individuals who may require closer monitoring, early interventions, or specialized care. This allows for more timely interventions to optimize maternal and fetal health outcomes.

Other prediction tools are created to better elucidate to patients their individual risk of an outcome that may be modifiable, aiding physician counseling on mitigating factors to improve overall results. A relevant example is the American Diabetes Association’s risk of type 2 diabetes calculator used for counseling patients on risk reduction. This model includes both preexisting (ethnicity, family history, age, sex assigned at birth) and modifiable risk factors (body mass index, hypertension, physical activity) to predict risk of type 2 diabetes and is widely used in clinical practice to encourage integration of lifestyle changes to decrease risk.⁴ This model highlights the utility of prediction tools in counseling, providing quantitative data to clinicians to discuss a patient’s individual risk and how to mitigate that risk.

While predictive models clearly have many advantages and potential to improve personalized medicine, concerns have been raised that their interpretation and application can sometimes have unintended consequences as the complexity of these models can lead to variation in understanding among clinicians that impact decision-making. Different clinicians may assign different levels of importance to the predicted risks, resulting in differences in treatment plans and interventions. This variability can lead to disparities in care and outcomes, as patients with similar risk profiles may receive different management approaches based on the interpreting clinician.

Providers may either overly rely on prediction models or completely disregard them, depending on their level of trust or skepticism. Overreliance on prediction models may lead to the neglect of important clinical information or intuition, while disregarding the models may result in missed opportunities for early intervention or appropriate risk stratification. Achieving a balance between clinical judgment and the use of prediction models is crucial for optimal decision-making.

An example of how misinterpretation of the role of prediction tools in patient counseling can have far reaching consequences is the vaginal birth after cesarean (VBAC) calculator where race and ethnicity naturalized racial differences and likely contributed to cesarean overuse in Black pregnant people as non-White race was associated with a decreased chance of successful VBAC. Although the authors of the study that created the VBAC calculator intended it to be used as an adjunct to counseling, institutions and providers used low calculator scores to discourage or prohibit pregnant people from attempting a trial of labor after cesarean (TOLAC). This highlighted the importance of contextualizing the intent of prediction models within the broader clinical setting and individual patient circumstances and preferences.

This gap between intent and interpretation and subsequent application is influenced by individual clinician experience, training, personal biases, and subjective judgment. These subjective elements can introduce inconsistencies and variability in the utilization of prediction tools, leading to potential discrepancies in patient care. Inadequate understanding of prediction models and their statistical concepts can contribute to misinterpretation. It is this bias that prevents prediction models from serving their true purpose: to inform clinical decision-making, improve patient outcomes, and optimize resource allocation.

Clinicians may struggle with concepts such as predictive accuracy, overfitting, calibration, and external validation. Educational initiatives and enhanced training in statistical literacy can empower clinicians to better comprehend and apply prediction models in their practice. Researchers should make it clear that models should not be used in isolation, but rather integrated with clinical expertise and patient preferences. Understanding the limitations of prediction models and incorporating additional clinical information is essential.

Prediction models in obstetrics should undergo continuous evaluation and improvement to enhance their reliability and applicability. Regular updates, external validation, and recalibration are necessary to account for evolving clinical practices, changes in patient populations, and emerging evidence. Engaging clinicians in the evaluation process can foster ownership and promote a sense of trust in the models.

As machine learning and artificial intelligence improve the accuracy of prediction models, there is potential to revolutionize obstetric care by enabling more accurate individualized risk assessment and decision-making. Machine learning has the potential to significantly enhance prediction models in obstetrics by leveraging complex algorithms and advanced computational techniques. However, the unpredictable nature of clinician interpretation poses challenges to the effective utilization of these models.

By emphasizing communication, collaboration, education, and continuous evaluation, we can bridge the gap between prediction models and clinician interpretation that optimizes their use. This concerted effort will ultimately lead to improved patient care, enhanced clinical outcomes, and a more harmonious integration of these tools into obstetric practice.

Dr. Ramos is assistant professor of maternal fetal medicine and associate principal investigator at the Mother Infant Research Institute, Tufts University and Tufts Medical Center, Boston.

References

1. Ramos SZ et al. Predicting primary cesarean delivery in pregnancies complicated by gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Jun 7;S0002-9378(23)00371-X. doi: 10.1016/j.ajog.2023.06.002.

2. Beninati MJ et al. Prediction model for vaginal birth after induction of labor in women with hypertensive disorders of pregnancy. Obstet Gynecol. 2020 Aug;136(2):402-410. doi: 10.1097/AOG.0000000000003938.

3. Levine LD et al. A validated calculator to estimate risk of cesarean after an induction of labor with an unfavorable cervix. Am J Obstet Gynecol. 2018 Feb;218(2):254.e1-254.e7. doi: 10.1016/j.ajog.2017.11.603.

4. American Diabetes Association. Our 60-Second Type 2 Diabetes Risk Test.

In the dawn of artificial intelligence’s potential to inform clinical practice, the importance of understanding the intent and interpretation of prediction tools is vital. In medicine, informed decision-making promotes patient autonomy and can lead to improved patient satisfaction and engagement in their own care.

Prediction models can assist clinicians in providing comprehensive antenatal counseling that promotes discussion of potential risks and outcomes to help patients understand the implications of different management options. This shared understanding enables patients to make informed choices about their care, reducing anxiety and increasing confidence in medical decision-making.

Tufts University

In obstetric clinical practice, prediction tools have been created to assess risk of primary cesarean delivery in gestational diabetes,¹ cesarean delivery in hypertensive disorders of pregnancy,² and failed induction of labor in nulliparous patients with an unfavorable cervix.³ By assessing a patient’s risk profile, clinicians can identify high-risk individuals who may require closer monitoring, early interventions, or specialized care. This allows for more timely interventions to optimize maternal and fetal health outcomes.

Other prediction tools are created to better elucidate to patients their individual risk of an outcome that may be modifiable, aiding physician counseling on mitigating factors to improve overall results. A relevant example is the American Diabetes Association’s risk of type 2 diabetes calculator used for counseling patients on risk reduction. This model includes both preexisting (ethnicity, family history, age, sex assigned at birth) and modifiable risk factors (body mass index, hypertension, physical activity) to predict risk of type 2 diabetes and is widely used in clinical practice to encourage integration of lifestyle changes to decrease risk.⁴ This model highlights the utility of prediction tools in counseling, providing quantitative data to clinicians to discuss a patient’s individual risk and how to mitigate that risk.

While predictive models clearly have many advantages and potential to improve personalized medicine, concerns have been raised that their interpretation and application can sometimes have unintended consequences as the complexity of these models can lead to variation in understanding among clinicians that impact decision-making. Different clinicians may assign different levels of importance to the predicted risks, resulting in differences in treatment plans and interventions. This variability can lead to disparities in care and outcomes, as patients with similar risk profiles may receive different management approaches based on the interpreting clinician.

Providers may either overly rely on prediction models or completely disregard them, depending on their level of trust or skepticism. Overreliance on prediction models may lead to the neglect of important clinical information or intuition, while disregarding the models may result in missed opportunities for early intervention or appropriate risk stratification. Achieving a balance between clinical judgment and the use of prediction models is crucial for optimal decision-making.

An example of how misinterpretation of the role of prediction tools in patient counseling can have far reaching consequences is the vaginal birth after cesarean (VBAC) calculator where race and ethnicity naturalized racial differences and likely contributed to cesarean overuse in Black pregnant people as non-White race was associated with a decreased chance of successful VBAC. Although the authors of the study that created the VBAC calculator intended it to be used as an adjunct to counseling, institutions and providers used low calculator scores to discourage or prohibit pregnant people from attempting a trial of labor after cesarean (TOLAC). This highlighted the importance of contextualizing the intent of prediction models within the broader clinical setting and individual patient circumstances and preferences.

This gap between intent and interpretation and subsequent application is influenced by individual clinician experience, training, personal biases, and subjective judgment. These subjective elements can introduce inconsistencies and variability in the utilization of prediction tools, leading to potential discrepancies in patient care. Inadequate understanding of prediction models and their statistical concepts can contribute to misinterpretation. It is this bias that prevents prediction models from serving their true purpose: to inform clinical decision-making, improve patient outcomes, and optimize resource allocation.

Clinicians may struggle with concepts such as predictive accuracy, overfitting, calibration, and external validation. Educational initiatives and enhanced training in statistical literacy can empower clinicians to better comprehend and apply prediction models in their practice. Researchers should make it clear that models should not be used in isolation, but rather integrated with clinical expertise and patient preferences. Understanding the limitations of prediction models and incorporating additional clinical information is essential.

Prediction models in obstetrics should undergo continuous evaluation and improvement to enhance their reliability and applicability. Regular updates, external validation, and recalibration are necessary to account for evolving clinical practices, changes in patient populations, and emerging evidence. Engaging clinicians in the evaluation process can foster ownership and promote a sense of trust in the models.

As machine learning and artificial intelligence improve the accuracy of prediction models, there is potential to revolutionize obstetric care by enabling more accurate individualized risk assessment and decision-making. Machine learning has the potential to significantly enhance prediction models in obstetrics by leveraging complex algorithms and advanced computational techniques. However, the unpredictable nature of clinician interpretation poses challenges to the effective utilization of these models.

By emphasizing communication, collaboration, education, and continuous evaluation, we can bridge the gap between prediction models and clinician interpretation that optimizes their use. This concerted effort will ultimately lead to improved patient care, enhanced clinical outcomes, and a more harmonious integration of these tools into obstetric practice.

Dr. Ramos is assistant professor of maternal fetal medicine and associate principal investigator at the Mother Infant Research Institute, Tufts University and Tufts Medical Center, Boston.

References

1. Ramos SZ et al. Predicting primary cesarean delivery in pregnancies complicated by gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Jun 7;S0002-9378(23)00371-X. doi: 10.1016/j.ajog.2023.06.002.

2. Beninati MJ et al. Prediction model for vaginal birth after induction of labor in women with hypertensive disorders of pregnancy. Obstet Gynecol. 2020 Aug;136(2):402-410. doi: 10.1097/AOG.0000000000003938.

3. Levine LD et al. A validated calculator to estimate risk of cesarean after an induction of labor with an unfavorable cervix. Am J Obstet Gynecol. 2018 Feb;218(2):254.e1-254.e7. doi: 10.1016/j.ajog.2017.11.603.

4. American Diabetes Association. Our 60-Second Type 2 Diabetes Risk Test.

In the dawn of artificial intelligence’s potential to inform clinical practice, the importance of understanding the intent and interpretation of prediction tools is vital. In medicine, informed decision-making promotes patient autonomy and can lead to improved patient satisfaction and engagement in their own care.

Prediction models can assist clinicians in providing comprehensive antenatal counseling that promotes discussion of potential risks and outcomes to help patients understand the implications of different management options. This shared understanding enables patients to make informed choices about their care, reducing anxiety and increasing confidence in medical decision-making.

Tufts University

In obstetric clinical practice, prediction tools have been created to assess risk of primary cesarean delivery in gestational diabetes,¹ cesarean delivery in hypertensive disorders of pregnancy,² and failed induction of labor in nulliparous patients with an unfavorable cervix.³ By assessing a patient’s risk profile, clinicians can identify high-risk individuals who may require closer monitoring, early interventions, or specialized care. This allows for more timely interventions to optimize maternal and fetal health outcomes.

Other prediction tools are created to better elucidate to patients their individual risk of an outcome that may be modifiable, aiding physician counseling on mitigating factors to improve overall results. A relevant example is the American Diabetes Association’s risk of type 2 diabetes calculator used for counseling patients on risk reduction. This model includes both preexisting (ethnicity, family history, age, sex assigned at birth) and modifiable risk factors (body mass index, hypertension, physical activity) to predict risk of type 2 diabetes and is widely used in clinical practice to encourage integration of lifestyle changes to decrease risk.⁴ This model highlights the utility of prediction tools in counseling, providing quantitative data to clinicians to discuss a patient’s individual risk and how to mitigate that risk.

While predictive models clearly have many advantages and potential to improve personalized medicine, concerns have been raised that their interpretation and application can sometimes have unintended consequences as the complexity of these models can lead to variation in understanding among clinicians that impact decision-making. Different clinicians may assign different levels of importance to the predicted risks, resulting in differences in treatment plans and interventions. This variability can lead to disparities in care and outcomes, as patients with similar risk profiles may receive different management approaches based on the interpreting clinician.

Providers may either overly rely on prediction models or completely disregard them, depending on their level of trust or skepticism. Overreliance on prediction models may lead to the neglect of important clinical information or intuition, while disregarding the models may result in missed opportunities for early intervention or appropriate risk stratification. Achieving a balance between clinical judgment and the use of prediction models is crucial for optimal decision-making.

An example of how misinterpretation of the role of prediction tools in patient counseling can have far reaching consequences is the vaginal birth after cesarean (VBAC) calculator where race and ethnicity naturalized racial differences and likely contributed to cesarean overuse in Black pregnant people as non-White race was associated with a decreased chance of successful VBAC. Although the authors of the study that created the VBAC calculator intended it to be used as an adjunct to counseling, institutions and providers used low calculator scores to discourage or prohibit pregnant people from attempting a trial of labor after cesarean (TOLAC). This highlighted the importance of contextualizing the intent of prediction models within the broader clinical setting and individual patient circumstances and preferences.

This gap between intent and interpretation and subsequent application is influenced by individual clinician experience, training, personal biases, and subjective judgment. These subjective elements can introduce inconsistencies and variability in the utilization of prediction tools, leading to potential discrepancies in patient care. Inadequate understanding of prediction models and their statistical concepts can contribute to misinterpretation. It is this bias that prevents prediction models from serving their true purpose: to inform clinical decision-making, improve patient outcomes, and optimize resource allocation.

Clinicians may struggle with concepts such as predictive accuracy, overfitting, calibration, and external validation. Educational initiatives and enhanced training in statistical literacy can empower clinicians to better comprehend and apply prediction models in their practice. Researchers should make it clear that models should not be used in isolation, but rather integrated with clinical expertise and patient preferences. Understanding the limitations of prediction models and incorporating additional clinical information is essential.

Prediction models in obstetrics should undergo continuous evaluation and improvement to enhance their reliability and applicability. Regular updates, external validation, and recalibration are necessary to account for evolving clinical practices, changes in patient populations, and emerging evidence. Engaging clinicians in the evaluation process can foster ownership and promote a sense of trust in the models.

As machine learning and artificial intelligence improve the accuracy of prediction models, there is potential to revolutionize obstetric care by enabling more accurate individualized risk assessment and decision-making. Machine learning has the potential to significantly enhance prediction models in obstetrics by leveraging complex algorithms and advanced computational techniques. However, the unpredictable nature of clinician interpretation poses challenges to the effective utilization of these models.

By emphasizing communication, collaboration, education, and continuous evaluation, we can bridge the gap between prediction models and clinician interpretation that optimizes their use. This concerted effort will ultimately lead to improved patient care, enhanced clinical outcomes, and a more harmonious integration of these tools into obstetric practice.

Dr. Ramos is assistant professor of maternal fetal medicine and associate principal investigator at the Mother Infant Research Institute, Tufts University and Tufts Medical Center, Boston.

References

1. Ramos SZ et al. Predicting primary cesarean delivery in pregnancies complicated by gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Jun 7;S0002-9378(23)00371-X. doi: 10.1016/j.ajog.2023.06.002.

2. Beninati MJ et al. Prediction model for vaginal birth after induction of labor in women with hypertensive disorders of pregnancy. Obstet Gynecol. 2020 Aug;136(2):402-410. doi: 10.1097/AOG.0000000000003938.

3. Levine LD et al. A validated calculator to estimate risk of cesarean after an induction of labor with an unfavorable cervix. Am J Obstet Gynecol. 2018 Feb;218(2):254.e1-254.e7. doi: 10.1016/j.ajog.2017.11.603.

4. American Diabetes Association. Our 60-Second Type 2 Diabetes Risk Test.

Once again, McLean Hospital in Belmont, Mass., is ranked as the best U.S. hospital for psychiatric care, according to U.S. News & World Report.
 

McLean Hospital claimed the top spot in the 2022-2023 ranking as well.

Massachusetts General Hospital in Boston holds the No. 2 spot in the 2023-2024 U.S. News ranking for best psychiatry hospitals, up from No. 3 in 2022-2023.

New York–Presbyterian Hospital–Columbia and Cornell sits at No. 3 in 2023-2024, up from No. 4 in 2022-2023, while Johns Hopkins Hospital, Baltimore is ranked No. 4, down from No. 2.

Resnick Neuropsychiatric Hospital at the University of California, Los Angeles, is ranked No. 5 in 2023-2024 (up from No. 6 in 2022-2023), while UCSF Health–UCSF Medical Center, San Francisco, dropped to No. 6 in 2023-2024 (from No. 5 in 2022-2023).

No. 7 in 2023-2024 is Menninger Clinic, Houston, which held the No. 10 spot in 2022-2023.

According to U.S. News, the psychiatry rating is based on the expert opinion of surveyed psychiatrists. The seven ranked hospitals in psychiatry or psychiatric care were recommended by at least 5% of the psychiatric specialists responding to the magazine’s surveys in 2021, 2022, and 2023 as a facility where they would refer their patients.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Honor roll

This year, as in prior years, U.S. News also recognized “honor roll” hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making the honor roll. Instead, they are listed in alphabetical order.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate the magazine’s website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024 there are 22.
 

2023-2024 Honor Roll Hospitals

• Barnes-Jewish Hospital, St. Louis
• Brigham and Women’s Hospital, Boston
• Cedars-Sinai Medical Center, Los Angeles
• Cleveland Clinic
• Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
• Houston Methodist Hospital
• Johns Hopkins Hospital, Baltimore
• Massachusetts General Hospital, Boston
• Mayo Clinic, Rochester, Minn.
• Mount Sinai Hospital, New York
• New York–Presbyterian Hospital–Columbia and Cornell
• North Shore University Hospital at Northwell Health, Manhasset, N.Y.
• Northwestern Memorial Hospital, Chicago
• NYU Langone Hospitals, New York 
• Rush University Medical Center, Chicago
• Stanford (Calif.) Health Care–Stanford Hospital
• UC San Diego Health–La Jolla and Hillcrest Hospitals
• UCLA Medical Center, Los Angeles
• UCSF Health–UCSF Medical Center, San Francisco
• University of Michigan Health–Ann Arbor
• UT Southwestern Medical Center, Dallas
• Vanderbilt University Medical Center, Nashville, Tenn.

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion. 

In addition, hospital profiles on USNews.com feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

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

Once again, McLean Hospital in Belmont, Mass., is ranked as the best U.S. hospital for psychiatric care, according to U.S. News & World Report.
 

McLean Hospital claimed the top spot in the 2022-2023 ranking as well.

Massachusetts General Hospital in Boston holds the No. 2 spot in the 2023-2024 U.S. News ranking for best psychiatry hospitals, up from No. 3 in 2022-2023.

New York–Presbyterian Hospital–Columbia and Cornell sits at No. 3 in 2023-2024, up from No. 4 in 2022-2023, while Johns Hopkins Hospital, Baltimore is ranked No. 4, down from No. 2.

Resnick Neuropsychiatric Hospital at the University of California, Los Angeles, is ranked No. 5 in 2023-2024 (up from No. 6 in 2022-2023), while UCSF Health–UCSF Medical Center, San Francisco, dropped to No. 6 in 2023-2024 (from No. 5 in 2022-2023).

No. 7 in 2023-2024 is Menninger Clinic, Houston, which held the No. 10 spot in 2022-2023.

According to U.S. News, the psychiatry rating is based on the expert opinion of surveyed psychiatrists. The seven ranked hospitals in psychiatry or psychiatric care were recommended by at least 5% of the psychiatric specialists responding to the magazine’s surveys in 2021, 2022, and 2023 as a facility where they would refer their patients.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Honor roll

This year, as in prior years, U.S. News also recognized “honor roll” hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making the honor roll. Instead, they are listed in alphabetical order.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate the magazine’s website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024 there are 22.
 

2023-2024 Honor Roll Hospitals

• Barnes-Jewish Hospital, St. Louis
• Brigham and Women’s Hospital, Boston
• Cedars-Sinai Medical Center, Los Angeles
• Cleveland Clinic
• Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
• Houston Methodist Hospital
• Johns Hopkins Hospital, Baltimore
• Massachusetts General Hospital, Boston
• Mayo Clinic, Rochester, Minn.
• Mount Sinai Hospital, New York
• New York–Presbyterian Hospital–Columbia and Cornell
• North Shore University Hospital at Northwell Health, Manhasset, N.Y.
• Northwestern Memorial Hospital, Chicago
• NYU Langone Hospitals, New York 
• Rush University Medical Center, Chicago
• Stanford (Calif.) Health Care–Stanford Hospital
• UC San Diego Health–La Jolla and Hillcrest Hospitals
• UCLA Medical Center, Los Angeles
• UCSF Health–UCSF Medical Center, San Francisco
• University of Michigan Health–Ann Arbor
• UT Southwestern Medical Center, Dallas
• Vanderbilt University Medical Center, Nashville, Tenn.

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion. 

In addition, hospital profiles on USNews.com feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

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

Once again, McLean Hospital in Belmont, Mass., is ranked as the best U.S. hospital for psychiatric care, according to U.S. News & World Report.
 

McLean Hospital claimed the top spot in the 2022-2023 ranking as well.

Massachusetts General Hospital in Boston holds the No. 2 spot in the 2023-2024 U.S. News ranking for best psychiatry hospitals, up from No. 3 in 2022-2023.

New York–Presbyterian Hospital–Columbia and Cornell sits at No. 3 in 2023-2024, up from No. 4 in 2022-2023, while Johns Hopkins Hospital, Baltimore is ranked No. 4, down from No. 2.

Resnick Neuropsychiatric Hospital at the University of California, Los Angeles, is ranked No. 5 in 2023-2024 (up from No. 6 in 2022-2023), while UCSF Health–UCSF Medical Center, San Francisco, dropped to No. 6 in 2023-2024 (from No. 5 in 2022-2023).

No. 7 in 2023-2024 is Menninger Clinic, Houston, which held the No. 10 spot in 2022-2023.

According to U.S. News, the psychiatry rating is based on the expert opinion of surveyed psychiatrists. The seven ranked hospitals in psychiatry or psychiatric care were recommended by at least 5% of the psychiatric specialists responding to the magazine’s surveys in 2021, 2022, and 2023 as a facility where they would refer their patients.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Honor roll

This year, as in prior years, U.S. News also recognized “honor roll” hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making the honor roll. Instead, they are listed in alphabetical order.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate the magazine’s website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024 there are 22.
 

2023-2024 Honor Roll Hospitals

• Barnes-Jewish Hospital, St. Louis
• Brigham and Women’s Hospital, Boston
• Cedars-Sinai Medical Center, Los Angeles
• Cleveland Clinic
• Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
• Houston Methodist Hospital
• Johns Hopkins Hospital, Baltimore
• Massachusetts General Hospital, Boston
• Mayo Clinic, Rochester, Minn.
• Mount Sinai Hospital, New York
• New York–Presbyterian Hospital–Columbia and Cornell
• North Shore University Hospital at Northwell Health, Manhasset, N.Y.
• Northwestern Memorial Hospital, Chicago
• NYU Langone Hospitals, New York 
• Rush University Medical Center, Chicago
• Stanford (Calif.) Health Care–Stanford Hospital
• UC San Diego Health–La Jolla and Hillcrest Hospitals
• UCLA Medical Center, Los Angeles
• UCSF Health–UCSF Medical Center, San Francisco
• University of Michigan Health–Ann Arbor
• UT Southwestern Medical Center, Dallas
• Vanderbilt University Medical Center, Nashville, Tenn.

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion. 

In addition, hospital profiles on USNews.com feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

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

Early, intriguing research suggests that preventing acute graft-versus-host disease (GVHD) in the gut – a potentially life-threatening complication of allogeneic hematopoietic cell transplantation (allo-HCT) – could be accomplished by the administration of a single antibody that targets the anti-DLL4 Notch signaling pathway, without compromising the stem cell transplant.

“The major surprise was that none of the anti–DLL4-treated animals developed acute gastrointestinal GVHD for the entire duration of the study. This was a remarkable finding, given that intestinal GVHD is otherwise seen in the vast majority of nonhuman primate transplant recipients that receive either no prophylaxis, or prophylaxis with agents other than anti-DLL4 antibodies,” co–senior author Ivan Maillard, MD, PhD, a professor of medicine and vice chief for research in hematology-oncology at the University of Pennsylvania, Philadelphia, said in an interview.

“The timing was critical,” the authors noted in the study, recently published in Science Translational Medicine. “Intervening before any symptoms of GvHD appear made the long-term protection possible.”

While GVHD may be mild to moderate in chronic forms, acute cases can be serious, if not fatal, and nearly all severe acute GVHD prominently involves the gastrointestinal tract, which can drive activation of pathogenic T cells and potentially lead to tissue damage following allo-HCT.

Systemic corticosteroids are standard first-line treatment for acute GVHD. However, response rates generally range only from 40% to 60%, and there are concerns of side effects. Meanwhile, second-line treatments are of inconsistent benefit.

With previous studies on mice showing benefits of targeting Notch pathway inhibition, particularly DLL4, Dr. Maillard and colleagues further investigated the effects in nonhuman primates that were allo-HCT recipients, using the anti-DLL4 antibody REGN421, which has pharmacokinetic and toxicity information available from previous studies.

The nonhuman primates were treated with one of two dosing regimens: a single dose of REGN421 3 mg/kg at baseline, post HCT, (n = 7) or three weekly doses at days 0, 7 and 14, post transplant (n = 4). Those primates were compared with 11 primates receiving allo-HCT transplants that received supportive care only.

Primates receiving three weekly doses of REGN421 showed antibody concentrations of greater than 2 mcg/mL for more than 30 days post HCT. A single dose of REGN421 was associated with protection from acute GVHD at day 0, while three weekly doses showed protection at day 0, 7, and 14, consistent with an impact of REGN421 during the early phases of T-cell activation.

Compared with animals receiving only supportive care, prophylaxis with REGN421 was associated with delayed acute GVHD onset and lengthened survival.

Of the 11 primates treated with REGN421, none developed clinical signs of gastrointestinal acute GVHD, whereas the majority of those receiving standard care or other preventive interventions did.

“Detailed analysis of acute GVHD clinical presentations in REGN421-treated animals in comparison to no treatment controls revealed near complete protection from GI-acute GvHD with REGN421,” the authors reported.

Furthermore, pathology scores in the gastrointestinal tract were lower with REGN421 treatment, compared with the no-treatment cohort, and the scores matched those of healthy nontransplanted nonhuman primates.

The primates treated with REGN421 did ultimately develop other clinical and pathologic signs of skin, hepatic or pulmonary acute GVHD, but without gastrointestinal disease.

The treatment was not associated with any adverse effects on the allo-HCT, with primates receiving either a single dose or three weekly doses of REGN421 showing rapid donor engraftment after allo-HCT, including high bone marrow, whole blood, and T-cell donor chimerism.

“Reassuringly, short-term systemic DLL4 blockade with REGN421 did not trigger unexpected side effects in our nonhuman primate model, while preserving rapid engraftment as well hematopoietic and immune reconstitution.”

The mechanism preserving the engraftment, described as a “major surprise,” specifically involved DLL4 inhibition blocking the homing of pathogenic T cells to the gut while preserving homing of regulatory T cells that dampen the immune response, Dr. Maillard explained.

“This effect turned out to be at least in part through a posttranslational effect of DLL4/Notch blockade on integrin pairing at the T-cell surface,” he explained. “This was a novel and quite unexpected mechanism of action conserved from mice to nonhuman primates.”

The results are encouraging in terms of translating to humans because of their closer similarities in various physiological factors, Dr. Maillard said.

“The nonhuman primate model of transplantation [offers] a transplantation model very close to what is being performed in humans, as well as the opportunity to study an immune system very similar to that of humans in nonhuman primates,” he said.

Dr. Maillard noted that, while trials in humans are not underway yet, “we are in active discussions about it,” and the team is indeed interested in testing REGN421 itself, with the effects likely to be as a prophylactic strategy.

There are currently no approved anti-DLL4 antibody drugs for use in humans.

“Our approach is mostly promising as a preventive treatment, rather than as a secondary treatment for GVHD, because DLL4/Notch blockade seems most active when applied early after transplantation during the time of initial seeding of the gut by T cells (in mice, we had observed the critical time window for a successful intervention to be within 48 hours of transplantation),” Dr. Maillard said.“There remain questions about which other prophylactic treatments we should ideally combine anti-DLL4 antibodies with.”

Dr. Maillard has received research funding from Regeneron and Genentech and is a member of Garuda Therapeutics’s scientific advisory board.

Early, intriguing research suggests that preventing acute graft-versus-host disease (GVHD) in the gut – a potentially life-threatening complication of allogeneic hematopoietic cell transplantation (allo-HCT) – could be accomplished by the administration of a single antibody that targets the anti-DLL4 Notch signaling pathway, without compromising the stem cell transplant.

“The major surprise was that none of the anti–DLL4-treated animals developed acute gastrointestinal GVHD for the entire duration of the study. This was a remarkable finding, given that intestinal GVHD is otherwise seen in the vast majority of nonhuman primate transplant recipients that receive either no prophylaxis, or prophylaxis with agents other than anti-DLL4 antibodies,” co–senior author Ivan Maillard, MD, PhD, a professor of medicine and vice chief for research in hematology-oncology at the University of Pennsylvania, Philadelphia, said in an interview.

“The timing was critical,” the authors noted in the study, recently published in Science Translational Medicine. “Intervening before any symptoms of GvHD appear made the long-term protection possible.”

While GVHD may be mild to moderate in chronic forms, acute cases can be serious, if not fatal, and nearly all severe acute GVHD prominently involves the gastrointestinal tract, which can drive activation of pathogenic T cells and potentially lead to tissue damage following allo-HCT.

Systemic corticosteroids are standard first-line treatment for acute GVHD. However, response rates generally range only from 40% to 60%, and there are concerns of side effects. Meanwhile, second-line treatments are of inconsistent benefit.

With previous studies on mice showing benefits of targeting Notch pathway inhibition, particularly DLL4, Dr. Maillard and colleagues further investigated the effects in nonhuman primates that were allo-HCT recipients, using the anti-DLL4 antibody REGN421, which has pharmacokinetic and toxicity information available from previous studies.

The nonhuman primates were treated with one of two dosing regimens: a single dose of REGN421 3 mg/kg at baseline, post HCT, (n = 7) or three weekly doses at days 0, 7 and 14, post transplant (n = 4). Those primates were compared with 11 primates receiving allo-HCT transplants that received supportive care only.

Primates receiving three weekly doses of REGN421 showed antibody concentrations of greater than 2 mcg/mL for more than 30 days post HCT. A single dose of REGN421 was associated with protection from acute GVHD at day 0, while three weekly doses showed protection at day 0, 7, and 14, consistent with an impact of REGN421 during the early phases of T-cell activation.

Compared with animals receiving only supportive care, prophylaxis with REGN421 was associated with delayed acute GVHD onset and lengthened survival.

Of the 11 primates treated with REGN421, none developed clinical signs of gastrointestinal acute GVHD, whereas the majority of those receiving standard care or other preventive interventions did.

“Detailed analysis of acute GVHD clinical presentations in REGN421-treated animals in comparison to no treatment controls revealed near complete protection from GI-acute GvHD with REGN421,” the authors reported.

Furthermore, pathology scores in the gastrointestinal tract were lower with REGN421 treatment, compared with the no-treatment cohort, and the scores matched those of healthy nontransplanted nonhuman primates.

The primates treated with REGN421 did ultimately develop other clinical and pathologic signs of skin, hepatic or pulmonary acute GVHD, but without gastrointestinal disease.

The treatment was not associated with any adverse effects on the allo-HCT, with primates receiving either a single dose or three weekly doses of REGN421 showing rapid donor engraftment after allo-HCT, including high bone marrow, whole blood, and T-cell donor chimerism.

“Reassuringly, short-term systemic DLL4 blockade with REGN421 did not trigger unexpected side effects in our nonhuman primate model, while preserving rapid engraftment as well hematopoietic and immune reconstitution.”

The mechanism preserving the engraftment, described as a “major surprise,” specifically involved DLL4 inhibition blocking the homing of pathogenic T cells to the gut while preserving homing of regulatory T cells that dampen the immune response, Dr. Maillard explained.

“This effect turned out to be at least in part through a posttranslational effect of DLL4/Notch blockade on integrin pairing at the T-cell surface,” he explained. “This was a novel and quite unexpected mechanism of action conserved from mice to nonhuman primates.”

The results are encouraging in terms of translating to humans because of their closer similarities in various physiological factors, Dr. Maillard said.

“The nonhuman primate model of transplantation [offers] a transplantation model very close to what is being performed in humans, as well as the opportunity to study an immune system very similar to that of humans in nonhuman primates,” he said.

Dr. Maillard noted that, while trials in humans are not underway yet, “we are in active discussions about it,” and the team is indeed interested in testing REGN421 itself, with the effects likely to be as a prophylactic strategy.

There are currently no approved anti-DLL4 antibody drugs for use in humans.

“Our approach is mostly promising as a preventive treatment, rather than as a secondary treatment for GVHD, because DLL4/Notch blockade seems most active when applied early after transplantation during the time of initial seeding of the gut by T cells (in mice, we had observed the critical time window for a successful intervention to be within 48 hours of transplantation),” Dr. Maillard said.“There remain questions about which other prophylactic treatments we should ideally combine anti-DLL4 antibodies with.”

Dr. Maillard has received research funding from Regeneron and Genentech and is a member of Garuda Therapeutics’s scientific advisory board.

Early, intriguing research suggests that preventing acute graft-versus-host disease (GVHD) in the gut – a potentially life-threatening complication of allogeneic hematopoietic cell transplantation (allo-HCT) – could be accomplished by the administration of a single antibody that targets the anti-DLL4 Notch signaling pathway, without compromising the stem cell transplant.

“The major surprise was that none of the anti–DLL4-treated animals developed acute gastrointestinal GVHD for the entire duration of the study. This was a remarkable finding, given that intestinal GVHD is otherwise seen in the vast majority of nonhuman primate transplant recipients that receive either no prophylaxis, or prophylaxis with agents other than anti-DLL4 antibodies,” co–senior author Ivan Maillard, MD, PhD, a professor of medicine and vice chief for research in hematology-oncology at the University of Pennsylvania, Philadelphia, said in an interview.

“The timing was critical,” the authors noted in the study, recently published in Science Translational Medicine. “Intervening before any symptoms of GvHD appear made the long-term protection possible.”

While GVHD may be mild to moderate in chronic forms, acute cases can be serious, if not fatal, and nearly all severe acute GVHD prominently involves the gastrointestinal tract, which can drive activation of pathogenic T cells and potentially lead to tissue damage following allo-HCT.

Systemic corticosteroids are standard first-line treatment for acute GVHD. However, response rates generally range only from 40% to 60%, and there are concerns of side effects. Meanwhile, second-line treatments are of inconsistent benefit.

With previous studies on mice showing benefits of targeting Notch pathway inhibition, particularly DLL4, Dr. Maillard and colleagues further investigated the effects in nonhuman primates that were allo-HCT recipients, using the anti-DLL4 antibody REGN421, which has pharmacokinetic and toxicity information available from previous studies.

The nonhuman primates were treated with one of two dosing regimens: a single dose of REGN421 3 mg/kg at baseline, post HCT, (n = 7) or three weekly doses at days 0, 7 and 14, post transplant (n = 4). Those primates were compared with 11 primates receiving allo-HCT transplants that received supportive care only.

Primates receiving three weekly doses of REGN421 showed antibody concentrations of greater than 2 mcg/mL for more than 30 days post HCT. A single dose of REGN421 was associated with protection from acute GVHD at day 0, while three weekly doses showed protection at day 0, 7, and 14, consistent with an impact of REGN421 during the early phases of T-cell activation.

Compared with animals receiving only supportive care, prophylaxis with REGN421 was associated with delayed acute GVHD onset and lengthened survival.

Of the 11 primates treated with REGN421, none developed clinical signs of gastrointestinal acute GVHD, whereas the majority of those receiving standard care or other preventive interventions did.

“Detailed analysis of acute GVHD clinical presentations in REGN421-treated animals in comparison to no treatment controls revealed near complete protection from GI-acute GvHD with REGN421,” the authors reported.

Furthermore, pathology scores in the gastrointestinal tract were lower with REGN421 treatment, compared with the no-treatment cohort, and the scores matched those of healthy nontransplanted nonhuman primates.

The primates treated with REGN421 did ultimately develop other clinical and pathologic signs of skin, hepatic or pulmonary acute GVHD, but without gastrointestinal disease.

The treatment was not associated with any adverse effects on the allo-HCT, with primates receiving either a single dose or three weekly doses of REGN421 showing rapid donor engraftment after allo-HCT, including high bone marrow, whole blood, and T-cell donor chimerism.

“Reassuringly, short-term systemic DLL4 blockade with REGN421 did not trigger unexpected side effects in our nonhuman primate model, while preserving rapid engraftment as well hematopoietic and immune reconstitution.”

The mechanism preserving the engraftment, described as a “major surprise,” specifically involved DLL4 inhibition blocking the homing of pathogenic T cells to the gut while preserving homing of regulatory T cells that dampen the immune response, Dr. Maillard explained.

“This effect turned out to be at least in part through a posttranslational effect of DLL4/Notch blockade on integrin pairing at the T-cell surface,” he explained. “This was a novel and quite unexpected mechanism of action conserved from mice to nonhuman primates.”

The results are encouraging in terms of translating to humans because of their closer similarities in various physiological factors, Dr. Maillard said.

“The nonhuman primate model of transplantation [offers] a transplantation model very close to what is being performed in humans, as well as the opportunity to study an immune system very similar to that of humans in nonhuman primates,” he said.

Dr. Maillard noted that, while trials in humans are not underway yet, “we are in active discussions about it,” and the team is indeed interested in testing REGN421 itself, with the effects likely to be as a prophylactic strategy.

There are currently no approved anti-DLL4 antibody drugs for use in humans.

“Our approach is mostly promising as a preventive treatment, rather than as a secondary treatment for GVHD, because DLL4/Notch blockade seems most active when applied early after transplantation during the time of initial seeding of the gut by T cells (in mice, we had observed the critical time window for a successful intervention to be within 48 hours of transplantation),” Dr. Maillard said.“There remain questions about which other prophylactic treatments we should ideally combine anti-DLL4 antibodies with.”

Dr. Maillard has received research funding from Regeneron and Genentech and is a member of Garuda Therapeutics’s scientific advisory board.

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

• The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
• Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
• Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

• Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
• Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
• Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
• In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

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

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

• The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
• Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
• Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

• Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
• Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
• Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
• In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

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

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

• The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
• Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
• Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

• Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
• Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
• Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
• In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

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

A daily prednisolone dose of 5 mg or higher is associated with increased risk for major adverse cardiovascular events (MACE) among patients with rheumatoid arthritis (RA), data suggest. Patients taking daily doses below this threshold did not appear to have an increased risk of MACE, compared with those not taking glucocorticoids (GCs).

Chinese University of Hong Kong

Is there a ‘safe’ dose for glucocorticoids?

To analyze this relationship, Dr. Lam and colleagues used the Hospital Authority Data Collaboration Laboratory, a citywide health care database. The investigators recruited patients with RA who had no history of MACE from 2006 to 2015 and followed them until the end of 2018. The primary outcome was the first occurrence of a MACE, defined as a composite of myocardial infarction (MI), unstable angina, ischemic or hemorrhagic cerebrovascular accident, transient ischemic attack, and CV death.

The study was published in Annals of the Rheumatic Diseases.

The analysis included 12,233 patients with RA and had over 105,826 person-years of follow-up. The average follow-up time was 8.7 years. During the study period, 860 patients had their first MACE. After controlling for confounding factors, a daily prednisolone dose of 5 mg or higher doubled the risk for MACE, compared with GC nonusers. MACE risk increased by 7% per month.

University of Wisconsin School of Medicine and Public Health

Long-term glucocorticoid use discouraged

Daily doses of less than 5 mg were not associated with higher MACE risk, but more research is necessary to understand whether these low doses are clinically efficacious, Dr. Tam said. “The study results suggest that a very-low-dose GC (less than 5 mg prednisolone daily) may be cardiovascular risk–neutral. However, further evaluation is needed to determine whether this dose is therapeutic. Other potential side effects, such as bone loss, increased infection risk, dyslipidemia, and hyperglycemia, should also be considered.”

Both the American College of Rheumatology and the European Alliance of Associations for Rheumatology acknowledge that short-term GCs may be necessary for some RA patients, but they emphasize using the smallest necessary dose for the shortest period possible because of the known toxicity of GCs.

“We recommend stopping GCs as soon as it is clinically feasible, in line with previous recommendations, until these issues are investigated further,” Dr. Tam added.

Dr. Bartels agreed that long-term use of GCs should be avoided if possible, even at lower doses, because although CV risk may be less of an issue, studies have shown an increased risk for infection even at GC doses of less than 5 mg a day.
 

How might risk increase with dose?

While the study showed a distinct difference in risk with doses of prednisolone higher and lower than 5 mg, more information on how risk increases with dose could be useful, said Beth Wallace, MD, an assistant professor in internal medicine at the University of Michigan, Ann Arbor, and a staff rheumatologist at the VA Ann Arbor Healthcare Center. She was also unaffiliated with the research. “If someone is on 5-10 mg ... how much better is that than being on 10-20 mg or being on 20-30 mg?” she asked. While these study findings are “very important,” she said, it would be useful to know the risk associated with 7.5 mg vs. a higher dose.

University of Michigan

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

A daily prednisolone dose of 5 mg or higher is associated with increased risk for major adverse cardiovascular events (MACE) among patients with rheumatoid arthritis (RA), data suggest. Patients taking daily doses below this threshold did not appear to have an increased risk of MACE, compared with those not taking glucocorticoids (GCs).

Chinese University of Hong Kong

Is there a ‘safe’ dose for glucocorticoids?

To analyze this relationship, Dr. Lam and colleagues used the Hospital Authority Data Collaboration Laboratory, a citywide health care database. The investigators recruited patients with RA who had no history of MACE from 2006 to 2015 and followed them until the end of 2018. The primary outcome was the first occurrence of a MACE, defined as a composite of myocardial infarction (MI), unstable angina, ischemic or hemorrhagic cerebrovascular accident, transient ischemic attack, and CV death.

The study was published in Annals of the Rheumatic Diseases.

The analysis included 12,233 patients with RA and had over 105,826 person-years of follow-up. The average follow-up time was 8.7 years. During the study period, 860 patients had their first MACE. After controlling for confounding factors, a daily prednisolone dose of 5 mg or higher doubled the risk for MACE, compared with GC nonusers. MACE risk increased by 7% per month.

University of Wisconsin School of Medicine and Public Health

Long-term glucocorticoid use discouraged

Daily doses of less than 5 mg were not associated with higher MACE risk, but more research is necessary to understand whether these low doses are clinically efficacious, Dr. Tam said. “The study results suggest that a very-low-dose GC (less than 5 mg prednisolone daily) may be cardiovascular risk–neutral. However, further evaluation is needed to determine whether this dose is therapeutic. Other potential side effects, such as bone loss, increased infection risk, dyslipidemia, and hyperglycemia, should also be considered.”

Both the American College of Rheumatology and the European Alliance of Associations for Rheumatology acknowledge that short-term GCs may be necessary for some RA patients, but they emphasize using the smallest necessary dose for the shortest period possible because of the known toxicity of GCs.

“We recommend stopping GCs as soon as it is clinically feasible, in line with previous recommendations, until these issues are investigated further,” Dr. Tam added.

Dr. Bartels agreed that long-term use of GCs should be avoided if possible, even at lower doses, because although CV risk may be less of an issue, studies have shown an increased risk for infection even at GC doses of less than 5 mg a day.
 

How might risk increase with dose?

While the study showed a distinct difference in risk with doses of prednisolone higher and lower than 5 mg, more information on how risk increases with dose could be useful, said Beth Wallace, MD, an assistant professor in internal medicine at the University of Michigan, Ann Arbor, and a staff rheumatologist at the VA Ann Arbor Healthcare Center. She was also unaffiliated with the research. “If someone is on 5-10 mg ... how much better is that than being on 10-20 mg or being on 20-30 mg?” she asked. While these study findings are “very important,” she said, it would be useful to know the risk associated with 7.5 mg vs. a higher dose.

University of Michigan

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

A daily prednisolone dose of 5 mg or higher is associated with increased risk for major adverse cardiovascular events (MACE) among patients with rheumatoid arthritis (RA), data suggest. Patients taking daily doses below this threshold did not appear to have an increased risk of MACE, compared with those not taking glucocorticoids (GCs).

Chinese University of Hong Kong

Is there a ‘safe’ dose for glucocorticoids?

To analyze this relationship, Dr. Lam and colleagues used the Hospital Authority Data Collaboration Laboratory, a citywide health care database. The investigators recruited patients with RA who had no history of MACE from 2006 to 2015 and followed them until the end of 2018. The primary outcome was the first occurrence of a MACE, defined as a composite of myocardial infarction (MI), unstable angina, ischemic or hemorrhagic cerebrovascular accident, transient ischemic attack, and CV death.

The study was published in Annals of the Rheumatic Diseases.

The analysis included 12,233 patients with RA and had over 105,826 person-years of follow-up. The average follow-up time was 8.7 years. During the study period, 860 patients had their first MACE. After controlling for confounding factors, a daily prednisolone dose of 5 mg or higher doubled the risk for MACE, compared with GC nonusers. MACE risk increased by 7% per month.

University of Wisconsin School of Medicine and Public Health

Long-term glucocorticoid use discouraged

Daily doses of less than 5 mg were not associated with higher MACE risk, but more research is necessary to understand whether these low doses are clinically efficacious, Dr. Tam said. “The study results suggest that a very-low-dose GC (less than 5 mg prednisolone daily) may be cardiovascular risk–neutral. However, further evaluation is needed to determine whether this dose is therapeutic. Other potential side effects, such as bone loss, increased infection risk, dyslipidemia, and hyperglycemia, should also be considered.”

Both the American College of Rheumatology and the European Alliance of Associations for Rheumatology acknowledge that short-term GCs may be necessary for some RA patients, but they emphasize using the smallest necessary dose for the shortest period possible because of the known toxicity of GCs.

“We recommend stopping GCs as soon as it is clinically feasible, in line with previous recommendations, until these issues are investigated further,” Dr. Tam added.

Dr. Bartels agreed that long-term use of GCs should be avoided if possible, even at lower doses, because although CV risk may be less of an issue, studies have shown an increased risk for infection even at GC doses of less than 5 mg a day.
 

How might risk increase with dose?

While the study showed a distinct difference in risk with doses of prednisolone higher and lower than 5 mg, more information on how risk increases with dose could be useful, said Beth Wallace, MD, an assistant professor in internal medicine at the University of Michigan, Ann Arbor, and a staff rheumatologist at the VA Ann Arbor Healthcare Center. She was also unaffiliated with the research. “If someone is on 5-10 mg ... how much better is that than being on 10-20 mg or being on 20-30 mg?” she asked. While these study findings are “very important,” she said, it would be useful to know the risk associated with 7.5 mg vs. a higher dose.

University of Michigan

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

Hospitalizations fell by 11% in patients assigned to integrated social needs case management, a randomized controlled study conducted in California found.

The reduction in acute care use was likely because of the 3% increase in primary care visits with this approach, according to lead study author Mark D. Fleming, PhD, MS, assistant professor of health and social behavior at the University of California, Berkeley. The study was published in Annals of Internal Medicine.

The study

The current data came from a secondary analysis of a randomized encouragement study in Costa County, Calif., during 2017 and 2018. That study allocated adult California Medicaid beneficiaries of diverse race and ethnicity, relatively high social needs, and high risk for acute care use to two arms: social needs case management (n = 21,422) or administrative observation (22,389 weighted). Chronic health issues ranged from arthritis, diabetes, and back conditions to heart or lung disease, and psychological disorders. About 50% in both groups were younger than age 40 and 60% were women.

Case managers assessed patient needs, created a patient-centered care plan, and facilitated community resource referrals, primary care visits, and applications for public benefits.

The professionally diverse managers included public health nurses, social workers, substance misuse counselors, and mental health clinicians, as well as homeless service specialists and community health workers. Case management was offered as in-person or remote telephonic services for 1 year.

While rates of primary care visits were significantly higher in the case management group – incidence rate 1.03 (95% confidence interval [CI],1.00-1.07) – no intergroup differences emerged in visits for specialty care, behavioral health, psychiatric emergency visits, or jail intakes.

Although the analysis could not measure a direct effect of primary care use on hospitalizations, the results suggested it would take 6.6 primary care visits to avert one hospitalization. As a limitation, the outcomes were studied for only 1 year, but further effects of case management on health and service use could take longer to appear.

Commenting on the analysis but not involved in it, Laura Gottlieb, MD, MPH, professor in the department of family and community medicine at the University of California, San Francisco, said a few studies have suggested several pathways through which case management might influence health and health care utilization – and not solely through access to social services.

Dr. Gottlieb

“The current findings underscore that one of those pathways is likely via connection to health care services,” she said.

As to the cost effectiveness of social needs case management given the necessary increase in personnel costs, she added, that it is a matter of society’s priorities. “If we want to achieve equity, we need to invest dollars differently. That is not a hospital-level issue. It is a society-level issue. Hospitals need to be able to stay afloat, so health care policies need to enable them to make different decisions,” she added. Broadly implementing such an approach will obviously take investment, Dr. Gottlieb continued.

“California Medicaid is trying to enable this shift in investments, but it is hard to move existing structures.” She added that more data are needed on the interaction between social services, patient experiences of care, and self-efficacy to understand a wider array of mechanisms through which case management might affect outcomes.

This analysis was supported by the Agency for Healthcare Research and Quality and Contra Costa Health Services. The authors disclosed no relevant conflicts of interest.

Hospitalizations fell by 11% in patients assigned to integrated social needs case management, a randomized controlled study conducted in California found.

The reduction in acute care use was likely because of the 3% increase in primary care visits with this approach, according to lead study author Mark D. Fleming, PhD, MS, assistant professor of health and social behavior at the University of California, Berkeley. The study was published in Annals of Internal Medicine.

The study

The current data came from a secondary analysis of a randomized encouragement study in Costa County, Calif., during 2017 and 2018. That study allocated adult California Medicaid beneficiaries of diverse race and ethnicity, relatively high social needs, and high risk for acute care use to two arms: social needs case management (n = 21,422) or administrative observation (22,389 weighted). Chronic health issues ranged from arthritis, diabetes, and back conditions to heart or lung disease, and psychological disorders. About 50% in both groups were younger than age 40 and 60% were women.

Case managers assessed patient needs, created a patient-centered care plan, and facilitated community resource referrals, primary care visits, and applications for public benefits.

The professionally diverse managers included public health nurses, social workers, substance misuse counselors, and mental health clinicians, as well as homeless service specialists and community health workers. Case management was offered as in-person or remote telephonic services for 1 year.

While rates of primary care visits were significantly higher in the case management group – incidence rate 1.03 (95% confidence interval [CI],1.00-1.07) – no intergroup differences emerged in visits for specialty care, behavioral health, psychiatric emergency visits, or jail intakes.

Although the analysis could not measure a direct effect of primary care use on hospitalizations, the results suggested it would take 6.6 primary care visits to avert one hospitalization. As a limitation, the outcomes were studied for only 1 year, but further effects of case management on health and service use could take longer to appear.

Commenting on the analysis but not involved in it, Laura Gottlieb, MD, MPH, professor in the department of family and community medicine at the University of California, San Francisco, said a few studies have suggested several pathways through which case management might influence health and health care utilization – and not solely through access to social services.

Dr. Gottlieb

“The current findings underscore that one of those pathways is likely via connection to health care services,” she said.

As to the cost effectiveness of social needs case management given the necessary increase in personnel costs, she added, that it is a matter of society’s priorities. “If we want to achieve equity, we need to invest dollars differently. That is not a hospital-level issue. It is a society-level issue. Hospitals need to be able to stay afloat, so health care policies need to enable them to make different decisions,” she added. Broadly implementing such an approach will obviously take investment, Dr. Gottlieb continued.

“California Medicaid is trying to enable this shift in investments, but it is hard to move existing structures.” She added that more data are needed on the interaction between social services, patient experiences of care, and self-efficacy to understand a wider array of mechanisms through which case management might affect outcomes.

This analysis was supported by the Agency for Healthcare Research and Quality and Contra Costa Health Services. The authors disclosed no relevant conflicts of interest.

Hospitalizations fell by 11% in patients assigned to integrated social needs case management, a randomized controlled study conducted in California found.

The reduction in acute care use was likely because of the 3% increase in primary care visits with this approach, according to lead study author Mark D. Fleming, PhD, MS, assistant professor of health and social behavior at the University of California, Berkeley. The study was published in Annals of Internal Medicine.

The study

The current data came from a secondary analysis of a randomized encouragement study in Costa County, Calif., during 2017 and 2018. That study allocated adult California Medicaid beneficiaries of diverse race and ethnicity, relatively high social needs, and high risk for acute care use to two arms: social needs case management (n = 21,422) or administrative observation (22,389 weighted). Chronic health issues ranged from arthritis, diabetes, and back conditions to heart or lung disease, and psychological disorders. About 50% in both groups were younger than age 40 and 60% were women.

Case managers assessed patient needs, created a patient-centered care plan, and facilitated community resource referrals, primary care visits, and applications for public benefits.

The professionally diverse managers included public health nurses, social workers, substance misuse counselors, and mental health clinicians, as well as homeless service specialists and community health workers. Case management was offered as in-person or remote telephonic services for 1 year.

While rates of primary care visits were significantly higher in the case management group – incidence rate 1.03 (95% confidence interval [CI],1.00-1.07) – no intergroup differences emerged in visits for specialty care, behavioral health, psychiatric emergency visits, or jail intakes.

Although the analysis could not measure a direct effect of primary care use on hospitalizations, the results suggested it would take 6.6 primary care visits to avert one hospitalization. As a limitation, the outcomes were studied for only 1 year, but further effects of case management on health and service use could take longer to appear.

Commenting on the analysis but not involved in it, Laura Gottlieb, MD, MPH, professor in the department of family and community medicine at the University of California, San Francisco, said a few studies have suggested several pathways through which case management might influence health and health care utilization – and not solely through access to social services.

Dr. Gottlieb

“The current findings underscore that one of those pathways is likely via connection to health care services,” she said.

As to the cost effectiveness of social needs case management given the necessary increase in personnel costs, she added, that it is a matter of society’s priorities. “If we want to achieve equity, we need to invest dollars differently. That is not a hospital-level issue. It is a society-level issue. Hospitals need to be able to stay afloat, so health care policies need to enable them to make different decisions,” she added. Broadly implementing such an approach will obviously take investment, Dr. Gottlieb continued.

“California Medicaid is trying to enable this shift in investments, but it is hard to move existing structures.” She added that more data are needed on the interaction between social services, patient experiences of care, and self-efficacy to understand a wider array of mechanisms through which case management might affect outcomes.

This analysis was supported by the Agency for Healthcare Research and Quality and Contra Costa Health Services. The authors disclosed no relevant conflicts of interest.