This month, two studies reported on the addition of novel therapies to the backbone of low dose cytarabine. The first study, evaluated the role of adding quizartinib to low-dose cytarabine (LDAC) in older patients with acute myeloid leukemia (AML) not suitable for intensive chemotherapy. The addition of quizartinib to LDAC vs. LDAC alone improved survival and response in older patients with AML with an FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) mutation who were unfit for intensive chemotherapy (IC). Among patients with FLT3-ITD mutation, LDAC+quizartinib improved response in 38% of patients vs. 0% of patients receiving LDAC alone (P = .02). The 2-year overall survival also improved significantly in patients receiving LDAC+quizartinib (hazard ratio [HR] 0.36; P = .024). The study included 202 older patients with AML (de novo AML 63%; secondary AML 25%; high-risk myelodysplastic syndrome 11%) unsuitable for IC with (n = 27) or without FLT3-ITD mutation randomly assigned to receive LDAC+quizartinib or LDAC alone.¹

The second study evaluated the combination of LDAC with venetoclax vs. placebo in treatment-naive patients with AML ineligible for IC. LDAC+venetoclax vs. LDAC+placebo improved median overall survival (HR 0.70; P = .04), along with higher rates of complete response (CR) or CR with incomplete hematologic recovery (CRi) (48.3% vs. 13.2%; P < .001) and postbaseline red blood cell and platelet transfusion independence (39.2% vs. 17.6%; P = .002). This was a post hoc analysis performed after an additional 6 months of follow-up of the phase 3 VIALE-C trial, including 211 adult patients with AML who were treatment-naive and unsuitable for IC. Patients were randomly assigned to receive LDAC with venetoclax (n = 143) or placebo (n = 68).² This study was previously reported with a shorter follow up and ddi not demonstrate a survival difference for LDAC+venetoclax vs. LDAC alone. It is very reassuring to see these results with longer follow-up with an improvement of the median overall survival from 4.1 months with LDAC alone to 8.4 months with LDAC+venetoclax. In addition, responses were seen in patients who had prior hypomethylating agents. The CR, CR/CRi and CR/CR with partial hematologic recovery (CRh) rates were 7%, 29%, and 21% respectively.

Finally in a study by Roboz et al. patients who received oral azacytidine as maintenance had no worsening of fatigue or health-related quality of life. Maintenance therapy with oral azacitidine (oral-AZA) did not negatively affect fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC). Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo. Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC. One caveat is that the assessments were performed on Day 1 of each 28 day cycle, which may have allowed for the recovery from side effects of oral azacytidine.³

References

1. Dennis M et al. Randomised evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients. Blood Adv. 2021 Oct 1.
2. Wei AH et al. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy. Blood Cancer J. 2021;11:163.
3. Roboz GJ et al. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase 3, placebo-controlled QUAZAR AML-001 trial. Haematologica. 2021 Sep 23.

This month, two studies reported on the addition of novel therapies to the backbone of low dose cytarabine. The first study, evaluated the role of adding quizartinib to low-dose cytarabine (LDAC) in older patients with acute myeloid leukemia (AML) not suitable for intensive chemotherapy. The addition of quizartinib to LDAC vs. LDAC alone improved survival and response in older patients with AML with an FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) mutation who were unfit for intensive chemotherapy (IC). Among patients with FLT3-ITD mutation, LDAC+quizartinib improved response in 38% of patients vs. 0% of patients receiving LDAC alone (P = .02). The 2-year overall survival also improved significantly in patients receiving LDAC+quizartinib (hazard ratio [HR] 0.36; P = .024). The study included 202 older patients with AML (de novo AML 63%; secondary AML 25%; high-risk myelodysplastic syndrome 11%) unsuitable for IC with (n = 27) or without FLT3-ITD mutation randomly assigned to receive LDAC+quizartinib or LDAC alone.¹

The second study evaluated the combination of LDAC with venetoclax vs. placebo in treatment-naive patients with AML ineligible for IC. LDAC+venetoclax vs. LDAC+placebo improved median overall survival (HR 0.70; P = .04), along with higher rates of complete response (CR) or CR with incomplete hematologic recovery (CRi) (48.3% vs. 13.2%; P < .001) and postbaseline red blood cell and platelet transfusion independence (39.2% vs. 17.6%; P = .002). This was a post hoc analysis performed after an additional 6 months of follow-up of the phase 3 VIALE-C trial, including 211 adult patients with AML who were treatment-naive and unsuitable for IC. Patients were randomly assigned to receive LDAC with venetoclax (n = 143) or placebo (n = 68).² This study was previously reported with a shorter follow up and ddi not demonstrate a survival difference for LDAC+venetoclax vs. LDAC alone. It is very reassuring to see these results with longer follow-up with an improvement of the median overall survival from 4.1 months with LDAC alone to 8.4 months with LDAC+venetoclax. In addition, responses were seen in patients who had prior hypomethylating agents. The CR, CR/CRi and CR/CR with partial hematologic recovery (CRh) rates were 7%, 29%, and 21% respectively.

Finally in a study by Roboz et al. patients who received oral azacytidine as maintenance had no worsening of fatigue or health-related quality of life. Maintenance therapy with oral azacitidine (oral-AZA) did not negatively affect fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC). Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo. Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC. One caveat is that the assessments were performed on Day 1 of each 28 day cycle, which may have allowed for the recovery from side effects of oral azacytidine.³

References

1. Dennis M et al. Randomised evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients. Blood Adv. 2021 Oct 1.
2. Wei AH et al. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy. Blood Cancer J. 2021;11:163.
3. Roboz GJ et al. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase 3, placebo-controlled QUAZAR AML-001 trial. Haematologica. 2021 Sep 23.

This month, two studies reported on the addition of novel therapies to the backbone of low dose cytarabine. The first study, evaluated the role of adding quizartinib to low-dose cytarabine (LDAC) in older patients with acute myeloid leukemia (AML) not suitable for intensive chemotherapy. The addition of quizartinib to LDAC vs. LDAC alone improved survival and response in older patients with AML with an FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) mutation who were unfit for intensive chemotherapy (IC). Among patients with FLT3-ITD mutation, LDAC+quizartinib improved response in 38% of patients vs. 0% of patients receiving LDAC alone (P = .02). The 2-year overall survival also improved significantly in patients receiving LDAC+quizartinib (hazard ratio [HR] 0.36; P = .024). The study included 202 older patients with AML (de novo AML 63%; secondary AML 25%; high-risk myelodysplastic syndrome 11%) unsuitable for IC with (n = 27) or without FLT3-ITD mutation randomly assigned to receive LDAC+quizartinib or LDAC alone.¹

The second study evaluated the combination of LDAC with venetoclax vs. placebo in treatment-naive patients with AML ineligible for IC. LDAC+venetoclax vs. LDAC+placebo improved median overall survival (HR 0.70; P = .04), along with higher rates of complete response (CR) or CR with incomplete hematologic recovery (CRi) (48.3% vs. 13.2%; P < .001) and postbaseline red blood cell and platelet transfusion independence (39.2% vs. 17.6%; P = .002). This was a post hoc analysis performed after an additional 6 months of follow-up of the phase 3 VIALE-C trial, including 211 adult patients with AML who were treatment-naive and unsuitable for IC. Patients were randomly assigned to receive LDAC with venetoclax (n = 143) or placebo (n = 68).² This study was previously reported with a shorter follow up and ddi not demonstrate a survival difference for LDAC+venetoclax vs. LDAC alone. It is very reassuring to see these results with longer follow-up with an improvement of the median overall survival from 4.1 months with LDAC alone to 8.4 months with LDAC+venetoclax. In addition, responses were seen in patients who had prior hypomethylating agents. The CR, CR/CRi and CR/CR with partial hematologic recovery (CRh) rates were 7%, 29%, and 21% respectively.

Finally in a study by Roboz et al. patients who received oral azacytidine as maintenance had no worsening of fatigue or health-related quality of life. Maintenance therapy with oral azacitidine (oral-AZA) did not negatively affect fatigue and health-related quality of life (HrQoL) in patients with acute myeloid leukemia (AML) in complete remission (CR) or CR with incomplete hematologic recovery (CRi) after intensive chemotherapy (IC). Effects of oral-AZA on fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue: difference in overall least square mean change [D] −0.89; 95% CI −2.37- 0.59) and HrQoL (EQ-5D-3L health utility index: D −0.01; 95% CI, −0.03-0.01; EQ-5D visual analog: D −0.95; 95% CI, −4.38-2.47) were comparable to placebo. Findings are from the QUAZAR AML-001 trial, including 444 patients with AML with intermediate- or poor-risk cytogenetics at diagnosis and unsuitable for transplantation. The patients were randomly assigned to receive either oral-AZA (n = 225) or placebo (n = 219) in first CR/CRi after IC. One caveat is that the assessments were performed on Day 1 of each 28 day cycle, which may have allowed for the recovery from side effects of oral azacytidine.³

References

1. Dennis M et al. Randomised evaluation of quizartinib and low-dose ara-C vs low-dose ara-C in older acute myeloid leukemia patients. Blood Adv. 2021 Oct 1.
2. Wei AH et al. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy. Blood Cancer J. 2021;11:163.
3. Roboz GJ et al. Oral azacitidine preserves favorable level of fatigue and health-related quality of life for patients with acute myeloid leukemia in remission: results from the phase 3, placebo-controlled QUAZAR AML-001 trial. Haematologica. 2021 Sep 23.

An oral treatment with freeze-dried human stool can successfully treat Clostridioides difficile infections by increasing the diversity of microorganisms in the colon, researchers say.

CP101, under development by Finch Therapeutics, proved more effective than a placebo in preventing recurrent infections for up to 24 weeks.

The CP101 capsules contain a powder of freeze-dried human stools from screened donors. They restore natural diversity that has been disrupted by antibiotics, said Jessica Allegretti, MD, MPH a gastroenterologist at Brigham and Women’s Hospital in Boston.

The treatment offers an alternative to fecal microbiota transplant, which can effectively treat antibiotic-resistant C. difficile infections but is difficult to standardize and administer – and doesn’t have full approval from the U.S. Food and Drug Administration, she added.

“I think this marks a moment in this space where we’re going to have better, safer, and more available options for patients,” she said in an interview. “It’s exciting.”

Dr. Allegretti is an author on three presentations of results from PRISM3, a phase 2 trial of CP101. They will be presented this week at the annual meeting of the American College of Gastroenterology. These results extend out to 24 weeks, whereas the 8-week results of this trial were presented a year ago at the same meeting.
 

Study details

The study enrolled 198 people who received antibiotics for recurrent C. difficile infections. Some patients had two or more recurrences, while others had only one recurrence but were 65 years of age or older.

“That was a unique aspect of this study, to see the effect of bringing a therapy like CP101 earlier in the treatment paradigm,” said Dr. Allegretti. “You can imagine for an older, frail, or more fragile patient that you would want to get rid of this [infection] earlier.”

After waiting 2-6 days for the antibiotics to wash out, the researchers randomly assigned 102 of these patients to take the CP101 pills orally and 96 to take placebo pills, both without bowel preparation.

The two groups were not significantly different in age, gender, comorbidities, the number of C. difficile recurrences, or the type of test used to diagnose the infection (PCR-based vs. toxin EIA-based).

After 8 weeks, 74.5% of those given the CP101 pills had not had a recurrence, compared with 61.5% of those given the placebo. The difference was just barely statistically significant (P = .0488).

Sixteen weeks later, the effect endured, with 73.5% of the CP101 group and 59.4% of the placebo group still free of recurrence. The statistical significance of the difference improved slightly (P = .0347).

Drug-related emergent adverse events were similar between the two groups: 16.3% for the CP101 group vs. 19.2% for the placebo group. These were mostly gastrointestinal symptoms, and none were serious.

Some of the patients received vancomycin as a first-line treatment for C. difficile infections, and the researchers wondered if the washout period was not sufficient to purge that antibiotic, leaving enough to interfere with the effectiveness of CP101.

Therefore, they separately analyzed 40 patients treated with fidaxomicin, which they expected to wash out more quickly. Among these patients, 81% who received CP101 were free of recurrences, at 8 weeks and 24 weeks. This compared with 42.1% of those who received the placebo, at both time points. This difference was more statistically significant (P = .0211).
 

Understanding how it works

To understand better how CP101 achieves its effects, the researchers collected stool samples from the patients and counted the number of different kinds organisms in each sample.

At baseline, the patients had about the same number, but after a week the diversity was greater in the patients treated with CP101, and that difference had increased at week 8. The researchers also found much less diversity of organisms in the stools of those patients who had recurrences of C. difficile infection.

The diversity of microbes in the successfully treated patients appeared to have been introduced by CP101. Dr. Allegretti and colleagues measured the number of organisms in the stool samples that came from CP101. They found that 96% of patients colonized by the CP101 organisms had avoided recurrence of the C. difficile infections, compared with 54.2% of those patients not colonized by these microbes.

“We now have some microbiome-based markers that show us as early as week 1 that the patient is going to be cured or not,” Dr. Allegretti said.

Based on these results, Finch plans to launch a phase 3 trial soon, she said.

The data on colonization is interesting because it has not been found with fecal microbiota transplants, said Purna Kashyap, MBBS, codirector of the Microbiome Program at the Mayo Clinic College of Medicine in Rochester, Minn., who was not involved in the study.

But to better interpret the data, it would be helpful to know more about how the placebo and CP101 groups compared at baseline with regard to medications, immunosuppression, and antibiotics used to treat the C. difficile infections, Dr. Kashyap said. He was struck by the lower cure rate in the portion of the placebo group treated with fidaxomicin.

“Overall, I think these are exciting observations based on the data but require careful review of the entire data to make sense of [them], which will happen when it goes through peer review,” he told this news organization in an email.

Several other standardized microbiota restoration products are under development, including at least two other capsules. In contrast to CP101, which is made up of whole stool, VE303 (Vedanta Biosciences) is a “rationally defined bacterial consortium,” and SER-109 (Seres Therapeutics) is a “consortium of highly purified Firmicutes spores.” VE303 has completed a phase 2 trial, and SER-109 has completed a phase 3 trial.

Dr. Allegretti is a consultant for Finch Therapeutics, which funded the trial. Dr. Kashyap has disclosed no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff. 

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

An oral treatment with freeze-dried human stool can successfully treat Clostridioides difficile infections by increasing the diversity of microorganisms in the colon, researchers say.

CP101, under development by Finch Therapeutics, proved more effective than a placebo in preventing recurrent infections for up to 24 weeks.

The CP101 capsules contain a powder of freeze-dried human stools from screened donors. They restore natural diversity that has been disrupted by antibiotics, said Jessica Allegretti, MD, MPH a gastroenterologist at Brigham and Women’s Hospital in Boston.

The treatment offers an alternative to fecal microbiota transplant, which can effectively treat antibiotic-resistant C. difficile infections but is difficult to standardize and administer – and doesn’t have full approval from the U.S. Food and Drug Administration, she added.

“I think this marks a moment in this space where we’re going to have better, safer, and more available options for patients,” she said in an interview. “It’s exciting.”

Dr. Allegretti is an author on three presentations of results from PRISM3, a phase 2 trial of CP101. They will be presented this week at the annual meeting of the American College of Gastroenterology. These results extend out to 24 weeks, whereas the 8-week results of this trial were presented a year ago at the same meeting.
 

Study details

The study enrolled 198 people who received antibiotics for recurrent C. difficile infections. Some patients had two or more recurrences, while others had only one recurrence but were 65 years of age or older.

“That was a unique aspect of this study, to see the effect of bringing a therapy like CP101 earlier in the treatment paradigm,” said Dr. Allegretti. “You can imagine for an older, frail, or more fragile patient that you would want to get rid of this [infection] earlier.”

After waiting 2-6 days for the antibiotics to wash out, the researchers randomly assigned 102 of these patients to take the CP101 pills orally and 96 to take placebo pills, both without bowel preparation.

The two groups were not significantly different in age, gender, comorbidities, the number of C. difficile recurrences, or the type of test used to diagnose the infection (PCR-based vs. toxin EIA-based).

After 8 weeks, 74.5% of those given the CP101 pills had not had a recurrence, compared with 61.5% of those given the placebo. The difference was just barely statistically significant (P = .0488).

Sixteen weeks later, the effect endured, with 73.5% of the CP101 group and 59.4% of the placebo group still free of recurrence. The statistical significance of the difference improved slightly (P = .0347).

Drug-related emergent adverse events were similar between the two groups: 16.3% for the CP101 group vs. 19.2% for the placebo group. These were mostly gastrointestinal symptoms, and none were serious.

Some of the patients received vancomycin as a first-line treatment for C. difficile infections, and the researchers wondered if the washout period was not sufficient to purge that antibiotic, leaving enough to interfere with the effectiveness of CP101.

Therefore, they separately analyzed 40 patients treated with fidaxomicin, which they expected to wash out more quickly. Among these patients, 81% who received CP101 were free of recurrences, at 8 weeks and 24 weeks. This compared with 42.1% of those who received the placebo, at both time points. This difference was more statistically significant (P = .0211).
 

Understanding how it works

To understand better how CP101 achieves its effects, the researchers collected stool samples from the patients and counted the number of different kinds organisms in each sample.

At baseline, the patients had about the same number, but after a week the diversity was greater in the patients treated with CP101, and that difference had increased at week 8. The researchers also found much less diversity of organisms in the stools of those patients who had recurrences of C. difficile infection.

The diversity of microbes in the successfully treated patients appeared to have been introduced by CP101. Dr. Allegretti and colleagues measured the number of organisms in the stool samples that came from CP101. They found that 96% of patients colonized by the CP101 organisms had avoided recurrence of the C. difficile infections, compared with 54.2% of those patients not colonized by these microbes.

“We now have some microbiome-based markers that show us as early as week 1 that the patient is going to be cured or not,” Dr. Allegretti said.

Based on these results, Finch plans to launch a phase 3 trial soon, she said.

The data on colonization is interesting because it has not been found with fecal microbiota transplants, said Purna Kashyap, MBBS, codirector of the Microbiome Program at the Mayo Clinic College of Medicine in Rochester, Minn., who was not involved in the study.

But to better interpret the data, it would be helpful to know more about how the placebo and CP101 groups compared at baseline with regard to medications, immunosuppression, and antibiotics used to treat the C. difficile infections, Dr. Kashyap said. He was struck by the lower cure rate in the portion of the placebo group treated with fidaxomicin.

“Overall, I think these are exciting observations based on the data but require careful review of the entire data to make sense of [them], which will happen when it goes through peer review,” he told this news organization in an email.

Several other standardized microbiota restoration products are under development, including at least two other capsules. In contrast to CP101, which is made up of whole stool, VE303 (Vedanta Biosciences) is a “rationally defined bacterial consortium,” and SER-109 (Seres Therapeutics) is a “consortium of highly purified Firmicutes spores.” VE303 has completed a phase 2 trial, and SER-109 has completed a phase 3 trial.

Dr. Allegretti is a consultant for Finch Therapeutics, which funded the trial. Dr. Kashyap has disclosed no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff. 

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

An oral treatment with freeze-dried human stool can successfully treat Clostridioides difficile infections by increasing the diversity of microorganisms in the colon, researchers say.

CP101, under development by Finch Therapeutics, proved more effective than a placebo in preventing recurrent infections for up to 24 weeks.

The CP101 capsules contain a powder of freeze-dried human stools from screened donors. They restore natural diversity that has been disrupted by antibiotics, said Jessica Allegretti, MD, MPH a gastroenterologist at Brigham and Women’s Hospital in Boston.

The treatment offers an alternative to fecal microbiota transplant, which can effectively treat antibiotic-resistant C. difficile infections but is difficult to standardize and administer – and doesn’t have full approval from the U.S. Food and Drug Administration, she added.

“I think this marks a moment in this space where we’re going to have better, safer, and more available options for patients,” she said in an interview. “It’s exciting.”

Dr. Allegretti is an author on three presentations of results from PRISM3, a phase 2 trial of CP101. They will be presented this week at the annual meeting of the American College of Gastroenterology. These results extend out to 24 weeks, whereas the 8-week results of this trial were presented a year ago at the same meeting.
 

Study details

The study enrolled 198 people who received antibiotics for recurrent C. difficile infections. Some patients had two or more recurrences, while others had only one recurrence but were 65 years of age or older.

“That was a unique aspect of this study, to see the effect of bringing a therapy like CP101 earlier in the treatment paradigm,” said Dr. Allegretti. “You can imagine for an older, frail, or more fragile patient that you would want to get rid of this [infection] earlier.”

After waiting 2-6 days for the antibiotics to wash out, the researchers randomly assigned 102 of these patients to take the CP101 pills orally and 96 to take placebo pills, both without bowel preparation.

The two groups were not significantly different in age, gender, comorbidities, the number of C. difficile recurrences, or the type of test used to diagnose the infection (PCR-based vs. toxin EIA-based).

After 8 weeks, 74.5% of those given the CP101 pills had not had a recurrence, compared with 61.5% of those given the placebo. The difference was just barely statistically significant (P = .0488).

Sixteen weeks later, the effect endured, with 73.5% of the CP101 group and 59.4% of the placebo group still free of recurrence. The statistical significance of the difference improved slightly (P = .0347).

Drug-related emergent adverse events were similar between the two groups: 16.3% for the CP101 group vs. 19.2% for the placebo group. These were mostly gastrointestinal symptoms, and none were serious.

Some of the patients received vancomycin as a first-line treatment for C. difficile infections, and the researchers wondered if the washout period was not sufficient to purge that antibiotic, leaving enough to interfere with the effectiveness of CP101.

Therefore, they separately analyzed 40 patients treated with fidaxomicin, which they expected to wash out more quickly. Among these patients, 81% who received CP101 were free of recurrences, at 8 weeks and 24 weeks. This compared with 42.1% of those who received the placebo, at both time points. This difference was more statistically significant (P = .0211).
 

Understanding how it works

To understand better how CP101 achieves its effects, the researchers collected stool samples from the patients and counted the number of different kinds organisms in each sample.

At baseline, the patients had about the same number, but after a week the diversity was greater in the patients treated with CP101, and that difference had increased at week 8. The researchers also found much less diversity of organisms in the stools of those patients who had recurrences of C. difficile infection.

The diversity of microbes in the successfully treated patients appeared to have been introduced by CP101. Dr. Allegretti and colleagues measured the number of organisms in the stool samples that came from CP101. They found that 96% of patients colonized by the CP101 organisms had avoided recurrence of the C. difficile infections, compared with 54.2% of those patients not colonized by these microbes.

“We now have some microbiome-based markers that show us as early as week 1 that the patient is going to be cured or not,” Dr. Allegretti said.

Based on these results, Finch plans to launch a phase 3 trial soon, she said.

The data on colonization is interesting because it has not been found with fecal microbiota transplants, said Purna Kashyap, MBBS, codirector of the Microbiome Program at the Mayo Clinic College of Medicine in Rochester, Minn., who was not involved in the study.

But to better interpret the data, it would be helpful to know more about how the placebo and CP101 groups compared at baseline with regard to medications, immunosuppression, and antibiotics used to treat the C. difficile infections, Dr. Kashyap said. He was struck by the lower cure rate in the portion of the placebo group treated with fidaxomicin.

“Overall, I think these are exciting observations based on the data but require careful review of the entire data to make sense of [them], which will happen when it goes through peer review,” he told this news organization in an email.

Several other standardized microbiota restoration products are under development, including at least two other capsules. In contrast to CP101, which is made up of whole stool, VE303 (Vedanta Biosciences) is a “rationally defined bacterial consortium,” and SER-109 (Seres Therapeutics) is a “consortium of highly purified Firmicutes spores.” VE303 has completed a phase 2 trial, and SER-109 has completed a phase 3 trial.

Dr. Allegretti is a consultant for Finch Therapeutics, which funded the trial. Dr. Kashyap has disclosed no relevant financial relationships.

Help your patients understand their C. difficile diagnosis by sharing patient education from the AGA GI Patient Center: www.gastro.org/Cdiff. 

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

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Approximately 12,000 new cases of cervical cancer are diagnosed in women in the United States each year, based on data from the Centers for Disease Control and Prevention, said B.J. Rimel, MD, of Cedars-Sinai Medical Center, Los Angeles, in a presentation at the virtual Advancing NIH Research on the Health of Women conference sponsored by the National Institutes of Health.

Despite increased cervical cancer prevention and screening efforts, the incidence of, and mortality from, cervical cancer has remained stable for the past 2 decades, said Dr. Rimel.

Cervical cancer is the only cancer that can be prevented by vaccination, Dr. Rimel noted. It is essential to identify the women who are dying from cervical cancer, as well as who gets screened, who gets vaccinated, and who ends up in clinical trials, she said.

Novel agents for treating cervical cancer suggest that improvement in stagnant mortality rates is possible, said Dr. Rimel. She noted recent studies of cemiplimab, tisotumab vedotin, and a combination therapy involving pembrolizumab and platinum/paclitaxel, with and without bevacizumab.

Dr. Rimel suggested several opportunities to improve the identification and treatment of cervical cancer: Treat it like a rare disease; address structural racism through clinical trials; create opportunities for low–socioeconomic status patients to be involved in research; and develop solutions according to location (urban vs. rural), she said.

Compared with other cancers, cervical cancer is relatively rare in the United States, Dr. Rimel said. However, “It is important that those with cervical cancer can get treated and get healed from the disease,” she said. To better identify the women with cervical cancer who need treatment and to get them into clinical trials, she suggested using strategies employed by rare disease groups, such as seeking out patient support groups and registries.

Significant racial and ethnic disparities persist in cervical cancer, Dr. Rimel emphasized. Data from the CDC show that Black and Hispanic women in the United States are diagnosed with cervical cancer more frequently than women of other races and ethnicities and are less likely to survive.

“Reimagine cervical cancer as a disease of patients who are historically underrepresented due to race, language, poverty, and location,” she said.

Improving equity in cervical cancer care involves structural and trial-specific issues, said Dr. Rimel. Structural issues start with addressing how women enter into the health care system, she said. Consider where women receive care, and whether women have the opportunity to be vaccinated, and later screened, she said. Consider barriers to cervical cancer trials in centers with larger underserved populations, not only cost or insurance, but also issues of language and trust between patients and health care providers, she noted.

To improve the equity of cervical cancer clinical trials, consider potential barriers to enrollment, she added.

“Low English fluency is a barrier to trial enrollment,” said Dr. Rimel. In-person translation is essential for consent to participate in a trial, and “clinical trial budgets must reflect this requirement,” she added. Patient-reported outcomes need to be in the patient’s preferred language, “this includes online content,” Dr. Rimel said.

Dr. Rimel presented other strategies for clinical trial designs to improve equity.

“Compensate patients for their travel, or provide them with tech to allow for off-site monitoring,” she proposed. Patients of lower socioeconomic status in rural and urban areas have different barriers to enrollment, but virtual visits might be an option for those able to access the Internet when given a device. For others, smaller trial sites closer to home, combined with compensation for travel or missed work, might create more opportunities to participate, Dr. Rimel said. Finally, researchers should consider potential roles for smaller or broader studies that involve less travel and testing that would be feasible for more patients who might not otherwise participate in a clinical trial, she concluded.

Dr. Rimel had no financial conflicts to disclose.

Patients in the United States continue to experience rising out-of-pocket medical costs, with little access to the price information they desire when making decisions regarding medical care.¹ The Centers for Medicare & Medicaid Services (CMS) has taken steps toward transparency by requiring hospitals to publish price information.² In this issue of the Journal of Hospital Medicine, White and Liao³ break down the new rule, and we further discuss how this policy affects patients, hospitals, and hospitalists.

The new CMS rule requires hospitals to publish the prices of 300 “shoppable” services, including those negotiated with different payors. The rule standardizes how this information is displayed and accessed, with a daily penalty for facilities that fail to comply. Clinics and ambulatory surgical centers are currently excluded, as are facility and ancillary fees, such as those billed by pathology or anesthesiology. As White and Liao point out, a limitation for hospitalists is that this rule will only affect orders for the outpatient setting at discharge. In addition, this rule separates cost from quality. Although quality data are publicly available via CMS, price data are posted directly by hospitals, making a true value assessment difficult. To strengthen the rule, White and Liao recommend the following: increasing the financial penalty for noncompliance; aggregating data centrally to allow for comparisons; adding quality data to cost; expanding included sites and types of services; and adding common additional fees to the service price.

The larger question is whether patients will use these data in the manner intended. Previous studies have found a paradoxical relationship between patients’ expressed desire to compare prices for medical services vs documented low levels of price-shopping behavior. Mehrotra et al¹ found that lack of access to data as well as loyalty to providers were significant barriers to using price data effectively. The CMS rule increases access to the price information patients desire but cannot find. However, it is unclear whether available prices will be sufficient to change behaviors given that, aside from those with no insurance and those with high-deductible plans, most patients are fairly removed from the actual cost of service.

This rule may have a larger, unexpected impact on hospitals and access to care. Sharing price data could increase pressure on facilities to merge with larger systems in order to obtain more favorable rates via increased negotiating power. Hospitals that serve poorer communities may not be attractive merger candidates for large systems and could be left out of the push toward consolidation. Charging higher prices for the same services could lead to hospital closures or cuts in resources, potentially exacerbating health inequities for underserved populations.

On the provider end, it is unlikely that price transparency will influence resource utilization. Mummadi et al⁴ found that displaying price information in the electronic health record did not significantly influence physician ordering behavior. For hospitalists today, the emphasis on “high-value care” is already an important consideration when utilizing healthcare resources, considering the Accreditation Council for Graduate Medical Education (ACGME) requirements for residency, restrictive insurance protocols, and guidelines such as the ACR Appropriateness Criteria and the American Board of Internal Medicine’s Choosing Wisely^® campaign. Outside of extremes, separate cost data likely will not make a difference in provider ordering practices.

Although the information from this rule may not cause dramatic practice change, it will allow us to help our patients by providing those interested in price-shopping with data. This policy represents a large step toward a more transparent healthcare system, though it may have limited impact on overall healthcare costs.

Patients in the United States continue to experience rising out-of-pocket medical costs, with little access to the price information they desire when making decisions regarding medical care.¹ The Centers for Medicare & Medicaid Services (CMS) has taken steps toward transparency by requiring hospitals to publish price information.² In this issue of the Journal of Hospital Medicine, White and Liao³ break down the new rule, and we further discuss how this policy affects patients, hospitals, and hospitalists.

The new CMS rule requires hospitals to publish the prices of 300 “shoppable” services, including those negotiated with different payors. The rule standardizes how this information is displayed and accessed, with a daily penalty for facilities that fail to comply. Clinics and ambulatory surgical centers are currently excluded, as are facility and ancillary fees, such as those billed by pathology or anesthesiology. As White and Liao point out, a limitation for hospitalists is that this rule will only affect orders for the outpatient setting at discharge. In addition, this rule separates cost from quality. Although quality data are publicly available via CMS, price data are posted directly by hospitals, making a true value assessment difficult. To strengthen the rule, White and Liao recommend the following: increasing the financial penalty for noncompliance; aggregating data centrally to allow for comparisons; adding quality data to cost; expanding included sites and types of services; and adding common additional fees to the service price.

The larger question is whether patients will use these data in the manner intended. Previous studies have found a paradoxical relationship between patients’ expressed desire to compare prices for medical services vs documented low levels of price-shopping behavior. Mehrotra et al¹ found that lack of access to data as well as loyalty to providers were significant barriers to using price data effectively. The CMS rule increases access to the price information patients desire but cannot find. However, it is unclear whether available prices will be sufficient to change behaviors given that, aside from those with no insurance and those with high-deductible plans, most patients are fairly removed from the actual cost of service.

This rule may have a larger, unexpected impact on hospitals and access to care. Sharing price data could increase pressure on facilities to merge with larger systems in order to obtain more favorable rates via increased negotiating power. Hospitals that serve poorer communities may not be attractive merger candidates for large systems and could be left out of the push toward consolidation. Charging higher prices for the same services could lead to hospital closures or cuts in resources, potentially exacerbating health inequities for underserved populations.

On the provider end, it is unlikely that price transparency will influence resource utilization. Mummadi et al⁴ found that displaying price information in the electronic health record did not significantly influence physician ordering behavior. For hospitalists today, the emphasis on “high-value care” is already an important consideration when utilizing healthcare resources, considering the Accreditation Council for Graduate Medical Education (ACGME) requirements for residency, restrictive insurance protocols, and guidelines such as the ACR Appropriateness Criteria and the American Board of Internal Medicine’s Choosing Wisely^® campaign. Outside of extremes, separate cost data likely will not make a difference in provider ordering practices.

Although the information from this rule may not cause dramatic practice change, it will allow us to help our patients by providing those interested in price-shopping with data. This policy represents a large step toward a more transparent healthcare system, though it may have limited impact on overall healthcare costs.

Patients in the United States continue to experience rising out-of-pocket medical costs, with little access to the price information they desire when making decisions regarding medical care.¹ The Centers for Medicare & Medicaid Services (CMS) has taken steps toward transparency by requiring hospitals to publish price information.² In this issue of the Journal of Hospital Medicine, White and Liao³ break down the new rule, and we further discuss how this policy affects patients, hospitals, and hospitalists.

The new CMS rule requires hospitals to publish the prices of 300 “shoppable” services, including those negotiated with different payors. The rule standardizes how this information is displayed and accessed, with a daily penalty for facilities that fail to comply. Clinics and ambulatory surgical centers are currently excluded, as are facility and ancillary fees, such as those billed by pathology or anesthesiology. As White and Liao point out, a limitation for hospitalists is that this rule will only affect orders for the outpatient setting at discharge. In addition, this rule separates cost from quality. Although quality data are publicly available via CMS, price data are posted directly by hospitals, making a true value assessment difficult. To strengthen the rule, White and Liao recommend the following: increasing the financial penalty for noncompliance; aggregating data centrally to allow for comparisons; adding quality data to cost; expanding included sites and types of services; and adding common additional fees to the service price.

The larger question is whether patients will use these data in the manner intended. Previous studies have found a paradoxical relationship between patients’ expressed desire to compare prices for medical services vs documented low levels of price-shopping behavior. Mehrotra et al¹ found that lack of access to data as well as loyalty to providers were significant barriers to using price data effectively. The CMS rule increases access to the price information patients desire but cannot find. However, it is unclear whether available prices will be sufficient to change behaviors given that, aside from those with no insurance and those with high-deductible plans, most patients are fairly removed from the actual cost of service.

This rule may have a larger, unexpected impact on hospitals and access to care. Sharing price data could increase pressure on facilities to merge with larger systems in order to obtain more favorable rates via increased negotiating power. Hospitals that serve poorer communities may not be attractive merger candidates for large systems and could be left out of the push toward consolidation. Charging higher prices for the same services could lead to hospital closures or cuts in resources, potentially exacerbating health inequities for underserved populations.

On the provider end, it is unlikely that price transparency will influence resource utilization. Mummadi et al⁴ found that displaying price information in the electronic health record did not significantly influence physician ordering behavior. For hospitalists today, the emphasis on “high-value care” is already an important consideration when utilizing healthcare resources, considering the Accreditation Council for Graduate Medical Education (ACGME) requirements for residency, restrictive insurance protocols, and guidelines such as the ACR Appropriateness Criteria and the American Board of Internal Medicine’s Choosing Wisely^® campaign. Outside of extremes, separate cost data likely will not make a difference in provider ordering practices.

Although the information from this rule may not cause dramatic practice change, it will allow us to help our patients by providing those interested in price-shopping with data. This policy represents a large step toward a more transparent healthcare system, though it may have limited impact on overall healthcare costs.

Care concordant with patient goals of care (GOC) is a central component of quality. Communication about GOC is associated with improved quality of life, reduced resource utilization, and optimized end-of-life (EOL) care. Prior literature has focused on outpatient populations, with little knowledge based on preferences elicited from patients hospitalized for serious acute illness.¹ The consequent knowledge gap relates to a dimension of practice through which hospitalists can improve patient-centered care by clarifying patient preferences for goal-directed treatments both during and following hospitalization.² Implementing interventions that optimize shared decision-making through a personalized serious- illness care plan is a high-priority research area.²

In this issue, to estimate how frequently GOC are assessed during hospitalization for serious illness and the concordance between identified goals and postdischarge care, Taylor et al³ retrospectively evaluated a cohort of sepsis survivors through electronic health record (EHR) review. A standardized EHR care alignment tool and a comprehensive EHR assessment demonstrated that only 19% and 40% of patients, respectively, had identifiable GOC documented. Goal-concordant care was subsequently observed among 68% of patients with identified goals, consistent with prior work demonstrating goal-concordance in this range.¹ Data on EOL care provided to decedents in an integrated health system notably showed that 89% received goal-concordant treatments.⁴ This difference may stem from clinicians’ emphasis on goal ascertainment at the EOL, a propensity reflected in the comparative characteristics of patients with goals documented in the current study’s Table.³ Investigators took advantage of unique inpatient and postdischarge clinical information from a sepsis patient sample to provide novel insights into the inadequacy of patient preference assessment and the substantial frequency of goal-discordant care resulting from insufficient attention to GOC.

This study suggests a critical need to improve practices related to identification of GOC in patients hospitalized with serious illness. After adjusting for relevant confounding characteristics, completion of a standardized EHR care alignment tool was strongly associated with receipt of goal-concordant care following discharge.³ Although this tool was only completed in 19% of patients, this finding suggests that elicitation of patient preferences is an under-addressed step in facilitating patient-centered transitions of care. In particular, the low 39% rate of goal-concordant care among patients prioritizing comfort over longevity is noteworthy, but consistent with prior literature.¹ This degree of discordance highlights provision of goal-concordant care following hospitalization as a key, yet unfulfilled, patient-centered-care quality metric.

The identified shortcomings in communication and care represent an important opportunity for hospitalists to enhance the extent to which survivors of critical illness receive care respectful of their preferences and values. Given the importance of effective discharge handoff practices in hospital medicine,² future work should address assertively incorporating GOC into transitions after serious acute illness. Enhancing communication of these goals at discharge may benefit patients at high risk of readmission and other postdischarge adverse events, particularly for patients with comfort-focused GOC.

The study is limited in its derivation from trial participants with a specific clinical syndrome in a single health system. Also, investigators’ classification of a single patient goal does not reflect the multifactorial objectives of health interventions. In addition, since patient-reported GOC discussions correlate more highly with goal-concordant care than those identified through EHRs,⁵ future work should ascertain the generalizability of the identified gaps in practice.

The findings of this study underscore the need for clinicians to promote GOC assessment and documentation during hospitalization for high-risk conditions, such as sepsis. Tracking rates of GOC elicitation and goal-concordant care following discharge should be incorporated into quality measurement systems as important patient-centered dimensions of care. Hospitalists can fill a critical void by helping to correct the deficiencies that exist in respecting the preferences of survivors of serious acute illness.

Care concordant with patient goals of care (GOC) is a central component of quality. Communication about GOC is associated with improved quality of life, reduced resource utilization, and optimized end-of-life (EOL) care. Prior literature has focused on outpatient populations, with little knowledge based on preferences elicited from patients hospitalized for serious acute illness.¹ The consequent knowledge gap relates to a dimension of practice through which hospitalists can improve patient-centered care by clarifying patient preferences for goal-directed treatments both during and following hospitalization.² Implementing interventions that optimize shared decision-making through a personalized serious- illness care plan is a high-priority research area.²

In this issue, to estimate how frequently GOC are assessed during hospitalization for serious illness and the concordance between identified goals and postdischarge care, Taylor et al³ retrospectively evaluated a cohort of sepsis survivors through electronic health record (EHR) review. A standardized EHR care alignment tool and a comprehensive EHR assessment demonstrated that only 19% and 40% of patients, respectively, had identifiable GOC documented. Goal-concordant care was subsequently observed among 68% of patients with identified goals, consistent with prior work demonstrating goal-concordance in this range.¹ Data on EOL care provided to decedents in an integrated health system notably showed that 89% received goal-concordant treatments.⁴ This difference may stem from clinicians’ emphasis on goal ascertainment at the EOL, a propensity reflected in the comparative characteristics of patients with goals documented in the current study’s Table.³ Investigators took advantage of unique inpatient and postdischarge clinical information from a sepsis patient sample to provide novel insights into the inadequacy of patient preference assessment and the substantial frequency of goal-discordant care resulting from insufficient attention to GOC.

This study suggests a critical need to improve practices related to identification of GOC in patients hospitalized with serious illness. After adjusting for relevant confounding characteristics, completion of a standardized EHR care alignment tool was strongly associated with receipt of goal-concordant care following discharge.³ Although this tool was only completed in 19% of patients, this finding suggests that elicitation of patient preferences is an under-addressed step in facilitating patient-centered transitions of care. In particular, the low 39% rate of goal-concordant care among patients prioritizing comfort over longevity is noteworthy, but consistent with prior literature.¹ This degree of discordance highlights provision of goal-concordant care following hospitalization as a key, yet unfulfilled, patient-centered-care quality metric.

The identified shortcomings in communication and care represent an important opportunity for hospitalists to enhance the extent to which survivors of critical illness receive care respectful of their preferences and values. Given the importance of effective discharge handoff practices in hospital medicine,² future work should address assertively incorporating GOC into transitions after serious acute illness. Enhancing communication of these goals at discharge may benefit patients at high risk of readmission and other postdischarge adverse events, particularly for patients with comfort-focused GOC.

The study is limited in its derivation from trial participants with a specific clinical syndrome in a single health system. Also, investigators’ classification of a single patient goal does not reflect the multifactorial objectives of health interventions. In addition, since patient-reported GOC discussions correlate more highly with goal-concordant care than those identified through EHRs,⁵ future work should ascertain the generalizability of the identified gaps in practice.

The findings of this study underscore the need for clinicians to promote GOC assessment and documentation during hospitalization for high-risk conditions, such as sepsis. Tracking rates of GOC elicitation and goal-concordant care following discharge should be incorporated into quality measurement systems as important patient-centered dimensions of care. Hospitalists can fill a critical void by helping to correct the deficiencies that exist in respecting the preferences of survivors of serious acute illness.

Care concordant with patient goals of care (GOC) is a central component of quality. Communication about GOC is associated with improved quality of life, reduced resource utilization, and optimized end-of-life (EOL) care. Prior literature has focused on outpatient populations, with little knowledge based on preferences elicited from patients hospitalized for serious acute illness.¹ The consequent knowledge gap relates to a dimension of practice through which hospitalists can improve patient-centered care by clarifying patient preferences for goal-directed treatments both during and following hospitalization.² Implementing interventions that optimize shared decision-making through a personalized serious- illness care plan is a high-priority research area.²

In this issue, to estimate how frequently GOC are assessed during hospitalization for serious illness and the concordance between identified goals and postdischarge care, Taylor et al³ retrospectively evaluated a cohort of sepsis survivors through electronic health record (EHR) review. A standardized EHR care alignment tool and a comprehensive EHR assessment demonstrated that only 19% and 40% of patients, respectively, had identifiable GOC documented. Goal-concordant care was subsequently observed among 68% of patients with identified goals, consistent with prior work demonstrating goal-concordance in this range.¹ Data on EOL care provided to decedents in an integrated health system notably showed that 89% received goal-concordant treatments.⁴ This difference may stem from clinicians’ emphasis on goal ascertainment at the EOL, a propensity reflected in the comparative characteristics of patients with goals documented in the current study’s Table.³ Investigators took advantage of unique inpatient and postdischarge clinical information from a sepsis patient sample to provide novel insights into the inadequacy of patient preference assessment and the substantial frequency of goal-discordant care resulting from insufficient attention to GOC.

This study suggests a critical need to improve practices related to identification of GOC in patients hospitalized with serious illness. After adjusting for relevant confounding characteristics, completion of a standardized EHR care alignment tool was strongly associated with receipt of goal-concordant care following discharge.³ Although this tool was only completed in 19% of patients, this finding suggests that elicitation of patient preferences is an under-addressed step in facilitating patient-centered transitions of care. In particular, the low 39% rate of goal-concordant care among patients prioritizing comfort over longevity is noteworthy, but consistent with prior literature.¹ This degree of discordance highlights provision of goal-concordant care following hospitalization as a key, yet unfulfilled, patient-centered-care quality metric.

The identified shortcomings in communication and care represent an important opportunity for hospitalists to enhance the extent to which survivors of critical illness receive care respectful of their preferences and values. Given the importance of effective discharge handoff practices in hospital medicine,² future work should address assertively incorporating GOC into transitions after serious acute illness. Enhancing communication of these goals at discharge may benefit patients at high risk of readmission and other postdischarge adverse events, particularly for patients with comfort-focused GOC.

The study is limited in its derivation from trial participants with a specific clinical syndrome in a single health system. Also, investigators’ classification of a single patient goal does not reflect the multifactorial objectives of health interventions. In addition, since patient-reported GOC discussions correlate more highly with goal-concordant care than those identified through EHRs,⁵ future work should ascertain the generalizability of the identified gaps in practice.

The findings of this study underscore the need for clinicians to promote GOC assessment and documentation during hospitalization for high-risk conditions, such as sepsis. Tracking rates of GOC elicitation and goal-concordant care following discharge should be incorporated into quality measurement systems as important patient-centered dimensions of care. Hospitalists can fill a critical void by helping to correct the deficiencies that exist in respecting the preferences of survivors of serious acute illness.

The advent of COVID-19 saw a precipitous decline in inpatient admissions. Even before the COVID-19 pandemic, hospitals were seeing a trend toward fewer inpatient admissions for Medicare beneficiaries, which has not been thoroughly examined or explained.¹ In this issue, Keohane et al² studied Medicare inpatient episode trends between 2009 and 2017 and found that, during this period, inpatient episodes per 1000 Medicare fee-for-service (FFS) beneficiaries declined by 18.2%, from 326 to 267 per 1000 beneficiaries.

This trend can be partly explained by changes in the way that care is delivered. First, observation stays have risen, and these are excluded in the authors’ analysis. From 2010 to 2017, observation visits per 1000 beneficiaries increased from 28 to 51.¹ Second, due to improved outpatient management, margin constraints, and efficiency gains, hospitals are less likely to admit patients with less complex problems or keep patients overnight for uncomplicated procedural interventions. In cardiology, there has been an increase in the proportion of same-day percutaneous coronary interventions, from 4.5% in 2009 to 28.6% in 2017.³ The authors do not include a quantitative measure of complexity, but their data support this conclusion as they find larger declines in episodes that began with a planned admission and those that involved no use of post–acute care services, and thus were likely less complicated admissions. Finally, the increased use of alternative care sites such as home-based care settings and urgent care clinics, the proliferation of telemedicine, and the continual development of guideline-based therapy have resulted in better outpatient management of diseases.

The growth of value-based care has also contributed to the reduction in inpatient admission. The past decade has seen the growth of bundled-payment contracts, accountable care organizations (ACO), and advanced primary care models. In 2018, an estimated 20% of Medicare beneficiaries were part of an ACO.⁴ These changes have led healthcare systems to invest in care management and postdischarge interventions, such as postdischarge phone calls, transitional clinics, and transition guides to reduce admissions and readmissions. Johns Hopkins adopted all these strategies to drive performance on the Maryland Total Cost of Care Model, which like an ACO holds hospitals accountable for both inpatient and outpatient costs incurred by Medicare FFS beneficiaries. A consistent theme among successful ACOs has been a reduction in inpatient spending.⁵

The authors are likely undercounting the volume of admissions by Medicare beneficiaries. First, to define an episode, they leverage the Medicare definition of bundles and include traditional Medicare inpatient, outpatient, and Part D services 30 days prior to hospitalizations and up to 90 days after. Admissions for the same diagnosis related group that occur in the 90 days after the anchor hospitalization are included in the same episode. From a clinical perspective, it is not intuitively clear why an admission for heart failure or pneumonia that occurs 3 months after an anchor hospitalization would not be defined as a separate and distinct admission rather than a readmission. Second, their analysis focuses on Medicare FFS and does not include Medicare Advantage, which now accounts for 42% of total Medicare beneficiaries. In fact, Medicare Advantage experienced significant growth in enrollment during the study period, increasing from 10 million to 24 million beneficiaries.⁶

Despite the reduction in inpatient volumes, the authors find that inpatient spending has increased. Spending per episode increased by 11.4% over this period, when adjusted for Medicare payment increases. Actual spending per episode unadjusted for payment increases rose by 25%. Thus, they astutely point out that most of the increase has been driven by Medicare payment increases. It is likely that increases in the complexity of patients and more dedicated focus on appropriate coding have also contributed. The authors, however, do not provide information on changes to the total cost of care outside of their defined inpatient episodes, a relevant measure to those participating in value-based models.

It is likely that the trend toward fewer inpatient admissions and increased outpatient management of medical conditions will continue as value-based care models grow. Studies like these are important in documenting this trend, but it will be important in future studies to understand how these changes have impacted the quality of care delivered to patients. Prior studies have found that reductions in readmissions through the Hospital Readmission Reduction Program were associated with increases in mortality as a potential unintended consequence.⁷

The advent of COVID-19 saw a precipitous decline in inpatient admissions. Even before the COVID-19 pandemic, hospitals were seeing a trend toward fewer inpatient admissions for Medicare beneficiaries, which has not been thoroughly examined or explained.¹ In this issue, Keohane et al² studied Medicare inpatient episode trends between 2009 and 2017 and found that, during this period, inpatient episodes per 1000 Medicare fee-for-service (FFS) beneficiaries declined by 18.2%, from 326 to 267 per 1000 beneficiaries.

This trend can be partly explained by changes in the way that care is delivered. First, observation stays have risen, and these are excluded in the authors’ analysis. From 2010 to 2017, observation visits per 1000 beneficiaries increased from 28 to 51.¹ Second, due to improved outpatient management, margin constraints, and efficiency gains, hospitals are less likely to admit patients with less complex problems or keep patients overnight for uncomplicated procedural interventions. In cardiology, there has been an increase in the proportion of same-day percutaneous coronary interventions, from 4.5% in 2009 to 28.6% in 2017.³ The authors do not include a quantitative measure of complexity, but their data support this conclusion as they find larger declines in episodes that began with a planned admission and those that involved no use of post–acute care services, and thus were likely less complicated admissions. Finally, the increased use of alternative care sites such as home-based care settings and urgent care clinics, the proliferation of telemedicine, and the continual development of guideline-based therapy have resulted in better outpatient management of diseases.

The growth of value-based care has also contributed to the reduction in inpatient admission. The past decade has seen the growth of bundled-payment contracts, accountable care organizations (ACO), and advanced primary care models. In 2018, an estimated 20% of Medicare beneficiaries were part of an ACO.⁴ These changes have led healthcare systems to invest in care management and postdischarge interventions, such as postdischarge phone calls, transitional clinics, and transition guides to reduce admissions and readmissions. Johns Hopkins adopted all these strategies to drive performance on the Maryland Total Cost of Care Model, which like an ACO holds hospitals accountable for both inpatient and outpatient costs incurred by Medicare FFS beneficiaries. A consistent theme among successful ACOs has been a reduction in inpatient spending.⁵

The authors are likely undercounting the volume of admissions by Medicare beneficiaries. First, to define an episode, they leverage the Medicare definition of bundles and include traditional Medicare inpatient, outpatient, and Part D services 30 days prior to hospitalizations and up to 90 days after. Admissions for the same diagnosis related group that occur in the 90 days after the anchor hospitalization are included in the same episode. From a clinical perspective, it is not intuitively clear why an admission for heart failure or pneumonia that occurs 3 months after an anchor hospitalization would not be defined as a separate and distinct admission rather than a readmission. Second, their analysis focuses on Medicare FFS and does not include Medicare Advantage, which now accounts for 42% of total Medicare beneficiaries. In fact, Medicare Advantage experienced significant growth in enrollment during the study period, increasing from 10 million to 24 million beneficiaries.⁶

Despite the reduction in inpatient volumes, the authors find that inpatient spending has increased. Spending per episode increased by 11.4% over this period, when adjusted for Medicare payment increases. Actual spending per episode unadjusted for payment increases rose by 25%. Thus, they astutely point out that most of the increase has been driven by Medicare payment increases. It is likely that increases in the complexity of patients and more dedicated focus on appropriate coding have also contributed. The authors, however, do not provide information on changes to the total cost of care outside of their defined inpatient episodes, a relevant measure to those participating in value-based models.

It is likely that the trend toward fewer inpatient admissions and increased outpatient management of medical conditions will continue as value-based care models grow. Studies like these are important in documenting this trend, but it will be important in future studies to understand how these changes have impacted the quality of care delivered to patients. Prior studies have found that reductions in readmissions through the Hospital Readmission Reduction Program were associated with increases in mortality as a potential unintended consequence.⁷

The advent of COVID-19 saw a precipitous decline in inpatient admissions. Even before the COVID-19 pandemic, hospitals were seeing a trend toward fewer inpatient admissions for Medicare beneficiaries, which has not been thoroughly examined or explained.¹ In this issue, Keohane et al² studied Medicare inpatient episode trends between 2009 and 2017 and found that, during this period, inpatient episodes per 1000 Medicare fee-for-service (FFS) beneficiaries declined by 18.2%, from 326 to 267 per 1000 beneficiaries.

This trend can be partly explained by changes in the way that care is delivered. First, observation stays have risen, and these are excluded in the authors’ analysis. From 2010 to 2017, observation visits per 1000 beneficiaries increased from 28 to 51.¹ Second, due to improved outpatient management, margin constraints, and efficiency gains, hospitals are less likely to admit patients with less complex problems or keep patients overnight for uncomplicated procedural interventions. In cardiology, there has been an increase in the proportion of same-day percutaneous coronary interventions, from 4.5% in 2009 to 28.6% in 2017.³ The authors do not include a quantitative measure of complexity, but their data support this conclusion as they find larger declines in episodes that began with a planned admission and those that involved no use of post–acute care services, and thus were likely less complicated admissions. Finally, the increased use of alternative care sites such as home-based care settings and urgent care clinics, the proliferation of telemedicine, and the continual development of guideline-based therapy have resulted in better outpatient management of diseases.

The growth of value-based care has also contributed to the reduction in inpatient admission. The past decade has seen the growth of bundled-payment contracts, accountable care organizations (ACO), and advanced primary care models. In 2018, an estimated 20% of Medicare beneficiaries were part of an ACO.⁴ These changes have led healthcare systems to invest in care management and postdischarge interventions, such as postdischarge phone calls, transitional clinics, and transition guides to reduce admissions and readmissions. Johns Hopkins adopted all these strategies to drive performance on the Maryland Total Cost of Care Model, which like an ACO holds hospitals accountable for both inpatient and outpatient costs incurred by Medicare FFS beneficiaries. A consistent theme among successful ACOs has been a reduction in inpatient spending.⁵

The authors are likely undercounting the volume of admissions by Medicare beneficiaries. First, to define an episode, they leverage the Medicare definition of bundles and include traditional Medicare inpatient, outpatient, and Part D services 30 days prior to hospitalizations and up to 90 days after. Admissions for the same diagnosis related group that occur in the 90 days after the anchor hospitalization are included in the same episode. From a clinical perspective, it is not intuitively clear why an admission for heart failure or pneumonia that occurs 3 months after an anchor hospitalization would not be defined as a separate and distinct admission rather than a readmission. Second, their analysis focuses on Medicare FFS and does not include Medicare Advantage, which now accounts for 42% of total Medicare beneficiaries. In fact, Medicare Advantage experienced significant growth in enrollment during the study period, increasing from 10 million to 24 million beneficiaries.⁶

Despite the reduction in inpatient volumes, the authors find that inpatient spending has increased. Spending per episode increased by 11.4% over this period, when adjusted for Medicare payment increases. Actual spending per episode unadjusted for payment increases rose by 25%. Thus, they astutely point out that most of the increase has been driven by Medicare payment increases. It is likely that increases in the complexity of patients and more dedicated focus on appropriate coding have also contributed. The authors, however, do not provide information on changes to the total cost of care outside of their defined inpatient episodes, a relevant measure to those participating in value-based models.

It is likely that the trend toward fewer inpatient admissions and increased outpatient management of medical conditions will continue as value-based care models grow. Studies like these are important in documenting this trend, but it will be important in future studies to understand how these changes have impacted the quality of care delivered to patients. Prior studies have found that reductions in readmissions through the Hospital Readmission Reduction Program were associated with increases in mortality as a potential unintended consequence.⁷

Two children who presented to emergency departments in different cities were diagnosed with diabetes mellitus and ketoacidosis. On presentation, both had significant anion gap metabolic acidosis. Because the patients were deemed unsafe for discharge, the admitting physician placed orders that dictated hospital care, including an order that designated the stay as observation (OBS) or inpatient (IP) status. During their stay, both patients received care including continuous infusion of insulin, intravenous fluids, and frequent lab monitoring. Each child recovered quickly and was discharged in less than 48 hours.

Despite both patients receiving comparable care, recovering well, and being discharged home after a similar length of stay, their encounter designation may be different. Although the patient outcome is of utmost importance, the consequences of labeling an encounter as OBS or IP status are complex and may impact the financial standing of patients, hospitals, and payors. Determining the trajectory of OBS status and its utilization in the pediatric population is vital to understanding the consequences of this designation.

In this issue of the Journal of Hospital Medicine, Tian et al¹ describe the increase in OBS status hospitalizations between 2010 and 2019, with OBS stays accounting for approximately one-third of pediatric hospitalizations within children’s hospitals in 2019. The increase in OBS status use was described in 19 of 20 of the most common All Patient Refined Diagnosis Related Groups, with the highest growth noted for surgical conditions and diabetes mellitus.¹ These frequently seen, high-stakes conditions, when expertly managed, may result in a safe discharge within 48 hours of admission, but the labor-intensive technical skills to ensure patient safety and high-value care often differ greatly from the idea of simply “observing” a patient.

The scope creep of OBS status in pediatrics is evident. OBS status was initially designed to acknowledge a prolonged outpatient period of monitoring with a goal of determining whether inpatient hospitalization was warranted. However, in most circumstances, the care of children under OBS status differs little from those under IP status; OBS status patients are usually cared for in the same wards and by the same providers as IP status patients. The similarities in care lead to nearly equivalent hospital costs for IP and OBS stays.² Comparable hospital costs would be less concerning if reimbursement were proportional, but OBS status hospitalizations are reimbursed at lower outpatient rates.³ The combination of similar costs and lower reimbursement results in a financial liability for children’s hospitals.

Tian et al add to the growing body of literature that underscores concerns with OBS stays.¹ Its increasing use over the past decade represents a troubling continuation of increased OBS status use described by Macy et al³ nearly a decade ago, and the variability with which it is applied suggests that the designation has little connection to the clinical status of patients. Instead, its use is more likely influenced by local payor contracts, individual state laws, and provider culture. For individual institutions, this differential application affects more than just reimbursement. OBS stays are often excluded from nationally representative administrative databases, which makes hospital benchmarking, research on outcomes, and accurate comparison of patient populations impossible.^4,5

The trends described by Tian et al¹ raise concerns about the potential impact that OBS stays have on patients and hospital systems across the country. OBS status was created to serve a clinical need, but its inconsistent use places hospitals and the children they treat at risk. This erratic application of OBS status and the serious results of its assignment to pediatric hospitalizations provide evidence that criteria for OBS need to be standardized or otherwise abandoned outright.

Two children who presented to emergency departments in different cities were diagnosed with diabetes mellitus and ketoacidosis. On presentation, both had significant anion gap metabolic acidosis. Because the patients were deemed unsafe for discharge, the admitting physician placed orders that dictated hospital care, including an order that designated the stay as observation (OBS) or inpatient (IP) status. During their stay, both patients received care including continuous infusion of insulin, intravenous fluids, and frequent lab monitoring. Each child recovered quickly and was discharged in less than 48 hours.

Despite both patients receiving comparable care, recovering well, and being discharged home after a similar length of stay, their encounter designation may be different. Although the patient outcome is of utmost importance, the consequences of labeling an encounter as OBS or IP status are complex and may impact the financial standing of patients, hospitals, and payors. Determining the trajectory of OBS status and its utilization in the pediatric population is vital to understanding the consequences of this designation.

In this issue of the Journal of Hospital Medicine, Tian et al¹ describe the increase in OBS status hospitalizations between 2010 and 2019, with OBS stays accounting for approximately one-third of pediatric hospitalizations within children’s hospitals in 2019. The increase in OBS status use was described in 19 of 20 of the most common All Patient Refined Diagnosis Related Groups, with the highest growth noted for surgical conditions and diabetes mellitus.¹ These frequently seen, high-stakes conditions, when expertly managed, may result in a safe discharge within 48 hours of admission, but the labor-intensive technical skills to ensure patient safety and high-value care often differ greatly from the idea of simply “observing” a patient.

The scope creep of OBS status in pediatrics is evident. OBS status was initially designed to acknowledge a prolonged outpatient period of monitoring with a goal of determining whether inpatient hospitalization was warranted. However, in most circumstances, the care of children under OBS status differs little from those under IP status; OBS status patients are usually cared for in the same wards and by the same providers as IP status patients. The similarities in care lead to nearly equivalent hospital costs for IP and OBS stays.² Comparable hospital costs would be less concerning if reimbursement were proportional, but OBS status hospitalizations are reimbursed at lower outpatient rates.³ The combination of similar costs and lower reimbursement results in a financial liability for children’s hospitals.

Tian et al add to the growing body of literature that underscores concerns with OBS stays.¹ Its increasing use over the past decade represents a troubling continuation of increased OBS status use described by Macy et al³ nearly a decade ago, and the variability with which it is applied suggests that the designation has little connection to the clinical status of patients. Instead, its use is more likely influenced by local payor contracts, individual state laws, and provider culture. For individual institutions, this differential application affects more than just reimbursement. OBS stays are often excluded from nationally representative administrative databases, which makes hospital benchmarking, research on outcomes, and accurate comparison of patient populations impossible.^4,5

The trends described by Tian et al¹ raise concerns about the potential impact that OBS stays have on patients and hospital systems across the country. OBS status was created to serve a clinical need, but its inconsistent use places hospitals and the children they treat at risk. This erratic application of OBS status and the serious results of its assignment to pediatric hospitalizations provide evidence that criteria for OBS need to be standardized or otherwise abandoned outright.

Two children who presented to emergency departments in different cities were diagnosed with diabetes mellitus and ketoacidosis. On presentation, both had significant anion gap metabolic acidosis. Because the patients were deemed unsafe for discharge, the admitting physician placed orders that dictated hospital care, including an order that designated the stay as observation (OBS) or inpatient (IP) status. During their stay, both patients received care including continuous infusion of insulin, intravenous fluids, and frequent lab monitoring. Each child recovered quickly and was discharged in less than 48 hours.

Despite both patients receiving comparable care, recovering well, and being discharged home after a similar length of stay, their encounter designation may be different. Although the patient outcome is of utmost importance, the consequences of labeling an encounter as OBS or IP status are complex and may impact the financial standing of patients, hospitals, and payors. Determining the trajectory of OBS status and its utilization in the pediatric population is vital to understanding the consequences of this designation.

In this issue of the Journal of Hospital Medicine, Tian et al¹ describe the increase in OBS status hospitalizations between 2010 and 2019, with OBS stays accounting for approximately one-third of pediatric hospitalizations within children’s hospitals in 2019. The increase in OBS status use was described in 19 of 20 of the most common All Patient Refined Diagnosis Related Groups, with the highest growth noted for surgical conditions and diabetes mellitus.¹ These frequently seen, high-stakes conditions, when expertly managed, may result in a safe discharge within 48 hours of admission, but the labor-intensive technical skills to ensure patient safety and high-value care often differ greatly from the idea of simply “observing” a patient.

The scope creep of OBS status in pediatrics is evident. OBS status was initially designed to acknowledge a prolonged outpatient period of monitoring with a goal of determining whether inpatient hospitalization was warranted. However, in most circumstances, the care of children under OBS status differs little from those under IP status; OBS status patients are usually cared for in the same wards and by the same providers as IP status patients. The similarities in care lead to nearly equivalent hospital costs for IP and OBS stays.² Comparable hospital costs would be less concerning if reimbursement were proportional, but OBS status hospitalizations are reimbursed at lower outpatient rates.³ The combination of similar costs and lower reimbursement results in a financial liability for children’s hospitals.

Tian et al add to the growing body of literature that underscores concerns with OBS stays.¹ Its increasing use over the past decade represents a troubling continuation of increased OBS status use described by Macy et al³ nearly a decade ago, and the variability with which it is applied suggests that the designation has little connection to the clinical status of patients. Instead, its use is more likely influenced by local payor contracts, individual state laws, and provider culture. For individual institutions, this differential application affects more than just reimbursement. OBS stays are often excluded from nationally representative administrative databases, which makes hospital benchmarking, research on outcomes, and accurate comparison of patient populations impossible.^4,5

The trends described by Tian et al¹ raise concerns about the potential impact that OBS stays have on patients and hospital systems across the country. OBS status was created to serve a clinical need, but its inconsistent use places hospitals and the children they treat at risk. This erratic application of OBS status and the serious results of its assignment to pediatric hospitalizations provide evidence that criteria for OBS need to be standardized or otherwise abandoned outright.

Nothing changes without personal transformation.

—W Edwards Deming, 1986

Failure is common among quality improvement projects, but also predictable. Health professionals have multiple competing priorities. Improvement projects rarely reduce an individual’s workload. In our experience coaching health professionals, we have found that improvement teams often overlook two important facts: improvement requires behavior change, and everyone resists change.

Quality improvement education focuses on the development of technical skills (eg, process mapping, measure development, data analysis). Technical skills are necessary, but insufficient, to lead change. Process maps and run charts guide improvement work but alone do not motivate frontline staff to change workflows. Rather, soft skills (eg, communication, negotiation, change management, influencing others) convince frontline staff and hospital leaders that change is worth their time and effort.^1,2 Successful improvement teams combine technical skills and soft skills to inspire behavior change.

We propose three practical skills that all improvement teams can adopt to inspire change:

Understand your stakeholders’ needs. Early identification and engagement of stakeholders (individuals or groups who may affect or be affected by the project) is critical. Improvement teams must consider stakeholders at multiple levels in the organization, from frontline staff to executives. The easiest way to understand stakeholders is by talking to them. Often, stakeholders lack time for scheduled meetings, so teams must rely on informal conversations in hallways and elevators. The key is to understand what will motivate the stakeholder to change. Put yourself in the stakeholders’ shoes: What are their needs and priorities? How might their needs and priorities motivate them to change? What potential barriers exist that prevent the stakeholder from making a change?

Tailor your message to establish a rationale for change. Build upon what was learned from stakeholders and decide how the rationale for change will be communicated. What can you say that will influence others to see the problem as important? Recognize that the rationale is different for different stakeholders; a financial rationale may inspire hospital leaders but alienate staff who are driven by patient and staff satisfaction. Even carefully crafted messages may not resonate with stakeholders as intended. Improvement teams must monitor the impact of their message with different stakeholders. Developing a clear, concise, and compelling rationale for change is often challenging and iterative. Multiple communication channels (ie, email, newsletters, formal and informal conversations) must be employed to spread your message.

Share small and large wins. Talking with stakeholders is not a one-time event. Stakeholder interest may decrease over time. Frontline staff can become complacent, falling back into old behaviors. Priorities of hospital leadership can shift. Successful teams maintain lines of communication throughout the project to share successes and sustain stakeholder buy-in. Small and large wins matter. Project outcomes (large wins) may take months to achieve. Teams can maintain stakeholder interest by demonstrating that project processes are feasible and acceptable (small wins). Maintaining regular communication also affords teams the opportunity for early identification of organizational barriers and facilitators that may impact their project. Ongoing communication of project wins sets the stage for sustainment by embedding the change within the local culture.

The goal of any improvement project is to create sustainable change. To do this, improvement teams often need hundreds of people to change the way they work. Change is hard, but improvement teams can overcome resistance to it by strategically engaging stakeholders and thoughtfully communicating the rationale for change.

Nothing changes without personal transformation.

—W Edwards Deming, 1986

Failure is common among quality improvement projects, but also predictable. Health professionals have multiple competing priorities. Improvement projects rarely reduce an individual’s workload. In our experience coaching health professionals, we have found that improvement teams often overlook two important facts: improvement requires behavior change, and everyone resists change.

Quality improvement education focuses on the development of technical skills (eg, process mapping, measure development, data analysis). Technical skills are necessary, but insufficient, to lead change. Process maps and run charts guide improvement work but alone do not motivate frontline staff to change workflows. Rather, soft skills (eg, communication, negotiation, change management, influencing others) convince frontline staff and hospital leaders that change is worth their time and effort.^1,2 Successful improvement teams combine technical skills and soft skills to inspire behavior change.

We propose three practical skills that all improvement teams can adopt to inspire change:

Understand your stakeholders’ needs. Early identification and engagement of stakeholders (individuals or groups who may affect or be affected by the project) is critical. Improvement teams must consider stakeholders at multiple levels in the organization, from frontline staff to executives. The easiest way to understand stakeholders is by talking to them. Often, stakeholders lack time for scheduled meetings, so teams must rely on informal conversations in hallways and elevators. The key is to understand what will motivate the stakeholder to change. Put yourself in the stakeholders’ shoes: What are their needs and priorities? How might their needs and priorities motivate them to change? What potential barriers exist that prevent the stakeholder from making a change?

Tailor your message to establish a rationale for change. Build upon what was learned from stakeholders and decide how the rationale for change will be communicated. What can you say that will influence others to see the problem as important? Recognize that the rationale is different for different stakeholders; a financial rationale may inspire hospital leaders but alienate staff who are driven by patient and staff satisfaction. Even carefully crafted messages may not resonate with stakeholders as intended. Improvement teams must monitor the impact of their message with different stakeholders. Developing a clear, concise, and compelling rationale for change is often challenging and iterative. Multiple communication channels (ie, email, newsletters, formal and informal conversations) must be employed to spread your message.

Share small and large wins. Talking with stakeholders is not a one-time event. Stakeholder interest may decrease over time. Frontline staff can become complacent, falling back into old behaviors. Priorities of hospital leadership can shift. Successful teams maintain lines of communication throughout the project to share successes and sustain stakeholder buy-in. Small and large wins matter. Project outcomes (large wins) may take months to achieve. Teams can maintain stakeholder interest by demonstrating that project processes are feasible and acceptable (small wins). Maintaining regular communication also affords teams the opportunity for early identification of organizational barriers and facilitators that may impact their project. Ongoing communication of project wins sets the stage for sustainment by embedding the change within the local culture.

The goal of any improvement project is to create sustainable change. To do this, improvement teams often need hundreds of people to change the way they work. Change is hard, but improvement teams can overcome resistance to it by strategically engaging stakeholders and thoughtfully communicating the rationale for change.

Nothing changes without personal transformation.

—W Edwards Deming, 1986

Failure is common among quality improvement projects, but also predictable. Health professionals have multiple competing priorities. Improvement projects rarely reduce an individual’s workload. In our experience coaching health professionals, we have found that improvement teams often overlook two important facts: improvement requires behavior change, and everyone resists change.

Quality improvement education focuses on the development of technical skills (eg, process mapping, measure development, data analysis). Technical skills are necessary, but insufficient, to lead change. Process maps and run charts guide improvement work but alone do not motivate frontline staff to change workflows. Rather, soft skills (eg, communication, negotiation, change management, influencing others) convince frontline staff and hospital leaders that change is worth their time and effort.^1,2 Successful improvement teams combine technical skills and soft skills to inspire behavior change.

We propose three practical skills that all improvement teams can adopt to inspire change:

Understand your stakeholders’ needs. Early identification and engagement of stakeholders (individuals or groups who may affect or be affected by the project) is critical. Improvement teams must consider stakeholders at multiple levels in the organization, from frontline staff to executives. The easiest way to understand stakeholders is by talking to them. Often, stakeholders lack time for scheduled meetings, so teams must rely on informal conversations in hallways and elevators. The key is to understand what will motivate the stakeholder to change. Put yourself in the stakeholders’ shoes: What are their needs and priorities? How might their needs and priorities motivate them to change? What potential barriers exist that prevent the stakeholder from making a change?

Tailor your message to establish a rationale for change. Build upon what was learned from stakeholders and decide how the rationale for change will be communicated. What can you say that will influence others to see the problem as important? Recognize that the rationale is different for different stakeholders; a financial rationale may inspire hospital leaders but alienate staff who are driven by patient and staff satisfaction. Even carefully crafted messages may not resonate with stakeholders as intended. Improvement teams must monitor the impact of their message with different stakeholders. Developing a clear, concise, and compelling rationale for change is often challenging and iterative. Multiple communication channels (ie, email, newsletters, formal and informal conversations) must be employed to spread your message.

Share small and large wins. Talking with stakeholders is not a one-time event. Stakeholder interest may decrease over time. Frontline staff can become complacent, falling back into old behaviors. Priorities of hospital leadership can shift. Successful teams maintain lines of communication throughout the project to share successes and sustain stakeholder buy-in. Small and large wins matter. Project outcomes (large wins) may take months to achieve. Teams can maintain stakeholder interest by demonstrating that project processes are feasible and acceptable (small wins). Maintaining regular communication also affords teams the opportunity for early identification of organizational barriers and facilitators that may impact their project. Ongoing communication of project wins sets the stage for sustainment by embedding the change within the local culture.

The goal of any improvement project is to create sustainable change. To do this, improvement teams often need hundreds of people to change the way they work. Change is hard, but improvement teams can overcome resistance to it by strategically engaging stakeholders and thoughtfully communicating the rationale for change.

Tyrosine kinase inhibitors are the mainstay of systemic HCC therapy, however treatment at FDA-approved doses frequently leads to unacceptable toxicities, leading to reductions in the prescribed dose. Tokunaga et al. investigated whether lenvatinib dose intensity affects outcomes of patients with unresectable HCC. This was a retrospective analysis of 100 patients who received lenvatinib in the first- or later-line settings. Fifty-one patients started lenvatinib at the standard dose and 49 patients at a reduced dose. Dose reduction was carried out in 29 patients during cycle 1, and 62 patients during all cycles, with the cumulative dose reduction rate in all cycles of 79.9%.  Upon analysis, the authors confirmed that tumor responses and stable disease on lenvatinib correlated favorably with overall survival (OS) and time to progression (TTP). In addition, they found that higher dose intensity correlated with a higher response rate, though most (56%) patients were unable to maintain the recommended dose intensity due to unacceptable adverse events. In the final analysis, dose modification was not negatively associated with OS, TTP, or disease control with lenvatinib. Therefore, it remains reasonable to adjust the dose of lenvatinib to minimize toxicity that would affect adversely patient quality of life. Disease control remains the best predictor of longer survival, though it does not seem that highest doses of lenvatinib are needed to achieve that benefit.

Cabozantinib is approved for previously treated patients with unresectable HCC based on the phase III CELESTIAL trial that enrolled patients with Child Pugh A liver disease who had received up to two previous systemic treatments, one of which was sorafenib. This study demonstrated a statistically significant improvement in overall- and disease-free survival. Kelley et al analyzed the outcomes based on the albumin-bilirubin (ALBI) grade, an objective measure of liver function, of patients in the CELESTIAL trial. ALBI scores were retrospectively calculated based on baseline serum albumin and total bilirubin. The median OS was 17.5 months in the cabozantinib arm versus 11.4 months in the placebo arm for the ALBI grade 1 subgroup, and 8.0 months in the cabozantinib arm versus 6.4 months in the placebo arm for the ALBI grade 2 subgroup. The authors concluded that cabozantinib benefits patients with unresectable HCC irrespective of their ALBI grade, though liver dysfunction remains a poor prognostic indicator in patients with HCC.

Finally, Liu et al analyzed 27 patients with HCC (8 with extrahepatic spread) who received a combination of chemotherapy via hepatic artery infusion, anti-PD-1 immunotherapy, and tyrosine kinase inhibitor. Combination chemotherapy and immunotherapy resulted in a median progression-free survival of 10.6 months with a median 12.9 months’ follow up; the objective response rate was 63.0% and the disease control rate was 92.6%. The authors concluded that this combination of therapies was effective and well-tolerated, with a confirmatory phase 3 study planned.

Tyrosine kinase inhibitors are the mainstay of systemic HCC therapy, however treatment at FDA-approved doses frequently leads to unacceptable toxicities, leading to reductions in the prescribed dose. Tokunaga et al. investigated whether lenvatinib dose intensity affects outcomes of patients with unresectable HCC. This was a retrospective analysis of 100 patients who received lenvatinib in the first- or later-line settings. Fifty-one patients started lenvatinib at the standard dose and 49 patients at a reduced dose. Dose reduction was carried out in 29 patients during cycle 1, and 62 patients during all cycles, with the cumulative dose reduction rate in all cycles of 79.9%.  Upon analysis, the authors confirmed that tumor responses and stable disease on lenvatinib correlated favorably with overall survival (OS) and time to progression (TTP). In addition, they found that higher dose intensity correlated with a higher response rate, though most (56%) patients were unable to maintain the recommended dose intensity due to unacceptable adverse events. In the final analysis, dose modification was not negatively associated with OS, TTP, or disease control with lenvatinib. Therefore, it remains reasonable to adjust the dose of lenvatinib to minimize toxicity that would affect adversely patient quality of life. Disease control remains the best predictor of longer survival, though it does not seem that highest doses of lenvatinib are needed to achieve that benefit.

Cabozantinib is approved for previously treated patients with unresectable HCC based on the phase III CELESTIAL trial that enrolled patients with Child Pugh A liver disease who had received up to two previous systemic treatments, one of which was sorafenib. This study demonstrated a statistically significant improvement in overall- and disease-free survival. Kelley et al analyzed the outcomes based on the albumin-bilirubin (ALBI) grade, an objective measure of liver function, of patients in the CELESTIAL trial. ALBI scores were retrospectively calculated based on baseline serum albumin and total bilirubin. The median OS was 17.5 months in the cabozantinib arm versus 11.4 months in the placebo arm for the ALBI grade 1 subgroup, and 8.0 months in the cabozantinib arm versus 6.4 months in the placebo arm for the ALBI grade 2 subgroup. The authors concluded that cabozantinib benefits patients with unresectable HCC irrespective of their ALBI grade, though liver dysfunction remains a poor prognostic indicator in patients with HCC.

Finally, Liu et al analyzed 27 patients with HCC (8 with extrahepatic spread) who received a combination of chemotherapy via hepatic artery infusion, anti-PD-1 immunotherapy, and tyrosine kinase inhibitor. Combination chemotherapy and immunotherapy resulted in a median progression-free survival of 10.6 months with a median 12.9 months’ follow up; the objective response rate was 63.0% and the disease control rate was 92.6%. The authors concluded that this combination of therapies was effective and well-tolerated, with a confirmatory phase 3 study planned.

Tyrosine kinase inhibitors are the mainstay of systemic HCC therapy, however treatment at FDA-approved doses frequently leads to unacceptable toxicities, leading to reductions in the prescribed dose. Tokunaga et al. investigated whether lenvatinib dose intensity affects outcomes of patients with unresectable HCC. This was a retrospective analysis of 100 patients who received lenvatinib in the first- or later-line settings. Fifty-one patients started lenvatinib at the standard dose and 49 patients at a reduced dose. Dose reduction was carried out in 29 patients during cycle 1, and 62 patients during all cycles, with the cumulative dose reduction rate in all cycles of 79.9%.  Upon analysis, the authors confirmed that tumor responses and stable disease on lenvatinib correlated favorably with overall survival (OS) and time to progression (TTP). In addition, they found that higher dose intensity correlated with a higher response rate, though most (56%) patients were unable to maintain the recommended dose intensity due to unacceptable adverse events. In the final analysis, dose modification was not negatively associated with OS, TTP, or disease control with lenvatinib. Therefore, it remains reasonable to adjust the dose of lenvatinib to minimize toxicity that would affect adversely patient quality of life. Disease control remains the best predictor of longer survival, though it does not seem that highest doses of lenvatinib are needed to achieve that benefit.

Cabozantinib is approved for previously treated patients with unresectable HCC based on the phase III CELESTIAL trial that enrolled patients with Child Pugh A liver disease who had received up to two previous systemic treatments, one of which was sorafenib. This study demonstrated a statistically significant improvement in overall- and disease-free survival. Kelley et al analyzed the outcomes based on the albumin-bilirubin (ALBI) grade, an objective measure of liver function, of patients in the CELESTIAL trial. ALBI scores were retrospectively calculated based on baseline serum albumin and total bilirubin. The median OS was 17.5 months in the cabozantinib arm versus 11.4 months in the placebo arm for the ALBI grade 1 subgroup, and 8.0 months in the cabozantinib arm versus 6.4 months in the placebo arm for the ALBI grade 2 subgroup. The authors concluded that cabozantinib benefits patients with unresectable HCC irrespective of their ALBI grade, though liver dysfunction remains a poor prognostic indicator in patients with HCC.

Finally, Liu et al analyzed 27 patients with HCC (8 with extrahepatic spread) who received a combination of chemotherapy via hepatic artery infusion, anti-PD-1 immunotherapy, and tyrosine kinase inhibitor. Combination chemotherapy and immunotherapy resulted in a median progression-free survival of 10.6 months with a median 12.9 months’ follow up; the objective response rate was 63.0% and the disease control rate was 92.6%. The authors concluded that this combination of therapies was effective and well-tolerated, with a confirmatory phase 3 study planned.

For parents living in poverty, “diaper math” is a familiar and distressingly pressing daily calculation. Babies in the U.S. go through 6-10 disposable diapers a day, at an average cost of $70-$80 a month. Name-brand diapers with high-end absorption sell for as much as a half a dollar each, and can result in upwards of $120 a month in expenses.

One in every three American families cannot afford enough diapers to keep their infants and toddlers clean, dry, and healthy, according to the National Diaper Bank Network. For many parents, that leads to wrenching choices: diapers, food, or rent?

The COVID-19 pandemic has exacerbated the situation, both by expanding unemployment rolls and by causing supply chain disruptions that have triggered higher prices for a multitude of products, including diapers. Diaper banks – community-funded programs that offer free diapers to low-income families – distributed 86% more diapers on average in 2020 than in 2019, according to the National Diaper Bank Network. In some locations, distribution increased by as much as 800%.

Yet no federal program helps parents pay for this childhood essential. The government’s food assistance program does not cover diapers, nor do most state-level public aid programs.

California is the only state to directly fund diapers for families, but support is limited. CalWORKS, a financial assistance program for families with children, provides $30 per month to help families pay for diapers for children under age 3. Federal policy shifts also may be in the works: Democratic lawmakers are pushing to include $200 million for diaper distribution in the massive budget reconciliation package.

Without adequate resources, low-income parents are left scrambling for ways to get the most use out of each diaper. This stressful undertaking is the subject of a recent article in American Sociological Review by Jennifer Randles, PhD, professor of sociology at California State University–Fresno. In 2018, Randles conducted phone interviews with 70 mothers in California over nine months. She tried to recruit fathers as well, but only two men responded.

Dr. Randles spoke with KHN’s Jenny Gold about how the cost of diapers weighs on low-income moms, and the “inventive mothering” many low-income women adopt to shield their children from the harms of poverty. The conversation has been edited for length and clarity.

Q: How do diapers play into day-to-day anxieties for low-income mothers?

In my sample, half of the mothers told me that they worried more about diapers than they worried about food or housing.

I started to ask mothers, “Can you tell me how many diapers you have on hand right now?” Almost every one told me with exact specificity how many they had – 5 or 7 or 12. And they knew exactly how long that number of diapers would last, based on how often their children defecated and urinated, if their kid was sick, if they had a diaper rash at the time. So just all the emotional and cognitive labor that goes into keeping such careful track of diaper supplies.

They were worrying and figuring out, “OK, I’m down to almost my last diaper. What do I do now? Do I go find some cans [to sell]? Do I go sell some things in my house? Who in my social network might have some extra cash right now?” I talked to moms who sell blood plasma just to get their infants diapers.

Q: What coping strategies stood out to you?

Those of us who study diapers often call them diaper-stretching strategies. One was leaving on a diaper a little bit longer than someone might otherwise leave it on and letting it get completely full. Some mothers figured out if they bought a [more expensive] diaper that held more and leaked less, they could leave the diaper on longer.

They would also do things like letting the baby go diaperless, especially when they were at home and felt like they wouldn’t be judged for letting their baby go without a diaper. And they used every household good you can imagine to make makeshift diapers. Mothers are using cloth, sheets, and pillowcases. They’re using things that are disposable like paper towels with duct tape. They’re making diapers out their own period supplies or adult incontinence supplies when they can get a sample.

One of the questions I often get is, “Why don’t they just use cloth?” A lot of the mothers that I spoke with had tried cloth diapers and they found that they were very cost- and labor-prohibitive. If you pay for a full startup set of cloth diapers, you’re looking at anywhere from $500 to $1,000. And these moms never had that much money. Most of them didn’t have in-home washers and dryers. Some of them didn’t even have homes or consistent access to water, and it’s illegal in a lot of laundromats and public laundry facilities to wash your old diapers. So the same conditions that would prevent moms from being able to readily afford disposable diapers are the same conditions that keep them from being able to use cloth.

Q: You found that, for many women, the concept of being a good mother is wrapped up in diapering. Why is that?

Diapers and managing diapers was so fundamental to their identity as good moms. Most of the mothers in my sample went without their own food. They weren’t paying a cellphone bill or buying their own medicine or their own menstrual supplies, as a way of saving diaper money.

I talked to a lot of moms who said, when your baby is hungry, that’s horrible. Obviously, you do everything to prevent that. But there’s something about a diaper that covers this vulnerable part of a very young baby’s body, this very delicate skin. And being able to do something to meet this human need that we all have, and to maintain dignity and cleanliness.

A lot of the moms had been through the welfare system, and so they’re living in this constant fear [of losing their children]. This is especially true among mothers of color, who are much more likely to get wrapped up in the child welfare system. People can’t necessarily see when your baby’s hungry. But people can see a saggy diaper. That’s going to be one of the things that tags you as a bad mom.

Q: Was your work on diapers influenced by your experience as a parent?

When I was doing these interviews, my daughter was about 2 or 3. So still in diapers. When my daughter peed during a diaper change, I thought, “Oh, I can just toss that one. Here, let me get another clean one.” That’s a really easy choice. For me. That’s a crisis for the mothers I interviewed. Many of them told me they have an anxiety attack with every diaper change.

Q: Do you see a clear policy solution to diaper stress?

What’s kind of ironic is how much physical, emotional, and cognitive labor goes into managing something that society and lawmakers don’t even recognize. Diapers are still not really recognized as a basic need, as evidenced by the fact that they’re still taxed in 35 states.

I think what California is doing is an excellent start. And I think diaper banks are a fabulous type of community-based organization that are filling a huge need that is not being filled by safety net policies. So, public support for diaper banks.

The direct cash aid part of the social safety net has been all but dismantled in the last 25 years. California is pretty generous. But there are some states where just the cost of diapers alone would use almost half of the average state TANF [Temporary Assistance for Needy Families] benefit for a family of three. I think we really do have to address the fact that the value of cash aid buys so much less than it used to.

Q: Your body of work on marriage and families is fascinating and unusual. Is there a single animating question behind your research?

The common thread is: How do our safety net policies support low-income families’ parenting goals? And do they equalize the conditions of parenting? I think of it as a reproductive justice issue. The ability to have a child or to not have a child, and then to parent that child in conditions where the child’s basic needs are met.

We like to say that we’re child and family friendly. The diaper issue is just one of many, many issues where we don’t really put our money or our policies where our mouth is, in terms of supporting families and supporting children. I think my work is trying to get people to think more collectively about having a social responsibility to all families and to each other. No country, but especially the richest country on the planet, should have one in three very young children not having one of their basic needs met.

I interviewed one dad who was incarcerated because he wrote a bad check. And as he described it to me, he had a certain amount of money, and they needed both diapers and milk for the baby. And I’ll never forget, he said, “I didn’t make a good choice, but I made the right one.”

These are not fancy shoes. These are not name-brand clothes. This was a dad needing both milk and diapers. I don’t think it gets much more basic than that.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

For parents living in poverty, “diaper math” is a familiar and distressingly pressing daily calculation. Babies in the U.S. go through 6-10 disposable diapers a day, at an average cost of $70-$80 a month. Name-brand diapers with high-end absorption sell for as much as a half a dollar each, and can result in upwards of $120 a month in expenses.

One in every three American families cannot afford enough diapers to keep their infants and toddlers clean, dry, and healthy, according to the National Diaper Bank Network. For many parents, that leads to wrenching choices: diapers, food, or rent?

The COVID-19 pandemic has exacerbated the situation, both by expanding unemployment rolls and by causing supply chain disruptions that have triggered higher prices for a multitude of products, including diapers. Diaper banks – community-funded programs that offer free diapers to low-income families – distributed 86% more diapers on average in 2020 than in 2019, according to the National Diaper Bank Network. In some locations, distribution increased by as much as 800%.

Yet no federal program helps parents pay for this childhood essential. The government’s food assistance program does not cover diapers, nor do most state-level public aid programs.

California is the only state to directly fund diapers for families, but support is limited. CalWORKS, a financial assistance program for families with children, provides $30 per month to help families pay for diapers for children under age 3. Federal policy shifts also may be in the works: Democratic lawmakers are pushing to include $200 million for diaper distribution in the massive budget reconciliation package.

Without adequate resources, low-income parents are left scrambling for ways to get the most use out of each diaper. This stressful undertaking is the subject of a recent article in American Sociological Review by Jennifer Randles, PhD, professor of sociology at California State University–Fresno. In 2018, Randles conducted phone interviews with 70 mothers in California over nine months. She tried to recruit fathers as well, but only two men responded.

Dr. Randles spoke with KHN’s Jenny Gold about how the cost of diapers weighs on low-income moms, and the “inventive mothering” many low-income women adopt to shield their children from the harms of poverty. The conversation has been edited for length and clarity.

Q: How do diapers play into day-to-day anxieties for low-income mothers?

In my sample, half of the mothers told me that they worried more about diapers than they worried about food or housing.

I started to ask mothers, “Can you tell me how many diapers you have on hand right now?” Almost every one told me with exact specificity how many they had – 5 or 7 or 12. And they knew exactly how long that number of diapers would last, based on how often their children defecated and urinated, if their kid was sick, if they had a diaper rash at the time. So just all the emotional and cognitive labor that goes into keeping such careful track of diaper supplies.

They were worrying and figuring out, “OK, I’m down to almost my last diaper. What do I do now? Do I go find some cans [to sell]? Do I go sell some things in my house? Who in my social network might have some extra cash right now?” I talked to moms who sell blood plasma just to get their infants diapers.

Q: What coping strategies stood out to you?

Those of us who study diapers often call them diaper-stretching strategies. One was leaving on a diaper a little bit longer than someone might otherwise leave it on and letting it get completely full. Some mothers figured out if they bought a [more expensive] diaper that held more and leaked less, they could leave the diaper on longer.

They would also do things like letting the baby go diaperless, especially when they were at home and felt like they wouldn’t be judged for letting their baby go without a diaper. And they used every household good you can imagine to make makeshift diapers. Mothers are using cloth, sheets, and pillowcases. They’re using things that are disposable like paper towels with duct tape. They’re making diapers out their own period supplies or adult incontinence supplies when they can get a sample.

One of the questions I often get is, “Why don’t they just use cloth?” A lot of the mothers that I spoke with had tried cloth diapers and they found that they were very cost- and labor-prohibitive. If you pay for a full startup set of cloth diapers, you’re looking at anywhere from $500 to $1,000. And these moms never had that much money. Most of them didn’t have in-home washers and dryers. Some of them didn’t even have homes or consistent access to water, and it’s illegal in a lot of laundromats and public laundry facilities to wash your old diapers. So the same conditions that would prevent moms from being able to readily afford disposable diapers are the same conditions that keep them from being able to use cloth.

Q: You found that, for many women, the concept of being a good mother is wrapped up in diapering. Why is that?

Diapers and managing diapers was so fundamental to their identity as good moms. Most of the mothers in my sample went without their own food. They weren’t paying a cellphone bill or buying their own medicine or their own menstrual supplies, as a way of saving diaper money.

I talked to a lot of moms who said, when your baby is hungry, that’s horrible. Obviously, you do everything to prevent that. But there’s something about a diaper that covers this vulnerable part of a very young baby’s body, this very delicate skin. And being able to do something to meet this human need that we all have, and to maintain dignity and cleanliness.

A lot of the moms had been through the welfare system, and so they’re living in this constant fear [of losing their children]. This is especially true among mothers of color, who are much more likely to get wrapped up in the child welfare system. People can’t necessarily see when your baby’s hungry. But people can see a saggy diaper. That’s going to be one of the things that tags you as a bad mom.

Q: Was your work on diapers influenced by your experience as a parent?

When I was doing these interviews, my daughter was about 2 or 3. So still in diapers. When my daughter peed during a diaper change, I thought, “Oh, I can just toss that one. Here, let me get another clean one.” That’s a really easy choice. For me. That’s a crisis for the mothers I interviewed. Many of them told me they have an anxiety attack with every diaper change.

Q: Do you see a clear policy solution to diaper stress?

What’s kind of ironic is how much physical, emotional, and cognitive labor goes into managing something that society and lawmakers don’t even recognize. Diapers are still not really recognized as a basic need, as evidenced by the fact that they’re still taxed in 35 states.

I think what California is doing is an excellent start. And I think diaper banks are a fabulous type of community-based organization that are filling a huge need that is not being filled by safety net policies. So, public support for diaper banks.

The direct cash aid part of the social safety net has been all but dismantled in the last 25 years. California is pretty generous. But there are some states where just the cost of diapers alone would use almost half of the average state TANF [Temporary Assistance for Needy Families] benefit for a family of three. I think we really do have to address the fact that the value of cash aid buys so much less than it used to.

Q: Your body of work on marriage and families is fascinating and unusual. Is there a single animating question behind your research?

The common thread is: How do our safety net policies support low-income families’ parenting goals? And do they equalize the conditions of parenting? I think of it as a reproductive justice issue. The ability to have a child or to not have a child, and then to parent that child in conditions where the child’s basic needs are met.

We like to say that we’re child and family friendly. The diaper issue is just one of many, many issues where we don’t really put our money or our policies where our mouth is, in terms of supporting families and supporting children. I think my work is trying to get people to think more collectively about having a social responsibility to all families and to each other. No country, but especially the richest country on the planet, should have one in three very young children not having one of their basic needs met.

I interviewed one dad who was incarcerated because he wrote a bad check. And as he described it to me, he had a certain amount of money, and they needed both diapers and milk for the baby. And I’ll never forget, he said, “I didn’t make a good choice, but I made the right one.”

These are not fancy shoes. These are not name-brand clothes. This was a dad needing both milk and diapers. I don’t think it gets much more basic than that.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

For parents living in poverty, “diaper math” is a familiar and distressingly pressing daily calculation. Babies in the U.S. go through 6-10 disposable diapers a day, at an average cost of $70-$80 a month. Name-brand diapers with high-end absorption sell for as much as a half a dollar each, and can result in upwards of $120 a month in expenses.

One in every three American families cannot afford enough diapers to keep their infants and toddlers clean, dry, and healthy, according to the National Diaper Bank Network. For many parents, that leads to wrenching choices: diapers, food, or rent?

The COVID-19 pandemic has exacerbated the situation, both by expanding unemployment rolls and by causing supply chain disruptions that have triggered higher prices for a multitude of products, including diapers. Diaper banks – community-funded programs that offer free diapers to low-income families – distributed 86% more diapers on average in 2020 than in 2019, according to the National Diaper Bank Network. In some locations, distribution increased by as much as 800%.

Yet no federal program helps parents pay for this childhood essential. The government’s food assistance program does not cover diapers, nor do most state-level public aid programs.

California is the only state to directly fund diapers for families, but support is limited. CalWORKS, a financial assistance program for families with children, provides $30 per month to help families pay for diapers for children under age 3. Federal policy shifts also may be in the works: Democratic lawmakers are pushing to include $200 million for diaper distribution in the massive budget reconciliation package.

Without adequate resources, low-income parents are left scrambling for ways to get the most use out of each diaper. This stressful undertaking is the subject of a recent article in American Sociological Review by Jennifer Randles, PhD, professor of sociology at California State University–Fresno. In 2018, Randles conducted phone interviews with 70 mothers in California over nine months. She tried to recruit fathers as well, but only two men responded.

Dr. Randles spoke with KHN’s Jenny Gold about how the cost of diapers weighs on low-income moms, and the “inventive mothering” many low-income women adopt to shield their children from the harms of poverty. The conversation has been edited for length and clarity.

Q: How do diapers play into day-to-day anxieties for low-income mothers?

In my sample, half of the mothers told me that they worried more about diapers than they worried about food or housing.

I started to ask mothers, “Can you tell me how many diapers you have on hand right now?” Almost every one told me with exact specificity how many they had – 5 or 7 or 12. And they knew exactly how long that number of diapers would last, based on how often their children defecated and urinated, if their kid was sick, if they had a diaper rash at the time. So just all the emotional and cognitive labor that goes into keeping such careful track of diaper supplies.

They were worrying and figuring out, “OK, I’m down to almost my last diaper. What do I do now? Do I go find some cans [to sell]? Do I go sell some things in my house? Who in my social network might have some extra cash right now?” I talked to moms who sell blood plasma just to get their infants diapers.

Q: What coping strategies stood out to you?

Those of us who study diapers often call them diaper-stretching strategies. One was leaving on a diaper a little bit longer than someone might otherwise leave it on and letting it get completely full. Some mothers figured out if they bought a [more expensive] diaper that held more and leaked less, they could leave the diaper on longer.

They would also do things like letting the baby go diaperless, especially when they were at home and felt like they wouldn’t be judged for letting their baby go without a diaper. And they used every household good you can imagine to make makeshift diapers. Mothers are using cloth, sheets, and pillowcases. They’re using things that are disposable like paper towels with duct tape. They’re making diapers out their own period supplies or adult incontinence supplies when they can get a sample.

One of the questions I often get is, “Why don’t they just use cloth?” A lot of the mothers that I spoke with had tried cloth diapers and they found that they were very cost- and labor-prohibitive. If you pay for a full startup set of cloth diapers, you’re looking at anywhere from $500 to $1,000. And these moms never had that much money. Most of them didn’t have in-home washers and dryers. Some of them didn’t even have homes or consistent access to water, and it’s illegal in a lot of laundromats and public laundry facilities to wash your old diapers. So the same conditions that would prevent moms from being able to readily afford disposable diapers are the same conditions that keep them from being able to use cloth.

Q: You found that, for many women, the concept of being a good mother is wrapped up in diapering. Why is that?

Diapers and managing diapers was so fundamental to their identity as good moms. Most of the mothers in my sample went without their own food. They weren’t paying a cellphone bill or buying their own medicine or their own menstrual supplies, as a way of saving diaper money.

I talked to a lot of moms who said, when your baby is hungry, that’s horrible. Obviously, you do everything to prevent that. But there’s something about a diaper that covers this vulnerable part of a very young baby’s body, this very delicate skin. And being able to do something to meet this human need that we all have, and to maintain dignity and cleanliness.

A lot of the moms had been through the welfare system, and so they’re living in this constant fear [of losing their children]. This is especially true among mothers of color, who are much more likely to get wrapped up in the child welfare system. People can’t necessarily see when your baby’s hungry. But people can see a saggy diaper. That’s going to be one of the things that tags you as a bad mom.

Q: Was your work on diapers influenced by your experience as a parent?

When I was doing these interviews, my daughter was about 2 or 3. So still in diapers. When my daughter peed during a diaper change, I thought, “Oh, I can just toss that one. Here, let me get another clean one.” That’s a really easy choice. For me. That’s a crisis for the mothers I interviewed. Many of them told me they have an anxiety attack with every diaper change.

Q: Do you see a clear policy solution to diaper stress?

What’s kind of ironic is how much physical, emotional, and cognitive labor goes into managing something that society and lawmakers don’t even recognize. Diapers are still not really recognized as a basic need, as evidenced by the fact that they’re still taxed in 35 states.

I think what California is doing is an excellent start. And I think diaper banks are a fabulous type of community-based organization that are filling a huge need that is not being filled by safety net policies. So, public support for diaper banks.

The direct cash aid part of the social safety net has been all but dismantled in the last 25 years. California is pretty generous. But there are some states where just the cost of diapers alone would use almost half of the average state TANF [Temporary Assistance for Needy Families] benefit for a family of three. I think we really do have to address the fact that the value of cash aid buys so much less than it used to.

Q: Your body of work on marriage and families is fascinating and unusual. Is there a single animating question behind your research?

The common thread is: How do our safety net policies support low-income families’ parenting goals? And do they equalize the conditions of parenting? I think of it as a reproductive justice issue. The ability to have a child or to not have a child, and then to parent that child in conditions where the child’s basic needs are met.

We like to say that we’re child and family friendly. The diaper issue is just one of many, many issues where we don’t really put our money or our policies where our mouth is, in terms of supporting families and supporting children. I think my work is trying to get people to think more collectively about having a social responsibility to all families and to each other. No country, but especially the richest country on the planet, should have one in three very young children not having one of their basic needs met.

I interviewed one dad who was incarcerated because he wrote a bad check. And as he described it to me, he had a certain amount of money, and they needed both diapers and milk for the baby. And I’ll never forget, he said, “I didn’t make a good choice, but I made the right one.”

These are not fancy shoes. These are not name-brand clothes. This was a dad needing both milk and diapers. I don’t think it gets much more basic than that.
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.