Comparing chemotherapy recovery at home versus in the hospital for children with acute myeloid leukemia
OBJECTIVES: We compared clinical outcomes (aim 1), patient experiences (aim 2), and patient health-related quality of life (HRQOL) (aim 3) between the 2 strategies (outpatient management vs inpatient management) in a nationally representative sample of patients <19 years old with newly diagnosed...
| Main Authors: | , , , |
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| Corporate Author: | |
| Format: | eBook |
| Language: | English |
| Published: |
Washington (DC)
Patient-Centered Outcomes Research Institute (PCORI)
2021, [2021]
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| Series: | Final research report
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | OBJECTIVES: We compared clinical outcomes (aim 1), patient experiences (aim 2), and patient health-related quality of life (HRQOL) (aim 3) between the 2 strategies (outpatient management vs inpatient management) in a nationally representative sample of patients <19 years old with newly diagnosed AML. METHODS: For aim 1, we used standardized medical abstraction for patients with AML treated between 2011 and 2019 at 17 centers in the United States. The unit of analysis was chemotherapy courses; the primary exposure was inpatient vs outpatient management, and the primary outcomes were bacteremia and time-to-next-treatment course. Only courses in which the patient met "discharge-eligible" criteria were included. Log-binomial regressions compared bacteremia incidence, and generalized linear regression compared times to next course. Generalized estimating equations accounted for correlation between courses from the same patient. We used propensity score methods to control for demographic, clinical, and hospital-level factors that we determined to be potential confounders. For aim 1, we found that overall rates of bacteremia were not significantly different in patients receiving outpatient vs inpatient management (23.8% for outpatient vs 29.0% for inpatient; adjusted relative risk, 0.73; 95% CI, 0.56-1.06; P = .082). Additionally, there were no delays to the start of the next chemotherapy course for patients managed in the outpatient setting vs in the hospital. For aim 2, 86% of families receiving inpatient management expressed satisfaction, and 85% of those receiving outpatient management expressed satisfaction. Dissatisfaction with inpatient management was driven by concerns for hospital-acquired infections and separation from family. Dissatisfaction with outpatient management stemmed from the stress of caring for a neutropenic child at home. For aim 2, patients/families at 9 centers were enrolled from November 2015 to February 2017 and underwent semistructured qualitative interviews that were analyzed using a hybrid inductive-deductive modified grounded theory approach. For aim 3, participants were enrolled from June 2016 through May 2019. Parent-proxies at 14 centers completed a validated assessment of patient HRQOL called the Pediatric Quality of Life (PedsQL) 4.0 Generic Core Scales at the start of chemotherapy and then after neutrophil recovery in a single treatment course. Only "discharge-eligible" patients were included. Follow-up scores on the parent-proxy PedsQL Generic Core Scales were compared by management strategy using an analysis of covariance accounting for baseline scores. RESULTS: Distributions of sex, ethnicity, diagnosis year, central line type, and individual antibacterial prophylaxis were generally comparable between patients who were managed as outpatients and those managed as inpatients. Although individual details of site-directed protocols for monitoring for infection at home were not captured, differential underascertainment of bacteremia was minimized by capturing results of all cultures drawn during inpatient admissions and outpatient clinic encounters as well as those submitted to treating hospitals by transferring institutions. CONCLUSIONS: Rates of bacteremia during outpatient management were not significantly different from those observed during inpatient management, with no delay to the start of the next chemotherapy course or meaningful differences in patient HRQOL. Semistructured interviews revealed strong alignment between patient/family satisfaction and center discharge practice. However, families experiencing outpatient management noted that this strategy would not be suitable for all families. These clinical and patient-centered results suggest that outpatient management during neutropenia is a viable approach without excess risk for children with AML. BACKGROUND: Pediatric acute myeloid leukemia (AML) requires multiple courses of intensive chemotherapy. Each course of chemotherapy destroys a child's white blood cells, called neutrophils, leaving the child in a state of neutropenia for 2 or more weeks. During neutropenia, the child is at significant risk for life-threatening infection; such toxicities can result in delays in starting the next course of chemotherapy and significant morbidity and mortality. Current supportive care guidelines recommend hospitalization after chemotherapy completion until neutrophil recovery. Although ~70% of US treatment centers adhere to this recommendation, there are little data to support inpatient over outpatient management during neutrophil recovery. Patients/families reporting satisfaction with outpatient management emphasized that the approach would not be appropriate for all families. For aim 3, the mean (SD) parent-proxy follow-up PedsQL total score did not differ between outpatient (70.1 (+/-) 18.9) and inpatient management (68.7 (+/-) 19.4), with an adjusted mean difference of −2.8 (SD, −11.2 to 5.6). LIMITATIONS: Our results are susceptible to confounding, which was mitigated by the capture of detailed demographic, diagnostic, clinical, and hospital-level factors to enable control for such bias. Patient HRQOL was only assessed at a single treatment course, which limited the ability to explore potential heterogeneity by course. However, implementation studies are needed to identify patient/family characteristics that portend a positive experience with an outpatient strategy |
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| Physical Description: | 1 PDF file (86 pages) illustrations |