Comparative effectiveness of high-power holmium laser lithotripsy for pediatric patients with kidney and ureteral stones.

2022

463.e1-463.e8

08/2022

1873-4898

BACKGROUND: The comparative effectiveness of high-power laser technology for kidney stone surgery in pediatric patients is poorly understood. We compared outcomes for the 120 W Holmium:yttrium-aluminum-garnet (Ho:YAG) laser with MOSES technology to 30 W Ho:YAG laser for pediatric patients undergoing ureteroscopy with laser lithotripsy for kidney and ureteral stones.

OBJECTIVE: We evaluated the outcomes of the new MOSES laser technology as compared to low-power Ho:YAG lasers commonly used for kidney stone treatment in the pediatric population.

METHODS: We performed a retrospective cohort study of 131 consecutive patients aged 1-18 years who underwent ureteroscopy and laser lithotripsy for renal and ureteric calculi at a large freestanding children's hospital between 2013 and 2020. The primary outcome was the efficiency quotient, which incorporates stone clearance, auxiliary procedures, and retreatment rates. Outcomes were compared between groups using Chi-square or Fisher's exact tests and multivariable regression. A sensitivity analysis was performed extending the age limit to ≤21 years.

RESULTS: Outcomes are summarized in the table below. Median age of the cohort was 14 years with 53% of patients being female. MOSES laser had a higher efficiency quotient and was associated with a lower odds of post-operative emergency department visits (OR 0.2, 95% CI 0.0-1.0; p = 0.047). Operative time was similar. In the sensitivity analysis of patients ≤21 years, the statistical significance with fewer emergency department visits was lost and the efficiency quotient was lower.

DISCUSSION: Our results show that stone clearance is similar between the 120 W MOSES and 30 W Ho:YAG lasers. However, there are indications that high-power laser lithotripsy is more efficient due to fewer auxiliary procedures and a reduction in retreatment. In addition, higher power lasers were associated with fewer emergency department visits. The benefits appear to be greater among children ≤18 years. These exploratory findings are important for pediatric patients due to the requirement for general anesthesia for each procedure and their associated impact on children and their caregivers.

CONCLUSIONS: High-power laser lithotripsy may be more efficient than lower power laser lithotripsy, which is driven by the fewer auxiliary procedures and reduction in retreatment particularly among youth ≤18 years old.

10.1016/j.jpurol.2022.05.022

J Pediatr Urol

35715329

Absolute lymphocyte count recovery following initial acute myelogenous leukemia therapy: Implications for adoptive cell therapy.

2022

e30062

11/2022

1545-5017

BACKGROUND: An adequate absolute lymphocyte count (ALC) is an essential first step in autologous chimeric antigen receptor (CAR) T-cell manufacturing. For patients with acute myelogenous leukemia (AML), the intensity of chemotherapy received may affect adequate ALC recovery required for CAR T-cell production. We sought to analyze ALC following each course of upfront therapy as one metric for CAR T-cell manufacturing feasibility in children and young adults with AML.

PROCEDURE: ALC data were collected from an observational study of patients with newly diagnosed AML between the ages of 1 month and 21 years who received treatment between the years of 2006 and 2018 at one of three hospitals in the Leukemia Electronic Abstraction of Records Network (LEARN) consortium.

RESULTS: Among 193 patients with sufficient ALC data for analysis, the median ALC following induction 1 was 1715 cells/μl (interquartile range: 1166-2388), with successive decreases in ALC with each subsequent course. Similarly, the proportion of patients achieving an ALC >400 cells/μl decreased following each course, ranging from 98.4% (190/193) after course 1 to 66.7% (22/33) for patients who received a fifth course of therapy.

CONCLUSIONS: There is a successive decline of ALC recovery with subsequent courses of chemotherapy. Despite this decline, ALC values are likely sufficient to consider apheresis prior to the initiation of each course of upfront therapy for the majority of newly diagnosed pediatric AML patients, thereby providing a window of opportunity for T-cell collection for those patients identified at high risk of relapse or with refractory disease.

10.1002/pbc.30062

Pediatr Blood Cancer

36370087

Comparative effectiveness of high-power holmium laser lithotripsy for pediatric patients with kidney and ureteral stones.

2022

06/2022

1873-4898

BACKGROUND: The comparative effectiveness of high-power laser technology for kidney stone surgery in pediatric patients is poorly understood. We compared outcomes for the 120 W Holmium:yttrium-aluminum-garnet (Ho:YAG) laser with MOSES technology to 30 W Ho:YAG laser for pediatric patients undergoing ureteroscopy with laser lithotripsy for kidney and ureteral stones.

OBJECTIVE: We evaluated the outcomes of the new MOSES laser technology as compared to low-power Ho:YAG lasers commonly used for kidney stone treatment in the pediatric population.

METHODS: We performed a retrospective cohort study of 131 consecutive patients aged 1-18 years who underwent ureteroscopy and laser lithotripsy for renal and ureteric calculi at a large freestanding children's hospital between 2013 and 2020. The primary outcome was the efficiency quotient, which incorporates stone clearance, auxiliary procedures, and retreatment rates. Outcomes were compared between groups using Chi-square or Fisher's exact tests and multivariable regression. A sensitivity analysis was performed extending the age limit to ≤21 years.

RESULTS: Outcomes are summarized in the table below. Median age of the cohort was 14 years with 53% of patients being female. MOSES laser had a higher efficiency quotient and was associated with a lower odds of post-operative emergency department visits (OR 0.2, 95% CI 0.0-1.0; p = 0.047). Operative time was similar. In the sensitivity analysis of patients ≤21 years, the statistical significance with fewer emergency department visits was lost and the efficiency quotient was lower.

DISCUSSION: Our results show that stone clearance is similar between the 120 W MOSES and 30 W Ho:YAG lasers. However, there are indications that high-power laser lithotripsy is more efficient due to fewer auxiliary procedures and a reduction in retreatment. In addition, higher power lasers were associated with fewer emergency department visits. The benefits appear to be greater among children ≤18 years. These exploratory findings are important for pediatric patients due to the requirement for general anesthesia for each procedure and their associated impact on children and their caregivers.

CONCLUSIONS: High-power laser lithotripsy may be more efficient than lower power laser lithotripsy, which is driven by the fewer auxiliary procedures and reduction in retreatment particularly among youth ≤18 years old.

10.1016/j.jpurol.2022.05.022

J Pediatr Urol

35715329

Validating Use of ICD-10 Diagnosis Codes in Identifying Physical Abuse Among Young Children.

2022

06/2022

1876-2867

OBJECTIVE: Evaluate the positive predictive value of International Classification of Disease, 10th Revision, Clinical Modification (ICD-10-CM) codes in identifying young children diagnosed with physical abuse.

METHODS: We extracted 230 charts of children <24 months of age who had any emergency department, inpatient, or ambulatory care encounters between Oct 1, 2015 and Sept 30, 2020 coded using ICD-10-CM codes suggestive of physical abuse. Electronic health records were reviewed to determine if physical abuse was considered during the medical encounter and assess the level of diagnostic certainty for physical abuse. Positive predictive value of each ICD-10-CM code was assessed.

RESULTS: Of 230 charts with ICD-10 codes concerning for physical abuse, 209 (91%) had documentation that a diagnosis of physical abuse was considered during an encounter. The majority of cases, 138 (60%), were rated as definitely or likely abuse, 36 cases (16%) were indeterminate, and 35 (15%) were likely or definitely accidental injury. Other forms of suspected maltreatment were discussed in 16 (7%) charts and 5 (2%) had no documented concerns for child maltreatment. The positive predictive values of the specific ICD-10 codes for encounters rated as definitely or likely abuse varied considerably, ranging from 0.89 (0.80-0.99) for T74.12 "Adult and child abuse, neglect, and other maltreatment, confirmed" to 0.24 (95% CI: 0.06-0.42) for Z04.72 "Encounter for examination and observation following alleged child physical abuse."

CONCLUSIONS: ICD-10-CM codes identify young children who experience physical abuse, but certain codes have a higher positive predictive value than others.

10.1016/j.acap.2022.06.011

Acad Pediatr

35777658

Rates of laboratory adverse events by course in paediatric leukaemia ascertained with automated electronic health record extraction: a retrospective cohort study from the Children's Oncology Group.

2022

e678-e688

07/2022

2352-3026

BACKGROUND: Adverse events are often misreported in clinical trials, leading to an incomplete understanding of toxicities. We aimed to test automated laboratory adverse event ascertainment and grading (via the ExtractEHR automated package) to assess its scalability and define adverse event rates for children with acute myeloid leukaemia and acute lymphoblastic leukaemia.

METHODS: For this retrospective cohort study from the Children's Oncology Group (COG), we included patients aged 0-22 years treated for acute myeloid leukaemia or acute lymphoblastic leukaemia at Children's Healthcare of Atlanta (Atlanta, GA, USA) from Jan 1, 2010, to Nov 1, 2018, at the Children's Hospital of Philadelphia (Philadelphia, PA, USA) from Jan 1, 2011, to Dec 31, 2014, and at the Texas Children's Hospital (Houston, TX, USA) from Jan 1, 2011, to Dec 31, 2014. The ExtractEHR automated package acquired, cleaned, and graded laboratory data as per Common Terminology Criteria for Adverse Events (CTCAE) version 5 for 22 commonly evaluated grade 3-4 adverse events (fatal events were not evaluated) with numerically based CTCAE definitions. Descriptive statistics tabulated adverse event frequencies. Adverse events ascertained by ExtractEHR were compared to manually reported adverse events for patients enrolled in two COG trials (AAML1031, NCT01371981; AALL0932, NCT02883049). Analyses were restricted to protocol-defined chemotherapy courses (induction I, induction II, intensification I, intensification II, and intensification III for acute myeloid leukaemia; induction, consolidation, interim maintenance, delayed intensification, and maintenance for acute lymphoblastic leukaemia).

FINDINGS: Laboratory adverse event data from 1077 patients (583 from Children's Healthcare of Atlanta, 200 from the Children's Hospital of Philadelphia, and 294 from the Texas Children's Hospital) who underwent 4611 courses (549 for acute myeloid leukaemia and 4062 for acute lymphoblastic leukaemia) were extracted, processed, and graded. Of the 166 patients with acute myeloid leukaemia, 86 (52%) were female, 80 (48%) were male, 96 (58%) were White, and 132 (80%) were non-Hispanic. Of the 911 patients with acute lymphoblastic leukaemia, 406 (45%) were female, 505 (55%) were male, 596 (65%) were White, and 641 (70%) were non-Hispanic. Patients with acute myeloid leukaemia had the most adverse events during induction I and intensification II. Hypokalaemia (one [17%] of six to 75 [48%] of 156 courses) and alanine aminotransferase (ALT) increased (13 [10%] of 134 to 27 [17%] of 156 courses) were the most prevalent non-haematological adverse events in patients with acute myeloid leukaemia, as identified by ExtractEHR. Patients with acute lymphoblastic leukaemia had the greatest number of adverse events during induction and maintenance (eight adverse events with prevalence ≥10%; induction and maintenance: anaemia, platelet count decreased, white blood cell count decreased, neutrophil count decreased, lymphocyte count decreased, ALT increased, and hypocalcaemia; induction: hypokalaemia; maintenance: aspartate aminotransferase [AST] increased and blood bilirubin increased), as identified by ExtractEHR. 187 (85%) of 220 total comparisons in 22 adverse events in four AAML1031 and six AALL0923 courses were substantially higher with ExtractEHR than COG-reported adverse event rates for adverse events with a prevalence of at least 2%.

INTERPRETATION: ExtractEHR is scalable and accurately defines laboratory adverse event rates for paediatric acute leukaemia; moreover, ExtractEHR seems to detect higher rates of laboratory adverse events than those reported in COG trials. These rates can be used for comparisons between therapies and to counsel patients treated on or off trials about the risks of chemotherapy. ExtractEHR-based adverse event ascertainment can improve reporting of laboratory adverse events in clinical trials.

FUNDING: US National Institutes of Health, St Baldrick's Foundation, and Alex's Lemonade Stand Foundation.

10.1016/S2352-3026(22)00168-5

Lancet Haematol

35870472

Rates of laboratory adverse events by course in paediatric leukaemia ascertained with automated electronic health record extraction: a retrospective cohort study from the Children's Oncology Group.

2022

e678-e688

07/2022

2352-3026

BACKGROUND: Adverse events are often misreported in clinical trials, leading to an incomplete understanding of toxicities. We aimed to test automated laboratory adverse event ascertainment and grading (via the ExtractEHR automated package) to assess its scalability and define adverse event rates for children with acute myeloid leukaemia and acute lymphoblastic leukaemia.

METHODS: For this retrospective cohort study from the Children's Oncology Group (COG), we included patients aged 0-22 years treated for acute myeloid leukaemia or acute lymphoblastic leukaemia at Children's Healthcare of Atlanta (Atlanta, GA, USA) from Jan 1, 2010, to Nov 1, 2018, at the Children's Hospital of Philadelphia (Philadelphia, PA, USA) from Jan 1, 2011, to Dec 31, 2014, and at the Texas Children's Hospital (Houston, TX, USA) from Jan 1, 2011, to Dec 31, 2014. The ExtractEHR automated package acquired, cleaned, and graded laboratory data as per Common Terminology Criteria for Adverse Events (CTCAE) version 5 for 22 commonly evaluated grade 3-4 adverse events (fatal events were not evaluated) with numerically based CTCAE definitions. Descriptive statistics tabulated adverse event frequencies. Adverse events ascertained by ExtractEHR were compared to manually reported adverse events for patients enrolled in two COG trials (AAML1031, NCT01371981; AALL0932, NCT02883049). Analyses were restricted to protocol-defined chemotherapy courses (induction I, induction II, intensification I, intensification II, and intensification III for acute myeloid leukaemia; induction, consolidation, interim maintenance, delayed intensification, and maintenance for acute lymphoblastic leukaemia).

FINDINGS: Laboratory adverse event data from 1077 patients (583 from Children's Healthcare of Atlanta, 200 from the Children's Hospital of Philadelphia, and 294 from the Texas Children's Hospital) who underwent 4611 courses (549 for acute myeloid leukaemia and 4062 for acute lymphoblastic leukaemia) were extracted, processed, and graded. Of the 166 patients with acute myeloid leukaemia, 86 (52%) were female, 80 (48%) were male, 96 (58%) were White, and 132 (80%) were non-Hispanic. Of the 911 patients with acute lymphoblastic leukaemia, 406 (45%) were female, 505 (55%) were male, 596 (65%) were White, and 641 (70%) were non-Hispanic. Patients with acute myeloid leukaemia had the most adverse events during induction I and intensification II. Hypokalaemia (one [17%] of six to 75 [48%] of 156 courses) and alanine aminotransferase (ALT) increased (13 [10%] of 134 to 27 [17%] of 156 courses) were the most prevalent non-haematological adverse events in patients with acute myeloid leukaemia, as identified by ExtractEHR. Patients with acute lymphoblastic leukaemia had the greatest number of adverse events during induction and maintenance (eight adverse events with prevalence ≥10%; induction and maintenance: anaemia, platelet count decreased, white blood cell count decreased, neutrophil count decreased, lymphocyte count decreased, ALT increased, and hypocalcaemia; induction: hypokalaemia; maintenance: aspartate aminotransferase [AST] increased and blood bilirubin increased), as identified by ExtractEHR. 187 (85%) of 220 total comparisons in 22 adverse events in four AAML1031 and six AALL0923 courses were substantially higher with ExtractEHR than COG-reported adverse event rates for adverse events with a prevalence of at least 2%.

INTERPRETATION: ExtractEHR is scalable and accurately defines laboratory adverse event rates for paediatric acute leukaemia; moreover, ExtractEHR seems to detect higher rates of laboratory adverse events than those reported in COG trials. These rates can be used for comparisons between therapies and to counsel patients treated on or off trials about the risks of chemotherapy. ExtractEHR-based adverse event ascertainment can improve reporting of laboratory adverse events in clinical trials.

FUNDING: US National Institutes of Health, St Baldrick's Foundation, and Alex's Lemonade Stand Foundation.

10.1016/S2352-3026(22)00168-5

Lancet Haematol

35870472