Introduction Increasing children’s cycling to school and physical activity are national health goals. The objective was to conduct an RCT of a bicycle train program to assess impact on students’ school travel mode and moderate to vigorous physical activity (MVPA). Study design Pilot cluster RCT with randomization at the school level and N=54 participants. Setting/participants Fourth–fifth graders from four public schools serving low-income families in Seattle, WA in 2014 with analyses in 2015–2016. All participants were provided and fitted with bicycles, safety equipment (helmets, locks, and lights), and a 2 to 3–hour bicycle safety course. Intervention The intervention was a bicycle train offered daily (i.e., students volunteered to cycle with study staff to and from school). Main outcome measures Time 1 assessments occurred prior to randomization. Time 2 assessments occurred after 3–5 weeks of the intervention (i.e., during Weeks 4–6 of the intervention period). The primary outcome was the percentage of daily commutes to school by cycling measured by validated survey. MVPA, measured by accelerometry and GPS units and processed by machine learning algorithms, was a secondary outcome. Results For two separate adjusted repeated measures linear mixed effects models in which students (N=54) were nested within schools (N=4), intervention participants had: (1) an absolute increase in mean percentage of daily commutes by cycling of 44.9%, (95% CI=26.8, 63.0) and (2) an increase in mean MVPA of 21.6 minutes/day, (95% CI=8.7, 34.6) from Time 1 to Time 2 compared with controls. Conclusions A pilot bicycle train intervention increased cycling to school and daily MVPA in the short term among diverse, inner-city elementary school students. The bicycle train intervention appears promising and warrants further experimental trials among large, diverse samples with longer follow-up. Clinicaltrial.gov identifier number NCT02006186; Date of registration: December 4, 2013.
19 symptoms or if they had been in contact with someone suspected or confirmed to be positive for the virus. Only patients determined to be at low risk for COVID-19 were allowed to enter the clinic for fertility treatment. Both patients and staff were required, upon arrival at the clinic, to wear a mask, complete a symptom-based questionnaire, record body temperature, and keep a safe social distance of more than 6 feet at all times. Any individual recording a fever over 100.4 O F and/or two or more symptoms was instructed to stay/return home for self-quarantine. Specimen collection for viral screening involved an anterior nare sampling method and storage in a FDA approved viral transport medium. Viral RNA was isolated using the MagMAXÔ Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit (Thermo Fisher Scientific). Molecular testing for active SARS-CoV-2 viral RNA infection was performed using the FDA emergency use authorized TaqPathÔ RT-PCR COVID-19 test (Thermo Fisher Scientific) for every patient within 3-5 days prior to oocyte retrieval or an attempt to achieve a pregnancy, and for all staff bi-weekly. Positive cases were reported to each respective local State Health Department.RESULTS: Of the 2,074 patients tested for COVID-19 between May and July 2020 across nine fertility clinics in the US, only 3 (0.15%) were found to be positive for SARS-CoV-2 viral RNA infection. In all cases the patients were asymptomatic and passed the triage protocol. PCR testing of staff bi-weekly identified 6 positive cases. All but one indicated having one or two mild symptoms. There were no recorded community transmissions among either patients to staff or between staff members.CONCLUSIONS: A comprehensive risk mitigation strategy that includes a combined triage protocol, safe social distancing and molecular testing for active SARS-CoV-2 viral RNA infection in both patients and staff enables early detection and isolation of infected asymptomatic or pre-symptomatic individuals, thereby creating a safe environment for patient care and staff welfare during the global COVID-19 pandemic.
IMPORTANCE Pediatric acute myeloid leukemia (AML) requires multiple courses of intensive chemotherapy that result in neutropenia, with significant risk for infectious complications.Supportive care guidelines recommend hospitalization until neutrophil recovery. However, there are little data to support inpatient over outpatient management. OBJECTIVETo evaluate outpatient vs inpatient neutropenia management for pediatric AML. DESIGN, SETTING, AND PARTICIPANTSThis cohort study used qualitative and quantitative methods to compare medical outcomes, patient health-related quality of life (HRQOL), and patient and family perceptions between outpatient and inpatient neutropenia management. The study included patients from 17 US pediatric hospitals with frontline chemotherapy start dates ranging from January 2011 to July 2019, although the specific date ranges differed for the individual analyses by design and relative timing. Data were analyzed from August 2019 to February 2020. EXPOSURES Discharge to outpatient vs inpatient neutropenia management. MAIN OUTCOMES AND MEASURESThe primary outcomes of interest were course-specific bacteremia incidence, times to next course, and patient HRQOL. Course-specific mortality was a secondary medical outcome. RESULTSPrimary quantitative analyses included 554 patients (272 [49.1%] girls and 282 [50.9%] boys; mean [SD] age, 8.2 [6.1] years). Bacteremia incidence was not significantly different during outpatient vs inpatient management (67 courses [23.8%] vs 265 courses [29.0%]; adjusted rate ratio, 0.73; 95% CI, 0.56 to 1.06; P = .08). Outpatient management was not associated with delays to the next course compared with inpatient management (mean [SD] 30.7 [12.2] days vs 32.8 [9.7]days; adjusted mean difference, −2.2; 95% CI, −4.1 to −0.2, P = .03). Mortality during intensification II was higher for patients who received outpatient management compared with those who received inpatient management (3 patients [5.4%] vs 1 patient [0.5%]; P = .03), but comparable with inpatient management at other courses (eg, 0 patients vs 5 patients [1.3%] during induction I; P = .59). Among 97 patients evaluated for HRQOL, outcomes did not differ between outpatient and inpatient management (mean [SD] Pediatric Quality of Life Inventory total score, 70.1 [18.9] vs 68.7
Efficacy of therapeutic strategies relative to patient- and family-centered outcomes in pediatric oncology must be assessed. We sought to identify outcomes important to children with acute myeloid leukemia and their families related to inpatient versus at-home management of neutropenia. We conducted qualitative interviews with 32 children ≥8 years old and 54 parents. Analysis revealed the impact of neutropenia management strategy on siblings, parent anxiety, and child sleep quality as being outcomes of concern across respondents. These themes were used to inform the design of a questionnaire that is currently being used in a prospective, multiinstitutional comparative effectiveness trial.
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