ImportanceUnstable chest wall injuries have high rates of mortality and morbidity. In the last decade, multiple studies have reported improved outcomes with operative compared with nonoperative treatment. However, to date, an adequately powered, randomized clinical trial to support operative treatment has been lacking.ObjectiveTo compare outcomes of surgical treatment of acute unstable chest wall injuries with nonsurgical management.Design, Setting, and ParticipantsThis was a multicenter, prospective, randomized clinical trial conducted from October 10, 2011, to October 2, 2019, across 15 sites in Canada and the US. Inclusion criteria were patients between the ages of 16 to 85 years with displaced rib fractures with a flail chest or non–flail chest injuries with severe chest wall deformity. Exclusion criteria included patients with significant other injuries that would otherwise require prolonged mechanical ventilation, those medically unfit for surgery, or those who were randomly assigned to study groups after 72 hours of injury. Data were analyzed from March 20, 2019, to March 5, 2021.InterventionsPatients were randomized 1:1 to receive operative treatment with plate and screws or nonoperative treatment.Main Outcomes and MeasuresThe primary outcome was ventilator-free days (VFDs) in the first 28 days after injury. Secondary outcomes included mortality, length of hospital stay, intensive care unit stay, and rates of complications (pneumonia, ventilator-associated pneumonia, sepsis, tracheostomy).ResultsA total of 207 patients were included in the analysis (operative group: 108 patients [52.2%]; mean [SD] age, 52.9 [13.5] years; 81 male [75%]; nonoperative group: 99 patients [47.8%]; mean [SD] age, 53.2 [14.3] years; 75 male [76%]). Mean (SD) VFDs were 22.7 (7.5) days for the operative group and 20.6 (9.7) days for the nonoperative group (mean difference, 2.1 days; 95% CI, −0.3 to 4.5 days; P = .09). Mortality was significantly higher in the nonoperative group (6 [6%]) than in the operative group (0%; P = .01). Rates of complications and length of stay were similar between groups. Subgroup analysis of patients who were mechanically ventilated at the time of randomization demonstrated a mean difference of 2.8 (95% CI, 0.1-5.5) VFDs in favor of operative treatment.Conclusions and RelevanceThe findings of this randomized clinical trial suggest that operative treatment of patients with unstable chest wall injuries has modest benefit compared with nonoperative treatment. However, the potential advantage was primarily noted in the subgroup of patients who were ventilated at the time of randomization. No benefit to operative treatment was found in patients who were not ventilated.Trial RegistrationClinicalTrials.gov Identifier: NCT01367951

Objective: To describe the experiences and perspectives of parents of pediatric patients with acute lymphoblastic leukemia (ALL) regarding oral chemotherapy administration during maintenance therapy.Methods: English-speaking parents of patients 4 to <18 years who were receiving ALL maintenance oral chemotherapy were eligible to participate in this mixed methods study. Using semi-structured interviews, we asked participants how difficult they found oral chemotherapy administration. We also probed regarding barriers and facilitators of oral chemotherapy administration and strategies used to overcome challenges. Lastly, we asked participants for their advice to future parents giving oral chemotherapy to their children.Results: Twenty-three participants were interviewed. One-fifth of participants stated that oral chemotherapy administration at home was hard or very hard. Common factors influencing oral chemotherapy administration were product-related (e.g., formulation) and treatment-related adverse effects (e.g., nausea), lifestyle adjustment (e.g., fitting in with family schedule), and attitudes (e.g., onus of medication administration).Strategies to address oral chemotherapy administration included several administration techniques, scheduling of medication administration, and normalization of medication taking.Conclusions: Oral chemotherapy administration during ALL maintenance therapy was hard for some parents. Identification of these parents and discussion of strategies to facilitate adherence to oral chemotherapy regimens may optimize patient outcomes.

ObjectiveTo evaluate the feasibility of a large prospective trial aimed at improving chemotherapy-induced nausea and vomiting (CINV) control in paediatric patients undergoing oral chemotherapy during acute lymphoblastic leukaemia (ALL) maintenance therapy.MethodsEnglish-speaking children, 4.0–17.99 years old and undergoing ALL maintenance treatment with an English-speaking guardian, were eligible to participate in this observational, serial, cross-sectional feasibility study. Data were collected from participants over one to three 7-day periods during months 2–3, 5–6 and 11–12 of ALL maintenance treatment. A future trial was considered feasible if the mean time to enrol 10 patients in each of three data collection periods was ≤1 year with ≥80% of patients returning evaluable data. CINV control was described as a secondary endpoint.ResultsTwenty-nine of 31 consenting patients (median age: 6.5 years, IQR: 5.1–9.2) completed the study: 10 in months 2–3, 10 in months 5–6 and 9 in months 11–12. The total time to recruit 29 patients was 1.2 years. In each of the three data collections periods, 72% of the patients provided evaluable data. Complete CINV control was reported in 6/21 (29%) evaluable study periods.ConclusionsA future trial to evaluate interventions to improve CINV control in patients with ALL undergoing oral maintenance chemotherapy as designed in this study is not feasible. An electronic data capture method and deferring patient recruitment until the mid-maintenance to late-maintenance phase should be considered in the design of a future trial.

Results: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6-and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment.Conclusions: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional effort s to improve the outcomes of these challenging injuries are still needed.

Introduction: We aimed to create a Spanish-language version of the Pediatric Nausea Assessment Tool (PeNAT) and examine its understandability among Spanish-speaking, Hispanic American children. Methods: Translation: Forward and backward translations of the PeNAT documents were performed and verified by a bilingual panel. Four monolingual, Spanish-speaking dyads (child/parent) and four bilingual dyads piloted the Spanish-language PeNAT documents. Four additional bilingual dyads read both versions and completed the PeNAT using their preferred version. These were reviewed for errors due to misunderstanding. Understandability: Children aged 4–18 years about to receive chemotherapy who spoke Spanish at home and were without impairments precluding PeNAT use were eligible. Participants used the Spanish-language PeNAT during a chemotherapy block. Parents gave feedback on the PeNAT documents. Recruitment continued until 10 consecutive participants offered no substantive suggestions for revision. Results: Translation: All child/parent dyads completed the PeNAT without errors attributable to misunderstanding. The Spanish-language PeNAT was preferred by three of four bilingual dyads. Understandability: Ten cancer patients (mean age: 10.6 years) used the Spanish-language PeNAT. All parents felt their child understood the PeNAT; none felt the documents were hard or very hard to use. Conclusion: The Spanish-language PeNAT was understood by Spanish-speaking Hispanic American children. Further psychometric testing is warranted.