ImportanceIn patients with cancer who have venous thromboembolism (VTE) events, long-term anticoagulation with low-molecular-weight heparin (LMWH) is recommended to prevent recurrent VTE. The effectiveness of a direct oral anticoagulant (DOAC) compared with LMWH for preventing recurrent VTE in patients with cancer is uncertain.ObjectiveTo evaluate DOACs, compared with LMWH, for preventing recurrent VTE and for rates of bleeding in patients with cancer following an initial VTE event.Design, Setting, and ParticipantsUnblinded, comparative effectiveness, noninferiority randomized clinical trial conducted at 67 oncology practices in the US that enrolled 671 patients with cancer (any invasive solid tumor, lymphoma, multiple myeloma, or chronic lymphocytic leukemia) who had a new clinical or radiological diagnosis of VTE. Enrollment occurred from December 2016 to April 2020. Final follow-up was in November 2020.InterventionParticipants were randomized in a 1:1 ratio to either a DOAC (n = 335) or LMWH (n = 336) and were followed up for 6 months or until death. Physicians and patients selected any DOAC or any LMWH (or fondaparinux) and physicians selected drug doses.Main Outcomes and MeasuresThe primary outcome was the recurrent VTE rate at 6 months. Noninferiority of anticoagulation with a DOAC vs LMWH was defined by the upper limit of the 1-sided 95% CI for the difference of a DOAC relative to LMWH of less than 3% in the randomized cohort that received at least 1 dose of assigned treatment. The 6 prespecified secondary outcomes included major bleeding, which was assessed using a 2.5% noninferiority margin.ResultsBetween December 2016 and April 2020, 671 participants were randomized and 638 (95%) completed the trial (median age, 64 years; 353 women [55%]). Among those randomized to a DOAC, 330 received at least 1 dose. Among those randomized to LMWH, 308 received at least 1 dose. Rates of recurrent VTE were 6.1% in the DOAC group and 8.8% in the LMWH group (difference, −2.7%; 1-sided 95% CI, −100% to 0.7%) consistent with the prespecified noninferiority criterion. Of 6 prespecified secondary outcomes, none were statistically significant. Major bleeding occurred in 5.2% of participants in the DOAC group and 5.6% in the LMWH group (difference, −0.4%; 1-sided 95% CI, –100% to 2.5%) and did not meet the noninferiority criterion. Severe adverse events occurred in 33.8% of participants in the DOAC group and 35.1% in the LMWH group. The most common serious adverse events were anemia and death.Conclusions and RelevanceAmong adults with cancer and VTE, DOACs were noninferior to LMWH for preventing recurrent VTE over 6-month follow-up. These findings support use of a DOAC to prevent recurrent VTE in patients with cancer.Trial RegistrationClinicalTrials.gov Identifier: NCT02744092

We are implementing Connect for Health, a primary care-based intervention to improve family-centered outcomes for children, ages 2–12 years, in organizations that care for low-income children. We will use the ‘Reach-Effectiveness-Adoption-Implementation-Maintenance’ framework to guide our mixed-methods evaluation to examine the effectiveness of stakeholder-informed strategies in supporting program adoption and child outcomes. We also describe characteristics of children, ages 2–12 years with a BMI ≥85th percentile and obesity-related care practices. During the period prior to implementation, 26,161 children with a BMI ≥85th percentile were seen for a primary care visit and a majority lacked recommended diagnosis codes, referrals and laboratory evaluations. The findings suggest the need to augment current approaches to increase uptake of proven-effective weight management programs. Clinical trial registration number: Clinicaltrials.gov, NCT04042493 , Registered on 2 August 2019; https://clinicaltrials.gov/ct2/show/NCT04042493 .

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