Peacock 2018.

Methods	Design: international, open‐label, randomised, parallel group, multicentre. Multicentre study: 35 sites in the US. Sample size: 114. Follow‐up: 90 days after randomisation.
Participants	Inclusion criteria: adult patients (age ≥ 18 years) with objectively confirmed PE (with or without symptomatic DVT) who are deemed to be at low risk for recurrent VTE, major bleeding, or all‐cause mortality based on Hestia criteria, and a life expectancy of at least 6 months. The authors adapted the Hestia criteria by removing the 24‐hour time markers. Exclusion criteria: women of child‐bearing age with no use of a highly effective birth control method, patients with any Hestia criteria present, any concomitant contraindicated medications, and individuals with contraindications to anticoagulant therapy, allergies to rivaroxaban, or with barriers to treatment adherence or follow‐up.
Interventions	Intervention (51): outpatient treatment with rivaroxaban 15 mg orally twice daily for the first 21 days followed by 20 mg orally once daily for approximately 69 days for a total treatment duration of 90 days. Comparison (63): local standard‐of‐care, participants received local standard‐of‐care according to local protocol and defined by the medical team caring for the participant, which typically involves bridging therapy and hospitalisation, but also included any of the NOACs.
Outcomes	Mean duration of hospitalisation expressed in hours for venous thromboembolic or bleeding events, in the 30 days after randomisation Major bleeding based on the International Society on Thrombosis and Haemostasis (ISTH) within 90 days Percentage of participants with new/recurrence of VTE, or VTE‐related death, within 7, 14, 30, or 90 days from randomisation Percentage of participants with number of unplanned hospital visits or physician office for VTE symptoms and/or bleeding (up to 7, 14, 30 and 90 days) Mean combined duration of initial and subsequent ED hospitalisation for any reason (up to 30 and 90 days) Percentage of participants satisfied using site‐of‐care satisfaction questionnaire (day 7) and by ACTS (day 90) Clinically relevant non major bleeding, based on ISTH definitions Total, all‐cause mortality Total, serious adverse events Costs
Notes	Sponsored by a pharmaceutical industry (Janssen Pharmaceuticals, Raritan, NJ) The authors used the Hestia criteria to classify patients, therefore we considered that most patients were symptomatic.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	They used an interactive web system. Quote: "After obtaining written informed consent, patients were randomly assigned in a 1:1 ratio to ED discharge on open‐label rivaroxaban or standard care (as determined by the attending physician) by an interactive Web system within 12 hours of diagnosis."
Allocation concealment (selection bias)	Low risk	They used an interactive web system. Quote: "After obtaining written informed consent, patients were randomly assigned in a 1:1 ratio to ED discharge on open‐label rivaroxaban or standard care (as determined by the attending physician) by an interactive Web system within 12 hours of diagnosis."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The analysers were masked to treatment group assignment. Quote: "Principal investigators and outcome adjudicators were masked to group assignment"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Less than 20% of dropouts and withdrawals (7 participants in the outpatient group and 8 participants in the inpatient group), however the authors did not perform intention‐to‐treat analysis. All outpatients completed the study and authors could confirm that all of them were alive, however in inpatient group they could not confirm this for two patients.
Selective reporting (reporting bias)	Low risk	There is no evidence of selective reporting.
Other bias	Low risk	We did not find aspects of methodology that might be been influenced by vested interests and which may lead directly to a risk of bias. However, comparison of two sites of care (inpatient versus outpatient) was imbalanced by different pharmacotherapy between the arms: the outpatient group received 15 mg oral rivaroxaban twice daily for the first 21 days, followed by 20 mg oral rivaroxaban once daily for approximately 69 days for a total treatment duration of 90 days. The inpatient comparison group received local standard‐of‐care, according to local protocol and defined by the medical team caring for the participant, which typically involved intravenous UFH or subcutaneous LMWH and hospitalisation, but also included any of the NOACs (75% of all patients were initially treated with unfractionated or low‐molecular‐weight heparin but ultimately received NOACs, most commonly rivaroxaban (51%) or apixaban (25%)).

ACTS: anti‐clot treatment scale
 CT: computed tomography
 DVT: deep vein thrombosis
 ED: emergency department
 HIT: heparin‐induced thrombocytopenia
 ISTH: International Society on Thrombosis and Haemostasis
 LMWH: low molecular weight heparin
 NOACs: non‐vitamin K antagonist oral anticoagulants
 PE: pulmonary embolism
 PESI: Pulmonary Embolism Severity Index
 SBP: systolic blood pressure
 UFH: unfractionated heparin
 VTE: venous thromboembolism