Summary of findings for the main comparison. Outpatient compared with inpatient treatment for acute pulmonary embolism.
Outpatient compared with inpatient treatment for acute pulmonary embolism | ||||||
Patient or population: people with low‐risk acute pulmonary embolism Settings: outpatient and inpatient settings Intervention: outpatient setting1 Comparison: inpatient setting2 | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (RCTs) | Quality of the evidence (GRADE) | Comments | |
risk with inpatient setting | risk with outpatient setting | |||||
Short‐term all‐cause mortality Follow‐up: 7‐10 days after randomisation |
Study population | RR 0.33 (0.01 to 7.98) | 453 (2) |
⊕⊕⊝⊝ low3 | 1/168 deaths in the inpatient group vs 0/171 deaths in the outpatient group. No deaths occurred in Peacock 2018. No deaths reported by Aujesky 2011 were PE‐related. | |
4 per 1000 | 1 per 1000 (0 to 35) | |||||
Long‐term all‐cause mortality Follow‐up: 90 days after randomisation |
Study population | RR 0.98 (0.06 to 15.58) | 4514 (2) |
⊕⊕⊝⊝ low3 | 1/168 deaths in the inpatient group vs 1/171 deaths in the outpatient group. No deaths occurred in Peacock 2018. No deaths reported by Aujesky 2011 were PE‐related. | |
4 per 1000 | 4 per 1000 (0 to 68) | |||||
Major bleeding Follow‐up: 14 days after randomisation |
Not estimable | RR 4.91 (0.24 to 101.57) | 445 (2) |
⊕⊕⊝⊝ low3 | 0/168 major bleeding events in the inpatient group vs 2/171 major bleeding events in the outpatient group. No major bleeding occurred in Peacock 2018. | |
Major bleeding Follow‐up: 90 days after randomisation |
Not estimable | RR 6.88 (0.36 to 132.14) | 445 (2) |
⊕⊕⊝⊝ low3 | 0/168 major bleeding events in the inpatient group vs 3/171 major bleeding events in the outpatient group. No major bleeding occurred in Peacock 2018. | |
Minor bleeding | Study population | RR 1.08 (0.07 to 16.79) | 106 (1) |
⊕⊕⊝⊝ low3 | One participant in each treatment arm reported minor bleeding. | |
18 per 1000 | 20 per 1000 (1 to 305) | |||||
Recurrent PE Follow‐up: within 90 days |
Not estimable | RR 2.95 (CI 0.12 to 71.85) | 445 (2) |
⊕⊕⊝⊝ low3 | 0/168 recurrent PE in inpatient groups vs 1/171 recurrent PE in the outpatient group, had a recurrent PE within 90 days. No recurrent PE occurred in Peacock 2018. | |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio; PE: pulmonary embolism | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. |
1 Outpatients received subcutaneous enoxaparin twice daily (Aujesky 2011); or 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 (Peacock 2018). 2 In Aujesky 2011, the inpatient group was admitted to hospital and received subcutaneous enoxaparin 1 mg/kg twice daily. In Peacock 2018, the inpatient group was admitted to hospital and received variable pharmacotherapy (standard‐of‐care treatment). 3 We downgraded by two levels due to the overall small sample size, small number of events, imprecision in the confidence intervals and the fact that publication bias could not be discounted. 4 Additional information was requested from the study authors but as they were unable to provide it, we used only the available data.