GRADE summary: should we treat at home rather than admit to the hospital patients with PE and low risk of complications?
| Certainty assessment . | Summary of findings . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of participants (studies) follow-up . | Risk of bias . | Inconsistency . | Indirectness . | Imprecision . | Publication bias . | Overall certainty of evidence . | Study event rates, n/N (%) . | Relative effect (95% CI) . | Anticipated absolute effects . | ||
| With hospital treatment . | With home treatment . | Risk with hospital treatment . | Risk difference with home treatment . | ||||||||
| Mortality short-term; follow-up: mean, 30 d | |||||||||||
| 451 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 1/229 (0.4) | 0/222 (0.0) | RR 0.33 (0.01-7.98) | • Study population: 4 per 1000 | • Study population: 3 fewer per 1000 (from 4 fewer to 30 more) |
| • Low-risk PE patients treated in hospital (30-d risk of mortality): 2 per 100032 ,† | • Low-risk PE patients treated in hospital (30-d risk of mortality): 2 fewer per 1000 (from 2 fewer to 16 more) | ||||||||||
| Mortality-long-term; follow-up: mean, 90 d | |||||||||||
| 451 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 1/229 (0.4) | 1/222 (0.5) | RR 0.98 (0.06-15.58) | • Study population: 4 per 1000 | • Study population: 0 fewer per 1000 (from 4 fewer to 64 more) |
| • Low-risk PE patients treated in hospital (90-d risk of mortality): 7 per 100032 ,† | • Low-risk PE patients treated in hospital (90-d risk of mortality): 0 fewer per 1000 (from 7 fewer to 108 more) | ||||||||||
| PE; follow-up: mean, 90 d | |||||||||||
| 445 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 0/223 (0.0) | 1/222 (0.5) | RR 2.95 (0.12-71.85) | • Study population: 0 per 1000 | • Study population: 0 fewer per 1000 (from 0 fewer to 0 fewer) |
| • Low-risk PE patients treat in hospital (90-d risk of recurrence of PE): 12 per 100032 ,† | • Low-risk PE patients treat in hospital (90-d risk of recurrence of PE): 23 more per 1000 (from 11 fewer to 850 more) | ||||||||||
| DVT; follow-up: mean, 90 d | |||||||||||
| 445 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 0/223 (0.0) | 0/222 (0.0) | Not estimable | • Study population: 0 per 1000 | |
| • Low-risk PE patients treat in hospital (90-d risk of recurrence of DVT): 12 per 100032 ,† | |||||||||||
| Major bleeding; follow-up: mean, 90 d | |||||||||||
| 445 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 0/223 (0.0) | 3/222 (1.4) | RR 6.88 (0.36-132.14) | • Study population: 0 per 1000 | • Study population: 0 fewer per 1000 |
| • Low-risk PE patients treat in hospital (90-d risk of major bleeding): 10 per 100032 ,† | • Low-risk PE patients treat in hospital (90-d risk of major bleeding): 59 more per 1000 | ||||||||||
| Mortality long-term; follow up: mean, 90 d | |||||||||||
| 234 (3 observational studies)24-26 | Serious‡ | Serious§ | Not serious | Serious* | None | ⊕◯◯◯ Very low | 12/125 (9.6) | 11/109 (10.1) | RR 0.81 (0.42-1.58) | 96 per 1000 | 18 fewer per 1000 (from 56 fewer to 56 more) |
| PE; follow-up: mean, 90 d | |||||||||||
| 105 (1 observational study)24 | Serious‡ | Not serious | Not serious | Serious* | None | ⊕◯◯◯ Very low | 2/62 (3.2) | 1/43 (2.3) | RR 0.72 (0.07-7.70) | 32 per 1000 | 9 fewer per 1000 (from 30 fewer to 216 more) |
| Major bleeding; follow up: mean 90 d | |||||||||||
| 234 (3 observational studies)24-26 | Serious‡ | Not serious | Not serious | Very serious* | None | ⊕◯◯◯ Very low | 0/125 (0.0) | 1/109 (0.9) | RR 2.68 (0.11-63.45) | 0 per 1000 | 0 fewer per 1000 |
| Certainty assessment . | Summary of findings . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of participants (studies) follow-up . | Risk of bias . | Inconsistency . | Indirectness . | Imprecision . | Publication bias . | Overall certainty of evidence . | Study event rates, n/N (%) . | Relative effect (95% CI) . | Anticipated absolute effects . | ||
| With hospital treatment . | With home treatment . | Risk with hospital treatment . | Risk difference with home treatment . | ||||||||
| Mortality short-term; follow-up: mean, 30 d | |||||||||||
| 451 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 1/229 (0.4) | 0/222 (0.0) | RR 0.33 (0.01-7.98) | • Study population: 4 per 1000 | • Study population: 3 fewer per 1000 (from 4 fewer to 30 more) |
| • Low-risk PE patients treated in hospital (30-d risk of mortality): 2 per 100032 ,† | • Low-risk PE patients treated in hospital (30-d risk of mortality): 2 fewer per 1000 (from 2 fewer to 16 more) | ||||||||||
| Mortality-long-term; follow-up: mean, 90 d | |||||||||||
| 451 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 1/229 (0.4) | 1/222 (0.5) | RR 0.98 (0.06-15.58) | • Study population: 4 per 1000 | • Study population: 0 fewer per 1000 (from 4 fewer to 64 more) |
| • Low-risk PE patients treated in hospital (90-d risk of mortality): 7 per 100032 ,† | • Low-risk PE patients treated in hospital (90-d risk of mortality): 0 fewer per 1000 (from 7 fewer to 108 more) | ||||||||||
| PE; follow-up: mean, 90 d | |||||||||||
| 445 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 0/223 (0.0) | 1/222 (0.5) | RR 2.95 (0.12-71.85) | • Study population: 0 per 1000 | • Study population: 0 fewer per 1000 (from 0 fewer to 0 fewer) |
| • Low-risk PE patients treat in hospital (90-d risk of recurrence of PE): 12 per 100032 ,† | • Low-risk PE patients treat in hospital (90-d risk of recurrence of PE): 23 more per 1000 (from 11 fewer to 850 more) | ||||||||||
| DVT; follow-up: mean, 90 d | |||||||||||
| 445 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 0/223 (0.0) | 0/222 (0.0) | Not estimable | • Study population: 0 per 1000 | |
| • Low-risk PE patients treat in hospital (90-d risk of recurrence of DVT): 12 per 100032 ,† | |||||||||||
| Major bleeding; follow-up: mean, 90 d | |||||||||||
| 445 (2 RCTs)22,23 | Not serious | Not serious | Not serious | Very serious* | None | ⊕⊕◯◯ Low | 0/223 (0.0) | 3/222 (1.4) | RR 6.88 (0.36-132.14) | • Study population: 0 per 1000 | • Study population: 0 fewer per 1000 |
| • Low-risk PE patients treat in hospital (90-d risk of major bleeding): 10 per 100032 ,† | • Low-risk PE patients treat in hospital (90-d risk of major bleeding): 59 more per 1000 | ||||||||||
| Mortality long-term; follow up: mean, 90 d | |||||||||||
| 234 (3 observational studies)24-26 | Serious‡ | Serious§ | Not serious | Serious* | None | ⊕◯◯◯ Very low | 12/125 (9.6) | 11/109 (10.1) | RR 0.81 (0.42-1.58) | 96 per 1000 | 18 fewer per 1000 (from 56 fewer to 56 more) |
| PE; follow-up: mean, 90 d | |||||||||||
| 105 (1 observational study)24 | Serious‡ | Not serious | Not serious | Serious* | None | ⊕◯◯◯ Very low | 2/62 (3.2) | 1/43 (2.3) | RR 0.72 (0.07-7.70) | 32 per 1000 | 9 fewer per 1000 (from 30 fewer to 216 more) |
| Major bleeding; follow up: mean 90 d | |||||||||||
| 234 (3 observational studies)24-26 | Serious‡ | Not serious | Not serious | Very serious* | None | ⊕◯◯◯ Very low | 0/125 (0.0) | 1/109 (0.9) | RR 2.68 (0.11-63.45) | 0 per 1000 | 0 fewer per 1000 |
Small number of events in included studies, also wide CI covers appreciable benefit and harm.
A meta-analysis of 2 cohort studies and 2 RCTs including 329 PE patients treated as inpatients had recurrent VTE risk as 1.2% (95% CI, 0.16-8.14%). Within 383 PE patients treated as inpatients, the major bleeding risk was 1.0% (95% CI, 0.39-2.75%), the all-cause mortality was 0.74% (95% CI, 0.04-11.14).32
There is a high risk of bias because the adjustment for additional factors, assessment of outcomes, and adequacy of follow-up was not reported for most studies.
There was a high degree of inconsistency among the pooled estimates. One of the trials consisted of patients who had active or palliative cancer and may have had a higher risk of dying as compared with the other patient populations included in the systematic review.