GRADE summary: should we treat at home rather than admit to the hospital patients with DVT?
| 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 . | ||||||||
| All-cause mortality, short-term; follow-up: 10 d | |||||||||||
| 214 (1 RCT)21 | Serious*a | Not serious | Not serious | Serious† | None | ⊕⊕◯◯ Low | 0/103 (0.0) | 0/111 (0.0) | Not estimable | 0 per 1000 | |
| Long-term mortality; follow-up: range, 3-12 mo | |||||||||||
| 1708 (6 RCTs)4,5,17-20 | Serious‡ | Not serious | Not serious§ | Serious† | None | ⊕⊕◯◯ Low | 39/851 (4.6) | 28/857 (3.3) | RR 0.72 (0.45-1.15) | • Study population: 46 per 1000 | • Study population: 13 fewer per 1000 (from 25 fewer to 7 more)|| |
| • DVT patients treated in hospital (90-d risk of symptomatic PE): 66 per 1000|| | • DVT patients treat in hospital (90-d risk of symptomatic PE): 19 fewer per 1000 (from 37 fewer to 10 more) | ||||||||||
| PE, moderate; follow-up: range, 10 d to 12 mo | |||||||||||
| 1922 (7 RCTs)4,5,17-21 | Serious‡ | Not serious | Not serious§ | Not serious | None | ⊕⊕⊕◯ Moderate | 65/954 (6.8) | 42/968 (4.3) | RR 0.64 (0.44-0.93) | • Study population: 68 per 1000 | • Study population: 25 fewer per 1000 (from 38 fewer to 5 fewer) |
| • DVT patients treated in hospital (90-d risk of symptomatic PE): 6 per 1000|| | • DVT patients treated in hospital (90-d risk of symptomatic PE): 2 fewer per 1000 (from 4 fewer to 0 fewer) | ||||||||||
| Proximal DVT in the upper leg, moderate; follow-up: range, 3-12 mo | |||||||||||
| 1708 (6 RCTs)4,5,17-20 | Serious‡ | Not serious | Not serious§ | Not serious | None | ⊕⊕⊕◯ Moderate | 63/851 (7.4) | 39/857 (4.6) | RR 0.61 (0.42-0.90) | • Study population: 74 per 1000 | • Study population: 29 fewer per 1000 (from 43 fewer to 7 fewer) |
| • DVT patients treated in hospital (90-d risk of recurrence of DVT): 11 per 1000|| | • DVT patients treated in hospital (90-d risk of recurrence of DVT): 4 fewer per 1000 (from 6 fewer to 1 fewer) | ||||||||||
| Major bleeding; follow-up: range 10 d to 12 mo | |||||||||||
| 1922 (7 RCTs)4,5,17-21 | Serious‡ | Not serious | Not serious§ | Serious† | None | ⊕⊕◯◯ Low | 18/954 (1.9) | 12/968 (1.2) | RR 0.67 (0.33-1.36) | • Study population: 19 per 1000 | • Study population: 6 fewer per 1000 (from 13 fewer to 7 more) |
| • DVT patients treated in hospital (90-d risk of recurrence of major bleeding): 17 per 1000|| | • DVT patients treated in hospital (90-d risk of recurrence of major bleeding): 5 fewer per 1000 (from 11 fewer to 6 more) | ||||||||||
| 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 . | ||||||||
| All-cause mortality, short-term; follow-up: 10 d | |||||||||||
| 214 (1 RCT)21 | Serious*a | Not serious | Not serious | Serious† | None | ⊕⊕◯◯ Low | 0/103 (0.0) | 0/111 (0.0) | Not estimable | 0 per 1000 | |
| Long-term mortality; follow-up: range, 3-12 mo | |||||||||||
| 1708 (6 RCTs)4,5,17-20 | Serious‡ | Not serious | Not serious§ | Serious† | None | ⊕⊕◯◯ Low | 39/851 (4.6) | 28/857 (3.3) | RR 0.72 (0.45-1.15) | • Study population: 46 per 1000 | • Study population: 13 fewer per 1000 (from 25 fewer to 7 more)|| |
| • DVT patients treated in hospital (90-d risk of symptomatic PE): 66 per 1000|| | • DVT patients treat in hospital (90-d risk of symptomatic PE): 19 fewer per 1000 (from 37 fewer to 10 more) | ||||||||||
| PE, moderate; follow-up: range, 10 d to 12 mo | |||||||||||
| 1922 (7 RCTs)4,5,17-21 | Serious‡ | Not serious | Not serious§ | Not serious | None | ⊕⊕⊕◯ Moderate | 65/954 (6.8) | 42/968 (4.3) | RR 0.64 (0.44-0.93) | • Study population: 68 per 1000 | • Study population: 25 fewer per 1000 (from 38 fewer to 5 fewer) |
| • DVT patients treated in hospital (90-d risk of symptomatic PE): 6 per 1000|| | • DVT patients treated in hospital (90-d risk of symptomatic PE): 2 fewer per 1000 (from 4 fewer to 0 fewer) | ||||||||||
| Proximal DVT in the upper leg, moderate; follow-up: range, 3-12 mo | |||||||||||
| 1708 (6 RCTs)4,5,17-20 | Serious‡ | Not serious | Not serious§ | Not serious | None | ⊕⊕⊕◯ Moderate | 63/851 (7.4) | 39/857 (4.6) | RR 0.61 (0.42-0.90) | • Study population: 74 per 1000 | • Study population: 29 fewer per 1000 (from 43 fewer to 7 fewer) |
| • DVT patients treated in hospital (90-d risk of recurrence of DVT): 11 per 1000|| | • DVT patients treated in hospital (90-d risk of recurrence of DVT): 4 fewer per 1000 (from 6 fewer to 1 fewer) | ||||||||||
| Major bleeding; follow-up: range 10 d to 12 mo | |||||||||||
| 1922 (7 RCTs)4,5,17-21 | Serious‡ | Not serious | Not serious§ | Serious† | None | ⊕⊕◯◯ Low | 18/954 (1.9) | 12/968 (1.2) | RR 0.67 (0.33-1.36) | • Study population: 19 per 1000 | • Study population: 6 fewer per 1000 (from 13 fewer to 7 more) |
| • DVT patients treated in hospital (90-d risk of recurrence of major bleeding): 17 per 1000|| | • DVT patients treated in hospital (90-d risk of recurrence of major bleeding): 5 fewer per 1000 (from 11 fewer to 6 more) | ||||||||||
The allocation was probably unconcealed in 1 with unspecified opaque envelope; participants and personnel, outcome assessors were probably not blinded.
CI includes values suggesting substantial benefit and values suggesting substantial harm
Of 6 RCTs, the allocation was clearly concealed in 3 (unclear in 3); outcome adjudicators were clearly blinded in the 2 largest RCTs (unclear in remaining 4), and missing data were significant in 1 small RCT.
Four RCTs had partial hospital treatment of some participants in the home group: Levine et al5 (mean hospital stay 1.1 vs 6.5 days in home and hospital arms, respectively), Koopman et al4 (2.7 vs 8.1 days), Boccalon et al17 (1 vs 9.6 days), and Ramacciotti et al18 (3 vs 7 days). Chong et al,19 Daskalopoulos et al,20 and Romera-Villegas et al21 did not report mean duration of hospital stay.
The Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) registry data compared outcomes in consecutive outpatients with acute lower-limb DVT according to initial treatment at home (n = 4456) or in the hospital (n = 9037). Among 9037 patients treated in the hospital, the 90-day all-cause mortality rate was 6.64%, recurrent DVT was 1.11%, symptomatic PE was 0.64%, major bleeding rate was 1.65%.33