Table 9.

—[Section 2.7] Summary of Findings: Home Treatment vs Hospital Treatment of Acute DVT^a-d,442

Outcomes	No. of Participants (Studies), Follow-up	Quality of the Evidence(GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects
				Risk With Hospital Treatment	Risk Difference With Home Treatment (95% CI)
Mortality	1,708 (6 studies), 3 mo	Lowc-f due to indirectness and imprecision	RR 0.72 (0.45-1.15)	46 per 1,000	13 fewer per 1,000 (from 25 fewer to 7 more)
Recurrent VTE	1,708 (6 studies), 3 mo	Moderatec-e due to indirectness	RR 0.61 (0.42-0.9)	74 per 1,000	29 fewer per 1,000 (from 7 fewer to 43 fewer)
Major bleeding	1,708 (6 studies), 3 mo	Moderatec-e,g due to indirectness	RR 0.67 (0.33-1.36)	21 per 1,000	7 fewer per 1,000 (from 14 fewer to 8 more)
QOL	0 (3 studiesh), 3 mo	Lowi-k due to indirectness and imprecision	Not estimable	…	h

The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Working group grades of evidence are as follow: 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. See Table 1 and 3 legends for expansion of abbreviations.

^aStudies included in the systematic review should have recruited patients whose home circumstances were adequate.

^bAll studies included patients with lower-extremity DVT and excluded patients with suspected or confirmed PE. Studies also excluded patients who were pregnant.

^cFour studies had partial hospital treatment of many in the home arm: Koopman et al⁹² (mean hospital stay, 2.7 in home arm vs 8.1 d in hospital arm), Levine et al⁹³ (2.1 vs 6.5 d), Boccalon et al⁸⁹ (1 vs 9.6 d), and Ramacciotti et al⁹⁴ (3 vs 7 d). In Daskalopoulos et al,⁹¹ there was no hospital stay at all in the home group. Chong et al⁹⁰ did not report duration of hospital stay.

^dOnly one study (Boccalon et al⁸⁹) used LMWH in both treatment arms. Remaining studies used UFH in the inpatient arm and LMWH in the outpatient arm.

^eOut of six studies, allocation was clearly concealed in three (unclear in remaining three), outcome adjudicators were blinded in the two largest studies (unclear in remaining four), loss to follow-up was significant in only one small study, intention-to-treat analysis was conducted in four (unclear in remaining two), and no study was stopped early for benefit. Overall, the judgment was that these limitations would not warrant downgrading of quality; it has already been downgraded by at least one level based on other factors.

^fThe CI includes values suggesting benefit and harm.

^gJudged as precise based on the narrow CI around absolute effect.

^hBäckman et al⁹⁵ reported evaluation of health-related QOL using the EQ-5D. They found no differences in mean QOL scores or in the proportion of patients showing improvement in self-rated health state. Koopman et al⁹² evaluated health-related QOL using the Medical Outcome Study Short Form-20 and an adapted version of the Rotterdam Symptom Checklist. The changes over time were similar in both groups, except that the patients receiving LMWH had better scores for physical activity (P = .002) and social functioning (P = .001) at the end of the initial treatment. The authors did not report enough data to assess precision and clinical significance of results. O’Brien et al⁹⁶ assessed changes in QOL using the Medical Outcome Study Short Form-36 in 300 patients participating in Levine et al.⁹³ They found that the change in scores from baseline to day 7 was not significantly different between the treatment groups for seven of the eight domains. The one exception was the domain of social functioning, where a greater improvement was observed for the outpatient group.

ⁱPotential inconsistency as Bäckman et al⁹⁵ showed no effect, whereas Koopman et al⁹² and O’Brien et al⁹⁶ showed potential benefit.

^jTwo of the three studies had partial hospital treatment of many in the home arm: Koopman et al⁹² (mean hospital stay, 2.7 in home arm vs 8.1 d in hospital arm) and Levine et al⁹³ (2.1 vs 6.5 d).

^kNot able to evaluate, but imprecision is possible. Taken together with the potential inconsistency, we downgraded the quality of evidence by one level.