Table 26.

—[Section 4.2.2] Summary of Findings: Intermittent Compression Device vs No Intermittent Compression Device for Patients With Severe PTS^a-c,233,240

Outcomes	No. of Participants (Studies), Follow-up	Quality of the Evidence (GRADE)	Relative Effect (95% CI)	Anticipated Absolute Effects
				Risk With No Intermittent Compression Device	Risk Difference With Intermittent Compression Device (95% CI)
Symptomatic relief: symptom score includes scoring of pain, swelling, and limitation of activity on a scale of 10-70	82 (2 studiesd), 8 wk	Moderatee-i due to imprecision		The mean symptomatic relief in the control groups was 0	The mean symptomatic relief in the intervention groups was 0.41 SDs higher (0.02 lower to 0.85 higher)
QOL: VEINES-QOL scale of 0-100.	0 (1 studyd,j), 8 wk	Moderateg-i,k,l due to imprecision		The mean QOL in the control groups was 50.2	The mean QOL in the intervention groups was 2.3 higher (1.04 lower to 5.64 higher)
Recurrent VTEm not reported	…		Not estimablem
Ulcerationn not reported	…		Not estimablen

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. VEINES = Venous Insufficiency Epidemiological and Economic Study. See Table 1, 3, and 25 legends for expansion of other abbreviations.

^aPatients with previous DVT with symptoms of severe PTS.

^bIntervention group: Ginsberg et al²³⁹: Extremity pump used bid for 20 min each session; 50 mm Hg (therapeutic pressure) for 1 mo. O’Donnell et al²⁴⁰: Venowave lower-limb venous return assist device to wear for most of the day for 8 wk.

^cControl group: Ginsberg et al²³⁹: Extremity pump used bid for 20 min each session; 15 mm Hg (placebo pressure) for 1 mo. O’Donnell et al²⁴⁰: Venowave lower-limb venous return assist device with no connection between motor and planar sheet for 8 wk.

^dCrossover RCTs.

^eIn both studies, sequence generation was adequate; patients were blinded, analysis adhered to intention-to-treat principle, and there were no missing outcome data. In Ginsberg et al²³⁹ (but not O’Donnell et al²⁴⁰), outcome assessors were not blinded, and it was not clear whether allocation was concealed.

^fI² = 0%.

^gSome concerns with indirectness, given relatively short follow-up (8 wk).

^hVery small number of patients. CI includes both values suggesting no effect and values suggesting a beneficial effect.

ⁱPublication bias not detected but not ruled out given that we identified only two small studies, with one (Ginsberg et al²³⁹) partially supported by industry (provision of devices).

^jO’Donnell et al et al.²⁴⁰

^kSequence generation was adequate; patients were blinded, analysis adhered to intention-to-treat principle, and there were no missing outcome data. However, outcome assessors were not blinded, and it was not clear whether allocation was concealed.

^lPublication bias was not detected but not ruled out given that we identified only a small study.

^mO’Donnell et al²⁴⁰ indicated no cases of recurrent VTE by the end of this study but judged the follow-up period to be short.

ⁿO’Donnell et al²⁴⁰ indicated that one patient in the control group developed a venous ulceration. Three other participants developed nonserious skin-related side effects. Indirect evidence from the CLOTS1 suggests that compression stockings are associated with an RR of 4 for skin complications. Common side effects attributed to Venowave were heat sensation, skin irritation, and increased sweating.