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Study flow diagram.
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Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Summary of findings for the main comparison. Graduated elastic compression stockings for the treatment of PTS

Graduated elastic compression stockings compared with placebo stockings or no compression for the treatment of PTS

Patient or population: adults with PTS

Settings: hospitals and clinical centres

Intervention: GECSa

Comparison: placebo stockings or no compression

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

placebo stockings

GECS

Severity of post‐thrombotic syndromeb

(follow‐up: 0–25.6 months)

Ginsberg 2001 reported 61.1% (11/18) treatment failures in the GECS group and 58.8% (10/17) treatment failure in the placebo group.

Lattimer 2013 reported the VFI, VFT90, and VV significantly improved with GECS compared with no compression.

VFI: no compression median 4.9 (range 1.7 to 16.3)

BKI median 3.7 (range 0–14; 24.5% percentage improvement)

AKI median 3.6 (range 0.6–14.5; 26.5%)

BKII median 4.0 (range 0.3–16.2; 18.8%)

AKII median 3.7 (range 0.5–14.2; 24.5%)

69

(2 RCTs)

⊕⊝⊝⊝
Very lowc

2 small studies of short duration were identified. 1 reported benefit and 1 no benefit from GECS use.

Adverse effects

(follow‐up: 25.6 months)

Ginsberg 2001 reported no participants developed ulceration in both groups

Lattimer 2013 did not assess adverse effects.

Patient satisfaction and quality of life

See comments

No study measured quality of life. Lattimer 2013 assessed patient preferences. 52.5% of participants indicated they wanted to change their compression to another type of stocking, 38% of these preferred an AK stocking.

Compliance rate

See comments

Lattimer 2013 and Ginsberg 2001 did not assess compliance rates during the study period.

*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).

AKI/II: above‐knee thigh length stocking class I or II; BKI/II: below‐knee class I or II; CI: confidence interval; GECS: graduated elastic compression stockings; PTS: post‐thrombotic syndrome; RCT: randomised controlled trial; VFI: venous filling index; VFT90: venous filling time; VV: venous volume.

GRADE Working Group grades of evidence
High certainty: further research is very unlikely to change our confidence in the estimate of effect.
Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low certainty: 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 certainty: we are very uncertain about the estimate.

aGinsberg 2001 compared compression stockings (30 mmHg to 40 mmHg) with placebo stockings (one to two sizes too large). Calf length or thigh length compression stockings were administered depending on the localisation of complaints. Lattimer 2013 assessed four different stockings and assessed improvements of compression and length (of their size in random order: class I (18 mmHg to 21 mmHg) and class II (23 mmHg to 32 mmHg), BK and AK.
bGinsberg 2001 defined treatment failure as pain and swelling that did not improve, or worsened, after the first three months; or worsening of symptoms during further follow‐up; or symptoms that prevented participants from performing their daily activities for five or more days in any three‐month period; or developing a leg ulcer. Lattimer 2013 used Venous Clinical Severity Score, the C part of the CEAP and the Villalta Scale to assess the severity of PTS.
cDowngraded three levels owing to conflicting results, small sample size, and different outcome measures.
dDowngraded two levels due to small study size and self‐reported outcomes.

Figuras y tablas -
Summary of findings for the main comparison. Graduated elastic compression stockings for the treatment of PTS
Summary of findings 2. Intermittent pneumatic compression devices for the treatment of PTS

Intermittent pneumatic compression devices compared with control devices for the treatment of PTS

Patient or population: adults with PTS

Settings: hospitals and clinical centres

Intervention: medical compression devicea

Comparison: control device

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control device

Medical compression device

Severity post‐thrombotic syndromeb

(follow‐up: 8–20 weeks)

Ginsberg 1999: 80% (12/15) of participants had an improvement in symptom score that was considered a treatment success. The mean difference in scoring at the 2 pressure levels was –2.1 (95% CI –3.6 to –0.7; P = 0.007)

O'Donnell 2008: an improvement in Villalta score was reported in the Venowave group (12) compared to the control device group (15) (P = 0.004)

47

(2 RCTs)

⊕⊕⊝⊝
Lowc

Control devices were used on the same participants that used medical device.

Adverse effects

(follow‐up: 20 weeks)

O'Donnell 2008 reported 9% (3/32) of participants experienced adverse effects, including leg swelling, irritation, superficial bleeding, and skin itching related to Venowave device use

32

(1 RCT)

⊕⊕⊕⊝
Moderated

Not measured by Ginsberg 1999.

Patient satisfaction and quality of life

(follow‐up: 20 weeks)

O'Donnell 2008 reported the mean VEINES‐QoL score at the end of the study period was significantly higher for Venowave (53) than for the control device (50) (P = 0.004)

32

(1 RCT)

⊕⊕⊕⊝
Moderated

Not measured by Ginsberg 1999.

Compliance rate

See comments

No study measured this outcome.

*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; PTS: post‐thrombotic syndrome; RCT: randomised controlled trial; QoL: quality of life; VEINES‐QOL: VEnous INsufficiency Epidemiological and Economic Study – Quality of Life.

GRADE Working Group grades of evidence
High certainty: further research is very unlikely to change our confidence in the estimate of effect.
Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low certainty: 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 certainty: we are very uncertain about the estimate.

aGinsberg 1999 used an extremity pump twice daily at either 50 mmHg pressure or 15 mmHg pressure. O'Donnell 2008 used Venowave, a lower‐limb venous‐return assist device.
bStudies measured severity differently. Ginsberg 1999 assessed severity using own method (questionnaire assessing symptoms and functional status). O'Donnell 2008 assessed severity using Villalta score.
cDowngraded two levels owing to high heterogeneity between studies, different measurements used by studies reporting on this outcome and small studies of short duration.
dDowngraded one level owing to one small study of short duration.

Figuras y tablas -
Summary of findings 2. Intermittent pneumatic compression devices for the treatment of PTS