Partsch 2004.
| Methods | Study design: randomised clinical trial (3 treatment arms) Method of randomisation: sealed envelopes Concealment of allocation: yes, sealed envelopes were supplied by a statistician Blinding: no Follow‐up: 2 years Losses to follow‐up: 3 died, 1 had an ulcer, 7 were reported to be well without specific problems, and 5 could not be contacted |
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| Participants | Country: Vienna, Austria No. of participants: 53 in primary study. For assessment of PTS incidence, 37 participants were reinvestigated 2 years later. Age: mean age 58 years (baseline data available from 45 participants in first study, Partsch 2000) Sex: males 29; females 16 (baseline data available from 45 participants in first study, Partsch 2000) Inclusion criteria: proximal DVT, confirmed by compression ultrasound scan or phlebography in mobile patients older than 18 years. Duration of symptoms had to be less than 14 days. Exclusion criteria: compression therapy or heparin therapy already started; massive symptomatic PE or need for thrombolysis or thrombectomy; ABI < 0.8; pregnancy or breastfeeding; and contraindication for compression, anticoagulants, or both Participants included 7 patients with previous DVT in the same leg and 11 with previous DVT in the contralateral leg. |
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| Interventions | Group A (n = 18): inelastic compression bandages (Unna boots on the lower leg, adhesive bandages on the thigh) Group B (n = 18): thigh‐length compression stockings (class II, 30 mmHg) Group C (n = 17): bed rest for 9 days without compression After 9 days, all participants were encouraged to walk with compression class II stockings. |
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| Outcomes | Reduced pain and leg circumference on days 0 and 9; on both days, PE and extent of DVT
Clinical score calculated for the following symptoms: pain during walking; painful foot sole; painful calf palpation; subfascial oedema; increase in skin temperature; redness/cyanosis. Severity score comprised 4 stages: absent, mild, marked, and severe. Cumulative incidence of PTS |
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| Notes | Information on cumulative incidence of PTS is available only for the mobile group (treatment arms A + B combined) vs the group with bed rest (arm C). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information available on allocation sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Randomisation was performed with sealed envelopes. Methods of allocation and sequence generation are not described, and concealment of allocation cannot be judged. |
| Blinding (performance bias and detection bias) Objective outcome(s) | High risk | Participants and investigators were not blinded. |
| Blinding (performance bias and detection bias) Subjective outcome(s) | High risk | Participants and investigators were not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Numbers and reasons for incomplete outcome data are described. |
| Selective reporting (reporting bias) | Low risk | All primary outcomes are reported. PTS was not a primary outcome. PTS scores are described as bed rest vs mobile. No information is available on the comparison of PTS scores for the 3 treatment groups, but it is judged unlikely that this introduces bias. |
| Other bias | Low risk | Study appears to be free of other sources of bias. |