Ginsberg 2001.
Methods | Study design: randomised double‐blind clinical trial Method of randomisation: prerandomisation stratification applied, randomisation not stated Concealment of allocation: not stated Blinding: observer and outcome assessor blinded Follow‐up: mean 4.6 to 4.9 years Losses to follow‐up: not reported, but 3 participants in the treatment group died (none in the control group) |
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Participants | Country: Ontario, Canada No. of participants: 47 Age: mean age 61 years Sex: males 26; females 21 Inclusion criteria: asymptomatic postphlebitic syndrome and venous valvular incompetence (as assessed by photoplethysmography or venous Doppler) Exclusion criteria: previous graduated compression stocking therapy, geographic inaccessibility, and failure to provide informed consent |
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Interventions | Intervention group (n = 24): elastic compression stockings; below‐knee elastic compression stockings with ankle pressure of 20 to 30 mmHg at the ankle region Control (n = 23): placebo stocking Start of compression stockings: 1 year after DVT diagnosis |
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Outcomes | Cumulative incidence of PTS | |
Notes | Three‐part study; only data from study 2 are taken into account Study was terminated after an interim analysis owing to slow recruitment of patients. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of random sequence generation |
Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment |
Blinding (performance bias and detection bias) Objective outcome(s) | Low risk | Participants and outcome assessors were blinded. For participants, placebo stockings were provided. Participants were informed not to wear stockings to the assessments. |
Blinding (performance bias and detection bias) Subjective outcome(s) | Low risk | Participants and outcome assessors were blinded. For participants, placebo stockings were provided. Participants were informed not to wear stockings to the assessments. The definition of PTS contained both objective and subjective items. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Incomplete outcome data are not described, but 3 participants (in the active stocking group) died. |
Selective reporting (reporting bias) | Low risk | Only PTS was a prespecified outcome; this is reported. |
Other bias | Low risk | Study seems to be free of other risk of bias. |