Methods | Trial design: randomised controlled trial (parallel). Country principal investigators: Italy, UK, Australia. Where trial conducted: UK. Date of trial: May to July 2002. Multi‐centre: yes. Funder: multiple sources. Blinding: outcome assessor not blinded. Lost to follow‐up: 5/184 (stocking) 9/188 (control); dropouts due to low compliance or flight connection problems. | |
Participants | Inclusion criteria: low‐ to medium‐risk participants. Participants were recruited through flight shops. Exclusion criteria: high‐risk participants defined as those with previous episodes of DVT, coagulation disorders, severe obesity, limited mobility due to bone or joint problems, neoplastic disease within the previous 2 years, large varicose veins or participants taller than 190 cm and heavier than 90 kg. No. randomised: 372 No. analysed: 358 Age (years): mean 49 (stocking), 48.4 (control). Sex: 101 M, 78 F (stocking), 98 M, 81 F (control) ‐ based on the number analysed. | |
Interventions | Stocking Group Type of stocking: below‐knee Scholl flight sock UK with 14 to 17 mmHg of pressure at the ankle. Stockings were put on 2 to 3 hours before the flight. No. randomised: 184. No. analysed: 179. Length of flight: 7 to 8 hours. Type of seat: Economy, seat pitch 31 inches. Route and time of flight: London to New York. Additional interventions: suggestions were given to participants, i.e. mild exercise, walking, drinking water and avoiding salty food and excessive baggage restricting leg motion. Control Group Type of control: no intervention No. randomised: 188 No. analysed: 179 Length of flight: 7 to 8 hours Type of seat: Economy, seat pitch 31 ins Route and time of flight: London to New York Additional interventions: the same advice as the stocking group was given. |
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Outcomes | Outcomes assessed: incidence of DVT, SVT and oedema score. DVT diagnosed by: pre‐ and post‐flight ultrasound scanning using Sonosite scanners with a 7.5 to 13 MHz, high‐resolution probe (Sonosite, Bothell, WA, USA). This was done by compressing the major veins (femoral, popliteal and tibial). Site of DVT: not mentioned. Site of SVT: none developed. Other investigations performed: oedema test (ankle circumference, volume, swelling, discomfort). Additional complications reported: increased oedema in the control group. | |
Notes | See Feedback. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States randomised but no further details |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Oedema measured both parametrically and non‐parametrically |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All accounted for and dropouts similar between groups |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No evidence of other bias |