Abstract
BACKGROUND: The aim of this study was to assess behavioural recovery from the patient's perspective as a prespecified secondary outcome in a multicentre parallel-group randomized clinical trial comparing ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA) and surgery for the treatment of primary varicose veins.
METHODS: Participants were recruited from 11 UK sites as part of the CLASS trial, a randomized trial of UGFS, EVLA or surgery for varicose veins. Patients were followed up 6 weeks after treatment and asked to complete the Behavioural Recovery After treatment for Varicose Veins (BRAVVO) questionnaire. This is a 15-item instrument that covers eight activity behaviours (tasks or actions an individual is capable of doing in an idealized situation) and seven participation behaviours (what the individual does in an everyday, real-world situation) that were identified to be important from the patient's perspective.
RESULTS: A total of 798 participants were recruited. Both UGFS and EVLA resulted in a significantly quicker recovery compared with surgery for 13 of the 15 behaviours assessed. UGFS was superior to EVLA in terms of return to full-time work (hazard ratio 1·43, 95 per cent c.i. 1·11 to 1·85), looking after children (1·45, 1·04 to 2·02) and walks of short (1·48, 1·19 to 1·84) and longer (1·32, 1·05 to 1·66) duration.
CONCLUSION: Both UGFS and EVLA resulted in more rapid recovery than surgery, and UGFS was superior to EVLA for one-quarter of the behaviours assessed. The BRAVVO questionnaire has the potential to provide important meaningful information to patients about their early recovery and what they may expect to be able to achieve after treatment.
| Original language | English |
|---|---|
| Pages (from-to) | 374-381 |
| Number of pages | 8 |
| Journal | British Journal of Surgery |
| Volume | 103 |
| Issue number | 4 |
| Early online date | 25 Jan 2016 |
| DOIs | |
| Publication status | Published - Mar 2016 |
Bibliographical note
AcknowledgementsThe authors thank J. Cruden for secretarial support and data management; G. McPherson and the programming team at the Centre for Healthcare Randomized Trials; members of the Project Management Group for their ongoing advice and support of the trial; D. Bolsover, who contributed to the development of the BRAVVO questionnaire; the independent members of the Trial Steering Committee (A. Davies (Chair), I. Loftus, J. Nixon) and Data Monitoring Committee (G. Stansby (Chair), W. Banya, M. Flather); and the staff at recruitment sites who facilitated recruitment, treatment and follow-up of trial participants.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 06/45/02). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, National Health Service or the Department of Health. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorate.