Lane 2017.

Study characteristics
Methods	Study design: multicentre, randomised control trial Country: UK Setting/Location: Charing Cross Hospital (Imperial College Healthcare NHS Trust) and Northwick Park Hospital (London North West Healthcare NHS Trust) in London, UK Source of funding: the study author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: "This study was supported by a research grant from the Clarivein device manufacturer, Vascular Insights and an educational research grant from the Graham‐Dixon Charitable Trust. Vascular Insights provided funding for Clarivein devices, patient follow‐up and DUS. Case funding was not used in this study. All trial particulars (design, data collection, analysis, discussion and data access) were performed independently of the funding bodies and the trial’s research sponsor was Imperial College London." Intention‐to‐treat analysis: yes
Participants	No of participants randomised: 170 No of participants analysed (n, %): 1 month follow‐up 69 MOCA and 60 RFA (129, 79%), 6 months 121, 71% Exclusions post‐randomisation: 0 Losses to follow‐up (n, %): 1 month follow‐up 69 MOCA and 60 RFA (129, 79%), 6 months 62 MOCA and 59 RFA (121, 71%) Age ‐ median: 50 overall; MOCA 54.5, RFA 58 Sex ‐ percent female: MOCA 57.5%, RFA 60.2% Inclusion criteria: people with symptomatic primary varicose veins with either great saphenous vein (GSV) incompetence (> 0.5 s reflux on colour DUS) Exclusion criteria: people with recurrent varicose veins, current deep vein thrombosis, arterial disease (ankle brachial pressure index < 0.8), veins < 3 mm in diameter or hypercoagulability were excluded from participation. Additionally, people unable or unwilling to complete questionnaires or to participate were also excluded.
Interventions	Treatment(s): MOCA (Clarivein, Vascular Insights, USA), DUS guided cannulation. MOCA chemical‐ablative catheter. Control: RFA Closure system, using local (tumescent) anaesthesia, managed as day patients; ClosureSystem VNUS Medical Technologies Inc Duration: assessed at 1 month and 6 months.
Outcomes	Primary outcomes: degree of pain experience during endovenous ablation using a validated patient‐reported VAS and 0–10 number scale, prior to completion of any phlebectomies Secondary outcomes: improvement in patient‐reported quality of life, both disease specific (Aberdeen Varicose Vein Questionnaire – AVVQ) and generic (EuroQol 5 Domain 3 Level – EQ‐5D‐3L and EuroQol VAS), clinical scores (Venous Clinical Severity Score – VCSS, Venous Disability Score – VDS and Clinical Etiology Anatomy Pathology score) and time taken to return to normal activities and work Recurrence definition: clinically‐evident varicose veins at least 3 mm in diameter and not present at 1 month.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Consenting participants were then randomised on the day of treatment to either MOCA (group one) or RFA (group two), using an online computerised randomisation software (SealedEnvelope, London, UK)"
Allocation concealment (selection bias)	Low risk	Methods of allocation concealment adequately described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Given the nature of the interventions, blinding of the participant to the intervention allocated would be impossible.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"blinded venous duplex ultrasound scanning"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropouts were reported and similar between groups, although reasons were not given
Selective reporting (reporting bias)	Low risk	All outcomes reported on
Other bias	Low risk	No other potential risk detected