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Table 1 Secondary outcome measures

From: BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial

Overall survival

 

Major adverse limb events (MALE), defined as amputation (transtibial or above) or any major vascular re-intervention (thrombectomy, thrombolysis, PBA, stenting, or surgery)

 

In-hospital and 30-day morbidity and mortality

 

Major adverse cardiac events (MACE), defined as SLI and amputation affecting the contralateral limb, ACS, or stroke

 

Relief of ischaemic pain (VAS, medication usage)

 

Psychological morbidity (using HADS)

 

Quality of life using generic (EQ-5D-5L, ICECAP-O, SF-12) and disease-specific (VascuQoL) tools

 

Re- and cross-over intervention rates

 

Healing of tissue loss (ulcers, gangrene) as assessed by the PEDIS and the WIFI scoring and classification systems

 

Extent and healing of minor (toe and forefoot) amputations (also using PEDIS and WIFI)

 

Haemodynamic changes; absolute ankle and toe pressures, ABPI, TBPI

 
  1. ABPI ankle-brachial pressure index, PBA plain balloon angioplasty, EQ-5D-5L European quality of life 5 level score, HADS Hospital Anxiety and Depression Scale, ICECAP-O ICEpop CAPability measure for Older people, PEDIS Perfusion Extent Depth Ischaemia Sensation, SF-12 Short form-12 health survey version 2, TBPI toe-brachial pressure index, VAS Visual Analogue Scale, WIFI Wound, Ischaemia, and Foot Infection tool
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