Impact of venous leg ulceration on health-related quality of life: A synthesis of data from randomized controlled trials compared to population norms Andrew Jull, RN, PhD 1,2 ; Sara Muchoney 2 ; Varsha Parag, MSc 2 ; Angela Wadham, RN, BSc 2 ; Chris Bullen, MBChB PhD FAFPHM 2 ; Jill Waters, MBChB FRACP 3 1. School of Nursing, 2. National Institute for Health Innovation, University of Auckland, and 3. Auckland District Health Board, Auckland, New Zealand Reprint requests: Professor Andrew Jull, School of Nursing, University of Auckland, Private Bag 92019, Auckland 1023, New Zealand Tel: 164 9 923 4259; Fax: 164 9 367 7158; Email: a.jull@auckland.ac.nz Manuscript received: November 2, 2017 Accepted in final form: April 2, 2018 DOI:10.1111/wrr.12636 ABSTRACT Venous insufficiency is the most common cause of leg ulceration, but the impact of venous leg ulceration on health-related quality of life has not been adequately assessed. This study compared data from randomized controlled trials to population norms obtained from a large national population survey. We combined the baseline Short Form-36 (SF-36) version 1 data from two New Zealand randomized controlled trials that recruited participants with VLU and compared the pooled data to the population scores obtained from the New Zealand Health Survey using general linear regression to adjust for age, sex, and ethnicity differences between the cohorts. Baseline SF-36 scores obtained from 618 trial participants were compared to the SF-36 scores obtained from the 12,529 participants in the New Zealand Health Survey. Participants with VLU had significantly lower crude SF-36 scores across all eight SF-36 domains, but there was interaction between age and group. Adjusted mean differences for participants aged 65 years or younger were 225.8, 232.1, 221.2, 29.6, 27.6, 223.9, 221.5, and 29.3, respectively, for Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health whereas the adjusted mean differences for older participants were 215.7, 223.8, 213.8, 20.3 (nonsignificant), 24.6, 215.3, 221.2, and 26.6. This study is the first to compare a VLU population to norms from a general population survey and the first to show VLU interacts with age creating stronger impact in younger patients compared their age cohort. Younger patients may have need of more pastoral care as a consequence. Qualitative studies and surveys have shown venous leg ulceration (VLU) has significant personal impacts. In par- ticular, pain, sleep impairment, and reduced mobility are common, 1–5 social activities are avoided in order to reduce the risk of injury to legs, 6 work capacity is restricted, and personal finances are adversely affected. 7,8 Patients report feelings of powerlessness, loss of control, and states of hopelessness. 1,5,8–10 VLU account for up to 84% of all leg ulcers, 11,12 and about 1% of the adult population enrolled in family practices will suffer a VLU during any one year. 13 The impact of VLU on health-related quality of life has not been quantified in comparison to population health- related quality of life. The Short-Form 36 item question- naire (SF-36) and its variants (SF-12, SF-8) measure per- ceived health on four physical and four mental domains 14 and can be used to make comparions between populations. It has been among the most commonly used instruments to assess the impact of all-cause leg ulceration on health- related quality of life, 15,16 but few of these studies have compared participants to general populations and only one study using SF-36 has restricted their sample to VLU as distinct from all-cause leg ulceration. 17 That study had a very small sample size, was conducted in one clinic, and did not undertake any statistical testing. Thus the purpose of this investigation was to quantify the effect of VLU on health-related quality of life in comparison to population norms obtained from a national health survey. MATERIALS AND METHODS Participants The Honey as Adjuvant Leg ulcer Therapy (HALT) trial (ISRCTN.com 06161544) recruited 368 participants between 2003 and 2005 from four centres in New Zealand (Auck- land, South Auckland Waikato, and Christchurch), 18 while the Aspirin4VLU trial (ClinicalTrials.gov NCT02158806) recruited 251 participants between 2014 and 2016 from the same four centres plus one in Dunedin. 19,20 The case defini- tion for VLU was a nonhealing skin break present on the lower leg for 4–6 weeks, clinical presentation for venous ulceration (moist, shallow, irregularly shaped ulcer with associated hemosiderin pigmentation, venous eczema, ankle Wound Rep Reg (2018) 00 00–00 V C 2018 by the Wound Healing Society 1