DEVELOPMENT OF A PREFERENCE-BASED, CONDITION SPECIFIC PATIENT REPORTED OUTCOME MEASURE FOR USE WITH VENOUS ULCERATION Simon Palfreyman 1, John E Brazier 2 1 Sheffield Teaching Hospitals NHS Foundation Trust/ ScHARR, University of Sheffield, 2 ScHARR, University of Sheffield The SPVU-5D is a new condition-specific preference-based measure of health related quality of life for use in the assessment of the impact of venous ulceration. It has five dimensions encompassing physical, psychological and social aspects. The measure was developed from the bottom-up and incorporates items generated from patients. The measure has been shown to have good practicality and validity. Preference-weights and a scoring algorithm were produced based on valuations from the UK population. Introduction Venous ulcers are non-healing wound on the lower leg that have been present for > 6weeks. They are more prevalent in the elderly and women but can also occur in illicit intra-venous drug users. The underlying cause is thought to be damage to the valves in the veins which results in venous hypertension leading to restricted oxygenation and eventually to tissue damage. They account for 1.3% of the UK health budget cost the NHS between In the US result in the loss of approximately two million work days per year. The main treatment is by the application of compression bandages which have to be worn continuously until the ulcer is healed. Healing times can vary from several weeks to many months, and some ulcers never achieve healing. Background FURTHER DETAILS: Palfreyman SJ et al (2007) Impact of intravenous drug use on quality of life for patients with venous ulcers. Journal of Advanced Nursing 58(5), 458–467 Palfreyman SJ et al. (2007) Development of a tool to examine the effect of venous ulcers on patients’ quality of life. Nursing Standard 21 (45), Palfreyman, S. (2008) Assessing the impact of venous ulceration on quality of life. Nursing Times; 104: 41, 34–37. Palfreyman SJ et al. (2010) Assessing current health related quality of life questionnaires administered to patients with venous ulcers: can they be used in economic evaluations? Journal of Clinical Nursing 19 (5) Palfreyman SJ, Tod AM, Brazier JE, Michaels JA (2010) A systematic review of health related quality of life instruments used for people with venous ulcers: an assessment of their suitability and psychometric properties. Journal of Clinical Nursing 19 (19/20); Acknowledgements PICTURE OF A VENOUS LEG ULCER 1. Generation of items and descriptive system Methods Bottom-up approach used. Qualitative interviews and focus groups conducted with patients and clinical staff. Interviews taped and transcribed. Framework analysis used to identify themes and issues. A selected sample re-interviewed to check interpretation and ensure data saturation achieved. Results Thirty-one interviews and one focus group conducted. Three main themes identified related to symptoms, social restrictions and attribution. A total of 12 items identified for inclusion in PROM 2. Testing and Refinement of the Instrument Methods The draft questionnaire sent to 266 patients with a history of venous ulceration. Item performance assessed on the basis of predefined criteria (missing data of over 10%, presence of floor or ceiling effects and poor sensitivity). Factor and Rasch analysis (RA) performed on questionnaire responses to identify poorly performing items. Results Response rate of 57% obtained (n= 152). 4 items (personal care, personal relationships, social isolation and clothes) dropped due to poor item performance including poor completion rate and floor/ ceiling effects Factor analysis showed that the 12 item questionnaire had some evidence of construct validity. Rasch analysis showed that two items (leisure and smell severity) showed little to no spread at logit zero. The items with the widest spread were pain frequency (0.74), mood frequency (0.73) and mobility frequency (0.6). Final questionnaire (the SPVU-5D) consisted of five items with between three and five levels: pain frequency (4 levels), mobility frequency (4 levels), mood frequency (5 levels), smell frequency (3 levels), and social isolation (3 levels) 3. Valuation of the health states Methods Fractional factorial design used to select 26 health states from the 720 described by the PROM for valuation using time trade-off (TTO). Interviewer administered to 160 member of the UK general public. In addition, a discrete choice experiment (DCE) using a postal survey of pair-wise choices was administered to 200 patients and 160 members of the general public. Regression models were used to predict health states and these compared with results from obtained from the valuations. Results TTO produced logical ordering of health state values (best to worse). Predicted and observed values for health states in TTO showed strong correlation. Algorithm from regression models compared well with existing studies. DCE confirmed adaption of patients to health states by showing higher values for worse states than given by the general public. Development of SPVU-5D most to least severe health state value Observed Values Predicted Value GRAPH OF OBSERVED VS PREDICTED VALUES FOR HEALTH STATES Contact: Simon Palfreyman Tel: 44 (0)