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Venous leg ulcers (VLUs) are a common chronic often undertreated condition, which affects individual's health-related quality of life (HRQoL). Numerous patient-reported outcome measures (PROMs) have been validated to capture HRQoL in patients with VLUs. However, available instruments contain many items, are hard to use in clinical practice, and present with weak responsiveness. This study aims to determine clinical utility of an existing VLU-QoL instrument and to develop a comprehensive PROs assessment framework to guide clinical practice treatment in people with VLUs in Australia. Semi-structured qualitative interviews were conducted with VLU patients (N = 13) and their managing clinicians (N = 6) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of the VLU-QoL instrument to determine suitable and appropriate for use in clinical practice. Clinicians and patients agreed that a VLU-QoL instrument was needed in clinical practice. Both clinicians and patients agreed it would be appropriate to answer PROMs questions prior to consultation with clinicians every 3-6 months. However, patients considered that some of the questions are ambiguous and too technical. Patients reported that it would be useful to include additional items relating to daily wound care, compression bandaging, and dressings. Clinicians reported that the VLU-QoL instrument was too long and required restructuring to facilitate utility in practice. A conceptual framework for HRQoL in VLUs included traditional HRQoL components and VLU-specific issues. Overall, the VLU-QoL was well accepted, although changes to make it more concise, comprehensive, and to clearly reflect consumers' perspectives were lacking. The proposed conceptual framework will inform the development of a new PROM for use by clinicians and patients in clinical settings.

Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures' ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument-prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the effects of decision coaching when used to provide non‐directive support to help people prepare to make decisions related to their health care.

Few pain assessment scales have been used in pressure ulcer (PU) research and none developed or validated for people with PUs. We examined the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale to determine its utility as an outcome measure for people with pressure area-related pain.Leeds Assessment of Neuropathic Symptoms and Signs data from 728 participants underwent psychometric analyses: traditional tests for data quality, scaling assumptions, reliability and validity and a Rasch analysis including tests of fit, spread and targeting of item locations, response dependency, person separation index (reliability) and differential item functioning.Our findings offer support for a unidimensional scale; confirmatory factor analysis indicated a non-significant chi-square test of model fit [(df = 14) 23.48, p = 0.053]. However, some misfit was identified at the overall scale and individual item levels, and internal construct validity of the LANSS as an outcome measure for neuropathic pain in people with pressure area-related pain was not supported; low to moderate item-total correlations [Chi Square (df = 28) 55.546, p = 0.002] and inter-item correlations (mean 0.117 and range from 0.063 to 0.415); and low Cronbach's alpha (0.549) and Person Separation Index (0.334).Requirements for reliable and valid measurement do not support the use of the LANSS as an outcome measure in people with PUs at the individual level or as a generalized measurement scale of neuropathic pain across ulcer severity groups. Expanding the number of items to aid differentiation between neuropathic pain levels and improving scale reliability is recommended. WHAT DOES THIS STUDY ADD?: The Leeds Assessment of Neuropathic Symptoms and Signs scale (LANSS) is not suitable as an outcome measure of pressure ulcer-related neuropathic pain as it did not meet requirements for reliable and valid measurement in this population.