Incidence of Pressure Injury Among Older Adults Transitioning from Long-term Care to the ED.

OBJECTIVE: To identify sociodemographic, health condition, and organizational/process factors associated with pressure injury (PI) incidence during older adults' emergency transitions from long-term care (LTC) to the ED. METHODS: Emergency transitions were tracked for older adults within included LTC facilities to participating EDs in two urban centers located in provinces in Canada. Binary logistic regression was used to examine the influence of sociodemographic, service use, and client health and function factors on the incidence of PIs during transitions from LTC facilities to EDs. RESULTS: Having a mobility issue (odds ratio [OR], 4.318; 95% CI, 1.344-13.870), transitioning from a publicly owned versus a nonprofit volunteer LTC facility (OR, 4.886; 95% CI, 1.157-20.634), and time from ED arrival to return to LTC being 7 to 9 days (OR, 41.327; 95% CI, 2.691-634.574) or greater than 9 days (OR, 77.639; 95% CI, 5.727-1,052.485) significantly increased the odds of experiencing a new skin injury upon return to LTC. A higher number of reported reasons for emergency transition (up to 4) significantly decreased the odds of a new PI upon return to LTC (OR, 0.315; 95% CI, 0.113-0.880). CONCLUSIONS: The study findings can be used to identify LTC residents at increased risk for developing new skin injuries during an emergency transition, namely, those with mobility impairment, those requiring inpatient care for 6 or more days, and those transitioning from publicly owned LTC facilities. Evaluating the uptake and effectiveness of single-pronged and multipronged interventions such as visual cues for patient turning through online monitoring, consistent risk assessments, and improved nutrition in all care settings are vital next steps in preventing skin injuries in this population.

Patient-Reported Outcome Measures in Carotid Artery Revascularization: Systematic Review and Psychometric Analysis.

BACKGROUND: Patient-reported outcome measures (PROMs) provide a way to measure the impact of a disease and its associated treatments on the quality of life (QoL) from the patients' perspective. The aim of this review was to identify PROMs that have been developed and/or validated in patients with carotid artery stenosis (CAS) undergoing revascularization and to assess their psychometric properties and examine suitability for research and clinical use. METHODS: Eight electronic databases including MEDLINE and CINAHL were searched using a 2-stage search approach to identify studies reporting the development and/or validation of relevant PROMs in patients with CAS undergoing revascularization. Supplementary citation searching and hand-searching reference lists of included studies were also undertaken. The COnsensus-based Standards for the selection of health Measurement INstruments and Oxford criteria were used to assess the methodological quality of the included studies, and the psychometric properties of the PROMs were evaluated using established assessment criteria. RESULTS: Five studies reporting on 6 PROMs were included: 36-Item Short Form Health Survey (SF-36), Euro-QoL-5-Dimension Scale (EQ-5D), Hospital Anxiety and Depression Scale, Dizziness Handicap Inventory, QoL for carotid artery disease scale, and a disease-specific PROM for CAS. The rigor of the psychometric assessment of the PROMs was variable with most only attempting to assess a single psychometric criterion. No study reported evidence on construct validity and test-retest reliability. Evidence for acceptability for the use of SF-36, EQ-5D, and the disease-specific PROM was rated good in most studies. Only one study reported a Cronbach alpha score >0.70 as evidence of internal consistency. Overall, the psychometric evaluation of all included PROMs was rated as poor within the CAS population undergoing revascularization. CONCLUSIONS: This review highlighted a lack of evidence in validated PROMs used for patients undergoing carotid artery revascularization. As a result, the development and validation of a new PROM for this patient population is warranted to provide data which can supplement traditional clinical outcomes (stroke<30 days post-procedural, myocardial infarction, and death) and capture changes in health status and QoL to help inform treatment decisions.

Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties.

BACKGROUND: Peripheral arterial disease (PAD) is generally associated with considerable morbidity and reduced quality of life. Patient-reported outcome measures (PROMs) provide important information about the burden of disease and impact of treatment in affected patients. OBJECTIVES: The objective of the review was to identify and appraise studies reporting the psychometric evaluation of PROMs administered to a specified population of patients with PAD with a view to recommending suitable PROMs. METHODS: A systematic review of peer-reviewed English language articles was undertaken to identify primary studies reporting psychometric properties of PROMs in English-speaking patients with various stages of PAD. Comprehensive searches were completed up until January 2015. Study selection, data extraction and quality assessment were undertaken independently by at least two researchers. Findings were presented as tabular and narrative summaries based on accepted guidance. RESULTS: Psychometric evaluation of 6 generic and 7 condition-specific PROMs reported in 14 studies contributed data to the review. The frequently reported measure was the SF-36 (n = 11 studies); others included the Walking Impairment Questionnaire (n = 8 studies), EQ-5D (n = 5 studies) and the Vascular Quality of Life Questionnaire (n = 3 studies). Studies included a diverse PAD population and varied in methodology, including approach to validation of PROMs. CONCLUSIONS: Various PROMs have been validated in patients with PAD but no study provided evidence of a full psychometric evaluation in the patient population. Careful selection is required to identify reliable and valid PROMs to use in clinical and research settings.

The psychometric performance of generic preference-based measures for patients with pressure ulcers.

BACKGROUND: Pressure ulcers are wounds that result from reduced mobility, and can have a significant impact on morbidity, mortality and quality of life. As pressure ulcers are a consequence of a wide range of conditions and interventions, it is unclear whether the best means of capturing the quality of life impacts is via generic or condition specific Patient Reported Outcome Measures (PROMs). The aim of this study was to investigate the psychometric performance of the generic EQ-5D and SF-6D amongst patients identified as having or being at risk of developing pressure ulceration. METHODS: A survey of patients who were using pressure relieving mattresses and other equipment was undertaken within inpatient and community settings using a handheld tablet and postal survey. Data on EQ-5D-3L, SF-12 (used to calculate SF-6D), an EQ-5D dignity bolt-on question, demographic and wound specific questions were collected. Convergent validity was assessed using Spearman's correlations, and agreement using Bland-Altman plots. Known group validity was assessed by examining whether the instruments discriminated between different pressure ulcer severity groups. Multivariate linear regression was used to examine the impact of a range of pressure ulcer related variables. RESULTS: The total number of participants was 307, including 273 from the acute setting (52% response rate) and 41 from the community (32%). SF-6D and EQ-5D were moderately correlated (0.61), suggesting that both instruments were capturing similar quality of life impacts. Both measures were able to significantly discriminate between groups based on the ulcer grade. Presence of a pressure ulcer and number of comorbidities were significant explanatory variables of EQ-5D and SF-6D score. CONCLUSIONS: The results suggest that generic PROMs can effectively capture the impact of pressure ulcers on quality of life, although there are significant challenges in collecting data from this group of patients related to poor clinical condition and mental capacity. The most effective method for obtaining survey data was through the hand held devices and interviewers.

A qualitative study to explore the attitude of clinical staff to the challenges of caring for obese patients.

AIMS AND OBJECTIVES: To examine, from the perspective of staff, if obese patients have any additional care needs, and what the impact of these care requirements are on care provision. We have selected obese patients with venous leg ulceration as an example patient population to explore these questions. BACKGROUND: Anecdotal evidence indicates obesity can increase care requirements and have implications for obesity for care provision. However, little research exists nationally or internationally that provides evidence from a health care perspective. Obesity is a contributory causative factor of lower limb ulceration. In addition to affecting the development of venous leg ulceration, obesity may also impact on the care an obese patient may require and receive. DESIGN: Qualitative study using semi-structured in interviews and framework analysis. METHODS: Interviews were conducted with 18 health care professionals and one focus group with 12 health care professionals who cared for patients with venous ulceration. Data were analysed to identify recurring themes relating to the impact of obesity on care provision. RESULTS: This study found that the increasing numbers of obese patients with leg ulcers are currently presenting challenges to care delivery in many different ways. There was an impact of obesity on patient experience in terms of dignity, safety and quality. Data indicated that neither hospital nor community care services were adequately set up to meet the needs of obese patients in general. CONCLUSION: Health care providers need to recognise that increasing numbers of overweight and obese patients are presenting challenges to care delivery. The study also indicated the need for senior strategic leadership in planning for meeting the needs of obese patients. RELEVANCE TO CLINICAL PRACTICE: Nursing is well placed to provide specialist support to co-ordinate services for obese/oversize patients if a suitable strategic and leadership role is developed. Nurses are used to offering patients help in areas of health promotion such as smoking cessation. Lessons learnt from this area could be applied to help and encourage staff to support patients with weight management.

Endovascular repair of abdominal aortic aneurysm.

BACKGROUND: An abnormal dilatation of the abdominal aorta is referred to as an abdominal aortic aneurysm (AAA). Due to the risk of rupture, surgical repair is offered electively to individuals with aneurysms greater than 5.5 cm in size. Traditionally, conventional open surgical repair (OSR) was considered the first choice approach. However, over the past two decades endovascular aneurysm repair (EVAR) has gained popularity as a treatment option. This article intends to review the role of EVAR in the management of elective AAA. OBJECTIVES: To assess the effectiveness of EVAR versus conventional OSR in individuals with AAA considered fit for surgery, and EVAR versus best medical care in those considered unfit for surgery. This was determined by the effect on short, intermediate and long-term mortality, endograft related complications, re-intervention rates and major complications. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (January 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 12). The TSC also searched trial databases for details of ongoing or unpublished studies. SELECTION CRITERIA: Prospective randomised controlled trials (RCTs) comparing EVAR with OSR in individuals with AAA considered fit for surgery. and comparing EVAR with best medical care in individuals considered unfit for surgery. We excluded studies with inadequate data or using an inadequate randomisation technique. DATA COLLECTION AND ANALYSIS: Three reviewers independently evaluated trials for appropriateness for inclusion and extracted data using pro forma designed by the Cochrane PVD Group. We assessed the quality of trials using The Cochrane Collaboration's 'Risk of bias' tool. We entered collected data in to Review Manager (version 5.2.3) for analysis. Where direct comparisons could be made, we determined odds ratios (OR). We tested studies for heterogeneity and, when present, we used a random-effects model; otherwise we used a fixed-effect model. We tabulated data that could not be collated. MAIN RESULTS: Four high-quality trials comparing EVAR with OSR (n = 2790) and one high-quality trial comparing EVAR with no intervention (n = 404) fulfilled the inclusion criteria. In individuals considered fit for surgery, a pooled analysis, including 1362 individuals randomised to EVAR and 1361 randomised to OSR, found short-term mortality (including 30-day or inhospital mortality, excluding deaths prior to intervention) with EVAR to be significantly lower than with OSR (1.4% versus 4.2%, OR 0.33, 95% confidence interval (CI) 0.20 to 0.55; P < 0.0001). Using intention-to-treat analysis (ITT) there was no significant difference in mortality at intermediate follow-up (up to four years from randomisation), with 221 (15.8%) and 237 (17%) deaths in the EVAR (n = 1393) and OSR (n = 1390) groups, respectively (OR 0.92, 95% CI 0.75 to 1.12; P = 0.40). There was also no significant difference in long-term mortality (beyond four years), with 464 (37.3%) deaths in the EVAR and 470 (37.8%) deaths in the OSR group (OR 0.98, 95% CI 0.83 to 1.15; P = 0.78). Similarly, there was no significant difference in aneurysm-related mortality between groups, either at the intermediate- or long-term follow up.Studies showed that both EVAR and OSR were associated with similar incidences of cardiac deaths (OR 1.14, 95% CI 0.86 to 1.52; P = 0.36) and fatal stroke rate (OR 0.81, 95% CI 0.42 to 1.55; P = 0.52). The long-term reintervention rate was significantly higher in the EVAR group than in the OSR group (OR 1.98, 95% CI 1.12 to 3.51; P = 0.02; I(2) = 85%). Results of the reintervention analysis should be interpreted with caution due to significant heterogeneity. Operative complications, health-related quality of life and sexual dysfunction were generally comparable between the EVAR and OSR groups. However, there was a slightly higher incidence of pulmonary complications in the OSR group compared with the EVAR group (OR 0.36, 95% CI 0.17 to 0.75; P = 0.006).In individuals considered unfit for conventional OSR, the one included trial found no difference between the EVAR and no-intervention groups with regard to all-cause mortality at final follow up, with 21.0 deaths per 100 person-years in the EVAR group and 22.1 deaths per 100 person years in the no-intervention group (adjusted hazard ratio (HR) with EVAR 0.99, 95% CI 0.78 to 1.27; P = 0.97). Aneurysm-related deaths were, however, significantly higher in the no-intervention group than in the EVAR group (adjusted HR 0.53, 95% CI 0.32 to 0.89; P = 0.02). There was no difference in myocardial events (HR 1.07, 95% CI 0.60 to 1.91) between the groups in this study. AUTHORS' CONCLUSIONS: In individuals considered fit for conventional surgery, EVAR was associated with lower short-term mortality than OSR. However, this benefit from EVAR did not persist at the intermediate- and long-term follow ups. Individuals undergoing EVAR had a higher reintervention rate than those undergoing OSR. Most of the reinterventions undertaken following EVAR, however, were catheter-based interventions associated with low mortality. Operative complications, health-related quality of life and sexual dysfunction were generally comparable between EVAR and OSR. However, there was a slightly higher incidence of pulmonary complications in the OSR group than in the EVAR group.In individuals considered unfit for open surgery, the results of a single trial found no overall short- or long-term benefits of EVAR over no intervention with regard to all-cause mortality, but individuals may differ and individual preferences should always be taken into account.

Elevation devices for the prevention of heel pressure ulcers: a review.

AIM: The objective of this systematic literature review was to gain insight into the effectiveness of off-loading devices to prevent heel pressure ulcers within the acute hospital setting. BACKGROUND: Heels have been identified as the second most common site for pressure ulcers. Devices which off-load pressure can include pillows, wedges and boots. It is unclear as to which method or device is best at preventing pressure ulcers. DESIGN AND METHODS: A systematic review was carried out through the search of electronic databases and bibliographies of relevant publications. Randomised controlled trials (RCTs) and systematic reviews that compared devices which off-load heels to prevent pressure ulcers were identified. RESULTS: A total of five studies were included in the review. The methodological quality of the studies was generally poor. The studies reported that heel-boot elevation devices appeared more beneficial. However, poor compliance with wearing the devices was identified, as well as a perceived increased risk of falls. There were little data on cost-effectiveness. CONCLUSIONS: There is little high-quality trial evidence to support the routine use of heel devices to prevent pressure ulcers. However, they may have a role to play within a multifaceted programme of pressure-ulcer prevention.

Surgery for varicose veins: use of tourniquet.

BACKGROUND: Varicose vein surgery is a common surgical procedure but there is no consensus regarding the best surgical technique. The use of tourniquets during varicose vein surgery has been advocated as a means of reducing the potential for blood loss during the operation. OBJECTIVES: To identify whether the use of a tourniquet should be recommended when undertaking surgery for the management of primary varicose veins. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched April 2013) and the CENTRAL (2013, Issue 3). SELECTION CRITERIA: All studies described as randomised controlled trials that examined the use of tourniquets during surgery for patients with primary varicose veins were included. DATA COLLECTION AND ANALYSIS: Data from eligible studies were extracted and summarised independently by two authors. All studies were cross-checked independently by the authors. MAIN RESULTS: No additional studies were included or excluded in the updated review. Twenty papers detailing 18 trials were considered. Only three trials were randomised controlled trials and were included in the review. The remaining fifteen studies were excluded for various reasons. All three included trials had a small sample size and reported the trial design, outcome measures and analysis poorly. There were also variations in the outcome measures used between the trials. In addition, there was no consistency on the reporting of mean and medians for blood loss during the operation. It was therefore not possible to pool the data to perform meta-analysis. However, the reported blood loss when using a tourniquet was between 0 and 16 ml compared to between 107 to 133 ml when not using a tourniquet (P < 0.01). AUTHORS' CONCLUSIONS: Although there were significant quality issues with the available evidence, the use of a tourniquet would appear to reduce blood loss during surgery. There were no reported differences between the use or non-use of a tourniquet in terms of complications and morbidity. However, the available trials were not of sufficient size to detect rarer complications such as nerve damage.

The use of qualitative methods in developing the descriptive systems of preference-based measures of health-related quality of life for use in economic evaluation.

OBJECTIVES: To describe how qualitative methods can be used in the development of descriptive systems of preference-based measures (PBMs) of health-related quality of life. METHODS: The requirements of the National Institute for Health and Clinical Excellence and other agencies together with the increasing use of patient-reported outcome measures has led to an increase in the demand for PBMs. Recently, interest has grown in developing new PBMs and while previous research on PBMs has mainly focused on the methods of valuation, research into the methods of developing descriptive systems is an emerging field. RESULTS: Traditionally, descriptive systems of PBMs were developed by using top-down methods, where content was derived from existing measures, the literature, or health surveys. A contrasting approach is a bottom-up methodology, which takes the views of patients or laypeople on how their life is affected by their health. This approach generally requires the use of qualitative methods. Qualitative methods lend themselves well to the development of PBMs. They also ensure that the measure has appropriate language, content validity, and responsiveness to change. While the use of qualitative methods in the development of non-PBMs is fairly standard, their use in developing PBMs was until recently nonexistent. CONCLUSIONS: In this article, we illustrate the use of qualitative methods by presenting two case studies of recently developed PBMs, one generic and one condition specific. We outline the stages involved, discuss the strengths and weaknesses of the approach, and compare with the top-down approach used in the majority of PBMs to date.

Managing the delivery of venous leg ulcer services: A willingness to pay study.

Background and Aims: There is widespread variation in venous leg ulcer (VLU) wound care contributing to inadequate service provision resulting in poor outcomes to patients. Little has been published on the perspectives of where treatments should be carried out. The aim of the study was to quantify respondents' preferences for the preferred place of treatment for VLU. Methods: A UK general population sample was interviewed to elicit preferences for clinic or home care treatment using the willingness to pay elicitation method. Participants were presented with two vignettes describing clinic or home care of VLU, and were asked to select the treatment process that they preferred and provide a detailed explanation for selecting that choice. Then they were asked to state their maximum hypothetical amounts that they were willing to pay for the treatment processes. Results: One hundred fifty-four participants completed the interviews. Respondents were willing to pay £498.96 to receive VLU treatment at a clinic and £505.60 to receive care at home. This difference between the clinic compared to home care was not statistically significant. Advantages of clinic care include being able to book an appointment allowing participants to plan events around the booking and for home care the convenience for those with impaired mobility who may have difficulty traveling. Conclusions: The results show that respondents placed an equal valuation on the place of treatment suggesting no strong preference for either home or clinic care. However, qualitative findings emphasized that impaired mobility may be a barrier to accessing VLU services for some therefore, individuals should be given the choice to select their preferred setting to receive treatment where possible.

Patient-reported outcome measures and how they are used.

Patient-reported outcome measures (PROMs) are increasingly being used in the NHS to inform clinical treatments and even the funding of individual healthcare providers. This article examines the background to their increasing use. It aims to provide nurses with information and advice about resources to increase their knowledge of PROMs. It outlines the importance of patient-centred outcomes, describes the different types of PROMs and their use in clinical practice.

A systematic review of health-related quality of life instruments used for people with venous ulcers: an assessment of their suitability and psychometric properties.

AIMS AND OBJECTIVES: To review the quality of life questionnaires used to measure the impact of venous ulceration and to evaluate their psychometric properties. BACKGROUND: Venous leg ulcers have a negative impact on quality of life. Health-related quality of life can be measured using structured questionnaires. Nurses are the primary care providers for patients with venous ulceration and are ideally placed to assess and develop these types of questionnaires. There may also be an opportunity to use such quality of life instruments to measure the impact of nursing interventions in other areas where nurses are the key care providers. DESIGN: Systematic review. METHOD: Studies were sought that used quality of life instruments to evaluate the impact of venous ulceration. Fourteen electronic bibliographical databases and 11 Internet-based health services research related resources were searched. In addition, grey literature was sought and the reference lists of relevant articles checked. Data were extracted regarding the type of instrument used, sample, number of items and domains and psychometric performance of the instrument. RESULTS: The initial search identified a total of 338 potential citations. After review, a total of 31 studies were included: 17 used generic and 14 used disease-specific instruments. Five different types of generic and seven disease-specific instruments were identified. There was significant heterogeneity between the studies in terms of study design, aetiology of ulceration and times of assessment. The disease-specific instruments showed limitations in relation to their applicability to venous ulcer patients because of flaws in design or validation. CONCLUSIONS: The literature on quality of life related to venous ulceration failed to sufficiently distinguish between those with different causes of leg ulceration. There appeared to be problems with the ability of current quality of life instruments to detect changes in quality of life related to ulcer healing. Relevance to clinical practice. There appears to be an opportunity for nurses to develop a health-related quality of life health-related quality of life instruments to evaluate their impact on patient outcomes. Such instruments could potentially allow nursing interventions to be assessed more effectively than the recently proposed nursing metrics.

Use of Hydrofilm and Hydrofilm Plus in the community: an assessment.

The aim of this article was to critically examine the case for using film dressings with a particular emphasis on two dressing manufactured by Paul Hartmann Ltd: Hydrofilm and Hydrofilm Plus. The authors undertook a review of the current published evidence and present four case studies where Hydrofilm and Hydrofilm Plus were used in the community setting.

Assessing the impact of venous ulceration on quality of life.

BACKGROUND: There can be difficulties in measuring how quality of life is affected by having a leg ulcer. AIM: To assess the impact of venous ulceration on quality of life and to pilot a draft questionnaire for patients with venous ulcers. METHOD: Questions on the impact of venous ulceration were identified through a literature review, semi-structured interviews and focus groups. A self-completed postal questionnaire containing 16 disease-specific items, EuroQol, SF-6 and life-satisfaction questions was sent to 266 people with a history of venous ulceration. RESULTS AND DISCUSSION: A response rate of 61% (n = 152) was obtained. The most frequent symptoms reported were pain (80%), exudate (75%), and depression (65%). The presence of an ulcer resulted in statistically significant lower quality-of-life and life-satisfaction scores. CONCLUSION: Patients with venous ulcers experience reduced quality of life. Those with a healed ulcer also have a poorer quality of life compared with the general population.

Cultural adaptation of the Pieper-Zulkowski Pressure Ulcer Knowledge Test for use in Brazil.

OBJECTIVE: To carry out the cultural adaptation of the Pieper-Zulkowski Pressure Ulcer Knowledge Test (PZ-PUKT) for use in Brazil and analyze the internal consistency of the adapted version. METHOD: This was a methodological study. The PZ-PUKT is a knowledge test consisting of 72 items, divided into: prevention, staging, and wound description. The present study was developed in two phases: (1) translation of the questionnaire from English to Brazilian Portuguese, back-translation, and assessment of equivalence between the original and back-translated version by an expert panel; (2) pre-testing with nurses. RESULTS: The questionnaire showed face and content validity according to the opinions of the experts. Cronbach's alpha for the total test score was higher than 0.70. The adapted version presented satisfactory internal consistency for the studied sample. CONCLUSION: The adapted version of the instrument for Portuguese can be used in intervention studies as a tool to measure "nursing knowledge about pressure injury/ulcers" as a dependent variable.

A review of the treatment for venous leg ulcers.

Venous ulcers, sometimes termed varicose or stasis ulcers, are a consequence of damage to the valves in the veins of the legs, leading to raised venous pressure. They are characterized by a cyclical pattern of healing and recurrence. There is a need to have a thorough assessment of patients with leg ulcers by an appropriately experienced clinician to maximize the chance of healing the ulcer. The main treatment is the application of compression, either in the form of compression bandages or hosiery. Dressings are applied beneath the compression with a view to controlling exudate, comfort and to aid healing. There are a large number of dressing products and types available but the evidence to justify their use is poor. The main treatment for venous ulcers should therefore be the application of compression therapy with a simple, low adherent dressing.

Development of a tool to examine the effect of venous ulcers on patients' quality of life.

AIM: Nurses should be able to demonstrate the effectiveness of their practice. One method of measuring the effectiveness of nursing is to determine how nurses improve a patient's quality of life. The aim of this study is to develop a quality of life questionnaire that can be used to measure quality of life and outcome in patients with venous leg ulcers. METHODS: The project consists of three stages. The first used semi-structured interviews and focus groups to talk to patients and clinical staff about how venous ulcers affect patients. The second stage uses the data from the interviews and focus groups to design the questionnaire. The third stage involves validating the questionnaire. RESULTS: The project started in October 2005 and is due to finish in October 2008. The first stage of the project has been completed and used qualitative techniques to identify items to be included in the questionnaire. The questionnaire is now being developed. CONCLUSION: This project will result in the production of a quality of life questionnaire that can be used to measure quality of life and outcome in patients with venous leg ulcers.