Cardiff Wound Impact Schedule Research Articles

Simplified noncultured autologous cell grafting for the treatment of chronic nonhealing ulcers: the six-well plate technique

Chronic recalcitrant ulcers are associated with severe morbidity, and there are few effective treatment options available. Living skin substitutes are an important form of adjuvant therapy to enhance healing of such wounds. We investigated a novel, simplified, noncultured, autologous, cell grafting procedure, using a six-well plate technique, to treat chronic recalcitrant wounds. This was a prospective pilot study that involved harvesting an ultrathin split-skin graft from the gluteal region, which was washed, separated and prepared in six different wells to obtain an autologous mixture of keratinocytes, melanocytes and fibroblasts; this was subsequently applied directly to the wound using a hyaluronic acid (HA) matrix. Eight patients with a total of 14 ulcers were recruited. The primary endpoint assessed was the percentage of re-epithelialization of the ulcers. Secondary endpoints included quality of life and wound bed indices. At baseline, the median wound surface area was 7.4 cm(2) (mean 17.6 ± 23.6 cm(2) , range 0.5-80.0 cm(2) ) with a median duration of 18 months (mean 70.2 ± 95.9, range 3-216 months). The median wound surface area was reduced by 74.3%, from 7.4-1.9 cm(2) , at the final visit. Overall, 28.3% of the ulcers achieved complete healing, and 71.3% of the ulcers had reduction in wound size. Post-graft, there was also improvement in secondary wound bed parameters and all quality of life domains of the Cardiff Wound Impact Schedule. These results suggest that this noncultured autologous six-well technique might be beneficial for treating recalcitrant ulcers.

Clinical characteristics of foot ulceration in people with chronic gout.

Gout is the most common form of inflammatory arthritis and it has an affliction to the foot. Foot involvement in gout has been linked to foot pain, impairment and disability. There has been limited research on the effect of ulceration on foot pain, impairment, disability and health-related quality of life in patients already living with gout. The aim of the study was to describe the wound characteristics and the effect on foot pain, disability and health-related quality of life in patients with foot ulceration associated with gout. Participants were recruited from rheumatology clinics in Auckland, New Zealand. All the current foot ulceration sites and wound characteristics were recorded using the TIME wound assessment tool. The outcome measures included general pain, patient global assessment scale, foot pain, disability and impairment. Participants completed the Cardiff Wound Impact Schedule to assess the effect of ulcers on health-related quality of life. Sensory loss, vibrational thresholds and ankle brachial pressure index were collated to assess for lower limb arterial disease. Six participants were predominantly older men with a long duration of gout, high rates of obesity and co-morbidities such as hypertension, hyperlipidaemia, diabetes and cardiovascular disease. The mean (SD) duration of the foot ulcers was 4 (2) months. The majority of foot ulcers observed were 0·5 cm(2) or smaller superficial thickness with surrounding callus. Partial thickness and full-thickness ulcers were also observed. Two patients presented with ulcers on multiple sites. There was only one case of infection. Gouty tophi were evident in most of the wounds. The dorsal aspect of the third toe was found to ulcerate in most cases. Moderate scores of foot pain, disability, impairment and health-related quality of life were observed. Most participants wore shoes deemed as poor. Foot ulceration in gout is chronic and multiple ulcers can occur with the potential of leading to delayed wound healing, infection and a reduced quality of life. Poor footwear may contribute to the development and delayed healing of ulceration in people with gout.

Translation and Validation of the Chinese Cardiff Wound Impact Schedule

The objectives of the study were to translate the Cardiff Wound Impact Schedule (CWIS), a disease-specific quality-of-life measure, into Chinese, and to evaluate its psychometric properties. The CWIS went through the full linguistic translation process and was evaluated in patients with current diabetic foot ulcers (DFU). Patients were categorized using the Wagner grade. Mean CWIS scores were compared between categories to evaluate the scale's ability to differentiate ulcer severity (Wagner grade). There were a total of 131 consecutive patients included in the study. Except item A22 (I am confident that the wound I have will heal), the results of item-domain correlation (r ranged from .391 to .827) and small-group analysis (critical ratio, P < .05) were satisfactory. Furthermore, the Chinese CWIS also demonstrated good criterion validity when correlated with the Short Form-36 (r = .79, P < .01). After deleting item 22, exploratory factor analysis of the items confirmed the existence of 3 hypothesized domains, physical symptoms and daily living (12 items), social life (7 items), and well-being (6 items), and totally explained 57.194% of the variance. The internal consistency of all scales of the Chinese CWIS was consistently high (Cronbach's α ranged from .789 to .929). Split-half reliability was 0.748. Sensitivity was demonstrated between patients with different etiologies of diabetic foot ulcer and those with different ulcer severity (Wagner grade). From the authors' view, the lately validated Chinese CWIS has good psychometric performance and may be appropriately used to assess the health-related quality of life of Chinese patients with DFUs.

PRM144 - The ‘Wound-QoL’: A Short Questionnaire Measuring Quality of Life in Patients with Chronic Wounds

Objectives To develop a short questionnaire measuring health-related quality of life (HRQoL) in patients with chronic wounds. Methods Three validated instruments assessing HRQoL in chronic wounds, the Freiburg Life Quality Assessment for wounds (FLQA-w), the Cardiff Wound Impact Schedule (CWIS), and the Wurzburg Wound Score (WWS), were filled in by 154 leg ulcer patients in a prospective study under routine care. For implementation in the new, shorter questionnaire Wound-QoL, those of all 92 items were selected that covered the core content of the three questionnaires and showed good psychometric properties (e. g. number of missing values, inter-item correlations). Internal consistency, convergent validity regarding four generic HRQoL measures such as the EQ-5D, and responsiveness of the Wound-QoL were analysed using the longitudinal study data on the selected items (so-called virtual validation). Subscales were determined with factor analysis. Item, instruction, and response scale wording of the Wound-QoL were harmonized. Results Seventeen items were included in the Wound-QoL questionnaire which could be attributed to three subscales on everyday life, body, and psyche. Both global score and subscale scores were internally consistent with Cronbach’s alpha values between 0.71 and 0.91. The global score showed significant convergent validity (r=0.48 to 0.69, depending on the criterion) and responsiveness regarding change in generic HRQoL (r=0.18 to 0.52); the same was true for the subscale scores. Conclusions The Wound-QoL for measurement of HRQoL in chronic wounds proved to be internally consistent, valid, and responsive in the virtual validation analysis.

Translation and validation of the wound‐specific quality of life instrument Cardiff Wound Impact Schedule in a Swedish population

To translate and validate the wound-specific health-related quality of life instrument, the Cardiff Wound Impact Schedule (CWIS) in a Swedish population. The instrument was first translated into Swedish, using the Standard Linguistic Validation Process. The Swedish version of the CWIS was then tested for its psychometric properties in a Swedish context. A total of 117 patients with acute and hard-to-heal wounds were included. The patients were asked to fill in the Swedish version of the CWIS and the generic instrument SF-36 at baseline and after 1 week. Patients with acute wounds were also asked to fill in both instruments after 6 weeks. Face validity and content validity were assessed by patients and an expert group, and judged as good. Criterion validity was calculated with correlation between CWIS and SF-36, reaching moderate to high values. Reliability of the three domains of the CWIS measured with internal consistency and test-retest stability was acceptable to excellent. Internal responsiveness was assessed with standardised response mean and showed moderate to high sensitivity. This study concludes that the Swedish version of CWIS is a valid and reliable tool for measuring health-related quality of life in patients with acute and hard-to-heal wounds.

A pilot study exploring quality of life experienced by patients undergoing negative‐pressure wound therapy as part of their wound care treatment compared to patients receiving standard wound care

The use of negative pressure wound therapy (NPWT) has been widely documented as a technique to help heal complex wounds. This article presents the findings of a preliminary study which aimed to explore quality of life (QoL) experienced by patients undergoing NPWT as part of their wound care treatment in comparison to that of patients with a wound using traditional (standard) wound care therapies. A quasi-experimental study was undertaken, with patients treated in wound care/vascular clinics with chronic/acute wounds. QoL impact was measured using the Cardiff Wound Impact Schedule and administered post-consent at timed intervals. Our results identified that there were no real differences in QoL scores recorded by patients over the 12-week period. Although there was no overall interaction between the therapies used for wound healing, NPWT did have an effect on social life: during the first 2 weeks of the application of therapy, patients in the NPWT group reported an increase in the social life domain. The authors conclude that true QoL can only be elicited if an accurate baseline is established or if data is collected over a long enough period to allow comparison of scores over time.

Quality of life in people with venous leg ulcers: an integrative review

To explore the impact of venous leg ulcers on health-related quality of life and analyse the quality of life instruments that have been used for this topic. Venous leg ulcers represent more than 80% of all chronic leg ulcers. Several studies have demonstrated that health-related quality of life is affected in patients with such lesions. An integrative review was conducted, together with an additional methodological review of quality of life instruments. Eight electronic databases were searched, and all studies published between 2003 and 2008 were considered in with both qualitative and quantitative approaches and in Spanish, English, French, German and Portuguese. Thus, no restrictions were applied as regards study design. Twenty-two studies were included; one used mixed methods, three employed qualitative methods and the remaining articles used a quantitative approach. Pain was the factor most frequently identified as affecting health-related quality of life. The generic instruments most commonly used were Short Form-36 and adaptations, the Nottingham Health Profile and EuroQol-5, whilst the disease-specific tools were Hyland, Cardiff Wound Impact Schedule and Charing Cross Venous Leg Ulcer Questionnaire. Two new instruments were also identified, venous leg ulcer quality of life and Sheffield Preference-based Venous Leg Ulcer 5D. The negative impact of venous leg ulcers on health-related quality of life is confirmed in this review. This impact has been measured using a variety of specific health-related quality of life instruments. However, the review findings suggest that the Charing Cross Venous Leg Ulcer Questionnaire is the most appropriate instrument due to its disease-specific psychometric characteristics.

Quality of life in patients with diabetic foot ulcers: validation of the Cardiff Wound Impact Schedule in a Canadian population

The purpose of this study was to evaluate and validate the Cardiff Wound Impact Schedule (CWIS), a disease-specific quality-of-life measure, in a diabetic foot ulcer (DFU) population. Patients with DFUs have restrictions as part of their treatment and rehabilitation, which can affect health-related quality of life (HRQoL). Because of the high number of comorbidities experienced in diabetes, a disease-specific quality-of-life measure is needed to best assess the affect of a foot ulcer on HRQoL. Patients with DFUs completed the CWIS and a World Health Organization generic quality-of-life questionnaire. Validity was assessed by comparing domains of the questionnaires. Patients were categorised using the University of Texas wound classification system. Mean CWIS scores were compared between categories to assess the questionnaire's ability to differentiate wound severity. Patients with open ulcers scored significantly lower on the CWIS than those with healed ulcers. Correlations between questionnaire domains were as follows: Social Life with Social Functioning (r = 0·641, P < 0·001); Well-Being with General Health (r = 0·533, P < 0·01); Physical Symptoms and Daily Living with Physical Functioning (r = 0·631, P < 0·01) and Health-Related Quality of Life with Vitality (r = 0·425, P < 0·01). However, there was no significant difference in mean CWIS scores between categories of wound severity. We have demonstrated the ability of the CWIS in assessing HRQoL in a DFU population and its ability to differentiate between healed and non healed states.

Unroofing and Marsupialization vs. Rhomboid Excision and Limberg Flap in Pilonidal Disease

The aim of the study was to compare clinical outcomes and quality of life in patients undergoing surgery for pilonidal disease with unroofing and marsupialization (UM) or rhomboid excision and Limberg flap (RELP) procedures. One hundred forty consecutive patients with pilonidal sinus were randomly assigned to receive either UM or RELP procedures. A specifically designed questionnaire was administered at three months to assess time from the operation until the patient was able to walk, return to daily activities, or sit without pain, time to return to work or school, and time to healing. Postoperative pain was assessed with a visual analog scale and the McGill Pain Questionnaire. Patients' quality of life was evaluated with the Cardiff Wound Impact Schedule (CWIS). Questionnaires were administered by a clinician blinded to treatment. Compared with RELP, patients receiving UM had significantly shorter duration of operation and hospital stay, shorter time periods to walk, return to daily activities, or sit without pain and to return to work or school, and fewer complications. Time to final healing was significantly shorter and quality of life scores on the CWIS were higher in patients receiving RELP than in those receiving UM. Patients with UM had lower levels of pain one week after surgery. The unroofing and marsupialization procedure provides more clinical benefits in the treatment of pilonidal disease than rhomboid excision and Limberg flap and should be considered the procedure of choice. However, it may be associated with more inconvenience in wound care and longer healing time than rhomboid excision and Lindberg flap.

A pilot study on the effect of topical negative pressure on quality of life

To discover the impact of topical negative pressure (TNP) on quality of life. An exploratory prospective cohort study was conducted on 26 patients undergoing TNP. The Cardiff Wound Impact Schedule (CWIS), a wound-specific tool, was used to investigate quality-of-life scores before therapy and four weeks after therapy or at wound closure. Wound dimensions were measured at both assessments, and the values for the CWIS domains (physical symptoms, social functioning, well-being and overall quality of life) were investigated using parametric and non-parametric tests. The mean duration of TNP therapy was 3.3 +/- 1.7 weeks. Topical negative pressure therapy helped to achieve complete wound closure in 14 patients (54%), and there was a mean reduction in wound surface area from 52.2 cm2 (range 4-150) to 26.8 cm2 (0-120). While there was no significant change in quality of life in patients whose wounds healed (1 +/- 11.9), the physical-functioning domain improved in obese patients (20 +/- 21, p < 0.05) and worsened in ambulatory patients (-3 +/- 13, p < 0.05). The portableTNP system had no significant impact on quality of life (-3 +/- 16), while the global quality-of-life score worsened with surgical intervention (-0.5 +/- 2, p < 0.05). Although TNP aids wound closure in patients with complex wounds, in selected cases their quality of life can worsen. This is the first exploratory cohort study of its kind, and has identified an urgent need to validate the use of patient-based outcome measures in TNP therapy. Such data can be useful in allocating resources and justifying funding in wound care.

Linguistic validation of the Cardiff Wound Impact Schedule into French, German and US English

Chronic leg wounds can represent a major health problem and have a negative emotional impact on patients' lives. The Cardiff Wound Impact Schedule (CWIS) was developed by the Wound Healing Research Unit at University of Wales College of Medicine to assess the quality of life in patients with chronic wounds. To perform the linguistic validation (translation) of the CWIS into German, French and US English as a first step in making the questionnaire available globally. The standard linguistic validation process employed by the Mapi Research Institute was used to translate the CWIS into French and German. An adjusted process was used for the US English translation. The linguistic validation of the US English version was straightforward as it shares the same root language with the original UK version. The problems encountered in the French and German translations were mostly related to semantics and syntax. The CWIS is now available for further validation testing by the international community (the psychometric evaluation of each translated questionnaire). These translations will be useful to health-care providers undertaking formal quality-of-life assessments of patients with chronic leg wounds.

Cardiff Wound Impact Schedule: the development of a condition-specific questionnaire to assess health-related quality of life in patients with chronic wounds of the lower limb.

The purpose of this study was to develop and validate a questionnaire to measure the impact of chronic wounds (leg ulcers and diabetic foot ulcers) on patient health-related quality of life (HRQoL) and identify areas of patient concern. The Cardiff Wound Impact Schedule (CWIS) was created following a three-stage process. Stage 1 included a focus group (n=10) and a series of semi-structured interviews (n=13) to generate items for the questionnaire. Stage 2 involved piloting the 28-item questionnaire on 124 patients (64.5% with leg ulceration and 35.5% with diabetic foot ulceration): data from this stage were analysed using factor analysis. The reliability, validity and reproducibility of the resulting scale were assessed in Stage 3, a 3-month follow-up study of 135 patients in which patients completed the CWIS and the SF-36. Factor analysis identified three domains of HRQoL: physical symptoms and daily living, social life and well-being. There were no significant differences in scores across the wound types. Internal consistency was good (alpha=0.77-0.96) as was reproducibility (P<0.001). The CWIS was able to discriminate between those with healed ulcers and active ulcers (P<0.01). Construct validity was demonstrated by strong correlations between related items on CWIS and SF-36 (P<0.01-P<0.0001). The data suggest that CWIS has high internal consistency and the ability to discriminate between health states and good reproducibility. CWIS is a valid tool for studying the impact of chronic wounds of the lower leg on HRQoL. CWIS allows clinicians to identify items of patient concern, which can then be used to negotiate options of care most suited to individual patients.

Cardiff Wound Impact Schedule: the development of a condition‐specific questionnaire to assess health‐related quality of life in patients with chronic wounds of the lower limb.

Price P, Harding K. Cardiff Wound Impact Schedule: the development of a condition‐specific questionnaire to assess health‐related quality of life in patients with chronic wounds of the lower limb. Int Wound J 2004;1:1017.