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      Quality of life: Venous leg ulcers

      Indian Dermatology Online Journal

      Medknow Publications & Media Pvt Ltd

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          BACKGROUND Leg ulcers are one of those conditions wherein the patient distress is in much greater proportions to than what meets the eye on examination. Venous leg ulcers represent more than 80% of all chronic leg ulcers and chronic venous leg ulceration (CVLU) results in a significant decline in health related quality of life (HRQoL) for the patient. Hence, it is essential that the care delivered focuses on the factors that affect the HRQoL of the sufferer, in addition to the factors concentrating on the wound management. A holistic assessment of the needs of these patients suffering from CVLU is therefore recommended for optimal and cost-effective management.[1] FACTORS DETERMINING THE QUALITY OF LIFE IN LEG ULCERATION Various factors play a role in determining the quality of life in leg ulceration. These factors relate to physical functioning, psychosocial functioning, and treatment aspects. Physical factors include pain, exudate and odor pertaining to the ulcer; effect on mobility, sleep and routine daily activities. Irrespective of the study design, pain emerged as the most significant factor affecting HRQoL (Level B).[1] The chronic nature of leg ulcers, irrespective of the etiology is responsible for the various psychosocial and treatment aspects. Psychosocial parameters include social isolation, depression, feelings of regret, loss of power, and helplessness. Various studies have pointed out that patients with chronic wounds of the lower extremity often experience functional disability and emotional distress, which negatively affects patient quality of life, hence incorporating HRQoL measurements in clinical practice may improve understanding of chronic wound patients’ healthcare needs.[2] The treatment parameters include efficacy of treatment with respect to improvement of the wound, time taken for healing and cost-effectiveness of the therapy. In addition, the quality of life is also determined by the patient's concepts regarding wound hygiene, dressing and nursing care; and the quality of care being provided to them.[3] QUALITY OF LIFE INDICES/INSTRUMENTS Health-related quality of life can be defined as “the functional effect of an illness and its consequent therapy upon a patient, as perceived by the patient.”[4] Various generic and specific instruments have been used to evaluate QoL in leg ulcer patients. Pain scales have also been used in several studies, together with HRQoL instruments. An integrative review has been performed to analyze various generic and specific instruments (Level A).[5] A brief outline of the various indices commonly used in leg ulcers has been outlined in Table 1. Table 1 Generic and Specific Indices/Instruments to evaluate quality of life Generic tools are widely available in various languages and have been frequently used since they are the most validated. Short form 36 (SF-36) and its adaptations are useful for establishing HRQoL in people with VLU compared with the general population. However, the responsiveness of the SF-36 to changes in wound status is unclear.[6] EuroQol 5D (EQ-5D) is effective for economic and cost-effectiveness analysis.[5] The generic tools have consistently demonstrated pain to be a significant problem for leg ulcer patients but are unable to accurately differentiate between pain that is directly related to leg ulceration and that experienced owing to comorbidities (Level B).[7] Hence, many studies incorporate generic tools along with pain scales for assessment. Generic instruments are also unable to identify changes in VLU in relation to the wound characteristics and its consequences, such as chronicity, recurrence, course of the disease, pain, odor, edema, exudation, mobility limitation, physical appearance, emotional, and social aspects and the effect of these on HRQoL measurement (Level B).[4 5] Specific tools have therefore been developed and these contribute to establishing clinical care based on individual needs. Hyland and Cardiff Wound Impact Schedule (CWIS) are applicable to all leg ulcers; whereas the other specific tools outlined in Table 1 are used for venous leg ulcers. Hyland has good reliability and ability to discriminate changes in VLU patients, by age, mobility, size, and duration of VLU, but is not a good tool to assess treatment responsiveness (Level C).[6 8] The CWIS is a good HRQoL measurement instrument for chronic wounds in general and can differentiate well between healed and non-healed states (Level C).[9] Of the various specific tools, Charing Cross Venous Leg Ulcer (CCVLU) Questionnaire has a high reliability, validity and responsiveness and shows good correlation with SF-36 (Level B).[10] It is the most appropriate instrument for use with VLU patients, due to its disease-specific psychometric characteristics (Level B).[4 5] Two new specific scores (SPVLU-5D and VLU-QoL) have shown great promise in measuring HRQoL in VLU patients, although more research is needed to establish their specific reliability and validity (Level C).[5] A combination of generic and disease-specific QoL indices should be a standard measure in patients with chronic venous disease.[4] DEVELOPMENT AND ASSESSMENT OF QUALITY OF LIFE INDEX The implementation of a QoL index depends on the ease of application and the time taken for calculation. An ideal index should have high sensitivity and specificity. Larger number of questions increases the sensitivity but takes a lot of time; whereas lesser number of questions provides ease of implementation at the cost of sensitivity. It is important to assess the psychometric parameters of a QoL index by its reliability and validity. The process of development and validation of the specific measure CCVLU has been reviewed and the full text article is available online (Level B).[10] A validation study with two generic HRQoL indices (SF-12 and EQ-5D) and one specific CVLU (Hyland) validation study extending over a 1 year period has compared their discriminative and responsive characteristics (Level C).[6] A VLU specific tool Freiburg Life Quality Assessment (German language questionnaire) was developed and validated and found suitable to assess QoL in both course and cross sectional studies (Level C).[11] Similarly, tools can be developed, translated into various languages with validation to suit the regional needs in the Indian context. IMPLICATIONS IN CLINICAL PRACTICE AND RESEARCH Quality of life indices in CVLU have been used in various clinical settings and are usually administered at intervals of 0, 3, 6, and 12 months. The selection of the tool may vary depending on the clinical or study based context, the number of questions and the time required to complete the questionnaire. SF-36, Nottingham Health Profile, CCVLU takes about 5-10 min to complete; whereas sickness impact profile is a long instrument with 136 items and may take approximately 30 min. A novel concept of a computerized questionnaire has been developed with patients filling the information in a touch screen interface kiosk. This is useful in a busy practice set up with easy availability of statistical analysis (Level C).[2] The clinical contexts in which QoL instruments are used include assessment of etiology of leg ulcers, correlation of clinical and social factors and evaluation of psychosocial aspects.[12] The efficacy of health services delivering evidence based care to leg ulcer patients can also be documented using QoL instruments (Level C).[3] These indices are used to assess various newer therapeutic interventions and their cost-effectiveness (Level B).[13] QoL indices have been used to compare pain symptoms at initiation and end of therapy and assess the role of conservative versus surgical modalities. A study has demonstrated a statistically significant positive effect on QoL with surgical treatment of ulcers and reduction in pain with reduction of the ulcer area (Level C).[8] The QoL tools are now routinely used in various randomized controlled trials to measure and compare the therapeutic efficacy of various modalities (Level B).[6 13 14] CONCLUSION Newer treatment modalities continue to emerge for treatment of CVLU, however pain and poor QoL in these patients leads to significant morbidity. Hence use of various generic and VLU specific QoL instruments should be incorporated in the management and care of these patients. These would help in planning treatment strategies, which would aim to provide a better quality of life for these patients. RECOMMENDATION Quality of life assessment should be an integral part in the management of CVLU patients. Use of a generic tool such as SF-36 and a specific tool such as CCVLU in cases of venous leg ulcers is recommended to assess QoL. Development, translation into various languages with validation of specific VLU-QoL instruments should be done to suit the regional needs in the Indian context.

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          Most cited references 14

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          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. © 2011 Blackwell Publishing Ltd.
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            Quality of life of people with venous leg ulcers: a comparison of the discriminative and responsive characteristics of two generic and a disease specific instruments.

            Venous leg ulcers are an important source of morbidity in society. Measuring the impact of leg ulcers on quality of life is important within clinical and economic evaluations. In this study we report a validation study of the leg ulcer disease specific Hyland questionnaire and compare its discriminative and responsive characteristics to general health quality of life measures: the SF-12 and EQ-5D. HRQoL of venous leg ulcer patients from 9 UK regions was measured using SF-12, EQ-5D and Hyland, at baseline and every three months for 1 year. Psychometric analysis was used to confirm the validity of the Hyland questionnaire. Quarterly scores for all instruments were calculated. Effect size and standardised mean difference were used to investigate the responsiveness to ulcer healing and discriminative abilities of the instruments. Three hundred and eighty seven individuals were recruited into the VenUS I study. Baseline health related quality of life data from the study participants suggested a two factor solution for the Hyland. This questionnaire was associated with small and moderate ability to discriminate individuals according to age, mobility, initial ulcer size and ulcer duration. SF-12 and EQ-5D had good evaluative properties; both instruments were responsive to changes in HRQoL after ulcer healing. High levels of bodily pain were reported in the SF-12 questionnaire, whilst only minor ulcer related discomfort was reported in the Hyland. SF-12 and EQ-5D are suitable for exploring dimensions of health related quality of life in people with chronic venous leg ulceration. The responsiveness to healing of the Hyland questionnaire is unclear. We would recommend the use of generic instruments for the measurement of HRQoL in patients with venous leg ulcers.
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              Measuring the quality of life in patients with venous ulcers.

              This prospective study aimed to validate a newly designed specific measure of quality of life for patients with venous ulcers. The study was set in a London teaching hospital and surrounding community clinics. Items for the questionnaire were selected by means of patient interviews, a literature review, and expert opinion. The questionnaire and the Short Form 36-item (SF-36) Health Survey were given to a prospective consecutive cohort of 98 patients with proven venous ulcers that were diagnosed by means of clinical and color duplex examination. Fifty-eight of the patients were women (60%), and the median age of patients was 76 years. The questionnaire was assessed for reliability, validity, and responsiveness. The ulcer-specific questionnaire showed good reliability, as assessed by means of the internal consistency (Cronbach alpha = 0.93) and test-retest analysis (r = 0.84). Factor analysis identified four important health factors: social function, domestic activities, cosmesis, and emotional status. Validity was demonstrated by means of a high correlation with all eight domains of the SF-36 general health measure (r > 0.55, P <.001). Responsiveness was demonstrated by means of a significant reduction in the score on the ulcer questionnaire as ulcers healed at 6 and 11 weeks (P <.05). Good evidence exists that a clinically derived measure for patients with venous ulcers has validity to measure the quality of life.

                Author and article information

                Indian Dermatol Online J
                Indian Dermatol Online J
                Indian Dermatology Online Journal
                Medknow Publications & Media Pvt Ltd (India )
                Jul-Sep 2014
                : 5
                : 3
                : 397-399
                Department of Dermatology, Rajiv Gandhi Medical College, Thane, Maharashtra, India
                Author notes
                Address for correspondence: Dr. Vishalakshi Vishwanath, Head of Department, Dermatology, Rajiv Gandhi Medical College, Thane, Maharashtra, India. E-mail: visha1967@
                Copyright: © Indian Dermatology Online Journal

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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