Introducing the ‘Wound Quality of Life’ Measurement Tool

  Chronic wounds can heavily impair a patient’s quality of life (QoL). The most common underlying diseases are chronic venous insufficiency, peripheral arterial occlusive disease, diabetes (diabetic foot ulcers), or pathologic pressure (pressure ulcer). These conditions and the wounds associated with them can cause severe pain, social isolation, and restricted mobility, thus burdening daily life.   Patients who are living with chronic wounds may also experience psychological challenges and conditions such as clinical depression. As most affected patients are elderly, chronic wounds often coincide with other morbidities common among this age group (eg, vascular disease, hypertension, obesity), adding further physical and psychological strain. Medical care in the outpatient wound clinic should focus on maintaining or enhancing QoL. In order to do so, a patient-reported assessment of QoL can be useful to help inform both the patient and the medical professional regarding the level to which QoL is affected and thus the degree to which action is needed. This article will discuss an appropriate QoL tool that’s been developed by Prof. Matthias Augustin and colleagues to assist the wound care provider in identifying psychological issues among patients and how to more effectively manage their care.

QoL Assessment

  Given the burden of disease from which our patients suffered, a need for an instrument to assess health-related QoL that would be easy to administer and understand had been identified. Existing questionnaires were found to be too complex and lengthy, so we decided to develop an instrument to summarize key QoL criteria via a short questionnaire. Drawing on three well-established but extensive wound-related QoL instruments, we created a one-page questionnaire called “Wound-QoL,” condensing the most important aspects of QoL threatened by chronic wounds.

  The more complex an instrument is, the greater the likelihood that patients will be unable or unwilling to perform it, leading to incomplete results. By avoiding additional text in the instructions, item questions, and response scales, we aimed to minimize the time that patients and staff members needed to complete the questionnaire. Minimizing the time it takes to complete the tool is particularly important given the time constraints in a typical healthcare setting and the possible need for multiple assessments during the course of care.

The Wound-QoL

  Based on the Freiburg Life Quality Assessment for wounds (FLQA-w), the Cardiff Wound Impact Schedule (CWIS), and the Würzburg Wound Score (WWS), the Wound-QoL consists of 17 items addressing impairments experienced by the patient during the preceding seven days. (For a copy of the US version of the Wound-QOL, visit www.woundqol.com.)

  As the FLQA-w, CWIS, and WWS had been developed by three independent research groups with a focus on wound-related QoL, we assumed that pooling (and subsequently reducing) their items would provide a reliable and encompassing account of the most relevant QoL impairments. In our prospective, non-interventional multicenter study on adult patients living with chronic wounds under routine care, 154 leg ulcer patients completed these questionnaires as well as the EQ-5D-3L, a tool that measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as the corresponding EuroQol visual analogue scale, which records the respondent’s self-rated health on a vertical scale where the endpoints are labeled “best imaginable health state” and “worst imaginable health state” in order to assess current health status. The Wound-QoL questionnaire is self-explanatory and is completed by the patient to ensure objectivity and reduce workload for healthcare professionals. Impairments can be rated in five categories ranging from “not at all” to “very much.” Clinical trials employ the instrument’s overall score, which is based on the individual patient’s answers to the questionnaire.

  For clinical purposes, the need for action is indicated by the categories “quite a lot” and “very much.” In order to assist clinical practice, patients as well as experienced wound care specialists (three nurses and four practitioners) helped to develop a one-page Wound-ACT that is designed as a decision aid for taking further action with regard to wound-specific QoL impairments. (For a copy of the Wound-ACT, visit www.woundqol.com.)

  Corresponding to the 17 items of possible wound-related impairments of health-related QoL, optional measures were identified drawing from German national guidelines on pain, venous leg ulcer and diabetic foot ulcer treatment, national standards for care, and the Patient Benefit Index questionnaire for wounds.

Methods

  The three wound-related questionnaires (FLQA-w, CWIS, and WWS) cover 92 items that we grouped by content. Through quantitative analysis with regard to psychometric properties and qualitative analysis regarding item content, we found that we could drastically reduce item count to 17. Main selection criteria were patient relevance, non-redundancy, generality, and unambiguity. Employing factor analysis, we determined three subscales (everyday life, body, and psyche). An expert panel helped with harmonizing item and instruction wording.

  Our study was particularly focused on patients living with leg ulcers, since our center is specialized in their treatment. Accordingly, generalization of our findings to patients living with ulcers in other body areas should be done carefully. We are, however, confident that the Wound-QoL will prove to be a reliable and valid tool in the longitudinal studies currently being conducted. Compared to the aforementioned well-established instruments, it benefits from brevity, consistence, comprehensibility, and wound-related item wording. In a newly developed pilot testing approach we call “virtual validation,” we could demonstrate the tool’s internal consistency and validity.

The Translation Process

  In order to provide versions that could be globally used, the German Wound-QoL version underwent a complex and thorough translation process. According to international best practice of patient-reported outcomes translation, this process included independent double translations and back-translations. These were tabulated highlighting differences between translations, back-translations, and the original item. To achieve consensus on the final wording, translators and authors attended a consensus conference. Subsequently, an additional proofread by a native speaker was performed.

  The questionnaire’s brevity and comprehensibility are prerequisites for a high acceptance, thus ensuring high data quality. The Wound-QoL collects highly demanded patient-reported data on QoL that helps center clinical research focused on patient well-being. In conjunction with the “Wound-ACT” tool, the QoL tool helps to determine the appropriate treatment of identified impairments. Correlation with the EQ-5D scale showed satisfactory construct validity. Our study also demonstrated high feasibility with < 1% of missing items and a high patient acceptance rate (> 95% approval).

  David Lohrberg, Dipl.-Pol, is a research associate at the Institute for Health Services Research in Dermatology and Healthcare, University Medical Center Hamburg-Eppendorf, Germany.