Validation of the Spanish Version of the Wound-QoL-14 Wound-Specific Health-Related Quality of Life Questionnaire.

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Learn more: PMC Disclaimer | PMC Copyright Notice Int Wound J . 2026 Jun 2;23(6):e70965. doi: 10.1111/iwj.70965 Validation of the Spanish Version of the Wound‐QoL‐14 Wound‐Specific Health‐Related Quality of Life Questionnaire Celia Horcajada‐Reales 1 , Matthias Augustin 2 , Manuel Gerónimo‐Pardo 3, 4 , Carmen Selva‐Sevilla 4, 5, ✉ Author information Article notes Copyright and License information 1 Department of Dermatology, Hospital Universitario de Fuenlabrada, Madrid, Spain 2 German Center for Health Services Research in Dermatology (CVderm), Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg‐Eppendorf (UKE), Hamburg, Germany 3 Department of Anesthesiology, Integrated Care Management, Albacete, Spain 4 ECOHEALTH Research Group, University of Castilla La Mancha, Albacete, Spain 5 Department of Applied Economy, Faculty of Economics, University of Castilla La Mancha, Albacete, Spain * Correspondence: Carmen Selva‐Sevilla ( carmen.selva@uclm.es ) ✉ Corresponding author. Revised 2026 Apr 28; Received 2025 Oct 7; Accepted 2026 May 22; Collection date 2026 Jun. © 2026 The Author(s). International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. PMC Copyright notice PMCID: PMC13239895  PMID: 42230158 ABSTRACT The aim was to validate the Spanish/Spain version of the Wound‐QoL‐14. Clinical data were prospectively collected from participants who completed the questionnaire at baseline and at a follow‐up visit. COSMIN guidelines were followed to evaluate feasibility, reliability, construct validity and responsiveness. Overall, 323 participants (71.1 ± 14.6 years; 52% males) were included. Feasibility was excellent (missing items: 0.95%). Reliability was good (very good internal consistency [McDonald's omega: 0.934] and test–retest reliability [concordance correlation coefficient: 0.915; 95% CI: 0.837–0.956. Standard error of measurement: 0.141]). Regarding construct validity, the survey showed good structural validity since the three factors extracted after the exploratory factor analysis were confirmed (Comparative fit index: 0.942. Tucker–Lewis index: 0.927. Standardized root mean square residual: 0.042. Root mean square error of approximation: 0.089; 90% CI: 0.077–0.102) and good known‐groups and convergent validities (4/4 and 7/9 predefined hypotheses supported, respectively). Criterium validity was excellent (Spearman's rho with Wound‐QoL‐17 global score: 0.934). Finally, the instrument was suitable to detect improvement (Floor effect: 0.3%. Ceiling effect: 1.5%. Area under the receiving operator characteristic curve: 0.795; 95% CI: 0.732–0.858; p < 0.001. Standardized effect size: 0.928. Standardized response mean: 0.852). The Spanish/Spain version of the Wound‐QoL‐14 is a reliable and valid instrument to assess the health‐related quality of life in Spanish patients with chronic wounds. Keywords: chronic wound, health‐related quality of life, psychometric properties, Spanish version, wound‐QoL questionnaire Highlights This study aimed to validate the Spanish version of the Wound‐QoL‐14 questionnaire in a Spanish population of patients with chronic wounds. This instrument showed excellent feasibility, good reliability (internal consistency and test‐retest reliability), and good construct validity (convergent, known‐groups, and criterion validity). Sensitivity to improvement was fair, making the instrument suitable for detecting clinical improvements in this patient population over time. Overall, the Spanish version of the Wound‐QoL‐14 questionnaire is a reliable and valid instrument to assess health‐related quality of life in Spanish patients with chronic wounds. 1. Introduction Chronic wounds are a major health problem with an estimated global prevalence of 1.5 to 2.2 per 1000 people [ 1 , 2 , 3 ]. The prevalence of chronic wounds in people over 15 years of age in Spain is 1.59%, with an annual cumulative incidence of 1.46%. Regarding aetiologies, vascular ulcers predominate over other types such as post‐traumatic or post‐surgical [ 4 ]. A non‐healing wound, which is often painful, exuding and malodorous, typically requires frequent dressing changes and can significantly impact the life of patients, their relatives or caregivers, as well as their work performance and overall well‐being. It can lead to patient exhaustion, partly due to disrupted sleep and is commonly associated with anxiety and depression [ 5 ]. Health‐related quality of life (HRQoL) is a multidimensional concept that encompasses various aspects of a patient's physical, psychological and social well‐being. Assessing HRQoL has become an essential component of patient care. In this context, patient‐reported outcome measures (PROMs) have become crucial tools for evaluating healthcare outcomes from the patient's perspective [ 6 ]. The use of PROMs allows clinicians to capture subjective symptoms, assess treatment efficacy and improve both symptom control and physician–patient communication [ 7 ]. Assessing HRQoL in patients with chronic wounds is important to identify the factors that most negatively affect their well‐being and guide more effective and personalised interventions [ 8 ]. Several instruments have been validated to assess HRQoL. Some of them are limited to one particular type of wounds, like the Charing ethic Venous Leg Ulcer Questionnaire [ 9 ], which covers venous ulcers exclusively. Some others are applicable to all types of chronic wounds, such as the Wound‐QoL. The Wound‐QoL questionnaire was developed after integrating elements from three validated tools (Freiburg Life Quality Assessment‐ wound module, Cardiff Wound Impact Questionnaire and Würzburg Wound Score), resulting in a shorter, self‐explanatory and patient‐friendly instrument to assess HRQoL in patients with chronic wounds of any aetiology [ 10 ]. The original version includes 17 items distributed across three domains (Body, Psyche and Everyday life) in addition to a standalone item related to financial burden, allowing for the calculation of total and domain‐specific scores. Considering that patients with chronic wounds are usually older people, PROMs should ideally be brief, concise and easy to complete—criteria that many existing tools do not fully meet. To address this, the authors of the Wound‐QoL conducted a psychometric reanalysis of data from multi‐country validations of the questionnaire, resulting in a shortened version: the Wound‐QoL‐14. This version comprises 14 items identical with those in the Wound‐QoL‐17 version, covering the same three core dimensions (Body, Psyche and Everyday life). Compared with the original version, the Wound‐QoL‐14 demonstrated improved psychometric properties, with the added benefit of being shorter, an advantage given the target population [ 11 , 12 ]. In this regard, the authors of a recent content validity assessment of the German version of the Wound‐QoL‐17 recommended this long version for clinical purposes, but the Wound‐QoL‐14 for research due to its improved psychometric properties [ 13 ]. Until now, the Wound‐QoL‐14 has been validated in Austria, Lithuania, The Netherlands, Poland, Slovakia and Ukraine in single a multicentre study [ 14 ] and recently also in Türkiye [ 15 ]. Additionally, the validity, reliability and responsiveness to healing of the Wound‐QoL‐14 have also been recently evaluated in people living with a diabetic foot ulcer [ 16 ]. Concerning Spain, although both the Cardiff Wound Impact Questionnaire [ 17 ] and the Wound‐QoL‐17 [ 18 ] have been validated in Spanish, the Wound‐QoL‐14 represents an improvement over the previous versions, as it demonstrates enhanced psychometric properties, eliminates items that function as statistical ‘noise’ and is shorter in length. The general aim of this study was to validate the Spanish version of the Wound‐QoL‐14. In particular, the objective was to evaluate the feasibility, reliability (internal consistency, test–retest reliability and test–retest error of measurement), construct validity (structural validity, known‐groups and convergent validity and criterion validity) and responsiveness (with floor and ceiling effects) of the Wound‐QoL‐14 in patients with chronic wounds of any aetiology, in order to determine its suitability for use in both routine clinical practice and research in Spain. 2. Methods 2.1. Study Design and Ethical Considerations This observational, multicentre, prospective validation study was conducted from January to December 2024 after obtaining approval from our Institutional Review Board ( Comité de Ética de la Investigación con medicamentos de la Gerencia de Atención Integrada , Albacete, Spain: internal code 2023–140). The study was conducted in accordance with applicable Spanish and European regulations, including Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD), which adapts Spanish legislation to the EU General Data Protection Regulation (Regulation (EU) 2016/679, GDPR); Law 14/2007 of 3 July on Biomedical Research; and the principles of the Declaration of Helsinki. Patients provided written informed consent before participating. The Wound‐QoL questionnaires were used with permission from the original development team [ 10 , 11 ] and the EQ‐5D‐5L with permission from the EuroQol Research Foundation ( https://euroqol.org ). 2.2. Sample Size The sample size was calculated on two premises. First, a minimum sample size of 140 patients was established to perform a factor analysis for assessing structural validity, after considering a minimum ratio of 10 patients per item [ 19 ]. This sample size exceeded the usual sample size recommended by COSMIN guidelines for assessing most psychometric properties, which is set at 100 patients [ 20 ]. Second, since it was impossible to predict how many professionals would participate or how many patients would be included due to the open‐participation design of the study, it was decided to keep the recruitment period open for a full year (2024) as a strategy to increase the chances of obtaining the calculated minimum sample size. Once the minimum sample was reached, patient recruitment continued throughout the year, as planned, but also for two additional reasons. First, many professionals across Spain were willing to participate, which would improve the external validity of the study. Second, the resulting increase in sample size would increase the likelihood of having at least 50 patients in each of the known groups, thus strengthening the construct validity analysis [ 20 ]. 2.3. Subject Recruitment and Data Collection Healthcare professionals from all over Spain who care for patients with chronic wounds were invited to participate (See Acknowledgements). The study used a non‐probability (convenience) multistage sampling approach for both site selection and subject recruitment. Eligibility criteria included adults aged 18 years and older with chronic wounds of any aetiology lasting at least 1 month. Exclusion criteria included patients hospitalised for any reason, patients who refused to complete the questionnaires and patients who were unable to complete them due to illiteracy or language barriers, even with the assistance of a caregiver. Caregivers of patients who were willing to participate but unable to respond independently were allowed to assist them. Caregivers were allowed to provide assistance exclusively in completing the questionnaires. They were instructed to read the items exactly as written, without interpreting or rephrasing them and without interpreting the patients' responses. Patients answered sociodemographic and clinical questions, the Wound‐QoL‐14, the three remaining items for the Wound‐QoL‐17 attached at the end of the survey and the generic EQ‐5D‐5L questionnaire in this precise order. Healthcare professionals collected additional demographic and clinical information. Demographic variables comprised gender, age, body mass index and educational level (illiterate, primary, secondary or university). Clinical variables included wound aetiology (venous, ischemic, diabetic, other), wound duration (months), wound size (cm 2 , calculated from long and short diameters) [ 21 ], pain intensity measured using the Numeric Rating Scale (NRS), bad odour (yes or no) and exudate (yes or no). The Wound‐QoL‐14 was administered again during another routine visit, approximately 1 month after the recruitment visit. Patients also reported eventual changes in their wound status using a 7‐point Likert anchor scale (ranging from ‘1‐Much worse’ to ‘7‐Much better’) and whether they considered the changes to be important [ 22 ]. Patients were classified as maintaining the same health status if they responded ‘4‐Same’ or if they responded ‘3‐Slightly worse’ or ‘5‐Slighty better’ but the change was not considered important. Patients who responded ‘5‐Slightly improved’ and considered the change important were assigned the improvement category, as were those who responded ‘6‐Moderately improved’ and ‘7‐Much improved’. The remaining patients were assigned to the worsening category. 2.4. Wound‐QoL‐14 and Wound‐QoL‐17 The Wound‐QoL‐17 questionnaire consists of 17 items which are answered on a 5‐point Likert scale (0 = not at all, to 4 = very much), with a 7‐day recall period. Item scores are averaged to obtain a score for the total scale and the three subscales (Body, Psyche and Everyday life) [ 8 ]. Compared with the original Wound‐QoL‐17, the shortened Wound‐QoL‐14 differs only in the exclusion of item #10 (‘wound‐related injuries’), #12 (‘climbing stairs’) and #17 (‘financial burden’). All remaining items are kept unchanged, both in wording and order and the scoring system remains the same. Responses to the Wound‐QoL‐14 were analysed as is, while those to the Wound‐QoL‐17 were reconstructed by adding three additional items to the end of the Wound‐QoL‐14 to complete the full set of 17 questions. This ‘virtual’ reconstruction of the version 17 reflects the methodology used by the authors of the instruments to validate the Wound‐QoL‐14, who virtually reconstructed the version 14 after eliminating three items from the original 17 [ 10 ]. 2.5. EQ‐5D‐5L The EQ‐5D‐5L is a generic, one‐day recall questionnaire that assesses HRQoL using five items/dimensions (mobility, self‐care, usual activities, pain/discomfort and anxiety/depression) with five response levels. The information obtained through this descriptive system was summarised in a utility index calculated using Spanish tariffs [ 23 ], ranging from 1 (‘full health’) to 0 (‘death’) or even negative values (‘worse than death’). In addition, the questionnaire includes an EQ‐VAS scale for patients to rate their health status on a scale of 0 (worst) to 100 (best). 2.6. Statistical Methods Following the developer's instructions, patients who left more than three items blank were excluded for further analysis. Then, missing data were described at both the case and variable level. Blank items were imputed individually based on the results of Little's Chi‐square test, following the hybrid κ‐nearest neighbour imputation within strata method (where κ = 6). Patients were stratified according to main attributes, specifically sex and age and any other variable considered relevant. In addition, a sensitivity analysis was performed to confirm that the main results were similar between the unimputed and imputed datasets. Categorical variables were reported as frequencies and percentages. Quantitative variables were fully described as the mean with standard deviation and as the median with the 25th and 75th percentiles, but nonparametric tests were used for comparisons according to the Shapiro–Wilk test. The strength of associations between quantitative variables was categorised according to Spearman's rank correlation coefficient (rho): ‘very weak’ (0.00 < rho < 0.19), ‘weak’ (0.20 < rho < 0.39), ‘moderate’ (0.40 < rho < 0.59), ‘strong’ (0.60 < rho < 0.79) or ‘very strong’ (rho > 0.80) [ 24 ]. Statistical analyses were performed using the open‐source statistical software jamovi (version 2.4). A p ‐value < 0.05 was considered statistically significant. 3. Assessing Psychometric Properties The psychometric properties of the Wound‐QoL‐14 were evaluated following the COSMIN guidelines [ 25 ]. The items included in the Wound‐QoL‐14 retain the original wording and conceptual meaning of the original Wound‐QoL‐17, whose Spanish version has already been translated, adapted and cross‐culturally validated [ 26 ]. Therefore, the Spanish version of the Wound‐QoL‐14 was obtained after shortening in three items the Spanish version of the Wound‐QoL‐17. The 14‐items version retains the linguistic and cultural validity established in the previous adaptation process of the 17‐items version, making further translation or cultural adaptation unnecessary. Feasibility was assessed based on the percentage of items left blank. Additionally, the time it took 15 patients to complete the Wound‐QoL‐14 was measured at a single centre. Reliability was evaluated through internal consistency, test–retest reliability and test–retest error of measurement. Internal consistency was assessed using McDonald's omega total, a more precise index of internal consistency than Cronbach's alpha [ 27 ], although the latter was also calculated to allow for comparison with the literature. Good values were between 0.70 and 0.90. Furthermore, the change in coefficient values if each item was deleted should not exceed 0.1. Finally, item‐total and item‐domain correlations should be greater than 0.4 [ 28 ]. To evaluate test–retest reliability, only patients assigned to the same health status were included. Shieh's exact test of agreement between both versions was performed with a confidence level of 95%, a level of agreement of 95% and agreement bounds of ±MID‐I around zero [ 29 ], where MID‐I stands for minimal important difference for improvement and it was calculated as the mean average change in score for those patients who responded ‘Slightly improved’ to the anchor question. Two test–retest reliability coefficients were calculated, the concordance‐correlation coefficient (CCC) because most domains did not follow a parametric distribution and the two‐way mixed effects model of intraclass correlation coefficient (ICC) for absolute agreement to allow comparison with the literature. The criteria were to find ‘substantial’ (CCC > 0.60) or ‘almost perfect’ (CCC > 0.80) CCC values [ 30 ] and ‘good’ (ICC > 0.75) or ‘excellent’ (ICC > 0.90) ICC values [ 28 ]. The coefficient of variation (objective: < 20%) and the standard error of measurement (SEM) were calculated to assess the test–retest error of measurement [ 31 ]. SEM was calculated by multiplying the standard deviation of patients who remained unchanged by the squared root of 1 minus CCC. Further, the smallest detectable change (SDC) was calculated as SEM multiplied by 1.96 and by the square root of 2 [ 22 ]. The level of agreement between the test and retest scores of the Wound‐QoL‐14 was assessed using the Bland–Altman method to calculate the upper and lower limits of agreement [ 31 ]. The validity of the instrument was established by assessing construct validity—which in turn was evaluated by structural validity and by testing predefined hypotheses in known‐groups and convergent validity—and criterion validity. Structural validity was initially assessed using exploratory factor analysis. The maximum likelihood extraction method was used in combination with the oblique promax rotation to account for the theoretical correlation between factors and the number of factors to be extracted was determined by the number of eigenvalues > 1. If three factors were identified, a confirmatory factor analysis of this model was performed. The fit of this three‐factor model was assessed by examining factor loadings (> 0.50) and fit indices such as the comparative fit index (CFI: > 0.90), the Tucker–Lewis index (TLI: > 0.90), the Standardized Root Mean Square Residual (SRMR: < 0.08) and the root mean square error of approximation (RMSEA: < 0.08). If more than one model was subjected to confirmatory analysis, the model with the lowest values of the Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC) was chosen, seeking the most accurate and simple model. The maximum likelihood method assumes multivariate normality and data were likely to exhibit skewness. However, this method was chosen over principal axis factoring and minimum residuals because it allows for further assessment of model fit indices (CFI, TLI, SRMR, RMSEA). Nevertheless, the stability of the results was verified using the other two methods as sensitivity analysis. Construct validity was considered good if at least 75% of the predefined hypotheses about known‐groups and convergent validity were supported [ 32 ]. The four predefined hypotheses for known‐groups validity included finding significantly worse (higher) scores for ischemic and painful wounds (NRS > 4 points) [ 33 ] and for those with malodor or exudate; the rank‐biserial correlation coefficient was used to assess the effect size (ES) of the differences between groups, which should be at least medium (ES ≥ 0.26) [ 34 ]. Regarding convergent validity, the hypotheses were to find moderate to strong (rho > 0.4) correlations for the global score (negative with EQ‐5D‐5L utility index and EQ‐VAS, positive with wound size in cm 2 , wound duration in months and pain‐NRS) and for the dimensions Body (positive with pain‐NRS and pain/discomfort on EQ‐5D‐5L), Psyche (positive with anxiety/depression on EQ‐5D‐5L) and Everyday life (positive with usual activities on EQ‐5D‐5L). The original Wound‐QoL‐17 was used as the gold standard to assess criterion validity and the correlations between the two versions, for both total and domain‐specific scores, were expected to be positive and strong (rho > 0.6). Responsiveness was assessed in patients who had improved or worsened. First, floor and ceiling effects were considered absent if less than 15% of the individuals endorsed the lowest (floor, score 4) or highest (ceiling, score 0) extreme ends [ 32 ]. Second, the correlation between the 7‐point anchor question and changes in Wound‐QoL‐14 scores should be moderate. Then, the area under the receiver operating characteristic (AUC‐ROC) curve was expected to be higher than 0.70 [ 35 ]. Finally, the standardized effect size (SES) and the standardized response mean (SRM) were calculated to assess sensitivity to change based on the distribution of responses. The ability of the Wound‐QoL‐14 to detect changes was considered low for values below 0.50, moderate between 0.50 and 0.80 and excellent for values above 0.80 [ 36 ]. 4. Results A total of 347 patients were recruited at 32 centres by 100 professionals. Twenty‐four (6.9%) were excluded: Ten after leaving the Wound‐QoL survey completely blank and the remainder due to meeting some exclusion criteria, mainly related to ulcer aetiology ( n = 6) or duration ( n = 8). Therefore, the final sample consisted of 323 patients. Baseline characteristics of patients, wounds and HRQoL surveys are shown in Table 1 , while the description of the Wound‐QoL‐14 items is shown in Table S1 . TABLE 1. Patients and wounds characteristics and scores for patient‐reported outcomes measures. n (%) Mean (SD) Median [P25–P75] Gender, male 168 (52) — — Age — 71.1 (14.6) 74 [62–82] Body mass index — 29.1 (6.7) 27.7 [24.6–31.9] Educative level Illiterate 65 (20.1) — — Primary 147 (45.5) — — Secondary 84 (26.0) — — University 27 (8.4) — — Wound aetiology Venous 131 (40.6) — — Ischemic 63 (19.5) — — Diabetic 37 (11.5) — — Others 92 (28.5) — — Wound duration (months) — 18.9 (44.7) 6 [3–14] Wound size (cm 2 ) — 20.2 (45.8) 4.7 [1.2–15.6] Pain (NRS) — 4.2 (3.1) 4 [2–7] Pain > 4 151 (46.7) — — Bad odour 53 (16.4) — — Exudate 200 (61.9) — — Wound‐QoL‐14 Global — 1.71 (1.06) 1.57 [0.79–2.57] Body subscale — 1.39 (1.13) 1.25 [0.50–2.00] Psyche subscale — 2.23 (1.20) 2.25 [1.25–3.25] Everyday life subscale — 1.62 (1.35) 1.40 [0.40–2.80] Wound‐QoL‐17 — 1.72 (1.03) 1.59 [0.82–2.53] EQ‐5D‐5L utility — 0.560 (0.321) 0.635 [0.361–0.819] EQ‐VAS — 56.1 (24.5) 60 [40–75] Open in a new tab Abbreviation: NRS, numerical rating scale. 4.1. Feasibility and Missing Data All 15 patients took less than 5 min to complete the Wound‐QoL‐14, a time considered acceptable. Additionally, feasibility was considered excellent according to the low percentage of surveys not entirely completed (11.8%) and of missing items (0.95%; five patients left blank two items and 33 patients left blank one item). They were manually imputed according to the MCAR test (Chi‐square = 238.918; df = 204; p = 0.050). 4.2. Reliability: Internal Consistency Internal consistency was good at both the scale and subscale levels (Table 2 and Table S2 ). TABLE 2. Internal consistency. Cronbach's alpha McDonald's omega Global score 0.934 0.934 Body subscale 0.808 0.809 Psyche subscale 0.862 0.862 Life subscale 0.928 0.929 Coefficient if the item is deleted (range) 0.925–0.933 0.926–0.934 Item‐total correlation (range) 0.524–0.801 Open in a new tab 4.3. Reliability: Test–Retest Reliability Of 323 patients, 197 (61%) participated in the retest phase (34.1 ± 23.4 days elapsed). The survey completion rate was relatively high, both at the item level (99.6%) and at the survey level (92.9%). Missing data were imputed as described above. Of 197 retests, 30 (15.2%) patients were considered to have maintained the same health status. The coefficient of variation was marginally high, likely due to the relatively small sample size. However, the Wound‐QoL‐14 demonstrated good test–retest reliability, supported by the high CCC (CCC = 0.915; 95% CI: 0.837/0.956), even though six of the 30 patients fell outside the agreement bounds and the non‐agreement hypothesis was not rejected (Table 3 and Table S3 ). Regarding dimensions, Everyday life showed the best reliability and Psyche the poorest (Table 3 ). TABLE 3. Test–retest reliability. Global Body Psyche Everyday life Test score, mean (SD) 1.51 (1.26) 1.38 (1.29) 1.87 (1.31) 1.42 (1.53) Retest score, mean (SD) 1.46 (1.09) 1.18 (0.98) 2.00 (1.19) 1.33 (1.35) Test score, median [P25–75] 0.97 [0.64–2.82] 0.88 [0.50–2.19] 1.38 [0.63–2.94] 0.60 [0.20–3.15] Retest score, median [P25–75] 1.18 [0.55–2.57] 0.75 [0.50–1.94] 2.00 [1.00–2.75] 0.80 [0.20–2.50] CCC 95% CI 0.915 0.837/0.956 0.852 0.739/0.918 0.767 0.571/0.881 0.918 0.842/0.958 ICC 95% CI 0.917 0.853/0.955 0.856 0.745/0.921 0.773 0.618/0.871 0.921 0.858/0.956 CV (%) 22.75 32.84 30.78 29.61 SEM 0.141 0.230 0.408 0.165 SDC 0.39 0.64 1.13 0.46 MID‐I 0.64 0.78 0.53 0.55 B‐A, mean bias 95% CI 0.051 −0.130/0.231 0.200 −0.023/0.423 −0.133 −0.449/0.182 0.093 −0.122/0.309 B‐A, lower LoA 90% CI −0.897 −1.101/−0.693 −0.968 −1.220/−0.717 −1.790 −2.147/−1.433 −1.038 −1.281/−0.794 B‐A, upper LoA 90% CI 0.998 0.794/1.202 1.368 1.117/1.620 1.523 1.167/1.880 1.225 0.981/1.468 Shieh test, exact 90% CI −1.090/1.191 −1.206/1.606 −2.127/1.860 −1.268/1.455 Shieh test, reject H 0 NO NO NO NO Open in a new tab Abbreviations: B‐A, Bland–Altman; CCC, correlation concordance coefficient; CV, coefficient of variation; H 0 , there is no agreement between the two measurements; ICC, intraclass correlation coefficient (two‐way random, total agreement); LoA, limit of agreement; MID‐I, minimal important difference for improvement; SDC, smallest detectable change; SEM, standard error of measurement. 4.4. Construct Validity: Structural Validity Structural validity was initially assessed using exploratory factor analysis after confirming that the data were adequate (Kaiser–Meyer–Olkin: 0.929, range for items between 0.898 and 0.907) and there were sufficient inter‐item correlations (Bartlett's test of sphericity: χ 2 = 3025; df = 91; p < 0.001). The analysis revealed a neat three‐factor structure without cross‐loadings, consistent with the original theoretical model, which explained 63% of the total variance. All items except one showed factor loadings above 0.50 and seven items had factor loadings above 0.70, indicating that the items were strongly related to their respective factors (Table S4 ). The weakest item (#2) was kept in the scale for two main reasons. Its factor loading (0.481) was very close to the predefined limit (0.50). The item itself refers to bad odour and even patients not suffering it consider that the item deserves to be kept in the survey [ 13 ]. Sensitivity analysis using principal axis factoring and minimum residuals methods yielded near‐identical factor loadings and structures, as well as a similar percentage of explained covariance (data not shown). This suggests that the maximum likelihood estimates were stable and unbiased, which also indicates a robust underlying structure. Then, confirmatory factor analysis revealed a similar good fit for the original three‐factor model with 13 items created by developers ( χ 2 = 222; df = 62; p < 0.001. CFI = 0.942. TLI = 0.927. SRMR = 0.042. RMSEA: 0.089; 90% CI: Lower = 0.077, Upper = 0.102) and for the 14‐items model derived from the exploratory analysis ( χ 2 = 242; df = 74; p < 0.001. CFI = 0.944. TLI = 0.931. SRMR = 0.043. RMSEA: 0.084; 90% CI: Lower = 0.072, Upper = 0.096). But the original 13‐items model was preferred over the 14‐items based on information‐theoretic model selection criteria, exhibiting lower AIC (12 545 vs. 13 441) and BIC (12 704 vs. 13 611) values, which indicated improved trade‐off between goodness of fit and model complexity. 4.5. Construct Validity: Known‐Groups and Convergent Validity All four known‐groups validity hypotheses were considered supported, even for ischemic aetiology as the difference between ischemic and nonischemic was very significant and the ES was very close to the predefined threshold (Table 4 ) as well as all but two of the convergent validity hypotheses (Table 5 ). Therefore, more than 75% (84.6%) of predefined hypotheses were met. TABLE 4. Known‐group validity. YES NO p ES n (%) Mean (SD) Median [P25–P75] n (%) Mean (SD) Median [P25–P75] Ischemic aetiology 63 (19.5) 2.06 (1.03) 2.00 [1.14–2.79] 260 (80.5) 1.62 (1.06) 1.40 [0.71–2.50] 0.002 0.244 Pain, NRS > 4 151 (46.7) 2.20 (1.01) 2.36 [1.43–3.07] 172 (53.3) 1.27 (0.91) 1.00 [0.64–1.93] < 0.001 0.507 Malodour 53 (16.4) 2.47 (1.01) 2.50 [1.86–3.43] 270 (83.6) 1.56 (1.01) 1.36 [0.71–2.43] < 0.001 0.482 Exudate 200 (61.9) 1.93 (1.08) 1.90 [0.93–2.86] 123 (38.1) 1.34 (0.94) 1.00 [0.64–2.00] < 0.001 0.320 Open in a new tab Note: One‐sided Mann–Whitney U test for comparisons. Abbreviation: ES, effect size. TABLE 5. Convergent and criterium ǂ validity. Variable Wound‐QoL‐14 Spearman's rho p EQ‐5D‐5L utility index Global score −0.670 < 0.001 EQ‐VAS Global score −0.443 < 0.001 Wound size (cm 2 ) Global score 0.309 < 0.001 Wound duration (months) Global score 0.038 0.250 Pain (NRS) Global score 0.500 < 0.001 Pain (NRS) Body 0.574 < 0.001 EQ‐5D‐5L, Pain/discomfort Body 0.592 < 0.001 EQ‐5D‐5L, Anxiety/depression Psyche 0.657 < 0.001 EQ‐5D‐5L, Usual activities Everyday life 0.562 < 0.001 ǂ Wound‐QoL‐17 global score Global score 0.989 < 0.001 ǂ Wound‐QoL‐17, Body Body 0.983 < 0.001 ǂ Wound‐QoL‐17, Psyche Psyche 0.977 < 0.001 ǂ Wound‐QoL‐17, Everyday life Everyday life 0.989 < 0.001 Open in a new tab ǂ Indicates the three variables used to assess criterium validity. 4.6. Construct Validity: Criterion Validity Criterion validity was excellent based on the strong correlation found with the original Wound‐QoL‐17 (Table 5 ). Overall, the Wound‐QoL‐14 showed good construct validity based on structural, known‐group, convergent and criterion validity results. 4.7. Responsiveness No floor effect was found for the global score and for the Body, Psyche and Everyday life subscales (0.3%, 3.1%, 9.9%, 5.9%, respectively). The Everyday life subscale showed a marginal ceiling effect (16.1%), but none was observed for the Wound‐QoL‐14 and Body and Psyche subscales (1.5%, 10.5%, 2.8%, respectively). Spearman's rank correlation coefficients between changes in test–retest responses and the 7‐point anchoring question were all highly significant ( p < 0.001) and greater than 0.4, except for Everyday life (Global: 0.455. Body: 0.437. Psyche: 0.422. Everyday life: 0.283). Sensitivity to change was assessed only for improvement (150 out of 197 patients, 76.1%) as only 17 patients (8.6%) experienced worsening. Regarding the external anchor, the ability of the Wound‐QoL‐14 to detect improvement ( n = 150) vs. no improvement ( n = 47) was fair according to the AUC‐ROC value (Figure 1 ). Regarding the distribution of responses, the ability to detect improvement was very good. Regardless of the method employed, the poorest results were observed for the Everyday life subscale (Figure S1 ). FIGURE 1. Open in a new tab The area under the receiver operating characteristic curve of Wound‐QoL‐14 scores for patients reporting improvement. 5. Discussion The results of this multicentre prospective validation study provide strong evidence that the Wound‐QoL‐14 is a feasible, reliable and valid instrument to assess HRQoL in Spanish patients with chronic wounds. Direct comparison with the literature was limited to a few previous studies. Some of the psychometric properties of the Wound‐QoL‐14 (internal consistency reliability with test–retest reliability, construct validity via convergent validity and floor and ceiling effects) were evaluated in a European sample of 305 patients recruited from six countries (Austria, Lithuania, The Netherlands, Poland, Slovakia and Ukraine) [ 14 ]. Recently, psychometric properties of the Turkish version of the Wound‐QoL‐14 (content validity, structural validity through confirmatory factor analysis, internal consistency, test–retest reliability and convergent validity) were assessed in a sample of 141 patients with chronic wounds [ 15 ] and also validity, reliability and responsiveness to healing were assessed in 107 English patients with diabetes related foot ulcers [ 16 ]. Due to the scarcity of publications involving the short version, the discussion of psychometric properties was also based on the literature evaluating the Wound‐QoL‐17, when available. Feasibility was excellent, as judged by the extremely low percentage of missing data. Although direct comparison was not possible [ 14 , 15 , 16 ], this was in line with the literature for the original 17‐items version. So far, the highest percentage of missing data was observed in a Dutch validation for the item ‘climbing stairs’, with a striking 25% [ 37 ]. Interestingly, this item is not present in the abbreviated version, making the Wound‐QoL‐14 version more feasible. Values for both reliability coefficients were higher than the preestablished threshold, indicating good internal consistency. However, McDonald's omega coefficient values above 0.9 for the scale and Everyday life subscale may reflect redundancy. Concerning Cronbach's alpha, the same finding was observed in four countries (Austria, Poland, Slovakia and Turkey) for the global score and in three others (Lithuania, The Netherlands, Poland and Turkey) for the Everyday life subscale [ 14 , 15 ]. The poorest outcome was observed in the Body subscale as well as in all these countries, which showed insufficient internal consistency (Cronbach's alpha < 0.7) in The Netherlands and Ukraine [ 14 ]. These findings were parallel to those of the study involving English patients with diabetic foot, in which Cronbach's alpha was above 0.9 for the scale, but lower than 0.7 for the Body subscale [ 16 ]. Overall, internal consistency was deemed to be good. There was a relatively great variability in the time elapsed from the test to the retest due to the noninterventional nature of the design, but the anchor question counterbalanced its eventual influence on the results. Based on the results observed for test–retest reliability, the performance of the Spanish version of the Wound‐QoL‐14 can be considered stable and the survey reliable over time. Both CCC and ICC showed values well above 0.7 in all European countries except for Austria (ICC: 0.623) and The Netherlands (ICC: 0.653) [ 14 , 15 ]. In terms of dimensions, the poorest outcome was observed for the Psyche subscale. Based exclusively on ICC values lower than 0.7, Psyche agreement was poor for Austria, The Netherlands and Slovakia, in addition to Body in Austria and Slovakia [ 14 ]. In general, the relative reliability was excellent, meaning that the instrument was highly stable in discriminating patients' health status over time. Unlike the high stability and reproducibility, absolute agreement was not achieved, since the hypothesis of no agreement could not be rejected. This failure indicated that baseline and retest scores fluctuated slightly beyond the bounds determined by the MID‐I, which did not necessarily imply clinical significance. We cannot look for similar results or for an explanation in the literature because, to the best of our knowledge, this is the first time the Shieh test has been used with this survey. In our opinion, these unexpected results might be a consequence of the relatively low sample size and could be solved with larger sample sizes. Overall, the instrument is reliable and robust for group‐level research and longitudinal tracking. The relatively low sample size might also account for the marginally high values observed for the coefficient of variation and for obtaining higher SEM values than those observed in a Danish population of 54 retest patients with Wound‐QoL‐17 [ 38 ]. Apart from sample size, these differences may also reflect cultural or contextual factors or variation in sample characteristics and highlight the importance of population‐specific validation. However, our SEM values observed remain within an acceptable range, supporting the instrument's overall measurement precision in our population. Structural validity was supported by both exploratory and confirmatory factor analyses. The identified three‐factor structure aligned well with the original theoretical three‐factor structure and explained a substantial proportion of the variance. Model fit indices indicated a good overall fit of the 13‐items and 14‐items models because, despite the RMSEA suggesting a marginal fit, CFI and TLI were high and SRMR low and factor loadings were strong. We then chose the 13‐items model based on AIC and BIC values. Overall, structural validity remained supported, confirming the instrument's construct validity. Until now, the structural validity of Wound‐QoL‐14 had not been evaluated through an exploratory factor analysis [ 14 , 15 ], but several studies confirmed a three‐factor structure for the Wound‐QoL‐17 [ 18 , 39 ]. Interestingly, two [ 40 ] and four [ 41 ] factors have also been reported in the literature. Remarkably, the number of factors was identified using the principal component analysis method instead of an EFA and the matrices of item correlations were subjected to a varimax instead of a promax rotation. The methodology shared by those two studies (principal component analysis and varimax rotation) focuses on summarising observed data without modelling latent constructs. In contrast, a maximum likelihood EFA with promax rotation is theory‐driven, models only shared variance and allows for correlated latent factors—making it more appropriate for psychometric validation and construct validity. Abounding on that, we found only one factor instead of three after using principal component analysis and varimax rotation on our data (results not shown), highlighting the importance of the methods selected to evaluate the psychometric properties. Additionally, a recent Turkish validation of the Wound‐QoL‐14 [ 15 ] found a good fit for a 4‐factor model, taking the item #5 separately as an independent factor. But these authors did not actually conduct a previous exploratory factor analysis to explore the number of factors to be extracted. Instead, they directly confirmed the 4‐factor model based on the reports by the original developers of the instrument. The Wound‐QoL‐14 discriminated well between the predefined known groups, supporting construct validity. The short version also showed a good discriminant power between diabetic feet which healed and those which did not [ 16 ]. These results were in line with the results reported for the Wound‐QoL‐17, which always showed a good discriminatory power between groups, despite differences in the number and type of known groups defined by other authors, as well as the boundary categories [ 40 , 41 ]. Seven out of nine hypotheses predefined to assess convergent validity were supported. Correlations were moderate to strong between the Wound‐QoL‐14 global score and scores derived from the EQ‐5D‐5L generic instrument, as well as with pain scores. Furthermore, all subscales of the questionnaire showed good correlations with their corresponding EQ‐5D‐5L dimensions, confirming good convergent validity across related domains. These results were in line with the literature for both versions [ 14 , 16 , 38 , 42 ]. The poorest outcomes were found for characteristics related to wounds, like wound size and duration of wound, in line with other European patients [ 14 ]. These results further support the convergent validity profile of the instrument, reflecting its focus on patient‐reported quality of life rather than clinical wound parameters. The criterion validity was very good. This was an expected outcome considering that the original version was reconstructed from the answers to the abbreviated version. Until now, no other study had assessed this property using the Wound‐QoL‐17 as the gold standard [ 14 , 15 , 16 ]. The Freiburg Life Quality Assessment‐ wound module was one of the three surveys used to create the original Wound‐QoL‐17 and it was used as a gold standard in two studies [ 43 , 44 ]. Correlations between them were strong (rho > 0.8), indirectly supporting criterion validity for Wound‐QoL‐14. Regarding floor or ceiling effects, we only found a ceiling effect for the domain Everyday life. However, the value was so low that the ability of the survey to detect improvement should not be impaired. This is in line with the literature, as significant floor or ceiling effects have never been reported [ 14 , 38 ]. Regarding responsiveness, the instrument demonstrated a high sensitivity to detect improvement, making the survey suitable to be used in longitudinal evaluations. Responsiveness was found to be good in a partial assessment based on correlations performed in patients with diabetic foot, but these authors claimed for further refinement [ 16 ]. The other two available studies on Wound‐QoL‐14 did not assess this property [ 14 , 15 ], but some others assessed it for the original 17‐item version [ 38 , 45 , 46 ]. A study performed in a Norwegian population reported values of standardized response mean ranging from 0.337 to 0.551 across different time points [ 45 ] and it was 0.45 in another study performed in a Swedish population [ 46 ]. The AUC‐ROC value reported in a Danish population was moderate (0.63) [ 38 ]. We found much better values for those parameters, demonstrating superior responsiveness for the Wound‐QoL‐14. The clinical implication would be that the abbreviated version not only exhibited better sensitivity for detecting improvement, but it might perform better for detecting meaningful clinical improvement—although the latter remains to be demonstrated. 5.1. Strengths The main strength of this study is that it expanded the evaluation of the psychometric properties of the Wound‐QoL‐14 to include several properties that had not been evaluated until now, such as structural validity through an exploratory factor analysis, criterion validity and sensitivity to change. The use of the 7‐point Likert anchor scale to assess responsiveness is also a major strength. Additionally, Spanish‐specific tariffs for the EQ‐5D‐5L instrument were used to assess convergent validity. Finally, the large sample size—substantially larger than that used for validation in other studies [ 14 , 15 , 16 ]—further enhances the robustness of our findings. 5.2. Limitations Information is lacking on some details related to the level and quality of participation, such as how many patients refused to participate or the level of adherence to the study protocol by the collaborating centres. Besides, a double selection bias could not be ruled out. Healthcare professionals who are more committed to optimal ulcer care are more likely to volunteer for studies like this one and their patients are expected to experience better clinical outcomes. Patients with better clinical conditions are expected to participate more frequently. These eventual biases could influence the representativeness of the sample and, therefore, caution is advised when generalising to the broader population. Criterium validity was assessed after correlating the scores from the real short version with a reconstructed long version. Placing the three additional items at the end of the short version might have introduced a slight ‘context effect’ compared to their theoretical interleaved positions. However, we chose this procedure to avoid ‘memory and carryover effects’ [ 47 , 48 ] and to reduce the burden for participants. We did not evaluate content validity of Wound‐QoL‐14. In general, this property has been scarcely evaluated [ 13 , 38 , 42 ]. Of particular relevance is a recent study in which nurses from Catalonia, a Spanish region where Spanish and Catalan coexist, found that the Wound‐QoL‐17 reflected the construct of wound‐specific HRQoL [ 42 ]. Pending proper evaluation, it seems reasonable to assume that the content validity of the Spanish version of Wound‐QoL‐14 will also be adequate. A few patients worsened. Therefore, the sensitivity to detect worsening was not assessed, leaving this property still unevaluated. 6. Conclusion This evaluation of the Spanish version of the Wound‐QoL‐14 demonstrated that the survey has good psychometric properties, making it a valid and reliable instrument. Additionally, the availability of shortened questionnaire formats is particularly relevant in clinical practice, where consultation time is often limited. Therefore, the Wound‐QoL‐14 is recommended as a preferred instrument for assessing wound‐related quality of life in both clinical and research settings. Funding This work was supported by the Universidad de Castilla‐La Mancha. Ethics Statement This study was conducted after obtaining approval from our Institutional Review Board (Comité de Ética e Investigación con medicamentos de la Gerencia de Atención Integrada de Albacete; internal code 2023‐140). Consent Patients provided written informed consent before participating. Conflicts of Interest The authors declare no conflicts of interest. Supporting information Table S1: Descriptive characteristics of Wound‐QoL‐14 items. IWJ-23-e70965-s003.pdf (59.1KB, pdf) Table S2: Item‐total and item‐domain correlations and coefficients if the item was deleted. IWJ-23-e70965-s001.pdf (134.2KB, pdf) Table S3: Factor loadings after the exploratory factorial analysis. IWJ-23-e70965-s004.pdf (112.5KB, pdf) Table S4: Sensitivity to detect improvement. IWJ-23-e70965-s005.pdf (37.5KB, pdf) Figure S1: Concordance plot between Wound‐QoL‐14 scores at baseline and retest. IWJ-23-e70965-s002.pdf (62.3KB, pdf) Acknowledgements The authors are especially grateful to the following Spanish scientific societies for disseminating and publicising participation of health professionals dedicated to wounds in the AlbaMad study: Asociación Española de Enfermería Vascular y Heridas (AEEVH), Grupo Nacional para el Estudio y Asesoramiento en Úlceras por Presión y Heridas Crónicas (GNEAUPP), Sociedad Española de Heridas (SEHER), Sociedad Gallega de Heridas (SGH). Also, the authors are grateful to Diputación de Albacete and Universidad de Castilla‐La Mancha for funding the Article Processing Charges. Data Availability Statement The data that support the findings of this study are available from the corresponding author upon reasonable request. References 1. 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IWJ-23-e70965-s003.pdf (59.1KB, pdf) Table S2: Item‐total and item‐domain correlations and coefficients if the item was deleted. IWJ-23-e70965-s001.pdf (134.2KB, pdf) Table S3: Factor loadings after the exploratory factorial analysis. IWJ-23-e70965-s004.pdf (112.5KB, pdf) Table S4: Sensitivity to detect improvement. IWJ-23-e70965-s005.pdf (37.5KB, pdf) Figure S1: Concordance plot between Wound‐QoL‐14 scores at baseline and retest. IWJ-23-e70965-s002.pdf (62.3KB, pdf) Data Availability Statement The data that support the findings of this study are available from the corresponding author upon reasonable request. 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