Abstract
A specific assessment tool is urgently needed to guide effective wound care for diabetic foot ulcers. However, the tool has not been available in Chinese. We aimed to culturally translate and verify the validity and reliability of the new Diabetic Foot Ulcer Assessment Scale (DFUAS). The original scale was translated into Chinese according to the Brislin guidelines. Patients satisfying the inclusion and exclusion criteria were recruited. Each of the included foot ulcers was evaluated independently by two wound care specialists using the new DFUAS and by the third wound care specialists at the same time using the Bates‐Jensen Wound Assessment Tool according to per guidelines. 210 diabetic foot ulcers were included for data analysis. The S‐CVI of the Chinese version of the DFUAS was 0.96, and the I‐CVIs ranged from 0.89 to 0.98. The total Cronbach's Alpha of the scale was 0.709, and the corrected item‐total correlation of the items ranged from 0.4 to 0.872. The DFUAS had high inter‐observer reliability of 0.997, and there were weak, moderate, and strong correlations between each pair of the items. The Bland–Altman plots showed a good agreement between the scale and the Bates‐Jensen Wound Assessment Tool. We concluded that the Chinese version of the DFUAS showed good validity and reliability and is a reliable instrument for the assessment of diabetic foot ulcers.
Keywords: diabetic foot ulcer, reliability and validity, translation, wound assessment
1. INTRODUCTION
Diabetic foot ulcer (DFU) is ulceration or destruction of tissues as a result of neurological abnormalities and peripheral vascular disease in the lower extremity of people with diabetes mellitus(DM). 1 DFU mostly occurs in patients with a long course of disease, affecting more than 15% of people with diabetes, and often results in lower limb amputations. 2 , 3 As is estimated, the prevalence of DFU in developed countries ranges from 2% to 4% per year, and that of China is as high as 8.1%. 4 DFU is one of the most expensive diabetes‐related complications, and the medical expenditure of DM patients with foot ulcers is 5.4 times that of those without. 5 As a result, DFU places a tremendous strain on patients and how to effectively promote ulcer healing is an urgent problem to be solved.
Comprehensive assessment is a primary step for wound care and ulcer healing. As is well established, wound characteristics have the potential to predict wound outcome, 6 for which accurate and integrated wound assessment lays an essential foundation for effective wound treatment while inappropriate or inaccurate wound assessment causes delayed wound healing, even wound deterioration. Wound assessment tools help healthcare providers to formulate practical treatment goals and decision‐making, continuously monitor wound progression, and predict prognosis. The development and application of a specific assessment tool for DFUs remain a crucial problem in clinical practice for the following reasons. The special anatomical structure and co‐infection of diabetic foot are the important reasons for the rapid progression of foot wound 1 and the characteristics of inflammation/infection, slough, tunnelling render foot ulcers distinguished from common chronic wounds. However, these characteristics have been rarely assessed by general chronic wound assessment tools; which, therefore, cannot accurately and comprehensively assess the characteristics of foot ulcers. Furthermore, DFUs are notoriously for rapid progression and difficulty in healing. 7 , 8 So, a specific assessment tool is urgently needed to guide effective foot ulcer care and healing.
There have already been several general chronic wound assessment tools, such as the Wound Colour Assessment System, 9 the Pressure Ulcer for Healing(PUSH), 10 and the Bates‐Jensen Wound Assessment Tool(BWAT). 11 However, the tools that specifically assess DFUs are quite limited. To the best of our knowledge, the new DFU Assessment Scale (DFUAS)is the only assessment tool specifically for DFUs, 12 it has been confirmed to be a valid tool for assessing DFUs in Japan and Indonesia. 13 However, there is no Chinese version of the scale, and the reliability and validity of the Chinese version are unknown. Therefore, we aim to verify the validity and reliability of Chinese version of DFUAS to provide a reliable instrument for the assessment of DFUs for Chinese healthcare specialists.
2. MATERIALS AND METHODS
2.1. Aim and study design
We conducted a descriptive cross‐sectional study to translate the DFUAS into Chinese and test its validity and reliability in Chinese patients with DFUs.
2.2. Translation of the DFUAS
The original DFUAS was translated into Chinese according to the Brislin guidelines. 14 , 15 The English version was first translated into Chinese by two nursing postgraduates with bilingual literacy in Chinese and English independently; if obscure terminology were encountered, a wound specialist would give guidance. The two nursing postgraduates compared the differences between the two translated versions, then discussed and resolved. If consensus cannot be reached, a Chinese wound specialist with work experience in native English‐speaking countries was consulted, and then an initial Chinese version was formed. The initial Chinese version was then translated into English by two bilingual graduates educated in English independently. The two nursing postgraduates compared the two back‐translated versions with the original English version; differences were analysed and modified until the agreement was attained to complete the final Chinese version of the scale.
2.3. Participants recruitment
Patients followed up in the Diabetic Foot Clinic of Sun Yat‐sen Memorial Hospital between July 2021 and September 2022 were recruited in our study. Patients were included if they were 18–75 years old, diagnosed as DFU and the targeted ulcer was classified as Wagner grade 1–4, 4 understood the purpose of the study, and had their informed consent form signed. In the case of participants who presented with more than one ulcer, the ulcer of the largest area was deemed as the target ulcer.
2.4. Data collection procedure
The demographic and clinical characteristics of the participants were obtained from electronic medical records. Each of the included foot ulcers was evaluated independently by two wound care specialists on the following items: depth, size, inflammation/infection, granulation tissue, necrotic tissue, slough, maceration, type of wound edge, and tunnelling. The ulcer depth was measured at the deepest point of the wound. The ulcer size was estimated by measuring the longest and widest aspect of the wound surface in centimetres and then multiplying them. Clinical assessment of infection was conducted after appropriate debridement to remove necrotic sections and callus to fully visualise the wound. The proportion of granulation tissue was assessed by giving a grade according to an estimated proportion of granulation tissue covering the wound area. The type of necrotic tissue was assessed by picking the predominant necrotic tissue in the wound according to colour, consistency, and adherence. Slough was soft necrotic tissue and maceration was peri‐wound skin damage as a result of excessive moisture/exudate. Type of wound edge included no wound edge (complete epithelialization), intact wound edge (no special feature), pink ring, hyperkeratosis or lining, red ring, and no developed wound edge (initial stage). Tunnelling depth was assessed by inserting a sterile cotton swab into the tunnel's deepest location and measuring the swab's length below the tunnel exit plane. Besides, all of the included foot ulcers were also assessed by the other wound care specialist at the same time using the BWAT according to per guidelines. 16
2.5. Data collection instruments
2.5.1. Diabetic foot ulcer assessment scale (DFUAS)
The DFUAS was developed by Professor Sugama et al. 12 from Japan; the scale contains 11 domain items including depth, size, size scores, inflammation/infection, proportion of granulation tissue, type of necrotic tissue, proportion of necrotic tissue, proportion of slough, maceration, type of wound edge, and tunnelling. The scale scores range from 0 to 98, with higher scores indicating more severe wounds. A prospective cohort study was conducted to confirm the newly developed DFUAS being a valid tool for assessing DFUs. 13 Eight wound specialists evaluated the Chinese version in our study to assess its content validity. Each item was rated using a 4‐point Likert scale, indicating how well the experts believed it was related to the DFU assessment. The scale's content validity index (S‐CVI) was calculated as the mean of CVI of all the items with S‐CVI values ≥0.9 considered acceptable. 17
2.5.2. Bates‐Jensen wound assessment tool (BWAT)
BWAT was originally a pressure ulcer assessment tool developed by Bates‐Jensen et al. 11 then gradually recognised as the gold standard tool for chronic wound assessment. BWAT contains 15 items, of which two items of wound site and wound shape are not scored. The remaining 13 scoring items are size, depth, edges, under‐mining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin colour surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization. Each item is scored from 1 to 5 with a total score of 13 to 65. A higher score indicates a worse wound. The scale has comprehensive evaluation content and can effectively assess the condition of chronic wounds. 18 The Chinese version of BWAT has been confirmed to have good reliability and validity. 19
2.6. Statistical analysis
Subject characteristics were presented by mean (standard deviation, SD) or n (%). Standardised Cronbach's alpha coefficients and Intraclass Correlation Coefficient (ICC) were used to assess the internal consistency and inter‐observer reliability of the Chinese version of DFUAS. The structural validity of the DFUAS was evaluated by calculating the Pearson correlation coefficients of the items. Bland–Altman plots were used to analyse the consistency between the DFUAS and the BWAT. Data were analysed using SPSS 26.0 statistical software, and the P < .05 was deemed statistical significance.
2.7. Ethical consideration
This study was approved by the ethics committee of Sun Yat‐sen Memorial Hospital in Guangdong Province (2021‐KY‐042‐001). All participants gave their written informed consent.
3. RESULTS
3.1. Demographics and clinical characteristics of the subjects
Two hundred ten patients with a mean age of 64.1 ± 10.8 years old were included for data analysis. One hundred and 17 (55.7%) of the patients were males, and 93 (44.3%) were females. Education level of primary school or below, junior high school, senior high school, and college degree or above accounted for 19.5%, 23.8%, 32.4%, and 24.3% of the included participants, respectively. 91.9% of the patients were diagnosed with type 2 diabetes, and the rest (8.1%) were type 1 diabetes. Their mean diabetes duration was 12.4 ± 5.5 years. The Wagner grade of their ulcers was also listed in Table 1.
TABLE 1.
Subject characteristics(n = 210).
| Characteristics | n (%)/mean ± SD |
|---|---|
| Age(years) | 64.1 ± 10.8 |
| Sex | |
| Male | 117 (55.7) |
| Female | 93 (44.3) |
| Education level | |
| Primary school or below | 41 (19.5) |
| Junior high school | 50 (23.8) |
| Senior high school | 68 (32.4) |
| College degree or above | 51 (24.3) |
| Diabetes type | |
| Type 1 | 17 (8.1) |
| Type 2 | 193 (91.9) |
| Diabetes duration(years) | 12.4 ± 5.5 |
| Wagner grade | |
| Grade 1 | 66 (31.4) |
| Grade 2 | 105 (50.0) |
| Grade 3 | 32 (15.2) |
| Grade 4 | 7 (3.3) |
3.2. CVIs, Cronbach's alpha coefficients, and ICC results for the reliability of the DFUAS
The Chinese version of the DFUAS showed good content validity, with S‐CVI being 0.96, and the I‐CVIs ranging from 0.89 to 0.98, suggesting the DFUAS was a valid tool for assessing DFUs among the Chinese population. The score distribution and internal consistency reliability of the DFUAS are shown in Table 2. The total Cronbach's Alpha of the DFUAS was 0.709, and the corrected item‐total correlation of 10 of the items ranged from 0.4 to 0.74, indicating moderate internal consistency reliability. The second item (size) showed strong internal consistency reliability, 20 with its corrected item‐total correlation being 0.872. The results presented in Table 3 showed that the DFUAS had high inter‐observer reliability of 0.997, which is statistically significant.
TABLE 2.
The score distribution and internal consistency reliability of the DFUAS (n = 210).
| Item | Mean | Std. deviation | Corrected tem‐Total correlation | Cronbach's Alpha if item deleted |
|---|---|---|---|---|
| Q1 | 2.67 | .882 | .449 | .675 |
| Q2 | 2.29 | 1.066 | .872 | .611 |
| Q3 | 5.17 | 5.533 | .734 | .740 |
| Q4 | 2.34 | .861 | .688 | .651 |
| Q5 | 2.45 | .795 | −.457 | .741 |
| Q6 | 1.37 | .530 | .473 | .689 |
| Q7 | 1.40 | .666 | .638 | .669 |
| Q8 | .73 | .662 | .523 | .679 |
| Q9 | .52 | .555 | .451 | .702 |
| Q10 | 1.22 | .479 | .402 | .695 |
| Q11 | .62 | .857 | .425 | .689 |
| Total Cronbach's Alpha | 0.709 | |||
TABLE 3.
ICC for inter‐observer reliability of the DFUAS(n = 210).
| Intraclass correlation | 95% confidence interval | Value | Sig | |
|---|---|---|---|---|
| Lower bound | Upper bound | |||
| 0.997 | 0.997 | 0.998 | 756.635 | <0.001 |
3.3. The structural validity of the DFUAS and the consistency between the DFUAS and the BWAT
The Pearson correlation coefficients among all of the items were shown in Table 4 with a coefficient <0.3 meaning weak correlation, 0.3 <coefficient <0.6 meaning moderate correlation, and coefficient >0.6 meaning strong correlation. 21 As presented in Table 4, there were strong correlations between item 1 (depth) and item 4 (inflammation /infection), item 1 (depth) and item 11 (tunnelling), item 2 (size) and item 3 (size scores), item 4 (inflammation/infection) and item 6 (type of necrotic tissue), item 4 (inflammation/infection) and item 7 (proportion of necrotic tissue), item 7 (proportion of necrotic tissue) and item 8 (proportion of slough); there were weak correlations between item 11 (tunnelling) and item 2 (size), 3 (size scores), 5 (proportion of granulation tissue) and, item 6 (type of necrotic tissue); while the correlations between any other two items were moderate. The Bland–Altman plots between the DFUAS and the BWAT showed that only 3.8% of the points were outside the 95% limits of agreement (Figure 1).
TABLE 4.
Pearson correlation coefficients among the DFUAS items (n = 210).
| Q1 | Q2 | Q3 | Q4 | Q5 | Q6 | Q7 | Q8 | Q9 | Q10 | Q11 | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Q1 | 1 | ||||||||||
| Q2 | .327** | 1 | |||||||||
| Q3 | .323** | .935** | 1 | ||||||||
| Q4 | .754** | .549** | .562** | 1 | |||||||
| Q5 | −.396** | −.399 | −.333* | −.364** | 1 | ||||||
| Q6 | .426** | .353** | .404** | .649** | −.302** | 1 | |||||
| Q7 | .524** | .481** | .537** | .728** | −.492** | .472** | 1 | ||||
| Q8 | .387** | .404** | .454** | .464** | −.384** | .353** | .642** | 1 | |||
| Q9 | .357** | .332 | .311** | .392** | −.322** | .328** | .309** | .318** | 1 | ||
| Q10 | .362* | .369** | .342** | .395** | −.361* | .321** | .501** | .475** | .326** | 1 | |
| Q11 | .675** | .242** | .275** | .318** | −.055* | −.007* | .338** | .381** | .396* | .339** | 1 |
Correlation is significant at the .05 level (2‐tailed).
Correlation is significant at the .01 level (2‐tailed).
FIGURE 1.
Bland–Altman plots.
4. DISCUSSION
Successful implementation of ulcer care depends upon accurate ulcer assessment, and both of them synergistically promote ulcer healing. A specific assessment tool for patients with DFUs in Chinese has not been available. In this study, we translated the DFUAS into Chinese and tested its validity and reliability.
A prospective cohort study was conducted by Sugama et al. 12 to evaluate the concurrent validity and construct validity of DFUAS. In their study, 70 DFUs were assessed with the DFUAS tool, BWAT, and PUSH. The results showed that the total DFUAS score was significantly correlated with chronic wound status, confirming that the newly developed DFUAS is a valid tool for assessing DFUs. To the best of our knowledge, we are the first to translate the DFUAS into Chinese and verify its validity and reliability. In our results, the Chinese version of the DFUAS showed good content validity, with S‐CVI being 0.96 and the I‐CVIs ranging from 0.89 to 0.98. The total Cronbach's Alpha of the DFUAS was 0.709, and the corrected item‐total correlation of 10 of the items ranged from 0.4 to 0.74. The Bland–Altman plots between the DFUAS and the BWAT showed that 96.2% of the points were inside 95% limits of agreement. These results suggested that the DFUAS was a valid tool for evaluating DFUs among the Chinese population. The Pearson correlation coefficient results indicated different levels of correlation between the included items, perhaps as a result of intrinsic properties discrepancy between the included assessment items. For instance, correlations between item ‘depth’ and item ‘inflammation /infection’, item ‘tunnelling’ were strong, and it is not difficult to infer that deeper wounds have more severe infection symptoms and are more likely to have deep tunnelling.
It has been well established that wound size is an important aspect of evaluating DFU intervention and a predictor of DFU healing. 22 A weekly reduction of 10%–15% in wound area or a ≥ 50% reduction in wound area within 4 weeks can increase the chance of wound healing and reduce infection and complications after amputation. Ulcers that do not decrease significantly in size within 4 weeks tend to have a poor prognosis and are difficult to heal. 23 Therefore, size assessment has been composed as one of the main assessment indicators in the DFUAS and other general chronic wound assessment tools. Tissue type is one of the assessment items included in the PUSH 10 and is classified into neucrotic, slough, granulation, and epithelial tissue. In the DFUAS, various kinds of tissue types have also been evaluated. Moreover, the proportion of different tissue types in the wound was quantitatively assessed, particularly applicable to diabetic foot wounds where multiple tissue types exist simultaneously in the same wound. Exudate evaluation is an important part of wound bed preparation and guides to assess the progress of wound healing and dress selection. 24 Exudate amount assessment is included in the PUSH 10 and the BWAT, while in the DFUAS, the item is substituted by maceration. Maceration is defined as peri‐wound skin damage as a result of excessive moisture, commonly occurring in DFUs. 25 The amount of exudate and its detrimental effects and consequences on wound healing were contained in the connotation of maceration, rendering it more accurate and appropriate than solely exudate amount assessment. The PUSH has not included the depth and undermining assessment, yet reflected in the BWAT and the DFUAS. Depth and undermining are important characteristics of DFU. They have been referred to in the development of the Wagner classification and TEXAS classification 26 to indicate the severity of the wound, demonstrating the specificity and necessity of incorporating these two items into the assessment of foot ulcers. Inflammation/infection is one of the specificity evaluation indicators included only in the DFUAS. Heavy exudate and increasing slough and necrotic tissue adhering to the wound bed often indicate an infected ulcer; thus, inflammation/ infection should also be included in the evaluation indicators, the same as tissue type and exudate amount. Furthermore, most foot ulcers are accompanied by diabetic foot infection(DFI). DFI is a key factor in the development of osteofasciitis or osteomyelitis and is also an important cause of amputation and even death. 27 , 28 Therefore, we suppose it reasonable and necessary to include infection as an indicator in the evaluation of foot ulcers.
Our study bears some limitations. The first limitation of this study was that, as a cross‐sectional survey, the influence of changes in the condition of ulcers on the DFUAS score was not analysed. Second, cross‐cultural adjustment was not performed in our study. However, the names of objective wound assessment items in various regions are not affected by national or cultural differences, so we believe this deficiency can be ignored. Another limitation of this study was that the predictive validity test was not conducted, and the cutoff score of the best balance of sensitivity, specificity, positive predictive value, and negative predictive value was not produced.
5. CONCLUSION
The Chinese version of the DFUAS showed good validity and reliability and is a reliable instrument for the assessment of DFUs in Chinese.
AUTHOR CONTRIBUTIONS
Yixin Luo: Data curation and formal analyse, Writing‐Original draft. LiFang Mai: Data curation. XingZhou Liu: Data curation. Chuan Yang: Conceptualization, Supervision, Writing – review & editing.
CONFLICT OF INTEREST STATEMENT
The authors declared no conflicts of interest.
ETHICS STATEMENT
This study was approved by the ethics committee of Sun Yat‐sen Memorial Hospital in Guangdong Province(2021‐KY‐042‐001). All participants gave their written informed consent.
ACKNOWLEDGEMENTS
We would like to acknowledge Guangdong Basic and Applied Basic Research Foundation (2020B1515120076) for funding our work.
Luo Y, Mai L, Liu X, Yang C. Validity and reliability of Chinese version of the new diabetic foot ulcer assessment scale. Int Wound J. 2023;20(9):3724‐3730. doi: 10.1111/iwj.14266
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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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.