Adaptation and validation of the Diabetic Foot Ulcer Scale- Short Form scale in Chinese diabetic foot ulcer individuals

doi:10.21203/rs.3.rs-2064328/v1

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Adaptation and validation of the Diabetic Foot Ulcer Scale- Short Form scale in Chinese diabetic foot ulcer individuals

https://doi.org/10.21203/rs.3.rs-2064328/v1

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Background: The quality of life (QoL) of diabetic foot ulcer patients is worse than that of diabetic patients. The Diabetic Foot Ulcer Scale-Short Form (DFS-SF) is an available instrument to evaluate the quality of life of diabetic foot individuals. The aim of this study was to translate the DFS-SF into Chinese and evaluate its validity and reliability.

Methods: This study was conducted in two phases. We followed the Brislin Translation and Back-translation model to translate the DFS-SF into Mandarin Chinese in the first phase. In the second phase, we examined the reliability and validity of the Chinese version of the DFS-SF.

Results: A total of 208 participants were recruited for our study. The I-CVI of the Chinese version of the Diabetic Foot Ulcer Scale varied from 0.800-1.000, and the S-CVI/Ave was 0.911. The Cronbach’s α coefficient of the scale was 0.952. The confirmatory factor analysis showed the evitable structural validity of the scale, with CFI=0.911 and RMSEA=0.072 (P <0.001). The results of the criterion-related validity showed that the subscales were significantly related to the subscales of the SF-36, with coefficients ranging from 0.116 to 0.571 (P<0.05).

Discussion: The procedure of the translation and the examination of the scale rigidly followed the suggested model. The reliability of our study was similar to that of other studies. Furthermore, the validity results showed that the scale structure was reliable. It could be a reliable instrument to evaluate the quality of life in the diabetic foot population.

Conclusion: The adaptation and validation of the Chinese version of the Diabetic Foot Ulcers Scale-Short Form are good and it will be a reliable instrument to evaluate the QoL of Chinese diabetic foot ulcer patients.

DFS-SF

adaptation

validity

reliability

Chinese

quality of life.

Diabetic foot ulcer (DFU) brings risks of morbidity and mortality[1, 2] and is a common and severe complication of diabetes mellitus. It also imposes a physical, mental, and economic burden on the population. Diabetic foot ulcer individuals suffer greatly in their daily life. Therefore, a better assessment of their quality of life is needed to provide further support to them.

The quality of life of diabetic foot ulcer patients is affected by the multidisciplinary situation and treatment. Many studies have reported that the quality of life in diabetic foot ulcers is worse than that in diabetic people and the general population in terms of physical and psychological factors [3, 4]. The measurements of quality of life vary. Nevertheless, there is a limited instrument to focus only on the quality of life of people with diabetic foot ulcers.

The Diabetic Foot Ulcer Scale-Short Form (DFS-SF) was developed from the Diabetic Foot Ulcer Scale (DFS). The DFS[5] contains 64 items to evaluate the quality of life affected by diabetic foot ulcers. Dr. Bann promoted the final DFS-SF more briefly and conveniently [6]. It consists of 29 items with six subscales defined as leisure, physical health, dependence/daily life, negative emotions, worried about ulcer/feet, and bothered by ulcer care. Each item scored followed a 5-point Likert scale from 1 to 5 points, ranging from “not at all” to “very common”. A higher score indicates a higher quality of life among diabetic foot individuals. The scale has been translated and tested for reliability and validity in Spain[7], Greece [8], Turkey [9], Korea [10], and the Netherlands [11]. However, in China, there is no specific validated instrument to assess the QoL of patients with DFU. Therefore, the study aims to translate the Diabetic Foot Ulcer Scale-Short Form into Mandarin Chinese and test its validity among Chinese diabetic foot individuals.

Design

The procedure of the study was two steps. The first aim was to produce the Chinese version of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) based on an established translation and cross-cultural consideration. The second purpose was to examine the reliability and validity of the Chinese Revision DFS-SF scale and apply it to Chinese diabetic foot ulcer individuals with well-designed measurements.

Quality of life measurements

Diabetic Foot Ulcer Scale-Short Form

After connecting with Mapi Research Trust, we obtained the Diabetic Foot Ulcer Scale-Short Form in English. Then we translated it into Mandarin Chinese using Brislin’s model [12] of forwarding and backward-translation by five translators. A nursing graduate who did well in English, and one is an English language professor with no medical background. The primary Chinese version of the scale is as follows. Then, after an expert in diabetic foot ulcers evaluated the content equivalence, we produced the second Chinese version of the DFS-SF scale. To ensure the semantic equivalence of the Mandarin Chinese translation, a doctor unfamiliar with the original questionnaire with a bilingual background and a translation expert in English-Chinese independently translated the second Chinese version back to an English version. After contacting these two translators, the product finally became the back-translated English version.

After the back translation, these five experts examined the meaning of the items among the original Diabetic Foot Ulcer Scale-Short Form, the back-translation Diabetic Foot Ulcer Scale-Short Form, and the second Chinese translation of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF-C). Then, the revised version was used to pretest 30 diabetic foot ulcer individuals to confirm that the items were easy to understand and met the Chinese language habits. The participants expressed that the items on the scale were easy to understand. After some minor adjustments and modifications, the final product was Chinese version of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF-C) adopted in the current study, which is attached to the Supplementary material.

36-Item Short-Form Health Survey (SF-36).

The SF-36 contains 36 items [13] and is a standard scale to measure the quality of life among the general population in any situation. It consists of 9 subscales: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Validity (VT), Social Functioning (SF), Role-Emotional (RE), Mental Health (MH), and Reported Health Transition (HT).

Psychometric testing

Participants

According to the structural equation modeling sample calculation method, the sample size is at least 200. The sample size of our study is efficient.

We performed a multicenter cross-sectional study. With convenient sampling, we selected patients recruited from West China Hospital of Sichuan University, Sichuan Provincial People’s Hospital, The Fourth People’s Hospital of Sichuan Province, Chengdu First People’s Hospital, and Chengdu Second People’s Hospital from April 2021 to February 2022. All participants met the following inclusion criteria: (1) diagnosed with diabetic foot; (2) age ≥ 18; (3) conscious and could be appropriately communicated; and (4) informed consent and volunteered to participate in the research. The exclusion criteria were as follows: (1) hearing impairment; (2) cognitive impairment; (3) inability to cooperate with the completion of this study; and (4) serious complications postoperatively.

Validity

Ten experts then reviewed the content validity of the translated DFS-SF. They evaluated the relevance of each item to the corresponding subscale. The content validity was established on a 4-point rating scale (1 = not relevant, 2 = somehow relevant, 3 = relevant, and 4 = much relevant). The item-level content validity index (I-CVI) is the proportion of total items evaluated by the experts as either 3 or 4, with a value of > 0.8 indicating good content validity. The average scale-level content validity index (S-CVI) described the content validity as well. Confirmatory factor analysis (CFA) was selected to evaluate the construct validity. The \({x}^{2}\)/df < 3.000, comparative fit index (CFI) > 0.900, root mean square error of approximation (RMSEA) < 0.080 will detect good model fit[14, 15]. The criterion-related validity test was conducted with the SF-36.

Reliability

The internal consistency Cronbach’s alpha coefficient[16], split-half reliability, and test-retest reliability were used to describe the internal consistency of the total scale and six subscales. The test-retest reliability was conducted among the 30 pretest participants. After the first test, we tested the scale among them again. The values 0.70 to 0.80 are considered acceptable, and over 0.90 are expected[17, 18].

Correlation

The product-moment correlation method was conducted to measure the correlation among each subscale that belonged to the DFS-SF scale. Pearson correlation analysis was conducted to evaluate the criterion validity. The correlation was valued as follows: weak correlation (0.10–0.29), moderate correlation (0.30–0.49), and strong correlation (0.50–1.00) [19].

Data analysis

The quantitative data were analyzed using SPSS V.23 and Amos 23.0 (IBM Corp, Armonk, New York, USA). Continuous variables are depicted as the means and standard deviations, and categorical variables are reported as frequencies and percentages. P < 0.05 was considered statistically significant.

Ethical considerations

This study received ethical approval from the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University. All the participants in this study volunteered, and their private information was anonymized. They all signed the informed consent form after being informed of the significance of the study.

Characteristics of the participants

There were a total of 208 participants included in the study. The average score was 98.88 ± 25.904. The participants’ mean age was 64.37(ranging from 23 to 93), 30.3% (63) were female, and 69.7% (145) were male. The details of the participants’ characteristics are given in Table 1.

Table 1

Characteristics of participants (N = 208)
Demographics	n	(%)
Age
Mean (SD)	64.37	13.125
Gender
Male	145	69.7
Female	63	30.3
Education level
Primary school or below	87	41.8
Middle school	62	29.8
High school	31	14.9
College above	28	13.5
Marriage
Married	172	82.7
Divorced	4	1.9
Widows	24	11.5
Unmarried	8	3.8
Duration of diabetes
༜5 years	31	14.9
5–10 years	55	26.4
༞10 years	122	58.7
Whether amputation
Yes	40	19.2
No	168	80.8
Duration of diabetic foot
≤ 1 month	59	28.4
1-≤3months	62	29.8
༞3 months	87	41.8
The number of ulcers
1	96	46.2
> 1	112	53.8
Whether the first ulcer occurrence
Yes	150	72.1
No	58	27.9
Ulcer type
Neuropathic	77	37
Ischemic	52	25
Neuro-ischemic	79	38
Other diabetes complications
Diabetic nephropathy	37	17.8
Diabetic retinopathy	85	40.9
Diabetic peripheral neuropathy	152	73.1
Diabetic peripheral vascular disease	81	38.9
Diabetic autonomic neuropathy	93	44.7

Validity

Content validity

Ten experts assessed the content validity. The I-CVI was tested from 0.800 to 1.000. However, there were three items tested below 0.800. After communicating further with experts, we decided to delete the item “Drained” (I-CVI scored 0.500). As most experts suggested, this item has repeated the item “Fatigued or Tired”. Therefore, the final Chinese version of the Diabetic Foot Ulcer Scale-short Form consists of 28 items compared with the original scale. The following construct validity and reliability are based on the revised Chinese scale. The final S-CVI/Ave was 0.911.

Structure validity

We performed confirmatory factor analysis (CFA) to confirm the structural validity. The model is shown in Fig. 1.

The data of the model fit well. The \({x}^{2}\)/df was 2.027 (P < 0.001), RMSEA = 0.072 (stands for the root mean square error of approximation, and a value < 0.080 indicates good model fit), CFI = 0.911 (stands for comparative fit index, and a value > 0.900 is indicative of good fit).

Criterion-related validity

We conducted Pearson’s correlation with the SF-36 scale to test the criterion-related validity. The total scores of DFS-SF were highly correlated with the total scores of SF-36, with a coefficient of 0.586 (P < 0.001). The correlation coefficients of the subscales of the DFS-SF and SF-36 are shown in Table 2.

Table 2

Criterion-related validity of the Diabetic Foot Ulcer Scale- Short Form by Pearson’s correlation with the SF-36
	HT	PF	RP	RE	SF	BP	VT	MH	GH
Leisure	0.079	0.030	0.136	0.173^**	0.278^**	0.234^**	0.242^**	0.288^**	0.275^**
Physical health	0.111	0.102	0.263^**	0.241^**	0.347^**	0.412^**	0.571^**	0.545^**	0.352^**
Dependence/daily life	0.133	0.227^**	0.181^**	0.222^**	0.307^**	0.278^**	0.376^**	0.387^**	0.416^**
Negative emotions	0.092	0.024	0.153^**	0.273^**	0.425^**	0.249^**	0.424^**	0.478^**	0.445^**
Worried about ulcers/feet	0.116^*	0.023	0.234^**	0.235^**	0.392^**	0.286^**	0.336^**	0.466^**	0.365^**
Bothered by ulcer care	0.118	0.125	0.194^**	0.246^**	0.389^**	0.228^**	0.372^**	0.452^**	0.345^**
P < 0.005, *P < 0.001
Abbreviations: PF, Physical Functioning; RP, Role-Physical; BP, Bodily Pain; GH, General Health; VT, Vitality; SF, Social Functioning; RE, Role-Emotional; MH, Mental Health; HT, Reported Health Transition.

Reliability

Table 3 shows the reliability of the DFS-SF. The reliability test contained Cronbach’s α coefficient, split-half reliability and test-retest reliability. A reliability > 0.70 would be acceptable. The full-scale Cronbach’s α coefficient was 0.952, and the subscales’ Cronbach’s α coefficient ranged from 0.772 to 0.923.

Table 3

Reliability of the DFS-SF
	N	Cronbach’s α coefficient	Spilt-half reliability	Test-retest reliability
Total	28	0.952	0.866	0.937
Leisure	5	0.923	0.896	0.888
Physical health	4	0.772	0.854	0.740
Dependence/daily life	5	0.870	0.768	0.710
Negative emotions	6	0.921	0.896	0.802
Worried about ulcers/feet	4	0.846	0.818	0.819
Bothered by ulcer care	4	0.815	0.803	0.811

Correlation

The correlation of each subscale is shown in Table 4. The correlation of the six subscales was significantly increased from 0.346 to 0.758 (P < 0.001).

Table 4

Correlation of each subscale of DFS-SF
	Leisure	Physical health	Dependence/daily life	Negative emotions	Worried about ulcers/feet	Bothered by ulcer care
Leisure	1.000
Physical health	0.346^**	1.000
Dependence/daily life	0.642^**	0.447^**	1.000
Negative emotions	0.703^**	0.437^**	0.597^**	1.000
Worried about ulcers/feet	0.490^**	0.446^**	0.403^**	0.627^**	1.000
Bothered by ulcer care	0.706^**	0.469^**	0.589^**	0.758^**	0.616^**	1.000
**P < 0.001

The findings of our study indicate that the Chinese revision of the Diabetic Foot Ulcer Scale-Short Form is a suitable measurement to assess the quality of life for diabetic foot individuals. The translation process strictly followed the international scale introduction procedure[20, 21], namely the methods of “translation-back translation-cultural debugging- pretest”, which forms the Chinese version of DFS-SF (DFS-SF-C). After conducting the content validity test, we deleted an item from the scale. We formed the final Chinese revision scale (DFS-SF-CV).

There were three items with an I-CVI below 0.800. The I-ICV of the items “meat that you had to spend more time planning and organizing for leisure activities” and “drained” were scored 0.500. The I-ICV of item “frustrated by others doing things for you when you would rather do things yourself” scored 0.700. However, after consulting with the diabetic foot professors, we decided only to exclude only one item, “drained”, which repeated the meaning of the item “fatigue and tired”, no matter whether we tried any word to describe the translation of this item into Chinese. Nevertheless, we kept the other two items as we considered them significant to their belonging subscales. We also compared the final results with or without excluded items. There was not a massive distance between the two results.

As the DFS-SF has been a mature scale, we did not conduct the explored factor analysis (EFA) to test the validity of the scale. We chose only confirmatory factor analysis (CFA) to confirm the structure of the scale. The analysis result was also confirmed compared with other research[6]. Thus, the structural validity of the DFS-SF scale was reliable.

The criterion validity should choose a gold standard scale to evaluate the quality of life. In the study of Dutch and Spain [11, 22, 7], they chose the EQ-5D scale to be related. A Jordanian study related the SF-8 scale[23]. We decided to follow the other studies[6, 24, 8, 10, 7] to choose the SF-36 as the gold standard.

Furthermore, in our study, the correlation between the DFS-SF scale and the SF-36 scale was weak or moderate, with coefficients ranging from 0.154 to 0.571 (P < 0.001). Such results were not excellent [25, 26], but the results were similar to Bann’s study, ranging from 0.24 to 0.62[6]. The DFS-SF was moderately related to the SF-36. The reason may be that the SF-36 is more prevalent in the general population and it lacks NICE approval for use in utility studies[27]. Therefore, the DFS-SF is more acceptable for diabetic foot people with 29 items and more sensitivity.

The Chinese version of the DFS-SF was reliable, and we can conclude that the internal consistency was acceptable. Cronbach’s α of our study ranged from 0.772 to 0.952, which is similar to other studies. The Cronbach’s α was reported to range from 0.740 to 0.990[6, 10, 7, 28].

After translating and testing the scale, we kept the scale’s original structure and deleted one item. The validity of the Diabetic Foot Ulcer Scale-Short Form structure was acceptable. Moreover, it is related to the SF-36. It could be considered a reliable instrument to measure the quality of life in the Chinese diabetic foot population.

There were also some limitations of our study, such as the convenience sampling, and the participants may not have presented the target population well. There was limitation in the number of samples. In further study, we will still collect the data among diabetic foot patients.

The Diabetic Foot Ulcer Scale-Short Form is a reliable instrument to assess the quality of life in diabetic foot ulcer people. The revised Chinese version of this scale would be more acceptable for the Chinese population. It could be used more widely in the future to develop interventions to improve the quality of life of Chinese people with diabetic foot people and better support them.

Acknowledgment

We are grateful to Mapi Research Trust for permitting us to use this instrument in our stud, and all the participants and immense personnel commitment of the doctors in our study.

Author contributions

Lin Ma and Wanxia Ma conceived the idea; Lin Ma designed the project, Lin Ma, Wanxia Ma, Yan Li, Shuang Lin collected data, Lin Ma performed statistical analyses, Lin Ma, Xingwu Ran wrote and revised the manuscript; Xingwu Ran provided scientifc support and professional guidance. All authors read and approved the manuscript.

Funding

This study is partial supported by West China Nursing Discipline Development Special Fund Project, Sichuan University [Grant No. HXHL20005], 1.3.5 Project for disciplines of excellence, West China Hospital, Sichuan University [Grant No. ZYGD18025], Science and Technology Bureau of Sichuan Province [Grant No. 2021JDKP004], Health Medical Big Data Application and Innovation Project in Sichuan [Grant No.2018gfgw001].

Availability of data and materials

The datasets used and/or analyzed during the current study are available from

the corresponding author on reasonable request.

Ethics Approval and Consent to participants

Ethics approval was obtained from the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University with No.2021(641).

Conflict for publication

Not available.

Competing interests

The authors have no conflicts of interest to declare.

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No competing interests reported.

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Adaptation and validation of the Diabetic Foot Ulcer Scale- Short Form scale in Chinese diabetic foot ulcer individuals

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Abstract

Figures

Introduction

Methods

Design

Quality of life measurements

Diabetic Foot Ulcer Scale-Short Form

Psychometric testing

Participants

Validity

Reliability

Correlation

Data analysis

Ethical considerations

Results

Characteristics of the participants

Validity

Content validity

Structure validity

Criterion-related validity

Reliability

Correlation

Discussion

Conclusion

Declarations

References

Additional Declarations

Supplementary Files

Status:

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