Cross-cultural adaptation and psychometric validation of a Chinese self-intermittent catheterization quality of life scale among patients with neurogenic bladder

Introduction

Neurogenic bladder (NB) or neurogenic lower urinary tract dysfunction (NLUTD) refers to vesicourethral dysfunction resulting from damage to the central or peripheral nervous systems that control urination. This condition is characterized by symptoms such as urinary incontinence, urinary retention, frequent urination, and painful urination (Kennelly et al., 2022). Severe cases can lead to life-threatening complications such as renal failure, significantly impacting the patient’s quality of life (Panicker, 2020).

The diagnosis and treatment of NB have become more sophisticated, with intermittent self-catheterization (ISC) being the preferred clinical treatment option (Nambiar et al., 2022). The procedure involves the insertion of a catheter into the bladder when the patient needs catheterization and removing it after emptying (Wang et al., 2021). The principle behind ISC is to reduce the bladder’s residual urine volume, restore blood flow to the bladder wall, induce intermittent bladder expansion, and prevent continuous filling or expansion of the bladder. As per the guidelines, ISC not only effectively reduces the risk of urinary infections but also aids in the reconstruction of the reflective bladder, optimizes renal function, and significantly improves patients’ overall quality of life (Kinnear et al., 2020).

The study highlights that the compliance of ISC patients is low, and while 60% of discharged patients can independently perform ISC, within 5 years, only 30% of patients can sustain it. The psychological issues NB patients face during ISC include anxiety, low self-confidence, and low acceptance (Newman et al., 2020; Xiang et al., 2022), while objective issues include discomfort during catheter insertion and inadequate public toilet facilities. These factors severely impact patient compliance, leading to recurrent urinary infections and significantly reducing their overall quality of life (Gacci et al., 2022).

It is essential to understand the objective problems and psychological state of NB patients during ISC, which can ensure the effective implementation of ISC and improve patients’ quality of life (Roberson et al., 2021). Currently, the assessment tools for NB patients in China mainly focus on the psychological field or individual behaviour, such as the Intermittent Catheterization Acceptance Test (I-CAT), which evaluates the psychological acceptance of patients, and the Intermittent Catheterization Adherence Scale (ICAS), which assesses patient compliance. However, few studies have addressed specific assessment scales encompassing psychological state, objective problems, cognitive attitude, and other dimensions (Elmelund, Klarskov & Biering-Sørensen, 2019).

Pinder et al. (2012) developed the Intermittent Self-Catheterization Questionnaire (ISC-Q) in 2012, which consists of four dimensions of ease of use, convenience, discreetness, and psychological well-being with 24 items. It is mainly used to assess the quality of life of ISC patients (Tate et al., 2020), and has been translated into several versions, including Japan and Korean (Zachariou et al., 2022; Scivoletto et al., 2017; Yeşil et al., 2020), all of which show good reliability and validity. However, there is no Chinese version (C-ISC-Q). The aim of this study was to translate, back-translate, and culturally adapt the ISC-Q in order to create a reliable and valid C-ISC-Q, which would provide a scientifically valid assessment tool for Chinese healthcare professionals.

Methods

Study procedures

The authors have permission to use this instrument from the copyright holders. This study followed the cross-cultural guidelines for scales proposed by Bitton (Beaton et al., 2000, 2007), which involves six steps: initial translation, synthesis of translation, back translation, synthesis of back translation, review by a committee of experts, and pretesting (see Fig. 1 Cross-cultural steps of C-ISC-Q). The study was reported following the STARD standards introduced by Pereira et al. (2019).

Translation of English scale into Chinese

Two Chinese researchers, one a physician from the rehabilitation department who has studied abroad in the United States, and the other a master of applied linguistics who has studied in the United Kingdom for 1 year, independently translated the scale into Chinese. They formed two separate translations: Translation Language 1 (TL1) and Translation Language 2 (TL2). The research team then integrated and revised TL1 and TL2 with the help of bilingual team members who grew up speaking Chinese and English. Finally, a comprehensive Chinese version of the scale was formed, referred to as Version I (Sousa & Rojjanasrirat, 2011).

Back translation of Chinese scale into English

Two English native researchers were invited to independently back-translate the Chinese scale. One is a rehabilitation doctor who has studied in China for 2 years, creating Back Translation Version 1 (B-TL1), and the other is an American English-speaking doctor, creating Back Translation Version 2 (B-TL2). The research team then compared B-TL1 and B-TL2 with the original English scale and integrated the results to form a comprehensive English version of the scale, referred to as Version II.

Cultural adaptation

Five experts were selected to conduct cultural adaptation of the scale based on the following inclusion criteria: holding a bachelor’s degree or above, having a deputy senior professional title or above, and having at least 10 years of work experience. The team comprised two clinical nursing experts, two chief physicians from the rehabilitation department, and one nursing college professor. Three experts held doctoral degrees, one had a master’s degree, and one held an undergraduate degree. Among them, three held senior professional titles, and two held deputy senior professional titles. Their working years ranged from 11 to 42 years, averaging 29.2 ± 13.22 years. The experts were asked to provide modification suggestions in four areas: cultural background conformity, language expression clarity, professional conformity, and content relevance of the scale. The Likert four scale was used to evaluate the suggestions, with a score of one indicating “very irrelevant,” a score of two indicating “irrelevant,” a score of three indicating “relevant,” and a score of four indicating “very relevant.” Details of the evaluation results can be found in Table 1.

Table 1:

General information of experts (n = 5).

No.	Gender	Title	Major	Highest education	Familiarity	Age/Working year	Judgment basis
							Theoretical knowledge	Practical experience	Reference	Subjective judgment
1	Female	Chief nurse	Nursing	Doctor	Very familiar	60/42	Large	Large	Large	Small
2	Female	Deputy chief nurse	Nursing	Doctor	Very familiar	48/20	Large	Large	Large	Medium
3	Female	Professor	Nursing	Undergraduate	Very familiar	60/39	Large	Large	Medium	Small
4	Female	Deputy chief physician	Clinical	Doctor	Very familiar	42/11	Large	Medium	Large	Large
5	Female	Chief physician	Clinical	Master	Familiar	60/34	Medium	Large	Medium	Small

DOI: 10.7717/peerj.18319/table-1

Pretest

To assess the comprehensibility and feasibility of the scale items and options, the research group used a convenient sampling method to select 30 subjects who met the inclusion criteria for the pretest. The pretest answer format was open-ended to encourage subjects to provide suggestions for modification.

Results

Participant characteristics

A total of 155 questionnaires were distributed in this study, out of which 149 were valid, and six were invalid (three were repeated, and the response time of four questionnaires was <3 min). The questionnaire response rate was 96.13%. Refer to Fig. 2 for the flowchart depicting the inclusion of subjects. Of the 149 respondents, 98 were males, and 51 were females, with an average age of 35.45 ± 10.74 years. Refer to Table 3 for further details regarding the subjects’ general information.

Table 3:

The general information of subjects (n = 149).

Content		Number	Percentage (%)
Gender	Male	98	65.77
	Female	51	34.23
Age	≤30 years old	54	36.24
	31~50 years old	74	49.67
	≥50 years old	21	14.09
Residence	Rural areas	69	46.31
	City	80	53.69
Marital status	Unmarried	36	24.16
	Married	104	69.80
	Divorce	5	3.36
	Bereavement	4	2.68
Education	Junior high school and below	28	18.79
	High school	43	28.86
	Junior college or above	78	52.35
Care mode	Live alone	40	26.85
	Spouse care	79	53.02
	Child care	10	6.71
	Parental care	14	9.40
	Sibling care	6	4.03
Length of illness	<1 year	36	24.16
	1~5 year	49	32.89
	≥5 year	64	42.95
Cause of illness	Spinal cord injury	63	42.28
	Cerebrovascular accident	31	20.81
	Basal ganglia lesions	6	4.03
	Intervertebral disc disease	13	8.72
	Spinal stenosis	9	6.04
	Spina bifida	10	6.72
	Brain tumor	9	6.04
	Multiple sclerosis	4	2.68
	Other	4	2.68
Have you ever experienced any complications	Yes	78	52.35
	No	71	47.65

DOI: 10.7717/peerj.18319/table-3

Discussion

The results of this study suggest that the C-ISC-Q scale can be used to assess the quality of life of patients with intermittent catheterization of neurogenic bladder. The scale has high internal consistency and retest reliability, good content validity and calibration correlation validity. The scale has a moderate number of entries and an easy-to-understand presentation, and is rated on a 5-point Likert scale (0–4), with higher scores indicating higher quality of life. It was concluded that the localized C-ISC-Q scale can be promoted as a proprietary tool for assessing the quality of life of patients with intermittent catheterization.

During the cross-cultural adaptation process, this study followed the BEATON theory, which consists of six steps. In step five, only five experts were included, which may be considered a small number of experts. However, the BEATON theory does not specify the exact number of experts to be included. According to the literature, the number of experts in similar studies ranges from 5 to 12. Therefore, this study included five experts in the consultation process and made eight modifications to develop C-ISC-Q.

The discrimination of each item is mostly reflected by CR (Rechenchosky et al., 2022). In this study, the CR of each item indicates that there are statistical differences between the high and low groups, that is, each item has good discrimination, so no item is deleted. Therefore, each item can effectively identify the difference in quality of life with different scores. In addition, this study analyzes the common variability of each item and the scale. The results showed that the content measured by the items and the content reflected by the scale had a high correlation; that is, the common variation was large, indicating that the homogeneity between the items was good. Few studies have reported CR in ISC-Q intercultural adaptation, so this study could not find relevant studies reported for comparison.

Internal consistency and stability are important indicators of scale reliability. This study uses Cronbach’s α to reflect internal consistency and retest reliability to reflect stability. The Cronbach’s α value is 0.930 for the scale and 0.870–0.92 for each dimension, indicating that the scale has excellent internal consistency (Pinder et al., 2012), consistent with the source scale. Moreover, the retest reliability of each dimension and the scale is higher than 0.80, consistent with the retest reliability of the source scale, indicating that C-ISC-Q has good stability. In conclusion, the C-ISC-Q scale has good internal consistency and stability, suggesting that it has good reliability.

Validity reflects the degree to which a measuring tool accurately reflects the expected concept (Menegol et al., 2022). In this study, content validity was evaluated by five experts. The item-level content validity index (I-CVI) ranged from 0.8 to 1.0. The scale-level content validity index (S-CVI) was 0.975, indicating that the measured content had a high correlation with the target measurement content. The original version of ISC-Q did not report content validity, so there is no basis for comparison. Moreover, this study used SF-qualiveen as the criterion (Rong et al., 2022). The criterion-related validity was acceptable, but the correlation of each dimension was low. In 2012, Pinder’s study reported that the correlation coefficient between ISC-Q and Qualiveen was 0.64, and the correlation coefficient of each dimension was 0.27~0.77, similar to the results of this study (Kako et al., 2022). This may be because SF-qualiveen focuses on the psychological field of quality of life, while ISC-Q focuses more on the problem of dysfunction. Although both scales evaluate the quality of life, they focus on different aspects, resulting in lower dimension correlation. Finally, the construct validity results showed that the number of common factors was consistent with the source scale. The cumulative contribution rate of the four factors was 67.85%, higher than the 48.90% of the source scale. The possible reason for the difference is that the sample size in this study was smaller (149 patients) than that in the source study (306 patients) (Pinder et al., 2012). Therefore, further verification is needed.

The study has several limitations. The sample size used in this study is relatively limited as only neurogenic bladder patients in Shenzhen were selected, and the investigation was not conducted in other regions using larger sample sizes. This may result in some sampling bias, and further exploration is needed to assess the applicability of the scale in the different areas. Moreover, confirmatory factor analysis was not conducted due to the inclusion of only 149 subjects in the study, which is insufficient for the requirement of confirmatory factor analysis of having a sample size of more than 100 cases (Fatoye et al., 2022). As a result, the study has certain limitations.

Conclusion

In conclusion, the ISC-Q has been widely used since its early development. In this study, the C-ISC-Q scale was translated into Chinese and was found to have reasonable content, clear expression, and consistency with the cultural background. It takes only 5–10 min to complete and has good reliability and validity, making it a useful tool for medical staff to understand the dysfunction and psychological problems of patients with neurogenic bladder during ISC. The C-ISC-Q can effectively evaluate the quality of life of ISC patients and play a significant role in monitoring, evaluating, and comparing patients’ quality of life with different causes.

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