Validation of the Vietnamese version of the low anterior resection syndrome score questionnaire

Article information

Ann Coloproctol. 2022;.ac.2022.00514.0073
Publication date (electronic) : 2022 November 25
doi : https://doi.org/10.3393/ac.2022.00514.0073
1Department of General Surgery, Nhan dan Gia Dinh Hospital, Ho Chi Minh City, Vietnam
2Department of Medicine, Nguyen Tat Thanh University, Ho Chi Minh City, Vietnam
Correspondence to: Tuong-Anh Mai-Phan, M.D., Ph.D. Department of General Surgery, Nhan dan Gia Dinh Hospital, 1 No Trang Long, Ho Chi Minh City, Vietnam Tel: +84-28-38412692, Fax: +84-28-38412700 E-mail: anhmpt@bvndgiadinh.org.vn
Received 2022 July 24; Revised 2022 August 22; Accepted 2022 August 26.

Abstract

Purpose

The aim of this study was to validate the low anterior resection syndrome (LARS) score questionnaire in the Vietnamese language among Vietnamese patients who underwent sphincter-preserving surgery for rectal cancer.

Methods

The LARS score questionnaire was translated from English into Vietnamese and then back-translated as recommended internationally. From January 2018 to December 2020, 93 patients who underwent sphincter-preserving surgery completed the Vietnamese version of the LARS score questionnaire together with an anchored question assessing the influence of bowel function on quality of life (QoL). To validate test-retest reliability, patients were requested to answer the LARS score questionnaire twice.

Results

Ninety-three patients completed the LARS score questionnaire, of whom 89 responded twice. The patients who responded twice were included in the analysis of test-retest reliability. Fifty-eight patients had a “major” LARS score. The LARS score was able to discriminate between patients who were obese and those who were not (P<0.001) and between the low anterior resection and anterior resection procedures (P<0.001). Age and sex were not associated with higher LARS scores (P=0.975). There was a perfect fit between the QoL category question and the LARS score in 56.2% of cases, and a moderate fit was found in 42.7% of cases, showing reasonable convergent validity. The test-retest reliability of 89 patients showed a high intraclass correlation coefficient.

Conclusion

The Vietnamese version of the LARS score questionnaire is a valid tool for measuring LARS.

INTRODUCTION

The outcomes of rectal cancer worldwide have dramatically improved for decades [1]. Implementing an early diagnosis policy, applying chemoradiation, and performing sphincter-preserving surgery more frequently have yielded excellent outcomes for rectal cancer patients. Together with a high survival rate, survivors following radical surgery for rectal cancer suffer from low anterior resection syndrome (LARS) and symptoms including frequent bowel movements, gas and fecal incontinence, fragmentation, and urgency [2, 3]. Of various oncologic outcomes, quality of life (QoL) is an important measure for rectal cancer treatment [4, 5]. Among several tools and questionnaires published to evaluate LARS, the LARS score by Emmertsen et al. [6] has shown feasibility and validity for recording LARS. The LARS score precisely reflects the severity of bowel disorders after sphincter-preserving surgery by scoring the symptoms of LARS [2]. After the original LARS score was published in Danish, this questionnaire was validated in many languages, including English, Slovene, Dutch, Greek, Lithuania, Korean, Japanese, Chinese, and Persian [7-14]. There has been, however, no validated Vietnamese version of the LARS score questionnaire. The aim of this study was to develop a Vietnamese version of the LARS score questionnaire and evaluate its convergent validity, discriminative validity, and reliability.

METHODS

Ethics statement

This study was approved by the Institutional Review Board of Nhan dan Gia Dinh Hospital (No. was 66/NDGĐ–HĐĐĐĐ). All recruited patients signed a written informed consent form for participation in the study.

Participants

The electronic records of a public tertiary hospital were searched for patients with rectal cancer who were treated with sphincterpreserving surgery between January 2018 and December 2020. All patients, 18 years and older, operated for rectal cancer within 15 cm from the anal verge by sphincter-preserving procedures (anterior resection [AR], low anterior resection [LAR], intersphincteric resection, and LAR with the transanal approach) were included. The exclusion criteria were the formation of a stoma, known disseminated or recurrent disease, inability to read and write in Vietnamese, or any psychiatric conditions that might affect the questionnaire assessment. In January and March 2021, questionnaires regarding bowel function were sent to all 172 eligible patients identified in our database, who had undergone all kinds of sphincter-preserving surgery for rectal cancer. Demographic and clinical data were obtained from patients’ medical files.

Methods

Description of the LARS score

Bowel function was assessed with the LARS score. A 5-question questionnaire evaluated functional symptoms. The questions and scoring system of the LARS score questionnaire in the Vietnamese language are shown in Appendix 1. Scores were assigned to possible responses in order to calculate the LARS score, which was allocated into “no LARS” (score of 0–20 points), “minor LARS” (21–29 points), and “major LARS” (30–42 points) [11]. All questions were required for inclusion in our analysis.

Translation into Vietnamese

The translation procedure followed international guidelines, and included independent forward- and back-translations, as well as adaptive testing of the final Vietnamese version [15-17]. Two independent professional translators, both native Vietnamese speakers, carried out the forward translation (English to Vietnamese). The translators discussed any differences between the 2 versions to reach a final version. This was then back-translated (Vietnamese to English) by a third independent native English translator who had not seen the original English version. The final Vietnamese version was only approved by the study team when the differences between the back-translated English version and the original English version were resolved.

Psychometric validation

1) Test-retest reliability

The consistency and the ability to achieve consistent results between the first and second responses were classified as perfect, moderate, and no fit. Perfect fit was defined as the same responses for both the first and second interview. A difference in 1 or 2 categories was classified as moderate or no fit, respectively.

2) Validity

Convergent validity refers to agreement between measures that are supposed to be related, and it is evaluated using different methods. The convergent validity of the Vietnamese LARS score was verified by adding an anchored question (“Overall, how much does your bowel function affect your quality of life?”) to observe the association between LARS score and QoL. This question was sent with the LARS score questionnaire. The answers for the anchored QoL question were “no impact,” “a little,” “some,” and “a lot.”

Discriminative validity measures the ability to discriminate between groups with known differences. Discriminative validity was evaluated by assessment of the following groups in the LARS numerical score: presence or absence of obesity, type of surgery (AR vs. LAR), sex (male or female), and being older or younger than the mean age of the participants.

RESULTS

Study participants’ characteristics

Out of 172 patients eligible for the study, 93 (54.1%) responded. After 14 days, the questionnaire was sent again to all responding participants. Out of those, 89 participants (95.7%) responded a second time. Overall, 89 participants were included in the test-retest analysis. There were 37 (41.6%), 31 (34.8%), and 21 participants (23.6%) with no LARS, minor LARS, and major LARS, respectively (Table 1).

Patients’ characteristics

Psychometric validation

Test-retest reliability

As shown in Table 2, each of the 5 categories presented a high proportion of perfect fit (85.4%–96.6%). The intraclass correlation coefficients (ICCs) ranged from 0.874 to 0.934, showing high agreement. Fig. 1 shows a Bland-Altman plot of the extent of agreement between the first and second LARS scores. The percentages with 95% confidence intervals (CIs) of perfect, moderate, and no fit between the first and second responses to each of the LARS score questions are shown in Table 2.

Agreement between the first and second low anterior resection syndrome scores (%)

Fig. 1.

Bland-Altman plot of agreement between the first and second low anterior resection syndrome scores. The 95% limits of the agreement were –10.63 to 9.15.

Convergent validity, sensitivity, and specificity

According to the QoL categorization, perfect, moderate, and no fit were found in 56.2%, 42.7%, and 1.1% of responses, respectively (Table 3). The agreement between the 2 groups was the highest (25.8%) for minor LARS and minor impact of bowel function on QoL. The percentages of perfect, moderate, and no fit between the LARS and QoL groups with 95% CIs are shown in Table 4. No fit was found in 1.1% of the data.

Agreement between the LARS score and QoL

Percentage of agreement between the LARS score and QoL

Fig. 2 presents a box plot showing that the QoL groups had statistically significant differences in the LARS numerical score (P< 0.001). The post hoc difference was found between all levels of impact of bowel function in the QoL group (P< 0.001).

Fig. 2.

Differences among groups of numerical low anterior resection syndrome (LARS) scores and groups of quality of life.

The sensitivity and specificity of the LARS score in differentiating patients with a moderate or severe impact on QoL from those with no or a minor impact on QoL were 87.5% and 89.2%, respectively. This shows that the LARS score could predict the influence of symptoms related to LARS on QoL. The receiver operating characteristic curve of the LARS scores predicting patients with a moderate or severe influence on QoL revealed an area under the curve of 0.902 (Fig. 3).

Fig. 3.

The sensitivity and specificity of the low anterior resection syndrome score in differentiating levels of the effect of bowel function on quality of life. ROC curve, receiver operating characteristic curve.

Discriminative validity

Obesity and the AR procedure were associated with significantly lower LARS scores. The LARS score was not significantly different among groups according to sex, age, or adjuvant radiochemotherapy (Fig. 4).

Fig. 4.

Box plots comparing the low anterior resection syndrome (LARS) numerical score by age (A), sex (B), neoadjuvant radiochemotherapy (C), body mass index (D), and resection procedures (E). AR, anterior resection; LAR, low anterior resection.

DISCUSSION

This study developed a cross-culturally appropriate Vietnamese translation of the LARS score and revealed the validity and reliability of the questionnaire. The LARS score questionnaire was shown to be an easily understood, simple, and applicable tool for LARS assessment. The results of this study were close to those of published validation studies. As such, it was confirmed that the Vietnamese LARS score is a cross-culturally equivalent tool to the original version.

The test-retest reliability was excellent, with ICCs ranging from 0.874 to 0.934, indicating minimal measurement error and high internal consistency of the translated version. These results are comparable to the Danish, Lithuanian, Dutch, English, Korean, Japanese, and Chinese results [8, 9, 11, 18].

A meticulous translation and cross-cultural adaptation process was followed to provide an equivalent Vietnamese version of the LARS score. An anchored QoL category question was added to validate the Vietnamese LARS score. The proportion of our patients with a perfect fit between the LARS score and QoL was 56.2%, which is comparable to the results reported by other authors, ranging from 41% to 63% [12-14]. The percentage of respondents with “no fit” between the LARS score and QoL was lower in our study than in other studies, in which it was up to 8% [12-14].

The sensitivity and specificity of the previously validated version have been reported to be up to 88.3% and 88.8%, respectively [19]. The Vietnamese LARS score showed reasonable sensitivity (87.5%) and specificity (89.3%) compared to previous publications.

Finally, the LARS score was higher in patients who were not obese and had undergone LAR, which is in agreement with the results of other studies [9, 11, 14]. Since it has been shown that sphincter-preserving surgery, such as AR and LAR, has negative effects on anorectal function, resulting in LARS [19], our study confirmed that patients who underwent LAR would develop LARS more frequently than those who underwent AR [20].

The main limitation of our study is that it is a single-center study at a tertiary hospital. To draw a better picture of functional complaints in Vietnamese patients, a multi-center study is required. Another weak point of this study is that the LARS score was not able to discriminate patients who had undergone radiotherapy, even though radiotherapy has been proven to have a strong relationship to LARS [20].

Local control and long-term survival are the primary therapeutic goals of rectal cancer surgery. However, due to concerns about QoL after surgery, LARS must be a concern in the management of rectal cancer prior to surgical treatment.

In conclusion, a valid Vietnamese version of the LARS score questionnaire is now available and can be applied with confidence to recognize and follow up with patients who have anorectal disorders after rectal surgery. The psychometric properties indicate that the Vietnamese version of the LARS score is valid, consistent, and reliable. This also strengthens the evidence that the LARS score is a strong and valid tool for the assessment of QoL in patients who have undergone sphincter-preserving operations for rectal cancer.

Notes

CONFLICT OF INTEREST

No potential conflict of interest relevant to this article was reported.

FUNDING

None.

AUTHOR CONTRIBUTIONS

Conceptualization, Formal analysis, Methodology, Project administration, Supervision, Visualization: TAMP. Data curation, Investigation: VQP. Writing–original draft: TAMP. Writing–review & editing: TAMP, VQP.

All authors have read and approved the final manuscript.

Acknowledgements

The authors would like to thank Dr. Tran Trong Tan, Dr. Le Kim Long, and Dr. Do Thi Thu Phuong for their support.

References

1. Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Nikšić M, et al. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 populationbased registries in 71 countries. Lancet 2018;391:1023–75.
2. Emmertsen KJ, Laurberg S, ; Rectal Cancer Function Study Group. Impact of bowel dysfunction on quality of life after sphincterpreserving resection for rectal cancer. Br J Surg 2013;100:1377–87.
3. Bregendahl S, Emmertsen KJ, Fassov J, Krogh K, Zhao J, Gregersen H, et al. Neorectal hyposensitivity after neoadjuvant therapy for rectal cancer. Radiother Oncol 2013;108:331–6.
4. Konanz J, Herrle F, Weiss C, Post S, Kienle P. Quality of life of patients after low anterior, intersphincteric, and abdominoperineal resection for rectal cancer: a matched-pair analysis. Int J Colorectal Dis 2013;28:679–88.
5. Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, et al. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum 2014;57:585–91.
6. Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg 2012;255:922–8.
7. Juul T, Battersby NJ, Christensen P, Janjua AZ, Branagan G, Laurberg S, et al. Validation of the English translation of the low anterior resection syndrome score. Colorectal Dis 2015;17:908–16.
8. Akizuki E, Matsuno H, Satoyoshi T, Ishii M, Usui A, Ueki T, et al. Validation of the Japanese version of the low anterior resection syndrome score. World J Surg 2018;42:2660–7.
9. Hou XT, Pang D, Lu Q, Yang P, Jin SL, Zhou YJ, et al. Validation of the Chinese version of the low anterior resection syndrome score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients. Eur J Oncol Nurs 2015;19:495–501.
10. Hupkens BJ, Breukink SO, Olde Reuver Of Briel C, Tanis PJ, de Noo ME, van Duijvendijk P, et al. Dutch validation of the low anterior resection syndrome score. Colorectal Dis 2018;20:881–7.
11. Samalavicius NE, Dulskas A, Lasinskas M, Smailyte G. Validity and reliability of a Lithuanian version of low anterior resection syndrome score. Tech Coloproctol 2016;20:215–20.
12. Grosek J, Košir JA, Novak J, Omejc M, Tomažič A, Norčič G. Validation of the Slovenian version of the low anterior resection syndrome score for rectal cancer patients after surgery. Zdr Varst 2019;58:148–54.
13. Buzatti KC, Petroianu A, Laurberg S, Silva RG, Rodrigues BD, Christensen P, et al. Validation of low anterior resection syndrome score in Brazil with Portuguese. Ann Coloproctol 2022;May. 13. [Epub]. https://doi.org/10.3393/ac.2022.00136.0019.
14. Liapi A, Mavrantonis C, Lazaridis P, Kourkouni E, Zevlas A, Zografos G, et al. Validation and comparative assessment of low anterior resection syndrome questionnaires in Greek rectal cancer patients. Ann Gastroenterol 2019;32:185–92.
15. Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol 1993;46:1417–32.
16. Bullinger M, Alonso J, Apolone G, Leplège A, Sullivan M, WoodDauphinee S, et al. Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment. J Clin Epidemiol 1998;51:913–23.
17. World Health Organization (WHO). Translation and linguistic evaluation protocol and supporting material: WHODAS 2.0 translation package (version 1.0) [Internet] Geneva: WHO; 2012. . Available from: https://terrance.who.int/mediacentre/data/WHODAS/Guidelines/WHODAS%202.0%20Translation%20guidelines.pdf.
18. Kim CW, Jeong WK, Son GM, Kim IY, Park JW, Jeong SY, et al. Validation of Korean version of Low Anterior Resection Syndrome Score Questionnaire. Ann Coloproctol 2020;36:83–7.
19. Keramati MR, Abbaszadeh-Kasbi A, Keshvari A, Ahmadi-Tafti SM, Behboudi B, Kazemeini A, et al. Translation, validation and psychometric evaluation of the Persian (Farsi) version of the Low Anterior Resection Syndrome Score (LARS-P). PLoS One 2021;16e0247054.
20. Benli S, Çolak T, Türkmenoğlu MÖ. Factors influencing anterior/ low anterior resection syndrome after rectal or sigmoid resections. Turk J Med Sci 2021;51:623–30.

Appendices

Appendix 1. The Vietnamese version of the low anterior resection syndrome score questionnaire

ac-2022-00514-0073-app1.pdf

Article information Continued

Fig. 1.

Bland-Altman plot of agreement between the first and second low anterior resection syndrome scores. The 95% limits of the agreement were –10.63 to 9.15.

Fig. 2.

Differences among groups of numerical low anterior resection syndrome (LARS) scores and groups of quality of life.

Fig. 3.

The sensitivity and specificity of the low anterior resection syndrome score in differentiating levels of the effect of bowel function on quality of life. ROC curve, receiver operating characteristic curve.

Fig. 4.

Box plots comparing the low anterior resection syndrome (LARS) numerical score by age (A), sex (B), neoadjuvant radiochemotherapy (C), body mass index (D), and resection procedures (E). AR, anterior resection; LAR, low anterior resection.

Table 1.

Patients’ characteristics

Characteristic Data
No. of patients 89
Male sex 52 (58.4)
Age (yr) 61.5 ± 9.2
Obesity 14 (15.7)
Carcinoma stage 86 (96.6)
 I–II 29 (32.5)
 III–IV 57 (64.0)
Type of surgery
 AR 45 (50.6)
 LAR 42 (47.2)
 ISR 1 (1.1)
 TaTME 1 (1.1)
Laparoscopy 88 (98.9)
Circular stapler 88 (98.9)
End-to-end anastomosis 88 (98.9)
Tumor to anal verge (cm) 10.96 ± 4.6
Neoadjuvant radiochemotherapy 12 (13.5)
Leak rate 3 (3.4)

Values are presented as number only, number (%), or mean±standard deviation.

AR, anterior resection; LAR, low anterior resection; ISR, intersphincteric resection; TaTME, transanal total mesorectal excision.

Table 2.

Agreement between the first and second low anterior resection syndrome scores (%)

Question Perfect fit Moderate fit No fit ICC (95% CI)
1 91.0 (85.4–96.6) 7.9 (3.4–13.5) 1.1 (0.1–3.4) 0.934 (0.899–0.956)
2 94.4 (88.8–98.9) 5.6 (1.1–11.2) 0 0.933 (0.898–0.956)
3 96.6 (92.1–100) 3.4 (0.1–7.9) 0 0.899 (0.847–0.934)
4 93.3 (87.6–97.8) 6.7 (2.2–12.4) 0 0.925 (0.886–0.951)
5 85.4 (77.5–92.1) 14.6 (7.9–22.5) 0 0.874 (0.808–0.917)

ICC, intraclass correlation coefficient; CI, confidence interval.

Table 3.

Agreement between the LARS score and QoL

Impact of bowel function on QoL No LARS Minor LARS Major LARS
No 12 (13.5) 0 (0) 0 (0)
Minor 24 (27.0) 23 (25.8) 6 (6.7)
Some/major 1 (1.1) 8 (9.0) 15 (16.9)

Values are represented as number (%).

LARS, low anterior resection syndrome; QoL, quality of life.

Table 4.

Percentage of agreement between the LARS score and QoL

Fit Percentage (95% CI)
No 1.1 (0–3.4)
Moderate 42.7 (32.6–52.8)
Perfect 56.2 (46.1–66.3)

LARS, low anterior resection syndrome; QoL, quality of life; CI, confidence interval.