Validation of Portuguese version of the low anterior resection syndrome score

The authors aim to perform a thorough translation with cultural adaptation of the patient reported outcome tool, Low Anterior Resection Syndrome (LARS) Score, to the Portuguese language (LARS-PT) in the Portuguese population with rectal cancer, after proctectomy with anastomosis.

Methods:

According to the current international recommendations, we designed this study encompassing three main phases: (i) cultural and linguistic validation to European Portuguese; (ii) feasibility and reliability tests of the version obtained in the previous phase; and (iii) validity tests to produce a final version. The questionnaire was completed by 154 patients from six Portuguese Colorectal Cancer Units, and 58 completed it twice.

Results:

Portuguese version of LARS score showed high construct validity. Regarding the test-retest, the global Intraclass Correlation showed very strong test-retest reliability. Looking at all five items, only items 3 and 5 present a moderate correlation. LARS score was able to discriminate symptoms showing worse quality of life, in patients submitted to preoperative radio and chemotherapy.

Conclusions:

LARS questionnaire has been properly translated into European Portuguese, demonstrating high construct validity and reliability. This is a precise, reproducible, simple, clear and user-friendly tool for evaluating bowel function in rectal cancer patients after sphincter saving operation.

Keywords:
Rectal neoplasms; Bowel dysfunction; Low anterior resection syndrome score; Quality of life; Validation

	Variable	n	%
Participants		154	100.0
Gender	Male	89	57.9
Gender	Female	65	42.1
Age (years)	<65 years	60	39.0
	65-74 years	46	29.9
	>75 years	48	31.2
	Mean ± SD	68.1 ± 10.9
	Min-max	36-89
Family status	Married	126	82.9
	Single	5	3.3
	Widow	13	8.6
	Divorced/separated	8	5.3
Labour status	Active	38	25.7
Labour status	Non-active	110	74.3
Education	Less than basic	14	9.2
	Basic (years 1-9)	100	65.8
	Secondary (years 10-12)	18	11.8
	Higher	20	13.2
Stage, TNM	I	38	28.8%
	II	24	18.2%
	III	70	53.0%
Tumour localization	Upper third	45	31.0%
	Middle third	76	52.4%
	Lower third	24	16.6%
Type of anastomosis	Mechanic	136	94.4%
Type of anastomosis	Manual	8	5.6%
Neoadjuvant radiotherapy	Yes	71	49.0%
Neoadjuvant radiotherapy	No	74	51.0%
Length of the postoperative period	<3 years	63	44.1%
	≥3 years	80	55.9%
	Mean ± SD	10.3 ± 3.7
	Min-max	0.0-10.3
Type of surgery	TME	97	71.3%
Type of surgery	PME	39	28.7%
LARS score	No LARS	52	34.2%
	Minor LARS	37	24.3%
	Major LARS	63	41.4%
	Mean ± SD	23.9 ± 12.4
	Min-max	0-42

QoL measure	Dimension	Min	Max	Mean	SD
EORTC-QLQ-C30	Physical function	0.0	100.0	83.7	19.6
Functional scales	Role physical	0.0	100.0	85.9	24.9
	Emotional function	25.0	100.0	85.9	16.9
	Cognitive function	16.7	100.0	86.1	17.0
	Social function	0.0	100.0	86.7	22.0
EORTC-QLQ-C30	Fatigue	0.0	88.9	18.0	21.1
Symptom scales	Nausea and vomiting	0.0	50.0	1.2	6.9
	Pain	0.0	100.0	14.9	22.1
	Dyspnoea	0.0	66.7	1.5	8.0
	Sleep disturbance	0.0	100.0	18.5	25.6
	Appetite loss	0.0	66.7	5.0	14.7
	Constipation	0.0	100.0	11.1	20.2
	Diarrhoea	0.0	100.0	12.4	20.9
	Financial impact	0.0	100.0	9.8	19.8
	Quality of life	16.7	100.0	73.3	19.0
EQ-5D-5L	Index	16	1.00	0.90	0.16
EQ-5D-5L	VAS	10	100.0	74.5	0.19

Items	ICC	95% CI
Item 1	0.763	0.600-0.860
Item 2	0.863	0.769-0.919
Item 3	0.652	0.413-0.794
Item 4	0.761	0.596-0.859
Item 5	0.669	0.441-0.804
LARS total score	0.864	0.771-0.920

Hypothesis	Variable	Value	Mean rank	Statistics	Sig.
H1	Gender	Male	73.7	U = 2568	0.354
H1	Gender	Female	80.4	U = 2568	0.354
H2	Age (years)	<65 years	84.3	H = 3.359	0.186
		65-74 years	78.1
		>75 years	68.5
H3	Family status	Married	76.8	U = 1599	0.849
H3	Family status	Non-married	75.0	U = 1599	0.849
H4	Labour status	Active	74.5	U = 2088	0.993
H4	Non-active	Active	74.5	U = 2088	0.993
H5	Neoadjuvant radiotherapy	Yes	81.5	U = 2022	0.017
H5	Neoadjuvant radiotherapy	No	64.8	U = 2022	0.017
H6	Anastomosis	Mechanic	69.8	U = 184	0.002
H6	Anastomosis	Manual	117.5	U = 184	0.002
H7	Length of the postoperative period	≤2 years	69.2	U = 1406	0.622
H7	Length of the postoperative period	>2 years	73.8	U = 1406	0.622
H8	Type of surgery	TME	70.3	U = 1718	0.405
H8	Type of surgery	PME	64.1	U = 1718	0.405

QoL measure	Dimension	LARS scores	p-value
EORTC-QLQ-C30	Physical function	-0.116	0.153
Functional dscales	Role physical	-0.125	0.123
	Emotional function	-0.131	0.105
	Cognitive function	-0.122	0.134
	Social function	-0.163	0.044
EORTC-QLQ-C30	Fatigue	0.130	0.110
Symptom scales	Nausea and vomiting	0.062	0.448
	Pain	0.206	0.011
	Dyspnoea	0.015	0.856
	Sleep disturbance	0.086	0.289
	Appetite loss	-0.054	0.507
	Constipation	0.073	0.367
	Diarrhoea	0.353	0.000
	Financial impact	0.189	0.020
	Quality of life	-0.150	0.064
EQ-5D-5L	Index	-0.116	0.153
EQ-5D-5L	VAS	-0.089	0.274

Sociedade Brasileira de Coloproctologia Av. Marechal Câmara, 160/916, 20020-080 Rio de Janeiro/RJ Brasil, Tel.: (55 21) 2240-8927, Fax: (55 21) 2220-5803 - Rio de Janeiro - RJ - Brazil
E-mail: sbcp@sbcp.org.br

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[1] *Corresponding author. E-mail: ramanuno@gmail.com (N.J.Rama).