validation of the english version of the low anterior ... · validation of the english version of...
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Validation
of the English version of the
Low Anterior Resection Syndrome Score (LARS score)
Therese Juul
RN, MHSc, PhD, Assistant professor
Department of Surgery, Aarhus University Hospital
Aarhus, Denmark
I declare no conflict of interest
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• Basingstoke & North Hampshire Hospital B Moran, N Battersby • Airedale NHS Foundation Trust R Basit Khan • West Hertfordshire (Lister Hospital) R Glynne- Jones • Harrogate District Hospital Mr Leinhardt • Luton and Dunstable NHS Trust Dr Mawdsley • Mount Vernon Hospital R Glynne-Jones • Pinderfields Hospital N Narula • Royal Shrewsbury Hospital J Lacy-Colson • Wolverhampton NHS Trust N Mirza • Salisbury NHS Foundation Trust G Branagan • Leeds Teaching Hospital (St James) D Jayne • York NHS FT Mr N Woodcock, Dr K Last
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Background
Bowel dysfunction after Low Anterior Resection is…
…common, distressing, and affects quality of life
…inconsistently measured
…often unrecognized and untreated
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Low Anterior Resection Syndrome (LARS)
• Frequent bowel movements • Gas incontinence • Fecal incontinence • Fragmentation/clustering • Urgency
Background
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The LARS score – a bowel function questionnaire
• Based on data from > 900 Danish LAR patients
• Five items selected from 27 candidate items
• Item selection and scoring is weighted according
to impact on QoL
Bowel dysfunction
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(5): 922-8.
Low Anterior Resection Syndrome Score (LARS Score)
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Bowel dysfunction
• Do you ever have occasions when you cannot control your flatus (wind)? • Do you ever have any accidental leakage of liquid stool?
• How often do you open your bowels?
• Do you ever have to open your bowels again within one hour of the last bowel opening?
• Do you ever have such a strong urge to open your bowels that you have to rush to the toilet?
□ No, never 0 □ Yes, less than once per week 4 □ Yes, at least once per week 7 □ No, never 0 □ Yes, less than once per week 3 □ Yes, at least once per week 3 □ More than 7 times per day (24 hours) 4 □ 4-7 times per day (24 hours) 2 □ 1-3 times per day (24 hours) 0 □ Less than once per day (24 hours) 5 □ No, never 0 □ Yes, less than once per week 9 □ Yes, at least once per week 11 □ No, never 0 □ Yes, less than once per week 11 □ Yes, at least once per week 16
0-20 = No LARS 21-29 = Minor LARS 30-42 = Major LARS
Translated to: English Dutch Italian Turkish Portuguese Chinese Korean Malay Mandarin Tamil
Validated in: German Spanish Swedish Danish
The LARS score is
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• Convergent validity
– The association with quality of life
• Discriminative validity
– The ability to distinguish between known groups
• Reliability
– Test-retest reliability
Aim
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Questionnaire-based cross-sectional survey
• LARS score • EORTC QLQ-C30 • Single anchor question
A subgroup of patients received the LARS score twice (test-retest)
Methods
”Overall, how much does your bowel function affect your quality of life?” ”Not at all”
”Very little” ”Somewhat” ”A lot”
Clinical/demographic information
N 451 (resp.rate 80%)
Males 60 %
Age at survey, median (range) 70 (35-97) years
Time since surgery, median (range) 4.9 (1.6-12.4) years
Tumour level, median (range) 9.0 (1.5-15) cm
Surgery TME PME
82 % 18 %
T stage T0-2 T3-4
53 % 47 %
Pre radiotherapy 32 %
Chemotherapy Pre Post
19 % 33 %
LARS group Major Minor No
47 % 23 % 30 %
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Convergent validity The association btw LARS and QoL
LARS group Quality of life group
No Minor Some/Major
No 11.8% 14.4 % 3.5 %
Minor 2.9 % 11.5 % 8.4 %
Major 0.9 % 18.4 % 28.2 %
Perfect fit: 52 % Moderate fit: 44 % No fit: 4 %
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Impact of bowel function on QoL
010
2030
40
LAR
S s
core
No Minor Some/major
Convergent validity association btw LARS score and QoL group
No Minor Some/major -impact on QoL 12
50
60
70
80
90
100
EO
RT
C Q
LQ
-C3
0 s
co
re
Global QoL Physical Role Emotional Cognitive Social
EORTC QLQ-C30 functional scales
No LARS
Minor LARS
Major LARS
95 % CI
LARS group
Convergent validity The association btw LARS and QoL
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Discriminative validity The ability to distinguish btw groups
01
02
03
04
0
LA
RS
sco
re
No yesp=0.02
Radiotherapy
01
02
03
04
0
>5 cm <5 cmp=0.003
Tumour height
01
02
03
04
0
PME TMEp=0.0001
Surgery
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Reliability N=126
Days between tests: median 22 (range 6-99)
-20
-10
010
20
Diffe
rence
0 10 20 30 40Average
95 % limits of agreement: -12.9 to 14.2
Kappa: 0.63 (Good agreement*)
*Altman D. Practical Statistics for Medical Research. Chapman and Hall: London, 1991, p 404-409. 15
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The English version of the LARS score… • Has shown a high convergent and discriminative validity
and reliability
• Has demonstrated results similar to previous results from an international validation study (Spain, Sweden, Germany, Denmark)
• Is a valid and reliable tool for measuring LARS in English
RC/LAR patients
Conclusions
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Optimised Conservative Treatment
• Diet/ fibres/ Husk
• Toilet habits
• Medicine
• Rinse with water (50-100 ml)
• Transanal Irrigation (TAI) (up to 1000 ml)
• Stoma
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Har prøvet Bruger stadig Kommentarer Behandlingsopsta
rt 1. justering 2. justering 3. justering
HUSK (1spsk x 2)
Klystersprøjte
Glycerolstikpille
Loperamid
Laxantia (type,
dosis)
Pædagogik:
Kostråd
Toiletvaner
Andet?
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Discriminative validity The ability to distinguish btw groups
0
20
40
60
80
100
Pe
r ce
nt
No yes
Radiotherapy
0
20
40
60
80
100
Pe
r ce
nt
>5 cm <5 cm
Tumour level
0
20
40
60
80
100
Pe
r ce
nt
PME TME
Surgery
Major Minor No
LARS group
21
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