Abstracts Division 2
39. Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS): Development, Reliability and Construct Validity
S.Z. Kuiper1*, M.L. Kimman2,
R.R. Van Tol3, S.F. Waardenburg2,4, S.M.J. Van Kuijk2,
C.D. Dirksen2, S.O. Breukink1,5,6
1 Department of Surgery, Maastricht University, School of Nutrition and Translational Research in Metabolism (NUTRIM), Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands
2 Department of Clinical Epidemiology and Medical Technology, Care and Public Health
Research Institute (CAPHRI), Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands
3 Department of Surgery, Diakonessenhuis Medical Centre, Bosboomstraat 1, 3582 KE, Utrecht, the Netherlands
4 Department of Anaesthesiology and Pain Medicine, Maastricht University Medical Center+, the Netherlands
5 Department of Surgery, Maastricht University, School for Oncology and Developmental Biology (GROW), Universiteitssingel 50, 6229 ER, Maastricht, the Netherlands
6 Department of Surgery, Maastricht University Medical Centre, Oxfordlaan 10, 6202 AZ, Maastricht, the Netherlands
Background
Haemorrhoidal disease (HD) is a frequently occurring disorder with a significant negative impact on a patient’s quality of
life. The Core Outcome Set (COS) for HD states that symptoms and satisfaction
as reported by patients are the core outcomes to be evaluated in clinical
studies. We describe the development and validation of the Patient Reported
Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS).
Methods
The development of the PROM-HISS followed recommended guidelines. Face and content validity, structural properties,
reliability and construct validity were evaluated. Reliability was tested by
assessing the test-retest reliability, defined by the Intraclass Correlation
Coefficient (ICC), and internal consistency measured with Cronbach’s alpha. Construct
validity was evaluated using confirmatory factor analysis (CFA) and hypotheses
testing.
Results
The PROM-HISS consists of three domains: (1) HD symptoms (blood loss; pain; prolapse; soiling; itching), (2) impact of symptoms
on daily life, and (3) satisfaction with treatment. The PROM-HISS showed good
face and content validity. The PROM-HISS was completed by 102 patients (65%
male), with a mean age of 58 years (23-81 years). The ICCs of the different
items in the domain HD symptoms ranged between 0.56 and 0.79 and were
interpreted as good. The Cronbach’s alpha value was 0.80 and considered
satisfactory. The CFA provided further evidence for construct validity with a
good model fit. A high score on the symptoms of HD correlated with a high
impact of HD on daily life (Pearson’s r = 0.632, p<0.01) and a low degree of
satisfaction (Pearson’s r = 0.378, p<0.01).
Conclusions
The PROM-HISS is a reliable and valid instrument to evaluate symptoms of HD, impact on daily activities and satisfaction with treatment.
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NUTRIM aims to contribute to health maintenance and personalised medicine by unraveling lifestyle and disease-induced derangements in metabolism and by developing targeted nutritional, exercise and drug interventions. This is facilitated by a state of the art research infrastructure and close interaction between scientists, clinicians, master and PhD students.
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