Introduction
Accurate symptom assessment and monitoring over time is critical for effective patient management and research. Standard history taking is unavoidably influenced by both patient-related and physician-related factors. Patient reported outcome measures (PROMs) facilitate evaluation of patients and allow to better assess treatment effects. Validated tools are lacking for paediatric gastroenterological patients.
Aims & Methods
We aimed to adapt and validate for paediatric populations a self-administered Structured Assessment of Gastrointestinal Symptoms (SAGIS) tool that previously has been validated in adult cohorts. Each item of the original SAGIS instrument was thoroughly reviewed for its relevance in the paediatric population. The resulting paediatric (p)SAGIS was utilized over a 35 months’ period in consecutive patients in a paediatric outpatient GI-clinic. Principal components analysis (PCA) followed by Varimax rotation and confirmatory factor analysis (CFA) was performed in derivation and validation samples. Responsiveness to change was assessed in 32 children with inflammatory bowel disease (IBD) after 12 months of therapy.
Results
The final paediatric SAGIS consisted of 21 GI-related Likert-type questions, 8 dichotomous questions assessing extra-intestinal symptoms and two most bothersome symptoms. 1153 children/adolescents completed a total of 2647 questionnaires. Cronbach’s alpha was 0.89, indicating good internal consistency. PCA supported a five-factor model (symptom groups: abdominal pain, dyspepsia, diarrhoea, constipation, dysphagia/nausea), CFA showed good model fit (CFI:0.96, RMSEA:0.075). The initial mean total GI-symptom score in IBD-patients (8.7±10.3) decreased to 3.6±7.7 after 1 year of therapy (p<0.01), and four of five symptom group scores decreased significantly upon treatment (p<0.05). The table shows responsiveness of p-SAGIS in children with IBD, total GI-symptom scores and symptom scores of pSAGIS-domains at the initial visit and after 1 year of therapy (data are given as mean±standard deviation).
Children with IBD
(n=32) | Initial Visit | After 1 year of
therapy | p-value |
| Mean total GI-symptom score | 0.41 ± 0.49 | 0.14 ± 0.33 | <0.01 |
| Abdominal pain | 0.49 ± 0.66 | 0.19 ± 0.44 | <0.01 |
| Dyspepsia | 0.42 ± 0.56 | 0.24 ± 0.54 | <0.05 |
| Diarrhea | 0.37 ± 0.60 | 0.13 ± 0.49 | <0.05 |
| Constipation | 0.57 ± 0.74 | 0.14 ± 0.35 | <0.001 |
| Dysphagia/Nausea | 0.25 ± 0.39 | 0.14 ± 0.29 | =0.09 |
Conclusion
The pSAGIS is a novel, easy to use, self-administered instrument for GI-symptom assessment in children/adolescents with excellent psychometric properties. It may standardize GI-symptom assessment and may enable uniform clinical analysis of treatment outcomes.
References
Koloski NA, Jones M, Hammer J, et al. The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting. Dig Dis Sci. 2017;62:1913-1922
