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Reporting on outcome measures in pediatric chronic intestinal failure: A systematic review
S C J Nagelkerke1, D J Mager2, M A Benninga1
1Amsterdam UMC, University of Amsterdam, Emma Children's Hospital, Department of Pediatric Gastroenterology, Hepatology and Nutrition, Amsterdam, the Netherlands.
Insights
Pediatric chronic intestinal failure (IF) research lacks consistent definitions and outcome measures. Developing a core outcome set is recommended to improve therapeutic trial comparability and reporting quality for children with IF.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Methodology
- Rare Diseases
Background:
- Chronic intestinal failure (IF) in children is a rare, heterogeneous condition necessitating parenteral nutrition.
- Current therapeutic trials for pediatric IF lack uniform definitions and standardized outcome measures.
- This heterogeneity hinders the comparison of treatment efficacy and research findings.
Purpose of the Study:
- To systematically assess the definitions and outcome measures used in therapeutic trials for pediatric chronic IF.
- To identify the extent of variation in definitions and outcome reporting.
- To provide a basis for developing standardized reporting guidelines.
Main Methods:
- A comprehensive literature search was conducted across MEDLINE, EMBASE, and Cochrane CENTRAL databases.
- Studies were included from inception until August 2018, with no language restrictions.
- Included studies were analyzed for reported definitions of IF and outcome measures.
Main Results:
- Out of 70 included studies, 76% (54 studies) did not define IF.
- Among studies that did define IF (23%), seven different definitions were identified.
- A total of 117 different outcomes were reported, with mortality, liver enzymes, and growth being the most frequent.
- The quality of reporting in most studies was rated as fair to poor.
Conclusions:
- There is a significant lack of standardized definitions for pediatric IF in published research.
- Substantial heterogeneity exists in the outcome measures reported in studies on pediatric chronic IF.
- The development of a core outcome set is recommended to enhance consistency and comparability in future research.
Background & Aims:
Chronic intestinal failure (IF) in children is a rare and heterogeneous disease requiring treatment with parenteral nutrition. A uniform definition for chronic IF and standardized outcome measures to compare therapeutic trials in these children are lacking. Therefore, the aim of this study is to systematically assess how definitions and outcome measures are defined in therapeutic trials of children with chronic IF.
Methods:
MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from inception till August 2018. No language restriction was used.
Results:
A total of 1766 articles was found of which 70 studies fulfilled our inclusion criteria. 54 studies (76%) did not report any definition of IF. Of the 16 studies (23%) which reported a definition of IF, 7 different definitions were found. The two most frequently used definitions were: (1) the inability to absorb adequate nutrients to maintain body weight or normal growth and development (n = 5), and (2) the dependence upon parenteral nutrition to maintain minimal energy requirements for growth and development (n = 5). A total of 117 different outcomes were reported. The three most reported outcome measures were: mortality (n = 27), liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl trans peptidase) (n = 27), and growth (n = 23). Quality of reporting was considered fair to poor in most studies.
Conclusion:
There is a lack of reported definitions in studies concerning pediatric IF. Heterogeneity exists in outcome reporting in research concerning pediatric chronic IF. Therefore, we recommend the development of a core outcome set.
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