Heterogeneous outcome reporting in adult slow-transit constipation studies: Systematic review towards a core outcome set

Abstract

Background and aim: Standardizing evaluative outcomes and their assessment facilitates comparisons between clinical studies and provides a basis for comparing direct effects of different treatment options. The aim of this study was to systematically review types of outcomes and measurement instruments used in studies regarding treatment options for slow-transit constipation (STC) in adults.

Methods: In this systematic review of the literature, we searched MEDLINE, Embase, and PsycINFO from inception through February 2018, for papers assessing any STC treatment in adult patients. Outcomes were systematically extracted and categorized in domains using the conceptual framework of the Outcome Measures in Rheumatology filter 2.0. Outcome reporting was stratified by decade of publication, intervention, and study type.

Results: Forty-seven studies were included in this systematic review. Fifty-nine different types of outcomes were identified. The outcomes were structured in three core areas and 18 domains. The most commonly reported domains were defecation functions (94%), gastrointestinal transit (53%), and health-care service use (51%). The most frequently reported outcomes were defecation frequency (83%), health-related quality of life (43%), and adverse events and complications (43%). In 62% of the studies, no primary outcome was defined, whereas in two studies, more than one primary outcomes were selected. A wide diversity of measurement instruments was used to assess the reported outcomes.

Conclusion: Outcomes reported in studies on STC in adults are heterogeneous. A lack of standardization complicates comparisons between studies. Developing a core outcome set for STC in adults could contribute to standardization of outcome reporting in (future) studies.

Keywords: Core outcome set; OMERACT; Outcomes; Slow-transit constipation.