title: Development of the Brussels Infant and Toddler Stool Scale ('BITSS'): protocol of the study.
abstract: The Bristol Stool Form Scale (BSS) which consists of 7 photographs of different stool forms allows assessment of stool consistency (scale 1 for hard lumps to scale 7 for watery stools), in an objective manner in adults. The BSS is also sometimes used to characterise the stools of infants and young children. Despite its use, there is general agreement among paediatric gastroenterologists that the BSS is not adequate to be used in infants and young children who wear diapers; thus, a new scale specifically designed for this population is needed. Our aim is to develop a paediatric stool scale, the Brussels Infant and Toddler Stool Scale ('BITSS'), and to evaluate the interobserver agreement of stool assessment with the BITSS between the patient's parent and healthcare providers (physicians and nurses).
  
  
  
  This study has two phases. In the first phase, 11 key-opinion leaders in the field of paediatric gastroenterology representing different areas of the world selected seven coloured photographs of infants and/or young children wearing diapers to match the original descriptors of the BSS. The selected photographs were used to create a new scale in which the drawings of stools of the BSS were replaced by infant/toddlers stool photographs. In phase II, we aim at demonstrating that parents, nurses and primary healthcare physicians interpret the stool-pictures of the BITSS with a high degree of consensus and that the agreement is independent of whether it is a parent or a healthcare provider. Interobserver variability of stool assessment with the BITSS between the patient's parent and healthcare providers will be assessed.
  
  
  
  The study will be approved by the Ethics Committee of the participating centres. The findings of this study will be submitted to a peer-reviewed journal. Abstracts will be submitted to national and international conferences.
  
  
  
  NCT02913950.
authors.affiliation: Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
authors.affiliation: Department of Pediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Hania
authors.initials: H
authors.lastname: Szajewska
authors.affiliation: Department of Pediatrics, Emma Children's Hospital/AMC, Amsterdam, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: Benninga
authors.affiliation: Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Lorenzo
authors.affiliation: Department of Pediatric Gastroenterology Hepatology and Nutrition, Hôpital Necker Enfants Malades, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Dupont
authors.affiliation: Pediatric Gastroenterology, Sainte-Justine Hospital, Montreal, Quebec, Canada.
authors.forename: Christophe
authors.initials: C
authors.lastname: Faure
authors.affiliation: Sheikh Khalifa Medical City, Abu Dhabi, UAE.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Miqdadi
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand.
authors.forename: Seksit
authors.initials: S
authors.lastname: Osatakul
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, La Fe University Hospital, Valencia, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Ribes-Konickx
authors.affiliation: Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
authors.forename: Miguel
authors.initials: M
authors.lastname: Saps
authors.affiliation: Schneider Children's Medical Centre of Israel, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Raanan
authors.initials: R
authors.lastname: Shamir
authors.affiliation: Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Staiano
mesh_terms: D002675:Child, Preschool; D003672:Defecation / Q000502:physiology*; D005243:Feces; D005762:Gastroenterology / Q000379:methods*; D006305:Health Status Indicators; D006801:Humans; D007223:Infant; D015588:Observer Variation; D010781:Photography
keywords: Bristol stool scale; defecation; stool