OBJECTIVE: Our objective was to identify characteristics of infants and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of Diabetes in the Young (TEDDY) study. METHOD: 16,435 infants screened at birth and identified as at increased genetic risk for type 1 diabetes (T1DM) were placed into one of three categories: enrolled, excluded, or refused to enroll. Enrollment, exclusion and refusal rates were compared across countries and between infants from the general population (GP) and infants with a first degree T1DM relative (FDR). A multivariate logistic model was used to identify factors associated with TEDDY enrollment. RESULTS: TEDDY enrollment, exclusion, and refusal rates differed by country and by GP/FDR status but reasons for refusal to enroll were similar across countries and GP/FDR populations. Sweden had the highest enrollment rate, US had the highest exclusion rate, and Finland had the highest refusal rate. FDR infants were more likely to enroll than GP infants. Inability to re-contact the family was the most common reason for exclusion. Primary reasons for refusal to enroll included protocol factors (e.g. blood draws) or family factors (e.g., too busy). Study enrollment was associated with FDR status, European country of origin, older maternal age, a singleton birth, and having another child in TEDDY. CONCLUSIONS: Findings highlight the importance of country specific estimates for enrollment targets in longitudinal pediatric studies and suggest that enrollment estimates should be lowered when the study involves the general population, painful procedures, or makes multiple demands on families.
OBJECTIVE: Our objective was to identify characteristics of infants and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of Diabetes in the Young (TEDDY) study. METHOD: 16,435 infants screened at birth and identified as at increased genetic risk for type 1 diabetes (T1DM) were placed into one of three categories: enrolled, excluded, or refused to enroll. Enrollment, exclusion and refusal rates were compared across countries and between infants from the general population (GP) and infants with a first degree T1DM relative (FDR). A multivariate logistic model was used to identify factors associated with TEDDY enrollment. RESULTS: TEDDY enrollment, exclusion, and refusal rates differed by country and by GP/FDR status but reasons for refusal to enroll were similar across countries and GP/FDR populations. Sweden had the highest enrollment rate, US had the highest exclusion rate, and Finland had the highest refusal rate. FDR infants were more likely to enroll than GP infants. Inability to re-contact the family was the most common reason for exclusion. Primary reasons for refusal to enroll included protocol factors (e.g. blood draws) or family factors (e.g., too busy). Study enrollment was associated with FDR status, European country of origin, older maternal age, a singleton birth, and having another child in TEDDY. CONCLUSIONS: Findings highlight the importance of country specific estimates for enrollment targets in longitudinal pediatric studies and suggest that enrollment estimates should be lowered when the study involves the general population, painful procedures, or makes multiple demands on families.
Authors: Sabina Resic-Lindehammer; K Larsson; E Ortqvist; A Carlsson; E Cederwall; C M Cilio; S-A Ivarsson; B A Jönsson; H E Larsson; K Lynch; J Neiderud; A Nilsson; S Sjöblad; A Lernmark; M Aili; L E Bååth; E Carlsson; H Edenwall; G Forsander; B W Granstro; I Gustavsson; R Hanås; L Hellenberg; H Hellgren; E Holmberg; H Hörnell; Sten-A Ivarsson; C Johansson; G Jonsell; K Kockum; B Lindblad; A Lindh; J Ludvigsson; U Myrdal; J Neiderud; K Segnestam; S Sjöblad; L Skogsberg; L Strömberg; U Ståhle; B Thalme; K Tullus; T Tuvemo; M Wallensteen; O Westphal; J Aman Journal: Acta Diabetol Date: 2008-09-04 Impact factor: 4.280
Authors: Emily K Sims; Susan Geyer; Suzanne Bennett Johnson; Ingrid Libman; Laura M Jacobsen; David Boulware; Lisa E Rafkin; Della Matheson; Mark A Atkinson; Henry Rodriguez; Maria Spall; Helena Elding Larsson; Diane K Wherrett; Carla J Greenbaum; Jeffrey Krischer; Linda A DiMeglio Journal: Diabetes Care Date: 2019-09-26 Impact factor: 19.112
Authors: Carin Andrén Aronsson; Hye-Seung Lee; Elin M Hård Af Segerstad; Ulla Uusitalo; Jimin Yang; Sibylle Koletzko; Edwin Liu; Kalle Kurppa; Polly J Bingley; Jorma Toppari; Anette G Ziegler; Jin-Xiong She; William A Hagopian; Marian Rewers; Beena Akolkar; Jeffrey P Krischer; Suvi M Virtanen; Jill M Norris; Daniel Agardh Journal: JAMA Date: 2019-08-13 Impact factor: 56.272
Authors: Kaisa M Kemppainen; Kendra Vehik; Kristian F Lynch; Helena Elding Larsson; Ronald J Canepa; Ville Simell; Sibylle Koletzko; Edwin Liu; Olli G Simell; Jorma Toppari; Anette G Ziegler; Marian J Rewers; Åke Lernmark; William A Hagopian; Jin-Xiong She; Beena Akolkar; Desmond A Schatz; Mark A Atkinson; Martin J Blaser; Jeffrey P Krischer; Heikki Hyöty; Daniel Agardh; Eric W Triplett Journal: JAMA Pediatr Date: 2017-12-01 Impact factor: 16.193