title: Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians' perceptions: a multicenter survey.
abstract: OBJECTIVE
  The aim of this survey was to quantify refusal rates and identify factors of refusal pertaining to studies and recruiting pediatricians in the research recruitment process.
  
  
  METHODS
  We performed a cross-sectional survey on all clinical studies conducted in six pediatric Clinical Investigation Centers in France over an 18-month period. Data were retrieved using a data collection form for the characteristics of each of the studies included in the survey and a questionnaire addressed to recruiting pediatricians. Multilevel models were used for the statistical analysis.
  
  
  RESULTS
  Overall, 145 pediatricians approached the families of 999 children and adolescents for participation in 44 studies. In the 36 of the 44 studies that enrolled subjects, median refusal rate was 12.5% (Q1-Q3, 0-28%). Lower refusal rates were associated with therapeutic drug use as the focus of the study [odds ratio (OR), 0.51; 95% CI: 0.25, 1.05], additional hospital stays required for the study (OR, 0.53; 95% CI: 0.28, 0.99), longer duration of the inclusion visit (OR, 0.93/10 min; 95% CI: 0.87, 1), and recruitment by a pediatrician with university teaching responsibilities (OR, 0.26; 95% CI: 0.10, 0.68). Refusal rate was higher when the recruiting pediatrician perceived the study as generating heavy practical burden for the subject and/or its family (OR, 1.3; 95% CI: 1.17, 1.45).
  
  
  CONCLUSIONS
  Refusal to participate in clinical research was low and was influenced by factors associated to the objectives and conduct of the studies and factors related to the characteristics and perceptions of the recruiting pediatricians.
authors.affiliation: AP-HP, Hôpital Robert Debré, Unité d'Épidémiologie Clinique, 48 boulevard Sérurier, 75019, Paris, France. florentia.kaguelidou@rdb.aphp.fr
authors.forename: Florentia
authors.initials: F
authors.lastname: Kaguelidou
authors.forename: Philippe
authors.initials: P
authors.lastname: Amiel
authors.forename: Audrey
authors.initials: A
authors.lastname: Blachier
authors.forename: Catalina
authors.initials: C
authors.lastname: Iliescu
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Rozé
authors.forename: Michel
authors.initials: M
authors.lastname: Tsimaratos
authors.forename: Christian
authors.initials: C
authors.lastname: Brandt
authors.forename: Behrouz
authors.initials: B
authors.lastname: Kassai-Koupai
authors.forename: Evelyne
authors.initials: E
authors.lastname: Jacqz-Aigrain
authors.forename: Claude
authors.initials: C
authors.lastname: Gaultier
authors.forename: Corinne
authors.initials: C
authors.lastname: Alberti
mesh_terms: D000293:Adolescent; D001291:Attitude of Health Personnel; D035843:Biomedical Research / Q000458:organization & administration*; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D003625:Data Collection; D005260:Female; D005602:France; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D055361:Multilevel Analysis; D018579:Patient Selection; D010372:Pediatrics; D010820:Physicians / Q000523:psychology*; D045808:Refusal to Participate / Q000706:statistics & numerical data*; D012107:Research Design; D011795:Surveys and Questionnaires
keywords: Clinical research; Participation; Pediatrician perception; Pediatrics; Recruitment; Refusal rate