Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians' perceptions: a multicenter survey

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• 作者：Florentia Kaguelidou ; Philippe Amiel ; Audrey Blachier ; Catalina Iliescu ; Jean-Christophe Roz¨¦ ; Michel Tsimaratos ; Christian Br ; t ; Behrouz Kassai-Koupai ; Evelyne Jacqz-Aigrain ; Claude Gaultier ; Corinne Alberti
• 关键词：Recruitment ; Pediatrics ; Participation ; Refusal rate ; Clinical research ; Pediatrician perception
• 刊名：Journal of Clinical Epidemiology
• 出版年：2013
• 出版时间：October, 2013
• 年：2013
• 卷：66
• 期：10
• 页码：1151-1157
• 全文大小：214 K

文摘

Objectives

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.

Study Design and Setting

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).

Conclusion

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.