Clinical trials in perinatal-neonatal medicine: Outcome of Abstracts Submitted for Annual Conference of The American Pediatric Society and The Society for Pediatric Research - Limited to Randomized Control Trials in Neonatology

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Wail R, Orison A
Abstract
Introduction:

Objectives: To study the outcome (whether published or not) of abstracts submitted for the annual conference of the American Pediatric Society and the Society for Pediatric Research (APS-SPR), related to neonatal care, limiting our study to randomized control trials.

Methods: All randomized control trials (RCT), in neonatal medicine, published in the program issue of 1993 and 1994 were identified by manual hand searching. Medline, Embase and Cochrane library were searched to identify subsequent publication of these studies by names of individual authors and subject titles, till March 1999, i.e. 5 years or more from the time of initial presentation.

Results: For 1993 and 1994 APS-SPR annual conference 141 abstracts involving RCT were submitted in the Neonatology and related subspecialties. 107 (75 % of submitted abstracts) were accepted for presentation (poster session 74, poster symposium 7, subspecialty platform 21, joint subspecialty platform 3, joint poster session 2). There were 4 (median value) authors per study (range 1 to >13). Out of all submissions 51 % of abstracts included 30 or less number of enrolled cases. Only 73 (51%) studies were fully published till March 1999 (of all published studies, 38% within 1 year, 64% within 2 years, and 90% by 4 years of initial submission). 64% were fully published with new title (modified or different) and 46% with different (increased) number of authors. 57% of full publications had 5 or less number of authors. 15% of abstracts not presented at the conference were fully published. 39% of all published studies were with different numbers of enrolled patients. One full publication was presented in two poster sessions.

Discussion: Randomized control trial is widely accepted in research to provide an answer to a study hypothesis. This endeavor highlights that the outcome (in terms of full publication) of a RCT is quite variable. One must be cautious if including abstracts in meta-analysis, before its fate is finally decided. Early in depth planning and selection of study hypothesis plays very important role in final outcome of the study undertaken.