Reporting of randomized clinical trial descriptors and use of structured abstracts

Abstract

Context: Structured abstracts, that is, abstracts that describe a study using requisite content headings, provide more informative content. Concomitant reporting in the text of the report might improve with structured abstract use because of increased awareness by authors or editors of important study areas associated with content headings.

Objective: To assess whether structured abstract use is associated with improved reporting of randomized clinical trials.

Design and setting: Survey of trial reports published the year preceding, of, and following new use of structured abstracts, found by hand searching Archives of Ophthalmology (1992-1994) and Ophthalmology (1991-1993), as well as trial reports published concurrently without change in abstract format (American Journal of Ophthalmology, 1991-1994).

Main outcome measures: We measured the inclusion of 56 criteria derived from Consolidated Standards of Reporting Trials (CONSORT) descriptors (JAMA 1996;276:637-639) in the text of each report and calculated the number of criteria included per report and the proportion of reports including individual criteria. Reports with structured abstracts were compared with those without, and reports published in 1993 and 1994 in the American Journal of Ophthalmology were compared with those published in 1991 and 1992.

Results: The mean (SEM) number of criteria included by authors was 15.8 (0.4) per report in 125 trial reports. We found no difference in the mean number of criteria included or the proportion of reports that included specific criteria by journal. Following structured abstract use, there was no difference in either the mean number of criteria per report or the proportion of reports including a majority of criteria within each CONSORT subheading. Four criteria were included more often and 2 less often following structured abstract use in individual journals.

Conclusion: Using CONSORT descriptor criteria to evaluate reporting quality, we found no difference in text reporting associated with structured abstract use in the journals examined.