Abstract
Item 1b - Structured summary of trial design, methods, results, and conclusions
For specific guidance see CONSORT for abstracts.(45) (65)
Explanation
Clear, transparent, and sufficiently detailed abstracts are important because readers often base their assessment of a trial on such information. Some readers use an abstract as a screening tool to decide whether to read the full article. However, as not all trials are freely available and some health professionals do not have access to the full trial reports, healthcare decisions are sometimes made on the basis of abstracts of randomised trials.(66)
A journal abstract should contain sufficient information about a trial to serve as an accurate record of its conduct and findings, providing optimal information about the trial within the space constraints and format of a journal. A properly constructed and written abstract helps individuals to assess quickly the relevance of the findings and aids the retrieval of relevant reports from electronic databases.(67) The abstract should accurately reflect what is included in the full journal article and should not include information that does not appear in the body of the paper. Studies comparing the accuracy of information reported in a journal abstract with that reported in the text of the full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69) (70) (71) Conversely, omitting important harms from the abstract could seriously mislead someone’s interpretation of the trial findings.(42) (72)
A recent extension to the CONSORT statement provides a list of essential items that authors should include when reporting the main results of a randomised trial in a journal (or conference) abstract (see table 2).(45) We strongly recommend the use of structured abstracts for reporting randomised trials. They provide readers with information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation.(73) Some studies have found that structured abstracts are of higher quality than the more traditional descriptive abstracts (74) (75) and that they allow readers to find information more easily.(76) We recognise that many journals have developed their own structure and word limit for reporting abstracts. It is not our intention to suggest changes to these formats, but to recommend what information should be reported.
Table 2 - Items to include when reporting a randomised trial in a journal abstract
| Item | Description |
|---|---|
| Authors | Contact details for the corresponding author |
| Trial design |
Description of the trial design (such as parallel, cluster, non-inferiority) |
| Methods: | |
| Participants | Eligibility criteria for participants and the settings where the data were collected |
| Interventions | Interventions intended for each group |
| Objective | Specific objective or hypothesis |
| Outcome | Clearly defined primary outcome for this report |
| Randomisation | How participants were allocated to interventions |
| Blinding (masking) | Whether participants, care givers, and those assessing the outcomes were blinded to group assignment |
| Results: | |
| Numbers randomised | Number of participants randomised to each group |
| Recruitment | Trial status |
| Numbers analysed | Number of participants analysed in each group |
| Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision |
| Harms | Important adverse events or side effects |
| Conclusions | General interpretation of the results |
| Trial registration | Registration number and name of trial register |
| Funding | Source of funding |
Page last edited: 24 March 2010
