The value of CONSORT in interpreting dramatic findings
Sir, we read with great interest the paper by Kiss et al  and were
struck by the dramatic difference in outcomes between the intervention and
control arms. We did, however, notice that there was a difference in
adverse outcomes in women who did not have infection present on screening
and thus did not have any ‘active’ treatment as well as in women who did
have infection. Tables 4 and 5 suggest that there were 81 pre-term births
in women in the control group who without infection compared with 48 pre-
term births in women without infection in the intervention group. It is
unconvincing to attribute the differences to some non-specific effect of
additional care as, in general, increased care does not seem to
significantly affect obstetric outcomes. This implies that the difference
in outcomes between the two groups may be due to other reasons that the
study has not highlighted.
We note that 68 patients were excluded after randomisation as they
‘did not fulfil inclusion criteria’ and 140 patients were lost to follow-
up whilst these numbers are small compared to the study group they may
have had a significant bearing on the outcomes. If those who failed the
inclusion criteria were actually symptomatic of infection on closer
questioning then the study results might be biased. A ‘consort’, style
flow chart with information about the losses to follow up by treatment
allocation would assist the reader in interpreting the results of this
study, as would information about any intention to treat analysis.
We would value a response from the authors to our questions about
what appears to be an interesting and thought provoking piece of research.
Dr Helen Stokes-Lampard, Dr Jonathan Mant, Dr Angela Newnham, Dr
Amanda Daley, Dr John Macleod, Dr Richard Mc Manus
1.Herbert Kiss, Ljubomir Petricevic, and Peter Husslein. Prospective
randomised controlled trial of an infection screening programme to reduce
the rate of preterm delivery
BMJ 2004; 329: 371- 0
2 Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al.
Improving the quality of reporting of randomized controlled trials: the
CONSORT statement. JAMA 1996;276:637-9.
Competing interests: No competing interests