Study authors respond to points in editorialBMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2098 (Published 27 May 2009) Cite this as: BMJ 2009;338:b2098
- Nicky Cullum, deputy head of department (research)1,
- Martin Bland, professor of health statistics1,
- Jo Dumville, research fellow1,
- Cynthia Iglesias, senior research fellow1,
- Susan O’Meara, research fellow1,
- Marta Soares, research fellow1,
- David Torgerson, professor, director York trials unit1,
- Andrea Nelson, reader in wound healing and director of research2,
- Gill Worthy, trial statistician2
- 1Department of Health Sciences, University of York, York YO10 5DD
- 2School of Healthcare, University of Leeds
They do not like our selection of time to healing as the primary outcome in the larval therapy study, but debridement is practised precisely because it is thought to aid healing. They claim that debridement “is more valuable to clinicians,” but is it more valuable to patients if it is not associated with quicker healing? We are baffled by their declaration that “it may be unrealistic to use complete healing as the primary outcome measure in wound healing studies, and time to healing may be an equally valid outcome measure” because time to healing was our primary end point, and, anyway, both complete healing and time to healing rely on the occurrence of healing.
We used extremely broad inclusion criteria for the larval therapy trial. The main reason for exclusion was that debridement was unnecessary and therefore large numbers of eligible people were not excluded. Since the economic evaluation was planned at the outset and all relevant economic data were collected in the trial, we are confident in its results.
Grey and colleagues seem to believe that systematic reviews are unhelpful as they conclude that more research is needed and randomised trials which measure healing as the outcome are unhelpful because they do not demonstrate treatment effects. Simply put, patients with wounds deserve treatments based on research evidence as good as that required for the rest of health care, despite the best efforts of some in the field to promote the abandonment of the randomised controlled trial5 and the application of the results of animal studies to clinical decision making.6
Cite this as: BMJ 2009;338:b2098
Competing interests: AN has a PhD student funded by, and has been reimbursed for speaking at educational events by, Convatec UK, a manufacturer of wound products. The remaining authors declare that they have no competing interests.