EDITOR--Our paper on hernia repair produced much correspondence.[1 2] In response to the letter from Notaras we agree that patients unfit for general anaesthetic, and therefore not suitable for laparoscopic repair, would be suitable for local anaesthetic, and this is how we would treat them. We do not agree that the reduced pain after laparoscopic repair, the improved quality of life, and the faster return to work and other activities are unimportant to the patient. Our view that these constitute important improvements from the patients' perspective is borne out by our table showing patient satisfaction (table 6).
Rose et al point out the absence of serious complications in any of our patients. We state in our discussion that our trial was not powered to detect a difference in serious but rare complications. Good training is essential to avoid these. We have not experienced such complications (vascular injury, gut injury, etc) in over 1000 laparoscopic repairs. Figure 3 in our paper was coloured erroneously in the published article and an erratum has been printed. It shows that the patients having unilateral and bilateral laparoscopic repairs (unbroken lines) returned to normal activities more quickly than either the patients who had unilateral open repair or those who had bilateral open repairs (broken lines).
We congratulate Kark et al on their figures for return to work after open mesh repair. It is only fair to point out that their patients are self paying and may be under more pressure to return to work. They may also have a younger average age. We agree with Taylor et al that the hospital cost of laparoscopic repair may be reduced, and we have stated this at the end of the article.
Anayanwu and O'Riordan are concerned that trainees and consultants may not have a standardised surgical technique, but this is not the case. The operating technique was standardised and the surgeon designated before randomisation. We do not feel it was possible to blind surgeons, patients, and assessors in our trial as informed consent included the description of wounds and their position and the use of local anaesthetic for the open repair only. Can the authors tell us how blinding could have been achieved?
On the issue of whether observational studies are less biased than unblinded clinical trials, most of our outcomes were measured by questionnaires completed by the patients and did not require professional judgment.
In answer to Kernick and Reinhold, costing the difference between the treatments in recovery times (and hence in healthy time at work or undertaking other activities) is an area of methodological controversy.[3] However, we did present information on recovery times that would facilitate an estimate of differential productivity costs. The question of the relative cost effectiveness of the procedures has also been raised. We did not address this in the paper. Such an analysis requires assessment of the extent to which any additional cost of laparoscopic repair (and our sensitivity analysis showed this to be sensitive to the use of disposables with the procedure) is justified by an overall improvement in outcome. This requires outcomes to be valued on a single dimension and in generic units that can be compared with other uses of healthcare resources. Future research is currently being planned to address this question.
James Wellwood Consultant surgeon Whipps Cross Hospital, London E11 1NR
Mark Sculpher Senior research fellow Centre for Health Economics, University of York, York YO1 5DD
David Stoker Consultant surgeon North Middlesex Hospital, London N18 1QX dlstoker1@aol.com
[1] Wellwood J, Sculpher MJ, Stoker D, Nicholls GJ, Geddes C, Whitehead A, et al. Randomised controlled trial of laparoscopic versus open mesh repair of inguinal hernia: outcome and cost. BMJ 1998;317:103-10. (11 July.)
[2] Correspondence. Laparoscopic versus open mesh repair of inguinal hernia. BMJ 1999;318:189-91. (16 January.)
[3] Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost effectiveness in health and medicine. New York, NY: Oxford University Press, 1996.
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