Follow-up study for PROSPECT (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trial)
The lifetime risk of undergoing surgery for prolapse is nearly 10%. There are several different traditional surgical techniques, none of which have been properly evaluated. The initial study embedded two large RCTs investigating different surgical techniques for two distinct patient populations of women with vaginal prolapse (primary and secondary) within a comprehensive cohort of all patients. The economic evaluation investigated the costs and cost-effectiveness of the interventions from the perspective of the NHS and for the women and their families. Information on the cost of the intervention and the use of primary and secondary NHS services by the women (including referral for specialist management) were collected, as were personal costs to the women (such as costs of travelling to appointments and work/social restrictions). Trial participants were asked to complete the EQ–5D at baseline and at 6, 12 and 24 months after randomisation, and responses were used to compute QALYs. In a sensitivity analysis, QALYs were also estimated from the SF–12 completed at the same time points.
Since the long-term effects of the treatments are not known, participants are being followed up over an extended period of five years. These longer-term data will be used to update model based estimates of cost-effectiveness that were previously derived by extrapolation of the data observed to 24 months.
External collaborators: C. Glazener, A. Grant, J. Norrie, G. MacLennan, A. McDonald, G. McPherson (Health Services Research Unit (HSRU), University of Aberdeen); A.R.B. Smith, (St. Mary’s Hospital Manchester); R.M. Freeman (Plymouth Hospital NHS Trust); C. Bain, K. Cooper (NHS Grampian); S. Hagan (Glasgow Caledonian University); I.B.G. Montgomery (Aberdeen).