Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer

DESIGN:The research has the following inter-related components (a) Mapping of pathways for chosen treatment options, (b) Systematic literature review determining effectiveness and safety of the procedures, (c) Systematic review of economic evaluations, and (d) Statistical and economic modelling determining effectiveness, cost-consequences and cost-utility of the procedures. SEARCH STRATEGY:Extensive and comprehensive electronic searches will be conducted to identify reports of published studies. The highly sensitive search strategies will include appropriate subject headings and text word terms that reflect the clinical topic, interventions under consideration and included study designs. There will be no language restriction but searches will be restricted to the years 1995 onwards to reflect the introduction of the surgical techniques involved. The following databases will be searched: Medline, Medline In Process, Embase,CINAHL, Biosis, Science Citation Index, Cochrane Controlled Trials Register (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Review of Effectiveness (DARE) and the HTA database. Reference lists of all included studies will be scanned and appropriate experts will be contacted for details of additional reports. REVIEW STRATEGY: (1) Description of care pathway - informed by the project Panel of Experts, the protocol will map out care pathways, identifying key measures of clinical outcome and resource use. (2) Systematic review of the safety and effectiveness of the procedures - evidence from randomised controlled trials, non-randomised comparative studies and case series; the latter primarily for estimates of rare adverse events and longer-term effects, will be reviewed including estimation of learning curves using methods previously developed by this team. The quality of studies will be assessed using standard methods. Tabulated data will be meta-analysed using a Bayesian mixed method approach. (3) Economic modelling - the model structure will be based on the care pathways and detailed analysis of previous evaluations. A state transition model using multiple cohorts will be applied with Monte Carlo simulations. A formal value of information will be estimated for each parameter in the model to guide future research. EXPERTISE IN THE TEAM: The research project team is a strong, established and successful multi-disciplinary partnership between the Universities of Aberdeen and Newcastle with additional specialist expertise provided by experts in University of Cambridge and NHS centre for laparoscopic prostatectomy in Guildford. An expert panel has also been established and consists of patient representatives, a clinician with health service implementation management experience, established European and American users of the technology and clinicians with recent experience training towards competency in the procedures.