The influence of centre selection on the generalisability of economic evaluations conducted alongside randomised controlled trials: a case study from the Rossini trial

Gheorghe, Adrian (2014). The influence of centre selection on the generalisability of economic evaluations conducted alongside randomised controlled trials: a case study from the Rossini trial. University of Birmingham. Ph.D.

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Abstract

The thesis investigated the influence of centre selection on the generalisability across locations of trial-based economic evaluations. A novel methodology to assess and enhance the generalisability of trial findings was demonstrated using the comparison between wound-edge protection devices (WEPDs) and standard care to reduce surgical site infection (SSI) after open abdominal surgery as a case study. A systematic review and a preliminary economic model suggested that WEPDs may be effective and cost-effective in reducing SSI compared to standard care, although the methodological quality of available studies was poor. ROSSINI was a high quality multi-centre randomised controlled trial (RCT) which demonstrated that WEPDs are unlikely to be effective or cost-effective, so their routine use cannot be recommended. The impact of centre selection on trial results was then investigated using ROSSINI as a case study. Mixed methods research demonstrated that most RCTs do not enrol centres so as to ensure a representative sample at jurisdiction level. The Generalisability index (Gix) was introduced as the basis of a novel methodology to assess generalisability, which was demonstrated using simulation methods and ROSSINI data. The results suggested that the characteristics of the sample of participating centres can significantly affect RCT clinical and cost-effectiveness estimates.

Type of Work:

Thesis (Doctorates > Ph.D.)

Award Type:

Doctorates > Ph.D.

Supervisor(s):