Objectives

• Investigate the extent to which the findings of randomised and non-randomised studies differ when conducted for the same clinical question and explore potential reasons for observed discrepancies, in particular choice of analytical method

• Assess whether different analytical methods used in non-randomised studies are likely to produce valid and unbiased estimates of relative effectiveness (a key input to economic evaluations)

• Provide findings as methodological recommendations that help HTA agencies, regulators and the wider research community and other interested stakeholders to analyse and interpret non-randomised data in economic evaluations 

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Methodology

• Perform a large-scale meta-epidemiological review to obtain estimates of the discrepancy in treatment effects in randomised and non-randomised studies using various analytical methods

• Develop empirically based recommendations that include input from international stakeholders gathered from a series of workshops

• Pilot test recommendations using published NICE guidance

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Outputs

• Deliverable D6.1: Meta-epidemiological comparison of effect sizes in matched studies [PDF]
   

• Deliverable D6.2: Recommendations on how to analyse and interpret non-randomised studies [PDF]
   

• Dataset: Effect estimates obtained from randomised and nonrandomised studies (available December 2022)

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Publications

• Kent S, Salcher-Konrad M, Boccia S, Bouvy JC, De Waure C, Espin J, Facey K, Nguyen M, Rejon-Parrilla JC, Jonsson P (2021). The use of nonrandomized evidence to estimate treatment effects in health technology assessment. Journal of Comparative Effectiveness Research https://doi.org/10.2217/cer-2021-0108