Use of real-world evidence in meta-analyses and cost-effectiveness models

Figures & data

Figure 1. Recommendations for the development of an real-world evidence meta-analysis protocol.

Table 1. RWE used as a key source of inputs.

Inputs	Sources
Patients characteristics	French real-world study^42
Clinical event rates for VKA	Real-world studies^13
Persistence rates for VKA	Real-world studies^43
Treatment effect for rivaroxaban	HRs from the RWE MA (incident and prevalent)^13
All-cause mortality	French life tables
Event-specific mortality	Real-world studies^44–47
Utility	European real-world studies^48–50
Costs	French real-world studies^44^,^51^,^52

Abbreviations. HR, Hazard ratio; MA, Meta-analysis; RWE, Real-world evidence; VKA, Vitamin K antagonist.

Figure 2. Recommendations for the development of an RWE cost-effectiveness model. Abbreviations. HTA, Health technology agency; RCT, Randomized controlled trial; RWD, Real-world data; RWE, Real-world evidence.

Table 2. Items related to relative treatment effect in existing tools to evaluate cost-effectiveness analyses.

Adams et al. (1992)^58	• Were direct incremental benefits measured correctly? • Were indirect incremental benefits measured correctly? • Were the incremental benefits adjusted appropriately for differential timing?
Sacristan et al. (1993)^59	• Are the data on the effectiveness of alternatives adequately established?
Drummond and Jefferson (1996)^56	• Are the sources of effectiveness estimates used stated? • Are details of the design and results of effectiveness study given (if based on a single study)? • Are details of the method of synthesis or meta-analysis of estimates given (if based on an overview of a number of effectiveness studies)?
Sculpher et al. (2000)^60 and Philips et al. (2006)^61	• If relative treatment effects have been derived from trial data, have they been synthesized using appropriate techniques? • Have alternative assumptions been explored through sensitivity analysis?
Ungar et al. (2003)^62	• Is effectiveness, rather than efficacy, assessed? • What approach is used to assess the effectiveness/efficacy? • Are the details of the design of the effectiveness/efficacy study(s) provided? • Are the results of the efficacy/effectiveness of alternatives reported?
Chiou et al. (2003)^63	• Were the health outcomes measures/scales valid and reliable? If previously tested valid and reliable measures were not available, was justification given for the measures/scales used?
Evers et al. (2005)^57	• Are all outcomes measured appropriately? • Are outcomes valued appropriately?
Drummond et al. (2005)^64	• Where data from different sources are pooled, is this done in a way that the uncertainty relating to their precision and possible heterogeneity is adequately reflected? • If data from other settings are used, have these been assessed for relevance in the settings of interest?
Husereau et al. (2013)^65	• If synthesis-based estimates, is there a full description of the methods used for identification of included studies and synthesis of clinical effectiveness data?
Caro et al. (2014)^66	• Are the data used in populating the model suitable for the decision problem? • Were the analyses performed using the model adequate to inform your decision problem?

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