CRITICAL APPRAISAL OF REAL WORLD EVIDENCE – A REVIEW OF RECOMMENDED AND COMMONLY USED TOOLS

Author(s)

Quigley JM1, Thompson JC2, Halfpenny NJ3, Scott DA2
1ICON Clinical Research UK Ltd, Abingdon, UK, 2ICON, Oxford, UK, 3ICON Health Economics, Abingdon, UK

OBJECTIVES: In an absence of randomized controlled trials (RCTs) and to verify RCT evidence, health technology assessment (HTA) agencies commonly rely on real-world (RW) studies to provide efficacy evidence  for healthcare interventions. RW study designs can introduce considerable bias into a systematic review (SR) and several methodologies exist to evaluate the risk of bias in such studies. We conducted a series of reviews to identify which tools are commonly used and which are recommended by HTA bodies. METHODS: A targeted search of SRs including RW studies, conducted in MEDLINE and EMBASE (OVID SP), identified reviews published January 2013-June 2015. Studies identified were reviewed to determine which appraisal tool was used. Secondly, recommendations for the critical appraisal of RW studies by expert review groups (Cochrane, CRD) and HTA bodies (NICE, SMC, NCPE, AWMSG, IQWiG, PBAC, AMCP, AHRQ and CADTH) were reviewed.  RESULTS:

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PRM9

Topic

Clinical Outcomes

Topic Subcategory

Clinical Outcomes Assessment

Disease

Multiple Diseases

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