Background: Trials may address efficacy, i.e. intervention effects under ideal conditions, or effectiveness, i.e. intervention effects in real world circumstances. When systematic reviews are used to inform clinical or policy decisions, it is important to understand how applicable the evidence from the included trials is to the decision-maker’s context. Authors of systematic reviews can help by explaining where included trials are on the efficacy/effectiveness continuum.
Objectives: To develop a valid, comprehensive tool that informs systematic review readers about the placement of individual trials on the efficacy/effectiveness continuum.
Methods: We identified all relevant existing tools, then extracted the domains and the advantages and limitations of each tool as described in the literature. We conducted two online surveys with 72 stakeholders and organized two teleconferences and written consultations with 10 methodological experts to condense the domains and develop a draft of the tool. The feasibility and inter-rater reliability of the tool is being tested by piloting the tool with 10 trials included in three recent Cochrane complementary medicine reviews. The tool will be refined after piloting.
Results: The RITES (Rating Included Trials along the Efficacy-effectiveness Spectrum) tool consists of four domains: 1) participant characteristics; 2) trial setting; 3) flexibility of interventions; and 4) clinical relevance of interventions. Evidence from the trial is rated in each domain on a 5-point Likert scale along a continuum from maximum emphasis on efficacy to maximum emphasis on effectiveness. Piloting is ongoing and results will be presented.
Conclusions: RITES will help users of systematic reviews assess the ways in which the evidence from included trials provides pertinent information about effectiveness or efficacy. This will aid in the appropriate application of systematic review evidence in clinical practice or policy decisions.