WORK PACKAGE 1 - FALL PREVENTION TRIALS - THE NEED FOR A TAXONOMY OF INTERVENTIONS AND AGREED SET OF OUTCOMES.

Abstract

Introduction: Randomised Controlled Trials (RCTs) of interventions to reduce the incidence of falls have used a variety of methods to define and measure outcomes. A standardised approach to defining and measuring outcomes, and a shared taxonomy of interventions is a prerequisite to interpret and disseminate the findings of studies.

Method: We agreed to focus on five areas: falls, injuries, psychological consequences, physical activity and quality of life. A systematic literature review has been performed to identify outcome definitions currently used in RCTs and is focusing on the quality of outcome measures in terms of reliability, validity and acceptability. A consensus building process is being performed using a modified nominal group technique to define a core set of outcome definitions and measures, which can then be piloted in a number of sites across Europe. Where consensus cannot be achieved, suggestions are made for future research to develop and/or appraise new methods of measurement and these will feed into future revisions of the recommendations. The taxonomy of interventions is being developed in parallel with this process.

Results: The presentation will demonstrate how varying methods of defining falls can lead to a different interpretation of trial results and suggest a range of definitions than might be included in future trials. We consider the number of falls, number of fallers, time to first fall, and fractures per fall ratios as examples.

Conclusions: An agreed and standardised set of outcome definitions and measures is important to improve the robustness of data from intervention studies, will enable comparison across studies, good quality measurement in multi-centre trials, and facilitate meta-analysis of trial results. A taxonomy of interventions facilitates comparisons between studies, helps to determine the most effective components or sub-components of interventions, and aids the decision making process of policy makers and health insurance plans.