A RESPONSE LETTER TO DRS. HAUSDORFF AND YOGEV

Abstract

To the Editor: We welcome the comments of Drs. Hausdorff and Yogev. We agree that the wording of the text requires clarification with respect to the role of cognitive functions. We are aware that cognitive functions are important risk factors for falls and related injuries. The purpose of the consensus exercise was to determine and develop operational definitions for the primary outcomes of fall prevention trials and develop a framework for macro-evaluation.1 It was not our purpose to make recommendations about the treatments that should be used to reduce falls, serious injury, and other major consequences of falls. For fall- and injury-prevention interventions, the consensus was that cognitive functions, akin to changes in balance and postural stability, are intermediary measures and do not provide proof, in themselves, that interventions reduce falls and serious injuries. Not all studies will target cognitive functions or recruit populations in which cognitive functions are impaired. Whether cognitive risk factors for falling are modifiable is an unanswered question, but ultimately the reduction of falls, serious injuries, and major consequences is the issue of primary importance for clinical trials. A separate scenario is trials of interventions that aim to improve cognitive impairment and reduce dementia and in which falls and serious injuries should be recorded as a safety or secondary measure. Several new classes of medications might affect falls (either by increase or decrease) (e.g.,2,3), and we would encourage investigators in these fields to adopt our methodology for measuring falls outcome. In summary, as stated in the consensus paper, measures of cognitive function should be included at baseline to allow adequate description of the sample. The optimal methods for doing this will be considered in a future revision of the statement, and we welcome wide involvement in this process. Cognitive function may have a role as an intermediary outcome measure in some trials, depending on the intervention being tested, the context, and availability of funding. However, we stand by our decision that cognitive impairment cannot be recommended as a primary outcome of generic importance to all trials that aim to reduce falls and fall-related injury. The authors are participants in the ‘Prevention of Falls Network Europe (ProFaNE)’ Thematic Network; which is a project within Key Action #6 (The Ageing Population and their Disabilities), part of the European Union's Quality of Life and Management of Living Resources Programme, funded by the European Commission (QLRT-2001-02705). Financial Disclosure(s): The authors have no further financial disclosures or any conflicts of interest to report. Author Contributions: Lamb and Becker co-wrote the response. Sponsor' Role: The content of the manuscript does not represent the opinion of the European Community and the Community is not responsible for any use that might be made of the information presented in the text.