Defining adverse events in manual therapies: A modified Delphi consensus study
Received 24 November 2008; received in revised form 9 February 2009; accepted 17 February 2009. published online 14 May 2009.
Abstract
A pragmatic agreed definition of adverse events in manual therapy is required to explore incidence and prevalence. We aimed to identify and describe such adverse events and seek a consensus definition.
A focus group identified issues surrounding the definition of adverse events and generated the content for a questionnaire. This questionnaire was used to conduct a modified Delphi consensus survey with an expert panel (n=50). Consensus was defined as >74% agreement. Three consensus rounds were executed.
There was a 50% response rate for round one, 62% for round two and 55% for round three. A layered pragmatic definition was agreed:
•‘Major’ adverse events are medium to long term, moderate to severe and unacceptable, they normally require further treatment and are serious and distressing;
•‘Moderate’ adverse events are as ‘major’ adverse events but only moderate in severity; and
•‘Mild’ and ‘not adverse’ adverse events are short term and mild, non-serious, the patient's function remains intact, and they are transient/reversible; no treatment alterations are required because the consequences are short term and contained.
We concluded that classifying adverse events was difficult without context or detail. Classification may be improved by using the taxonomy and descriptions suggested in this study.
aInstitute of Health Sciences Education, Centre for Health Sciences, Barts and The London School of Medicine and Dentistry, 2 Newark St, London E1 2AT, United Kingdom
bEuropean School of Osteopathy, Boxley House, Boxley, Maidstone, Kent, ME14 3DZ, United Kingdom
cWarwick Medical School, Coventry CV4 7AL, United Kingdom
ABSTRACT