Defining adverse events in manual therapies

Abstract

Background:Definingwhat anadverse event is inmanual therapy is complexasperceptionsmaydifferbetweenpractitioners andpatients. Aim: To understand and identify constructs that provide meaning and describe adverse events in manual therapy and seek a consensus definition. Method: Firstly, an expert focus group was convened to identify issues surrounding the definition of adverse events and to generate constructs that may give meaning and description. Secondly, a modified Delphi consensus study was conducted with an expert panel (50) and patients (30) to seek an agreement about a pragmatic definition of adverse events for use by manual therapy practitioners. Results: There was a 50% response rate from experts for round one, 56% responded to round two and 60% of those responding to round 2 replied to round 3. Patients completed round one and round two only response rates were 90% and 80% respectively. Consensus at 75% or more, described major/moderate adverse events as severe, unacceptable, unexpected, requires further intervention, serious, distressing. Minor and not adverse events were described as expected, non serious, function remains in tact, transient/ reversible, short term duration, no treatment alterations required, short term consequences and contained. Additionally patients used the terms mild and acceptable. Using a cut off of 75% consensus or over, major adverse events were long term (weeks) and medium or severe in intensity, or medium term (days) and severe in intensity. Moderate adverse events were described as long term and mild in intensity, or medium term and moderate severity. Short term (hours) and mild intensity reactions were regarded as mild adverse events or not adverse at all. Conclusions: There were no major differences in consensus agreements between patients and experts. Participants found classifying adverse events difficult without context or detail. Classifying reactions to treatment may be improved by used the defining criteria identified in this study. Acknowledgements: National Centre for Osteopathic Research, UK for funding, Brenda Mullinger, European School of Osteopathy (collaborator) and to the Expert panel.