Objectives: To obtain consensus-based agreement on a classification system of adverse events (AE) following cervical spinal manipulation. The classification system should be comprised of clear definitions, include patients' and clinicians' perspectives, and have an acceptable number of categories.
Methods: Design: A three-round Delphi study. Participants: Thirty Dutch participants (medical specialists, manual therapists, and patients) participated in an online survey. Procedure: Participants inventoried AE and were asked about their preferences for either a three- or a four-category classification system. The identified AE were classified by two analysts following the International Classification of Functioning, Disability and Health (ICF), and the International Classification of Diseases and Related Health Problems (ICD-10). Participants were asked to classify the severity for all AE in relation to the time duration.
Results: Consensus occurred in a three- category classification system. There was strong consensus for 16 AE in all severities (no, minor, and major AE) and all three time durations [hours, days, weeks]. The 16 AE included anxiety, flushing, skin rash, fainting, dizziness, coma, altered sensation, muscle tenderness, pain, increased pain during movement, radiating pain, dislocation, fracture, transient ischemic attack, stroke, and death. Mild to strong consensus was reached for 13 AE.
Discussion: A consensus-based classification system of AE is established which includes patients' and clinicians' perspectives and has three categories. The classification comprises a precise description of potential AE in accordance with internationally accepted classifications. After international validation, clinicians and researchers may use this AE classification system to report AE in clinical practice and research.