Kranenburg Hendrikus A, Lakke Sandra E, Schmitt Maarten A, Van der Schans Cees P
Research Group Healthy Ageing, Allied Health Care and Nursing, Hanze University of Applied Sciences, Groningen, The Netherlands.
Department of Rehabilitation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
J Man Manip Ther. 2017 Dec;25(5):279-287. doi: 10.1080/10669817.2017.1332556. Epub 2017 May 31.
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.
: A three-round Delphi study. : Thirty Dutch participants (medical specialists, manual therapists, and patients) participated in an online survey. : 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.
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.
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.
就颈椎手法治疗后不良事件（AE）的分类系统达成基于共识的一致意见。该分类系统应包括明确的定义，涵盖患者和临床医生的观点，且类别数量可接受。
开展三轮德尔菲研究。30名荷兰参与者（医学专家、手法治疗师和患者）参与在线调查。参与者列出不良事件，并被问及对三类或四类分类系统的偏好。两名分析人员根据《国际功能、残疾和健康分类》（ICF）以及《国际疾病及相关健康问题分类》（ICD - 10）对确定的不良事件进行分类。要求参与者根据持续时间对所有不良事件的严重程度进行分类。
在三类分类系统中达成了共识。对于所有严重程度（无、轻度和重度不良事件）以及所有三个时间段[小时、天、周]的16种不良事件，存在强烈共识。这16种不良事件包括焦虑、脸红、皮疹、昏厥、头晕、昏迷、感觉改变、肌肉压痛、疼痛、运动时疼痛加剧、放射性疼痛、脱位、骨折、短暂性脑缺血发作、中风和死亡。对于13种不良事件达成了轻度至强烈的共识。
建立了一个基于共识的不良事件分类系统，该系统涵盖患者和临床医生的观点，分为三类。该分类根据国际公认的分类对潜在不良事件进行了精确描述。经过国际验证后，临床医生和研究人员可在临床实践和研究中使用此不良事件分类系统来报告不良事件。
