Monitoring self-reported adverse events : a prospective, pilot study in a UK osteopathic teaching clinic

Background: When obtaining informed consent osteopaths should explain to patients the potential risks from treatment. However, relevant literature is lacking in this area and none relates to a teaching clinic environment. Objective: The aim of this pilot study was to explore the feasibility of conducting a survey to determine which adverse events are reported most often by patients following treatment at an osteopathic teaching clinic. Subjects and methods: Adult patients with any ‘new’ complaint (not treated by manual therapy in the previous six months) were eligible. They completed a confidential two-part self-assessment questionnaire: data were recorded immediately prior to treatment and at 10 min, 1, 2, 3 and 7 days post-treatment. Patients, at each time-point, answered a health transition question and reported ‘additional effects of treatment’ on a 15-item check-list. Treatment was delivered by final year students following normal clinic procedures. Results: Sixty-three ‘new’ patients were recruited and treated. Part I data were provided by 60 (34F, 26 M); Part II data by 52 (29F, 23 M) participants. Presenting complaints most often affected the lower back (33%) or head/neck (20%); 48% were acute. Pain (83%), stiffness (47%) and/or lack of mobility (27%) were reported before treatment, as were various concomitant symptoms (e.g. headache, light headedness, vision disturbances). Post-treatment, all but four patients reported at least one ‘additional effect of treatment’ at least once: from all 5 time-points the total number of reports was 535. Local pain, local stiffness and worsening of the presenting complaint were most common (24.3%, 18.3% and 11.8% of all reports, respectively), peaking around 2 days post-treatment; 96% of reports were rated mild or moderate. Fifty-nine percent of patients noted some improvement in the presenting complaint at 10 min; this increased to 80% at 7 days post-treatment (n=47). Conclusions: Collecting adverse events data in a busy osteopathic teaching clinic is feasible. This pilot study showed that local pain and local stiffness of slight or moderate severity are reported most often post-treatment. A validated, standardised questionnaire for monitoring adverse events is needed to facilitate the development of an evidence base for use in osteopathic training and practise