P02.30
Purpose: Although spinal manipulation therapy (SMT) is used throughout the world, there are no systematic data collection mechanisms in place to monitor and assess adverse events (AE) after SMT. SafetyNet, a multidisciplinary research team, has established a reporting and learning system to fill this void.
Methods: Development and validation occurred in a step-wise fashion: 1) definition of relevant terms (adverse event, seriousness, causality/relatedness, preventability, patient disposition); 2) identification and development of key domains, items, and sub-items (to assess the relationship between exposure and outcome and to be feasible to complete); and 3) assessment of relevant measurement properties (content validity, hypotheses testing, internal consistency, structural validity, cross-cultural validity, criterion validity, responsiveness).
Results: Two provider short forms, a provider long form, and a patient comment form were developed, refined, and pilot tested with 12 providers and 300 patients. Given that terminology differs amongst SMT professions, two provider forms were designed to be profession-specific. The provider long form is designed to be completed for all moderate, serious, or severe patient reported AEs. These forms contain mostly text boxes to allow for narrative descriptions. The patient comment form is two-sided and designed to collect information on satisfaction and potential AEs after the SMT visit from the patient perspective. Pilot testing refined the forms to versions which providers and patients found reasonable to complete, as well as collected necessary information to assess AEs according to the relevant terms.
Conclusion: The development and validation of instruments to evaluate SMT AEs may benefit the SMT research community as well as clinicians and their patients by providing the opportunity for rigorous prospective assessment of potential SMT-related AEs and their risk factors, thus enhancing patient safety and promotion of a safety culture. Placing the instruments in providers' offices for use on consecutive patients is next on the SafetyNet research agenda.
Contact: Katherine Pohlman, pohlman@ualberta.ca
