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Introduction Spinal manipulation therapy (SMT) is used throughout the world by chiropractors, osteopaths, physiotherapists and other manual therapists, yet there are no systematic data collection mechanisms in place to monitor and evaluate adverse events (AE) that occur after SMT. We established a reporting and learning system (“SafetyNet”) to fill this void and to address several aims, one of which is a prospective population-based active surveillance study to (a) document AE after SMT, (b) identify potential risk factors, and (c) develop potential strategies to mitigate risk. The purpose of this paper is to describe the development and validation of provider and patient measurement instruments to identify potential SMT AE in provider offices. Methods Instrument development and validation occurred in a step-wise fashion: (1) definition of terms (e.g. adverse event, seriousness); (2) identification and development of key domains, items, and sub-items; and (3) assessment of relevant measurement properties. Results Two provider short instruments, a provider long instrument, and a pre and post treatment patient comment instruments were developed, refined, and pilot tested with 12 providers and 300 patients. Conclusions 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 rigorous prospective assessment of potential SMT-related AEs and their risk factors, thus enhancing patient safety and the promotion of a safety culture. Placing the instruments in providers’ offices for use on consecutive patients is next on the SafetyNet research agenda.

IntroductionA team of interdisciplinary research leaders have taken a novel approach to support a patient safety culture for spinal manipulation therapy (SMT) providers. The aim was to devise a team-based approach to identify modifiable and non-modifiable patient and provider risk factors.MethodsSafetyNET has four main areas of inquiry, led by five principal investigators. The SafetyNET initiative began with qualitative research regarding patient safety, including identification of potential facilitators and barriers to patient safety research. Simultaneously, a health law team is conducting research to identify potential barriers to patient safety research, including the risk of litigation.ResultsFeedback from both the qualitative and health law team is informing the development and implementation of an active surveillance reporting and learning system. This information in turn, helps inform our basic science team toward investigation of the potential mechanism of action for SMT-related adverse events.ConclusionOne outcome of the SafetyNET initiative is to provide a model for other disciplines and jurisdictions with respect to improving safety in procedures common to several regulated health disciplines.This article belongs to the Special Issue: Ensuring and Improving Patients Safety in Integrative Health Care.