Comparison of active versus passive surveillance adverse event reporting in a paediatric ambulatory chiropractic care setting: a cluster randomised controlled trial

Abstract

Objectives: This pragmatic, cluster, stratified randomised controlled trial (RCT) compared the quantity and quality of adverse event (AE) reports after chiropractic manual therapy in children less than 14 years of age, using active versus passive surveillance reporting systems.

Method: Data were collected between November 2014 and July 2017 from 60 consecutive paediatric patient visits to participating chiropractors. Those allocated to active surveillance collected AE information with three paper-based questionnaires (two from patients, one from chiropractors) to identify any new or worsening symptoms after treatment. Passive surveillance involved AE information reported by chiropractors on a web-based system. To assess quality of reporting, AE reports greater than mild were reviewed by content experts. The primary outcome was the cumulative incidence of AE reports in active versus passive surveillance.

Results: Ninety-six chiropractors agreed to participate and enrolled in the study: 34 chiropractors in active surveillance with 1894 patient visits from 1179 unique patients and 35 chiropractors in passive surveillance with 1992 patient visits from 1363 unique patients. In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001). The quality of AE reports was not evaluated because the five AE reports reviewed by the content experts were determined to be of mild severity.

Conclusion: We found that active surveillance resulted in significantly more AE reports than passive surveillance. Further prospective active surveillance research studies should be conducted with children receiving chiropractic manual therapy to understand mechanisms and risk factors for moderate and severe AEs, and to further explore how and when to solicit patient safety information.

Keywords: Adverse events; Patient safety; Randomised controlled trial; epidemiology and detection.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

CONSORT flow diagram of participants in this cluster randomised trial.

Figure 2

Total number of AE reports by symptom, severity (mildˆ- solid; moderateˆˆ/severeˆˆˆ - dotted pattern) and age groups. ˆ Mild: the AE required self-care only (no further treatment sought/needed). ˆˆ Moderate: temporary limitation of age-appropriate activities of daily living (n=24), care was sought from a medical doctor (n=7), or both temporary limitation of age-appropriate activities of daily living and care was sought from a medical doctor (n=24). ˆˆˆ severe: limitation in self-care (eg, bathing, eating, dressing) (n=24) or need for urgent medical assessment (n=0). *- other symptoms reported by parent/caregiver: balance, blocked tear duck/eye blinking, eye pain, hoarseness, daytime enuresis, speech. AE, adverse event.