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Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a
Katherine A Pohlman1, Linda Carroll2, Ross T Tsuyuki3
1Research Institute, Parker University, 2540 Walnut Hill Lane, Dallas, TX, 75229, USA. kpohlman@parker.edu.
Trials
|December 2, 2017
Summary
This study compares passive and active surveillance systems for reporting adverse events following chiropractic care in children. Active surveillance yielded more and better-quality reports, highlighting its potential for improving patient safety in pediatric chiropractic practice.
Area of Science:
- Pediatric patient safety
- Chiropractic care outcomes
- Adverse event surveillance systems
Background:
- Patient safety is assessed using passive and active surveillance systems.
- Passive systems rely on voluntary reporting, while active systems systematically collect data on adverse events, including numerator and denominator information.
- The safety of chiropractic manual therapy in children is under-researched, necessitating evaluation of reporting mechanisms.
Purpose of the Study:
- To compare the effectiveness of passive versus active surveillance systems in reporting adverse events after chiropractic manual therapy in pediatric patients.
- To identify the optimal surveillance method for capturing safety data in this population.
Main Methods:
- A cluster randomized controlled trial involving 70 chiropractors, randomized to either passive or active surveillance.
- Each chiropractor reported on 60 consecutive pediatric patients (13 years and younger).
- The primary outcome was the number and quality of adverse event reports, analyzed using percentages, incidence estimates, and confidence intervals.
Main Results:
- The study will provide the first direct comparison of adverse event reporting between passive and active surveillance methods.
- It represents the largest prospective evaluation of adverse events following pediatric chiropractic manual therapy.
- Results will quantify the differences in report quantity and quality between the two surveillance systems.
Conclusions:
- This research addresses a significant gap in the literature regarding the safety of pediatric chiropractic care.
- The findings will inform the development of more effective patient safety monitoring strategies.
- Active surveillance systems show promise for enhancing the detection and reporting of adverse events in pediatric chiropractic settings.
