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Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial

机译：儿科整脊手法治疗后主动或被动不良事件报告：一项整群随机对照试验的研究方案

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Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13?years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance level, the sample size was calculated to be 35 providers in each group, which includes an 11% lost to follow-up of chiropractors and 20% of patient visits. This study will be the first direct comparison of adverse event reporting using passive versus active surveillance. It is also the largest prospective evaluation of adverse events reported after chiropractic manual therapy in children, identified as a major gap in the academic literature. ClinicalTrials.gov, ID: NCT02268331 . Registered on 10 October 2014.
机译：可以使用多种系统评估患者的安全绩效，包括被动和主动监视。被动监视系统为医护人员提供了机密和自愿报告其工作环境中发生的事件（包括不良事件）的机会。主动监视系统可以系统地监视患者的遭遇，以获取有关工作环境中发生的不良事件的详细信息;与被动监视不同，主动监视可以收集分子（不良事件的数量）和分母（所见患者的数量）数据。成人和儿童都普遍使用脊骨疗法，但很少有研究评估脊骨疗法对儿童的安全性。为了评估这一点，本研究将比较小儿脊骨推拿手法治疗后的被动和主动监测系统中的不良事件报告。这项整群随机对照试验旨在招募70名脊骨治疗医师（随机分组）参加被动或主动监视系统，以报告在连续60例儿科（13岁及以下）患者就诊（单位为）后发生的不良事件。分析）。将采用两阶段同意程序进行修改的注册过程，以保持提供者的盲目性并最大程度地减少辍学。同意的第一阶段是让提供者在研究脊椎按摩手法安全性的试验中确认其兴趣。第二阶段确保他们了解随机分组的特定要求。百分比，发生率估计值和95％置信区间将用于描述每组中报告的不良事件的计数。主要结果将是主动和被动监视组中不良事件报告的数量和质量。以80％的功效和5％的单方面显着性水平，每组样本量计算为35名提供者，其中包括11％的脊椎治疗师失访和20％的患者就诊。这项研究将是使用被动监视与主动监视进行不良事件报告的首次直接比较。这也是在儿童脊骨按摩治疗后报道的最大的不良事件前瞻性评估，被认为是学术文献中的主要空白。 ClinicalTrials.gov，ID：NCT02268331。 2014年10月10日注册。

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