Northwest Center to Reduce Oral Health Disparities, Department of Oral Health Sciences, Box 357475, University of Washington, Seattle, WA 98195-7475, USA.
BMC Oral Health. 2014 Feb 24;14:15. doi: 10.1186/1472-6831-14-15.
BACKGROUND: Fidelity assessments are integral to intervention research but few published trials report these processes in detail. We included plans for fidelity monitoring in the design of a community-based intervention trial. METHODS: The study design was a randomized clinical trial of an intervention provided to low-income women to increase utilization of dental care during pregnancy (mother) or the postpartum (child) period. Group assignment followed a 2 × 2 factorial design in which participants were randomly assigned to receive either brief Motivational Interviewing (MI) or Health Education (HE) during pregnancy (prenatal) and then randomly reassigned to one of these groups for the postpartum intervention. The study setting was four county health departments in rural Oregon State, USA. Counseling was standardized using a step-by-step manual. Counselors were trained to criteria prior to delivering the intervention and fidelity monitoring continued throughout the implementation period based on audio recordings of counselor-participant sessions. The Yale Adherence and Competence Scale (YACS), modified for this study, was used to code the audio recordings of the counselors' delivery of both the MI and HE interventions. Using Interclass Correlation Coefficients totaling the occurrences of specific MI counseling behaviors, ICC for prenatal was .93, for postpartum the ICC was .75. Participants provided a second source of fidelity data. As a second source of fidelity data, the participants completed the Feedback Questionnaire that included ratings of their satisfaction with the counselors at the completion of the prenatal and post-partum interventions. RESULTS: Coding indicated counselor adherence to MI protocol and variation among counselors in the use of MI skills in the MI condition. Almost no MI behaviors were found in the HE condition. Differences in the length of time to deliver intervention were found; as expected, the HE intervention took less time. There were no differences between the overall participants' satisfaction ratings of the HE and MI sessions by individual counselor or overall (p > .05). CONCLUSIONS: Trial design, protocol specification, training, and continuous supervision led to a high degree of treatment fidelity for the counseling interventions in this randomized clinical trial and will increase confidence in the interpretation of the trial findings.
背景:保真度评估是干预研究的重要组成部分,但很少有已发表的试验详细报告这些过程。我们在一项基于社区的干预试验的设计中纳入了保真度监测计划。
方法:该研究设计是一项针对低收入妇女的干预措施的随机临床试验,旨在增加怀孕期间(母亲)或产后(儿童)期间利用牙科保健的频率。组分配遵循 2×2 析因设计,参与者随机分配在怀孕期间接受简短的动机访谈(MI)或健康教育(HE),然后随机重新分配到产后干预的其中一组。研究地点是美国俄勒冈州四个县卫生部门。咨询采用逐步手册进行标准化。在提供干预措施之前,培训顾问达到标准,并且在实施期间根据顾问-参与者会议的音频记录继续进行保真度监测。为这项研究修改的耶鲁依从性和能力量表(YACS)用于对 MI 和 HE 干预措施的咨询师交付情况进行编码。使用特定 MI 咨询行为的总出现次数的组内相关系数(ICC),产前的 ICC 为.93,产后的 ICC 为.75。参与者提供了保真度数据的第二个来源。作为保真度数据的第二个来源,参与者在完成产前和产后干预后完成了反馈问卷,其中包括对咨询师的满意度评分。
结果:编码表明咨询师遵守 MI 协议,并且在 MI 条件下咨询师使用 MI 技能的情况存在差异。在 HE 条件下几乎没有发现 MI 行为。干预措施交付时间长短存在差异;如预期的那样,HE 干预措施花费的时间更少。个别咨询师或总体上,参与者对 HE 和 MI 课程的总体满意度评分没有差异(p>.05)。
结论:试验设计、方案规范、培训和持续监督为这项随机临床试验中的咨询干预措施实现了高度的治疗保真度,并将增加对试验结果的解释的信心。
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