Gruß Inga, Bunce Arwen, Davis James, Gold Rachel
Kaiser Permanente Center for Health Research, 3800 N. Interstate, Portland, OR, 97227, USA.
OCHIN, Inc., 1881 SW Naito Pkwy, Portland, OR, 97201, USA.
Implement Sci Commun. 2020 Nov 4;1(1):101. doi: 10.1186/s43058-020-00093-7.
Qualitative data are crucial for capturing implementation processes, and thus necessary for understanding implementation trial outcomes. Typical methods for capturing such data include observations, focus groups, and interviews. Yet little consideration has been given to how such methods create interactions between researchers and study participants, which may affect participants' engagement, and thus implementation activities and study outcomes. In the context of a clinical trial, we assessed whether and how ongoing telephone check-ins to collect data about implementation activities impacted the quality of collected data, and participants' engagement in study activities.
Researchers conducted regular phone check-ins with clinic staff serving as implementers in an implementation study. Approximately 1 year into this trial, 19 of these study implementers were queried about the impact of these calls on study engagement and implementation activities. The two researchers who collected implementation process data through phone check-ins with the study implementers were also interviewed about their perceptions of the impact of the check-ins.
Study implementers' assessment of the check-ins' impact fell into three categories: (1) the check-ins had no effect on implementation activities, (2) the check-ins served as a reminder about study participation (without relating a clear impact on implementation activities), and (3) the check-ins caused changes in implementation activities. The researchers similarly perceived that the phone check-ins served as reminders and encouraged some implementers' engagement in implementation activities; their ongoing nature also created personal connections with study implementers that may have impacted implementation activities. Among some study implementers, anticipation of the check-in calls also improved their ability to recount implementation activities and positively affected quality of the data collected.
These results illustrate the potential impact of qualitative data collection on implementation activities during implementation science trials. Mitigating such effects may prove challenging, but acknowledging these consequences-or even embracing them, perhaps by designing data collection methods as implementation strategies-could enhance scientific rigor. This work is presented to stimulate debate about the complexities involved in capturing data on implementation processes using common qualitative data collection methods.
ClinicalTrials.gov, NCT02325531 . Registered 15 December 2014.
定性数据对于记录实施过程至关重要，因此对于理解实施试验结果是必要的。获取此类数据的典型方法包括观察、焦点小组和访谈。然而，对于这些方法如何在研究人员和研究参与者之间产生互动，进而可能影响参与者的参与度，以及实施活动和研究结果，却很少有人考虑。在一项临床试验的背景下，我们评估了持续的电话随访以收集关于实施活动的数据是否以及如何影响所收集数据的质量，以及参与者对研究活动的参与度。
在一项实施研究中，研究人员与作为实施者的诊所工作人员进行定期电话随访。在该试验进行约1年后，询问了其中19名研究实施者这些电话对研究参与度和实施活动的影响。还采访了通过与研究实施者进行电话随访收集实施过程数据的两位研究人员，了解他们对随访影响的看法。
研究实施者对随访影响的评估分为三类：（1）随访对实施活动没有影响；（2）随访起到了关于参与研究的提醒作用（但对实施活动没有明显影响）；（3）随访导致了实施活动的变化。研究人员同样认为电话随访起到了提醒作用，并鼓励一些实施者参与实施活动；随访的持续性还与研究实施者建立了个人联系，这可能对实施活动产生了影响。在一些研究实施者中，对随访电话的预期也提高了他们叙述实施活动的能力，并对所收集数据的质量产生了积极影响。
这些结果说明了定性数据收集在实施科学试验期间对实施活动的潜在影响。减轻这种影响可能具有挑战性，但认识到这些后果——或者甚至接受它们，也许通过将数据收集方法设计为实施策略——可以提高科学严谨性。本文旨在引发关于使用常见定性数据收集方法获取实施过程数据所涉及的复杂性的讨论。
ClinicalTrials.gov，NCT02325531。2014年12月15日注册。
