Cruvinel Erica, Richter Kimber P, Stoney Catherine, Duffy Sonia, Fellows Jeffrey, Harrington Kathleen F, Rigotti Nancy A, Sherman Scott, Tindle Hilary A, Shireman Theresa I, Shelley Donna, Waiwaiole Lisa, Cummins Sharon
Department of Psychology, Federal University of Juiz de Fora, Minas Gerais, Brazil.
Department of Preventive Medicine and Public Health and The University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas.
Am J Prev Med. 2016 Oct;51(4):630-6. doi: 10.1016/j.amepre.2016.05.025.
It is important to consider the degree to which studies are explanatory versus pragmatic to understand the implications of their findings for patients, healthcare professionals, and policymakers. Pragmatic trials test the effectiveness of interventions in real-world conditions; explanatory trials test for efficacy under ideal conditions. The Consortium of Hospitals Advancing Research on Tobacco (CHART) is a network of seven NIH-funded trials designed to identify effective programs that can be widely implemented in routine clinical practice.
A cross-sectional analysis of CHART trial study designs was conducted to place each study on the pragmatic-explanatory continuum. After reliability training, six raters independently scored each CHART study according to ten PRagmatic Explanatory Continuum Indicator Summary (PRECIS) dimensions, which covered participant eligibility criteria, intervention flexibility, practitioner expertise, follow-up procedures, participant compliance, practitioner adherence, and outcome analyses. Means and SDs were calculated for each dimension of each study, with lower scores representing more pragmatic elements. Results were plotted on "spoke and wheel" diagrams. The rating process and analyses were performed in October 2014 to September 2015.
All seven CHART trials tended toward the pragmatic end of the spectrum, although there was a range from 0.76 (SD=0.23) to 1.85 (SD=0.58). Most studies included some explanatory design elements.
CHART findings should be relatively applicable to clinical practice. Funders and reviewers could integrate PRECIS criteria into their guidelines to better facilitate pragmatic research. CHART study protocols, coupled with scores reported here, may help readers improve the design of their own pragmatic trials.
为了理解研究结果对患者、医疗保健专业人员和政策制定者的影响，考虑研究在解释性与实用性方面的程度很重要。实用性试验在现实世界条件下测试干预措施的有效性；解释性试验在理想条件下测试疗效。烟草推进研究医院联盟（CHART）是一个由七项由美国国立卫生研究院资助的试验组成的网络，旨在确定可在常规临床实践中广泛实施的有效项目。
对CHART试验研究设计进行横断面分析，以将每项研究置于实用性 - 解释性连续统一体上。经过可靠性培训后，六位评估者根据十个实用性解释性连续统一体指标摘要（PRECIS）维度独立对每项CHART研究进行评分，这些维度涵盖参与者资格标准、干预灵活性、从业者专业知识、随访程序、参与者依从性、从业者坚持性和结果分析。计算每项研究每个维度的均值和标准差，得分越低代表实用性元素越多。结果绘制在“辐条和轮盘”图上。评分过程和分析于2014年10月至2015年9月进行。
所有七项CHART试验都倾向于该范围的实用性一端，尽管范围从0.76（标准差 = 0.23）到1.85（标准差 = 0.58）。大多数研究都包含一些解释性设计元素。
CHART的研究结果应该相对适用于临床实践。资助者和评审者可以将PRECIS标准纳入他们的指南，以更好地促进实用性研究。CHART研究方案，再加上此处报告的分数，可能有助于读者改进他们自己实用性试验 的设计。
