CHARTing a Path to Pragmatic Tobacco Treatment Research

Abstract

Introduction 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. Methods 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. Results 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. Conclusions 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.

Application of an adapted PRECIS-2 instrument to assess efficacy- and effectiveness-study designs in a systematic review of intervention studies of the hepatitis C virus-care continuum among people who use drugs

“…Some studies have utilized composite PRECIS-2 scores for each report in metaregression, rather than examining each domain as a distinct covariate. 30,37 This study is subject to limitations. One limitation is that the systematic review examined only reports that specifically included PWUD and that reported data for PWUD separately.…”

“…Although primarily intended to assist in study design, PRECIS-2 has also been applied post hoc to assess for the degree of efficacy or effectiveness in published trials. 8,37 We have modestly adapted the PRECIS-2 instrument to allow post hoc assessments of where on an efficacy-effectiveness spectrum studies identified and included in this systematic review of outcomes of the steps of the HCV-care continuum lie. 84 We have now applied this adapted instrument in the context of this systematic review of outcomes of the steps of the HCV-care continuum.…”

“…While wheel charts have been utilized in reviews of modest numbers of publications, 36,37 they lose their visual clarity and potency as the number of reviewed reports increases. It becomes impractical either to depict each paper separately or as superimposed wheel charts.…”

“…The PRECIS-2 instrument is a useful, validated tool intended to guide study design and characterize degrees of efficacy and effectiveness in studies, and it has been applied to trial design in various settings and a few post hoc analyses. 30,[36][37][38] PRE-CIS-2 has been shown to have good interrater reliability. 39 The nine domains of PRECIS-2 are eligibility, recruitment, setting, organization, flexibility of delivery, flexibility of adherence, follow-up, outcome, and analysis.…”

Use of the PRECIS-II instrument to categorize reports along the efficacy-effectiveness spectrum in an hepatitis C virus care continuum systematic review and meta-analysis

“…[2] Further, while the PRECIS instruments (both the initially proposed PRECIS instrument and the subsequently revised PRECIS-II) have been mainly applied to randomized controlled trials, these instruments are being increasingly applied to a wider range of studies (including cluster-randomized trials, trials with factorial designs, and observational studies). [32–34]…”