Evaluating Pragmatism of Lung Cancer Screening Randomized Trials with the PRECIS-2 Tool.

Abstract

Objective: Lung cancer screening (LCS) implementation has been challenging for community and rural primary care settings. One contributing factor may be that the randomized clinical trials (RCTs) that form the evidence base are guided by explanatory methods not reflective of primary care settings. This study applied the PRagmatic Explanatory Continuum Indicator Summary (PRECIS - 2) tool to determine the pragmatism of LCS RCTs envisioned through a decentralized, primary care lens.

Methods: LCS RCTs were identified from efficacy meta-analyses, and the VA Demonstration Project was chosen as a nonrandomized multi-center comparator case. Two independent raters evaluated PRECIS-2 domains for each trial. Ratings were completed on a 5-point scale, where 1 indicated completely explanatory and 5 indicated completely pragmatic. Mean PRECIS-2 scores were calculated for each study and each domain. Descriptive information from raters' comments was used to describe differences between the most pragmatic and most explanatory RCTs.

Results: Eleven RCTs and the VA Demonstration Project were evaluated. Mean PRECIS-2 scores for each study ranged from 2.12 to 3.33, with the DLSCT rated the most explanatory and the Lung Screening Study and ITALUNG studies rated the most pragmatic. Six domains had a mean score <3, indicating more explanatory (eligibility, recruitment, setting, organization, staff flexibility, follow-up). The remaining 3 domains had mean scores >3, indicating more pragmatic (adherence, outcome, analysis).

Discussion: This approach of evaluating each study from a primary care lens demonstrated that LCS RCTs trended toward a more explanatory nature, incorporating considerable support and infrastructure that extend beyond the capacity of typical primary care settings in the US.