An analysis of published trials found that current use of pragmatic trial labels is uninformative
August 18, 2022
Randomized trials labelled as “pragmatic” imply that the results are directly applicable to clinical care. IMPACT members Monica Taljaard, PhD, and Spencer Hey, PhD, examine use of the label and conclude that its current use is uninformative. They instead recommend that authors should clarify the decision and what the trial is intended to support and include a PRECIS (Pragmatic Explanatory Continuum Indicator Summary) – 2 table in their design.
Abstract
Objectives: Randomized trials labelled as “pragmatic” are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS [PRagmatic Explanatory Continuum Indicator Summary]-2 domains).
Study design and setting: We reviewed primary trial reports published 2014-2019, registered in ClinicalTrials.gov and using the pragmatic label anywhere in the report.
Results: Among 415 trials, the label was justified by reference to at least one design element in 282 (68.0%); of these, 240 (85.1%) referenced trial characteristics that can be mapped to one or more of the PRECIS-2 domains, most commonly eligibility (91, 32.3%), setting (90, 31.9%), flexibility delivery (89, 31.6%), and organization (75, 26.6%); 42 (14.9%) referenced characteristics that are not PRECIS-2 domains, most commonly type of intervention/comparator (48, 17%), recruitment without consent (22, 7.8%), routinely collected data (22, 7.8%), and cluster randomization (20, 7.1%). Most reports referenced only one or two design elements. Overall, 9/415 (2.2%) provided PRECIS wheels.
Conclusion: Current use of pragmatic labels is uninformative. Authors should clarify the decision the trial is intended to support and include a PRECIS-2 table to make the design transparent.