Pragmatic Free Trial Meta
Pragmatic Free Trail Meta is an open data platform that enables research into pragmatic trials. It collects and distributes cleaned trial data, ratings, and evaluations using PRECIS-2. This allows for diverse meta-epidemiological studies to evaluate the effects of treatment across trials of various levels of pragmatism.
Background
Pragmatic trials are becoming more widely acknowledged as providing evidence from the real world for clinical decision-making. The term "pragmatic", however, is not used in a consistent manner and its definition and measurement require further clarification. Pragmatic trials are designed to guide the practice of clinical medicine and policy decisions rather than prove a physiological or clinical hypothesis. A pragmatic trial should also aim to be as similar to actual clinical practice as possible, such as the participation of participants, setting up and design of the intervention, its delivery and execution of the intervention, as well as the determination and analysis of the outcomes, and primary analysis. This is a major distinction from explanation trials (as described by Schwartz and Lellouch1) which are designed to provide more thorough confirmation of a hypothesis.
Studies that are truly pragmatic must be careful not to blind patients or clinicians in order to lead to bias in estimates of the effect of treatment. Practical trials also involve patients from various health care settings to ensure that their results can be generalized to the real world.
Furthermore, trials that are pragmatic must concentrate on outcomes that are important to patients, such as the quality of life and functional recovery. This is especially important for trials involving the use of invasive procedures or potential for serious adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients with chronic heart failure. The catheter trial28 however, used symptomatic catheter associated urinary tract infection as the primary outcome.
In addition to these characteristics, pragmatic trials should minimize the procedures for conducting trials and requirements for data collection to cut down on costs and time commitments. Finally pragmatic trials should strive to make their findings as applicable to clinical practice as possible by making sure that their primary analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).
Many RCTs that don't meet the requirements for pragmatism but have features that are in opposition to pragmatism, have been published in journals of different kinds and incorrectly labeled pragmatic. This can lead to false claims of pragmaticity, and the usage of the term should be standardized. The creation of a PRECIS-2 tool that offers an objective and standardized assessment of pragmatic features is a good start.
Methods
In a practical study the aim is to inform clinical or policy decisions by showing how an intervention can be integrated into routine treatment in real-world contexts. This differs from explanation trials that test hypotheses regarding the cause-effect connection in idealized situations. Therefore, pragmatic trials could have lower internal validity than explanatory trials, and could be more susceptible to bias in their design, conduct and analysis. Despite these limitations, pragmatic trials can contribute valuable information to decision-making in the context of healthcare.
The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging between 1 and 5 (very pragmatist). In this study the areas of recruitment, organisation, flexibility in delivery, flexible adherence and follow-up were awarded high scores. However, the principal outcome and the method for missing data scored below the pragmatic limit. This suggests that it is possible to design a trial with excellent pragmatic features without damaging the quality of its outcomes.
However, it is difficult to assess how practical a particular trial really is because pragmaticity is not a definite attribute