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 permits a variety of meta-epidemiological analyses that examine the effect of treatment across trials of different levels of pragmatism.
Background
Pragmatic trials are becoming more widely acknowledged as providing evidence from the real world to support clinical decision-making. The term "pragmatic", however, is a word that is often used in contradiction and its definition and measurement require clarification. The purpose of pragmatic trials is to guide clinical practice and
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Trials that are truly practical should be careful not to blind patients or healthcare professionals, as this may lead to distortions in estimates of the effects of treatment. Pragmatic trials should also seek to recruit patients from a wide range of health care settings, to ensure that the results are generalizable to the real world.
Furthermore the focus of pragmatic trials should be on outcomes that are crucial to patients, such as quality of life or functional recovery. This is especially important when it comes to trials that involve invasive procedures or those with potential for serious adverse events. The CRASH trial29, for instance, focused on functional outcomes to evaluate a two-page case report with an electronic system to monitor the health of hospitalized patients with chronic heart failure. Similarly, the catheter trial28 used symptomatic catheter-associated urinary tract infections as the primary outcome.
In addition to these characteristics pragmatic trials should reduce the procedures for conducting trials and requirements for data collection to reduce costs and time commitments. Furthermore pragmatic trials should try to make their findings as applicable to real-world clinical practice as they can by ensuring that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).
Many RCTs that do not meet the criteria for pragmatism, but have features that are in opposition to pragmatism, have been published in journals of different types and incorrectly labeled as pragmatic. This can lead to false claims of pragmatism and the use of the term should be standardized. The development of the PRECIS-2 tool, which offers an objective and standard assessment of practical features, is a good first step.
Methods
In a practical study it is the intention to inform clinical or policy decisions by demonstrating how an intervention could be integrated into routine care in real-world contexts. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised conditions. In this way, pragmatic trials could have less internal validity than studies that explain and be more prone to biases in their design analysis, conduct, and design. Despite these limitations, pragmatic trials may be a valuable source of information for decisions in the context of healthcare.
The PRECIS-2 tool evaluates the level of pragmatism that is present in an RCT by assessing it across 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study, the recruit-ment organization, flexibility in delivery and follow-up domains scored high scores, but the primary outcome and the method of missing data fell below the limit of practicality. This suggests that it is possible to design a trial using high-quality pragmatic features, without compromising the quality of its outcomes.
However, it is difficult to assess the degree of pragmatism a trial is since pragmaticity is not a definite attribute; some aspects of a study can be more pragmatic than others. Furthermore, logistical or protocol modifications during the course of an experiment can alter its pragmatism score. Additionally, 36% of the 89 pragmatic trials identified by Koppenaal and co. were placebo-controlled or conducted before licensing and most were single-center. Thus, they are not as common and can only be described as pragmatic when their sponsors are accepting of the lack of blinding in these trials.
A typical feature of pragmatic research is that researchers try to make their findings more meaningful by studying subgroups of the trial sample. However, this can lead to unbalanced comparisons and lower statistical power, which increases the risk of either not detecting or incorrectly detecting differences in the primary outcome. This was a problem in the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for differences in covariates at baseline.
Furthermore, pragmatic studies may pose challenges to collection and interpretation of safety data. This is due to the fact that adverse events are generally reported by the participants themselves and prone to reporting errors, delays or coding errors. Therefore, it is crucial to improve the quality of outcomes for these trials, in particular by using national registries instead of relying on participants to report adverse events on the trial's own database.
Results
Although the definition of pragmatism does not mean that trials must be 100% pragmatic, there are benefits to incorporating pragmatic components into clinical trials. These include:
Increased sensitivity to real-world issues which reduces cost and size of the study as well as allowing trial results to be more quickly transferred into real-world clinical practice (by including patients from routine care). However, pragmatic trials may also have drawbacks. The right type of heterogeneity, like, can help a study expand its findings to different patients or settings. However the wrong type of heterogeneity could reduce the assay sensitivity and, consequently, decrease the ability of a study to detect minor treatment effects.
Numerous studies have attempted to classify pragmatic trials with a variety of definitions and scoring systems. Schwartz and Lellouch1 have developed a framework to distinguish between explanatory trials that confirm a clinical or physiological hypothesis and pragmatic trials that help in the selection of appropriate treatments in the real-world clinical setting. The framework consisted of nine domains assessed on a scale of 1-5, with 1 being more explanatory while 5 being more pragmatic. The domains covered recruitment of intervention, setting up, delivery of intervention, flex adherence and primary analysis.
The initial PRECIS tool3 included similar domains and scales from 1 to 5. Koppenaal et al10 created an adaptation of this assessment called the Pragmascope that was easier to use in systematic reviews. They discovered that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.
This distinction in the main analysis domain could be explained by the fact that most pragmatic trials analyze their data in an intention to treat manner, whereas some explanatory trials do not.