Whether or not an RCT is pragmatic is difficult to judge without knowing what the trial involved. Even if the investigator knows what the trial was about and how it was done, it is not possible to tell if the trial was actually pragmatic. Nevertheless, there are several ways to assess pragmatism.
For instance, the PRECIS-2 tool can be used to determine how pragmatic a trial is. It contains nine domains, each scored from one to five. The scores reflect the intentions of the investigator at the time the trial is being designed and implemented. While a high score indicates a pragmatic trial, a low score may indicate a less pragmatic trial.
The PRECIS-2 tool is also useful to assess the level of pragmatism after the trial is over. If the trial involved a non-regulated intervention, it is likely to be more pragmatic than a regulated trial. For example, trials of non-regulated interventions that are closely aligned with real world approaches to recruitment and follow-up can be highly pragmatic. However, these types of trials are harder to judge than regulated ones.
The classical period of pragmatics focused on two main models. The first, known as “near-side pragmatics,” focuses on what is said and how it is said. In contrast, the second, called “far-side pragmatics,” focuses on what happens beyond what is said. Both approaches have their merits. The first approach is deductive and reflects Grice’s theory of conversation. The second approach, called “critical pragmatics,” emphasizes the hierarchy of intentions and the speaker’s plan.
Both near-side and far-side pragmatics have been described as a linguistic and philosophical discipline. The first approach is based on the premise that pronouns such as “I” and “you” are fundamentally different from other pronouns. For instance, the “I” and “you” are created by the speaker, while other pronouns are created by the context.
For instance, the word “I” is usually referred to as a subject, while the word “you” is referred to as an object. The speaker’s plan is important in supplementing the incremental meaning of the word. For example, if the sentence, “Elwood touched Eloise,” is said, the referential content of the word will be the proposition, “Elwood touched Eloise.”
The PRECIS-2 tool also has a reasonable discriminant validity. It has been shown to be effective in assessing pragmatism during the protocol development stage. It has good interrater reliability. As long as the scores are disclosed to readers, it should be possible to understand the reasons for the label. For instance, if the trial emphasized the organization of care, the scores should be high. But if the trial emphasized the outcomes, the scores should be low. In addition, the PRECIS-2 tool is also useful for determining the relevance of a clinical research project.
The PRECIS-2 tool should be used before a trial begins to ensure that the protocol is pragmatism-focused. The assessment should be honest and should include information not typically reported in manuscripts. The PRECIS-2 tool should be publicly disclosed so that others can assess the extent to which the trial was pragmatism-focused.