Table 1 Overview of the nine domains of the PRECIS-2 instrument, their descriptions, and the corresponding questions that users of the tool need to ask themselves when evaluating the degree of pragmatism exhibited by a particular trial [21, 47]
PRECIS-2 domain | Description | Question |
|---|---|---|
Eligibility | The extent to which the trial is open for recruitment to patients with varying demographic characteristics and medical histories | To what extent do the participants of the trial resemble the patients that would receive the intervention in clinical practice? |
Recruitment | The amount of effort that is expended to enroll new participants onto the trial | How much effort is made to recruit participants for the study, going beyond what can be considered a standard level of interaction between patients and their doctor? |
Setting | The environment in which the trial takes place | To what extent does the environment in which the study is conducted mirror the usual care setting? |
Organization | The resources and the expertise that are required to deliver the intervention | To what extent are the resources and the expertise needed to deliver the intervention different from those that would be available in the clinic? |
Flexibility—delivery | The degree of flexibility that is permitted with respect to the delivery of the intervention by investigators | How much discretion is granted to the investigators in terms of their administration of the intervention, as compared with the usual care setting in which doctors may or may not choose to prescribe the standard treatment schedule? |
Flexibility—adherence | The level of flexibility that is allowed with regard to the compliance of trial participants with the investigational treatment schedule | How much discretion is granted to the participants in terms of their adherence to the intervention, as compared with the usual care setting in which patients may or may not follow the treatment schedule that their doctor prescribes them? |
Follow-up | The intensity with which trial participants are monitored and followed up, and the amount of data that are collected during the follow-up period | How intensively are the participants of the study followed up, going beyond what can be considered a standard monitoring and data collection schedule? |
Primary outcome | The nature of the endpoint that the trial was statistically designed to measure | To what extent is the primary outcome measure relevant for patients? |
Primary analysis | The nature of the method by which the primary outcome data are analyzed statistically | To what extent are all the primary outcome data that were collected for the study included in the analysis? |