Table 1

Domains of the PRECIS-2 tool11

EligibilityHow similar are the trial’s participants to a patient encountered in routine clinical practice? Does the trial include a narrowly selected patient population (explanatory) or a heterogeneous patient population that represents most populations (pragmatic)?
RecruitmentHow much additional effort is made to recruit patients compared with how you normally interact with patients during routine care? Does the study focus on the recruitment of specialized patients with targeted approaches (explanatory) or aimed at all potentially eligible patients encountered during routine care (pragmatic)?
SettingHow different is the setting of the trial compared with the setting of routine care at the participating center? Are patients cared for in specialized research units or centers (explanatory) or in a hospital setting more likely for the intervention to be implemented (pragmatic)?
OrganizationHow different are the available resources, provider experience, and delivery of care compared with what is available in routine care? Can only the most experienced clinicians provide care to enrolled patients (explanatory) or do all clinicians in a group provide the intervention embedded in the routine care of the population (pragmatic)?
Flexibility: deliveryHow different is the flexibility in delivering the intervention in the trial compared with the flexibility in how the intervention would be delivered in normal practice? Is the intervention highly protocolized and close monitoring performed to ensure standard delivery (explanatory) compared allowing the clinician flexibility to implement the intervention as dictated by the patient’s routine clinical care (pragmatic)?
Flexibility: adherenceHow different is the flexibility in monitoring and adherence to the treatment in the trial compared with how monitoring and adherence might be addressed in routine care? Is significant effort made to ensure patient adherence to the intervention (explanatory) or is patient adherence not monitored as is done in normal care (pragmatic)?
Follow-upHow different is the follow-up compared with routine care? Are extra clinic appointments scheduled (explanatory) than what is required by normal clinical care (pragmatic)?
Primary outcomeTo what extent is the primary outcome directly relevant to the participants? Is the outcome a short-term or surrogate primary outcome (explanatory) or a recognizable, meaningful outcome to the patient (pragmatic)?
Primary analysisTo what extent are all the data included in the analysis? Are patients found to be non-adherent to the treatment excluded from analysis (explanatory) or is non-adherence considered to be a function of the treatment and part of routine clinical care (pragmatic)?
  • PRECIS-2, PRagmatic-Explanatory Continuum Indicator Summary.