Table 1 Comparison of PRECIS-2 and PRECIS-2-PS on domains, key questions, and scores

Eligibility

To what extent are the patients in the trial similar to those who would receive this intervention if it was part of usual care?

Score 1 for a very explanatory approach with lots of exclusions for patients (e.g., those who don’t comply, respond to treatment, or are not at high-risk for primary outcome, are children or elderly), or uses many selection tests not used in usual care.

Score 5 for very pragmatic criteria essentially identical to those in usual care.

Eligibility

To what extent are the healthcare professionals in the trial similar to those in usual care?

Score 1 for a very explanatory approach that only allows for a select, narrow, and non-representative sample of healthcare professionals.

Score 5 for a very pragmatic approach with broad inclusion criteria and minimal exclusion criteria for healthcare professionals.

Recruitment

How much extra effort is made to recruit patients over and above what would be used in the usual care setting to engage with patients?

Score 1 for a very explanatory approach with targeted invitation letters, advertising in newspapers, radio plus incentives and other routes that would not be used in usual care.

Score 5 for very pragmatic recruitment through usual appointments or clinic.

Recruitment

How much extra effort is made to recruit healthcare professionals into the trial compared to what is available to encourage their engagement in usual care settings?

Score 1 for a very explanatory approach with extensive approaches (e.g., personalized invitation letters, free CME credits, personalized outreach from physician opinion leaders, support or endorsement from professional societies) that would not otherwise be available or used in usual care.

Score 5 for a very pragmatic approach with feasible approaches that leverage information channels (e.g., flyers posted in break rooms, emails to staff, word-of-mouth, lunch discussions/seminars) that are commonplace and available in usual care settings.

Setting

How different is the setting of the trial (or are the settings of the trial) from the usual care setting?

Score 1 for a very explanatory approach with only a single center, or only specialized trial or academic center.

Score 5 for a very pragmatic choice using identical settings to usual care.

Setting

How different is the health care or public health setting (e.g., hospital, clinic, health department) in which the trial is conducted compared to usual care settings?

Score 1 for a very explanatory approach that includes sites in a limited geographic region, lack of diversity in organizational characteristics, few number of sites, and/or a single delivery setting or system.

Score 5 for a very pragmatic approach that includes a representative sample of sites in terms of location, number, size, system, and organizational characteristics.

Organization

How different are the resources, provider expertise, and the organization of care delivery in the experimental arm of the trial and those available in usual care?

Score 1 for a very explanatory approach if the trial increases staff levels, gives additional training, requires more than usual experience or certification and increases resources.

Score 5 for a very pragmatic choice that uses identical organization to usual care.

Implementation resources

How different are the resources needed to support the delivery of the provider-focused strategies from resources that are readily available in usual care?

Score 1 for a very explanatory approach if the trial provides more resources, time, and effort needed to deliver the provider-focused strategies (e.g., staff, financial incentives, training, equipment, consultation) than would otherwise be available in usual care.

Score 5 for a very pragmatic approach if the trial uses resources, time, and effort to deliver the provider-focused strategies that are identical to those available in usual care.

Flexibility (delivery)

How different is the flexibility in how the intervention is delivered and the flexibility likely (or anticipated) in usual care?

Score 1 for a very explanatory approach if there is a strict protocol, monitoring, and measures to improve compliance, with specific advice on allowed co-intervention and complications.

Score 5 for a very pragmatic choice with identical flexibility to usual care.

Flexibility of provider-focused strategies

How different is the flexibility in how provider-focused strategies are delivered in the trial and the flexibility in how provider-focused strategies are likely to be delivered in usual care?

Score 1 for a very explanatory approach if there is a strict protocol for how provider-focused strategies must be delivered (e.g., frequency, intensity, structure, process) and/or if adaptations to strategies are strongly discouraged.

Score 5 for a very pragmatic approach that allows for flexibility and adaptation of provider-focused strategies.

Flexibility (adherence)

How different is the flexibility in how patients must adhere to the intervention (or are monitored and encouraged to adhere to the intervention) from the flexibility likely (or anticipated) in usual care?

Score 1 for a very explanatory approach that involves exclusion based on adherence, and measures to improve adherence if found wanting. In some trials (e.g., surgical trials), where patients are being operated on or ICU trials where patients are being given IV drug therapy, this domain is not applicable as there is no compliance issue after consent has been given, so this score should be left blank.

Score 5 for a very pragmatic choice involving no more than usual encouragement to adhere to the intervention.

Flexibility of intervention

How different is the flexibility in how the intervention is delivered by healthcare providers to patients and the flexibility in how the intervention would be delivered in usual care?

Score 1 for a very explanatory approach that discourages intervention adaptation and encourages strict fidelity to the intervention.

Score 5 for a very pragmatic choice that explicitly allows for or encourages adaptations to the intervention.

Follow-up

How different is the intensity of measurement and follow-up of patients in the trial and the likely follow-up in usual care (or from the typical follow-up in usual care)?

Score 1 for a very explanatory approach with more frequent, longer visits, unscheduled visits triggered by primary outcome event or intervening event, and more extensive data collection.

Score 5 for a very pragmatic approach with no more than usual follow-up.

Data collection

How different is the frequency and intensity of measurement and data collection throughout the trial compared to what is considered routine in usual care?

Score 1 for a very explanatory approach that includes frequent, time-intensive, and extensive measurement and data collection.

Score 5 for measurement and data collection that are routinely collected, readily available, or relatively easy to administer and obtain.

Primary outcome

To what extent is the trial’s primary outcome (directly) relevant to patients?

Score 1 for a very explanatory approach using a surrogate, physiological outcome, central adjudication, or use assessment expertise that is not available in usual care, or the outcome is measured at an earlier time than in usual care.

Score 5 for a very pragmatic choice where the outcome is of obvious importance to patients.

Primary outcome

To what extent is the trial’s primary outcome important to healthcare professionals?

Score 1 for a very explanatory approach where the primary outcome variable is irrelevant or unimportant to healthcare professionals.

Score 5 for a very pragmatic choice where the primary outcome is highly relevant and very important to healthcare professionals.

Primary analysis

To what extent are all data included in the analysis of the primary outcome?

Score 1 for a very explanatory analysis that excludes ineligible post-randomization patients, includes only completers or those following the treatment protocol.

Score 5 for a very pragmatic approach using intention to treat with all available data.

Primary analysis

To what extent are all data included in the analysis of the primary outcome

Score 1 for a very explanatory approach where data analysis is limited to those participants who complete all measures and participate in all aspects of the trial (“on protocol”) and/or analysis that uses less robust and extensive imputation techniques to account for missing data.

Score 5 for a very pragmatic approach using an intent-to-treat or modified intent-to-treat analytic approach with robust and limited imputation techniques.