Table 2. PRECIS-2 Score.
Domain | Score | Rationale |
---|---|---|
Eligibility | 5 | Eligibility criteria are very broad and include all patients with fractures who would be treated in all hospital environments. |
Recruitment | 5 | Recruitment of all consenting patients with fractures treated at each participating hospital will be performed. |
Setting | 4 | Recruitment is occurring at multiple sites across the US and Canada; however, since most of the recruiting hospitals are regional referral centers the setting is mostly pragmatic. |
Organization | 5 | The interventions do not need an increase in clinicians or care delivery compared with the usual antiseptic care provided. For each antiseptic solution, a brief in-service training session will be provided to the clinical sites, as per any new product or procedure that is being introduced into an operating room. |
Flexibility (delivery) | 5 | The interventions will be delivered in the usual care manner with no advice on allowed cointerventions or strict protocols to ensure compliance. |
Flexibility (adherence) | This section is left blank according to PRECIS-2 guidance because the intervention is provided prior to patient consent and individual patient adherence is not an issue. If clinician compliance is considered, the study design is rather pragmatic because there will be limited encouragement to follow the manufacturer’s directions for use, other than periodic newsletters, investigator meetings, and possible clinician survey during the recruitment period. | |
Follow-up | 5 | All study follow-up is consistent with usual care. |
Primary outcome | 5 | The outcome has been validated by patients as being very relevant to the study participants and it does not require specialized expertise beyond the treating physician for diagnosis. |
Primary analysis | 5 | All available study data will be used for analysis following the intention-to-treat principle. |
Abbreviation: PRECIS-2, Pragmatic-Explanatory Continuum Indicator Summary.