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Table 2 PRECIS score

From: A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania

Domain

Score

Rationale

Eligibility

3

Eligibility criteria include all open tibial shaft fractures, but exclude people (a) with delayed presentation, (b) unlikely to follow-up, and (c) with significant associated injuries (TBI, burns, bilateral fractures).

Recruitment

5

No recruitment outside of ‘usual care’ occurs.

Setting

4

Study is conducted at a center in which the results are intended to be applied but is conducted a single center only.

Organization

3

Study intervention is done in the course of ‘usual care’ without need for increased care providers, but the use of intraoperative local antibiotic represents an increased cost and service above ‘usual care’.

Flexibility (delivery)

3

Though minimal training is needed for administering surgeons, correct injection protocol must be followed in order to achieve ideal placement of active agent.

Flexibility (adherence)

 

N/A according to PRECIS-2 guidelines because after intraoperative intervention, no further adherence is required.

Follow-up

3

Study follow-up includes additional follow-up visits and collection of additional data above ‘usual care’.

Primary outcome*

5

The primary outcome is of great interest to both patients and health care providers and does not require expertise beyond the treating physician for diagnosis.

Primary analysis

5

All available data will be used according to the intention-to-treat principle.