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Table 2 PRECIS-2 scores for trial domains

From: Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design

Domain

Score

Rationale

Eligibility criteria

4

The participants in the trial accurately represent the patients who would receive one of the treatments in usual care, as it concerns all elderly with a traumatic ASDH for whom clinical equipoise exists except for the most severely injured patients, as these are not suited for randomization due to ethical reasons.

Recruitment path

5

There will be no overt recruitment effort as patients will be recruited in the usual clinical care setting.

Setting

4

The trial will be conducted in the setting of daily clinical practice in multiple academic and peripheral hospitals in Belgium and The Netherlands spanning a large geographical area, leading to a realistic cross-sectional patient population of both countries. However, the large variability in neurotrauma care between countries, even within Europe, partly hampers generalizability beyond Belgium and The Netherlands.

Organization intervention

5

The trial will compare two treatment modalities that are already widely applied in current clinical practice as standard treatments in all participating hospitals. Therefore, only existing diagnostic procedures, healthcare staff and resources are necessary for the interventions under investigation.

Flexibility of intervention - delivery

5

The details of the treatments under investigation, including the specifics of the surgical procedure as well as the conservative-medical management protocol will be left up to the participating centers. Thus, the trial takes the existing variability in usual care between centers into account and therefore allows for flexibility in delivery of the intervention and implementation of the results.

Flexibility of intervention - adherence

Not applicable

As this is a surgical trial, there is no adherence issue after patients are randomized to either surgical intervention or initial conservative treatment with the possibility of delayed surgery in case of neurological deterioration. Therefore, this domain of the PRECIS-2 is not applicable in this trial.

Follow-up

3

Follow-up visits are more frequent and more intense (i.e., more data is collected per follow-up visit) than would be typical under usual care. However, follow-up in this surgical trial will not result in care management that differs from usual care (i.e., it is not possible for follow-up visits to have an impact on treatment engagement and it is highly unlikely that they would effect response to treatment). Therefore, the longer and more intense follow-up in this trial is not inconsistent with a pragmatic approach.

Outcome

5

The primary outcome measure is highly relevant from a patient’s perspective, as it scores functional outcome including mortality. Moreover, the primary outcome of this trial (as well as secondary outcomes) was chosen after extensive discussions between the investigators and representatives of relevant patient organizations, patients and their caregivers. Secondary outcomes including the economic analyses will also be meaningful to policymakers in both Belgium and The Netherlands.

Analysis

5

All data will be analyzed according to an intention-to-treat analysis. Also, a proportional odds regression model will be used, which is a more sensitive method compared to traditional dichotomized analyses and allows more data to contribute to the analyses.