2.4. Primary and secondary outcomes and definitions of the outcome measures

Our primary outcome of interest will be reduction in mortality from all causes by upfront use of WBCT in comparison with conventional management (KQ 4a). Here, mortality outcomes include 24-h mortality, 30-d mortality, in-hospital mortality, and overall mortality. For all subquestions under KQ 4, we will consider the effect of “assignment” to WBCT-based management (vs conventional, selective CT-based management) at baseline (i.e., the ITT-type effect) to be the main analysis; the effect of “starting and adhering” to the WBCT-based management (vs conventional, selective CT-based management) (i.e., the per-protocol-type effect) will be regarded as the sensitivity analysis. We will also assess the effect of WBCT regardless of whether it is performed upfront or as the subsequent-line imaging survey (i.e., as the treated-type effect).

We will assess short-term non-mortality clinical outcomes (KQs 4b-c) including time spent before ED disposition for multiple phases of ED stay including time from ED admission to CT, time from ED admission to diagnosis, time from ED admission to specific therapies (e.g., intubation followed by mechanical ventilation, operation, or IVR), time from admission to discharge from ED, time spent for specific therapeutic or supportive interventions, and time spent for ICU or hospital stay by WBCT in comparison with conventional management as the secondary outcomes. Specific clinical characteristics that are associated with better mortality or other short-term clinical outcomes using WBCT (i.e., effect modifiers) will be assessed simultaneously in this context as a secondary outcome (KQ 5).

We will also assess clinical outcomes stemming from incidental findings other than trauma, such as cancer or aneurysm, as secondary outcomes (KQ 6). These outcomes will include detection of incidental cancers, aneurysms, and other incidental findings. Two other clinical outcomes related to these incidental findings—additional management required for the incidental findings and their subsequent outcomes—will also be assessed as the secondary outcomes (KQ 7). Additional management will include specific diagnostic and/or therapeutic interventions deemed necessary (KQ 7a-1) and actually performed (KQ 7a-2) for the incidental findings. The subsequent clinical outcomes will include any benefits (KQ 7b-1) and harms (KQ 7b-2) associated with the detection of incidental findings (e.g., reduction in the incidence of [or prevention of the progression of] cancers or aneurysms, detected disease-specific mortality; or, morbidity or mortality due to additional interventions).

Additional immediate outcomes, also assessed as secondary outcomes, include sensitivity and specificity of WBCT to detect traumatic injuries (KQ 1), change in the diagnosis of traumatic injuries between WBCT in comparison with conventional imaging-based assessment (KQ 2), management decision impact of WBCT, such as additional use of other diagnostic tests or supportive (e.g., blood transfusion, presser, and ventilator) or therapeutic interventions (e.g., surgery and IVRs) ordered based on the WBCT results in comparison with conventional imaging-based assessment (KQ 3).

Note: The content above has been extracted from a research article, so it may not display correctly.



Q&A
Please log in to submit your questions online.
Your question will be posted on the Bio-101 website. We will send your questions to the authors of this protocol and Bio-protocol community members who are experienced with this method. you will be informed using the email address associated with your Bio-protocol account.



We use cookies on this site to enhance your user experience. By using our website, you are agreeing to allow the storage of cookies on your computer.