All patients will be screened in the ED by their treating clinicians for eligibility. Prospective enrolment may occur at any time during an ED presentation through the completion of a paper-based Clinical Report Form by the treating clinician (CRF, online supplemental file). This will include perceived severity of disease and level of suspicion for sepsis using a Likert scale. Verbal or written consent (depending on jurisdiction) will be sought and documented at the time of enrolment for permission to contact families 90 days after the ED visit for follow-up. Should prospective consent not be obtained, the study team will seek consent either during the in-patient stay, or at the time of follow-up. Clinical management will not be delayed and will proceed independent of study participation.
For prospectively enrolled patients, a parental sepsis awareness survey will be administered via quick response (QR) code at the time of enrolment (online supplemental file). Parents/guardians will provide implied consent by completing the survey.
Identification of missed eligible patients will be undertaken by the research team in each participating centre by a review of the daily ED attendance and ICU admission record for patients meeting inclusion criteria (figure 1). Retrospectively identified eligible participants will be enrolled by the research team and approached on the hospital wards or by telephone for verbal consent for follow-up. The CRF will not be completed on this patient group.
We will extract certain deidentified data from medical records on patients enrolled both prospectively and retrospectively and enter the data into an electronic database. Data to be extracted is outlined in box 2. The data will be stored in a web-based Research Electronic Data Capture (REDCap) database securely housed at MCRI.48 Comorbidities recorded will include immunodeficiency or immunosuppression, presence of central venous access device, long-term steroid treatment, diabetes, congenital heart disease, congenital syndrome, ex-prematurity, chronic respiratory disorder, home ventilation, chronic renal failure, neurodevelopmental condition and recent surgery or burns.
Data to be collected by all participating emergency departments (EDs) by time point
Initial ED attendance
Clinician-reported severity of illness and likelihood of sepsis (Likert scale) and clinical variables (eg, *GCS score, CRT, presence of non-blanching rash/severe unexplained pain/blue or grey colour/grunting).
Detailed patient demographic information (age, sex, Indigenous status and comorbidities).
Vital signs (†HR, MBP, SBP, RR, SpO2, RR, GCS score and CRT).
Pathology tests (‡VBG, FBC, UEC, LFT, coagulation profile and troponin).
Therapies administered (antibiotics, oxygen, fluids—bolus/maintenance/drug administration line, steroids and organ support).
Admission diagnosis
Parental sepsis awareness and understanding survey.
During hospital stay.
Disposition (hospital ward and ICU).
Vital signs (4, 8, 12 and 24 hours from ED arrival).
Pathology tests (4, 8, 12 and 24 hours from ED arrival).
Therapies administered (duration of hospitalisation censored at 30 days).
Intensive care unit and hospital length of stay (censored at 30 days).
Discharge diagnosis
Results of all microbiological tests.
In-hospital mortality (censored at 30 days).
Follow-up contact 90 days after hospitalisation.
Paediatric Overall Performance Category score.
Parent-reported outcome measures.
Days off work and out-of-pocket expenses for parents.
Repeat hospitalisations.
90-day mortality.
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*GCS, Glasgow Coma Scale; CRT, capillary refill time.
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†HR, heart rate; MBP, mean blood pressure; SBP, systolic blood pressure; RR, respiratory rate.
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‡VBG, venous blood gas; FBC, full blood count; UEC, urea electrolytes creatinine; LFT, liver function test.
Follow-up at 90 days (90–120 days) post-ED presentation will be undertaken by telephone, text message, email or REDCap survey link depending on the patients’/caregivers’ preference. Three contact attempts will be made. If more than 120 days have elapsed since presentation to ED or if there have been three failed contact attempts, the patient follow-up will be considered unsuccessful, and the patient will be considered lost to follow-up. Medical record review will be conducted on all patients lost to follow-up to ensure capture of return visits.
Paper-based CRFs will be deidentified after all data points have been extracted and entered, and all data queries have been addressed.
All research assistants (RAs) will receive formal training in the completion of the study CRFs and REDCap database prior to commencing enrolment. Identical materials and procedures will be used across all sites. The study CRF was piloted on 20 patients prior to use. Data will be regularly audited by the central coordinating team.
This post was originally published on https://bmjopen.bmj.com