Clinical trial NCT03935360: Oakland-Jairath Score Validation
Official title: External Validation of a Prognostic Risk Score for Safe Discharge Among Patients With Lower Gastrointestinal Bleeding: A Prospective Multi-centre Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Gastrointestinal Bleeding
Keywords: lower gastrointestinal bleeding
external validation
prognostic risk score
safe discharge
multi-centre cohort study
obscure gastrointestinal bleeding
hospital presentation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Western University, Canada
name: Université de Montréal
name: University of Alberta
name: McGill University
name: University of Oxford
First posted: 2019-05-02
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any adult person who presents with lower gastointestinal bleeding as defined by: bright red blood per rectum, and/or maroon coloured stool.

Brief summary: Lower gastrointestinal bleeding (LGIB) is a common presentation in the Emergency Room. It can deteriorate into severe adverse event. However some are discharged before these events occur. The Oakland-Jairath score was developed to help determine which patients can be safely discharged and which should be admitted from the ER to the hospital. The score did well in its development, but now needs to be externally validated by other independent cohorts. The limitations of the first study will be addressed in our study. The goal of this study is to perform the first prospective, multi-centered, external validation of the Oakland-Jairath risk score on an independent and diverse population who present to the emergency room with LGIB.

Detailed description: Of critical importance in the approach to care of these patients is differentiating the majority of people who can be safely discharged for outpatient management from those who are at risk for serious adverse events and require hospitalization. Recently, Oakland and Jairath developed a clinical prediction rule for safe discharge among patients with LGIB using data from their UK National Audit. The next step in the development of a clinical prediction rule is external validation in independent cohorts. Measures of predictive accuracy for risk scores, such as the AUC, are overly optimistic when calculated from the derivation cohort from which the risk score was derived. Therefore, it is essential to evaluate its performance using independent and diverse validation cohorts. Thus, the goal of this study is to perform the first prospective, multi-centered, external validation of the Oakland-Jairath risk score on an independent and diverse population who present to the emergency room with LGIB. This is a prospective multi-centre observational study to externally validate the Oakland-Jairath LGIB risk score, herein referred to simply as the "risk score".

Consecutive patients presenting to hospital over a 6 month period will have their risk score calculated and followed for the development of an adverse outcome over a 28 day period. The risk score will be determined for research purposes only but will be shared with the treating physician if requested as the details of the risk score itself is within the public domain. Patients will be eligible regardless of discharge status and all admission decisions will be made solely by the treating physicians. To increase the diversity of the validation cohort, increase generalizability, and hasten recruitment, the study will be conducted at 4 centres: Western University, University of Alberta, University of Montreal, and McGill University.

Eligibility criteria: Inclusion Criteria:

1. Presenting complaint of LGIB, defined as any of the following:

1. Bright red blood per rectum
2. Maroon coloured stool
3. Criteria A and B applies regardless if the blood is seen without stool, with stool of any consistency, or only on the toilet paper

Exclusion Criteria:

1. Age ≤ 18
2. Hematemesis, defined as bright blood or coffee ground emesis
3. Patients who developed LGIB while already admitted to hospital for any reason
4. Patients transferred between hospitals
5. Failure to obtain informed consent
6. Occult bleeding, defined as the presence of a positive FOBT/FIT or iron deficiency anemia in the absence of bright red blood per rectum or maroon coloured stool
7. Perceived inability to contact the subject by telephone or e-mail for the 28 day follow up assessment

Primary outcomes:
measure: Discrimination of the Oakland-Jairath score for predicting safe discharge
timeFrame: 28 days after enrollment
Secondary outcomes:
measure: Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores
timeFrame: 28 days after enrollment
measure: Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores
timeFrame: 28 days after enrollment
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: Health Science Centre
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health - Victoria General Site
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Lawson Research; Western University
name: Michael Sey, MD
role: PRINCIPAL_INVESTIGATOR
References: