Oakland-Jairath Score Validation

Lower Gastrointestinal Bleeding Clinical Trial

Official title:

External Validation of a Prognostic Risk Score for Safe Discharge Among Patients With Lower Gastrointestinal Bleeding: A Prospective Multi-centre Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935360
• Other study ID #: 113116
• Status: Completed
• Start date: November 25, 2019
• Est. completion date: March 2, 2024

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: March 2, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Lower Gastrointestinal Bleeding

Intervention

Other:
• Oakland-Jairath Risk Score
Oakland and Jairath developed a clinical prediction rule for safe discharge among patients with LGIB using data from their UK National Audit. They defined safe discharge as the absence of rebleeding, blood transfusion, need for endoscopic/radiologic/surgical intervention for hemostasis, readmission with LGIB, and death and developed a seven variable risk score: age, sex, previous history of LGIB admission, presence of blood on digital rectal exam, heart rate, systolic blood pressure, and hemoglobin. Using a cut-off score =8, they reported excellent discrimination (AUC 0.84, 95% CI 0.82-0.86), good calibration, and a 95% probability of safe discharge.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Nova Scotia Health - Victoria General Site	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec
Canada	Health Science Centre	Winnipeg	Manitoba

Sponsors (6)

Lead Sponsor	Collaborator
Lawson Health Research Institute	McGill University, Université de Montréal, University of Alberta, University of Oxford, Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination of the Oakland-Jairath score for predicting safe discharge	Discrimination, defined as the ability of the prediction model to differentiate between those who develop and do not develop the outcome event of interest, as measured by the c-statistic, and calibration, defined as the agreement between predicted and observed outcomes, measured by a calibration plot, of the Oakland-Jairath score for predicting safe discharge, defined as the absence of ALL of the following: i. Rebleeding, defined as [additional blood transfusions] or [a further decrease in hematocrit concentration of 20% or more], both after 24h clinical stability ii. Readmission for LGIB within 28 days iii. Red blood cell transfusion iv. Therapeutic intervention for hemostasis (endoscopic/IR/surgery) v. Death within 28 days	28 days after enrollment
Secondary	Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores	Measured by the c-statistic and compared using the DeLong test The scale is Oakland & Jairath score for the prediction of safe discharge after LGIB. There are seven variables that are scored. Having a lower score in all variables and overall represents a better outcome for a safe discharge after LGIB.; Age: <40 = 0; 40-69 =1; =70 =2 Sex: F = 0; M =1 Previous LGIB admission: No = 0; Yes = 1 DRE findings: No blood = 0; Blood = 1 Heart rate (bpm): =70 = 0; 70-89= 1; 90-109= 2; =110 = 3 Systolic blood pressure (mmHg): 50-89 = 5; 90-119 = 4; 120-129 = 3; 130-159 = 2; =160 = 0 Hemoglobin (g/dL): 36-69 = 22; 70-89 = 17; 90-109 = 13; 110-129 = 8; 130-159 = 4; =160 = 0; Total with variables added together that translates to the probability of safe discharge: 0-2 = 0.99; 3 = 0.98; 4 = 0.97; 5-7 = 0.96; 8 = 0.95; 9 = 0.93; 10 = 0.91; 11 = 0.89; 12-13 = 0.87-0.89; 14-15 = 0.77-0.81; 16-17 = 0.67-0.72; 18-20 = 0.50-0.62; 21-23 = 0.33-0.45; 24-26 = 0.20-0.28; 27-29 = 0.11-0.16; =30 = <0.1	28 days after enrollment
Secondary	Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores	Measured by the c-statistic and compared using the DeLong test The scale is Oakland & Jairath score for the prediction of safe discharge after LGIB. There are seven variables that are scored. Having a lower score in all variables and overall represents a better outcome for a safe discharge after LGIB.; Age: <40 = 0; 40-69 =1; =70 =2 Sex: F = 0; M =1 Previous LGIB admission: No = 0; Yes = 1 DRE findings: No blood = 0; Blood = 1 Heart rate (bpm): =70 = 0; 70-89= 1; 90-109= 2; =110 = 3 Systolic blood pressure (mmHg): 50-89 = 5; 90-119 = 4; 120-129 = 3; 130-159 = 2; =160 = 0 Hemoglobin (g/dL): 36-69 = 22; 70-89 = 17; 90-109 = 13; 110-129 = 8; 130-159 = 4; =160 = 0; Total with variables added together that translates to the probability of safe discharge: 0-2 = 0.99; 3 = 0.98; 4 = 0.97; 5-7 = 0.96; 8 = 0.95; 9 = 0.93; 10 = 0.91; 11 = 0.89; 12-13 = 0.87-0.89; 14-15 = 0.77-0.81; 16-17 = 0.67-0.72; 18-20 = 0.50-0.62; 21-23 = 0.33-0.45; 24-26 = 0.20-0.28; 27-29 = 0.11-0.16; =30 = <0.1	28 days after enrollment