Oakland-Jairath Score Validation

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03935360
Collaborator
University of Western Ontario, Canada (Other), Université de Montréal (Other), University of Alberta (Other), McGill University (Other), University of Oxford (Other)
344
4
50.2
86
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oakland-Jairath Risk Score

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
344 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
External Validation of a Prognostic Risk Score for Safe Discharge Among Patients With Lower Gastrointestinal Bleeding: A Prospective Multi-centre Cohort Study
Actual Study Start Date :
Nov 25, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Discrimination of the Oakland-Jairath score for predicting safe discharge [28 days after enrollment]

    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

Secondary Outcome Measures

  1. Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores [28 days after enrollment]

    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

  2. Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores [28 days after enrollment]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Presenting complaint of LGIB, defined as any of the following:

  2. Bright red blood per rectum

  3. Maroon coloured stool

  4. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
2 London Health Sciences Centre London Ontario Canada N6A 5W9
3 McGill University Health Centre Montreal Quebec Canada H4A 3J1
4 Centre hospitalier de l'Université de Montréal (CHUM) Montréal Quebec Canada H2X 3E4

Sponsors and Collaborators

  • Lawson Health Research Institute
  • University of Western Ontario, Canada
  • Université de Montréal
  • University of Alberta
  • McGill University
  • University of Oxford

Investigators

  • Principal Investigator: Michael Sey, MD, Lawson Research; Western University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT03935360
Other Study ID Numbers:
  • 113116
First Posted:
May 2, 2019
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lawson Health Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022