Oakland-Jairath Score Validation
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| ClinicalTrials.gov Identifier: NCT03935360 |
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Recruitment Status :
Recruiting
First Posted : May 2, 2019
Last Update Posted : September 2, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Lower Gastrointestinal Bleeding | Other: Oakland-Jairath Risk Score |
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 Type : | Observational |
| Estimated 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 : | November 25, 2019 |
| Estimated Primary Completion Date : | March 1, 2022 |
| Estimated Study Completion Date : | September 1, 2022 |
- 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.
- Discrimination of the Oakland-Jairath score for predicting safe discharge [ Time Frame: 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
- Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores [ Time Frame: 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
- Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
1. Presenting complaint of LGIB, defined as any of the following:
- Bright red blood per rectum
- Maroon coloured stool
- 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:
- Age ≤ 18
- Hematemesis, defined as bright blood or coffee ground emesis
- Patients who developed LGIB while already admitted to hospital for any reason
- Patients transferred between hospitals
- Failure to obtain informed consent
- 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
- Perceived inability to contact the subject by telephone or e-mail for the 28 day follow up assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935360
| Contact: Michael Sey, MD | 519-667-6582 ext 5 | msey2@uwo.ca | |
| Contact: Cassandra McDonald | cassandra.mcdonald@lhsc.on.ca |
| Canada, Alberta | |
| University of Alberta Hospital | Not yet recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Sander Veldhuyzen van Zanten | |
| Canada, Ontario | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Cassandra McDonald, BSc 519-685-8500 ext 56554 cassandra.mcdonald@lhsc.on.ca | |
| Canada, Quebec | |
| McGill University Health Centre | Not yet recruiting |
| Montreal, Quebec, Canada, H4A 3J1 | |
| Contact: Myriam Martel myriam_martel@yahoo.com | |
| Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting |
| Montréal, Quebec, Canada, H2X 3E4 | |
| Contact: Alexia Monges alexia.monges.chum@ssss.gouv.qc.ca | |
| Principal Investigator: | Michael Sey, MD | Lawson Research; Western University |
| Responsible Party: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT03935360 |
| Other Study ID Numbers: |
113116 |
| First Posted: | May 2, 2019 Key Record Dates |
| Last Update Posted: | September 2, 2021 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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lower gastrointestinal bleeding external validation prognostic risk score safe discharge |
multi-centre cohort study obscure gastrointestinal bleeding hospital presentation |
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Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Gastrointestinal Diseases Digestive System Diseases |