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Oakland-Jairath Score Validation
| 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, 2021 |
| Estimated Study Completion Date : | September 1, 2021 |
- 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
| Tracking Information | |||||||||
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| First Submitted Date | April 30, 2019 | ||||||||
| First Posted Date | May 2, 2019 | ||||||||
| Last Update Posted Date | September 3, 2020 | ||||||||
| Actual Study Start Date | November 25, 2019 | ||||||||
| Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | 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.
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
344 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 1, 2021 | ||||||||
| Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria: 1. Presenting complaint of LGIB, defined as any of the following:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Canada | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT03935360 | ||||||||
| Other Study ID Numbers | 113116 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Lawson Health Research Institute | ||||||||
| Study Sponsor | Lawson Health Research Institute | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Lawson Health Research Institute | ||||||||
| Verification Date | September 2020 | ||||||||
