Predicting Morbidity and Mortality in Elderly Surgical Patients

Study Overview
=================
Brief Summary
-----------------
This proposed multicentre study builds on the findings of our recent validation of USEM and mCriSTAl predictive tools in a single centre at the Complejo Hospitalario de Navarra, whose results were recently published (https://europepmc.org/article/med/33111261). By expanding to a multicentre cohort and comparing to a third instrument, the investigators aim to examine the independent validity and generalizability of three scores and investigate potential for simplification of the prediction with anticipated greater accuracy. The ultimate goal is to determine whether these predictive tool can be used to assist surgical decision-making about older patients with expected poorer prognosis or high risk of death in the short term.

Detailed Description
-----------------
Eligible institutions: large hospitals (>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. Procedures: Recruitment is anticipated to take 6-12 months and will be conducted prospectively after screening by non-specialist hospital staff (junior doctors, medical students, nurses) confirms eligibility. The 3-month follow-up for outcomes will include completion of a standard questionnaire/form via either review of clinical record, access to death records (where applicable), or telephone call to families/proxy/next of kin/person responsible at 3 months after initial recruitment. Findings will be published in aggregated and anonymized form, but if the sample from individual participating institutions is large enough, hospital-specific profiles can be delivered in identifiable form to relevant hospitals for the benefit of clinicians and service administrators.

Official Title
-----------------
Predicting Morbidity and Mortality in Elderly Surgical Patients: Prospective Multicentre Study

Conditions
-----------------
Surgery--Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥65 years. Present in the ED with acute abdominal pathology that requires urgent abdominal surgery Exclusion Criteria: Patients who receive non-operative management Informed consent form not signed by patient or their proxy

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 105 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital Universitario de Álava, Spain<br>large hospitals (>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. | |
| Hospital Universitario de Basurto, Spain<br>large hospitals (>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. | |
| Hospital Universitario de Cruces, Spain<br>large hospitals (>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. | |
| Hospital Universitario de Donostia, Spain<br>large hospitals (>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. | |
| Hospital San Pedro (Logroño), Spain<br>large hospitals (>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. | |
| Hospital of Navarra, Spain<br>large hospitals (>200 beds) with wards admitting older surgical patients where (a) electronic medical records are available, (b) have staff committed to recruiting a minimum of 100 participants with complete follow-up, and (c) give consent for the Lead statistician in Spain to access de-identified data for aggregated analysis. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of postoperative mortality | prediction of the individual tools as ascertained from the official mortality records | 30 day | 
| Number of postoperative mortality | prediction of the individual tools as ascertained from the official mortality records | 90 day | 
| In-hospital surgery-related adverse events | Defined by the Clavien-Dindo classification | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validity of the score | Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA | 30-day | 
| validity of the score | Discrimination and calibration of the new tool, compared to the: m CRISTAL, USEM, NELA | 90-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, urgent abdominal surgery, 30-day mortality