Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this diagnostic accuracy study is to develop a clinical prediction rule based on signs, symptoms, patient characteristics and blood tests, to be used in ambulatory care to help physicians safely rule out a serious infection in an older patient.
It will be performed in general practices and emergency care departments across Flanders (Belgium).
This is a cross-sectional diagnostic cohort study in older adults presenting to ambulatory care, including a follow-up period of 30 days. This study will be used to construct an algorithm consisting of clinical features and blood test results to identify serious infections.
The study will run in ambulatory care in Flanders. Recruitment is expected to last 2.5 years, with each patient entering the study only once. Older adults will be approached for possible participation in the study by practice staff. There is only one study visit.
Those who agree to participate via written informed consent will have demographics and clinical features recorded. A blood sample will be taken in all participants on study entry. Follow-up information for all participants will be collected using electronic medical record notes (EMD) and patient diaries.
Treatment and other management decisions will be left to the treating physicians' discretion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emergency care | Consecutive enrolment of acutely ill older adults in emergency care |
| |
| General practice | Consecutive enrolment of acutely ill older adults in general practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| signs and symptoms, blood tests | Diagnostic Test | signs and symptoms as observed by the treating physician + blood tests (CRP, Procalcitonin, White blood cell count) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy 1 | Sensitivity and specificity of clinical prediction rules that are based on signs, symptoms, patient characteristics with and without blood tests, to be used in ambulatory care to help physicians safely rule out a serious infection in an older patient | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy 2 | Sensitivity, specificity, positive and negative predictive value and likelihood ratios of individual signs, symptoms, patient characteristics and blood tests for diagnosing a serious infection in persons aged ≥65 years | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Net benefit: number of patients correctly classified as having a serious infection | To assess the added value of prediction model based decisions over treat all and treat none at clinically relevant thresholds | 30 days |
| Diagnostic accuracy 3 |
Inclusion Criteria:
Exclusion Criteria:
The participant may not enter the study if any of the following apply:
Not provided
Not provided
Not provided
All acutely ill adults aged 65 years or older presenting to ambulatory care in whom a physician suspects an infection will be eligible. Ambulatory care is defined as in-hours general practice and emergency care.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ann Van den Bruel, MD, PhD | Department of Public Health and Primary Care, KU leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| De Driehoek Paal | Paal | Limburg | 3583 | Belgium | ||
| De Wijkpraktijk |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood serum
Sensitivity, specificity, positive and negative predictive value and likelihood ratios of tests across the most often occurring infection types
| 30 days |
| Descriptive 1: Prevalence (%) of serious infections in the study population | To investigate the potential for incorporation bias (diagnostic review bias) when establishing the reference standard in an expert review panel, with and without information on biomarker results. | 30 days |
| Descriptive 2: multivariate analysis (no outcome) | To describe features independently associated with a physicians' gut feeling of serious infection in an older patient | 30 days |
| Diagnostic accuracy 4 | Sensitivity and specificity of the developed prediction rules compared to existing prediction rules | 30 days |
| Diagnostic accuracy, sensitivity analysis | Sensitivity and specificity of the prediction rules taking all-cause mortality versus mortality due to infection as an outcome | 30 days |
| Antwerp |
| Belgium |
| De Leeuwenkaart | Brasschaat | Belgium |
| Huisartsenpraktijk Arcade | Gelrode | Belgium |
| De Bilter 28 | Heers | Belgium |
| Emergency Department Heilig Hart hospital Leuven | Leuven | Belgium |
| Emergency Department University Hospitals Leuven | Leuven | Belgium |
| Emergency Department St.-Jozef Hospital Malle | Malle | Belgium |
| DRLA | Mortsel | Belgium |
| De Driehoek Paal | Paal | Belgium |
| Huisartspraktijk Brustempoort | Sint-Truiden | Belgium |
| Onspraktijk | Wilrijk | Belgium |