Infection
Conditions
Keywords
geriatric, diagnosis, ambulatory care, general practice, emergency care
Brief summary
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).
Detailed description
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.
Interventions
DIAGNOSTIC_TESTsigns and symptoms, blood tests
signs and symptoms as observed by the treating physician + blood tests (CRP, Procalcitonin, White blood cell count)
Sponsors
KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 65 years or older * Presenting to a general practice with an acute illness with a maximum duration of 10 days since onset * Suspicion of infectious disease (this may include suspicion of an acute exacerbation of COPD) * Patient or proxy of the patient is willing and able to give informed consent for participation.
Exclusion criteria
The participant may not enter the study if any of the following apply: * Too clinically unstable to waste time on study procedures * Indwelling catheter in situ * Immunocompromised or currently receiving medication for systemic immune-suppression, including corticosteroids * Being admitted to hospital for longer than 24 hours less than 7 days before study entry, or having undergone surgery in the previous 30 days * Living in a nursing home (both short term and long term stay) (only in general practice cohort) * Patient was already included in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy 1 | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy 2 | 30 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Descriptive 1: Prevalence (%) of serious infections in the study population | 30 days | 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. |
| Descriptive 2: multivariate analysis (no outcome) | 30 days | To describe features independently associated with a physicians' gut feeling of serious infection in an older patient |
| Net benefit: number of patients correctly classified as having a serious infection | 30 days | To assess the added value of prediction model based decisions over treat all and treat none at clinically relevant thresholds |
| Diagnostic accuracy, sensitivity analysis | 30 days | Sensitivity and specificity of the prediction rules taking all-cause mortality versus mortality due to infection as an outcome |
| Diagnostic accuracy 4 | 30 days | Sensitivity and specificity of the developed prediction rules compared to existing prediction rules |
| Diagnostic accuracy 3 | 30 days | Sensitivity, specificity, positive and negative predictive value and likelihood ratios of tests across the most often occurring infection types |
Countries
Belgium
Outcome results
None listed