Development of a clinical prediction rule for sepsis in primary care: protocol of the TeSD-IT study

Abstract

Background Early recognition and treatment of sepsis is crucial to prevent detrimental outcomes. General practitioners (GPs) are often the first healthcare providers to encounter seriously-ill patients. The aim of this study is to assess the value of clinical information and additional tests to develop a clinical prediction rule (CPR) to support early diagnosis and management of sepsis by GPs.Methods We will perform a diagnostic study in the setting of out-of-hours home visits in four GP cooperatives in the Netherlands. Acutely ill adult patients suspected of a serious infection are screened for eligibility by the GP. The following candidate predictors are prospectively recorded: 1) age; 2) body temperature; 3) systolic blood pressure; 4) heart rate; 5) respiratory rate; 6) peripheral oxygen saturation; 7) altered mental status; 8) rigors and 9) rapid illness progression. After the clinical assessment of the GP, blood samples are collected in all patients to measure C-reactive protein, lactate and procalcitonin. All patients receive care as usual. The primary outcome is presence or absence of sepsis within 72 hours of inclusion, according to an expert panel. The need for hospital treatment for any indication will be assessed by the expert panel as a secondary outcome. Multivariable logistic regression is used to design an optimal prediction model first, and subsequently derive a simplified CPR that enhances feasibility of using the model in daily clinical practice. Bootstrapping will be performed for internal validation of both the optimal model and simplified CPR. Performance of both models will be compared to existing CPRs for sepsis.Discussion This study will enable us to develop a CPR for the recognition of sepsis in a high-risk primary care setting to aid in the decision which patients have to be immediately referred to a hospital and who can be safely treated at home. As clinical signs and blood samples will be retrieved prospectively in all participants, near complete data will be available for analyses. External validation is needed before the CPR is implemented in routine care and to determine in which pre-hospital settings care can be improved using the CPR.Trial registration The study is registered in the Netherlands Trial Registry (registration number NTR7026).