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

Diagnostic and Prognostic Research

卷:4

Jan Jelrik Oosterheert¹  Arthur R. H. van Zanten²  Ann Van den Bruel³  Geert W. J. Frederix⁴  Alma C. van de Pol⁴  Theo J. M. Verheij⁴  Feike J. Loots⁴  Kevin Jenniskens⁴  Marleen Smits⁵  Rogier Hopstaken⁶ 

[1] Academic Centre for Primary Care, KU Leuven;

[2] Department of Intensive Care Medicine, Gelderse Vallei Hospital;

[3] Department of Internal Medicine, Division Infectious Disease, University Medical Centre Utrecht;

[4] Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht;

[5] Radboud University Medical Center, Radboud Institute for Health Sciences, Scientific Center for Quality of Healthcare (IQ healthcare);

[6] Star-shl Diagnostic Centres;

关键词: Sepsis;    Clinical prediction rule;    Diagnosis;    Primary care;    General practice;    Out-of-hours medical care;    Practitioner cooperative;    Point-of-care testing;   

DOI  :  10.1186/s41512-020-00080-5

来源: DOAJ

【 摘 要 】

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 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 will be screened for eligibility by the GP. The following candidate predictors will be prospectively recorded: (1) age, (2) body temperature, (3) systolic blood pressure, (4) heart rate, (5) respiratory rate, (6) peripheral oxygen saturation, (7) mental status, (8) history of rigors, and (9) rate of progression. After clinical assessment by the GP, blood samples will be collected in all patients to measure C-reactive protein, lactate, and procalcitonin. All patients will receive care as usual. The primary outcome is the presence or absence of sepsis within 72 h after 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 will be used to design an optimal prediction model first and subsequently derive a simplified clinical prediction rule 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 prediction rule. Performance of both models will be compared to existing clinical prediction rules for sepsis. Discussion This study will enable us to develop a clinical prediction rule 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 obtained prospectively, near-complete data will be available for analyses. External validation will be needed before implementation in routine care and to determine in which pre-hospital settings care can be improved using the prediction rule. Trial registration The study is registered in the Netherlands Trial Registry (registration number NTR7026 ).

【 授权许可】

Unknown