BISON (Bloodstream Infections and Sepsis Outcomes measurement Network) initiative: an ESGBIS proposal

Motivation

Outcome of a bloodstream infection/sepsis (BSI/S) is defined in different ways in different research projects.[1] In this, BSI/S share the characteristics of other fields of medicine; specific issues are related to diversity of causative agents, the clinical focus of infection, severity of comorbid conditions, presence of indwelling devices, multiplicity of affected patient populations, and others.[2] A preliminary list of putative core outcome set (COS) might be:

• mortality

• time-to-clinical stability

• time-to-microbial clearance

• development/resolution of metastatic foci

• adverse events of treatment

• salvage of infected device

• relapse

• compliance

Therefore, the European Society of Clinical Microbiology and Infectious Diseases working group on bloodstream infections and sepsis (ESGBIS) is currently designing a project for the development of a COS in BSI/S.

Objectives

• 1. generate a comprehensive long-list of all outcome variables reported in recent randomised controlled studies on BSI/S

• 2. refine the outcome long-list into a COS agreed by key stakeholders

• 3. define the best measurement methods of proposed COS

• 4. identify unresolved issues for further research

• 5. publish the proposed COS in the relevant scientific journals

• 6. build a COS database with standard fields easily shared across studies

• 7. monitor uptake of the selected core outcomes in future relevant publications

Methods

Overall timetable: 2 year from first meeting.

The ESGBIS group is composed by approximately 30 people with different backgrounds (infectious disease, microbiology, intensive care medicine, epidemiology and statistics). We will adopt a combination of methods: two preparatory meetings, restricted and extended Delphi rounds (via email exchanges), semi-structured interviews with patients, systematic review of the literature, final consensus conference (Figure 1).

Figure 1

proposed structure of the BISON project

Expected outputs

Publication of the systematic review and of the COS in medical journals and development of a standard set of database fields, to be included in eCRF of future studies.