Clinical Priority Program-Bone Infection Registry
Condition: Bone Infection; Staphylococcus Aureus
MeSH terms: Infections; Communicable Diseases; Osteomyelitis
Study type: Observational

Summary: 
      Establish an international registry of over 400 patients with deep infections involving the
      bone and/or joint from≥20 centers representing all regions of the world with varied hospital
      and surgeon practice settings to ensure that registry analyses and research reflect typical
      clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare
      researchers. Using a data collection platform that minimizes entry burden, collects most
      information at the time of surgery, and uses Internet technology to minimize data entry. The
      registry will include:

        1. baseline patient attributes;

        2. surgical approach, implants and technology;

        3. hospital course;

        4. surgeon and institutional characteristics;

        5. longitudinal patient outcome,

        6. post-procedure complications and revisions,

        7. serum/tissue/drainage samples.
    

Detailed description: 
      Establish an international registry with AOCID of over 400 patients with deep infections
      involving the bone and/or joint from ≥ 20 centers representing all regions of the world with
      varied hospital and surgeon practice settings to ensure that registry analyses and research
      reflect typical clinical practice thereby providing optimal guidance for patients,
      clinicians, and healthcare researchers. Creation of an AOCID Registry for musculoskeletal
      infection cases will permit better analysis of the causes, contributing factors including
      patient immune responses, treatments and clinical outcomes of musculoskeletal infections.

        -  Establish a practice network that includes ≥ 20 geographically distributed centers.
           These busy practices will be treating patients with varied geographic status to assure
           balanced representation of diverse patients and practices.

        -  Establish a Data Coordinating Core team with AOCID using a data collection platform that
           minimizes entry burden, collects most information at the time of surgery, and uses
           Internet technology to minimize data entry.

      The registry will include:

        -  baseline patient attributes

        -  surgical approach, implants and technology

        -  hospital course

        -  surgeon and institutional characteristics

        -  longitudinal patient outcome

        -  post-procedure complications and revisions

        -  serum/tissue/drainage samples

             -  Establish a Statistical Support team with AOCID to implement cutting-edge
                statistical techniques including the use of hierarchical generalized linear latent
                and mixed effects models to address the complex structure and longitudinal nature
                of registry data. Multivariable predictive models for outcome(s) of infection will
                be developed.

             -  Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP
                team to advance the science of infection-specific and global patient-reported
                outcomes to support efficient data collection of web-based, longitudinal data in
                this registry and future comparative effectiveness research.

             -  Develop new assessment tools and conduct research useful to clinical practice.
                Establish consensus on the definition of treatment failure- characterized as lack
                of clinically meaningful improvement in infection, pain or physical function
                following treatment, validate, and refine prediction algorithms for patients at
                risk for failure.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with diagnosis of Staphylococcus aureus bone infection
      
Biospecimen description: 
      blood samples nasal and wound specimen
    
Keywords: bone infection; staphylococcus aureus; registry