About the study

This study will help us understand how helpful ultrasound and MRI (Magnetic Resonance Imaging) scans are in diagnosing bone and joint infections in children.

Aims of the study

To understand how helpful ‘special tests’ (i.e. ultrasound and MRI scans) are in diagnosing bone and joint infections in children.
To create a pathway that doctors and nurses can use in emergency departments to aid the diagnosis of bone and joint infections.

In order to do this we will:

Learn from children who have previously been suspected to have bone and joint infection (retrospective study) - We will look at past records from at least 30 hospitals in the UK. These will tell us which tests were performed and when. We will work-out how useful the ‘special tests’ were at detecting bone infections and identify patterns in how and when tests should be performed. We will use the information to develop a pathway to investigate suspected bone infections.
Apply what we’ve learnt to diagnose future infections in children (prospective study) - We will test how well the pathway that we develop works on data collected from a new group of children with suspected infections.
Determine the acceptability and concerns in treating bone and joint infection (qualitative study) - We will interview families to see if this pathway is acceptable to children, parents and doctors and assess how best to address children’s and parents’ needs and concerns

Prospective Study

Retrospective Study

Locations

Information about the Study

Study Participants

Prospective and Retrospective Studies: Children and young people under 16 years old with a diagnosis of BJI suspected by the treating clinician.

Qualitative Information Study: Patients and families with a proven BJI and a sub-set of patients and families who have undergone investigations for suspected BJI but received other diagnoses. Also, health professionals involved with the care of children with a suspected BJI.

Study Funders

National Institute for Health Research Health (NIHR) Technology Assessment Programme (HTA)

NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) University of Southampton Alpha House, Enterprise Road Southampton, SO16 7NS; netsmonitoring@nihr.ac.uk

Sample Size

Prospective study: A minimum of 111 children with a proven BJI

Retrospective study: A minimum of 444 children with a proven BJI

Qualitative Information Study: approximately 20 families with a proven BJI and a subset of patients/families who have undergone investigations for suspected BJI but received other diagnoses. Plus focus group interviews of approximately 12 health professionals

Study Design

Multi-centre cohort study of children with suspected bone and/or joint infection (BJI) combining a retrospective cohort, a prospective validation cohort and a qualitative evaluation.

Timescales

Planned Recruitment Period: 15 months

Planned Study Period: 30 months

Primary Objective

To estimate the sensitivity and specificity of MRI and USS in the investigation of BJI in children.

Study Team

Prof Tim Theologis

Chief Investigator

Prof Tim Theologis is a Senior Research Fellow at Oxford University and an honorary Consultant Orthopaedic Surgeon at Oxford University Hospitals. He looks after children with orthopaedic conditions and is involved in the teaching of medical students, the supervision of postgraduate degrees and the training of orthopaedic residents. He has an active academic interest in children’s orthopaedics and is leading multi-centre clinical research studies.

Prof Dan Perry

Co-Lead Applicant

Dan is an NIHR Research Professor and a consultant in children's orthopaedic surgery. He leads international clinical research in a broad array of conditions & injuries that affect children, and loves to ensure that research is presented in a way that is accessible to everyone.

Dr Anjali Shah

Clinical Trial Manager

Anjali is an experienced research manager and epidemiologist with a keen interest in improving outcomes in orthopaedics, and formerly maternal health and cancer survival. She is also a skilled lecturer in epidemiology and statistics who has supervised Masters and PhD students.