Skip to Main Content Skip to Site Map Skip to Accessibility Statement
Home Service FROG FROG Participant Information

FROG Participant Information

 

Lay Summary

 

 

 Background and study aims
Internationally, the approach to urine collection varies. For example, in Europe and North America, national guidelines typically favour invasive urine collection methods, given their advantage of much lower rates of bacterial contamination. A UK-based study is required to determine which invasive or non-invasive urine sampling infants, children, and young people should be offered. However, it is not clear if potential participants could be recruited to a randomised controlled trial (RCT) comparing the various urine collection methods and a feasibility study is required to determine if a definitive RCT would be possible and, if so, to inform its design.The researchers aim to conduct a study of feasibility to assess which participants and interventions should be included in a subsequent randomised controlled trial, explore potential barriers to recruitment and determine the feasibility of randomisation to invasive versus noninvasive urine testing.This study will be conducted in three parts or work packages.
Work Package 1: a randomised controlled feasibility trial
Work Package 2: a mixed-methods feasibility study
Work Package 3: consensus meeting

Who can participate?
Work Package 1:
Children who are under 16 years old who have a suspected urinary tract infection and cannot provide a midstream urine sample
Work Packages 2 & 3:
1. Parents/guardians of children (0 to under 16 years) and children (aged 7 to under 16 years) who are approached to participate in Work Package 1 including those who decline randomisation, or who have required urine testing in hospital setting for suspected UTI in the last 3 years.
2. Healthcare practitioners (doctors, nurses, research staff and Allied Health professionals) involved in recruitment to the FROG feasibility trial (Work Package 1) or who are not involved in recruitment to the FROG feasibility trial (WP1).

What does the study involve?
Work Package 1 assesses the feasibility of randomising children to receive invasive (catheter or needle) and non-invasive (clean catch urine in a pot) urine sampling.
Invasive urine sampling involves a catheter inserted into the urethra to collect the urine or a needle placed in the bladder to collect the urine. Non-invasive urine sampling involves catching the urine in a pot while doing a wee.
Children and parents/guardians can consent to share their clinical data, answer brief questions about the sampling method they received, whether randomised or not, and complete a questionnaire 3- 6 months after the urine sample was collected.

Work Package 2 is a mixed methods study including a questionnaire, interviews and focus groups to explore parent/guardian, children’s and healthcare professional’s views and acceptability of the proposed study and sampling methods.
Work Package 3 is a stakeholder consensus meeting to discuss and describe the feasibility of a final definitive study design.
Document Version
Participant Information – Work Package 1 (English) FROG Participant Information – Work Package 1 (English)
Participant Information – Work Package 1 (Arabic) FROG Participant Information – Work Package 1 (Arabic)
Participant Information – Work Package 1 (Hindi) FROG Participant Information – Work Package 1 (Hindi)
Participant Information – Work Package 1 (Polish) FROG Participant Information – Work Package 1 (Polish)
Participant Information – Work Package 1 (Romanian) FROG Participant Information – Work Package 1 (Romanian)
Participant Information – Work Package 1 (Urdu) FROG Participant Information – Work Package 1 (Urdu)
Participant Information – Work Package 1 (Somali) FROG Participant Information – Work Package 1 (Somali)

 

Quick Links