Introduction to running a study

The BPSU system offers researchers access to data collected from over 3500 active paediatricians to be utilized for study surveillance. This provides a coordinated data collection system that minimises the reporting burden on clinicians. The BPSU Scientific Committee also provides expertise and support to prospective researchers to ensure that research methodologies are effective and appropriate.

For researchers wishing to have a study included on BPSU eCard reporting scheme they must submit an application to the BPSU Scientific Committee (SC). As the success of the BPSU methodology relies entirely on the willingness of consultant paediatricians to complete and return the monthly eCard and study questionnaires, it is essential that BPSU studies are scientifically robust, adequately resourced, and contribute to clinical and public health practice without putting too great a burden on reporting doctors.

The BPSU is committed to ensuring that patient and public involvement (PPI) is embedded in its work in every way possible. The Unit works with investigators to ensure that public and patient involvement is appropriately considered in any submission considered by the BPSU. Useful resources for public and patient involvement can be found on our patients and the public pages.

The application process has been developed to reflect these responsibilities.

Eligibility and funding

Studies considered eligible to be undertaken through the BPSU are those in which:

• The condition is a relatively rare childhood disorder or a rare complication of a more common disease of such low incidence or prevalence as to require ascertainment of cases on a national scale. In practice, the condition studied should have an expected incidence in the UK of no more than 360 cases per year
• Cases can be easily identified and defined using a clear case definition
• Study data is easily accessible from the normal clinical notes
  approval to collect unconsented identifiable data is sought from the CAG of the HRA and PBPP

Examples of studies which would not normally be eligible for study through the BPSU are those which:

• Are interventional studies
• Require controls
• Can be undertaken through a regional study
• Can be undertaken though a study involving specialist clinicians only
• Require retrospective reporting
• Involve any additional clinical intervention for reported cases (other than the results of diagnostic tests on samples collected during routine clinical management)