Exploring variation in prescribing practices in ADPKD
Research type
Research Study
Full title
Exploring variation in prescribing practices in rare diseases using ADPKD as a disease model to improve the quality and safety of healthcare
IRAS ID
337538
Contact name
Matthew Gittus
Contact email
Sponsor organisation
Sheffield Teaching Hospitals Trust
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This study will explore the variation in guideline implementation and prescribing practices of tolvaptan for people with Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD is the most common inherited condition affecting the kidneys; 70,000 people are known to have the disease in the UK. It leads to cyst formation in the kidneys, eventually resulting in kidney failure. Tolvaptan is the only approved medication to slow cyst growth and kidney function decline. However, how this medication is used in clinical practice is unknown. Some people may receive it without any potential benefit exposing them to risks and side effects, while others who could benefit do not receive it.
The study follows a multi-phase approach. Phase 0 is an overview of reviews of factors that influence the prescribing decisions of healthcare professionals, this provides a conceptual framework for subsequent phases. Phases 1 to 3 follow a Qualitative Residual Analysis design. Phase 1 is secondary data analysis of the RaDaR database to identify four renal units with deviant prescribing practices according to established guidance. Phase 2a is a sequential multiple-embedded case study of these four renal units. Document analysis, direct observations and semi-structured interviews intend to uncover explanatory variables. In phase 2b, an electronic survey disseminated to all UK renal units will supplement the understanding of these variables at other renal units. Phase 3 integrates the findings from phase 2 to re-evaluate the phase 1 data to better explain variation and estimate potential outcomes of interventions targeting sources of variation.
This study seeks to serve as a model for future investigations of variation in prescribing or guideline implementation for rare diseases in the UK. It is part of a PhD project sponsored by the Sheffield Teaching Hospitals NHS Foundation Trust with the University of Sheffield as the data processor. It has been funded by The Healthcare Improvement Studies (THIS) Institute.
REC name
London - Dulwich Research Ethics Committee
REC reference
24/PR/0106
Date of REC Opinion
21 Mar 2024
REC opinion
Further Information Favourable Opinion