The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) has officially launched! PDOPPS is one of the largest prospective observational cohort studies among peritoneal dialysis (PD) patients. Modeled upon the success of the Dialysis Outcomes and Practice Patterns Study (DOPPS) and coordinated by Arbor Research Collaborative for Health, PDOPPS is designed to advance our understanding of optimal practices for PD patients worldwide. Study goals are to increase the appropriate use of PD, extend PD technique survival, and improve quality of life for patients. PDOPPS will provide a much needed infrastructure and forum to guide effective collaborative international clinical research in PD. The primary scientific aim of the PDOPPS study is to understand the impact of modifiable practices in the management of PD patients on the risk of all-cause peritoneal dialysis technique failure and mortality. Further details on PDOPPS, in particular study design, will be highlighted in a future issue of Peritoneal Dialysis International.
Data collection instruments have been created in collaboration with scientific input from workgroups operating under the leadership of the International Society for Peritoneal Dialysis (ISPD). Study funding has come from a central consortium of industry sponsors (primary: Baxter Healthcare; secondary: Fresenius Medical Care) and the acquisition of country-level funding to support local study costs that includes peer-reviewed grants from national research councils (Australia - National Health and Medical Research Council, Canada - Canadian Institute of Health Research, Japan - Japanese Society of Peritoneal Dialysis).
In its first wave, PDOPPS is enrolling a representative sample of 170 PD facilities and an estimated 5,000 patients from Australia, Canada, Japan, the USA and the United Kingdom (UK). Discussions are underway with additional interested countries and a process for inclusion of additional countries has been established (http://www.ispd.org). Data collection for PDOPPS commenced in Canada in October 2013 and in the United States in the first quarter of 2014. Japan began its pilot phase of data collection in mid-2014 and Australia and the UK are poised to initiate data collection by the end of 2014.
The study’s scope continues to expand with the successful funding of 3 ancillary studies: the Empowering Patients on Choices for Renal Replacement Therapy (EPOCH-RRT) study funded by the Patient Centered Outcomes Research Institute (PCORI) in the USA; the Biological Determinants of Peritoneal Dialysis Outcomes (Bio-PD) study funded by the US National Institutes of Health. Bio-PD seeks to establish a genetic and bio-repository of both dialysate effluent samples and plasma among patients in Canada, the UK, and the USA, in an effort to better understand genetic determinants of baseline and longitudinal changes in peritoneal membrane function. The third ancillary study, Optimizing Early Dialysis Catheter Function, funded by the National Institute of Health Research in the UK, seeks to understand determinants of early PD access function that will inform the optimal clinical pathway to achieve responsive and effective catheter placement.
The success of the PDOPPS to date hinges on the central collaboration between Arbor Research Collaborative for Health, the ISPD, country investigators, and the ongoing support of participating PD facilities. It is our hope that PDOPPS will serve as an invaluable resource to the PD community and will help strengthen the evidence base supporting PD treatment decisions and the use of PD therapy.