The DOPPS is overseen by the DOPPS Steering Committee and investigators representing each of the DOPPS countries, and coordinated by the Arbor Research Collaborative for Health (Arbor Research). Research is guided by these investigators, as well as Task Forces of experts in different study areas.
Arbor Research is a non-profit organization, located in Ann Arbor, Michigan, USA, focused on conducting health-outcomes research utilizing a multidisciplinary approach with expertise in epidemiology, biostatistics, medicine, and health economics.
The DOPPS started as a haemodialysis study in 1996, and now tracks over 50,000 patients on haemodialysis, peritoneal dialysis, and with chronic kidney disease, in over 20 countries:
- DOPPS – Since 1996; in-centre HD; 50,000+ patient/now in over 20 countries
- PDOPPS – PD patients; data collection starting in late 2013; 4 countries
- CKDopps – Advanced CKD (stage 3-5) patients; beginning in 2013; 4 countries
What is unique about the DOPPS?
The DOPPS is longitudinal and collects information on haemodialysis centres and patients in more than twenty countries using a common protocol over time. With a focus on the full range of unit practice patterns that may relate to clinically important outcomes, the outcomes measures will be adjusted for patient comorbidities and adjusted to a greater extent than previously possible in other studies.
The international scope of the DOPPS provides greater variability in practice patterns and outcomes than can be observed in one country. This increased variation along with the study's large sample size leads to a greatly enhanced ability to understand the relationships between various treatment effects and patient outcomes.
The efforts of the DOPPS to obtain a representative, random sample of facilities and patients within each country allows for practice patterns within a participating country to be described.
A detailed protocol of more than 1,000 data fields, repeated across time and geography
Data Elements/Collection: Common protocol of 1,000 questions
- Patient-Level Data – includes comorbidities; hospitalizations; detailed monthly laboratory, treatment, and & medication data
- Medical Director and Facility Unit Practice surveys
- Patient Self-Reported Survey
In each of the selected units, the Study Coordinator records a census of all patients undergoing treatment. 20-40 of the patients are then selected for follow up with all aspects of their treatment being recorded on a regular basis. The data includes details of medication, access and dialysis given. At regular intervals the patients are asked to complete their own assessment of the treatment they have received and of their state of health. The Medical Directors, too, complete regular reports on the patients under observation. All this data is collated and consolidated by Arbor Research for study and analysis. Some of the findings of such analysis can be seen on the Arbor Research web site.
The impact of DOPPS in the Renal community has been steadily growing since its set up back in 1996. Over the past 18 years, several sets of clinical practice guidelines have been developed to help practitioners provide the best possible care to dialysis patients.
DOPPS also develop a series of individual DOPPS Country Reports to provide information at the individual country level regarding the attainment of guidelines and their potential impact on outcomes. These country reports suggest the practices that appear to have the greatest impact upon patient longevity and forecast how guideline achievement could possibly improve HD patient longevity in each DOPPS country.
In addition DOPPS Facilities receive the Facility Feedback Reports (FFR) including: feedback modules, with facility and country specific DOPPS research findings on:
- Mineral Bone Disease (calcium, phosphorus, PTH, vitamin D).
- Quality of Life (KDQOL SF-36 measures, kidney disease burden)
- Vascular Access (access use, rates of prior access use, hospitalization).
Additional content areas for FFR modules include:
- Clinical outcomes (mortality, hospitalization)
- Quality of Life – (related to Facility Care)
- Laboratory Values
- Demographics and Comorbidities.
Data on Home Dialysis modalities: Adding home dialysis (PD and home HD) patients to the census, i.e., collecting basic demographic data on all dialysis patients, not just in-centre HD patients. This will allows to readily expand to study home dialysis (via ancillary studies outside of core DOPPS).
DOPPS has a long history of successful collaborations with investigators outside of Arbor Research Collaborative for Health. We are committed to collaboration with external investigators to maximize the scientific value of the wealth of data made possible by all the participating facilities and patients. Past activities have allowed scientists to explore a very broad range of topics of interest to the dialysis community. To continue our tradition of providing unique opportunities for scientific investigation, we invite interested researchers to learn more about opportunities for collaboration with us.
There are generally three types of collaborative and ancillary studies:
Studies to perform novel analyses of core DOPPS data. These studies may include:
- Release of a limited data set to an external investigator for independent analyses
- Analyses conducted by Arbor Research to address a scientific question from external investigators (external investigators will typically provide scientific leadership for these projects)
- Studies that collect new data (data not captured as part of the core study, e.g., bio samples or new patient surveys)
- Implementation of the core DOPPS, PDOPPS or CKDopps protocol in a new country
Ancillary studies are supported by sources outside the DOPPS and must be independently funded by the investigator or by resources obtained by the investigator. Similarly, implementation of the core study in a new country typically requires obtaining country-level funding for participation. Approval by one of the DOPPS studies’ steering committees (DOPPS, PDOPPS, CKDopps) is required prior to submitting for outside funding.
DOPPS is funded by a consortium of private industry and public funders, with the shared mission of providing a strong scientific basis for the identification of haemodialysis practices that are most associated with improved patient survival and quality of life. Since starting in 1996, the base of funding has expanded to include grants from over 15 funders to support different facets of the collection, analysis, and dissemination of this important information.
Principal sponsors for the DOPPS program are: Amgen, Kyowa Hakko Kirin, AbbVie Inc., Sanofi Renal, Baxter Healthcare, Vifor, Fresenius Medical Care Renal Pharma, Ltd
Additional support for specific projects and countries is provided in Canada by Amgen, BHC Medical, Janssen, Takeda, Kidney Foundation of Canada (for logistics support); in Germany by Hexal AG, Deutsche Gesellschaft für Nephrologie e. V. (German Society of Nephrology), Shire, Wissenschaftliches Institut für Nephrologie (Scientific Institute for Nephrology); for PDOPPS in Japan by the Japanese Society for Peritoneal Dialysis; for PDOPPS by Fresenius Medical Care.
Public funding and support is provided for specific DOPPS projects, ancillary studies, or affiliated research projects by: CIHR in Canada; Agence Nationale de la Recherche in France; National Institute for Health Research (NIHR) via the Comprehensive Clinical Research Network (CCRN) in the United Kingdom; and NIH and PCORI in the United States.
All support is providedwithout restrictions on publications.