European Dialysis and Transplant Nurses Association/European Renal Care Association
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DOPPS

The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a collection of studies designed to identify best practices for treating patients with chronic kidney failure. By observing patients over time, and correlating practices and outcomes in different medical settings around the world, the DOPPS helps researchers identify practices and other modifiable characteristics that improve patient lives.
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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?

Longitudinal
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.

International
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:

  1. Studies to perform novel analyses of core DOPPS data. These studies may include:
    1. Release of a limited data set to an external investigator for independent analyses
    2. Analyses conducted by Arbor Research to address a scientific question from external investigators (external investigators will typically provide scientific leadership for these projects)
  2. Studies that collect new data (data not captured as part of the core study, e.g., bio samples or new patient surveys)
  3. 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.
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All support is providedwithout restrictions on publications.


EDTNA/ERCA and DOPPS

EDTNA/ERCA started involved with DOPPS back in 2005, with phase III, since then we have been able to build a strong and fruitful relationship under the leadership of Althea Mahon,Jitka Pancirova, Anastasia Laskari (EDTNA/ERCA Presidents) David Ashwanden, Anna Marti I Monros (DOPPS Project Manager 2005-2008, 2009-onwards ) and Alessandra Zampieron and Edita Noruišienė (EDTNA/ERCA Treasurer and Executive Committee link) that ended up with the DOPPS III and DOPPD IV completion and signature and of DOPPS V and just recently DOPPS VI (2016-2018) contracts with Arbor Research.
Since 2009 and as a result of the excellent collaboration EDTNA/ERCA has a sit on the DOPPS Steering Committee.

In Europe, the task of facilitating and coordinating the data collection is managed by EDTNA/ERCA volunteers. In each participating country (Germany, Italy, Spain, Sweden, Belgium, United Kingdom) there is an EDTNA/ERCA Clinical Research Associate who is responsible for liaising with and supporting the staff at the dialysis units. In each participating dialysis unit there is a Study Coordinator who is responsible for the actual data collection. The Study Coordinators work closely with the Medical Directors of their units who in turn liaise with the Country Investigator who is the leader of the research project in the country.

Every year during the EDTNA/ERCA International Conference a DOPPS Symposium is held presenting the state of the art of different core aspects of the renal care.

For EDTNA/ERCA working with ARBOR Research and being part of DOPPS is a great experience.

For more information about DOPPS, please visit www.dopps.org were you will find:

  • Slides from peer-reviewed publications for downloading, slides include goals, methods, results, etc.
  • Meeting study details, organizational information
  • External links and other resources

For more details please contact Anna Marti i Monros, Project Manager at: anna.marti.monros@gmail.com