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INTRODUCTION
Despite the fact that several guidelines and directions for appropriate medical management have been developed for end stage renal disease, little or none has been done so far concerning acute renal failure and its treatment. For this reason we decided to undertake a process seeking consensus and evidence based statements guidelines in the field of acute renal failure. The name of this process is ADQI: Acute Dialysis Quality Initiative.


BACKGROUND



OBJECTIVES OF ADQI



RATIONALE FOR ADQI



THE FIRST ADQI CONFERENCE



ADQI CONFERENCE METHODOLOGY



ACKNOWLEDGEMENT




REFERENCES


NEWS!


The AQDI Conference is officially endorsed by the American Society of Nephrology and the Society of Critical Care Medicine

BACKGROUND
The intent of ADQI is to provide an objective, dispassionate distillation of the literature and description of the current state of practice of dialysis and related therapies. The purpose is to develop a consensus of opinion, with evidence where possible, on best practice and to articulate a research agenda to focus on important unanswered questions. This approach is a blend of "expert panel" and "evidence appraisal" and was chosen in order to achieve the best of both methods. We recognize that the expert panel in absence of the literature can lead to statements at odds with high quality research and that evidence appraisal without expert input to question the framework can lead to erroneous interpretation (1). Furthermore, this combined approach has led to important practice guidelines with wide acceptance and adoption into clinical practice (2)

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OBJECTIVES OF ADQI
The final objectives for ADQI are the following:

  • Standardize and possibly optimize the process of dialysis for the critically ill patient
  • Develop consensus recommendations for best practice
  • Establish evidence based statements and possibly guidelines where applicable
  • Identify questions for future research and consider study design options
To obtain such these results, a first step was required and the first ADQI conference was organized (New York on August 28-30, 2000) specifically focusing on CRRT. The objectives for this first phase were:
  • To describe the current clinical applications of CRRT (therapeutic options, current practice, and evidence).
  • To identify and prioritize issues within each CRRT topic requiring standardization and to define current state of consensus.
  • To propose a strategy to address unresolved issues (consensus development, further research).(Fig 1)
(Fig 1)


Figure 1: *When conflicting studies were found, a full evaluation and appraisal was recommended. Individual workgroups did not attempt to synthesize and combine data from individual studies (meta-analysis) nor were attempts made to adjudicate between individual studies on the basis of quality.

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RATIONALE FOR ADQI
An increasing number of patients develop acute renal failure each year, and mortality is still higher than 50% despite new treatment strategies. In recent years, there have been considerable advances in our understanding and technical capabilities, but consensus over the optimal way to deliver care does not exist. Consequently, we decided to initiate a process which will include a series of conferences and interactions with a large number of reviewers and experts defined Acute Dialysis Quality Initiative (ADQI). ADQI aims at establishing an evidence-based appraisal and set of consensus recommendations to standardize care and direct further research.
CRRT is being used at ever increasing rates worldwide. Today, approximately one quarter of all patients with acute renal failure are treated with CRRT. Despite the increasing use, there are presently no published standards for the application of this therapy and practice patterns vary widely between individual centers. Results from recent clinical trials on selection of dialysis membranes, and dialysis dose provide strong, yet conflicting evidence to guide therapy. Other areas of uncertainty have not been sufficiently addressed by clinical studies and directives for future research are needed. Finally, the success of multi-centered clinical trials in supportive care in the ICU (transfusion thresholds and ventilator management) have intensified and renewed interest in the study of supportive care methods as a major target for future research. These developments have set the stage for the first ADQI conference held in New York on August 28-30, 2000. The conference focused on the application of continuous renal replacement therapy (CRRT) in the critically ill patient with acute renal failure.
While the primary aims of this conference was were to establish the methodology for the consensus process, to describe current clinical practice and to identify important clinical and research questions, the final objectives of ADQI are the development of evidence-based practice guidelines and directions for future research. Since among the several controversial points concerning CRRT there is the question of who should be in change charge of patient's care and what should be the specific contribution of intensive care and renal physicians, the founding group of ADQI in New York was constituted by a balanced group of scientists of both branches.

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THE FIRST ADQI CONFERENCE
The Renal Research Institute of New York is the Organiser of the First ADQI Conference and its Major Sponsor.
Chaired by John Kellum, Claudio Ronco and Ravindra Mehta as directors of the ADQI conference, the group featured 7 intensivists (Drs Murray, Stewart, Corwin, Bellomo, Skippen, Schetz and Angus) and 7 nephrologists (Drs Paganini, Leblanc, Bunchman, Levin, Depner Palevsky and Davenport) (figure 2). In the group a few members from the industry (Drs Tetta, Lazarus and Clark) and two representatives from the American National Institute of Health (Drs Star and Kimmel) were included. Since the meeting took place in the US, the American Society of Nephrology (represented by Dr. Palevsky) and the Society of Critical Care Medicine (represented by Dr. Angus) endorsed the scientific event. Nevertheless, for the future we are very much looking forward to receiving further sponsorships and endorsement from other scientific societies in Europe and Asia and possibly to organize focused conferences of ADQI on different specific issues in various countries. The Conference in New York was hosted by the Renal Research Institute that we must congratulate for the efficient organization and the excellent logistics. Specific objectives for this conference were:
To establish a methodology for the development of a series of evidence based recommendations on dialytic intervention in the ICU.
This methodological analysis included:
the systematic search for evidence in different areas based on review and evaluation of the available literature;
the establishment of clinical and physiologic outcomes as well as measure parameters to be utilized for comparison of different treatments;
the description of the current practice and the rationale for the use of current techniques;
the analysis of areas in which evidence is lacking and future research is required to obtain new valuable information.

To focus first on CRRT and define the topics that will require development of evidence based guidelines. Summary statements were drafted by seven different working groups to describe the current state of the art for each topic. The covered topics were as follows:
Definitions/Nomenclature
Patient Selection
Solute Control (Treatment Dose)
Membranes
Operational characteristics (Convection/Diffusion)
Fluid Management/Composition
Anticoagulation / Access


PHOTO ALBUM FROM THE FIRST ADQI CONFERENCE IN NEW YORK

(Fig 2)

ADQI founding group

Clik the pictures









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ADQI CONFERENCE METHODOLOGY
PRECONFERENCE ACTIVITY CONFERENCE ACTIVITIES PART 1 CONFERENCE ACTIVITIES PART 2 POST-CONFERENCE ACTIVITY AND FUTURE PLANS CONCLUSIONS

Given the multidisciplinary aspects of CRRT, a multidisciplinary group (nephrologists and intensivists) was assembled. This group was organized into smaller workgroups. Each workgroup was assigned a particular topic area. Topics are shown in table one and were selected on the basis of the following criteria:
Prevalence of the clinical problem
Variation in clinical practice
Potential influence on outcome
Potential for development of EBM guidelines
Availability of scientific evidence

Studies were identified via MEDLINE search, bibliographies of review articles and participants' files. Searches were limited to English language articles. However, articles written in other languages were used when identified and presented by members of the group. Evidence was classified according to levels per EBM methodology. Qualitative commentary was provided when deemed necessary by the group. However, there was no critical appraisal of individual studies during this phase. Outcomes were grouped into the following major categories: physiologic (eg. blood pressure, BUN, etc.), clinical (short-term morbidity/ mortality, long-term morbidity/mortality, renal recovery, functional class/quality of life) and economic. Different types of outcomes were considered separately for each area. Animal research was not considered evidence except that it contributed to commentary. Each work group was composed of three members, one who served as the group facilitator. Summary statements were developed through a series of breakout sessions where individual work group members were required to identify key issues for which guidelines are needed and to classify current state of consensus and identify supporting evidence for each issue. Workgroup members were then required to present their findings to the entire group, revising each statement as needed until a final version was agreed upon. The responsibilities for presenting the findings of the work group to the rest of the participants was shared by each member on a rotating basis. Group facilitators revised work group findings as needed after each plenary session. Directives for future research were achieved by asking the participants to: a. identify deficiencies in the literature, b. determine if more evidence is necessary, and c. if more evidence is necessary, articulate general research questions. When possible, pertinent study design issues were also considered. Conference activities were divided into three steps: pre-conference, conference and post-conference. In the pre-conference step, the methodology was developed, work groups were assembled and assigned to specific topics (Table 1). Each group identified a list of key questions, conducted a systematic literature search and generated a bibliography of key studies. During this stage, the scope of the conference was also defined and some topics were excluded from this phase (Table 1). During the next step, the conference itself, the methodology was approved by the group and the conference was divided into breakout sessions where work groups addressed the issues in their assigned topic area, and plenary sessions where their findings were presented, debated and refined. During the first plenary session, the key questions were discussed and debated. Revised versions (some added, some deleted and others rewritten) of each question were then presented at the second plenary. At this point evidence was assembled for each question and summary statements was were drafted. These statements were further refined in subsequent plenary sessions until final versions were agreed upon. A writing committee assembled the individual reports from the work groups. Each report was edited to conform to a uniform style and for length. The final reports were posted on the internet (www.ADQI.net) and mailed to each participant for comment and revision. Finally, international consultants were identified and reports were sent to them for comment. Once final reports were completed, the writing committee summarized the individual reports into a final conference document. In detail, the following steps can be summarized to identify the first ADQI conference:

PRECONFERENCE ACTIVITY
Each participant was part of a working group to cover a single topic. Each member was required to perform the tasks listed below. Participants were encouraged to communicate with other group members via Email or other means in order to streamline their efforts and work collectively. Participants were also encouraged to communicate with other experts both locally and internationally.

1. Define a list of questions within the topic
For each topic, a list of questions was generated. For example under membranes: "Which membranes should be used for CRRT?", "should bio-compatible membranes be used for CRRT", "how often should filters be changed during CRRT?".

2. Perform a systematic literature search
Each participant was provided with a list of references from the directors. Participants were required to perform their own literature search to find any additional articles. Search strategy and terms had to be specified and participants had to be prepared to defend any exclusion criteria. In general, the trend was to be as broad and inclusive as possible.

3. Compile a bibliography
One complete set of references was brought to the meeting by the group members. A bibliography was compiled prior to the meeting, and this was organized in a single format used by JAMA (this is only to keep the references in a single format).

4. Assess the current status of consensus
It was determined for local institutions and regions what questions were already fairly settled vs. ones that were not. It was also determined what questions will be likely to be answerable with current literature vs. ones that have insufficient evidence. Each question was rated as either: a. consensus already exists, b. data exists but controversy and variability of practice is still present, c. insufficient evidence is available. Note: we did not try to judge the quality of the evidence at this stage.

CONFERENCE ACTIVITIES PART 1

The entire group was asked to consider methodology for the ADQI process. Specific tasks included the following:

The incorporation of Evidence-based Medicine principles into the literature review process. Definition of levels of evidence and terms to be used. Definition of what the literature sources should be and how far back the literature should be reviewed.

Determination of what clinical, physiologic, and health economic outcomes should be considered evidence of effectiveness in clinical trials in RRT.

Definition of how, physiologic outcomes (e.g. arterial blood pressure) should be rated in relation to clinical outcomes (e.g. survival, need for long-term dialysis) and health economic outcomes (e.g. total costs, length of hospitalization) in evidentiary tables used for further ADQI consensus statements.

Debate on the role of evidence from animal research in RRT.

Draft and review forms to be used for review of literature and data extraction

Definition of how peer review should be done and who will be the peer group

Discussion on how "best clinical practice" will be established in the absence of evidence.

Determination of how consensus will be achieved on directions for future research.

Draft methodology statement.

Discuss who will be sponsoring bodies for overall effort and how we will approach this issue

CONFERENCE ACTIVITIES PART 2

Breakout sessions were used for each group to catalog and review the literature in each area and define areas of established consensus as well as areas where consensus is lacking. Each group reviewed pre-conference work and present a draft set of statements that summarize the questions for their topic and the state of the current literature. The specific tasks for each group were:
Create a list of individuals to serve as consultants (for each topic) for the final consensus
Develop the final list of questions and identify key evidence that should be reviewed. (Each topic required a few the key references associated with it).
Work groups rated the current status of the literature based on the ratings above (a. b. or c. from above).
A summary statement listing what is needed to proceed further for each question and the current state of the literature was drafted. The spokesperson presented the draft summary statements and presented findings from any key studies.
Note, at this stage, we did not attempt to develop NEW consensus; that will be covered in the second stage of the ADQI process. Instead, summary statements listed questions, described current practices and noted the presence or absence consensus already existing.

The entire group evaluated the statements and suggested revisions.
Final statements were drafted "on line" with all members present. A 2/3 majority vote was required to approve all statements. Indeed, unanimous agreement existed for most.

POST-CONFERENCE ACTIVITY AND FUTURE PLANS

A writing committee will include the conference directors and 1-2 other members nominated by the group to compile the findings of the conference. This document will be completed as soon as all the necessary revisions will be made from the original drafts and will be posted on the internet http://www.adqi.net/ for comment by the remainder of the participants. The period for comment will be limited in time and revisions will be made accordingly. The final product will be submitted as a manuscript for publication immediately following this process.

CONCLUSIONS
In conclusion, ADQI is a moving process that will produce evidence - based statements on different issues concerning acute dialysis. The first step was to try to reach consensus on Continuous Renal replacement Therapies, an area where major controversies are still present. The next step will be the development of consensus statements that should provide the basis for recommendations to be used in clinical practice. Our effort aims at obtaining a common ground where acute dialysis should be discussed and hopefully optimized. At the present time there is very little agreement on how much , when and how dialysis should be provided. We hope to move a little further with the cooperation of anybody all who may be interested in helping and becoming temporary or permanent members of the commission for the development of the ADQI tasks.

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ACKNOWLEDGEMENT
The ADQI directors would like to express their gratitude to Renal Research institute for the organizational and scientific support to the first ADQI conference. The generous support of the sponsors should also be acknowledged. In particular we would like to thank: Baxter, Bellco, B.Braun, Fresenius Medical Care, Gambro Renal Care, Kimal, Medica, Nextrom Med Tech and Renaltech.

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REFERENCES
Kellum JA, Ramakrishnan N, Angus D. Appraising and Using Evidence in Critical Care. In, Grenvik A, Shoemaker PK, Ayers S, Holbrook (eds). Textbook of Critical Care, W.B. Saunders Co, Philadelphia, 1999; Chapter 193; pp 2059-2069.
Chestnut RM. Implications of the guidelines for the management of severe head injury for the practicing neurosurgeon. Surg Neurol 1998; 50:187-93.
National Kidney Foundation : KDOQI: www.kdoqi.org

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