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INTRODUCTION process, topic discussion, and consensus
This chapter provides a very brief summary of the development.
methods Evidence selection, appraisal, and presentation used to develop this guideline. Detailed methods We first defined the topics and goals for the are guideline and provided in Appendix F. The overall aim of the identified key clinical questions for review. The project was ERT to create a clinical practice guideline with performed literature searches, organized abstract recommendations and article for AKI using an evidence-based approach. After screening, coordinated methodological and topics and analytic processes relevant clinical questions were identified, the of the report, defined and standardized the search pertinent methodology, scientific literature on those topics was performed data extraction, and summarized the systematically evidence. The Work Group members reviewed all searched and summarized. included Group member selection and meeting process articles, data extraction forms, summary tables, The KDIGO Co-Chairs appointed the Co-Chairs and evidence of the Work profiles for accuracy and completeness. The four Group, who then assembled the Work Group to be major topic responsible areas of interest for AKI included: i) definition for the development of the guideline. TheWork and Group consisted classification; ii) prevention; iii) pharmacologic of domain experts, including individuals with treatment; expertise in and iv) RRT. Populations of interest were those at nephrology, critical care medicine, internal risk for medicine, pediatrics, AKI (including those after intravascular contrast- cardiology, radiology, infectious diseases and media epidemiology. For exposure, aminoglycosides, and amphotericin) support in evidence review, expertise in methods, and those and guideline with or at risk for AKI with a focus on patients development, the NKF contracted with the with sepsis or Evidence Review trauma, receiving critical care, or undergoing Team (ERT) based primarily at the Tufts Center cardiothoracic for Kidney surgery. We excluded studies on AKI from Disease Guideline Development and rhabdomyolysis, Implementation at Tufts specific infections, and poisoning or drug Medical Center in Boston, Massachusetts, USA. overdose. Overall, The ERT we screened 18 385 citations. consisted of physician-methodologists with Outcome selection judgments, values, and expertise in nephrology preferences and internal medicine, and research associates and We limited outcomes to those important for assistants. decision making, The ERT instructed and advised Work Group including development of AKI, need for or members in all dependence on steps of literature review, critical literature RRT, and all-cause mortality. When weighting the appraisal, and evidence guideline development. The Work Group and the across different outcomes, we selected as the ERT ‘‘crucial’’ outcome collaborated closely throughout the project. The that which weighed most heavily in the Work Group, assessment of the KDIGO Co-Chairs, ERT, liaisons, and NKF overall quality of evidence. Values and support staff met for preferences articulated four 2-day meetings for training in the guideline by the Work Group included: i) a desire to be development inclusive in terms of meeting criteria for AKI; ii) a progressive guideline topics involve diagnosis and staging or approach to AKI, and risk and cost such that, as severity increased, the here the Work Group chose to provide ungraded group put statements. greater value on possible effectiveness of These statements are indirectly supported by strategies, but evidence on risk maintained high value for avoidance of harm; iii) relationships and resulted from unanimous intent to consensus of the guide practice but not limit future research. Work Group. Thus, the Work Group feels they Grading the quality of evidence and the strength of should not be recommendations viewed as weaker than graded recommendations. The grading approach followed in this guideline is adopted SPONSORSHIP from the GRADE system.40,41 The strength of each KDIGO gratefully acknowledges the following recommendation sponsors that is rated as level 1 which means ‘‘strong’’ or level make our initiatives possible: Abbott, Amgen, 2 Belo Foundation, which means ‘‘weak’’ or discretionary. The Coca-Cola Company, Dole Food Company, wording corresponding Genzyme, to a level 1 recommendation is ‘‘We recommend Hoffmann-LaRoche, JC Penney, NATCO—The y Organization should’’ and implies that most patients should for Transplant Professionals, NKF—Board of receive the Directors, course of action. The wording for a level 2 Novartis, Robert and Jane Cizik Foundation, recommendation Shire, is ‘‘We suggestymight’’ which implies that Transwestern Commercial Services, and Wyeth. different choices KDIGO is will be appropriate for different patients, with the supported by a consortium of sponsors and no suggested funding is course of action being a reasonable choice in accepted for the development of specific many patients. guidelines. In addition, each statement is assigned a grade for DISCLAIMER the quality While every effort is made by the publishers, of the supporting evidence, A (high), B editorial board, (moderate), C (low), and ISN to see that no inaccurate or misleading or D (very low). Table 1 shows the implications of data, opinion the or statement appears in this Journal, they wish to guideline grades and describes how the strength of make it clear the that the data and opinions appearing in the articles recommendations should be interpreted by and guideline users. advertisements herein are the responsibility of the Furthermore, on topics that cannot be subjected to contributor, systematic evidence review, the Work Group copyright holder, or advertiser concerned. could issue Accordingly, the statements that are not graded. Typically, these publishers and the ISN, the editorial board and provide their respective guidance that is based on common sense, e.g., employers, office and agents accept no liability reminders of whatsoever for the obvious and/or recommendations that are not the consequences of any such inaccurate or sufficiently misleading data, specific enough to allow the application of opinion or statement.While every effort is made to evidence. The ensure that GRADE system is best suited to evaluate evidence drug doses and other quantities are presented on accurately, comparative effectiveness. Some of our most readers are advised that new methods and important techniques involving drug usage, and described within this Journal, should only be followed in conjunction with the drug manufacturer’s own published literature. SUPPLEMENTARY MATERIAL Appendix F: Detailed Methods for Guideline Development. Supplementary material is linked to the online version of the paper at http://www.kdigo.org/clinical_practice_guidelines/AKI.php
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