In August 2009, the journal Kidney International published the Supplement 113 entitled “KDIGO-Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD)”. It was based on the best information available as of March 2009, including a final updated literature search as of December 2008.
It was designed to provide information and assist in decision-making at clinics for adults and children with stage 3-5 chronic kidney disease (CKD), undergoing dialysis or transplantation. It does not aim to define a standard treatment because variations are expected (and appropriate) in clinical practice, and, as clinicians, we consider the individual needs of each patient and the resources available, as well as the limitations that could affect a given institution or clinical practice.
The disclaimer considers that every health care professional making use of these recommendations is responsible for evaluating the appropriateness of applying them in the setting of any particular situation.
The most important part of developing these guidelines is that they can be applied universally, in the context of the KDIGO programme (Kidney Disease: Improving Global Outcomes; www.kdigo.org). Furthermore, they are the product of an exhaustive evidence-based review and a systematic review of relevant clinical trials.
One of the greatest novelties of the KDIGO guidelines is that they have adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.
There are only three recommendations in the guidelines for which the overall quality of evidence was graded ‘A’; 12 were graded ‘B’; 23 graded ‘C’; and 11 were graded ‘D’. Ten recommendations had a strength of recommendation grade of ‘1’, and 39 ‘2’. In general, there were two ‘1A’ recommendations, five ‘1B’ and three ‘1C’ (none ‘1D’). There was one graded ‘2A’, seven ‘2B’, twenty ‘2C’ and eleven ‘2D’. Twelve statements were not graded as they provided guidance that was based on common sense, reminders of the obvious and/or recommendations that are not specific enough to allow the application of evidence.
The preponderance of grade ‘2’ recommendations suggests that patient preferences and other circumstances should be considered when implementing most recommendations. The lack of ‘A’ and ‘B’ grades suggests that additional research is needed in the area.
The Spanish Society of Nephrology (S.E.N.) published their first Spanish Society of Nephrology recommendations for controlling mineral and bone disorder in chronic kidney disease patients (Recomendaciones de la S.E.N. para el manejo de las alteraciones del metabolismo óseo-mineral en los pacientes con ERC) in the Nefrología journal, in the first supplement of 2008, stating that the therapeutic arsenal is continuously undergoing changes. At that moment in time, the KDIGO commission was completing its study and there was very little evidence available. They still decided to devise the most up-to-date recommendations that they could, which would be reviewed “when necessary”.
Given that the KDIGO guidelines were published on a global scale, the S.E.N. should make their standpoint on the matter clear. Although the review is academically impeccable, S.E.N. commission members believe that some of the statements could be interpreted too literally by nephrologists, whose main interest does not lie in chronic kidney disease-mineral and bone disorder (CKD-MBD) patients. This could therefore lead to slackness with regards to treatments, which would not be recommended.
Meanwhile, as the associated Guidelines and Editorials have stated (Eknoyan G. Nature Clinical Practice Nephrology 4[10]:521), adopting and implementing global nephrology guidelines also involves “regional” decision-making, given the differences between health care systems and the availability of resources in different places.
The S.E.N. consequently intends to update their recommendations for controlling mineral and bone disorder (MBD) in CKD patients. Once again, the aim is to serve as support for nephrologists to treat this disorder.
As applied to the above mentioned Recommendations, this document is an institutional recommendation, and should not be viewed as Clinical Practice Guidelines.
We have adapted our Recommendations to the contributions made by KDIGO, including recent changes in the physiopathology and new alternative therapies that have been developed during recent months.
The S.E.N. decided to update the Recommendations, and the work group responsible for developing this task was assigned on merit of their documented experience.
The work group distributed the subjects that needed to be reviewed and updated, and these different work groups updated the proposed sections in accordance with the KDIGO recommendations using the best scientific evidence available.
Once the sections were revised, the draft committee summarised and classified them focusing on the following objectives:
- Assessing the problem.
- Diagnostic strategies.
- Biochemical values recommended.
- Alternative therapies.
The whole committee then assessed guidelines considering the project’s final philosophy.
As previously mentioned, the quality of evidence is mostly “low” or “very low”, meaning that the Recommendations’ final outcome is once more dependent on the authors’ experience and an extensive literature review. The S.E.N. has once again intended on the updated Recommendations being useful and practical, being of scientific rigour. The financial implications of the different alternative therapies have not been taken into account, only having evaluated the expected benefits for the patient.
