Includes References

Nephrology practice has been informed over the last quarter of a century by a large number of
clinical trials that translated animal experimentation findings into the bedside. These clinical
trials have also informed and shaped the Nephrology Practice Guidelines worldwide.
However, a closer look at many of these clinical trials finds them wanting and reveals major
flaws that make their conclusions challengeable and their subsequent impact of practice misguided. Consequently, our practice and guidelines have been shaped in some instances by
clinical trials that are inconclusive at best and misleading in their conclusions and recommendations at worst.
This has prompted the editors of this monograph along with its publisher to call upon
experts in the various fields of nephrology to undertake a thorough and critical appraisal and
evaluation of the published clinical trials that have shaped our practice in recent times in general nephrology, dialysis, and transplantation. We have also included a critical appraisal template based on standard guidelines including the CONSORT statement to allow for a
comparative evaluation of clinical trials within one area of nephrology and also across its different fields: General Nephrology, Dialysis, and Transplantation. Of note, the implementation
of the Critical Appraisal template was left entirely to individual authors’ evaluations.
Parameters Yes No Comment
Validity
Is the Randomization Procedure well described? +1 −1
Double blinded? +2 −2
Is the sample size calculation described/adequate? +3 −3
Does it have a hard primary endpoint? +1 −1
Is the endpoint surrogate? −2 0
Is the follow-up appropriate? +1 −1
Was there a Bias? −2 +2
Is the drop out >25 %? −1 +1
Is the analysis ITT? +3 −3
Utility/Usefulness
Can the findings be generalized? +1 −1
Was the NNT <100? +1 −1
Score …
The critical appraisals of mostly randomized clinical trials (RCT) have revealed the strength
but also the weakness of the published literature upon which we base our current practice.
We hope that the monograph will alert nephrologists worldwide to the value of published
RCT and provide them with a most valuable reference that assists them in their understanding
and evaluation of key publications in nephrology. This in turn should allow them to better
judge the literature upon which they base their daily clinical practice and avoid misplaced and
unfounded assumptions.
The quality of the clinical practice and health care we deliver as nephrologists depend to a
large extent on the quality of the RCT and publications we base our knowledge and guidelines
upon.