By Mohsen El Kossi, Arif Khwaja, Meguid El Nahas
Historically, medical judgements in renal medication were challenged via the scarce availability of strong supportive facts. not just are the variety of randomized managed trials (RCTs) in Nephrology the 3rd lowest among the scientific specialties yet frequently the pains themselves are of terrible caliber. furthermore, perform has been extra stimulated through extrapolation from the results of basic inhabitants scientific trials which exclude renal sufferers. the adaptation among definitely the right trial player and actual complicated instances encountered in day-by-day perform is easily well-known and extra compounded in renal sufferers with advanced pathophysiology - this finally makes determination making during this subset of sufferers a true problem. lately, there was a turning out to be curiosity in engaging in good designed RCTs in numerous parts of renal drugs. despite the fact that, although medical directions are invaluable in delivering the clinicians with a body of most sensible to be had facts for a scientific situation, it denies the original nature of every person sufferer.
This ebook deals a radical and important appraisal and review of the main released scientific trials that experience formed present perform in nephrology, dialysis and transplantation. it's going to aid the working towards general practitioner shut the distance among the rigid and generalized nature of scientific instructions and the day by day medical decision-making for person sufferers. it is going to give you the clinician with the instruments required to enquire and extract the correct assistance to use to person instances in day-by-day perform. furthermore, it is going to aid enhance the facility of junior colleagues to appraise to be had facts in a scientific approach whilst there's loss of neighborhood instructions or whilst the information are tough to use because of logistic constraints or limitations. finally, this e-book will function a reference for key scientific trials in several parts of renal medication including literature and authors perspectives of those trials and their impression on altering practice.
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Extra resources for Informing Clinical Practice in Nephrology: The Role of RCTs
Trial #12 Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011;365:1886–95. Critical Appraisal Parameters Validity Is the randomization procedure well described? Double blinded? Is the sample size calculation described/ adequate? Yes +1 +2 +3 No Comment Random from sealed envelops 2 Lupus Nephritis Clinical Trials: A Critical Appraisal Parameters Does it have a hard primary endpoint?
Conclusions Although plausibly underpowered to examine the main endpoints, this study did promote a conversion from the then commonly used high-dose, prolonged CYC regimen of the NIH to one involving lower IV CYC dosage over shorter intervals combined with AZA consolidation (maintenance). A 10-year follow-up cohort analysis of 84 patients from the original study showed equivalent “hard” outcomes for the two groups (doubling of serum creatinine), 14 % in the EuroLupus protocol group and 11 % in the NIH protocol group .
2 Is the follow-up appropriate? 0 Was there a Bias? Is the dropout >25 %? Is the analysis ITT? Utility/usefulness Can the findings be generalized? Was the NNT <100? Score 0 +1 −2 Followed for more than 12 months—too short for a renal function endpoint Possible in randomization Cumulative relapse-free survival +1 +0 0% Comparative Summary and Discussion This is the only RCT in “pure” membranous LN—it is flawed due to small sample size (n = 42), thus possibly underpowered. The patient characteristics were balanced at the time of entry, but patients were not randomized to CsA if there were concerns of toxicity (n = 7), so the groups were of unequal size.