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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Screening and study enrolment in the randomized evaluation of normal vs. augmented level (RENAL) replacement therapy trial
Blood Purification, Volume 27, No. 2, Year 2009
Notification
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Description
Background and Objectives: Aspects of trial design, screening and study efficiency can affect recruitment and the findings of the trial itself. A clear understanding of the screening and study inclusion process will assist clinicians in interpreting trial results. Design: Prospective observational data collection on all patients screened for possible inclusion in a randomized controlled trial of normal vs. augmented renal replacement therapy in critically ill patients (the RENAL Trial). Setting: 35 hospitals in Australia and New Zealand. Participants: All patients screened for the RENAL Trial. Results: We screened 4,551 patients. Of these patients, 767 were ineligible because of lack of inclusion criteria and 2,085 because of exclusion criteria. Of the remaining 1,699, 1,508 (88.7%) were enrolled. The three most common exclusion criteria which prevented recruitment of potentially eligible patients were that the patient had end-stage kidney failure and was already on chronic dialysis (484; 23.2%), the patient's body weight was either <60 or >120 kg (456; 21.8%), and the fact that the patient had already received renal replacement therapy during the index admission. Important modifiable impediments to recruitment were inability to obtain consent in 191 cases, unavailability of research staff in 124 cases, physician objection in 89 cases, and inability to deliver the trial protocol in 78 cases. Conclusion: The RENAL Trial's enrolment efficiency was high and compared favourably with previous large intensive care units trials and with that of trials in patients with acute renal failure. The high rate of enrolment suggests that the results can be applied with confidence to most patients with de novo acute renal failure. The loss of close to 1.5% of patients due to consent issues highlights a common problem in critical care trials. The low rate of physician objection suggests clinical equipoise. Copyright © 2009 S. Karger AG.
Authors & Co-Authors
Bellomo, Rinaldo
Australia, Melbourne
Austin Health
Cass, Alan
Unknown Affiliation
Finfer, Simon R.
Unknown Affiliation
Gallagher, Martin P.
Unknown Affiliation
Myburgh, John A.
Unknown Affiliation
Norton, Robyn N.
Unknown Affiliation
Cade, John Francis
Unknown Affiliation
Dobb, Geoffrey J.
Unknown Affiliation
French, Craig J.
Unknown Affiliation
Henderson, Seton J.
Unknown Affiliation
Joyce, Christopher John
Unknown Affiliation
Lipman, Jeffrey
Unknown Affiliation
McArthur, Colin J.
Unknown Affiliation
Orford, Neil R.
Unknown Affiliation
Shehabi, Yahya
Unknown Affiliation
Statistics
Citations: 16
Authors: 15
Affiliations: 1
Identifiers
Doi:
10.1159/000195091
ISSN:
02535068
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study
Grounded Theory
Study Approach
Quantitative