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. 2008 Jul;3(4):955-61.
doi: 10.2215/CJN.05621207. Epub 2008 Apr 2.

Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study

Susan T Crowley  1 , Glenn M Chertow, Joseph Vitale, Theresa O'Connor, Jane Zhang, Roland M H Schein, Devasmita Choudhury, Kevin Finkel, Anitha Vijayan, Emil Paganini, Paul M Palevsky; VA/NIH Acute Renal Failure Trial Network Study Group
Collaborators, Affiliations

Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study

Susan T Crowley et al. Clin J Am Soc Nephrol. 2008 Jul.

Abstract

Background and objectives: Design elements of clinical trials can introduce recruitment bias and reduce study efficiency. Trials involving the critically ill may be particularly prone to design-related inefficiencies.

Design, setting, participants, & measurements: Enrollment into the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study was systematically monitored. Reasons for nonenrollment into this study comparing strategies of renal replacement therapy in critically ill patients with acute kidney injury were categorized as modifiable or nonmodifiable.

Results: 4339 patients were screened; 2744 fulfilled inclusion criteria. Of these, 1034 were ineligible by exclusion criteria. Of the remaining 1710 patients, 1124 (65.7%) enrolled. Impediments to informed consent excluded 21.4% of potentially eligible patients. Delayed identification of potential patients, physician refusal, and involvement in competing trials accounted for 4.4, 2.7, and 2.3% of exclusions. Comfort measures only status, chronic illness, chronic kidney disease, and obesity excluded 11.8, 7.8, 7.6, and 5.9% of potential patients. Modification of an enrollment window reduced the loss of patients from 6.6 to 2.3%.

Conclusions: The Acute Renal Failure Trial Network Study's enrollment efficiency compared favorably with previous intensive care unit intervention trials and supports the representativeness of its enrolled population. Impediments to informed consent highlight the need for nontraditional acquisition methods. Restrictive enrollment windows may hamper recruitment but can be effectively modified. The low rate of physician refusal acknowledges clinical equipoise in the study design. Underlying comorbidities are important design considerations for future trials that involve the critically ill with acute kidney injury.

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Figures

Figure 1.
Figure 1.
Algorithm and reasons for patient enrollment or exclusion. Patients may have had more than one exclusion criterion. *A total of 593 potentially eligible patients before modification of enrollment window and 2151 potentially eligible patients afterward.
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