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.
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.
Authors: D G Altman; K F Schulz; D Moher; M Egger; F Davidoff; D Elbourne; P C Gøtzsche; T Lang Journal: Ann Intern Med Date: 2001-04-17 Impact factor: 25.391
Authors: Herbert P Wiedemann; Arthur P Wheeler; Gordon R Bernard; B Taylor Thompson; Douglas Hayden; Ben deBoisblanc; Alfred F Connors; R Duncan Hite; Andrea L Harabin Journal: N Engl J Med Date: 2006-05-21 Impact factor: 91.245
Authors: Ravindra L Mehta; Maria T Pascual; Sharon Soroko; Brandon R Savage; Jonathan Himmelfarb; T Alp Ikizler; Emil P Paganini; Glenn M Chertow Journal: Kidney Int Date: 2004-10 Impact factor: 10.612
Authors: Glenn M Chertow; Maria T Pascual; Sharon Soroko; Brandon R Savage; Jonathan Himmelfarb; T Alp Ikizler; Emil P Paganini; Ravindra L Mehta Journal: Am J Kidney Dis Date: 2003-09 Impact factor: 8.860
Authors: Kamyar Kalantar-Zadeh; Susan T Crowley; Srinivasan Beddhu; Joline L T Chen; John T Daugirdas; David S Goldfarb; Anna Jin; Csaba P Kovesdy; David J Leehey; Hamid Moradi; Sankar D Navaneethan; Keith C Norris; Yoshitsugu Obi; Ann O'Hare; Tariq Shafi; Elani Streja; Mark L Unruh; Tushar J Vachharajani; Steven Weisbord; Connie M Rhee Journal: Semin Dial Date: 2017-04-18 Impact factor: 3.455
Authors: Paul M Palevsky; Jane Hongyuan Zhang; Theresa Z O'Connor; Glenn M Chertow; Susan T Crowley; Devasmita Choudhury; Kevin Finkel; John A Kellum; Emil Paganini; Roland M H Schein; Mark W Smith; Kathleen M Swanson; B Taylor Thompson; Anitha Vijayan; Suzanne Watnick; Robert A Star; Peter Peduzzi Journal: N Engl J Med Date: 2008-05-20 Impact factor: 91.245
Authors: Kristin L McBain; Eric T Payne; Rohit Sharma; Helena Frndova; Nicholas S Abend; Sarah M Sánchez; William B Gallentine; Karen M Cornett; Kendall B Nash; O Carter Snead; Christopher S Parshuram; Jamie S Hutchison; Cecil D Hahn Journal: Pediatr Crit Care Med Date: 2016-03 Impact factor: 3.624
Authors: Paul M Palevsky; Theresa Z O'Connor; Glenn M Chertow; Susan T Crowley; Jane Hongyuan Zhang; John A Kellum Journal: Crit Care Date: 2009-08-11 Impact factor: 9.097