Co-enrollment and Deferred Consent, Strategies to optimize recruitment in critical care trials: The DYNAMICS DUO study
CCCF ePoster library. McDonald E. Oct 28, 2015; 114748; P116
Ellen McDonald
Ellen McDonald
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Abstract
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P116


Topic: Retrospective or Prospective Cohort Study


Co-enrollment and Deferred Consent, Strategies to optimize recruitment in critical care trials: The DYNAMICS DUO study



Ellen McDonald, J. Bryson, M. Xu, P. Liaw, A. Fox-Robichaud, O. Smith

Medicine, McMaster University, Hamilton, Canada | NA, Westmount Secondary School, Hamilton, Canada | Faculty of Health Sciences, McMaster University, Hamilton, Canada | Medicine, Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada | Medicine, McMaster University, Hamilton, Canada | Critical Care, St. Michael's Hospital, Toronto, Canada

Introduction:

Patient recruitment is essential to research. Obtaining a priori consent within restrictive timelines from critically ill patients or substitute decision makers (SDMs) can be difficult due to both psychological strain on family and practical barriers. Deferred consent is a suitable strategy to avoid such obstacles while maintaining patient autonomy. In addition, co-enrollment of patients into multiple studies allows for recruitment to be maximized.



Objectives:

To document recruitment strategies for a national observational critical care research study of septic patients using the DYNAMICS (ClinicalTrials.gov NCT01355042) study as a model. This multi-centre observational study captured plasma DNA levels as predictors of mortality and featured successful patient recruitment, with rates exceeding 98% in regions.



Methods:

Information on co-enrollment and deferred consent practices was captured prospectively during the DYNAMICS study. When deferred consent was used, patients or SDMs had three options: a) full participation in the study, b) partial participation – allowing data to be utilized only from the previously collected specimen, or c) refusing to participate.

Retrospectively, the 758 patient DYNAMICS database was reviewed. The proportion of patients recruited using deferred versus a priori consent was documented overall, and as a modality of time. Consent rejections and withdrawals were also recorded.

In addition, the proportion of co-enrolled patients was documented, as well as the design and funding source of studies they participated in.



Results:

Of the 758 patients enrolled in DYNAMICS, 529 (70%) were recruited using deferred consent. 499 (94%) of these patients gave full consent and 27 (5%) partial consent. Only 3 (<1%) of those enrolled using deferred consent fully declined participation.

Co-enrollment was utilized in 208 cases (27%). 165 (79%) of these patients were co-enrolled in 1 study, 37 (18%) in 2 studies, and 6 (3%) in ≥3 studies. Of these 208 patients, 2 (1%) were co-enrolled with an industry-funded study.



Conclusion:

The deferred consent strategy was the method of choice for recruitment. Although it is impossible to determine the response of these patients to a priori consent, it is reasonable to conclude that patient recruitment would have been considerably lower in the absence of the deferred consent model. Patients and SDMs accepted the deferred consent strategy, as demonstrated by minimal full refusals to participate.

Co-enrollment also made significant contributions to overall ICU study recruitment. The practice allowed for at least 257 additional data sets to be collected for other studies.

Overall, where ethically and scientifically permissible, the utilization of both deferred consent and co-enrollment is a pragmatic strategy to optimize recruitment in critical care trials.



References: NA
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