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01-12-2013 | Original Article

Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis

Authors: D. Cook, Y. Arabi, N. D. Ferguson, D. Heels-Ansdell, A. Freitag, E. McDonald, F. Clarke, S. Keenan, G. Pagliarello, W. Plaxton, M. Herridge, T. Karachi, S. Vallance, J. Cade, T. Crozier, S. Alves da Silva, R. Costa Filho, N. Brandao, I. Watpool, T. McArdle, G. Hollinger, Y. Mandourah, M. Al-Hazmi, N. Zytaruk, N. K. J. Adhikari, The PROTECT Research Coordinators, PROTECT Investigators, Canadian Critical Care Trials Group and the, Australian and New Zealand Intensive Care Society Clinical Trials Group

Published in: Intensive Care Medicine | Issue 12/2013

Abstract

Purpose

To analyze the frequency, rationale and determinants of attending physicians requesting that their eligible patients not be approached for participation in a thromboprophylaxis trial.

Methods

Research personnel in 67 centers prospectively documented eligible non-randomized patients due to physicians declining to allow their patients to be approached.

Results

In 67 centers, 3,764 patients were enrolled, but 1,460 eligible patients had no consent encounter. For 218 (14.9 %) of these, attending physicians requested that their patients not be approached. The most common reasons included a high risk of bleeding (31.2 %) related to fear of heparin bioaccumulation in renal failure, the presence of an epidural catheter, peri-operative status or other factors; specific preferences for thromboprophylaxis (12.4 %); morbid obesity (9.6 %); uncertain prognosis (6.4 %); general discomfort with research (3.7 %) and unclear reasons (17.0 %). Physicians were more likely to decline when approached by less experienced research personnel; considering those with >10 years of experience as the reference category, the odds ratios (OR) for physician refusals to personnel without trial experience was 10.47 [95 % confidence interval (CI) 2.19–50.02] and those with less than 10 years experience was 1.72 (95 % CI 0.61–4.84). Physicians in open rather than closed units were more likely to decline (OR 4.26; 95 % CI 1.27–14.34). Refusals decreased each year of enrollment compared to the pilot phase.

Conclusions

Tracking, analyzing, interpreting and reporting the rates and reasons for physicians declining to allow their patients to be approached for enrollment provides insights into clinicians’ concerns and attitudes to trials. This information can encourage physician communication and education, and potentially enhance efficient recruitment.

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Title: Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis
Authors: D. Cook
Y. Arabi
N. D. Ferguson
D. Heels-Ansdell
A. Freitag
E. McDonald
F. Clarke
S. Keenan
G. Pagliarello
W. Plaxton
M. Herridge
T. Karachi
S. Vallance
J. Cade
T. Crozier
S. Alves da Silva
R. Costa Filho
N. Brandao
I. Watpool
T. McArdle
G. Hollinger
Y. Mandourah
M. Al-Hazmi
N. Zytaruk
N. K. J. Adhikari
The PROTECT Research Coordinators
PROTECT Investigators
Canadian Critical Care Trials Group and the
Australian and New Zealand Intensive Care Society Clinical Trials Group
Publication date: 01-12-2013
Publisher: Springer Berlin Heidelberg
Published in: Intensive Care Medicine / Issue 12/2013
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-013-3074-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Physicians declining patient enrollment in a critical care trial: a case study in thromboprophylaxis

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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