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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Physicians declining patient enrollment in a critical care trial: A case study in thromboprophylaxis
Intensive Care Medicine, Volume 39, No. 12, Year 2013
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Description
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. © 2013 Springer-Verlag Berlin Heidelberg and ESICM.
Authors & Co-Authors
Cook, Deborah J.
Canada, Hamilton
Mcmaster University Medical Centre
Canada, Hamilton
Mcmaster University
Arabi, Yaseen M.
Saudi Arabia, Riyadh
National Guard Health Affairs
Ferguson, Niall D.
Canada, Toronto
University of Toronto
Heels-Ansdell, Diane M.
Canada, Hamilton
Mcmaster University
Freitag, Andreas P.
Canada, Hamilton
Mcmaster University Medical Centre
McDonald, Ellen
Canada, Hamilton
Mcmaster University
Clarke, France
Canada, Hamilton
Mcmaster University
Keenan, Sean Patrick
Canada, Vancouver
The University of British Columbia
Pagliarello, Giuseppe
Canada, Ottawa
University of Ottawa
Plaxton, W.
Canada, Kitchener
Grand River Hospital
Herridge, Margaret S.
Canada, Toronto
University of Toronto
Karachi, Tim
Canada, Hamilton
Mcmaster University Medical Centre
Vallance, Shirley A.
Unknown Affiliation
Cade, J.
Australia, Melbourne
Royal Melbourne Hospital
Crozier, Tim
Australia, Clayton
Monash Medical Centre
Da Silva, S. Alves
Brazil, Rio de Janeiro
Hospital Pro-cardiaco
Costa-Filho, Rubens Carmo
Brazil, Rio de Janeiro
Hospital Pro-cardiaco
Brandao, N.
Brazil, Porto Alegre
Universidade Federal de Ciencias da Saúde de Porto Alegre
Watpool, Irene
Canada, Ottawa
University of Ottawa
McArdle, Tracy
Canada, Ottawa
University of Ottawa
Hollinger, G.
Canada, Guelph
Guelph General Hospital
Mandourah, Yasser
Saudi Arabia, Riyadh
Riyadh Military Hospital
Al Hazmi, Manal
Saudi Arabia, Riyadh
King Fahad Medical City
Zytaruk, Nicole L.
Canada, Hamilton
Mcmaster University
Adhikari, Neill K.J.
Canada, Toronto
University of Toronto
Statistics
Citations: 25
Authors: 25
Affiliations: 14
Identifiers
Doi:
10.1007/s00134-013-3074-x
ISSN:
03424642
e-ISSN:
14321238
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Quasi Experimental Study
Case Study
Study Approach
Qualitative