Patient attitudes toward granting consent to participate in perioperative randomized clinical trials

Angira Patel, Hans J. Wilke, David Mingay, John E. Ellis*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Study objective To determine the factors that affect patients' decisions to provide informed consent to participate in perioperative clinical trials. Design Survey instrument (questionnaire). Setting Urban, tertiary-care, university-affiliated hospital. Measurements and main results Of 52 patients who had been asked to participate in a randomized control trial (RCT), 43 agreed to be participate in our survey. Almost all consenters (97%), but only 62% of nonconsenters agreed to answer the survey questions (p = 0.002). No significant difference in gender, ethnic background, marital status, or education level was found between groups who were or were not willing to participate. Univariate correlates of agreement to participate in RCTs included older age (>60 yrs;p = 0.02), a reassuring attitude conveyed by study personnel (p = 0.02), and trust in study personnel (p = 0.02). Those who declined participation in clinical trials more frequently indicated that the study made them feel like a "guinea pig" (p = 0.02). Conclusion Patient age and personal attitudes predict the likelihood of participation in perioperative clinical trials. Neither gender nor race affected willingness to participate. Further work in larger groups is needed to identify predictors of consent and techniques to increase willing participation.

Original languageEnglish (US)
Pages (from-to)426-434
Number of pages9
JournalJournal of Clinical Anesthesia
Volume16
Issue number6
DOIs
StatePublished - Sep 2004

Funding

Keywords

  • Informed consent
  • medical ethics
  • patient satisfaction
  • randomized control trials

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

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