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Factors associated with refusal to enter a clinical trial: epidural anesthesia is a deterrent to participation

[Les facteurs associés au refus de participer à un essai clinique : l'anesthésie péridurale est un élément dissuasif]

Timothy V. Salomons, BA BSc^*, Adarose Ardiel Wowk, BSc RN^*, Ann Fanning, FFARCSI, Vincent W.S. Chan, MDCM FRCPC and Joel Katz, PhD

^* From the Acute Pain Research Unit, Department of Anaesthesia and Pain Management, University Health Network and Mount Sinai Hospital, Toronto, Ontario, Canada;
the Department of Anesthesia, Our Lady's Hospital, Navan Ireland;
the Regional Anesthesia and Acute Pain Service, University Health Network, University of Toronto, Toronto, Ontario, Canada; and
the Acute Pain Research Unit, Department of Anaesthesia and Pain Management, University Health Network and Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.

Address correspondence to: Dr. Joel Katz, Department of Anaesthesia and Pain Management, University Health Network, EN 3-440, 200 Elizabeth Street, Toronto, Ontario M5G 2C4, Canada. Phone: 416-340-3777; Fax: 416-340-3698; E-mail: jkatz{at}uhnres.utoronto.ca

Purpose: To compare patients who participate in a clinical trial for pain management involving epidural anesthesia to those who refuse and document their reasons for refusing.

Methods: Demographic and health history information was collected from 621 female patients who were screened for inclusion in a pain management trial involving epidural anesthesia. Patients who completed the clinical trial (n = 149) were compared to those who consented to provide screening information but did not enter the trial (n = 472).

Results: Sixty-seven percent of women who refused cited unwillingness to have an epidural as the reason for their decision. Non-Caucasians (P < 0.01), patients with no history of mood/anxiety disorders (P < 0.016) or systemic disease (P < 0.02), and patients with certain types of pain (P < 0.02) were more likely to refuse to participate in the clinical trial. A longer duration between recruitment and surgery was also found to be associated with higher participation rates (P < 0.01). A logistic regression equation significantly predicted which patients would participate or refuse (P < 0.0001), indicating that a specific set of health and demographic factors strongly influence the decision to participate in a trial.

Conclusions: The decision to participate in a clinical trial is viewed as a risk/benefit analysis. Factors such as short recruitment to surgery intervals and pre-existing pain, which increase the salience of risks associated with the trial, may result in lower participation rates. Overall, epidural anesthesia is a strong deterrent to participation in a clinical trial.

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