Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period

Paul S. Myles, Helen E. Fletcher, Sesto Cairo, Hilary Madder, Roderick McRae, James Cooper, Debra Devonshire, Jennifer O. Hunt, Jo Richardson, Howard Machlin, E. Brian Morgan, John Moloney, Glen Downey

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29 Citations (Scopus)

Abstract

Background: The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns. Methods: After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified. Results: The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6%; prerandomized consent to experimental treatment, 53.3%; prerandomized consent to standard treatment, 53%; one-sided physician-modified informed consent, 60.7%; and one-sided patient-modified informed consent, 56.7% (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95% confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57). Conclusions: No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.

Original languageEnglish
Pages (from-to)969-978
Number of pages10
JournalAnesthesiology
Volume91
Issue number4
DOIs
Publication statusPublished - Oct 1999

Keywords

  • Consumer principle
  • Equipoise
  • Ethics
  • Prerandomization

Cite this

Myles, Paul S. ; Fletcher, Helen E. ; Cairo, Sesto ; Madder, Hilary ; McRae, Roderick ; Cooper, James ; Devonshire, Debra ; Hunt, Jennifer O. ; Richardson, Jo ; Machlin, Howard ; Morgan, E. Brian ; Moloney, John ; Downey, Glen. / Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period. In: Anesthesiology. 1999 ; Vol. 91, No. 4. pp. 969-978.
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abstract = "Background: The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns. Methods: After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified. Results: The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6{\%}; prerandomized consent to experimental treatment, 53.3{\%}; prerandomized consent to standard treatment, 53{\%}; one-sided physician-modified informed consent, 60.7{\%}; and one-sided patient-modified informed consent, 56.7{\%} (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95{\%} confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57). Conclusions: No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.",
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author = "Myles, {Paul S.} and Fletcher, {Helen E.} and Sesto Cairo and Hilary Madder and Roderick McRae and James Cooper and Debra Devonshire and Hunt, {Jennifer O.} and Jo Richardson and Howard Machlin and Morgan, {E. Brian} and John Moloney and Glen Downey",
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Myles, PS, Fletcher, HE, Cairo, S, Madder, H, McRae, R, Cooper, J, Devonshire, D, Hunt, JO, Richardson, J, Machlin, H, Morgan, EB, Moloney, J & Downey, G 1999, 'Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period', Anesthesiology, vol. 91, no. 4, pp. 969-978. https://doi.org/10.1097/00000542-199910000-00016

Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period. / Myles, Paul S.; Fletcher, Helen E.; Cairo, Sesto; Madder, Hilary; McRae, Roderick; Cooper, James; Devonshire, Debra; Hunt, Jennifer O.; Richardson, Jo; Machlin, Howard; Morgan, E. Brian; Moloney, John; Downey, Glen.

In: Anesthesiology, Vol. 91, No. 4, 10.1999, p. 969-978.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period

AU - Myles, Paul S.

AU - Fletcher, Helen E.

AU - Cairo, Sesto

AU - Madder, Hilary

AU - McRae, Roderick

AU - Cooper, James

AU - Devonshire, Debra

AU - Hunt, Jennifer O.

AU - Richardson, Jo

AU - Machlin, Howard

AU - Morgan, E. Brian

AU - Moloney, John

AU - Downey, Glen

PY - 1999/10

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N2 - Background: The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns. Methods: After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified. Results: The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6%; prerandomized consent to experimental treatment, 53.3%; prerandomized consent to standard treatment, 53%; one-sided physician-modified informed consent, 60.7%; and one-sided patient-modified informed consent, 56.7% (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95% confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57). Conclusions: No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.

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KW - Consumer principle

KW - Equipoise

KW - Ethics

KW - Prerandomization

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