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Patients' willingness to enter clinical trials: Measuring the association with perceived benefit and preference for decision participation

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  • Llewellyn-Thomas, H. A.
  • McGreal, M. J.
  • Thiel, E. C.
  • Fine, S.
  • Erlichman, C.

Abstract

Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms. These differences, if they exist, have implications for the process of obtaining informed consent and for the generalization of the results of a clinical trial. This paper describes the development and initial application of methods designed to detect such differences. Developmental work involved creating an inventory of instruments designed to determine patients' attitudes towards participating in treatment decision making, permitting random selection of treatment, and undertaking the risks and benefits associated with the various treatments in a trial. Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma, seeking responses to these measures from 60 non-eligible colorectal cancer patients, then determining whether those who would agree to trial entry differed systematically on these measures from those who indicated that they would refuse such a trial. Twenty-five of the respondents reported that, if faced with the actual decision, they would agree to trial entry: 35 would refuse. Refusers demanded more participation in decision making (Chi-square; P= 0.01) and a greater increment in treatment benefit (t-test; P= 0.0001). Twenty-two of the 35 refusers reported aversion to randomization as their primary reason for trial refusal. Since their particular content can be modified, these measures may be applicable to all clinical trials. They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trial's results.

Suggested Citation

  • Llewellyn-Thomas, H. A. & McGreal, M. J. & Thiel, E. C. & Fine, S. & Erlichman, C., 1991. "Patients' willingness to enter clinical trials: Measuring the association with perceived benefit and preference for decision participation," Social Science & Medicine, Elsevier, vol. 32(1), pages 35-42, January.
    • Handle: RePEc:eee:socmed:v:32:y:1991:i:1:p:35-42
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    Citations

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    Cited by:

    1. Malcolm Man-Son-Hing & Brian F. Gage & Alan A. Montgomery & Alistair Howitt & Richard Thomson & P. J. Devereaux & Joanne Protheroe & Tom Fahey & David Armstrong & Andreas Laupacis, 2005. "Preference-Based Antithrombotic Therapy in Atrial Fibrillation: Implications for Clinical Decision Making," Medical Decision Making, , vol. 25(5), pages 548-559, September.
    2. Hilary A. Llewellyn-Thomas & J. Michael Paterson & Judy A. Carter & Antoni Basinski & Martin G. Myers & Gordon D. Hardacre & Earl V. Dunn & Ralph B. D’Agostino & Philip A. Wolf & C. David Naylor, 2002. "Primary Prevention Drug Therapy: Can It Meet Patients’ Requirements for Reduced Risk?," Medical Decision Making, , vol. 22(4), pages 326-339, August.
    3. Annette M. O'Connor & Peter Tugwell & George A. Wells & Tom Elmslie & Elaine Jolly & Gary Hollingworth & Ruth Mcpherson & Elizabeth Drake & Wilma Hopman & Thomas Mackenzie, 1998. "Randomized Trial of a Portable, Self-administered Decision Aid for Postmenopausal Women Considering Long-term Preventive Hormone Therapy," Medical Decision Making, , vol. 18(3), pages 295-303, August.
    4. Verheggen, Frank W. S. M. & van Wijmen, Frans C. B., 1996. "Informed consent in clinical trials," Health Policy, Elsevier, vol. 36(2), pages 131-153, May.
    5. Hilary A. Llewellyn-Thomas & M. June McGreal & Elaine C. Thiel, 1995. "Cancer Patients' Decision Making and Trial-entry Preferences," Medical Decision Making, , vol. 15(1), pages 4-12, February.
    6. Michael D. Brundage & Judith R. Davidson & William J. Mackillop & Deb Feldman-Stewart & Patti Groome, 1998. "Using a Treatment-tradeoff Method to Elicit Preferences for the Treatment of Locally Advanced Non-Small-cell Lung Cancer," Medical Decision Making, , vol. 18(3), pages 256-267, August.
    7. Hilary A. Llewellyn-Thomas & J. Ivan Williams & Linda Levy & C.D. Naylor, 1996. "Using a Trade-off Technique to Assess Patients' Treatment Preferences for Benign Prostatic Hyperplasia," Medical Decision Making, , vol. 16(3), pages 262-272, August.
    8. Birthe Andrea Lehmann & Lara Lindert & Silke Ohlmeier & Lara Schlomann & Holger Pfaff & Kyung-Eun Choi, 2020. "“And Then He Got into the Wrong Group”: A Qualitative Study Exploring the Effects of Randomization in Recruitment to a Randomized Controlled Trial," IJERPH, MDPI, vol. 17(6), pages 1-16, March.
    9. Vivek Goel & Carol A. Sawka & Elaine C. Thiel & Elaine H. Gort & Annette M. O’Connor, 2001. "Randomized Trial of a Patient Decision Aid for Choice of Surgical Treatment for Breast Cancer," Medical Decision Making, , vol. 21(1), pages 1-6, February.
    10. Myra E. Percy & Hilary Llewellyn-Thomas, 1995. "Assessing Preferences about the DNR Order," Medical Decision Making, , vol. 15(3), pages 209-216, August.
    11. Brett Hauber & Joshua Coulter, 2020. "Using the Threshold Technique to Elicit Patient Preferences: An Introduction to the Method and an Overview of Existing Empirical Applications," Applied Health Economics and Health Policy, Springer, vol. 18(1), pages 31-46, February.

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