PMID: 12757993May 22, 2003Paper

Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study

Controlled Clinical Trials
N MillsFreddie C Hamdy

Abstract

Recruitment to trials is known to be difficult. Previous research suggests that a crucial factor may be participants' difficulty with the concept of randomization. This study explored patients' perceptions of randomization and reasons for consent or refusal to participate in the ProtecT study (a randomized trial of surgery, radiotherapy, and monitoring for localized prostate cancer). In-depth interviews were conducted with 21 men diagnosed with localized prostate cancer who were invited to participate in the ProtecT treatment trial. Interviewees were selected purposefully from three U.K. clinical centers to ensure the inclusion of similar proportions of those agreeing or refusing random treatment allocation in each of the treatment groups. Interviews explored men's recall and understanding of chance, comparison, and equipoise, and reasons for consent/refusal of randomization and acceptance/rejection of treatment allocation. Data were analyzed methodically using the techniques of constant comparison. Checking of coding and interpretation was assured by four experienced qualitative researchers. Recall and understanding of the major principles of the randomized design were good and were similar for "chance" and "comparison" betwee...Continue Reading

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Citations

Sep 24, 2010·Journal of Cancer Education : the Official Journal of the American Association for Cancer Education·Karen A StepanScott B Cantor
Apr 6, 2005·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·James A Talcott, Jack A Clark
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Aug 12, 2009·BMC Musculoskeletal Disorders·Carina A ThorstenssonRachael Gooberman-Hill
Feb 18, 2009·BMC Medical Ethics·Valerie Shilling, Bridget Young
Jun 15, 2006·Reproductive Health·Denise A M PerquinFrans M Helmerhorst
May 15, 2004·Arthritis Research & Therapy·James F Fries, Eswar Krishnan
Dec 3, 2008·The Journal of Bone and Joint Surgery. American Volume·Lori A DolanKevin F Spratt
Mar 17, 2007·Drugs & Aging·Miles D Witham, Marion E T McMurdo
May 1, 2009·Journal of Medical Internet Research·Elizabeth MurrayPaul Wallace
Mar 5, 2016·Social Work in Health Care·Michael C SouleJeff C Huffman
Sep 29, 2009·Lancet·Patrick L ErginaJan Vandenbroucke
Sep 29, 2009·Lancet·Peter McCullochJan Vandenbroucke
Sep 18, 2009·Contemporary Clinical Trials·D LindströmH Tönnesen
Jul 16, 2008·Journal of Clinical Epidemiology·Jenny L DonovanUNKNOWN ProtecT Study Group
Sep 22, 2007·Journal of Clinical Epidemiology·Debra FayterAlison Eastwood
Oct 13, 2015·La Presse médicale·Clarisse Dibao-DinaBruno Giraudeau
Feb 2, 2012·The Journal of Manual & Manipulative Therapy·Chad Cook, Charles Sheets
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Apr 25, 2012·Patient Education and Counseling·Kristen J WellsPaul B Jacobsen
Jan 13, 2015·Annals of Surgery·Sam AdieJonathan C Craig

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