The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011).
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Date
2012-11-29Author
Moynihan, C
Lewis, R
Hall, E
Jones, E
Birtle, A
Huddart, R
SPARE Trial Management Group
Type
Conference Proceeding
Metadata
Show full item recordAbstract
Background Evidence suggests that poor recruitment into clinical trials rests on a patient 'deficit' model - an inability to comprehend trial processes. Poor communication has also been cited as a possible barrier to recruitment. A qualitative patient interview study was included within the feasibility stage of a phase III non-inferiority Randomized Controlled Trial (RCT) (SPARE, CRUK/07/011) in muscle invasive bladder cancer. The aim was to illuminate problems in the context of randomization.Methods The qualitative study used a 'Framework Analysis' that included 'constant comparison' in which semi-structured interviews are transcribed, analyzed, compared and contrasted both between and within transcripts. Three researchers coded and interpreted data.Results Twenty-four patients agreed to enter the interview study; 10 decliners of randomization and 14 accepters, of whom 2 subsequently declined their allocated treatment.The main theme applying to the majority of the sample was confusion and ambiguity. There was little indication that confusion directly impacted on decisions to enter the SPARE trial. However, confusion did appear to impact on ethical considerations surrounding 'informed consent', as well as cause a sense of alienation between patients and health personnel.Sub-optimal communication in many guises accounted for the confusion, together with the logistical elements of a trial that involved treatment options delivered in a number of geographical locations.Conclusions These data highlight the difficulty of providing balanced and clear trial information within the UK health system, despite best intentions. Involvement of multiple professionals can impact on communication processes with patients who are considering participation in RCTs. Our results led us to question the 'deficit' model of patient behavior. It is suggested that health professionals might consider facilitating a context in which patients feel fully included in the trial enterprise and potentially consider alternatives to randomization where complex interventions are being tested.Trial registration ISRCTN61126465.
Collections
Subject
SPARE Trial Management Group
Humans
Neoplasm Invasiveness
Confusion
Chemotherapy, Adjuvant
Neoadjuvant Therapy
Radiotherapy, Adjuvant
Cystectomy
Attitude of Health Personnel
Health Knowledge, Attitudes, Practice
Communication
Professional-Patient Relations
Comprehension
Perception
Models, Psychological
Qualitative Research
Patient Selection
Informed Consent
Aged
Middle Aged
Research Subjects
Patient Acceptance of Health Care
Female
Male
Urinary Bladder
Urinary Bladder Neoplasms
Interviews as Topic
Therapeutic Equipoise
Organ Sparing Treatments
United Kingdom
Research team
Clinical Trials & Statistics Unit
ICR-CTSU Urology and Head and Neck Trials Team
Clinical Academic Radiotherapy (Huddart)
Language
eng
Date accepted
2012-11-02
License start date
2012-11-29
Citation
Trials, 2012, 13 pp. 228 - ?
Except where otherwise noted, this item's license is described
as
https://creativecommons.org/licenses/by/4.0
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