BACKGROUND: The randomized controlled trial (RCT) has a well-established role in assessing drug therapies, but its adoption in developing surgical interventions has been slow. Patients' perspectives on surgical RCTs, especially those including a patient preference option, have received little attention. PURPOSE: To characterize participants' experiences and views of recruitment to a pilot trial (CARPET1) of two surgical treatments for urinary incontinence and vaginal prolapse that included a patient preference option. METHODS: Semi-structured qualitative interviews with 16 women who participated in the CARPET1 trial. Data analysis was based on the constant comparative method. MAIN OUTCOME MEASURES: Women's experiences of taking part in a patient preference trial. RESULTS: Women's motives for participating in CARPET1 focused on the possibility of additional care and, as a secondary motive, the wish to help with research. Most participants expressed a treatment preference rather than accepting randomization. Most were pleased with the information they received, and acknowledged the principle of equipoise, but there was substantial variability in their understanding of aspects of the trial, including randomization. Randomization was considered by women to be appropriate only when both treatments were equally suitable and they had no strong preference. Women suggested that the main influence on their willingness to be randomized was the recruiting clinician's opinion. Importantly, despite the recruiting clinicians being heavily involved in conception of CARPET1, they did not seem to be in equipoise at the level of the individual patient. LIMITATIONS: This being a small study it was not possible to interview women who declined trial participation or to observe consultations between surgeons and patients. CONCLUSIONS:CARPET1 appears to have been more a surgeon preference trial than a patient preference trial. Substantial challenges may remain in conducting RCTs in surgery, particularly where surgeons have preferences about what they perceive as the best option for an individual patient.
RCT Entities:
BACKGROUND: The randomized controlled trial (RCT) has a well-established role in assessing drug therapies, but its adoption in developing surgical interventions has been slow. Patients' perspectives on surgical RCTs, especially those including a patient preference option, have received little attention. PURPOSE: To characterize participants' experiences and views of recruitment to a pilot trial (CARPET1) of two surgical treatments for urinary incontinence and vaginal prolapse that included a patient preference option. METHODS: Semi-structured qualitative interviews with 16 women who participated in the CARPET1 trial. Data analysis was based on the constant comparative method. MAIN OUTCOME MEASURES: Women's experiences of taking part in a patient preference trial. RESULTS:Women's motives for participating in CARPET1 focused on the possibility of additional care and, as a secondary motive, the wish to help with research. Most participants expressed a treatment preference rather than accepting randomization. Most were pleased with the information they received, and acknowledged the principle of equipoise, but there was substantial variability in their understanding of aspects of the trial, including randomization. Randomization was considered by women to be appropriate only when both treatments were equally suitable and they had no strong preference. Women suggested that the main influence on their willingness to be randomized was the recruiting clinician's opinion. Importantly, despite the recruiting clinicians being heavily involved in conception of CARPET1, they did not seem to be in equipoise at the level of the individual patient. LIMITATIONS: This being a small study it was not possible to interview women who declined trial participation or to observe consultations between surgeons and patients. CONCLUSIONS: CARPET1 appears to have been more a surgeon preference trial than a patient preference trial. Substantial challenges may remain in conducting RCTs in surgery, particularly where surgeons have preferences about what they perceive as the best option for an individual patient.
Authors: Daniel B Sonshine; Amber Caldwell; Richard A Gosselin; Christopher T Born; R Richard Coughlin Journal: Clin Orthop Relat Res Date: 2012-04-10 Impact factor: 4.176
Authors: Helen C Eborall; Marlene C W Stewart; Sarah Cunningham-Burley; Jackie F Price; F Gerry R Fowkes Journal: Trials Date: 2011-01-11 Impact factor: 2.279