As a result of their unique practice patterns, many specialist physicians typically only meet patients on the date of an intervention such as surgery. However, some of the world's most prestigious academic centers do not allow research participants to be recruited on the same day as surgery. This is because of concerns, shared by researchers and research ethics boards, that patients may be too anxious or rushed to provide informed, voluntary consent immediately before an operation. This is not supported by evidence, and leads to potential inequities by restricting patients' opportunities to contribute to and benefit from research. The investigators undertook a randomized controlled trial incorporating deception to study the voluntariness of research consent provided by patients invited to enroll in a fabricated anesthesia research study at Women's College Hospital in Toronto, Ontario, Canada. Patients undergoing day surgery were randomized to receive research recruitment opportunities either days before surgery in the pre-operative assessment clinic, or on the surgical date. Post-operatively, patient's perceptions of undue influence or coercion in the consent process were examined with questionnaires and compared between these groups. This trial will help to design future perioperative studies, and will answer the important question of whether truly voluntary and informed same-day consent can be provided for participation in perioperative research.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
114
In this trial, the intervention being studied was the timing of an invitation to participate in a fabricated low-risk clinical anesthesia research trial. Patients were recruited into this fictitious trial either several days in advance of surgery, or on the day of surgery, and post-operative evaluations aimed to measure whether these groups experienced different degrees of coercion or voluntariness in their decisions to participate.
Women's College Hospital
Toronto, Ontario, Canada
Average score on combined modified coercion scales
Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.
Time frame: Measured on postoperative day one.
Average Score on modified Iowa Coercion Questionnaire
Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.
Time frame: Measured on postoperative day one.
Average Score on Modified Coercion Assessment Scale
Minimum average score of 1 and maximum average score of 4, with higher scores corresponding to a greater degree of coercion.
Time frame: Measured on postoperative day one.
Rate of enrollment into the fictitious trial
Time frame: Measured when patients were approached with an invitation to participate in the trial. For patients in the Advance Consent Group this was, on average, preoperative day seven. For patients in the Day of Surgery Group this was postoperative day zero.
Responses to individual items on the combined modified coercion scales
Each item has a minimum score of 1 and maximum score of 4, with higher scores corresponding to a greater degree of coercion.
Time frame: Measured on postoperative day one.
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