Pål Gulbrandsen1, Bård Fossli Jensen. 1. HØKH, Research Centre, Akershus University Hospital, Mail drawer 95, Lørenskog 1478, Norway. pal.gulbrandsen@ahus.no
Abstract
BACKGROUND: To allow patients to reflect about a decision to participate in a clinical trial, guidelines suggest a 24-h delay from when they are informed about the trial to when they give consent. In certain clinical settings, this is likely to hamper recruitment. METHOD: After oral and written information about the trial has been given in person, the patient signs the declaration of consent knowing that they will be asked again after 24 h whether they confirm or regret the decision. This procedure can be done by SMS. The investigators must document the response. The procedure was tried in a study in which the doctors were randomly assigned to receive a clinical communication skills course, and encounters with patients were videotaped before and after the course. RESULTS:553 patients were approached, 530 (95.8%) gave initial consent, eight of these later regretted their consent. DISCUSSION: The low level of regrets suggests this is an acceptable procedure for patients. TRIAL REGISTRATION: The RCT was registered before initiation - registration # ISRCTN22153332.
RCT Entities:
BACKGROUND: To allow patients to reflect about a decision to participate in a clinical trial, guidelines suggest a 24-h delay from when they are informed about the trial to when they give consent. In certain clinical settings, this is likely to hamper recruitment. METHOD: After oral and written information about the trial has been given in person, the patient signs the declaration of consent knowing that they will be asked again after 24 h whether they confirm or regret the decision. This procedure can be done by SMS. The investigators must document the response. The procedure was tried in a study in which the doctors were randomly assigned to receive a clinical communication skills course, and encounters with patients were videotaped before and after the course. RESULTS: 553 patients were approached, 530 (95.8%) gave initial consent, eight of these later regretted their consent. DISCUSSION: The low level of regrets suggests this is an acceptable procedure for patients. TRIAL REGISTRATION: The RCT was registered before initiation - registration # ISRCTN22153332.
Authors: Eirik Hugaas Ofstad; Jan C Frich; Edvin Schei; Richard M Frankel; Jūratė Šaltytė Benth; Pål Gulbrandsen Journal: BMJ Open Date: 2018-01-05 Impact factor: 2.692