BACKGROUND: Information sheets for clinical research are becoming increasingly complex but the extent to which they are understood is uncertain. AIMS: To assess, as our primary outcome, recall by healthy volunteers of key facts in a patient information sheet in a phase 3 clinical trial. As secondary outcomes, we examined whether there was a difference between medical student and non-medically trained volunteers. DESIGN: Questionnaire to determine recall by healthy volunteers of informed consent information. METHODS:Eighty-two healthy volunteers participating in a capsule endoscopy study were given a 13 page written information sheet and allowed to asked questions. After indicating they were ready to give consent they were asked to complete a 6-item questionnaire covering the identity and adverse effects of trial treatments and of the procedure, the duration of the trial and value of the inconvenience allowance. RESULTS: All 82 healthy volunteers were questioned. Of the volunteers, 74 (90%) had university level education and 49 (60%) were clinical medical students. However, only 10 subjects (12%) could name the three trial drugs. The maximum number of risks remembered was 6 (n = 2) of 23. Only 14 (17%) could name three or more potential risks of the medication they might be exposed to, whilst 17 (20%) could identify none. Most subjects (77/82, 90%) identified capsule endoscopy as the trial procedure and impaction/obstruction as its main risk (52/82, 64%). All but one subject (98.8%) could recall the exact value of the inconvenience payment. CONCLUSION: A comprehensive information sheet resulted in limited recall of trial risks. Shorter information sheets with a test and feedback session should be trialled so that informed consent becomes valid informed consent.
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BACKGROUND: Information sheets for clinical research are becoming increasingly complex but the extent to which they are understood is uncertain. AIMS: To assess, as our primary outcome, recall by healthy volunteers of key facts in a patient information sheet in a phase 3 clinical trial. As secondary outcomes, we examined whether there was a difference between medical student and non-medically trained volunteers. DESIGN: Questionnaire to determine recall by healthy volunteers of informed consent information. METHODS: Eighty-two healthy volunteers participating in a capsule endoscopy study were given a 13 page written information sheet and allowed to asked questions. After indicating they were ready to give consent they were asked to complete a 6-item questionnaire covering the identity and adverse effects of trial treatments and of the procedure, the duration of the trial and value of the inconvenience allowance. RESULTS: All 82 healthy volunteers were questioned. Of the volunteers, 74 (90%) had university level education and 49 (60%) were clinical medical students. However, only 10 subjects (12%) could name the three trial drugs. The maximum number of risks remembered was 6 (n = 2) of 23. Only 14 (17%) could name three or more potential risks of the medication they might be exposed to, whilst 17 (20%) could identify none. Most subjects (77/82, 90%) identified capsule endoscopy as the trial procedure and impaction/obstruction as its main risk (52/82, 64%). All but one subject (98.8%) could recall the exact value of the inconvenience payment. CONCLUSION: A comprehensive information sheet resulted in limited recall of trial risks. Shorter information sheets with a test and feedback session should be trialled so that informed consent becomes valid informed consent.
Authors: Megan L Salter; Babak Orandi; Mara A McAdams-DeMarco; Andrew Law; Lucy A Meoni; Bernard G Jaar; Stephen M Sozio; Wen Hong Linda Kao; Rulan S Parekh; Dorry L Segev Journal: J Am Soc Nephrol Date: 2014-08-28 Impact factor: 10.121
Authors: Iain C Sanderson; Jihad S Obeid; Kapil Chalil Madathil; Katherine Gerken; Katrina Fryar; Daniel Rugg; Colin E Alstad; Randall Alexander; Kathleen T Brady; Anand K Gramopadhye; Jay Moskowitz Journal: Clin Trials Date: 2013-08 Impact factor: 2.486