Anita N Shukla1, Mary K Daly, Paul Legutko. 1. Department of Ophthalmology, Veterans Affairs Boston Healthcare System, Boston University School of Medicine, Boston, Massachusetts, USA.
Abstract
PURPOSE: To determine the effectiveness of verbal, written, and videotaped descriptions of cataract surgery on patients' understanding of the risks, benefits, and treatment alternatives. SETTING:Veterans Affairs Boston Healthcare System, Boston, Massachusetts, USA. DESIGN: Randomized prospective study. METHODS:Patients eligible for cataract surgery were randomized into 1 of 4 arms of the informed consent process as follows: Group 1, conventional verbal information; Group 2, conventional verbal information plus second-grade reading level brochure; Group 3, conventional verbal information plus eighth-grade reading level brochure; Group 4, conventional verbal information plus American Academy of Ophthalmology DVD Understanding Cataract Surgery: Patient Education DVD Featuring an Aid to Informed Consent. After the informed consent process, patients in each group completed a 12-question questionnaire discussing the surgical procedure, its benefits, its foreseeable and unforeseeable risks, and the alternatives to cataract surgery. Scores in each group were calculated as the number of correct responses out of 12 questions. RESULTS: Patients in Group 2 (mean score 10.8 ± 1.29 [SD]) and Group 4 (mean score 10.56 ± 1.44) scored significantly higher than patients in Group 1 (mean score 7.68 ± 2.80) or Group 3 (mean score 9.08 ± 1.60). Previous cataract surgery and education level had no significant influence on recall of the informed-consent process. CONCLUSIONS: Concise informed consent information sheets at lower reading grade levels and videotape presentation optimized patient understanding of the risks, benefits, and treatment alternatives to cataract surgery. The cost-benefit of these results is important because better patient understanding has the potential to decrease the risk for indemnity payments awarded because of inadequate informed consent. Published by Elsevier Inc.
RCT Entities:
PURPOSE: To determine the effectiveness of verbal, written, and videotaped descriptions of cataract surgery on patients' understanding of the risks, benefits, and treatment alternatives. SETTING: Veterans Affairs Boston Healthcare System, Boston, Massachusetts, USA. DESIGN: Randomized prospective study. METHODS:Patients eligible for cataract surgery were randomized into 1 of 4 arms of the informed consent process as follows: Group 1, conventional verbal information; Group 2, conventional verbal information plus second-grade reading level brochure; Group 3, conventional verbal information plus eighth-grade reading level brochure; Group 4, conventional verbal information plus American Academy of Ophthalmology DVD Understanding Cataract Surgery: Patient Education DVD Featuring an Aid to Informed Consent. After the informed consent process, patients in each group completed a 12-question questionnaire discussing the surgical procedure, its benefits, its foreseeable and unforeseeable risks, and the alternatives to cataract surgery. Scores in each group were calculated as the number of correct responses out of 12 questions. RESULTS:Patients in Group 2 (mean score 10.8 ± 1.29 [SD]) and Group 4 (mean score 10.56 ± 1.44) scored significantly higher than patients in Group 1 (mean score 7.68 ± 2.80) or Group 3 (mean score 9.08 ± 1.60). Previous cataract surgery and education level had no significant influence on recall of the informed-consent process. CONCLUSIONS: Concise informed consent information sheets at lower reading grade levels and videotape presentation optimized patient understanding of the risks, benefits, and treatment alternatives to cataract surgery. The cost-benefit of these results is important because better patient understanding has the potential to decrease the risk for indemnity payments awarded because of inadequate informed consent. Published by Elsevier Inc.
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