April 2009
Volume 50, Issue 13
ARVO Annual Meeting Abstract  |   April 2009
Comprehension of Written Informed Consent for Cataract Surgery: A Pilot Study
Author Affiliations & Notes
  • P. Bettin
    Ophthalmology, San Raffaele Scientific Institute, Milan, Italy
  • E. Campanini
    Clinical Psychology, Università Vita-Salute San Raffaele, Milan, Italy
  • Footnotes
    Commercial Relationships  P. Bettin, None; E. Campanini, None.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 6106. doi:
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      P. Bettin, E. Campanini; Comprehension of Written Informed Consent for Cataract Surgery: A Pilot Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):6106.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : phacoemulsification is a very common surgical procedure: understanding of informed consent is crucial to avoid unrealistic expectations and minimize the risk of litigation, which is more and more frequent. The aim of this study was to assess comprehension of the informed consent for cataract surgery and its correlation with patient age, scholarity, locus of control, quality of life, completeness of reading and additional oral explanation.

Methods: : following approval by local ethics committee, we enrolled consecutive patients aged 18-70 scheduled for cataract surgery and willing to participate into the study right after the preoperative visit, during which our institutional informed consent for phaco must be signed for acceptance. Mini Mental State was administered to exclude subjects with cognitive deterioration. Subjects had to fill 4 self-adminisered questionnaires (SAQ): 1) comprehension SAQ: 13 questions assessing document reading and comprehension; 2) satisfaction SAQ: 21 questions about form distribution, oral explanation, satisfaction with the document and with shared decision making; 3) Multidimensional Health Locus of Control Scale C (MHLC); 4) SF-12 Health Survey.

Results: : 108 subjects were included (M/F: 53/55; mean ± SD age 60.6 ± 10.0; mean scholarity 9.9 ± 4.3 years).Correct answers at comprehension SAQ were 69% ± 19%. 28% of the patients agreed with the statement that cataract surgery can be followed by severe complications even leading to complete loss of vision (37% disagreed, 35% did not answer); 67% correctly believed that phaco is quite safe and 46% remembered about possible posterior capsule rupture. 42% had had additional explanation; 82% declared they had read the whole document and 6% they had read none of it. 85% judged it satisfactory and 94% stated that information was useful but 19% would have preferred not to be informed and rely on the surgeon.Number of correct answers at comprehension SAQ was independent of age and of presence of additional oral explanation, but was correlated with scholarity (Spearman r=0.40, p=0.000), quality of life for physical health (r=0.37, p=0.000) and complete reading (r=0.48, p=0.000). High Fate MHLC scores were negatively correlated with comprehension (r=-0.28, p=0.013).

Conclusions: : comprehension of our institutional informed consent for cataract surgery was independent of age and additional oral explanation. Higher scholarity was associated with better comprehension, fatalism with worse. Only 28% of the patients about to undergo phaco were aware that, rarely, severe complications even leading to complete loss of vision may occur in the operated eye.

Keywords: cataract • small incision cataract surgery • clinical (human) or epidemiologic studies: health care delivery/economics/manpower 

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