ORIGINAL ARTICLES Parental comprehension following informed consent for pediatric cataract surgery Vasudha Erraguntla, MD*, Irina De la Huerta, MD † , Sunita Vohra, MD ‡ , Mohamed Abdolell, MSc § , Alex V. Levin, MD  ABSTRACT ● RÉSUMÉ Objective: To investigate the effectiveness of information transfer by the pediatric cataract surgeon to the parents or guardians of children during the informed-consent process. Design: Prospective observational case series. Participants: Parents of 31 children undergoing cataract surgery. Methods: Parents were enrolled from the clinical practice of 1 pediatric cataract surgeon. Using a checklist developed in consultation with other pediatric cataract surgeons, the surgeon discussed the nature of the disease, the course without surgical intervention, the surgical procedure, the risks and benefits, and the postoperative care. Immediately after the discussion, parents were invited to complete a questionnaire assessing information recall. Analysis of variance and the t test were used to determine associations between questionnaire scores and demographic variables. The surgeon subsequently called parents and discussed again the issues that they had not remem- bered correctly, as identified by the questionnaire responses. The study and data accumulation were carried out with the approval of the Research Ethics Board at The Hospital for Sick Children, Toronto, Ont. Informed consent for the research was obtained from the parents or legal guardians of the children enrolled in the study. The study adhered to the tenets of the Declaration of Helsinki. Results: Of 31 parents, 18 (58%) overestimated their understanding of the informed-consent discussion. Parents scored well on questions about the nature of the disease and the postoperative follow-up but scored lower on questions regarding surgical risks and outcomes. Parents identified several barriers to understanding, including the large amount of information, stress, and preoccupation with the child. No association was noted between the level of understanding and demographic factors. Conclusions: Parents may overestimate their understanding of informed-consent discussions. Some parents may be overly optimistic about risks and outcomes. The surgeon’s follow-up communication with parents that addressed aspects insufficiently understood during the initial discussion provided a way of improving comprehension. Objet : Investigation sur l’efficacité du transfert de l’information par le chirurgien de la cataracte pédiatrique aux parents et aux gardiens d’enfants dans la procédure de consentement éclairé. Nature : Étude prospective par observation d’une série de cas. Participants : Les parents de 31 enfants subissant une chirurgie de la cataracte. Méthodes : Contexte : Clinique de pratique d’un chirurgien de la cataracte pédiatrique. Procédure : À l’aide d’une liste de vérification mise au point avec des collègues de la chirurgie de cataracte pédiatrique, le chirurgien discute de la nature de la maladie, du traitement sans chirurgie, de la procédure chirurgicale, des risques et bienfaits ainsi que des soins postopératoires. Les parents ont aussitôt été invités à remplir un questionnaire pour évaluer ce qu’ils en ont retenus. L’analyse du test T et de la variance permettent de déterminer les associations entre les résultats du questionnaire et les variantes démographiques. Le chirurgien rappelle les parents pour discuter davantage des questions qu’ils n’auraient pas retenues correct- ement, selon leurs réponses au questionnaire. Résultats : Parmi les 31 patients, 18 (58 %) avaient surestimé leur compréhension de l’entretien sur le consentement éclairé. Les parents ont bien répondu aux questions sur la nature de la maladie et le suivi postopératoire, mais moins bien sur les risques chirurgicaux et les résultats. Les parents ont identifié plusieurs barrières à la compréhension, y compris l’importante quantité d’informations, le stress et les préoccupations de leur enfant. L’on n’a pas relevé d’association entre le degré de compréhension et les facteurs démographiques. Conclusions : Les parents peuvent surestimer leur compréhension des entretiens sur le consentement éclairé. Certains d’entre eux peuvent se montrer trop optimistes quant aux risques et aux résultats. Pour ce qui est du manque de compréhension des parents sur certains aspects lors du premier entretien, la communication suivante du chirurgien a permis d’améliorer cette compréhension. Informed consent is a fundamental duty and responsi- bility that is recognized by virtually every professional medical organization. Patients are expected to reach auton- omous decisions about whether to undergo medical pro- cedures. 1  Physicians must inform patients about their conditions, proposed treatments, risks and benefits, and reasonable alternatives. Consent must be voluntary, and patients must demonstrate capacity for consent and under- standing of the provided information. 2 Authors have challenged the doctrine of informed consent by indicating that patients’ decisions may be based on other factors. Interviews with patients who recovered from esoph- From the * Department of Ophthalmology, University of Saskatchewan, Saskatoon, Sask.; the † Program in Neuroscience, Harvard Medical School, Boston, Mass.; the ‡ Department of Pediatrics, University of Alberta, Edmonton, Alba.; the § Department of Diagnostic Radiology, Dalhousie University, Halifax, N.S.; and the  Pediatric Ophthalmology and Ocular Genetics, Wills Eye Institute, Philadelphia, Penn. Originally received December 7, 2010. Accepted Feb. 22, 2011 Correspondence to Alex V. Levin, Pediatric Ophthalmology and Ocular Genetics, Wills Eye Institute, 840 Walnut St., Philadelphia PA 19107-5109; alevin@willseye.org Can J Ophthalmol 2012;47:107–112 0008-4182/11/$-see front matter © 2012 Published by Elsevier Inc on behalf of the Canadian Ophthalmological Society. doi:10.1016/j.jcjo.2012.01.014 CAN J OPHTHALMOL—VOL. 47, NO. 2, APRIL 2012 107