Discussion

Paediatric congenital heart surgery is an exceedingly complex procedure, and it is imperative that the informed consent process facilitates sufficient understanding among caregivers to ensure that they make the best medical decision given the circumstances for their child. With that in mind, the intent of this study was to evaluate the content of informed consent documents. This multisite descriptive survey study revealed that a majority of informed consent documents for paediatric congenital heart surgery do not contain specific sections for all elements specified in the Federal Regulations. ²⁴ In addition, specific information on risks, benefits, and alternative treatments is often not adequately described within the informed consent document. In the absence of interviews with individuals obtaining comj nsent, or an assessment of parental comprehension, we were unable to quantify the extent to which we believe the procedure, its risks and benefits and alternative treatments are discussed, which was not the intent of this study. However, it is possible that the absence of this information on the generic institutional informed consent forms may contribute to a poor understanding and retention of the verbal discussion between caregivers and healthcare professionals, including when there is the need for an interpreter, although this is only speculation. Moreover, we recognise that customised informed consent forms for every cardiac procedure has the potential to create challenges, especially as procedures change and are often times personalised for the patient. This lack of written information emphasises one of the potential barriers to the informed consent process in that patients are presented with the information the clinical team deems important and not always the information the patient wants to hear. ^{Reference Firdouse, Wajchendler, Koyle and Fecteau27}

Despite widespread availability of electronic health records, only 8% of the informed consent documents reported in this study were available electronically. As medicine and technology advance, the use of electronic medical records is becoming more widely used in health care centres. This has the potential to help enhance the informed consent process, including customisation for specific procedures. ^{Reference Glaser, Nouri and Fernandez28} A systematic review by Kiernan et al showed that the use of electronic informed consent forms had a positive effect on the informed consent process. ^{Reference Parker and Mortimore8} Electronic informed consent documents allow for the addition of supplemental information to be added into the document when certain conditions are met (i.e., risks, benefits, and alternatives). A surgical team could work with their information technology department to customise the informed consent document based on a particular procedure. For CHD surgical procedures, the electronic informed consent document could populate information specific to the use of cardiopulmonary bypass, risk of cardiac arrest and/or death, risk of infection, or risk of arrhythmias to name a few. However, even in these circumstances, paper versions or print outs of electronic versions should still be available for parents wish to reference the material at a later time.

Results of the qualitative assessment of the six consent forms generally supported the results of the survey outcomes (Table 2). All of the provided informed consent documents contained a single sentence stating that the surgical procedure risks, benefits, and alternatives had been explained to the parents/guardians but did not contain any information regarding what information was covered, how the information was presented, or who discussed the information with the parents/legal guardian. Several studies have shown that individuals retain information better when it is presented in formats other than just verbal discussion. ^{Reference Book, Goedeke, Poplawski and Muensterer4–Reference Gentry, Lepere and Opel6,Reference Firdouse, Wajchendler, Koyle and Fecteau27,Reference Friedlander, Loeben and Finnegan29} Glaser et al performed a systematic review assessing ways to improve patient comprehension for medical and surgical procedures. This review showed that written material provided to patients at a 2nd grade reading level in addition to the informed consent document was best understood when compared to the standard informed consent document alone. ^{Reference Dreisinger and Zapolsky30} The current standard regulation for informed consent documents is to be written at an 8th grade level. ¹⁴

Table 2. Assessment of centre-specific IC documents.

Each informed consent discussion is unique and based on the individual patient’s cardiac lesion and the procedure being performed. This can be a complex and nuanced discussion for clinicians, not only because of the complicated types of repairs but also because they are engaging in this discussion most often with a proxy to the patient (parents, legal guardians, or medical proxies). ^{Reference Gentry, Lepere and Opel6,Reference Friedlander, Loeben and Finnegan29,Reference O’Brien, Jacobs and Pasquali31} The Society of Thoracic Surgeons had developed a mortality assessment score, which is assigned to each congenital heart surgical procedure and is based on the complexity of the surgery and risk of mortality. ^{Reference Blake, Copel and Kleinman32} Cardiac surgical procedures with a mortality score of 5 will inherently have more risks than those whose mortality score is 1. However, this study has shown that the same informed consent document is used to consent patients for all mortality categories and that it contains the same information regardless of the procedure being performed. While we are not marginalising the extensive discussions that take place between the surgeon and patient and parent/guardian, we do want to highlight opportunities for process improvement in the extisting informed consent documents evaluated from the multiple participating institutions.

For cyanotic congenital heart lesions that require intervention within the neonatal period, the alternatives to treatment include death. ^{Reference Fontana and Edwards33–Reference Chan, Di Gennaro, Farris, Radman and McMullan38} In such complex and stressful decision-making situations, the comprehension of the consenting adult may be impaired and may result in decisions based on fear of death versus true understanding. In instances such as these, there is an informed consent discussion that occurs, there is an informed consent document that is signed, but in reality, the consenting adult is providing consent for the procedure to be performed but to call it an informed decision may be an exaggeration. Indeed, future studies focusing on qualitative assessments of the process and parental comprehension are needed. This concept of informed consent is often a common theme in research on improvement of the informed consent process as healthcare advances and changes are made to move from practices grounded in paternalism to those that truly encompass shared decision making. ^{Reference Parker and Mortimore8,Reference White, Kelleman, Sidonio, Kochilas, Patel and Sidonio39,Reference Mishuris and Linder40}

This descriptive study has several limitations. First, the questionnaire was only emailed mainly to Paediatric Cardiologists and Paediatric Cardiac Intensivists whose email addresses are publicly available online (only three surgeons were emailed directly), the 22 members of the surgical team who completed the questionnaire had it forwarded to them by the receiving clinician, thus requiring further steps and likely reducing the response rate from the surgical team who are obtaining consent. Second, responses were de-identified, making it impossible to discern whether more than one response was obtained from a single centre. Third, although the questions asked via the questionnaire were designed to be objective, several responses were very subjective, suggesting the informed consent process is indeed a process and not a set protocol. Lastly, this questionnaire did not assess items involved in the informed consent process (i.e., length of informed consent discussion, information provided to individuals prior to the informed consent discussion to improve comprehension, time of the informed consent discussion in relation to the surgical procedure being performed).

This descriptive study provides a glimpse into the informed consent document used for these surgical procedures. The informed consent document used for congenital cardiac surgery does not always contain the information as outlined by federal regulations, which may have negative impacts on the decision making of the parents/legal guardians. Further research is needed into the informed consent process for congenital cardiac surgery and how information regarding procedural risks, benefits, and alternatives is provided to the parents/legally authorised representatives and ways to improve comprehension so that true informed consent can be obtained.