Introduction

The incidence of congenital heart disease is less than 1%. Overall, three out of 1000 live births will have congenital heart disease that will require an immediate intervention, including cardiac catheterization (CC) and surgery . CC should be used in any circumstance in which the anatomy of the heart of a child with congenital heart disease is inadequately defined by non-invasive means. On some occasions, particularly in very complex lesions, more specific details about the anatomy or haemodynamic features are necessary. Paediatric CC is a safe and effective procedure used to obtain detailed information about heart anatomy as well as to repair the heart without surgery. Advances in non-invasive imaging have allowed CC to become increasingly a catheter-based therapeutic option rather than a diagnostic tool.

Paediatric CC has evolved to include a variety of interventional procedures, including the closure of atrial septal defect, the closure of ventricular septal defect, the closure of patent ductus arteriosus, the creation of holes such as septostomy, angioplasty, valvuloplasty, the placement of stents to open up narrowed vessels, the embolization of vessels such as collateral vessels or, more recently, the replacement of heart valves .

Paediatric CC is not without risk to the patient. In the last decade, there have been significant improvements in technology and equipment. Nonetheless, the risk of complications remains and these risks adversely affect outcomes.

Healthcare professionals have to explain to patients/parents why they intend to carry out a particular diagnostic test or a procedure, such as CC. We propose to review the purpose of the information sheet for paediatric CC.

Concept in terms of medical ethics: notion of autonomy

Autonomy from the Greek autos ‘one’s self’ and nomos ‘rule’ designates the power of persons to make decisions that concern themselves. To be autonomous, a person must be able to evaluate his/her options rationally, according to the facts and taking account of the consequences .

Since the 1970s, the relationship between doctors and their patients has evolved considerably. The concept of autonomy of the patient has substantially changed the practice of medicine and the paternalistic notion that ‘the doctor is always right’ has fallen by the wayside. In the past, the doctor ‘spared’ the patient the responsibility of decision. Today, doctors must provide patients with information. They must help them to make informed choices. They must abide by their choice to refuse treatment. They must withhold nothing from their patients. Doctors cannot impose their desires and preferences on those of the competent patient. Currently, patients are considered Persons, with, as the corollary, the emergence of patients’ rights . Patients have become ‘actors’ with regard to their health, free to decide for themselves.

Modern healthcare ethics is based on the following concepts: benevolence, autonomy, absence of malice, equity and responsibility. The health authorities (Haute Autorité de santé [HAS]) and healthcare policy emphasize the ‘absence of malice’ or rather ‘good treatment’ as the appropriate healthcare attitude, which should be professional, active and dynamic, individual and collective and have its roots in human values. It is based on ‘good manners’ .

The European concept of autonomy is accompanied by notions of vulnerability, dignity and integrity. This is an essential notion in that it makes the person a moral actor. Consent is the unequivocal condition in the principle of autonomy. Consent must be obtained only after the information has been given to and received by the patient. This assumes that the patient must be able to understand and assimilate the information .

Technical advances in the world of medicine and the apprehension of society as a right make it more and more difficult to apply the concept of autonomy strictly.

Purpose of information sheets

The need to inform patients using validated scientific data is acknowledged internationally. The Council of Europe acknowledges ‘the right of patients and citizens to be provided with and to have easy access to relevant information about their health and healthcare in a format and language they can understand’. This information should be based on scientific data derived from practice guidelines and be made available in formats suited to several target audiences (healthcare professionals, patients and decision-makers) .

Particularities of French legislation

The obligation to inform patients is based on a fundamental principle of French law: the principle of the inviolability and inalienability of the human body.

This principle is defined in article 16-3 of the Civil Code, which stipulates that ‘the integrity of the human body cannot be interfered with except for the medical needs of that person or exceptionally in the therapeutic interest of others. The consent of the person concerned must be collected beforehand, unless the state of the person makes it impossible for him/her to provide consent for the necessary therapeutic intervention’ .

To obtain this required consent and before the care is provided, the patient (or their legal representative for minors) must have received clear, accurate and understandable information .

Article 3 of the Charter for Hospitalized Persons states that the information given must be ‘understandable and accurate’. Hospitalized persons take part in the therapeutic choices that concern them. They can be assisted by a person of trust whom they can choose freely. A medical act can only be performed once the patient has freely provided informed consent. The patient has the right to refuse any treatment .

The law relative to patients’ rights and the quality of the healthcare system, enacted on 4th March 2002 , made it possible to incorporate into the Public Health Code the procedures to follow with regard to information and patients’ consent. The principles are based on the Hedreul jurisprudence resulting from a Supreme Court decision dated 25 February 1997 .

In accordance with the law of 4th March 2002, the healthcare professional is obliged to provide information about all of the risks unless they are benign or rare. This information can be provided orally unless the law states otherwise. Written consent is necessary in the following situations:

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  medical assistance for procreation;

  
  
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  donation and utilization of elements and products of the human body;

  
  
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  the taking of organs for transplants;

  
  
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  samples taken for scientific purposes;

  
  
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  voluntary termination of pregnancy;

  
  
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  genetic examinations;

  
  
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  fallopian-tube sterilization;

  
  
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  biomedical screening; and research .

Paediatric cardiac catheterization: an information sheet

It is not compulsory to obtain written consent before medical acts such as paediatric CC, but as it is a procedure performed on a minor, it is recommended to have both parents sign a document authorizing the treatment in order to ensure traceability. Consent must be obtained only after clear understandable information has been provided verbally or in writing by the practitioner during a specific interview .

The laws and recommendations have encouraged the development of good practices. Through a series of questions, we propose to help practitioners respond appropriately in certain situations of conflict or in medical emergencies.

In paediatric cardiac catheterization, to whom must the information be given and who must provide the consent?

Whatever the minor’s family situation, both parents must be consulted, in principle, if they are joint holders of parental authority. Unless otherwise decided by a judge, divorced or separated parents jointly exercise parental authority.

The person the information is given to is the patient, who may be a minor or an adult under guardianship, in which case the information must be adapted to their level of maturity and their faculties of discernment. Holders of parental authority will also be informed unless the minor objects.

Article L1111-2 of the Public Health Code (PHC) states that: ‘This information bears on the different investigations, treatments or preventive actions that are proposed, their usefulness, the immediate need if necessary, their consequences, the foreseeable frequent or serious risks they carry and other possible solutions and the foreseeable consequences in case of refusal. When, in the wake of investigations, treatments or preventive actions, new risks are identified, the person concerned must be informed about them, unless the person cannot be traced’ .

Article L1111-2 of the PHC states that: ‘Every person has the right to be informed about his/her state of health. It is incumbent on every healthcare professional to provide this information in accordance with his/her expertise and in the respect of professional rules that apply to him/her. Only emergencies or the impossibility to inform the patient release the professional from this obligation. This information is delivered during an individual interview. The wish of persons not to be informed about a diagnosis or prognosis must be respected, unless third parties may be exposed to a risk of transmission. The rights of minors or adults under guardianship mentioned in the present article are exercised, depending on the case, by those with parental authority or by the legal guardian. These will receive the information provided for in the present article, subject to the provisions set out in article L1111-5. The parties concerned have the right to receive the information themselves and to take part in making decisions that concern them, in a manner that for minors is in keeping with their level of maturity, and for adults under guardianship, that is in keeping with their faculties of discernment’ .

What is the procedure if the holders of parental authority are separated or divorced?

Article R4127-42 of the French PHC stipulates that ‘divorced or separated parents jointly exercise parental authority, unless the judge has decided otherwise. Divorced or separated parents therefore exercise parental authority jointly and must both be informed and consulted for major decisions concerning their child’ .

Article 372-2 of the French Civil Code specifies that ‘in the view of a third party acting in good faith, each of the parents is considered to act with the agreement of the other, when he/she alone effects a usual act of parental authority for the child’ .

CC cannot be considered a usual act in the eyes of the law.

How must the information on cardiac catheterization be communicated?

Verbal information is essential and must be adapted to each individual. It is necessary to spend time to be patient, to listen carefully and, if needs be, to modulate the information depending on the situation of the child and their family. A document or comprehensive information sheet is a complement to the verbal information given by the healthcare professional but in no way replaces it. The sole aim is to give written information to the child and the parents so that they can think about the situation after the interview; it is not necessarily given for the parents or their representatives to sign. There must be no statement obliging the patient to sign.

It is recommended to provide objective information without dramatizing the situation or expressing undue optimism according to the following principles:

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  give quantitative information about the frequency of the disease or its symptoms;

  
  
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  describe the benefits/risks and the consequences of treatments on the patient’s everyday life;

  
  
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  propose a list of questions that the patient can ask a healthcare professional;

  
  
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  indicate sources of complementary information;

  
  
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  clearly mention the authors of the information, the different fields they work in, the sources of information and any funding, as well as the date the document was drawn up.

Generally, this information is given at the time of the interview with the parents and the infant. Written consent is not compulsory. In the majority of cases the information covers the following points:

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  the indication;

  
  
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  the procedure itself;

  
  
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  the objectives;

  
  
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  the risks;

  
  
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  possible complications.

As often as possible, if the child’s state of health allows, the parents and the child if they are old enough to understand must be given a period of reflection between the time the information is provided and the procedure itself .