In pediatric and adolescent gynecology (PAG), consent is required for a vast array of interventions ranging from commonplace procedures such as cystoscopy to controversial interventions such as labiaplasty. The process may be more or less involved according to the clinical scenario. A simple and low-risk procedure for clear medical reasons will require less discussion than an invasive intervention whose benefits and risks are disputed. A single blanket protocol to fit all clinical scenarios is therefore unacceptable [1].
Informed consent to elective and non-lifesaving medical interventions is the focus of this chapter. These situations are emblematic of dilemmatic decision making in conditions of uncertainty and highlights the influence of complex psychosocial factors. Social and psychological theories emphasize the individual, familial, cultural, and political contexts in which choices relating to health and illness are made. Some knowledge of the intra- and interpersonal processes can facilitate the translation of sound ethical principles into sound professional behaviors.
Nobel Prize winner Daniel Kahneman has deciphered decades of social psychological research to help us understand that much decision making is driven by cognitive shortcuts known as “heuristics” or “rules of thumb” that are influenced by, among other factors, how the information is framed and its emotional valence for the decision maker [2]. Heuristics are especially active under conditions of uncertainty and may be particularly influential in persons whose cognitive and emotional maturity is not yet optimal or who has had fewer opportunities to learn from the outcomes of previous treatment decisions.
The aim of this chapter is to provide practical solutions to address the gap between principles and practice of bioethics. The chapter begins by outlining the core principles, proceeds to discuss pertinent psychosocial variables that can impede implementation, and ends with practical ideas for improving informed consent.
Core Principles of Bioethics
Myriad clinical scenarios mean that formulas and templates for informed consent may always have limited applicability. However, the generic core principles cannot be compromised. In this section, the basic requirements are outlined, before considering the psychosocial barriers to their translation into clinical practice.
Beyond Legal Requirement
Legal standards generally require informing the patient of the diagnosis and prognosis; the procedure; the risks, benefits, and unknowns of any proposed treatment; and the risks, benefits, and unknowns of any available alternatives including no treatment. As much as possible, this information should be made specific to the individual for whom the treatment is proposed. A common way of stating the legal mandate in US jurisdictions, for example, is that physicians must provide the patient “as much information as [he/she] needs to make an informed decision, including any risk that a reasonable person would consider important in deciding to have the proposed treatment or procedure” [3].
However, informed consent is an ethical as well as a legal imperative, and ethical standards may go beyond bare legal requirements [4]. It is a well-accepted principle of bioethics that physicians have a responsibility to respect the autonomy of patients, including the patient’s right to complete information when determining whether or not to undergo a proposed medical intervention. To give full informed consent, patients must be aware of their medical condition and able to weigh the risks and benefits of all possible options (including no treatment) to ensure that their decision reflects their personal goals and values [1].
Patients who feel appropriately involved in decision making have better outcomes, which makes it vital to allow flexibility and choice in how much patients are involved [5,6]. However, research suggests that more than one-third of patients are dissatisfied with the level of involvement in their care [5,7]. What complicates the situation is that the quantity of patient involvement is not static [8]. For example, in oncology, a patient may be happy for the clinician to make a decision based on “best practice” at the point of diagnosis, but within palliative care a patient may prefer more active involvement in decision making [9,10].
Patient Capacity
Children can participate in some medical decisions before they are old enough to provide legally valid consent to treatment. Younger children who can understand the basic aspects of an intervention can provide assent (informed agreement) for and may sometimes refuse treatment. By age 14, many children have the cognitive ability (if not the legal capacity) to make medical decisions [11]. Respect for children’s developing autonomy requires involving them in medical decisions to the extent capable, which means explaining the most complex of treatments in terms that are developmentally relevant and can be understood, and respecting their right to refuse treatment when appropriate. It also requires practitioners to allow for progression toward children’s greater involvement in their health care decisions as they develop, and it sometimes requires postponing elective procedures until the child matures.
Best Interest
Certain parental decisions may be culturally or religiously expedient but in the long term limit the child’s open future, for instance, a child with a life-threatening need for a blood transfusion while the parents who are Jehovah’s Witnesses prefer their child not to be transfused because of their religious beliefs [12]. Because the child is too immature to choose her own religion, she has a right to receive lifesaving interventions (even over parental objection) so that she can mature sufficiently to make her own religious decisions. As such, the child’s right to an open future trumps the parents’ right to raise their child as they wish.
The child’s right to an open future requires clinicians and surrogates to balance the short- and long-term benefits and risks of all options. If the openness of the child’s future is clearly enhanced by a particular option, which may include no treatment, then the deciding adults have an obligation to choose that option on behalf of the child, in the absence of an option that serves the child’s best interest. As the child matures, she may choose from among the various options open to her. In some clinical situations this can be a highly complex, dilemmatic, and emotional process. Where the treatment option is not lifesaving, sufficient time and opportunities for discussion are crucial.
In situations where a surrogate, such as a parent, provides consent, respect for autonomy requires the decision makers to consider the perspective of the child’s open future. Caregivers’ preferences should not override the focus on the patient’s best interest in the long term. While parents may make many medical decisions on behalf of their children, there are limits to parental authority in the medical context [11]. For example, parents in most US jurisdictions do not have authority to consent to elective sterilization of a child without court oversight [13]. Parents in many countries do not have the authority to consent to female genital cutting for social, religious, or cultural reasons even if carried out in a medical setting.
Barriers to the Implementation
The information given to patients or their surrogates is of central importance in ensuring that all three ethical principles – legal requirement, patient capacity, and best interests – are addressed and met. A range of psychosocial factors also needs addressing. These factors can impinge on decision dynamics in ways not always obvious; that is, they can subtly influence what [14] and how [15] information is shared with consequences for informed decision making.
Patient and Surrogate Factors
Emotion processing is integral to decision making; the recognition of this is implicit in the routine recommendation of a “cooling off” period before a decision is made. That is to say, health professionals are advised not to ask patients or surrogates to sign a written consent after a single discussion. Cancer specialists are perhaps the most adept at recognizing that treatment options are, more often than not, contemplated, discussed, and decided on in highly emotive contexts. Psychological research in cancer has demonstrated that people’s recall of “bad news consultations” is often fragmented and not organized in a coherent narrative, at times with stark misconceptions about what was and was not said [16]. These observations are compatible with cognitive scientists’ evidence that emotional arousal can alter our computation of probability and value [17]. Treatment decisions made suboptimal by overwhelming emotional distress is highly significant for informed consent.
Many clinical situations can trigger high emotions. One such example in PAG is the birth of a child with a genital difference. The shock of finding out the diagnosis and the fear of the child failing to develop socially acceptable gender and sexuality could have a number of effects. One of them may be a premature decision to opt into a surgical trajectory involving multiple operations and genital examinations without clear evidence of benefits and with case examples of catastrophic outcomes [18]. Part of the parental motivation for consenting to such controversial interventions is to create certainty, when living with uncertainty is often manageable with consistent and quality psychosocial input. Making decisions under duress may be unavoidable in emergencies. In nonemergency situations, health professionals have a responsibility to address the emotional barriers to informed decision making [14]. When a mother with a newborn baby presenting genital differences reflected back to a doctor her emotional struggles in the early days, he said, “We don’t need five urologists on our team, we need five psychologists” [19].
Some care providers have likened girls’ and women’s reaction to the diagnosis of utero-vaginal agenesis (Mayer-Rokitansky-Kuster-Hauser Syndrome, MRKH) as on the spectrum of posttraumatic stress disorder [20]. The incoming information about the body conflicts with internalized gendered expectations. The conflicted and emotive information cannot be coded, matched, stored, and retrieved as usual [21]. In such circumstances, a woman may rush to choose a medical intervention without having processed the relevant information including the non-curative nature of medical interventions. From a psychotherapeutic point of view, a rush into treatment often reflects emotional avoidance, that is, avoidance of the distress of contemplating the diagnosis and its implications.
Box 5.1 The following comment from a woman with a DSD after her first-time elective vaginoplasty in adulthood suggests insufficient processing of pretreatment information:
“Having to have [ ] having to go to a doctor every year for a physical, rather than [ ] the assumption that, OK, when the surgery’s over that’s all you get for a lifetime, you know? [ ] And I didn’t know that I’d … have to dilate.” [22]
Health Professional Factors
Just as emotional distress can impair the patient’s/surrogate’s understanding of the proposed intervention, clinicians may also be vulnerable to the emotional charge of their interaction with patients or surrogates. Many doctors and nurses in a number of fields find aspects of their work highly stressful. These are often related to the emotive transactions they find themselves in, typically with limited support within their hierarchy or organization. Fuelled by patient distress, the clinician may feel under a great deal of pressure to provide a solution. This may make it more difficult to decenter their personal biases, such as those pertaining to normalcy [23]. The care provider may filter in and out certain cues from the patient or misunderstand them, or fail to probe and elicit the patient’s subjective appraisal of the condition and treatment options.
The way that the information is presented can have undue influence on the patient’s or surrogate’s decision making. For example, research shows that a disease narrative of genital differences can lead to more people opting for cosmetic genital surgery, compared to a less medicalized narrative [24]. Health professionals can be unduly optimistic about the impact of their interventions. A study of online advertisements for cosmetic labiaplasty is a case in point [25]. Labiaplasty was presented as an effective treatment for “labial hypertrophy,” an unproven construct invented relatively recently. References to vulva appearance diversity, alternative ways for managing body distress and dissatisfaction, and scientific information on benefits and risks were absent from the US and UK provider websites.
Some health professionals may be unduly pessimistic about the patient’s ability to manage without treatment. In an attempt to maintain hope, the treating clinician may minimize the risk of physical and/or psychological complications. To avoid putting off patients who have expressed a desire for treatment, the clinician may gloss over the challenging self-managed regime afterward. Furthermore, the ongoing psychological and financial costs of attending medical follow-ups and submitting to clinical procedures can easily be underestimated because, for health professionals who have spent years in clinical environments doing clinical activities, these demands are routine.
Physicians and surgeons trained in an intensive, competitive, and exclusively biomedical subculture may be prone to confuse treatment with care. The idea that many patients are better off untreated may lead to feelings of inadequacy and is resisted. For some clinicians, professional activity may be measured by the amount of treatment done, rather than the quality doctoring that they provide. Payment structures can inadvertently encourage over treatment, when an intervention however equivocal always triggers a cost, whereas expert advice and support for the same patient or family does not. These arrangements can create a situation whereby the only way for a patient or surrogate to access specialist input is to opt into a treatment trajectory [26]. The kind of expert advice and support that is so valuable for patients and families is at risk of being continuously marginalized. These systemic factors may compromise the principles of ethical care, and health professionals so affected would need to challenge the status quo.
Theories of Decision Making
Although decision making is a process, it is not usually sequential. The brain makes decisions by processing the same information simultaneously using systems that have different functions. Mukharjee [27] illustrates the point by differentiating between System A and System D processing. System A refers to a fast, associative, and affect-based mode of decision making heavily influenced by emotional arousal and mood states. System D is an analytical and logic-based mode of decision making that is typically slower. In general, situations experienced as emotive by the decision maker tend to shift the balance toward System A outputs to gain short-term relief from threat, and away from System D outputs, which may be more advantageous for complex and nuanced decisions.
Box 5.2 The following advice from a mother of a newborn baby presenting atypical genitalia recommends waiting several months for emotions to return to baseline before making far-reaching treatment decisions for the child:
“Take a few months to recover from childbirth, get your feet back on the ground, and take some time to adapt to the diagnosis. Only then are you in a position to consider properly all the options for your child’s care. During that time you learn so much about the diagnosis; it becomes less overpowering and less all-consuming and less frightening.” (19)
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