Non-Medical Consequences: The 6th Element of Informed Consent

Informed consent is critical to the daily practice of medicine. Conversations about the risks and benefits of treatment options are both a legal requirement and an ethical duty. However, another important question remains: In addition to clinical consequences, should informed consent include a discussion of the non-medical consequences?

Informed consent

The Joint Commission requires informed consent to be documented with five main elements prior to any procedure or treatment.¹ The elements consist of:

1. Nature of the procedure
2. Risks and benefits of the procedure
3. Reasonable alternatives to the procedure
4. Risks and benefits of the alternatives
5. An assessment of the patient’s understanding of the first four elements

In only a few instances would a practitioner not need explicit informed consent, such as the incapacitation of a patient or life-threatening emergencies. Without one of these exceptions, there is a need for “agreement or permission accompanied by full notice about the care, treatment, or service.”² In addition to the Joint Commission requirements on informed consent, there exists an ethical duty for physicians to tell patients the truth.³

Physicians commonly emphasize things like bleeding, infection, and postoperative management such as “no lifting more than 10 pounds for one week or until your follow-up.” However, physicians who are not strongly involved in care coordination or discharge planning tend not to consider other consequences of treatments that affect patients and families.

This article argues that a discussion of long-term prognosis, functional status, financial constraints, potential burdens to caregivers, and other “non-medical” consequences, in addition to the Joint Commission requirements, is a necessary part of consent.

Need for non-medical aspect of informed consent

BF is the 61-year-old patient who inspired this article, and her case illustrates the need for a better informed consent process to include nonmedical and more practical information.

BF experienced a significant stroke and brain injury, which left her dependent on a ventilator, tube feeds, and 24/7 care. Her family was extremely supportive and consistently wanted “everything done.” Unfortunately, she was uninsured, and since there was only a very small chance of recovery, the medical team recommended a timed trial of at least six months to determine whether her condition was recoverable. With no insurance and modest family finances, it was impossible to place BF in a care facility, and her family was not prepared to care for her at home, even though a hospital-funded home ventilator was offered.

Ethics opined on the case and agreed that, with such an unclear prognosis at the time, suggestions to withdraw life-sustaining treatments (LST) were not appropriate. The ethics team noted that continuing LST aligned with the principles of autonomy (respecting her wishes as reported by her surrogate decision maker) and non-maleficence, as there was no proof of significant harm with continuing LST.

Due to BF’s significant care needs, the multidisciplinary team struggled to find a safe discharge plan. In frustration, the care team wondered if the family would have chosen the same treatment plan, if they were made aware of the long-term implications of their decisions.

While there is not much research on the ethics or discussion of non-medical implications as part of informed consent, a handful of papers exist on the ethical challenges in home mechanical ventilation, the considerations of informed consent, and the expectations of patients with prolonged mechanical ventilation. In these papers, there was a relationship between the current informed consent practices and the lack of understanding of burdens as well as long-term implications for the patient (and family).

For physicians, quality of life considerations can be one of the most impactful ethical challenges they face, especially in patients with long-term mechanical ventilation.⁴ In a study of ventilated patients, only 56% of patients survived one year, with 33% having a good quality of life and only 9% with good functional status.⁵ This poor perceived quality of life value extends beyond the patient to the caregivers, as 49% of caregivers reported experiencing “a lot” or “severe” stress and 84% quit or altered their work status due to the burdens of having a long-term ventilated family member.⁵

Surrogates or caregivers of long-term mechanical ventilation patients indicated that there was a failure to discuss the non-medical aspects of proceeding with tracheostomy; 71% indicated they expected their family member to have no major functional limitations after one year, but only 6% of physicians thought the patient would attain this, and only 4% expected good quality of life.⁵ Other studies indicate surrogates had much more optimism than physicians regarding prognosis and recovery.⁵

The burdens of caregivers are often overlooked as they are not the patients. Caregivers felt overwhelmed, unsupported, scared, and even isolated when helping their family members.⁶ Beyond the emotional distress, many families felt as if their homes were invaded by home health staff, further increasing the perceived level of burden.⁷ These frustrations from patients and caregivers prove that the “physical and psychological trauma may have been more than clinicians were aware of.”⁶

Dybwik et al. stated, “It may be easy to be enthusiastic on behalf of others when you do not feel the physical burden.”⁷ When obtaining informed consent, practitioners need to consider the ethical implications of autonomy versus paternalism against beneficence and non-maleficence, as decisions make life more complicated due to possible high costs, burdens, and variations in care given due to social determinants of health. They need to put themselves in the position of the caregivers and recognize that some patients require up to 14.4 hours of care per day, which causes up to 2.4 awakenings a night for the caregiver.⁸ These burdens were considered so significant that in Singapore, the Mental Capacity Act instructs a clinician to “take care and act diligently to them [patients and caregivers],” which included obtaining “informed consent and not informed compliance” with treatment team recommendations.⁸

Beyond the focus of long-term ventilation or tracheostomy, the need for non-medical informed consent extended to other procedures like plastic surgery and joint replacements. Even in these elective procedures, there was a disconnect between the non-medical information given to patients as part of consent.

The following case of KG reflects poor or missing non-medical consent and the effects it had on one patient.

KG was a 42-year-old female who had a “mommy makeover,” which included a tummy tuck as well as a breast lift. She consented to the procedure knowing she would have drains post-operatively for “a while,” sleep inclined for six weeks, and wear compression garments for “about six weeks.” She felt that she was very informed going into the surgery as she was provided with multiple pages of information in her consent process and pre-operative planning.

Postoperatively, while the doctor was accurate in the six weeks of inclined sleeping, she ended up with one drain for four weeks and compression garments for 12 weeks. KG found the garments cumbersome and uncomfortable as they caused skin maceration to the groin, which she was concerned would lead to infection. The length of wear was beyond what she was told in what she thought was a very complete informed consent process. While these burdens were not as limiting as those in ventilated patients, the discussion of post-operative burdens (the non-medical consequences) was lacking in her opinion. Trying to return to normalcy and work was very difficult with garments and drains.

The story of unexpected, unexplained non-medical post-procedure concerns is not just KG’s alone. A simple Google search provides a plethora of articles such as “10 Things I Wish I Knew Before My Tummy Tuck,” “9 Things No One Ever Tells You About Getting a Knee Replacement,” and an article from AARP discussing how “up to a third” of knee replacement patients had “pain and regret.”⁹ If informed consent conversations were thorough and included more non-medical components, there would not be as many articles from upset patients, including one article that quoted a knee replacement patient saying, “I didn’t expect [it to be this bad] and how long it would take to regain my strength.”¹⁰

Why physicians do not tell everything

Many physicians argue that they have a therapeutic privilege when discussing treatment plans with patients. Physicians have many reasons for concealing the full truth, including an attempt not to confuse the ill, cause unnecessary pain, or remove hope.¹¹ Bok noted in an article that this “lying” was a right that belonged only to physicians. In other cases, it may be that the physician does not fully comprehend the non-medical complications, including what life is like living in a long-term acute care hospital, how it feels to wear long-term compression garments, or have continued pain despite expectations for return to functionality or normalcy.

Returning to KG’s post-operative case, she was very happy with her results and understood the need for garments for that prolonged period to attain the best result. However, even though KG appreciated the surgical results, out of curiosity, she asked the physician why he did not tell her it was going to be 12 weeks when she first consented. His response was simple: “Do you think that people would go through the surgery if they knew it was going to be 12 weeks [of garments]?”

In this case, it appears the surgeon felt the need to omit some of the consequences in order not to hinder KG’s decision-making process for her desired results. Even with KG being happy with the results, it is not ethically supported or appropriate to withhold information from a patient. He should have been honest and truthful with KG.

The argument for limiting information beyond the Joint Commission’s five elements for informed consent theoretically may balance the principles of beneficence and non-maleficence, with physicians assuming they are doing good and not inflicting harm. In the case of KG and some ventilator or tracheostomy patients, the omission of the non-medical aspects may have been the physician’s way of allowing the beneficence, or good, to outweigh the potential detriment or burden. For the ventilated patients, it is presumed that the physician felt the therapeutic benefits and preservation of life did not cause significant harm, and therefore, the knowledge that only a few percentages of these patients would have a good quality of life at the one-year point did not need to be disclosed. However, as physicians, this paternalistic approach is not ethically supported and can indeed cause harm to patients and caregivers.

Unfortunately, there remains a lack of empirical knowledge or retrospective analysis on patient acceptance of the omission of non-medical consent. In reviewing previous studies on expectations and burdens, it would be beneficial to ask if the patient or surrogate knew then what they knew at the one-year point, would they still have proceeded with long-term ventilation? KG proved, in one much simpler case, that they might answer yes. One can imagine that many patients or surrogates faced with an unacceptable (to them) quality of life would never have agreed to aggressive interventions if they knew the statistics that had been withheld from them.

Beyond therapeutic privilege as a reason to limit the information given in informed consent, one could argue patients can retain only limited information when discussing treatment plans with providers; in one study, 40% to 80% of what patients were told during an encounter was forgotten, and when information was remembered, it was typically only 50% correct.¹² In the setting of stress, which is often seen in the ICU when decisions were being made about tracheostomy and long-term ventilation, recall of pertinent information was affected.¹³ Further, in the hospital setting, the Joint Commission noted that while 90% of patients felt confident in their post-discharge treatment plans, only 50.9% were correct in their recall.¹⁴ If the recall was so poor for patients, it can be easy to argue (wrongly) that providing copious information would not have benefited the decision-making process, even if non-medical aspects were discussed.

Conclusion

Including non-medical aspects in informed consent discussions is part of a physician’s obligation to tell the truth, consider both beneficence and non-maleficence, and empower patient autonomy. Physicians should ensure patients or surrogates are fully informed of not just the medical risks or benefits of the treatment but also of the overall impact on their lives. This non-medical information should be the sixth element required for true informed consent, as it remains a physician’s duty to provide patients with realistic expectations of medical treatments. 

Dr. Simmon is the medical director of care coordination at Banner-University Medical Center Phoenix and vice president of SHM’s Arizona chapter.

References

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