Surgery Research Paper Example

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Abstract

In recent decades, the ethical issues that arise in the care of surgical patients have received increasing attention. Although these issues in surgical ethics are not completely different from the ethical issues that arise in the care of nonsurgical patients, there are signiﬁcant considerations that warrant speciﬁc attention in surgical patients. Central to the ethical issues in surgery are challenges to informed consent for surgery that requires surgeons to transmit information and engender their patients’ trust prior to engaging in potentially dangerous acts. The necessity of weighing risks and beneﬁts in surgery is clear since every surgical intervention carries the potential for signiﬁcant harm to the patient. Innovations in surgery require speciﬁc attention since novel techniques designed to beneﬁt speciﬁc patients do not require prior approval or review before a surgeon can undertake them. Surgical research, on the other hand, does require prior approval and speciﬁc research informed consent and also raises additional ethical considerations when compared to research in other areas of medicine. Although ethical issues in the care of surgical patients are not different in kind from the ethical issues in other areas of medical care, they are different enough in degree that they warrant speciﬁc attention.

Introduction

In the following paragraphs, important ethical issues that arise in the care of surgical patients will be examined. Although there are subspecialties in surgery that raise speciﬁc and often problematic issues (e.g., transplantation, pediatric surgery, and cosmetic plastic surgery), these areas will not be explored. Rather, focus will be placed on issues central to the care of all surgical patients. In particular, the following paragraphs will explore why, although surgery is a technical discipline, surgeons must be much more than technicians. Informed consent for surgery is central to the ethical care of surgical patients and will be examined. Informed consent requires not only a disclosure of risks, beneﬁts, and alternatives, but also the patient must trust the surgeon to act in the patient’s best interests even when the patient is completely vulnerable in the operating room. The responsibility that surgeons have for their interventions will be explored along with how that sense of responsibility shapes the surgeon-patient relationship. The inherent risks involved in surgery will be considered relative to the potential beneﬁts. The necessity of weighing risks and beneﬁts requires restrictions on the extent to which surgeons will go along with patients’ wishes. The nature of surgical innovation will be examined relative to the differences with the process used to bring new drugs into practice. Although there is no requirement for outside review and oversight of surgeons’ decisions to solve their patients’ problems in novel ways, there are signiﬁcant challenges for surgical research that will be explored.

History And Development

The ethical issues in the care of surgical patients are not different in kind but in degree when compared to the ethical issues in the care of any patient. The challenges of the doctor-patient relationship and the importance of communication are present for all clinical interactions between patients and their physicians. Similarly, the challenge of determining when treatments become too burdensome to patients is present in the ﬁeld of surgery as well as in nonsurgical ﬁelds of healthcare. There are no distinctively different standards for surrogate decision making in surgery compared to other areas of medical care. However, in the past few decades, it has become clear that in the broad category of clinical ethics, there are distinctive features of the ethical issues that arise in the care of surgical patients. Although no list of these distinctive features can be fully complete, in the following pages, attention will be focused on several of the most important items that inﬂuence most of surgical care of patients throughout the world.

In the early decades of the rise of medical ethics discussions, much of the work focused on patients cared for by internists, pediatricians, and obstetricians. There was a widely held view that surgeons were uninterested, and perhaps too busy, to take time to engage in extensive discussions about numerous alternative treatments for every patient. The old adage that “surgeons operate while internists discuss pros and cons” often suggested that surgeons were uninterested in nuanced discussions of ethical issues. However, in recent years, there has been a widespread acceptance by surgical organizations, academic surgeons, and community surgeons that the ethical issues in the care of surgical patients are signiﬁcant and warrant attention. A few decades ago, many surgical residents and fellows would ﬁnish their training without ever having engaged in a formal discussion of the ethical issues associated with caring for patients. Today, most surgical trainees are acutely aware of many of the important ethical questions that arise in the care of their patients. These ethical issues that are central to the care of surgical patients will be considered in the following paragraphs.

Conceptual Clarification/Definition

The ﬁeld of surgery is a very broad one with many different specialties and subspecialties that are all surgical. There are several areas of surgical practice that raise more ethical issues on a regular basis than others. Consider three surgical specialties that regularly raise numerous and speciﬁc ethical issues: transplant surgery, pediatric surgery, and cosmetic plastic surgery.

In transplant surgery, there are numerous issues involving an absolutely scarce resource (solid organs) and the many challenges of ﬁnding a just allocation system for that scarce resource. In addition, transplant surgeons must be attentive to the issues associated with both deceased donors and live donors. In the realm of deceased donors, questions of deﬁnitions of death become central along with questions about whether the deceased donor has any prerogative to direct the donation of his or her organs to a speciﬁc recipient or group of recipients. Certainly in the area of living donor transplantation, there are many ethical issues surrounding the questions of how to avoid coercive pressures on donors within families or among close friends, how to evaluate requests by people to be altruistic donors (i.e., to be live donors for unknown recipients), and whether donors should be paid for organs.

Within the area of pediatric surgery, numerous different ethical issues arise. How much discretion should parents have over deciding whether neonates should have lifesaving surgical interventions? When should doctors step in to assume guardianship of children whose parents decline to consent for curative operations? How should the well-being of an infant patient be safeguarded when the only possible treatment for a life-threatening disease or illness is a high-risk surgical procedure? These are just some of the many ethical issues that pediatric surgeons face on a regular basis.

In the realm of cosmetic plastic surgery, surgeons must consider what are the appropriate goals of medicine. For example, is there a standard of physical appearance that surgeons should try to uphold or should surgeons offer any body modiﬁcation that the patient requests? Such a question becomes even more complicated when most cosmetic surgical procedures are paid for out of pocket by patients. A related question is how much risk a surgeon should be willing to subject his or her patients to when the patient is happy to assume the very high risks?

These are just a few of the many ethical questions that arise in the care of surgical patients in the areas of transplant surgery, pediatric surgery, and cosmetic plastic surgery. As important as the ethical questions in these speciﬁc areas of surgery are, in the following paragraphs, focus will not be on any of these speciﬁc issues. Instead, the focus will be on the more central ethical issues that all surgeons must address in their care of patients. Although surgery is clearly a technical discipline that demands merging detailed anatomic knowledge with operative skill that can only be obtained by thousands of hours of practice, surgeons are more than simply technicians. Every surgeon’s encounter with a patient raises a series of important ethical issues that will be addressed in the upcoming pages. By focusing on the ethical issues central to the practice of any type of surgery, the considerations raised in the following paragraphs should have the most relevance to the largest numbers of surgeons and patients.

Ethical Dimension

Informed Consent

Central to the surgical care of patients is the requirement for surgeons to obtain informed consent from patients prior to undertaking any operative intervention on the patient. Although informed consent has not always been required prior to surgery, in recent decades, informed consent is a uniform requirement throughout the world. Although the legal requirements may vary among countries, the ethical requirement for informed consent prior to surgery is based on the importance of respecting the autonomous choices of patients. Surgeons are not allowed to operate on patients purely because the patient has a medical indication for surgery. Rather, a surgeon must explain to a patient why he or she needs an operation, as well as what the risks of the procedure are and what alternatives, if any, there are for the patient to consider. Only patients with the capacity to make autonomous choices are allowed to give informed consent after they have been told what are the risks, beneﬁts, and alternatives to the surgery (Childers et al. 2009).

Although obtaining informed consent for an operation is a routine exercise for any surgeon, the process of explaining the operation to a patient and soliciting the patient’s acceptance of the operation requires much more than simply the transmission of information. During the process of obtaining informed consent from a patient for surgery, the surgeon must encourage sufﬁcient trust from the patient that the patient is willing to place his or her well-being in the surgeon’s hands. Although this necessity for the patient to trust a physician is not unique to surgery, the level of vulnerability that surgery entails and the level of risk that the patient assumes are greater than in most other areas of medicine.

The Surgeon-Patient Relationship And Responsibility For Surgical Outcomes

The informed consent process is generally the beginning of the relationship between the surgeon and the patient. When giving informed consent to allow a surgeon to perform an operation, the patient is essentially acknowledging his or her willingness to trust the surgeon. Moving forward from that trust, the surgeon must assume responsibility for the patient’s outcome. The relationship, therefore, between the surgeon and the patient is focused on the surgeon’s commitment to act to beneﬁt the patient. What is different between the surgeon-patient relationship and the more general relationship between physicians and patients is the surgeon’s personal involvement in the surgery. Surgery does not “happen” the way, for example, a patient may respond to the administration of a medication. Surgeons “do” surgery on patients. In this manner, the surgeon’s actions actually are the means for the treatment.

The nature of the surgeon’s direct involvement in the patient’s outcomes is perhaps best explained by Bosk who stated that “When the patient of an internist dies, colleagues ask, ‘What happened?’ When the patient of a surgeon dies, colleagues ask, ‘What did you do?’”[Bosk 2003, p. 30]. Although this difference may appear to be a subtle one, it weighs heavily on surgeons in their interactions with patients. Few surgeons would be willing to put a patient through a risky operation without a high degree of conﬁdence that the patient will beneﬁt from the operation (Kruser et al. 2015).

Inherent Challenge Of Weighing Benefit And Harm

One of the central ethical issues in surgery involves the inherent challenge of weighing the risks and beneﬁts of the operation. Every surgical procedure involves the very real possibility of harm. There is no surgical intervention that has only beneﬁts. All operations begin with the deliberate actions of a surgeon that, in any other circumstance, would be considered harmful. For example, a straightforward surgical procedure such as removing a thyroid gland that has cancer in it involves ﬁrst an incision. In any context other than in an operating room when a surgeon has the patient’s informed consent, a slash of the knife across a person’s neck would be a criminal activity. However, in the operating room when the surgeon makes an incision in the neck, this act is considered part of the therapeutic activity of the operation. Because every surgical procedure necessarily involves the potential for real harm, surgeons must carefully consider the possible beneﬁts and whether they outweigh the risks.

As noted previously, informed consent for surgery requires the patient to be informed of the risks, beneﬁts, and alternatives of an operation, and then the patient must choose to proceed with surgery. However, there may be circumstances when patients are willing to assume more risks than surgeons are willing to put them through. Although it is challenging to respect the autonomous choices of a patient while not abiding by those choices, surgeons are not ethically required to perform any operation that a patient wants regardless of the risks. Surgeons can recommend operations that patients may decline, but surgeons are not required to perform every operation that a patient may request. The autonomous choice of a patient extends to the reasonable medical or surgical options available but not to every possible option. In deciding whether to offer an operation to a patient, the surgeon must carefully weigh the risks of the procedure for the speciﬁc patient in view of the patient’s medical condition and in view of the patient’s goals.

The Nature Of Surgical Innovation

One of the central differences between surgery and medicine emerges out of the differences between innovative drugs and innovative surgical procedures. In the USA, the Food and Drug Administration (FDA) must approve drugs that are offered to patients. Although the actual oversight may vary from country to country, every country requires new drugs to have at least some documented evidence for safety and efﬁcacy before being used to treat patients. By contrast, there is no oversight of innovative surgical procedures. For example, when in the operating room and faced with complicated anatomy, surgeons are not only allowed to devise innovative surgical solutions to their patients’ problems, but they are expected to seek such creative solutions. The ability to creatively solve a patient’s problem in the operating room by the use of an innovative surgical technique is central to surgical practice and occurs without any regulation or oversight.

Innovative surgical techniques must be disclosed to patients preoperatively when planned before surgery or as soon as possible postoperatively if the innovation was unplanned (Bifﬂ et al. 2008). Nevertheless, such innovative techniques need not have ever been tested prior to a surgeon trying it out on a patient. This level of creativity in surgery can be either beneﬁcial or harmful to patients and is completely dependent on the surgeon’s assessment of the risks and beneﬁts to the patient. In this manner, even though patients must give informed consent prior to having any surgical procedure, patients must place their trust in their surgeons to make decisions about whether to use innovative techniques to beneﬁt individual patients. The leeway that a surgeon is given to decide what procedure to perform on any given patient allows the surgeon a level of independence that is unparalleled in other areas of medicine.

When surgeons are obtaining informed consent from patients for planned innovative surgical procedures, by deﬁnition, the risks and beneﬁts are not well known. In such circumstances, surgeons must carefully explain the uncertainty of both the beneﬁts and the risks. The disclosure of uncertainty is often difﬁcult to explain since patients understandably expect that surgeons have knowledge of the procedures that are to be performed (Angelos 2010). The requirement for obtaining adequate informed consent for innovative surgical procedures is one that demands a level of transparency that is challenging for many surgeons and patients.

An additional challenge of innovative surgical procedures is that patients are completely dependent on the surgeon’s assessment of whether the novel operation will be beneﬁcial. By deﬁnition, there can be no well-documented evidence to support the use of a novel surgical procedure. Patients are forced to trust that their surgeons will accurately assess the risks and beneﬁts even when these risks and beneﬁts are not well known (Angelos 2014). If there were strong evidence to support the use of the innovative procedure, then it would no longer be truly innovative. When there is little data to determine if an innovative surgical procedure is safe, the patient must depend on the surgeon to provide a thoughtful assessment of risks and beneﬁts and then accurately communicate these risks and beneﬁts to the patient.

An important concept in the area of surgical innovation is that although novel techniques can be performed on patients with no oversight, surgeons must be careful not to plan innovative techniques for research purposes without obtaining prior approval from an institutional review board (IRB). There is a critical distinction between performing an innovative procedure on a patient for the beneﬁt of the patient and performing the innovative procedure with the goal of gathering the data to answer the question of whether the innovative procedure is better or not (Bifﬂ et al. 2008). The former circumstance is surgical innovation and is unregulated. The latter circumstance is surgical research and must therefore follow all regulations associated with human subject research.

Challenges Of Surgical Research

As noted in the prior section, innovative surgical procedures that are performed for the beneﬁt of the patient are not regulated. In other words, if a surgeon believes that he or she can help a patient by performing an operation in a novel manner, the surgeon can proceed to do that novel procedure without any prior review by anyone. In contrast, however, if a surgeon wants to study a novel operation to determine if it is better, then the surgeon is no longer engaged in innovative surgery for the beneﬁt of the patient but rather is doing surgical research. The distinction between doing an innovative operation to beneﬁt a patient and doing that same operation in order to gather data may seem like a subtle one. However, the intent of the surgeon is critically important. Although surgeons have tremendous latitude to creatively solve their patient’s problems in innovative ways with no oversight, surgical research requires the same level of prior review and oversight that is required of all research involving human subjects.

In order to engage in research, surgeons must create a protocol that follows the same rigorous template as in any other medical research. In particular, surgical research must be carefully designed with a clearly written protocol. It must be based on prior research that justiﬁes putting human subjects at any risk. Surgical research must be performed in a manner that minimizes risks to patients (who are also subjects), and there must be a formal informed consent document that outlines risks, beneﬁts, and alternatives of participation in the research protocol. Furthermore, the informed consent document must have been reviewed and approved by an IRB prior to obtaining a subject’s consent. The research consent form is different from the usual consent form for a therapeutic surgical procedure in that a research consent must spell out risks in much greater detail and should specify what is research and what is accepted therapy.

Even when a surgeon has gone through the steps of IRB approval for a surgical research protocol with all of the detail regarding inclusion and exclusion criteria and the subject/patient has signed the research consent form, there remains the challenge of variability in surgical practice. Medical research is focused on obtaining data to add to generalizable knowledge. The problem with surgical research is that there are myriad small ways in which surgeons differ in how they perform any given operation. In addition, there may be many small variations in how the same surgeon performs the same operation in different patients. The anatomy of every patient is slightly different, and operations cannot follow a strict plan that ignores the differences of each patient. Although surgeons may, for the purposes of a research protocol, attempt to standardize an operation, there will be some level of variability that is inevitably present. This inherent variability does not make it impossible to perform surgical research but does create challenges for the ethical performance of such research.

Another challenge for surgical research involves randomization. The gold standard for medical research is the prospective randomized controlled trial. In trials of new medicines, the randomization involves the subject/patient being randomly assigned to receive the trial drug or standard therapy or sometimes the trial drug or a placebo medication. Often when surgical trials are randomized, a subject/patient will be randomly assigned to receive either the experimental surgical procedure or a standard operation. Perhaps it is not surprising, but many subjects/patients are uneasy about being randomly assigned to a speciﬁc surgical arm. For the reasons noted previously, surgeons are inherently involved in surgical interventions. The operation does not just happen, but a surgeon has to perform the operation. Perhaps for this reason, many subjects/patients are often very uneasy with the idea that the choice of their operation will be randomly assigned. This psychological ﬁnding does not make a surgical trial unethical, but it does push surgeons engaged in such trials to emphasize to subjects/patients that there is equipoise – namely, the surgeon does not know which treatment is better, and the study is designed to answer this question.

As noted in the paragraph above, placebos are often used in medication trials when there is no effective medical therapy. Placebo arms in surgical trials are much more problematic although not unethical (Angelos 2003). Often, when the outcomes of an operation are subjective, the potential placebo effect of actually undergoing an operation may be signiﬁcant. In such cases, having a placebo (or sham) surgery arm may be critically important to determine if it is the actual surgical intervention that is the cause of the patient’s subjective improvement, or rather they feel better because they have been through an operation and they assume that the surgery will help them. In order to distinguish between these possibilities, a placebo surgery arm can be very helpful. However, the more closely the sham operation resembles the “real” operation, the greater the risks for the subjects who are having the placebo surgery. For example, if the study is to determine if an operation on the abdomen alleviates a painful syndrome, then the sham procedure would need to involve more than just a general anesthetic. The sham operation would require an actual incision on the subject’s abdomen that could become infected. Furthermore, if the “real” operation involves cutting through muscles to enter the abdomen, then in order for the sham operation to be more similar to the “real” operation, one might suggest that the muscles be cut in the sham operation as well. Thus, the closer the sham is to the “real” operation, the greater the risks to the subject. For this reason, a placebo surgical arm would carry risks to a research subject with no potential for beneﬁt which makes placebo surgery essentially unlike a placebo drug or sugar pill.

Conclusion

In the previous paragraphs, several suggestions have been made regarding the ways in which surgical ethics is different from other areas of medical ethics. In particular, it has been shown that informed consent for surgery requires a high degree of trust by the patient in the surgeon. Informed consent for surgery, thus, requires the surgeon to communicate risks, beneﬁts, and alternatives to patients so that competent patients can make autonomous choices. However, informed consent for surgery is more than simply the transmission of information. Surgical consent requires the patient to place great trust in the surgeon to perform potentially harmful and even disﬁguring procedures that may ultimately beneﬁt the patient. The need to constantly weigh the potential for harm against the potential for beneﬁt shapes the manner in which surgeons conceptualize their personal responsibility for their patients’ outcomes.

In order for surgical care to improve in the future, there must be the possibility for change over time. Such change occurs in surgery most commonly as a result of individual surgeons’ attempts to solve their patients’ problems through creative approaches in the operating room. This unplanned surgical innovation is the primary driver for change over time. There is no requirement for oversight of this type of surgical innovation. In contrast to new drugs that require (at least in the USA) approval of the FDA, new procedures can be undertaken with no such formal review. This freedom to innovate in the operating room can potentially result in tremendous beneﬁt or tremendous harm to patients. How surgeons manage such innovative procedures is central not only to the future of surgical care but also of the future of the surgeon-patient relationship. In order to prove that innovative surgical ideas are actually beneﬁcial to patients, it is essential that there be well-constructed surgical research protocols. Although there are clear challenges to surgical research related to problems of standardization, randomization, and even whether placebo surgery arms can be used in clinical trials, surgical research is essential to provide the evidence necessary to ensure patient safety.

In the decades to come, more focused attention to ethical issues in the care of surgical patients will further enrich the overall understanding of clinical medical ethics. Through careful explorations of the similarities and differences between surgical ethics and medical ethics in general, surgeons will better understand how to best care for their patients in an ethical fashion.

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