Introduction
The process of patients giving their informed consent to medical treatment is a legal device that began in the 1950s in an attempt to enable patients a higher degree of autonomy in their treatment while simultaneously protecting doctors from a malpractice suit whenever a procedure went awry. More recently, The Institute of Medicine 2001 report, "Crossing the Quality Chasm: A new health system for the 21st century"1 and other studies2,3 have put the spotlight on adopting a patient-centered care (versus disease-centered care) approach in efforts to improve the quality of patient care. The process of informed consent has been identified as one of the most problematic areas in medicine today that can be targeted and improved using this new approach to healthcare. Increasingly, physicians are not only finding ways to ensure their patients are fully educated about their conditions and treatment options, but they are also using the informed consent process as a tool to further conversation, increase communication and improve patient satisfaction.
The issues that complicate the informed consent process fall into several general categories: ethics, information and communication. Naturally, these categories are somewhat indistinct but inform each other in myriad ways, but to gain a more comprehensive understanding of the issues and pitfalls of the informed consent process, a close analysis of these categories is beneficial. A hypothetical case study provides an illustrative example of how to incorporate the best practices of patient-centered care and thorough informed consent.
Ethics
A surgeon who works in a subspecialty area benefits from years of formal medical education as well as years of clinical practice experience and expertise, which contribute to his or her knowledge of clinical conditions and their treatments. The physician's role as a patient-centered caregiver is to appropriately inform the patient. Providing the patient with the necessary information to allow him or her, with the support of the appropriate significant others, family or partners, to give a well-educated consent to a specific course of treatment is a critical step in the treatment process.
Since the patient has a medical need that has driven them to seek professional help, they are dependent on experts they consult. It is the physician's fiduciary responsibility to honor the trust that a patient places in them and to act in the patient's best interest4,5. Decisions should be made without regard for financial gain. It is understood, by physicians, patients and insurance companies, that there is payment for care rendered, i.e., professional fees. However, there may be additional sources of income generated by ancillary services, such as imaging, therapy or operative facilities that should also be disclosed to patients.
It is a doctor's legal duty to provide as much information as necessary for the patient to understand the subsequent events5. The doctor must also decide what information is or is not necessary to present, and this decision must be made based on the doctor's assessment of the individual patient's experience, education, culture and personal preferences. It should be noted that beyond this obligation there are no official or legal guidelines, rules or regulations as to the details of the information that is transmitted. These details are left to the discretion of the physician.
Lastly, because the physician is the one who ultimately performs the treatment (in the case of surgical treatment), there are biases in the options they may choose to present and how they are presented. These biases are based on their professional opinion regarding the various options, their comfort level with the array of treatments and their personal preferences. These preferences may be affected by a host of factors. Those that apply directly to patient outcome may involve the time required to perform a treatment or procedure, the relative risks and benefits, and the likelihood of complications in terms of both incidence and severity. Concerns regarding economics, utilization of resources, availability of appropriate equipment and implant devices may also be considerations.
Information
Once the physician has made the decision regarding the appropriate information with which a patient should be educated, a number of obstacles remain as to how that information is conveyed to the patient. One of the most confounding aspects of the verbal informed consent process is poor patient understanding of material at the time of presentation6. There is often a discrepancy between what information the physician or health professional thinks he or she has imparted, and what the patient understands or perceives6,7. This gap may be attributed to a variety of causes such as emotional distress8, low level of education achieved8 and cultural/linguistic differences9. Appreciation of the impact of this problem is compounded by the fact that patients themselves are unreliable indictors of their level of comprehension — many times reporting that explanations were sufficient or fully understood when, in fact, doctors failed to provide any explanation at all or else the patient was unable to recite specific information that had been given6.
One way to test the quality of information transfer is to ask patients to summarize their understanding of the condition and the relevant treatment options. This can provide the physician or the ancillary healthcare provider with immediate feedback on how well the patient has comprehended information. Even if proper information is given, and initially absorbed by the patient, recollection of information diminishes quite rapidly after the procedure10. While the physician is not responsible for the patient's memory, it is in his or her best interest to take every effort at providing all of the necessary information and tools to help reinforce the education, seeing that patients have been shown to be highly unreliable at recalling important and relevant information (i.e., treatment risks, hospitalization time, etc.).
Communication
Not only is it important to note what information is transferred from the doctor to the patient, but it is also essential to be aware of how the information is communicated. Verbal communication is the most common medium, both for the initial interview as well as handling questions and given through explanations. Written and visual media are also very effective in improving clarity and allowing the patient to review important or complex information at their own pace. Healthcare providers may even inquire how patients best receive information, and adjust their modes of communication accordingly.
Verbal communication
The first few minutes of a patient's first office consultation is the most important for establishing a favorable impression of the physician9, which has been shown to be an important indicator of a doctor's competence in the patient's opinion. Beyond first impressions, patients often feel their doctors do not spend enough time performing the interview and asking lifestyle questions11. When doctors allow their patients to view their grievances or explain their concerns in their own words, which is correlated with higher rates of patient satisfaction9, 80 percent of the time they are cut off within 18 seconds9. The same study has reflected that physicians believe they are far better listeners than their peers, while patients rate <20 percent of orthopedic surgeons as "excellent" in "spending enough time to listen" and "caring and compassionate." Even when the doctor and the patient are able to establish a good relationship, and all of the informed consent criteria have been met, sometimes patients and doctors differ in their opinions of a successful procedure. A common source of patient dissatisfaction comes from the discrepancy between operative goals and patient-centered goals. By asking a patient how a treatment procedure can best improve their lifestyle, doctors may be able to present treatment options that would best benefit patients based on their personal needs.
Written and visual communication
Videos and take-home or printout pamphlets are effective in increasing patient comprehension of diseases, treatment options and surgical procedures. Unfortunately many of the written materials are above the national reading level for adults12. Literature that features shorter words and sentences and includes simple line-drawing diagrams has a lower reading level and is more accessible to the average American patient. Physical aids, such as three-dimensional models and pen markings on a patient's skin, can also be used to communicate information such as anatomy, pathology and surgical approaches.
Additionally, as more patients use the Internet to educate and diagnose themselves12,13, the accuracy and quality of the information they receive declines. A pamphlet hand-distributed by one's physician containing all the relevant information to one's condition and treatment eliminates the need to search the Internet for any seemingly related materials. Another issue with literature distributed by the physician's office may be that the reading is too long or too technical for patients to understand. One key step to overcome these pitfalls is to increase caregiver awareness of patients looking for multiple sources of information. Statistics13 show that patients are becoming proactive about health literature, seeking information about their conditions wherever they can. Healthcare professionals should be eager to use this increased demand for accessible knowledge as an opportunity to provide their patients with quality information that is tailored to their needs.
Using informed consent as a tool to enhance patient satisfaction
While the informed consent process directly concerns itself with the specifics of a treatment plan, the process can be used as a more general starting point for a conversation between the doctor and the patient. Extending the dialogue beyond what law requires in order to protect the physician has the opportunity to increase patient satisfaction, as well as surgical outcomes, through facilitating realistic patient expectations, increasing the clarity of patient needs, and adapting the treatment plan accordingly. Patient-centered conversations can reveal more subtle patient needs and desires, as well as potential complications to a given procedure — two incentives to take extra measures when developing a treatment plan. Additionally, the simple act of describing one's ailments can have therapeutic value for a patient, and can improve a patient's perception of physician competentce9, a contributing factor to overall patient satisfaction. To ensure the informed consent process is both complete and legally thorough, the physician should take care that he or she at least provides the nature of the condition, the recommended treatment plan, associated risks and reasonable alternatives to the proposed treatment14. While there is no official guideline to what information physicians must provide to their patients, or in what manner, there is an undefined level of comprehension that the patient must achieve before consenting to a treatment plan.
Ideal model for physician-patient exchange (office visit through post-operative)
Hypothetical case
A 40-year-old female with severe osteoarthritis in the right wrist receives a referral from her primary care provider to an orthopedic specialist. When she calls the office to make an appointment, the receptionist takes down all of her information, confirms it with her and encourages her to visit the institution's webpage or call the office again should she have any questions. On the day of her appointment, she visits the webpage and is able to read the mission statement, accreditations and qualifications of her referred physician. She also is able to find directions to the office, and finds information encouraging her to bring a family member or friend to her consultation.
Upon arrival at the office, she is greeted by the receptionist, and asked to fill out some paperwork. She and her husband spend less than 45 minutes in the waiting room. The orthopedist introduces himself and takes a medical history, and asks the woman to explain her condition in her own words before he begins the examination. Throughout the visit, the doctor also tries to establish a sense of the patient's lifestyle demands and how her disease affects her daily functioning. At the end of the physical examination, the specialist agrees with the primary care physician's diagnosis of osteoarthritis and begins to relay information to the patient.
The doctor explains the nature of the condition, perhaps including causes and natural history if the disease is left untreated. While the patient appears mildly emotional after hearing about the severity of her condition, her husband is able to listen more attentively and takes a few notes. The orthopedist recommends arthroplasty, based on his experience treating similar cases and the patient's specific needs. He uses a skeletal model of a human hand to indicate which bones are diseased and which should be removed. Next, the doctor asks and is given permission to draw out the incision on the patient's own affected hand, and an area of potential sensory loss on the back side of her thumb and hand. He outlines the process of the surgery, including any hospitalization time or physical therapy, and also notes the most common risks. The doctor takes care to note that there are other treatment options, but explains that in similar cases he has treated, arthroplasty has yielded the most consistent and satisfactory results. The physician takes the opportunity to discuss what "satisfactory results" means to him — increased range of motion, improved level of function, decreased pain and an improved condition compared to her current state.
He then asks the patient what "satisfactory results" would look like to her. She replies that as an avid tennis player, pain management and high functionality are important so she can resume playing. The physician takes her desires into consideration and explains why he still recommends arthroplasty, but will encourage a different type of physical therapy. He takes care not to pressure the patient into choosing his recommended option, and answers her honestly about the associated risks.
Finally, the doctor asks if she or her husband have any remaining questions about the diagnosis, the procedure, alternative treatments or any other relevant matter. He encourages them to visit the webpage again and print out and review the prepared literature on her specific condition as well as the procedure to be preformed. A photograph of the markings on the patient's hand is given to the couple to take with them, while another copy is added to her file. Notation that a thorough conversation has taken place, complete with a diagram on the involved joint, her primary concerns and the treatment options they discussed are also included in the patient's record.
The couple returns to their home and prints out the aforementioned literature. They find that the information is clear and written in short, simple sentences, and accompanied with clarifying diagrams. They discuss what the physician told them and they consult the husband's notes taken during the consultation. After becoming more educated about osteoarthritis they feel more confident in the decision to proceed with surgical treatment and they print out literature from the webpage about preparing for the day of the operation.
The woman receives two reminders about her upcoming procedure from the office and arrives on the day of the surgery feeling nervous, but otherwise well prepared. The same orthopedist visits her to answer any last minute questions. He confirms the correct extremity and surgical site, again drawing out the intended incision and anticipated at-risk anatomic structures. She is asked to sign the Informed Consent form while a healthcare provider stands by, should she have any questions. The document itself is not very long, and the wording is very clear and concise. She undergoes the operation as planned and is discharged later the same day and driven home by her husband.
The office calls the next day to schedule her postoperative visit and remind her to feel free to call back if she has any questions or concerns aside from what her physician had told her to expect after surgery.
Conclusion
There are numerous advantages in adopting a patient-centered care approach. Focusing treatment on the patient, as opposed to the disease, enables specialized and more comprehensive care, insofar as it encourages the healthcare team to improve relationships with the patient. The increase of patients' interest regarding their health is a prime opportunity for physicians to provide more accessible and patient-specific information. The use of visual media to supplement explanations, as well as the presence of a friend or family member, are effective methods for increasing patient's retention of information.
These techniques combined with increased physician attentiveness and conversation results in better compliance with the legal aspects of informed consent, improved patient satisfaction, improved physician satisfaction, closer adhesion to rehabilitation plans and better overall operative outcomes. While there remains a need for further studies on the specific aspects of how to best provide patient-centered care, it is important that individual physicians continue using this new view towards healthcare as the impetus for better informed consent processes and increased patient satisfaction.
Julia Diao is a research fellow, and Douglas H Chin, MD, is a plastic surgeon and executive manager for Midtown Surgery Center, New York, and East Bay Special Surgery, Oakland, Calif. Contact Ms. Diao at diao.julia@gmail.com.
References
1. Edington M, editor. Crossing the quality chasm: a new health system for the 21st century. Committee on Quality of Health Care in America. Institute of Medicine, Washington, DC: National Academy Press; 2001.
2. Farley FA, Weinstien SL. The Case for Patient-Centered Care in Orthopaedics. JAAOS 2006 14:8 447-451.
3. Wong A, Lewis B, Herndon J, Martin C, Brooks R. Patient safety in North America: beyond "Operate Through Your Initials" and "Sign Your Site." J Bone Joint Surg Am. 2009;91:1534-1541.
4. Capozzi JD, Rhodes R, Chen D. Discussing Treatment Options. JBJS 2009 91:3 740-742.
5. Suk M, Udale AM, Helfet DL. Orthopaedics and the Law. JAAOS 2005 13:6 397-406. Wenger NS, Lieberman JR. An Assesment of Orthopaedic Surgeons' Knowledge of Medical Ethics JBJS 1998 80:1 198-206.
6. Ghrea M, Dumontier C, Sautet A, Herve C. Quality of Information Transfer for Informed Consent: An experimental study in 21 patients. Revue de chirurgie orthopedique 2006 92:1 7-14.