Stepping Up Informed Consent: Navigating Foot and Ankle Orthopedics

Introduction

The maintenance of patient autonomy and the facilitation of collaborative decision-making between providers and patients depends on a comprehensive informed consent process. informed consent is the process in which the physician comprehensively educates their patient on the (1) diagnosis; (2) treatment; and (3) the risks and benefits of both the proposed treatment and alternative treatments, including the option of no treatment^1,2 and obtains the patients approval prior to initiating treatment. Physicians have both ethical and legal obligations to describe a patient’s diagnoses and potential procedures in a manner appropriate to a patient’s education level and comprehension.^1-3 However, providing this information alone is not sufficient, as it is the responsibility of the physician to ensure patient comprehension. ² To allow for shared decision-making, diligent patient education and objective determination of patient comprehension are necessary.

The growing number of foot and ankle surgical cases, coupled with an increase in the complexity and diversity of such cases,^4,5 poses a challenge to foot and ankle orthopaedic surgeons seeking to obtain quality informed consent, leading to increases in claims of negligence. ⁴ A refined informed consent process may help mitigate these negative outcomes and enhance overall patient satisfaction. Some of the persistent inadequacies observed in the current informed consent process include poor patient comprehension of medical information, ⁶ lack of patient involvement in decision-making, ⁷ and special considerations in surgical outcomes that require a more comprehensive patient education.^8-10 These problems are further complicated by a lack of standardized measurement of informed consent quality and limited literature.

This review attempts to identify flaws in current informed consent processes and propose appropriate solutions to address shortcomings within orthopaedic foot and ankle surgery. Authors sought to improve the quality of the informed consent process by answering the following questions: (1) What is the current state of the informed consent process within foot and ankle orthopaedic surgery?; (2) What barriers exist in foot and ankle surgery that impede the ability to obtain adequate informed consent?; (3) How can the current informed consent process be improved in light of these identified barriers?

Shortcomings in Current Informed Consent

While the quality of informed consent has been assessed in previous literature, there remains no consistent measure by which the quality of informed consent can be objectively defined. The most common method used has been postconsent recall testing, as it is affordable and time efficient.^11-14 Postconsent recall consists of patients recalling details from their preoperative discussions during the informed consent process. The ability of the patient to recall this information serves as a proxy for the quality of the informed consent process provided by the physician. ¹¹ However, postconsent recall testing may assess patient memory rather than patient comprehension, and does not directly assess the quality of discussions between the patient and provider.^11,15 Closed-ended assessment modalities, such as questionnaires, are prevalent in previous evaluations of informed consent within foot and ankle orthopedics, but these measures have been found to overestimate patient understanding when compared to open-ended assessments in recall testing. ¹¹ The lack of standardization and suboptimal measurement methods demonstrate the need for improved quality control of informed consent, as previous quality measurements evaluating informed consent may provide an inaccurate and possibly excessively optimistic view of the current state of the informed consent process within foot and ankle orthopedics. ¹⁵

The use of audio and/or video recordings of informed consent conversations are a less popular approach to assessing quality of informed consent, but may provide a superior option for future studies. In an analysis of audiotapes of primary care visits it was found that only 9% of visits met criteria for “adequate informed consent.” ¹⁶ While audio recordings may provide insight into physician communication and patient comprehension, video recordings offer the ability to assess nonverbal communication that may further contribute to patient understanding. ¹¹ Through assessment of these recordings, the quality of informed consent discussions can be directly evaluated and corrective action can be instituted when inadequacies are identified. However, implementing audio and/or video recordings to determine the quality of informed consent requires greater resource expenditure. ¹¹ As the quality of informed consent in foot and ankle orthopedics has not been previously evaluated using this method, future studies implementing this process may more accurately define the quality of these integral discussions.

Despite current shortcomings in the evaluation of informed consent, inadequacies in the informed consent process are still apparent in orthopaedic foot and ankle surgery. A major deficit in the state of consent in orthopedics is poor patient comprehension of informed consent discussions, as evidenced by the inability of most patients to recall the major risks associated with their completed surgery. ⁶ Previous literature has demonstrated that only 30% to 40% of patients were able to recall a single risk following discussions of forefoot procedures. ⁶ Poor patient comprehension may lead to subpar outcomes and can be attributed to 2 factors: failure by the provider to discuss information required for patients to make an informed decision or due to patient factors that may prevent adequate comprehension of presented information.^2,17 Without adequate physician communication and patient comprehension, patients are unable to participate in shared decision-making and thus autonomy is unable to be preserved.

Several orthopaedic subspecialties, including foot and ankle, have been found to have a low degree of patient involvement in the decision-making process. ⁷ Orthopaedic surgeons have been reported to perform poorly in the assessment of patient preferences, expectations, and concerns during the informed consent process. ⁷ The tendency for operative discussions to be “one-sided” can be attributed to the scheduling and time constraints imposed on orthopaedic surgeons, making it difficult to engage in detailed conversations. ¹⁸ Furthermore, patients might find it challenging to actively engage in the informed consent process, regardless of their educational background, due to the complex nature of the pathological conditions they are presenting with. ¹⁸ By recognizing these limitations, physicians can become more cognizant of both their own constraints and those of their patients, educating when necessary and improving patient participation in their own medical decisions.

In addition to poor information recall and a lack of patient involvement, several unique factors exist within the field of foot and ankle surgery that further exacerbate the inadequacies within the informed consent process. For example, the reported outcomes of foot and ankle injuries, such as calcaneal fractures and Lisfranc injuries, are often suboptimal even with anatomic reductions. Long-term functional deficits and persistent pain are the most common complications, due to the development of posttraumatic osteoarthritis (PTOA).^9,10,18 Such outcomes are not limited to these 2 injury patterns, In fact, most of the malpractice claims for foot and ankle surgery in the Netherlands are due to postoperative functional restriction, pain, and readmission for the same injury. ¹⁹ Patients who are not properly educated regarding the development of PTOA may attribute this pathology to a failure of the procedure performed instead of the unfortunate pathophysiology of the injury pattern. Patients must be aware of this to maintain accurate expectations of their surgical outcomes.

Although general complications occur in all surgical specialties, some outcomes are unique to foot and ankle procedures, highlighting the importance of a comprehensive consent process for certain foot and ankle procedures and surgeries.^19,20 Patients undergoing total ankle arthroplasty due to end-stage arthritis frequently encounter issues such as aseptic loosening or subsidence. ⁸ The relatively high rate of these particular complications is attributed to the small joint surface compared to other weight-bearing joints. ⁸ These patients often have pre-existing deformities, making these procedures even more difficult due to the inherent anatomy of the ankle joint. ⁸ The informed consent process is not exclusive to surgical procedures; while nonsurgical options are generally safer than surgery, they still pose certain risks. For instance, alcohol injections for Morton’s neuroma can lead to skin and subcutaneous tissue necrosis. ²¹ Although these injections offer short-term pain relief, long-term outcomes are less favorable and have been associated with significant postinjection morbidity. ²² Corticosteroid injections are also extensively used to treat Morton’s Neuroma as well as other foot and ankle injuries such as plantar fasciitis and achilles tendonitis. ²³ While these injections are viewed as conservative management, they pose a risk of plantar fascia rupture and achilles tendon rupture. ²³ As a result, the informed consent process for nonsurgical treatment should be held to the same standard as surgical consent. By adequately informing patients of potential outcomes, complications, and the possibility of needing subsequent procedures, expectations can be appropriately managed.

One of the major factors leading to increased complication rates within foot and ankle surgery is the rising prevalence of diabetes mellitus (DM). Diabetic patients undergoing foot and ankle surgery are more likely to have wound healing problems and poor tissue perfusion, often leading to amputation. ²⁴ This can be secondary to diabetic peripheral neuropathy which preferentially affects the distal lower extremities symmetrically and bilaterally, as well as Charcot neuropathy which is most commonly localized to the foot and ankle.^25,26 In addition, patients with at least one complication of diabetes had a 7.25 fold greater risk of surgical site (foot and ankle) infection when compared to nondiabetic patients without neuropathy. ²⁰ It was also found that peripheral neuropathy and hemoglobin A1C >7% were significantly associated with increased foot and ankle bone healing complications, including nonunion, delayed union, and malunion, postoperatively. ²⁷ Operating on diabetic patients adds a layer of complexity not only to the surgery but also to the informed consent discussions that must take place. Failure of foot and ankle surgeons to educate DM patients on the increased likelihood of complications postoperatively does not meet basic informed consent standards and can lead to patient dissatisfaction.

While the prevalence of foot and ankle injury and malpractice claims has grown worldwide,^4,28 literature assessing informed consent and malpractice has not been focused on this subspecialty of othopaedics.^19,29 This lack of literature may contribute to certain deficiencies in the informed consent process. ³⁰ Without comprehensive literature, physicians remain unaware of shortcomings within the informed consent process, allowing current issues with the process to persist. Furthermore, the growth of the field of foot and ankle surgery has not come without consequence, as litigation against foot and ankle surgeons constitutes a significant proportion of orthopaedic malpractice claims. ³ It has been previously reported that 12.6% of malpractice claims against orthopaedic surgeons were against foot and ankle specialists. ⁴ Of these claims, the sixth most common cause was improper informed consent, accounting for 6.4% of all settled claims. ⁴ “Dissatisfaction,” determined by subjective assessment and often involving the consent process, was the fourth most common cause for malpractice claims, comprising 8.6% of settled claims. The current rate of lawsuits citing informed consent may, in part, stem from inadequate documentation. ³ While addressing the pitfalls of informed consent is necessary to maintain patient autonomy, solutions to improve the process will also mitigate legal risk faced by orthopaedic foot and ankle surgeons.

To reduce litigation risks, meticulous documentation and strengthening the physician-patient relationship are 2 promising strategies.^31,32 As improper documentation has been found to be a contributing factor to informed consent litigation, a comprehensive documentation, focusing on all treatment options and their respective risks and benefit profiles may be an effective method of avoiding a common pitfall.^3,31,32 Additionally, following an actual or perceived lapse in informed consent, apologizing and expressing empathy have been shown to be effective methods for repairing the physician patient relationship and protecting against litigation.^33,34

Barriers of Informed Consent

To properly educate a patient on risks, benefits and alternatives of their upcoming foot and/or ankle procedure, patients must first understand the fundamental principles of pertinent anatomy and surgical technique. While these topics may be commonly discussed by foot and ankle surgeons, these topics are complex, and often exceed the medical knowledge of patients, most of whom have been found to have a very poor understanding of even basic anatomy and have limited health literacy.^35-37 It has been reported that over 33% of patients older than 65 and 80% of patients presenting to public hospitals have low health literacy. ³⁶ If a patient cannot understand language used by the physician, it becomes nearly impossible for physicians to obtain proper consent. Without properly educating patients to overcome the challenges of poor health literacy, patients will not possess the insight and understanding of their diagnoses and available treatment options to participate in shared decision-making, thus stripping them of their autonomy.

To combat low literacy levels, The Joint Commission recommends that patient education materials are written at no higher than a 5th grade reading level to maximize patient comprehension. ³⁵ Unfortunately, these guidelines are not always followed, with adherence to these guidelines dependent on the region and institution. For instance, the American Orthopaedic Foot and Ankle Society (AOFAS), based in Schaumberg, Illinois, offers patient education materials on their website to provide patients with easily comprehensible education materials on various foot and ankle conditions. An assessment of these patient education materials found them to have an average reading grade-level of 8.3, with 79.2% exceeding a 6th grade level and almost 30% exceeding an 8th grade reading level. ³⁸ Additionally, the average reading level across all entries on the patient education website hosted by the AOFAS - FootCareMD.org - vary between 9.1 and 12.1, well above the reading level recommended by the Joint Commission. ¹⁷ These inappropriately high-reading-level patient education materials are not exclusive to the United States, as foot and ankle patient consent forms from the Queensland, Australia public hospital system were found to have a reading grade-level of 11.6 ± 1.2. ³⁹ This exceeds the sixth to eighth grade reading-level that is recommended for Australian patient education materials. ³⁹ As hospital systems and acclaimed journals are failing to provide patients with comprehensible consent forms and associated patient education materials, more stringent evaluation of these critical documents is required to allow patients to participate in shared decision-making.

Surgeons have the responsibility of spending sufficient time with patients to ensure their complete comprehension of the risks, benefits and alternatives of proposed treatment options. While there is limited literature evaluating length of time spent with surgeons for foot and ankle appointments, one study in America found that foot and ankle orthopaedic surgeons spent an average of 7.4 minutes in the exam room with their patient. ⁴⁰ These data are corroborated by data in other subspecialties in which multiple studies have found orthopaedic hand surgery visit times to be limited to 7 to 10 minutes.^41,42 In one of these studies, 11% of patients reported that they felt rushed during their encounter. ⁴¹ Another study evaluating informed consent across multiple specialties in South African public hospitals showed that most of the physicians reporting appointment times of 5 to 10 minutes, with 45% stating that the amount of time spent with each patient being insufficient. ⁴³ Furthermore, 86.9% of these physicians emphasized that “time constraints” were a major barrier to obtaining informed consent. ⁴³ Time limitations with patients is likely a factor contributing to the lack of high quality informed consent in foot and ankle orthopedics.

These barriers can be further exacerbated by language barriers during discussions between physicians and their patients. In an urban orthopaedic clinic in London, only 74% of patients spoke English as their first language. Patients who spoke English as a second language had increased difficulty with defining common orthopaedic terms, such as “fracture,” “ligament,” and “arthroscopy.” ⁴⁴ When compared to native speakers, these patients were far more likely to incorrectly define the medical terms presented in the study. ⁴⁴ Furthermore, in Saudi Arabia, 84.7% of orthopaedic residents reported difficulty in obtaining informed consent due to “communication and language barriers,” with utmost difficulty translating medical terminology into the local language. ⁴⁵ In the United States, there have been specific concerns regarding the lack of resources for Spanish-speaking orthopaedic patients. While no studies were identified assessing language barriers within orthopaedic foot and ankle, pediatric orthopaedic offices were found to lack quality translation services, presence of Spanish-speaking surgeons, and patient education materials written in Spanish. ⁴⁶ To mitigate these shortcomings, translation assistance should be implemented as it has been found to be associated with higher levels of patients comprehension. ⁴⁴ While the impact of language barriers may viewed locally, the lack of adequate resources for nonnative language speakers presents a global issue that must be appropriately addressed. This challenge of acquiring high quality informed consent is further exacerbated by low patient health literacy, high-reading-level patient education materials, and physician time restraints.

Solutions for Improving Informed Consent

Adjustments must be made to address barriers if patient autonomy is to be preserved.^45,47 Scant literature was identified that assesses solutions to improve informed consent within foot and ankle orthopaedic surgery. Nevertheless, it is imperative to consider potential improvements to the consent process, including the implementation of language appropriate to a patient’s level of comprehension,^48,49 standardized patient education materials, ⁴⁸ extended physician-patient visit times, ⁵⁰ and translation assistance^51,52—approaches that have proved effective in other subspecialties.

Before discussing ways to improve the delivery of informed consent, it is essential to first establish the necessary content, ensuring that foot and ankle orthopedists have a clear understanding of the key information to convey. Among spinal surgery malpractice lawsuits due to improper informed consent, the most common claims were failure to explain the risks of surgery and failure to discuss alternative treatment options. ³¹ Similarly, a retrospective review of malpractice claims in the Netherlands found that 67% of claims involving informed consent stemmed from inadequate disclosure of risks or complications of the treatment. ³² Special attention must be given to thoroughly discussing and documenting treatment options along with their associated risks and benefits, as inadequate disclosure is a common source of litigation in foot and ankle orthopedics.

For surgical management of fractures, key complications to address and document include surgical site infection, bleeding, neurological injury, malunion, nonunion, decreased range of motion, and PTOA are some important complications to address and document. In arthroplasty, it is important to address risks such as prosthetic joint infection, bleeding, neurological injury, venous thromboembolic event, decreased range of motion, and aseptic loosening. Due to decreased perfusion/neuropathy/peripheral vascular disease that may limit wound healing in foot and ankle procedures, it is vital to also always mention the possibility of osteomyelitis, amputation, and mortality. While surgeons have the choice to emphasize some more common complications depending on the surgical procedure being performed, (i.e. nonunion for an arthrodesis procedure), all possible complications should be mentioned and patients should verbalize understanding. To protect themselves legally and uphold patient autonomy, foot and ankle orthopedists must ensure that all available treatment options and their potential complications are clearly disclosed.

To address patients with a lower health literacy, medical jargon should be minimized. The utilization of plain language in preoperative conversation can improve patient comprehension, leading to improvements in shared decision-making. The use of supplemental patient education materials, including both text-based and multimedia resources, in informed consent discussions has been demonstrated to improve patient comprehension and to direct appropriate discussions during the consent process.^48,49 When animated videos portraying the resection of a Morton’s neuroma were implemented to augment usual surgeon and patient discussions, these patients demonstrated improved comprehension of their procedure. ⁴⁸ The utilization of recorded video explaining the pertinent ankle anatomy, the surgical procedure, and the subsequent postoperative care, has been demonstrated to improve patient comprehension prior to operative fixation of ankle fractures. ⁵³ Patients with education levels below the 12th grade experienced the greatest benefit from the use of supplemental video, and thus these education techniques should be strongly considered in this population. ⁵³ Standardized online reading materials have been reported to improve patient understanding of various common general orthopaedic surgeries. ⁴⁹ The utilization of standardized patient education materials has been found to answer patient questions more appropriately than discussions between the patient and their foot and ankle orthopaedic surgeon. ⁴⁸ Patient education materials help ensure that all necessary information is provided, but this information still needs to be written at a level comprehensible by the patient to ensure patient understanding. To aid in this, supplemental reading materials should utilize bullet points that consist of sentences that are less than 30 words long, with the avoidance of words that are more than 3 syllables long.^48,54 This may be achieved through the use of large language model-based chatbots, which have demonstrated the ability to generate consent documentation that is more readable than that produced by surgeons. ⁵⁵

Although supplemental material may provide a beneficial adjunct, patient-surgeon discussions allow for patient-specific questions to be answered and patient comprehension to be assessed. These discussions are critical for establishing a trusting relationship between the patient and surgeon and should not be replaced by these modalities. In an evaluation of informed consent in orthopaedic foot and ankle surgery, a combination of standardized patient education materials with individualized conversation between patient and physician lead to the highest quality informed consent when compared to a “physician discussion only” group. ⁵⁶

A thorough patient interview and education assists in building a rapport between surgeon and patient. However, these discussions are often limited due to the insufficient time that surgeons are able to spend with their patients. Previous studies have shown that most of the patients visits do not meet the minimum time threshold needed for an optimal informed consent process. ⁵⁰ Physicians in South Africa endorse the idea that patients should ideally receive counseling for 30 minutes, allowing ample time for questions and clarification, far exceeding their current visit times. ⁴³ A review of possible interventions to improve patient understanding prior to engaging in medical research trials found that extended discussion with physicians and/or nurses was among the most effective methods for improving patient understanding.^57,58 As a result, a goal for foot and ankle surgeons should be to increase the amount of time they spend obtaining informed consent to 15 to 30 minutes, as this has been shown to maximize patient comprehension. ⁵⁰ Recognizing the challenges of increasing visit times due to busy clinic schedules, another viable option may be to provide the patient additional one-on-one time with a nurse who is thoroughly educated in both obtaining informed consent and the details of the proposed procedure. It is likely that additional time with a healthcare provider other than the patient’s surgeon will be an effective substitute as studies across various fields have found extended discussions with both nurses and counselors significantly increased patient comprehension of informed consent.^58-60

To provide appropriate care for all patients, interpreter services should be utilized in all discussions with nonnative language speakers to avoid miscommunication. Bedside interpreter systems and patient education materials that are written in the patients’ first language have been shown to improve the quality of informed consent among minority populations.^51,52 While the incorporation of translator services and documents written in the patient’s primary language is critical, it is imperative that plain language, standardized patient education materials, and increased physician-patient visit times are also incorporated to ensure equal care to minority patient populations.^44,46

Conclusion

Multiple pitfalls in the current informed consent process within foot and ankle orthopaedic surgery have contributed to poor quality of consent, ultimately limiting patient autonomy. To optimize the informed consent process within foot and ankle orthopaedic surgery, simplified language, use of standardized patient education materials, extended patient visits for informed consent discussions, and incorporation of translative services are required. The implementation of these solutions is necessary for patient autonomy to be maintained.