Reevaluating Informed Consent: Integrating Shared Decision-Making into Spinal Surgery for Better Patient Outcomes
Jeffrey N. Wang, Mohamed A. Elhakeem, Matthew J. Mesimer, Paul G. Mastrokostas, Salman Ahmad, Tim Reed, Brandon Klein, Lucas E. Bartlett, Adam D. Bitterman, Andrew Megas
Global Spine Journal, 26 October 2024
Abstract
Study Design
Narrative review.
Objectives
The objectives of this study were to answer the following questions: (1) What is the quality of informed consent in spine surgery, including both neurosurgery and orthopaedic spine surgery? (2) What limitations impede the ability of surgeons to engage in effective shared decision-making (SDM) and obtain adequate informed consent? (3) What strategies and solutions may improve the quality of informed consent and SDM? (4) What factors decrease the incidence of litigation in spine surgery?
Methods
N/A.
Results
SDM is a collaborative process where patients are involved in their treatment choices through open communication about risks, alternatives, and postoperative expectations. Informed consent is a vital component of this process, ensuring that patients are fully informed and empowered to make decisions based on their values and preferences. This review highlights the current state of informed consent within the context of SDM in spine surgery and explores how enhancing this process can improve patient outcomes, reduce dissatisfaction, and decrease litigation. By emphasizing patient autonomy and improving the quality of risk communication, SDM fosters better physician-patient relationships and more positive clinical outcomes.
Conclusions
Orthopaedic surgery and neurosurgery are highly litigated specialties, with failure to obtain informed consent frequently cited in lawsuits. These legal challenges are costly and time-consuming for both physicians and patients. Integrating SDM into the informed consent process can help mitigate these issues, leading to improved patient satisfaction and fewer legal disputes.

Development and early Evaluation of a novel tool for assessment of individualised risk tolerance during surgical consent
Research Article
James Booker, Jack Penn, Nicola Newall, David Rowland, Siddharth Sinha, Hani J Marcus
British Journal of Neurosurgery, 17 October 2024
Abstract
Purpose
The legal interpretation of consent has transitioned over the last decade. Surgeons must identify what patients value to individualise surgical consent. This presents a considerable challenge during busy ward rounds or outpatient clinics. We aimed to develop and evaluate a novel risk tolerance tool to aid surgical consent.
Methods
This prospective, longitudinal cohort study evaluated the views of adult, elective surgical patients from a single centre. Attitudes to the existing surgical consent process were assessed (n = 48) and responses underwent thematic analysis. From these responses and a stakeholder focus group, a novel risk tolerance tool was developed. The risk tool was evaluated using questionnaires in 25 pre-operative patients. Post-operatively, the same cohort were followed-up with a telephone clinic 6–8 weeks after discharge.
Results
Overall patients were satisfied with the current consent process, but negative themes emerged including that it is generalised, impersonal, and time pressured. The developed risk tool contained six domains: death, pain, loss of physical function, loss of cognitive function, need for repeat medical interventions, and social disability. Loss of physical function (mean = 34.0, SD = 12.8) and loss of cognitive function (mean = 34.0, SD = 6.1) had lowest risk tolerance, and need for repeat medical interventions (mean = 18.8, SD = 10.9) had the highest risk tolerance. Thirteen (93%) patients had a positive experience of the consent process vs 85% of patients in pre-consent tool cohort.
Conclusions
The tool demonstrated good patient acceptability and patient reported experience. The tool gathered data that may enhance understanding of patient risk tolerance and personalise the surgical consent process.

Pain Management Consent Considerations
Book Chapter
Elizabeth Wilson, Kristopher Schroeder
Perioperative Pain Management, 16 October 2024 [Springer]
Abstract
Healthcare professionals must consider patients as collaborators in the process of healthcare decision making. In matters of perioperative pain management, it is important to consider and include patients in decisions that may be impacted by their personal history of pain management/analgesic administration, value system/thought process regarding pain management, and the relative impact of potential complications related to analgesic procedures and opioid analgesics. To make these decisions, healthcare professionals must consider the ability of patients to make decisions in the setting of pain and polypharmacy and if the use of adjunct/surrogate decision makers may be appropriate/beneficial. In addition, it is important to consider how information is conveyed and the degree of detail that is required to ensure that patients are equipped to make a decision that best aligns with their belief system and values. Finally, patient decisions must be respected, and they must know that they possess the autonomy to be ultimately responsible for the decisions that will impact their healthcare delivery.

Role of procedure-specific consent forms in clinical practice: a systematic review
Research Article
J Norvill, C Bent, JA Mawhinney, N Johnson
The Annals of The Royal College of Surgeons of England, 3 October 2024
Open access
Abstract
Introduction
Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria.
Methods
This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using ‘RoB 2’ and ‘ROBINS-I’. Meta-analysis was not possible because of the results’ heterogeneity.
Findings
We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%–100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF.
Conclusions
The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

A tool for optimising shared decision making and informed consent for surgical innovation: development and implementation of a core information set
Christin Hoffmann, Daisy Elliott, Cynthia Ochieng, Samuel Lawday, Abigail Vallance, Leila Rooshenas, Barry Main, Jane Blazeby, Pete Wheatstone, Angus McNair
BMJ Surgery, Interventions, & Health Technologies, 27 September 2024
Abstract
Introduction
There are significant challenges in achieving high-quality shared decision making (SDM) and informed consent for surgical innovation. Evidence shows that patients’ information needs are insufficiently addressed. We co-developed a core information set (CIS) to provide baseline information for consultation discussions between clinicians and patients offered novel surgical procedures/devices.
Methods
This study adhered to guidance for CIS and core outcome set development (COS-STAD) to (i) generate a provisional CIS from data sources (44 stakeholder interviews, 34 consultations, 213 studies, 58 policies) applying thematic content analysis, (ii) refine/agree CIS with stakeholders (patients, surgeons, anaesthetists, lawyers, ethicists, medical directors, SDM experts, regulators) using nominal group technique, (iii) conduct UK public consultation, (iv) implement the CIS nationally.
Results
A provisional CIS contained 8 themes/28 subthemes. Some 25 stakeholders refined/agreed a final 7-theme CIS covering what is ‘new’ about the procedure, conflicts of interest, reasons for the innovation, treatment alternatives, unknowns, surgeons’ expertise, and governance. Public consultation (N=136) endorsed all themes. Industry collaboration will implement the CIS in digital consent platforms across 38 institutions.
Conclusions
An evidence-based CIS has been co-developed with key stakeholders and is the recommended standard to optimise SDM and informed consent for surgical innovation.

Exploring consent for animal-derived products in surgery
Tega Ebeye, Chantal R. Valiquette, Natalia Ziolkowski
The American Journal of Surgery, 24 September 2024
Abstract
Informed consent is integral to the practice of ethical and patient-centered medicine. Barring specific life and limb emergencies where there is no capable decision maker to provide consent, surgeons typically rely on informed consent to decide on provision of surgical care. However, determining what constitutes informed consent – what risks are deemed material enough, how to appropriately weigh risks, benefits, and alternatives, as well as answering procedure-related questions – is ever evolving. An emerging area of discovery, with limited literature, has focused on how to obtain informed consent when animal-derived products (ADPs) are used. Here, ADPs include both human and animal-derived products used in surgery. As surgeons and surgical trainees, we have encountered different approaches to including ADPs in informed consent – from failure to discuss ADP use in general, to the blanket statement indicating the use of potential animal-derived products in surgery, to actually discussing and listing known ADPs like “nerve glue” and “AlloDerm” on the consent form – prompting our interest in this topic as it affects surgical practice and patient autonomy. However, while it has been argued that disclosing the use of ADPs is warranted under Beauchamp and Childress’ four principles of biomedical ethics, it remains unclear how detailed our discussions need to be to meet this ethical standard without creating undue burden, and potentially substandard care, for patients.

Co-Designing Body Donation Consent Processes
Conference Abstract [published in special journal edition]
Georgina C. Stephens
International Federation of Associations of Anatomists Congress 2024 – Kimdaejung Convention Centre, Gwangju, Korea, South
Published: Anatomy & Cell Biology, September 2024
Abstract
It is widely accepted that body donation programs should obtain informed consent from donors during life. Despite the existence of consent guidelines, consent form content varies considerably. Furthermore, consent forms are typically developed by anatomical and legal experts, and may not include details valued by donors or students. Co-design is a form of participatory action research which engages end users to understand phenomena and inform change. Co-design may therefore be ideal to develop consent processes that better incorporate values of donors, students and educators, alongside ethical and legal considerations. As a first step to developing consent processes for a proposed body donor program at an Australian university, this study aimed to bring together participants from these groups to co-design a consent process. Study participants included 7 prospective donors, 9 anatomy students and 6 anatomy educators. Data were collected through 4 focus groups involving at least one member of each participant group. During focus groups, the facilitator worked with participants to identify priorities relating to consent processes. Thematic analysis was used to develop draft consent principles encompassing perspectives across groups. Draft principles were sent to participants, and feedback on these collected through a survey. Four principles for body donation consent processes were established: 1. Consent processes should be informative, transparent and community-focused, 2. Consent processed should include personalised and flexible options, 3. Consent processes should be developed on legal and ethical foundations, and 4. Consent processes should be future-focused. Although some principles addressed aspects within existing consent guidelines (e.g. information adequacy), participants highlighted ways consent processes typical of body donor programs in Australia could be enhanced (e.g. personalised options including naming preferences after death). Participants also expressed how co-design facilitated a deeper understanding of the value of body donation. Ongoing work will now focus on developing consent resources based on these principles.

Global considerations for informed consent with shared decision-making in the digital age
Education
Edward Robert St John, Connor James Stewart Moore, Raghu Ram Pillarisetti, Erica Sarah Spatz
BMJ Evidence-Based Medicine, 20 September 2024
Background
Shared decision-making (SDM) is increasingly recognised as fundamental to patient-centred care and enabling patients to make voluntary, informed decisions about their health. SDM is the process whereby patients and clinicians come together to share their expertise. The patient acts as an expert of themselves, understanding their own preferences and their attitudes to risk. The clinician is an expert on the medical knowledge and scientific evidence. Together, treatment options should be explored, arriving at a treatment decision that is right for the patient and supported by the clinician. When dealing with invasive or high-risk procedures (eg, operations, chemotherapy, radiotherapy, immunotherapy), once the treatment decision has been made, the conversation turns to informed consent. This is the process of communicating and agreeing to the potential risks and benefits of the procedure, while acknowledging that there are alternative treatment options that have not been chosen. Though informed consent should be the culmination of SDM, alone it does not encapsulate the entire process. There is a distinction between decision-making and consent and this should ideally be accompanied by a period for reflection. Despite advances in SDM, the subsequent informed consent process has remained stagnant, often failing to meet ethical or legal standards of supporting meaningful patient autonomy.

Multidisciplinary Team Discussions and the Inclusion of Individualized Patient Factors May Improve Informed Consent in Sports Medicine
John Grossi, Lexi Garber, Brandon Klein, Luke Bartlett, Adam Bitterman, Randy Cohn, Nicholas Sgaglione
Arthroscopy, Sports Medicine, and Rehabilitation, 20 September 2024
Open Access
Abstract
Informed consent allows for the maintenance of patient autonomy and is essential in establishing trusting relationships between physicians and their patients. This process involves thorough discussion of the risks and alternatives, as well as the short- and long-term outcomes, of proposed treatment options. Inadequacies with informed consent can lead to inferior patient outcomes and may be subject to severe legal consequences. Individualized discussions are warranted to address the questions of these patients, whether it be the high-level athlete or the weekend warrior. This review highlights factors, identifies barriers, and proposes potential solutions to improve informed consent within orthopaedic sports medicine.

Developing a computer based standardised consent form for laparoscopic cholecystectomy
Charles Carey, Stuart James, Gemma Richardson, Shameen Jaunoo
British Journal of Surgery, 9 September 2024
Abstract
Aims
Laparoscopic cholecystectomy is a common general surgical procedure with approximately 65,000 procedures performed per year. The consent process is imperative as serious life changing and life-threatening risks must be discussed with the patient before surgery. At our trust [East Sussex Healthcare NHS Trust], this is currently performed with a generic consent proforma which is filled in during each consent process. We aimed to streamline this process for clinicians and ensure all risks were discussed. Further, we aimed to ensure the process was more medico-legally sound with increased legibility by removing the handwritten aspect and ensure concordance with GMC and RCS informed consent guidance.
Methods
We produced a standard computerised consent form for laparoscopic cholecystectomy. This included a diagram to aid patient explanation and sections where all the key risks of the procedure could be checked off once discussed.
Results
The consent form has proven popular with clinicians and has streamlined the consent process. It has ensured legibility of the consent form for all involved and is therefore preferable from a medico-legal perspective. It also ensures consistency for all patients undergoing the same consent process.
Conclusions
Standardising the consent process using this procedure specific form has helped clinicians cover all the necessary areas with patients before surgery and should be considered for other common operations. Producing the consent form has also been an excellent educational opportunity for trainees, who can now consider all risks associated with laparoscopic cholecystectomy using a single document.