Surgical advanced clinical practitioners (SACPs) are now considered core members of the extended surgical team (Royal College of Surgeons (RCS), 2018a). Health Education England (HEE) (2017) refers to advanced practice as the level of practice underpinned by master's level award or equivalent experience, as opposed to a distinct role (Leary and MacLaine, 2019) Mortimore et al, 2021). Correspondingly, the role and duties of an SACP vary between specialties and trusts. Within the authors' Trust, both qualified and trainee SACPs are rostered to undertake medical shifts comparable to core surgical trainees. This provides a flexible workforce, thus reducing instability of rotas, and enabling core trainees to meet their training requirements (NHS England, 2017; Intercollegiate Surgical Curriculum Programme (ISCP), 2021). Locally, duties include managing patients on the unselected emergency take, assisting in theatre and performing procedures such as incision and drainage of abscesses. This raises the question of whether SACPs can, or should, obtain consent for surgical procedures.
Informed consent
Seeking informed consent prior to examination or treatment is a fundamental legal and ethical requirement within duty of care, regardless of a health professional's governing body or experience (Nursing and Midwifery Council (NMC), 2018). Consent should be given voluntarily, with patients supported to make their own decisions, and can be withdrawn at any point (NMC, 2018; General Medical Council (GMC), 2020). The landmark case of Montgomery versus Lanarkshire health Board [2015] highlighted the importance of consent being informed, as opposed to grounded in the paternalism of what a practitioner thinks a patient should know (Chan et al, 2017). Without possession or comprehension of all the relevant evidence-based information regarding a proposed intervention, patients will be unable to determine their own autonomous decision (Beauchamp and Childress, 2013). This marks a shift from the previously accepted ‘Bolam test’, resulting from the case of Bolam versus Friern Hospital Management Committee [1957], where conduct would be supported by a responsible body of medical opinion (Herring et al, 2017; Shah et al, 2020).
Schencker et al (2011) suggested that studies regarding consent often prioritised malpractice risk reduction over enhancing patient autonomy and understanding of risks. Nicholas (2018) has since illustrated an evolution of change in practice whereby, rather than merely asking permission to perform a procedure, the process of consent has become a dialogue, with shared responsibility between the patient and practitioner (Department of Health (DH), 2009; RCS, 2014; GMC, 2020).
Disclosure of risks and complications
Current guidance advises that discussion regarding consent should take into account the materiality of a patient's values and wishes concerning their care, which O'Daly-Miller (2021) describes as factors to which the patient is likely to attribute personal significance (RCS, 2018a; Royal College of Anaesthetists (RCOA), 2019). Diagnosis and prognosis should be explained, alongside proffering treatment options, including no treatment or disease-modifying lifestyle changes, the purpose and intended benefits of proposed treatment, its likelihood of success, and who will be involved in providing care. Inherent risks, complications or side-effects should be disclosed, alongside the likelihood of their occurrence, and need for follow-up (RCS, 2018b; GMC, 2020). It is therefore necessary to have a sound understanding of these facts in order to be able to effectively communicate these to the patient (Herring et al, 2017).
Despite this, in a study that evaluated audiotaped surgeon-patient interactions, Etchells et al (2011) rated 23% of consultations for major vascular surgery as less than basic on informed decision-making. This may result from poor training in consent and communication skills, as suggested by White et al (2020); however, Khan et al (2018) deduced that junior medical staff to whom gaining consent may have been delegated have themselves often insufficient knowledge of the procedure or the risks involved. This contrasts with GMC (2020) recommendations for appropriate delegation of consent; however, delegation to junior medical staff is commonplace in clinical practice, particularly considering the frequent rotation of medical staff between specialties (Anderson and Wearne, 2007).
Implied consent
Activities such as venepuncture are commonly undertaken with implied consent if a patient rolls up their sleeve, however more invasive interventions require a formalised process of obtaining consent (Wheeler, 2006). Both the RCS (2018b) and the GMC (2020) recommend that the person obtaining consent should either be performing the procedure or that it be undertaken by a suitably trained and qualified delegate with sufficient knowledge to understand the risks involved (Anderson and Wearne, 2007; DH, 2009). The precedent for medical associate professions to assist in operations or perform procedures independently already exists (Dalby and Manu, 2021). In fact, a 5-year retrospective cohort study by Taib et al (2021) found that SACPs dedicated to undertaking select surgical ‘lumps and bumps’ procedures proved financially beneficial for trusts, with similar operating times to doctors. Despite this, there is little literature exploring the SACP's role in obtaining consent, their efficacy, or effect on patient satisfaction with procedures performed by SACPs (Gokani et al, 2016).
Valid consent
For consent to be valid, it should be contemporaneous, with the patient having the capacity to provide consent in line with legal requirements of the Mental Capacity Act 2005. Adults should be assumed to be competent to make decisions unless demonstrated otherwise (GMC, 2020). Practitioners must be mindful that an unwise decision in their view does not prove lack of capacity, and must be respected under both the Mental Capacity Act 2005 and the Human Rights Act 1998.
Where there is doubt, capacity is ascertained by assessing a person's ability to understand, retain and weigh up the relevant information, and subsequently communicate their decision (DH, 2009). Anderson and Wearne (2007) advised that, where capacity is temporarily lost, consideration should be given to deferring elective surgery until it returns; however, this may not be feasible in emergency situations.
Lacking capacity
For patients lacking capacity, decisions must be made in their best interests, while remaining the least restrictive action upon their basic rights and freedoms, as stipulated under the Mental Capacity Act 2005 and incorporated in guidance from the RCOA (2019). The RCS (2014) also recommends consultant involvement when planning care for those lacking capacity to affirm a procedure is in their best interest. Views of proxy decision-makers, such as a court-appointed deputy or those with Lasting Power of Attorney in relation to health care, and any legally valid advance directives, should be taken into consideration when formulating welfare decisions (Department for Constitutional Affairs, 2007; National End of Life Care Programme, 2012). Where no one other than paid staff are able to represent the patient in decision-making regarding serious medical treatment, an Independent Mental Capacity Advocate (IMCA) should be instructed to ensure that the process is carried out in line with the Mental Capacity Act 2005, as opposed to the IMCA making a decision on behalf of the patient (DH, 2009).
Patients detained for treatment without their consent under the Mental Health Act 1983 should not automatically be considered incapable of decision-making regarding their physical health, unless it is a direct result of, or contributing to, their mental disorder (RCOA, 2019). Capacity in accordance with the Mental Capacity Act 2005 must be assessed, with judgement based against the complexity of each decision, regardless of the potential gravity of its consequence.
Consent in the under-16s
Children aged under 16 years of age have the right to consent to treatment providing they have been assessed to meet the requirements of ‘Gillick competence’ (Gillick v West Norfolk and Wisbech Area Health Authority [1985]), according to Lord Fraser's guidelines, whereby they understand the nature of treatment, its purpose and implications, rather than the Mental Capacity Act 2005. Beyond this, consent is provided by those with legal parental responsibility, as set out in the Children Act 1989 and supported in Care Quality Commission (2019) guidance. Although SACPs at the lead author's (JP) Trust assist in paediatric operations, as an adult registered nurse by profession, participating in the consent process for a child would currently be beyond the author's scope of competence without further training (NMC, 2018; HEE, 2020).
Importance of documentation
Equally important in the process of consent is documentation. Medical records act as a form of communication to aid continuity of care, as well as to assist in the justification of any decisions or actions based on the information available at that time (GMC, 2020). The lead author has witnessed many surgeons obtain verbal consent only prior to the incision and drainage of an abscess under local anaesthetic in a clinic setting, instead simply recording details in medical notes. Although this may be regarded as a reasonable standard of care in local practice, lack of documentation may leave the practitioner open to medico-legal litigation (Wheeler, 2006). O'Daly-Miller (2021) advised that the absence of a signed consent form is acceptable, providing that a record has been made in the documentation regarding discussion and agreement of valid verbal consent.
Negligence claims
Despite awareness of the need for informed consent and development of best practice guidelines, benchmark standards continue not to be met (Khan et al, 2018). According to the NHS Litigation Authority (2016), between 2015 and 2016, 9% of clinical negligence claims were related to general surgery, amounting to over £86 million. Of this, almost £5 million was attributed to failure to inform with regards to consent (NHS Resolution, 2021). Although consent forms are not legally binding since consent can be withdrawn, nor a substitute for meaningful individualised dialogue with a patient, they are evidence of a contract between patient and health professional (GMC, 2020; O'Daly-Miller, 2021). They are also a standard requirement for patients undergoing a procedure or operation in hospital (Saunders, 2020:16). Bajada et al (2017), however, identified concerns over legibility of consent documentation, particularly regarding the complications section, and an inadequate list of complications compared with an accepted standard, in 62% of cases. Such variation in documentation may potentially mean that this information was not in fact conveyed to patients (Shah et al, 2020).
Checklists
The use of checklists is well established in surgery, having been found to significantly reduce adverse events, alongside improving communication, quality of care and evidence-based management of complications (Pucher et al, 2019). Studies have attempted to address the variation in documentation standards through the use of procedure-specific consent stickers or forms (Bajada et al, 2017; Tan et al, 2017). Khan et al (2018) found that implementation of procedure-specific consent stickers improved documentation compliance with best practice from 66% to 100% compared with handwritten consent forms.
Nicholas (2018), however, argued that stickers are not appropriate due to the risk of the adhesive failing over time. Although this may be a possibility, patient administration system labels are used in abundance throughout paper records. Tan et al (2017) found positive results attributed to standardisation of procedure-specific consent forms, but raised concern regarding the risk of involuntary automatism of the process, rather than individualisation.
Ultimately, introduction of new methods of documentation would need approval of a trust's legal, ethics and safety committees to ensure that the risks and benefits are considered, alongside any financial implications (Wheeler, 2006).
Importance of open discussion
The GMC (2020) emphasised that, regardless how well a consent form is written, it does not substitute for meaningful individualised dialogue with a patient. The case of Thefaut v Johnston [2017] also highlighted the need to minimise the use of medical jargon and allow patients adequate time and space in which to make decisions. Infact, Etchells et al (2011) established that multiple consultations with a health professional prior to an intervention resulted in improved patient comprehension, deducing that information shared at successive visits all contributed to the informed consent process. If a delegate has undertaken the consent process ahead of time, the operating health professional remains ultimately responsible for ensuring that the patient has been given adequate information to understand the intervention and their decision prior to proceeding, together with realistic expectations of its outcome (British Medical Association (BMA), 2019; GMC, 2020).
Poor-quality consent processes and documentation may render consent invalid, with the potential to not only induce stress for the patient, but also delay the operative pathway (Chong et al, 2018). Provision of additional written leaflets may allow patients time to absorb and reflect on the information without duress, with consent forms often having space to document whether a specific leaflet has been provided (Etchells et al, 2011). However, language barriers, and patients' visual impairment and health literacy may limit their benefit (O'Sullivan et al, 2020; Meuter et al, 2015).
A systematic review by Glaser et al (2020) found that novel interactive digital interventions improved patient comprehension of what they were consenting to, and the implications. Positive outcomes from such interventions and multimodal enhanced recovery pathways have been studied for elective surgery, but there may be potential to employ such techniques in the case of common emergency procedures, since few take place in such a short space of time to make this unachievable (National Institute for Health and Care Excellence (NICE), 2020; Stone and Scheib, 2021). Regardless of this, every effort should be made to present information to the patient in a way that they may be able to understand (GMC, 2020; BMA, 2019).
Extended roles
There is currently no combined register for advanced clinical practitioners (ACPs), nor a specific accredited programme, that provides for annotation to the register of a practitioner's governing body indicating authority to carry out extended roles. The RCS has, however, recently followed the example of the Royal College of Emergency Medicine (RCEM) to endorse the SACP curriculum and assessment framework (HEE, 2020; RCEM, 2021). Regulated frameworks such as these enable standardisation of care and contribute to clinical governance (HEE, 2017). They also reassure medical colleagues working alongside SACPs that they have achieved a nationally recognised standard of competence, ultimately improving patient safety (RCEM, 2021; Wallis et al, 2022).
The GMC (2020) recognises existing multidisciplinary involvement with delegated activities such as providing patients with information regarding specific interventions. However, given that SACPs undertake complex decision-making for patients with a high level of autonomy, they are optimally placed to actively participate in the consent process, rather than simply relay information (HEE, 2017; RCS, 2018a). Although the issue of SACPs obtaining consent for surgery had previously not been addressed explicitly, it is now listed as a core clinical capability of peri-operative care. However, the HEE curriculum and framework specify that the way this is implemented and evaluated will be in line with local policy (HEE, 2020).
Scope of practice
SACPs are accountable not only to their professional governing body, but to their patients, by means of duty of care, their employer, and wider society through civil and criminal law (NMC, 2018; Dalby and Manu, 2021). Consequently, SACPs are obliged to recognise and voice any concern regarding limitations to their own competence to perform tasks that may be delegated to them, including the consent process (NMC, 2018; BMA, 2019; GMC, 2020). Although growth beyond a practitioner's comfort zone is necessary for professional development, the transition from novice to expert needs to be undertaken safely, with appropriate supervisory arrangements in place (Benner, 1982; Moran and Nairn, 2018; RCS, 2018b; Mortimore et al, 2021).
Torrens et al (2020) described ongoing challenges for health professionals extending their scope of practice including role ambiguity, alongside legislative and regulatory considerations. Unlike our medical colleagues, many SACPs' professional indemnity is covered solely through their employers' vicarious liability (NMC, 2022). As such, the RCS (2018a) advises that the boundaries of extended surgical care team roles should be documented in protocols. Equally, employers have a duty to ensure that effective governance procedures are in place to support safeguarding against the risk of an SACP's unconscious incompetence (HEE, 2020).
Continuing professional development
Continuous professional development and critical reflection are required by the NMC to be evidenced through 3-yearly revalidation, alongside annual appraisal (NMC, 2018; 2021). However, the SACP role relates closely to the medical model, requiring an aligned approach to assessment, in addition to concurrent academic learning (Dalby and Manu, 2021; Wallis et al, 2022).
The ICSP (2021) and HEE (2017; 2021) advocate the importance of continuous systematic feedback and reflection to aid learning from clinical practice. This takes the form of a portfolio of evidence including multi-source feedback, case-based discussions, reflective accounts and self-assessment, alongside clinical and educational supervision. Moran and Nairn (2018) concluded that clinical supervisor engagement is integral to successful role transition for ACPs, and reducing associated stresses (Fleming and Carberry, 2011). Although some authors report difficulties in engaging with supervisors who understand the ACP role and assessment process, successful collaboration can assist in the development of meaningful learning goals and guide training opportunities (Moran and Nairn, 2018; ICSP, 2021). Supervisors are also essential to identifying knowledge gaps and, ultimately, assessing whether an SACP is able to demonstrate competence and progression of safe, evidence-based practice in accordance with HEE (2021) frameworks (Wallis et al, 2022).
Locally, SACPs are required to undertake mandatory safeguarding level 3 training every 3 years (Millard, 2022). In addition, education is provided at induction regarding the principles of informed consent and the Mental Capacity Act 2005, since assessment of capacity in line with legislative frameworks is a core clinical skill (HEE, 2020; O'Daly-Miller, 2021). Local trust consent policy will stipulate that delegation of consent to non-medical health professionals is appropriate, providing that they have been assessed as competent to do so and are registered as having that authority with the divisional lead and medical director (O'Daly-Miller, 2021). This process culminates in an agreed list of specific procedures for which the health professional can obtain consent, but may or may not perform themselves. Competency documents related to consent are available for three specific procedures, two of which are relevant to SACPs: flexible sigmoidoscopy and gastroscopy. Beyond this, specialties and divisions are advised to develop further procedure-specific consent training packages if there is sufficient need.
Variation in consent
There is currently great variation in the undertaking of consent by trainee and qualified SACPs, and no clear pathway for establishing competency, since the majority of SACP skills are assessed through direct observation of procedures, rather than trust-wide competency documents. Such inconsistencies may adversely affect service efficiency, or cause interprofessional frustration, if there is lack of awareness or understanding of an individual's particular limitations (RCS, 2018a; Reynolds and Mortimore, 2021). More importantly, absence of formalised assessment of competency may be considered to contribute to avoidable harm should quality of services not be maintained, as emphasised by the Francis Inquiry into poor care at Mid Staffordshire NHS Foundation Trust (Francis, 2013; Gokani et al, 2016).
Advancing and extending scope of practice is both personally satisfying and professionally useful in terms of service provision (Sharrock et al, 2013; NHS England, 2017; Mannix and Jones, 2020). However, this must be balanced with effective processes to maintain the quality and safety of care (Wallis et al, 2022). Murphy and Mortimore (2020) propose d that ACPs take responsibility for making changes to improve practice. Through embracing the four pillars of advanced practice – clinical practice, leadership and management, education and research – SACPs are optimally placed to transform practice by conducting audits that benchmark against best practice, developing quality improvement initiatives such as procedure-specific consent forms incorporating the various Royal Colleges guidelines, and establishing up-to-date protocols and documentation (Tan et al, 2017; Glendinning and Walker, 2019; Mortimore et al, 2021). O'Grady (2019) suggested that senior ACPs also harness their leadership skills by facilitating learning for trainees.
Implementation of individualised induction plans, as recommended by Murphy and Mortimore (2020), could be incorporated using this approach: these would offer clearly identified competencies related to SACPs obtaining informed consent and include a timeline for when they should be achieved. This would provide SACPs with reassurance regarding their development, while promoting an inclusive peer support network. Dalby and Manu (2021) reiterated the RCS's (2018a) recommendations regarding the need for all stakeholders to understand the role of SACPs within the surgical team. By extending educational sessions to rotating medical staff there is potential to improve overall standards when seeking consent, alongside providing an opportunity to gain insight into the SACPs' scope of practice (Gokani et al, 2016; RCS, 2018b). This could work towards counteracting any perceived barriers to interprofessional collaboration (Sharrock et al 2013; Supper et al, 2014; Cashin et al, 2009).
Conclusion
As part of the surgical team, SACPs are appropriate delegates to be entrusted with obtaining informed consent, providing that this is endorsed within local protocols, and that appropriate education and assessment are in place to ensure competence. From meaningful patient-centred discussion to accurate documentation, even as trainees, SACPs are autonomous practitioners who hold professional accountability. However, by being diligent in all aspects of the consent process, including maintaining excellent documentation, in keeping with best practice guidelines will safeguard compliance with the law.
KEY POINTS
- In 2015–2016 issues relating to poor informed consent cost the NHS £5 million
- Maintaining excellent documentation is key when taking informed consent
- For consent to be valid, it should be contemperaneous with the patient having the capacity to provide consent in line with the Mental capacity Act 2005
CPD reflective questions
- What are the key differences between informed and implied consent?
- If you reviewed a patient to take informed consent for a minor procedure but they refused to listen to the potential risks of the procedure, what would you do?