Consent for Medical Treatment: What is 'Reasonable'?

The General Medical Council (GMC) instructs doctors to act 'reasonably' in obtaining consent from patients. However, the GMC does not explain what it means to be reasonable: it is left to doctors to figure out the substance of this instruction. The GMC relies on the Supreme Court's judgment in Montgomery v Lanarkshire Health Board; and it can be assumed that the judges' idea of reasonability is adopted. The aim of this paper is to flesh out this idea of reasonability. This idea is commonly personified as the audience that has to be satisfied by the doctor's justification for offering, or withholding, certain treatments and related information. In case law, this audience shifted from a reasonable doctor to a 'reasonable person in the patient's position'; and Montgomery expands the audience to include 'particular' patients, too. Senior judges have clarified that the reasonable person is a normative ideal, and not a sociological construct; but they do not set out the characteristics of this ideal. John Rawls has conceived the reasonable person-ideal as one that pursues fair terms of co-operation with other members of society. An alternative ideal can be inferred from the feminist ethic of care. However, the reasonable patient from Montgomery does not align with either theoretical ideal; but, instead, is an entirely rational being. Such a conception conflicts with both real-life constraints on rationality and the doctor's duty to care for the patient, and it challenges the practice of medicine.

The Supreme Court's decision in McCulloch v Forth Valley Health Board: Does it condone healthcare injustice?

The UK Supreme Court's recent judgement in McCulloch v Forth Valley Health Board clarifies the standard for the identification of 'reasonable' alternative medical treatments. The required standard is that of a reasonable doctor: treatments that would be accepted as proper by a responsible body of medical opinion. Accordingly, the assessment of consent involves a two-stage test: first, a 'reasonable doctor' test for identifying alternative treatments; followed by a 'reasonable person in the patient's position' test for identifying the material risks of these reasonable alternative treatments. The separation of consent into two stages is consistent with not only a certain conception of freedom but also a nuanced construct of respect for autonomy that has a normative base. Furthermore, reliance on a reasonable doctor in the first stage is in keeping with a sociological account of medical professionalism, which posits that only doctors, and none others, can determine what is a proper treatment. Yet, reliance on a reasonable doctor permits a plurality of standards for reasonableness, because differences in opinion among doctors are pervasive. The reasons for some differences might be acceptable as unavoidable imperfections in medical decision-making to a reasonable person. But reasons for other differences might be objectionable; and the resultant inequalities in medical treatments would be considered unfair. One solution is to make the plurality of reasonable alternatives available to the patient, but this would introduce practical uncertainty and it is rejected by the Court. The Court's approach may be pragmatic; however, it seems to allow avoidable injustice in healthcare.

Rawlsian justice in healthcare: a response to Cox and Fritz.

Cox and Fritz state the central problem as the absence of a framework for healthcare policy decisions; but, they overlook the theoretical underpinnings of public law. In response, they propose a two-step procedure to guide fair decision-making. The first step relies on Thomas Scanlon's 'contractualism' for stakeholders to consider whether, or not, they could reasonably reject policy proposals made by others; then in the second step, John Rawls's principles of justice are applied to these proposals; a fair policy requires to pass both steps. I argue that Cox and Fritz misinterpret Rawls. His theory has two stages: first, public reason is used to generate principles of justice; second, public reason is used to interpret and apply these principles. The second stage requires that proposals are based on the principles of justice from the first stage, and these proposals have to be acceptable to reasonable persons. Thus, Rawls's theory does not need Scanlonian supplementation. Moreover, the application of Rawls's theory in Cox and Fritz's model is confusing. In any case, the problems with applying Rawlsian justice to healthcare can be located elsewhere. First, Rawls's theory would treat healthcare simply as a 'primary good' or resource. Social justice ought to, instead, consider healthcare as an opportunity, in the manner conceived by Amartya Sen. Second, Rawlsian justice rests, ultimately, on the conception of a reasonable person; until and unless the characteristics of reasonable stakeholders are clarified, any model of health justice will remain hostage to the unreasonable.

Does the General Medical Council's 2020 guidance on consent advance on its 2008 guidance?

The General Medical Council renewed its guidance on consent in 2020. In this essay, I argue that the 2020 guidance does not advance on the earlier, 2008 guidance in regard to treatments that doctors are obliged to offer to patients. In both, doctors are instructed to not provide treatments that are not in the overall benefit, or clinical interests, of the patient; although, patients are absolutely entitled to decline treatment. As such, consent has two aspects, and different standards apply to each aspect. To explore this paradigm, I propose the reconceptualisation of consent as a person's freedom to achieve treatment, using Amartya Sen's approach. Sen explains that freedom has two aspects: process and opportunity. Accordingly, a patient's freedom to achieve treatment would comprise a process for the identification of proper treatment, followed by an opportunity for the patient to accept or decline this treatment. As per Sen, the opportunity aspect is to be assessed by the standard of public reason, whereas the standard for the process aspect is variable and contingent on the task at hand. I then use this reconceptualised view of consent to analyse case law. I show that senior judges have conceived the patient's opportunity to be encompassed in information, which is to be decided by public reason. On the other hand, the process aspect relies on the private reason of medical professionals. Given the nature of professionalism, this reliance is inescapable, and it is maintained in the case law that is cited in both guidances.

First UK experience of endoscopic vacuum therapy for the management of oesophageal perforations and postoperative leaks.

Oesophageal perforations and anastomotic leaks are associated with high morbidity and mortality. Endoscopic vacuum therapy (EVT) is a promising novel treatment that promotes healing and avoids sepsis. There are no data reporting its use in the UK. We report the first British experience of EVT in two elderly frail patients. Two patients were treated in our institution with EVT using Eso-SPONGE®. One patient had spontaneous oesophageal perforation and the other had anastomotic leakage post-Merendino oesophageal reconstruction (oesophagogastric continuity with jejunal interposition anastomosis). Both patients were over 65 years of age. One patient had 13 endoscopic Eso-SPONGE® exchanges over 8 weeks, while the other one had 6 exchanges over 4 weeks. Complete resolution of oesophageal leakage was achieved in both cases. EVT should be considered in the management of patients with oesophageal perforations and postoperative leaks. This novel therapeutic intervention has the potential to significantly reduce morbidity and mortality in these patients.

Surveillance Is Important After Surgical Excision of Giant Fibrovascular Polyps of the Esophagus.

Giant fibrovascular polyps of the esophagus are rare benign tumors arising from the cervical esophagus or hypopharynx. Radiologic and endoscopic investigation may struggle to identify a stalk or to delineate the tumor as luminal or submucosal in origin. Excision is advised, although the diagnosis, and therefore the optimal operative approach, may not be apparent until the time of operation. Individual case reports describe the technical success of surgical excision but rarely include follow-up. Our case series highlights the range of approaches for surgical excision and also the importance of long-term follow-up because of the risk of recurrence and potential for airway obstruction.

DiPALS: Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis - a randomised controlled trial.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease resulting in death, usually from respiratory failure, within 2-3 years of symptom onset. Non-invasive ventilation (NIV) is a treatment that when given to patients in respiratory failure leads to improved survival and quality of life. Diaphragm pacing (DP), using the NeuRx/4(®) diaphragm pacing system (DPS)™ (Synapse Biomedical, Oberlin, OH, USA), is a new technique that may offer additional or alternative benefits to patients with ALS who are in respiratory failure. OBJECTIVE: The Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis (DiPALS) trial evaluated the effect of DP on survival over the study duration in patients with ALS with respiratory failure. DESIGN: The DiPALS trial was a multicentre, parallel-group, open-label, randomised controlled trial incorporating health economic analyses and a qualitative longitudinal substudy. PARTICIPANTS: Eligible participants had a diagnosis of ALS (ALS laboratory-supported probable, clinically probable or clinically definite according to the World Federation of Neurology revised El Escorial criteria), had been stabilised on riluzole for 30 days, were aged ≥ 18 years and were in respiratory failure. We planned to recruit 108 patients from seven UK-based specialist ALS or respiratory centres. Allocation was performed using 1 : 1 non-deterministic minimisation. INTERVENTIONS: Participants were randomised to either standard care (NIV alone) or standard care (NIV) plus DP using the NeuRX/4 DPS. MAIN OUTCOME MEASURES: The primary outcome was overall survival, defined as the time from randomisation to death from any cause. Secondary outcomes were patient quality of life [assessed by European Quality of Life-5 Dimensions, three levels (EQ-5D-3L), Short Form questionnaire-36 items and Sleep Apnoea Quality of Life Index questionnaire]; carer quality of life (EQ-5D-3L and Caregiver Burden Inventory); cost-utility analysis and health-care resource use; tolerability and adverse events. Acceptability and attitudes to DP were assessed in a qualitative substudy. RESULTS: In total, 74 participants were randomised into the trial and analysed, 37 participants to NIV plus pacing and 37 to standard care, before the Data Monitoring and Ethics Committee advised initial suspension of recruitment (December 2013) and subsequent discontinuation of pacing (on safety grounds) in all patients (June 2014). Follow-up assessments continued until the planned end of the study in December 2014. The median survival (interquartile range) was 22.5 months (lower quartile 11.8 months; upper quartile not reached) in the NIV arm and 11.0 months (6.7 to 17.0 months) in the NIV plus pacing arm, with an adjusted hazard ratio of 2.27 (95% confidence interval 1.22 to 4.25; p = 0.01). CONCLUSIONS: Diaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure. FUTURE WORK: It may be that certain population subgroups benefit from DP. We are unable to explain the mechanism behind the excess mortality in the pacing arm, something the small trial size cannot help address. Future research should investigate the mechanism by which harm or benefit occurs further. TRIAL REGISTRATION: Current Controlled Trials ISRCTN53817913. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 45. See the HTA programme website for further project information. Additional funding was provided by the Motor Neurone Disease Association of England, Wales and Northern Ireland.

Neurostimulation of the gastrointestinal tract: review of recent developments.

OBJECTIVE: Neurostimulation is one manifestation of neuromodulation of the gastrointestinal (GI) tract. This manuscript reviews the history of neurostimulation of the GI tract with emphasis on current methods of stimulation. MATERIALS AND METHODS: A review was completed of the current research on GI neurostimulation methods with an emphasis on their clinical applications. RESULTS: Upper GI disorders can be modulated with both temporary (placed endoscopically or surgically) or permanent (placed surgically) gastric electrical stimulation (GES) devices. The current GI neurostimulation of stomach (GES) devices have been used in both children and adults, and some patients have been followed in excess of 15 years with good long-term results. Similar GES devices also have been used for a variety of lower GI disorders, including constipation and fecal incontinence, for a number of years. CONCLUSIONS: GI neurostimulation, as a type of neuromodulation, has been demonstrated to function at several locations in the GI tract for a variety of disorders. The future of neurostimulation in the GI tract will likely be influenced by a better understanding of pathophysiology as well as the development of new techniques and devices for neuromodulation.

Informed decision-making for bariatric surgery: benefits, risks, uncertainties and choices.

Decision-making is a critical aspect of good surgical care, and this principle is particularly important in bariatric surgery. Adequate communication of information to patients is essential in order to facilitate optimal uptake of bariatric surgery and choice of the most suitable procedure. This article reviews the most relevant advances in understanding of long-term efficacy associated with gastric banding, gastric bypass and sleeve gastrectomy.

Gastric electrical stimulation for treatment of clinically severe gastroparesis.

BACKGROUND: Severe, drug-resistant gastroparesis is a debilitating condition. Several, but not all, patients can get significant relief from nausea and vomiting by gastric electrical stimulation (GES). A trial of temporary, endoscopically delivered GES may be of predictive value to select patients for laparoscopic-implantation of a permanent GES device. MATERIALS AND METHODS: We conducted a clinical audit of consecutive gastroparesis patients, who had been selected for GES, from May 2008 to January 2012. Delayed gastric emptying was diagnosed by scintigraphy of ≥50% global improvement in symptom-severity and well-being was a good response. RESULTS: There were 71 patients (51 women, 72%) with a median age of 42 years (range: 14-69). The aetiology of gastroparesis was idiopathic (43 patients, 61%), diabetes (15, 21%), or post-surgical (anti-reflux surgery, 6 patients; Roux-en-Y gastric bypass, 3; subtotal gastrectomy, 1; cardiomyotomy, 1; other gastric surgery, 2) (18%). At presentation, oral nutrition was supplemented by naso-jejunal tube feeding in 7 patients, surgical jejunostomy in 8, or parenterally in 1 (total 16 patients; 22%). Previous intervention included endoscopic injection of botulinum toxin (botox) into the pylorus in 16 patients (22%), pyloroplasty in 2, distal gastrectomy in 1, and gastrojejunostomy in 1. It was decided to directly proceed with permanent GES in 4 patients. Of the remaining, 51 patients have currently completed a trial of temporary stimulation and 39 (77%) had a good response and were selected for permanent GES, which has been completed in 35 patients. Outcome data are currently available for 31 patients (idiopathic, 21 patients; diabetes, 3; post-surgical, 7) with a median follow-up period of 10 months (1-28); 22 patients (71%) had a good response to permanent GES, these included 14 (68%) with idiopathic, 5 (71%) with post-surgical, and remaining 3 with diabetic gastroparesis. CONCLUSIONS: Overall, 71% of well-selected patients with intractable gastroparesis had good response to permanent GES at follow-up of up to 2 years.