Ethical and legal issues of tracheostomy ventilation in patients with amyotrophic lateral sclerosis

Ang, Kexin; Lim, Ming Yi; Srinivasan, Sheila

doi:10.1177/2010105819828753

Cited by 4 publications

(5 citation statements)

References 54 publications

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“…In particular, mobility aids and ventilator support (being tracheostomized and undergoing non-invasive ventilation) were associated with better QoL. Being tracheostomized even showed a greater beta coefficient than in previous studies [61][62][63]. It should be noted here that without the ALSFRS-R as a covariate, patients who had been tracheostomized had a much worse QoL than those who had not (mean ALSAQ-5 total score 85.09 vs. 55.81; best QoL = 0).…”

Section: Positive Influence Of Mobility Aids and Ventilator Support On Hrqolmentioning

confidence: 78%

“…Tracheostomy, despite the procedure-associated risks and the potential of patients to reach a “locked-in” state, has previously been found to result in acceptable QoL [ 61 , 62 , 63 ] and increased survival in ALS [ 67 ]. Additionally, a Cochrane review noted that while tracheostomy prolongs life, it does not necessarily improve QoL, again comparing it with non-invasive ventilation [ 68 ].…”

Section: Discussionmentioning

confidence: 99%

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A Nation-Wide, Multi-Center Study on the Quality of Life of ALS Patients in Germany

et al. 2021

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Improving quality of life (QoL) is central to amyotrophic lateral sclerosis (ALS) treatment. This Germany-wide, multicenter cross-sectional study analyses the impact of different symptom-specific treatments and ALS variants on QoL. Health-related QoL (HRQoL) in 325 ALS patients was assessed using the Amyotrophic Lateral Sclerosis Assessment Questionnaire 5 (ALSAQ-5) and EuroQol Five Dimension Five Level Scale (EQ-5D-5L), together with disease severity (captured by the revised ALS Functional Rating Scale (ALSFRS-R)) and the current care and therapies used by our cohort. At inclusion, the mean ALSAQ-5 total score was 56.93 (max. 100, best = 0) with a better QoL associated with a less severe disease status (β = −1.96 per increase of one point in the ALSFRS-R score, p < 0.001). “Limb onset” ALS (lALS) was associated with a better QoL than “bulbar onset” ALS (bALS) (mean ALSAQ-5 total score 55.46 versus 60.99, p = 0.040). Moreover, with the ALSFRS-R as a covariate, using a mobility aid (β = −7.60, p = 0.001), being tracheostomized (β = −14.80, p = 0.004) and using non-invasive ventilation (β = –5.71, p = 0.030) were associated with an improved QoL, compared to those at the same disease stage who did not use these aids. In contrast, antidepressant intake (β = 5.95, p = 0.007), and increasing age (β = 0.18, p = 0.023) were predictors of worse QoL. Our results showed that the ALSAQ-5 was better-suited for ALS patients than the EQ-5D-5L. Further, the early and symptom-specific clinical management and supply of assistive devices can significantly improve the individual HRQoL of ALS patients. Appropriate QoL questionnaires are needed to monitor the impact of treatment to provide the best possible and individualized care.

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Section: Positive Influence Of Mobility Aids and Ventilator Support On Hrqolmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 99%

A Nation-Wide, Multi-Center Study on the Quality of Life of ALS Patients in Germany

et al. 2021

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“…Many articles focus on the Court's elevation of patient autonomy and its disapproval of medical paternalism 3,5‐10,12‐17,19,22,25‐28,30‐68,70‐86,90 . The case is described as ‘the final step in a legal power shift from paternalism to patient autonomy’ 40 and ‘a landmark case…which shifted focus from a traditional paternalistic model of consent towards a more patient‐centred approach’ 33 .…”

Section: Resultsmentioning

confidence: 99%

“…Many articles focus on the Court's elevation of patient autonomy and its disapproval of medical paternalism. 3,[5][6][7][8][9][10][12][13][14][15][16][17]19,22,[25][26][27][28][70][71][72][73][74][75][76][77][78][79][80][81][82][83][84][85][86]90 The case is described as 'the final step in a legal power shift from paternalism to patient autonomy' 40 and 'a landmark case…which shifted focus from a traditional paternalistic model of consent towards a more patientcentred approach'. 33 However, others argue that this narrative is overly simplistic, with one paper noting that pitting autonomy and paternalism against one another does not adequately reflect how 'medical decision making involves a nuanced negotiation of information'.…”

Section: Patient-centred Care and Autonomymentioning

confidence: 99%

Montgomery's legal and practical impact: A systematic review at 6 years

Gallez

Skopek

Liddell

et al. 2021

Evaluation Clinical Practice

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Rationale, Aims and Objectives Six years ago, the Supreme Court judgement in Montgomery v Lanarkshire changed medical law. It introduced a new patient‐based standard of care for the communication of treatment risks and alternatives, rejecting the doctor‐based standard that had long governed all aspects of medical negligence. This is the first systematic review to analyse the literature on Montgomery. Our aim is to appraise and synthesize the literature on Montgomery's impact on medicine and the law and to identify areas for further academic enquiry and implications for professional guidance and training. Methods Searches were run in Medline, Embase, PsycINFO, Web of Science, Scopus, Westlaw UK, HeinOnline, and LexisNexis. Two reviewers screened papers. Extracted data was analysed and discussed by an interdisciplinary team. PRISMA guidelines were followed. Results Of the 1134 papers identified, 100 met the inclusion criteria. These papers revealed significant disagreement on four core sets of issues, focusing on Montgomery's impact on: (1) legal and professional duties; (2) medical practice; (3) the patient experience; and (4) litigation. The first set addresses whether the case actually changed doctors' legal and professional duties, the relationship between GMC guidance and medical law, and the boundaries of Montgomery. The second explores whether the decision has incentivized defensive medicine, its resource implications, and doctors' knowledge of it. The third concerns whether and how the decision has promoted patient autonomy and involvement in their own care. The fourth focuses on whether the case has caused an increase in litigation. Conclusions Despite the abundance of legal and medical literature on Montgomery, many issues remain unresolved. Empirical research is required for many of the questions. Doctrinal analysis informed by medical knowledge is also required to assess whether Montgomery may have unrecognized ramifications—for example, whether it will require the disclosure of risks associated with diagnostic uncertainty, where doctors advise patients without performing procedures.

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“…Amyotrophic lateral sclerosis (ALS) is a progressive motor neuron disorder typically culminating in death from respiratory failure 1 2. Non-invasive ventilation (NIV) or, when NIV is not possible, tracheostomy and invasive ventilation may prolong survival and maintain or improve quality of life in people with ALS 1 3. From a societal standpoint, interventions such as assisted ventilation and hospitalisation are significant drivers of aggregate costs attributable to ALS in the USA each year 4 5.…”

Section: Introductionmentioning

confidence: 99%

Effect of sodium phenylbutyrate/taurursodiol on tracheostomy/ventilation-free survival and hospitalisation in amyotrophic lateral sclerosis: long-term results from the CENTAUR trial

Paganoni

Hendrix

Dickson

et al. 2022

J Neurol Neurosurg Psychiatry

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BackgroundCoformulated sodium phenylbutyrate/taurursodiol (PB/TURSO) was shown to prolong survival and slow functional decline in amyotrophic lateral sclerosis (ALS).ObjectiveDetermine whether PB/TURSO prolonged tracheostomy/ventilation-free survival and/or reduced first hospitalisation in participants with ALS in the CENTAUR trial.MethodsAdults with El Escorial Definite ALS ≤18 months from symptom onset were randomised to PB/ TURSO or placebo for 6 months. Those completing randomised treatment could enrol in an open-label extension (OLE) phase and receive PB/TURSO for ≤30 months. Times to the following individual or combined key events were compared in the originally randomised treatment groups over a period spanning trial start through July 2020 (longest postrandomisation follow-up, 35 months): death, tracheostomy, permanent assisted ventilation (PAV) and first hospitalisation.ResultsRisk of any key event was 47% lower in those originally randomised to PB/TURSO (n=87) versus placebo (n=48, 71% of whom received delayed-start PB/TURSO in the OLE phase) (HR=0.53; 95% CI 0.35 to 0.81; p=0.003). Risks of death or tracheostomy/PAV (HR=0.51; 95% CI 0.32 to 0.84; p=0.007) and first hospitalisation (HR=0.56; 95% CI 0.34 to 0.95; p=0.03) were also decreased in those originally randomised to PB/TURSO.ConclusionsEarly PB/TURSO prolonged tracheostomy/PAV-free survival and delayed first hospitalisation in ALS.Trial registration numberNCT03127514; NCT03488524.

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Ethical and legal issues of tracheostomy ventilation in patients with amyotrophic lateral sclerosis

Cited by 4 publications

References 54 publications

A Nation-Wide, Multi-Center Study on the Quality of Life of ALS Patients in Germany

A Nation-Wide, Multi-Center Study on the Quality of Life of ALS Patients in Germany

Montgomery's legal and practical impact: A systematic review at 6 years

Effect of sodium phenylbutyrate/taurursodiol on tracheostomy/ventilation-free survival and hospitalisation in amyotrophic lateral sclerosis: long-term results from the CENTAUR trial

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