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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.
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.
AimThe aim of this scoping review was to provide an overview of the literature about the process of obtaining consent from adult patients undergoing planned surgery from the healthcare professionals' perspective and analyse knowledge gaps.BackgroundThe process of obtaining consent for planned elective surgery manifests an individual's fundamental right to decide what happens to their body. The process is often suboptimal and problematic, placing a significant resource burden on health systems globally. Deficiencies in the documentation on consent forms have also been shown to increase the risk of operating room error.DesignScoping review.MethodsArksey and O′Malley's (International Journal of Social Research Methodology, 8, 2005 and 19) five‐step scoping review methodology was used.ResultsFifty‐three articles were included; 39 primary and 14 secondary research publications. Three key findings were identified; there is currently low‐level evidence about surgical consent processes to inform clinical practice; junior doctors obtain surgical consent frequently, yet this process was likely undertaken sub‐optimally; and current knowledge gaps include capacity assessment, decision‐making and pre‐procedural consent checks.ConclusionPlanned surgical consent processes are complex, and both surgeons and perioperative nurses are essential during the process. While surgeons have responsibility to obtain consent, perioperative nurses provide a safety net in the surgical consent process checking the surgical consent information is correct and has been understood by the patient. Such actions may influence consent validity and patient safety in the operating room. Knowledge gaps about capacity assessment, decision‐making, pre‐procedural checks and the impact of junior doctors obtaining consent on patient understanding, safety and legal claims are evident.Relevance to clinical practiceThis review highlights the importance of the surgical nurse's role in the planned surgical consent process. While the responsibility for obtaining surgical consent lies with the surgeon, the nurse's role verifying consent information is crucial as they act as a safety net and can reduce error in the operating room.No patient or public contributionThe authors declare that no patient or public contribution was made to this review in accordance with the aim to map existing literature from the healthcare professionals' perspective.
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.
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