Clinical risk最新文献

{"title":"Consent after Montgomery: What next for healthcare professionals?","authors":"Philippa White","doi":"10.1177/1356262216665489","DOIUrl":"https://doi.org/10.1177/1356262216665489","url":null,"abstract":"The standard of care for consent to treatment has moved to the ‘prudent patient’ or ‘Montgomery’ standard, following the case of Montgomery v Lanarkshire (2015). The standard of care for treatment itself remains the ‘prudent practitioner’ or Bolam Standard following Bolam v Friern Hospital Management Committee (1957). What does this splitting of the legal standard of care for consent mean for the health professionals who deliver care to patients, and what does it mean for the quality of information patients now ought to expect to receive when they consent to treatment? This article considers the advent of true legal ‘informed consent’ into UK healthcare practice, and what it means for information provision to patients from an allied health professional medicolegal perspective.","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"22 1","pages":"33 - 37"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216665489","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65478120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Montgomery and informed choice: Not yet uhuru","authors":"L. Edozien","doi":"10.1177/1356262216671472","DOIUrl":"https://doi.org/10.1177/1356262216671472","url":null,"abstract":"","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"22 1","pages":"1 - 3"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216671472","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65477737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Montgomery and patient consent: perceived problems addressed","authors":"J. Badenoch","doi":"10.1177/1356262216664442","DOIUrl":"https://doi.org/10.1177/1356262216664442","url":null,"abstract":"The unanimous decision of seven Supreme Court Justices in Montgomery v. Lanarkshire Health Board [2015] UKSC 11 has been much discussed and written about (see, e.g. Christopher Hough QC’s excellent piece in this issue of the journal (pages 6–11). Their ruling was that the adequacy of a doctor’s disclosure of the risks, benefits and alternatives to proposed treatment when a patient’s consent is sought is not judged, as the old law required, by reference to the sanction or approval of a body of other doctors, however small a minority – the Bolam test. Instead, it must be judged by reference to the risks to which a reasonable patient (objectively), and one in the particular circumstances of the given patient (subjectively), would be likely to attach significance, and so would need andwant to knowbefore decidingwhether to consent or not – the ‘Patient Centred Test’. Thus was finally and belatedly overruled as wrong the Law Lords’ long-standing and widely criticised ruling in the case of Sidaway v. Board of Governors of Bethlem and Maudsley Hospitals [1985 AC 871] that the Bolam test applied to consent, which I had long argued (and argued in the Supreme Court) was as illogical as it was unjust. The obvious point was that it is the patient’s choice whether to submit or not to proposed treatment, and it is in reality no real choice at all if made on the basis of information limited and rationed, to an extent which the patient cannot know or guess, by the idiosyncratic, endlessly varied and widely inconsistent views of doctors, whether few ormany. TheBolam test for disclosure legitimised and perpetuated a patronising, condescending and in the modern age obsolete attitude to the doctor– patient relationship. The gross injustice to patients generally of the decision in Sidaway is perhaps best illustrated by the opinion of Lord Diplock in that case that although patients as a whole need not be told any more about their treatment than their doctors may choose to reveal, that would not apply to a judge like himself because (and I quote from his judgement at p. 895):","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"43 1","pages":"12 - 15"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216664442","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65478064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient power: The duty to explain post Montgomery and the statutory duty of candour","authors":"Chris Hough","doi":"10.1177/1356262216654039","DOIUrl":"https://doi.org/10.1177/1356262216654039","url":null,"abstract":"The combination of the introduction of a statutory duty of candour and the Supreme Court decision in Montgomery v Lanarkshire Health Board emphasises the profound change in the doctor–patient relationship that has occurred over the last few decades. As a society, we have moved a long way from the paternalistic doctor deciding what is best for his (and it was usually a his) patient. This article considers the changes and how they may be used in a clinical negligence claim.","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"22 1","pages":"11 - 6"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216654039","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65477339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Progress towards a decision record is lamentable","authors":"B. Leigh","doi":"10.1177/1356262216667164","DOIUrl":"https://doi.org/10.1177/1356262216667164","url":null,"abstract":"The debate about the decision in Montgomery reveals a much deeper malaise in which hospital practice has failed to keep pace with a silent revolution in medical practice. The use of a Form recording that a patient consents to undergo an operation distracts doctors from the real problem, which is that patients need to undergo a formal training process to take any major decision about their healthcare. This training needs to be recorded for medical as well as legal reasons. It applies to decisions to use conservative therapy as well as surgery. The author describes what such a process might look like and how proper defensible records could be made.","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"22 1","pages":"16 - 20"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216667164","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65477693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Consent in surgery: Is there a Montgomery effect?","authors":"R. Wheeler","doi":"10.1177/1356262216664854","DOIUrl":"https://doi.org/10.1177/1356262216664854","url":null,"abstract":"In the aftermath of Montgomery, hospitals across the UK have been bombarded by offers to ‘update’ their clinicians’ understanding of the ‘new consent law’. Even surgeons have now heard the story of Mrs Montgomery’s plight, and the Supreme Court’s reaction to the events that unfolded during the birth of her son. In truth, the reasonable surgeon has seen little change to the advice that he or she is offered when considering what should be disclosed when seeking a patient’s consent to surgery. From the non-lawyer’s perspective, the Lanarkshire case makes no alterations to the advice set down within the GMC’s guidance in 2008; itself, a synthesis grounded in another obstetric case from the last century.","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"22 1","pages":"21 - 24"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216664854","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65478105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The implications of Montgomery vs. Lanarkshire Health Board for NHS patient information services","authors":"Evelyn Scott, Omer Aziz, Helen Rushton, C. Anandadas","doi":"10.1177/1356262216672615","DOIUrl":"https://doi.org/10.1177/1356262216672615","url":null,"abstract":"English law around the sufficiency of the information provided to a patient as part of the consent process has evolved over time from being a decision for the clinician to make about what to disclose to one where the information must be bespoke to the individual patient about risks that would be material to them personally, but perhaps not necessarily to the next person. Failure to provide sufficient information for decision-making could result in a clinical negligence claim for ‘failure to warn’. The recent case of Montgomery versus Lanarkshire Health Board has significant implications for clinicians obtaining a patient's consent to treatment. The outcome of this case makes the planning of care truly patient-centred and puts the onus on the clinician to ascertain exactly what would be a material risk to that individual and ensure that they are given sufficient information on which to base an informed decision. This article discusses this step change in the legal requirements for the provision of information and how clinicians at The Christie, an English tertiary cancer centre, supported by our information services, have grasped this challenge of ensuring that patients are adequately informed about their treatment options. This article considers only competent adults being prepared for treatment.","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"22 1","pages":"38 - 41"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216672615","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65477761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Montgomery v Lanarkshire Health Board: Implications of the Supreme Court ruling for psychiatry","authors":"Michael Yousif","doi":"10.1177/1356262216666982","DOIUrl":"https://doi.org/10.1177/1356262216666982","url":null,"abstract":"In ruling in favour of Nadine Montgomery in her claim of negligence against Lanarkshire Health Board, the Supreme Court changed the law in matters of informed consent. Having previously relied on the Bolam test of the professional opinion of medical peers, the information doctors must disclose to their patients is now determined by a much more patient-centred test. Despite this, it is not clear how, if at all, the ruling affects modern medical practice. In this article, the implications of the Supreme Court’s ruling for psychiatry are considered. It is unlikely the ruling will alter day-to-day clinical practice. It does, however, serve to highlight and reinforce key principles of good psychiatric practice.","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"22 1","pages":"30 - 32"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216666982","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65478132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA Adverse Event Reporting System (FAERS).","authors":"Katherine J Hahn, Shannon J Morales, James H Lewis","doi":"10.1007/s40800-015-0018-0","DOIUrl":"10.1007/s40800-015-0018-0","url":null,"abstract":"<p><p>Anticoagulants are a well known cause of drug-induced liver injury (DILI). We recently encountered a 45-year-old male who developed DILI during treatment with enoxaparin, a low-molecular-weight heparin (LMWH), for dural venous thrombosis. The man received enoxaparin 80 mg subcutaneously, twice daily. After 4 days, the patient was asymptomatic but he developed liver aminotransferase elevations: AST 340 U/L and ALT 579 U/L. Investigation revealed an R ratio of 19.9 by day 5 and a Roussel Uclaf Causality Assessment Method score of 10, giving a high probable likelihood that enoxaparin was the cause of hepatic injury. Enoxaparin was discontinued on day 7, and 1 week later AST and ALT had decreased to 61 and 273 U/L, respectively. This case prompted a literature search and a review of the FDA Adverse Event Reporting System (FAERS) database for the range of hepatic adverse events (HAEs) associated with this class. A MEDLINE/PubMed search was conducted using DILI terms and cross-referenced with the anticoagulant classes. A Freedom of Information Act (FOIA) request was also made to identify adverse events (AEs) associated with enoxaparin in FAERS. Case type, severity of outcome, and demographic information were analyzed. Five publications have reported DILI with enoxaparin. Trial data found elevations in ALT >3 times the upper limit of normal (ULN) for unfractionated heparins (UFH) and LMWH in 8 and 4-13 % of subjects, respectively. However, liver injury in all cases was mild, self-limited, and asymptomatic. Our FOIA request yielded 8336 adverse events related to enoxaparin over a 14-year period (Jan 2000-Sept 2014). Specific HAEs were found in 4 % of reports, but all were described with other serious adverse events. The reported outcomes of hospitalization (75 %), death (17 %), and life-threatening medical events (5 %) were likely due to other related serious adverse events such as hemorrhage (28 %) and thrombocytopenia (11 %). We conclude that LMWH-related liver injury is uncommon and reversible. The mechanism of liver injury is not known, although an idiosyncratic effect is postulated. Although the FAERS database lists hepatic injury in 4 % of all enoxaparin-related AEs, it appears that serious outcomes are related to non-hepatic events.</p>","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"10 1","pages":"17"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5005670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88440675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medicines formularies: And your point is?","authors":"D. McLean","doi":"10.1177/1356262216655938","DOIUrl":"https://doi.org/10.1177/1356262216655938","url":null,"abstract":"Search the internet for ‘hospital drug formularies’; the return is an extensive list from healthcare organisations with a number listed as joint formulary publications for the local healthcare economy. The purpose of the formulary is to promote evidence based, safe, clinically effective and cost-effective prescribing; however, if that is the case, why do all formularies not contain the same medicines for treating the same conditions? Does this mean that, instead of increasing rational prescribing, formularies promote variation? The processes leading to formulary inclusion usually require a consideration of the evidence supporting a medicine’s use and the associated financial consequences. This process is potentially repeated many times over by different local formulary committees which can result in different decisions, leaving significant duplication of effort. The uptake of new medicines within the UK is significantly slower than in healthcare systems in other developed countries. Do formulary processes impede the earlier use of new medicines? What happens when the formularies of primary and secondary care organisations within the same healthcare economy differ? Or the patient sits between two healthcare economies or receives elements of care from different healthcare economies? With the growth of NICE, the emergence of regional medicines optimisation committees, commissioning on a national level and perhaps most important of all patient choice, do formularies still fulfil their original purpose or are they simply lists of medicines which the hospital keeps in stock and the Clinical Commissioning Group is happy to pay for? What are the some of the risks associated with local formularies?","PeriodicalId":89664,"journal":{"name":"Clinical risk","volume":"21 1","pages":"116 - 120"},"PeriodicalIF":0.0,"publicationDate":"2015-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1356262216655938","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65477381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}