Responsible Practice or Restricted Practice? an Empirical Study of the Use of Clinical Guidelines in Medical Negligence Litigation.

In medical negligence litigation, the standard for breach of duty is measured against the Bolam test which reflects accepted practice. Despite protracted debate and common law development, the Bolam standard remains the touchstone for litigation in this area. Clinical guidelines (CGs) are statements based upon best available medical evidence and are designed to facilitate clinical decision-making to optimise outcomes thereby reflecting expected practice. Nevertheless, there is little research that considers how CGs engage in litigation and their influence on judicial reasoning. Given the increasing pressures on the NHS amid rising costs of litigation, these are important issues. This study provides an original contribution to the literature on CGs in determining breach of duty in law. Using a mixed methods' approach, data from multiple sources have been gathered and analysed to assess the use of CGs by lawyers and the courts thereby adding to the discourse on the judicial shift away from deference to Bolam. It concludes by offering a conceptual basis for the use of CGs within a framework for reasonableness and promotes their principled use while avoiding constraints on expert testimony, experience, and exercise of clinical discretion. This study has relevance for academics, legal and medical practitioners, and policy makers.

Gross Negligence Manslaughter and the Delivery of Healthcare: A Time for Change?

Manslaughter caused by gross negligence is a common law offence that has long existed in English jurisdiction. Although circumstances and context can be highly influential in determining the outcome of inadvertent errors, English law does not permit sufficient consideration of such issues. The recent and controversial case of R v. Bawa-Garba is used to illustrate some of the central issues that are pertinent to the debate. We examine some of the key considerations that mitigate against punishment alone from being the optimal response to death caused by gross negligence during healthcare delivery. Instead we suggest that a broader focus on patient safety and the public interest is called for to ensure safe systems of work by enhancing organisational accountability and the promotion of professional and institutional duty of candour. We conclude by offering positive proposals for change.

Gross negligence manslaughter and doctors: ethical concerns following the case of Dr Bawa-Garba.

Dr Bawa-Garba, a senior paediatric trainee who had been involved in the care of a child who died shortly after admission to hospital, was convicted of gross negligence manslaughter and subsequently erased from the medical register. We argue that criminalisation of doctors in this way is fraught with ethical tensions at levels of individual blameworthiness, systemic failures, professionalism, patient safety and at the interface of the regulator and doctor. The current response to alleged manslaughter during clinical care is not fit for purpose because of its narrow focus on criminalisation and punishment of individual doctors. The justice system fails to take into account systemic issues in a sufficiently proper and informed way particularly in respect of human factors involved in decision-making. It is easier to convict individual doctors for gross negligence manslaughter than it is to effect legal accountability upon organisations. If educational reflections are used to apportion blame, then this could impact detrimentally on honesty and the duty of candour, with negative implications for patient safety. Regulatory processes should not be deployed without consideration of context. There is an urgent need for a fresh and open evaluation of professional and societal expectations from the regulator that should include positive action as well as those that are proportionately punitive. Justice and patient safety would be served better by more sophisticated contextualisation through an approach that balances accountability in healthcare with failures that can occur within complex systems, and by working to a radical shift towards a just culture.

A rights-based proposal for managing faith-based values and expectations of migrants at end-of-life illustrated by an empirical study involving South Asians in the UK.

International migration is an important issue for many high-income countries and is accompanied by opportunities as well as challenges. South Asians are the largest minority ethnic group in the United Kingdom, and this diaspora is reflective of the growing diversity of British society. An empirical study was performed to ascertain the faith-based values, beliefs, views and attitudes of participants in relation to their perception of issues pertaining to end-of-life care. Empirical observations from this study, as well as the extant knowledge-base from the literature, are used to support and contextualise our reflections against a socio-legal backdrop. We argue for accommodation of faith-based values of migrants at end-of-life within normative structures of receiving countries. We posit the ethically relevant principles of inclusiveness, integration and embedment, for an innovative bioethical framework as a vehicle for accommodating faith-based values and needs of migrants at end-of-life. These tenets work conjunctively, as well as individually, in respect of individual care, enabling processes and procedures, and ultimately for formulating policy and strategy.

Awake and (Only Just) Aware? A Typology, Taxonomy, and Holistic Framework for Withdrawing Clinically Assisted Nutrition and Hydration in the Minimally Conscious State.

Decisions to withdraw clinically assisted nutrition and hydration (CANH) from people in the minimally conscious state are predicated on the question as to whether it is in the individual's best interests to continue with CANH and determined traditionally using a 'balance sheet' approach. The emerging case law in this area suggests that decisions may appear inconsistent and lack sufficient certainty and clarity of process. Using an analysis of statute, common law and academic commentary we articulate a typology for the elements that tend to engage in these decisions. Next, we construct a taxonomy of overarching legal and ethical issues and then proceed to develop a novel framework for holistic decision-making. We validate this on the principle upon which it is grounded: coherent weighting of elements and theoretical proof of concept. The framework has potentially far-reaching benefits that include consistency and transparency of decision-making, thereby enabling a more uniform judicial approach. We suggest this as a foundational paradigm for decision-making in this context.

Balancing on the edge: implications of a UK national audit of the use of BSR-BHPR guidelines for the diagnosis and management of polymyalgia rheumatica.

INTRODUCTION: The British Society for Rheumatology and British Health Professionals in Rheumatology (BSR-BHPR) guidelines for management of polymyalgia rheumatica (PMR) were published in 2010, aiming to provide guidance for diagnosis, management and disease monitoring. A national study was conducted across multiple rheumatology units throughout the UK in order to study the level of adoption of guidelines in clinical practice. METHODS: This study was a retrospective analysis of patient records with a diagnosis of PMR from multiple centres across the UK. The primary objective was to explore the national compliance of PMR management according to BSR guidelines. RESULTS: We included 81 responses across 10 rheumatology units in the UK. The guideline core inclusion criteria were followed in more than 90% in making the diagnosis of PMR, but limited concordance was observed with respect to excluding PMR-mimics, the initial recommended glucocorticoid dosage (74%), steroid taper (41%), treatment of relapse (76%), bone protection (84%) and patient follow-up (43%). CONCLUSIONS: We observed a wide variation in clinical practice and limited adherence to BSR-BHPR guidelines in the UK. This study highlights the need for robust multilayered and multifaceted implementation strategies involving the providers and the consumers for apposite dissemination of guideline-based practice and consistency of care. We believe that the findings of this study have significant relevance for formulation and dissemination of PMR guidelines in the future.

Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation.

Innovative therapy is a matter of recent public interest, particularly following Lord Saatchi's Medical Innovation Bill. The purpose of the Bill is to encourage responsible innovation in medical treatment. We argue for the need to achieve a balance between the risks of medical innovation and patient safety considerations. We make the case for statutory regulation of medical innovation on the basis of responsible innovation, choice and patient-centred care. At the heart of regulation of medical innovation is care delivered by a process which is accountable, transparent and allows full consideration of all relevant matters. This paper proposes a two-stage test (to assess applicability of medical innovation as well as suitability for the choice of intervention to be undertaken). It is suggested that this model would provide safeguards for patients as well as define limits for doctors in the context of innovative therapy. Implementation and application of such therapy must be underpinned by due process and governance oversight, which could be provided through context-specific professional peer review. A combination of these ethicolegal principles would permit responsible medical innovation and maximise benefit in terms of therapy and patient-centred care.

Análise sistemática da influência do antifator de necrose tumoral [anti-TNF] sobre as taxas de infecção em pacientes com artrite reumatoide / A systematic review of the influence of anti-TNF on infection rates in patients with rheumatoid arthritis

OBJETIVO: O presente trabalho tem como objetivo fornecer uma análise sistemática da influência do anti-TNF sobre as taxas de infecção em pacientes com artrite reumatoide (AR). MÉTODO: Pesquisamos na Medline para obter informações de controle de qualidade sobre as taxas de infecção em pacientes com AR tratados com anti-TNF. RESULTADOS: Atualmente, uma proporção elevada de pacientes com AR é usuária de agentes anti-TNF. Dados de registros nacionais em países da Europa de pacientes com AR tratados com anti-TNF sugerem que terapias biológicas estão intimamente ligadas à sepse. Apesar de estudos anteriores terem relatado um maior risco de infecções, atualmente há dados emergentes com maior duração de acompanhamento que sugerem um risco ajustado de 1,2. Os pacientes idosos e os com doença de longa data poderão apresentar uma taxa mais elevada de infecções graves em comparação às suas contrapartes mais novas com doença inicial. Hoje, há dados emergentes que sugerem que a terapia com anti-TNF está associada ao desenvolvimento de neutropenia logo após o início do tratamento. Os registros biológicos constataram que os pacientes com ARES tratados com anticorpos monoclonais apresentam aumento no risco de tuberculose (TB), em comparação aos tratados com bloqueadores dos receptores de TNF. Esse risco de infecção precisa ser ponderado em relação aos benefícios estabelecidos dos bloqueadores de TNF. CONCLUSÃO: A evidência atual sugere que o tratamento com anti-TNF na AR está intimamente associado à infecção. Os pacientes precisam estar cientes do risco de infecção, assim como dos benefícios estabelecidos dos bloqueadores de TNF, para que possam fornecer o consentimento informado para o tratamento.

OBJECTIVE: The present article aims to provide a systematic review of the influence of antitumor necrosis factor (TNF) on infection rates in patients with rheumatoid arthritis (RA). METHOD: Medline was searched to obtain quality control information on infection rates in RA patients treated with anti-TNF. RESULTS: A high proportion of RA patients are now established users of anti-TNF agents. Data from national registries in European countries of patients with RA treated with anti-TNF suggest that biological therapies are closely linked to sepsis. Although previous studies reported a higher risk of infections, there are now emerging data with longer duration of follow-up that suggested an adjusted hazard risk of 1.2. Elderly patients and those with longstanding disease may have a higher rate of serious infections compared to their counterparts who were younger with early disease. There are now emerging data to suggest that anti-TNF therapy is associated with the development of neutropenia shortly after the commencement of treatment. The biologic registries found that RA patients treated with monoclonal antibodies are at increased risk of tuberculosis (TB) compared to those on TNF receptor blockers. This risk of infection needs to be weighed against the established benefits of TNF blockers. CONCLUSION: Current evidence suggests that anti-TNF treatment in RA is closely linked to infection. Patients need to be aware of the risk of infection together with the established benefits of TNF blockers in order to give informed consent for treatment.

A systematic review of the influence of anti-TNF on infection rates in patients with rheumatoid arthritis.

OBJECTIVE: The present article aims to provide a systematic review of the influence of antitumor necrosis factor (TNF) on infection rates in patients with rheumatoid arthritis (RA). METHOD: Medline was searched to obtain quality control information on infection rates in RA patients treated with anti-TNF. RESULTS: A high proportion of RA patients are now established users of anti-TNF agents. Data from national registries in European countries of patients with RA treated with anti-TNF suggest that biological therapies are closely linked to sepsis. Although previous studies reported a higher risk of infections, there are now emerging data with longer duration of follow-up that suggested an adjusted hazard risk of 1.2. Elderly patients and those with longstanding disease may have a higher rate of serious infections compared to their counterparts who were younger with early disease. There are now emerging data to suggest that anti-TNF therapy is associated with the development of neutropenia shortly after the commencement of treatment. The biologic registries found that RA patients treated with monoclonal antibodies are at increased risk of tuberculosis (TB) compared to those on TNF receptor blockers. This risk of infection needs to be weighed against the established benefits of TNF blockers. CONCLUSION: Current evidence suggests that anti-TNF treatment in RA is closely linked to infection. Patients need to be aware of the risk of infection together with the established benefits of TNF blockers in order to give informed consent for treatment.

Catch me if you can: a national survey of rheumatologists and obstetricians on the use of DMARDs during pregnancy.

The use of disease-modifying anti-rheumatic drugs and biological therapy is variable throughout pregnancy. This questionnaire-based study was undertaken to explore and compare the current practice amongst rheumatologists and obstetricians across the UK, regarding the use of drugs during pregnancy. A questionnaire was devised to address issues regarding individual drugs used during preconception, pregnancy and lactation. Members of the British Society of Rheumatology, Midlands Rheumatology Society and the British Maternal Fetal Medicine Society were emailed. Results were analysed by the online survey software and Fisher's exact testing. Our results show differences between rheumatologists and obstetricians. A total of 500 members of each society were emailed. There were 102 (20 %) versus 33 (7 %) respondents. With regard to medication, in relation to advice given before conception, hydroxychloroquine 80 versus 61 % continue, 19 versus 15 % discontinue (p = 1.0); sulphasalazine 59 versus 70 % continue, 41 versus 6 % discontinue (p = 0.002); azathioprine 62 versus 58 % continue, 36 versus 21 % discontinue (p = 0.37); methotrexate 0 versus 3 % continue, 100 versus 76 % discontinue (p = 0.2); leflunomide 0 versus 0 % continue, 98 versus 42 % discontinue (p = 1.0); anti-TNF therapy 7 versus 15 % continue, 54 versus 54 % discontinue (p = 0.05); and rituximab 2 versus 12 % continue, 95 versus 52 % (p = 0.01) would discontinue prior to conception. This survey is the first of its nature amongst rheumatologists and obstetricians. Most would give advice to continue with sulphasalazine, azathioprine and stop methotrexate and leflunomide. We observed no uniform practice and therefore recommend guidelines.

Update on biologic therapies in ankylosing spondylitis: a literature review.

AIM: The present paper aims to review the recent advances in diagnosis and management of ankylosing spondylitis (AS). METHOD: Medline and abstracts submitted to the recent European League Against Rheumatism (EULAR) congress were searched to obtain quality-controlled information on the management of AS. RESULTS: The use of magnetic resonance imaging (MRI) allows the diagnosis of AS to be made in the pre-radiographic stage. The Assessment in Spondylarthritis International Society recommendations for the management of AS have been modified so that patients with non-radiographic spondyloarthritis (SpA) can now be considered for biological therapy. The 'older' anti-tumour necrosis factor (TNF) continued to be effective in longer-term studies. Studies with longer duration of follow-up have shown that some patients with pre-radiographic SpA entered into prolonged drug-free remission. It is likely that in the foreseeable future, more AS patients will be treated with biological therapies at an earlier stage of the disease. New biologic therapies, golimumab and secukinumab, are looking promising in improving the signs and symptoms of AS, at least in the short-term. CONCLUSION: Longer-term studies of AS patients treated with infliximab, etanercept and adalimumab continued to show a good clinical response. There is a need for more long-term studies to examine the longitudinal efficacy of golimumab and secukinumab in AS.

Should anti-TNF therapy be discontinued in rheumatoid arthritis patients undergoing elective orthopaedic surgery? A systematic review of the evidence.

Anti-tumour necrosis factor (TNF) therapies have revolutionized the management of rheumatoid arthritis (RA). A high proportion of RA patients are now established users of anti-TNF agents. Unfortunately, many RA patients with longstanding disease still require elective orthopaedic procedures. Published studies on the influence of TNF antagonist on infection rates in RA patients undergoing surgery are conflicting. However, national registries of RA patients on anti-TNF reported an increased risk of infection. The risk of anti-TNF-related infection is highest at the start of treatment with frequent involvement of the skin and subcutaneous tissue. Infection at these sites could negatively influence the healing of surgical wound. Current guidelines suggest that treatment with biologics should be discontinued prior to surgery. Patients with established disease are more likely to flare compared to those with early disease on stopping treatment. Consequently, TNF blockers need to be reinstated promptly after surgery to avoid the risk of RA flare.

Association analysis of TNFR2, VDR, A2M, GSTT1, GSTM1, and ACE genes with rheumatoid arthritis in South Asians and Caucasians of East Midlands in the United Kingdom.

Genetic associations of TNFR2, VDR (Bsm I and Fok I), A2M, GSTT(1), GSTM(1) and ACE in South Asian and Caucasian patients with rheumatoid arthritis (RA) were assessed in this study. DNA samples from South Asians (134 cases, 149 controls) and Caucasians (137 cases, 150 controls) from the East Midlands of the United Kingdom were genotyped for seven polymorphisms. All cases were rheumatoid-factor positive. Significant genetic associations were observed with TNFR2 R-R (OR = 3.16, CI 1.20-9.26, P < 0.05), A2M 1-1 (OR = 2.09, CI 1.21-3.64, P < 0.05) and GST T(1)null (OR = 1.97, CI 1.07-3.68, P < 0.05) among Caucasian patients. In South Asians, VDR Bsm I B-B genotype (OR = 2.08, CI 1.23-3.52, P < 0.05), A2M 2-2 genotype (OR = 3.99, CI 1.19-17.18, P < 0.05), and GST T(1)null genotype (OR = 2.81, CI 1.40-5.77, P < 0.002) genotypes were associated with RA. In the majority of cases, recessive and multiplicative modes of inheritance explained the observed associations. This study demonstrates that ethnicity affects the genetic associations in RA.

Advance care planning: the role of the nurse.

Advance care planning is a process designed to enable patients to discuss and record their values and treatment preferences to inform future care in the event that they lose decision-making capacity. Current law provides for the appointment of a proxy decision-maker under a Lasting Power of Attorney, or advance decisions for treatment refusal. A further option is a statement of wishes to record the values and views to be used to inform the determination of best interests. Nurses can play an invaluable role in facilitating open and frank discussion.

Association of PTPN22 with rheumatoid arthritis among South Asians in the UK.

OBJECTIVE: To compare the distribution and assess genetic associations of the PTPN22 R620W single-nucleotide polymorphism among South Asian (Asiatic Indian) patients with rheumatoid arthritis (RA) and ethnically matched controls. METHODS: DNA samples from 133 rheumatoid factor-positive South Asian RA patients and 149 control subjects from the East Midlands of the UK were genotyped for PTPN22 R620W polymorphism. Genotyping was performed by the polymerase chain reaction-restriction fragment length polymorphism method. RESULTS: The PTPN22 *T allele frequency was lower than in the Caucasian populations, but the disease association was significant (odds ratio 5.87, 95% confidence interval 1.68-20.52). Similar association was observed for genotypes containing *T allele. CONCLUSION: Our results suggest that the T variant acts as a susceptibility allele for autoantibody-positive RA among South Asians.

Rheumatology nurse practitioners' perceptions of their role.

OBJECTIVES: To identify the current practices of rheumatology nurse practitioners and ascertain their perceptions of how their role could be enhanced. METHOD: A cross-sectional questionnaire study of currently employed nurse practitioners in rheumatology in the United Kingdom (UK) was undertaken. RESULTS: 200 questionnaires were distributed and 118 nurses responded. Ninety-five respondents met the inclusion criteria for undertaking an advanced nursing role. Typical conditions dealt with included: rheumatoid arthritis (96.8%); psoriatic arthritis (95.8%); osteoarthritis (63.2%); ankylosing spondylitis (62.8%); systemic lupus erythematosus (51.6%); and scleroderma (34.7%). Drug monitoring, education, counselling of patients and arranging basic investigations were routinely performed by more than 80% of respondents. A smaller proportion performed an extended role that included dealing with referrals, research and audit, the administration of intra-articular injections, and admission of patients. Specific attributes identified as being necessary for competence were: knowledge and understanding of rheumatic diseases (48.4%); drug therapy (33.7%); good communication skills (35.8%); understanding of the roles of the team (27.4%); working effectively (23.2%) as part of a multidisciplinary team; assessment of patients by physical examination (28.4%); teaching (26.3%), research (17.9%); organizational skills (14.7%); and the interpretation of investigations (9.5%). Factors that could enhance their role included: attendance at postgraduate courses (30.5%); obtaining further qualifications (13.7%); active participation in the delivery of medical education (41.1%); training in practical procedures (31.6%); protected time and resources for audit and research (11.6%); formal training in counselling (11.6%); and implementation of nurse prescribing (10.5%). CONCLUSION: Nurse practitioners already have a wide remit and play an invaluable part in the delivery of modern rheumatology services. An extended role could improve patient care and enhance nursing career pathways in rheumatology.