This guideline, which updates the 2006 National Institute for Health and Care Excellence (NICE) guideline (NCCMH, 2006; NICE, 2006), has been developed to advise on the assessment and management of bipolar disorder in adults, children (aged under 13 years) and young people (aged 13 to 18 years) in primary and secondary care. It applies to people with bipolar I, bipolar II, mixed affective and rapid cycling disorders. Non-bipolar affective disorders are not covered because these are addressed by other guidelines.
Since the publication of the previous guideline on bipolar disorder in 2006, there have been some important advances in our knowledge of the care pathway and treatment approaches that are most likely to benefit people with bipolar disorder. All areas of the 2006 guideline have therefore been updated. It should be noted that because the NICE guideline on Service User Experience in Adult Mental Health (NCCMH, 2012; NICE, 2011a) covers the experience of care for people accessing mental health services (including people with bipolar disorder), this guideline update does not specifically cover service user experience of care; it does, however, include a review of carers’ experience of care because this was not the explicit focus of Service User Experience in Adult Mental Health. This guideline is published contemporaneously with Psychosis and Schizophrenia in Adults (NCCMH, 2014; NICE, 2014) and Psychosis and Schizophrenia in Children and Young People (NCCMH, 2013; NICE, 2013c) and the Guideline Development Group (GDG) for the guideline on bipolar disorder sought to maintain consistency with both of these guidelines where appropriate – the method of incorporation and adaptation (see section 3.7) was used where relevant, and in each case full details are provided in the relevant chapter.
The guideline recommendations have been developed by a multidisciplinary team of healthcare professionals, people with bipolar disorder and guideline methodologists after careful consideration of the best available evidence. It is intended that the guideline will be useful to clinicians and service commissioners in providing and planning high-quality care for people with bipolar disorder (see Appendix 1 for more details on the scope of the guideline).
Although the evidence base is rapidly expanding, there are a number of major gaps. The guideline makes a number of research recommendations specifically to address gaps in the evidence base. In the meantime, it is hoped that the guideline will assist clinicians, and people with bipolar disorder and their carers by identifying the merits of particular treatment approaches where the evidence from research and clinical experience exists.
1.1. National Clinical Guidelines
1.1.1. What are clinical guidelines?
Clinical guidelines are ‘systematically developed statements that assist clinicians and service users in making decisions about appropriate treatment for specific conditions’ (Mann, 1996). They are derived from the best available research evidence, using predetermined and systematic methods to identify and evaluate the evidence relating to the specific condition in question. Where evidence is lacking, the guidelines include statements and recommendations based upon the consensus statements developed by the Guideline Development Group (GDG).
Clinical guidelines are intended to improve the process and outcomes of healthcare in a number of different ways. They can:
provide up-to-date evidence-based recommendations for the management of conditions and disorders by healthcare professionals
be used as the basis to set standards to assess the practice of healthcare professionals
form the basis for education and training of healthcare professionals
assist service users and their carers in making informed decisions about their treatment and care
improve communication between healthcare professionals, service users and their carers
help identify priority areas for further research.
1.1.2. Uses and limitations of clinical guidelines
Guidelines are not a substitute for professional knowledge and clinical judgement. They can be limited in their usefulness and applicability by a number of different factors: the availability of high-quality research evidence, the quality of the methodology used in the development of the guideline, the generalisability of research findings and the uniqueness of individuals.
Although the quality of research in this field is variable, the methodology used here reflects current international understanding on the appropriate practice for guideline development (AGREE Collaboration, 2003), ensuring the collection and selection of the best research evidence available and the systematic generation of treatment recommendations applicable to the majority of people with bipolar disorder. However, there will always be some people and situations where clinical guideline recommendations are not readily applicable. This guideline does not, therefore, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual, in consultation with the person with bipolar disorder or their carer.
In addition to the clinical evidence, cost-effectiveness information, where available, is taken into account in the generation of statements and recommendations in clinical guidelines. While national guidelines are concerned with clinical and cost effectiveness, issues of affordability and implementation costs are to be determined by the National Health Service (NHS).
In using guidelines, it is important to remember that the absence of empirical evidence for the effectiveness of a particular intervention is not the same as evidence for ineffectiveness. In addition, and of particular relevance in mental health, evidence-based treatments are often delivered within the context of an overall treatment programme including a range of activities, the purpose of which may be to help engage the person and provide an appropriate context for the delivery of specific interventions. It is important to maintain and enhance the service context in which these interventions are delivered, otherwise the specific benefits of effective interventions will be lost. Indeed, the importance of organising care in order to support and encourage a good therapeutic relationship is at times as important as the specific treatments offered.
1.1.3. Why develop national guidelines?
The National Institute for Health and Care Excellence (NICE) was established as a Special Health Authority for England and Wales in 1999, with a remit to provide a single source of authoritative and reliable guidance for service users, professionals and the public. NICE guidance aims to improve standards of care, diminish unacceptable variations in the provision and quality of care across the NHS, and ensure that the health service is person-centred. All guidance is developed in a transparent and collaborative manner, using the best available evidence and involving all relevant stakeholders.
NICE generates guidance in a number of different ways, four of which are relevant here. First, national guidance is produced by the Technology Appraisal Committee to give robust advice about a particular treatment, intervention, procedure or other health technology. Second, NICE commissions public health intervention guidance focused on types of activity (interventions) that help to reduce people’s risk of developing a disease or condition, or help to promote or maintain a healthy lifestyle. Third, NICE commissions the production of national clinical guidelines focused upon the overall treatment and management of a specific condition. To enable this latter development, NICE has established four National Collaborating Centres in conjunction with a range of professional organisations involved in healthcare. Fourth, NICE has a new responsibility, from April 2013, to develop guidelines and quality standards for social care in England. This provides an opportunity to apply an evidence-based system to decision-making in the social care sector, similar to that provided for the NHS. It will also allow guidelines to be produced that promote better integration between health, public health and social care services.
1.1.4. From national clinical guidelines to local protocols
Once a national guideline has been published and disseminated, local healthcare groups will be expected to produce a plan and identify resources for implementation, along with appropriate timetables. Subsequently, a multidisciplinary group involving commissioners of healthcare, primary care and specialist mental health professionals, service users and carers should undertake the translation of the implementation plan into local protocols, taking into account both the recommendations set out in this guideline and the priorities in the National Service Framework for Mental Health (Department of Health, 1999) and related documentation. The nature and pace of the local plan will reflect local healthcare needs and the nature of existing services; full implementation may take a considerable time, especially where substantial training needs are identified.
1.1.5. Auditing the implementation of clinical guidelines
This guideline identifies key areas of clinical practice and service delivery for local and national audit. Although the generation of audit standards is an important and necessary step in the implementation of this guidance, a more broadly-based implementation strategy will be developed. Nevertheless, it should be noted that the Care Quality Commission in England, and the Healthcare Inspectorate Wales, will monitor the extent to which commissioners and providers of health and social care and Health Authorities have implemented these guidelines.
1.2. The National Bipolar Disorder (Update) Guideline
1.2.1. Who has developed this guideline?
This guideline has been commissioned by NICE and developed within the National Collaborating Centre for Mental Health (NCCMH). The NCCMH is a collaboration of the professional organisations involved in the field of mental health, national service user and carer organisations, a number of academic institutions and NICE. The NCCMH is funded by NICE and is led by a partnership between the Royal College of Psychiatrists and the British Psychological Society’s Centre for Outcomes Research and Effectiveness, based at University College London.
The GDG was convened by the NCCMH and supported by funding from NICE. The GDG included people with bipolar disorder and carers, and professionals from psychiatry, clinical psychology, general practice, nursing, occupational therapy, psychiatric pharmacy, and the private and voluntary sectors.
Staff from the NCCMH provided leadership and support throughout the process of guideline development, undertaking systematic searches, information retrieval, appraisal and systematic review of the evidence. Members of the GDG received training in the process of guideline development from NCCMH staff, and the service users and carers received training and support from the NICE Public Involvement Programme. The NICE Guidelines Technical Adviser provided advice and assistance regarding aspects of the guideline development process.
All GDG members made formal declarations of interest at the outset, which were updated at every GDG meeting. The GDG met a total of 13 times throughout the process of guideline development. It met as a whole, but key topics were led by a national expert in the relevant topic. The GDG was supported by the NCCMH technical team, with additional expert advice from special advisers where needed. The group oversaw the production and synthesis of research evidence before presentation. All statements and recommendations in this guideline have been generated and agreed by the whole GDG.
1.2.2. For whom is this guideline intended?
This guideline will be relevant for adults and young people with bipolar disorder and covers the care provided by primary, community, secondary, tertiary and other healthcare professionals who have direct contact with, and make decisions concerning the care of, adults and young people with bipolar disorder.
The guideline will also be relevant to the work, but will not cover the practice, of those in:
1.2.3. Specific aims of this guideline
The guideline makes recommendations for the assessment and management of bipolar disorder. It aims to:
improve access and engagement with treatment and services for people with bipolar disorder
evaluate the role of specific psychological, psychosocial and pharmacological interventions in the treatment of bipolar disorder
evaluate the role of psychological and psychosocial interventions in combination with pharmacological interventions in the treatment of bipolar disorder
evaluate the role of specific service-level interventions for people with bipolar disorder
integrate the above to provide best-practice advice on the care of individuals throughout the course of their treatment
promote the implementation of best clinical practice through the development of recommendations tailored to the requirements of the NHS in England and Wales.
1.2.4. The structure of this guideline
The guideline is divided into chapters, each covering a set of related topics. The first three chapters provide a general introduction to guidelines, an introduction to the topic of bipolar disorder and to the methods used to develop them. Chapter 4 to Chapter 10 provide the evidence that underpins the recommendations about the treatment and management of bipolar disorder.
Each evidence chapter begins with a general introduction to the topic that sets the recommendations in context. Depending on the nature of the evidence, narrative reviews or meta-analyses were conducted, and the structure of the chapters varies accordingly. Where appropriate, details about current practice, the evidence base and any research limitations are provided. Where meta-analyses were conducted, information is given about both the interventions included and the studies considered for review. Clinical summaries are then used to summarise the evidence presented. Finally, recommendations related to each topic are presented at the end of each chapter. Full details about the included studies can be found in Appendices 11, 12, 16, 18, 22 and 26. Where meta-analyses were conducted, the data are presented using forest plots in Appendices 13, 21, 25 and 29. See for details of what is included in the appendices.
Clinical and economic evidence appendices.
