Implementing the National Programme for IT BEST CURRENT EVIDENCE STRATEGY CONSULTATION PAPER – MARCH 2006 Comments to J A Muir Gray Version Version 1.0 Date 21 March 2006 NPFIT/Bestcurrentevidence/29.3.06 Prepared by J A Muir Gray, following a meeting with patient representatives. Consultation period open until 31 May 2006 1 CONTENTS Knowledge is the enemy of disease. Best Current Evidence – concepts and plans List of appendices Appendix 1: Providing clean clear knowledge for busy clinicians and patients Appendix 2: Decision Support Programme – knowledge support, computer-based clinical decision support systems, and patient decision aids Appendix 3: National Library of Tools and Rules – project initiation document Appendix 4: The 500 most common problems encountered in primary care NPFIT/Bestcurrentevidence/29.3.06 2 KNOWLEDGE IS THE ENEMY OF DISEASE The application of what we know will have a bigger impact on health and disease than any single drug or technology likely to be introduced in the next decade. By putting knowledge into practice, we can prevent or minimise the seven universal problems of healthcare: unknowing variation in clinical practice and service delivery; errors of commission and omission; waste; failure to implement new knowledge and technology systematically and appropriately; over-use and under-use – inappropriate care; unsatisfactory patient experience; poor quality clinical practice. Evidence is one particular type of knowledge, namely the knowledge derived from research, and clinical practice and healthcare are evidence-based activities. Evidence is necessary but, of course, not sufficient; it has to be combined with the condition of the individual patient and the values of each patient, but without evidence it is impossible for patients, professionals, and those who manage resources to make good decisions, and we must ensure that patients, professionals, managers and public health professionals can base their decisions on best current evidence. The National Knowledge Service has three main themes of work: the Best Current Evidence Service, set out in more detail in this paper; the National Library for Health, responsible for organising and mobilising the evidence; the National Knowledge Infrastructure containing technical standards, tools and services. Obviously Connecting for Health is only one contributor to the Best Current Evidence Service because it holds only a limited number of the relevant contracts and it is, of course, not a producer of evidence in the way that NICE or the Research and Development Programme or the Health Protection Agency are producers of evidence. Connecting for Health, therefore, has to work with knowledge partners and all of the key national knowledge partners are described in this paper which attempts to set the Connecting for Health resources in context. A partner of particular importance is NHS Direct. The principle on which the National Library for Health has been developed is that patients should have full access to all the knowledge to which clinicians have access. This is for a number of simple and practical reasons, notably because many patients are at least as intelligent as clinicians but also because almost all patients have more time than clinicians, even if they have not had the basic biological training required to understand all of the terms used in all of the clinical documents. This paper, however, is about the production and procurement of evidence primarily for clinicians; in parallel a Ministerial review is being undertaken on the basis of the White Paper to consider all the sources of evidence primarily for patients and how they should evolve. NPFIT/Bestcurrentevidence/29.3.06 3 This consultation takes place in a time of resource constraints. The case is being made to invest more resources in the production, procurement and mobilisation of evidence, but it is hard to justify more money until the publicly funded knowledge services have co-ordinated their production and procurement so weakly. This consultation paper focuses not only on the needs of the users but also on the needs of all those public agencies involved in the production and procurement of knowledge to work even more closely together. This strategy consultation is part of the refresh of the strategy paper produced by the Service Implementation Directorate of Connecting for Health which set out the National Knowledge Service strategy and indicated that Connecting for Health had been given lead responsibility for the development of the National Library for Health. Comments to Muir Gray by 31 May 2006 NPFIT/Bestcurrentevidence/29.3.06 4 BEST CURRENT EVIDENCE CONCEPTS AND PLANS J A Muir Gray March 2006 NPFIT/Bestcurrentevidence/29.3.06 5 EXECUTIVE SUMMARY Best current evidence needs to be produced and procured as a basis for a National Knowledge Service. This consultation paper focuses primarily on knowledge for professionals. A separate Ministerial review of knowledge for patients is underway. Evidence is knowledge produced by research; it needs to be linked to the knowledge produced from data analysis, sometimes called statistics, and knowledge from the experience of clinicians and patients. Ignorance is a type of knowledge, and a Database of Uncertainties about the Effects of Treatments needs to be developed to complement the database of evidence. Evidence is generalisable and relevant across the country and often internationally. To be useful it needs to relate to a particular patient and a particular service; the National Care Record Service allows the former, the Map of Medicine, mobilised through NHS Broadband, NHS e-mail and Internet, will allow the latter. Studies: a wide range of journals are currently procured; the peer review system is so unreliable that these are not suitable for busy clinicians and patients unless the journals conform to very strict protocols. Steps are being taken to promote and facilitate the introduction of such protocols. This strategy is based on the Four S approach developed in McMaster University – Study reports, Systematic reviews and guidelines, Synopses, and Systems. This strategy is based on studies of the needs of end users. Systematic reviews and guidelines: these are the most valid source of knowledge, for example the Cochrane Database of Systematic Reviews and NICE guidelines, but they are not always easy to use in their current form. Synopses: these are readable documents produced from systematic reviews and guidelines. Systems: the introduction of the Care Record Service allows the incorporation of knowledge in systems. A National Library of Pathways is being developed and will be launched in 2006. In addition a National Library of Tools and Rules is being developed. These will complement the National Library for Guidelines and all of the documents reporting research findings and systematic reviews already in the National Library for Health. Knowledge support is simple and effective; clinicians and patients should be offered knowledge just in time, where and when they need it. A set of quality assured pathways, tools and rules will be provided to all information system providers as a National Clinical Decision Support Service. NPFIT/Bestcurrentevidence/29.3.06 6 More complicated computer-based decision support has not been shown to be effective except for a few conditions. Further work will be done with NICE to develop criteria and systems to appraise decision support systems. Patient decision aids are of vital importance. Work will be done with all the national agencies producing knowledge to make all of their knowledge available through a search engine in a consistent form. The procurement of an NHS-wide search engine will allow all of these sources to be searched through a one stop shop. The seven sources of synopses currently procured by the Department of Health or the NHS will be more closely related to one another and when current contracts run out the procurement, the business case for which was approved in September 2005, will be for an integrated Clinical Synopsis Service. A National Library for Medicines will be created; all advertising will be removed from NHS computers. Steps will be taken to procure sources of study reports which have filters in addition to peer review to reduce the number of articles which clinicians have to search and provide them with assurance that these articles are valid, relevant and new. The knowledge for common problems will be co-ordinated and presented in National Knowledge Weeks, for example the Breast Cancer Knowledge Week. Open access to the Cochrane Library will be provided. The Map of Medicine will be used to allow best current evidence to be represented in the form of national care pathway templates. The Map of Medicine will also be used to provide localised versions of the national care pathway templates, allowing generablisable knowledge to be set in the context of local constraints and opportunities. The Best Current Evidence Service will cover both the 50 biggest health problems and the 500 conditions most commonly seen in primary care and walk-in centres. Rare diseases will receive separate consideration and a National Library for Rare Diseases will be prepared. The Best Current Evidence Service will be developed in partnership with the National Library for Health to create a National Knowledge Service, based on a common technical infrastructure and using to the full the skills of librarians and their local services. NPFIT/Bestcurrentevidence/29.3.06 7 1. Developing a National Knowledge Service The mission of the National Knowledge Service is to provide best current evidence where and when it is needed for patients, clinicians, and for those who manage resources. The benefits that will result from this will be not only an improvement in the health of the population but also a dramatic change in the quality of the health service and the value derived from the resources invested in health care. The application of what we know from research, from the analysis of routinely collected audit data, and from experience will have a bigger impact on health and disease than any other single drug or technology likely to be introduced in the next decade and contribute significantly to the reduction of the seven most common problems in health care: unknowing variation in clinical practice and service delivery; errors of commission and omission; waste; failure to implement new knowledge and technology systematically and appropriately; over-use and under-use – inappropriate care; unsatisfactory patient experience; poor quality clinical practice. The components of the National Knowledge Service are shown in the diagram below (Figure 1). NPFIT/Bestcurrentevidence/29.3.06 8 National Knowledge Service Production & Procurement Organisation Question Answering Service Localisation Mobilisation Utilisation Best Current Evidence Service National Library of Health NHS Direct Online Map of medicine Best Current Evidence Service (Pathways, Tools and Rules) Patient & professional education Better Consultations, Better Decisions, Better Communication Figure 1 The mission of the Best Current Evidence Service is to ensure that best current evidence is produced or procured for organisation, mobilisation and, the end goal, utilisation by patients, clinicians, and those who make decisions about health care. This paper focuses on the evidence that is primarily written for clinicians, although the aim is for it to be open to patients also. 2. Three types of generalisable knowledge There are many definitions of knowledge and within the National Knowledge Service three different types of generalisable knowledge are distinguished: knowledge from research, sometimes called evidence; knowledge from the analysis of routinely collected and audit data, sometimes called statistics; and knowledge from the experience of clinicians and patients. The priority of the National Knowledge Service is to provide easy access to evidence, namely to knowledge derived from research. Working in partnership with organisations such as the Public Health Observatory and Dr Foster, the Information Centre for health and Social Care , we will be NPFIT/Bestcurrentevidence/29.3.06 9 identifying ways in which direct links can be made to relevant statistics. Knowledge from the experience of clinicians and patients, either presented as guidelines from a professional association or as patient experience, for example through the Database of Individual Patient Experience (DIPEX), will also be made available, but the main focus of this paper is on evidence. 2.1 Ignorance as a type of knowledge It is important to emphasise that it is often important to clinicians and patients to be certain that there is no answer to a particular question. One of the benefits of the National Library for Health will be to help the person who asks the question to find the best available answer, and to be clear whether or not there is an answer. For this reason a Database of Uncertainties about the Effects of Treatment (DUETS) is being developed in partnership with the Department of Health and the Medical Research Council. The lead organisation in this work is the James Lind Library and the work is being done in partnership with the Medical Research Council and the R&D Directorate of DH. In future, therefore, when there are uncertainties about effects, these will be made explicit. It is essential to help the clinician or patient find out if nobody knows the answer to a question; this then allows the patient to make a decision on the basis of their values. 3. Generalisable knowledge and particular knowledge Best current generalisable knowledge needs to be related to knowledge about: this particular patient, and this particular service. The integration of the National Library for Health with the National Care Record Service will allow the former link to be easily and automatically made. However, with increasing reliance on agency and locum staff in the NHS, together with more rapid turnover of staff, it is necessary to link generalisable knowledge to information about the particular service with which the clinician and the patient are engaging. This will be greatly facilitated by N3, the system which will ensure that 18,000 healthcare locations have Broadband connection, and Contact, the NHS e-mail system. The use of the Map of Medicine software will not only allow evidence to be related to local constraints and opportunities but will also set out explicitly how evidence-based care is delivered both nationally and within each health community. This consultation is linked to the Integrated Service Implementation Programme. 4. The four S approach In a landmark article, Brian Haynes, who has contributed so much to knowledge management research, proposes a simple classification of knowledge into four types: studies – research reports which appear in journals, paper or digital; systematic reviews and guidelines – summaries of syntheses of studies; NPFIT/Bestcurrentevidence/29.3.06 10 synopses - brief readable chunks of knowledge prepared primarily for ease of use while not losing accuracy, specifically for busy end users who are not familiar with the research literature and its deficiencies; systems – ways in which knowledge can be incorporated into the electronic patient record or into the many documents that clinicians and patients receive, for example appointment letters, radiology request forms, or laboratory reports. A diagram illustrating the relationship between these four types of source is set out below (Figure 2). Systems Synopses Systematic reviews and guidelines Study reports in journal articles Figure 2 5. The needs of the end user A number of studies have been conducted on end user needs. Obviously clinicians are learners and researchers as well as practitioners, but the main focus of the Best Current Evidence Service is to provide evidence for clinicians to help them with patient care. Primary responsibility for the provision of knowledge for patients rests with NHS Direct, a special health authority responsible not only for the telephone support service but also for NHS Direct New Media, including NHS Direct Online. This work is being done in close partnership with NHS Direct which is currently involved with the Department of Health in undertaking a major review of all information for patients and the public, stimulated by the White Paper Our Health, Our Care, Our Say. NPFIT/Bestcurrentevidence/29.3.06 11 There are about a hundred different professional groups within the National Health Service, in addition to those people primarily responsible for education and those involved in research, and the main groups identified as a focus for the production and procurement of evidence are listed below: nurses; midwives; district nurses; practice nurses; mental health professionals; learning disability professionals; allied health professions; healthcare scientists; Foundation Year doctors; clinicians in specialist training; GP registrars; general practitioners; consultants; managers. User needs have been evaluated systematically and work will continue with the National Advisory Group of the National Clinical Leads of Connecting for Health to ensure continuing involvement of users in providing feedback to those who produce and procure evidence for decision-making. A user group has been set up and will be expanded in consultation with the National Advisory Groups of Connecting for Health. 6. Relevance of the four types of knowledge to healthcare professionals 6.1 Studies Professional education rightly emphasises the important contribution that research has made and continues to make to patient care and health care management. The development of peer reviewed scientific literature has made a major contribution to the evolution of clinical practice and health care in the last fifty years. However, research into the peer review process, and the scientific literature, has revealed a number of very important weaknesses. The introduction of peer review undoubtedly improved the editing of scientific journals but it is a system whose limitations, both in terms of scope and execution, are now well documented (Appendix 1). There is good evidence, for example, that: journals are more likely to publish articles with positive findings – “positive publication bias”; information about harm is less well presented than information about benefit; NPFIT/Bestcurrentevidence/29.3.06 12 unless abstracts conform to CONSORT and QUORUM criteria, they tend to reinforce the positive effects of publication bias by emphasising the positive and beneficial results within studies; peer reviewers and editors fail to spot methodological and statistical mistakes; there is a failure to base both the research and the reporting of the research on a synthesis of pre-existing knowledge; the articles by Iain Chalmers, Mike Clarke and Phil Alderson, cited in Appendix 1, make powerful reading; the way in which journal articles are published often makes it impossible for the busy clinician or patient, or even research worker, reading the article to spot the deficiencies; sometimes it is easy to identify the weaknesses in published trials, and Chalmers, Clarke and Alderson report a study that was brilliant in its conception but relatively simple in its execution. In contrast Chan and colleagues report a study, cited in Appendix 1, (which was also brilliant in its conception but very time-consuming and difficult to carry out), which demonstrates how researchers selectively forget the results that are less impressive or less interesting. For all these reasons journal articles, even those peer-reviewed and published in “good” journals, must be treated with great circumspection and should not be brought to the attention of the busy clinician or patient without careful appraisal and a health warning. Primary responsibility for the procurement of journals rests with library services. There is national procurement of electronic access to a set of journals but no additional quality criteria other than peer review are used to define the set. 6.2 Systematic reviews and guidelines A systematic review is a synthesis of research findings which follows an explicit methodology, namely: 1. 2. 3. 4. 5. the identification of best sources of research; the conduct of a search for studies with an explicit search strategy; agreement on the use of quality criteria to divide the studies found into those of adequate quality and those that are unacceptable; the synthesis of the results of the studies of adequate quality; the publication of the systematic review, providing references not only to the acceptable but also to the unacceptable studies to allow the reader of the systematic review to identify evidence that was not included in the review; this emphasises the fact that the choice of explicit criteria, set out objectively, involves value judgements. Some systematic reviews are regularly kept up to date, for example the reviews in the Cochrane Database of Systematic Reviews. The Department of Health’s R&D Programme also funds an excellent abstracting service of systematic reviews through the Centre for Reviews and Dissemination in York. NPFIT/Bestcurrentevidence/29.3.06 13 A guideline has been defined as “systematically developed statements to assist practitioner and patient on decisions about appropriate health care for specific clinical circumstances”. The adverb “systematically” refers in part to the basing of a guideline on a systematic review, although it also includes other steps including the involvement of clinicians and patients in the production of the guideline. One of the criteria used for the inclusion of guidelines in the National Library for Health’s “Guidelines Finder”, to be re-launched as the National Library of Guidelines, is that they are prepared on a systematic review of the literature. Systematic reviews and guidelines are often, of necessity, complex documents, and although their results are expressed in a structured abstract, they are not particularly easy for the busy clinician to use, and for this reason synopses are required. 6.3 Synopses A synopsis is a document prepared about a clinical topic, based on a systematic review of the evidence but designed primarily for readability and usability. Obviously there is a risk that something is lost in distillation but the producers of quality assured synopses take steps to ensure that this is not a major problem, for example by checking back with the authors of the original guideline or systematic review. One of the standards set by the National Knowledge Service is that knowledge should be able to be read in under 15 seconds with the synopsis itself being able to be read in two minutes. The production of 15 second reads offers the opportunity for embedding knowledge within synopses. 6.4 Systems The National Knowledge Service is also responsible for the National Clinical Decision Support Service, on which it works with the National Institute for Health and Clinical Excellence (NICE). A paper describing the decision support service is attached as Appendix 2. There are two different ways of considering knowledge delivered as part of systems. The first relates to the representation of knowledge, the second to the relationship of the knowledge to the decision. 6.4.1 Representation of knowledge Study reports, systematic reviews, and synopses are documents written in flowing prose. Knowledge can, however, be presented in different ways. An integrated care pathway is a document that describes the process in a discrete element of a service. It may be represented as a pathway, for example in the Map of Medicine which uses elegant software to represent pathways diagrammatically, or it may be represented to the clinician as a form which guides the clinician, or the patient because many pathways are used by patients, through a process of gathering and assimilating knowledge. A National Library of Pathways is being developed and will be launched in 2006. NPFIT/Bestcurrentevidence/29.3.06 14 At certain points in the pathway tools are made available to the clinician to help with decisionmaking, and simple rules can be incorporated. A National Library of Tools and Rules is being developed to complement the National Library for Guidelines and the National Library of Pathways (Appendix 3). The availability of knowledge presented as tools and rules allows this incorporation in all the documents that are routinely used in health care, and the tools and rules that are being assembled will need to be made “machine readable” for easy incorporation in the Care Record Service and related documentation. 6.4.2 Relating knowledge to decision-making The distinction made in the work being done to develop a National Decision Support Service between knowledge support and decision support has proved useful. In knowledge support the clinician or patient is offered knowledge based on a single piece of clinical information, for example the patient’s diagnosis. In this context the computer is strengthening and supplementing the memory of the clinician. There is good evidence that this approach, often delivered as prompts and sometimes as reminders and alerts, is effective and cost-effective. A second approach has been to seek to use computers to replicate the powers of inference of the clinician. The diagram that has been used to described decision-making processes is set out below and the primary function of knowledge support is to provide evidence where and when it is needed (Figure 3). Knowledge Support provides evidence ‘just in time’ Evidence The values the patient places on benefits and harms of the options Choice Decision Patient’s clinical condition; other diagnoses & risk factors Figure 3 NPFIT/Bestcurrentevidence/29.3.06 15 Computer-based decision support seeks to combine the evidence with the patient’s condition. At present there is little research to support the widespread use of computers in this way but research should continue in this area and will be done in partnership with NICE. It is important also to emphasise that patient decision aids, which allow the patient to reflect not only on the evidence and how it relates to their condition but also on their values, have been shown to be effective in improving decision quality and are being supported by the National Knowledge Service. 7. The evidence base available at 31 March 2006 7.1 Evidence produced by national agencies Each year the Department of Health and NHS spend about £100 million producing knowledge of high quality. The agencies listed below are major producers of knowledge for busy healthcare professionals and patients: the Department of Health’s guidance and knowledge base, including that of the are Service Improvement Partnership; the NHS Institute; NICE; the National Patient Safety Agency; the Medicines and Healthcare Products Regulatory Agency; the National Screening Committee; the Health Protection Agency; the British National Formulary; the HTA and Service Delivery and Organisation Reports of the NHS R&D Programme; the UK National Screening Committee; NHS Direct new media; the Social Care Institute of Excellence; the products of organisations acting as agencies for, or on contract to, these organisations, for example the National Histopathology Academy, the National Radiological Academy, the Pathology Modernisation Programme, and Royal College and professional association guidelines that meet adequate quality standards. These producers of knowledge provide both studies and systematic reviews. Increasingly they are also providing synopses, and in future they will provide very small knowledge objects that can be inserted into, for example, laboratory request forms or radiology reports or other types of “knowledge vector” and resources are included in the plan to facilitate this. The procurement of an NHS-wide search engine will allow all of these sources to be searched through a one stop shop. NPFIT/Bestcurrentevidence/29.3.06 16 7.2 Procured information 7.2.1 Studies A wide range of journals are procured by libraries with a number of library services procuring variations on a common core. Many of these are now made available digitally through the Core Content contract.. Librarians, the most valuable resource in any library, are being helped to improve their skills in educating clinicians. 7.2.2 Systematic reviews and guidelines The main sources of systematic reviews at present are the Cochrane Database of Systematic Reviews and the Database of Reviews of Effectiveness, but the specialist libraries of the National Library for Health will be asked to identify other systematic reviews. Discussions are currently taking place with the publisher of the Cochrane Database of Systematic Reviews with a view to obtaining these without cost because of the investment the Department of Health currently makes in the Cochrane Collaboration. A wide range of guidelines are produced either by the Department of Health and other national bodies or by national professional societies. These are assembled in the Guidelines Finder of the National Library for Health which will be re-launched as the National Library of Guidelines. 7.2.3 Synopses Currently there are five synopses services available to clinicians. These are produced in a relatively unco-ordinated fashion, with the contracts being held by different parts of the Department and Connecting for Health. The relationship of these is shown in Figure 4. NPFIT/Bestcurrentevidence/29.3.06 17 GP Notebook Clinical Evidence Prodigy Mentor BNF Figure 4 These resources are: Mentor, made available to 60% of primary care staff though the EMIS system; GP Notebook, available through the Isoft GP system and now working in partnership with Mentor; the British National Formulary, made available to all clinicians, and now supplemented by the British National Formulary for Children; Clinical Evidence, procured from BMJ Knowledge by Connecting for Health; Prodigy, procured from the Sowerby Centre for Health Informatics Ltd by Connecting for Health. In addition there are two other synopses which are produced on a regular basis but are not comprehensive knowledge bases. These are: the Drugs and Therapeutics Bulletin, procured by the Department of Health from the Consumers’ Association; and the Bulletins from the National Prescribing Centre which are commissioned by NICE. Of course many of the producers of Departmental guidance also produce synopses of guidance and the position for medicines is particularly complicated, as shown in Figure 5. NPFIT/Bestcurrentevidence/29.3.06 18 GP Clinical Prodigy Notebook Evidence FDB & Multium ukmi BNF Mentor DTB NICE MHRA NPC NPSA Figure 5 The development of a National Library for Medicines is a high priority for the National Knowledge Service. It is important to note that some of the GP information systems use synopses which carry drug advertising. The Service Implementation Board of Connecting for Health wishes this practice to cease. 7.2.4 Systems at present At present the delivery of evidence through systems is chaotic. Numerous tools and rules and a few decision support systems are in place but virtually none have been formally appraised, and very few are derived from the systematic reviews described in the previous section. 8. Best Current Evidence Base – Development Plan 2006/7 8.1 Studies A number of changes are taking place in journal publishing and distribution which will have an impact on anything done by the NHS, notably: the move to open access publishing, namely the requirement by research funders that the products of their investment will be made available without charge to the reader; NPFIT/Bestcurrentevidence/29.3.06 19 the development of digital document delivery; the move away from paper to digital journal publication. To provide a service for clinicians, patients and those who manage health care it is necessary to put in additional quality filters; peer review is necessary but not sufficient. 8.1.1 The MORE Service The team at the Health Informatics Research Unit in McMaster University has been responsible for developing the filters used in the PubMed search engine of the National Library of Medicine. Furthermore, no team in the world has done more research on the quality of articles published in the scientific literature. This gives them a unique opportunity to develop a knowledge filtering service. Funded by the National Library of Medicine and the government of Canada, they have developed a service to provide to physicians and nurses working in rural Canada a subset of the scientific literature, about 1%. The first step in the process is the identification of high quality articles and a team of trained librarians undertakes this task. An international panel of clinicians then assesses the articles found for relevance and novelty. At present the 120 most important medical journals are searched, and although this does not cover the needs of all health care professionals the possibility of accessing the MORE knowledge service would allow us to offer to clinicians a knowledge service in which 99% of poor quality articles had been filtered out. 8.1.2 Procurement of journals of secondary publication A journal of secondary publication is one that uses a system like the system which leads to the production of the MORE knowledge service; in the case of some journals of secondary publication the MORE service is the service used. The articles found are then turned into structured abstracts, because in most journals the preparation of abstracts is biased, leading to an over-emphasis on the positive aspects of a research report, and the structured abstract is then strengthened by the provision of a declarative title, namely a title that summarises the conclusion and not the objective of the research project. These journals of secondary publication also produce the literature for a specialty to about 2% of the total literature published in the relevant journals, and such journals exist for: nursing; medicine; dentistry; mental health. The procurement of access to the journals of secondary publication digitally as part of the Core Content Service would allow nurses, mental health professionals, physicians and dentists easy access to a highly filtered and structured subset of the relevant literature relating to about 400 journals. NPFIT/Bestcurrentevidence/29.3.06 20 8.1.3 The development of National Knowledge Weeks The specialist libraries of the National Library for Health, in partnership with NHS and Higher Education libraries, are now developing National Knowledge Weeks, namely weeks in which they will present to the service all of the important information published in the preceding year. For example, in the first of these weeks the 8,569 articles published on breast cancer were reduced to less than 50 articles by the National Library for Cancer. In the long term it is planned to develop National Knowledge Weeks for the 50 most common health problems. 8.1.4 Improving the quality of the knowledge found The steps listed below are being taken to improve the quality of the knowledge found by readers searching journals. A request has been made to the Core Content Purchasing Group to purchase all of the journals of secondary publication. Each of these has an explicit methodology for selecting journal articles and the process usually results in no more than one or two percent of articles in journals being presented to the reader. The National Knowledge Service has commissioned the Centre for Statistics in Medicine at Oxford to promote the use of CONSORT and other tools to improve the quality of research reporting (www.nks.nhs.uk). The National Library for Health, with the support of the National Knowledge Service, is negotiating for access to the article filtering process managed by the Health Informatics Research Unit at McMaster University. In this process over a hundred journals are scanned regularly by a team of librarians specially trained and working to explicit quality criteria. They select articles that are methodologically sound, and these are then appraised for their relevance and novelty by a panel of clinicians. The Knowledge Management Specialist Library will make critical appraisal checklists available. 8.1.4 Caveat lector Priority will continue to be given not only to the education of clinicians and patients in the skills of critical appraisal but also to the development of librarians as educators. 8.2 Systematic reviews and guidelines In addition to establishing best links to the guidelines being produced by Departmental and national bodies, the National Knowledge Service will also seek to provide access to high quality systematic reviews. The MORE service will also identify systematic reviews which are not Cochrane Reviews as part of this service. Open access to the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effectiveness, the reviews produced by R&D, and the reviews which underpin NICE guidance, provide a firm foundation for clinicians and patients. NPFIT/Bestcurrentevidence/29.3.06 21 8.2.1 The Database of Abstracts and Reviews of Effectiveness This database is maintained by the Centre for Reviews and Dissemination which is supported by the Department of Health and these reviews will be included in the National Library for Health search engine. 8.2.2 DUETS The Database of Uncertainties about the Effects of Treatments systematically identifies questions for which there is no answer expressed in a systematic review. This database, which can be described as expressing certain uncertainty, namely emphasising that no-one knows the answer, will be used not only to provide information to clinicians and patients but also to provide invaluable input to the research process by indicating research priorities. 8.2.3 National Library of Guidelines A National Library of Guidelines will be launched in 2006, in partnership with NICE. 8.3 Synopses The following work will be undertaken in 2006/7. 8.3.1 Mentor and GP Notebook Mentor is available to only 60% of GPs at present. Some other GP information system providers provide synopses that include pharmaceutical company information and advertising. Priority must be given to replacing this during 2006/7. 8.3.2 Prodigy and Clinical Evidence The contracts for these two synopsis services come to an end this year and the business case for their replacement was approved by Connecting for Health in September 2005. 8.3.3 Integrating synopses Priority will also be given to helping those who prepare systematic reviews, for example NICE and the R&D Programme, to produce a quality readable synopsis to complement the high quality systematic reviews they already produce. The procurement of synopses will be to complement and supplement the resources produced by the Department of Health and related national bodies. 8.3.4 Development of the National Library of Medicines The National Library for Health will be responsible for organising all the knowledge about medicines in a more systematic fashion. Discussions will take place with the relevant part of the Department of Health responsible for the Drugs and Therapeutics Bulletin, with the British National NPFIT/Bestcurrentevidence/29.3.06 22 Formulary, and with NICE which is responsible for National Prescribing Bulletins, to ensure that there is an integrated source of medicines knowledge based on the British National Formulary and available both digitally through searching and incorporated into the electronic prescribing service. 8.3.5 Evidence-based books By nature of the publishing process, books can get out of date between editions unless they are produced by “print on demand”. Work is starting in McMaster University to develop quality criteria for books, either paper or digital, which would allow the reader to know the currency and quality of the knowledge provided. The National Knowledge Service will support this work. 8.3.6 Quality assurance of synopses Lost in translation is a common experience and any attempt to précis a long document or present it in other ways means careful handling. At present the methods used by Prodigy are run through an Audit Committee chaired by the Director of Clinical Knowledge, Process and Safety. Explicit methods for ensuring the quality and safety of the other synopses need to be developed. 8.4 Systems – a National Decision Support Service The development of the National Library of Rules and Tools and the National Library of Pathways, and the signing of a contract with the Map of Medicine, will allow the systematic appraisal of rules, tools, and, pathways to be organised. The work with NICE to develop criteria and methods for appraising decision support systems will also make an important contribution to the development of a National Decision Support Service (Figure 6). NPFIT/Bestcurrentevidence/29.3.06 23 Evidence from the National Library for Health National Library of Tools and Rules National Library of Guidelines National Library of Pathways National decision support service Common user Interface team Local Health Communities Map of Medicine NASP’s EMIS CSC Accenture BT Fujitsu iSoft IDX Cerner Figure 6 8.4.1 Quality assurance of the Map of Medicine An process analogous to that used for synopses arises with the Map of Medicine which is a framework for knowledge and not the originator of knowledge. Nevertheless, the translation of a document that may be 100 pages or more long into five or six pathways offers the opportunity for differences to occur during the process of translation. The Map is currently available to 60% of the country through Accenture and CSC. Negotiations are taking place which will lead to a contract between Connecting for Health and Informa, the company owning the Map, which will allow the investment of resources, for example to allow a clinician from the British Society of Gastroenterology to work closely with the Map team on the development of pathways derived from BSG guidance. In the interim the Map pathways are checked by the Directorate of Clinical Knowledge, Process and Safety which has responsibility for the quality of the knowledge of the NHS, to ensure a single knowledge source. The focus has been on the safety of the Map and, with the ability to look at the processes used by the Map, and a report has been made to the Risk and Safety Board of Connecting for Health that the Map presentation of knowledge is at least as safe as any other form of synopsis currently offered to the NHS. It is important to note that there is no scrutiny at all for some of the knowledge made available to clinicians or patients. NPFIT/Bestcurrentevidence/29.3.06 24 9. Scope of Best Current Evidence Priority will be given to the more common conditions. The “Big Fifty” list prepared for the Do Once and Share project lists those conditions which make the biggest use of health service resources, and the specialist libraries will focus primarily on them. These conditions are listed below. Allergy Intensive care Alzheimer’s disease Renal failure Child health Oral health Asthma TB HIV and AIDS Prostate hypertrophy and cancer Stomach cancer Bowel cancer Skin cancer Breast cancer Lung Cancer Rheumatoid Arthritis Osteoarthritis Glaucoma Visual failure Deafness Stroke Parkinson’s Epilepsy Multiple sclerosis Sexual health Headache Chest pain Heart failure and rhythm disorders Coronary disease Diabetes Renal failure Falls Complex problems of later life Incontinence Inflammatory bowel disease Hepatitis and Liver failure Disability Pain COPD (Bronchitis) NPFIT/Bestcurrentevidence/29.3.06 25 Psoriasis Acne Eczema Dysmenorrhoea and Menorrhagia Antenatal care Depression Schizophrenia Drug and alcohol dependence Osteoporosis Obesity From the point of view of primary care, however, there is a much wider range of conditions which are now dealt with in a variety of settings, for example walk-in centres. A review was conducted of the existing sources of knowledge by a knowledge management company called Bazian and they found, as expected, overlaps and gaps. In addition to ensuring that the Big Fifty problems, listed below, are covered, the 500 most common problems encountered in primary care will also be covered by a synopsis service (Appendix 4). For each of these conditions and health problems, synopses will be procured relating to: prevention; screening, if relevant; diagnosis; self-care and informal care; treatment; drug treatment; complementary medicine; long-term care; service organisation. 9.1 Rare diseases Rare diseases require separate consideration. The National Office for Rare Diseases in the United States has about 6,000 conditions on its inventory, many of which will be encountered only once or twice in the lifetime of a clinician. A project will be carried out in 2006/7 to develop a National Library for Rare Diseases, perhaps giving direct access to web sites approved by the National Office for Rare Diseases or, in the UK, by Contact a Family, a charity with a special interest in rare diseases. Other sources of information about rare diseases are found in the disciplines of clinical genetics and the medical and laboratory specialty dealing with inherited metabolic disorders, and these two will be included in the National Library for Rare Diseases development project. NPFIT/Bestcurrentevidence/29.3.06 26 10. Best Current Evidence and the National Library for Health The production and procurement of Best Current Evidence is the first step in the development of a National Knowledge Service. The evidence has to be organised and delivered, and this paper needs to be read in association with the strategy for the National Library for Health. J A Muir Gray, CBE, DSc, MD, FRCP, FRCPSGlas, FCILIP Director of Clinical Knowledge, Process and Safety NPFIT/Bestcurrentevidence/29.3.06 27 APPENDICES 1. Improving the quality assurance of knowledge for clinicians and patients 2. Decision Support Programme – knowledge support, computer-based clinical decision support systems, and patient decision aids 3. National Library of Tools and Rules – project initiation document 4. The 500 most common problems encountered in primary care NPFIT/Bestcurrentevidence/29.3.06 28 APPENDIX 1 IMPROVING THE QUALITY ASSURANCE OF KNOWLEDGE FOR CLINICIANS AND PATIENTS J A Muir Gray Version Date Version 1.0 17 November 2004 Version 2.0 7 December 2004 Version 3.0 8 July 2005 Version 4.0 21 December 2005 Version 5.0 2 March 2006 NPFIT/Bestcurrentevidence/29.3.06 Prepared by J A Muir Gray J A Muir Gray following review by Paul Glasziou, Director of Centre for Evidence-Based Medicine J A Muir Gray following meeting with Tom Jefferson, author of Peer Review in Health Sciences J A Muir Gray J A Muir Gray – addition of evidence contained in references 17, 29, 30, 31, 32. 29 EXECUTIVE SUMMARY The peer review research report about an intervention with apparent clinical benefit should not be used by a reader, either clinician or patient, unless it is a report of a systematic review of the literature on a particular topic. Important safety information is an exception, but this type of knowledge should be actively implemented and not disseminated through journal publication. Research reports published in journals are primarily written by researchers for researchers. Clinicians, managers and patients cannot rely on the peer review process alone and should be offered, and use, resources which have been treated by additional measures to minimise bias and error. NPFIT/Bestcurrentevidence/29.3.06 30 PROVIDING CLEAN CLEAR KNOWLEDGE FOR BUSY CLINICIANS AND PATIENTS The provocative title of a BMJ Editorial, The Scandal of Poor Medical Research (1), highlighted two major problems of clinical research that was either badly designed or badly conducted, or both. To this pair a third problem can now be added – poor reporting. This has very significant implications for clinicians and those who educate them because the scientific approach to medical education has, until recently, emphasised the need for clinicians to look to journals to answer questions and to put their faith in peer reviewed articles as quality assured and reliable knowledge. 1. Misplaced faith in peer review There is evidence that peer review and editing can improve the quality of medical research reporting (2) but peer reviewing, although beneficial, has severe limitations. Clinical journals consist of a number of different types of documents, of which the two main types consulted by readers in search of evidence were, for many years, review articles, including editorials, and peer reviewed articles. In the former some senior member of a specialty or profession was asked to review a topic and the review was published backed by their reputation and sapiential authority. These review articles were popular because they were often written for the clinician, whereas the peer reviewed reports of research were written primarily by researchers for researchers. Useful though such reviews and editorials were, their deficiencies were also significant, as two landmark studies in the eighties revealed (3, 4). These classic studies had two effects. The first was to highlight the need for systematic reviews of research which were explicit in their methods of literature searching, appraisal and data synthesis, culminating in the creation of the Cochrane Collaboration which was committed not only to these principles but also to the need to ensure that the reviews were kept up to date. The second effect was to highlight the benefits and weaknesses of the peer review process. Review articles written by a person generally considered to be an authority were usually only scrutinised by the editor and not reviewed by the writer’s peers, namely other authorities than the one who had been invited to write; they were not peer reviewed. For this reason the term “peer reviewed” came to be synonymous with the term “quality assured”, but the peer review process, although an improvement on the editor’s scrutiny, was shown to have many flaws when it itself was examined (5). 2. The failures of peer review Because of the “scandal of poor medical research” (1), which had obviously existed long before this article, peer review was introduced but peer reviewers fail to spot errors of chance and bias. For example studies that have yielded relatively dramatic results are more likely to be cited in reports of subsequent similar studies than previous studies yielding unremarkable point estimates of effects, and in a study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis, Rochon and colleagues found that the data presented did not support the claims made about toxicity in about half the articles (6). Anyone managing or using scientific literature needs to understand the weaknesses of peer review. NPFIT/Bestcurrentevidence/29.3.06 31 2.1 The failure of peer review to spot poor literature retrieval Recent research has shown that the very foundation of the scientific article, namely the prior state of knowledge on which the research hypothesis was formulated, is all too often flawed. In a landmark article Chalmers and Clarke (7) examined reports of randomised controlled trials in a single month in the five major medical journals. The results are shown below (Figure 1). Discussion sections in reports of controlled trials published in general medical journals: Islands in Search of Continents Clarke M and Chalmers I (1998) JAMA, 280: 280-282 Method: 26 trials published in the Big 5 general medical journals (Lancet, BMJ, NEJM, JAMA and Annals) in May 1997 were appraised. Six of the 26 trials claimed to be reports of the first trial addressing a particular question. However, “following a search of the Cochrane Controlled Trials Register and discussions with relevant Cochrane Review Groups, similar previously published trials were identified for 5 of the 6 trials. 26 trials 1 report was of a genuine first trial 2 reports discussed the results in the context of a systematic review 4 reports mentioned previous systematic reviews but made no effort to integrate the results of the trials in these reviews 19 reports gave no information about how the trials cited in the references were identified or selected Figure 1 NPFIT/Bestcurrentevidence/29.3.06 32 Depressingly they found that the position had not improved three years later (8). What this demonstrates is that research studies are based on an inaccurate estimate of the current state of knowledge and then fail to add any results that emerge from the study to the existing knowledge base, thus making it very difficult for the reader to assess their implications. 2.2 The failure of peer review to detect statistical problems Some of the problems in the published reports of randomised controlled trials may be very difficult for the busy clinical reader to spot, as a recent analysis by statisticians of fifty clinical trials in a three month period in four top journals – BMJ, JAMA, Lancet and New England Journal of Medicine – demonstrated (9). The findings of the review included: “about half the trials inappropriately used significance tests for baseline comparison”; “methods of randomisation …. were often poorly described”; “two-thirds of the reports presented sub-group findings, but most without appropriate statistical tests for interaction”; “many reports put too much emphasis on sub-group analysis that commonly lacked statistical power”. Another review (10) concluded that the CONSORT Statement which recommended a standard approach to the reporting of clinical trials, has not yet produced a standardised approach to reporting. They conclude that “there are substantial risks of exaggerated claims of treatment effects arising from post-hoc emphases across multiple analyses. Sub-group analyses are particularly prone to over-interpretation and one is tempted to suggest “don’t do it” (or at least “don’t believe it”) for many trials. 2.3 Failure of peer review to spot unsystematic systematic reviews Words are tools. A word initially performs helpful functions, defining and clarifying the concept or object and providing a new tool for people to use. However, as the word gets more widely used, its meaning often changes or multiplies, and there comes a time when a word has so many meanings that it causes more confusion than clarity; one of the principles of linguistic philosophy, proposed by Wittgenstein, was that when a word caused more confusion than clarity it should be discontinued. The term “systematic review” is still a useful term if rigorously defined but it can no longer be accepted on face value as indicating reliable evidence, for there is good evidence that systematic reviews are often unreliable. A critical evaluation of systematic reviews and meta-analyses on the treatment of asthma (11) found that of all the 50 systematic reviews and meta-analyses included in the study: NPFIT/Bestcurrentevidence/29.3.06 33 12 reviews were published in the Cochrane Library and 38 were published in peer review journals; 40 of the reviews were judged to have “serious or extensive flaws”; all 6 reviews associated with industry had “serious or extensive flaws”; 7 out of the 10 most rigorous reviews were published in the Cochrane Library (Table 1). Most rigorous Least rigorous Cochrane Reviews 7 5 “Systematic reviews” in peer reviewed journals 3 35 Table 1 The critiques of review articles published in 1987 and 1988 have been repeated, and a team carrying out an analysis of “review articles” identified 158 review articles in 12 “core” medical journals, using the Science Citation Index to define the core journals. Of the 158 review articles: only 2 satisfied all 10 methodological criteria of good quality; less than one quarter described how evidence was identified, evaluated or integrated; of the 111 reviews that made treatment recommendations, only 45% cited randomised controlled clinical trials to support their recommendations (12). 2.4 The failure of peer review to spot duplicate publication In a study of “covert duplicate publication” (13), the authors found: 17% of published full reports of trials and 28% of patient data were duplicated; none of these reports cross-references the original source; covert publication can take place because articles submitted for publication are “masked” by change of authors or language or by adding extra data; duplication [of data] leads to an overestimation of ondanestron’s antiemetic efficacy by 23%; trials reporting greater treatment effects were significantly more likely to be duplicated. Peer review is the best process that we have at present but it is not a reliable process for producing journal articles, particularly for busy clinicians who have to read at speed. NPFIT/Bestcurrentevidence/29.3.06 34 3. Positive publication bias The general effect of these flaws in the peer review system is to emphasise the beneficial effects of interventions and therefore lead the reader to overestimate the benefits and underestimate the harms of an intervention. These effects are compounded by other factors with the same effect, for example the tendency of authors to submit, and editors to publish, studies with a positive result rather than no result. The combined effect is known as positive publication bias and one estimate is that this bias overestimates the benefits of treatments by up to one-third (14). 4. Solutions For all these reasons services which can help the busy reader compensate for, and mitigate the effects of, these problems are needed. There are a number of actions that can be taken, each focusing on a different part of the knowledge production line. 4.1 better reviewing and selection of research applications; better conduct of research; more complete and accurate reporting; better reporting; filtering out of poor quality research before publication; systematic reviews of high quality research; regular updating of systematic reviews; critical appraisal skills training for peer reviewers and clinicians. Better reviewing of research applications The failure of peer review occurs not only in journal editing but also in research management (5). Steps taken to improve research governance should include steps taken to improve the process of peer review, particularly the need to base research on a comprehensive synthesis, or systematic review, or previous work in the field. 4.2 Better conduct of research Even when the correct method has been chosen, it still has to be managed, and steps have been taken to provide better information for trials managers and other research managers which will reduce this problem even though it will never be solved. 4.3 More complete reporting An important cause of positive publication bias is the failure of researchers, particularly those supported by the pharmaceutical industry, to report negative findings. It is only by relating the outputs of research to registers of trials approved for implementation that the failure to report negative findings can be identified, and, after thirty years of campaigning, steps have been taken to ensure that all trials will be registered in future; as a Leader in JAMA said: “a great idea switches from ignored to irresistible” (15). The systematic review of clinical trials stopped earlier than NPFIT/Bestcurrentevidence/29.3.06 35 planned because of apparent benefit (16) concluded that: “clinicians should treat the results of such trials with scepticism” because they were incomplete reports. 4.4 Better reporting The 21st century should not, however, be viewed as a time when this paradigm was realised. In a trenchant report of a study in which Chalmers and Clarke repeated their study of discussion sections of controlled trials four years after the first study, and after the publication of CONSORT guidelines which were intended to improve the reporting of controlled trials, they came to a sombre conclusion. Their conclusion was that: “Between 1997 and 2001 there was no evidence of progress in the proportion of reports of trials published in general medical journals that discussed the new results written in the context of, or with reference to, up-to-date systematic reviews of relevant evidence from other controlled trials” (8). However, other aspects of trial reporting had appeared to improve. It is important to emphasise the many weaknesses in the peer review process, if only because many professionals assume that “peer reviewed” means “quality assured”. The more closely journals are studied, the more problems are found. For example, one study comparing the protocols of randomised controlled trials to the published articles found that the reporting of trial outcomes was frequently incomplete, was also biased, and inconsistent with protocols. 50% of outcomes relating to efficacy and 65% of outcomes relating to harm in the controlled trial protocols were incompletely reported. Even more worryingly, when the authors of the articles were contacted, 86% denied the existence of unreported outcomes “despite clear evidence to the contrary” (17). Even when journal editors try to help the reader by introducing structured abstracts, and the case for structured abstracts is very strong, these abstracts do have their problems and can themselves contributed to positive reporting bias. For this reason the Annals of Internal Medicine, which first introduced structured abstracts, has now included a compulsory section called “Limitations” which is put immediately before “Conclusions” because, the editors surmised, this was “a spot that should attract the attention of the most hurried reader” (18). Obviously this is an evolving field and CONSORT is continually renewed, improved and extended (19). For example, “because CONSORT is primarily aimed at improving the quality of reporting efficacy”, members of the CONSORT group published a new CONSORT statement with “10 new recommendations about harm related issues” in 2004 (20). In addition a number of other similar tools have been introduced, notably: QUOROM, for “Improving the quality of reports of meta-analyses of randomised controlled trials” (21); STARD, an initiative “towards complete and accurate reporting of studies of diagnostic accuracy (22); STROBE, an initiative to improve the “Standards for the Reporting of Observational Studies in Epidemiology”, the need for which was highlighted in an editorial entitled “The Scandal of Poor Epidemiological Research” (23), used by the British Medical Journal to draw attention to the importance of an article reporting “issues in the reporting of epidemiological studies” (24). This is the report of a study of 73 articles in public, environmental and occupational health journals with an impact greater than 2, leading general medical journals and the highest impact journals in circulation, and cancer. The result of the study was that “there is a serious risk that some epidemiological studies reach the wrong conclusion”. NPFIT/Bestcurrentevidence/29.3.06 36 5.5 MOOSE, an initiative to improve the reporting of meta-analyses of observational studies (25). Selection of better quality articles for clinicians and patients In the last ten years a number of organisations have been developed to undertake the tasks of: purifying the “primary research” evidence by identifying studies of low quality, even though they have been peer reviewed; synthesising the results of high quality studies, if necessary using the technique called metaanalysis to combine the statistics of individual studies; writing the conclusions in a style that is useful for busy clinicians and patients; keeping the evidence base up to date by identifying new studies of high quality for inclusion in the synthesis of research. 5.5.1 Purification The first step in synthesising research is the removal of impurities, namely the identification and removal of studies which, although they have passed the peer review filter, have such significant flaws in methodology that they are unfit to be included in the systematic review of the research evidence. Explicit criteria are used to appraise articles, all of them based on the work originally done by clinical epidemiologists at McMaster University and published as a landmark series of articles in the Journal of the American Medical Association to constitute the scientific basis of critical appraisal. The impure articles are filtered out leaving only the pure articles, and these can be either converted into systematic reviews, or published in journals of secondary publication, or made available as a filtrate of the research literature. Three such filtrates are available: PEDro, a database of quality assured articles specifically aimed at physiotherapists; OTSeeker, a similar database specifically aimed at occupational therapists; MORE, a filtrate of general medicine and primary care journals which are used as the basis for the journals of secondary publication Evidence-Based Medicine, Evidence-Based Mental Health and Evidence-Based Nursing, and in addition are made directly available to clinicians in Canada who work in areas far distant from libraries. 5.5.2 Journals of secondary publication No-one can keep up with the literature; Dave Sackett estimated that a general physician would need to read about 19 papers a day simply to keep up. These 17 pages are a small subset of no more than 1,500 indexed in Medline each day so how can we find the right 19? During the 1990s, the American College of Physicians developed its ACP Journal Club, a journal which: developed explicit methods for scanning over 100 top medical journals; NPFIT/Bestcurrentevidence/29.3.06 37 selected journal articles based on strict and explicit quality criteria; selected a sub-set of these articles on the basis of their clinical relevance; prepared structured abstracts of the selected articles; invited a clinician with expertise in the topic to comment on the structured abstract; prepared a “declarative title” which summarised the finding of the research study in a single sentence that can usually be read in under fifteen seconds. This model of a journal of secondary publication has been, rightly, widely copied and there now exists: Evidence-Based Medicine, now twinned with the ACP Journal Club; Evidence-Based Mental Health; Evidence-Based Cardiovascular Medicine; Evidence-Based Oncology; Evidence-Based Nursing. These journals of secondary publication distil over 300 journals by selecting about two percent of the articles that are both of high quality and relevant to the target readers, and they represent a new and important source of quality improved knowledge. An analysis of the work of the team filtering out poor quality published articles to identify those that were both of good methodological quality and high clinical relevance revealed how much of the published literature does not meet those standards (26). They reviewed 170 journals for the year 2000 and of the 60,352 articles in these journals only 3,059 original articles and 1,073 review articles met those criteria. Furthermore, the journals did not make an equal contribution to this total. Journal title Contributions Number of journals in which no article met the criteria ACP Journal Club (Internal medicine) 4 titles contributed 56.5% 27 title contributed 43.5% 55 Evidence-Based Medicine (general practice/primary care) 5 titles contributed 50.7% 40 titles contributed 49.3% 0 Evidence-Based Nursing 7 titles contributed 51% 34 titles contributed 49% 33 Evidence-Based Mental Health 9 titles contributed 53.2% 34 titles contributed 46.8% NPFIT/Bestcurrentevidence/29.3.06 8 38 The authors introduced the criteria of journal usefulness called the NNR – the Number Needed to Read – namely, the number of articles that needed to be read before one that was of adequate quality and clinically relevant was found. Obviously in those in which no article was found the NNR was infinity but for many journals more than 100 articles had to be appraised by a trained librarian and then assessed by a clinician to identify a single article that was of adequate quality and clinically relevant. Top of the league table was the Cochrane Database of Systematic Reviews. 5.6 Systematic reviews The problems highlighted in the papers by Cindy Mulrow and Oxman and Guyatt had been tackled by the National Perinatal Epidemiology Unit in Oxford from 1979 onwards. This Unit undertook a programme of work to: find all the high quality evidence that was available, both published and unpublished; develop quality criteria to determine which of the evidence, published and unpublished, met explicit quality standards; combined those pieces of evidence that met these explicit criteria into what became known as a systematic review; when data are combined, a technique called meta-analysis can be used, but it is not necessary to carry out meta-analysis within a systematic review and the two terms should not be regarded as synonyms. These systematic reviews covered the field of antenatal and perinatal care and, based on this experience, the Director of the National Perinatal Epidemiology Unit, Iain Chalmers, proposed to the first Director of the National R&D Programme in England that the same method be used to cover the whole of healthcare. The R&D Programme funded a Centre to do this work and the UK Cochrane Centre was created when Scotland, Wales and Northern Ireland joined with the English R&D Programme to support this programme of work. The UK Cochrane Centre was able to build on the work done by the National Perinatal Epidemiology Unit, not only because of the accumulated expertise in preparing systematic reviews but also because of the dramatic developments that took place in the early 1990s in the Internet and the various tools that were developed to create the World Wide Web. From the work of the UK Cochrane Centre the international Cochrane Collaboration has developed, committed to the production, maintenance and dissemination of reviews of the effects of healthcare. The characteristics of Cochrane Reviews, which are a sub-set of systematic reviews, are that, in addition to the basic characteristics listed above, they: are kept regularly up to date; involve consumers at all stages in the process; are published only electronically, in the Cochrane Library. Systematic reviews can be prepared on any type of research finding and it is important that the term should not be regarded as applying only to systematic reviews of randomised controlled trials. It is, for example, possible to carry out a systematic review of qualitative research. NPFIT/Bestcurrentevidence/29.3.06 39 As with peer review, which for many years has been regarded as a synonym for dependable quality assurance, the fact that something is called a systematic review should not lull the reader into accepting everything that is written simply because the authors say that it is a systematic review. All that glisters is not gold; some reviews that claim to be systematic are not. 5.7 Regular updating The evidence that a significant number of trials published in high prestige journals were contradicted by subsequent articles emphasises the need that readers who are completely conversant with the literature about a particular topic, that is anyone who is not actively involved in either preparing or maintaining a systematic review, or in gathering new data based on a systematic review, should not change their practice on the basis of a single paper (27). Although Cochrane Reviews are noted for their commitment to updating, all documents have to be updated either explicitly and regularly or treated with caution. 5.8 Developing the skills of critical appraisal Readers should be suspicious of everything they read, no matter the eminence of the author or the venerability of its source. They must learn to appraise papers and all sources of medical information, including guidelines, advertisements, and articles in medical weeklies. They need to appraise papers not only for their research quality and the quality of reporting but also for their contribution to the solution of the problems of the individual patient or population for which the professional is responsible. This often requires results to be rewritten to make them more usable, for example by converting relative risk data into absolute risk data. 6. Being aware of certain uncertainty When a patient or professional is first faced with a problem they may be uncertain what to do, but this uncertainty is usually what has been called “uncertain uncertainty”, namely the decision-making does not know whether the knowledge that would help them make the decisions exists or not. By organising knowledge properly, as described above, the person looking for knowledge can quickly find whether an answer exists or whether no-one knows the answer, the latter type of uncertainty being known as “certain uncertainty”. The James Lind Library has set as its mission the development of a database of uncertainties about the effects of treatments which will register the uncertainties which cannot be solved by the rigorous analysis and appraisal of the research literature. This initiative, called DUETS, will allow the knowledge cycle to be completed because it will allow a feedback to be built into the system so that those who procure and produce knowledge are clear about the unanswered questions of professionals and patients (28). NPFIT/Bestcurrentevidence/29.3.06 40 7. Supporting systematic reviews The investment of resources in the production of systematic reviews by research funders is now having a major impact, and meta-analyses are now cited more often than all other study designs (29). The promise of increased investment in the Cochrane Collaboration made buy the English Department of Health in its new R&D Strategy Best Research for Best Health (30), and the outputs of the Centres for Evidence-Based Practice on both healthcare and systematic review methodology summarised in a supplement to the Annals of Internal Medicine (31) will lead to further improvements in the quality of systematic reviews. Not all systematic reviews are good reviews (32). 8. Supporting editors and peer reviewers Of central importance in the improvement of research reporting is the contribution made by journal editors. The publication of the Journal of the American Medical Association on 5 June 2002 was based on the papers presented to the Fourth International Congress on Peer Review and Biomedical Publication held in Barcelona in September 2001, and the scope of work is impressive and encouraging, for example, the quality of peer review can be measured and reviewed systematically (33). A Fifth Internal Congress has taken place and further progress was made at that meeting. It would be expected that journal editors and publishers themselves should be primarily responsible for this activity but it is important that those who use evidence also contribute by supporting education and research in this area. 9. Taking action to help the busy reader The gap amount between the amount of information available and the time available to process it yawns increasingly wide. For this reason providers of information have to take steps to help readers but the process of synthesis and summarising is, as described above, one that can introduce bias. Busy clinicians and patients might be able to rely on peer reviewed reports of primary research but even if all articles conformed perfectly to standards and reported without abbreviation, using the Internet to supplement the conventional journal articles, the reader who is not familiar with all the relevant literature would struggle. Good quality systematic reviews are more reliable but may be equally difficult to read. What busy clinicians and patients need are synopses based on high quality systematic reviews (34), combined with the opportunity to know that there is no reliable evidence about a particular topic. Journals have a valuable contribution to make in research but not as a source of knowledge support for clinicians and patients. NPFIT/Bestcurrentevidence/29.3.06 41 References 1. Altman, D. The scandal of poor medical research. BMJ, 1994; 308: 283-4. 2. Goodman SN, Berlin J, Fletcher SW, Fletcher RH. Manuscript quality before and after peer review and editing at Annals of Internal Medicine. Ann. Intern. Med. 1994; 121: 11-21. 3. Mulrow CW. The medical review article: state of the science. Ann. Intern. Med. 1987; 106: 485-8. 4. Oxman AD and Guyatt GH. Guidelines for reading literature reviews. Can. Med. Assoc. J. 1988; 128: 697-703. 5. Jefferson T and Godlee F. Peer Review in Health Sciences BMJ Publications, 1999. 6. Rochon PA, Gurwitz JH, Simms RW. et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch. Intern. Med. 1994; 154: 157-163. 7. Chalmers I and Clarke M. 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Pocock SJ, Collier TJ, Dandreo KJ, de Stavola BL, Goldman MB, Kalish LA, Kasten LE and McCormack VA. Issues in the reporting of epidemiological studies: a survey of recent practice. BMJ. doi:10.1136/bmj.38250.571088.55 (published 6 October 2004). 25. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Bekcer BJ, Sipe TA and Thacker SB. For the Meta-analysis of Observational Studies in Epidemiology (MOOSE) Group. Meta-analysis of observational studies in epidemiology: a proposal for reporting. JAMA 2000; 283: 2008-2012. 26. McKibbon KA, Wilczynski NLK and Haynes RB. What do evidence-based secondary journals tell us about the publication of clinically important articles in primary healthcare journals? BMC Medicine, 2004; 2: 33-47. 27. Ionnides, JPA. Contradicted and initially stronger effects in highly cited clinical research. JAMA, 2005; 294: 218-228. 28. Chalmers, I. Well informed uncertainties about the effects of treatments. Brit. Med. J., 2004; 328: 475-6. NPFIT/Bestcurrentevidence/29.3.06 43 29. Patsopoulos NA et al. Relative Citation Index of various study designs in the health sciences. JAMA, 2005; 293: 2362-66. 30. Department of Health. Best Research, Best Health. London, 2006. 31. Atkins D, Fink K and Slutsky J. Better information for better health care: the EvidenceBased Practice Center Program and the Agency for Healthcare Research and Quality. Ann. Intern. Med. 2005; 142: 1035-41. 32. Biondi-Zoccai G, Lotrionte M, Abbate A, Testa L, et al. Compliance with QUORUM and quality of reporting of overlapping meta-analyses on the role of acetylcysteine in the prevention of contrast associated nephropathy: case study. BMJ, 2006; 332: 202-6. 33. Haynes RB. Of studies, summaries, synopses and systems: the 4 S evolution of services for funding current best evidence. Evidence-Based Nursing, 2005; 8: 4-6. NPFIT/Bestcurrentevidence/29.3.06 44 APPENDIX 2 DECISION SUPPORT PROGRAMME –KNOWLEDGE SUPPORT, COMPUTER-BASED CLINICAL DECISION SUPPORT SYSTEMS, AND PATIENT DECISION AIDS J A Muir Gray Version Version 1.0 Version 2.0 Author J A Muir Gray J A Muir Gray Date 20.09.03 26.11.03 Version 3.0 J A Muir Gray 2.12.03 Version 4.0 J A Muir Gray 17.12.03 Version 5.0 J A Muir Gray 21.12.03 NPFIT/Bestcurrentevidence/29.3.06 Amendments First draft prepared by NeLH Team. Comments by National Programme for IT incorporated Patient decisions aids and governance sections added, the latter after consultation with Chair of National Clinical Advisory Board Additional section on evaluation and quality assurance added, based on input from NHSIA Information Standards Board References to algorithms and clinical prediction rules 45 CONTENTS Executive Summary 1. Background questions and foreground questions 2. Three types of knowledge 3. Knowledge for diagnosis and knowledge for treatment. 3.1 3.2 3.3 4. Knowledge for diagnosis Knowledge for treatment Guidelines, protocols and pathways The determination of searches by people and machines 4.1 4.2 Person-determined delivery Machine-determined delivery 4.2.1 Knowledge support 4.2.2 Computer-based clinical decision support systems 5. The evidence base 6. Harnessing existing resources 6.1 6.2 6.3 6.4 6.5 Integrating knowledge and care records Knowledge support for diagnosis Knowledge support for treatment decisions Developing a framework for knowledge support Patient decision aids 7. Evaluation and quality assurance 8. Governance 8.1 8.2 8.3 8.4 9. Governance of content Technical standards Clinical governance Evaluation of decision support and decision aids Project management References NPFIT/Bestcurrentevidence/29.3.06 46 EXECUTIVE SUMMARY The aim of this paper is to set out definitions of a range of terms commonly used when knowledge is being mobilised and delivered to clinicians and patients. The paper covers terms such as guidelines, protocols and pathways. The definitions of these are set out below. Facts are propositions which describe relationships based on information, for example aspirin given to people who have had a myocardial infarction is associated with reduced risk of a second infarction. Guidance sets out for the health service a wide range of measures that should be put in place, including the configuration of services, for example guidance on cancer services includes action that the service should take to increase specialisation. Guidelines are propositions which either stand alone or appear in guidance documents which make recommendations relevant to patient and clinician behaviour, for example clinicians should discuss with patients the benefits and risks of aspirin following myocardial infarction. Protocols are local versions of guidelines, a definition introduced by the Changing Workforce Programme in 2003. A protocol would be a local version of guidance or guidelines which take into account local circumstances, for example the availability of CT scanning, and also summarise local responsibilities for different aspects of the guideline or guidance. Pathways are forms which set out the protocol, or guideline if there is no localised protocol, for clinicians to follow to minimise the risk of errors of omission or commission, and to ensure that the necessary data are collected for audit. Pathways, sometimes called care pathways, describe the patient journey, and the term patient journey is sometimes used as a synonym for pathway. They may also be called integrated care pathways if they cut across primary and secondary care. Pathways may be made available in either paper or electronic form. The paper also sets out definitions for different types of activity commonly referred to generically as “decision support”. It is recommended that the term “decision support” should not be used and that three terms be used in its place. Knowledge support when knowledge is delivered to clinicians and patients at the point of knowledge need, either in the form of facts or the form of guidelines or protocols, or embedded in the pathway; in knowledge support one variable in the patient’s condition, for example the diagnosis, is used to alert or remind the clinician, and if possible the patient, about the existence of relevant knowledge. NPFIT/Bestcurrentevidence/29.3.06 47 Computer-based clinical decision support systems are tools that incorporate two or more data items from the patient record and produce individualised advice about a particular patient’s clinical situation; clinical prediction rules serve a similar function. A clinical prediction rule or clinical decision rule has been defined as “a clinical tool that quantifies the individual contributions that various components of the history, physical examination, and basic laboratory tests make towards the diagnosis, prognosis or likely response to treatment in a patient. The term triage algorithm is used to describe rules used for rapid triage. These rules can be presented on paper or digitally. Patient group direction is the term applied when the clinical decision rule relates to treatment. Decision aids are tools primarily for patients but because they facilitate shared decision-making they also have implications for clinicians. In addition there is a need for a framework for knowledge support which allows such tools to be made available through the NHS Care Record Service. A project has been funded by the National Knowledge Service to develop the Decision Support Programme. This project would agree appraisal criteria that could be used when considering new tools and maintain an inventory of the tools deemed to be of sufficient quality to be used in the service. NPFIT/Bestcurrentevidence/29.3.06 48 SUPPORTING DECISIONS – COMPUTER-BASED KNOWLEDGE SUPPORT, DECISION SUPPORT SYSTEMS, AND PATIENT DECISION AIDS Clinicians ask questions frequently. The easier the access to knowledge, the more often they ask questions, and by integrating NHS Direct Online, the National electronic Library for Health (NeLH) and the Integrated Care Record System (ICRS) it will be possible to provide clinicians, and patients, who share in many clinical decisions, with easy access to best current knowledge where and when it is needed. However, the terms “knowledge” and “decision support” are so widely used that they have different meanings to different individuals, and it is necessary to develop a common nomenclature for knowledge and decision support guidance. 1. Background questions and foreground questions In Evidence-based Medicine, David Sackett and colleagues distinguished between background and foreground questions (Figure 1). Background Foreground Figure 1 Background questions are general questions such as: “What are the symptoms of hyperthyroidism?” and “What are the best treatments for hyperthyroidism?”. Foreground questions relate to individual patients, for example: “Is drug A or drug B better for this 55-year-old woman with hyperthyroidism and rheumatoid arthritis?”. Students ask background questions; clinicians still have a need for background questions but increasingly formulate foreground questions and need support by the provision of knowledge. 2. Three types of knowledge The definition of the term “knowledge” is also necessary and for the purpose of this paper the definitions below have been used. Data are generated by research, by experience, and by the measurement of healthcare activity. Information is produced when data are assimilated into research reports or systematic reviews, audit reports, healthcare statistics, and case studies based on experience. NPFIT/Bestcurrentevidence/29.3.06 49 Knowledge is produced when information is mobilised for decision-making. Thus there are three sources of knowledge: research; regular or audit measurements of healthcare or public health activity; experience of professionals and the public. When dealing with individual patients the clinician needs knowledge from research but they often need knowledge from experience and obtain this from a colleague more experienced in the management of that particular type of problem. It is also important to distinguish between questions asked to establish a diagnosis and questions about treatment. 3. Knowledge for diagnosis and knowledge for treatment The types of knowledge required for diagnosis and treatment are different. 3.1 Knowledge for diagnosis The process of diagnosis is still poorly understood but diagnosis involves three questions: 1. on the basis of the patient’s symptoms and signs, what is the likely diagnosis, or diagnoses, on the basis of probability? This is the process of defining pre-test probability; 2. what test or tests would increase the probability of confirming a diagnosis or exclude some options? This is the process of test selection; 3. having the test results, how does that change the probability and does it result in a definite diagnosis? This is the process of defining the post-test probability which will exclude some of the options identified before testing and may confirm one of the options as the diagnosis. Knowledge about the pre-test probability is listed in what is usually called the differential diagnosis. Knowledge about the appropriateness of a test and the meaning of its result can be contained within the test request forms and report forms. 3.2 Knowledge for treatment In the textbook Evidence-Based Medicine the authors postulate that there are a number of questions in all treatment decisions, notably: What is the preferred treatment for a patient with this condition? How does this compare with other treatment options, including no treatment? What is the probability of benefit and the probability of harm associated with each option? How strong is the evidence for each option? NPFIT/Bestcurrentevidence/29.3.06 50 The clinician then has to tailor this knowledge to take into account the condition of the individual patient and their values, as shown in the figure below (Figure 2). Patients’ values and expectations EVIDENCE CHOICE DECISION Baseline risk Figure 2 3.3 Facts, guidance, guidelines, protocols and pathways Knowledge is presented in a number of different types of proposition. Facts are propositions which describe relationships based on information, for example aspirin given to people who have had a myocardial infarction is associated with reduced risk of a second infarction. Guidance sets out for the health service a wide range of measures that should be put in place, including the configuration of services, for example guidance on cancer services includes action that the service should take to increase specialisation. Guidelines are propositions which either stand alone or appear in guidance documents which make recommendations relevant to patient and clinician behaviour, for example clinicians should discuss with patients the benefits and risks of aspirin following myocardial infarction. Protocols are local versions of guidelines, a definition introduced by the Changing Workforce Programme in 2003. A protocol would be a local version of guidance or guidelines which take into account local circumstances, for example the availability of CT scanning, and also summarise local responsibilities for different aspects of the guideline or guidance. Pathways are forms which set out the protocol, or guideline if there is no localised protocol, for clinicians to follow to minimise the risk of errors of omission or commission, and to ensure that the necessary data are collected for audit. Pathways, sometimes called care pathways, describe the patient journey, and the term patient journey is sometimes used as a synonym for pathway. They may also be called integrated care pathways if they cut across primary and secondary care. Pathways may be made available in either paper or electronic form. NPFIT/Bestcurrentevidence/29.3.06 51 4. The determination of searches by people and machines Both background knowledge and foreground knowledge can be delivered by persons and machines. 4.1 Person-determined delivery Passive delivery is by an unprompted search of a web site by a human being – a professional or a patient. At present this is not possible in many places in which consultations and clinical decisionmaking take place, but this barrier is reducing and many clinicians now have access to the Internet without leaving their desk. The National electronic Library for Health (NeLH) will be integrated in the Integrated Care Record Service, allowing people to search the NeLH during the consultation or, more probably, before or after the consultation. Furthermore, the NeLH team is working to identify bottom lines that can be read in 15 seconds and asking all providers of knowledge to prepare their outputs in this way. 4.2 Machine-determined delivery The use of machines, computers and the Internet, allows the delivery to the clinician and to the patient. Background knowledge about a disease and its diagnosis and treatment can be delivered actively by sending e-mails to clinicians, and each community of practice within the NeLH will be developing its own e-mail list, facilitated by the growth of the e-mail within the NHS. However, the Integrated Care Record Service also allows the opportunity for the active presentation of knowledge, providing knowledge to support decision-making, building on the foundation laid by the NeLH and the national network of NHS and Higher Education libraries. 4.2.1 Knowledge support Prompts, reminders, alerts and aids – these terms are used confusingly and the definitions listed below are proposed. Prompts: by taking one or more data items and applying some knowledge rules, the machine prompts the user to do something. Reminder: this is a special form of prompt which highlights to the healthcare professional and/or patient that a planned action is due. Alerts: by taking one or more data items and applying some knowledge rules, the machine questions the action the user is planning. Aids: by taking one or more data items and applying some knowledge rules, the machine aids the user in interpretation of the data and offers one or more options. They identify some feature about the patient’s condition from the record and draw the attention of the clinician to the existence of relevant knowledge in the knowledge base. NPFIT/Bestcurrentevidence/29.3.06 52 The features that can be identified are: the patient’s age and gender; the principal diagnosis; other diagnoses already made; medications prescribed for the patient. The type of knowledge that could be provided from the knowledge base include: evidence from research; guidelines and pathways; the existence of controlled trials that the patient may wish to enter; relevant online educational opportunities; patient information to improve shared decision-making and reduce the risk of litigation; specialist services, for example tertiary referral services, of which the clinician may be unaware, a particular feature for rare diseases. 4.2.2 Computer-based clinical decision support systems “Computer-based clinical decision support systems” is a term used in the best systematic review of their effectiveness to describe not only the delivery of knowledge from the knowledge base at points in care determined by the machine but also personalised advice about a particular patient by the identification of factors such as those listed above or other variables, for example the patient’s blood pressure, and the incorporation of these additional variables in an algorithm to tailor advice about a particular patient. This is an example of a system giving foreground as well as background knowledge and trying to make the decision about an individual patient, and was first defined as “a tool that uses clinical knowledge to produce patient-specific advice using two or more items of patient data (1). 4.2.3 Clinical prediction rules A clinical prediction rule or clinical decision rule has been defined as “a clinical tool that quantifies the individual contributions that various components of the history, physical examination, and basic laboratory tests make towards the diagnosis, prognosis or likely response to treatment in a patient. The term “triage algorithm” is used to describe rules used for rapid triage. These rules can be presented on paper or digitally. The term “patient group direction” is applied when the clinical decision rule relates to treatment. 5. The evidence base The evidence base for knowledge and computer-based clinical decision support systems is strong and is growing, and this is co-ordinated by a team at McMaster University, Ontario (2). They are about to issue a new version of the systematic review last published in the Journal of the American Medical Association in 1998. In that review there was clear evidence about the effectiveness of NPFIT/Bestcurrentevidence/29.3.06 53 prompts, alerts and reminders but little evidence about the beneficial effects for patients from more complex types of computer-based decision support. 6. Harnessing existing resources 6.1 Integrating knowledge and care records The NeLH, primarily for clinicians, and NHS Direct Online, primarily for patients, will be completely interoperable using the standards set out in the National Knowledge Infrastructure (Appendix 1). Thus knowledge will be able to made available through the Integrated Care Record Service. 6.2 Knowledge support for diagnosis We have an important range of resources to support the process of diagnosis and these can be linked to the framework for knowledge support and delivered where and when they are needed, as shown in Figure 3. Patient presents with symptoms and signs Provisional diagnosis or diagnoses Choice of tests ISABEL Royal College of Radiology Guidelines www.labtestsonline.org (being adopted for UK) www.assayfinder.co.uk Interpretation of test results National electronic Library for Communicable Disease Figure 3 NPFIT/Bestcurrentevidence/29.3.06 54 6.3 Knowledge support for treatment decisions Once a diagnosis has been made, the clinician and patient set off on a new pathway (Figure 4). Patient with established diagnosis Knowledge resources like Clinical Evidence, Mentor or the other resources listed in Table 1 Treatment options Shared decision-making tools like Dipex Drug treatment chosen British National Formulary Patient education Self-management documents like Dipex Figure 4 One of the aims of the National Knowledge Service is to promote interoperability of all the sources of knowledge procured, commissioned or produced by the Department of Health and the NHS nationally. Between £20 million and £30 million is used to produce the knowledge sources listed in the table below. NPFIT/Bestcurrentevidence/29.3.06 55 Table 1: Sources of knowledge The National Network of Health Libraries, The Cochrane Library, Clinical Evidence, Mentor, GP Notebook, Drugs and Therapeutics Bulletin, MeReC Bulletins, The British National Formulary, R&D Outputs, Pharmacovigilance Bulletins, NICE guidance, NPSA alerts, Public health information from the HPA and the National Screening Committee, Prodigy, CHI Reports, National Screening Committee recommendations, NHS Direct CAS system, Evidence-based journals, DIPEX. These sources often cover the same topics and the degree of overlap is being mapped at present. It is entirely appropriate to have more than one way of expressing knowledge as clinicians and patients have different needs at different times. Further work will need to be done to ensure that the knowledge is expressed in a way that can be read quickly by clinicians and patients, and the NeLH accepts responsibility for negotiating with the producers of knowledge to ensure that it is produced not only to high standards of quality but also to high standards of usability. 6.4 Developing a Framework for Knowledge Support The Map of Medicine, a system that allows generalised knowledge, including national guidelines, to be localised to each healthcare trust, for example by including local forms and telephone numbers, thus greatly increasing its attractiveness to clinicians. It can also act as a framework for knowledge support, allowing the specific components within NeLH, described in Sections 6.2 and 6.3, to be made available in every type of care record (Figure 5). NPFIT/Bestcurrentevidence/29.3.06 56 Machine-determined NHS Direct Online Framework for knowledge support Patient ICRS NeLH Clinician Person-determined Figure 5 Prodigy Release 2.0 can also act as a support for knowledge services other than its own, and the NHSIA Disease Management Systems Programme is also piloting care pathways. 6.5 Patient decision aids There are about two million consultations in the NHS, probably about ten million decisions because many decisions, for example those about laboratory results, do not take place in consultations. Some decisions are made by clinicians alone or by patients alone, for example the decision to consult or not to consult, and some are made by patients and clinicians together – shared decisionmaking, as shown in the diagram below (Figure 6). Clinicians’ decisions Shared decisions Patients’ decisions Figure 6 Within shared decision-making there is a continuous spectrum of participation, as shown in Figure 7. NPFIT/Bestcurrentevidence/29.3.06 57 Clinical-led decisions Patient-led decisions Figure 7 The satisfaction of the patient with the process of decision-making depends in part on the degree to which the clinician identifies the patient’s “preferred consulting style” and then provides information accordingly. Knowledge support and computer-based clinical decision support systems for professionals often help the professional identify options; decision aids for patients help the patient come to a decision about which option to choose. In 1999 the first systematic review of 17 randomised controlled trials evaluating decision aids was published and since then many other decision aids have been produced and evaluated. The Cochrane Collaboration has now set up an inventory of patient decision aids, the lead being taken by Professor O’Connor of the University of Ottawa as part of an ongoing Cochrane systematic review of patient decision aids. The goals of the inventory are to catalogue patient decision aids and their development and to appraise the quality of available decision aids using a pre-defined set of criteria, the CREDIBLE criteria. Public access to the inventory is at www.ohri.ca/decisionaid. There are now over 400 decision aids in the inventory and the number is growing. The Integrated Care Record Service will undoubtedly wish to make decision aids for patients available because decision aids “explain options, clarify values, and develop skills in shared decision-making” and are now seen as an essential adjunct to the counselling of a clinician. The systematic review currently being prepared for the Cochrane Library indicates that the appropriate use of patient decision aids has significant impacts on decisionmaking. These are complementary to knowledge support and decision support primarily for clinicians. 7. Evaluation and quality assurance Clinicians have always used knowledge in the consultation and there are now valid and reliable techniques for assessing the quality of the research that produced the evidence, and therefore the strength of the evidence itself, whether that knowledge is presented as a simple conclusion or in the form of a guideline. The NeLH and NHS Direct Online have criteria by which they appraise some of the evidence and the National Knowledge Service is doing further work on the most appropriate way of describing and presenting information which describes the quality of the knowledge presented. Computer-assisted decision support systems require a different approach, however. Such a system is an intervention which the clinician uses in addition to their clinical skills and best current knowledge. It is an intervention analogous to a biochemical test or a drug or an operation, and should be evaluated with equal rigour because computer-assisted decision support systems can do NPFIT/Bestcurrentevidence/29.3.06 58 harm as well as good. The randomised controlled trial is therefore the best method for evaluating a computer-assisted decision support system, with a systematic review being prepared if more than one trial has been conducted (3). The need for care is important because of the possibility of publication bias, namely positive trials being more likely to be published. It is also important to appreciate that clinical decision or prediction rules and algorithms are also decision support systems, even if they exist as a list on paper rather than being expressed in software. Such rules and algorithms also need rigorous evaluation (4, 5). The evaluation of decision aids for patients also needs this approach but the approach is complicated by the fact that decision aides are used to achieve different outcomes, ranging from better clinical outcomes to greater satisfaction with decision-making. Nevertheless, each decision aid also needs rigorous evaluation because a decision aid is an intervention distinct from the direct provision of best current knowledge to patients (6). The clinician, of course, can also be regarded as an intervention because there is now considerable evidence that the way in which the clinician presents the evidence influences the choice made (7) and methods are also being developed to appraise the input of the clinician, and tools and training designed to reduce the bias that the professional can unknowingly impart (8, 9). 8. Governance One of the problems encountered by people who wished decisions made on knowledge support, decisions support and patient decision aids is the very process of decision-making itself, namely decision-making by the public sector It is not possible to identify any one organisation which has the authority or skills to manage all aspects of this process and the following governance process is proposed. 8.1 Governance of content Content of knowledge support and decision support, patient decision aids, other than those produced by a body with clear processes for quality assured knowledge such as NICE, rests with NeLH and NHS Direct Online. 8.2 Technical standards There are two types of technical standard involved in these resources. The first are those technical standards that relate to document management and these are the responsibility of the National Knowledge Service, expressed in the National Knowledge Infrastructure, a document which sets out a set of web document management standards which comply with the Office of the e-Envoy’s metadata framework. Messaging standards are the standards that relate to the interaction between these resources and the National Programme for IT but rest with the NHSIA Information Standards Board. These cover issues such as messaging standards. NPFIT/Bestcurrentevidence/29.3.06 59 8.3 Clinical governance The main source of advice on clinical relevance will be the National Clinical Advisory Board of the National Programme for IT. 8.4 Evaluation of decision support and decision aids. The responsibility for formal evaluation of these two technologies rests with the R&D Programme and with NICE. 9. Project management It is clear that there needs to be a programme that co-ordinates the work being done on knowledge support, computer-based clinical decision support systems, and patient decision aids, and a development project has been funded for a six month period by the National Knowledge Service to set up this programme. The responsibility for the project has been given to the National electronic Library for Health by the National Knowledge Service which is managed by the Modernisation Agency. NPFIT/Bestcurrentevidence/29.3.06 60 REFERENCES 1. Wyatt J and Spiegelhalter D. Field trials of medical decision-aids: potential problems and solutions. Pp 3-7 in Clayton P (Ed). Proc. 15th Symposium on computer Applications in Medical Care, Washington 1991. New York: McGraw Hill Inc. 1991. 2. Hunt DL, Haynes RB, Hanna ST, Smith K. Effects of computer-based clinical decision support systems on physician performance and patient outcome: a systematic review. JAMA, 1998; 280: 1339-46. 3. Bennett JW and Glasziou PP. Computerised reminders and feedback can improve provider medication management; a systematic review of randomised controlled trials. Med. J. Aust. 2003; 178: 217-22. 4. Sox HC. A triage algorithm for inhalational anthrax. Ann. Int. Med. 2003; 139: 379-81. 5. Laupacis A, Sekar N, and Stiell IG. Clinical prediction rules: a review and suggested modifications of methodological standards. JAMA, 1997; 277: 488-94. 6. O’Connor et al. Decision aids for patients facing health treatment or screening decisions: a systematic review. Brit. Med. J. 1999; 319: 731-4. 7. Gray JAM The Resourceful Patient. e-Rosetta Press, 2002. 8. Guimond P et al. Validation of a tool to assess health practitioners’ decision support and communication skills. Patient Education and Counselling, 2003; 50: 235-45. 9. Edwards A et al. The development of COMRADE (Combined Outcome Measure for Risk Communication and Treatment Decision-Making Effectiveness) – a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision-making in consultation. Patient Education and Counselling, 2003; 50: 311-22. NPFIT/Bestcurrentevidence/29.3.06 61 APPENDIX 3 NATIONAL LIBRARY OF TOOLS AND RULES PROJECT INITIATION DOCUMENT J A Muir Gray Version Version 1.0 Version 2.0 NPFIT/Bestcurrentevidence/29.3.06 Date 21 December 2005 28 March 2006 Prepared by J A Muir Gray J A Muir Gray 62 NATIONAL LIBRARY OF TOOLS AND RULES – PROJECT INITIATION DOCUMENT 1. Background Discussions have taken place about the need for libraries, i.e. the systematic collection of: assessment tools; monitoring tools to deal with chronic disease; prescribing rules; laboratory rules. Rules are often embedded in tools. Two papers have been produced as a result of meetings and these are attached for ease of reference. 2. Rules, tools, pathways and guidelines 2.1 Guidelines The distinction between these different ways of presenting knowledge is not always clear-cut. Guidelines and guidance are high level documents, covering conditions such as lung cancer. The definition of guidelines from NICE is that they are: ………. recommendations by NICE on the appropriate treatment and care of people with specific diseases and conditions within the NHS. They are based on the best available evidence. Guidelines help health professionals in their work, but they do not replace their knowledge and skills. Guidelines often contain pathways that should be followed, tools that should be used, and rules that can increase the probability of effective, safe treatment. 2.2 Pathways A care pathway has been defined as: ………….a document that describes the process for a discreet element of service. It sets out anticipated, evidence-based, best practice and outcomes that are locally agreed and that that reflect a patient-centred, multi-disciplinary, multi-agency approach. The ICP document is structured around the unique ICP Variance Tracking tool. When used with a patient/client, the ICP document becomes all or part of the contemporaneous patient/client record, where both completed activities and outcomes, and variations between planned and actual activities and outcomes, are recorded at the point of delivery. NPFIT/Bestcurrentevidence/29.3.06 63 At distinct points in the pathway rules may operate. 2.3 Tools The definition of “tools” as defined by the Oxford Shorter English Dictionary is “a means of effecting something”. A tool is an instrument, relating certain inputs, for example data from laboratory tests, to the possibility of an action. A rule may be linked to a tool. Tools can be used for: assessing risk; reaching a diagnosis; monitoring, namely the periodic measurement of a patient’s condition to manage a chronic or recurrent health problem. Libraries of guidelines, pathways and tools will be developed and linked to this library of rules. 2.4 Rules A rule is a principle, regulation, or maxim governing individual conduct (Oxford Shorter English Dictionary). The meaning of a term is best defined by giving examples of its use. Examples of rules would include: “a chest x-ray should be carried out on patients who have been hoarse for more than three weeks”; “if the potassium is more than 6, the clinician who requested the test should be informed by telephone”. Using the simple model of decision-making set out in Figure 1, rules relate evidence to risk in particular situations, but rule-making is not straightforward. Patients’ values and expectations EVIDENCE CHOICE DECISION Baseline risk Figure 1 NPFIT/Bestcurrentevidence/29.3.06 64 2.4.1 Rules and heuristics School rules had to be obeyed if punishment were to be avoided. Clinical rules are expressed with the expectation that they will be followed, but the job of the clinician is often to make a decision that does not conform to the rule. If the clinician does so they need to justify their action, and if they have behaved reasonably that decision will be supported. The term “rules” sometimes applies to closed systems, for example a nuclear power station, but clinical practice is an open system with the values and expectations of individual patients, as well as their unique biological profile, requiring the interpretation of rules. For this reason the term “heuristics” is preferable with the meaning of a heuristic being a rule of thumb, the Oxford Shorter English Dictionary definition. There are diagnostic and treatment rules; A diagnostic rule suggests a course of action that a clinician should consider when trying to make a decision; it is usually expressed in the form “if ………… then”, for example: “If the result of the ELISA test for hepatitis C is above the reference range and the patient lives in a low prevalence population then a PCR test should be used as a confirmatory test.” A prescribing rule suggests a course of action that a clinician should consider when trying to make a decision; it is usually expressed in the form “if ………… then”. Rules may be presented to clinicians at specified points in a care pathway to prompt the clinician to consider an action that is the next step to be taken. Two types of prompt are considered. 2.4.2 Displaying rules Further discussions have taken place about the way in which rules should be presented. There appears to be general agreement on the following uses of commonly employed words. A prompt or reminder is an indication that the clinician should remember that there is a piece of guidance or relevant documentation that they could consider before: deciding to do something, or deciding not to do something. An alert is an indicator that the clinician should not take further action without taking into account a piece of knowledge about the intervention or the patient or both. The latter group has been further subdivided by some people into absolute and relative alerts: the absolute alert is a complete contraindication; NPFIT/Bestcurrentevidence/29.3.06 65 the relative alert indicates that action could be taken either because it is thought that the risk justified the action or because the risk could be mitigated by some additional intervention or action. As we learn more about drug interaction databases, for example First DataBank, we learn that they grade their warnings using four grades but usually present only two of them. 3. Deliverables The National Library of Tools and Rules will be collected, organised, and the 1.0 version will be released to LSPs and suppliers by 1 April 2006. This work will be co-ordinated by the Evidence-Based Content Service, the part of Knowledge, Process and Safety focusing on the collation of knowledge and documents of different types and sources for presentation to suppliers. The tools and rules in the National Library will be linked to other relevant information relating to care processes and pathways. J A Muir Gray, CBE, DSc, MD, FRCP, FRCPSGlas, FCILIP Director of Clinical Knowledge, Process and Safety NPFIT/Bestcurrentevidence/29.3.06 66 APPENDIX 4 THE 500 MOST COMMON PROBLEMS ENCOUNTERED IN PRIMARY CARE Topics to be covered by a synopsis service NPFIT/Bestcurrentevidence/29.3.06 67 Term from original dataset Synonyms/explanation ICD 9 description Bazian expansion of codes acute URTI of multiple or unspecified site contraceptive management acute bronchitis & bronchiolitis need for prophylactic vaccination & inoculation asthma disorders of conjunctiva essential hypertension disorders of external ear acute pharyngitis acute tonsillitis ill defined intestinal infections other and unspecified disorders of back non suppurative otitis media and eustachian tube disorders neurotic disorders common cold osteoarthrosis and allied disorders candidiasis atopic dermatitis & related conditions certain adverse effects NEC allergic rhinitis other disorders of urethra and urinary tract other symptoms involving abdomen and pelvis acute sinusitis disorders of menstruation & other abnormal bleeding from female genital tract symptoms involving skin and other integumentary tissue functional digestive disorders NEC other diseases due to viruses and chlamydiae influenza contact dermatitis & other eczema diseases of sebaceous glands peripheral enthesopathies and allied syndromes symptoms involving head and neck sprains and strains of other and unspecified parts of the back menopausal and postmenopausal disorders suppurative and unspecified otitis media disorders of function of stomach dermatophytoses normal pregnancy pain and other symptoms associated with female genital organs acute laryngitis & tracheitis health supervision of infant or child spondylosis and allied disorders migraine NPFIT/Bestcurrentevidence/29.3.06 upper respiratory tract infection assessment, screening and counselling before prescribing contraceptive pill; emergency contraception; counselling about contraception acute bronchitis; bronchiolitis routine vaccination; pre-travel vaccination acute or chronic asthma conjunctivitis hypertension without known cause otitis externa; wax in ear; perichondritis of external ear sore throat acute tonsillitis diarrhoea in the absence of causative organism low back pain; unspecified back pain; spinal stenosis middle ear infection; blocked ears anxiety disorder; panic disorder; phobias; obsessive compulsive disorders common cold osteoarthritis; including occupationally induced; includes osteoarthritis of specific joints vaginal or oral candidiasis; thrush eczema anaphylaxis; food allergy; adverse effects of drugs hay fever urinary tract infection abdo or pelvic pain - unspecified diagnosis acute sinusitis menorrhagia; intermenstrual bleeding; oligomenorrhoea; amenorrhoea; post-coital bleeding rash, pallor, swelling, oedema, cyanosis, flushing, spontaneous bruising, jaundice. (Only if in absence of specific diagnosis) constipation; irritable bowel syndrome mumps; viral hepatitis; chlamydial infection influenza nickel allergy; contact allergy sebaceous cyst; acne; blackheads; whiteheads; comedones; 'spots' tendinitis or bursitis of specific or unspecified site; non-specific shoulder pain; rotator cuff syndrome; painful arc syndrome; adhesive capsulitis; frozen shoulder ; epicondylitis; tennis elbow headache, including chronic tension headache (excludes specific type eg migraine; cluster etc); nosebleed sprains and strains of the back menopausal symptoms; atrophic vaginitis; post-menopausal bleeding otitis media; chronic suppurative otitis media; chronic mastoiditis; chronic tympanomastoiditis dyspepsia; indigestion ringworm; tinea (tinea capitis, tinea soleum; tinea corporis; tinea cruris - excludes tinea blanca and tinea nigra) normal pregnancy vulvodynia; premenstrual syndrome; dyspareunia; vaginismus; mittelschmerz; stress incontinence; pelvic congestion syndrome croup and acute epiglottitis routine child health visit; routine developmental check any spondylosis of back (excluding ankylosing spodylitis) or of neck migraine headache or migraine aura without headache 68 other disorders of ear angina pectoris diabetes mellitus depressive disorder, not elsewhere classified cystitis other cellulitis and abscess haemorrhoids diseases of the oesophagus chronic pharyngitis & nasopharyngitis postpartum care & examination special symptoms or syndromes not elsewhere classified (mental health) other disorders of cervical region sprains and strains of ankle and foot heart failure varicose veins of lower extremities other family circumstances other disorders of breast obesity & other hyperalimentation other disorders of synovium tendon and bursa herpes simplex inflammation of the eyelids symptoms involving urinary system sprains and strains of knee and leg erythematosquamous dermatosis pruritus and related conditions benign neoplasm of skin gastritis and duodenitis vertiginous syndromes and other disorders of vestibular system psoriasis and similar disorders inflammatory disease of cervix, vagina and vulva urticaria chicken pox erythematous conditions impetigo diseases of the oral soft tissues, excluding lesions specific for gingiva and tongue disorders of lipid metabolism cellulitis & abscess of finger and toe diseases of nail symptoms involving cardiovascular system corns and callosities affective psychoses iron deficiency anaemias contusion of lower limb and of other unspecified sites acquired hypothyroidism herpes zoster sprains and strains of shoulder and upper arm chronic airways obstruction NEC other forms of chronic ischaemic heart disease cardiac dysrhythmias chronic bronchitis other local infections of skin and subcutaneous tissue sprains and strains of sacroiliac region NPFIT/Bestcurrentevidence/29.3.06 includes tinnitus, sudden hearing loss, earache without specific diagnosis; ear discharge without specific diagnosis stable angina; chronic stable angina; chest pain due to coronary/ischaemic heart disease type 1 or type 2 diabetes mellitus depression acute, recurrent or chronic cystitis cellulitis / abscess of unspecified site piles; haemorrhoids oesophagitis; achalasia; oesophageal ulcer; oesophageal stricture; oesophageal diverticulum; Mallory-Weiss tear/syndrome chronic rhinitis; chronic pharyngitis; chronic nasopharyngitis routine post-natal visit anorexia; tics; bulimia; encopresis non-specific neck pain syndromes eg whiplash sprains and strains of ankle and foot congestive heart failure; left ventricular failure varicose veins counselling for family problems; problems with caring for relatives; arranging respite care; arranging or helping with care in the home cosmetic concerns; galactorrhoea (milk leakage); breast mass/lump of unknown diagnosis; nipple fissure/crack; mastitis obesity, overweight bunions; bursitis; ganglion; tendon rupture genital herpes; oral herpes; cold sore; HSV1 ; HSV2 blepharitis; chalazion; sty renal colic; dysuria; urinary retention; urge incontinence; frequency; discharge NB only if a specific diagnosis is absent sprains and strains of knee and leg seborrhoeic dermatitis pruritis ani; pruritis vulvi; lichen simplex chronicus; prurigo benign mole; benign naevus; blue naevus; pigmented naevus; dermatofibroma gastritis of any type meniere's disease; labyrinthitis; vertigo; benign paroxysmal positional vertigo; vestibular neuronitis chronic plaque psoriasis; pityriasis; psoriatic arthropathy cervicitis; vulvovaginitis; Bartholin's cyst/abscess urticaria, hives varicella zoster toxic erythema; erythema nodosum; lupus (SLE); rosacea impetigo (any type) stomatitis; aphthous ulcers; cellulitis of mouth hyperlipidaemia; hypercholesterolaemia; hypertriglyceridaemia; lipodystrophy whitlow; herpetic whitlow; finger or toe cellulitis fungally infected nails; ingrowing nail; onycholysis murmur; tachycardia; palpitations corns, calluses mania; bipolar disorder; bipolar depression iron deficiency anaemias bruises (due to trauma) of leg clinically low thyroxine, excluding congenital (ie people born with hypothyroidsim) shingles sprains and strains of shoulder/upper arm COPD (chronic obstructive pulmonary disease); COAD (chronic obstructive airways disease); smoker's lung Acute myocardial infarction; old myocardial infarct; secondary prevention of ischaemic or coronary events; angina pectoris; unstable angina arrhythmias; atrial fibrillation; tachyarrhythmias; bradyarrhythmias; cardiac syncope also COAD (chronic obstructive airways disease); COPD (chronic obstructive pulmonary disease) pyoderma; pyoderma gangrenosum sprain; strain of low back 69 deafness symptoms concerning nutrition, metabolism, and development sprains and strains of wrist and hand other persons seeking consultation without complaint or sickness other intestinal helminthiases other complications of procedures NEC gout (other) peripheral vascular disease diseases of hair and hair follicles other hernia of abdominal cavity without mention of obstruction of gangrene other dermatoses intervertebral disc disorders other open wound of head rheumatoid arthritis & other inflammatory polyarthropathies adjustment reaction epilepsy Acariasis cataract diseases of pulp and periapical tissues other disorders of intestine sprains and strains of hip and thigh duodenal ulcer non-inflammatory disorders of vagina pediculosis and phthirus infestation disorders of penis internal derangement of knee open wound of finger(s) superficial injury of hip, thigh, leg & ankle inguinal hernia inflammatory disease of ovary, fallopian tube, pelvic cellular tissue and peritoneum transient cerebral ischaemia acute myocardial infarction other disorders of bone and cartilage disorders of lacrimal system contusion of upper limb acute but ill-defined cerebrovascular disease acute reaction to stress anal fissure & fistula chronic sinusitis delivery in a completely normal case other viral exanthemata phlebitis and thrombophlebitis contusion of trunk genital prolapse disorders of sweat glands other and unspecified arthropathies diverticula of intestine superficial injury of foot and toe(s) lipoma mononeuritis of upper limb and mononeuritis multiplex glaucoma visual disturbances haemorrhage in early pregnancy open wound of knee, leg (except thigh) and ankle superficial injury of face, neck and scalp except eye NPFIT/Bestcurrentevidence/29.3.06 conductive; sensorineural or mixed hearing loss loss of appetite; unexplained weight loss or weight gain; difficulty swallowing; excessive thirst sprains and strains of wrist and hand management of people with no specific symptoms or diagnosis ascariasis; strongyloides; other gut helminths postoperative complictions; dehiscence; fistula; blood loss; foreign body - all after operation gout, podagra peripheral vascular disease; intermittent claudication; critical limb ischaemia; ischaemic leg ulcer alopecia; hirsutism diaphragmatic hernia; femoral hernia; umbilical hernia --- only if they are not complicated by acute symptoms actinic keratosis; seborrhoeic keratosis slipped disc; prolapsed disc cut or laceration to head/scalp (not face or neck) rheumatoid arthritis; Felty's syndrome; juvenile rheumatoid arthritis adjustment disorder any form of epilepsy or epileptic fit mite infestation cataract periapical abscess; cavity rectal prolapse; anal stricture; anal polyp sprains and strains of hip/thigh duodenal ulcer old vaginal tear; vaginal polyp; vaginal dysplasia head or pubic lice balanitis; priapism (painful erection); erectile dysfunction secondary to some other cause (eg diabetes) - not erectile dysfunction of unknown cause meniscal tear; cartilage tear; chondromalacia patellae; cartilage defect; cruciate ligament tear cut, bite or traumatic amputation of finger or thumb blister, cut, abrasion, foreign body (e.g. knife) in these sites inguinal hernia pelvic inflammatory disease Transient ischaemic attack; amaurosis fugax heart attack - excludes old myocardial infarct osteoporosis; pathological fracture; costochondritis dacryoadenitis; epiphora bruises (due to trauma) of arm stroke; cerebrovascular accident stress reaction anal fissure; anal fistula chronic sinusitis normal vaginal delivery following uncomplicated pregnancy rash due to presumed and unknown virus phlebitis or thrombophlebitis (NB this excludes deep vein thrombosis) bruising (due to trauma) to trunk uterine or uterovaginal prolapse anidrosis / heat rash unspecified arthropathies, other than disorders of spine diverticulosis; diverticulitis foot/toe blisters or splinters in foot/toe lipoma carpal tunnel syndrome; median, radial or ulnar nerve palsy any type of glaucoma ; diplopia (double vision); night blindness first trimester bleeding; threatened abortion avulsion; laceration; animal bite; cut to these sites blisters/ abrasions/ insect bites/ splinters in these sites 70 chronic ulcer of skin other ill defined and unknown causes of morbidity and mortality superficial injury of hand(s) except finger(s) alone drug dependence other disorders of eye pleurisy acute lymphadenitis fracture of radius and ulna contusion of face, scalp and neck except eye(s) dermatomycosis other & unspecified senile and presenile organic psychotic conditions benign mammary dysplasias other and unspecified infectious and parasitic diseases nondependent abuse of drugs other noninfective gastroenteritis and colitis disorders of fluid, electrolyte and other acid-base balance other deficiency anaemias chronic venous ulcers; decubitus ulcer; non-decubitus ulcer; bedsore; pressure necrosis; pressure sore death due to unknown cause blisters/ abrasions/ insect bites/ splinters in these sites any drug dependence scleritis; episcleritis; nystagmus of unknown cause pleurisy with or without pleural effusion lymphadenitis; abscess of lymph gland or node; painful, tender, inflamed lymph nodes open or closed fracture of forearm; broken forearm bruising (due to trauma) to these sites pityriasis versicolor; tinea blanca; tinea nigra alzheimer's dementia; dementia; multi-infarct dementia; benign breast cyst; fibroadenosis; fibrocystic diease of breast; mammary duct ectasia; fibrosclerosis of breast pneumocystis carinii; Behcet's syndrome nicotine addiction non-infectious gastroenteritis (ie not due to micro-organisms); colitis or ileitis/jejunitis NB excludes Crohn's and ulcerative colitis. Also excludes food poisoning dehydration; hypo- or hypernatraemia or hypo- or hyperkalaemia; acidosis; alkalosis unspecified deficiency anaemia (excludes iron; b12, folate deficiency and pernicious anaemia) infertility, female any cause of female infertility (eg ovarian, tubal, hypoythalamic dysfunction) malignant neoplasm of female breast breast cancer; adenocarcinoma of breast personality disorders any personality disorder sexual deviations and disorders psychosexual dysfunction, including premature ejaculation; anorgasmia parkinsons disease Parkinson's disease (not parkinsonism) orchitis and epididymitis orchitis or epididymitis spontaneous abortion any spontaneous abortion/miscarriage contact with or exposure to communicable diseases post-exposure prophylaxis or prophylaxis for close contacts for any infectious disease need for prophylactic vaccination & inoculation against routine immunisation; travel vaccination single disease disturbance of conduct NEC conduct disorder dentofacial anomalies including malocclusion temporomandibular joint disorder infections of kidney pyelonephritis (acute or chronic) or renal abscess redundant prepuce and phimosis tight foreskin, phimosis other disorders of male genital organs testicular torsion; testicular atrophy; disorders of ejaculation superficial injury of trunk blisters/ abrasions/ insect bites/ splinters in these sites alcohol dependent syndrome alcoholism; alcohol addictoin; alcohol dependence other disorders of eyelids ectropion (out-turned lids) diseases of hard tissues of teeth caries peptic ulcer, site unspecified gastroduodenal ulcer or presumed gastric or duodenal ulcer, in which the site (gastric or duodenal) is not known hyperplasia of prostate benign prostatic hyperplasia (benign enlarged prostate) sprains and strains of elbow and forearm excludes tennis elbow other extrapyramidal disease and abnormal movement benign essential tremor; tics; torticollis; huntingtons chorea and other chorea; disorders other retinal disorders diabetic retinopathy; age related macular degeneration bronchopneumonia, organism unspecified pneumonia gastrointestinal haemorrhage gastrointestinal bleed; haematemesis; melaena; PR (per rectum) bleed concussion concussion (with or without loss of consciousness) due to trauma open wound of hand except finger(s) alone animal bite, cut, laceration to hand (excluding fingers) foreign body on external eye foreign body in eye/cornea/sclera infectious mononucleosis glandular fever; epstein barr virus; schizophrenic psychoses any type of schizophrenia physiological malfunction arising from mental factors any psychosomatic disorder or physical symptom of psychogenic origin hypotension low blood pressure cholelithiasis gallstones and gall stone disease or biliary colic non-inflammatory disorders of cervix cervical dysplasia; cervical ectropion polymyalgia rheumatica polymyalgia rheumatica acquired deformities of toe bunions; hallux valgus fracture of rib(s), sternum, larynx and trachea rib fracture streptococcal sore throat & scarlatina strep throat NPFIT/Bestcurrentevidence/29.3.06 71 specific diseases due to Coxsackie virus transient organic psychotic conditions pneumonia, organism unspecified other diseases of respiratory system diseases and other conditions of the tongue idiopathic proctocolitis other disorders of gall bladder other complications of pregnancy NEC other hypertrophic and atropic conditions of skin ankylosing spondylitis and other inflammatory spondylopathy non-specific findings on examination of urine intracranial injury of other and unspecified nature superficial injury of eye and adnexa thyrotoxicosis with or without goitre other disorders of blood and blood-forming organs trigeminal nerve disorders strabismus and other disorders of binocular eye movements other disorders of tympanic membrane other diseases of upper respiratory tract diseases of the salivary glands infections of the breast and nipple associated with childbirth osteochondropathy infections specific to the perinatal period open wound of elbow, forearm and wrist superficial injury of shoulder and upper arm malignant neoplasm of other and ill-defined sites blindness and low vision nasal polyps chronic disease of tonsils and adenoids emphysema gingival and periodontal diseases excessive vomiting in pregnancy burn of wrist(s) and hand(s) effects of reduced temperature rubella intestinal infections due to other organisms malignant neoplasm of trachea; bronchus and lung NPFIT/Bestcurrentevidence/29.3.06 hand, foot and mouth disease; carditis due to coxsackie virus delirium pneumonia pneumothorax; empyema glossitis; glossodynia (tongue pain); burning tongue/mouth; geographic tongue ulcerative colitis; pseudopolyposis of the colon; pseudopolyposis coli; ulcerative proctitis acute cholecystitis; cholecystitis; hydrops of gallbladder; gallstones; gallbladder perforation; gallbladder fistula ; cholelithiasis excessive weight gain in pregnancy; peripheral neuritis / peripheral neuropathy in pregnancy; bacteruria in pregnancy; urinary tract infection in pregnancy; jaundice in pregnancy (exclude hypertension in pregnancy and exclude pre-eclampsia/eclampsia) circumscribed scleroderma; acquired keratoderma; acquired acanthosis nigricans; striae atrophicae; keloid ankylosing spondylitis; spinal enthesopathy; sacroiliitis; inflammatory spondylopathies, abnormal urinanlysis; abnormal urine dipstick; proteinuria; haemoglobinuria; myoglobinuria; biliuria; glycosuria; acetonuria; cells or casts in urine. brain/cerebral injury; intracranial injury, cerebral contusion; contre-coup injury. (exclude: head injury that involves open wound of head without intracranial injury, skull fracture alone, intracranial injury with skull fracture). superficial injury (including abrasion) of eyelids, orbit, cornea/conjunctiva of eye hyperthyroidism, thyroid storm, thyrotoxic crisis, thyrotoxic storm; thyrotoxicosis. (excl. neonatal thyrotoxicosis, endocrine and metabolic disturbances specific to the foetus and newborn.), with or without goitre or thyroid nodule secondary (NOT primary) polycythaemia; lymphadenitis; hypersplenism; methaemoglobinaemia; NB EXCLUDE anaemia of pregnancy trigeminal neuralgia; atypical face pain. esotropia; exotropia; heterotropia; strabismus; diplopia myringitis (without otitis media); perforation of ear drum / tympanic membrane; vocal cord paralysis; vocal cord or laryngeal polyp; laryngeal oedema; allergic or hypersensitive reaction involving upper respiratory tract or larynx salivary gland (or duct) atrophy/hypertrophy/abscess/fistula/stone; sialoadenitis; sialolithiasis; xerostomia puerperal abscess / breast abscess / mastitis associated with new baby osteochondrosis; slipped upper femoral epiphysis; osteochondritis dissecans (exclude specific arthritis e.g. rheumatoid / osteoarthritis). congenitally / perinatally acquired infection: congenital rubella/CMV (cytomegalovirus) infection/ HIV infection; neonatal tetanus/ tetanus neonatorum; omphalitis of newborn; neonatal infective conjunctivitis / neonatal herpes. animal bite / laceration / cut of elbow, forearm, and wrist. (exclude: burn, crushing, puncture of internal organs, superficial injury, but include if it occurs along with dislocation or fracture or other more generalised trauma; internal injury; intracra superficial injury of axilla and/or scapula region. superficial abrasion; friction burn; blister; insect bite; foreign body in shoulder/scapula and/or upper arm/axilla. malignant neoplasm / malignancy of / cancer of head, face, and neck, or other sites if not specific (e.g. exclude breast cancer; lung cancer; sarcoma; melanoma etc). involving one or both eyes: blindness; profound visual impairment; legal blindness(USA); unspecified visual loss. nasal polyp; polypoid sinus degeneration; sinus polyp. chronic tonsillitis or chronic adenoiditis; tonsillar/adenoid hypertrophy emphysema; emphysematous bulla/bullae caries; periodontitis; gingivitis vomiting during pregnancy, hyperemesis gravidarum, (exclude: friction burns, sunburn). frostbite; trenchfoot (immersion foot); chilblains; hypothermia. rubella / German measles bacterial or viral or infective colitis/diarrhoea/dysentery/gastroenteritis/ enterocolitis/enteritis due to following specified organisms: E.coli; aerobacter aerogenes/proteus/any and all viruses (if organism unspecified, then capture under “illdefined i bronchial adenocarcinoma, bronchogenic/bronchial carcinoma; lung cancer/ tracheal cancer 72 other malignant neoplasm of skin benign neoplasm of breast multiple scelrosis hypertensive heart disease other and ill-defined cerebrovascular disease regional enteritis abscess of anal and rectal regions calculus of kidney and ureter other complications of labour and delivery, not elsewhere classified congenital anomalies of genital organs fracture of metacarpal bones fracture of one or more phalanges of hand fracture of neck of femur fracture of tibia and fibula fracture of ankle fracture of one or more tarsal and metatarsal bones open wound of foot except toes alone contunsion of eye and adnexa malignant neoplasm of prostate uterine leiomyoma ovarian dysfunction keratitis old myocardial infarction other diseases of endocardium diseases of capillaries pneumococcal pneumonia gastric ulcer intestinal obstruction without mention of hernia other disorders of bladder hydrocele endometriosis pilonidal cyst certain congenital musculoskeletal deformities senility without mention of psychosis sudden death, cause unknown fracture of face bones burn of lower limb(s) other venereal diseases malignant neoplasm of colon other disorders of pancreatic internal secretion purpura and otherhaemorrhagic conditions specific non-psychotic mental disorders following NPFIT/Bestcurrentevidence/29.3.06 BCC, basal cell carcinoma; Bowen’s disease, focal dermal hypoplasia syndrome (Goltz), Goltz’s syndrome, Goltz-Gorlin syndrome, Gorlin syndrome, malignancy of skin or lips (exclude melanoma, rodent ulcer, squamous cell carcinoma). benign cystosarcoma phylloides, benign breast lump; benign neoplasm of breast, breast trichoepithelioma, breast fibroadenoma, papillomatosis. multiple sclerosis hypertensive cardiomyopathy; left ventricular hypertrophy or cardiomegaly due to hypertension; hypertensive heart failure. cerebral atherosclerosis; generalised ischaemic cerebrovascular disease; hypertensive encephalopathy; nonruptured cerebral aneurysm; intracranial sinus thrombosis; transient global amnesia (exclude acute cerebrovascular events e.g stroke, haemorrhage, tra Crohn’s disease; Crohn’s colitis/enteritis/enterocolitis/ileitis (excludes pilonidal sinus/cyst) kidney stone, nephrolithiasis, renal calculi, renal stone, ureteral/urinary stone/calculus. maternal distress in labour and delivery; maternal shock/hypotension associated with labour and delivery; instrumental delivery (forceps/vacuum extraction/ventouse delivery; breech delivery; caesarean delivery/section). undescended and retracted testicle/testes; hypospadias, epispadias; indeterminate sex; pseudohermaphroditism; congenital anomalies of reproductive organs/ genitalia; fracture of any metacarpal bone (whether or not other hand/finger bones involved) finger fracture, phalanx/phalangeal fracture; thumb fracture (whether or not other hand/finger bones involved) femur neck fracture / fractured neck of femur/ femoral neck fracture; transcervical femoral fracture (exclude: Dupuytren’s fracture, ankle fracture, Pott’s fracture, pathological or spontaneous fracture). closed/open fracture of lower leg, unspecified part. fracture of malleolus/ malleoli; ankle fracture fracture of calcaneus; fracture of other tarsal and metatarsal bones. animal bite, avulsion, laceration, cut, open wound of foot or heel. (exclude if only toes are so injured.) black eye; contusion/bruising of eyelids/orbit/eyeball. prostate/prostatic cancer, prostate/prostatic carcinoma. uterine fibroids/ uterine leiomyoma uterine myoma. hyperoestrogenism ovarian failure; polycystic ovarian disease; PCOS; polycystic ovary syndrome corneal ulcer; keratitis; keratoconjunctivitis; corneal neovascularisation; ECG diagnosis of old MI; healed MI; old heart attack. old coronary artery thrombosis. cardiac valvular disease; mitral valve disorder; aortic valve disorder; tricuspid valve disorder; pulmonary valve disorder; endocarditis. hereditary haemorrhagic telangiectasia; benign nevus. pneumococcal pneumonia; pneumonia due to streptococcus pneumoniae; lobar pneumonia (even if pneumococcus not specified as causative organism) gastric/ stomach ulcer; peptic ulcer; prepyloric ulcer; pyloric ulcer; stomach ulcer. intestinal obstruction (exclude if associated with hernia) vesical fistula; bladder diverticulum; atonic bladder; functional bladder disorder; urinary retention. hydrocele/hydrocoele (of testis/tunica vaginalis). endometriosis, endometrioma. coccygeal fistula/abscess, coccygeal sinus, pilonidial fistula; pilonidial sinus, pilonidal abscess, pilonidial cyst with/without abscess. congenital dislocation of hip; congenital deformities of long bones of legs; varus deformities of feet; valgus deformities of feet; club foot; talipes ageing; age related degeneration/degenerative changes/debility/debilitation; old age; senescence; senility. SIDS/ cot death; sudden death (of unknown cause). fracture of facial/face bones; nasal fracture; fracture of mandible/mandibular fracture; malar and/or maxillary fracture; orbital floor fracture/ blowout fracture of orbit burn of lower limb(s)/legs; chancroid; lymphogranuloma venereum; granuloma inguinale; Reiter;s disease; nongonococcal urethritis; chlamydial infection of reproductive tract. adenocarcinoma of colon; colon cancer (include colorectal cancer) hypoglycaemic coma; hypoglycaemia allergic purpura; platelet dysfunction; purpura; thrombocytopenia. mental disorder following brain damage 73 organic brain damage specific delays in development dyslexia; dyscalculia/acalculia; learning difficulties; developmental language or speech disorder; development disorder; developmental delay; autism/autistic spectrum disorder other cerebral degenerations Alzheimer’s disease; Pick’s disease; senile degeneration of the brain; dementia didorders of iris and ciliary body iridocyclitis; disorders of iris and/or ciliary body. acute pulmonary heart disease acute cor pulmonale; pulmonary embolism and pulmonary infarction; acute pulmonary heart disease. deflected nasal septum deviated/deflected/crooked nasal septum. bronchiectasis bronchiectasis; bronchiolectasis. disorders of tooth development and eruption teething; teething pain. appendicitis, unqualified appendicitis chronic liver disease and cirrhosis alcoholic liver disease; alcoholic hepatitis/steatohepatitis; cirrhosis (of the liver); chronic hepatitis; biliary cirrhosis non-inflammatory disorders of ovary, fallopian tube ovarian cyst; follicular cyst of ovary; corpus luteum cyst; prolapse of ovary and/or and broad ligament fallopian tube; ovarian torsion/torsion of ovary legally induced abortion (induced) abortion (exclude spontaneous abortion) other current conditions in the mother classifiable specific diseases in the mother, only if complicating childbirth: diabetes mellitus; elsewhere but complicating pregnancy, childbirth and thyroid dysfunction (hypo- or hyperthyroidism); anaemia; drug dependence/ substance the puerperium abuse; mental disorder; cardiovascular disease; musculoskeletal disorders other disorders of the breast associated with childbirth, only if associated with childbirth and breastfeeding: Retracted nipple / cracked nipple; and disorders of lactation engorgement of breasts; failure of lactation; galactorrhoea lichen lichen planus; lichen nitidus other congenital anomalies of upper alimentary tract congenital tongue tie; cleft palate/ cleft lip; tracheoesophageal fistula; oesophageal atresia and/or stenosis; congenital oesophageal anomalies; congenital pyloric stenosis; congenital hiatal hernia fracture of humerus fracture of humerus fracture of carpal bones carpal bone fracture; scaphoid fracture fracture of one or more phalages of foot toe fracture; fracture of phalanges of foot effects of other external causes radiation sickness; barotrauma; exposure measles measles; morbilli; rubeola; measles complications viral hepatitis viral hepatitis; Hepatitis A, B or C; unspecified viral hepatitis mumps mumps; mumps orchitis; mumps meningitis; mumps encephalitis; mumps pancreatitis; mumps complications malignant neoplasm of bladder adenocarcinoma of bladder; bladder cancer; carcinoma of bladder; transitional cell carcinoma of bladder. secondary malignant neoplasm of other specified sites secondary cancer (i.e. metastasis/ metastatic deposit / metastatic tumour / secondary tumour) haemangioma and lymphangioma, any site angioma; haemangioma; cavernous angioma; glomus tumor; lymphangioma; arteriovenous malformation simple and unspecified goitre simple goitre; goitre (NB if associated with hyperthyroidism then capture under hyperthyroidism/thyrotoxicosis). paranoid states paranoia; paranoid delusions; paranoid disorders; paraphrenia; (exclude paranoid schizophrenia, which is captured under schizophrenia) other nonorganic psychoses psychotic state due to environmental factors; emotional stress; reactive psychosis hemiplegia hemiplegia (exclude congenital, infantile, or hemiplegia due to stroke or other cerebrovascular accident) facial nerve disorders seventh nerve palsy; Bell’s palsy; disorders of refraction and accommodation hyperopia; myopia; astigmatism; anisometropia; aniseikonia; presbyopia; accommodative disorders other venous embolism and thrombosis Budd-Chiari syndrome; thrombophlebitis migrans; deep vein thrombosis; venous thromboembolism (regardless of site – include vena caval thrombosis/ renal vein thrombosis). (exclude pulmonary embolism) other disorders of circulatory system haemorrhage; postpheblitic syndrome; chronic laryngitis and laryngotracheitis laryngitis/laryngotracheitis (exclude acute laryngitis/laryngotracheitis) acute appendicitis acute appendicitis chronic renal failure chronic renal failure; end stage renal disease; chronic uraemia. inflammatory diseases of prostate acute/chronic prostatitis; prostate abscess. inflammatory diseases of uterus, except cervix unspecified inflammatory disease/inflammation of uterus. venous complications in pregnancy and the varicose veins (of legs or of genitalia/perineum) in pregnancy; haemorrhoids in puerperium pregnancy; thrombophlebitis in pregnancy; venous thrombosis / deep vein thrombosis in pregnancy diffuse diseases of connective tissue multi-system collagen diseases; systemic lupus erythematosus; systemic sclerosis; Sjogren's disease; dermatomyositis; polymyositis; eosinophilia myalgia syndrome. flat foot acquired arch weakness; acquired pes planus; broken arches; fallen arches; flat foot. NPFIT/Bestcurrentevidence/29.3.06 74 other acquired deformaties of limbs other congenital muscoskeletal anomalies nonspecific abnormal histological and immunological findings fracture of vertebral column without mention of spinal cord legion fracture of clavical dislocation of shoulder open wound of toe(s) superficial injury of finger(s) crushing injury of upper limb foreign body in ear burn of upper limb, except wrist and hand other salmonella infections erysipelas trichomoniasis malignant neoplasm of rectum, rectosigmoid junction and anus other benign neoplasm of connective and other soft tissue carcinoma in situ of breast and genitourinary system neoplasm of uncertain behaviour of other and unspecified sites and tissues disorders of carbohydrate transport and metabolism other and unspecified disorders of metabolism mononeuritis of lower limb inflammatory and toxic neuropathy corneal opacity and other disorders of cornea diseases of mitral valve occlusion of cerebral arteries aortic aneurysm polyarteritis nodosa and allied conditions peritonsillar abscess other disorders of biliary tract intestinal malabsorption infertility, male ectopic pregnancy hypertension complicating pregnancy, childbirth and the puerperium other derangement of joint curvature of spine congenital anomalies of eye NPFIT/Bestcurrentevidence/29.3.06 mallet finger; acquired deformities of finger / hand/ wrist/ arm/ forearm/ hip/ leg/ knee/ ankle/ foot. congenital anomalies of skull and facial bones/spine/diaphragm/abdominal wall/abdominal muscle/tendon/fascia/cervical rib; chondrodystrophy; osteodystrophy. abnormal cervical pap smear; non-specific abnormality on chromosomal analysis; nonspecific positive culture findings; non-specific reaction to tuberculin skin test (without active TB) vertebral fracture; crush fracture of vertebra; neural arch fracture; spinal fracture; fracture of spinous process or transverse process; fractured neck; back; sacrum or coccyx; cervical spine fracture clavical/ calvicular fracture; fracture of collar bone dislocation of shoulder (exclude congenital dislocation). animal bite; avulsion; cut/laceration of toe(s) superficial injury / abrasion /blister /insect bite / foreign body / splinter in finger, fingernail, thumb, thumbnail crush injury of shoulder and upper arm/elbow and forearm/wrist and hand(s) (exclude such injuries if confined to finger(s) alone). foreign body in ear; foreign body in external auditory canal/ external auditory meatus; foreign body in auricle. burn of upper limb/ arm/ forearm/ wrist/ hand/fingers. salmonella gastroenteritis; salmonella septicaemia; salmonella infection. erysipelas. trichmonas vaginalis infection; trichmoniasis anal cancer; rectal cancer; include colorectal cancer benign lump or neoplasm of connective tissue carcinoma in situ (include CIS breast/cervix/uterus/other female genitalia/prostate/penis/other male genitalia/bladder/urinary organs); also include DCIS (ductal carcinoma in situ); vaginal intraepithelial neoplasi (VIN); cervical intraepithelial neoplasi breast lumps (when malignant/benign status unknown); suspicious skin lesions (when malignant/benign status unknown); histiocytoma; plasmacytoma; polycythemia vera. inborn error of (carbohydrate) metabolism: glycogenosis; galactosemia; hereditary fructose intolerance; intestinal disaccharidase deficiencies; renal glycosuria. cystic fibrosis; porphyria; amyloidosis; disorders of bilirubin excretion; mucopolysaccharidosis; metabolic syndrome X. sciatica; sciatic neuropathy; lateral cutaneous nerve compression; common peroneal nerve lesion; lesion of medial popliteal nerve; tarsal tunnel syndrome; plantar nerve lesion neuritis; mononeuritis multiplex; diabetic neuropathy; alcoholic neuropathy; malignancy-induced neuropathy; vascular neuropathy; Guillain-Barre syndrome; unspecified inflammatory or toxic neuropathy. corneal scars and opacities; corneal pigmentations and deposits; corneal oedema; corneal dystrophy; keratoconus; mitral stenosis; mitral reflux/regurgitation; mitral valve prolapse. cerebral thrombosis; cerebrovascular thrombosis; cerebral/cerebrovascular thromboembolism; cerebral/cerebrovascular embolism. aortic aneurysm; aortic dissection; dissecting aortic aneurysm. polyarteritis nodosa; Kawasaki disease; hypersensitivity angiitis; Wegener’s granulomatosis; giant cell arteritis; thrombotic microangiopathy; Takayasu’s disease; temporal arteritis. peritonsillar abscess; peritonsilitis; quinsy. cholangitis (include sclerosing cholangitis); choledocholithiasis; bile duct obstruction; bile duct perforation; bile duct fistula; sphincter of Oddi spasm. coeliac disease; tropical sprue; blind loop syndrome; pancreatic steatorrhoea. azoospermia; oligospermia; male infertility. abdominal/tubal/ovarian/other/unspecified site ectopic pregnancy. benign essential hypertension in pregnancy; transient HT of pregnancy; pregnancyinduced hypertension; pre-eclampsia; eclampsia. articular cartilage disorder; loose body in joint; recurrent dislocation (not current injury); contracture of joint; ankylosis (exclude ankylosing spondylitis). kyphosis; lordosis; kyphoscoliosis; scoliosis. anophthalmos; microphthalmos; buphthalmos; congenital cataract and lens anomalies; coloboma. 75 fracture of other and unspecified parts of femur dislocation of knee open wound of eyeball open wound of other and unspecified sites, except limbs open wound of shoulder and upper arm superficial injury of elbow, forearm and wrist certain early complications of trauma complications peculiar to certain specified procedures shigellosis other food poisoning (bacterial) bacterial infection in conditions classified elsewhere and of unspecified site malignant neoplasm of oesophagus malignant neoplasm of stomach malignant melanoma of skin malignant neoplasm of cervix uteri malignant neoplasm of ovary and other uterine adnexa malignant neoplasm without specification of site benign neoplasm of other and unspecified sites nontoxic nodular goitre other disorders of thyroid deficiency of b-complex components disorders of mineral metabolism drug psychoses other organic psychotic conditions (chronic) other condition of brain retinal detachments and defects disorders of the orbit secondary hypertension cardiomyopathy conduction disorders intracerebral haemorrhage occlusion and stenosis of precerebral arteries atherosclerosis varicose veins of other sites noninfective disorders of lymphatic channels viral pneumonia other bacterial pneumonia pneumothorax other alveolar and parietoalveolar pneumopathy other diseases and conditions of the teeth and supporting structures diseases of the pancreas urethritis, not sexually transmitted, and urethral syndrome urethral stricture disorders of uterus, not elsewhere classified noninflammatory disorders of vulva and perineum missed abortion NPFIT/Bestcurrentevidence/29.3.06 fracture of femur (exclude fractured neck of femur). subluxation/dislocation of knee; meniscus/meniscal tear; dislocation of patella/patellar dislocation. animal bite /cut /puncture/laceration of eyeball, (ocular laceration). wounds of trunk / torso /abdomen/ chest. animal bite /avulsion of/cut /laceration of shoulder and upper arm. superficial abrasion/injury or friction burn/ insect bite to/ foreign body in elbow, forearm, and wrist. air / fat embolism after trauma; haemorrhage after trauma; posttraumatic wound infection; traumatic shock; traumatic anuria; rhabdomyolysis after trauma; Volkman’s contracture; traumatic subcutaneous emphysema. complications following implants/prostheses/graft/transplant bacillary dysentery; shigella; shigellosis (bacterial) food poisoning sepsis/toxaemia/septicaemia/toxic shock/diseminated infection due to bacteria. cancer of oesophagus; oesophageal cancer/carcinoma. gastric cancer/carcinoma/adenocarcinoma; cancer of stomach malignant melanoma cervical cancer; cancer of cervix ovarian cancer; cancer of ovary cancer of unknown or no specific site; disseminated malignancy benign neoplasm of lymph nodes thyroid adenoma; thyroid nodule (EXCLUDE if associated with hyperthyroidism) thyroid cyst; thyroid haemorrhage. vitamin B deficiency (inc all vit B components). pernicious anaemia; intrinsic factor deficiency; Wilson’s disease; haemachromatosis; hyperparathyroidism; hyper/hypocalcaemia; hyper/hypomagnesaemia; hyper/hypophosphataemia drug withdrawal syndrome; drug psychosis; drug intoxication; drug induced paranoia and/or hallucination;. amnestic syndrome; dementia cerebral cyst; anoxic brain injury; cerebral hypoxia/anoxia; pseudotumor cerebri; encephalopathy; cerebral oedema. retinal detachment; retinoschisis; retinal cysts; retinal defects. orbital cellulitis; inflammation of orbit; exophthalmos; enophthalmous renovascular hypertension; secondary hypertension, (excluding HTN complicating pregnancy or childbirth); malignant hypertension. myocardiopathy; cardiomyopathy (of any cause, include also hypertrophic cardiomyopathy); myocardial fibrosis; endomyocardial fibrosis atrioventricular block; heart block; bundle branch blocks. cerebral/cerebellar/ brain stem haemorrhage carotid (artery) stenosis; vertebral artery stenosis; basilar artery stenosis; embolism/thrombosis/thromboembolism of these arteries. atherosclerosis; atherosclerotic disease; atheromatous disease; atheroma; cardiovascular disease/cerebrovascular disease/peripheral vascular disease oesophageal varices sublingual varices; pelvic varices; vulval varices. lymphoedema; lymphangitis. viral pneumonia; viral pneumonitis; respiratory syncytial virus (RSV) pneumonia; bronchiolitis pneumonia due to specified bacteria other than pneumococcus; legionnaires disease. pneumothorax pulmonary haemosiderosis; fibrosing alveolitis loss of teeth due to trauma; tooth extraction; periodontal disease; caries. pancreatitis; pancreatic cyst / pancreatic pseudocysts urethritis; non-specific urethritis (exclude gonococcal; chlamydial). urethral stricture uterine polyp; uterine hypertrophy; uterine/endometrial hyperplasia; haematometra; uterine inversion/retroversion/ retroverted uterus. vulval/vaginal atrophy/dystrophy; clitoral hypertrophy; labial hypertrophy; labial polyp. missed miscarriage; missed abortion; retained products of conception. 76 antepartum haemorrhage, abruptio placentae, and placenta praevia early or threatened labour other fetal and placental problems affecting management of mother postpartum haemorrhage bullous dermatosis osteomyelitis, periostitis and other infections involving bone osteitis deformans and osteopathies associated with other disorders classified elsewhere congenital anomalies of ear, face and neck bulbus cordis anomalies and anomalies of cardiac septal closure other congenital anomalies of limbs fracture of pelvis fracture of patella fracture of unspecified bones dislocation of finger other, multiple and ill-defined dislocations open wound of ocular adnexa open wound of ear open wound of genital organs (external), including traumatic amputation multiple and unspecified open wound of lower limb crushing injury of lower limb foreign body in genitourinary tract burn of face, head and neck burn of trunk burn, unspecified injury to periferal nerve(s) of shoulder girdle and upper limb injury to other and unspecified nerves toxic effect of other substances, chiefly nonmedicinal as to source complications of medical care, not elsewhere specified other protozoal intestinal diseases pulmonary tuberculosis whooping cough meningococcal infection tetanus septicaemia actinomycotic infections other non-arthropod-borne viral diseases of central nervous system malaria gonococcal infections other and unspecified helmithiases sarcoidosis malignant neoplasm of pancreas malignant neoplasm of larynx malignant neoplasm of body of uterus malignant neoplasm of testis malignant neoplasm of kidney and other and NPFIT/Bestcurrentevidence/29.3.06 placenta previa; abruptio placentae/ placental abruption; antepartum haemorrhage. preterm labour/premature labour; threatened preterm/premature labour; early onset of delivery. foetal-maternal haemorrhage; rhesus incompatibility; ABO isoimmunisation; haemolytic disease of the newborn; foetal distress; intrauterine foetal death; intrauterine growth retardation; microsomia; macrosomia; oligohydramnios; polyhydramnios; placental i postpartum haemorrhage dermatitis herpetiformis; bullous dermatosis; pemphigus; pemphigoid. osteomyelitis;. osteitis deformans; osteitis deformans; hypertrophic pulmonary osteoarthropathy congenital anomaly of ear/ face/ neck; accessory auricle; branchial cleft; cyst or fistula; preauricular sinus; webbing of neck. ventricular septal defect; common trunchus; transposition of great vessels; tetraology of fallot; common ventricle; atrial septal defect; endocardial cushion defect. polydactyly; syndactyly; micromelia; amelia. pelvic fracture; acetabular fracture; pubic fracture fracture of kneecap/ patella; patellar fracture fracture of unspecified bone(s); fractures in general dislocation/subluxation of finger/thumb/phalanx/phalanges vertebral/cervical/thoracic/lumbar dislocation/subluxation animal bite to/avulsion of/cut to/laceration of/ foreign body in periorbital area, eyelid, tear ducts. animal bite to/avulsion of/cut to/foreign body in tissue of /amputation of / laceration to ear/ auricle/pinna. animal bite to/avulsion of/cut to/foreign body in tissue of / amputation of / laceration to penis; scrotum; testes; vulva; vagina. multiple: animal bite to/avulsion of/cut to/foreign body in tissue of / amputation of / laceration of lower limbs crush injury of any part of leg (hip/thigh/knee/ankle/foot, excluding toes alone) foreign body in bladder/urethra/uterus/vulva/vagina/penis. burns of face, head, and neck burns of trunk burn or burns, not otherwise specified; burns in general axillary/median/ulnar/radial/musculocutaneous/cutaneous sensory/digital nerve injury; injury to nerves of hand/fingers injury to superficial nerves of head and neck; nerve injuries in general poisoning [due to ingestion or systemic introduction of any substance (exclude drug overdose)]. Include stings,venom,industrial and agricultural and household products. complications of dialysis/ extracorporeal circulation/ parenteral nutrition/percutaneous intra-gastric nutrition/infusion /inhaler/nebuliser/ /injction /inoculation/vaccination/perfusion/transfusion/ anaphylaxis folowing medical treatment. amoebiasis; balantidiasis; giardiasis; coccidiosis; intestinal trichmoniasis; cryptosporidosis; cyclosporiasis. pulmonary tuberculosis; tuberculosis. pertussis; whooping cough. meningococcal meningitis; meningococcal septicaemia; waterhous-friedrichson syndrome; meningococcal encephalitis. tetanus; lockjaw. bacterial sepsis; bacterial septicaemia. actinomycosis; actinomadura infection; actinomyces infection; actinomycotic mycetoma; nocardia infection; streptomyces infection. . abacterial meningitis; viral meningitis; viral encephalitis; viral meningo-encephlitis; lymphocytic choriomeningitis malaria; blackwater fever; other pernicious complications of malaria. gonococcal infection of any site; gonorrhoea. helminthiasis; toxocariasis; gnathostomiasis. sarcoid; sarcoidosis. pancreatic cancer; pancreatic carcinoma/adenocarcinoma laryngeal cancer endometrial cancer; uterine cancer testicular cancer; cancer of testis; testicular carcinoma renal cell carcinoma; kidney cancer; renal cancer; cancer of ureter/urethra. (exclude 77 unspecified urinary organs malignant neoplasm of brain malignant neoplasm of thyroid gland other malignant neoplasm of lymphoid and histiocytic tissue multiple myeloma and immunoproliferative neoplasms lymphoid leukaemia myeloid leukaemia leukaemia of unspecified cell type benign neoplasm of lip, oral cavity and pharynx benign neoplasm of other parts of digestive system benign neoplasm of bone and articular cartlidge benign neoplasm of ovary benign neoplasm of male genital organs benign neoplasm of kidney and other urinary organs benign neoplasm of brain and other parts of nervous system benign neoplasm of thyroid gland carcinoma in situ of respiratory system neoplasm of uncertain behaviour of digestive and respiratory systems neoplasm of uncertain behaviour of genitourinary organs neoplasm of uncertain behaviour of endocrine glands and nervous system congenital hypothyroidism thyroiditis disorders of parathyroid gland disorders of adrenal glands other endocrine disorders other nutritional deficiencies hereditary haemolytic anaemias coagulation defects diseases of white blood cells alcoholic psychoses disturbance of emotions specific to childhood and adolescence hyperkinetic syndrome of childhood mental retardation meningitis of unspecified cause encephalitis, myelitis and encephalomyelitis spinocerebellar disease anterior horn cell disease other diseases of spinal cord infantile cerebal palsy NPFIT/Bestcurrentevidence/29.3.06 bladder cancer and prostate cancer) astrocytoma; brain cancer/tumour; glioblastoma; glioma thyroid carcinoma/cancer of any type; malignant goitre; phaeochromocytoma of thyroid; hazard-crile tumor; hurthle cell carcinoma. lymphoma; mycosis fungoides multiple myeloma; plasma cell leukaemia lymphocytic/lymphonbalstic/lymphoid/lymphogenous leukaemia. myeloid/myeloblastic/myelogenous/myelocytic/myelosclerotic leukaemia other/unspecified leukaemia (unspecified cell type). benign neoplasm of lip/tongue/major salivary glands/ mouth benign neoplasm of oesophagus/stomach/small intestine/colon/rectum/anus/liver/bile ducts /pancreas. benign bone/cartilage/periosteal tumour; chondroblastoma; osteoblastoma; giant osteoid osteoma; fibroma of bone. benign ovarian tumour/teratoma; Brenner’s tumor; endometrioid cyst/cystadenofibroma; ovarian cyst. benign neoplasm/tumour of testicle/penis/prostate/epididymis/scrotum. benign neoplasm/tumour of kidney /ureter/bladder/urinary tract. benign neoplasm/tumour of brain/cranial nerves/ meninges/spinal cord carcinoma in situ of larynx/trachea/bronchus/lung lump if unknown whether malignant or benign in following sites: salivary glands/lip; oral cavity; pharynx/stomach; gastrointestinal tract/liver/ biliary tree/retroperitoneum and peritoneum; larynx/trachea; bronchus; and lung/pleura; thymus and mediastinum lump if unknown whether malignant or benign in following sites: uterus/placenta/ovary/vulva/vagina/testis/prostate/penis/bladder/urinary tract. lump if unknown whether malignant or benign in following sites: pituitary gland/pineal gland/adrenal gland/brain and spinal cord/meninges; neurofibromatosis. congenital hypothyroidism; congenital myxoedema; congenital subthyroidism; congenital thyroid insufficiency; cretinism; Pendred’s syndrome. thyroiditis. hyperparathyroidism; hypoparathyroidism. Cushing’s syndrome; hyperaldosteronism; Conn’s syndrome; adrenocortical insufficiency delayed sexual development; precocious sexual development; carcinoid syndrome; ectopic hormone secretion vitamin K deficiency; other vitamin deficiency (exclude B deficiency); mineral deficiency. haemolytic anaemias; thalassaemia; sickle-cell trait; sickle-cell anaemia; haemoglobinopathy; other hereditary haemolytic anaemia. bleeding disorder; coagulation abnormalities; clotting disorder/deficiency; coagulopathy; haemorrhagic disorder; haemophilia; factor XIII deficiency; factor IX deficiency; factor XI deficiency; clotting factor deficiency; Von Willebrands disease; dissemin agranulocytosis; neutropenia; leukopenia; neutrophil dysfunction; neutrophilia; eosinophilia. alcoholic/ alcohol-induced psychosis; alcohol withdrawal; alcoholic dementia overanxious disorder; misery and unhappiness disorder; shyness; social withdrawal; childhood mixed emotional disorder; emotional disturbance/ disorder in childhood/adolescence. (exclude these conditions if in adults) attention deficit disorder/ attention deficit hyperactivity disorder/ADHD; hyperkinetic disorder/syndrome mental retardation meningitis/meningoencephalitis/arachnoiditis, regardless of chronicity. Exclude if cause is specified (e.g. viral meningitis; pneumococcal; meningococcal). encephalitis; myelitis and encephalomyelitis; whether or not cause is specified. Friedrich’s ataxia; cerebellar ataxia; hereditary spastic paraplegia; spinocerebellar atrophy. amyotrophic lateral sclerosis; motor neurone disease; spinal muscular atrophy; anterior horn cell disease. syringomyelia; syringobulbia; vascular myelopathy; subacute combined degeneration of spinal cord; myelopathy. cerebral palsy. 78 other paralytic syndromes other and unspecified disorders of the nervous system hereditary and idiopathic peripheral neuropathy myoneural disorders muscular dystrophies and other myopathies chorioretinal inflammations and scars and other disorders of choroid disorders of optic nerve and visual pathways mastoiditis and related conditions other disorders of middle ear and mastoid otosclerosis NPFIT/Bestcurrentevidence/29.3.06 quadriplegia; paraplegia; cauda equina syndrome; spinal cord compression; paralysis not further specified unspecified disorders of central nervous system; other CNS disorders. Reaction to lumbar puncture; nervous system complication from surgically implanted device; disorder of meninges, not elsewhere classified; other specified/unspecified disorder of nervo hereditary peripheral neuropathy; peroneal muscular atrophy; hereditary sensory neuropathy; hereditary sensorimotor neuropathy; Refsum’s disease. Myasthenia gravis muscular dystrophy; myopathy; familial periodic paralysis chorioretinitis/retinochoroiditis; chorioretinal scar; choroidal degeneration/dystrophy/haemorrhage/detachment papilloedema; optic atrophy; optic neuritis mastoiditis; petrositis tympanosclerosis; cholesteatoma otosclerosis 79