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National Collaborating Centre for Chronic Conditions (UK). Rheumatoid Arthritis: National Clinical Guideline for Management and Treatment in Adults. London: Royal College of Physicians (UK); 2009 Feb. (NICE Clinical Guidelines, No. 79.)

Cover of Rheumatoid Arthritis

Rheumatoid Arthritis: National Clinical Guideline for Management and Treatment in Adults.

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2Methodology

2.1. Aim

The aim of the National Collaborating Centre for Chronic Conditions (NCC-CC) is to provide a user-friendly, clinical, evidence-based guideline for the National Health Service (NHS) in England and Wales that:

  • offers best clinical advice for the management and treatment of rheumatoid arthritis (RA) in adults in primary and secondary care
  • is based on best published clinical and economics evidence, alongside expert consensus
  • takes into account patient choice and informed decision-making
  • defines the major components of NHS care provision for RA
  • details areas of uncertainty or controversy requiring further research
  • provides a choice of guideline versions for different audiences.

2.2. Scope

The guideline was developed in accordance with a remit originating from the Department of Health and specifying those aspects of RA care to be included and excluded.

Prior to the commencement of the guideline development, the scope was subjected to stakeholder consultation in accordance with processes established by NICE.1,7 The full scope is shown in Appendix B.

2.3. Audience

The guideline is intended for use by the following people or organisations:

  • all healthcare professionals
  • people with RA and their carers
  • patient support groups
  • commissioning organisations
  • service providers.

2.4. Involvement of people with RA

The NCC-CC was keen to ensure that the views and preferences of people with RA and their carers informed all stages of the guideline. This was achieved by:

  • including two people with RA as patient representatives on the guideline development group
  • consulting the Patient and Public Involvement Programme (PPIP) housed within NICE during the pre-development (scoping) and final validation stages of the guideline project
  • the inclusion of patient groups as registered stakeholders for the guideline.

2.5. Guideline limitations

Guideline limitations are as follows:

  • NICE clinical guidelines usually do not cover issues of service delivery, organisation or provision (unless specified in the remit from the Department of Health).
  • NICE is primarily concerned with health services and so recommendations are not provided for social services and the voluntary sector. However, the guideline may address important issues in how NHS clinicians interface with these sectors.
  • Generally, the guideline does not cover rare, complex, complicated or unusual conditions.
  • It is not possible in the development of a clinical guideline to complete an extensive systematic literature review of all pharmacological toxicity. NICE expects the guidelines to be read alongside the summaries of product characteristics.

2.6. Other work relevant to the guideline

Related NICE technology appraisals:

Related NICE clinical guidelines:

  • Osteoarthritis: the care and management of adults with osteoarthritis. (NICE clinical guideline 59; 2008)
  • Osteoporosis: assessment of fracture risk and the prevention of osteoporotic fractures in individuals at high risk (publication date to be confirmed)
  • Hypertension: management of hypertension in adults in primary care (NICE clinical guideline 34 (partial upgrade of CG18); 2006)
  • Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease (NICE clinical guideline 67; 2008).

2.7. Background

The development of this evidence-based clinical guideline draws upon the methods described by the NICE Guidelines manual1 (see www.nice.org.uk). The developers’ role and remit is summarised in Table 2.1.

Table 2.1. Role and remit of the developers.

Table 2.1

Role and remit of the developers.

2.8. The process of guideline development

The basic steps in the process of producing a guideline are:

  • Developing clinical questions
  • Systematically searching for the evidence
  • Critically appraising the evidence
  • Incorporating health economics evidence
  • Distilling and synthesising the evidence and writing recommendations
  • Grading the evidence statements
  • Agreeing the recommendations
  • Structuring and writing the guideline
  • Updating the guideline.

Developing evidence-based questions

The technical team drafted a series of clinical questions that covered the guideline scope. The GDG and Project Executive refined and approved these questions, which are shown in Appendix A.

Searching for the evidence

The information scientist developed a search strategy for each question. Key words for the search were identified by the GDG. In addition, the health economist searched for additional papers providing economics evidence or to inform detailed health economics work (for example, modelling). Papers that were published or accepted for publication in peer-reviewed journals were considered as evidence by the GDG. Conference paper abstracts and non-English language papers were excluded from the searches.

Each clinical question dictated the appropriate study design that was prioritised in the search strategy but the strategy was not limited solely to these study types. The research fellow or health economist identified relevant titles and abstracts from the search results for each clinical question and full papers were obtained. Exclusion lists were generated for each question together with the rationale for the exclusion. The exclusion lists were presented to the GDG. Exclusion criteria used in this guideline were studies that involved a ‘non-UK relevant population’. Populations considered to be ‘UK-relevant’ were Western Europe, North America, Canada, Australia and New Zealand. See Appendix A for literature search details.

Appraising the evidence

The research fellow or health economist, as appropriate, critically appraised the full papers. In general, no formal contact was made with authors however there were ad hoc occasions when this was required in order to clarify specific details. Critical appraisal checklists were compiled for each full paper. One research fellow undertook the critical appraisal and data extraction. The evidence was considered carefully by the GDG for accuracy and completeness.

All procedures are fully compliant with:

Health economics evidence

Published economics evaluations were retrieved, assessed and reviewed for every guideline question. Full economics evaluations were included – that is those studies that compare the overall health outcomes of different interventions as well as their cost. Cost analyses and cost-consequences analysis, which do not evaluate overall health gain, were not included.

Evaluations conducted in the context of non-OECD countries were also excluded, since costs and care pathways are unlikely to be transferable to the UK NHS.

Areas for health economics modelling were agreed by the GDG after the formation of the clinical questions. The health economist reviewed the clinical questions to consider the potential application of health economics modelling, and these priorities were agreed with the GDG.

The health economist performed supplemental literature searches to obtain additional data for modelling. Assumptions, data and structures of the models were explained to and agreed by the GDG members during meetings, and they commented on subsequent revisions.

Distilling and synthesising the evidence and developing recommendations

The evidence from each full paper was distilled into an evidence table and synthesised into evidence statements before being presented to the GDG. This evidence was then reviewed by the GDG and used as a basis upon which to formulate recommendations. The criteria for grading evidence are shown in Tables 2.1 and 2.2.

Table 2.2. Levels of evidence for intervention studies.

Table 2.2

Levels of evidence for intervention studies.

Evidence tables are available online at www.rcplondon.ac.uk/pubs/brochure.aspx?e=271

Grading the evidence statements

Table 2.3Levels of evidence for diagnostic studies1

Level of evidenceType of evidence
IaSystematic review (with homogeneitya) of level-1 studiesb
IbLevel-1 studiesb
IILevel-2 studiesc
Systematic reviews of level-2 studies
IIILevel-3 studiesd
Systematic reviews of level-3 studies
IVConsensus, expert committee reports or opinions and/or clinical experience without explicit critical appraisal; or based on physiology, bench research or ‘first principles’
a

Homogeneity means there are no or minor variations in the directions and degrees of results between individual studies that are included in the systematic review.

b

Level-1 studies are studies that use a blind comparison of the test with a validated reference standard (gold standard) in a sample of patients that reflects the population to whom the test would apply.

c

Level-2 studies are studies that have only one of the following:

  • narrow population (the sample does not reflect the population to whom the test would apply)
  • a poor reference standard (defined as that where the ‘test’ is included in the ‘reference’, or where the ‘testing’ affects the ‘reference’)
  • a comparison between the test and reference standard that is not blind
  • case-control design.

d

Level-3 studies are studies that have at least two of the features listed for level-2 studies.

Agreeing the recommendations

The GDG employed formal consensus techniques to:

  • ensure that the recommendations reflected the evidence base
  • approve recommendations based on lesser evidence or extrapolations from other situations
  • reach consensus recommendations where the evidence was inadequate
  • debate areas of disagreement and finalise recommendations.

The GDG also reached agreement on:

  • recommendations as key priorities for implementation
  • five key research recommendations
  • algorithms.

In prioritising key recommendations for implementation, the GDG took into account the following criteria:

  • high clinical impact
  • high impact on reducing variation in practice
  • more efficient use of NHS resources
  • allowing the patient to reach critical points in the care pathway more quickly.

Audit criteria for this guideline will be produced for NICE following publication in order to provide suggestions of areas for audit in line with the key recommendations for implementation.

Structuring and writing the guideline

The guideline is divided into sections for ease of reading. For each section the layout is similar and contains:

  • Clinical introduction: sets a succinct background and describes the current clinical context.
  • Methodological introduction: describes any issues or limitations that were apparent when reading the evidence base. Point estimates (PE) and confidence intervals (CI) are provided for all outcomes in the evidence tables available at www.rcplondon.ac.uk/pubs/brochure.aspx?e=271. In addition, within the guideline PE and CI are cited in summary tables for the evidence that pertains to the key priorities for implementation. In the absence of a summary table PE and CI are provided in the narrative text when the outcome adds something to the text and to make a particular point. These may be primary or secondary outcomes that were of particular importance to the GDG when discussing the recommendations. The rationale for not citing all statistical outcomes is to try to provide a ‘user friendly’ and readable guideline balanced with statistical evidence where this is thought to be of interest to the reader.
  • Evidence statements: provides a synthesis of the evidence-base and usually describes what the evidence showed in relation to the outcomes of interest. Where the evidence statements are considerable the GDG have attempted to summarise these into a useful summary.
  • Health economics: presents, where appropriate, an overview of the cost effectiveness evidence-base, or any economics modelling.
  • From evidence to recommendations: sets out the GDG decision-making rationale providing a clear and explicit audit trail from the evidence to the evolution of the recommendations.
  • Recommendations: provides standalone, action orientated recommendations.
  • Evidence tables: are not published as part of the full guideline but are available online at www.rcplondon.ac.uk/pubs/brochure.aspx?e=271. These describe comprehensive details of the primary evidence that was considered during the writing of each section.

The first draft version of the guideline was drawn up by the technical team in accordance with the decisions of the GDG, incorporating contributions from individual GDG members in their expert areas and edited for consistency of style and terminology. The guideline was then submitted for a formal public and stakeholder consultation prior to publication. The registered stakeholders for this guideline are detailed on the NICE website, www.nice.org.uk. Editorial responsibility for the full guideline rests with the GDG.

The different versions of the guideline are shown in Table 2.4.

Table 2.4. Different versions of the guideline.

Table 2.4

Different versions of the guideline.

Updating the guideline

Literature searches were repeated for all of the evidence based questions at the end of the GDG development process, allowing any relevant papers published up until 13 June 2008 to be considered. Future guideline updates will consider evidence published after this cut-off date.

Following publication and in accordance with the technical manual, NICE will ask a National Collaborating Centre to determine whether the evidence base has progressed significantly enough to alter the guideline recommendations and warrant an update.

2.9. Disclaimer

Healthcare providers need to use clinical judgement, knowledge and expertise when deciding whether it is appropriate to apply guidelines. The recommendations cited here are a guide and may not be appropriate for use in all situations. The decision to adopt any of the recommendations cited here must be made by the practitioner in light of individual patient circumstances, the wishes of the patient, clinical expertise and resources.

The NCC-CC disclaims any responsibility for damages arising out of the use or non-use of these guidelines and the literature used in support of these guidelines.

2.10. Funding

The National Collaborating Centre for Chronic Conditions was commissioned by the National Institute for Health and Clinical Excellence to undertake the work on this guideline.

Copyright © 2009, Royal College of Physicians of London.

All rights reserved. No part of this publication may be reproduced in any form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written permission of the copyright owner. Applications for the copyright owner’s written permission to reproduce any part of this publication should be addressed to the publisher.

Bookshelf ID: NBK51806

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