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National Clinical Guideline Centre (UK). Chronic Obstructive Pulmonary Disease: Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care [Internet]. London: Royal College of Physicians (UK); 2010 Jun. (NICE Clinical Guidelines, No. 101.)

Cover of Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease: Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care [Internet].

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2Methodology

2.1. The process of guideline development (for a partial update)

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

  • Identifying areas of existing guidance that need updating
  • Developing clinical questions
  • Developing the review protocol
  • Systematically searching for the evidence
  • Critically appraising the evidence
  • Undertaking new health economic analysis
  • Distilling and synthesising the evidence and writing recommendations
  • Agreeing the recommendations
  • Structuring and writing the guideline
  • Updating the guideline.

2.1.1. Identifying areas of existing guidance that need updating

The NCGC-ACC conducted a preliminary search for new evidence using the search strategies from the original guideline. The views of healthcare professionals and patients were also sought to identify any change in practice or additional relevant published evidence. Key areas that would directly result in changes to recommendations were highlighted for updating.

2.1.2. 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 H.

2.1.3. Developing the review protocol

For each clinical question, the Information Scientist and the Research Fellow (with input from the technical team) prepared a review protocol. This protocol explained how the review was to be carried out (see table 2.1), in order to formulate a plan of how to review the evidence, limit the introduction of bias, and for the purpose of reproducibility. A health economic literature review protocol was also developed. All review protocols can be found in appendix I.

Table 2.1. Components of the review protocol.

Table 2.1

Components of the review protocol.

2.1.4. Searching for the evidence

The Information Scientist developed a search strategy for each question. Key words for the search were identified by the GDG. A separate health economic search strategy was developed looking for economic studies in COPD. Papers that were published in peer-reviewed journals (including e-publications ahead print where identified) were considered as evidence by the GDG. Conference paper abstracts and non-English language papers were excluded from the searches. Where it was deemed appropriate and where there was lack of evidence in the literature on an area of clinical importance, the GDG decided to initiate a ‘call for evidence’ asking all registered stakeholders to submit any relevant unpublished evidence. Where this occurred this is detailed within the guideline write-up.

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 for each clinical question from the search results 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. See appendices I and J for review protocols and literature search details.

2.1.5. 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.

For non-observational studies, where possible this included meta-analysis of data and synthesis of data into a GRADE ‘evidence profile’. The evidence profile shows for each outcome an overall assessment of both the quality of the evidence as a whole (low, moderate or high), as well as an estimate of the size of effect. For observational and qualitative studies, a narrative summary (evidence statements) was written summarising the results.

For economic studies, an economic ‘evidence profile’ was constructed. The economic evidence profile shows, for each economic study, an assessment of applicability (directly applicable, partially applicable or not applicable) and methodological quality (minor limitations, potentially serious limitations, very serious limitations) with footnotes indicating the reasons for the assessment. It also shows incremental costs, incremental outcomes (e.g. QALYs) and the incremental cost-effectiveness ratio from the primary analysis, as well as information about the assessment of uncertainty in the analysis. In this guideline results are presented for the comparison specified in the clinical question irrespective of whether or not the comparison was ‘appropriate’ in the analysis being reviewed (that is where an intervention is compared with the next most expensive non-dominated option – a clinical strategy is said to ‘dominate’ the alternatives when it is both more effective and less costly). Footnotes indicated if a comparison was ‘inappropriate’ in the analysis.

A research fellows or health economist, as appropriate, 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 the NICE methodology as detailed in the ‘Guideline Development Methods – Information for National Collaborating Centres and Guideline Developers’ Manual36.

2.1.6. Undertaking new health economic analysis

Priority areas for new health economics modelling were agreed by the GDG after the formation of the clinical questions and consideration of available health economic evidence.

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. See appendix M for details of the modelling undertaken for the guideline.

2.1.7. Distilling and synthesising the evidence and developing recommendations

The evidence from each full paper was distilled into an evidence table and synthesised into an evidence profile and evidence statements before being presented to the GDG. The results of health economic modelling undertaken for the guideline were also presented to the GDG. This evidence was then reviewed by the GDG and used as a basis upon which to formulate recommendations.

Evidence tables are available at http://guidance.nice.org.uk/CG101/EvidenceTables/pdf/English.

2.1.8. 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 the following:

  • Recommendations as key priorities for implementation
  • Future research recommendations
  • Algorithms

In prioritising key priorities 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.

2.1.9. Structuring of the updated sections of the guideline

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

  • Clinical introduction
    This sets a succinct background and describes the current clinical context. It includes which section of the original guideline has been updated and why, and what the existing guideline recommends.
  • Methodological introduction
    This section outlines the a priori agreement of the GDG in relation to the inclusion and exclusion criteria together with the outcomes of interest.
  • GRADE Evidence profiles and forest plots
    The GRADE evidence profiles provide a synthesis of the evidence-base, the quality and describe what the evidence showed in relation to the outcomes of interest (including effect sizes). Forest plots showing meta-analysis results are also provided for outcomes where appropriate.
  • Evidence statements
    Provide a bottom-line narrative summary.
  • Health economics
    Presents, where appropriate, an overview of the cost effectiveness evidence-base, or any economic modelling.
  • From evidence to recommendations
    This section sets out the Guideline Development Group (GDG) decision-making rationale providing a clear and explicit audit trail from the evidence to the evolution of the recommendations.
  • Recommendations
    Provides stand-alone, action-orientated recommendations and details which of the original guideline recommendations have been amended or deleted and any new recommendations that have been added. Unlike the original guideline, recommendations made in this partial update are no longer graded on the strength of evidence, in keeping with the guidelines manual 2009.
  • Evidence tables
    The evidence tables are not published as part of the full guideline but are available on-line. These describe comprehensive details of the primary evidence that was considered during the writing of each section.

2.1.10. Writing the guideline

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 original guideline evidence tables from February 2004 are available at http://thorax.bmj.com/content/59/suppl_1

The following versions of the guideline are available:

Full version:Details the recommendations, the supporting evidence base and the expert considerations of the GDG. Published by the NCGC-ACC. Available from http://guidance​.nice​.org.uk/CG101/Guidance/pdf/English
NICE version:Documents the recommendations without any supporting evidence. Available from http://guidance​.nice​.org.uk/CG101/NICEGuidance/pdf/English

http://guidance​.nice​.org.uk/CG101/NICEGuidance/doc/English
“Quick reference guide”:An abridged version. Available from http://guidance​.nice​.org.uk/CG101/QuickRefGuide/pdf/English
“Understanding NICE guidance”:A lay version of the guideline recommendations. Available from http://guidance​.nice​.org.uk/CG101/PublicInfo/pdf/English

2.2. Re-run evidence

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 20th August 2009 to be considered. Future guideline updates will consider evidence published after this cut-off date. Further updates will take place in concordance with the specifications outlined in the NICE guidelines manual.

2.3. 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 NCGC-ACC 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.

2.4. Funding

The NCGC-ACC was commissioned by NICE to undertake the work on this guideline.

Copyright © 2010, National Clinical Guideline Centre - Acute and Chronic Conditions.

Apart from any fair dealing for the purposes of research or private study, criticism or review, as permitted under the Copyright, Designs and Patents Act, 1988, no part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page. The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use. The rights of National Clinical Guideline Centre to be identified as Author of this work have been asserted by them in accordance with the Copyright, Designs and Patents Act, 1988.

Bookshelf ID: NBK65030

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