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Respiratory Tract Infections - Antibiotic Prescribing: Prescribing of Antibiotics for Self-Limiting Respiratory Tract Infections in Adults and Children in Primary Care. London: National Institute for Health and Clinical Excellence (NICE); 2008 Jul. (NICE Clinical Guidelines, No. 69.)
NICE guidelines are developed in accordance with a scope that defines what the guideline will and will not cover (see appendix 1). The scope of this guideline is available from www.nice.org.uk/CG069.
The aim of this guideline is to provide evidence-based recommendations to guide healthcare professionals in the appropriate prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in primary care.
This section sets out in detail the methods used to generate the recommendations for clinical practice that are presented in the previous sections of this guideline. The methods used to develop the recommendations are in accordance with those set out by the National Institute for Health and Clinical Excellence (‘NICE’ or ‘the Institute’) in ‘The guidelines manual 2007’ (available from www.nice.org.uk).
The draft scope, which defined the areas the guideline would and would not cover, was prepared by the Short Clinical Guidelines Technical Team on the basis of the remit from the Department of Health, consultation with relevant experts and a preliminary search of the literature to identify existing clinical practice guidelines, key systematic reviews and other relevant publications. The literature search gave an overview of the issues likely to be covered by the guideline and helped define key areas. It also informed the Short Clinical Guidelines Technical Team of the volume of literature likely to be available in the topic area, and therefore the amount of work required.
The draft scope was tightly focused and covered five clinical topic areas.
The draft scope was the subject of public consultation.
The short clinical guideline on the prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in primary care was developed by a Guideline Development Group (GDG) consisting of nine full members and the Short Clinical Guidelines Technical Team. The GDG had a chair, healthcare professional members and patient/carer members who were recruited through open advertisement. Development took 5 months and the GDG met on five occasions, every 3 to 5 weeks.
The third step in the development of the guideline was to refine the scope into a series of key clinical questions. The key clinical questions formed the starting point for the subsequent evidence reviews and facilitated the development of recommendations by the GDG.
The key clinical questions were developed by the GDG with assistance from the Short Clinical Guidelines Technical Team. As necessary, the questions were refined into specific research questions by the project teams to aid literature searching, appraisal and synthesis. The full list of key clinical questions is shown in appendix 2.
The GDG and Short Clinical Guidelines Technical Team agreed appropriate review parameters (inclusion and exclusion criteria) for each question or topic area. A full table of the included and excluded studies is shown in appendix 4.
For each key question, recommendations were derived from the evidence summaries and statements presented to the GDG.
The reviews used to develop the guideline recommendations were underpinned by systematic literature searches, following the methods described in ‘The guidelines manual 2007.’ The purpose of systematically searching the literature is to attempt to comprehensively identify the published evidence to answer the review questions developed by the GDG and Short Clinical Guidelines Technical Team.
The search strategies for the reviews on the prescribing of antibiotics for self-limiting respiratory tract infections in adults and children in primary care were developed by the Short Clinical Guidelines Technical Team, in consultation with the GDG. Review questions were developed using the PICO model, and reflecting the inclusion criteria, which were translated in to search strategies using subject heading and free text terms. The strategies were run across a number of databases (e.g. MEDLINE, EMBASE and CINAHL) with no date restrictions imposed on the searches.
To identify economic evaluations the NHS Economic Evaluation Database (NHS EED) and the Health Economic Evaluations Database (HEED) were searched. Reports of economic evaluations added to bibliographic databases (e.g. MEDLINE) from 2006 onwards, and quality of life data, were also sought using search filters.
In addition to the systematic literature searches, the GDG was asked to alert the Short Clinical Guidelines Technical Team to any additional evidence, published, unpublished or in press, that met the inclusion criteria.
The searches were undertaken between August 2007 and December 2007. Full details of the systematic search, including the sources searched and the MEDLINE search strategy for each review, are presented in appendix 3.
The aim of the literature review was to systematically identify and synthesise relevant evidence in order to answer the specific key clinical questions developed from the guideline scope. The guideline recommendations were evidence based if possible; if evidence was not available, informal consensus of opinion within the GDG was used. The need for future research was also specified. This process required four main tasks: selection of relevant studies; assessment of study quality; synthesis of the results; and grading of the evidence. The Technical Analyst had primary responsibility for reviewing the evidence but was supported by the Project Lead, Information Scientist and Health Economist.
After the scope was finalised, searches based on individual key clinical questions were undertaken. The searches were first sifted by the Short Clinical Guidelines Technical Team using title and abstract to exclude papers that did not address the specified key clinical question. After selection based on title and abstract, the full text of the papers were obtained and reviewed by the Short Clinical Guidelines Technical Team in order to determine which studies should be included in the literature review. Studies suggested or submitted by the GDG and expert advisers were also reviewed for relevance to the key clinical questions and included if they met the inclusion criteria.
The papers chosen for inclusion were then critically appraised by the Short Clinical Guidelines Technical Team for their methodological rigour against a number of criteria that determine the validity of the results. These criteria differed according to study type and were based on the checklists included in ‘The guidelines manual 2007’.
The data were extracted to standard evidence table templates. The findings were summarised by the Short Clinical Guidelines Technical Team into both a series of evidence statements and an accompanying narrative summary.
Studies that meet the minimum quality criteria were ascribed a level of evidence to help the guideline developers and the eventual users of the guideline understand the type of evidence on which the recommendations have been based.
There are many different methods of assigning levels to the evidence and there has been considerable debate about what system is best. A number of initiatives are currently under way to find an international consensus on the subject. NICE has previously published guidelines using different systems and is now examining a number of systems in collaboration with the National Collaborating Centres and academic groups throughout the world to identify the most appropriate system for future use.
Until a decision is reached on the most appropriate system for the NICE guidelines, the Short Clinical Guidelines Technical Team will use the system for evidence shown in table 12.
Levels of evidence for intervention studies. Reproduced with permission from the Scottish Intercollegiate Guidelines Network
It was the responsibility of the GDG to endorse the final levels given to the evidence.
The reader of a guideline should be able to follow a clear path from the question posed, through the summary of the evidence collected to address the question (linking to detailed evidence tables if desired), to the consideration of the evidence and the formulation of appropriate recommendations.
Grading or Recommendations Assessment, Development and Evaluation (GRADE) is a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts. The system is a useful way to summarise evidence of effectiveness by the outcomes for which data have been collected. This approach uses an ‘evidence profile’ that combines presentation of quality assessment and outcome data. This then followed by a short evidence statement summarising what the evidence has shown.
In the GRADE system, the quality of evidence indicates the extent to which one can be confident that an estimate of effect is correct. The strength of a recommendation indicates the extent to which one can be confident that adherence to the recommendation will do more good than harm. The steps in this approach, which follow these judgements, are to make sequential judgements about:
A systematic and explicit approach to making judgements about the quality of evidence and the strength of recommendations can help to prevent errors, facilitate critical appraisal of these judgements, and improve communication of this information. More information about GRADE and its utilisation is available from www.grade.workinggroup.org
The system described above covers studies of treatment effectiveness. However, it is less appropriate for studies reporting diagnostic tests of accuracy. In the absence of a validated ranking system for this type of test, NICE has developed a hierarchy for evidence of accuracy of diagnostic tests that takes into account the various factors likely to affect the validity of these studies (table 13). Since this hierarchy has not been systematically tested, NICE recommends that the National Collaborating Centres use the system when appropriate, on a pilot basis, and report their experience to us.
Hierarchy for evidence of accuracy of diagnostic tests.
This evidence grading system was applied to the evidence reviews.
Studies that are reviewed for questions about prognosis were addressed using the newly developed pilot checklist for prognostic studies (see appendix 4. This checklist is based on a checklist for the quality appraisal of prognostic studies developed by Hayden et al (Hayden JA et al. 2006) and is designed to answer questions about prognosis and address the likelihood of an outcome, for patients from a population at risk for that outcome, based on the presence of a proposed prognostic factor. Prognostic factors may be disease-specific (for example, presence/absence of particular disease feature), demographic (for example, age or sex), or may be the likely response to treatment or the presence of comorbidities.
A well designed and validated approach to summarising a body of evidence on prognosis does not currently exist. In the absence of such a system, a narrative summary of the quality of the evidence should given, based on the quality appraisal criteria from the checklist (appendix 4) that were considered to be most important for the question addressed. Clinical input (such as from a GDG member) may be needed to identify the most appropriate quality criteria. This should be followed by a short evidence statement summarising what the evidence has shown. Finally, there should be a clear description of how the GDG has interpreted the evidence in reaching its recommendations.
The evidence tables and narrative summaries for the key clinical questions being discussed were made available to the GDG 1 week before the scheduled GDG meeting.
All GDG members were expected to have read the evidence tables and narrative summaries before attending each meeting. The review of the evidence had three components. First, the GDG discussed the evidence tables and narrative summaries or GRADE profiles and corrected any factual errors or incorrect interpretation of the evidence. Second, evidence statements, which had been drafted by the Short Clinical Guidelines Technical Team, were presented to the GDG and the GDG agreed the correct wording of these. Third, from a discussion of the evidence statements and the experience of GDG members recommendations were drafted. The Short Clinical Guidelines Technical Team explicitly flagged up with the GDG that it should consider the following criteria (considered judgement) when developing the guideline recommendations from the evidence presented:
The GDG was able to agree recommendations through informal consensus. The process by which the evidence statements informed the recommendations is summarised in an ‘evidence to recommendations’ section in the relevant evidence review. Each recommendation was linked to an evidence statement if possible. If there was a lack of available evidence of effectiveness, but the GDG was of the view that a recommendation was important based on the GDG members’ own experience, this was noted in the ‘evidence to recommendations’ section.
An economic evaluation aims to integrate data on the benefits (ideally in terms of quality-adjusted life years, or QALYs), harms and costs of alternative options. An economic appraisal will not only consider whether a particular course of action is clinically effective, but also whether it is cost effective (that is, value for money). If a particular treatment strategy is found to yield little health gain relative to the resources used, then it could be advantageous to redirect resources to other activities that yield greater health gain.
A systematic review of the economic literature relating to RTIs was conducted. In addition, the GDG and expert advisers were questioned over any potentially relevant unpublished data. The search of the published literature yielded one relevant economic study. This was the only study to specifically examine delayed prescribing versus no prescribing in a full cost-utility analysis for AOM (Coco 2007). The majority of studies identified examined strategies for the diagnosis of RTI and did not follow up patients after a result was obtained. No UK-based studies were identified and no studies were identified that examined the common cold or acute cough/acute bronchitis.
Given the potentially large resource implications of antibiotic use, the cost of complications of RTIs and the potential for development of antimicrobial resistance as a result of overuse of antibiotics, a de novo model was developed that considered strategies for the prescribing of antibiotics for acute sore throat in the UK.
Health economics statements are made in the guideline in sections where the use of NHS resources is considered.
The draft of the full guideline was available on the website for consultation, and registered stakeholders were informed by NICE that the documents were available. Non-registered stakeholders could view the guideline on the NICE website.
It is beyond the scope of the work to pilot the contents of this guideline or validate any approach to implementation. These limitations excepted, every effort has been made to maximise the relevance of recommendations to the intended audience through the use of a guideline development group with relevant professional and patient involvement, by use of relevant experienced expert reviewers and the stakeholder process facilitated by the NICE Short Clinical Guidelines Technical Team. Implementation support tools for this guideline will be available from the Implementation Team at NICE.
The guideline recommendations have been used to develop clinical audit support for monitoring local practice. This is an essential implementation tool for monitoring the uptake and impact of guidelines, and thus needs to be clear and straightforward for organisations and professionals to use.
NICE develops audit support for all its guidance programmes as part of its implementation strategy.
The guidance has been developed in accordance with the NICE guideline development process for short clinical guidelines. This has included allowing registered stakeholders the opportunity to comment on the draft guidance. In additional the first draft was reviewed by an independent Guideline Review Panel established by NICE.
The comments made by stakeholders, peer reviewers and the Guideline Review Panel were collated and presented anonymously for consideration by the GDG. All comments were considered systematically by the GDG and the Project Team recorded the agreed responses.
This guideline will be considered for an update following the current process (chapter 15 of ‘The guidelines manual’). However, if the evidence available has not changed the guideline will not be updated. Any agreed update would be carried out by the Short Clinical Guidelines Technical Team in conjunction with the Guideline Development Group. Alternatively the topic may be referred to the NICE Topic Selection Panel for it to consider developing a standard clinical guideline.
All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of the Institute.
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