• National Collaborating Centre for Nursing and Supportive Care. Irritable bowel syndrome in adults. Diagnosis and management of irritable bowel syndrome in primary care. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Feb. 27 p. (Clinical guideline; no. 61).

This is the current release of the guideline.

Irritable bowel syndrome (IBS)

Diagnosis
Evaluation
Management
Treatment

Family Practice
Gastroenterology
Internal Medicine
Psychology

Dietitians
Patients
Physicians
Psychologists/Non-physician Behavioral Health Clinicians

• To provide positive diagnostic criteria for people presenting with symptoms suggestive of irritable bowel syndrome (IBS)
• To provide guidance on clinical and cost-effective management of IBS in primary care
• To determine clinical indications for referral to IBS services, taking into account cost effectiveness

Adults (18 years and older) who present to primary care with symptoms suggestive of irritable bowel syndrome (IBS)

Note: This guideline does not cover:

• People with other gastrointestinal disorders such as non-ulcer dyspepsia or coeliac disease
• Children and young people under 18 years
• Inflammatory bowel disease

Diagnosis

1. Initial assessment
   • Evaluation of symptoms
   • Physical examination, including examination for "red flag" indicators
   • Referral to secondary care
2. Diagnostic tests
   • Full blood count (FBC)
   • Erythrocyte sedimentation rate (ESR) or plasma viscosity
   • C-reactive protein (CRP)
   • Antibody testing for coeliac disease (endomysial antibodies [EMA] or tissue transglutaminase [TTG])

Note: The following tests were considered, but were not recommended to confirm diagnosis: ultrasound, rigid/flexible sigmoidoscopy, colonoscopy, barium enema, thyroid function test, faecal ova and parasite test, faecal occult blood test, hydrogen breath test.

Management

1. Dietary and lifestyle advice
2. Pharmacological therapy
   • Antispasmodic agents
   • Laxatives
   • Loperamide
   • Tricyclic antidepressants (TCAs)
   • Selective serotonin reuptake inhibitors (SSRIs)
3. Referral for psychological interventions
   • Cognitive behavioural therapy (CBT)
   • Hypnotherapy
   • Psychological therapy
4. Complementary and alternative medicine (CAM), including acupuncture and reflexology (considered, but not recommended)
5. Follow-up

• Symptomatic improvement
• Quality of life
• Adverse effects

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Nursing and Supportive Care (NCC-NSC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Clinical Effectiveness Review Methods

Search Strategy

The search strategies and the databases searched are presented in detail in Appendix B in the full version of the original guideline document (see the "Availability of Companion Documents" field). All searches were carried out on the following core databases: Medline, Embase, Cinahl (all using the OVID interface) and The Cochrane Library. Additional databases were searched for individual reviews where appropriate.

For this guideline, a general set of terms was produced relating to irritable bowel syndrome (IBS). The relevance of the terms diarrhoea and constipation was explored before they were included in the IBS filter. For each review, terms related to the intervention were combined with the set of IBS terms. Where appropriate, study design filters (randomised controlled trial [RCT] and systematic review) were applied. Results were limited to papers published in English where possible. All searches were updated to June 2007.

Hand-searching was not undertaken following NICE advice that exhaustive searching on every guideline review topic is not practical or efficient. Reference lists of articles were checked for studies of potential relevance.

Methods of the Review

Sifting Process

Once the search had been completed, the following sifting process took place:

• 1st sift: one reviewer sifted the title/abstract for articles that potentially met the eligibility criteria
• 2nd sift: full papers were ordered that appeared relevant and eligible or where relevance/eligibility was not clear from the abstract
• 3rd sift: full papers were appraised, generally by one reviewer using an inclusion criteria form, and this was checked where necessary by a second reviewer.

Quality Assessment and Validity

Once individual papers were retrieved, the articles were checked for methodological rigour (using quality checklists appropriate for each study design), applicability to the United Kingdom (UK) and clinical significance. Assessment of study quality concentrated on dimensions of internal validity and external validity. At this stage, some studies were excluded if the interventions were not licensed for use in the UK or they were not regularly used in the UK. Studies in which the interventions were obsolete were also excluded.

Studies for which the methodological quality indicated a high potential for bias were included in the review, but were not included in the analysis.

Cost Effectiveness Review Methods

Objectives of Cost-Effectiveness Review

1. To determine the cost-effectiveness of tests to identify alternative diagnoses in patients meeting the diagnostic criteria for IBS who do not have any "red-flag" symptoms.
2. To assess the cost-effectiveness of interventions used in the management of IBS.

Search Strategy for Identification of Studies

Searches were performed on the MEDLINE database for objective 1 using the strategy given in appendix B in the full version of the original guideline document. Specific searches were also performed on the National Health Service economic evaluation database (NHS EED) database using the Medical Subject Heading (MeSH) terms for inflammatory bowel disease (exploded to include Crohn's disease and ulcerative colitis), lactose intolerance and coeliac disease. Free-text searching on the NHS EED database was explored but did not yield any further relevant papers.

Searches were performed on the MEDLINE database for objective 2 using the strategy in Appendix B of the full version of the original guideline document. Specific searches were also performed on the NHS EED database using the MeSH term for irritable bowel syndrome which yielded two further papers. Free-text searching on the NHS EED database was explored but did not yield any further relevant papers.

Not stated

Expert Consensus
Weighting According to a Rating Scheme (Scheme Given)

Grading Evidence

For some reviews, the Guideline Development Group used the GRADE scheme to assess the quality of the evidence for each outcome using the approach described below, and evidence summaries across all outcomes were produced)

According to the GRADE scheme, evidence is classified as high, moderate, low or very low:

• High - further research is very unlikely to change the confidence in the estimate of effect
• Moderate - further research is likely to have an important impact on the confidence in the estimate of effect and may change the estimate
• Low - further research is very likely to have an important impact on the confidence in the estimate of effect and is likely to change the estimate
• Very low - any estimate of effect is very uncertain

The procedure adopted when using GRADE was:

1. A quality rating was assigned, based on the study design – for example, randomised controlled trials (RCTs) started as high and observational studies as low.
2. This rating was up or downgraded according to specified criteria: study quality, consistency, directness, preciseness and reporting bias. These criteria are detailed in the full version of the guideline document (see the "Availability of Companion Documents" field). Criteria were given a downgrade mark of -1 or -2 depending on the severity of the limitations.
3. The downgrade/upgrade marks were then summed and the quality rating revised. For example, a decrease of -2 points for an RCT would result in a rating of 'low'.
4. Wherever possible, reasoning was explained for the downgrade marks.

Meta-Analysis of Randomized Controlled Trials
Systematic Review with Evidence Tables

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Nursing and Supportive Care (NCC-NSC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Data Abstraction

Data from the included studies were extracted by one reviewer for each review, with random checking by a second reviewer, and entered into a Microsoft Access relational database that had been especially designed for the guideline. The use of the database provided a more structured extraction, for example, only certain choices could be made for some items, although free text fields were also used. The main advantage of using a database for this purpose is that a large amount of detail can be input, and then an overview obtained using database sorting procedures. The following data were extracted from each study:

• Review being addressed
• Study details: study design (RCT, quasi-randomised, cohort study, etc); parallel/crossover, washout period; country where trial conducted; setting; funding
• Study quality
• Participants: age (mean and range), gender (ratio male:female), co-morbidities, inclusion/exclusion criteria, IBS diagnosis method, type of IBS, presence of bloating, presence of pain, measure of severity of IBS, symptom status at trial entry, length of time since diagnosis, duration of symptoms, ethnicity, socio-economic group, weight, postinfective/non post-infective initiated IBS
• Interventions: class (e.g. insoluble fibre) and sub-class (e.g. wheat bran), total amount per day, frequency/time of consumption, means of delivery (oral capsule, taken as a food, drink, etc), duration of treatment; concurrent treatment in both arms
• Comparator: placebo (details of what it is), other control group, other intervention
• Outcome: including follow-up period, scales used, definition of success (if using "improved", "complete response", etc)
• Results for each outcome

Appraisal of Methodological Quality

The methodological quality of each trial was assessed by one reviewer and randomly checked by a second. See section 5.2 in the full version of the original guideline document (see "Availability of Companion Documents" field) for a list of quality items that were assessed.

Data Synthesis

Meta-analysis of similar trials, where appropriate, was carried out using The Cochrane Collaboration's analysis software, Review Manager (Version 4.2). Trials were pooled using a fixed effects model and plotted on forest plots. Where there was significant heterogeneity, a random effects model was used as a sensitivity analysis.

For dichotomous studies, reviewers used the analyses reported by the authors, which was usually those reporting an outcome. Where there were incomplete data reported (more than 20% missing in any one group), reviewers carried out sensitivity analyses, excluding these studies.

Where it was possible to combine studies, outcomes were summarised for dichotomous data using odds ratios (as default), relative risks (where the event rate in either arm was greater than 20%), or Peto odds ratios (where there were studies with no events in one arm). Numbers needed to treat (with the control group rate to which they apply) were calculated from the risk difference, where appropriate. The number needed to treat (NNT) is the number of people who would have to be treated for one to have an improved outcome.

Refer to section 5.2 of the full version of the original guideline document (see the "Availability of Companion Documents" field) for additional information.

Expert Consensus (Nominal Group Technique)

Note from the National Guideline Clearinghouse (NGC): This guideline was developed by the National Collaborating Centre for Nursing and Supportive Care (NCC-NSC) on behalf of the National Institute for Health and Clinical Excellence (NICE). See the "Availability of Companion Documents" field for the full version of this guidance.

Formulating Recommendations and Determining Key Recommendations

Evidence to Recommendations

Each review summarises the evidence, and the guideline development group (GDG) are asked to interpret the evidence before drafting recommendations. In each case, this includes a consideration of the clinical and cost effectiveness evidence; an indication of the factors the GDG took into account, including the balance between benefits and harms; the GDG's reasoning and conclusions, and, where relevant, the level of agreement amongst the group. This is reported in each individual review section of the full guideline document (see the "Availability of Companion Documents" field), illustrating the relationship between published clinical and cost effective evidence and recommendations for clinical practice.

Key Recommendations

Process

The GDG was asked to vote on key recommendations by secret email ballot using an Excel spreadsheet. This incorporated the full list of recommendations and votes were allocated to the group, in order to try and determine the key priorities for the guideline. Developing consensus through validated instruments is key to ensure that the final list of up to ten key recommendations fully reflect the group as a whole. This enables all constituent members of the group to have equal weighting of opinion as their opinion moves towards a consensus group position. Typically, nominal group technique (NGT) works well for small groups, with 12 to 15 people widely acknowledged in the literature as the maximum number of people involved in this process.

See section 5.5 in the full guideline document to see the results of voting.

Summary

The NGT worked well in developing consensus opinion, reflected by the key recommendations emergent from the process. The nine key recommendations represent the heart of the full guideline and full guideline recommendations. They articulate the evidence supporting the key areas of healthcare practice that will be shaped by the guideline, providing the possibility with effective implementation for people with irritable bowel syndrome (IBS) symptoms being properly diagnosed and managed within primary care.

Not applicable

Cost Effectiveness Review Methods

Whilst cost-effectiveness is an important consideration for all recommendations made within the guideline, two areas were identified as being priority areas for which cost-effectiveness evidence would have particular importance for informing recommendations. These were identified by the health economist in conjunction with the Guideline Development Group (GDG) after consideration of the importance of each clinical question in terms of the number of patients likely to be affected and the impact on costs and health outcomes for those patients.

The use of tests to exclude alternative diagnoses in people with IBS-like symptoms was considered to be a high priority area for economic evaluation for the following reasons: diagnostic testing has the potential to result in earlier diagnosis of organic disease which may improve health outcomes; the widespread use of tests may have significant cost implications; the use of tests may result in unnecessary anxiety for patients, particularly if the rate of false positive results is high; invasive tests may have adverse consequences for patients in terms of complications.

The use of pharmacological and behavioural interventions in the management of IBS was also identified as a high priority area for economic evaluation. Pharmacological interventions were identified as an area of high priority because the ongoing use of these interventions in a large number of IBS patients would have significant implications for the use of NHS resources. Behavioural interventions were identified as an area of high priority because these are not widely used at present in the management of IBS and therefore significant additional resources may be required if these are recommended for widespread use.

Two approaches were employed to provide cost-effectiveness evidence for the GDG to consider when making recommendations. Firstly, a review of the health economic literature was carried out and relevant health economic evidence was presented to the GDG. Secondly, further economic analysis was carried out in the priority areas where there was insufficient evidence available from the published literature to inform recommendations and where there was sufficient evidence to demonstrate the clinical effectiveness for the intervention or diagnostic strategy. This further economic analysis was conducted in the form of a cost-effectiveness analysis where the additional benefits were measured in terms of quality-adjusted life-years (QALYs) and the additional costs were assessed from an NHS and personal social services perspective. The GDG considered the incremental cost per QALY for alternative management and diagnostic strategies alongside the clinical effectiveness evidence when formulating recommendations. Where one clinical strategy was clearly more effective and less costly than another it was considered cost-effective. Where one strategy was more effective but also more costly, the incremental cost per QALY was estimated and this was compared to a cost effectiveness threshold of 20,000 to 30,000 pounds sterling per QALY in line with the principals laid out in the NICE Guidelines Manual (NICE 2007). For those clinical questions not prioritised for economic analysis, the GDG considered the likely cost-effectiveness of associated recommendations by making a qualitative judgement on the likely balance of costs, health benefits and any potential harms.

See Section 5.3 in the full version of the original guideline document for methods and results of the cost-effectiveness review.

External Peer Review
Internal Peer Review

The guideline was validated through two consultations.

1. The first draft of the guideline (the full guideline, National Institute for Clinical Excellence (NICE) guideline and Quick Reference Guide) were consulted with Stakeholders and comments were considered by the Guideline Development Group (GDG)
2. The final consultation draft of the Full guideline, the NICE guideline and the Information for the Public were submitted to stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review prior to publication.

An algorithm for diagnosis and management of irritable bowel syndrome (IBS) is provided in the original guideline document.

Recommendations are based on clinical and cost effectiveness evidence, and where this is insufficient, the Guideline Development Group (GDG) used all available information sources and experience to make consensus recommendations using nominal group technique.

Effective diagnosis and management of irritable bowel syndrome (IBS)

Adverse effects of medications

• This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer and informed by the summary of product characteristics of any drugs they are considering.
• As with any clinical practice guideline, the recommendations contained in this guideline may not be appropriate in all circumstances. A limitation of a guideline is that it simplifies clinical decision-making. Decisions to adopt any particular recommendations must be made by practitioners in the context of:
  • Available resources
  • Local services, policies and protocols
  • The circumstances and wishes of the patient
  • Available personnel and devices
  • Clinical experience of the practitioner
  • Knowledge of more recent research findings

Living with Illness
Staying Healthy

Effectiveness
Patient-centeredness

• National Collaborating Centre for Nursing and Supportive Care. Irritable bowel syndrome in adults. Diagnosis and management of irritable bowel syndrome in primary care. London (UK): National Institute for Health and Clinical Excellence (NICE); 2008 Feb. 27 p. (Clinical guideline; no. 61).

Not applicable: The guideline was not adapted from another source.

2008 Feb

National Collaborating Centre for Nursing and Supportive Care - National Government Agency [Non-U.S.]

National Institute for Health and Clinical Excellence (NICE)

Guideline Development Group

Group Members: Mr Jonathan Blanchard-Smith, Patient/carer representative, The Gut Trust (formerly the IBS Network); Dr Ian Bullock, Director, National Collaborating Centre for Nursing and Supportive Care; Dr Jamie Dalrymple, General Practitioner, Norwich; Ms Sarah Davis, Senior Health Economist, National Collaborating Centre for Nursing and Supportive Care; Ms Jackie Eastwood, Specialist Pharmacist in Gastroenterology, St. Mark's Hospital, Harrow; Dr Charles Foster, Senior Researcher, University of Oxford; Dr Jenny Gordon, Research and Development Fellow, National Collaborating Centre for Nursing and Supportive Care; Mrs Jenny Gough, Nurse Consultant, Camden Primary Care Trust, London; Professor Elspeth Guthrie, Professor of Psychological Medicine & Medical Psychotherapy, Manchester Royal Infirmary; Dr Miranda Lomer, Consultant Dietician in gastroenterology, King's College London; Ms Marion Saunders, Patient/carer representative; Ms Theresa Shaw (Chair) Chief Executive, Foundation of Nursing Studies, London; Dr Richard Stevens, General Practitioner, Oxford; Dr Maggie Westby, Senior Research and Development Fellow, National Collaborating Centre for Nursing and Supportive Care; Professor Peter Whorwell (Clinical Lead) Professor of Medicine and Gastroenterology, Wythenshawe Hospital, Manchester; Dr Mary Wilson, Nurse Specialist, Westwood Hospital, North Humberside

All members of the Guideline Development Group (GDG) were required to make formal declarations of interest at the outset, and these were updated at every subsequent meeting throughout the development process. This information is recorded in the meeting minutes and kept on file at the National Collaborating Centre for Nursing and Supportive Care (NCC-NSC). The GDG declarations are recorded in Appendix K of the full version of the original guideline document.

This is the current release of the guideline.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.