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Ulcerative colitis

About

What is covered

This interactive flowchart covers the management of ulcerative colitis in adults, children and young people.
Ulcerative colitis is the most common type of inflammatory disease of the bowel. The cause of ulcerative colitis is unknown. It can develop at any age, but peak incidence is between the ages of 15 and 25 years, with a second, smaller peak between 55 and 65 years.

Updates

Updates to this interactive flowchart

25 June 2019 Reinforcement of a permanent stoma with a synthetic or biological mesh to prevent a parastomal hernia (NICE interventional procedures guidance 654) added to surgery.
2 May 2019 Update of ulcerative colitis: management (NICE guideline NG130), mainly affecting inducing remission section.
19 February 2019 Barnett Continent Intestinal Reservoir (modified continent ileostomy) to restore continence after colon and rectum removal (NICE interventional procedures guidance 642) added to surgery.
27 November 2018 Tofacitinib for moderately to severely active ulcerative colitis (NICE technology appraisal guidance 547) added to step 2 therapy.
10 February 2016 Irritable bowel syndrome in adults (NICE quality standard 114) added.
18 August 2015 Leukapheresis for inflammatory bowel disease (NICE interventional procedures guidance 126) added to maintaining remission.
4 June 2015 Vedolizumab for treating moderately to severely active ulcerative colitis (NICE technology appraisal guidance 342) added to step 2 therapy.
24 March 2015 Transanal total mesorectal excision of the rectum (NICE interventional procedures guidance 514) and insertion of a collagen plug to close an abdominal wall enterocutaneous fistula (NICE interventional procedures guidance 507) added to surgery.
25 February 2015 Inflammatory bowel disease (NICE quality standard 81) added.
24 February 2015 Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (NICE technology appraisal guidance 329) added.
1 October 2013 Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel (NICE diagnostics guidance 11) added to faecal calprotectin testing.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not 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.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Short Text

Everything NICE has said on managing ulcerative colitis in adults, children and young people in an interactive flowchart

What is covered

This interactive flowchart covers the management of ulcerative colitis in adults, children and young people.
Ulcerative colitis is the most common type of inflammatory disease of the bowel. The cause of ulcerative colitis is unknown. It can develop at any age, but peak incidence is between the ages of 15 and 25 years, with a second, smaller peak between 55 and 65 years.

Updates

Updates to this interactive flowchart

25 June 2019 Reinforcement of a permanent stoma with a synthetic or biological mesh to prevent a parastomal hernia (NICE interventional procedures guidance 654) added to surgery.
2 May 2019 Update of ulcerative colitis: management (NICE guideline NG130), mainly affecting inducing remission section.
19 February 2019 Barnett Continent Intestinal Reservoir (modified continent ileostomy) to restore continence after colon and rectum removal (NICE interventional procedures guidance 642) added to surgery.
27 November 2018 Tofacitinib for moderately to severely active ulcerative colitis (NICE technology appraisal guidance 547) added to step 2 therapy.
10 February 2016 Irritable bowel syndrome in adults (NICE quality standard 114) added.
18 August 2015 Leukapheresis for inflammatory bowel disease (NICE interventional procedures guidance 126) added to maintaining remission.
4 June 2015 Vedolizumab for treating moderately to severely active ulcerative colitis (NICE technology appraisal guidance 342) added to step 2 therapy.
24 March 2015 Transanal total mesorectal excision of the rectum (NICE interventional procedures guidance 514) and insertion of a collagen plug to close an abdominal wall enterocutaneous fistula (NICE interventional procedures guidance 507) added to surgery.
25 February 2015 Inflammatory bowel disease (NICE quality standard 81) added.
24 February 2015 Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (NICE technology appraisal guidance 329) added.
1 October 2013 Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel (NICE diagnostics guidance 11) added to faecal calprotectin testing.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Ulcerative colitis: management (2019) NICE guideline NG130
Tofacitinib for moderately to severely active ulcerative colitis (2018) NICE technology appraisal guidance 547
Infliximab for acute exacerbations of ulcerative colitis (2008) NICE technology appraisal guidance 163
Transanal total mesorectal excision of the rectum (2015) NICE interventional procedures guidance 514
Leukapheresis for inflammatory bowel disease (2005) NICE interventional procedures guidance 126
Irritable bowel syndrome in adults (2016) NICE quality standard 114
Inflammatory bowel disease (2015) NICE quality standard 81
Ulcerative colitis: budesonide multimatrix (Cortiment) (2015) NICE evidence summary ESNM58
Pouchitis: rifaximin (2014) NICE evidence summary ESUOM30
PredictSure-IBD for inflammatory bowel disease prognosis (2019) NICE medtech innovation briefing 178

Quality standards

Inflammatory bowel disease

These quality statements are taken from the inflammatory bowel disease quality standard. The quality standard defines clinical best practice for inflammatory bowel disease care and should be read in full.

Irritable bowel syndrome in adults

These quality statements are taken from the irritable bowel syndrome in adults quality standard. The quality standard defines clinical best practice for irritable bowel syndrome in adults and should be read in full.

Quality statements

Specialist assessment

This quality statement is taken from the inflammatory bowel disease quality standard. The quality standard defines clinical best practice for inflammatory bowel disease and should be read in full.

Quality statement

People with suspected inflammatory bowel disease have a specialist assessment within 4 weeks of referral.

Rationale

A confirmed diagnosis of inflammatory bowel disease is always made in an age-appropriate specialist setting using a combination of haematological, endoscopic, histological and imaging-based investigations. A delay in assessment and diagnosis can be associated with adverse consequences, such as clinical complications and a negative effect on the person’s quality of life. Some people with suspected inflammatory bowel disease who have severe symptoms will need an urgent specialist assessment, the urgency of which will depend on clinical need and might include an emergency admission, but no one should wait more than 4 weeks from referral for a specialist assessment.

Quality measures

Structure
Evidence of local referral pathways to ensure that people with suspected inflammatory bowel disease have a specialist assessment within 4 weeks of referral.
Data source: Local data collection. Data on referral pathways for urgent referrals are available in the National audit of inflammatory bowel disease (IBD) service provision, question OC1.2, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, question OC2.1.
Process
Proportion of people with suspected inflammatory bowel disease who have a specialist assessment within 4 weeks of referral.
Numerator – the number in the denominator who have a specialist assessment within 4 weeks of referral.
Denominator – the number of people with suspected inflammatory bowel disease who are referred for specialist assessment.
Data source: Local data collection. Data on the time it takes for urgent referrals to be seen are available in the National audit of inflammatory bowel disease (IBD) service provision, question OC1.3, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, questions OC2.4 and 2.6.
Outcome
Patient experience of the referral process.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (district general hospitals) ensure that local referral pathways are in place so that people with suspected inflammatory bowel disease are referred quickly and efficiently, and have a specialist assessment within 4 weeks of referral.
Healthcare professionals ensure that they follow agreed local referral pathways so that people with suspected inflammatory bowel disease are referred quickly and efficiently, and have a specialist assessment within 4 weeks of referral.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services that make use of agreed local referral pathways so that people with suspected inflammatory bowel disease are referred quickly and efficiently, and have a specialist assessment within 4 weeks of referral. This can be achieved through enhanced monitoring of contracts and establishing regular and timely auditing procedures.
People with suspected inflammatory bowel disease are seen by a specialist in hospital for an assessment within 4 weeks of being referred by their GP. This means that a diagnosis can be made without delay and treatment options can be discussed. The specialist assessment might involve having blood tests or endoscopy (using a camera to provide images of the inside of the body). Inflammatory bowel disease includes Crohn’s disease and ulcerative colitis. Sometimes it is not possible to tell whether a person has Crohn’s disease or ulcerative colitis, and they may be described as having ‘inflammatory bowel disease unclassified’ (IBDU).

Source guidance

Definitions of terms used in this quality statement

Suspected inflammatory bowel disease
People with any of the following lower gastrointestinal symptoms that have been present for at least 6 weeks should be suspected of having inflammatory bowel disease:
  • abdominal pain or discomfort
  • bloating
  • change in bowel habit (such as diarrhoea with or without rectal bleeding).
Faecal biomarkers, such as faecal calprotectin, alongside clinical assessment may be useful in primary care to distinguish between suspected inflammatory bowel disease and non-inflammatory bowel disease, such as irritable bowel syndrome.
[Adapted from NICE's diagnostic guidance on faecal calprotectin diagnostic tests for inflammatory diseases of the bowel, section 3.1, and IBD Standards, standard A4].
The Quality Standard Advisory Committee noted that, in some people with severe symptoms, inflammatory bowel disease might be suspected before the symptoms have been present for 6 weeks, and these people need earlier referral (before 6 weeks).
Specialist assessment
People with suspected inflammatory bowel disease should be referred for specialist assessment using local referral pathways by a GP directly to a defined specialist (consultant gastroenterologist or consultant paediatric gastroenterologist) or to an age-appropriate inflammatory bowel disease service. Specialist assessment enables consideration of a possible diagnosis of inflammatory bowel disease using a range of investigations. These include clinical evaluation and a combination of biochemical, endoscopic, radiological and histological investigations to confirm a diagnosis.
[Expert opinion and British Society of Gastroenterology guidelines, section 3.3]
Within 4 weeks of referral
The timeframe of 4 weeks is based on expert consensus and is intended to be a safety net to ensure that no one waits longer than 4 weeks for specialist assessment. However, it is recognised that some people with suspected inflammatory bowel disease who have severe symptoms will need an urgent specialist assessment. In such cases ‘within 4 weeks’ is subject to clinical judgement and a considerably shorter timeframe may be necessary, for example within 2 weeks. Therefore an effective local referral pathway should ensure that people with suspected inflammatory bowel disease are seen within 4 weeks of referral, or more rapidly if clinically necessary. Services that already see patients earlier than 4 weeks from referral should maintain this speed of referral and assessment.
[Expert opinion and IBD Standards, standard A4]

Equality and diversity considerations

The symptoms of inflammatory bowel disease may have a different impact on people of different gender, sexuality, culture and age. Referral processes and assessments need to be sensitive to individual anxieties and take into account any additional needs, such as the availability of doctors of the same sex, and any language barriers.

Multidisciplinary team support

This quality statement is taken from the inflammatory bowel disease quality standard. The quality standard defines clinical best practice for inflammatory bowel disease and should be read in full.

Quality statement

Services provide age-appropriate support from a multidisciplinary team for people with inflammatory bowel disease, and their family members or carers.

Rationale

Inflammatory bowel disease can have diverse effects on a person. In addition to its physical impact, there can be emotional, psychological and social consequences. A multidisciplinary team has a wide range of expertise that can help address these issues, and it is important that services for people with inflammatory bowel disease provide this support.

Quality measures

Structure
Evidence that services provide age-appropriate support from a multidisciplinary team for people with inflammatory bowel disease, and their family members or carers.
Data source: Local data collection. Data on patient support and the inflammatory bowel disease team are available in the National audit of inflammatory bowel disease (IBD) service provision, sections 2 and 3, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, sections 2 and 3.
Process
a) Proportion of people with inflammatory bowel disease where there is a documented discussion about their needs, and the needs of their family members or carers (if appropriate), for age-appropriate support from a multidisciplinary team.
Numerator – the number in the denominator where there is a documented discussion about their needs, and the needs of their family members or carers (if appropriate), for age-appropriate support from a multidisciplinary team.
Denominator – the number of people with inflammatory bowel disease.
Data source: Local data collection. Contained within the Royal College of Physicians' National clinical audit of inpatient care for adults with ulcerative colitis.
b) Proportion of people with inflammatory bowel disease whose needs, and the needs of their family members or carers (if appropriate), for age-appropriate support from a multidisciplinary team are met.
Numerator – the number in the denominator whose needs, and the needs of their family members or carers (if appropriate), for age-appropriate support from a multidisciplinary team are met.
Denominator – the number of people with inflammatory bowel disease whose needs for age-appropriate support from a multidisciplinary team are recorded.
Data source: Local data collection.
Outcome
a) Satisfaction of people with inflammatory bowel disease with the support provided.
Data source: Local data collection. The Experience of inpatients with ulcerative colitis throughout the UK audit asks various questions about patient experience of support in hospital.
b) Satisfaction of family members or carers of people with inflammatory bowel disease with the support provided.
Data source: Local data collection.

What the quality statement means for different audiences

Service providers (district general hospitals) ensure that systems are in place so that people with inflammatory bowel disease, and their family members or carers, have age-appropriate support from a multidisciplinary team.
Healthcare professionals work within a multidisciplinary team to provide age-appropriate support to people with inflammatory bowel disease, and their family members or carers.
Commissioners (clinical commissioning groups) ensure that they commission services in which people with inflammatory bowel disease, and their family members or carers, have age-appropriate support from a multidisciplinary team.
People with inflammatory bowel disease, and their family members or carers, have support from a care team made up of a range of different professionals (including nurses, doctors, dietitians and pharmacists). The type of support they get should depend on the person’s age (for example, whether they are an adult or a child), and should help to deal with any concerns about the condition and its treatment.

Source guidance

Definitions of terms used in this quality statement

Age-appropriate support
Age-appropriate support should be broad-based and offered by those who are best placed at the time to meet the needs of people with inflammatory bowel disease and their family members or carers. A person's support needs will vary depending on age. For example, a child or young person's concerns might be more focused on body image, transition between services and attending school and higher education, whereas an adult might be more concerned with employment and sexual issues. Other issues for which people may need support include concerns about the disease and its treatment, nutrition and diet, and other aspects of living with a chronic illness. Support could include signposting to reliable and accurate information on a broad range of topics or having access to a dedicated telephone or email service where people can raise concerns or questions.
[Adapted from NICE's guideline on Crohn's disease and IBD Standards, standard A11]
Multidisciplinary team
An inflammatory bowel disease multidisciplinary team should comprise gastroenterologists, colorectal surgeons and clinical nurse specialists with particular expertise and specialist interest in inflammatory bowel disease, a dietitian allocated to gastroenterology, and a pharmacist, pathologist and radiologist with special interest in gastroenterology. The team should have access to essential supporting services with an interest in inflammatory bowel disease, including a psychologist or counsellor, rheumatologist, ophthalmologist, dermatologist, obstetrician, nutrition support team, paediatric gastroenterology clinical network and general practice. There should be a named clinical lead for the inflammatory bowel disease team.
[Adapted from IBD Standards, standards A1 and A2]

Surgery

This quality statement is taken from the inflammatory bowel disease quality standard. The quality standard defines clinical best practice for inflammatory bowel disease and should be read in full.

Quality statement

People having surgery for inflammatory bowel disease have it undertaken by a colorectal surgeon who is a core member of the inflammatory bowel disease multidisciplinary team.

Rationale

Better patient outcomes are more likely if surgery for inflammatory bowel disease is undertaken by a colorectal surgeon with expertise and experience in inflammatory bowel disease surgery, with the support of an experienced clinical team. Such expertise is most likely to be in a unit where such surgery is performed regularly. The expertise and experience of the clinical team will enable the best judgement of when to undertake surgery, and should ensure the quality of clinical care before, during and after surgery.

Quality measures

Structure
Evidence of local arrangements to ensure that people having surgery for inflammatory bowel disease have it undertaken by a colorectal surgeon who is a core member of the inflammatory bowel disease multidisciplinary team.
Data source: Local data collection. Data on surgery for inflammatory bowel disease are available in the National audit of inflammatory bowel disease (IBD) service provision, section 3, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, section 3.
Process
Proportion of surgical procedures for inflammatory bowel disease undertaken by a colorectal surgeon who is a core member of the inflammatory bowel disease multidisciplinary team.
Numerator – the number in the denominator undertaken by a colorectal surgeon who is a core member of the inflammatory bowel disease multidisciplinary team.
Denominator – the number of surgical procedures for inflammatory bowel disease.
Data source: Local data collection and Hospital episode statistics from The Health and Social Care Information Centre.
Outcome
Complications after surgery.

What the quality statement means for different audiences

Service providers (district general hospitals and specialist tertiary centres) ensure that surgery for inflammatory bowel disease is undertaken by a colorectal surgeon who is a core member of the inflammatory bowel disease multidisciplinary team.
Healthcare professionals undertake inflammatory bowel disease surgery if they are colorectal surgeons with expertise and experience in such surgery, or refer people to a colorectal surgeon with relevant expertise and experience who is a core member of the inflammatory bowel disease multidisciplinary team.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services from providers who can demonstrate that surgery for inflammatory bowel disease is undertaken by colorectal surgeons who are core members of inflammatory bowel disease multidisciplinary teams.
People who have surgery for inflammatory bowel disease have their operation carried out by a specialist surgeon called a colorectal surgeon who is a member of the inflammatory bowel disease care team. This will make it more likely that the operation is a success and ensure good care. Patients should always be involved in the decision to have surgery after a discussion of the benefits and risks.

Source guidance

British Society of Gastroenterology (2011) Guidelines for the management of inflammatory bowel disease in adults, section 5.5 ‘Recommendations for surgery in ulcerative colitis’ and section 6.6.2 ‘Recommendations for surgery in Crohn’s disease’ (IBD Service Standards A7)

Definitions of terms used in this quality statement

Surgery for inflammatory bowel disease
The types of operation performed for inflammatory bowel disease include colectomy, ileo–anal pouch procedure, ileostomy and intestinal resection.
Colorectal surgeon who is a core member of the inflammatory bowel disease multidisciplinary team
The surgeon should have expertise and experience in undertaking surgery for inflammatory bowel disease and be able to make informed decisions about the need for surgery and the timing of surgery. Their predominant workload should involve inflammatory bowel disease and they should be a core member of the inflammatory bowel disease multidisciplinary team. Skilled and experienced surgeons, supported by an experienced clinical team, are most likely to be in units where such surgery is performed regularly.
When emergency procedures have to be performed, these may need to be done by a surgeon with the appropriate skills and experience who is available to perform the surgery. Children and young people should have their operations performed by surgeons with expertise in operating on children and young people with inflammatory bowel disease.
[Expert opinion and IBD Standards, standard A12]

Equality and diversity considerations

People from different cultures who need certain surgical procedures for inflammatory bowel disease, such as stoma operations, may need additional support if such procedures are not considered acceptable in their community.

Monitoring drug treatment

This quality statement is taken from the inflammatory bowel disease quality standard. The quality standard defines clinical best practice for inflammatory bowel disease and should be read in full.

Quality statement

People receiving drug treatment for inflammatory bowel disease are monitored for adverse effects.

Rationale

People with inflammatory bowel disease may experience different responses to drug treatment, including adverse effects. How a person responds to drug treatment therefore needs to be monitored using local safety policies and procedures, and treatment adjusted to ensure the best quality-of-life outcomes and patient safety.

Quality measures

Structure
Evidence of documented local safety policies and procedures to monitor for adverse effects in people receiving drug treatment for inflammatory bowel disease.
Data source: Local data collection. Data on local protocols and monitoring arrangements for immunosuppressives are available in the National audit of inflammatory bowel disease (IBD) service provision, section 3, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, section 3.
Process
Proportion of people receiving drug treatment for inflammatory bowel disease who are monitored for adverse effects.
Numerator – the number in the denominator for whom there is documented evidence that there is monitoring for adverse effects of drug treatment according to local safety policies and procedures.
Denominator – the number of people receiving drug treatment for inflammatory bowel disease.
Data source: Local data collection. Data on local protocols and monitoring arrangements for immunosuppressives are available in the National audit of inflammatory bowel disease (IBD) service provision, section 3, and the National audit of paediatric inflammatory bowel disease (IBD) service provision, section 3. Data on treatment follow-up, acute reactions and adverse events are available in the results tables of the National clinical audit of biological therapies, Adult report and Paediatric report.
Outcome
The number of adverse events reported because of drug treatment for inflammatory bowel disease.
Data source: Local data collection. Data on adverse events are available in the results tables of the National clinical audit of biological therapies, Adult report and Paediatric report.

What the quality statement means for different audiences

Service providers (general practices and district general hospitals) ensure that they have documented local safety policies and procedures that are used for monitoring for adverse effects in people receiving drug treatment for inflammatory bowel disease and for acting on abnormal results.
Healthcare professionals ensure that they monitor for adverse effects in people receiving drug treatment for inflammatory bowel disease, using documented local safety policies and procedures, and they act on abnormal results.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which there is monitoring for adverse effects in people receiving drug treatment for inflammatory bowel disease, using documented local safety policies and procedures, and abnormal results are acted on.
People taking medication for inflammatory bowel disease have regular check-ups for any side effects, and healthcare professionals take action if there are any concerns. This will lower the chances of the person having problems caused by the medication. People should be helped by their care team to understand treatment options and monitoring, including benefits, risks and possible consequences.

Source guidance

Definitions of terms used in this quality statement

Drug treatment for inflammatory bowel disease
A number of drugs are used to treat inflammatory bowel disease, depending on the type and severity of the disease, observed side effects, contraindications and patient preference. Drugs used include aminosalicylates, corticosteroids, biological treatments and immunosuppressives. Full details of treatment options for people with inflammatory bowel disease, including drug treatment, can be found in NICE's guidelines on Crohn's disease and ulcerative colitis.
[Adapted from NICE's guidelines on Crohn's disease and ulcerative colitis]
Monitoring for adverse effects
Treatment of inflammatory bowel disease aims to induce remission and control symptoms. Monitoring for adverse effects should identify side effects and potential adverse outcomes from long-term use. Treatments that can cause adverse outcomes include thiopurines, methotrexate, aminosalicylates, immunosuppressives and corticosteroids.
[Adapted from NICE's guidelines on Crohn's disease and ulcerative colitis]
Full details of side effects, contraindications and monitoring (including blood tests, procedures and clinical review) that should be carried out for specific drugs are detailed in the current online version of the BNF or BNF for children.
Local safety policies and procedures
There should be monitoring for adverse effects in people having drug treatment for inflammatory bowel disease using local safety policies and procedures. These should include:
  • shared care arrangements between primary and secondary care and clearly defined responsibilities for healthcare professionals in primary and secondary care
  • clear referral pathways
  • locally agreed monitoring guidelines
  • clear access routes to urgent care
  • a nominated member or members of the multidisciplinary team to act on abnormal results and reports of side effects and communicate with relevant healthcare professionals and people with inflammatory bowel disease (and/or their family members or carers, as appropriate).
[Adapted from NICE's guidelines on Crohn's disease and ulcerative colitis, and expert opinion]

Excluding inflammatory causes

This quality statement is taken from the irritable bowel syndrome in adults quality standard. The quality standard defines clinical best practice in irritable bowel syndrome in adults and should be read in full.

Quality statement

Adults with symptoms of irritable bowel syndrome are offered tests for inflammatory markers as first-line investigation to exclude inflammatory causes.

Rationale

Irritable bowel syndrome can be difficult to diagnose because the symptoms can be similar to other conditions such as inflammatory bowel disease and coeliac disease. Tests for inflammatory markers are particularly useful to exclude inflammatory bowel disease and mean that fewer people have invasive procedures (such as colonoscopies and sigmoidoscopies) to check for inflammatory causes of their symptoms.

Quality measures

Structure
Evidence of local arrangements to ensure that adults with symptoms of irritable bowel syndrome are offered tests for inflammatory markers as first-line investigation to exclude inflammatory causes.
Data source: Local data collection.
Process
Proportion of adults with symptoms of irritable bowel syndrome who have tests for inflammatory markers as first-line investigation to exclude inflammatory causes.
Numerator – the number in the denominator who have tests for inflammatory markers as first-line investigation to exclude inflammatory causes.
Denominator – the number of adults with symptoms of irritable bowel syndrome.
Data source: Local data collection.
Outcome
Number of adults diagnosed with irritable bowel syndrome.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (GP practices) ensure that systems are in place for adults with symptoms of irritable bowel syndrome to be offered tests for inflammatory markers (including faecal calprotectin and C-reactive protein) as first-line investigation to exclude inflammatory causes of symptoms.
Healthcare professionals in primary care (GPs) offer adults with symptoms of irritable bowel syndrome tests for inflammatory markers (including faecal calprotectin and C-reactive protein) as first-line investigation to exclude inflammatory causes of symptoms.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services that offer tests for inflammatory markers (including faecal calprotectin and C-reactive protein) to adults with symptoms of irritable bowel syndrome, as first-line investigation to exclude inflammatory causes of symptoms.

What the quality statement means for patients, service users and carers

Adults with symptoms of irritable bowel syndrome (such as constipation, diarrhoea and bloating) are offered blood and stool sample tests to check whether they have inflammation in their bowel. This will help their GP to find out what might be causing their symptoms and to diagnose their condition.

Source guidance

Definitions of terms used in this quality statement

Symptoms of irritable bowel syndrome
Irritable bowel syndrome should be considered if an adult presents with abdominal pain or discomfort, bloating or a change in bowel habit for at least 6 months. A diagnosis of irritable bowel syndrome should be considered only if the person has abdominal pain or discomfort that is either relieved by defaecation or is associated with altered bowel frequency or stool form. This should be accompanied by at least 2 of the following 4 symptoms:
  • altered stool passage (straining, urgency, incomplete evacuation)
  • abdominal bloating (more common in women than men), distension, tension or hardness
  • symptoms made worse by eating
  • passage of mucus.
Lethargy, nausea, backache and bladder symptoms are also common in people with irritable bowel syndrome, and may be used to support the diagnosis.
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61), recommendations 1.1.1.1 and 1.1.1.4 (key priorities for implementation)]
Tests for inflammatory markers
Tests for inflammatory markers to exclude inflammatory causes include tests for faecal calprotectin and C-reactive protein. Inflammatory causes are usually excluded to help the diagnosis of mixed symptom (alternating between diarrhoea and constipation) or diarrhoea-predominant irritable bowel syndrome.
[Adapted from Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel (NICE diagnostics guidance DG11), recommendation 1.1; Irritable bowel syndrome in adults (NICE guideline CG61), recommendations 1.1.1.3 and 1.1.2.1 (key priorities for implementation); and expert opinion]
Inflammatory causes
Chronic diseases that cause inflammation of the digestive system, such as Crohn's disease and ulcerative colitis.
[Adapted from Inflammatory bowel disease (2015) NICE quality standard 81, introduction]

Giving a diagnosis

This quality statement is taken from the irritable bowel syndrome in adults quality standard. The quality standard defines clinical best practice in irritable bowel syndrome in adults and should be read in full.

Quality statement

Adults with symptoms of irritable bowel syndrome are given a positive diagnosis if no red flag indicators are present and investigations identify no other cause of symptoms.

Rationale

Irritable bowel syndrome can be difficult to diagnose, and it is important to reach the correct diagnosis while striking the right balance between too few and too many investigations. Under diagnosis and over investigation can prevent effective management. When red flag indicators and other causes of symptoms, such as coeliac disease, have been ruled out, a positive diagnosis of irritable bowel syndrome can be made. Giving a positive diagnosis will help to reduce unnecessary anxiety in people with symptoms of irritable bowel syndrome.

Quality measures

Structure
Evidence of local arrangements to ensure that adults with symptoms of irritable bowel syndrome are given a positive diagnosis if no red flag indicators are present and investigations identify no other cause of symptoms.
Data source: Local data collection.
Process
Proportion of adults with symptoms of irritable bowel syndrome who receive a positive diagnosis if no red flag indicators are present and investigations identify no other cause of symptoms.
Numerator – the number in the denominator who receive a positive diagnosis of irritable bowel syndrome.
Denominator – the number of adults with symptoms of irritable bowel syndrome who have no red flag indicators and investigations identify no other cause of symptoms.
Data source: Local data collection.
Outcomes
a) Incidence of irritable bowel syndrome.
Data source: Local data collection, for example, from Read coded patient records on GP clinical information systems.
b) Satisfaction with the irritable bowel syndrome diagnostic process.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (GP practices) ensure that adults with symptoms of irritable bowel syndrome are given a positive diagnosis if no red flag indicators are present and investigations identify no other cause of symptoms.
Healthcare professionals in primary care (GPs) give adults with symptoms of irritable bowel syndrome a positive diagnosis if no red flag indicators are present and investigations identify no other cause of their symptoms.
Commissioners (clinical commissioning groups and NHS England) commission services that give adults with symptoms of irritable bowel syndrome a positive diagnosis if no red flag indicators are present and investigations identify no other cause of their symptoms.

What the quality statement means for patients, service users and carers

Adults with symptoms of irritable bowel syndrome (such as constipation, diarrhoea and bloating) are given a diagnosis of irritable bowel syndrome if they have no symptoms that need referral to a hospital consultant (these symptoms are known as red flag indicators) and tests show no other cause of their symptoms.

Source guidance

Definitions of terms used in this quality statement

Positive diagnosis
Positive diagnosis means the diagnosis is not merely one of exclusion. It is based on the person’s symptoms meeting the diagnostic criteria for irritable bowel syndrome (symptoms of irritable bowel syndrome) and the findings of investigations ruling out realistic alternatives. A positive diagnosis allows the person with symptoms of irritable bowel syndrome and the GP to work towards symptom control.
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61) full guideline]
Red flag indicators
These are symptoms that need referral to secondary care. They are signs and symptoms of cancer in line with the NICE guideline on recognition and referral for suspected cancer, and inflammatory markers for inflammatory bowel disease.
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61), recommendation 1.1.1.2 (key priority for implementation), and expert opinion]
Investigations
Investigations for adults presenting with suspected irritable bowel syndrome should include consideration of signs and symptoms of cancer in line with the NICE guidance on recognition and referral for suspected cancer (for example, sections 1.3 on lower gastrointestinal tract cancers and 1.5 on gynaecological cancers), and inflammatory markers for inflammatory bowel disease.
When the above have been excluded, the following tests should be done to exclude other diagnoses:
  • full blood count
  • erythrocyte sedimentation rate (ESR) or plasma viscosity
  • C-reactive protein (CRP)
  • antibodies for coeliac disease (endomysial antibodies [EMA] or tissue transglutaminase [TTG]).
The following tests are not necessary to confirm diagnosis in people who meet the diagnostic criteria for irritable bowel syndrome:
  • ultrasound
  • rigid/flexible sigmoidoscopy
  • colonoscopy, barium enema
  • thyroid function test
  • faecal ova and parasite test
  • faecal occult blood
  • hydrogen breath test (for lactose intolerance and bacterial overgrowth).
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61), recommendations 1.1.1.2, 1.1.2.1 and 1.1.2.2 (key priorities for implementation)]
Symptoms of irritable bowel syndrome
Irritable bowel syndrome should be considered if an adult presents with abdominal pain or discomfort, bloating or a change in bowel habit for at least 6 months. A diagnosis of irritable bowel syndrome should be considered only if the person has abdominal pain or discomfort that is either relieved by defaecation or is associated with altered bowel frequency or stool form. This should be accompanied by at least 2 of the following 4 symptoms:
  • altered stool passage (straining, urgency, incomplete evacuation)
  • abdominal bloating (more common in women than men), distension, tension or hardness
  • symptoms made worse by eating
  • passage of mucus.
Lethargy, nausea, backache and bladder symptoms are also common in people with irritable bowel syndrome, and may be used to support the diagnosis.
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61), recommendations 1.1.1.1 and 1.1.1.4 (key priorities for implementation)]

Dietary management

This quality statement is taken from the irritable bowel syndrome in adults quality standard. The quality standard defines clinical best practice in irritable bowel syndrome in adults and should be read in full.

Quality statement

Adults with irritable bowel syndrome are offered advice on further dietary management if their symptoms persist after they have followed general lifestyle and dietary advice.

Rationale

General lifestyle and dietary advice is important to empower people with irritable bowel syndrome to manage their condition and to improve their quality of life. However, when symptoms persist beyond a time agreed with their healthcare professional, specialist advice from a healthcare professional with expertise in dietary management can help people to manage persistent symptoms. This advice can be given in primary care by healthcare professionals with relevant expertise in dietary management or a referral may be made. This advice can also ensure that a person has an adequate nutritional intake when following food avoidance, restriction or exclusion diets.

Quality measures

Structure
Evidence of local arrangements to ensure that adults with irritable bowel syndrome are offered advice on further dietary management if their symptoms persist after they have followed general lifestyle and dietary advice.
Data source: Local data collection.
Process
Proportion of adults with irritable bowel syndrome who are offered advice on further dietary management if their symptoms persist after they have followed general lifestyle and dietary advice for an agreed time.
Numerator – the number in the denominator who receive advice on further dietary management.
Denominator – the number of adults with irritable bowel syndrome whose symptoms persist after they have followed general lifestyle and dietary advice for an agreed time.
Data source: Local data collection.
Outcomes
a) People with irritable bowel syndrome feel confident to manage their condition.
Data source: Local data collection.
b) Satisfaction with care received for irritable bowel syndrome.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (GP practices and dietetic services) ensure that adults with irritable bowel syndrome are offered advice on further dietary management from healthcare professionals with relevant expertise, if symptoms persist after following general lifestyle and dietary advice for an agreed time.
Healthcare professionals (such as GPs, and community and secondary care dietitians) ensure that adults with irritable bowel syndrome are offered advice on further dietary management, if symptoms persist after following general lifestyle and dietary advice for an agreed time. This advice can be given in primary care by healthcare professionals with relevant expertise in dietary management or a referral may be made.
Commissioners (clinical commissioning groups and NHS England) commission services in which people with irritable bowel syndrome are offered advice on further dietary management from healthcare professionals with relevant expertise, if symptoms persist after following general lifestyle and dietary advice for an agreed time.

What the quality statement means for patients, service users and carers

Adults with irritable bowel syndrome are offered further dietary advice from a healthcare professional with expertise in dietary management if their symptoms have not improved enough after following general advice on diet and lifestyle for a period of time agreed with their healthcare professional.

Source guidance

Definitions of terms used in this quality statement

General lifestyle and dietary advice
This is designed to help to minimise the symptoms of irritable bowel syndrome and should include:
  • creating relaxation time
  • increasing activity levels
  • having regular meals and taking time to eat
  • avoiding missing meals or leaving long gaps between eating.
Other general lifestyle and dietary advice includes:
  • drinking at least 8 cups (approximately 2,000 ml) of fluid per day, especially water or other non‑caffeinated drinks (for example, herbal teas)
  • restricting caffeinated tea and coffee to 3 cups (approximately 750 ml) per day
  • reducing intake of alcohol and soft drinks
  • limiting fresh fruit to 3 portions per day (a portion should be approximately 80 g)
  • avoiding sorbitol, an artificial sweetener found in sugar‑free sweets (including chewing gum), drinks and in some diabetic and slimming products, if the person has diarrhoea
  • eating 30 g per day of fibre
  • adjusting the amount of fibre consumed by restricting or increasing certain foods.
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61), recommendations 1.2.1.1 (key priority for implementation), 1.2.1.2, 1.2.1.3 and 1.2.1.4, and information for the public and expert opinion]
Further dietary management
There are specific types of diets which can be followed to help manage the symptoms of irritable bowel syndrome. Single food avoidance is the exclusion of 1 food from the diet if it is thought to cause symptoms. After an agreed time (usually between 2 and 4 weeks), the food can be reintroduced gradually to verify whether it causes or exacerbates the symptoms.
A restricted or exclusion diet is when 1 or more foods suspected to cause symptoms are completely excluded for an agreed time before structured reintroduction. These diets may improve the symptoms of irritable bowel syndrome and can include, for example, a low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet. FODMAPs are a collection of carbohydrates that are poorly absorbed in the small bowel and pass into the large bowel where they are quickly broken down (fermented) by bacteria. This can cause bloating, wind, and discomfort or pain. FODMAPs can also draw water into the bowel, causing diarrhoea.
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61), recommendation 1.2.1.8 and information for the public and expert opinion]

Equality and diversity considerations

Healthcare professionals should take into consideration the communication needs of people with irritable bowel syndrome, including cognitive impairment, when discussing and providing information on dietary management. All information should be culturally appropriate.

Reviewing treatment and management

This quality statement is taken from the irritable bowel syndrome in adults quality standard. The quality standard defines clinical best practice in irritable bowel syndrome in adults and should be read in full.

Quality statement

Adults with irritable bowel syndrome agree their follow-up with their healthcare professional.

Rationale

Regular review of treatment and management ensures that people with irritable bowel syndrome continue to be supported to manage their condition and to improve or maintain their quality of life. However, because self-management is the best approach for many people, the patients themselves should play a key role in determining when they need the review. The review, which may form part of an annual patient review, gives the opportunity for discussing and optimising medicines, lifestyle and diet, considering management alongside other related conditions, considering new treatments, and prompting further investigations or referrals if red flag indicators emerge.

Quality measures

Structure
a) Evidence of local arrangements to ensure that adults with irritable bowel syndrome agree their follow-up with their healthcare professional.
Data source: Local data collection.
b) Evidence of local arrangements (for example through local protocols on appointment reminders) to ensure that adults with irritable bowel syndrome have follow-up as agreed with their healthcare professional.
Data source: Local data collection.
Process
a) Proportion of adults with irritable bowel syndrome who agree their follow-up arrangements with their healthcare professional.
Numerator – the number in the denominator who agree their follow-up arrangements with their healthcare professional.
Denominator – the number of adults with irritable bowel syndrome.
Data source: Local data collection.
b) Proportion of adults with irritable bowel syndrome whose follow-up takes place by the date agreed with their healthcare professional.
Numerator – the number in the denominator whose follow-up takes place by the date agreed.
Denominator – the number of adults with irritable bowel syndrome who have a follow-up date agreed with their healthcare professional.
Data source: Local data collection.
Outcomes
a) People with irritable bowel syndrome feel confident to manage their condition.
Data source Local data collection.
b) Satisfaction with care received for irritable bowel syndrome.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (GP practices) ensure that adults with irritable bowel syndrome agree their follow-up with their healthcare professional. This can include the frequency and the format of the review; for example, it can be a face-to-face appointment or a telephone consultation. Adults with irritable bowel syndrome should be encouraged to make contact to arrange their follow-up appointments as part of the self-management of their symptoms.
Healthcare professionals in primary care (GPs) discuss the frequency and format of follow-up with adults with irritable bowel syndrome and agree with them how and when this will take place. The format can be a face-to-face appointment or, if appropriate, a telephone consultation. Healthcare professionals should encourage adults with irritable bowel syndrome to make contact to arrange their follow-up appointments as part of the self-management of their symptoms.
Commissioners (clinical commissioning groups and NHS England) commission services that ensure that adults with irritable bowel syndrome can agree their follow-up with their healthcare professional.

What the quality statement means for patients, service users and carers

Adults with irritable bowel syndrome agree how often they will see their healthcare professional to talk about their symptoms and their medications. They can agree whether the appointment will take place face-to-face or by telephone. They should be encouraged to make contact to arrange the appointments as part of the management of their own symptoms.

Source guidance

Definitions of terms used in this quality statement

Follow-up
This is an opportunity for a person with irritable bowel syndrome to discuss their symptoms and how these are managed with their healthcare professional. This appointment can take place at a frequency agreed by the person and their healthcare professional, and can take the form that they feel is the most appropriate (such as attending the GP practice or a telephone conversation). Adults with irritable bowel syndrome should be encouraged to make contact to arrange the appointment because this will empower them to self-manage their symptoms.
[Adapted from Irritable bowel syndrome in adults (NICE guideline CG61), recommendation 1.2.5.1 and expert opinion]

Equality and diversity considerations

Healthcare professionals should take into consideration the communication needs of people with irritable bowel syndrome, including cognitive impairment, when discussing and undertaking follow-up. For those people who are unable to arrange the follow-up appointments themselves, assistance should be provided to ensure their care continues appropriately.

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

Information for the public

NICE has written information for the public on each of the following topics.

Pathway information

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not 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.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Supporting information

Severity of ulcerative colitis

In this interactive flowchart, the categories of mild, moderate and severe are used to describe ulcerative colitis:
  • In adults these categories are based on the Truelove and Witts' severity index. The first table below is adapted from the Truelove and Witts' criteria.
  • In children and young people (the second table) these categories are based on the PUCAI.

Truelove and Witts' severity index

Mild
Moderate
Severe
Bowel movements (no. per day)
Fewer than 4
4–6
6 or more plus at least one of the features of systemic upset (marked with * below)
Blood in stools
No more than small amounts of blood
Between mild and severe
Visible blood
Pyrexia (temperature greater than 37.8°C)*
No
No
Yes
Pulse rate greater than 90 bpm*
No
No
Yes
Anaemia*
No
No
Yes
Erythrocyte sedimentation rate (mm/hour)*
30 or below
30 or below
Above 30
© Copyright British Medical Journal, 1955. Reproduced with permission.

Paediatric Ulcerative Colitis Activity Index (PUCAI)

Disease severity is defined by the following scores:
  • severe: 65 or above
  • moderate: 35–64
  • mild: 10–34
  • remission (disease not active): below 10.
Item
Points
1.
Abdominal pain
No pain
0
Pain can be ignored
5
Pain cannot be ignored
10
2.
Rectal bleeding
None
0
Small amount only, in less than 50% of stools
10
Small amount with most stools
20
Large amount (50% of the stool content)
30
3.
Stool consistency of most stools
Formed
0
Partially formed
5
Completely unformed
10
4.
Number of stools per 24 hours
0–2
0
3–5
5
6–8
10
>8
15
5.
Nocturnal stools (any episode causing wakening)
No
0
Yes
10
6.
Activity level
No limitation of activity
0
Occasional limitation of activity
5
Severe restricted activity
10
Sum of PUCAI (0–85)
© Copyright The Hospital for Sick Children, Toronto, Canada, 2006. Reproduced with permission.

Rationale and impact: proctitis

Rationale

The evidence showed that topical aminosalicylates (suppositories or enema) are the most effective treatments for achieving remission in people with mild-to-moderate proctitis, so these were recommended as first-line treatments. The evidence did not show any difference in effectiveness between enema and suppository.
Topical aminosalicylates alone are recommended for up to 4 weeks because the evidence showed that they were the most effective treatment within this timeframe. There was no direct evidence for combining topical and oral aminosalicylates for people with proctitis. However, evidence showed that this combination was effective for people with proctosigmoiditis, and the committee agreed that this evidence was also applicable to people with proctitis alone. The committee chose not to specify a dose for the oral aminosalicylate. It preferred to leave it open to clinical judgment depending on the specific situation (for example, the clinician could give a low dose if the person had not taken an aminosalicylate before, or a high dose if the person was already taking a low dose).
Some people will not achieve remission with topical and oral aminosalicylates. In clinical practice, oral or topical corticosteroids are commonly added at this stage, but there was no evidence on this combination. The committee agreed that, based on their experience, adding a topical or oral corticosteroid should be an option at this stage.
Despite the lack of direct evidence for the effectiveness of topical or oral corticosteroids, the committee agreed that, based on their experience, these should also be an option for people who cannot tolerate aminosalicylates.
Some people decline topical treatment, preferring oral to topical aminosalicylates. This is more common in children and young people, although proctitis is not common in this group. As the evidence showed that oral aminosalicylates are not as effective at inducing remission, the committee thought it was important to explain this to people who decline topical aminosalicylates.
There was cost-effectiveness evidence showing that using an immunomodulator as the next line of treatment after oral or topical corticosteroids and oral aminosalicylate produced greater health benefits at lower total costs than other strategies. However, the clinical evidence on topical immunomodulators was limited and it was unclear how applicable it was to UK clinical practice. Because of this, the committee recommended the sequence without this final treatment, and recommended further research on topical immunomodulators.
Most of the evidence was for adults. However, the committee agreed to generalise the recommendations to all people with a mild-to-moderate exacerbation or first presentation of ulcerative colitis.
There is limited evidence on oral corticosteroids. In addition, the committee agreed that the use of oral corticosteroids is generally reserved for later lines of treatment because of concerns about side effects. It is not clear which corticosteroid is most effective for each extent of disease. There is also limited evidence on immunomodulators, specifically oral tacrolimus and systemic methotrexate for each extent of disease. The committee recommended further research to address these uncertainties.

Impact

The new recommendations classify the extents of ulcerative colitis differently. This more closely reflects current practice, so will be clearer and more informative for people with mild-to-moderate ulcerative colitis and healthcare professionals.
The recommendations in the 2013 guideline referred to specific corticosteroids. To better reflect the available evidence, the updated recommendations refer to aminosalicylates and corticosteroids as a class rather than recommending individual treatments. This allows healthcare professionals and people with mild-to-moderate ulcerative colitis to choose the most appropriate corticosteroid or aminosalicylate, depending on patient preference, availability and acquisition cost.
The new recommendations specify that courses of oral corticosteroids should be time-limited. This should address varying practice in prescribing for some corticosteroids.
For more information see the evidence review on induction of remission in mild-to-moderate ulcerative colitis in the NICE guideline on ulcerative colitis.

Rationale and impact: proctosigmoiditis or left-sided ulcerative colitis

Rationale

There is evidence that topical aminosalicylates are effective for achieving remission in people with mild-to-moderate proctosigmoiditis or left-sided ulcerative colitis. In the committee's experience topical aminosalicylates also work faster and more effectively than topical corticosteroids. Topical aminosalicylates alone are recommended for up to 4 weeks because the evidence showed that they were effective within this timeframe. Cost-effectiveness evidence also showed that treatment sequences starting with topical aminosalicylates produced greater health benefits and incurred lower total costs than other strategies.
There is no direct evidence for the effectiveness of high-dose oral aminosalicylates combined with either topical aminosalicylates or topical corticosteroids. However, there is evidence that topical treatments or high-dose oral aminosalicylates individually provide some benefit. Therefore, the committee agreed it was reasonable to recommend combinations of these if remission is not achieved. While there was limited evidence for oral corticosteroids, in the committee's experience an oral corticosteroid may benefit people with proctosigmoiditis or left-sided disease if further treatment is needed. As a result, they recommended oral corticosteroids with oral aminosalicylates instead of topical treatment for these people. This reflects current practice for people who do not achieve remission with topical treatments and high-dose oral aminosalicylates.
Most of the evidence was for adults. However, the committee agreed to generalise the recommendations to all people with a mild-to-moderate exacerbation or first presentation of ulcerative colitis.
There is limited evidence on oral corticosteroids. In addition, the committee agreed that the use of oral corticosteroids is generally reserved for later lines of treatment because of concerns about side effects. It is not clear which corticosteroid is most effective for each extent of disease. There is also limited evidence on immunomodulators, specifically oral tacrolimus and systemic methotrexate for each extent of disease. The committee recommended further research to address these uncertainties.

Impact

The new recommendations classify the extents of ulcerative colitis differently. This more closely reflects current practice, so will be clearer and more informative for people with mild-to-moderate ulcerative colitis and healthcare professionals.
The recommendations in the 2013 guideline referred to specific corticosteroids. To better reflect the available evidence, the updated recommendations refer to aminosalicylates and corticosteroids as a class rather than recommending individual treatments. This allows healthcare professionals and people with mild-to-moderate ulcerative colitis to choose the most appropriate corticosteroid or aminosalicylate, depending on patient preference, availability and acquisition cost.
The new recommendations specify that courses of oral corticosteroids should be time-limited. This should address varying practice in prescribing for some corticosteroids.
For more information see the evidence review on induction of remission in mild-to-moderate ulcerative colitis in the NICE guideline on ulcerative colitis.

Rationale and impact: extensive ulcerative colitis

Rationale

The evidence showed that people with mild-to-moderate extensive ulcerative colitis would benefit most from a combination of high-dose oral aminosalicylates with topical aminosalicylates as first-line treatment. High-dose oral aminosalicylates combined with topical aminosalicylates are recommended for up to 4 weeks, because in the committee's experience they are the most effective treatment within this timeframe. There is evidence that an oral corticosteroid combined with a high-dose oral aminosalicylate is also effective, so the committee recommended this combination if remission is not achieved with aminosalicylates alone. In people who cannot tolerate aminosalicylates, oral corticosteroids are recommended as they are also an effective treatment option.
The sequence of drugs recommended was more effective than starting with a high-dose oral aminosalicylate alone. There was some uncertainty around the cost effectiveness of this sequence. The data on the effectiveness of high-dose oral aminosalicylates combined with topical aminosalicylates was from an 8-week clinical trial. The committee believed that in practice, people whose disease did not respond to treatment within 4 weeks would switch to another treatment. When the cost-effectiveness analysis allowed for early switching, the combination of a high-dose oral aminosalicylate and topical aminosalicylate was not cost effective. However, if it was assumed that everyone continued treatment as described in the trial, the combination of a high-dose oral aminosalicylate and topical aminosalicylate was more likely to be cost effective. The committee took the uncertainty about the cost-effectiveness results in the different scenarios into account in recommending the combination as first-line treatment.
There was some evidence on methotrexate for inducing remission, but it did not show a clear benefit, and there was no evidence on oral tacrolimus. To address these gaps in the evidence, the committee recommended further research on the effectiveness of tacrolimus and methotrexate.
Most of the evidence was for adults. However, the committee agreed to generalise the recommendations to all people with a mild-to-moderate exacerbation or first presentation of ulcerative colitis.
There is limited evidence on oral corticosteroids. In addition, the committee agreed that the use of oral corticosteroids is generally reserved for later lines of treatment because of concerns about side effects. It is not clear which corticosteroid is most effective for each extent of disease. There is also limited evidence on immunomodulators, specifically oral tacrolimus and systemic methotrexate for each extent of disease. The committee recommended further research to address these uncertainties.

Impact

The new recommendations classify the extents of ulcerative colitis differently. This more closely reflects current practice, so will be clearer and more informative for people with mild-to-moderate ulcerative colitis and healthcare professionals.
The recommendations in the 2013 guideline referred to specific corticosteroids. To better reflect the available evidence, the updated recommendations refer to aminosalicylates and corticosteroids as a class rather than recommending individual treatments. This allows healthcare professionals and people with mild-to-moderate ulcerative colitis to choose the most appropriate corticosteroid or aminosalicylate, depending on patient preference, availability and acquisition cost.
The new recommendations specify that courses of oral corticosteroids should be time-limited. This should address varying practice in prescribing for some corticosteroids.
For more information see the evidence review on induction of remission in mild-to-moderate ulcerative colitis in the NICE guideline on ulcerative colitis.

Rationale: tofacitinib for moderately to severely active ulcerative colitis

Clinical trial evidence shows that tofacitinib is more effective than placebo for treating moderately to severely active ulcerative colitis. An indirect comparison suggests that for people who have not had a TNF-alpha inhibitor, tofacitinib is more effective than adalimumab and golimumab as maintenance treatment. For people who have had a TNF-alpha inhibitor, tofacitinib is more effective than adalimumab as induction treatment. No other statistically significant differences between tofacitinib and biological therapies were identified.
Based on the health-related benefits and costs compared with conventional therapy and biologicals, tofacitinib is recommended as a cost-effective treatment for moderately to severely active ulcerative colitis in adults whose disease has responded inadequately to, or who cannot tolerate, conventional or biological therapy.
For more information see the committee discussion in the NICE technology appraisal guidance on tofacitinib for moderately to severely active ulcerative colitis.

Glossary

C-reactive protein
inflammatory bowel disease
irritable bowel syndrome
Paediatric Ulcerative Colitis Activity Index
(a course of corticosteroids used to treat active disease, normally given for 4 to 8 weeks, depending on the steroid)
tumour necrosis factor

Paths in this pathway

Pathway created: June 2013 Last updated: June 2019

© NICE 2019. All rights reserved. Subject to Notice of rights.

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