Dr Richard Stevens discusses how the NICE quality standard for irritable bowel syndrome aims to improve diagnosis, provision of dietary advice, and patient reviews
Read this article to learn more about:
- a the impact irritable bowel syndrome has on patients’ quality of life
- how to make a positive diagnosis of irritable bowel syndrome
- quality measures for irritable bowel syndrome diagnosis and management.
Irritable bowel syndrome (IBS) is the most common functional gastrointestinal disorder, with an estimated prevalence of 10–20% in the UK.1 It occurs most often in people aged 20–30 years old, though recent trends suggest that there is also a significant prevalence in older people. It is also twice as common in women as it is in men.1
The lack of structural or measurable pathology in people with IBS has sometimes been interpreted as there being 'nothing wrong'. This, together with the lack of effective treatments, has led to frustration and hopelessness in both the patient and the doctor. In fact, IBS has an impact on quality of life that, in one study, was shown to be similar to that of renal disease or diabetes,2 with patients with IBS having difficulties socially, at work, and in relationships.3
Characteristic symptoms of IBS can seem vague and to occur commonly within the general population. In the past IBS was seen as a diagnosis of exclusion, a view that is still sometimes perpetuated through teaching in a secondary care setting; when all other potential causes for the characteristic symptoms had been excluded, the label of IBS was given. A key point in NICE Clinical Guideline (CG) 61 for Irritable bowel syndrome in adults: diagnosis and management is that IBS should be a positive diagnosis.1
NICE Clinical Guideline 61 on irritable bowel syndrome
NICE CG61 was first published in 2008 and provided guidance on: diagnostic criteria; identification of red–flag symptoms; factors that would determine appropriate referral to IBS services; provision of lifestyle advice; pharmacological interventions; and appropriate follow up. An update to this guideline was published in 2015, which included additional dietary and lifestyle advice, and updated guidance on pharmacological therapy.1
Diagnosis and assessment of IBS
There has been good evidence for some time that a diagnosis of IBS can safely be made on clinical grounds alone.4 In the author's opinion, this should be considered alongside the clinical suspicion that repeated investigations in such cases are unlikely to be helpful, and may even delay the acceptance of the diagnosis and the start of treatments. General practitioners and, in turn, patients will be reassured and gain confidence from the knowledge that repeated investigations, which are often discomforting and distressing, will not change the diagnosis.
In line with the recommendations in NICE CG61, assessment for IBS should be considered if an adult presents with abdominal pain or discomfort, bloating, or a change in bowel habit for at least 6 months.1
A positive diagnosis of IBS would then be considered if the patient has abdominal pain or discomfort that is either relieved by defaecation or associated with altered bowel frequency or stool form, and accompanied by at least two of the following four symptoms:1
- altered stool passage (straining, urgency, incomplete evacuation)
- abdominal bloating (more common in women), distension, tension or hardness
- symptoms made worse by eating
- passage of mucus
Because the symptoms and signs of IBS can overlap with those of cancer it is paramount to exclude 'red flag' signs first. These red–flag indicators are set out in NICE CG61,1 with detailed referral criteria outlined in NICE Guideline (NG) 12 for Suspected cancer: recognition and referral.5 Freeing up the limited capacity for investigations, by not inflicting them on IBS patients who would not benefit from them anyway, will also facilitate the rapid diagnosis of colorectal and ovarian cancer.
In addition to making a positive diagnosis of IBS, another key element of NICE CG61 is the graded stepping up of interventions, as follows:1
- provide dietary and lifestyle advice
- use symptom–relieving medications as needed based on nature and severity of symptoms:
- consider anti–spasmodic agents
- consider laxatives for constipation (use of lactulose should be discouraged)
- linaclotide should be considered only if the patient has had constipation for at least 12 months, and optimal or maximal tolerated doses of previous laxatives from different classes have not helped
- consider anti–diarrhoeal agents (loperamide should be offered as first–choice)
- if the above have not helped, consider the following as second-line agents:
- tricyclic antidepressants (TCAs) at low dose
- serotonin reuptake inhibitors (SSRIs) if TCAs are ineffective
- take into account possible sideeffects associated with TCAs or SSRIs—follow up after 4 weeks
- when initially used in low doses, and then every 6–12 months
- consider psychological therapies in patients with refractory symptoms after 1 year despite adequate treatment
- review all patients regularly (nature and timing of this review was not specified).
NB at the time of publication of NICE CG61 (February 2015), TCAs and SSRIs did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing and managing medicines and devices6 for further information.
The need for a quality standard for IBS
The care of patients with symptoms of IBS is often patchy, usually unstructured, and can be associated with a poor patient and doctor experience.
There was also a perception that the recommended minimum set of investigations (full blood count [FBC], erythrocyte sedimentation rate [ESR], C–reactive protein [CRP], and coeliac antibodies) was not being adhered to. This led to some patients being misdiagnosed when the real pathology was inflammatory bowel disease (IBD) or coeliac disease, and some others being referred for unnecessary, unhelpful, and uncomfortable investigations.7–9 This would have also meant that diagnostic resources could have been more appropriately assigned.
NICE Quality Standard 114 for irritable bowel syndrome in adults
NICE quality standards take into account NICE–accredited evidence sources and aim to support quality improvement within a specific clinical area. NICE Quality Standard (QS) 114 for Irritable bowel syndrome in adults draws on recommendations made in NICE CG61, and was published in February 2016.7 This quality standard includes a modest four quality statements, but ones that have the potential to change practice and patient experience, and have implications for primary care. These statements are listed in Table 1 (see below) and are discussed in more detail below.
|1||Adults with symptoms of irritable bowel syndrome are offered tests for inflammatory markers as first-line investigation to exclude inflammatory causes.|
|2||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.|
|3||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.|
|4||Adults with irritable bowel syndrome agree their follow-up with their healthcare professional.|
Reproduced with permission
Excluding inflammatory causes—statement 1
In people presenting for the first time with symptoms of IBS the most likely and important differential diagnosis (assuming there are no red flags for cancer) is IBD. Therefore, testing for inflammatory markers in order to exclude IBD is recommended.7Interestingly, a second important differential diagnosis is coeliac disease, but no mention is made of the need to test for coeliac antibodies within NICE QS114.
NICE QS114 recommends including tests for CRP and faecal calprotectin in order to exclude inflammatory causes.7 Calprotectin is a marker for white cell activity and is stable in faeces thus allowing collection and delivery to the lab without degradation. It is striking that NICE CG61 only mentions the use of calprotectin indirectly in a list of related guidance: Diagnostics Guidance (DG) 11 for Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel, published in 2013, recommends the use of testing for calprotectin in order to distinguish between IBS and IBD ‘…in adults with recent onset lower gastrointestinal symptoms for whom specialist assessment referral is being considered.’10 For NICE to advise its use within QS114, as a baseline investigation to exclude an inflammatory cause of symptoms, and not overtly in CG61, would seem to be a departure from its own guidance.
It should be noted that this recommendation would seem to apply to newly presenting cases, as a first–line investigation, rather than for those individuals who already have a diagnosis of IBS.
NICE quality measures7
- Statement 1: Proportion of adults with symptoms of irritable bowel syndrome who have tests for inflammatory markers as first‑line investigation to exclude inflammatory causes
- Statement 2: 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
- Statement 3: 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
- Statement 4:
- Proportion of adults with irritable bowel syndrome who agree their follow‑up arrangements with their healthcare professional.
- Proportion of adults with irritable bowel syndrome whose follow up takes place by the date agreed with their healthcare professional.
NICE. Irritable bowel syndrome in adults. Quality Standard 114. NICE, 2016.
Reproduced with permission
Giving a positive diagnosis—statement 2
This statement encapsulates both the reassurance and confidence practitioners need to make a positive diagnosis, and the beneficial aspects of doing so. The stated rationale behind the quality statement is to reduce unnecessary anxiety in the patient,7 although I would expect the experience of both the patient and the doctor to be improved.
NICE CG61 recommends that the minimum set of diagnostic tests advised in new presentations of possible IBS are:1
- antibody testing for coeliac disease
Other investigations are not routinely advised as they have little diagnostic yield.1
Offering advice on dietary management—statement 3
A primary driver for this quality statement is likely to be the increasing understanding of the role played by the gut flora, and how imbalances in the microbiome can affect gut motility and inflammation. The search for scientific evidence is still in its preliminary stages, but while it has been known for some time that diet can be a notable factor in causing symptoms of IBS in some patients, we now have a potential mechanism.
Adjusting fibre intake has long been a mainstay in the treatment of IBS. It is important to know that the patient should be encouraged to eat soluble fibre (e.g. oats, pulses, fruit), and discouraged from eating insoluble fibre (e.g. bran).1If loose stools and bloating are symptoms, it may be necessary to decrease the amount of fibre in the patient’s diet.
The low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) diet is now receiving a lot of attention. The FODMAPs are complex carbohydrates that are poorly absorbed and, as a result, they can reach the colon intact and are then subject to fermentation.7 There is evidence to suggest that, in many cases, symptoms of IBS are improved by a low FODMAP diet;11 however, recent data has raised concerns that this diet may have a permanent effect on the microbiome, though the clinical significance of this is currently unknown.12
It is advised in NICE CG61 that a low FODMAP diet, or any strict exclusion diets, are supervised by a healthcare professional with expertise in dietary management. Without supervision, such diets may lead to potentially dangerous nutritional deficiencies.1
Reviewing treatment and management—statement 4
That patients with IBS should be reviewed was an important recommendation within NICE CG61,1 and this quality statement plays a major role in making sure this becomes a reality.
The purpose of the review is to optimise medicines, lifestyle and diet, to consider new or different treatments, and to watch for the emergence of any red–flag indicators.7As patient self–management is a goal of treatment, the quality statement makes a specific recommendation that the patients themselves should play a key role in determining when they need the review.
NICE Quality Standard 114 does not specify what would constitute a review or who should carry it out, and states that it could be either a face-to–face appointment or a telephone consultation.7 In reality, it could be done as part of an annual review or a medication review.
Implementing the quality standard
The biggest single shift will likely be in the minds of many healthcare professionals who may not currently take IBS as seriously as the patients. By implementing these statements, it starts to become a legitimate condition that is worthy of being taken seriously. It is likely that this will also lead to GPs being more confident in the treatment and management of IBS, helping to dispel the aura of helplessness and impotence that sometimes surrounds the condition.
More concrete changes would include the need to set up a register for regular patient reviews, and possibly training a practice nurse or healthcare assistant to conduct the reviews themselves. A nurse could also be trained to supervise patients' FODMAP or strict exclusion diets.
These measures have clear organisational and resourcing implications that are unlikely to be welcomed in the current climate; however, if implemented, there may be savings generated from the reduction in unnecessary referrals for investigations that could be re–invested. Given the potential to improve the quality of life for many patients, implementation of these measures seems relatively simple and should not be questioned.
NICE QS114 provides a framework for implementing existing NICE guidance on IBS. For such a prevalent condition that has consequences for the patient, including their ability to function socially and at work, and for the healthcare economy it makes sense for doctors to manage IBS in an evidence-based, structured way that provides the best outcomes. Gastroenterology is not covered by the Quality and Outcome Framework (QOF) and this seems to have diverted attention away from it. This quality standard will provide practical advice in delivering a high standard of care.
- IBS is a long-term disorder that has a significant impact on quality of life
- IBS should be a positive diagnosis, likely leading to a reduction in unnecessary patient anxiety
- Red-flag indicators should be considered and excluded before making a positive diagnosis of IBS
- The minimum set of investigations (FBC, ESR, CRP, and coeliac antibodies) is all that is needed for a positive diagnosis of IBS, and will exclude the main differential diagnoses of IBD and coeliac disease
- Dietary manipulation can be helpful in the management of IBS, but supervision from a healthcare professional with expertise in dietary management is recommended
- While successful self-management is a goal, regular review to optimise symptom control, assess whether any improvements could be suggested, and to monitor for the emergence of red-flag indicators is also recommended
IBS=irritable bowel syndrome; FBC=full blood count; ESR=erythrocyte sedimentation rate; CRP=C-reactive protein; IBD=inflammatory bowel disease
GP commissioning messages
written by Dr David Jenner, GP, Cullompton, Devon
- CCGs should seek to review their locally commissioned services against this quality standard:
- as IBS is not a feature of the QOF, however, this may prove difficult as it may not be consistently coded in primary care
- it may be possible to review patients who have been coded as IBS to see if they have had the required investigations and management plans but this is likely to be costly in time and resources
- an educational programme revisiting NICE guidance on the investigation and management of IBS to ensure that new cases are investigated, managed, and reviewed appropriately may be the most cost-effective option for implementing this quality standard
- CCGs may wish to ensure that faecal calciprotectin testing is available for primary care as part of the initial investigation of likely IBS, where referral to secondary care is being considered.
IBS=irritable bowel syndrome; QOF=quality and outcomes framework
- NICE. Irritable bowel syndrome in adults: diagnosis and management of irritable bowel syndrome in primary care. NICE Clinical Guideline 61. NICE, 2015. Available at: www.nice.org.uk/cg61
- Mönnikes H. Quality of life in patients with irritable bowel syndrome. J Clin Gastroenterol 2011; 45: 98–101.
- Wells N, Hahn B, Whorwell P. Clinical economics review: irritable bowel syndrome. Aliment Pharmacol Ther 1997; 11: 1019–1030.
- Vanner S, Depew W, Paterson W et al. Predictive value of the Rome criteria for diagnosing the irritable bowel syndrome. Am J Gastroenterol 1999; 94 (10): 2912–2917.
- NICE. Suspected cancer: recognition and referral. NICE Guideline 12. NICE, 2015. Available at: www.nice.org.uk/cg12
- General Medical Council. Good practice in prescribing and managing medicines and devices.GMC, 2013. Available at: www.gmc-uk.org/Prescribing_guidance.pdf_59055247.pdf
- NICE. Irritable bowel syndrome in adults. NICE Quality Standard 114. NICE, 2016. Available at: www.nice.org.uk/qs114
- Crohn’s and Colitis UK website. News and blog. Department of Health confuses IBS with IBD in parliament.www.crohnsandcolitis.org.uk/news/department-of-health-confuse-ibsibd-in-parliament (accessed 11 May 2016).
- Gray M, Papanicolas I. Impact of symptoms on quality of life before and after diagnosis of coeliac disease: results from a UK population survey. BMC Health Services Research 2010; 10: 105.
- NICE. Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. NICE Diagnostics Guidance 11. NICE, 2013. Available at: www.nice.org.uk/dg11
- Staudacher H, Whelan K, Irving P, Lomer M. Comparison of symptom response following advice for a diet low in fermentable carbohydrates (FODMAPs) versus standard dietary advice in patients with irritable bowel syndrome. J Hum Nutr Diet 2011; 24 (5): 487–495.
- Staudacher H, Lomer M, Anderson J et al. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr 2012; 142 (8): 1510–1518.