A. Faecal Calprotectin NIS AUDIT TEMPLATE

Service Specification Number

011COMMISSIONING DEVELOPMENT NIS - Audit

Commissioner Lead Tower Hamlets CCGProvider Lead GP NetworksPeriod 1st April 2016 - 31st March 2017Date of Review April 2016

(Version date 24/5/16)

INTRODUCTION:

As the Governing board member representing Network 8 I am also the lead for Planned Care. One of this year’s NIS is to increase the use of Calprotectin testing in General Practice with the resultant aim that we decrease the number of GI referrals for colonoscopy. We were aiming for around 3000 tests this year.

I am really passionate about this NIS as it can really make a difference in patients who have a suspected diagnosis of IBS but may in fact be suffering from IBD (Crohns and Ulcerative Colitis). It can also help in those patients where we have diagnostic uncertainly with regards to whether they have IBS or IBD. Rather than refer for a Colonoscopy we could do a Calprotectin test which if negative would strongly suggest the patient has IBS and hence we can effectively manage this in primary care.

There are two ways to organise a Calprotectin Test. You can either order a:

BARTS – T QUESTor

PRACTICE TEST KITS. For Those using practice test kits we will pay £30 per test to cover for the cost of the kit plus your admin time. This sum includes VAT.

The sheets at the end give further information about Calprotectin testing and its use and limitations. Please read through this light material and ensure as many clinicians are aware of its use as possible. Inappropriate use may indeed lead to a positive result which really perhaps need not have been referred to a gastroenterologist (Patient with recent gastroenteritis or taking NSAIDS)

Dr Shah Ali

Board Member – Tower Hamlets CCG

Introduction to the Audit

As you know the main aim of using Calprotectin within the GP’s armoury is to help distinguish between IBS and IBD. We hope doing so will lead to fewer gastro referrals but we could also envisage more referrals being made if there are indeed a cohort of IBD patients misdiagnosed as IBS.

Anecdotal discussions with colleagues has raised a theme that “more” referrals are being made to gastroenterology due to more positive tests. Furthermore most of these are not having colonoscopies but being discharged. This means the inherent aims of using Calprotectin to enable us to appropriately refer may not be happening and could in fact lead to the opposite.

For this reason we want to capture this information and see if we can interrogate it further both qualitatively and quantitatively and see what learning emerges. To enable this I have created the pro-former below.

Each practice needs to individually do the audit – But the submissions are to be collated and made at network level along with the reflection and summary. This will be shared out amongst all the networks so that ideas and thoughts can be reflected upon. The template below gives the practices an outline of how to collate the data and their thoughts. For submission we would expect the Network’s to fill in (having collated the individual practices results) the network results template.

We aim for each practice to have at least 10 positive patients to analyse and no more than 20 per practice is needed. The time line is arbitrary but looking back from April 2015 (or even earlier if you have been doing them) will allow you to follow the patient all the way through to possible discharge and diagnosis. The time line should be for at least a 1 year period.

Pro-former Template:

Individual Practice

Q1 Number of Calprotectin tests carried out – (TQuest/Practice) Between April 2015-16. This should be searchable via Emis if appropriately coded. You may choose a period other than above as long as it is one years’ worth of data.

Q2 No of negative Calprotectin tests

Q3 For each negative Calprotectin test what was the resultant management plan in summary. I.e Patient reassured, patient still referred, patient managed as IBS etc.

Q4 Number of positive Calprotectin tests

Q5 For each positive Calprotectin test how many were referred onto secondary care

Q6 For each patient referred to secondary care after a positive Calprotectin test how many went on to have any further investigations, i.e. colonoscopy, flexi-sigmoidoscopy, gastroscopy done.

Q7 For each patient referred to secondary care after a positive Calprotectin test if no further tests were done, what was the resultant management plan and any ideas as to why the test may have been positive?

Q8 How many patients of those referred to secondary care were given a diagnosis of IBD

Q9 Of those positive Calprotectin not given a diagnosis of IBD, what where the other diagnosis’s given?

Q10 How many patients of those referred to secondary care were discharged either on their first appointment or after any investigations – That is no further follow up arranged?

Network Summary

Q1 Number of Calprotectin tests carried out in the NETWORK – (TQuest/Practice) Between April 2015-16. This should be searchable via Emis if appropriately coded. You may choose a period other than above as long as it is one years’ worth of data.

Q1a

Q2 No of negative Calprotectin tests in the NETWORK

Q2a

Q3 For each negative Calprotectin test what was the resultant management plan. Please summarise the general management plans as a network rather than list them individually. This information will be fed back to all networks. Any qualitative information will be valuable. Please attribute numbers (How many patients) to the answers where possible.

Q3a For example……18 were given diagnosis of IBS 13 were reassured 7 we could not find record of further Mx plan.

Q4 Number of positive Calprotectin tests in the whole network

Q4a

Q5 For each positive Calprotectin test how many were referred to secondary care

Q5a

Q6 For those referred onto secondary care as a NETWORK, Please summarise how many of them went on to have further investigations like a Colonoscopy or Gastroscopy etc. Please attribute numbers (How many patients) to the answers where possible.

Q6a For example:

12 had colonoscopies 3 sigmoidoscopies Gastroscopies

Q7 Please summarise as a NETWORK what the resultant management plan was for those tested positive but in whom no further diagnostic test were carried out. We will use this section to see if there are any themes or learning in order to aid us better manage some of the positive tests in which no further Ix were carried out in hospital. Please attribute numbers (How many patients) to the answers where possible.

Q7a 13 positive discharged 8 labeled as constipation as a possible cause. 3 were on NSAIDS and had Gastritits 2 had gastroenteritis at the time of testing as a possible cause

Q8 How many patients of those referred to secondary care were given a diagnosis of IBD

Q8a

Q9 As a NETWORK of those POSITIVE CALPROTECTIN not given a diagnosis of IBD, please summarise the alternative diagnosis given and possible remarks as to why the Calprotectin could have been positive? Please attribute numbers (How many patients) to the answers where possible.

Q9a . .

Q10 Please summarise as a NETWORK how many patients of those referred to secondary care were discharged either after their colonoscopy/Ix or following fist appointment.

Q10a

If you have any other thoughts, please collate them on a network level and please feedback through this audit.

Please ensure that this work is complete by 1/12/2016

FAECAL CALPROTECTIN PATIENT TESTING

Purpose

To help with the differential diagnosis of IBD or IBS. This test is not appropriate for the exclusion of malignancy - If cancer is suspected refer using the 2WW pathway.

Reduce the need for invasive diagnostic tests such as colonoscopies and inappropriate gastroenterology referrals.

Background:

Faecal calprotectin is a substance released into the intestines in the presence of inflammation. The main diseases that cause an increased excretion of calprotectin are Crohn’s Disease, ulcerative colitis and neoplasms. Levels of calprotectin are normal in patients with IBS. As it measures inflammation other causes of inflammation such as gastritis can also give elevated results.

Exclusion Criteria Make sure patient do not have Gastroenteritis – Gut inflammation will give you a

positive reading. Make sure patients are not taking NSAIDs within 4 weeks of the test. NSAIDS can

lead to false positive Calprotectin results. Patients for whom cancer is suspected following assessment of risk factors

Inclusion Criteria Adults with recent onset lower gastrointestinal symptoms for whom a specialist

opinion is being considered and in whom a negative Calprotectin will enable you to consider IBS as a diagnosis.

Testing

o Test can be done Via T-QUEST and sent to BLT Labs or via practice kits. Please use them only where it will enable changes to patient care or pathway.

Reproduced with permission from Ferring Pharmaceuticals

Fast Facts About Faecal Calprotectin (FC) (Dr LISA DAS)

1. Faecal Calprotectin is a useful marker of intestinal neutrophilic inflammation. It exhibits excellent stability in stool for up to 7 days at room temperature.

2. The cut-off in primary care is: 50 μg/g. This is based on ensuring high sensitivity, and not missing people with IBD.

3. The value of FC testing in primary care is for ruling out IBD, and confirming a presumptive diagnosis of IBS, where the differential diagnosis is in doubt. By using FC we may be able to pick up earlier cases of IBD that may have been misdiagnosed as IBS. It is likely that delays in diagnosing IBD (especially Crohn’s Disease) could be reduced, as a raised calprotectin should alert clinicians.

4. FC will not be required in all people with IBS as other features in the history may tilt the balance of probability towards IBS.

5. Now FC is available in primary care, GPs can be much more selective in referrals to specialist care. We will likely see referrals falling considerably, plus perhaps, a reduction in the number of colonoscopies performed.

6. FC is not a specific marker for CRC, and is not recommended for popululation CRC screening.

7. Calprotectin testing will lead to cost savings in terms of monitoring and measurement of ESR and CRP in patients with IBS and IBD.

8. There are several known causes of raised calprotectin levels. These include:• NSAID treatment (excluding low dose aspirin 75mg)• Colonic adenomas/ malignancy• Shingles, salmonella and c. diff infection – (Gastroenteritis)

9. Borderline faecal calprotectin results- Uncertainty remains as to how to deal with patients who have calprotectin levels of between 50 and 200 μg/g. One option is repeat testing after 6–8 weeks. If this group includes some people with IBD it is likely a mild form of IBD. The trend over time will be a useful guide to management.

10. Some patients with IBS (diagnosed after negative endoscopies) have raised calprotectin levels for unclear reasons, and further research into this group is be indicated. It may be due to an inflammatory component in some patients with IBS, perhaps especially those with post Infectious IBS.

PLEASE NOTE: The GP Calprotectin test kit is a Qualitative analysis. Only the lab does Quantitative tests