PTH-059 The Absence of Clear Pathways Leads to Poor Utilisation of Faecal Calprotectin in Primary Care and Failure to Comply with Nice Guidance

ObjectiveTo evaluate the sensitivity and specificity of the York Faecal Calprotectin Care Pathway (YFCCP) and undertake a health economics analysis. The YFCCP has been introduced in support of the National Institute for Health and Care Excellence (NICE) guidance DG11. It is designed to improve the sensitivity and specificity of faecal calprotectin (FC) in discriminating the irritable bowel syndrome from inflammatory bowel disease in primary care.DesignTo prospectively evaluate the clinical outcomes at 6 months of the first 1005 patients entering the YFCCP. To develop a cost-consequence model using two comparators: one based on clinical assessment and the C reactive protein/erythrocyte sedimentation rate without using FC, and the second using single testing of the standard FC cut-off.SettingNorth Yorkshire primary care practices.PatientsPrimary care patients fulfilling NICE DG11.InterventionsThe YFCCP.Main outcome measuresClinical outcome measures from secondary care records.ResultsThe sensitivity and specificity of the YFCCP are 0.94 (0.85 to 0.98) and 0.92 (0.90 to 0.94), giving a negative and positive predictive value of 0.99 (0.98 to 1.0) and 0.51 (0.43 to 0.59), respectively.ConclusionsThe YFCCP overcomes the challenges experienced with FC use in primary care, its efficacy matching initial NICE projections. It is readily incorporated into clinical practice. It should represent the framework on which to increase NICE DG11 implementation nationally.

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Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-045444 ◽

2021 ◽

Vol 11 (7) ◽

pp. e045444

Author(s):

Sophie Ansems ◽

Marjolein Berger ◽

Patrick van Rheenen ◽

Karin Vermeulen ◽

Gina Beugel ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Gastrointestinal Symptoms ◽

Cluster Randomised Controlled Trial ◽

Referral Rate ◽

Faecal Calprotectin ◽

Cluster Randomised ◽

Randomised Controlled

IntroductionChildren with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care.Methods and analysisIn this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4–18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children.Ethics and disseminationThe Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences.Trial registration numberThe Netherlands Trial Register: NL7690 (Pre-results)

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Faecal haemoglobin and faecal calprotectin as indicators of bowel disease in patients presenting to primary care with bowel symptoms

Gut ◽

10.1136/gutjnl-2015-309579 ◽

2015 ◽

Vol 65 (9) ◽

pp. 1463-1469 ◽

Cited By ~ 75

Author(s):

Craig Mowat ◽

Jayne Digby ◽

Judith A Strachan ◽

Robyn Wilson ◽

Francis A Carey ◽

...

Keyword(s):

Primary Care ◽

Bowel Disease ◽

Faecal Calprotectin ◽

Bowel Symptoms

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Faecal calprotectin is not necessarily required as a screen for significant bowel disease in primary care

Annals of Clinical Biochemistry International Journal of Laboratory Medicine ◽

10.1177/00045632211063458 ◽

2021 ◽

pp. 000456322110634

Author(s):

Matthew Malcolm Andrew Waite ◽

Louise Langmead ◽

Ruth M Ayling

Keyword(s):

Primary Care ◽

Bowel Disease ◽

Test Performance ◽

Faecal Calprotectin ◽

Immunochemical Test ◽

Inflammatory Bowel ◽

Clinical Records ◽

Sensitivity Specificity ◽

Disease Specific ◽

Rule Out

Objective NICE recommends measurement of faecal haemoglobin (f-Hb) using faecal immunochemical test (FIT) when colorectal cancer is suspected and calprotectin (f-Cal) in the context of inflammatory bowel disease, though neither is disease specific. During the COVID-19 pandemic, f-Hb has been a requirement prior to referral for endoscopy in England; f-Cal is often performed simultaneously. The aim of this study was to investigate test performance of both tests for significant bowel disease in those patients referred. Design All adult patients with simultaneous measurements of f-Hb and f-Cal between April 2019 and September 2020 were included. For those referred, outcomes were determined from clinical records. Results 650 patients with simultaneous samples for f-Hb an f-Cal were managed in Primary Care; 319 patients were referred to hospital; SBD was found in 32 (10.0%) (CRC 5, high risk adenomas 5, IBD 22). At a cut-off of 10 μg/g for f-Hb and 200 μg/g for f-Cal, the sensitivity, specificity and negative predictive value for diagnosis of SBD were 84.4%, 58.2% and 96.7% and 68.8%, 89.6% and 95.7%, respectively. Performance of both tests would have enabled diagnosis of two more cases of significant, but non-malignant, bowel disease but required over 4% more referrals for investigation. Conclusion Use of FIT has become established to assist prioritisation of patients for referral from Primary Care. Whilst introduced specifically for CRC, FIT performs well as a rule out for IBD in Primary Care and the use of f-Cal is not required.

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PTU-138 Impact of new primary care faecal calprotectin (FCP) guidelines on secondary care workload and finance

10.1136/gutjnl-2018-bsgabstracts.516 ◽

2018 ◽

Author(s):

Anet Soubieres ◽

Taylor-Jane Owen ◽

Frances Boa ◽

Andrew Poullis

Keyword(s):

Primary Care ◽

Secondary Care ◽

Faecal Calprotectin

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Faecal calprotectin to detect inflammatory bowel disease: a systematic review and exploratory meta-analysis of test accuracy

BMJ Open ◽

10.1136/bmjopen-2018-027428 ◽

2019 ◽

Vol 9 (3) ◽

pp. e027428 ◽

Cited By ~ 7

Author(s):

Karoline Freeman ◽

Brian H Willis ◽

Hannah Fraser ◽

Sian Taylor-Phillips ◽

Aileen Clarke

Keyword(s):

Systematic Review ◽

Primary Care ◽

Inflammatory Bowel Disease ◽

Sensitivity And Specificity ◽

Bowel Disease ◽

Secondary Care ◽

Meta Analysis ◽

Test Accuracy ◽

Faecal Calprotectin ◽

Inflammatory Bowel

ObjectiveTest accuracy of faecal calprotectin (FC) testing in primary care is inconclusive. We aimed to assess the test accuracy of FC testing in primary care and compare it to secondary care estimates for the detection of inflammatory bowel disease (IBD).MethodsSystematic review and meta-analysis of test accuracy using a bivariate random effects model. We searched MEDLINE, EMBASE, Cochrane Library and Web of Science until 31 May 2017 and included studies from auto alerts up until 31 January 2018. Eligible studies measured FC levels in stool samples to detect IBD in adult patients with chronic (at least 6–8 weeks) abdominal symptoms in primary or secondary care. Risk of bias and applicability were assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 criteria. We followed the protocol registered as PROSPERO CRD 42012003287.Results38 out of 2168 studies were eligible including five from primary care. Comparison of test accuracy by setting was precluded by extensive heterogeneity. Overall, summary estimates of sensitivity and specificity were not recorded. At a threshold of 50 µg/g, sensitivity from separate meta-analysis of four assay types ranged from 0.85 (95% CI 0.75 to 0.92) to 0.94 (95% CI 0.75 to 0.90) and specificity from 0.67 (95% CI 0.56 to 0.76) to 0.88 (95% CI 0.77 to 0.94). Across three different definitions of disease, sensitivity ranged from 0.80 (95% CI 0.76 to 0.84) to 0.97 (95% CI 0.91 to 0.99) and specificity from 0.67 (95% CI 0.58 to 0.75) to 0.76 (95% CI 0.66 to 0.84). Sensitivity appears to be lower in primary care and is further reduced at a revised threshold of 100 µg/g.ConclusionsConclusive estimates of sensitivity and specificity of FC testing in primary care for the detection of IBD are still missing. There is insufficient evidence in the published literature to support the decision to introduce FC testing in primary care. Studies evaluating FC testing in an appropriate primary care setting are needed.

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Removing hospital-based triage from suspected colorectal cancer pathways: the impact and learning from a primary care-led electronic straight-to-test pathway

BMJ Quality & Safety ◽

10.1136/bmjqs-2019-009975 ◽

2020 ◽

pp. bmjqs-2019-009975

Author(s):

Philippa Orchard ◽

Nitin Arvind ◽

Alison Wint ◽

James Kynaston ◽

Ann Lyons ◽

...

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

Dramatic Improvement ◽

Hospital System ◽

Cancer Data ◽

Cancer Pathways ◽

Referral Criteria ◽

Nice Guidance ◽

Referral Form ◽

The Impact

BackgroundThe 2-week wait referral pathway for suspected colorectal cancer was introduced in England to improve time from referral from a general practitioner (GP) to diagnosis and treatment. Patients are required to be seen by a hospital clinician within 2 weeks if their symptoms meet the criteria set by the National Institute for Health and Care Excellence (NICE) and to start cancer treatment within 62 days. To achieve this, many hospitals have introduced a straight-to-test (STT) strategy requiring hospital-based triage of referrals. We describe the impact and learning from a new pathway which has removed triage and moved the process of requesting tests from hospital to GPs in primary care.MethodAn electronic STT pathway was introduced allowing GPs to book tests supported by a decision aid based on NICE guidance eliminating the need for a standard referral form or triage process. The hospital identified referrals as being on a cancer pathway and dealt with all ongoing management. Routinely collected cancer data were used to identify time to cancer diagnosis compared with national dataResults11357 patients were referred via the new pathway over 3 years. Time from referral to diagnosis reduced from 39 to 21 days and led to a dramatic improvement in patients starting treatment within 62 days. Challenges included adapting to a change in referral criteria and developing a robust hospital system to monitor the pathway.ConclusionWe have changed the way patients with suspected colorectal cancer are managed within the National Health Service by giving GPs the ability to order tests electronically within a monitored cancer pathway halving time from referral to diagnosis

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Evaluation of a faecal calprotectin care pathway for use in primary care

Primary Health Care Research & Development ◽

10.1017/s1463423616000049 ◽

2016 ◽

Vol 17 (05) ◽

pp. 428-436 ◽

Cited By ~ 15

Author(s):

James Turvill ◽

Shaun O’Connell ◽

Abigail Brooks ◽

Karen Bradley-Wood ◽

James Laing ◽

...

Keyword(s):

Primary Care ◽

Clinical Decision Making ◽

Diagnostic Yield ◽

Care Pathway ◽

Gastrointestinal Symptoms ◽

Clinical Decision ◽

Traffic Light ◽

Faecal Calprotectin ◽

Predictive Values ◽

Light System

BackgroundNational Institute for Health and Care Excellence have recommended faecal calprotectin (FC) testing as an option in adults with lower gastrointestinal symptoms for whom specialist investigations are being considered, if cancer is not suspected and it is used to support a diagnosis of inflammatory bowel disease (IBD) or irritable bowel syndrome. York Hospital and Vale of York Clinical Commissioning Group have developed an evidence-based care pathway to support this recommendation for use in primary care. It incorporates a higher FC cut-off value, a ‘traffic light’ system for risk and a clinical management pathway.ObjectivesTo evaluate this care pathway.MethodsThe care pathway was introduced into five primary care practices for a period of six months and the clinical outcomes of patients were evaluated. Negative and positive predictive values (NPV and PPV) were calculated. GP feedback of the care pathway was obtained by means of a web-based survey. Comparator gastroenterology activity in a neighbouring trust was obtained.ResultsThe care pathway for FC in primary care had a 97% NPV and a 40% PPV. This was better than GP clinical judgement alone and doubled the PPV compared with the standard FC cut-off (<50 mcg/g), without affecting the NPV. In total, 89% of patients with IBD had an FC>250 mcg/g and were diagnosed by ‘straight to test’ colonoscopy within three weeks. The care pathway was considered helpful by GPs and delivered a higher diagnostic yield after secondary care referral (21%) than the conventional comparator pathway (5%).ConclusionsA care pathway for the use of FC that incorporates a higher cut-off value, a ‘traffic light’ system for risk and supports clinical decision making can be achieved safely and effectively. It maintains the balance between a high NPV and an acceptable PPV. A modified care pathway for the use of FC in primary care is proposed.

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