Evaluation of the clinical and cost-effectiveness of the York Faecal Calprotectin Care Pathway

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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Audit of the impact of the York faecal calprotectin care pathway on colonoscopy activity

Frontline Gastroenterology ◽

10.1136/flgastro-2019-101315 ◽

2019 ◽

Vol 11 (4) ◽

pp. 285-289

Author(s):

James Turvill ◽

Daniel Turnock

Keyword(s):

Primary Care ◽

Care Pathway ◽

Teaching Hospitals ◽

Colonic Disease ◽

Faecal Calprotectin ◽

Number Of Patients ◽

Time To Diagnosis ◽

Clinical Diagnoses ◽

Irritable Bowel ◽

The Impact

BackgroundThe York faecal calprotectin care pathway (YFCCP) was developed to optimise effective primary care differentiation between irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). We undertook an audit of colonoscopy activity at York Teaching Hospitals after the introduction of the YFCCP, to assess its impact.MethodsFaecal calprotectin (FC) results were reconciled with colonoscopy activity in patients 18–60 years after the implementation of the YFCCP. This permitted individual patient tracking of their FC values, the timing of those requests by primary care, the date of subsequent referral and investigation and the end clinical diagnoses.ResultsPrimary care uptake of FC increased fourfold with the introduction of the YFCCP. Following implementation, FC-related referrals for colonoscopy fell from 24% to 13%. The number of patients needed to colonoscope to diagnose organic colonic disease (IBD, significant adenomatous polyps or colorectal cancer) fell from 6.8 to 3.8 when the YFCCP was applied. This represents a cost saving of £41 015 per thousand patients tested in primary care. We estimate that outpatient time to diagnosis fell from a median of 41 to 29 days.ConclusionThis audit of FC activity and colonoscopy outcomes provides substantial supportive evidence for the effectiveness of the YFCCP. Popular in primary care, it has led to a reduction in referrals. The diagnostic accuracy determined in this audit is in line with earlier evaluations. Accepting the weaknesses of audit we conclude that this evaluation likely underestimates the benefits of the YFCCP in terms of resource use saving and time to diagnosis.

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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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P471 What is the appropriate cut-off value of CRP to predict endoscopic remission in ulcerative colitis patients with clinical remission?

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.600 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S415-S415

Author(s):

J Shin ◽

G Seong ◽

J H Song ◽

S M Kong ◽

T J Kim ◽

...

Keyword(s):

Ulcerative Colitis ◽

Sensitivity And Specificity ◽

Clinical Remission ◽

Activity Index ◽

Area Under The Curve ◽

Endoscopic Evaluation ◽

Faecal Calprotectin ◽

Reactive Protein ◽

Endoscopic Remission ◽

Low Sensitivity

Abstract Background A noninvasive and reliable markers for predicting endoscopic remission (ER) in ulcerative colitis (UC) patients with clinical remission (CR) provide important information in predicting disease progression and in determining treatment. Faecal calprotectin test is known to be the most accurate to predict ER, but patients are reluctant to handle faecal materials. C-reactive protein (CRP) is one of the surrogate markers for assessing disease activity, but it is known to have low sensitivity and specificity of normal CRP value (<0.3 mg/dl). The sensitivity of the CRP test has been improved, and even fine values within the normal range can be measured. The aim of this study was to determine appropriate CRP cut-off values for the prediction of ER in UC patients with CR even though within normal CRP range. Methods A total of 132 UC patients who underwent endoscopic evaluation in CR were retrospectively reviewed. Serum biomarkers including haemoglobin, leukocytes, platelets, erythrocyte sedimentation rate, and CRP were evaluated within 1 week period from endoscopic evaluation. The clinical and endoscopic activity was measured by simple clinical colitis activity index and endoscopic Mayo subscore. Results In UC patient with CR, CRP level was significantly lower in ER (median 0.05, 0.03–2.57) vs. non-ER (median 0.11 0.03-2.81). (p < 0.005) The proportion of males in non-ER was slightly higher than in ER (24, 72.7% vs. 52, 52.5 %; p = 0.042), and only gender and CRP showed statistical differences in baseline clinical characteristics. CRP had predictive value of ER [Area under the curve (AUC = 0.760)] and the sensitivity was 71.4%, specificity was 71.7 % at cut-off value of 0.09mg/dl. In contrast, the sensitivity and specificity of normal CRP (0.3mg/dl) were low. (sensitivity 27.3%, specificity 90.9%). Conclusion Norma CRP cut-off values are not sufficient to reflect ER. It may be helpful to change the CRP cut-off value that predicts ER in CR to value other than 0.3 mg/dl.

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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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Integrating Patient Reported Outcome Measures (PROMs) into routine nurse-led primary care for patients with multimorbidity: a feasibility and acceptability study

Health and Quality of Life Outcomes ◽

10.1186/s12955-021-01748-2 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Ian Porter ◽

Antoinette Davey ◽

Jaheeda Gangannagaripalli ◽

Jonathan Evans ◽

Charlotte Bramwell ◽

...

Keyword(s):

Primary Care ◽

Outcome Measures ◽

Thematic Analysis ◽

Qualitative Interviews ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Convenience Sample ◽

Patient Reported ◽

Primary Care Practices ◽

High Degree

Abstract Background The use of Patient Reported Outcome Measures (PROMS) in clinical practice has the potential to promote patient-centred care and improve patients’ quality of life. Individualized PROMs may be particularly helpful in identifying, prioritizing and monitoring health problems of patients with multimorbidity. We aimed to develop an intervention centred around PROMs feedback as part of Primary Care annual reviews for patients with multimorbidity and evaluate its feasibility and acceptability. Methods We developed a nurse-oriented intervention including (a) training of nurses on PROMs; (b) administration to patients with multimorbidity of individualized and standardized PROMS; and (c) feedback to both patients and nurses of PROMs scores and interpretation guidance. We then tailored the intervention to patients with two or more highly prevalent conditions (asthma, COPD, diabetes, heart failure, depression, and hip/knee osteoarthritis) and designed a non-controlled feasibility and acceptability evaluation in a convenience sample of primary care practices (5). PROMs were administered and scores fed back immediately ahead of scheduled annual reviews with nurses. Patients and nurses rated the acceptability of the intervention using with a brief survey including optional free comments. Thematic analysis of qualitative interviews with a sample of participating patients (10) and nurses (4) and of survey free comments was conducted for further in-depth evaluation of acceptability. Feasibility was estimated based on rates of participation and completion. Results Out of 68 recruited patients (mean age 70; 47% female), 68 completed the PROMs (100%), received feedback (100%) and confirmed nurse awareness of their scores (100%). Most patients (83%) “agreed”/”strongly agreed” that the PROMs feedback had been useful, a view supported by nurses in 89% of reviews. Thematic analysis of rich qualitative data on PROMS administration, feedback and role in annual reviews indicated that both patients and nurses perceived the intervention as acceptable and promising, emphasizing its comprehensiveness and patient-centredness. Conclusions We have developed and tested an intervention focusing on routine PROM assessment of patients with multimorbidity in Primary Care. Preliminary findings support its feasibility and a high degree of acceptability from both patients and nurses. The next step is to conduct a full-scale trial for evaluating the effectiveness of the proposed intervention.

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Irritable bowel syndrome in adults in primary care: summary of updated NICE guidance

BMJ ◽

10.1136/bmj.h701 ◽

2015 ◽

pp. h701 ◽

Cited By ~ 43

Author(s):

Cheryl Hookway ◽

Sara Buckner ◽

Paul Crosland ◽

Damien Longson

Keyword(s):

Primary Care ◽

Irritable Bowel Syndrome ◽

Nice Guidance ◽

Irritable Bowel

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PTU-061 Use of faecal calprotectin in primary care to distinguish irritable bowel syndrome from inflammatory bowel disease: Abstract PTU-061 Table 1

Gut ◽

10.1136/gutjnl-2015-309861.176 ◽

2015 ◽

Vol 64 (Suppl 1) ◽

pp. A86.2-A87

Author(s):

JO Rouke ◽

A Dhaliwal ◽

V Sagar ◽

J Davies ◽

A Milestone

Keyword(s):

Primary Care ◽

Inflammatory Bowel Disease ◽

Irritable Bowel Syndrome ◽

Bowel Disease ◽

Faecal Calprotectin ◽

Inflammatory Bowel ◽

Irritable Bowel

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Unrestricted faecal calprotectin testing performs poorly in the diagnosis of inflammatory bowel disease in patients in primary care

Journal of Clinical Pathology ◽

10.1136/jclinpath-2017-204506 ◽

2017 ◽

Vol 71 (4) ◽

pp. 316-322 ◽

Cited By ~ 13

Author(s):

Samantha Conroy ◽

Melissa F Hale ◽

Simon S Cross ◽

Kirsty Swallow ◽

Reena H Sidhu ◽

...

Keyword(s):

Primary Care ◽

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Predictive Value ◽

Gastrointestinal Endoscopy ◽

Faecal Calprotectin ◽

Inflammatory Bowel ◽

Irritable Bowel ◽

Low Sensitivity ◽

Single Laboratory

BackgroundFaecal calprotectin (FC) measurement distinguishes patients with inflammatory bowel disease (IBD) from those with irritable bowel syndrome but evidence of its performance in primary care is limited.AimsTo assess the yield of IBD from FC testing in primary care.MethodsRetrospective review of hospital records to assess the outcome following FC testing in primary care. Investigations for all patients undergoing FC testing in a single laboratory for 6 months from 1 October 2013 to 28 February 2014 were reviewed.Results410 patients (162 male; median age 42; range 16–91) were included. FC>50 µg/g was considered positive (FC+). 148/410 (36.1%; median age 44 (17–91)) were FC+ (median FC 116.5 µg/g (51–1770)). 122/148 FC-positive patients (82.4%) underwent further investigation. 97 (65.5%) underwent lower gastrointestinal endoscopy (LGIE), of which 7 (7.2%) had IBD. 49/262 (18.7%) FC-negative (FC−) patients (FC ≤50 µg/g) (median age 47 (19–76)) also underwent LGIE, of whom 3 (6.1%) had IBD.IBD was diagnosed in 11/410 (2.7%; 4 ulcerative colitis, 3 Crohn’s disease, 4 microscopic colitis). 8/11 were FC+ (range 67–1170) and 3 FC−. At a 50 µg/g threshold, sensitivity for detecting IBD was 72.7%, specificity 64.9%, positive predictive value (PPV) 5.41% and negative predictive value 98.9%. Increasing the threshold to 100 µg/g reduced the sensitivity of the test for detecting IBD to 54.6%.ConclusionsFC testing in primary care has low sensitivity and specificity with poor PPV for diagnosing IBD. Its use needs to be directed to those with a higher pretest probability of disease. Local services and laboratories should advise general practitioners accordingly.

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