Objective To 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.
Design To 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.
Setting North Yorkshire primary care practices.
Patients Primary care patients fulfilling NICE DG11.
Interventions The YFCCP.
Main outcome measures Clinical outcome measures from secondary care records.
Results The 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.
Conclusions The 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.
- clinical decision making
- general practice
- irritable bowel syndrome
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Contributors JT is the guarantor of the article. JT directed the study and wrote the first draft. HH and VH contributed to the YHEC analysis. SM contributed to the patient survey. EM performed a comparator evaluation. DT and AJ provided the evaluation dataset. DT, HH, EM, VH and SM assisted in the preparation of the manuscript.The final version is approved by all the authors.
Funding The YHEC analysis was supported by the Yorkshire and Humber AHSN. Alpha Laboratories Limited has provided financial support, not in this, but another diagnostic accuracy study conducted by York Teaching Hospital NHS Foundation Trust.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement JT holds the original dataset upon which the study was based.
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