Background: Inflammatory Bowel Diseases (IBD) are characterized by alternating periods of flares and remission. Identifying patients at a significant risk of relapse during quiescent IBD could allow for early changes of treatment. Ileocolonoscopy is considered the gold standard in predicting IBD relapse, however it is invasive, expensive and not always well-accepted procedure. Measurement of calprotectin concentration in a stool sample is widely used as marker of gut inflammation and appears to be an alternative to endoscopy. Currently this test is not reimbursed by the National Health Fund in Poland. Aim: To evaluate the effectiveness of faecal calprotectin in predicting clinical and endoscopic recurrence of IBD and to decide whether its use in this indication would be cost-effective in Poland.
Methods: Medical databases (Medline, Embase, Cochrane) were searched. The predefined inclusion criteria comprised RCTs or cohort studies on adult patients with IBD in remission, calprotectin as index test and disease clinical activity assessment or colonoscopy as reference tests being performed and data on/enabling the calculation of diagnostic test accuracy parameters being present. The clinical and methodological heterogeneity of the included studies was judged and meta-analysis conducted. The decision tree opposing two strategies: Test an Don't test was built. The assumption about clinical utility was deemed true only in case of endoscopic recurrence. CEA was done from the public payer's perspective.
Results: 701 studies were firstly identified and as a result of selection process 13 were farther included into meta-analysis: 10 reporting clinical recurrence and 3 endoscopic one. The total number of patients was 1105. The sensitivity and specificity were estimated at 0.77 and 0.77 for clinical recurrence and 0.87 and 0.66 for endoscopic recurrence, respectively. In case of endoscopic recurrence the “test” strategy dominated over “don't test” strategy and in terms of one patient was about 1112 PLN cheaper allowing at the same time larger by 0.1 utility gain.
Conclusions: Faecal calprotectin concentration measurement can be used to predict clinical and endoscopic recurrence in IBD. The strategy assuming faecal calprotectin concentration measurement in all IBD patients in remission is more beneficial from the payer's perspective in Poland compared to the strategy that does not incorporate this test.