Intestinal research

Korean Association for the Study of the Intestinal Diseases (대한장연구학회)
권호 표지
DOI QR코드

DOI QR Code

Experience of patients with inflammatory bowel disease in using a home fecal calprotectin test as an objective reported outcome for self-monitoring

  • Wei, Shu-Chen (Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine) ;
  • Tung, Chien-Chih (Department of Integrated Diagnostics & Therapeutics, National Taiwan University Hospital) ;
  • Weng, Meng-Tzu (Department of Internal Medicine, Far Eastern Memorial Hospital) ;
  • Wong, Jau-Min (Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine)
  • Received : 2018.04.11
  • Accepted : 2018.06.04
  • Published : 2018.10.30
⟨ Previous Next ⟩

Abstract

Background/Aims: Fecal calprotectin (fC) level is a predictive marker of mucosal healing for patients with inflammatory bowel disease (IBD). Home fC tests are now available. We evaluated the performance of the smartphone-based IBDoc home testing system in patients with IBD and obtained their feedback as an objective patient-reported outcome. Methods: This prospective study enrolled consecutive patients with IBD in clinical remission. fC in the same stool sample was assessed by using both the laboratory test (Quantum Blue calprotectin test) and home test (IBDoc). The correlation between the 2 tests was analyzed using the Pearson method. In addition, the patients were asked to fill a questionnaire based on their experience. Results: Fifty-one patients with IBD (68 tests and 49 questionnaires) were included. The correlation between Quantum Blue test and IBDoc was good (r=0.776, P<0.0001). After the test, 56% patients found IBDoc easy to perform, and 96% were satisfied with it. Thirty-nine patients (80%) had a strong (>70%) probability to use it for future monitoring if the price was acceptable. By using $250{\mu}g/g$ as the cutoff, the agreement between home test and laboratory results was 80%, and by using $600{\mu}g/g$ as the cutoff, the agreement increased to 92%. Conclusions: The correlation between the laboratory and home tests was good. Most patients found the home test to be feasible and easy to use and preferred it over laboratory test and endoscopy for monitoring. Therefore, the home test could be used as an objective patient-reported outcome.

Keywords

References

  1. Rutter M, Saunders B, Wilkinson K, et al. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology 2004;126:451-459. https://doi.org/10.1053/j.gastro.2003.11.010
  2. Colombel JF, Panaccione R, Bossuyt P, et al. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet 2018;390:2779-2789.
  3. Nielsen OH, Vainer B, Madsen SM, Seidelin JB, Heegaard NH. Established and emerging biological activity markers of inflammatory bowel disease. Am J Gastroenterol 2000;95:359-367.
  4. Vermeire S, Van Assche G, Rutgeerts P. Laboratory markers in IBD: useful, magic, or unnecessary toys? Gut 2006;55:426-431. https://doi.org/10.1136/gut.2005.069476
  5. D'Haens G, Ferrante M, Vermeire S, et al. Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. Inflamm Bowel Dis 2012;18:2218-2224. https://doi.org/10.1002/ibd.22917
  6. Lin WC, Wong JM, Tung CC, et al. Fecal calprotectin correlated with endoscopic remission for Asian inflammatory bowel disease patients. World J Gastroenterol 2015;21:13566-13573. https://doi.org/10.3748/wjg.v21.i48.13566
  7. Wei SC. Could fecal calprotectin enter mainstream use for diagnosing and monitoring inflammatory bowel disease? Intest Res 2016;14:293-294. https://doi.org/10.5217/ir.2016.14.4.293
  8. Jang HW, Kim HS, Park SJ, et al. Accuracy of three different fecal calprotectin tests in the diagnosis of inflammatory bowel disease. Intest Res 2016;14:305-313. https://doi.org/10.5217/ir.2016.14.4.305
  9. Elkjaer M, Burisch J, Voxen Hansen V, et al. A new rapid home test for faecal calprotectin in ulcerative colitis. Aliment Pharmacol Ther 2010;31:323-330.
  10. Heida A, Knol M, Kobold AM, et al. Agreement between home-based measurement of stool calprotectin and ELISA results for monitoring inflammatory bowel disease activity. Clin Gastroenterol Hepatol 2017;15:1742-1749.e2. https://doi.org/10.1016/j.cgh.2017.06.007
  11. Bello C, Roseth A, Guardiola J, et al. Usability of a home-based test for the measurement of fecal calprotectin in asymptomatic IBD patients. Dig Liver Dis 2017;49:991-996. https://doi.org/10.1016/j.dld.2017.05.009
  12. Vinding KK, Elsberg H, Thorkilgaard T, et al. Fecal calprotectin measured by patients at home using smartphones: a new clinical tool in monitoring patients with inflammatory bowel disease. Inflamm Bowel Dis 2016;22:336-344. https://doi.org/10.1097/MIB.0000000000000619
  13. Elkjaer M. E-health: web-guided therapy and disease self-management in ulcerative colitis. Impact on disease outcome, quality of life and compliance. Dan Med J 2012;59:B4478.
  14. Kawashima K, Ishihara S, Yuki T, et al. Fecal calprotectin more accurately predicts endoscopic remission of Crohn's disease than serological biomarkers evaluated using balloon-assisted enteroscopy. Inflamm Bowel Dis 2017;23:2027-2034. https://doi.org/10.1097/MIB.0000000000001202
  15. Vazquez Moron JM, Pallares Manrique H, Machancoses FH, Ramos Lora M, Ruiz Frutos C. Accurate cut-offs for predicting endoscopic activity and mucosal healing in Crohn's disease with fecal calprotectin. Rev Esp Enferm Dig 2017;109:130-136.
  16. Sandborn WJ, Panes J, Zhang H, Yu D, Niezychowski W, Su C. Correlation between concentrations of fecal calprotectin and outcomes of patients with ulcerative colitis in a phase 2 trial. Gastroenterology 2016;150:96-102. https://doi.org/10.1053/j.gastro.2015.09.001
  17. Yamaguchi S, Takeuchi Y, Arai K, et al. Fecal calprotectin is a clinically relevant biomarker of mucosal healing in patients with quiescent ulcerative colitis. J Gastroenterol Hepatol 2016;31:93-98. https://doi.org/10.1111/jgh.13061
  18. Dhaliwal A, Zeino Z, Tomkins C, et al. Utility of faecal calprotectin in inflammatory bowel disease (IBD): what cut-offs should we apply? Frontline Gastroenterol 2015;6:14-19. https://doi.org/10.1136/flgastro-2013-100420
  19. Bjarnason I. The use of fecal calprotectin in inflammatory bowel disease. Gastroenterol Hepatol (N Y) 2017;13:53-56.
  20. Bossuyt P, Vermeire S. Treat to target in inflammatory bowel disease. Curr Treat Options Gastroenterol 2016;14:61-72. https://doi.org/10.1007/s11938-016-0077-z
  21. Bossuyt P, Pouillon L, Bonnaud G, Danese S, Peyrin-Biroulet L. E-health in inflammatory bowel diseases: more challenges than opportunities? Dig Liver Dis 2017;49:1320-1326. https://doi.org/10.1016/j.dld.2017.08.026
  22. Bossuyt P, Pouillon L, Peyrin-Biroulet L. Primetime for e-health in IBD? Nat Rev Gastroenterol Hepatol 2017;14:133-134. https://doi.org/10.1038/nrgastro.2017.11

Cited by

  1. Usability of IBDoc, a Novel Fecal Calprotectin Home-Based Rapid Test in Clinical Practice vol.18, pp.3, 2018, https://doi.org/10.1097/poc.0000000000000192
  2. Biochemical Biomarkers of Mucosal Healing for Inflammatory Bowel Disease in Adults vol.10, pp.6, 2018, https://doi.org/10.3390/diagnostics10060367
  3. Setting up a Virtual Calprotectin Clinic in Inflammatory Bowel Diseases: Literature Review and Nancy Experience vol.9, pp.9, 2020, https://doi.org/10.3390/jcm9092697
  4. Calprotectin in inflammatory bowel disease vol.510, pp.None, 2018, https://doi.org/10.1016/j.cca.2020.08.025
  5. The effect of a mindfulness-based therapy on different biomarkers among patients with inflammatory bowel disease: a randomised controlled trial vol.10, pp.None, 2018, https://doi.org/10.1038/s41598-020-63168-4
  6. Remote Monitoring Empowerment of Patients with IBDs during the SARS-CoV-2 Pandemic vol.8, pp.4, 2018, https://doi.org/10.3390/healthcare8040377
  7. Self-monitoring with home based fecal calprotectin is associated with increased medical treatment. A randomized controlled trial on patients with inflammatory bowel disease vol.56, pp.1, 2018, https://doi.org/10.1080/00365521.2020.1854342
  8. How to manage inflammatory bowel disease during the COVID-19 pandemic: A guide for the practicing clinician vol.27, pp.11, 2018, https://doi.org/10.3748/wjg.v27.i11.1022
  9. International consensus on methodological issues in standardization of fecal calprotectin measurement in inflammatory bowel diseases vol.9, pp.4, 2018, https://doi.org/10.1002/ueg2.12069
  10. A Patient Self-Made Point-of-Care Fecal Test Improves Diagnostic Accuracy Compared with Fecal Calprotectin Alone in Inflammatory Bowel Disease Patients vol.11, pp.12, 2021, https://doi.org/10.3390/diagnostics11122323