TY - JOUR
T1 - A prospective study comparing patient-reported outcomes in Crohn's disease
AU - Hoekman, Daniël R.
AU - Löwenberg, Mark
AU - van den Brink, Gijs R.
AU - Ponsioen, Cyriel Y.
AU - Benninga, Marc A.
AU - D'Haens, Geert R.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - BACKGROUND: Patient reported outcomes are important in Crohn's disease. In this prospective cohort, we investigated the performance of the Bristol Stool Form Scale (BSFS) and a visual analog scale (VAS) for abdominal pain as outcome measures in Crohn's disease. METHODS: Patients with active Crohn's disease starting glucocorticoids or anti-tumor necrosis factor were included. Before treatment and 10 weeks later we collected: clinical activity [Harvey Bradshaw Index (HBI) and Crohn's-Disease-Activity-Index (CDAI)], serum C-reactive protein (CRP) and fecal calprotectin, and BSFS (1-7) and a 100-mm VAS based on a 7-day diary. Clinical response was defined as a reduction by at least 3 and at least 100 of HBI and CDAI, respectively. Fecal calprotectin-response and CRP-response were defined as reduction of at least 50%. RESULTS: Thirty-eight patients completed follow-up. At baseline, BSFS-parameters correlated more strongly with clinical activity (range: rs: 0.31-0.74) than with CRP (rs: -0.01 to 0.16) and fecal calprotectin (rs: 0.14-0.26). VAS scores correlated very weakly to moderately with clinical activity (rs: 0.18-0.45), and weakly to moderately with CRP (rs: 0.24-0.34) and fecal calprotectin (rs: 0.35-0.43). Changes in VAS scores correlated moderately to strongly (rs: 0.55-0.71) with changes in clinical activity, and weakly with changes in CRP and fecal calprotectin (rs: 0.21-0.35). Changes in BSFS parameters correlated weakly to moderately (rs: 0.23-0.53) with changes in clinical activity, and very weakly to weakly (rs: 0.01-0.35) with changes in CRP and fecal calprotectin. Responsiveness of VAS and BSFS was moderate to high (Guyatt's statistic 0.41-2.17) and highly dependent on the definition of response. CONCLUSIONS: The BSFS and a VAS appear to be responsive with moderate-to-strong construct validity to monitor patients with Crohn's disease.
AB - BACKGROUND: Patient reported outcomes are important in Crohn's disease. In this prospective cohort, we investigated the performance of the Bristol Stool Form Scale (BSFS) and a visual analog scale (VAS) for abdominal pain as outcome measures in Crohn's disease. METHODS: Patients with active Crohn's disease starting glucocorticoids or anti-tumor necrosis factor were included. Before treatment and 10 weeks later we collected: clinical activity [Harvey Bradshaw Index (HBI) and Crohn's-Disease-Activity-Index (CDAI)], serum C-reactive protein (CRP) and fecal calprotectin, and BSFS (1-7) and a 100-mm VAS based on a 7-day diary. Clinical response was defined as a reduction by at least 3 and at least 100 of HBI and CDAI, respectively. Fecal calprotectin-response and CRP-response were defined as reduction of at least 50%. RESULTS: Thirty-eight patients completed follow-up. At baseline, BSFS-parameters correlated more strongly with clinical activity (range: rs: 0.31-0.74) than with CRP (rs: -0.01 to 0.16) and fecal calprotectin (rs: 0.14-0.26). VAS scores correlated very weakly to moderately with clinical activity (rs: 0.18-0.45), and weakly to moderately with CRP (rs: 0.24-0.34) and fecal calprotectin (rs: 0.35-0.43). Changes in VAS scores correlated moderately to strongly (rs: 0.55-0.71) with changes in clinical activity, and weakly with changes in CRP and fecal calprotectin (rs: 0.21-0.35). Changes in BSFS parameters correlated weakly to moderately (rs: 0.23-0.53) with changes in clinical activity, and very weakly to weakly (rs: 0.01-0.35) with changes in CRP and fecal calprotectin. Responsiveness of VAS and BSFS was moderate to high (Guyatt's statistic 0.41-2.17) and highly dependent on the definition of response. CONCLUSIONS: The BSFS and a VAS appear to be responsive with moderate-to-strong construct validity to monitor patients with Crohn's disease.
UR - http://www.scopus.com/inward/record.url?scp=85075962197&partnerID=8YFLogxK
U2 - https://doi.org/10.1097/MEG.0000000000001568
DO - https://doi.org/10.1097/MEG.0000000000001568
M3 - Article
C2 - 31651651
SN - 0954-691X
VL - 32
SP - 38
EP - 44
JO - European Journal of Gastroenterology & Hepatology
JF - European Journal of Gastroenterology & Hepatology
IS - 1
ER -