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P261 Diagnostic performance of the Simple Clinical Colitis Activity Index (SCCAI) in Ulcerative Colitis (UC) self-administered by the patient at home through an on-line platform compared with the onsite evaluation by a gastroenterologist. CRONICA-UC study

I. Marín-Jiménez*1, X. Cortés2, P. Nos3, E. Domènech4, S. Riestra5, E. Iglesias6, J.M. Huguet7, C. Taxonera8, J.P. Gisbert9, R. Fernández10, X. Calvet11, D. Carpio12, A. Gutiérrez13, J. Guardiola14, L. Castro15, B. Sicilia16, L. Bujanda17, L. Cea-Calvo18, O. Rincón18, C. Romero18, B. Juliá18, J. Panés19

1Hospital General Universitario Gregorio Marañón, Gastroenterology Unit, Madrid, Spain, 2Hospital de Sagunto, Gastroenterology Unit, Sagunto, Spain, 3Hospital Universitari I Politècnic La Fe, Gastroenterology Unit, Valencia, Spain, 4Hospital Universitari Germans Trias i Pujol and CIBERehd, Gastroenterology Unit, Badalona, Spain, 5Hospital Central de Asturias, Gastroenterology unit, Oviedo, Spain, 6Hospital Universitario Reina Sofia, Unidad Clinica de Aparato Digestivo, Cordoba, Spain, 7Hospital General Universitario de Valencia, Gastroenterology Unit, Valencia, Spain, 8Hospital Clinico San Carlos, Gastroenterology Unit, Madrid, Spain, 9Hospital La Princesa , IP and CIBERehd, Gastroenterology Unit, Madrid, Spain, 10Hospital General de Jaen, Gastroenterology Unit, Jaen, Spain, 11Hospital De Sabadell, Institut Universitari Parc Taulí, Digestive, Sabadell, Spain, 12Complejo Hospitalario de Pontevedra, Gastroenterology Unit, Pontevedra, Spain, 13Hospital General Universitario Alicante, Gastroenterology unit, Alicante, Spain, 14Hospital de Bellvitge. Idibell, Gastroenterology unit, Barcelona, Spain, 15Hospital Universitario Virgen Macarena, Gastroenterology Unit, Sevilla, Spain, 16Hospital General de Burgos, Gastroenterology unit, Burgos, Spain, 17Hospital de Cruces, Gastroenterologu Unit, Bilbao, Spain, 18MSD Spain, Medical Department, Madrid, Spain, 19Hospital Clinic Universitario de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain

Background

New e-health technologies can improve patient-physician communication and contribute to patient's optimal care. In patients with UC and at least one flare within the previous year, we aim to assess the diagnostic performance of the SCCAI self-administered by patients at home (through a website) compared with the SCCAI assessed by gastroenterologists at the clinic (considered as reference).

Change from V1 to V2

Patient SCCAI
ImprovementStabilityRelapseTotal
Improvement8 (5.0%)3 (1.9%)0 (0%)11 (6.8%)
Gastroenterologist SCCAIStability8 (5.0%)113 (70.2%)14 (8.7%)135 (83.9%)
Relapse0 (0%)3 (1.9%)12 (7.5%)15 (9.3%)
Total16 (9.9%)119 (73.9%)26 (16.1%)161 (100.0%)

Patient self-administered SCCAI versus onsite evaluation by gastroenterologist.

Patient SCCAI
Remission (SCCAI ≤2)Activity (SCCAI >2)Total
Gastroenterologist SCCAIRemission (SCCAI ≤2)206 (60.6%)39 (11.5%)245 (72.1%)
Activity (SCCAI >2)12 (3.5%)83 (24.4%)95 (27.9%)
Total218 (64.1%)122 (35.9%)340 (100%)

Methods

Patients were followed-up for 6 months. In 2 consecutive visits, at months 3 (V1) and 6 (V2), they completed the SCCAI at home through a website, and thereafter (< 48 hours later) it was completed onsite by gastroenterologists, who were blinded to patient's score. SCCAI scores were dichotomized to remission ( ≤ 2 points) or activity ( >2), and changes in SCCAI from V1 to V2 as: exacerbation (increase >2 points), stability (variation ≤ 2 points) or improvement (decrease >2 points).

Results

199 patients (mean age: 39 years [SD 11]; min: 18.5; max:67.4, 55.8% women), contributed with 340 pairs of questionnaires. Correlation of SCCAI scores by physicians and patients was good (Spearman's Rho: 0.79). For the status of remission or activity, the agreement was 85.0% (95% CI: 80.8-88.4, kappa: 0.657, table 1). The negative predictive value (NPV) for activity was 94.5% (91.4-96.6) and the positive predictive value (PPV) 68.0% (58.8-69.2). Results were similar irrespective of gender or age. The agreement between patients and physicians scores of SCCAI was higher in the 168 V2 pairs of questionnaires (89.3% [83.6-93.1] vs 80.8% [74.2-86.0], p= 0.027) The percentage of agreement in the change from V1 to V2 was 82.6% (95% CI: 75.9-88.1, kappa: 0.51, Spearman's: 0.60), with PPV for relapse: 91.9% (85.9-95.9) and NPV: 88.3% (81.9-93.0). (table 2).

Conclusion

In patients with UC, self-administration of the SCCAI through an on-line tool resulted in high percentage of agreement with the onsite evaluation by gastroenterologists, with high NPV for disease activity. Remote monitoring of UC patients, especially of those with stable disease, is possible and might avoid unnecessary visits to the hospital.

Funded by Merck Sharp & Dohme, Spain [1] [2]

References:

[1] R S Walmsley,R C S Ayres, R E Pounder, R N Allan, (1998), A simple clinical colitis activity index, gut, 43:29-32

[2] Bennebroek et al, (2013), The Patient Simple Clinical Colitis Activity Index (P-SCCAI) can detect ulcerative colitis (UC) disease activity in remission: A comparison of the P-SCCAI with clinician-based SCCAI and biological markers, Journal of Crohn's and Colitis , 7: 890-900