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P377 Clinical strategies based on patient-reported outcomes and physicians’ preferences to monitor biological therapy in inflammatory bowel disease

K. Risager Christensen*1, C. Steenholdt1, S. Buhl Næss-Schmidt1, J. Brynskov1, M. A. Ainsworth1,2

1Herlev and Gentofte Hospital, Gastroentrology, Copenhagen, Denmark, 2Odense University Hospital, Gastroentrology, Odense, Denmark

Background

There is a growing interest in clinical strategies to monitor and optimise biological treatment in patients with inflammatory bowel diseases (IBD), as this may lead to improved clinical outcomes. Such strategies rely on systematic recording of relevant symptoms, that is, patient-reported outcomes (PROs), combined with objective evaluation using, for example, biomarkers and endoscopy. However, the optimal combination of PROs and objective monitoring tools which is relevant for both patients and physicians is not well defined. The aim of the study was (1) to determine which PROs and examinations were rated most important and acceptable by patients, (2) to investigate which tools physicians consider ‘gold standard’ to monitor treatment with biologicals, and (3) to which extent healthcare professionals’ adhere to a clinical monitoring strategy with scheduled evaluations of patients with IBD on biologicals.

Methods

The study consisted of two parts: (1) questionnaire survey of (a) patients with IBD receiving biologicals and (b) Danish gastroenterologists routinely treating IBD patients with biologicals and (2) a retrospective study of adherence to the systematized clinical strategy.

Results

Part 1 comprised 164 patients. Patients rated fatigue (57%) and stool frequency (46%) as most important PROs. On a scale from 0 to 100 patients found blood samples, faecal calprotectin (FC), endoscopies, magnetic resonance enterography (MRE), and ultrasound examination (US) to be relevant monitoring tools (median (IQR): 97 (80–100), 92 (74–100), 97 (83–100), 86 (71–99), and 83 (53–99)). FC and endoscopies were reported to be highly stressful (median (IQR): 50 (11–77), 83 (61–98)), unlike blood samples, MRE, and US (median (IQR): 13 (12–2), 27 (5–51) and 11 (0–45)). Physicians (n = 87) considered blood samples (99%) and FC (82%) at both fixed time points and in case of flares as gold standard; endoscopy (74%) and MRE (70%) only in case of flares. Therapeutic drug monitoring and US were not considered as gold standard (20% and 23%). Part 2 comprised 139 patients included in the clinical strategy. Blood samples and FC were performed in 93% and 38% of the scheduled cases. Endoscopies scheduled for once a year, were only performed in 32% of cases. Clinical actions were taken in 44%, 55%, and 82% of cases of abnormal blood samples, FC and endoscopies, respectively.

Conclusion

This study shows that patients consider fatigue to be the most important PRO. Physicians and patients found standard monitoring tools relevant indicating that a systematized clinical strategy is feasible in everyday clinical work. The high rate of stress may explain low adherence to scheduled FC and endoscopies even though these examinations more often led to clinically relevant actions.