N806 Comparison of patient satisfaction between regular care and clinical trial care for IBD patients treated with biologicals

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Abstract

Background: Patients with Inflammatory Bowel Disease (IBD) can be treated with biologicals in a regular care or clinical trial setting. Nurse specialists play an important role in the regular care of patients receiving biologicals, whereas clinical trial nurses coordinate the care of patients who receive treatment in clinical trials. The aim of our study was to analyze and compare patient satisfaction in these two patient groups.

Methods: We conducted a cross-sectional comparative study in adult IBD patients (Crohn's disease and ulcerative colitis) receiving biological treatment as regular care (infliximab, adalimumab, golimumab, vedolizumab) or in a clinical trial (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, etrolizumab, IL-23 p19 monoclonal antibody, and an antibody against MAdCAM-1) at the Academic Medical Center in Amsterdam. Patients were invited to participate by email. Patient satisfaction and experience was registered using a validated online questionnaire focusing on outpatient care that consisted of 55 multiple choice questions and two open questions.

Results: In total 79 patients responded to the invitation (33 regular care patients and 46 trial patients). Response rate was 50%. Between the two groups no significant differences were found with regard to patients characteristics (proportion CD/UC, age, sex, co-morbidity, perceived state of health, ethnic background, etc.). Patient satisfaction about treatment, communication and how information was provided by health care providers was high:. Regular care and clinical trial patients appreciated the care on average with an 8.0 and 8.17 (on a scale from 0–10), resp. (p=0.34). Highly educated patients scored on average significantly lower on patient satisfaction compared to low to average educated participants (mean patient satisfaction 3.5 (min 1.3 – max 4; N=24) vs. 3.8 (min 2.9 – max 4; N=42), resp. (p=0.02). Clinical trial patients experienced significantly more autonomy compared to regular care patients: 3.20 vs. 2.75, resp. (p=0.03).

Twenty-nine patients did not have suggestions how to improve their care, 29 patients gave suggestions how to improve the care they received, and 12 patients did not have an opinion.

Conclusions: IBD out-patients who receive treatment with biologicals as regular care are equally satisfied as compared to patients that receive biologicals in a clinical trial. Patients who participated in a clinical trial experienced significantly more autonomy. Patients in both groups wanted more personal advice on lifestyle and how to cope with IBD.

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