Dataset Information

Remote Monitoring of Patient-Reported Outcomes in Ulcerative Colitis: A Prospective Real-World Pilot Study.

ABSTRACT:

Introduction

The 6-point version of the Mayo score relies on two patient-reported outcomes (PRO2): stool frequency and rectal bleeding. We assessed the feasibility and acceptability of remote online PRO2 reporting for golimumab-treated ulcerative colitis (UC) patients.

Patients and methods

This was a UK-based, multi-centre, prospective, real-world, non-interventional pilot study. Eligible patients completed PRO2 scores at baseline and every 4 weeks over a period of 6 months. Demographics were collected at baseline and a satisfaction questionnaire was completed at study end. Each patient provided data anonymously via an online platform.

Results

Fifty-two patients enrolled in the study. Mean (SD) patient age was 40.8 (13.6); 52% were male. Patients provided data on a personal computer (44%), mobile phone (38%) or tablet (18%). Forty-seven (90%) patients completed the baseline questionnaire within the accepted time range. Subsequent scores were reported on time by eligible patients with a success rate of 94%, 92%, 90%, 87%, 90% and 81% at end of months 1-6, respectively.

Conclusions

Remote monitoring of PRO2 in UC was feasible amongst the sample tested. Of those initially willing to provide data in this way, attrition was low. Formal roll-out of this system could be used to support a more frequent assessment of UC symptoms without over-burdening the healthcare system.

SUBMITTER: Sebastian S

PROVIDER: S-EPMC6710315 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

Remote Monitoring of Patient-Reported Outcomes in Ulcerative Colitis: A Prospective Real-World Pilot Study.

Sebastian Shaji S Roberts Jenna J Waller John J Judge Davneet D Brown Chloe C Davies Ruth R Kachroo Sumesh S

PharmacoEconomics - open 20190901 3

<h4>Introduction</h4>The 6-point version of the Mayo score relies on two patient-reported outcomes (PRO2): stool frequency and rectal bleeding. We assessed the feasibility and acceptability of remote online PRO2 reporting for golimumab-treated ulcerative colitis (UC) patients.<h4>Patients and methods</h4>This was a UK-based, multi-centre, prospective, real-world, non-interventional pilot study. Eligible patients completed PRO2 scores at baseline and every 4 weeks over a period of 6 months. Demog ...[more]

PMID: 30900117

Similar Datasets

Project description:BackgroundTreatment targets for ulcerative colitis are evolving towards achievement of endoscopic improvement and remission in addition to symptom resolution. It remains to be accurately quantified what proportion of patients with symptom resolution have residual endoscopic activity that might warrant treatment modification.AimTo quantify the prevalence of endoscopic improvement and remission amongst ulcerative colitis patients with various permutations of patient-reported outcomes.MethodsIndividual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab and tofacitinib were pooled to estimate the prevalence of endoscopic improvement (Mayo endoscopic sub-score [MES] 0 or 1) and remission (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6-8 weeks) and maintenance (30-54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring.ResultsData from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of endoscopic improvement and remission was highest among participants with a RBS 0 + SFS 0 post-induction (MES 0/1:81%, [95% CI 78-84]; MES 0:29% [26-33]) and during maintenance (MES 0/1:91% [87-93]; MES 0:57% [52-62]). Prevalence estimates were lower for more recently performed trials (P < .01). In comparison to locally scored endoscopy, when using central endoscopy scoring, the prevalence of endoscopic improvement and remission was lower post-induction (MES 0/1 57% [50-64], P < .001; MES 0 15% [11-21], P = .09) and during maintenance (MES 0/1 74% [67-81], P = .001; MES 0 31% [24-38], P = .001) for participants achieving a RBS 0 + SFS 0.ConclusionsApproximately 8 of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.

Dataset Information

Remote Monitoring of Patient-Reported Outcomes in Ulcerative Colitis: A Prospective Real-World Pilot Study.

Introduction

Patients and methods

Results

Conclusions

Publications

Remote Monitoring of Patient-Reported Outcomes in Ulcerative Colitis: A Prospective Real-World Pilot Study.

Similar Datasets

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