Original article
Alimentary tract
Development and Validation of an Inflammatory Bowel Diseases Monitoring Index for Use With Mobile Health Technologies

https://doi.org/10.1016/j.cgh.2015.10.035Get rights and content

Background & Aims

Mobile health technologies are advancing rapidly as smartphone use increases. Patients with inflammatory bowel disease (IBD) might be managed remotely through smartphone applications, but no tools are yet available. We tested the ability of an IBD monitoring tool, which can be used with mobile technologies, to assess disease activity in patients with Crohn’s disease (CD) or ulcerative colitis (UC).

Methods

We performed a prospective observational study to develop and validate a mobile health index for CD and UC, which monitors IBD disease activity using patient-reported outcomes. We collected data from disease-specific questionnaires completed by 110 patients with CD and 109 with UC who visited the University of California, Los Angeles, Center for IBD from May 2013 through January 2014. Patient-reported outcomes were compared with clinical disease activity index scores to identify factors associated with disease activity. Index scores were validated in 301 patients with CD and 265 with UC who visited 3 tertiary IBD referral centers (in California or Europe) from April 2014 through March 2015.

Results

We assessed activity of CD based on liquid stool frequency, abdominal pain, patient well-being, and patient-assessed disease control, and activity of UC based on stool frequency, abdominal pain, rectal bleeding, and patient-assessed disease control. The indices identified clinical disease activity with area under the receiver operating characteristic curve values of 0.90 in patients with CD and 0.91 in patients with UC. They identified endoscopic activity with area under the receiver operating characteristic values of 0.63 in patients with CD and 0.82 in patients with UC. Both scoring systems responded to changes in disease activity (P < .003). The intraclass correlation coefficient for test-retest reliability was 0.94 for CD and for UC.

Conclusions

We developed and validated a scoring system to monitor disease activity in patients with CD and UC that can be used with mobile technologies. The indices identified clinical disease activity with area under the receiver operating characteristic curve values of 0.9 or higher in patients with CD or UC, and endoscopic activity in patients with UC but not CD.

Section snippets

Design

We performed a prospective, observational study that aimed to develop and validate an mHealth index (mHI) for CD and UC that accurately monitors IBD disease activity using PROs. The study consisted of 2 phases: a development phase and a validation phase. During the development phase the mHIs were developed using collected PROs and clinical disease activity indices. During the validation phase the developed mHIs were validated in an independent cohort.

Development phase

Patients with IBD were identified during

Development Phase

In total, 219 patients (110 CD and 109 UC) were included in the development phase of the study (Figure 1A, Table 2). In 108 out of 110 patients with CD the HBI was calculated, whereas the CDAI could only be calculated in 93 out of 110. The pMayo, SCCAI, and modified Truelove and Witts index were calculated in all patients with UC. Complete laboratory and stool tests were obtained from only 48% of patients. Despite intensive follow-up by a dedicated research nurse (E.K.), 39% of patients did not

Discussion

We developed 2 questionnaires of 4 items consisting solely of PROs for remote monitoring of patients with IBD, which can be used on mobile technology. The questionnaires were validated in a multicenter validation study and showed excellent characteristics to monitor clinical disease activity and symptom changes. As previously shown, UC clinical disease activity highly correlates with endoscopic disease activity, whereas correlation between CD symptoms and endoscopic findings is poor.21

Although

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      Use of this app has been shown to result in improved QOL as well as perceived quality of care in patients with IBD.135 Another example is the UCLA eIBD app, which measures a validated 4-question PRO that correlates with disease activity in IBD.141 One of the key issues with mobile-based applications is that they are only effective if users input data.

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    Conflicts of interest The authors disclose no conflicts.

    Funding This study was partly supported by a grant from Genova Diagnostics. Genova Diagnostics provided stool collection kits and performed fecal calprotectin testing during the study.

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