VR Therapies for IBD

Generalized Anxiety Disorder-7 (GAD-7)

The GAD-7 is a 7-item scale for screening and assessing the severity of generalized anxiety disorder. It has a 2-week recall period and is scored on a 0-21 scale-0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21 severe. It has high reliability and criterion validity across many clinical contexts. The minimal clinically important difference (MCID) is 4 points.

System Usability Scale (SUS)

The SUS is a validated, widely-used ten-item Likert scale giving a global view of assessments of usability, with each item rated on a scale of 0 to 5. Higher scores indicate greater usability.

Short Inflammatory Bowel Disease Questionnaire (SIBD-Q)

The SIBDQ is a 10-item, disease-targeted Health-Related Quality of Life (HRQoL) measure that evaluates 4 domains: bowel symptoms, systemic symptoms, emotional function, and social function. Each item is rated on a 7-point Likert scale, with total scores ranging from 10 to 70, higher scores indicate a better HRQoL and fewer IBD symptoms. The SIBDQ has been validated to detect meaningful changes in HRQoL in an outpatient setting. The full version IBDQ, has been validated for its excellent internal consistency, test-retest reliability, and construct validity, distinguishing between active disease and remission, as well as convergent and divergent validity. The IBDQ is widely validated in clinical trials and real-world settings, making it a robust tool for assessing changes in HRQoL.

Patient Reported Outcome 2 (PRO2 for Ulcerative Colitis)

The PRO-2 is a simplified PRO measure used to assess Ulcerative Colitis (UC) activity. The PRO-2 focuses on rectal bleeding (ranging from 0-3; higher score indicates worse severity of bleeding) and average daily stool frequency. This tool provides a quick and reliable assessment of patient-reported disease activity. The PRO-2 has been validated against clinical markers of disease activity, such as endoscopic findings and biomarkers, and is sensitive to detecting changes in UC symptoms.Total PRO-2 scores range from 0 to 6, with higher scores indicating worse ulcerative colitis symptom severity.

Patient Reported Outcome 3 (PRO3 for Crohn's Disease)

The PRO-3 is a simplified PRO measures used to assess Crohn's Disease activity. The PRO-3 evaluates: abdominal pain (ranging from 0-3 with higher scores indicating worse abdominal pain), stool frequency (number of liquid or soft stools per day), and general well-being (5-point scale ranging from 0-4, higher score indicates worse general well-being). The PRO-3 has been validated against clinical markers of disease activity, such as endoscopic findings and biomarkers, and is sensitive to detecting changes in Crohn's Disease symptoms. Higher overall PRO-3 scores indicate worse Crohn's disease symptom severity.

29-item Patient Reported Outcomes Measurement System v2.1(PROMIS-29)

The PROMIS-29 is a validated 29-item questionnaire to assess general Health-Related Quality of Life (HRQoL) and treatment response in individuals with IBD. The assessment includes questions in each of the following domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. 28 of the items use a 5-point Likert response scale that is T-scored, 1-5 with higher T-scores representing more of the domain measured (higher physical function/ability to participate in social roles and activities= better; higher anxiety/depression/fatigue/sleep disturbance/ pain interference=worse). Pain intensity uses a numeric rating scale, 0 to 10 with higher scores indicating greater pain intensity.

Serum C-Reactive Protein (CRP)

A blood test that measures for systemic inflammation. CRP is a protein made by the liver, and increases when there is inflammation in the body. This biomarker is routinely used in clinical settings to monitor IBD activity and predict relapses.

Fecal Calprotectin (fCal)

A stool sample that measures for gastrointestinal inflammation. fCal is released by neutrophils in the intestine during inflammation. This biomarker is routinely used in clinical settings to monitor IBD activity and predict relapses.