Inflammatory Bowel Disease (IBD) Patient Reported Outcome (PRO): One week recall is as good as daily assessment in patients reported outcome

Healint's mission is improving the lives of patients by developing intelligent, evidence-based technologies to enable individuals to better manage their health and wellness, improve patient care, and create better outcomes for all. Our main focus is chronic diseases related to the immune system or the central nervous system.

Crohn’s disease and Ulcerative Colitis (grouped under the term IBD) are auto-immune diseases that have a heavy burden on the daily life of patients. The main objective of this study was to assess the difference in results between asking daily assessments to subjects for seven days and one weekly assessment. 

Study Objective

When designing a research study, it is important to take into consideration the impact of the study assessments on the subjects. It can impact their willingness to answer or the quality of responses. The hypothesis was that the quality of information gathered on the basis of a weekly assessment is close enough to gathering information on a daily basis. 

Methodology

The study had 2 arms: participants with Crohn’s disease or with Ulcerative Colitis. We focused on the patient-reported-outcome part of the scales respectively used for both diseases: CDAI (Crohn’s Disease Activity Index) and Mayo Score for Ulcerative colitis.

The study was divided in 3 steps: i) Day 1: screening and baseline. Questions covered demographic parameters, and questions about the past 7 days: number of soft/liquid stools, average daily abdominal pain, rectal bleeding, and general well being  ii) Daily questionnaire for 7 days with the same questions about the last 24 hours iii) Day 8: Final questionnaire with the same questions, about the last 7 days. The objective was to compare the values given at Day 8 vs the values given daily. 

Results

The completion rate of the screening was 81%. 61% of respondents had actually IBS and not IBD, and were consequently excluded from the study. 

A correlation was found between the number of soft/liquid stools and general well-being: respondents with an average of soft/liquid stools above 15 are more likely to have a poor or very poor well-being. 

In the Ulcerative Colitis group, most respondents reported Normal or 1–2 stools/day more than normal. For 70.2% of respondents there was no blood in their stool and 81% reported feeling Generally well or Slightly under par. 

In the Crohn’s disease group, there seems to be a link between general feeling and abdominal pain as well, with 33% of respondents having a poor or very poor or terrible well-being, all of them having either mild or moderate abdominal pain.

Day 8 questionnaire answers were 93% similar to the values entered in the daily questionnaire. 

Discussion

The fact that 61% of respondents didn’t suffer from IBD but from IBS is an important learning in terms of awareness about the disease: even though the study was clearly about IBD, many people with IBS thought they could participate in the study.

IBD (Inflammatory Bowel Disease) is a group of diseases (Crohn’s disease and Ulcerative Colitis) that cause chronic inflammation in the digestive tract, while IBS (Irritable Bowel Syndrome) is a functional disorder characterized by abdominal pain and altered bowel habits. IBD often involves ulcers, bleeding and other structural changes to the digestive tract, while IBS does not. IBD is an autoimmune disorder, meaning the immune system is attacking healthy parts of the body, while IBS does not have an autoimmune component. IBD is usually treated with medications and lifestyle changes, while IBS is typically managed through diet and lifestyle modifications. The prevalence of IBD is estimated to be about 0.4-1.4% worldwide. The prevalence of IBS is estimated to be about 10-15% worldwide.

The similarity between the answers given at Day 8 vs the daily input means that asking questions weekly was sufficient to obtain qualitative data. Asking questions weekly rather than daily to the patients led to the same result, but be less burdensome for the participant. The benefit of asking a daily questionnaire may be to reduce the dropout rate as each touch point is an opportunity for the study to stay in the mind of the participant. This hypothesis would need to be confirmed in a study with 2 groups: one with a daily assessment + weekly and one with the weekly only.