IBD PLEXUS COHORT PATIENT DATA
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1 IBD PLEXUS COHORT PATIENT DATA
2 Contents 1. Summary Data Collection... 2 EMR Data... 2 Case Report Forms... 3 RISK... 3 SPARC IBD... 4 IBD Qorus... 5 Partners Detailed Case Report Forms... 7 a. RISK... 7 Enrollment Year follow-up b. SPARC IBD ecrf IBD SmartForm c. IBD Qorus d. Partners Baseline and Follow-up Surveys Optional Modules V
3 Content as of Subject to change 1. Summary Data Collection EMR Data V
4 Case Report Forms RISK Field required * Only blood was longitudinally collected V
5 SPARC IBD * Blood biosamples collected 3 months after scope only for patients with a change of treatment 1 IBD Smartform data to be available starting January 2018 Field required Field optional V
6 IBD Qorus Field required Field optional *Fields to be required at time of clinician visit by January 2018 V
7 Partners * Subset of patient responses included within the patient surveys ** Indeterminate colitis V
8 2. Detailed Case Report Forms a. RISK Enrollment V
9 V
10 V
11 V
12 V
13 V
14 V
15 V
16 V
17 V
18 V
19 V
20 V
21 3-Year follow-up V
22 V
23 V
24 V
25 V
26 V
27 V
28 V
29 V
30 V
31 b. SPARC IBD ecrf IBD Symptoms Please answer the following questions based the symptoms you have been experiencing over past 3 to 10 days. DO NOT CONSIDER THE DAY(S) THAT YOU PREPARED FOR YOUR COLONOSCOPY WHEN ANSWERING THESE QUESTIONS. 1. When you are not experiencing symptoms of your inflammatory bowel disease, how many bowel movements do you typically have each day? [Numerical value] 2. What is your average (typical) number of bowel movements during last week? [Numerical value] 3. How would you describe the frequency of you bowel movements on average over the past 7 days? Normal 1-2 stools per day more than normal 3-4 stools per day more than normal 5 or more stools per day more than normal 4. How much bleeding have you experienced with bowel movements on average during last week? None Blood was visible in the stool less than half of the time Blood was visible in the stool at least half or more of the time Passing blood alone 5. How much abdominal pain have you experienced on average during last week? None Mild Moderate Severe V
32 6. How much urgency have you had before bowel movements on average during last week? None. I can wait 15 minutes or longer to have a bowel movement. Mild. I need to get to the bathroom within 5-15 minutes. Moderate. I need to get to the bathroom within 2-5 minutes. Moderately severe. I need to get to the bathroom in less than 2 minutes. Severe. Sometimes I am unable to make it to the bathroom in time. Not applicable, I have an ostomy 7. Which of the following best describes your general well-being on average over the past 7 days? Generally well Slightly under par Poor Very poor Terrible V
33 IBD Medications Site ID: Patient ID: PID- Date: / / MM / DD / YYYY IBD Medication IBD Medication Name: (pick list) Dose: Dosage unit: (pick list) Frequency: Daily PRN every day(s) Every (week(s) x/day Other: Start Date: / / Stop Date: / / estimated estimated Ongoing [Can enter several medications] Antibiotic information Have you taken any antibiotic in the last 3 months for a reason related to your IBD? Yes No (If answer is yes, then Antibiotic medication should be captured) Have you taken antibiotic for a reason other than IBD? Yes No (If answer is yes to the question above but no for the first question, Antibiotic details are not display) Antibiotic name: (pick list) Dose: Dosage unit: (pick list) Route of administration: Drops Intravenous Oral Vaginal self-injection (subcutaneous) Suppository Topical lotion/cream Frequency: Daily PRN every day(s) Every (week(s) x/day Other: V
34 Start Date: / / Stop Date: / / [Can enter several medications] estimated estimated ongoing Probiotics information Have you taken any probiotics in the last 3 months? Yes No IF YES, Probiotic VSL3 Other: Are you still taking this Probiotic? Yes No V
35 Colonoscopy / Sigmoidoscopy Score Modified Mayo Endoscopic Score V
36 Simple Endoscopic Score for Crohn s Disease (SES-CD) V
37 IBD Hospitalization V
38 Diagnosis Crohn s Disease Ulcerative Colitis IBD Unclassified V
39 IBD SmartForm V
40 V
41 V
42 V
43 V
44 V
45 V
46 V
47 V
48 V
49 c. IBD Qorus V
50 V
51 V
52 V
53 V
54 d. Partners Baseline and Follow-up Surveys 1. How old are you? Younger than 18 years old Between 18 and 25 years old Older than 25 years old 2. Has a doctor EVER told you that YOU have Inflammatory Bowel Disease? Yes, Crohn's disease Yes, ulcerative colitis Yes, indeterminate colitis No, I don't have IBD 3. Are you parent of a child (younger than 18 years) with IBD? Yes No Section 1: Demographics 4. How old were you on your last birthday? 5. Are you? Male Female 6. How tall are you? (please choose a unit) Feet/Inches or Meters 7. How much do you weigh? (enter your weight, then choose the appropriate units) Pounds (lbs) or Kilograms (kg) 8. Do you currently live in the United States (or a U.S. territory)? Yes No V
55 If yes, If no, In what country do you live? (Pick list of countries) V
56 9. In what country were you born? (Pick list of countries) 10. How old were you when you moved to the United States (or a U.S. territory)? 11. What is the highest grade of school that you have completed? Less than 12 th grade 12 th grade Some college College Graduate school 12. Do you consider yourself to be of Hispanic or Latino ethnicity? Yes No 13. Which of the following best describes you? White Black/African American Asian 4 Native Hawaiian Other Pacific Islander American Indian or Alaskan Native More than one race Other 14. Do you consider yourself of Jewish ancestry? Yes No Don t know V
57 Family History V
58 Health Care V
59 V
60 IBD Characteristics V
61 V
62 V
63 V
64 V
65 V
66 V
67 V
68 V
69 V
70 V
71 V
72 V
73 V
74 V
75 V
76 V
77 V
78 V
79 V
80 V
81 V
82 V
83 V
84 V
85 V
86 V
87 V
88 V
89 V
90 V
91 V
92 V
93 V
94 V
95 V
96 V
97 V
98 Optional Modules V
99 V
100 V
101 V
102 V
103 V
104 V
105 V
106 V
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