Inflammatory bowel disease in South-Eastern Norway III (IBSEN III): a new population-based inception cohort study from South-Eastern Norway

Figures & data

Figure 1. The geographical areas of inclusion of patients to the population-based inception cohort studies (a) IBSEN, recruited from the counties of Oslo, Østfold, Telemark and Aust-Agder during 1990–1994, and (b) IBSEN III, recruited from the counties of Agder (previously Aust-Agder and Vest-Agder), Innlandet (previously Oppland and Hedmark), Oslo, Vestfold and Telemark, and Viken (previously Buskerud, Akershus and Østfold), corresponding to the South-Eastern Health Region of Norway, during 2017–2019.

Table 1. Overview of data and biologic material collected in the IBSEN III study.

	Inclusion	Follow-up
	Baseline	3 months	6 months	1 year	3 years	5 years
Clinical interview	x			x		x
Clinical examination	X^a			x^a		x^a
Endoscopy including biopsies	x^b			x^b,c,d		x^b,c,d
Blood samples	x			x		x
Fecal samples^e	x	x	x	x	x	x
MRI small bowel (CD)	x			x^c		x^c
Module 2 extensive biobanking
Blood	x			x		x
Intestinal biopsies	x			x		x
Urine	x			x		x
Oropharyngeal swabs	x			x
PROM
Adult patients
SF-36	x	x	x	x	x	x
IBDQ	x	x	x	x	x	x
EQ 5D 5L	x	x	x	x	x	x
FQ	x			x	x	x
MARS			x	x	x	x
GSE	x			x	x	x
HADS	x	x	x	x	x	x
FSS	x	x	x	x	x	x
BPI				x	x	x
PSQI				x	x	x
Rome IV	x			x	x	x
FFQ	x			x	x	x
Pediatric patients
KIDSCREEN^f	x	x	x	x	x	x
GSE^g	x			x	x	x
FSS^g	x	x	x	x	x	x
HADS^g					x	x
BPI^g	x	x	x	x	x	x
Module 2 PROM
Adult patients
BPI	x	x	x	x	x	x
PSQI	x	x	x	x	x	x
MSAS	x	x	x	x

^a Clinical examination for assessment of disease activity with validated activity indices (Harvey Bradshaw Index and Simple Clinical Colitis Activity Index), complications, extra intestinal manifestations, comorbidity and treatment. Clinical phenotype according to Montreal classification.

^b Video recordings of endoscopies at module 2 centers.

^c If clinical indication.

^d ±3 months.

^e Fecal samples (tube without preservatives and PSP® Spin Stool DNA sampling tube) for biobanking and analysis of f-calprotectin.

^f From 8 years.

^g From 12 years.

BPI: Brief Pain Inventory; CD: Crohn’s disease; EQ 5D: 5 L,5-level version of the EQ 5 D; FQ: Fatigue Questionnaire; FSS: Fatigue Severity Scale; FFQ: Food Frequency Questionnaire; GSE: General Self-Efficacy Scale; HADS: Hospital Anxiety and Depression Scale; IBDQ: Inflammatory Bowel Disease Questionnaire; MARS: Medication Adherence Rating Scale; MSAS: Memorial Symptom Assessment Scale; PROM: patient reported outcome measures; PSQI: Pittsburgh Sleep Quality Index; SF-36: Short Form 36.

Table 2. Overview of National registries and databases to be linked with the IBSEN III study.

National registry	Data for linkage with participants in the IBSEN III study	Planned analyses
The Norwegian Patient Registry	Diagnostic and therapeutic activities in the specialist health care services	Epidemiological verification of the completeness of the cohort Evaluation of health care use by IBD patients compared to the general population
The Norwegian Prescription Database	Prescribed IBD-related medications including medication suspected to influence risk of IBD or gut microbiota	Verify completeness of data in electronic CRF and avoid recollection bias
The Norwegian Cause of Death Registry	Date and cause of death	Evaluation of mortality and causes of death compared to the general population
Norwegian Cancer Registry	Date and diagnoses of cancer	Evaluation of cancer-specific morbidity compared to the general population
Registry for social security benefits	Social security benefits including sick leave and work disability	Evaluation of direct and indirect costs of IBD
Database for refunds pursuant to the National Insurance Act	Refunds for treatment in primary and specialist health care services	Evaluation of direct and indirect costs of IBD
Registry for nursing and cares services	Registered received nursing and care services	Evaluation of direct and indirect costs of IBD
Norwegian Mother, Father and Child Cohort Study	Data regarding diet in childhood	Investigations of environmental risk factors

Figure 2. Flow chart of patients included in the study. Diagnosis of inflammatory bowel disease was set based on Lennard-Jones criteria for adults [14] and Porto criteria for children [15].

Figure 3. Number of included patients during the study period, from each center and total inclusion rate.

Table 3. Baseline characteristics of patients included in the IBSEN III cohort study.

	CD	UC	IBD-U	Susp. small bowel IBD	Susp. colonic IBD	Non-IBD controls	Other causes
N	626	1082	71	76	48	265	86
Age—median years (range)	31.5 (3–81)	34.0 (3–84)	30.0 (4–65)	34.5 (2–81)	31.0 (5–73)	27.0 (1–74)	27.5 (3–68)
Female gender. % of n	52.1	45.8	49.3	59.2	45.8	50.6	50
Current smoking yes. % of n^a	11.9	5.6	9.8	12.8	7.4	19.6	14.7
Level of education. % of n^b
≤9 years	9.8	10.1	2.4	17.4	11.1	8.6	11.8
10–12 years	45.5	41.2	48.8	39.1	48.1	41.7	35.3
>12 years	44.7	48.7	48.8	43.5	40.7	49.7	52.9
Time with symptoms. median months (range)	8.5 (0–576)	4.0 (0–240)	5.0 (0–132)	9.0 (0–396)	6.0 (0–600)	12.0 (0–240)	6.0 (0–132)
Age groups. % of n
Pediatric IBD <18 years	18.8	7.2	28.2	17.1	16.7	17	43
Adult IBD 18–65 years	75.9	87.2	71.8	72.4	77	81.5	55.8
Geriatric IBD >65 years	5.3	6.6	0	10.5	6.3	1.5	1.2

CD: Crohn’s disease; IBD-U: inflammatory bowel disease unclassified; susp: suspicion of; IBD: inflammatory bowel disease; UC: ulcerative colitis.

^aSmoking: patients >18 years (n = 1935), missing = 466.

^bLevel of education: patients >18 (n = 1935), missing = 467.

Table 4. Overview of collected biobank material at baseline.

	IBD	Suspected IBD	Symptomatic non-IBD control
Blood (serum, plasma, whole blood, Paxgene)	623	59	252
Intestinal biopsies	403	51	236
Urine	512	51	220
Fecal samples (all centers)	1218	85	183

Lennard-Jones JE. Classification of inflammatory bowel disease. Scand J Gastroenterol Suppl. 1989; 170:2–6.

 PubMedGoogle Scholar

Levine A, Koletzko S, Turner D, et al. ESPGHAN revised porto criteria for the diagnosis of inflammatory bowel disease in children and adolescents. J Pediatr Gastroenterol Nutr. 2014;58(6):795–806.

 PubMed Web of Science ®Google Scholar

Data availability statement

The data underlying this article cannot be shared publicly due to the privacy of individuals that participated in the study. The data will be shared on reasonable request to the corresponding author.